Prescription medicine
Clofazimine Brand names: Lamprene
Clofazimine (Lamprene) is a prescription medicine with an FDA approval on record since 1986. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the clofazimine FDA label on DailyMed (effective August 17, 2026, Novartis Pharmaceuticals Corporation); the NDA 19500 record on Drugs@FDA; every clofazimine label on DailyMed.
Highlights of the record
FDA label of August 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.
Forms and strengths
- 50 mg
Liquid-filled capsule.
On the market
- Earliest approval on file
- December 15, 1986 Lamprene, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,351 through July 30, 2026
What is clofazimine used for?
From the label: indications and usageLAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy. […]
FDA pharmacologic class: Antimycobacterial.
Source: FDA drug label (Lamprene), Novartis Pharmaceuticals Corporation, effective August 17, 2026 (SPL set 2e07448f-f888-4747-80ab-570c1b621250), via openFDA; the full label on DailyMed
Is there a generic for clofazimine (Lamprene)?
No generic clofazimine is approved (Drugs@FDA, October 8, 2026).
- 1986 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the clofazimine label say about other medicines?
The clofazimine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name clofazimine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bedaquiline | drug interactions | 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. |
Source: FDA drug label (Lamprene), Novartis Pharmaceuticals Corporation, effective August 17, 2026 (SPL set 2e07448f-f888-4747-80ab-570c1b621250), via openFDA; the full label on DailyMed
What do FAERS reports show for clofazimine?
The FDA Adverse Event Reporting System holds 6,351 reports that list clofazimine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,259 are coded as a death and 2,078 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antimycobacterials
- the pharmacologic class, with prices and generics
- Clofazimine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other