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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\RIFAMPIN: 614 Adverse Event Reports & Safety Profile

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614
Total FAERS Reports
46 (7.5%)
Deaths Reported
332
Hospitalizations
614
As Primary/Secondary Suspect
36
Life-Threatening
28
Disabilities

First Report: 1981 · Latest Report: 20250812

What Are the Most Common ISONIAZID\RIFAMPIN Side Effects?

#1 Most Reported
Hepatocellular injury
51 reports (8.3%)
#2 Most Reported
Hepatic cytolysis
46 reports (7.5%)
#3 Most Reported
Vomiting
35 reports (5.7%)

All ISONIAZID\RIFAMPIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatocellular injury 51 8.3% 0 31
Hepatic cytolysis 46 7.5% 1 32
Pyrexia 35 5.7% 1 25
Vomiting 35 5.7% 2 22
Condition aggravated 29 4.7% 11 7
Nausea 26 4.2% 2 14
Neutropenia 26 4.2% 1 7
Off label use 26 4.2% 1 19
Cholestasis 25 4.1% 1 17
Drug reaction with eosinophilia and systemic symptoms 24 3.9% 0 23
Lung disorder 23 3.8% 1 23
Hepatic steatosis 22 3.6% 0 22
Agranulocytosis 19 3.1% 0 18
Pruritus 18 2.9% 0 9
Asthenia 17 2.8% 0 8
Diarrhoea 17 2.8% 1 14
Paraesthesia 17 2.8% 0 4
Acute kidney injury 16 2.6% 2 13
Drug ineffective 16 2.6% 9 4
Hepatitis fulminant 16 2.6% 11 7

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

Gender: 52.6% female, 47.4% male. Average age: 52.1 years. Most reports from: FR. View detailed demographics →

Is ISONIAZID\RIFAMPIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 2
2004 1 0 0
2005 4 0 3
2006 1 0 0
2007 2 0 0
2008 2 0 2
2009 6 1 2
2010 5 1 2
2011 3 1 1
2012 8 0 5
2013 12 1 5
2014 35 0 20
2015 42 3 20
2016 51 0 28
2017 54 4 30
2018 37 0 20
2019 29 3 11
2020 41 1 27
2021 36 0 20
2022 41 8 19
2023 49 3 40
2024 46 0 35
2025 21 1 14

View full timeline →

What Is ISONIAZID\RIFAMPIN Used For?

IndicationReports
Tuberculosis 187
Latent tuberculosis 130
Product used for unknown indication 52
Pulmonary tuberculosis 31
Antibiotic prophylaxis 26
Disseminated tuberculosis 20
Lymph node tuberculosis 19
Prophylaxis 14
Tuberculosis of central nervous system 9
Disseminated bacillus calmette-guerin infection 7

ISONIAZID\RIFAMPIN vs Alternatives: Which Is Safer?

ISONIAZID\RIFAMPIN vs ISOPROPANOLAMINE ISONIAZID\RIFAMPIN vs ISOPROPYL ALCOHOL ISONIAZID\RIFAMPIN vs ISOPROPYL ALCOHOL\LEUPROLIDE ISONIAZID\RIFAMPIN vs ISOPROPYL ALCOHOL\LEUPROLIDE\NORETHINDRONE ISONIAZID\RIFAMPIN vs ISOPROTERENOL ISONIAZID\RIFAMPIN vs ISOSORBIDE ISONIAZID\RIFAMPIN vs ISOSORBIDE DINITRATE ISONIAZID\RIFAMPIN vs ISOSORBIDE MONONITRATE ISONIAZID\RIFAMPIN vs ISOTRETINOIN ISONIAZID\RIFAMPIN vs ISRADIPINE

Official FDA Label for ISONIAZID\RIFAMPIN

Official prescribing information from the FDA-approved drug label.