Clofazimine: uses, dosing, side effects & brands
Clofazimine is a medicine sold in the U.S. under one brand, for mycobacterium avium-intracellulare infection, borderline leprosy and lepromatous leprosy. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Mycobacterium Avium-Intracellulare Infection, Borderline Leprosy and Lepromatous Leprosy
- Available as
- Capsule
- Sold as
- Lamprene
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How clofazimine is dosed
From the FDA label for Lamprene (application NDA019500). Other clofazimine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For dapsone-sensitive lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals as a part of a combination regimen for at least 2 years is recommended. ( 2.1 ) For dapsone-resistant lepromatous leprosy, 100 mg (two 50 mg capsules) daily with meals in combination with one or more other agents for 3 years. ( 2.1 ) For lepromatous leprosy complicated by erythema nodosum leprosum, 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily for up to 3 months. Taper dose to 100 mg (two 50 mg capsules) as quickly as possible. (2.1 ) 2.1 Dosage Dapsone-sensitive Lepromatous (multibacillary) Leprosy Administer 100 mg (two 50 mg capsules) of LAMPRENE daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti-leprosy drug. Dapsone-resistant Lepromatous Leprosy Administer 100 mg (two 50 mg capsules) of LAMPRENE daily with meals in combination with one or more other anti-leprosy drugs for 3 years, followed by monotherapy with 100 mg (two 50 mg capsules) of LAMPRENE daily. Lepromatous Leprosy complicated by Erythema Nodosum Leprosum Reactions Administer LAMPRENE at 100 mg (two 50 mg capsules) to 200 mg (four 50 mg capsules) daily, in conjunction with baseline anti-leprosy treatment and steroids as clinically indicated. If LAMPRENE is…
Clofazimine side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Abdominal Obstruction and Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.1)] QT Prolongation [see Warnings and Precautions (5.2)] Skin and Body Fluid Discoloration and Other Skin Reactions [see Warnings and Precautions (5.3)] Psychological Effects of Skin Discoloration [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of LAMPRENE were identified. Because these adverse reactions are reported from different studies, these adverse reactions cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Occurring In More Than 1% of Patients Skin : Pigmentation from pink to brownish-black in 75% to 100% of the patients within a few weeks of treatment; ichthyosis and dryness (8% to 28%); rash and pruritus (1% to 5%). Gastrointestinal : Abdominal and epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance (40% to 50%). Ocular : Diminished vision, conjunctival and corneal pigmentation due to clofazimine crystal deposits; dryness; burning; itching; irritation. Other : Discoloration of urine, feces, sputum, sweat; elevated blood sugar; elevated erythrocyte sedimentation rate (ESR). Adverse Reactions Occurring In Less…
Who shouldn’t take clofazimine
LAMPRENE is contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of LAMPRENE. Known hypersensitivity to clofazimine or to any of the excipients of LAMPRENE. ( 4 )
Clofazimine drug interactions
Substrates of CYP3A4/5: Monitor for toxicities when used concomitantly with LAMPRENE. 7.1 Effect of LAMPRENE on Substrates of CYP3A Concomitant use of LAMPRENE may increase concentrations of drugs that are substrates of CYP3A4/5 [see Clinical Pharmacology (12.3)] which may increase the risk of toxicity of these drugs. Monitor for toxicities of these drugs when used concomitantly with LAMPRENE. 7.2 Drugs that Prolong QT Interval QT prolongation and Torsade de Pointes have been reported in patients receiving LAMPRENE in combination with QT prolonging medications, such as bedaquiline. Monitor ECGs for QT prolongation when LAMPRENE is administered with other drugs known to prolong the QT interval [see Warnings and Precautions (5.2)] .
Every clofazimine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Lamprene.
Clofazimine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for clofazimine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited information indicates that clofazimine appears in milk in relatively large amounts. Human milk enhances the solubilization and possibly the absorption of clofazimine in infants. Milk can be colored pink to red by the drug and breastfed infant's skin can be discolored the typical red color that is common in persons taking the drug. No serious or permanent toxicity has been reported in breastfed infants; however, an alternate drug might be considered.
National Institute of Child Health and Human Development, record revised February 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about clofazimine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,551 reports naming clofazimine, and the FDA flagged 90% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- electrocardiogram qt prolonged667 reports
- anaemia458 reports
- nausea458 reports
- vomiting447 reports
- neuropathy peripheral358 reports
- dyspnoea289 reports
- drug resistance261 reports
- diarrhoea221 reports
Read these as a signal, not a rate. A report does not mean clofazimine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is clofazimine?
LAMPRENE (clofazimine) is an antimycobacterial available as soft gelatin capsules for oral administration. Each capsule contains 50 mg of micronized clofazimine suspended in an oil-wax base. Clofazimine is a substituted iminophenazine bright-red dye.
Can you take clofazimine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run clofazimine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does clofazimine come in?
Across the brands we track, clofazimine is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic clofazimine?
We do not currently list a generic-labelled clofazimine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Clofazimine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/clofazimine
- MLA
- “Clofazimine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/clofazimine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for clofazimine on DailyMed (NIH) ↗.