Impavido Side Effects

Generic Name: miltefosine

Note: This page contains side effects data for the generic drug miltefosine. It is possible that some of the dosage forms included below may not apply to the brand name Impavido.

It is possible that some side effects of Impavido may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to miltefosine: oral capsule

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

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