Prescription medicine
Rifabutin First approved as Mycobutin
Rifabutin (Mycobutin) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $8.14 per rifabutin 150 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the rifabutin FDA label on DailyMed (effective September 1, 2026, REMEDYREPACK INC.); the NDA 50689 record on Drugs@FDA; every rifabutin label on DailyMed.
Highlights of the record
FDA label of September 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Forms and strengths
- 150 mg
Capsule.
On the market
- Earliest approval on file
- December 23, 1992 Mycobutin, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first February 24, 2014; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $8.14 per capsule Rifabutin 150 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,689 through July 30, 2026
What is rifabutin used for?
From the label: indications and usageRifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
FDA pharmacologic class: Rifamycin Antimycobacterial.
Source: FDA drug label (Rifabutin), NDA050689 (Pfizer), as published by REMEDYREPACK INC., effective September 1, 2026 (SPL set 25a60937-cbbe-4a50-994f-2ce15203f589), via openFDA; the full label on DailyMed
Is there a generic for rifabutin (Mycobutin)?
The FDA approved the first generic rifabutin on February 24, 2014. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists rifabutin from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1992 earliest approval on file
- 2014 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rifabutin (Mycobutin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.14 per Rifabutin 150 mg capsule, down 7% from $8.75 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Rifabutin 150 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rifabutin 150 mg capsule | Generic | $8.14 per capsule | $244.09 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the rifabutin label say about other medicines?
The rifabutin label names 30 other medicines in its interaction, contraindication or warning sections. The labels of 50 other medicines name rifabutin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Co-administered drug: Atazanavir/Ritonavir; Dosing regimen of co-administered drug: 300/100 mg once daily; Dosing regimen of rifabutin: 150 mg twice weekly; Study population (n): Healthy adult subjects; Effect on rifabutin: 48% ↑ in AUC, 149% ↑ C max of rifabutin. … |
| Azithromycin | drug interactions | Co-administered drug: Azithromycin; Dosing regimen of co-administered drug: 500 mg once a day for 1 day, then 250 mg once a day for 9 days; Dosing regimen of rifabutin: 300 mg once a day; Study population (n): Healthy subjects (6); Effect on rifabutin: ↔; Effect on co-administered drug: ↔ |
| Bedaquiline | drug interactions | Co-administered drug: Bedaquiline; Dosing regimen of co-administered drug: 400 mg daily on day 1 and day 29; Dosing regimen of rifabutin: 300 mg daily; Study population (n): Healthy subjects (17); Effect on rifabutin: ND; Effect on co-administered drug: No change in bedaquiline pharmacokinetics. … |
| Cabotegravir and rilpivirine | contraindications | Rifabutin capsules are contraindicated in patients being treated with cabotegravir/rilpivirine prolonged-release injectable suspension (see PRECAUTIONS-Drug Interactions, Table 2 ). |
| Clarithromycin | drug interactions | This effect may reduce the efficacy of standard doses of such drugs, which include itraconazole, clarithromycin, and saquinavir. |
| Cobicistat | drug interactions | Elvitegravir/Cobicistat 150/50 mg daily 300 mg daily Or 150 mg every other day Healthy subjects (12) No significant change in rifabutin pharmacokinetics. |
| Dapsone | drug interactions | Co-administered drug: Dapsone; Dosing regimen of co-administered drug: 50 mg once a day; Dosing regimen of rifabutin: 300 mg once a day; Study population (n): HIV-infected patients (16); Effect on rifabutin: ND; Effect on co-administered drug: ↓ AUC by 27 – 40% |
| Darunavir | drug interactions | Darunavir/Ritonavir 600/100 mg twice a day for 12 days 150 mg every other day for 12 days Healthy HIV- negative adults No significant change in rifabutin pharmacokinetics. |
| Dolutegravir | drug interactions | Co-administered drug: Dolutegravir; Dosing regimen of co-administered drug: 50 mg daily for 14 days; Dosing regimen of rifabutin: 300 mg daily for 14 days; Study population (n): Healthy adult subjects; Effect on rifabutin: ND; … |
| Doravirine | drug interactions | Co-administered drug: Doravirine; Dosing regimen of co-administered drug: 100 mg single dose; Dosing regimen of rifabutin: 300 mg once a day for 16 days; Study population (n): Healthy subjects (12); Effect on rifabutin: ND; Effect on co-administered drug: ↓ 50% in AUC, ↓ 68% in C 24 ↔ in C max; … |
| Emtricitabine | drug interactions | … AUC 38% ↓ C min 56% ↓ C max 20%; Recommendation: Co-administration of rifabutin with Biktarvy (bictegravir/emtricitabine/ tenofovir alafenamide) is not recommended due to an expected decrease in tenofovir alafenamide in addition to the reported reduction in bictegravir. … |
