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Bedaquiline Side Effects

In Summary

Commonly reported side effects of bedaquiline 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

In addition to its needed effects, some unwanted effects may be caused by bedaquiline. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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:
  • Fainting
  • irregular heartbeat recurrent

Minor Side Effects

Some of the side effects that can occur with bedaquiline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Not all side effects for bedaquiline may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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