Miltefosine: uses, dosing, side effects & brands
Miltefosine is an antileishmanial sold in the U.S. under one brand, for visceral leishmaniasis and cutaneous leishmaniasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Antileishmanial
- Treats
- Visceral Leishmaniasis and Cutaneous Leishmaniasis
- Available as
- Capsule
- Sold as
- Impavido
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How miltefosine is dosed
From the FDA label for Impavido (application NDA204684). Other miltefosine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions. Table 1: Miltefosine Dosage Weight Dosage and Administration 30 kg to 44 kg One 50 mg capsule twice daily with food (breakfast and dinner) 45 kg or greater One 50 mg capsule three times daily with food (breakfast, lunch, and dinner) Administer with food to ameliorate gastrointestinal adverse reactions. 30 to 44 kg: one 50 mg capsule twice daily for 28 consecutive days ( 2 ). 45 kg or greater: one 50 mg capsule three times daily for 28 consecutive days ( 2 ).
Miltefosine side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug 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 ≥2% of patients include nausea, vomiting, diarrhea, headache, decreased appetite, dizziness, abdominal pain, pruritus, somnolence, elevated transaminases, and elevated creatinine (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Profounda, Inc. at 1-866-588-5405 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Visceral Leishmaniasis One Phase 3 trial was conducted in patients ≥ 12 years of age in India. Two-hundred and ninety-nine (299) patients (211 men and 88 women) received oral IMPAVIDO at a target dose of 2.5 mg/kg/day for 28 days (50 mg capsule once daily if weight was less than 25 kg and 50 mg capsule twice daily if weight was 25 kg or greater). Patients ranged between 12 and 64 years of age. Weight ranged between 15 and 67 kg (mean weight 38.6 kg) and BMI ranged between 8.2 and 24 (mean 16.1). Ninety-nine (99) patients received 1 mg/kg/day amphotericin B deoxycholate intravenously every other day for 15 doses. A statistically significant higher percentage of men received IMPAVIDO compared to amphotericin B. Less than 1% of patients who received…
Who shouldn’t take miltefosine
Pregnancy ( 4.1 , 8.1 , 8.8 , 13.1 ). Sjögren-Larsson-Syndrome ( 4.2 , 12.3 ). Hypersensitivity to miltefosine or any of its excipients ( 4.3 ). 4.1 Pregnancy IMPAVIDO may cause fetal harm. IMPAVIDO is contraindicated in pregnant women. Obtain a urine or serum pregnancy test prior to prescribing IMPAVIDO [see Boxed Warning and Use in Specific Populations ( 8.1 )] . 4.2 Sjögren-Larsson-Syndrome IMPAVIDO is contraindicated in patients who have Sjögren-Larsson-Syndrome [see Clinical Pharmacology ( 12.3 )] . 4.3 Hypersensitivity IMPAVIDO is contraindicated in patients who are hypersensitive to miltefosine or any IMPAVIDO excipients.
Miltefosine drug interactions
In vitro and animal metabolism studies showed that miltefosine did not markedly induce or inhibit the activity of the major human cytochrome P450 enzymes [see Clinical Pharmacology ( 12.3 )] . The potential of miltefosine to interact with drug transporters has not been evaluated. IMPAVIDO did not inhibit human cytochrome P450 enzymes in vitro. IMPAVIDO did not induce cytochrome 3A activity in rats( 7 , 12.3 ).
Every miltefosine 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: Impavido.
What people report to the FDA about miltefosine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 275 reports naming miltefosine, and the FDA flagged 96% 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:
- nausea40 reports
- visceral leishmaniasis19 reports
- vomiting19 reports
- disease recurrence18 reports
- gastrointestinal disorder15 reports
- renal failure15 reports
- acanthamoeba infection14 reports
- acute kidney injury13 reports
Read these as a signal, not a rate. A report does not mean miltefosine 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 section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is miltefosine?
IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent.
What kind of drug is miltefosine?
The FDA classifies miltefosine as an antileishmanial. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take miltefosine 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 miltefosine 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 miltefosine come in?
Across the brands we track, miltefosine 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 miltefosine?
We do not currently list a generic-labelled miltefosine 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). Miltefosine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/miltefosine
- MLA
- “Miltefosine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/miltefosine.
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 miltefosine on DailyMed (NIH) ↗ — including its boxed warning in full.