Prescription medicine

Pretomanid

Pretomanid is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the pretomanid FDA label on DailyMed (effective November 15, 2024, Viatris Specialty LLC); the NDA 212862 record on Drugs@FDA; every pretomanid label on DailyMed.

Highlights of the record

FDA label of November 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy.

Forms and strengths

200 mg

Tablet.

On the market

Earliest approval on file: August 14, 2019 Pretomanid, Mylan Ireland Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 727 through July 30, 2026

What is pretomanid used for?

From the label: indications and usage
Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. […]

FDA pharmacologic class: Antimycobacterial.

Source: FDA drug label (Pretomanid), NDA212862 (Mylan Ireland Ltd), as published by Viatris Specialty LLC, effective November 15, 2024 (SPL set f1906fc9-cb3c-4e13-8a4a-da76100c1bf3), via openFDA; the full label on DailyMed

What does the patient leaflet for pretomanid say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid when taking the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid?
You should not drink alcohol while taking the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.

From the patient leaflet: How should I store Pretomanid Tablets?
Store Pretomanid Tablets, bedaquiline, and linezolid below 86°F (30°C). Ask your pharmacist if you have questions about how to store bedaquiline and linezolid. • Keep Pretomanid Tablets in the original container with the container tightly closed. Keep Pretomanid Tablets and all medicines out of the reach of children.

Is there a generic for pretomanid?

No generic pretomanid is approved (Drugs@FDA, October 8, 2026).

2019 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the pretomanid label say about other medicines?

The pretomanid label names 17 other medicines in its interaction, contraindication or warning sections. 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
Bedaquiline	contraindications	CONTRAINDICATIONS Pretomanid Tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. Refer to the bedaquiline and linezolid prescribing information.
Ciprofloxacin	drug interactions	If pretomanid is co-administered with OAT3 substrate drugs (e.g., methotrexate, indomethacin, ciprofloxacin), increase monitoring for OAT3 substrate drug-related adverse reactions and consider dosage reduction for OAT3 substrate drugs, if needed.
Dabigatran	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.
Digoxin	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.
Efavirenz	drug interactions	Strong or moderate CYP3A4 inducers such as rifampin or efavirenz: Avoid co-administration.
Glyburide	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.
Indomethacin	drug interactions	If pretomanid is co-administered with OAT3 substrate drugs (e.g., methotrexate, indomethacin, ciprofloxacin), increase monitoring for OAT3 substrate drug-related adverse reactions and consider dosage reduction for OAT3 substrate drugs, if needed.
Linezolid	contraindications	CONTRAINDICATIONS Pretomanid Tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. Refer to the bedaquiline and linezolid prescribing information.
Lopinavir and ritonavir	drug interactions	Lopinavir/Ritonavir Co-administration of pretomanid with lopinavir/ritonavir did not affect the plasma concentrations of pretomanid [see Clinical Pharmacology (12.3) ].
Methotrexate	drug interactions	If pretomanid is co-administered with OAT3 substrate drugs (e.g., methotrexate, indomethacin, ciprofloxacin), increase monitoring for OAT3 substrate drug-related adverse reactions and consider dosage reduction for OAT3 substrate drugs, if needed.
Midazolam	drug interactions	Pretomanid on Other Drugs Midazolam Co-administration of pretomanid with the CYP3A4 substrate, midazolam, resulted in no clinically significant effect on the pharmacokinetics of midazolam or its major metabolite, 1-hydroxy-midazolam [see Clinical Pharmacology (12.3) ].
Prazosin	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.
Rifampin	drug interactions	Strong or moderate CYP3A4 inducers such as rifampin or efavirenz: Avoid co-administration.
Rosuvastatin	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.

Every other medicine the pretomanid label names

Medicine named	Section	What the label says
Sulfasalazine	drug interactions	… statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.
Valsartan	drug interactions	Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide …
Verapamil	drug interactions	… sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.

Check pretomanid against other medicines

What do FAERS reports show for pretomanid?

The FDA Adverse Event Reporting System holds 727 reports that list pretomanid among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 286 are coded as a death and 154 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

Death (an outcome recorded in the report)121
Anaemia (named in the label)80
Neuropathy Peripheral (named in the label)78
Off Label Use (a use or a product term, not a reaction)63
Electrocardiogram Qt Prolonged51
Nausea (named in the label)50
Toxicity To Various Agents26
Acute Kidney Injury25

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other antimycobacterials: the pharmacologic class, with prices and generics
Pretomanid side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other