Pyrazinamide: adverse event reports filed with FDA

6,334

reports as suspect product

0% of all reports · about 282 a year

404

reports, 12 months to June 2026

458 in the 12 months before

97.7%

marked serious by the reporter

92.6% across the class

19.4%

record death among outcomes, as reported

1,227 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Pyrazinamide reports recording the termmedian drug in antimycobacterial

1. Drug-induced liver injury9.7%617
2. Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement8.5%541
3. Paradoxical drug reaction7.4%471
4. Pyrexiafever6.2%390
5. Vomitingbeing sick5.4%341
6. Drug ineffectivethe medicine did not work as expected5.4%339
7. Hepatotoxicityliver injury5.2%330
8. Off label useused for a purpose or in a way not on the label4.8%306
9. Nauseafeeling sick4.4%277
10. Drug resistance4.2%268
11. Anaemialow red blood cells4.2%266
12. Tuberculosistuberculosis4.2%263
13. Drug interactionan interaction between medicines4%251
14. Condition aggravatedthe condition being treated got worse3.8%238
15. Acute hepatic failure3.5%221
16. Jaundiceyellowing of the skin or eyes3.5%220
17. Neuropathy peripheralnerve damage in hands or feet3.2%200
18. Hepatitis3%192
19. Alanine aminotransferase increasedraised liver enzyme (ALT)2.8%179
20. Electrocardiogram QT prolongeda QT prolongation on the ECG2.8%177
21. Immune reconstitution inflammatory syndrome2.8%176
22. Rashskin rash2.6%164
23. Aspartate aminotransferase increasedraised liver enzyme (AST)2.3%148
24. Diarrhoealoose or frequent stools2.3%145
25. Dyspnoeashortness of breath2.3%144
26. Arthralgiajoint pain2.2%140
27. Disseminated tuberculosis2.2%137
28. Pulmonary tuberculosis2.1%134
29. Product use in unapproved indicationused for a purpose not on the label2%129
30. Acute kidney injurysudden loss of kidney function1.9%123

Top 30 of 1,023 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the antimycobacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 22,556 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 14.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 6,334 reports.

Drugs most often listed in the same reports

Other products listed in reports where Pyrazinamide is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the antimycobacterial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Pyrazinamide as a suspect or interacting product; reports listing it only as a concomitant medication (3,033) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.