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Rifabutin

Published: July 26, 2026Updated: July 26, 2026

Rifabutin is an antimycobacterial antibiotic belonging to the rifamycin class, primarily used to treat and prevent infections caused by Mycobacterium avium complex (MAC) in immunocompromised patients, particularly those with HIV/AIDS. It is also used as part of combination therapy for the treatment of tuberculosis when other agents are not suitable.

Quick summary

Rifabutin is an antimycobacterial agent used primarily to prevent and treat MAC infections in immunocompromised patients and as an alternative tuberculosis treatment.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy

Key facts at a glance

ATC
J04AB04
RxNorm
55672
Generic
Rifabutin
Class
atc-j04
Brands
Talicia, Mycobutin
Availability
rx
Lactation
unknown
Routes
oral
Forms
capsule
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
300mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
5mg/kg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
300mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose of 10g or more may cause serious toxicity
Chronic overdose: Cumulative doses significantly exceeding recommended amounts over extended periods may lead to toxicity
Immediate actions
gastric lavage within 1-2 hours of ingestion, activated charcoal administration, supportive care
Antidote
no specific antidote(supportive care only, no specific antidote available)
Poison Control: 1-800-222-1222

Special Populations

8 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh risks; consider alternative therapies

Monitor

regular fetal monitoring and ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if benefits outweigh risks; close monitoring required

Monitor

fetal monitoring, assessment of maternal liver function

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
C
Dose Adjustment

discontinue breastfeeding

Key Recommendations

rifabutin passes into breast milk; breastfeeding not recommended during treatment

Monitor

infant should be monitored for signs of hepatotoxicity or hematologic effects

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
C
Dose Adjustment

no specific adjustment; monitor closely

Key Recommendations

use with caution due to age-related decrease in hepatic and renal function; start at lower end of dosing range

Monitor

regular monitoring of liver function tests, complete blood count

Use with caution and monitor for adverse effects.

✓

pediatric_age

children 12 years and older
safe
FDA Category
C
Dose Adjustment

weight-based dosing

Key Recommendations

approved for use in pediatric patients; dosing based on weight (5 mg/kg/day)

Monitor

regular monitoring of liver function and blood counts

⚠

pediatric_age

children under 12 years
caution
FDA Category
C
Dose Adjustment

weight-based dosing with caution

Key Recommendations

use only when benefits outweigh risks; limited safety data in very young children

Monitor

close monitoring of liver function and hematologic parameters

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
C
Dose Adjustment

consider dose reduction in severe impairment

Key Recommendations

no standard dose adjustment; monitor drug levels if available; use with caution

Monitor

regular monitoring of renal function, drug levels if therapeutic drug monitoring available

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate to severe hepatic impairment
caution
FDA Category
C
Dose Adjustment

reduce dose or avoid

Key Recommendations

use with caution; dose reduction may be necessary; monitor liver function closely

Monitor

frequent liver function tests, monitoring for signs of hepatotoxicity

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:1992

FDA approval for Mycobacterium avium complex (MAC) disease

drug_classWHO
2023

Drug class

Value:Rifamycin antibiotic

ATC code J04AB04 - Antimycobacterials

usageCDC
2023

Primary indications

Value:MAC disease prevention and treatment, tuberculosis

Primary therapeutic uses in immunocompromised patients

usageFDA
2023

Combination therapy

Value:H. pylori eradication (Talicia)

Rifabutin combined with amoxicillin/clavulanate for H. pylori

Prevention and treatment of Mycobacterium avium complex (MAC) infections in patients with advanced HIV infection; treatment of pulmonary tuberculosis as part of combination therapy when rifampin cannot be used; treatment of other mycobacterial infections such as Mycobacterium xenopi.

Rifabutin inhibits DNA-dependent RNA polymerase in susceptible bacterial strains, blocking bacterial RNA synthesis. It is effective against mycobacteria and certain gram-positive and gram-negative bacteria, though resistance can develop through mechanisms similar to rifampin.

Rifabutin may cause discoloration of body fluids (orange-red). It has significant drug interactions due to cytochrome P450 enzyme induction. Common side effects include rash, gastrointestinal symptoms, and neutropenia. Requires monitoring for uveitis and liver function. Dosage adjustment may be needed in hepatic impairment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy