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MEFLOQUINE LARIAM

MEFLOQUINE LARIAM

Page 1: MEFLOQUINE LARIAM

Category:General

Number of Pages:1753

Date Created:April 9, 2012

Date Uploaded to the Library:February 20, 2014

Tags:outcome, lariam, DaCompany, Female, DURATION, Expedited, Roche, Disorder, Manufacturer, Route, Product, GENDER, number, GSA, ACLU, EPA, IRS, ICE, CIA


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Freedom Information (FOI) Report 
Date:11/04/97ISR Number: 100000135Report Type:Expedited (15-DaCompany Report #88781  
Outcome Report Source Product Role Manufacturer 
Other Serious 	Vaginal Haemorrhage Foreign Lariam Tablets Complication Pregnancy Health (MefloquinePremature Baby Professional Hydrochloride) Cervical IncompetenceUterine Haemorrhage 
Date:11/04/97ISR Number: 100000137Report Type:Expedited (15-DaCompany Report #88780       
Outcome Report Source Product Role Manufacturer 
Other Serious	 Vaginal Haematoma Foreign Lariam Cervical Incompetence Health Haematoma Professional Antepartum HaemorrhagePremature Baby 
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #80275  
Outcome Report Source Product Role Manufacturer 
Other Serious 	Drug Hypersensitivity Foreign Lariam Angioedema Health Tongue Oedema Professional Skin Test Positive  Premarin Toxicity VariousAgents 
Date:11/04/97ISR Number: 100000155Report Type:Expedited (15-DaCompany Report #85380                              
Outcome Report Source Product Role Manufacturer Other Serious Deafness Neurosensory  Foreign Lariam 
Tinnitus 	Health Professional Other Augmentin 
Date:11/06/97ISR Number: 3005648-7Report Type:Direct  Company Report 
Outcome Life-Threatening  Thinking AbnormalDisability  CryingOther Serious Decreased Appetite 
Age:29 Route  
ORAL Age:29 
Route ORAL 
Age:57 
Route ORAL 
Age:23 
Route ORAL 
Age:42 
Gender:Female I/FU:I 
Dose Duration 
250.000MG 1.0 PER WEEK
 ORAL
 
Gender:Female I/FU:I 
Dose Duration
 250 1.0
 PER WEEK
 
Gender:Female I/FU:F 
Dose Duration 250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Male I/FU:F 
Dose Duration 250.0000 1.0X PER WEEK ORAL 
Gender:Female I/FU:I 
RequiredIntervention  Panic Disorder Insomnia Related  
Prevent Permanent  Another Mental Condition  
Impairment/Damage  AnxietyPersonality ChangeFear  
Insomnia  
Paraesthesia  
03-Apr-2012   09:37  Page:  

DysarthriaConfusional State Suicidal Ideation Asthenia DepressionChills Abnormal Dreams  Report Source  Product Lariam  Role  Manufacturer Roche  Route ORAL  Dose TABS; 250 TAB ONCE WEEKLY;(PT D'CD DRUG)  Duration  
Date:11/10/97ISR Number: 3000073-7Report Type:Expedited (15-DaCompany Report #86849  Outcome Report Source Product Hospitalization Cough Foreign Lariam Initial Prolonged Dyspnoea Other Asthenia Bronchitis DptDizziness Yellow Fever Vaccine Red Blood Cell Havrix Sedimentation Rate TyphimIncreased Mercalm Vomiting Genhevac Nausea Pyrexia  Role  Manufacturer  Age:53 Route  ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:11/10/97ISR Number: 3005888-7Report Type:Direct  Outcome Disability Restlessness DepressionConfusional State Emotional Disorder Memory ImpairmentVisual ImpairmentAnxiety  Company Report Report Source Product  Lariam Mefloquine  Role  Manufacturer  Age:28 Route  Gender:Female Dose  I/FU:I Duration  
Date:11/12/97ISR Number: 3000157-3Report Type:Expedited (15-DaCompany Report #89097  Outcome Report Source Product Hospitalization -Dyspnoea Health Lariam Tablets Initial Prolonged Lung Infiltration Professional (MefloquineHydrochloride)  Role  Manufacturer   Age:39 Route ORAL  Gender:Female Dose  I/FU:I Duration  
Date:11/12/97ISR Number: 3000321-3Report Type:Expedited (15-DaCompany Report #89246  Outcome Report Source Product Required Uterine Contractions Foreign Lariam Tablets  Role  Manufacturer  Age:37 Route  Gender:Female Dose  I/FU:I Duration  

Intervention Abnormal Health (MefloquinePrevent Permanent Professional Hydrochloride) ORAL 250MG PER Impairment/Damage Other WEEK ORAL 
03-Apr-2012  09:37 Page: 
Date:11/12/97ISR Number: 3000325-0Report Type:Expedited (15-DaCompany Report #89247   Age:25  Gender:Female  I/FU:I  
Outcome Hospitalization Initial Prolonged Blood Amylase IncreasedPancreatitis Lipase Increased  Report SourceForeignHealth Professional Other   Product Lariam Tablets (MefloquineHydrochloride) Imodium (LoperamideHydrochloride)Flagyl(Metronidazole)  Role  Manufacturer  Route ORAL  Dose Duration 250MG PER WEEK, ORAL  
Date:11/12/97ISR Number: 3000331-6Report Type:Expedited (15-DaCompany Report #82871   Age:34  Gender:Female  I/FU:I  
Outcome Other Serious TachycardiaHyperventilationAlkalosis Hypokalaemic  Paraesthesia  Report SourceForeignHealth Professional Other  Product Lariam Tablets (MefloquiineHydrochloride) Cyclo-Menorette(Estradiol Valerate/Estradiol Succinate/Levonorgestrel)  Role  Manufacturer  Route ORAL  Dose Duration 250MG PER WEEK ORAL  
Date:11/12/97ISR Number: 3000529-7Report Type:Expedited (15-DaCompany Report #80739                Age:40  Gender:Female  I/FU:F  
Outcome Hospitalization Initial Prolonged AstrocytomaConvulsion Complex Partial SeizuresGrand Mal Convulsion Paresis Hallucination HemiplegiaAphasiaSpeech DisorderBlood Glucose Decreased Blood Lactic Acid Decreased Brain NeoplasmGlioma Simple Partial SeizuresParalysisBlood Albumin Abnormal Hemiparesis  Report SourceForeignHealth Professional  Product Lariam Phenhydan  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:11/17/97ISR Number: 3000972-6Report Type:Expedited (15-DaCompany Report #85820   Age:26  Gender:Male  I/FU:I  

Outcome  
Hospitalization Initial Prolonged  MigraineHeadache Gastroenteritis Bacterial  
Trance  
Illusion  
Paraesthesia  
03-Apr-2012   09:37  Page:  

Diarrhoea Disturbance Attention Restlessness Psychotic Disorder  Report SourceForeignHealth Professional  Product Lariam Ciprobay  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:11/17/97ISR Number: 3006058-9Report Type:Direct  Outcome Disability Amnesia FatigueDepressionImmune System DisorderWeight DecreasedDecreased Appetite  Company Report Report Source Product Mefloquine Prozac  Role  Manufacturer  Age:30  Route ORAL  Gender:Female Dose TABLET PER WEEK  I/FU:I Duration  
Date:11/17/97ISR Number: 3006086-3Report Type:Direct  Outcome Other Serious AnxietyGastrooesophageal RefluxDisease  Company Report Report Source Product Mefloquine  Role  Manufacturer  Age:27 Route ORAL  Gender:Female Dose WEEK  I/FU:I Duration  
Date:11/19/97ISR Number: 3001851-0Report Type:Expedited (15-DaCompany Report #85820  Outcome Report Source  Product Hospitalization Restlessness Foreign Lariam Initial Prolonged Sleep Disorder Health Trance Professional Headache CiprobayPsychotic DisorderParaesthesia MigraineIllusion Gastroenteritis Bacterial Suicidal Ideation Disturbance Attention Diarrhoea  Role  Manufacturer  Age:26 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:11/21/97ISR Number: 3002261-2Report Type:Expedited (15-DaCompany Report #88615  Outcome Report Source Product Other Serious Dyspnoea Foreign Lariam  Role  Manufacturer  Age:28 Route ORAL  Gender:Male Dose 250.0000  I/FU:I Duration  

Tachycardia Health  1.0 PER Arrhythmia Professional WEEK ORAL Anxiety 
03-Apr-2012  09:37 Page: 
Date:11/26/97ISR Number: 3002889-XReport Type:Expedited (15-DaCompany Report #89882                Outcome Report Source Product Hospitalization Paralysis Foreign Lariam Initial Prolonged Sensory Disturbance Health Gait Disturbance Professional Hypoaesthesia Insuline Coordination Abnormal Feeling DrunkSciatica  Role  Manufacturer  Age:82 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:11/26/97ISR Number: 3002892-XReport Type:Expedited (15-DaCompany Report #89097                          Outcome Report Source Product Hospitalization -Dyspnoea Health Lariam Initial Prolonged Lung Infiltration Professional  Role  Manufacturer  Age:39 Route ORAL  Gender:Female I/FU:F Dose Duration 10.0000 MG/KGDAILY ORAL  
Date:12/01/97ISR Number: 3003013-XReport Type:Expedited (15-DaCompany Report #86213  Outcome Report Source  Product Disability Muscle Spasms Health Lariam Medication Error Professional Pain Other Nausea Tetanus Vaccine Tremor Hepatitis VaccineDizziness Birth Control Pills AgitationConfusional State AnxietyCondition Aggravated  Role  Manufacturer  Age:36 Route ORAL  Gender:Female Dose 1.2500 GRAM 1.0 PER ODOS ORAL  I/FU:I Duration  
Date:12/01/97ISR Number: 3003015-3Report Type:Expedited (15-DaCompany Report #90214  Outcome Report Source Product Other Serious Bradycardia Foreign Lariam Abdominal Pain  Other SyncopeDizziness  Role  Manufacturer  Age:27 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/01/97ISR Number: 3003374-1Report Type:Expedited (15-DaCompany Report #90289  Outcome Report Source Product Other Serious Skin Infection Foreign Lariam Urticaria Consumer Erysipeloid  Role  Manufacturer  Age:64 Route ORAL  Gender:Male Dose  I/FU:I Duration  

Date:12/01/97ISR Number: 3003432-1Report Type:Expedited (15-DaCompany Report #92090   Age:72  Gender:Female   I/FU:I  
Outcome Other Serious Skin Infection Urticaria  
03-Apr-2012   09:37  Page:  

FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  
Erysipeloid  Report SourceForeign  Health Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose  Duration  
Date:12/01/97ISR Number: 3003541-7Report Type:Expedited (15-DaCompany Report #89097  Outcome Report Source Product Hospitalization -Dyspnoea Health Lariam Initial Prolonged Lung Infiltration Professional  Role  Manufacturer  Age:39 Route ORAL  Gender:Female I/FU:F Dose Duration 10.0000 MG/KG DAILY ORAL  
Date:12/01/97ISR Number: 3082443-4Report Type:Expedited (15-DaCompany Report #90612  Outcome Report Source Product Other Serious Parkinsonism Health Lariam Extrapyramidal Disorder Professional  Role  Manufacturer  Age: Route ORAL  Gender: Dose ORAL  I/FU:I Duration  
Date:12/02/97ISR Number: 3003685-XReport Type:Expedited (15-DaCompany Report #87481  Outcome Report Source Product Disability Dizziness Health  Lariam Other Serious Hypertension Professional Medication Error VomitingFatigueOedema Visual ImpairmentHypoaesthesiaParaesthesia Nausea Dysgeusia  Role  Manufacturer  Age:53  Route ORAL  Gender:Male I/FU:F Dose Duration 250.0000 1.0 PER DAY ORAL  
Date:12/02/97ISR Number: 3003799-4Report Type:Expedited (15-DaCompany Report #90767  Outcome Report Source Product Hospitalization Toxic Skin Eruption Foreign Lariam Initial Prolonged Other  Role  Manufacturer  Age:46 Route ORAL  Gender:Female I/FU:I Dose Duration 250.0000MG 1.0 PER WEEK ORAL  
Date:12/02/97ISR Number: 3003874-4Report Type:Expedited (15-DaCompany Report #90601   Age:36  Gender:Male  I/FU:I  

Outcome Other Serious Depressed MoodMood SwingsEar Infection Depression SuicidalPanic Attack  Report SourceForeignOther  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose  250.000 1.0 PER  Duration  
Suicidal Ideation  WEEK ORAL  
Yellow Fever Vaccine  
03-Apr-2012   09:37  Page:  

Rabies Vaccine Havrix  
Date:12/02/97ISR Number: 3003979-8Report Type:Expedited (15-DaCompany Report #85820                  Outcome Report Source Product Hospitalization Anxiety Foreign Lariam Initial Prolonged Diarrhoea Health Insomnia Professional Illusion Paraesthesia CiprobayGastroenteritis Bacterial  Disturbance Attention Restlessness Headache Psychotic DisorderHypoaesthesiaTrance  Role  Manufacturer  Age:26 Route ORAL ORAL  Gender:Male I/FU:F Dose Duration 250.0000 1.0 PER WEEK ORAL TAB 500.0000 2.0 PER DAY ORAL  
Date:12/02/97ISR Number: 3003982-8Report Type:Expedited (15-DaCompany Report #59906  Outcome Report Source Product Other Serious Adverse Event Foreign Lariam Health Paludrine  Professional Typhim ViNivaquine  Role  Manufacturer  Age:26 Route ORAL  Gender:Female Dose 250  I/FU:I Duration  
Date:12/02/97ISR Number: 3004047-1Report Type:Expedited (15-DaCompany Report #90736  Outcome Report Source Product Hospitalization Hostility Other Lariam Initial Prolonged Delusion Nervousness Psychotic DisorderAgitationToxicity VariousAgentsHypersensitivityHallucination, AuditoryTrance Aggression  Role  Manufacturer  Age:75 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/02/97ISR Number: 3004049-5Report Type:Expedited (15-DaCompany Report #90607  Outcome Report Source Product  Role  Manufacturer  Age:78 Route  Gender:Male Dose  I/FU:I Duration  

