Bedaquiline side effects: what 1,416 FDA adverse event reports show
Drug class
Diarylquinoline antimycobacterial drug
Label matched
Bedaquiline Fumarate (Sirturo)
Who reports
1,416 reports · 96% serious · 340 with death outcome · 41% female
Used for
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid.
What it is
SIRTURO ® contains bedaquiline fumarate, a diarylquinoline antimycobacterial drug for oral administration. Each SIRTURO 20 mg tablet contains 20 mg of bedaquiline (equivalent to 24.18 mg of bedaquiline fumarate).
Boxed warning
QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] .
Causality screen of the 27 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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. 16 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 |
|---|---|---|---|---|---|---|
| Hepatotoxicity (liver damage) | 149 | 100.1 86.0–116.6ROR 111.8 · χ² 14,442 / p <1e-300 | 98.2 EB05 85.7 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 61.1 · 99% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 223 | 92.3 81.7–104.1ROR 109.3 · χ² 19,947 / p <1e-300 | 91.0 EB05 81.4 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 55.8 · 97% clinician | no trial data cached |
| Tuberculosis | 33 | 38.1 27.2–53.4ROR 38.9 · χ² 1,152 / p 8e-253 | 37.2 EB05 27.7 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 23.3 | no trial data cached |
| Electrolyte imbalance | 19 | 24.5 15.7–38.3ROR 24.8 · χ² 404 / p 3e-90 | 23.9 EB05 16.1 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 | no trial data cached |
| Polyneuropathy | 16 | 19.9 12.2–32.4ROR 20.1 · χ² 269 / p 1e-60 | 19.3 EB05 12.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Nephropathy toxic | 14 | 18.6 11.1–31.4ROR 18.8 · χ² 216 / p 3e-49 | 17.9 EB05 10.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Myocardial ischaemia | 14 | 18.1 10.7–30.4ROR 18.2 · χ² 209 / p 1e-47 | 17.3 EB05 10.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Hepatocellular injury | 16 | 16.7 10.2–27.1ROR 16.8 · χ² 220 / p 4e-50 | 16.0 EB05 9.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Hepatic cytolysis | 13 | 15.8 9.2–27.1ROR 15.9 · χ² 165 / p 4e-38 | 14.7 EB05 8.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 100 | 15.7 13.0–18.9ROR 16.8 · χ² 1,363 / p 1e-298 | 15.6 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 97% clinician | no trial data cached |
| Drug-induced liver injury | 29 | 13.9 9.7–20.0ROR 14.2 · χ² 335 / p 3e-75 | 13.5 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 97% clinician | no trial data cached |
| Blood calcium decreased | 10 | 13.1 7.1–24.3ROR 13.2 · χ² 100 / p 7e-24 | 11.2 EB05 5.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 | no trial data cached |
| Hypokalaemia (low potassium) | 40 | 12.9 9.5–17.5ROR 13.3 · χ² 428 / p 2e-95 | 12.6 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 98% clinician | no trial data cached |
| Hypomagnesaemia | 12 | 12.8 7.3–22.5ROR 12.9 · χ² 119 / p 5e-28 | 11.2 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Gastroenteritis | 12 | 12.2 6.9–21.4ROR 12.3 · χ² 112 / p 1e-26 | 10.6 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Intentional product use issue | 72 | 12.1 9.7–15.2ROR 12.7 · χ² 726 / p 3e-160 | 11.9 EB05 9.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · 99% clinician | no trial data cached |
| Anaemia (low red blood cells) | 146 | 11.3 9.7–13.2ROR 12.5 · χ² 1,376 / p <1e-300 | 11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 97% clinician | no trial data cached |
| Transaminases increased | 16 | 10.7 6.6–17.4ROR 10.8 · χ² 131 / p 1e-30 | 9.4 EB05 5.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Haemoptysis | 20 | 10.6 6.9–16.4ROR 10.7 · χ² 164 / p 6e-38 | 9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Tinnitus (ringing in the ears) | 26 | 8.4 5.7–12.2ROR 8.5 · χ² 162 / p 3e-37 | 7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 73% (drug 41%) · 96% clinician | no trial data cached |
| Drug resistance | 14 | 8.1 4.8–13.6ROR 8.1 · χ² 80 / p 2e-19 | 6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Gamma-glutamyltransferase increased | 12 | 8.0 4.6–14.1ROR 8.1 · χ² 67 / p 2e-16 | 6.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | no trial data cached |
| Psychotic disorder | 15 | 7.5 4.5–12.4ROR 7.6 · χ² 78 / p 4e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Hepatic function abnormal | 18 | 7.2 4.5–11.4ROR 7.3 · χ² 90 / p 1e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Arrhythmia | 20 | 6.2 4.0–9.6ROR 6.3 · χ² 83 / p 5e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 · 100% clinician | no trial data cached |
| Visual acuity reduced | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hypoacusis | 12 | 4.1 2.4–7.3ROR 4.2 · χ² 26 / p 2e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Electrocardiogram qt prolonged | 223 | 92.3 81.7–104.1ROR 109.3 · χ² 19,947 / p <1e-300 | 91.0 EB05 81.4 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 55.8 · 97% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 149 | 100.1 86.0–116.6ROR 111.8 · χ² 14,442 / p <1e-300 | 98.2 EB05 85.7 · IC025 +6.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 61.1 · 99% clinician | no trial data cached |
| Anaemia (low red blood cells) | 146 | 11.3 9.7–13.2ROR 12.5 · χ² 1,376 / p <1e-300 | 11.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 97% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 100 | 15.7 13.0–18.9ROR 16.8 · χ² 1,363 / p 1e-298 | 15.6 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 97% clinician | no trial data cached |
| Intentional product use issue | 72 | 12.1 9.7–15.2ROR 12.7 · χ² 726 / p 3e-160 | 11.9 EB05 9.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · 99% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 40 | 12.9 9.5–17.5ROR 13.3 · χ² 428 / p 2e-95 | 12.6 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 98% clinician | no trial data cached |
| Tuberculosis | 33 | 38.1 27.2–53.4ROR 38.9 · χ² 1,152 / p 8e-253 | 37.2 EB05 27.7 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 23.3 | no trial data cached |
| Drug-induced liver injury | 29 | 13.9 9.7–20.0ROR 14.2 · χ² 335 / p 3e-75 | 13.5 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 · 97% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 26 | 8.4 5.7–12.2ROR 8.5 · χ² 162 / p 3e-37 | 7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 73% (drug 41%) · 96% clinician | no trial data cached |
| Arrhythmia | 20 | 6.2 4.0–9.6ROR 6.3 · χ² 83 / p 5e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.9 · 100% clinician | no trial data cached |
| Haemoptysis | 20 | 10.6 6.9–16.4ROR 10.7 · χ² 164 / p 6e-38 | 9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Electrolyte imbalance | 19 | 24.5 15.7–38.3ROR 24.8 · χ² 404 / p 3e-90 | 23.9 EB05 16.1 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 | no trial data cached |
| Hepatic function abnormal | 18 | 7.2 4.5–11.4ROR 7.3 · χ² 90 / p 1e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Transaminases increased | 16 | 10.7 6.6–17.4ROR 10.8 · χ² 131 / p 1e-30 | 9.4 EB05 5.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Hepatocellular injury | 16 | 16.7 10.2–27.1ROR 16.8 · χ² 220 / p 4e-50 | 16.0 EB05 9.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | 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.
- Electrocardiogram qt prolonged — n=223, PRR 92.3
- Neuropathy peripheral — n=100, PRR 15.7
- Drug-induced liver injury — n=29, PRR 13.9
- Hypokalaemia — n=40, PRR 12.9
- Anaemia — n=146, PRR 11.3
- Tinnitus — n=26, PRR 8.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Bedaquiline?
In FDA FAERS, the most frequently co-reported reaction terms for Bedaquiline are electrocardiogram qt prolonged, hepatotoxicity, anaemia, neuropathy peripheral, hypokalaemia, tuberculosis. 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 Bedaquiline have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: QTc PROLONGATION QTc prolongation can occur with SIRTURO. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Monitor ECGs. Discontinue SIRTURO if significant ventricular arrhythmia or QTc interval greater than 500 ms develops [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Bedaquiline 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 1534c9ae-4948-4cf4-9f66-222a99db6d0e, effective 20251017; matched on
openfda.generic_name.exact:"BEDAQUILINE FUMARATE") - 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, 43 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.