Clofazimine: adverse event reports filed with FDA

4,076

reports as suspect product

0% of all reports · about 183 a year

330

reports, 12 months to June 2026

265 in the 12 months before

90.8%

marked serious by the reporter

92.6% across the class

23.7%

record death among outcomes, as reported

964 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Clofazimine reports recording the termmedian drug in antimycobacterial

1. Electrocardiogram QT prolongeda QT prolongation on the ECG14.7%598
2. Off label useused for a purpose or in a way not on the label10.2%416
3. Vomitingbeing sick9.2%377
4. Anaemialow red blood cells8.5%348
5. Nauseafeeling sick8.4%343
6. Neuropathy peripheralnerve damage in hands or feet6%244
7. Dyspnoeashortness of breath5.7%234
8. Drug ineffectivethe medicine did not work as expected5.3%214
9. Drug resistance4.9%199
10. Hepatotoxicityliver injury4.2%172
11. Product use in unapproved indicationused for a purpose not on the label4.2%172
12. Diarrhoealoose or frequent stools4%165
13. Deaththe patient died; cause not stated by this term4%163
14. Tuberculosistuberculosis3.3%136
15. Astheniaweakness or lack of energy3.3%135
16. Decreased appetitereduced appetite3.3%134
17. Intentional product use issuedeliberate use not as intended3.3%133
18. Respiratory failurethe lungs could not supply enough oxygen3.1%126
19. Pyrexiafever3.1%125
20. Haemoglobin decreasedlow haemoglobin3%123
21. Treatment failurethe treatment did not work3%121
22. Aspartate aminotransferase increasedraised liver enzyme (AST)2.9%119
23. Drug-induced liver injury2.9%118
24. Coughcough2.9%117
25. Alanine aminotransferase increasedraised liver enzyme (ALT)2.8%113
26. Weight decreasedweight loss2.5%102
27. Hypokalaemialow blood potassium2.4%98
28. Drug interactionan interaction between medicines2.2%90
29. Pneumonialung infection2.1%87
30. Acute kidney injurysudden loss of kidney function2.1%86

Top 30 of 799 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the antimycobacterial class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 22,556 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 24.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,076 reports.

Drugs most often listed in the same reports

Other products listed in reports where Clofazimine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the antimycobacterial class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Clofazimine as a suspect or interacting product; reports listing it only as a concomitant medication (1,444) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.