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Bedaquiline Side Effects

For the Consumer

Applies to bedaquiline: oral tablet

Along with its needed effects, bedaquiline 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
  • Fainting
  • irregular heartbeat recurrent

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.

Some side effects of bedaquiline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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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