Bedaquiline Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 16, 2024.

Applies to bedaquiline: oral tablet.

Important warnings This medicine can cause some serious health issues

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.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects. Your doctor may also need to check your heart.

If your symptoms do not improve or if they get worse, call your doctor.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 side effects

• 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 side effects

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

For healthcare professionals

Applies to bedaquiline: oral tablet.

Musculoskeletal adverse events

• Very common (10% or more): Arthralgia (up to 40%)
• Common (1% to 10%): Myalgia^[Ref]

Arthralgia was reported in 40% of pediatric patients (12 to 18 years). The side effect occurred in up to 33% of adults.^[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]

See also:

Further information

Bedaquiline side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer