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. Continue reading for a comprehensive list of adverse effects.
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 Bedaquiline
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
- 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
- Dizziness or fainting
- fast or irregular heartbeat
Other side effects of Bedaquiline
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]
