What the label lists and what reports show
Bedaquiline side effects
Bedaquiline's FDA label: “The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO in Study 1 were nausea, arthralgia, headache, hemoptysis and chest pain.” FAERS holds 1,417 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is electrocardiogram qt prolonged (223 reports).
- No generic listed
- Boxed warning
Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SIRTURO?SIRTURO may cause serious side effects, including: See " What is the most important information I should know about SIRTURO? " liver problems (hepatotoxicity). Your healthcare provider should do blood tests to check your liver before you start taking SIRTURO and during treatment. […]
Source: FDA drug label, Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions reported in 10% or more adult patients treated with SIRTURO in Study 1 were nausea, arthralgia, headache, hemoptysis and chest pain.
Table 4: Select Adverse Reactions Occurring in 5% or Greater of Patients Receiving the 40-Week SIRTURO Regimen in Study 4
| Adverse Reactions | SIRTURO 40-week, bedaquiline, levofloxacin, clofazimine, ethambutol, and pyrazinamide,… | Active Control 40-week control treatment of moxifloxacin or levofloxacin, clofazimine,… |
|---|---|---|
| QTc prolongation | 128 (61) | 113 (56) |
| Nausea | 114 (54) | 126 (62) |
| Vomiting | 112 (53) | 125 (62) |
| Arthralgia | 93 (44) | 67 (33) |
| Transaminases increased Terms represented by 'transaminases increased' included AST… | 63 (30) | 59 (29) |
| Abdominal pain Terms represented by 'abdominal pain' included abdominal pain, abdominal… | 60 (28) | 48 (24) |
| Pruritus Terms represented by 'pruritus' included pruritus, pruritus generalized, and… | 58 (27) | 44 (22) |
| Dizziness | 37 (18) | 42 (21) |
| Headache | 36 (17) | 36 (18) |
| Chest pain | 33 (16) | 24 (12) |
| Rash Terms represented by 'rash' included rash, rash papular and rash maculopapular. | 30 (14) | 17 (8) |
| Insomnia | 30 (14) | 19 (9) |
| Dry skin | 25 (12) | 16 (8) |
| Palpitations | 21 (10) | 13 (6) |
| Myalgia | 19 (9) | 6 (3) |
| Paresthesia | 16 (8) | 8 (4) |
| Diarrhea | 12 (6) | 17 (8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: QTc Prolongation [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ] Mortality Imbalance in Clinical Trials [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Drug Interactions [see Warnings and Precautions (5.5) ] The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO in Study 1 were nausea, arthralgia, headache, hemoptysis and chest pain. ( 6.1 ) The most common adverse reactions reported in 10% or more adult patients treated with SIRTURO (40-week arm) in Study 4 were QTc prolongation, nausea, vomiting, arthralgia, transaminases increased, abdominal pain, pruritus, dizziness, headache, chest pain, rash, insomnia, dry skin, and palpitations. ( 6.1 ) The most common adverse reactions reported in 10% or more of pediatric patients (12 years to less than 18 years of age) treated with SIRTURO were arthralgia, nausea and abdominal pain. ( 6.1 ) The most common adverse reaction reported in 10% or more of pediatric patients (5 years to less than 12 years of age) treated with SIRTURO was elevation in liver enzymes. ( 6.1 ) The most common adverse reaction reported in 10% or more of pediatric patients (2 years to less than 5 years of age) treated with SIRTURO was vomiting.
Source: FDA drug label, Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,417 reports list bedaquiline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 340 are coded as a death and 470 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bedaquiline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions