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Rifabutin Side Effects

In Summary

Commonly reported side effects of rifabutin include: neutropenia and urine discoloration. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to rifabutin: oral capsule

Along with its needed effects, rifabutin 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 rifabutin:

More Common

  • Black, tarry stools
  • chest pain
  • chills
  • cough
  • diarrhea
  • fever
  • heartburn
  • indigestion
  • itching or skin rash
  • loss of appetite
  • painful or difficult urination
  • sore throat
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less Common

  • Loss of strength or energy
  • muscle pain

Rare

  • Bruising or purple spots on the skin
  • change in taste
  • eye pain
  • joint pain
  • loss of vision
  • lower back or side pain
  • muscle swelling or pain
  • pale skin
  • yellow skin

Some side effects of rifabutin 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

  • Abdominal or stomach pain
  • bad, unusual, or unpleasant (after) taste in the mouth
  • belching
  • bloated or full feeling
  • change in taste
  • discoloration of the urine
  • excess air or gas in the stomach or intestines
  • headache
  • nausea
  • passing gas
  • trouble sleeping

For Healthcare Professionals

Applies to rifabutin: oral capsule

General

The most commonly reported side effects included discolored urine, neutropenia, leukopenia, and jaundice.[Ref]

Genitourinary

Very common (10% or more): Discolored urine (up to 30%)[Ref]

Hematologic

The frequency and severity of hematological side effects may be increased with concomitant isoniazid use.[Ref]

Very common (10% or more): Neutropenia (up to 25%), leukopenia (up to 17%)

Common (1% to 10%): Anemia, eosinophilia, thrombocytopenia

Uncommon (0.1% to 1%): Agranulocytosis, granulocytopenia, lymphopenia, neutrophil count decreased, pancytopenia, platelet count decreased, white blood cell count decreased

Frequency not reported: hemolysis, thrombotic thrombocytopenic purpura, white blood cell disorder[Ref]

Hepatic

Very common (10% or more): Jaundice (up to 12%)

Common (1% to 10%): Increased alkaline phosphatase, increased ALT, increased AST

Uncommon (0.1% to 1%): Hepatic enzymes increased

Frequency not reported: Hepatitis[Ref]

Dermatologic

Very common (10% or more): Rash (up to 11%)

Uncommon (0.1% to 1%): Skin discoloration

Postmarketing reports: Urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, eructation, flatulence, gastrointestinal intolerance, nausea, nausea and vomiting, vomiting

Frequency not reported: Clostridium difficile colitis

Postmarketing reports: C difficile-associated diarrhea[Ref]

Other

Common (1% to 10%): Asthenia, fever, pain, pyrexia[Ref]

Nervous system

Common (1% to 10%): Headache, taste perversion

Frequency not reported: aphasia, paresthesia, seizure[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Arthralgia

Frequency not reported: Myositis[Ref]

Generalized arthralgia occurred in patients given 1050 to 2400 mg/day; symptoms abated when treatment was discontinued.[Ref]

Cardiovascular

Common (1% to 10%): Chest pain

Frequency not reported: Chest pressure, nonspecific T wave changes (on ECG), shock

Postmarketing reports: Hypotension[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Confusion[Ref]

Metabolic

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

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, other hypersensitivity reactions

Frequency not reported: Anaphylactic shock

Postmarketing reports: Angioedema[Ref]

Ocular

Uncommon (0.1% to 1%): Corneal deposits, uveitis

Postmarketing reports: Conjunctivitis[Ref]

Uveitis occurred in patients given 1050 to 2400 mg/day; symptoms abated when treatment was discontinued.

Uveitis was rare when this drug was used as a single agent at 300 mg/day, or in combination with fluconazole and/or macrolides (e.g., clarithromycin). However, the incidence of uveitis was greater if higher doses of this drug were used with these agents. Patients who developed uveitis had mild to severe symptoms that resolved following therapy with corticosteroids and/or mydriatic eye drops; however, in some severe cases, resolution of symptoms occurred after several weeks.[Ref]

Respiratory

Uncommon (0.1% to 1%): Bronchospasm

Frequency not reported: Dyspnea[Ref]

Immunologic

Frequency not reported: Flu-like syndrome[Ref]

References

1. "Product Information. Mycobutin (rifabutin)." Pharmacia and Upjohn, Kalamazoo, MI.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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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