Other Serious Dementia 	Foreign Lariam ORAL ORAL Health Professional 
03-Apr-2012  09:37 	Page: 
Date:12/02/97ISR Number: 3004114-2Report Type:Expedited (15-DaCompany Report #89618  Outcome Report Source Product Other Serious Decreased Appetite Consumer Lariam Abnormal Dreams CryingPalpitationsHyperreflexiaHypoaesthesiaInsomnia Abnormal Behaviour Muscle Contractions InvoluntaryMotor DysfunctionPanic Reaction Drug HypersensitivityParaesthesia  Role  Manufacturer  Age:42 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/03/97ISR Number: 3003946-4Report Type:Expedited (15-DaCompany Report #88694  Outcome Report Source Product Hospitalization -Paraesthesia Foreign Lariam Initial Prolonged Dizziness Consumer  Asthenia Health Blood Calcium Increased Professional AlopeciaArthralgiaHeadache HypoaesthesiaHypoparathyroidismHyperhidrosisVisual Impairment  Role  Manufacturer  Age:27 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL       I/FU:I Duration DAY  
Date:12/03/97ISR Number: 3007297-3Report Type:Direct  Outcome Required Panic Attack Intervention Insomnia Prevent Permanent AnxietyImpairment/Damage AgoraphobiaDyspnoea  Company Report Report Source Product Lariam  Role  Manufacturer  Age:42 Route   Gender:Female Dose PER WEEK  I/FU:I Duration  
Date:12/08/97ISR Number: 3004513-9Report Type:Expedited (15-DaCompany Report #90887  Outcome Report Source Product Hospitalization Muscle Rigidity Foreign Lariam Initial Prolonged Muscle Twitching Other  Role  Manufacturer  Age:21 Route ORAL  Gender:Male Dose 250.000 1.0 PER  I/FU:I Duration  

Blood Glucose Decreased WEEK ORAL 
03-Apr-2012  09:37 Page: 
Date:12/08/97ISR Number: 3004514-0Report Type:Expedited (15-DaCompany Report #90886  Outcome Report Source Product Other Serious Photosensitivity Reaction Foreign Lariam  Rash Pustular Other Skin Infection  Sakmonella Vaccine ImmunoglobulinsPoliomyelitisVaccine  Role  Manufacturer  Age:45 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/08/97ISR Number: 3004766-7Report Type:Expedited (15-DaCompany Report #90692  Outcome Report Source Product Disability Cough Consumer Lariam Deafness NeurosensoryTinnitus  Role  Manufacturer  Age:44 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/08/97ISR Number: 3004769-2Report Type:Expedited (15-DaCompany Report #89328  Outcome Report Source Product Other Serious Abortion Missed Foreign Lariam Health Professional  Role  Manufacturer  Age: Route ORAL  Gender:Female I/FU:I Dose Duration 250.0000MG 1.0X PER WEEK ORAL  
Date:12/09/97ISR Number: 3004654-6Report Type:Expedited (15-DaCompany Report #911054  Outcome Report Source Product Hospitalization Electrocardiogram Qrs Foreign Lariam Initial Prolonged Complex Abnormal Literature Chest Pain Atrial Flutter Condition AggravatedAtrioventricular Block PalpitationsHeart Rate Increased Conduction Disorder Tachycardia  Role  Manufacturer  Age:63 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/09/97ISR Number: 3004657-1Report Type:Expedited (15-DaCompany Report #90945                                             Outcome Report Source Product Hospitalization -Anaemia Foreign Lariam Initial Prolonged Jaundice Literature Asthenia  Role  Manufacturer  Age:28 Route ORAL  Gender:Male Dose 1.5000  I/FU:I Duration  

Pyrexia
Malaria
 Chills
 Chromaturia
 Blood Creatinine
 Increased
 Haemolysis
 
03-Apr-2012  09:37 Page: 
Date:12/09/97ISR Number: 3004686-8Report Type:Expedited (15-DaCompany Report #91054  Outcome Report Source Product Hospitalization Chest Pain Foreign Lariam Initial Prolonged Palpitations Literature Atrial Flutter Heart Rate Increased Tachycardia  Role  Manufacturer  Age:63 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:12/11/97ISR Number: 3007641-7Report Type:Direct  Outcome Hospitalization Coordination Abnormal Initial Prolonged PhotophobiaGait Disturbance Asthenia Headache  Company Report Report Source Product Mefloquine  Role  Manufacturer Roche  Age:8 Route ORAL  Gender:Male I/FU:I Dose Duration 125 WEEKLY  
Date:12/12/97ISR Number: 3006775-0Report Type:Expedited (15-DaCompany Report #91314  Outcome Report Source Product Death Abnormal Behaviour Foreign Lariam Completed Suicide Other Chlorquine  Role  Manufacturer  Age: Route ORAL  Gender:Male Dose 250.0000MG 1.0 PER WEEK ORAL UNKNOWN  I/FU:I Duration  
Date:12/16/97ISR Number: 3008113-6Report Type:Expedited (15-DaCompany Report #91370  Outcome Report Source Product Hospitalization Ulna Fracture Foreign Lariam Initial Prolonged Delusional Disorder, Other Persecutory TypeSuicide AttemptRadius Fracture Psychotic DisorderPelvic Fracture  Role  Manufacturer  Age:32 Route ORAL  Gender:Male Dose 250.0000MG 1.0 PER WEEK ORAL  I/FU:I Duration  

Date:12/16/97ISR Number: 3008116-1Report Type:Expedited (15-DaCompany Report #89882                          Age:82  Gender:Male  I/FU:F  
Outcome Hospitalization Initial Prolonged Gait Disturbance  ParalysisHypoaesthesiaMuscular Weakness  Report SourceForeignHealth Professional  Product Lariam Daonil  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Insulin  

Date:12/23/97ISR Number: 3010716-XReport Type:Expedited (15-DaCompany Report #91691   Age:50   Gender:Male  I/FU:I  
Outcome Hospitalization Initial Prolonged Hallucination, Tactile Hyperhidrosis  
03-Apr-2012   09:37  Page:  

Malaise Hallucination, Visual  Report SourceForeignOther  Product Lariam  Role  Manufacturer  Route ORAL  Dose 250.0000MG 1.0 PER WEEK ORAL  Duration  
Date:12/30/97ISR Number: 3097260-9Report Type:Direct  Outcome Life-Threatening  Nervousness Feeling JitteryMalaise Insomnia Panic Attack  Company Report Report Source Product Lariam  Role  Manufacturer  Age:37 Route  Gender:Male Dose 250MG /WK  I/FU:I Duration  
Date:01/02/98ISR Number: 3014141-7Report Type:Expedited (15-DaCompany Report #JAFRA-36938  Outcome Report Source Product Hospitalization Staphylococcal Infection Foreign Imodium Initial Prolonged Arthralgia ErcefurylPyrexia Smecta Aspartate Engerix BAminotransferase Increased Lariam Arthritis Reactive Tiorfan Diarrhoea HepatomegalyConjunctivitisAlanine Aminotransferase Increased  Role  Manufacturer Janssen  Age:25 Route ORAL ORAL INTRAMUSCULAR ORAL ORAL  Gender:Female I/FU:I Dose Duration ORAL ORAL DAY MCG TOTAL INTRAMUSCULAR WEEKLY ORAL 100 ORAL DAY  
Date:01/07/98ISR Number: 3015608-8Report Type:Expedited (15-DaCompany Report #90736  Outcome Report Source Product Hospitalization Psychotic Disorder Other Lariam Initial Prolonged Delusion AggressionNervousness Toxicity VariousAgentsAgitationTrance  Role  Manufacturer  Age:75 Route ORAL  Gender:Male Dose 250.0000MG 1.0 PER WEEK ORAL  I/FU:F Duration  

Date:01/08/98ISR Number: 3015567-8Report Type:Expedited (15-DaCompany Report #92037                                              Age: Gender:Female I/FU:I Anxiety WEEK 
03-Apr-2012  09:37 Page: 
Date:01/08/98ISR Number: 3016847-2Report Type:Expedited (15-DaCompany Report #92171   Age:58  Gender:Female  I/FU:I  
Outcome Hospitalization Initial Prolonged MyalgiaSick Sinus SyndromePost Viral FatigueSyndrome  Report SourceForeignOther  Product Lariam Thyroxine  Role  Manufacturer  Route ORAL  Dose Duration 250 1.0 PER WEEK ORAL  
Date:01/12/98ISR Number: 3016579-0Report Type:Expedited (15-DaCompany Report #92444   Age:24  Gender:Female  I/FU:I  
Outcome Hospitalization Initial ProlongedCongenital Anomaly Small For Dates BabyMaternal Drugs AffectingFoetus Premature BabyFoetal Growth Restriction   Report SourceForeignConsumer Other  Product Lariam Adepal  Role  Manufacturer  Route ORAL ORAL  Dose 250.0000 1.0 PER WEEK ORAL 1.0000 DOSE FORM 1.0  Duration  
PER DAY ORAL  
Yellow Fever Vaccine  SUBCUTANEOUS  1.0000 DOSE  
FORM 1.0  
PER ODOS  
SUBCUTANEOUS  
Hepatitis Vaccine  INTRAMUSCULAR   1.0 PER ODOS  
INTRAMUSCULAR  
Hepatitis Vaccine  INTRAMUSCULAR  1.0 PER ODOS  
INTRAMUSCULAR  
Date:01/15/98ISR Number: 3018437-4Report Type:Direct   Company Report  Age:80  Gender:Female  I/FU:I  
Outcome Disability Fall Gait Disturbance  Report Source  Product Lariam  Role  Manufacturer Laroche  Route  Dose WEEKLY FOR WKS  Duration  
Balance Disorder  Novaldex  
Date:01/15/98ISR Number: 3053811-1Report Type:Periodic   Company Report #WAES 97041992  Age:44  Gender:Male  I/FU:F  
Outcome  
Chills  
AnxietyFatigueDizziness  
Headache  
MyalgiaNausea  
PalpitationsAsthenia  

Tinnitus
 Accommodation Disorder
 Diarrhoea
 Decreased Appetite
Abdominal Pain
 Depression
Pruritus
 Drug Interaction
 
03-Apr-2012  09:37 Page: 
Freedom Information (FOI) Report  
DysgeusiaEmotional Disorder Salivary Hypersecretion   Report SourceConsumer Health Professional  Product Crixivan Lariam Unk Halicon Triazolam Retin-A  Valtrex Zerit Cimetidine Epivir(Beta)-Carotene  Nizoral  Role  Manufacturer Merck Research Laboratories Div Merck Inc  Route ORAL ORAL  Dose Duration 800 MG/Q8H/PO  
Date:01/21/98ISR Number: 3017831-5Report Type:Expedited (15-DaCompany Report #92564  Outcome Report Source Product Hospitalization -Bradycardia Foreign Lariam Initial Prolonged Gastroenteritis Health Professional  Role  Manufacturer  Age:17 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:01/22/98ISR Number: 3018708-1Report Type:Direct  Outcome Disability Balance Disorder Gait Disturbance  Company Report Report Source Product Lariam Nolvadex  Role  Manufacturer Roche Pharmaceutical  Age:80 Route  Gender:Female Dose PER WEEK FOR WEEKS  I/FU:I Duration  
Date:01/27/98ISR Number: 3019299-1Report Type:Expedited (15-DaCompany Report #92891                 Outcome Report Source Product Other Serious Vertigo Foreign Lariam Balance Disorder Health Gait Disturbance Professional Geluprane  Role  Manufacturer  Age: Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:01/27/98ISR Number: 3019406-0Report Type:Expedited (15-DaCompany Report #91568  Outcome Report Source  Product Other Serious Viith Nerve Paralysis Foreign Lariam Health  Role  Manufacturer  Age: Route ORAL  Gender:Female Dose 250.0000 1.0 PER  I/FU:I Duration  

Professional WEEK ORAL DAY Premarin Salazopyrine 
03-Apr-2012  09:37 Page: 
FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  
Date:02/02/98ISR Number: 3021867-8Report Type:Direct  Outcome Hospitalization Palpitations  Initial Prolonged FatigueChest Pain  Company Report Report Source Product Mefloquine  Role  Manufacturer  Age:53 Route ORAL  Gender:Male Dose 250 DOSES  I/FU:I Duration  
Date:02/02/98ISR Number: 3021875-7Report Type:Expedited (15-DaCompany Report #80873  Outcome Report Source Product Congenital Anomaly Thymus Enlargement Foreign Lariam Trisomy Health Congenital Anomaly Professional Ventricular Septal DefectAcquiredDysmorphismMaternal Drugs AffectingFoetus Abortion Induced  Role  Manufacturer  Age:31 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/02/98ISR Number: 3021893-9Report Type:Direct  Outcome Hospitalization FatigueInitial Prolonged Chest Discomfort Decreased AppetiteCardiac Disorder Asthenia Heart Rate Increased  Company Report Report Source Product Health Lariam Professional  Role  Manufacturer  Age:38 Route ORAL  Gender:Female I/FU:I Dose Duration 250 WEEKLY  
Date:02/02/98ISR Number: 3021894-0Report Type:Expedited (15-DaCompany Report #89618  Outcome Report Source  Product Other Serious Palpitations Consumer Lariam Insomnia CryingDecreased AppetiteHyperreflexiaPanic Attack Motor DysfunctionParaesthesia Abnormal Dreams  Role  Manufacturer  Age:42 Route ORAL  Gender:Female Dose 250.OOO 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:02/02/98ISR Number: 3022891-1Report Type:Expedited (15-DaCompany Report #87335   Age:25  Gender:Female  I/FU:I  

Outcome Hospitalization Initial Prolonged Diarrhoea PyrexiaEmbolism Arterial  Report SourceForeignOther  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250.00 1.0 PER WEEK ORAL  
Headache  Marvelon  
Hemiparesis  
03-Apr-2012   09:37  Page:  

