This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Malarone (Atovaquone / Proguanil) 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 (107)
Death (3)
Life Threatening Events (8)
Disability (6)
Reports by Reaction Type
Drug Interaction (12),
Hallucination (12),
Nausea (10),
Anxiety (10),
Dermatitis Acneiform (9),
Vomiting (9),
Dizziness (8),
Thrombocytopenia (8),
Diarrhoea (8),
Headache (7),
Pyrexia (7),
Abnormal Dreams (7)
Below are a few examples of reports where side effects / adverse reactions may be related to Malarone (Atovaquone / Proguanil). For a complete list or a specific selection of reports, please use the links above.
Possible Malarone side effects in male
Reported by a physician from France on 2012-08-24
Patient: male, weighing 13.5 kg (29.7 pounds)
Reactions: Diarrhoea, Accidental Overdose, Drug Dispensing Error
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in male
Reported by a consumer/non-health professional from Sweden on 2012-08-20
Patient: male
Reactions: Panic Attack, Insomnia, Acute Psychosis, Hallucination, Crying
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in male
Reported by a physician from France on 2012-08-10
Patient: male
Reactions: Polydactyly, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: female
Reactions: Anxiety, Psychotic Disorder, Insomnia, Depression
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in
Reported by a physician from United States on 2012-08-06
Patient:
Reactions: Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in male
Reported by a consumer/non-health professional from Canada on 2012-08-02
Patient: male
Reactions: Weight Decreased, Vomiting, Dyspnoea, Chest Discomfort, Stent Placement, Arrhythmia, Cardiac Disorder, Diarrhoea, Asthenia, Cough, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-20
Patient:
Reactions: Maternal Drugs Affecting Foetus, Congenital Hydronephrosis
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-20
Patient:
Reactions: Maternal Drugs Affecting Foetus, HIP Dysplasia
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-20
Patient:
Reactions: Gastroschisis, Maternal Drugs Affecting Foetus, Congenital Anomaly
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in male
Reported by a consumer/non-health professional on 2012-07-20
Patient: male, weighing 0.3 kg (0.7 pounds)
Reactions: Anencephaly, Maternal Drugs Affecting Foetus
Adverse event resulted in: death
Drug(s) suspected as cause:
Malarone
Other drugs received by patient: Folic Acid
Possible Malarone side effects in
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-20
Patient:
Reactions: Maternal Drugs Affecting Foetus, Congenital Hypothyroidism
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 20 year old female
Reported by a pharmacist from Germany on 2012-07-16
Patient: 20 year old female
Reactions: Malaria, Psychotic Disorder, Sleep Disorder, Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in male
Reported by a physician from Australia on 2012-07-12
Patient: male, weighing 81.0 kg (178.2 pounds)
Reactions: Drug-Induced Liver Injury
Drug(s) suspected as cause:
Malarone
Other drugs received by patient: Pravastatin; Deralin; Felocor
Possible Malarone side effects in 16 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-05
Patient: 16 year old male
Reactions: Depression
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 52 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-05
Patient: 52 year old female, weighing 63.5 kg (139.7 pounds)
Reactions: Migraine, Vomiting, Nausea, Visual Acuity Reduced, Headache, Photopsia, Vision Blurred, Eye Disorder, Influenza Like Illness
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-29
Patient: 55 year old male
Reactions: Photosensitivity Reaction, Drug Interaction, Rash
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Olmesartan Medoxomil
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Malarone
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Piroxicam
Dosage: oral
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Malarone side effects in 56 year old male
Reported by a physician from Costa Rica on 2012-06-27
Patient: 56 year old male
Reactions: Fatigue, Neutropenia, Asthenia, Thrombocytopenia
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 43 year old female
Reported by a physician from Switzerland on 2012-06-19
Patient: 43 year old female
Reactions: Abortion, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Malarone
Dosage: 250mg per day
Indication: Prophylaxis
Start date: 2011-05-30
End date: 2011-06-09
Stamaril
Dosage: .5ml single dose
Indication: Prophylaxis
Start date: 2011-05-17
End date: 2011-05-17
Possible Malarone side effects in female
Reported by a physician from Switzerland on 2012-06-08
Patient: female, weighing 2.5 kg (5.5 pounds)
Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Acetazolamide
Start date: 2011-04-07
End date: 2011-04-07
Ciprofloxacin IN Dextrose 5%
Start date: 2011-04-04
End date: 2011-04-08
Malarone
Start date: 2011-04-18
End date: 2011-04-20
Possible Malarone side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2012-06-06
Patient: male
Reactions: Malaria, Vomiting, Diarrhoea, Dizziness, Hyperhidrosis, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in female
Reported by a physician from Switzerland on 2012-06-01
Patient: female, weighing 2.5 kg (5.5 pounds)
Reactions: Foetal Growth Restriction, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Ciprofloxacin HCL
Dosage: 500mg per day
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-04
End date: 2011-04-08
Malarone
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-18
End date: 2011-04-20
Diamox
Dosage: 250mg single dose
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-07
End date: 2011-04-07
Possible Malarone side effects in female
Reported by a physician from Italy on 2012-06-01
Patient: female
Reactions: Syncope, Paraesthesia Oral, Wheezing
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in female
Reported by a physician from Netherlands on 2012-05-25
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Thrombocytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in
Reported by a physician from France on 2012-05-24
Patient:
Reactions: Foetal Exposure During Pregnancy, Arnold-Chiari Malformation
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Stamaril
Dosage: 1inj single dose
Indication: Prophylaxis
Start date: 2011-12-17
End date: 2011-12-17
Malarone
Dosage: 1tab per day
Indication: Malaria Prophylaxis
Start date: 2011-12-17
End date: 2012-01-10
Possible Malarone side effects in 61 year old male
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: 61 year old male, weighing 109.1 kg (240.0 pounds)
Reactions: Pancreatitis Acute, Abdominal Pain, Vomiting, Nausea, Pancreatic Pseudocyst, Lipase Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Malarone
Other drugs received by patient: Hydrochlorothiazide; Lipitor; Omeprazole; Aspirin
Possible Malarone side effects in 60 year old male
Reported by a pharmacist from Australia on 2012-05-11
Patient: 60 year old male, weighing 110.0 kg (242.0 pounds)
Reactions: Jaundice
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in female
Reported by a physician from Netherlands on 2012-05-04
Patient: female, weighing 77.0 kg (169.4 pounds)
Reactions: Hyponatraemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 51 year old male
Reported by a physician from Spain on 2012-04-30
Patient: 51 year old male
Reactions: Anxiety, Irritability, Hallucination, Nervousness, Myoclonic Epilepsy, Loss of Consciousness
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 51 year old male
Reported by a physician from Spain on 2012-04-30
Patient: 51 year old male
Reactions: Irritability, Anxiety, Hallucination, Nervousness, Myoclonic Epilepsy, Loss of Consciousness
Drug(s) suspected as cause:
Malarone
Possible Malarone side effects in 25 year old male
Reported by a physician from Germany on 2012-04-27
Patient: 25 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Anxiety, Persecutory Delusion, Restlessness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Malarone
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