Clofazimine
Clofazimine is an antimycobacterial antibiotic used to treat lepromatous leprosy, including drug-resistant forms and leprosy complicated by painful skin reactions called erythema nodosum leprosum.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Clofazimine (Lamprene), on the U.S. market since about 1986, is a specialist antibiotic for lepromatous leprosy, the most severe form of Hansen's disease; it slowly kills the bacteria, calms painful inflammatory flares (erythema nodosum leprosum), and is always paired with other anti-leprosy drugs so resistance does not develop. It works well but tints the skin pink to brownish-black in nearly everyone, plus urine, sweat and tears, and the color can take months or years to fade. Report stomach pain, vomiting or diarrhea quickly, since crystal deposits in the gut can cause blockage or bleeding. Expect ECG (heart tracing) checks, and speak up if the color change lowers your mood.
Clinical pearls
- Take it with a meal each time, since food helps the capsules absorb faster.
- Flag clofazimine before every new prescription, since it adds to heart-rhythm effects of drugs like bedaquiline and raises levels of many others.
- Use effective contraception, including condoms for men, during treatment and for at least 4 months after the final dose.
- It passes into breast milk and has discolored nursing infants' skin, so raise breastfeeding before starting.
Patient information guide A plain-language walkthrough of Clofazimine, written from its FDA label.
What Clofazimine is used for
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Clofazimine, available as Lamprene capsules, is an antimycobacterial antibiotic with a specific set of approved uses:
- Lamprene is used to treat lepromatous leprosy (the most severe form of Hansen's disease) in combination with other anti-leprosy drugs
- Lamprene is used for dapsone-resistant lepromatous leprosy — cases where the bacteria no longer respond to dapsone
- Lamprene is used for lepromatous leprosy complicated by erythema nodosum leprosum (ENL) — a painful inflammatory skin and tissue reaction
- For initial treatment of lepromatous (multibacillary) leprosy, Lamprene must always be combined with other anti-leprosy drugs to prevent drug resistance from developing
How Clofazimine works
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Clofazimine slowly kills Mycobacterium leprae — the bacterium that causes leprosy — by attacking the bacterial cell membrane. It disrupts the bacteria's ability to produce energy by interfering with their respiratory chain and blocking the uptake of certain ions, ultimately killing the cell. It also generates toxic molecules called reactive oxygen species (ROS) inside the bacteria. In addition to fighting the bacteria, clofazimine has anti-inflammatory effects: it suppresses T lymphocytes (key immune cells) and reduces the overactive immune response that drives erythema nodosum leprosum reactions.
Importantly, clofazimine does not show cross-resistance with dapsone or rifampin, meaning it remains effective even when those drugs stop working against the bacteria.
Clofazimine dosage
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Lamprene is taken as a capsule by mouth, once daily with meals — food helps the medicine reach its peak level in the blood faster. Treatment is long-term; depending on the type of leprosy, it may continue for several years. Higher daily doses, sometimes used for ENL reactions, should be given for as short a time as possible and only under close medical supervision.
- Always take Lamprene with a meal or food
- Take it as part of a combination regimen — never alone for initial treatment
- Do not stop or change your dose without talking to your prescriber
- If you miss a dose, follow your prescriber's guidance — do not double up without being told to
Dosing details from the FDA-approved label
From the Clofazimine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Dapsone-sensitive Lepromatous (multibacillary) Leprosy
- 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
- Given with meals
- Dapsone-resistant Lepromatous Leprosy
- 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
- Given with meals
- Lepromatous Leprosy complicated by Erythema Nodosum Leprosum Reactions
- 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 given at 200 mg, taper to 100 mg (two 50 mg capsules) as soon as possible after the erythema nodosum reaction is controlled
- Maximum: 200 mg (four 50 mg capsules) daily
- Doses of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision; up to 3 months
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 administered at 200 mg (four 50 mg capsules) dose, taper to 100 mg (two 50 mg capsules) as soon as possible after the erythema nodosum reaction is controlled. Doses of LAMPRENE of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision [see Warnings and Precautions (5.1)] . 2.2 Important Pre-test Prior to Administration Sexually-active females of reproductive potential should have a pregnancy test prior to LAMPRENE administration [see Use in Specific Populations (8.3)] .