Date:02/04/98ISR Number: 3022672-9Report Type:Expedited (15-DaCompany Report #90763   Age:36  Gender:Male  I/FU:I  
Outcome Hospitalization Initial Prolonged LeukopeniaHyperhidrosisMyalgiaAspartateAminotransferase Increased FatigueHepatic Enzyme IncreasedBlood Creatine Phosphokinase IncreasedSkin Discolouration MyopathyLiver Function Test Abnormal Alanine Aminotransferase Increased Chest Pain Pain ExtremityDiarrhoea HypogammaglobulinaemiaTongue CoatedCardiovascular Disorder Muscular Weakness MyocarditisHepatic SteatosisGamma-GlutamyltransferaseIncreased Headache Myoglobin Blood Increased  Report SourceForeignHealth Professional   Product Lariam  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:02/04/98ISR Number: 3022673-0Report Type:Expedited (15-DaCompany Report #92891   Age:54   Gender:Male  I/FU:F  
Outcome Other Serious Balance Disorder VertigoGait Disturbance Dizziness  Report SourceForeign  Health Professional  Product Lariam Geluprane  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:02/04/98ISR Number: 3023912-2Report Type:Expedited (15-DaCompany Report #87481   Age:54  Gender:Male  I/FU:F  
Outcome DisabilityOther Serious Amnesia FatigueNausea HypoaesthesiaNervous System Disorder  

Overdose
 Dysgeusia
Hypertension
Oedema
 Disturbance Attention
 Visual Field Defect
 Paraesthesia
 Vomiting
 
03-Apr-2012  09:37 Page: 
FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  
Dizziness  
Report SourceConsumer Health Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250.000 1.0 PER DAY ORAL  
Date:02/09/98ISR Number: 3025971-XReport Type:Expedited (15-DaCompany Report #88651  Outcome Report Source Product Other Serious  Diplopia Foreign Lariam Vith Nerve Paralysis Health Nausea Professional Headache  Role  Manufacturer  Age:28 Route ORAL   Gender:Female Dose 250.0000 1.0 PER WEEK ORAL TAB  I/FU:I Duration  
Date:02/09/98ISR Number: 3026005-3Report Type:Expedited (15-DaCompany Report #93517  Outcome Report Source Product Life-Threatening  Heart Rate Decreased Foreign Lariam Hospitalization -Atrioventricular Block Other Initial Prolonged Complete  Required Dizziness Intervention Pallor Prevent Permanent Impairment/Damage  Role  Manufacturer  Age:73 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/10/98ISR Number: 3027135-2Report Type:Expedited (15-DaCompany Report #87481  Outcome Report Source Product Disability Mental Impairment Health Lariam Medication Error Professional  Visual Impairment Other VomitingOverdose HypertensionDrug Level AboveTherapeuticDysgeusiaDizziness Brain InjuryVisual Acuity ReducedAmnesia FatigueParaesthesia Nausea Oedema  Role  Manufacturer  Age:53 Route ORAL  Gender:Male Dose 250.000 2.0 WEEK ORAL  I/FU:F Duration  

Date:02/12/98ISR Number: 3027269-2Report Type:Expedited (15-DaCompany Report #92564   Age:16  Gender:Female  I/FU:F  
Outcome Hospitalization Initial Prolonged BradycardiaGastroenteritis Asthenia  
03-Apr-2012   09:37  Page:  

FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  
HypotensionRed Blood Cell Sedimentation Rate  Increased  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:02/12/98ISR Number: 3028339-5Report Type:Expedited (15-DaCompany Report #93802  Outcome Report Source Product Hospitalization Depression Foreign Lariam Initial Prolonged Anxiety Other Thinking AbnormalTremor Personality DisorderAbnormal Behaviour  Role  Manufacturer  Age:62 Route ORAL  Gender:Male I/FU:I Dose Duration 50.000 1.0 PER WEEK  
Date:02/12/98ISR Number: 3030309-8Report Type:Expedited (15-DaCompany Report #89882                                              Outcome Report Source Product Hospitalization -Hypoaesthesia Foreign Lariam Initial Prolonged Feeling Drunk Health Coordination Abnormal Professional Paralysis Daonil Balance Disorder Insuline Muscular Weakness Monoparesis  Role  Manufacturer  Age:82 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:02/12/98ISR Number: 3030313-XReport Type:Expedited (15-DaCompany Report #87481  Outcome Report Source Product Disability  Hypoaesthesia Consumer Lariam Other Serious Dysgeusia Health Hypertension Professional Medication Error Nausea FatigueVisual ImpairmentDizziness Disturbance Attention VomitingMemory ImpairmentBrain InjuryOedema  Role  Manufacturer  Age:54 Route ORAL   Gender:Male I/FU:F Dose Duration 250.0000 1.0 PER DAY ORAL  

Date:02/13/98ISR Number: 3030113-0Report Type:Expedited (15-DaCompany Report #JAFRA-36938   Age:25  Gender:Female  I/FU:F  
Outcome Hospitalization Initial Prolonged Diarrhoea Hepatic Function AbnormalHepatomegalyPyrexiaArthralgia  
03-Apr-2012   09:37  Page:  

Conjunctivitis  Report SourceForeignHealth Professional  Product Imodium ErcefurylSmecta Engerix Lariam Tiorfan  Role  Manufacturer Janssen  Route ORAL ORAL INTRAMUSCULAR ORAL ORAL  Dose Duration ORAL ORAL DAY MCG TOTAL, INTRAMUSCULAR SUSPENSION MCG TABLET WEEKLY ORAL 100MG CAPSULES DAY  
Date:02/18/98ISR Number: 3032216-3Report Type:Expedited (15-DaCompany Report #94117  Outcome Report Source Product Required Polyneuropathy Foreign Lariam Intervention Gait Disturbance Health Prevent Permanent Spinal Osteoarthritis Professional Impairment/Damage Sciatica Back Pain Lumbar Spinal Stenosis  Role  Manufacturer  Age:67 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/18/98ISR Number: 3032221-7Report Type:Expedited (15-DaCompany Report #93891  Outcome Report Source Product Life-Threatening  Renal Failure Foreign Lariam Cardiac Arrest Consumer Malaria  Role  Manufacturer  Age: Route ORAL  Gender:Female Dose 250 ORAL;TAB  I/FU:I Duration  
Date:02/18/98ISR Number: 3036413-2Report Type:Direct  Outcome Disability Panic Attack Required Convulsion Intervention Dizziness Prevent Permanent Tremor Impairment/Damage Vision Blurred Anxiety  Company Report Report Source Product Lariam  Role  Manufacturer   Age:44 Route  Gender:Male Dose PRESCRIBED AMOUNTS  I/FU:I Duration  
Date:02/19/98ISR Number: 3032366-1Report Type:Expedited (15-DaCompany Report #94074  Outcome Report Source Product  Role  Manufacturer  Age:30 Route  Gender:Male Dose  I/FU:F Duration  

03-Apr-2012  09:37 	Page: 
Date:02/23/98ISR Number: 3035857-2Report Type:Expedited (15-DaCompany Report #93243                   	Age:58 Gender:Male I/FU:I
 
Role  Manufacturer  Route ORAL  Dose 1500.0000 ORAL  Duration  
Age:4 MON   Gender:Female  I/FU:I  
Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Age:22  Gender:Female  I/FU:I  
Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Age:49  Gender:Male  I/FU:I  
Role  Manufacturer  Route ORAL  Dose 250.0000MG 1.0 PER WEEK ORAL  Duration  
Age:  Gender:Female  I/FU:F  
Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  

Outcome 
Other Serious 	Blood Alkaline  Phosphatase IncreasedGamma-Glutamyltransferase  Increased Platelet Count Decreased White Blood Cell Count Decreased ThrombocytopeniaAlanine Aminotransferase Increased 
Date:02/23/98ISR Number: 3035884-5Report Type:Expedited (15-DaCompany Report #94429  
Outcome Report Source Product 
Death 	Pneumonia Viral Literature Lariam Maternal Drugs AffectingFoetus 
Date:02/23/98ISR Number: 3035887-0Report Type:Expedited (15-DaCompany Report #94430  
Outcome Report Source Product 
Other Serious 	Maternal Drugs Affecting Literature Lariam Foetus Benign Hydatidiform Mole 
Date:02/23/98ISR Number: 3036234-0Report Type:Expedited (15-DaCompany Report #94382  
Outcome Report Source Product 
Other Serious Coordination Abnormal Foreign Lariam 
Agraphia Other 

Date:02/23/98ISR Number: 3037257-8Report Type:Expedited (15-DaCompany Report #93562  Report Source Product Foreign Lariam Health Professional 
Outcome 
Hospitalization	Cardiolipin Antibody
Initial Prolonged 	Positive Abortion SpontaneousDna Antibody PositiveSystemic LupusErythematosusPre-Eclampsia Report Source Product Foreign Lariam Health Professional 
Maternal Drugs Affecting
Foetus
 
03-Apr-2012  09:37 Page: 
Date:02/23/98ISR Number: 3037262-1Report Type:Expedited (15-DaCompany Report #94371                                      Outcome Report Source Product Death Completed Suicide Foreign Lariam Health Professional  Role  Manufacturer  Age:33 Route ORAL  Gender:Male I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:02/24/98ISR Number: 3035602-0Report Type:Expedited (15-DaCompany Report #94035  Outcome Report Source Product Other Serious Disturbance Attention Foreign Lariam Dyskinesia Other Insomnia Dizziness Nausea  Role  Manufacturer  Age:43 Route ORAL  Gender:Female Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035604-4Report Type:Expedited (15-DaCompany Report #94037  Outcome Report Source Product Other Serious Urticaria Foreign Lariam Angioedema Other  Role  Manufacturer  Age:29 Route ORAL  Gender:Male Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035607-XReport Type:Expedited (15-DaCompany Report #947072  Outcome Report Source Product Other Serious  Psychotic Disorder Foreign Lariam Suicidal Ideation Other Anxiety  Role  Manufacturer  Age:30 Route ORAL   Gender:Female Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035611-1Report Type:Expedited (15-DaCompany Report #94073  Outcome Report Source Product Other Serious Disturbance Attention Foreign Lariam Agitation Other AnxietyPalpitationsAtrial Fibrillation  Role  Manufacturer  Age:28 Route ORAL  Gender:Male Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035613-5Report Type:Expedited (15-DaCompany Report #94074  Outcome Report Source Product Other Serious Depression Foreign Lariam Suicidal Ideation Other  Role  Manufacturer  Age:30 Route ORAL  Gender:Male Dose 250.000 ORAL  I/FU:I Duration  

Date:02/24/98ISR Number: 3035616-0Report Type:Expedited (15-DaCompany Report #94092   Age:24  Gender:Female  I/FU:I  
Outcome Other Serious DepressionPsychotic Disorder  
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Suicidal Ideation Anxiety  Report SourceForeignOther  Product Lariam  Role  Manufacturer   Route ORAL  Dose 250.000 ORAL  Duration  
Date:02/24/98ISR Number: 3035620-2Report Type:Expedited (15-DaCompany Report #94093  Outcome Report Source Product Other Serious Psychotic Disorder Foreign Lariam Renal Failure Acute Other Dermatitis Disorientation  Role  Manufacturer  Age:73 Route ORAL  Gender:Female  Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035623-8Report Type:Expedited (15-DaCompany Report #94101  Outcome Report Source Product Other Serious Anxiety Foreign Lariam Dyskinesia Other Agitation  Role  Manufacturer  Age:39 Route ORAL   Gender:Male Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035628-7Report Type:Expedited (15-DaCompany Report #04106  Outcome Report Source Product Other Serious Hyperhidrosis Foreign Lariam Vomiting Other PalpitationsPsychotic DisorderDiarrhoea Hallucination Paralysis  Role  Manufacturer  Age:32 Route ORAL  Gender:Female Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035644-5Report Type:Expedited (15-DaCompany Report #94124  Outcome Report Source Product  Other Serious Anaemia Foreign Lariam Coombs Direct Test Other Positive  Role  Manufacturer  Age:5 Route ORAL  Gender:Female Dose 250.000 ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035647-0Report Type:Expedited (15-DaCompany Report #94126    Outcome Report Source Product Other Serious  Fatigue Foreign Lariam  Role  Manufacturer  Age:59 Route ORAL  Gender:Male Dose 250.000  I/FU:I Duration  

Angina Pectoris Other 	1.0 PER WEEK ORAL 
03-Apr-2012  09:37 	Page: 
Date:02/24/98ISR Number: 3035650-0Report Type:Expedited (15-DaCompany Report #94128  Outcome Report Source Product Other Serious Bronchospasm Foreign Lariam Other  Role  Manufacturer  Age:27 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035652-4Report Type:Expedited (15-DaCompany Report #94131  Outcome Report Source Product Hospitalization Cardiac Failure Foreign Lariam  Initial Prolonged Other  Role  Manufacturer  Age:64 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035657-3Report Type:Expedited (15-DaCompany Report #94137                                            Outcome Report Source Product Other Serious Hepatitis Cholestatic Foreign Lariam Other  Role  Manufacturer  Age:78 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3035660-3Report Type:Expedited (15-DaCompany Report #94146               Outcome Report Source Product Hospitalization -Hypoglycaemia Foreign Lariam Initial Prolonged Other  Role  Manufacturer  Age:39 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:02/24/98ISR Number: 3103313-9Report Type:Expedited (15-DaCompany Report #94065  Outcome Report Source Product Other Serious Angioedema Foreign Lariam Dermatitis Other Depressed Mood  Role  Manufacturer  Age:36 Route ORAL  Gender:Female Dose 250.000 ORAL  I/FU:I Duration  
Date:03/02/98ISR Number: 3050236-XReport Type:Direct  Outcome Other Serious Nightmare  Company Report Report Source Product Mefloquine   Role  Manufacturer  Age:20 Route ORAL  Gender:Male Dose 250  I/FU:I Duration  
Date:03/03/98ISR Number: 3040313-1Report Type:Expedited (15-DaCompany Report #94569   Age:12  Gender:Male  I/FU:I  

