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Malarone (Atovaquone / Proguanil) - Side Effect Reports to FDA

 
 



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, 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

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 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 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 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 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: Irritability, Anxiety, 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: Anxiety, Irritability, 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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