Read the full Dosage and Administration section on DailyMed →
Clofazimine side effects
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The most common side effects of Lamprene affect the skin and digestive system and occur in the majority of patients:
Common side effects
- Skin discoloration — pink to brownish-black — in the vast majority of patients
- Abdominal or stomach pain
- Nausea, vomiting, or diarrhea
- Dry, itchy, or scaly skin
- Discoloration of urine, sweat, tears, and stool
- Eye irritation, dryness, or redness
- Rash or itching
- Skin and body fluid discoloration — pink to brownish-black coloring of the skin, eyes, urine, sweat, tears, and stool (75%–100% of patients)
- Eye irritation, dryness, burning, or blurred vision
- Elevated blood sugar
- Dizziness, drowsiness, or headache (less common)
- Depression or low mood, especially related to skin discoloration
When to get medical help
- Call your doctor right away if you have severe stomach pain, nausea, vomiting, or diarrhea — these can be signs of a serious bowel problem
- Seek emergency care if you faint or feel your heart beating irregularly — this could signal a dangerous heart rhythm problem (QT prolongation)
- Tell your doctor if you feel depressed or have thoughts of self-harm — skin discoloration from this medicine has been linked to depression and suicide
- Get medical attention if you have signs of liver problems: yellowing of the skin or eyes, severe fatigue, or upper right belly pain
- Seek care if you notice signs of intestinal blockage: severe cramping, inability to pass gas or stool, or extreme bloating
Serious but less common reactions include bowel obstruction, gastrointestinal bleeding, splenic infarction, dangerous heart rhythm changes (QT prolongation), and liver problems — contact your doctor immediately if you notice severe stomach pain, fainting, irregular heartbeat, or yellowing of the skin or eyes.
Clofazimine warnings and precautions
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- Bowel and stomach problems: Clofazimine can build up as crystals in the intestinal lining, potentially causing bowel obstruction (blockage), bleeding, or splenic infarction. These can be life-threatening. Report any stomach pain, nausea, vomiting, or diarrhea to your doctor promptly.
- Heart rhythm (QT prolongation): Lamprene can prolong the QT interval — an electrical signal in the heart — which can lead to a dangerous arrhythmia called Torsade de Pointes. Risk increases at higher doses or when combined with other drugs that affect heart rhythm, including bedaquiline. Regular ECG monitoring is required in these situations.
- Skin discoloration and mental health: Nearly all patients develop discoloration of the skin and body fluids. This can be distressing and has been associated with depression and suicide. Tell your doctor if you feel depressed or have thoughts of harming yourself.
- Liver impairment: Lamprene should generally be avoided in patients with liver disease unless the benefit clearly outweighs the risk.
Clofazimine interactions
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Clofazimine can interact with several other medications in clinically important ways:
- QT-prolonging drugs (including bedaquiline): Combining these with clofazimine increases the risk of a serious heart rhythm problem called Torsade de Pointes — ECG monitoring is required
- CYP3A4/5 substrates: Clofazimine inhibits enzymes that break down many drugs; this can raise the blood levels of those drugs and increase the risk of their side effects — monitor for toxicity
- CYP2C8 and CYP2D6 substrates: Similarly, clofazimine may raise blood levels of drugs processed by these enzymes
- Isoniazid (high doses): High-dose isoniazid taken alongside high-dose clofazimine has been associated with altered clofazimine blood levels; clinical significance is uncertain but warrants awareness
Interactions listed in the FDA-approved label
From the Clofazimine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Substrates of CYP3A4/5: Concomitant use of LAMPRENE may increase concentrations of drugs that are substrates of CYP3A4/5, which may increase the risk of toxicity of these drugs. Monitor for toxicities when used concomitantly with LAMPRENE.
- Drugs that prolong QT interval (such as bedaquiline): 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.
Read the label’s full interactions text
7 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)] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Clofazimine
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- Allergy: Do not take Lamprene if you have had a hypersensitivity (allergic) reaction to clofazimine or any ingredient in Lamprene capsules
- Liver disease: Avoid Lamprene if you have hepatic impairment unless your doctor determines the benefit outweighs the risk
- Severe kidney disease: Use with caution in severe renal impairment
- Pregnancy: Animal studies showed harm to the fetus; infants born to mothers who took Lamprene were pigmented at birth. A pregnancy test is required before starting, and effective contraception must be used during treatment and for at least 4 months after stopping
- Breastfeeding: Clofazimine passes into breast milk and has caused skin discoloration in nursing infants; discuss the risks and benefits with your doctor
- Males of reproductive potential: Use a condom during intercourse while on Lamprene and for at least 4 months after stopping
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults: Dose selection should be cautious, given the higher likelihood of reduced liver, kidney, or heart function in elderly patients
- HIV co-infection: No dose adjustment of Lamprene is needed for HIV-positive patients with leprosy
Clofazimine overdose
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There is no specific antidote for a clofazimine overdose. If an overdose occurs, the priority is to empty the stomach — either by inducing vomiting or through gastric lavage (stomach pumping) — along with supportive care. If you suspect an overdose, seek emergency medical attention right away.