Outcome Report Source Product Role Manufacturer Route Dose Duration 
Other Serious 	Obsessive-Compulsive  Health Lariam ORAL Disorder Professional Emotional Disorder Panic Attack 
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Date:03/03/98ISR Number: 3049890-8Report Type:Direct   Company Report  Age:15  Gender:Male  I/FU:I  
Outcome Life-Threatening  Hospitalization Initial ProlongedDisabilityRequiredIntervention Prevent Permanent Impairment/Damage Depressed Level OfConsciousness Hallucination, Visual MyalgiaMuscular Weakness DepressionPain ExtremityHypersensitivityDizziness  Report Source  Product Lariam  Role  Manufacturer Hoffmann-Laroche               Route  Dose 250MG WKLY  Duration  
Headache  
ParalysisBone Pain  
InjuryPain  
PyrexiaDyspnoeaPsychotic DisorderAgitationParaesthesia  
Tinnitus  
Educational Problem  
Heart Rate IrregularCoordination Abnormal  
Loss Consciousness  
Insomnia  
Chills  
Abnormal Behaviour  
Sleep DisorderHallucination, AuditoryAbnormal Dreams  
PalpitationsCold Sweat  
Speech DisorderVisual ImpairmentInfluenza Like Illness  
Date:03/05/98ISR Number: 3050365-0Report Type:Direct   Company Report  Age:53  Gender:Male  I/FU:I  
Outcome Other Serious Abnormal Dreams Pain ExtremityScab  Report SourceConsumer  Product Lariam  Role  Manufacturer Hoffman Roche  Route  Dose TAB/WEEK  Duration  
Insomnia  
Dermatitis Bullous  
Rash PapularUrticaria  

Outcome Report Source Product Role Manufacturer  Route Dose Duration Other Serious Sleep Disorder Consumer Lariam Hoffman Laroche TAB/WK
Dermatitis Bullous Freedom Information (FOI) Report 
03-Apr-2012   09:37  Page:  

Date:03/10/98ISR Number: 3049117-7Report Type:Direct  Company Report 	Age:24 Gender:Male I/FU:I 
Outcome Report Source Product Role Manufacturer Route Dose Duration 
Disability 	Abnormal Dreams Lariam ORAL PILL WEEKLY Photosensitivity Reaction Vitamins Scleral Discolouration Tooth Discolouration Sleep Disorder 
Date:03/10/98ISR Number: 3054941-0Report Type:Expedited (15-DaCompany Report #88694  	Age:28 Gender:Male I/FU:F 
Outcome Report Source Product Role Manufacturer Route  Dose Duration 
Hospitalization	Visual Impairment Foreign Lariam ORAL 250.0000 
Initial Prolonged 	Asthenia Consumer 1.0 PER Blood Calcium Decreased  Health WEEK ORAL Infectious Mononucleosis Professional Paraesthesia ArthralgiaDizziness HyperhidrosisMental Disorder HypoaesthesiaArrhythmiaTension Headache AlopeciaSensory DisturbanceHypoparathyroidismHeadache 
Date:03/12/98ISR Number: 3058545-5Report Type:Direct   Company Report  Age:24   Gender:Female  I/FU:I  
Outcome Other Serious RequiredIntervention AnxietyPanic Attack  Report Source  Product Lariam Birth Control Pills  Role  Manufacturer  Route  Dose Duration PER WEEK DOSES  
Prevent Permanent  
Impairment/Damage  
Date:03/12/98ISR Number: 3059187-8Report Type:Direct   Company Report  Age:50  Gender:Female  I/FU:I  
Outcome Other Serious Insomnia AgitationNervousness  Report SourceHealth Professional  Product Sibutamine Mefloquine  Role  Manufacturer Knoll Roche  Route ORAL ORAL  Dose Duration 250 WEEK  

Date:03/16/98ISR Number: 3055731-5Report Type:Expedited (15-DaCompany Report #94329   Age:2  Gender:Male  I/FU:I  
Outcome Other Serious InappropriateAntidiuretic Hormone Secretion Diabetes InsipidusPolyuria  
03-Apr-2012   09:37  Page:  

Polydipsia  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 1.0 PER WEEK ORAL  
Date:03/16/98ISR Number: 3055732-7Report Type:Expedited (15-DaCompany Report #95577  Outcome Report Source Product Hospitalization Anxiety Foreign Lariam Initial Prolonged Dehydration Other Abdominal Pain UpperCholecystitisVomitingGastroenteritis  Role  Manufacturer  Age:28 Route ORAL  Gender:Male I/FU:I Dose Duration DOSE FORM PER DAY ORAL  
Date:03/17/98ISR Number: 3055864-3Report Type:Expedited (15-DaCompany Report #940202190001  Outcome Report Source Product Other Serious Foetal Growth Restriction Other Lariam Premature Baby  Maternal Drugs AffectingFoetus Iron Orasthin Vitamins  Role  Manufacturer  Age:26 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:03/17/98ISR Number: 3055868-0Report Type:Expedited (15-DaCompany Report #940202190002  Outcome Report Source Product Other Serious Premature Labour Literature Lariam Polyhydramnios Other Meningococci VaccineCholera Vaccine Plague VaccineImmunoglobulinsTyphoid Vaccine  Role  Manufacturer  Age:20 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:03/17/98ISR Number: 3055872-2Report Type:Expedited (15-DaCompany Report #940202190003  Outcome Report Source Product Other Serious Jaundice Neonatal Literature Lariam Other  Role  Manufacturer  Age: Route  ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:F Duration  

Iron  
Tuberkulin Tine Test  
PpdYellow Fever Vaccine  
Influenza Virus  
ImmunoglobulinsVitamins  
Oral Contraceptive  
03-Apr-2012   09:37  Page:  

Date:03/17/98ISR Number: 3055892-8Report Type:Expedited (15-DaCompany Report #92796  Age:23 Gender:Female I/FU:I
 
Outcome Hospitalization Initial Prolonged Suicidal Ideation Flight IdeasPsychotic DisorderDiarrhoea Paranoia Hallucination, AuditoryDelusional Disorder, Unspecified TypeDystoniaThinking AbnormalAgitationMood Swings  Report SourceHealth Professional  Product Lariam Birth Control Pills  Role  Manufacturer  Route ORAL  Dose 1.0 PER WEEK ORAL  Duration  
Date:03/18/98ISR Number: 3056397-0Report Type:Direct  Outcome Disability Tooth Discolouration Scleral Discolouration Photosensitivity ReactionAbnormal Dreams Sleep Disorder  Company Report Report Source Product Lariam Vitamines  Role  Manufacturer  Age:24 Route  Gender:Male I/FU:I Dose Duration PILL WEEKLY  
Date:03/19/98ISR Number: 3057866-XReport Type:Direct  Outcome Life-Threatening  Hallucinations, Mixed Hospitalization HyperventilationInitial Prolonged Chest Pain Disability Insomnia Required Abnormal Behaviour Intervention Suicidal Ideation Prevent Permanent Psychomotor HyperactivityImpairment/Damage  Company Report Report Source  Product Lariam  Role  Manufacturer  Age:15 Route  Gender:Female I/FU:I Dose Duration TABLETS SINGLE DOSE  
Date:03/24/98ISR Number: 3059313-0Report Type:Expedited (15-DaCompany Report #95970                                              Outcome Report Source Product Hospitalization -Pancreatitis Foreign Lariam Initial Prolonged Other  Role  Manufacturer  Age:48 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:03/24/98ISR Number: 3059361-0Report Type:Expedited (15-DaCompany Report #96259                  Age:26  Gender:Female  I/FU:I  

Outcome Other Serious Vision Blurred NystagmusBronchospasmPanic Attack  Report SourceForeignOther  Product Lariam Beecham'S Powders  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
TyrozetsKalms Herbal  
03-Apr-2012   09:37  Page:  

Date:03/24/98ISR Number: 3059363-4Report Type:Expedited (15-DaCompany Report #96078   Age:41  Gender:Male  I/FU:I  
Outcome Other Serious EpilepsyBradycardiaLoss Consciousness  Paraesthesia Amnesia  Report SourceForeignHealth Professional  Product Lariam Colitofalk (Mesalamine)  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK  Duration  
Date:03/24/98ISR Number: 3059365-8Report Type:Expedited (15-DaCompany Report #95984   Age:28  Gender:Female  I/FU:I  
Outcome Other Serious Malaise Insomnia Balance Disorder Oropharyngeal PainPyrexiaCoordination Abnormal Anosmia FatigueConfusional State AnxietyDysgeusia  Report SourceForeignOther  Product Lariam Logynon  Role  Manufacturer  Route ORAL   Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:03/24/98ISR Number: 3060160-4Report Type:Expedited (15-DaCompany Report #96194   Age:52  Gender:Male  I/FU:I  
Outcome Other Serious FatigueDizziness Postural DepressionMedication Error Gamma-GlutamyltransferaseIncreased Nausea AspartateAminotransferase Increased Diarrhoea Tinnitus  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL   Dose Duration 250.0000 1.0 PER DAY ORAL  
Date:03/24/98ISR Number: 3060164-1Report Type:Expedited (15-DaCompany Report #96200   Age:23  Gender:Male  I/FU:I  
Outcome Other Serious Bleeding Time ProlongedAbdominal Pain C-Reactive Protein Increased  

Headache
 Dizziness
 Panic Reaction
 Encephalitis
Psychotic Disorder
Myalgia
Gastrointestinal Disorder
 Anxiety
 
03-Apr-2012  09:37 Page: 
Transferrin Increased  
Report SourceForeignOther  Product Lariam Hepatitis AVaccination FlagylYellow Fever Vaccine  Role  Manufacturer  Route ORAL  Dose 250.0000 1.O PER WEEK ORAL  Duration  
Date:03/24/98ISR Number: 3060304-4Report Type:Expedited (15-DaCompany Report #91489   Age:56  Gender:Female  I/FU:I  
Outcome Other Serious Cerebral Ischaemia Clonic Convulsion Spinal Disorder  Report SourceForeignHealth Professional  Product Lariam Flu Vaccine (Influenza VirusVaccine)Flixotide Salbutamol Prozac Tetracyclin   Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:03/24/98ISR Number: 3061536-1Report Type:Expedited (15-DaCompany Report #92796   Age:23  Gender:Female  I/FU:F  
Outcome Hospitalization Initial Prolonged Thinking AbnormalDiarrhoea DystoniaSuicidal Ideation Psychotic DisorderDelusion Hallucination, AuditoryParanoia AgitationMood Altered Toxicologic Test Abnormal  Report Source  Health Professional  Product Lariam Birth Control Pills  Role  Manufacturer  Route ORAL  Dose 1.0 PER WEEK ORAL  Duration  
Date:03/25/98ISR Number: 3058316-XReport Type:Expedited (15-DaCompany Report #96157   Age:58  Gender:Female  I/FU:I  
Outcome Disability  DiplopiaCondition Aggravated  Report SourceHealth Professional  Product Lariam Estratest  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  

Synthroid 
03-Apr-2012  09:37 Page: 
Date:03/27/98ISR Number: 3061119-3Report Type:Direct  Outcome Other Serious  PalpitationsDizziness  Company Report Report Source Product Mefloquine Prastitata Natural Vitamin  Role  Manufacturer Hoffman-La Roche   Age:57 Route ORAL  Gender:Male I/FU:I Dose Duration 250MG ONCE WEEK ONLY ONE DOSE  
Date:03/27/98ISR Number: 3065019-4Report Type:Direct  Outcome Hospitalization Nervous System Disorder  Initial Prolonged Dissociation Abnormal Dreams Ileus Paralytic  Company Report Report Source Product Lariam  Role  Manufacturer  Age:51 Route ORAL  Gender:Female I/FU:I Dose Duration TAB; 250 DAYS-8 DOSES LAST MONTHS  
Date:03/31/98ISR Number: 3060069-6Report Type:Expedited (15-DaCompany Report #93604  Outcome Report Source Product Hospitalization Nausea Foreign Lariam Initial Prolonged Fatigue Health Vomiting Professional Overdose Headache DysarthriaVision Blurred Somnolence DepressionConfusional State Diarrhoea  Role  Manufacturer  Age:49 Route ORAL  Gender:Female I/FU:I Dose Duration 250.0000 1.0 PER DAY DAY  
Date:03/31/98ISR Number: 3063290-6Report Type:Direct  Outcome Disability Insomnia Urinary BladderHaemorrhageHaematochezia Ear HaemorrhageWeight DecreasedDiarrhoea  Company Report Report Source Product Larium Primaquine OgenSynthroid  Role  Manufacturer Hoffman-La Roche  Age:69 Route  Gender:Female Dose LARIUM WEEK PRIMAQUINE DAY   I/FU:I Duration  
Date:03/31/98ISR Number: 3067124-5Report Type:Direct   Company Report  Age:  Gender:Male  I/FU:I  

Outcome Report Source Product Role Manufacturer  Route Dose Duration 
Other Serious 	Depression Lariam Mood Swings INSTRUCTED-DO Hallucination REMEMBER 
03-Apr-2012  09:37 	Page: 
Date:04/02/98ISR Number: 3059988-6Report Type:Expedited (15-DaCompany Report #96729                                               Age:57  Gender:Female  I/FU:I  
Outcome Other Serious Clonic Convulsion  Report SourceForeignOther  Product Lariam Influenza Vaccine Flixotide Salbutamol Prozac Tetracycline  Role  Manufacturer  Route ORAL  Dose 250.000 1.0 PER WEEK ORAL  Duration  
Date:04/02/98ISR Number: 3059990-4Report Type:Expedited (15-DaCompany Report #94329                               Age:2  Gender:Male  I/FU:F  
Outcome Other Serious Diabetes Insipidus  PolydipsiaPolyuria  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose 50.0000 1.0 PER WEEK ORAL  Duration  
Date:04/02/98ISR Number: 3059992-8Report Type:Expedited (15-DaCompany Report #96767   Age:53  Gender:Male  I/FU:I  
Outcome Disability PyrexiaIntraocular Pressure Test Chills Retinal Detachment Eye Pain  Report SourceHealth Professional Other  Product Lariam  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:04/03/98ISR Number: 3063293-1Report Type:Expedited (15-DaCompany Report #96727   Age:58  Gender:Male  I/FU:I  
Outcome Other Serious Platelet Count Decreased LeukopeniaThrombocytopeniaBlood Alkaline Phosphatase IncreasedGamma-GlutamyltransferaseIncreased ThrombocytosisWhite Blood Cell Count Increased AspartateAminotransferase Increased  Report SourceForeignOther  Product Lariam  Role  Manufacturer  Route ORAL  Dose 1500.0000 DAILY ORAL  Duration  

