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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.

CLOFAZIMINE: 4,433 Adverse Event Reports & Safety Profile

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4,433
Total FAERS Reports
1,021 (23.0%)
Deaths Reported
1,528
Hospitalizations
4,433
As Primary/Secondary Suspect
275
Life-Threatening
127
Disabilities
Dec 15, 1986
FDA Approved
Discontinued
Status

FDA Application: 019500 ·

First Report: 19820723 · Latest Report: 20250821

What Are the Most Common CLOFAZIMINE Side Effects?

#1 Most Reported
Electrocardiogram qt prolonged
629 reports (14.2%)
#2 Most Reported
Nausea
403 reports (9.1%)
#3 Most Reported
Vomiting
399 reports (9.0%)

All CLOFAZIMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Electrocardiogram qt prolonged 629 14.2% 107 223
Nausea 403 9.1% 58 185
Vomiting 399 9.0% 107 192
Off label use 389 8.8% 93 151
Anaemia 353 8.0% 81 182
Dyspnoea 313 7.1% 142 190
Neuropathy peripheral 238 5.4% 34 62
Diarrhoea 213 4.8% 53 97
Drug resistance 196 4.4% 12 47
Drug ineffective 191 4.3% 26 44
Cough 173 3.9% 31 87
Product use in unapproved indication 173 3.9% 25 33
Asthenia 171 3.9% 65 94
Death 171 3.9% 171 64
Hepatotoxicity 171 3.9% 8 28
Decreased appetite 162 3.7% 40 96
Pyrexia 161 3.6% 31 99
Respiratory failure 151 3.4% 135 76
Aspartate aminotransferase increased 139 3.1% 40 70
Intentional product use issue 135 3.1% 56 65

Who Reports CLOFAZIMINE Side Effects? Age & Gender Data

Gender: 47.1% female, 52.9% male. Average age: 44.5 years. Most reports from: US. View detailed demographics →

Is CLOFAZIMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2005 1 0 1
2008 2 0 0
2009 1 0 0
2010 1 0 0
2011 7 2 6
2012 4 0 3
2013 2 0 1
2014 19 3 7
2015 40 7 20
2016 126 44 62
2017 311 100 164
2018 730 255 309
2019 599 125 246
2020 216 57 82
2021 154 27 66
2022 181 30 88
2023 230 41 91
2024 167 31 73
2025 53 5 23

View full timeline →

What Is CLOFAZIMINE Used For?

IndicationReports
Tuberculosis 2,006
Pulmonary tuberculosis 473
Mycobacterium abscessus infection 398
Mycobacterium avium complex infection 374
Product used for unknown indication 343
Mycobacterial infection 204
Atypical mycobacterial infection 98
Lepromatous leprosy 84
Leprosy 84
Mycobacterium chelonae infection 59

CLOFAZIMINE vs Alternatives: Which Is Safer?

CLOFAZIMINE vs CLOMETHIAZOLE CLOFAZIMINE vs CLOMIPHENE CLOFAZIMINE vs CLOMIPRAMINE CLOFAZIMINE vs CLONAZEPAM CLOFAZIMINE vs CLONIDINE CLOFAZIMINE vs CLOPIDOGREL CLOFAZIMINE vs CLOPIDOGREL BESILATE CLOFAZIMINE vs CLOPIDOGREL BISULFATE CLOFAZIMINE vs CLORAZEPATE CLOFAZIMINE vs CLOSTRIDIUM TETANI TOXOID ANTIGEN

Official FDA Label for CLOFAZIMINE

Official prescribing information from the FDA-approved drug label.