What the label lists and what reports show
Rifapentine side effects
Rifapentine's FDA label: “The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia …” FAERS holds 509 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 pyrexia (66 reports).
- Generic approved
Check it at the source: the rifapentine FDA label on DailyMed (effective February 6, 2026, sanofi-aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of PRIFTIN?PRIFTIN may cause serious side effects, including: see " What is the most important information I should know about PRIFTIN? " relapse of your TB symptoms. Active TB disease may return after improvement (relapse) in some people, especially people who do not take PRIFTIN exactly as their doctor tells them to. It is important that you take PRIFTIN exactly as your doctor tells you to. Your doctor should check you for worsening signs and symptoms of your TB while you take PRIFTIN. change in the normal color of your skin, mouth and body fluids. PRIFTIN may cause your skin, teeth, tongue, urine, feces, saliva, sputum, tears, sweat, and breast milk to turn a red-orange color. Contact lenses or dentures may become permanently stained. diarrhea. A type of diarrhea called Clostridioides difficile –associated diarrhea (CDAD) may occur during or after taking antibiotics, including PRIFTIN. […]
Source: FDA drug label, sanofi-aventis U.S. LLC, effective February 6, 2026 (SPL set 3a64fb70-b85e-43d9-8bcd-7e893f568ae1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache.
Table 2: Selected Treatment Emergent Adverse Reactions during Treatment of Active Pulmonary Tuberculosis and through Three Months Follow-up
| System Organ Class Adverse Reaction | PRIFTIN Combination (N=361) N (%) | Rifampin Combination (N=361) N (%) | PRIFTIN Combination (N=317) N (%) | Rifampin Combination (N=304) N (%) |
|---|---|---|---|---|
| Anemia | 41 (11.4) | 41 (11.4) | 5 (1.6) | 10 (3.3) |
| Lymphopenia | 38 (10.5) | 37 (10.2) | 10 (3.2) | 9 (3.0) |
| Neutropenia | 22 (6.1) | 21 (5.8) | 27 (8.5) | 24 (7.9) |
| Leukocytosis | 6 (1.7) | 13 (3.6) | 5 (1.6) | 2 (0.7) |
| Thrombocytosis | 20 (5.5) | 13 (3.6) | 1 (0.3) | 0 (0.0) |
| Thrombocytopenia | 6 (1.7) | 6 (1.7) | 4 (1.3) | 6 (2) |
| Lymphadenopathy | 4 (1.1) | 2 (0.6) | 0 (0.0) | 2 (0.7) |
| Conjunctivitis | 8 (2.2) | 2 (0.6) | 1 (0.3) | 1 (0.3) |
| Dyspepsia | 6 (1.7) | 11 (3) | 4 (1.3) | 6 (2) |
| Vomiting | 6 (1.7) | 14 (3.9) | 3 (0.9) | 3 (1) |
| Nausea | 7 (1.9) | 3 (0.8) | 2 (0.6) | 1 (0.3) |
| Diarrhea | 5 (1.4) | 2 (0.6) | 2 (0.6) | 0 (0.0) |
| Back Pain | 15 (4.2) | 11 (3) | 11 (3.5) | 4 (1.3) |
| Abdominal Pain | 3 (0.8) | 3 (0.8) | 4 (1.3) | 4 (1.3) |
| Fever | 5 (1.4) | 7 (1.9) | 1 (0.3) | 1 (0.3) |
| Anorexia | 14 (3.9) | 18 (5) | 8 (2.5) | 6 (2) |
| ALT Increased | 18 (5) | 23 (6.4) | 7 (2.2) | 10 (3.3) |
| AST Increased | 15 (4.2) | 18 (5) | 7 (2.2) | 8 (2.6) |
| Blood urea increased | 4 (1.1) | 3 (0.8) | 10 (3.2) | 15 (4.9) |
| Arthralgia | 13 (3.6) | 13 (3.6) | 3 (0.9) | 5 (1.6) |
| Headache | 11 (3) | 13 (3.6) | 3 (0.9) | 7 (2.3) |
| Dizziness | 5 (1.4) | 5 (1.4) | 1 (0.3) | 1 (0.3) |
| Hemoptysis | 27 (7.5) | 20 (5.5) | 6 (1.9) | 6 (2) |
| Coughing | 21 (5.8) | 8 (2.2) | 9 (2.8) | 11 (3.6) |
| Rash | 15 (4.2) | 26 (7.2) | 8 (2.5) | 8 (2.6) |
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 and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4.1) and Warnings and Precautions (5.2) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.3) ] Paradoxical Drug Reactions [see Warnings and Precautions (5.5) ] Discoloration of Body Fluids [see Warnings and Precautions (5.7) ] Clostridioides Difficile –Associated Diarrhea [see Warnings and Precautions (5.8) ] Porphyria [see Warnings and Precautions (5.9) ] The most common adverse reactions with regimen for active pulmonary tuberculosis (3% and greater) are anemia, lymphopenia, hemoptysis, neutropenia, cough, thrombocytosis, increased sweating, increased ALT, increased AST, back pain, rash, anorexia, arthralgia, increased blood urea, and headache. The most common adverse reaction (3% and greater) with the regimen for latent tuberculosis infection is hypersensitivity reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, sanofi-aventis U.S. LLC, effective February 6, 2026 (SPL set 3a64fb70-b85e-43d9-8bcd-7e893f568ae1), via openFDA; the full label on DailyMed
What do FAERS reports show?
509 reports list rifapentine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 164 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, 15 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?
- Rifapentine: 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