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Mycobutin Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Mycobutin (rifabutin) is used to prevent mycobacterium avium complex (MAC) in people with HIV (human immunodeficiency virus) infection. It is also used with other medications to treat tuberculosis in people with HIV. It is an antibiotic, and is often given together with other antibiotics. Common side effects include diarrhea, stomach upset, changes in taste, or nausea/vomiting.
It is recommended that Mycobutin Capsules be administered at a dose of 300 mg once daily. Mycobutin may interact with other antibiotics, or HIV or AIDS medications. Many other medicines can interact with Mycobutin. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Mycobutin should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. If you have HIV disease, do not breastfeed because breast milk can transmit HIV.
Our Mycobutin (rifabutin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Mycobutin in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe skin rash or itching;
- pale skin, weakness, easy bruising or bleeding;
- fever, chills, body aches, flu symptoms; or
- eye pain or redness, vision loss.
Less serious side effects may include:
- red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;
- nausea, vomiting, diarrhea;
- stomach pain;
- belching, bloating, loss of appetite;
- headache; or
- mild skin rash or itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Mycobutin (Rifabutin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Mycobutin Overview - Patient Information: Side Effects
This medication may cause urine, sweat, saliva, or tears to turn brown-orange. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of a new infection (such as fever, persistent sore throat/cough), muscle weakness/pain, joint pain/swelling, eye pain/redness, vision problems, chest pain/pressure, persistent nausea/vomiting, unusual weakness/tiredness, dark urine, yellowing eyes/skin.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Mycobutin (Rifabutin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Mycobutin FDA Prescribing Information: Side Effects
MYCOBUTIN (rifabutin) Capsules were generally well tolerated in the controlled clinical trials. Discontinuation of therapy due to an adverse event was required in 16% of patients receiving MYCOBUTIN (rifabutin) compared to 8% of patients receiving placebo in these trials. Primary reasons for discontinuation of MYCOBUTIN (rifabutin) were rash (4% of treated patients), gastrointestinal intolerance (3%), and neutropenia (2%).
The following table enumerates adverse experiences that occurred at a frequency of 1% or greater, among the patients treated with MYCOBUTIN (rifabutin) in studies 023 and 027.
CLINICAL ADVERSE EXPERIENCES REPORTED IN ≤ 1% OF PATIENTS
TREATED WITH MYCOBUTIN (rifabutin)
(n = 566) %
(n = 580) %
|BODY AS A WHOLE|
|Nausea and Vomiting||3||2|
|SKIN AND APPENDAGES|
Clinical Adverse Events Reported In < 1% of Patients Who Received Mycobutin (rifabutin)
Considering data from the 023 and 027 pivotal trials, and from other clinical studies, MYCOBUTIN (rifabutin) appears to be a likely cause of the following adverse events which occurred in less than 1% of treated patients: flu-like syndrome, hepatitis, hemolysis, arthralgia, myositis, chest pressure or pain with dyspnea, and skin discoloration.
The following adverse events have occurred in more than one patient receiving MYCOBUTIN (rifabutin) , but an etiologic role has not been established: seizure, paresthesia, aphasia, confusion, and non-specific T wave changes on electrocardiogram.
When MYCOBUTIN (rifabutin) was administered at doses from 1050 mg/day to 2400 mg/day, generalized arthralgia and uveitis were reported. These adverse experiences abated when MYCOBUTIN (rifabutin) was discontinued.
The following table enumerates the changes in laboratory values that were considered as laboratory abnormalities in studies 023 and 027.
PERCENTAGE OF PATIENTS WITH LABORATORY ABNORMALITIES
(n = 566) %
(n = 580) %
|Increased Alkaline Phosphatase1||< 1||3|
|INCLUDES GRADE 3 OR 4 TOXICITIES AS SPECIFIED:
1 all values > 450 U/L
2 all values > 150 U/L
3 all hemoglobin values < 8.0 g/dL
4 all WBC values < 1,500/mm3
5 all ANC values < 750/mm3
6 all platelet count values < 50,000/mm3
The incidence of neutropenia in patients treated with MYCOBUTIN (rifabutin) was significantly greater than in patients treated with placebo (p = 0.03). Although thrombocytopenia was not significantly more common among patients treated with MYCOBUTIN (rifabutin) in these trials, MYCOBUTIN (rifabutin) has been clearly linked to thrombocytopenia in rare cases. One patient in study 023 developed thrombotic thrombocytopenic purpura, which was attributed to MYCOBUTIN (rifabutin) .
Uveitis is rare when MYCOBUTIN (rifabutin) is used as a single agent at 300 mg/day for prophylaxis of MAC in HIV-infected persons, even with the concomitant use of fluconazole and/or macrolide antibiotics. However, if higher doses of MYCOBUTIN (rifabutin) are administered in combination with these agents, the incidence of uveitis is higher.
Patients who developed uveitis had mild to severe symptoms that resolved after treatment with corticosteroids and/or mydriatic eye drops; in some severe cases, however, resolution of symptoms occurred after several weeks.
When uveitis occurs, temporary discontinuance of MYCOBUTIN (rifabutin) and ophthalmologic evaluation are recommended. In most mild cases, MYCOBUTIN (rifabutin) may be restarted; however, if signs or symptoms recur, use of MYCOBUTIN (rifabutin) should be discontinued (Morbidity and Mortality Weekly Report, September 9, 1994).
Read the entire FDA prescribing information for Mycobutin (Rifabutin)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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