ISONIAZID

N/A

Manufactured by CMP Pharma, Inc.

29,971 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ISONIAZID

ISONIAZID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CMP Pharma, Inc.. The most commonly reported adverse reactions for ISONIAZID include DRUG INEFFECTIVE, PYREXIA, DRUG INTERACTION, NAUSEA, DRUG-INDUCED LIVER INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ISONIAZID.

Top Adverse Reactions

DRUG INEFFECTIVE1,131 reports
PYREXIA1,079 reports
DRUG INTERACTION891 reports
NAUSEA882 reports
DRUG INDUCED LIVER INJURY841 reports
OFF LABEL USE805 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS731 reports
VOMITING620 reports
HEADACHE599 reports
PARADOXICAL DRUG REACTION533 reports
ARTHRALGIA528 reports
TUBERCULOSIS527 reports
DIARRHOEA491 reports
RASH489 reports
HEPATOTOXICITY488 reports
DYSPNOEA477 reports
CONDITION AGGRAVATED475 reports
ANAEMIA464 reports
MALAISE455 reports
DRUG RESISTANCE446 reports
FATIGUE407 reports
PAIN387 reports
JAUNDICE385 reports
HEPATITIS358 reports
ABDOMINAL PAIN355 reports
COUGH351 reports
PNEUMONIA349 reports
ALANINE AMINOTRANSFERASE INCREASED334 reports
WEIGHT DECREASED325 reports
ASTHENIA307 reports
TOXICITY TO VARIOUS AGENTS306 reports
ABDOMINAL PAIN UPPER298 reports
DIZZINESS290 reports
PRURITUS286 reports
HYPERTENSION284 reports
ACUTE HEPATIC FAILURE283 reports
ASPARTATE AMINOTRANSFERASE INCREASED283 reports
PULMONARY TUBERCULOSIS272 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME271 reports
HEPATIC ENZYME INCREASED270 reports
THROMBOCYTOPENIA258 reports
ERYTHEMA255 reports
DECREASED APPETITE251 reports
ACUTE KIDNEY INJURY237 reports
PRODUCT USE IN UNAPPROVED INDICATION233 reports
LIVER DISORDER230 reports
DEATH229 reports
DRUG HYPERSENSITIVITY226 reports
LYMPHADENOPATHY226 reports
HEPATIC FAILURE219 reports
NEUTROPENIA216 reports
PLEURAL EFFUSION216 reports
NEUROPATHY PERIPHERAL213 reports
PANCYTOPENIA211 reports
EXPOSURE DURING PREGNANCY210 reports
SEPSIS210 reports
HEPATIC FUNCTION ABNORMAL209 reports
DISSEMINATED TUBERCULOSIS201 reports
ABDOMINAL DISCOMFORT193 reports
TRANSAMINASES INCREASED193 reports
DRUG INTOLERANCE191 reports
RESPIRATORY FAILURE187 reports
PAIN IN EXTREMITY185 reports
ENCEPHALOPATHY183 reports
HYPOTENSION177 reports
MYALGIA177 reports
HYPERSENSITIVITY176 reports
SEIZURE176 reports
GASTROINTESTINAL DISORDER174 reports
LIVER INJURY173 reports
CARDIAC FAILURE172 reports
LIVER FUNCTION TEST ABNORMAL170 reports
HEPATIC STEATOSIS169 reports
OEDEMA PERIPHERAL168 reports
CONSTIPATION162 reports
PRODUCT USE ISSUE159 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME ASSOCIATED TUBERCULOSIS158 reports
CONFUSIONAL STATE157 reports
CARDIAC FAILURE CONGESTIVE155 reports
HEPATIC ENCEPHALOPATHY151 reports
RENAL FAILURE151 reports
INFUSION RELATED REACTION150 reports
ORAL CANDIDIASIS149 reports
EOSINOPHILIA146 reports
RENAL IMPAIRMENT146 reports
TREATMENT FAILURE142 reports
C REACTIVE PROTEIN INCREASED139 reports
SOMNOLENCE137 reports
BLOOD BILIRUBIN INCREASED136 reports
CHILLS136 reports
GENERAL PHYSICAL HEALTH DETERIORATION136 reports
INTERSTITIAL LUNG DISEASE136 reports
COLITIS ULCERATIVE135 reports
RASH MACULO PAPULAR135 reports
TREATMENT NONCOMPLIANCE135 reports
HAEMATOCHEZIA133 reports
HAEMOGLOBIN DECREASED132 reports
CARDIAC ARREST130 reports
DYSPEPSIA130 reports
ANXIETY128 reports

Report Outcomes

Out of 15,643 classified reports for ISONIAZID:

Serious 90.6%Non-Serious 9.4%

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

Male6,913 (50.1%)
Female6,845 (49.6%)
Unknown49 (0.4%)

Reports by Age

Age 65244 reports
Age 47226 reports
Age 45223 reports
Age 31217 reports
Age 30210 reports
Age 35209 reports
Age 50208 reports
Age 34202 reports
Age 41198 reports
Age 61198 reports
Age 71197 reports
Age 54191 reports
Age 39189 reports
Age 32187 reports
Age 52186 reports
Age 56185 reports
Age 58185 reports
Age 42183 reports
Age 64183 reports
Age 33180 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 ISONIAZID?

This profile reflects 29,971 FDA FAERS reports that mention ISONIAZID. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ISONIAZID?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PYREXIA, DRUG INTERACTION, NAUSEA, DRUG-INDUCED LIVER INJURY, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ISONIAZID?

Labeling and FAERS entries often list CMP Pharma, Inc. in connection with ISONIAZID. 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.