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Sirturo Side Effects

Generic name: bedaquiline

Medically reviewed by Drugs.com. Last updated on May 28, 2023.

Note: This document contains side effect information about bedaquiline. Some dosage forms listed on this page may not apply to the brand name Sirturo.

Applies to bedaquiline: oral tablet.

Warning

Oral route (Tablet)

An increased risk of death was seen bedaquiline treatment group compared to the placebo treatment group in one placebo-controlled trial in adults. Only use bedaquiline in patients 12 years or age and older when an effective treatment regimen cannot otherwise be provided. QT prolongation can occur with bedaquiline. Use of other QT prolonging drugs may cause additive QT prolongation. Monitor ECG. Discontinue bedaquiline if significant ventricular arrhythmia or if a QTc interval of greater than 500 milliseconds develops.

Serious side effects of Sirturo

Along with its needed effects, bedaquiline (the active ingredient contained in Sirturo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking bedaquiline:

More common

Incidence not known

Other side effects of Sirturo

Some side effects of bedaquiline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to bedaquiline: oral tablet.

Musculoskeletal

Arthralgia was reported in 40% of pediatric patients (12 to 18 years). The side effect occurred in up to 33% of adults.[Ref]

Very common (10% or more): Arthralgia (up to 40%)

Common (1% to 10%): Myalgia[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 38%), vomiting (up to 20.6%), abdominal pain (up to 13%)

Common (1% to 10%): Blood amylase increased, diarrhea[Ref]

Nervous system

Very common (10% or more): Headache (up to 28%), dizziness (up to 12.7%)[Ref]

Cardiovascular

Very common (10% or more): Hemoptysis (up to 18%), chest pain (up to 11%)

Common (1% to 10%): Electrocardiogram QT prolonged/QT prolongation[Ref]

Other

Very common (10% or more): Increased mortality risk (up to 11.4%)

Common (1% to 10%): Death

Frequency not reported: Drug interactions[Ref]

Hepatic

Very common (10% or more): Aminotransferases at least 3 times upper limit of normal (up to 10.8%)

Common (1% to 10%): Increased aminotransferases/increased transferases

Frequency not reported: ALT increased, AST increased, hepatotoxicity, liver enzyme increased, liver function abnormal[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Metabolic

Common (1% to 10%): Anorexia[Ref]

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Sirturo (bedaquiline). Janssen Pharmaceuticals. 2013.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.