Clofazimine Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 14, 2024.

Applies to clofazimine: oral capsules.

Side effects include:

Discoloration of skin, eyes, urine, feces, sputum, sweat, tears; GI effects (abdominal and epigastric pain, diarrhea, nausea, vomiting, GI intolerance); eye irritation, itching, dryness, burning.

For healthcare professionals

Applies to clofazimine: oral capsule.

General adverse events

The most common adverse reactions reported in 40% to 50% of patients included skin and body fluid discoloration, abdominal and epigastric pain, diarrhea, nausea, vomiting, and gastrointestinal intolerance.^[Ref]

Cardiovascular

• Frequency not reported: Thromboembolism, vascular pain, QT prolongation

Dermatologic

• Very common (10% or more): Skin discoloration (up to 100%), ichthyosis (up to 28%), dryness (up to 28%), rash (up to 5%), pruritus (up to 5%)
• Frequency not reported: Phototoxicity, erythroderma, acneiform eruptions, monilial cheilosis

Gastrointestinal

• Very common (10% or more): Gastrointestinal intolerance (up to 50%), abdominal/epigastric pain (up to 50%), diarrhea (up to 50%), nausea (up to 50%), vomiting (up to 50%)
• Frequency not reported: Abdominal/bowel obstruction, abdominal/epigastric pain, diarrhea, nausea, vomiting, bowel obstruction, gastrointestinal bleeding, constipation, eosinophilic enteritis

Hematologic

• Frequency not reported: Elevated erythrocyte sedimentation rate, elevated albumin, eosinophilia, anemia

Hepatic

• Frequency not reported: Elevated serum bilirubin, elevated AST, hepatitis, jaundice, enlarged liver

Metabolic

• Frequency not reported: Elevated blood sugar, hypokalemia, edema

Musculoskeletal

• Frequency not reported: Bone pain

Nervous system

• Frequency not reported: Dizziness, drowsiness, headache, neuralgia, taste disorder

Ocular

• Frequency not reported: Diminished vision, conjunctival and corneal pigmentation due to clofazimine crystal deposits, dryness, burning, itching, irritation, maculopathy (bull's eye retinopathy)

Other

• Frequency not reported: Discoloration of urine, feces, sputum, and sweat, splenic infarction, fever, lymphadenopathy, anorexia, weight loss, fatigue, giddiness

Psychiatric

• Frequency not reported: Depression and suicide secondary to skin discoloration

Renal

• Frequency not reported: Cystitis

Further information

Clofazimine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer