ATOVAQUONE

N/A

Manufactured by GlaxoSmithKline LLC

13,088 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ATOVAQUONE

ATOVAQUONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. The most commonly reported adverse reactions for ATOVAQUONE include OFF LABEL USE, PYREXIA, DIARRHOEA, DRUG INEFFECTIVE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATOVAQUONE.

Top Adverse Reactions

OFF LABEL USE737 reports
PYREXIA429 reports
DIARRHOEA408 reports
DRUG INEFFECTIVE387 reports
NAUSEA370 reports
PNEUMONIA355 reports
DEATH294 reports
FATIGUE286 reports
DYSPNOEA270 reports
ACUTE KIDNEY INJURY262 reports
RASH261 reports
VOMITING252 reports
THROMBOCYTOPENIA251 reports
CONDITION AGGRAVATED244 reports
NEUTROPENIA240 reports
FEBRILE NEUTROPENIA228 reports
ANAEMIA195 reports
PANCYTOPENIA191 reports
PAIN188 reports
SEPSIS183 reports
RESPIRATORY FAILURE178 reports
COVID 19170 reports
PLATELET COUNT DECREASED167 reports
ASTHENIA163 reports
HEADACHE163 reports
PRODUCT USE IN UNAPPROVED INDICATION158 reports
COUGH154 reports
RENAL FAILURE150 reports
DRUG INTERACTION141 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA141 reports
DIZZINESS136 reports
DECREASED APPETITE123 reports
CYTOKINE RELEASE SYNDROME118 reports
ANXIETY113 reports
SEPTIC SHOCK113 reports
HYPOTENSION110 reports
MALAISE110 reports
WEIGHT DECREASED104 reports
WHITE BLOOD CELL COUNT DECREASED104 reports
CHILLS103 reports
CONSTIPATION103 reports
PRURITUS101 reports
DISEASE PROGRESSION99 reports
ENCEPHALOPATHY93 reports
PRODUCT DOSE OMISSION ISSUE92 reports
ABDOMINAL PAIN91 reports
NOCARDIOSIS91 reports
HYPERTENSION89 reports
INFECTION89 reports
HEPATIC CYTOLYSIS87 reports
PLEURAL EFFUSION87 reports
HOSPITALISATION86 reports
THROMBOTIC MICROANGIOPATHY85 reports
RENAL IMPAIRMENT83 reports
DRUG RESISTANCE80 reports
HAEMOGLOBIN DECREASED80 reports
AGRANULOCYTOSIS79 reports
ARTHRALGIA78 reports
TREATMENT FAILURE77 reports
BACK PAIN76 reports
NEUTROPHIL COUNT DECREASED76 reports
EMOTIONAL DISTRESS73 reports
GRAFT VERSUS HOST DISEASE73 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION72 reports
NEUROPATHY PERIPHERAL72 reports
CHRONIC KIDNEY DISEASE71 reports
ABDOMINAL PAIN UPPER70 reports
ALANINE AMINOTRANSFERASE INCREASED70 reports
CHEST PAIN70 reports
LEUKOPENIA70 reports
INSOMNIA69 reports
ANHEDONIA68 reports
BLOOD PRESSURE INCREASED68 reports
DEHYDRATION68 reports
FALL67 reports
INTERSTITIAL LUNG DISEASE67 reports
RASH MACULO PAPULAR67 reports
COLITIS66 reports
PLASMA CELL MYELOMA66 reports
BLOOD CREATININE INCREASED65 reports
CONFUSIONAL STATE65 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS65 reports
URINARY TRACT INFECTION65 reports
OEDEMA PERIPHERAL64 reports
ATRIAL FIBRILLATION63 reports
HEPATIC ENZYME INCREASED62 reports
TOXIC EPIDERMAL NECROLYSIS62 reports
HEPATIC FUNCTION ABNORMAL61 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME61 reports
TACHYCARDIA61 reports
BABESIOSIS60 reports
GENERAL PHYSICAL HEALTH DETERIORATION59 reports
ASPARTATE AMINOTRANSFERASE INCREASED58 reports
CHOLESTASIS58 reports
CYTOMEGALOVIRUS INFECTION58 reports
PRODUCT USE ISSUE58 reports
HYPERKALAEMIA57 reports
CELLULITIS56 reports
INTENTIONAL PRODUCT USE ISSUE56 reports
STAPHYLOCOCCAL INFECTION55 reports

Report Outcomes

Out of 7,479 classified reports for ATOVAQUONE:

Serious 85.4%Non-Serious 14.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male3,649 (56.7%)
Female2,779 (43.2%)
Unknown7 (0.1%)

Reports by Age

Age 63183 reports
Age 64167 reports
Age 67160 reports
Age 69157 reports
Age 70155 reports
Age 52141 reports
Age 56140 reports
Age 59133 reports
Age 68127 reports
Age 74127 reports
Age 75126 reports
Age 71125 reports
Age 60122 reports
Age 65121 reports
Age 54118 reports
Age 66116 reports
Age 72116 reports
Age 73116 reports
Age 76102 reports
Age 55101 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ATOVAQUONE?

This profile reflects 13,088 FDA FAERS reports that mention ATOVAQUONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ATOVAQUONE?

Frequently reported terms in FAERS include OFF LABEL USE, PYREXIA, DIARRHOEA, DRUG INEFFECTIVE, NAUSEA, PNEUMONIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ATOVAQUONE?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with ATOVAQUONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.