What the label lists and what reports show
Pretomanid side effects
Pretomanid's FDA label: “Most common adverse reactions (≥ 10%) are peripheral neuropathy, anemia, nausea, acne, vomiting, increased transaminases, headache, musculoskeletal pain, dyspepsia, rash, pruritus, decreased appetite, abdominal pain, pleuritic pain, increased …” FAERS holds 727 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anaemia (80 reports).
- No generic listed
Check it at the source: the pretomanid FDA label on DailyMed (effective November 15, 2024, Viatris Specialty LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid?The combination regimen of Pretomanid Tablets, bedaquiline, and linezolid may cause serious side effects including: • See “What is the most important information I should know about the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid?” • Liver problems. Your healthcare provider should do blood tests to check your liver at least before you start taking the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid, 2 weeks after starting treatment, and then monthly during treatment. […]
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost common adverse reactions (≥ 10%) are peripheral neuropathy, anemia, nausea, acne, vomiting, increased transaminases, headache, musculoskeletal pain, dyspepsia, rash, pruritus, decreased appetite, abdominal pain, pleuritic pain, increased gamma-glutamyltransferase, hemoptysis and hyperamylasemia.
Table 1: Select Adverse Reactions (All Grades) Reported in ≥ 5% of Patients Receiving the Combination Regimen of Pretomanid Tablets, Bedaquiline, and Linezolid in Trials 1 and 2
| Adverse Reactions | Pretomanid Tablets, Bedaquiline and Linezolid (1,200 mg) Combination Regimen (N = 154) All Grades n (%) | Pretomanid Tablets, Bedaquiline and Linezolid (600 mg) Combination Regimen (N = 45) All Grades n (%) |
|---|---|---|
| Peripheral neuropathy Select terms are collapsed, as follows: peripheral neuropathy… | 105 (68) | 10 (22) |
| Acne | 44 (29) | 6 (13) |
| Transaminases increased | 39 (25) | 11 (24) |
| Pruritus | 25 (16) | 3 (7) |
| Pleuritic pain | 22 (14) | 4 (9) |
| Neutropenia | 12 (8) | 3 (7) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed here and elsewhere in the labeling: • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Myelosuppression [see Warnings and Precautions (5.3) ] • Peripheral and Optic Neuropathy [see Warnings and Precautions (5.4) ] • QT Prolongation [see Warnings and Precautions (5.5) ] • Reproductive Effects [see Warnings and Precautions (5.7) ] • Lactic Acidosis [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥ 10%) are peripheral neuropathy, anemia, nausea, acne, vomiting, increased transaminases, headache, musculoskeletal pain, dyspepsia, rash, pruritus, decreased appetite, abdominal pain, pleuritic pain, increased gamma-glutamyltransferase, hemoptysis and hyperamylasemia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, 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 do FAERS reports show?
727 reports list pretomanid among the medicines taken, 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. Of the 21 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pretomanid: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions