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Generic Name: miltefosine (MIL te FOE seen)
Brand Names: Impavido
Impavido (miltefosine) is used for the treatment of leishmaniasis affecting the skin, internal organs, and mucous membranes. Impavido information includes news, clinical trial results and side effects.
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Drug Information:
Impavido (miltefosine) is an anti-parasitic drug used to treat leishmaniasis, a disease caused by an infection with parasites that enter the body through the bite of an infected sand fly. Impavido is used to treat leishmaniasis affecting the skin, internal organs (such as the liver, spleen or bone marrow), and mucous membranes (nose, mouth, and throat). Impavido may also be used for purposes not listed in this medication guide. In animal studies, Impavido has caused birth defects and death of unborn offspring. It is not known whether these effects would occur in people. You should not use miltefosine you are pregnant. Learn more

Impavido Side Effects

Impavido Side Effects

Note: This document contains side effect information about miltefosine. Some of the dosage forms listed on this page may not apply to the brand name Impavido.

In Summary

Common side effects of Impavido include: nausea, diarrhea, increased serum creatinine, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to miltefosine: oral capsule


Oral route (Capsule)

Miltefosine may cause fetal harm, including fetal death in animals; do not administer to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing miltefosine. Females of reproductive potential should be advised to use effective contraception during miltefosine therapy and for 5 months after therapy.

Along with its needed effects, miltefosine (the active ingredient contained in Impavido) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking miltefosine:

Incidence not known

  • Abdominal or stomach pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody, black, or tarry stools
  • chills or fever
  • dizziness
  • itching or rash
  • pain in the scrotum
  • pinpoint red spots on the skin
  • smaller amount of semen ejaculated than usual
  • severe diarrhea or vomiting
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects of miltefosine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Decreased appetite
  • diarrhea
  • fever
  • lack or loss of strength
  • vomiting

Less common

  • General feeling of discomfort or illness
  • itching skin
  • sleepiness or unusual drowsiness

For Healthcare Professionals

Applies to miltefosine: oral capsule


The most common side effects resulting in discontinuation were Stevens-Johnson syndrome, melena, thrombocytopenia, arthritis, skin rash, diarrhea, and hyperbilirubinemia.


Very common (10% or more): Elevations in liver transaminases (ALT, AST) (up to 50%)

Frequency not reported: Hyperbilirubinemia

Postmarketing reports: Jaundice


Very common (10% or more): Creatinine elevations (up to 25%)


Common (1% to 10%): Anemia, lymphoadenopathy

Postmarketing reports: Thrombocytopenia, agranulocytosis, epistaxis


Common (1% to 10%): Pruritus, cellulitis, ecthyma, pyoderma, rash, urticaria

Frequency not reported: Stevens-Johnson syndrome, skin rash


Very common (10% or more): Diarrhea (up to 20.4%), vomiting (up to 27.5%), abdominal pain (up to 11.2%), nausea (up to 41.7%)

Common (1% to 10%): Abdominal distension, constipation, dysphagia, flatulence

Postmarketing reports: Melena


Common (1% to 10%): Testicular pain, testicular swelling

Postmarketing reports: Scrotal pain, decreased ejaculate volume, absent ejaculation


Common (1% to 10%): Lymphangitis, abscess


Very common (10% or more): Decreased appetite (up to 23.1%)

Postmarketing reports: Generalized edema


Frequency not reported: Arthritis

Nervous system

Very common (10% or more): Motion sickness (29.2%), headache (28.1%), dizziness (up to 12.5%)

Common (1% to 10%): Somnolence, paresthesia


Common (1% to 10%): Asthenia, malaise, pyrexia, fatigue, peripheral edema

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Impavido