Miltefosine
Miltefosine is an oral antiprotozoal medication used to treat leishmaniasis, a parasitic disease transmitted by sandfly bites that affects the skin, mucous membranes, and internal organs. It is one of the few oral treatments available for this neglected tropical disease, offering an alternative to injectable therapies. The medication works by disrupting the parasite's cell membranes and inducing cell death.
Miltefosine is an oral medication used to treat various forms of leishmaniasis, a parasitic disease caused by Leishmania parasites transmitted through sandfly bites.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- P01CX04
- RxNorm
- 1494066
- Generic
- Miltefosine
- Class
- atc-p01
- Brands
- Impavido
- Availability
- rx
- Pregnancy
- D
- Lactation
- unsafe
- Routes
- oral
- Forms
- capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Miltefosine is indicated for the treatment of cutaneous, mucocutaneous, and visceral leishmaniasis caused by various Leishmania species. It is particularly useful in regions where the disease is endemic and for patients who cannot tolerate or have contraindications to injectable medications like amphotericin B or antimonials.
Miltefosine is an alkylphosphocholine analog that disrupts the parasite's cell membrane integrity. It interferes with signal transduction pathways, inhibits cytochrome c oxidase, and causes mitochondrial dysfunction, leading to programmed cell death (apoptosis) of the Leishmania parasite.
Miltefosine is teratogenic and contraindicated in pregnancy; women of childbearing age must use effective contraception during and for several months after treatment. Common side effects include gastrointestinal symptoms (nausea, vomiting, diarrhea), elevated liver enzymes, and renal toxicity. Treatment requires monitoring of renal and hepatic function. The medication has a long half-life, and resistance has been reported in some regions.
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy