Miltefosine: uses, dosing, side effects & brands
Miltefosine is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Capsule
- Sold as
- Impavido
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
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 281 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:
- nausea41 reports
- vomiting20 reports
- visceral leishmaniasis19 reports
- disease recurrence18 reports
- acanthamoeba infection15 reports
- gastrointestinal disorder15 reports
- renal failure15 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.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
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) ↗.