Mycobutin Side Effects
Generic Name: rifabutin
Note: This page contains information about the side effects of rifabutin. Some of the dosage forms included on this document may not apply to the brand name Mycobutin.
Not all side effects for Mycobutin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to rifabutin: oral capsule
In addition to its needed effects, some unwanted effects may be caused by rifabutin (the active ingredient contained in Mycobutin). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking rifabutin:More common
- loss of appetite
- skin itching and/or rash
- Loss of strength or energy
- muscle pain
- Black, tarry, stools
- bruising or purple spots on skin
- change in taste
- eye pain
- joint pain
- loss of vision
- lower back or side pain
- muscle inflammation or pain
- pale skin
- painful or difficult urination
- shortness of breath
- ulcers, sores, or white spots in mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow skin
- sore throat
- sour stomach
Some of the side effects that can occur with rifabutin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Abdominal pain
- bad, unusual, or unpleasant (after) taste in mouth
- bloated, full feeling
- change in taste
- chest pain
- excess air or gas in stomach or intestines
- passing gas
- trouble in sleeping
This medicine commonly causes reddish-orange to reddish-brown discoloration of urine, stools, saliva, skin, sputum, sweat, and tears. This side effect usually does not need medical attention. However, tears that have been discolored by this medicine may also discolor soft contact lenses (see Precautions While Using This Medicine).
For Healthcare Professionals
Applies to rifabutin: oral capsule
Rifabutin was generally well tolerated in clinical trials. Discontinuation due to a side effect was reported in 16% of patients taking rifabutin (the active ingredient contained in Mycobutin) compared to 8% of patients taking placebo. Discontinuation of rifabutin was mainly due to rash (4%), gastrointestinal intolerance (3%), and neutropenia (2%).
Neutropenia and thrombocytopenia have been associated with rifabutin (the active ingredient contained in Mycobutin) 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.
Hematologic side effects have included neutropenia (less than 750/mm3; 25%), leukopenia (less than 1500/mm3; 17%), anemia (less than 8 g/dL; 6%), thrombocytopenia (less than 50,000/mm3; 5%), eosinophilia (1%), and hemolysis (less than 1%). At least one case of thrombotic thrombocytopenic purpura has been reported.
Dermatologic side effects have included rash (11%) and skin discoloration (less than 1%). Perspiration and skin may be discolored brown-orange with rifabutin (the active ingredient contained in Mycobutin) and some of its metabolites. At least one case of acute generalized exanthematous pustulosis has been reported.
Gastrointestinal side effects have included nausea (6%), nausea and vomiting (3%), dyspepsia (3%), diarrhea (3%), eructation (3%), anorexia (2%), flatulence (2%), vomiting (1%), and Clostridium difficile associated diarrhea. Feces and saliva may be discolored brown-orange with rifabutin (the active ingredient contained in Mycobutin) and some of its metabolites. Aphthous stomatitis has rarely been reported.
Ocular side effects have included uveitis, resulting in itching, decreased vision, photophobia, pain, and temporary blindness in some patients. Uveitis was reported at doses from 1050 mg/day to 2400 mg/day. Tears may be discolored brown-orange with rifabutin (the active ingredient contained in Mycobutin) and some of its metabolites. Soft contact lenses may be permanently stained.
Uveitis was rare when rifabutin was used as a single agent at 300 mg/day, even in combination with fluconazole and/or macrolides. However, the incidence of uveitis was greater if higher doses of rifabutin 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.
Hepatic side effects have included increased SGPT (greater than 150 units/L; 9%), increased SGOT (greater than 150 units/L; 7%), and hepatitis (less than 1%).
Three cases of drug-induced lupus syndrome (DILS) have been reported. All cases were receiving standard doses of rifabutin (the active ingredient contained in Mycobutin) and all had positive antinuclear 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.
Other side effects have included abdominal pain (4%), taste perversion (3%), fever (2%), asthenia (1%), chest pain (1%), pain (1%), and influenza-like syndrome. Sputum may be discolored brown-orange with rifabutin and some of its metabolites. Drug-induced lupus syndrome has been reported.
Nervous system side effects have included headache (3%), insomnia (1%), seizure, paresthesia, aphasia, and confusion.
Musculoskeletal side effects have included myalgia (2%), arthralgia (less than 1%), myositis (less than 1%), and polyarthralgia-arthritis syndrome (rare). Generalized arthralgia was reported at doses from 1050 mg/day to 2400 mg/day.
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.
Cardiovascular side effects have included nonspecific T wave changes on electrocardiogram.
Metabolic side effects have included increased alkaline phosphatase (greater than 450 units/L; less than 1%).
Respiratory side effects have included chest pressure or pain with dyspnea in less than 1% of patients.
Urine may be discolored brown-orange with rifabutin (the active ingredient contained in Mycobutin) and some of its metabolites.
Genitourinary side effects have included urine discoloration (30%).
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