Drug · FAERS side-effect profile with label screen
Atovaquone side effects: what 8,000 FDA adverse event reports show
Drug class
Antimalarial, Antiprotozoal
FDA label (Established Pharmacologic Class)
Who reports
8,000 reports · 85% serious · 1,348 with death outcome · 43% 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
Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 37
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
- 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. 990 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 |
|---|---|---|---|---|---|---|
| Myelodysplastic syndrome with multilineage dysplasia | 13 | 884.1 471.2–1,659.0ROR 885.5 · χ² 7,899 / p <1e-300 | 334.4 EB05 208.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Babesiosis | 61 | 729.8 549.7–968.9ROR 735.4 · χ² 34,055 / p <1e-300 | 482.7 EB05 389.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=60 | no trial data cached |
| Phalangeal hypoplasia | 12 | 525.6 282.7–977.4ROR 526.4 · χ² 4,794 / p <1e-300 | 257.8 EB05 157.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Ivth nerve paralysis | 34 | 462.5 321.3–665.7ROR 464.4 · χ² 12,891 / p <1e-300 | 321.4 EB05 240.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Cutaneous mucormycosis | 21 | 350.1 222.1–552.0ROR 351.0 · χ² 6,135 / p <1e-300 | 241.0 EB05 166.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 0% (drug 43%) | no trial data cached |
| Acanthamoeba infection | 17 | 256.9 156.1–422.7ROR 257.5 · χ² 3,712 / p <1e-300 | 185.4 EB05 122.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Malacoplakia | 28 | 201.6 137.3–295.9ROR 202.3 · χ² 4,999 / p <1e-300 | 166.1 EB05 120.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Pulmonary nocardiosis | 46 | 156.2 116.1–210.2ROR 157.1 · χ² 6,544 / p <1e-300 | 139.0 EB05 108.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=46 · 100% clinician | no trial data cached |
| Spontaneous bacterial peritonitis | 12 | 135.4 75.8–241.9ROR 135.6 · χ² 1,396 / p <1e-300 | 107.3 EB05 65.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Total lung capacity increased | 13 | 130.7 74.9–228.1ROR 130.9 · χ² 1,472 / p <1e-300 | 105.6 EB05 65.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Scrotal ulcer | 11 | 113.7 62.2–207.9ROR 113.9 · χ² 1,072 / p 2e-235 | 92.0 EB05 54.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Gastrointestinal tract mucosal pigmentation | 10 | 101.7 54.1–191.3ROR 101.9 · χ² 865 / p 2e-190 | 82.9 EB05 48.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Cerebellar stroke | 14 | 101.6 59.6–173.3ROR 101.8 · χ² 1,247 / p 2e-273 | 86.6 EB05 54.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Nocardiosis | 91 | 96.5 78.3–118.8ROR 97.6 · χ² 8,197 / p <1e-300 | 91.3 EB05 76.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=91 · ♀ 18% (drug 43%) · 98% clinician | no trial data cached |
| Morganella infection | 10 | 92.3 49.1–173.4ROR 92.4 · χ² 786 / p 3e-173 | 76.6 EB05 44.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Penile ulceration | 11 | 90.8 49.8–165.6ROR 90.9 · χ² 859 / p 4e-189 | 76.5 EB05 45.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Device related bacteraemia | 10 | 90.0 48.0–169.1ROR 90.2 · χ² 767 / p 4e-169 | 75.1 EB05 43.6 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 14 | 72.4 42.6–123.0ROR 72.5 · χ² 890 / p 7e-196 | 64.5 EB05 40.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Congenital foot malformation | 12 | 70.5 39.7–125.0ROR 70.6 · χ² 734 / p 6e-162 | 62.2 EB05 37.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Iga nephropathy | 37 | 61.1 44.1–84.5ROR 61.3 · χ² 2,077 / p <1e-300 | 58.0 EB05 43.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 43%) · 100% clinician | no trial data cached |
| Pneumocystis jirovecii infection | 24 | 55.7 37.2–83.4ROR 55.8 · χ² 1,209 / p 4e-265 | 52.4 EB05 37.0 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 · 100% clinician | no trial data cached |
| Enterococcal bacteraemia | 20 | 50.6 32.5–78.7ROR 50.7 · χ² 905 / p 4e-199 | 47.5 EB05 32.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Toxoplasmosis | 20 | 49.3 31.7–76.6ROR 49.4 · χ² 881 / p 5e-194 | 46.4 EB05 31.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Cerebral toxoplasmosis | 17 | 48.5 30.0–78.3ROR 48.6 · χ² 730 / p 4e-161 | 45.4 EB05 30.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Human herpesvirus 8 infection | 11 | 48.3 26.6–87.6ROR 48.3 · χ² 454 / p 4e-101 | 44.0 EB05 26.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Proteus infection | 13 | 48.0 27.7–83.0ROR 48.1 · χ² 542 / p 3e-120 | 44.3 EB05 27.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Chylothorax | 12 | 44.9 25.4–79.4ROR 44.9 · χ² 464 / p 4e-103 | 41.5 EB05 25.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Vasogenic cerebral oedema | 11 | 41.4 22.8–75.0ROR 41.4 · χ² 388 / p 1e-86 | 38.3 EB05 22.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 151 | 40.2 34.3–47.1ROR 40.9 · χ² 5,644 / p <1e-300 | 39.4 EB05 34.4 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 26.8 | no trial data cached |
