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Miltefosine Side Effects

Medically reviewed by Last updated on April 1, 2020.

In Summary

Commonly reported side effects of miltefosine 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.

Side effects requiring immediate medical attention

Along with its needed effects, miltefosine 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

Side effects not requiring immediate medical attention

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.[Ref]


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

Frequency not reported: Hyperbilirubinemia

Postmarketing reports: Jaundice[Ref]


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


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

Postmarketing reports: Thrombocytopenia, agranulocytosis, epistaxis[Ref]


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

Frequency not reported: Stevens-Johnson syndrome, skin rash[Ref]


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[Ref]


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

Postmarketing reports: Scrotal pain, decreased ejaculate volume, absent ejaculation[Ref]


Common (1% to 10%): Lymphangitis, abscess[Ref]


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

Postmarketing reports: Generalized edema[Ref]


Frequency not reported: Arthritis[Ref]

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[Ref]


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


1. "Product Information. Impavido (miltefosine)." Paladin Therapeutics Inc, Wilmington, DE.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.