What the label lists and what reports show
Pyrazinamide side effects
Pyrazinamide's FDA label lists its adverse reactions in its own words. FAERS holds 9,340 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 drug reaction with eosinophilia and systemic symptoms (679 reports).
- Generic listed
Check it at the source: the pyrazinamide FDA label on DailyMed (effective October 3, 2023, Hikma Pharmaceuticals USA Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsGeneral Fever, porphyria and dysuria have rarely been reported. Gout (see PRECAUTIONS ). Gastrointestinal The principal adverse effect is a hepatic reaction (see WARNINGS ). Hepatotoxicity appears to be dose related, and may appear at any time during therapy. GI disturbances including nausea, vomiting and anorexia have also been reported. Hematologic and Lymphatic Thrombocytopenia and sideroblastic anemia with erythroid hyperplasia, vacuolation of erythrocytes and increased serum iron concentration have occurred rarely with this drug. Adverse effects on blood clotting mechanisms have also been rarely reported. Other Mild arthralgia and myalgia have been reported frequently. Hypersensitivity reactions including rashes, urticaria, and pruritis have been reported. Fever, acne, photosensitivity, porphyria, dysuria and interstitial nephritis have been reported rarely.
Source: FDA drug label, Hikma Pharmaceuticals USA Inc, effective October 3, 2023 (SPL set 566db230-3d73-482f-b67d-defd0b2dc46c), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,340 reports list pyrazinamide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,645 are coded as a death and 4,030 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 20 reactions below, 5 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?
- Pyrazinamide: 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