| Lung transplant rejection | 10 | 39.9 21.4–74.6ROR 40.0 · χ² 337 / p 2e-75 | 36.8 EB05 21.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Fusarium infection | 10 | 38.9 20.8–72.5ROR 38.9 · χ² 327 / p 2e-73 | 35.9 EB05 20.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Syphilis | 10 | 36.5 19.6–68.1ROR 36.5 · χ² 306 / p 7e-69 | 33.9 EB05 19.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Disseminated cryptococcosis | 10 | 36.1 19.3–67.3ROR 36.1 · χ² 303 / p 4e-68 | 33.5 EB05 19.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mixed liver injury | 39 | 35.6 25.9–48.7ROR 35.7 · χ² 1,259 / p 6e-276 | 34.6 EB05 26.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=39 · 100% clinician | no trial data cached |
| Alpha haemolytic streptococcal infection | 12 | 34.2 19.4–60.5ROR 34.3 · χ² 350 / p 2e-78 | 32.2 EB05 19.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Anal ulcer | 10 | 32.5 17.4–60.6ROR 32.5 · χ² 271 / p 3e-61 | 30.4 EB05 17.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mucormycosis | 30 | 30.9 21.6–44.2ROR 31.0 · χ² 828 / p 2e-182 | 30.0 EB05 22.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 0% (drug 43%) · 92% clinician | no trial data cached |
| Immune reconstitution syndrome | 15 | 30.4 18.3–50.5ROR 30.4 · χ² 393 / p 1e-87 | 29.0 EB05 18.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Immune reconstitution inflammatory syndrome | 57 | 30.2 23.3–39.1ROR 30.4 · χ² 1,560 / p <1e-300 | 29.6 EB05 23.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 5% (drug 43%) · 91% clinician | no trial data cached |
| Mycobacterial infection | 19 | 29.2 18.6–45.9ROR 29.3 · χ² 484 / p 1e-107 | 28.2 EB05 19.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=19 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 809 | 2.4 2.3–2.6ROR 2.6 · χ² 718 / p 2e-158 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Pyrexia (fever) | 442 | 3.3 3.1–3.7ROR 3.5 · χ² 737 / p 2e-162 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Diarrhoea (diarrhea) | 425 | 1.7 1.6–1.9ROR 1.8 · χ² 135 / p 2e-31 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Drug ineffective (drug did not work) | 416 | 0.8 0.8–0.9ROR 0.8 · χ² 16 / p 4e-5 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Nausea | 398 | 1.3 1.2–1.5ROR 1.3 · χ² 32 / p 8e-9 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Pneumonia (lung infection) | 385 | 3.1 2.8–3.4ROR 3.2 · χ² 562 / p 2e-124 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.2 | no trial data cached |
| Death | 318 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.282 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | no trial data cached |
| Fatigue (tiredness) | 306 | 1.0 0.9–1.2ROR 1.0 · χ² 0 / p 0.297 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 291 | 1.3 1.2–1.5ROR 1.4 · χ² 27 / p 1e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 282 | 4.9 4.3–5.4ROR 5.0 · χ² 865 / p 2e-190 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Vomiting | 269 | 1.5 1.3–1.7ROR 1.5 · χ² 46 / p 6e-12 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Thrombocytopenia (low platelets) | 268 | 6.3 5.6–7.1ROR 6.5 · χ² 1,196 / p 3e-262 | 6.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Rash | 267 | 1.6 1.4–1.8ROR 1.6 · χ² 63 / p 1e-15 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 266 | 5.2 4.6–5.8ROR 5.3 · χ² 890 / p 8e-196 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 93% clinician | no trial data cached |
| Condition aggravated | 259 | 2.2 2.0–2.5ROR 2.3 · χ² 181 / p 2e-41 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | 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.
- Babesiosis — n=61, PRR 729.8
- Ivth nerve paralysis — n=34, PRR 462.5
- Cutaneous mucormycosis — n=21, PRR 350.1
- Malacoplakia — n=28, PRR 201.6
- Pulmonary nocardiosis — n=46, PRR 156.2
- Nocardiosis — n=91, PRR 96.5
- Iga nephropathy — n=37, PRR 61.1
- Enterococcal bacteraemia — n=20, PRR 50.6
- Toxoplasmosis — n=20, PRR 49.3
- Mixed liver injury — n=39, PRR 35.6
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?
In FDA FAERS, the most frequently co-reported reaction terms for Atovaquone are pyrexia, diarrhoea, nausea, pneumonia, fatigue, dyspnoea. 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 have an FDA boxed warning?
No. The FDA label retrieved for Atovaquone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Atovaquone 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, 1,030 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.