Date:04/03/98ISR Number: 3063295-5Report Type:Expedited (15-DaCompany Report #967761   Age:41  Gender:Male  I/FU:I  
Outcome Other Serious Haemangioma LiverNephrolithiasis  Report SourceConsumer  Product Lariam Tetanus Booster Polio Booster  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
03-Apr-2012   09:37  Page:  

PoliomyelitisVaccines Hepatitis VaccineHepatitis Vaccine  
Date:04/07/98ISR Number: 3061744-XReport Type:Expedited (15-DaCompany Report #90692  Outcome Report Source Product Disability Cough Consumer Lariam Influenza Tinnitus Deafness Neurosensory  Role  Manufacturer  Age:44 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:04/07/98ISR Number: 3061746-3Report Type:Expedited (15-DaCompany Report #83677                                     Outcome Report Source Product Hospitalization Atrial Fibrillation Foreign Lariam Initial Prolonged Maternal Drugs Affecting Health Required Foetus Professional Intervention Prevent Permanent Impairment/Damage  Role  Manufacturer  Age:30 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:04/07/98ISR Number: 3061749-9Report Type:Expedited (15-DaCompany Report #93562  Outcome Report Source Product Hospitalization Systemic Lupus Foreign Lariam Initial Prolonged Erythematosus Health Dna Antibody Positive Professional Abortion Spontaneous Other Cardiolipin AntibodyPositive Pre-Eclampsia  Role  Manufacturer  Age:32 Route  ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:F Duration  
Date:04/09/98ISR Number: 3062290-XReport Type:Expedited (15-DaCompany Report #96373       Outcome Report Source Product Hospitalization -Ecchymosis Health Lariam Initial Prolonged Professional Flonase Ventolin Amoxicillin Ortho-Cept   Role  Manufacturer  Age:20 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  

Date:04/10/98ISR Number: 3061854-7Report Type:Expedited (15-DaCompany Report #97149   Age:52  Gender:Female  I/FU:I  
Outcome  Hospitalization Initial Prolonged Ileus ParalyticDehydrationFeeling Abnormal  
03-Apr-2012   09:37  Page:  

White Blood Cell Count Increased Abnormal Dreams Decreased AppetiteNausea Abdominal Pain  Report SourceHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:04/10/98ISR Number: 3061856-0Report Type:Expedited (15-DaCompany Report #96157  Outcome Report Source Product Disability Diplopia Health Lariam Professional Estratest Synthroid  Role  Manufacturer  Age:58 Route ORAL  Gender:Female I/FU:F Dose Duration 250 PER WEEK ORAL  
Date:04/14/98ISR Number: 3073100-9Report Type:Direct  Outcome Disability DepressionAnxietyFlushingThinking AbnormalPyrexiaInsomnia Suicidal Ideation Diarrhoea Cold Sweat  Company Report Report Source  Product Lariam  Role  Manufacturer Roche  Age: Route  Gender:Female Dose ONCE PER WEEEK  I/FU:I Duration  
Date:04/15/98ISR Number: 3066252-8Report Type:Expedited (15-DaCompany Report #97094                      Outcome Report Source Product Other Serious Allergic Granulomatous  Other Lariam Angiitis  Role  Manufacturer  Age: Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK  I/FU:I Duration  
Date:04/15/98ISR Number: 3066253-XReport Type:Expedited (15-DaCompany Report #96103  Outcome Report Source Product Other Serious Brain Scan Abnormal Foreign Lariam Delirium Health Psychotic Disorder  Professional EncephalopathyMania  Role  Manufacturer  Age:67 Route ORAL  Gender:Male Dose 250.0000  I/FU:I Duration  

Date:04/15/98ISR Number: 3071734-9Report Type:Direct   Company Report  Age:64  Gender:Female  I/FU:I  
Outcome Other Serious FatigueMalaise Night SweatsDepression  
03-Apr-2012   09:37  Page:  

Disturbance Attention Confusional State Blood Pressure Fluctuation Asthenia Paraesthesia  Report Source  Product Lariam Mevacor Tenormin Moduretic  Role  Manufacturer Roche  Route ORAL  Dose Duration 250MGM ORAL ;ONCE WEEK  
Date:04/20/98ISR Number: 3065208-9Report Type:Expedited (15-DaCompany Report #97097                        Outcome Report Source Product Other Serious Coma Foreign Lariam Literature Health Professional Pyrimethamine  Sulfadoxine  Role  Manufacturer  Age: Route ORAL  Gender: I/FU:I Dose Duration 19.3000 MG/KG1.O PER ODOS ORAL  
Date:04/20/98ISR Number: 3066091-8Report Type:Expedited (15-DaCompany Report #97118  Outcome Report Source Product Hospitalization Rash Morbilliform Foreign  Lariam Initial Prolonged Neurotoxicity Literature Pyrexia Health Drug Interaction Professional Quinine Status EpilepticusConvulsion  Role  Manufacturer  Age:5  Route ORAL INTRAVENOUS  Gender: I/FU:I Dose Duration 50.0000 1.0 PER WEEK ORAL 21.0000 MG/KGDAILY INTRAVENOUS DAY  
Date:04/20/98ISR Number: 3069248-5Report Type:Expedited (15-DaCompany Report #97566  Outcome Report Source Product Other Serious Tinnitus Health Lariam Deafness Professional Premarin  Role  Manufacturer  Age:49 Route ORAL  Gender:Female  Dose 250 (TABLET) 1.0X PER WEEK  I/FU:I Duration  
Date:04/20/98ISR Number: 3073073-9Report Type:Direct  Outcome Disability Insomnia Other Serious HyperhidrosisAnxietyDisturbance Attention Restlessness Weight Decreased  Company Report Report Source Product Lariam  Role  Manufacturer Roche Laboratories  Age:61 Route  Gender:Male Dose PER WEEK  I/FU:I Duration  

Eating Disorder 
03-Apr-2012  09:37 Page: 
Date:04/20/98ISR Number: 3073074-0Report Type:Direct  Company Report  Age:36  
Outcome Report Source Product Life-Threatening  Ulcer Lariam Hospitalization Blood Pressure Increased Initial Prolonged  Role  Manufacturer  Route  
Date:04/21/98ISR Number: 3074855-XReport Type:Direct  Company Report  Age:68  
Outcome Report Source Product  Disability Headache Larium Balance Disorder  Role  Manufacturer  Route ORAL  
Hearing ImpairedVisual Impairment  
Date:04/23/98ISR Number: 3071860-4Report Type:Direct  Company Report  Age:24  
Outcome Report Source Product Hospitalization Paranoia Health Lariam Initial Prolonged Delusion Professional  Other Serious Psychotic Disorder Cipro  Role  Manufacturer  Route ORAL  
Date:04/24/98ISR Number: 3068735-3Report Type:Expedited (15-DaCompany Report #97094   Age:  
Outcome Report Source Product Other Serious Allergic Granulomatous Other Lariam Angiitis Unknown  Role  Manufacturer  Route ORAL  
Date:04/24/98ISR Number: 3068760-2Report Type:Expedited (15-DaCompany Report #97775   Age:74  
Outcome Report Source Product Hospitalization Pneumonia Viral Foreign Lariam Initial Prolonged Pneumonitis Health Alveolitis Allergic Professional Other  Role  Manufacturer  Route ORAL  
Date:04/24/98ISR Number: 3068768-7Report Type:Expedited (15-DaCompany Report #97779   Age:27  

Gender:Male I/FU:I 
Dose Duration TABLET
 DAY FOR ONE
 WEEK THEN ONE
 EVERY WEEK
 
Gender:Male I/FU:I 
Dose Duration
 ONE PILL EACH
 WEEK
 
Gender:Female I/FU:I 
Dose Duration 
(1) TAB Q/WK ORAL DAY 
Gender:Female I/FU:F 
Dose Duration 250 1XPER WEEK 
Gender:Female I/FU:I 
Dose Duration 250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Outcome Report Source Product Role Manufacturer Route Dose Duration Other Serious Maternal Drugs Affecting Foreign Lariam ORAL 250 PER 
Foetus Health WEEK ORAL 
Pre-Eclampsia  Professional 
03-Apr-2012  09:37 Page: 
Date:04/24/98ISR Number: 3068811-5Report Type:Expedited (15-DaCompany Report #83939  Role Manufacturer 
Role  Manufacturer Roche  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  

Age:26 
Route ORAL 
Age: Route 
Age:26 
Route ORAL 
Age:30 
Route ORAL 
Age:67 
Route ORAL Gender:Female I/FU:I 
Dose Duration 
250.000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Dose Duration 
ONCE PER WEEK 
Gender:Female I/FU:F 
Dose Duration 250 PER WEEK ORAL 
Gender:Female I/FU:I 
Dose Duration 250 PER WEEK ORAL 
Gender:Male I/FU:F 
Dose Duration 250 PER WEEK ORAL Date:04/24/98ISR Number: 3072341-4Report Type:Direct  
Outcome  
Congenital Anomaly  Pre-Eclampsia  Maternal Drugs AffectingFoetus  
Cleft Palate  

Outcome 
Disability 	Paranoia DepressionThinking AbnormalDermatitis Feeling BodyTemperature ChangeAnxietyDiarrhoea Suicidal Ideation Insomnia Pyrexia 
Date:04/27/98ISR Number: 3069033-4Report Type:Expedited (15-DaCompany Report #83939  
Outcome 
Congenital Anomaly 	Cleft Palate Maternal Drugs Affecting  Foetus Company Report 
Report SourceForeignHealth  Product Lariam  
Professional  

Report Source 	Product Lariam 
Date:04/27/98ISR Number: 3069037-1Report Type:Expedited (15-DaCompany Report #97885  
Outcome Report Source Product Hospitalization -Dry Mouth Foreign Lariam Initial Prolonged Oedema Mouth Health 
Pharyngeal Oedema 	Professional Levlen 
Date:04/27/98ISR Number: 3070615-4Report Type:Expedited (15-DaCompany Report #96103  Report Source Product Foreign Lariam Health Professional 
Outcome 
Other Serious  	Psychotic DisorderDelirium Progressive MultifocalLeukoencephalopathyMania Report Source Product Foreign Lariam Health Professional 
Date:04/27/98ISR Number: 3072501-2Report Type:Direct           Company Report  Age:40  Gender:Male  I/FU:I  
Outcome DisabilityRequired  
03-Apr-2012   09:37  Page:  

Intervention Prevent Permanent Impairment/Damage Personality Disorder  Disorientation Acute PsychosisParanoia Hallucination, AuditoryVisual ImpairmentAgitationNausea Disturbance Attention Headache  Report Source  Product Mefloquine  Role  Manufacturer  Route ORAL  Dose 250MG WEEKLY  Duration  
Date:04/29/98ISR Number: 3072953-8Report Type:Direct   Company Report  Age:28  Gender:Female  I/FU:I  
Outcome DisabilityOther Serious Fear Heat Exhaustion Paranoia Insomnia Nausea VomitingDecreased AppetitePanic Attack AlopeciaPalpitations  Report SourceHealth Professional  Product Lariam  Role  Manufacturer Roche   Route ORAL  Dose TABLET WEEKLY  Duration  
Date:04/30/98ISR Number: 3074393-4Report Type:Expedited (15-DaCompany Report #98097   Age:37  Gender:Male  I/FU:I  
Outcome Death Skull Fracture Facial Bones Fracture Completed SuicideAortic InjuryMultiple InjuriesFall  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL TAB  
Date:04/30/98ISR Number: 3074395-8Report Type:Expedited (15-DaCompany Report #98092   Age:  Gender:  I/FU:I  
Outcome Other Serious Paralysis  Report SourceForeignHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose ORAL  Duration  

Date:05/04/98ISR Number: 3073979-0Report Type:Expedited (15-DaCompany Report #93422   Age:28  Gender:Female  I/FU:I  
Outcome Hospitalization Initial ProlongedDisability Rash Pruritic Insomnia HypersensitivitySwellingSpider Naevus  
03-Apr-2012   09:37  Page:  

DepressionRestlessness Mental Disorder Asthma Nausea AnxietyVision Blurred Headache  Report SourceOther  Product Lariam Hepatitis VaccineAlbuterol Inhaler Triphasic BirthControl Pill  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Date:05/04/98ISR Number: 3073980-7Report Type:Expedited (15-DaCompany Report #96923  Outcome Report Source Product Other Serious Disturbance Attention Foreign Lariam Amnesia Health Brain Neoplasm Professional Mental Disorder  Role  Manufacturer  Age: Route ORAL  Gender:Female  Dose ORAL  I/FU:I Duration  
Date:05/05/98ISR Number: 3073586-XReport Type:Expedited (15-DaCompany Report #91747  Outcome Report Source Product Other Serious Maternal Drugs Affecting Foreign Lariam Foetus Health Dysmorphism Professional Vaccines Nos  Role  Manufacturer  Age:29 Route ORAL  Gender:Female Dose 250 PER WEEK  I/FU:I Duration  
Date:05/05/98ISR Number: 3073768-7Report Type:Expedited (15-DaCompany Report #98430  Outcome Report Source Product Other Serious Dyspnoea Lariam Pulmonary Fibrosis  Role  Manufacturer  Age:74 Route ORAL  Gender:Male Dose ORAL  I/FU:I Duration  
Date:05/05/98ISR Number: 3073808-5Report Type:Expedited (15-DaCompany Report #97885  Outcome Report Source Product Hospitalization -Hypoaesthesia Foreign Lariam Initial Prolonged Dry Mouth Health Oedema Mouth Professional Levlen Pharyngeal OedemaLiver Function Test Abnormal  Role  Manufacturer   Age:30 Route ORAL  Gender:Female I/FU:F Dose Duration 250 PER WEEK ORAL  
Date:05/12/98ISR Number: 3075378-4Report Type:Direct   Company Report  Age:21  Gender:Female  I/FU:I  

03-Apr-2012  09:37 Page: Date:05/12/98ISR Number: 3077579-8Report Type:Expedited (15-DaCompany Report #91489  Age:57 Gender:Female I/FU:F 
Date:05/12/98ISR Number: 3076411-6Report Type:Expedited (15-DaCompany Report #9905511   Age:27  Gender:Male  I/FU:I  
Outcome Death Psychotic DisorderEpilepsyDrug Level BelowTherapeuticDrug InteractionAbnormal Behaviour  Report SourceForeignConsumer  Product DepakeneMefloquineCarbamazepine  Role  Manufacturer Abbott  Route ORAL ORAL  Dose  Duration  
Date:05/12/98ISR Number: 3077372-6Report Type:Expedited (15-DaCompany Report #98566   Age:42  Gender:Male  I/FU:I  
Outcome Other Serious Thinking AbnormalMania  Report SourceForeignOther  Product Lariam  Role  Manufacturer Global Development  Route ORAL  Dose 250 PER DAY ORAL  Duration  
Date:05/12/98ISR Number: 3077375-1Report Type:Expedited (15-DaCompany Report #87481   Age:53  Gender:Male  I/FU:F  
Outcome Disability FatigueHypertensionOedema  Report SourceHealth Professional Other  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Nausea  
Sleep Apnoea SyndromeOverdose  
CoughEye IrritationVisual Acuity ReducedDizziness  
HypoaesthesiaBone Pain  
Chest Pain  
Paraesthesia  
Medication Error  
Brain InjuryNeck Pain  
Nocturia  
DysgeusiaThinking AbnormalVomitingUpper Respiratory TractInfection  

Outcome Report Source Product Role Manufacturer Route Dose Duration Other Serious Spinal Cord Injury Foreign Lariam ORAL 250 PER 
Cervical Cerebral Ischaemia   StudyHealth  Flu Vaccine  WEEK  
Clonic Convulsion Spinal Cord InjuryThoracic  Professional Other  (Influenza VirusVaccine)Flixotide(Fluticasone Propionate)Salbutamol  
(Albuterol)  
03-Apr-2012   09:37  Page:  

Prozac (FluoxetineHydrochloride)Tetracyclin(Tetracycline)  
Date:05/15/98ISR Number: 3079401-2Report Type:Expedited (15-DaCompany Report #96103  Outcome Report Source Product Other Serious Mania Foreign Lariam Encephalopathy Health Delirium Professional Psychotic Disorder  Role  Manufacturer  Age:67 Route ORAL  Gender:Male Dose 250 PER WEEK ORAL  I/FU:F Duration  
Date:05/15/98ISR Number: 3079404-8Report Type:Expedited (15-DaCompany Report #98742  Outcome Report Source Product Hospitalization Myocardial Infarction Foreign Lariam Initial Prolonged Health Professional  Role  Manufacturer  Age:54 Route ORAL  Gender:Male  I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:05/15/98ISR Number: 3079416-4Report Type:Expedited (15-DaCompany Report #89246  Outcome Report Source Product Required Premature Labour Foreign Lariam Intervention Health Prevent Permanent Professional Impairment/Damage  Role  Manufacturer  Age:37 Route ORAL  Gender:Female Dose 250 1XPER WEEK ORAL  I/FU:F Duration  
Date:05/15/98ISR Number: 3079420-6Report Type:Expedited (15-DaCompany Report #96729  Outcome Report Source Product  Other Serious Clonic Convulsion Foreign Lariam Other Influenza Vaccine Flixotide Salbutamol Prozac Tetracycline  Role  Manufacturer  Age:57 Route ORAL  Gender:Female Dose 250MG 1XPER WEEK ORAL  I/FU:F Duration  
Date:05/15/98ISR Number: 3079450-4Report Type:Expedited (15-DaCompany Report #93562                                          Outcome Report Source Product Hospitalization Renal Failure Foreign Larium  Role  Manufacturer  Age:32 Route ORAL  Gender:Female I/FU:F Dose Duration 250MG PER  

Initial Prolonged 	Systemic Lupus Health WEEK ORAL Erythematosus Professional Pre-Eclampsia  Other Abortion Spontaneous 
03-Apr-2012  09:37 	Page: 
Date:05/15/98ISR Number: 3079460-7Report Type:Expedited (15-DaCompany Report #98539   Age:26  Gender:Female  I/FU:I  
Outcome Hospitalization Initial ProlongedCongenital Anomaly DysmorphismOligohydramniosPlacental Disorder Maternal Drugs AffectingFoetus  Report SourceForeignOther  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Date:05/15/98ISR Number: 3079461-9Report Type:Expedited (15-DaCompany Report #97094   Age:66  Gender:Female  I/FU:F  
Outcome Other Serious Oedema PeripheralAllergic GranulomatousAngiitisSkin Mass  Report SourceOther  Product Lariam Proventil Inhaler AminophyllineFosamax Premarin Flovent Vitamin  Fish Oil Calcium Seliran Multivitamins Accolate Vitamin  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Date:05/19/98ISR Number: 3081150-1Report Type:Expedited (15-DaCompany Report #83711   Age:  Gender:Male   I/FU:I  
Outcome Other Serious Paranoia Visual ImpairmentAnxietySchizophreniaAbnormal Dreams Psychotic DisorderHallucination, Visual  Report SourceHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Date:05/19/98ISR Number: 3081153-7Report Type:Expedited (15-DaCompany Report #80215   Age:53  Gender:Female  I/FU:F  
Outcome Other Serious NightmareNausea Visual ImpairmentBlindness  Report SourceCompanyRepresentative  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  

Date:05/19/98ISR Number: 3081447-5Report Type:Expedited (15-DaCompany Report #85335                               Age:23  Gender:Male  I/FU:I  
Outcome Hospitalization Initial Prolonged Abnormal Behaviour  AggressionHallucination Schizophrenia  Report SourceHealth Professional  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration DOSE FROM PER WEEK ORAL  
03-Apr-2012   09:37  Page:  

FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  
Date:05/20/98ISR Number: 3080425-XReport Type:Direct  Outcome Disability Visual ImpairmentOther Serious Abnormal Dreams Mood Altered AnxietyPanic Attack  Company Report Report Source Product Lariam  Role  Manufacturer  Age: Route  Gender:Male Dose 250 WEEK  I/FU:I Duration  
Date:05/20/98ISR Number: 3081830-8Report Type:Expedited (15-DaCompany Report #98794  Outcome Report Source Product Other Serious Haemolysis Foreign Lariam Liver Function Test Health Abnormal Professional Platelet Count Decreased  Role  Manufacturer  Age:26 Route ORAL   Gender:Female I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:05/22/98ISR Number: 3082507-5Report Type:Expedited (15-DaCompany Report #96767  Outcome Report Source Product Disability Retinal Detachment Health Lariam Malaria Professional Intraocular Pressure Other Increased PyrexiaEye PainChills Hyperhidrosis  Role  Manufacturer  Age:53 Route ORAL  Gender:Male I/FU:F Dose Duration 250 1XPER WEEK ORAL  
Date:05/22/98ISR Number: 3082511-7Report Type:Expedited (15-DaCompany Report #88781                     Outcome Report Source Product Other Serious Premature Baby  Foreign Lariam Uterine Haemorrhage Health Respiratory Disorder Professional Neonatal Infection Uterine InjuryMaternal Drugs AffectingFoetus Cervical IncompetenceHaematoma Vaginal Haemorrhage  Role  Manufacturer  Age:29 Route ORAL  Gender:Female I/FU:F Dose Duration 250 PER WEEK ORAL  
Date:05/22/98ISR Number: 3082513-0Report Type:Expedited (15-DaCompany Report #88780                      Age:29  Gender:Female  I/FU:F  

Outcome Other Serious Premature Baby  Premature Labour  Report SourceForeignHealth  Product Lariam  Role  Manufacturer  Route ORAL  Dose Duration 250 PER WEEK ORAL  
Vaginal HaemorrhageInfection  Professional  
Cervical IncompetenceHaematoma  
03-Apr-2012   09:37  Page:  

Date:05/26/98ISR Number: 3084316-XReport Type:Direct  Outcome Other Serious Abnormal Dreams Dizziness Feeling AbnormalAnxiety  Company Report Report Source Product Health MefloquineProfessional  Role   Manufacturer  Age:25 Route ORAL  Gender:Female Dose TAB 250 MG/WK P.O.  I/FU:I Duration  
Date:05/28/98ISR Number: 3084620-5Report Type:Expedited (15-DaCompany Report #99368                  Outcome Report Source Product Other Serious Infectious Mononucleosis Foreign Lariam Mouth Ulceration Other Post Viral FatigueSyndromeLymphopenia  Role  Manufacturer  Age:19 Route ORAL  Gender:Male I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:06/01/98ISR Number: 3087636-8Report Type:Expedited (15-DaCompany Report #85972                           Outcome Report Source Product Other Serious Maternal Drugs Affecting  Foreign Lariam Foetus Health Jaundice Neonatal Professional Cabergoline  Role  Manufacturer  Age: Route ORAL  Gender:Female I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:06/01/98ISR Number: 3088034-3Report Type:Expedited (15-DaCompany Report #98742  Outcome Report Source Product Hospitalization Myocardial Infarction Foreign Lariam Initial Prolonged Health Professional  Role  Manufacturer  Age:54  Route ORAL  Gender:Male I/FU:F Dose Duration 250 PER WEEK ORAL  
Date:06/01/98ISR Number: 3088035-5Report Type:Expedited (15-DaCompany Report #99181  Outcome Report Source Product Hospitalization -Dyspnoea Foreign Lariam Initial Prolonged Hypersensitivity Health Asthma Professional  Role  Manufacturer  Age:53 Route ORAL  Gender:Male I/FU:I Dose Duration 250 PER WEEK ORAL  
Date:06/01/98ISR Number: 3088675-3Report Type:Expedited (15-DaCompany Report #80215  Outcome Report Source Product Other Serious Nausea Consumer Lariam Visual Acuity Reduced  Role  Manufacturer  Age:53 Route ORAL  Gender:Female I/FU:I Dose Duration 250 PER WEEK ORAL  

Nightmare Estrogen 
03-Apr-2012  09:37 Page: 
Freedom Information (FOI) Report 
Date:06/02/98ISR Number: 3088297-4Report Type:Expedited (15-DaCompany Report #98097                                              
Outcome Report Source Product Role Manufacturer Death Depression Foreign Lariam 
Completed Suicide Health 
Professional 
Other 
Date:06/04/98ISR Number: 3089762-6Report Type:Expedited (15-DaCompany Report #99833                                         
Outcome Report Source Product Role Manufacturer Other Serious Arthralgia Foreign Lariam 
Myalgia Other 
Date:06/04/98ISR Number: 3090175-1Report Type:Expedited (15-DaCompany Report #68408  
Outcome Report Source Product  Role Manufacturer 
Disability Spinal Fracture Health Lariam 
Hallucination Professional 
Paraplegia Other 
Mental Disorder 
Panic Attack 
Fall 
Date:06/04/98ISR Number: 3090177-5Report Type:Expedited (15-DaCompany Report #99753  
Outcome Report Source Product Role Manufacturer 
Other Serious Hallucination Other Lariam 
Agitation
Suicide Attempt
Suicidal Ideation 
Paranoia 
Flushing
Restlessness 
Diarrhoea 
Age:37  Gender:Male I/FU:F  
Route ORAL  Dose Duration 250 PER WEEK ORAL  
Age:36  Gender:Male I/FU:I  
Route ORAL  Dose Duration 250 PER WEEK ORAL  
Age:25  Gender:Male I/FU:F  
Route ORAL  Dose Duration 250 PER WEEK ORAL  
Age:24  Gender:Female I/FU:I  
Route ORAL  Dose Duration 250 PER WEEK ORAL  

Date:06/05/98ISR Number: 3179164-6Report Type:Periodic   Company Report #95701  Age:38  Gender:Male  I/FU:I  
Outcome Other Serious Abnormal Dreams  Nausea  Report SourceConsumer  Product Lariam Tablets (MefloquineHydrochloride)  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK  Duration DAY  

Date:06/08/98ISR Number: 3159668-2Report Type:Periodic   Company Report #81017  Age:53   Gender:Female  I/FU:I  
Outcome Other Serious Alopecia  Report SourceHealth  Professional  Product Lariam Tablets (MefloquineHydrochloride)  Role  Manufacturer  Route ORAL  Dose ORAL  Duration  
03-Apr-2012   09:37  Page:  

Synthroid  
Date:06/08/98ISR Number: 3159671-2Report Type:Periodic  Company Report #81018 Outcome Report Source Product Other Serious Pruritus Consumer Lariam Tablets Dizziness Health (MefloquineAlopecia Professional Hydrochloride)Abnormal Dreams 250.000 MgEye Irritation  Dyazide  Role  Manufacturer  Age:75 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK (ORAL)  I/FU:I Duration  
Date:06/08/98ISR Number: 3159674-8Report Type:Periodic  Company Report #82001 Outcome Report Source Product Other Serious Nausea Consumer Lariam Tablets Thirst (MefloquineEye Irritation Hydrochloride)Hypoaesthesia Oral  250.000 Zestril  Role  Manufacturer  Age:51 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159676-1Report Type:Periodic  Company Report #82176 Outcome Report Source Product Other Serious Abnormal Dreams Consumer Lariam Tablets Heart Rate Increased (MefloquineNervousness Hydrochloride)Paranoia 250.000 MgHallucinations, Mixed Anxiety  Role  Manufacturer  Age:29 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159680-3Report Type:Periodic  Company Report #82334 Outcome Report Source Product Other Serious Blood Phosphorus Health Lariam Tablets Increased  Professional (MefloquineGamma-Glutamyltransferase  Hydrochloride)Increased 250.000  Role  Manufacturer  Age:48 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  

Date:06/08/98ISR Number: 3159682-7Report Type:Periodic   Company Report #82521  Age:54  Gender:Male  I/FU:I  
Outcome Other Serious Tinnitus  Report SourceHealth Professional  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000  Duration  
03-Apr-2012   09:37  Page:  

FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3159683-9Report Type:Periodic  Company Report #82632 Outcome Report Source Product Other Serious Pain Extremity Health Lariam Tablets Pain Professional (MefloquineArthralgia Hydrochloride)250.000  Role  Manufacturer  Age:72 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159684-0Report Type:Periodic  Company Report #82726 Outcome Report Source Product Other Serious Disorientation Other Lariam Tablets Tremor (MefloquineAnxiety Hydrochloride)250.000  Role  Manufacturer  Age:20 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159685-2Report Type:Periodic  Company Report #83053 Outcome Report Source Product Other Serious Amnesia Other Lariam Tablets Judgement Impaired (MefloquinePanic Disorder Hydrochloride)Confusional State 250.000 MgCrying  Role  Manufacturer  Age:21 Route ORAL  Gender:Male I/FU:I Dose Duration 1.0000 DOSE FORM 1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3159686-4Report Type:Periodic  Company Report #83231 Outcome Report Source Product Other Serious Abnormal Dreams  Consumer Lariam Tablets Sedation (MefloquineMemory Impairment Hydrochloride)Vision Blurred 250.000 MgFatigueDizziness TachycardiaVisual Impairment  Role  Manufacturer  Age:38 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  

Date:06/08/98ISR Number: 3159687-6Report Type:Periodic   Company Report #83412  Age:24  Gender:Female  I/FU:I  
Outcome Other Serious Urinary IncontinenceMuscle Spasms  Report SourceOther  Product  Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000  Duration  
03-Apr-2012   09:37  Page:  

Yellow Fever Vaccine  Rabies Vaccine  1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3159688-8Report Type:Periodic  Company Report #83622 Outcome Report Source Product Other Serious Gynaecomastia Health  Lariam Tablets Professional (MefloquineHydrochloride)250.000 Sporanox(Itraconazole)250.000 Vitamin Vitamin Vitamin Complex  Role  Manufacturer  Age:48  Route ORAL ORAL  Gender:Male I/FU:I Dose Duration 250.000 1.0 PER WEEK ORAL 3.0 PER MON ORAL  
Date:06/08/98ISR Number: 3159690-6Report Type:Periodic  Company Report #83624  Outcome Report Source Product Other Serious  Visual Acuity Reduced Consumer Lariam Tablets Alopecia (MefloquineHydrochloride)250.000 Premarin Synthroid  Role  Manufacturer  Age:45 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159691-8Report Type:Periodic  Company Report #83790 Outcome Report Source Product Other Serious Visual Impairment Consumer Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:64 Route ORAL  Gender:Female Dose 250.000 1.O PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159692-XReport Type:Periodic   Company Report #83947  Age:58  Gender:Female  I/FU:I  

Outcome Other Serious HyporeflexiaParaesthesia  Report SourceConsumer  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000 1.0 PER  Duration  
WEEK ORAL  
Mevacor (Lovastatin)  ORAL  20.0000  
03-Apr-2012   09:37  Page:  

Premarin Provera  DAILY ORAL  
Date:06/08/98ISR Number: 3159694-3Report Type:Periodic  Company Report #83953 Outcome Report Source Product Other Serious Alopecia Consumer Lariam Tablets (MefloquineHydrochloride)250.000 Maxidex  Role  Manufacturer  Age:52 Route ORAL  Gender:Female  Dose 250.000 1.O PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159695-5Report Type:Periodic  Company Report #84120 Outcome Report Source Product Other Serious Depression Health Lariam Tablets Professional (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:52 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159697-9Report Type:Periodic  Company Report #84292 Outcome Report Source Product Other Serious Insomnia Consumer Lariam Tablets Palpitations (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:44 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159699-2Report Type:Periodic  Company Report #84462 Outcome Report Source Product Other Serious Nausea Health Lariam Tablets (Palpitations Professional MefloquineFlashback Hydrochloride)250.000   Role  Manufacturer  Age:39 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  

Date:06/08/98ISR Number: 3159701-8Report Type:Periodic   Company Report #84488  Age:22   Gender:Male  I/FU:I  
Outcome Other Serious Anxiety  Report SourceOther   Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000  Duration  
03-Apr-2012   09:37  Page:  

1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3159702-XReport Type:Periodic  Company Report #84805 Outcome Report Source Product Other Serious Dermatitis Exfoliative Health Lariam Tablets Professional (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:27 Route ORAL  Gender:Male Dose ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159703-1Report Type:Periodic  Company Report #84870 Outcome Report Source Product Other Serious Nausea Consumer Lariam Tablets Diarrhoea (MefloquineAsthenia Hydrochloride) Estrogen (EstrogensNos)  Role  Manufacturer  Age:59 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159705-5Report Type:Periodic  Company Report #84928 Outcome Report Source Product Other Serious  Paraesthesia Health Lariam Tablets Professional (MefloquineHydrochloride)  Sectral (Acebutolol)  Role  Manufacturer  Age:55 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159707-9Report Type:Periodic  Company Report #84953 Outcome Report Source Product Other Serious Blood Pressure Increased Consumer Lariam Tablets (MefloquineHydrochloride)  Role  Manufacturer  Age:57 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159709-2Report Type:Periodic  Company Report #84991  Outcome Report Source Product  Role  Manufacturer  Age:46 Route  Gender:Male Dose  I/FU:I Duration  

Other Serious  Dyspnoea Other Lariam Tablets 
(Mefloquine
Hydrochloride) ORAL 250.0000 
1.0 PER WEEK ORAL 
03-Apr-2012   09:37  Page:  

Date:06/08/98ISR Number: 3159710-9Report Type:Periodic  
Outcome  
Other Serious  Nausea  
Headache  
Dizziness  

Date:06/08/98ISR Number: 3159711-0Report Type:Periodic  
Outcome Other Serious Feeling Abnormal 
Date:06/08/98ISR Number: 3159712-2Report Type:Periodic  
Outcome  
Other Serious  Blood Pressure SystolicDecreased  
Eye IrritationNausea  
Insomnia  
Conjunctivitis Allergic  

Date:06/08/98ISR Number: 3159714-6Report Type:Periodic  
Outcome Other Serious Diarrhoea 
Date:06/08/98ISR Number: 3159716-XReport Type:Periodic  
Outcome 
Other Serious 	Psoriasis Abnormal Dreams Pruritus 
FDA -Adverse Event Reporting System (AERS)
 Freedom Information (FOI) Report
 
Company Report #85215  
Report SourceConsumer  Product Lariam Tablets  Role  Manufacturer  
(MefloquineHydrochloride)  

Company Report #85238 
Report Source 	Product Role Manufacturer 
Consumer 	Lariam Tablets (MefloquineHydrochloride) 
Company Report #85358 
Report Source 	Product Role Manufacturer 
Consumer 	Lariam Tablets (MefloquineHydrochloride)
250.000 
Company Report #85373 
Report Source 	Product Role Manufacturer 
Consumer 	Lariam Tablets (MefloquineHydrochloride) 
Company Report #85494  
Report SourceOther  Product Lariam Tablets  Role  Manufacturer  
(MefloquineHydrochloride)  

Age:44 Route 
ORAL 
Age:55 Route 
OCCLUSIVE DRESSING 
Age:57 Route 
ORAL  
Age: Route 
ORAL 
Age:44 Route 
ORAL Gender:Female I/FU:I 
Dose Duration 
250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Male I/FU:I 
Dose Duration 

250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Dose Duration 

250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Male I/FU:I 
Dose Duration 

250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Male I/FU:I 
Dose Duration 
250.0000 
1.0 PER 
WEEK ORAL 
03-Apr-2012  09:37 Page: 
Date:06/08/98ISR Number: 3159719-5Report Type:Periodic  Company Report #85538 Outcome Report Source Product Other Serious Metrorrhagia Health Lariam Tablets Professional (MefloquineHydrochloride) Synthroid(LevothyroxineSodium)  Role  Manufacturer  Age:31 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159721-3Report Type:Periodic  Company Report #85602 Outcome Report Source Product Other Serious Ecchymosis Health Lariam Tablets Professional (MefloquineHydrochloride) Cipro (CiprofloxacinHydrochloride)  Role  Manufacturer  Age:40 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3159722-5Report Type:Periodic  Company Report #85669 Outcome Report Source Product Other Serious Nausea Other Lariam Tablets Decreased Appetite (MefloquineHydrochloride)  Role  Manufacturer  Age:48 Route ORAL  Gender:Male I/FU:I Dose Duration 0.5000 DOSE FORM 1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3159725-0Report Type:Periodic     Company Report #85699 Outcome Report Source Product Other Serious Oligomenorrhoea Health Lariam Tablets Professional (MefloquineHydrochloride) Hepatitis Vaccine(Hepatitis Vaccine)Typhoid Vaccine(Typhoid Vaccines)  Polio Vaccination (PoliomyelitisVaccines)  Role  Manufacturer  Age:42 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  

Amoxicillin (Amoxicillin) Anaprox (NaproxenSodium) 
03-Apr-2012  09:37 Page: Date:06/08/98ISR Number: 3159726-2Report Type:Periodic  
Outcome Other Serious Urticaria 
Date:06/08/98ISR Number: 3159727-4Report Type:Periodic  
Outcome Other Serious Dermatitis 
Date:06/08/98ISR Number: 3159729-8Report Type:Periodic  
Outcome  
Other Serious  Chills  
PyrexiaMyalgia  

Date:06/08/98ISR Number: 3159730-4Report Type:Periodic  
Outcome 
Other Serious 	Emotional Disorder AggressionAbnormal Dreams Crying 
Date:06/08/98ISR Number: 3159731-6Report Type:Periodic  
Outcome Other Serious Alopecia 
Company Report #85807  Age:3  Gender:Male  I/FU:I  
Report Source Product Health Lariam Tablets  Role  Manufacturer  Route  Dose  Duration  
Professional (MefloquineHydrochloride)  ORAL  250.0000 1.0 PER  
WEEK ORAL  
Company Report #85892  Age:30  Gender:Female  I/FU:I  
Report Source Product Health Lariam Tablets  Role  Manufacturer  Route  Dose  Duration  
Professional (MefloquineHydrochloride)  ORAL  250.0000 1.0 PER  
WEEK ORAL  
Contraceptives(Contraceptives)  
Company Report #86520  Age:40  Gender:Male  I/FU:I  
Report Source Product Health Lariam Tablets  Role  Manufacturer  Route  Dose  Duration  
Professional (MefloquineHydrochloride)  ORAL  250.0000 1.0 PER  
WEEK ORAL  
Company Report #86747  Age:23  Gender:Female  I/FU:I  
Report Source Product Other Lariam Tablets  Role  Manufacturer  Route  Dose  Duration  
(MefloquineHydrochloride)  ORAL  250.0000 1.0 PER  
WEEK ORAL  
Company Report #86858  Age:35  Gender:Female  I/FU:I  
Report Source Product Consumer Lariam Tablets  Role  Manufacturer  Route  Dose  Duration  
(MefloquineHydrochloride)  ORAL  250.0000 1.0 PER  

WEEK ORAL 
03-Apr-2012  09:37 Page: 
Date:06/08/98ISR Number: 3159732-8Report Type:Periodic   Company Report #87231  Age:28  Gender:Female  I/FU:I  
Outcome Other Serious Pruritus Rash Maculo-Papular   Report SourceHealth Professional  Product Lariam Tablets (MefloquineHydrochloride) Ortho-Novum (EthinylEstradiol Menstranol/Norethindrone)  Role  Manufacturer  Route ORAL  Dose 250.0000 1.0 PER WEEK ORAL  Duration  
Date:06/08/98ISR Number: 3159734-1Report Type:Periodic   Company Report #87256  Age:53  Gender:Female  I/FU:I  
Outcome Other Serious FlushingInsomnia  Report SourceConsumer  Product Lariam Tablets (MefloquineHydrochloride) Zantac (Ranitidine)  Vivelle Transdermal System (Estradiol)  Role  Manufacturer  Route ORAL  Dose 125.0000 2.0 PER WEEK ORAL  Duration DAY  
Date:06/08/98ISR Number: 3160383-XReport Type:Periodic   Company Report #87379  Age:68  Gender:Female  I/FU:I  
Outcome Other Serious Tinnitus Insomnia Dizziness Nausea Nasal Congestion  Report SourceConsumer Health Professional  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000 1.0 PER WEEK ORAL  Duration  
Date:06/08/98ISR Number: 3160387-7Report Type:Periodic   Company Report #87446  Age:51  Gender:Male  I/FU:I  
Outcome Other Serious Blood Iron Increased Hepatomegaly  Report SourceConsumer  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.000 1.0 PER WEEK ORAL  Duration  

Date:06/08/98ISR Number: 3160390-7Report Type:Periodic   Company Report #87479  Age:41  Gender:Female  I/FU:I  
Outcome Other Serious Dizziness Nausea Hair Disorder  Report SourceHealth Professional  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL   Dose 250.000 1.0 PER WEEK  Duration  
03-Apr-2012   09:37  Page:  

FDA -Adverse Event Reporting System (AERS) Freedom Information (FOI) Report  ORAL  
Date:06/08/98ISR Number: 3160394-4Report Type:Periodic  Company Report #87727 Outcome Report Source Product Other Serious Blindness Other Lariam Tablets Deafness (MefloquineHydrochloride)  Role  Manufacturer  Age: Route ORAL  Gender: Dose ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3160396-8Report Type:Periodic  Company Report #87777 Outcome Report Source Product Other Serious Dyspepsia Consumer Lariam Tablets (MefloquineHydrochloride)250.000 Demulen  Role  Manufacturer  Age:35 Route ORAL  Gender:Female Dose 250.000 1.0 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3160398-1Report Type:Periodic  Company Report #87993 Outcome Report Source Product Other Serious Pollakiuria Health Lariam Tablets Thirst Professional (MefloquineHydrochloride) 250.000  Role  Manufacturer  Age: Route ORAL  Gender: Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3160401-9Report Type:Periodic  Company Report #87999 Outcome Report Source  Product Other Serious Insomnia Consumer Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:62 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3160403-2Report Type:Periodic  Company Report #88273 Outcome Report Source Product Other Serious Vertigo Health Lariam Tablets  Role  Manufacturer  Age:65 Route  Gender:Male Dose  I/FU:I Duration  

Professional (Mefloquine
Hydrochloride) 250.
000 ORAL 250.000 
1.0 PER WEEK ORAL 
03-Apr-2012   09:37  Page:  

Date:06/08/98ISR Number: 3160405-6Report Type:Periodic  
Outcome 
Other Serious 	Tremor Dizziness LymphadenopathyIrritabilityNausea Headache 
Date:06/08/98ISR Number: 3160406-8Report Type:Periodic  
Outcome Other Serious Headache 
Date:06/08/98ISR Number: 3160409-3Report Type:Periodic  
Outcome  
Other Serious  DyspepsiaNightmareInsomnia  
Headache  

Date:06/08/98ISR Number: 3160410-XReport Type:Periodic  
Outcome Other Serious Nightmare 
Date:06/08/98ISR Number: 3160412-3Report Type:Periodic  Outcome 
Company Report #88393 
Report SourceConsumer  Product Lariam Tablets  
(MefloquineHydrochloride)250.00  
CiproNordette  

Company Report #89194 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride) 250.000 
Company Report #89203 
Report Source  	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)

250.000 
Company Report #89287 
Report Source Product Health Lariam Tablets Professional (Mefloquine
Hydrochloride)

250.000 
Company Report #89617 Report Source Product 
Role  Manufacturer  
Role  Manufacturer   
Role  Manufacturer  
Role   Manufacturer  

Role Manufacturer 
Age:33 Route 
ORAL 
Age:34 Route 
ORAL 
Age:33 Route 
ORAL 
Age:30 Route 
ORAL 
Age:27 Route 
Gender:Female I/FU:I 
Dose Duration 

250.000 
1.0 PER WEEK
 ORAL
 
Gender:Male I/FU:I 
Dose Duration 

250.000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Dose Duration 
250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Dose Duration 

250.0000 
1.0 PER
 WEEK ORAL
 
Gender:Female  I/FU:I
 Dose Duration
 
Other Serious  VomitingPyrexiaPanic Attack Decreased AppetiteDizziness  Consumer  Lariam Tablets (MefloquineHydrochloride)250.000  ORAL  250.00 1.0 PER WEEK  
Disturbance Attention  ORAL  
Ortho Novum  
Hepatitis Vaccine  
03-Apr-2012   09:37  Page:  

Valium General Anesthesia Lortab Erytromycin  
Date:06/08/98ISR Number: 3160413-5Report Type:Periodic  Company Report #90262 Outcome Report Source Product Other Serious Paraesthesia Consumer Lariam Tablets (MefloquineHydrochloride)250.000 Estrace Prilosec  Role  Manufacturer  Age:63 Route ORAL  Gender:Female  Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3175254-2Report Type:Periodic  Company Report #90313 Outcome Report Source Product Other Serious Hallucination Health Lariam Tablets Insomnia Professional (MefloquineHydrochloride)250.00  Role  Manufacturer  Age:15 Route ORAL  Gender:Male Dose 250.000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3175260-8Report Type:Periodic  Company Report #90406 Outcome Report Source Product Other Serious Emotional Disorder  Literature Lariam Tablets Anxiety Consumer (MefloquineHydrochloride)250.00 Synthroid   Role  Manufacturer  Age:46 Route ORAL  Gender:Female Dose 250.000 1.0 PER WEEK, ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3175262-1Report Type:Periodic  Company Report #91164 Outcome Report Source  Product Other Serious Viral Infection Consumer Lariam Tablets Dyspepsia (MefloquineTachycardia Hydrochloride)Tremor 250.00  Role  Manufacturer  Age:69 Route ORAL  Gender:Male Dose 250.000  I/FU:I Duration  

Pyrexia 1.0 PER 
WEEK, ORAL Glucophage Glyburide Flu Shot Lotensin Date:06/08/98ISR Number: 3175264-5Report Type:Periodic  
03-Apr-2012   09:37  Page:  

Outcome  
Other Serious  DepressionDiarrhoea  
CryingDysphoria  

Date:06/08/98ISR Number: 3175267-0Report Type:Periodic  
Outcome  
Other Serious  Insomnia  
Pressure SpeechRestlessness  
Paranoia  

Date:06/08/98ISR Number: 3175269-4Report Type:Periodic  
Outcome Other Serious  Menstruation Irregular 

Date:06/08/98ISR Number: 3175271-2Report Type:Periodic  
Outcome  
Other Serious  NightmareHeart Rate Increased   
Insomnia  
Anxiety  

Date:06/08/98ISR Number: 3175273-6Report Type:Periodic     Outcome 
Company Report #91344 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)
250.00 
Company Report #91417 
Report Source 	Product 
Other 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Company Report #91527 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Vitamin 
Company Report #91582 
Report Source 	Product 

Consumer 	Lariam Tablets (MefloquineHydrochloride) 250Mg 
Ortho-Novum 7/7/7  
Company Report #91731 
Report Source 	Product 

Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  

Age:32 Route 
ORAL 

Age:40 Route 
ORAL 

Age:22 Route 
ORAL 

Age:33 Route 
ORAL 

Age:36 Route 
Gender:Male I/FU:I 
Dose Duration 

250.0000 
1.0 PER
 WEEK, ORAL
 
Gender:Female I/FU:I 
Dose Duration 
250.00 1.0 PER WEEK,
 ORAL
 
Gender:Female I/FU:I 
Dose Duration 

250.0000 
1.0 PER WEEK,
 ORAL
 
Gender:Female I/FU:I 
Dose Duration 
250 1.0
 PER WEEK,
 ORAL
 
Gender:Female I/FU:I
 Dose Duration
 
Other Serious  Restlessness  Other  Lariam Tablets  
Nausea Diarrhoea DyspepsiaFlatulence Dermatitis  (MefloquineHydrochloride)250.00  ORAL  250.00 1.0 PER WEEK, ORAL  
Dizziness  
03-Apr-2012   09:37  Page:  

Date:06/08/98ISR Number: 3175275-XReport Type:Periodic  
Outcome  
Other Serious  Prothrombin Time   
Prolonged  

Date:06/08/98ISR Number: 3175277-3Report Type:Periodic  
Outcome  
Other Serious  Nausea  
Diarrhoea  

Date:06/08/98ISR Number: 3175279-7Report Type:Periodic  
Outcome  
Other Serious  Diarrhoea  
Insomnia  
Visual Acuity ReducedParaesthesia  
Thinking AbnormalHallucination  

Date:06/08/98ISR Number: 3175282-7Report Type:Periodic  
Outcome 
Other Serious 	Diarrhoea Nausea Emotional Disorder Amoebic Dysentery 

Date:06/08/98ISR Number: 3175284-0Report Type:Periodic  Outcome 
Company Report #92041 
Report SourceOther  Product Lariam Tablets  
(MefloquineHydrochloride)250.00  
Coumadin   

Company Report #92512 
Report Source  	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)
250.00 
Company Report #92525 
Report Source Product Health Lariam Tablets Professional (Mefloquine
Hydrochloride)

250.00 
Company Report #92697 
Report Source Product Health Lariam Tablets Professional (Mefloquine
Hydrochloride)

250.00 
Flagyl 
Company Report #92713 
Report Source 	Product 

Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  

Age:56 Route 
ORAL 

Age:72 Route 
ORAL 

Age:19 Route 
ORAL 

Age:40 Route 
ORAL 

Age:38 Route 
Gender:Female I/FU:I 
Dose Duration 
250.00 1.0
 PER WEEK,
 ORAL
 
Gender:Female I/FU:I 
Dose Duration 
250.00 1.0 PER WEEK,
 ORAL
 
Gender:Male I/FU:I 
Dose Duration 
250.00 1.0 PER ODOS,
 ORAL
 
Gender:Female  I/FU:I 
Dose Duration 
250.000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I
 Dose Duration
 
Other Serious Anxiety Consumer Lariam Tablets Insomnia (MefloquineHydrochloride)
250.00 ORAL 250.00 1.0 PER WEEK ORAL Date:06/08/98ISR Number: 3175286-4Report Type:Periodic  
03-Apr-2012   09:37  Page:  

Outcome Other Serious Nightmare 

Date:06/08/98ISR Number: 3175288-8Report Type:Periodic  
Outcome  
Other Serious  VomitingAgitationDizziness  
Photosensitivity ReactionInsomnia  

Date:06/08/98ISR Number: 3175290-6Report Type:Periodic  
Outcome 
Other Serious 	ArthralgiaMyalgia 

Date:06/08/98ISR Number: 3175291-8Report Type:Periodic  
Outcome Other Serious Chromaturia 

Date:06/08/98ISR Number: 3175292-XReport Type:Periodic  
Outcome Other Serious  Laryngitis 
Company Report #92738 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Company Report #92825 
Report Source 	Product 
Other 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Company Report #93510 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Company Report #93511 
Report Source 	Product 
Consumer 	Lariam Tablets (MefloquineHydrochloride)

250.00 
Ortho-Novum 1/35  
Company Report #93513  
Report Source Product Consumer Lariam Tablets 

Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  
Role  Manufacturer  

Age:54 Route 
ORAL 

Age:13 Route 
ORAL 

Age:41 Route 
ORAL 

Age:31 Route 
ORAL 

Age:35 Route 
Gender:Male I/FU:I 
Dose Duration 

250.000 
1.0 PER
 WEEK, ORAL
 
Gender:Male I/FU:I 
Dose Duration 

250.000 
1.0 PER
 WEEK ORAL
 
Gender:Female I/FU:I 
Dose Duration 

250.000 
1.0 PER
 WEEK, ORAL
 
Gender:Female I/FU:I 
Dose Duration 
250.00 1.0 PER WEEK,
 ORAL
 
Gender:Female I/FU:I
 Dose Duration
 
Health Professional  (MefloquineHydrochloride)250.00  ORAL  250.00 1.0 PER WEEK  
ORAL  
Amoxycillin  
03-Apr-2012   09:37  Page:  

Date:06/08/98ISR Number: 3175294-3Report Type:Periodic  Company Report #93921  Outcome Report Source Product Other Serious Syncope Other Lariam Tablets Abdominal Pain (MefloquineDizziness Hydrochloride)Vomiting 250.00  Role  Manufacturer  Age:20 Route ORAL  Gender:Female I/FU:I Dose Duration 250.00 1.0 PER ODOS, ORAL  
Date:06/08/98ISR Number: 3175296-7Report Type:Periodic  Company Report #93923 Outcome Report Source Product Other Serious Depression Health Lariam Tablets Anxiety Professional (MefloquineNervousness  Hydrochloride) 250Mg  Role  Manufacturer   Age:20 Route ORAL  Gender:Female I/FU:I Dose Duration 250.00 1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3179135-XReport Type:Periodic  Company Report #76339 Outcome Report Source Product Other Serious Neurogenic Bladder Health Lariam Tablets Pollakiuria Professional (MefloquineMicturition Urgency Hydrochloride)250.000  Role  Manufacturer  Age:54 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3179137-3Report Type:Periodic  Company Report #77417 Outcome Report Source Product Other Serious Abortion Spontaneous Consumer Lariam Tablets (MefloquineHydrochloride)Typhoid Vaccine(Thphoid Vaccines)Dramamine (Dimenhydrinate)Measles, Mumps, Rubella Vaccine (Measles VirusVaccine Live/MumpsVirus Vaccine  Role  Manufacturer  Age:39 Route ORAL  Gender:Female Dose ORAL  I/FU:I Duration  

Date:06/08/98ISR Number: 3179139-7Report Type:Periodic   Company Report #78055  Age:34  Gender:Female  I/FU:I  
Outcome Other Serious Dizziness Hypoaesthesia OralHeadache  Report SourceHealth Professional  Product Lariam Tablets (MefloquineHydrochloride)250.000  Role  Manufacturer  Route ORAL  Dose 250.0000  Duration  
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1.0 PER WEEK ORAL  
Date:06/08/98ISR Number: 3179140-3Report Type:Periodic  Company Report #80073 Outcome Report Source Product Other Serious Sedation Other Lariam Tablets Petit Mal Epilepsy (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:10 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK, ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3179141-5Report Type:Periodic  Company Report #80172 Outcome Report Source Product Other Serious Prostatic Specific Health Lariam Tablets Antigen Increased Professional (MefloquineHydrochloride)250.000 Hytrin (TerazosinHydrochloride)  Role  Manufacturer  Age:50 Route ORAL  Gender:Male Dose 250.0000 1.0 PER WEEK, ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3179143-9Report Type:Periodic  Company Report #80199 Outcome Report Source Product Other Serious Diarrhoea Other Lariam Tablets (MefloquineHydrochloride)250.000 Accupril (QuinaprilHydrochloride)Prempro (Estrogens,Conjugated/Medroxyprogesterone Acetate)  Role  Manufacturer  Age:56 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK, ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3179145-2Report Type:Periodic  Company Report #80216 Outcome Report Source Product  Other Serious Nausea Consumer Lariam Tablets Abdominal Pain Upper (Mefloquine Muscle Spasms Hydrochloride)  Role  Manufacturer  Age:65 Route  Gender:Male Dose  I/FU:I Duration  

250.000  ORAL  250.0000 1.0 PER  
Klonopin(Clonazepam)Ritalin  WEEK,  ORAL  
(MethylphenidateHydrochloride)  
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Inderal (PropranololHydrochloride)Paxil (Paroxetine)  
Date:06/08/98ISR Number: 3179146-4Report Type:Periodic  Company Report #96623 Outcome Report Source Product Other Serious  Alopecia Consumer Lariam Tablets Depression Other (MefloquineHydrochloride)250.000  Role  Manufacturer  Age:23 Route ORAL  Gender:Female Dose 250.0000 1.0 PER WEEK ORAL  I/FU:I Duration  
Date:06/08/98ISR Number: 3179147-6Report Type:Periodic  Company Report #97072 Outcome Report Source Product Other Serious Abdominal Pain Upper Consumer Lariam Tablets Blood Cholesterol (MefloquineIncreased Hidrochloride) 250.000 Lipitor(AtorvastatinCalcium)Hepatitis Injection(Hepatitis InjectionNos)Calcium (CalciumNos)Magnesium (MagnesiumNos)Glucosamine Sulfate (GlucosamineSulfate)Vitamin (VitaminE)Mult