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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ISONIAZID\PYRAZINAMIDE\RIFAMPIN: 412 Adverse Event Reports & Safety Profile

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412
Total FAERS Reports
35 (8.5%)
Deaths Reported
253
Hospitalizations
412
As Primary/Secondary Suspect
27
Life-Threatening
12
Disabilities

First Report: 200502 · Latest Report: 20250915

What Are the Most Common ISONIAZID\PYRAZINAMIDE\RIFAMPIN Side Effects?

#1 Most Reported
Hepatic cytolysis
50 reports (12.1%)
#2 Most Reported
Drug reaction with eosinophilia and systemic symptoms
39 reports (9.5%)
#3 Most Reported
Hepatocellular injury
37 reports (9.0%)

All ISONIAZID\PYRAZINAMIDE\RIFAMPIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatic cytolysis 50 12.1% 5 31
Drug reaction with eosinophilia and systemic symptoms 39 9.5% 9 27
Hepatocellular injury 37 9.0% 4 24
Cholestasis 32 7.8% 10 16
Thrombocytopenia 20 4.9% 3 18
Rash maculo-papular 19 4.6% 2 14
Rash 17 4.1% 9 7
Pyrexia 16 3.9% 2 12
Jaundice 15 3.6% 2 14
Pruritus 15 3.6% 0 14
Mixed liver injury 14 3.4% 1 14
Vomiting 13 3.2% 1 11
Condition aggravated 12 2.9% 0 7
Eosinophilia 12 2.9% 2 9
Hepatic failure 12 2.9% 4 11
Nausea 12 2.9% 0 9
Acute hepatic failure 11 2.7% 2 4
Hepatitis 11 2.7% 0 10
Hepatotoxicity 11 2.7% 0 4
Neutropenia 11 2.7% 0 8

Who Reports ISONIAZID\PYRAZINAMIDE\RIFAMPIN Side Effects? Age & Gender Data

Gender: 40.2% female, 59.8% male. Average age: 50.8 years. Most reports from: FR. View detailed demographics →

Is ISONIAZID\PYRAZINAMIDE\RIFAMPIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 2 0 2
2007 1 0 1
2008 5 2 5
2009 1 0 0
2010 3 0 3
2011 1 0 0
2012 5 0 3
2013 1 0 1
2014 35 0 27
2015 32 5 19
2016 23 2 18
2017 23 0 19
2018 24 0 10
2019 41 12 24
2020 33 1 26
2021 22 3 12
2022 21 0 13
2023 36 3 17
2024 38 6 22
2025 19 0 15

View full timeline →

What Is ISONIAZID\PYRAZINAMIDE\RIFAMPIN Used For?

IndicationReports
Tuberculosis 196
Pulmonary tuberculosis 78
Lymph node tuberculosis 26
Disseminated tuberculosis 20
Product used for unknown indication 13
Bone tuberculosis 10
Meningitis tuberculous 7
Peritoneal tuberculosis 7
Pulmonary tuberculoma 5

ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs Alternatives: Which Is Safer?

ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISONIAZID\PYRIDOXINE\SULFAMETHOXAZOLE\TRIMETHOPRIM ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISONIAZID\RIFAMPIN ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOPROPANOLAMINE ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOPROPYL ALCOHOL ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOPROPYL ALCOHOL\LEUPROLIDE ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOPROPYL ALCOHOL\LEUPROLIDE\NORETHINDRONE ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOPROTERENOL ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOSORBIDE ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOSORBIDE DINITRATE ISONIAZID\PYRAZINAMIDE\RIFAMPIN vs ISOSORBIDE MONONITRATE

Official FDA Label for ISONIAZID\PYRAZINAMIDE\RIFAMPIN

Official prescribing information from the FDA-approved drug label.