Pretomanid side effects: what 727 FDA adverse event reports show
Who reports
727 reports · 98% serious · 286 with death outcome · 38% female
Used for
Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy.
What it is
Pretomanid is an oral nitroimidazooxazine antimycobacterial drug. Pretomanid is a white to off-white to yellow-colored powder.
Boxed warning
None in the current label
Causality screen of the 15 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 51 | 40.9 31.4–53.3ROR 43.9 · χ² 1,947 / p <1e-300 | 40.3 EB05 31.8 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.5 · 98% clinician | no trial data cached |
| Polyneuropathy | 12 | 29.1 16.6–51.1ROR 29.6 · χ² 298 / p 4e-67 | 27.9 EB05 16.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 | no trial data cached |
| Hepatotoxicity (liver damage) | 22 | 28.7 19.0–43.2ROR 29.5 · χ² 560 / p 5e-124 | 28.0 EB05 19.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · 100% clinician | no trial data cached |
| Drug level increased | 14 | 24.4 14.5–41.0ROR 24.9 · χ² 291 / p 1e-65 | 23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 78 | 23.8 19.3–29.4ROR 26.6 · χ² 1,688 / p <1e-300 | 23.7 EB05 19.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 96% clinician | no trial data cached |
| Myocardial ischaemia | 7 | 17.6 8.4–36.8ROR 17.8 · χ² 94 / p 2e-22 | 15.0 EB05 6.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Drug resistance | 14 | 15.7 9.4–26.4ROR 16.0 · χ² 179 / p 5e-41 | 14.8 EB05 8.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Tuberculosis | 7 | 15.7 7.5–32.8ROR 15.8 · χ² 82 / p 6e-20 | 12.9 EB05 5.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.4 | no trial data cached |
| Myocarditis | 6 | 15.3 6.9–33.9ROR 15.4 · χ² 66 / p 2e-16 | 11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Clostridium difficile infection | 11 | 14.6 8.1–26.3ROR 14.9 · χ² 127 / p 1e-29 | 13.1 EB05 6.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Nephropathy toxic | 5 | 13.0 5.4–31.0ROR 13.0 · χ² 44 / p 2e-11 | 8.6 EB05 3.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Hepatitis c | 5 | 11.8 4.9–28.3ROR 11.9 · χ² 39 / p 2e-10 | 7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Myelosuppression | 10 | 8.5 4.6–15.7ROR 8.6 · χ² 59 / p 9e-15 | 6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 7 | 7.9 3.8–16.5ROR 8.0 · χ² 36 / p 1e-9 | 5.6 EB05 2.9 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Drug effective for unapproved indication | 5 | 4.9 2.1–11.8ROR 5.0 · χ² 12 / p 3e-4 | 3.6 EB05 1.7 · IC025 +0.3 | Not in label — unassessed | serious n=5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Neuropathy peripheral (nerve damage in hands/feet) | 78 | 23.8 19.3–29.4ROR 26.6 · χ² 1,688 / p <1e-300 | 23.7 EB05 19.6 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.4 · 96% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 51 | 40.9 31.4–53.3ROR 43.9 · χ² 1,947 / p <1e-300 | 40.3 EB05 31.8 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.5 · 98% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 22 | 28.7 19.0–43.2ROR 29.5 · χ² 560 / p 5e-124 | 28.0 EB05 19.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.2 · 100% clinician | no trial data cached |
| Drug resistance | 14 | 15.7 9.4–26.4ROR 16.0 · χ² 179 / p 5e-41 | 14.8 EB05 8.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 | no trial data cached |
| Drug level increased | 14 | 24.4 14.5–41.0ROR 24.9 · χ² 291 / p 1e-65 | 23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 | no trial data cached |
| Polyneuropathy | 12 | 29.1 16.6–51.1ROR 29.6 · χ² 298 / p 4e-67 | 27.9 EB05 16.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 | no trial data cached |
| Clostridium difficile infection | 11 | 14.6 8.1–26.3ROR 14.9 · χ² 127 / p 1e-29 | 13.1 EB05 6.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Myelosuppression | 10 | 8.5 4.6–15.7ROR 8.6 · χ² 59 / p 9e-15 | 6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 7 | 7.9 3.8–16.5ROR 8.0 · χ² 36 / p 1e-9 | 5.6 EB05 2.9 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Tuberculosis | 7 | 15.7 7.5–32.8ROR 15.8 · χ² 82 / p 6e-20 | 12.9 EB05 5.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.4 | no trial data cached |
| Myocardial ischaemia | 7 | 17.6 8.4–36.8ROR 17.8 · χ² 94 / p 2e-22 | 15.0 EB05 6.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Myocarditis | 6 | 15.3 6.9–33.9ROR 15.4 · χ² 66 / p 2e-16 | 11.7 EB05 4.4 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Drug effective for unapproved indication | 5 | 4.9 2.1–11.8ROR 5.0 · χ² 12 / p 3e-4 | 3.6 EB05 1.7 · IC025 +0.3 | Not in label — unassessed | serious n=5 | no trial data cached |
| Hepatitis c | 5 | 11.8 4.9–28.3ROR 11.9 · χ² 39 / p 2e-10 | 7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Nephropathy toxic | 5 | 13.0 5.4–31.0ROR 13.0 · χ² 44 / p 2e-11 | 8.6 EB05 3.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Pretomanid?
In FDA FAERS, the most frequently co-reported reaction terms for Pretomanid are neuropathy peripheral, electrocardiogram qt prolonged, hepatotoxicity, polyneuropathy, clostridium difficile infection, myelosuppression. 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 Pretomanid have an FDA boxed warning?
No. The FDA label retrieved for Pretomanid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pretomanid 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 f1906fc9-cb3c-4e13-8a4a-da76100c1bf3, effective 20241115; matched on
openfda.generic_name.exact:"PRETOMANID") - 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, 17 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.