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Bedaquiline Side Effects

The most commonly reported side effects of bedaquiline include electrocardiogram qt prolonged, off label use, and anaemia, based on 4,207 FDA adverse event reports from 2004 to 2025.

Bedaquiline side effects

Percentages show how often each reaction appears relative to total reports for bedaquiline.

1
Electrocardiogram Qt Prolonged14.6%615
2
Off Label Use12.1%509
3
Anaemia10.1%426
4
Neuropathy Peripheral8.8%369
5
Vomiting7.4%310
6
Nausea6.5%272
7
Hepatotoxicity6.2%262
8
Death6.0%253
9
Dyspnoea5.2%218
10
Intentional Product Use Issue4.2%175
11
Tuberculosis3.9%162
12
Product Use In Unapproved Indication3.1%129
13
Asthenia2.9%123
14
Diarrhoea2.9%123
15
Haemoglobin Decreased2.8%118

These are voluntary reports and do not establish that bedaquiline caused these reactions.

Report severity

96.8%Serious4,071 reports
33.4%Hospitalizations1,407 reports
28.2%Fatal1,186 reports

Seriousness is determined by the reporter, not by OpenClaim.

Bedaquiline drug interactions

Other drugs that appear in adverse event reports alongside bedaquiline. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Linezolid70.8%2,977
2
Clofazimine54.7%2,300
3
Moxifloxacin-hydrochloride23.9%1,005
4
Cycloserine23.8%1,002
5
Pyrazinamide23.7%998
6
Levofloxacin22.8%959
7
Aminosalicylic14.5%609
8
Pretomanid12.2%515
9
Imipenem12.1%507
10
Ethambutol-hydrochloride9.6%404
11
Amikacin-sulfate8.4%352
12
Isoniazid8.3%348
13
Ethionamide7.7%325
14
Capreomycin-sulfate5.6%236
15
Cilastatin-sodium4.6%194

Taken alongside

1
Pyridoxine18.1%762
2
Clofazimine8.8%370
3
Omeprazole7.5%314
4
Cycloserine5.6%237
5
Metoclopramide-hydrochloride5.6%236
6
Linezolid5.2%220
7
Tenofovir4.2%178
8
Pyrazinamide4.1%172
9
Levofloxacin3.9%163
10
Amoxicillin3.9%162
11
Lamivudine3.7%157
12
Amikacin-sulfate3.7%156
13
Moxifloxacin-hydrochloride3.6%152
14
Nevirapine3.5%147
15
Ondansetron3.2%134

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports bedaquiline side effects

37.3% of bedaquiline adverse event reports involve female patients and 48.9% involve male patients. The largest age group is adult at 84%. These figures reflect who reports side effects, not underlying risk.

Sex

Female37.3%
Male48.9%
Unknown13.7%

Age group

< 21.0%
2–111.4%
12–172.6%
18–6483.7%
65+11.3%

What is bedaquiline used for

Conditions and purposes for which patients were taking bedaquiline when the adverse event was reported.

Antibiotic TherapyAtypical Mycobacterial InfectionAbscess BacterialAdverse Drug ReactionAnaemiaAntibiotic ProphylaxisAntibiotic TherapyAtypical Mycobacterial InfectionAtypical Mycobacterial Lower Respiratory Tract InfectionAtypical Mycobacterial PneumoniaBone TuberculosisBreast Cancer MetastaticBacterial InfectionBone TuberculosisBronchiectasis

Showing 15 of 100 indications

Bedaquiline brand names and reporting trend

Bedaquiline is sold under the brand name Sirturo.

Brand names

Sirturo4,131

Quarterly reports (20042025)

200420202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking bedaquiline with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.