| Ethambutol | drug interactions | Co-administered drug: Ethambutol; Dosing regimen of co-administered drug: 1200 mg; Dosing regimen of rifabutin: 300 mg once a day for 7 days; Study population (n): Healthy subjects (10); Effect on rifabutin: ND; Effect on co-administered drug: ↔ |
| Etravirine | drug interactions | Etravirine 800 mg twice daily for 21 days 300 mg daily on days 8 to 21 Healthy volunteers (18) No significant change in rifabutin pharmacokinetics. |
| Fluconazole | drug interactions | Therefore, carefully monitor for rifabutin associated adverse events in those patients also receiving CYP3A inhibitors, which include fluconazole and clarithromycin. |
Every other medicine the rifabutin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Fosamprenavir | drug interactions | Co-administered drug: Fosamprenavir/ritonavir; Dosing regimen of co-administered drug: 700 mg twice a day plus ritonavir 100 mg twice a day for 2 weeks; … |
| Isoniazid | drug interactions | Co-administered drug: Isoniazid; Dosing regimen of co-administered drug: 300 mg; Dosing regimen of rifabutin: 300 mg once a day for 7 days; Study population (n): Healthy subjects (6); … |
| Itraconazole | drug interactions | This effect may reduce the efficacy of standard doses of such drugs, which include itraconazole, clarithromycin, and saquinavir. |
| Lopinavir and ritonavir | drug interactions | Lopinavir/ ritonavir 400/100 mg twice a day for 20 days 150 mg once a day for 10 days Healthy subjects (14) ↑ AUC by 203% also taking zidovudine 500 mg once a day ↓ C max by 112% ↔ Reduce rifabutin … |
| Methadone | drug interactions | Co-administered drug: Methadone; Dosing regimen of co-administered drug: 20 – 100 mg once a day; Dosing regimen of rifabutin: 300 mg once a day for 13 days; … |
| Nelfinavir | drug interactions | Co-administered drug: Nelfinavir; Dosing regimen of co-administered drug: 1250 mg twice a day for 7–8 days; Dosing regimen of rifabutin: 150 mg once a day for 8 days; … |
| Norethindrone | drug interactions | Co-administered drug: Ethinylestradiol (EE)/ Norethindrone (NE); Dosing regimen of co-administered drug: 35 mg EE / 1 mg NE for 21 days; Dosing regimen of rifabutin: 300 mg once a day for 10 days; … |
| Posaconazole | drug interactions | Co-administered drug: Posaconazole; Dosing regimen of co-administered drug: 200 mg once a day for 10 days; Dosing regimen of rifabutin: 300 mg once a day for 17 days; … |
| Rifampin | drug interactions | Theophylline 5 mg/kg 300 mg for 14 days Healthy subjects (11) ND ↔ Other drugs The structurally similar drug, rifampin, is known to reduce the plasma concentrations of a number of other drugs (see … |
| Rilpivirine | drug interactions | Co-administered drug: Rilpivirine; Dosing regimen of co-administered drug: 25 mg once a day; Dosing regimen of rifabutin: 300 mg once a day; Study population (n): Healthy subjects (18); … |
| Ritonavir | drug interactions | Darunavir/Ritonavir 600/100 mg twice a day for 12 days 150 mg every other day for 12 days Healthy HIV- negative adults No significant change in rifabutin pharmacokinetics. |
| Sofosbuvir | drug interactions | Co-administered drug: Sofosbuvir; Dosing regimen of co-administered drug: 400 mg on day 1 and day 21; Dosing regimen of rifabutin: 300 mg daily on day 10 to day 29; … |
| Tenofovir alafenamide | drug interactions | … Co-administration of rifabutin with Biktarvy (bictegravir/emtricitabine/ tenofovir alafenamide) is not recommended due to an expected decrease in tenofovir alafenamide in addition to the reported … |
| Theophylline | drug interactions | Co-administered drug: Theophylline; Dosing regimen of co-administered drug: 5 mg/kg; Dosing regimen of rifabutin: 300 mg for 14 days; Study population (n): Healthy subjects (11); … |
| Voriconazole | drug interactions | Co-administered drug: Voriconazole; Dosing regimen of co-administered drug: 400 mg twice a day for 7 days (maintenance dose); Dosing regimen of rifabutin: 300 mg once a day for 7 days; … |
| Zidovudine | drug interactions | … Healthy subjects (14); Effect on rifabutin: ↑ AUC by 203% also taking zidovudine 500 mg once a day ↓ C max by 112%; Effect on co-administered drug: ↔; … |
Other labels that name rifabutin
- Aminophylline
- Atovaquone
- Cabotegravir
- Cabozantinib
- Cyclosporine
- Drospirenone
- Efavirenz
- Enzalutamide
- Erlotinib
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norgestimate
- Etonogestrel
- Everolimus
- Hydrocortisone
- Irinotecan
- Lenacapavir
- Letermovir
- Maribavir
- Mifepristone
- Nevirapine
- Ranolazine
- Sirolimus
- Tacrolimus
- Temsirolimus
Source: FDA drug label (Rifabutin), NDA050689 (Pfizer), as published by REMEDYREPACK INC., effective September 1, 2026 (SPL set 25a60937-cbbe-4a50-994f-2ce15203f589), via openFDA; the full label on DailyMed
What do FAERS reports show for rifabutin?
The FDA Adverse Event Reporting System holds 2,689 reports that list rifabutin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 304 are coded as a death and 950 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other rifamycin antimycobacterials
- the pharmacologic class, with prices and generics
- Rifabutin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other