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Sirturo Side Effects

Generic Name: bedaquiline

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

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

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

Incidence Not Known

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

Other

Very common (10% or more): Increased mortality risk/death (up to 12.7%), chest pain (up to 11%)[Ref]

Cardiovascular

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

Hepatic

Very common (10% or more): Elevated aminotransferases at least 3 times ULN (up to 10.8%)

Common (1% to 10%): Hepatotoxicity (increased ALT, increase AST, increased hepatic enzyme, abnormal hepatic function)[Ref]

Gastrointestinal

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

Common (1% to 10%): Diarrhea, increased blood amylase[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 33%)

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

Nervous system

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

Respiratory

Very common (10% or more): Hemoptysis (up to 18%)[Ref]

Metabolic

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

Dermatologic

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

References

1. "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.

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