PYRAZINAMIDE

N/A

Manufactured by ANI Pharmaceuticals, Inc.

17,268 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PYRAZINAMIDE

PYRAZINAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. The most commonly reported adverse reactions for PYRAZINAMIDE include DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, DRUG-INDUCED LIVER INJURY, PYREXIA, DRUG INTERACTION, PARADOXICAL DRUG REACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PYRAZINAMIDE.

Top Adverse Reactions

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS665 reports
DRUG INDUCED LIVER INJURY639 reports
PYREXIA590 reports
DRUG INTERACTION564 reports
PARADOXICAL DRUG REACTION503 reports
OFF LABEL USE489 reports
VOMITING472 reports
DRUG INEFFECTIVE465 reports
TUBERCULOSIS391 reports
NAUSEA390 reports
HEPATOTOXICITY354 reports
DRUG RESISTANCE351 reports
ANAEMIA348 reports
CONDITION AGGRAVATED321 reports
NEUROPATHY PERIPHERAL264 reports
JAUNDICE254 reports
HEPATITIS253 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME253 reports
ACUTE HEPATIC FAILURE234 reports
PULMONARY TUBERCULOSIS232 reports
ALANINE AMINOTRANSFERASE INCREASED226 reports
RASH226 reports
DIARRHOEA213 reports
DYSPNOEA211 reports
ELECTROCARDIOGRAM QT PROLONGED210 reports
ASPARTATE AMINOTRANSFERASE INCREASED192 reports
THROMBOCYTOPENIA184 reports
ARTHRALGIA180 reports
DISSEMINATED TUBERCULOSIS177 reports
ASTHENIA169 reports
ACUTE KIDNEY INJURY165 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME ASSOCIATED TUBERCULOSIS165 reports
PRODUCT USE IN UNAPPROVED INDICATION160 reports
DECREASED APPETITE157 reports
PRURITUS155 reports
LYMPHADENOPATHY154 reports
HEADACHE152 reports
PNEUMONIA151 reports
HEPATIC ENZYME INCREASED145 reports
RESPIRATORY FAILURE145 reports
ABDOMINAL PAIN143 reports
PANCYTOPENIA142 reports
TREATMENT FAILURE140 reports
DEATH139 reports
DIZZINESS134 reports
WEIGHT DECREASED127 reports
SEPSIS125 reports
TRANSAMINASES INCREASED124 reports
HEPATIC FAILURE123 reports
HYPOTENSION122 reports
FATIGUE120 reports
CONFUSIONAL STATE118 reports
EOSINOPHILIA115 reports
COUGH112 reports
HYPOKALAEMIA112 reports
PLEURAL EFFUSION111 reports
HEPATIC FUNCTION ABNORMAL110 reports
IMMUNE RECONSTITUTION SYNDROME110 reports
NEUTROPENIA109 reports
MALAISE105 reports
TOXICITY TO VARIOUS AGENTS104 reports
HAEMOGLOBIN DECREASED103 reports
RASH MACULO PAPULAR101 reports
RENAL IMPAIRMENT98 reports
DRUG LEVEL DECREASED97 reports
HEPATIC ENCEPHALOPATHY96 reports
EXPOSURE DURING PREGNANCY95 reports
TUBERCULOMA OF CENTRAL NERVOUS SYSTEM95 reports
SEIZURE93 reports
LEUKOPENIA92 reports
BLOOD BILIRUBIN INCREASED91 reports
LIVER FUNCTION TEST ABNORMAL91 reports
CHEST PAIN90 reports
MENINGITIS TUBERCULOUS88 reports
GASTROINTESTINAL DISORDER87 reports
RENAL FAILURE86 reports
TREATMENT NONCOMPLIANCE85 reports
GENERAL PHYSICAL HEALTH DETERIORATION84 reports
ERYTHEMA83 reports
LIVER INJURY83 reports
BLOOD CREATININE INCREASED81 reports
ASCITES80 reports
HEPATITIS TOXIC77 reports
SEPTIC SHOCK77 reports
INTENTIONAL PRODUCT USE ISSUE76 reports
MYALGIA75 reports
PSYCHOTIC DISORDER74 reports
DISEASE PROGRESSION73 reports
SOMNOLENCE72 reports
HYDROCEPHALUS71 reports
MULTIPLE DRUG RESISTANCE70 reports
FOETAL EXPOSURE DURING PREGNANCY69 reports
TUBULOINTERSTITIAL NEPHRITIS67 reports
HYPONATRAEMIA66 reports
PATHOGEN RESISTANCE66 reports
RENAL FAILURE ACUTE66 reports
ABDOMINAL PAIN UPPER65 reports
INTERNATIONAL NORMALISED RATIO INCREASED64 reports
OPTIC NEURITIS64 reports
HYPERTRANSAMINASAEMIA63 reports

Report Outcomes

Out of 9,038 classified reports for PYRAZINAMIDE:

Serious 96.6%Non-Serious 3.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male4,264 (55.0%)
Female3,445 (44.5%)
Unknown40 (0.5%)

Reports by Age

Age 30193 reports
Age 31166 reports
Age 25157 reports
Age 33157 reports
Age 34148 reports
Age 35147 reports
Age 39145 reports
Age 41143 reports
Age 40141 reports
Age 28139 reports
Age 32138 reports
Age 42138 reports
Age 37136 reports
Age 24135 reports
Age 27135 reports
Age 45132 reports
Age 65132 reports
Age 26128 reports
Age 38124 reports
Age 50120 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with PYRAZINAMIDE?

This profile reflects 17,268 FDA FAERS reports that mention PYRAZINAMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PYRAZINAMIDE?

Frequently reported terms in FAERS include DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, DRUG-INDUCED LIVER INJURY, PYREXIA, DRUG INTERACTION, PARADOXICAL DRUG REACTION, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PYRAZINAMIDE?

Labeling and FAERS entries often list ANI Pharmaceuticals, Inc. in connection with PYRAZINAMIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.