Rifabutin Side Effects

Brand Names: Mycobutin

Please note - some side effects for Rifabutin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rifabutin - for the Consumer

Rifabutin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rifabutin:

Changes in taste; diarrhea; discolored urine; headache; indigestion; loss of appetite; nausea; sleeplessness; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; eye pain, swelling, or sensitivity to light; flu-like symptoms (eg, fever, chills, sore throat); severe or persistent diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual muscle pain or weakness; vision changes or decreased vision; yellowing of skin or eyes.

Side Effects by Body System

General

Rifabutin is generally well tolerated.

Dermatologic

Dermatologic side effects have included rash and skin discoloration.

Rash occurs in about 4% of patients and is one of the main reasons patients choose to discontinue therapy. Orange-tan skin discoloration occurs in nearly all patients treated with rifabutin, more quickly at higher dosages.

Gastrointestinal

Gastrointestinal side effects such as nausea, vomiting, dyspepsia, anorexia, diarrhea, and flatulence have occurred in less than 5% of patients. Aphthous stomatitis has rarely been reported.

Hematologic

Neutropenia and thrombocytopenia have been associated with rifabutin use. However, the latter may be related to underlying disease since it has been observed at a similar rate in control groups in placebo-controlled trials. One case of thrombotic thrombocytopenic purpura has been reported with rifabutin.

Hematologic side effects are uncommon and have included neutropenia, leukopenia, hemolysis, and thrombocytopenia.

Ocular

Uveitis has been reported to develop between approximately two weeks and seven months of therapy at dosages of 300 to 1800 mg per day. Patients who developed uveitis while receiving 300 mg per day were also receiving fluconazole. Symptoms at presentation included acute eye pain and diminished visual acuity. Ocular symptoms resolved in all patients over several weeks following discontinuation of rifabutin therapy. Patients responded to topical therapy with prednisolone and atropine.

Ocular adverse effects have included uveitis, resulting in itching, decreased vision, photophobia, pain, and temporary blindness in some patients.

Hepatic

Hepatic side effects are rare, however, increases in liver function tests and hepatitis have been reported.

Musculoskeletal

In one study of 10 patients receiving greater than 1 gram of rifabutin per day, nine developed significant distal, small joint arthralgias. No evidence of concomitant rheumatic disease was evident and no effusions were observed.

Musculoskeletal side effects have included myalgia and, rarely, polyarthralgia-arthritis syndrome.

Other

Other side effects have included a rare flu-like syndrome (fever, arthralgias, malaise) that may have been associated with underlying disease. Abdominal pain, headache, asthenia, and taste perversion have also been reported. Sputum, tears, saliva, urine, fever, perspiration, skin, and contact lenses may be discolored orange-brown with rifabutin use.

Genitourinary

Genitourinary side effects have included urine discoloration.

Nervous system

Nervous system side effects are extremely rare, however, insomnia has been reported.

Cardiovascular

Cardiovascular side effects are not common. Chest pressure and chest pain with dyspnea have been reported in less than 1% of patients who received rifabutin in clinical trials.

Other

Three cases of DILS have been reported. All cases were receiving standard doses of rifabutin and all had positive anti-nuclear antibodies during their lupus-like reactions. Symptoms of DILS included malaise, myalgias, arthralgias, and fever. None of the cases experienced lupus-type nephritis or skin and CNS involvement.

Drug-induced lupus syndrome (DILS) has been reported with the use of rifabutin.

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