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Lariam (Mefloquine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lariam (Mefloquine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (80)
Life Threatening Events (10)
Disability (12)

Reports by Reaction Type

Anxiety (18)Depression (16)Tinnitus (12)Dizziness (12)Anger (11)Nightmare (11)Suicidal Ideation (10)Balance Disorder (10)Sleep Disorder (10)Paranoia (8)Psychotic Disorder (8)Insomnia (8)

Below are a few examples of reports where side effects / adverse reactions may be related to Lariam (Mefloquine). For a complete list or a specific selection of reports, please use the links above.

Possible Lariam side effects in 26 year old male

Reported by a consumer/non-health professional from Ireland on 2012-08-22

Patient: 26 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Completed Suicide

Drug(s) suspected as cause:
Lariam
    Indication: Malaria
    Start date: 2009-01-11
    End date: 2009-06-13

Lariam
    Indication: Malaria
    Start date: 2005-01-01
    End date: 2005-06-01



Possible Lariam side effects in 45 year old male

Reported by a physician from France on 2012-08-22

Patient: 45 year old male

Reactions: Agitation, Suicide Attempt, Delirium, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam

Other drugs received by patient: Aspirin; Simvastatin



Possible Lariam side effects in male

Reported by a consumer/non-health professional from Australia on 2012-08-20

Patient: male

Reactions: Headache, Somnolence

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: female, weighing 74.1 kg (163.0 pounds)

Reactions: Maternal Exposure During Pregnancy, Acute Psychosis

Drug(s) suspected as cause:
Lariam

Other drugs received by patient: Pregnacare



Possible Lariam side effects in 31 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: 31 year old male

Reactions: Electrocardiogram QT Prolonged, Arrhythmia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: male, weighing 77.1 kg (169.6 pounds)

Reactions: Balance Disorder, Photophobia, Reading Disorder, Toxicity To Various Agents

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 18 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-03

Patient: 18 year old female

Reactions: Claustrophobia, Loss of Consciousness, Delusion, Thinking Abnormal, Road Traffic Accident, Anger, Violence-Related Symptom, Depression, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Lariam

Lariam
    Dosage: 250 mg once a week po
    Administration route: Oral
    Indication: Malaria Prophylaxis
    Start date: 2012-05-29



Possible Lariam side effects in 29 year old female

Reported by a lawyer from United Kingdom on 2012-07-12

Patient: 29 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Anxiety, Depression, Hallucination

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 26 year old female

Reported by a lawyer from Italy on 2012-07-06

Patient: 26 year old female, weighing 44.0 kg (96.8 pounds)

Reactions: Weight Decreased, Labyrinthitis, Tinnitus, Nausea, Hypotension, Rash, Headache, Abdominal Pain Upper, Abnormal Dreams, Fatigue, Balance Disorder, Diarrhoea, Dizziness, Hallucination

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 18 year old female

Reported by a physician from Germany on 2012-07-06

Patient: 18 year old female

Reactions: Malaria, Fatigue, Fear, Dizziness, Agoraphobia

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05

Patient: 21 year old male, weighing 83.9 kg (184.6 pounds)

Reactions: Abnormal Dreams, Mania, Psychotic Disorder, Drug Ineffective, Insomnia, Cold Sweat

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 36 year old male

Reported by a individual with unspecified qualification from Ireland on 2012-07-05

Patient: 36 year old male, weighing 98.0 kg (215.6 pounds)

Reactions: Anxiety, Arthralgia, Insomnia, Pain, Anger, Skin Disorder, Depression, Suicidal Ideation

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam
    Dosage: 1 tablet weekly po
    Administration route: Oral
    Indication: Malaria Prophylaxis
    Start date: 2003-10-15
    End date: 2004-06-15

Lariam
    Dosage: 1 tablet weekly po
    Administration route: Oral
    Indication: Malaria Prophylaxis
    Start date: 2003-10-15
    End date: 2004-06-15



Possible Lariam side effects in 24 year old male

Reported by a consumer/non-health professional from Denmark on 2012-06-22

Patient: 24 year old male

Reactions: Malaise, Learning Disability, Memory Impairment, Depression, Ill-Defined Disorder, Epilepsy, Convulsion

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 23 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-13

Patient: 23 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Paranoia, Mental Disorder, Vertigo, Anger, Depression, Emotional Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a physician from Germany on 2012-06-11

Patient: male

Reactions: Abdominal Discomfort, Maternal Drugs Affecting Foetus, Kidney Malformation, Irritable Bowel Syndrome, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 20 year old male

Reported by a physician from Finland on 2012-06-08

Patient: 20 year old male

Reactions: Anxiety, Hyperventilation, Nausea, Dizziness, Hypoaesthesia, Salivary Hypersecretion, Panic Disorder

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in female

Reported by a physician from France on 2012-06-07

Patient: female

Reactions: Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 37 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 37 year old female, weighing 108.9 kg (239.5 pounds)

Reactions: Liver Injury, Tinnitus, Contusion, Restless Legs Syndrome, Deafness, Platelet Count Increased, Fatigue, Balance Disorder, Aplastic Anaemia, Mean Platelet Volume Decreased, Gingival Bleeding, Neutrophil Count Increased, Eosinophil Count Increased, Myoclonus, Sleep Disorder, Heart Rate Increased, Vertigo, Urticaria Chronic

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 20 year old male

Reported by a consumer/non-health professional from Finland on 2012-06-01

Patient: 20 year old male

Reactions: Anxiety, Nausea, Dizziness, Hypoaesthesia, Panic Disorder

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a physician from Germany on 2012-05-31

Patient: male

Reactions: Abdominal Discomfort, Maternal Drugs Affecting Foetus, Irritable Bowel Syndrome, Kidney Malformation, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a physician from Ireland on 2012-05-18

Patient: male

Reactions: Weight Decreased, Headache, Self Injurious Behaviour, Paraesthesia, Abnormal Dreams, Anxiety, Psychotic Disorder, Diarrhoea, Sleep Disorder, Dehydration, Decreased Appetite, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in female

Reported by a physician from United Kingdom on 2012-05-18

Patient: female

Reactions: Renal Disorder, Limb Injury, Proteinuria, Abdominal Distension, Mental Disorder, Ill-Defined Disorder, Face Injury, Nephrotic Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in female

Reported by a physician from Germany on 2012-05-09

Patient: female, weighing 6.2 kg (13.8 pounds)

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 23 year old male

Reported by a consumer/non-health professional from United States on 2012-04-20

Patient: 23 year old male, weighing 77.1 kg (169.6 pounds)

Reactions: Grand MAL Convulsion

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a physician from Netherlands on 2012-04-17

Patient: male

Reactions: Thinking Abnormal, Restlessness, Derealisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in

Reported by a pharmacist from Germany on 2012-04-13

Patient:

Reactions: Encephalitis Japanese B

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in

Reported by a pharmacist from United States on 2012-04-11

Patient:

Reactions: Homicide

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in male

Reported by a physician from Germany on 2012-04-10

Patient: male

Reactions: Abdominal Discomfort, Maternal Drugs Affecting Foetus, Kidney Malformation, Irritable Bowel Syndrome, Gastrooesophageal Reflux Disease

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 22 year old female

Reported by a consumer/non-health professional from United States on 2012-04-09

Patient: 22 year old female, weighing 99.8 kg (219.5 pounds)

Reactions: Nightmare, Paranoia, Personality Disorder, Intentional Self-Injury, Suicidal Ideation, Irritability, Psychotic Disorder, Post-Traumatic Stress Disorder, Bipolar Disorder, Major Depression, Anger, Homicidal Ideation, GUN Shot Wound, Flashback, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lariam



Possible Lariam side effects in 34 year old male

Reported by a consumer/non-health professional from United States on 2012-04-06

Patient: 34 year old male, weighing 72.7 kg (159.9 pounds)

Reactions: Anxiety, Abnormal Dreams, Panic Attack, Tinnitus, Paranoia, Nervous System Disorder, Hypoaesthesia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Lariam

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