OpenClaim

Clofazimine Side Effects

The most commonly reported side effects of clofazimine include electrocardiogram qt prolonged, off label use, and nausea, based on 6,022 FDA adverse event reports from 2004 to 2025. 4.5% of reports found the drug to be ineffective.

Clofazimine side effects

Percentages show how often each reaction appears relative to total reports for clofazimine.

1
Electrocardiogram Qt Prolonged11.9%716
2
Off Label Use10.9%657
3
Nausea8.7%525
4
Vomiting8.0%479
5
Anaemia7.3%440
6
Dyspnoea6.2%375
7
Neuropathy Peripheral5.6%340
8
Product Use In Unapproved Indication4.5%274
9
Drug Ineffective4.5%273
10
Diarrhoea4.5%273
11
Drug Resistance4.2%254
12
Cough4.2%250
13
Pyrexia3.6%216
14
Decreased Appetite3.4%204
15
Asthenia3.3%200

These are voluntary reports and do not establish that clofazimine caused these reactions.

Report severity

89.2%Serious5,372 reports
33.4%Hospitalizations2,013 reports
20.2%Fatal1,214 reports

Seriousness is determined by the reporter, not by OpenClaim.

Clofazimine drug interactions

Other drugs that appear in adverse event reports alongside clofazimine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Linezolid46.6%2,807
2
Bedaquiline-fumarate39.1%2,357
3
Moxifloxacin-hydrochloride17.1%1,028
4
Pyrazinamide16.8%1,010
5
Levofloxacin16.3%982
6
Cycloserine15.8%950
7
Amikacin-sulfate14.7%883
8
Ethambutol-hydrochloride12.0%720
9
Imipenem11.9%715
10
Azithromycin11.6%696
11
Aminosalicylic9.7%585
12
Isoniazid6.6%398
13
Rifampin6.1%365
14
Ethionamide6.0%364
15
Cilastatin-sodium4.5%271

Taken alongside

1
Pyridoxine12.1%731
2
Amikacin-sulfate9.4%564
3
Azithromycin7.9%475
4
Ethambutol-hydrochloride6.7%403
5
Omeprazole6.3%381
6
Linezolid5.8%352
7
Bedaquiline-fumarate5.2%314
8
Cycloserine4.8%291
9
Metoclopramide-hydrochloride4.2%254
10
Rifampin4.1%246
11
Albuterol3.8%228
12
Amoxicillin3.6%216
13
Tenofovir3.4%206
14
Ondansetron3.4%203
15
Imipenem3.3%198

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports clofazimine side effects

42.6% of clofazimine adverse event reports involve female patients and 47.7% involve male patients. The largest age group is adult at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.6%
Male47.7%
Unknown9.8%

Age group

< 21.0%
2–113.8%
12–173.1%
18–6473.7%
65+18.4%

What is clofazimine used for

Conditions and purposes for which patients were taking clofazimine when the adverse event was reported.

Abdominal InfectionAbdominal LymphadenopathyAbscessAcquired Immunodeficiency SyndromeAnti-infective TherapyAntibiotic ProphylaxisAntibiotic TherapyArthritis BacterialAtypical Mycobacterial InfectionAtypical Mycobacterial PneumoniaAbdominal Wall InfectionAbscessAbscess IntestinalAcid Fast Bacilli InfectionActinomycotic Pulmonary Infection

Showing 15 of 222 indications

Clofazimine brand names and reporting trend

Clofazimine is sold under the brand name Lamprene.

Brand names

Lamprene6,559

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking clofazimine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.