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Miltefosine Side Effects

For the Consumer

Applies to miltefosine: oral capsule

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

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

General

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

Hepatic

Very common (10% or more): Elevations in liver transaminases (ALT, AST) (up to 50%)
Frequency not reported: Hyperbilirubinemia
Postmarketing reports: Jaundice[Ref]

Renal

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

Hematologic

Common (1% to 10%): Anemia, lymphoadenopathy
Postmarketing reports: Thrombocytopenia, agranulocytosis, epistaxis[Ref]

Dermatologic

Common (1% to 10%): Pruritus, cellulitis, ecthyma, pyoderma, rash, urticaria
Frequency not reported: Stevens-Johnson syndrome, skin rash[Ref]

Gastrointestinal

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]

Genitourinary

Common (1% to 10%): Testicular pain, testicular swelling
Postmarketing reports: Scrotal pain, decreased ejaculate volume, absent ejaculation[Ref]

Immunologic

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

Metabolic

Very common (10% or more): Decreased appetite (up to 23.1%)
Postmarketing reports: Generalized edema[Ref]

Musculoskeletal

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]

Other

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

References

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

Some side effects of miltefosine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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