What Clofazimine does in the body
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The precise relationship between clofazimine blood levels and its therapeutic or adverse effects is not fully understood — the exposure-response relationship and the exact time course of its action in the body remain unknown. What is known is that it has a slow bactericidal (bacteria-killing) effect and also reduces inflammation associated with erythema nodosum leprosum reactions.
How your body processes Clofazimine
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Clofazimine is absorbed from 45% to 62% of an oral dose in leprosy patients, and food speeds up the time to peak blood concentration (from about 12 hours fasting to about 8 hours with food). It is highly lipophilic — meaning it is attracted to fat — and deposits extensively in fatty tissue, the liver, spleen, intestines, skin, and immune cells called macrophages throughout the body. The drug lingers in the body for a very long time: its average elimination half-life (the time for blood levels to fall by half) is about 25 days, though this can range from under a week to over 5 months in different individuals. It is excreted primarily through the bile and feces, with very little leaving the body through urine; small amounts are also eliminated in sweat, sputum, and sebum (skin oil).
How to store Clofazimine
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Store at 20℃ to 25℃ (68℉ to 77℉); excursions permitted between 15℃ and 30℃ (59℉ and 86℉) . Store and dispense in original container. Protect from moisture.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Clofazimine
64 supplements and herbal products have documented interactions with Clofazimine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 52
- Minor · 11
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Clofazimine has been associated with lower levels of 7 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 6
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Clofazimine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Clofazimine — the kind of thing our pharmacy team would talk through with you at the counter.
Why does my skin keep changing color while I'm on this medication?
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I've been having stomach pain and nausea since starting Lamprene. Is that normal?
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Do I really need to take this with food every time?
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Can I take my other medications alongside Lamprene?
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Is it safe to take this if I'm pregnant or trying to get pregnant?
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How long will I need to take this medication?
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Is Clofazimine available over the counter?
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When was Clofazimine first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Clofazimine on HelloPharmacist
Clofazimine forms and strengths (how it comes)
Clofazimine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Clofazimine inactive ingredients by manufacturer.
Capsule
How this form is used
- Lamprene capsules are used to treat lepromatous leprosy, including dapsone-sensitive and dapsone-resistant forms
- Lamprene capsules are used to treat lepromatous leprosy complicated by erythema nodosum leprosum (ENL) reactions
- Lamprene must be used in combination with other anti-leprosy drugs for initial treatment to prevent drug resistance
- Lamprene capsules are taken by mouth once daily with meals to improve absorption
- Lamprene should be taken as part of a combination regimen for initial treatment — do not take it alone at the start of therapy
- For leprosy complicated by ENL, higher daily doses may be used for a short period under close medical supervision, then tapered down as quickly as possible
- Sexually active women of reproductive potential should have a pregnancy test before starting Lamprene
Clofazimine on the U.S. market: products, makers and brands
How Clofazimine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Clofazimine product record with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1986. Brand names on the directory include Lamprene; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Clofazimine products
A representative set of FDA-listed product records for Clofazimine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 50 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Clofazimine NDCs →
Clofazimine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Clofazimine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Clofazimine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Clofazimine FDA approval history
How Clofazimine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Clofazimine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Clofazimine recalls since July 2021.
✅No Clofazimine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2592 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 371567In current FDA listingsClinical drug / strength (SCD) 50 MGRxCUI 197521100 MGRxCUI 313893
Look up RxCUI 2592 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Clofazimine supply and shortage status
Whether Clofazimine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Clofazimine brand names
Clofazimine is sold under one brand name in the FDA directory — Lamprene. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Clofazimine: manufacturers and labelers
One company lists Clofazimine products with the FDA. By number of product records, the largest are Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Clofazimine drug class (RxNorm)
Clofazimine belongs to the Antimycobacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Clofazimine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →