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Sirturo Side Effects

Generic Name: bedaquiline

Medically reviewed by Drugs.com. Last updated on Sep 28, 2020.

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

In Summary

Common side effects of Sirturo include: headache and nausea. Other side effects include: hepatic insufficiency, increased liver enzymes, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum transaminases, and anorexia. See below for a comprehensive list of adverse effects.

For the Consumer

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.

Side effects requiring immediate medical attention

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

  • Chest pain
  • coughing or spitting up blood
  • dark-colored urine
  • decreased appetite
  • fever
  • general feeling of tiredness or weakness
  • headache
  • itching or skin rash
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • stomach pain or tenderness
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin

Incidence not known

Side effects not requiring immediate medical attention

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

  • Difficulty with moving
  • muscle pain or stiffness
  • pain in the joints

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." O 0

2. "Product Information. Sirturo (bedaquiline)." Janssen Pharmaceuticals, Titusville, NJ.

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.