Drug · FAERS side-effect profile with label screen
Atovaquone and Proguanil side effects: what 2,119 FDA adverse event reports show
Drug class
Antimalarial, Antiprotozoal
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Atovaquone (Atovaquone)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,119 reports · 73% serious · 33 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
------------------- INDICATIONS AND USAGE -------------------- Atovaquone oral suspension is a quinone antimicrobial drug indicated for: Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX).
FDA label, Indications and Usage
What it is
11 DESCRIPTION Atovaquone oral suspension, USP is a quinone antimicrobial drug.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 5Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 29
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 42 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mouth ulceration | 48 | 22.6 17.1–29.9ROR 23.1 · χ² 970 / p 4e-213 | 22.4 EB05 17.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 74% consumer | no trial data cached |
| Anorexia | 24 | 18.2 12.2–27.1ROR 18.4 · χ² 373 / p 2e-83 | 17.8 EB05 12.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Abnormal dreams | 47 | 16.8 12.6–22.2ROR 17.1 · χ² 680 / p 3e-150 | 16.6 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 35% (drug 61%) | no trial data cached |
| Abortion induced | 15 | 15.8 9.5–26.1ROR 15.9 · χ² 193 / p 4e-44 | 14.9 EB05 9.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Schizophrenia | 19 | 15.5 9.9–24.2ROR 15.6 · χ² 243 / p 5e-55 | 14.9 EB05 9.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Erythema multiforme | 12 | 12.8 7.3–22.4ROR 12.8 · χ² 118 / p 7e-28 | 11.2 EB05 6.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 | no trial data cached |
| Psychotic disorder | 36 | 12.1 8.7–16.7ROR 12.3 · χ² 355 / p 2e-79 | 11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Drug exposure during pregnancy | 40 | 11.5 8.4–15.6ROR 11.7 · χ² 373 / p 2e-83 | 11.1 EB05 8.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · ♀ 91% (drug 61%) | no trial data cached |
| Transaminases increased | 25 | 11.1 7.5–16.5ROR 11.3 · χ² 221 / p 3e-50 | 10.4 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 40% (drug 61%) | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 28 | 10.3 7.1–14.8ROR 10.4 · χ² 225 / p 3e-51 | 9.6 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Hallucination (hallucinations) | 76 | 10.0 8.1–12.5ROR 10.4 · χ² 611 / p 3e-135 | 9.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Nightmare | 35 | 10.0 7.2–13.9ROR 10.1 · χ² 274 / p 8e-62 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Rash generalised | 25 | 9.4 6.4–13.9ROR 9.5 · χ² 180 / p 2e-41 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Blood bilirubin increased | 23 | 8.4 5.6–12.6ROR 8.5 · χ² 143 / p 3e-33 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Gamma-glutamyltransferase increased | 18 | 8.0 5.1–12.7ROR 8.1 · χ² 104 / p 1e-24 | 7.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Pharmaceutical product complaint | 20 | 7.5 4.9–11.6ROR 7.6 · χ² 107 / p 3e-25 | 6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 85% consumer | no trial data cached |
| Hepatotoxicity (liver damage) | 16 | 7.1 4.4–11.6ROR 7.2 · χ² 79 / p 4e-19 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Circulatory collapse | 12 | 6.9 4.0–12.2ROR 7.0 · χ² 55 / p 5e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Paranoia | 12 | 6.9 3.9–12.1ROR 6.9 · χ² 54 / p 8e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Eosinophilia | 12 | 6.8 3.9–12.0ROR 6.8 · χ² 54 / p 1e-13 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Panic attack | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 118 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Chromaturia | 15 | 6.6 4.0–10.9ROR 6.6 · χ² 65 / p 3e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Abortion spontaneous | 25 | 6.2 4.2–9.1ROR 6.2 · χ² 103 / p 2e-24 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 100% (drug 61%) | no trial data cached |
| Face oedema | 10 | 5.8 3.1–10.8ROR 5.9 · χ² 35 / p 1e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 13 | 5.8 3.4–9.9ROR 5.8 · χ² 47 / p 4e-12 | 4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Cholelithiasis | 18 | 5.4 3.4–8.6ROR 5.5 · χ² 61 / p 3e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hepatitis (liver inflammation) | 14 | 5.4 3.2–9.1ROR 5.4 · χ² 46 / p 6e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Oral pain | 12 | 5.3 3.0–9.3ROR 5.3 · χ² 38 / p 4e-10 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Thinking abnormal | 10 | 5.3 2.8–9.8ROR 5.3 · χ² 31 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Poor quality sleep | 11 | 5.1 2.8–9.2ROR 5.1 · χ² 32 / p 7e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Rash macular | 17 | 4.8 3.0–7.8ROR 4.9 · χ² 48 / p 2e-12 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Fear | 13 | 4.7 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Aggression | 24 | 4.7 3.2–7.1ROR 4.8 · χ² 67 / p 1e-16 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Visual acuity reduced | 16 | 4.7 2.9–7.7ROR 4.8 · χ² 43 / p 2e-11 | 4.2 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Blister | 26 | 4.6 3.1–6.7ROR 4.6 · χ² 70 / p 3e-17 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 20 | 4.5 2.9–6.9ROR 4.5 · χ² 51 / p 5e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| International normalised ratio increased | 13 | 4.5 2.6–7.7ROR 4.5 · χ² 32 / p 9e-9 | 3.9 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 | no trial data cached |
| Drug resistance | 11 | 4.2 2.4–7.6ROR 4.3 · χ² 24 / p 5e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Crying | 15 | 4.1 2.5–6.7ROR 4.1 · χ² 32 / p 9e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hallucination (hallucinations) | 76 | 10.0 8.1–12.5ROR 10.4 · χ² 611 / p 3e-135 | 9.8 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Mouth ulceration | 48 | 22.6 17.1–29.9ROR 23.1 · χ² 970 / p 4e-213 | 22.4 EB05 17.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 74% consumer | no trial data cached |
| Abnormal dreams | 47 | 16.8 12.6–22.2ROR 17.1 · χ² 680 / p 3e-150 | 16.6 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · ♀ 35% (drug 61%) | no trial data cached |
| Drug exposure during pregnancy | 40 | 11.5 8.4–15.6ROR 11.7 · χ² 373 / p 2e-83 | 11.1 EB05 8.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · ♀ 91% (drug 61%) | no trial data cached |
| Psychotic disorder | 36 | 12.1 8.7–16.7ROR 12.3 · χ² 355 / p 2e-79 | 11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Nightmare | 35 | 10.0 7.2–13.9ROR 10.1 · χ² 274 / p 8e-62 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 28 | 10.3 7.1–14.8ROR 10.4 · χ² 225 / p 3e-51 | 9.6 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Blister | 26 | 4.6 3.1–6.7ROR 4.6 · χ² 70 / p 3e-17 | 4.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Abortion spontaneous | 25 | 6.2 4.2–9.1ROR 6.2 · χ² 103 / p 2e-24 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 100% (drug 61%) | no trial data cached |
| Panic attack | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 118 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Rash generalised | 25 | 9.4 6.4–13.9ROR 9.5 · χ² 180 / p 2e-41 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Transaminases increased | 25 | 11.1 7.5–16.5ROR 11.3 · χ² 221 / p 3e-50 | 10.4 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 40% (drug 61%) | no trial data cached |
| Aggression | 24 | 4.7 3.2–7.1ROR 4.8 · χ² 67 / p 1e-16 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Anorexia | 24 | 18.2 12.2–27.1ROR 18.4 · χ² 373 / p 2e-83 | 17.8 EB05 12.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Blood bilirubin increased | 23 | 8.4 5.6–12.6ROR 8.5 · χ² 143 / p 3e-33 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Mouth ulceration — n=48, PRR 22.6
- Anorexia — n=24, PRR 18.2
- Abnormal dreams — n=47, PRR 16.8
- Psychotic disorder — n=36, PRR 12.1
- Transaminases increased — n=25, PRR 11.1
- Jaundice — n=28, PRR 10.3
- Hallucination — n=76, PRR 10.0
- Nightmare — n=35, PRR 10.0
- Rash generalised — n=25, PRR 9.4
- Pharmaceutical product complaint — n=20, PRR 7.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Atovaquone and Proguanil?
In FDA FAERS, the most frequently co-reported reaction terms for Atovaquone and Proguanil are hallucination, mouth ulceration, abnormal dreams, psychotic disorder, nightmare, jaundice. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Atovaquone and Proguanil have an FDA boxed warning?
No. The FDA label retrieved for Atovaquone and Proguanil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atovaquone and Proguanil causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 16b69156-e5de-c601-e063-6394a90afeae, effective 20250915; matched on
openfda.generic_name.exact:"ATOVAQUONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 82 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.