Summary

Commonly reported side effects of miltefosine include: nausea, diarrhea, increased serum creatinine, and vomiting. Continue reading for a comprehensive list of adverse effects.

Applies to miltefosine: oral capsule.

Serious side effects of Miltefosine

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

Other side effects of Miltefosine

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

Serious side effects and side effects resulting in discontinuation were Stevens-Johnson syndrome, melena, thrombocytopenia, arthritis, skin rash, diarrhea (grade 4), and hyperbilirubinemia (grade 4).^[Ref]

Genitourinary

This drug was associated with reductions in all sperm parameters at the end of therapy; all sperm parameter reductions (except sperm concentration) recovered on follow-up assessments at 3 and 6 months after therapy completion. For sperm concentration, small mean decreases persisted on follow-up assessments at 3 and 6 months after the last dose. Semen analyses were not conducted beyond 6 months in any patient.

At end of therapy, decreased semen volume (less than 1.5 mL: 75%), reduced sperm count (at least 50% reduction from baseline: 54%; less than 39 million: 33%), reduced sperm concentration (at least 50% reduction from baseline: 21%; less than 20 million sperm/mL: 12%), reduced sperm motility (at least 25% reduction from baseline: 51%; less than 40% with total motility: 33%), and reduced sperm morphology (at least 25% reduction from baseline: 31%) were reported. During the follow-up period at the last observation (either 3 or 6 months after therapy completion), decreased semen volume (less than 1.5 mL: 15%), reduced sperm count (at least 50% reduction from baseline: 19%; less than 39 million: 6%), reduced sperm concentration (at least 50% reduction from baseline: 26%; less than 20 million sperm/mL: 8%), reduced sperm motility (at least 25% reduction from baseline: 9%; less than 40% with total motility: 6%), and reduced sperm morphology (at least 25% reduction from baseline: 15%) were reported.

Among 33 young male patients treated with this drug at a single center, 21 reported decreased ejaculate volume, 2 reported temporary absent ejaculation, 4 reported scrotal tenderness, and 1 had epididymitis diagnosed.^[Ref]

Very common (10% or more): Abnormal sperm parameters/reductions in sperm parameters, decreased semen volume (up to 75%), reduced total sperm count (up to 54%), reduced sperm motility (up to 51%), reduced sperm morphology (up to 31%), reduced sperm concentration (up to 26%)

Frequency not reported: Testicular pain, testicular swelling

Postmarketing reports: Scrotal pain, decreased ejaculate volume, absent ejaculation, scrotal tenderness, epididymitis^[Ref]

Hematologic

In 1 study, decreased platelet counts (less than 150,000: 62%; less than 50,000: 2.4%) were reported at the end of therapy.^[Ref]

Very common (10% or more): Decreased platelet counts (up to 62%)

Common (1% to 10%): Lymphangitis

Frequency not reported: Anemia, lymphadenopathy

Postmarketing reports: Thrombocytopenia, agranulocytosis^[Ref]

Hepatic

In 1 study, transaminase elevations during therapy were reported in up to 50% of patients; elevations were mild (less than 3 times the upper limit of normal [3 x ULN]) or moderate (3 to 5 x ULN) in 94% and 6%, respectively, of patients who had an elevation. No patient discontinued therapy due to transaminase elevations.

About 5% of patients reported elevated AST and ALT above ULN at end of therapy.^[Ref]

Very common (10% or more): Transaminase elevations (up to 50%)

Common (1% to 10%): Elevated AST, elevated ALT

Frequency not reported: Hyperbilirubinemia

Postmarketing reports: Jaundice^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 41.7%), vomiting (up to 37.8%), diarrhea (up to 20.4%), abdominal pain (up to 11.2%)

Frequency not reported: Abdominal distension, constipation, dysphagia, flatulence

Postmarketing reports: Melena^[Ref]

Nervous system

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

Common (1% to 10%): Somnolence

Frequency not reported: Paresthesia

Postmarketing reports: Seizure^[Ref]

Renal

In 1 study, creatinine elevations (at least 1.5 times above baseline) were reported in about 10% of patients at the end of therapy and 10% of patients at 6 months follow-up. In the placebo-controlled trial, 13.4% of patients had creatinine elevations of 1.5 to 3 times above baseline at end of therapy. In the comparative trial, about 5% of patients had creatinine elevations above baseline at 3 and 6 months after therapy. In the 2 active controlled trials, about 25% of patients had creatinine elevations 1.5 to 3 times above baseline at end of therapy.^[Ref]

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

Metabolic

Very common (10% or more): Decreased appetite (up to 23.1%)^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Frequency not reported: Stevens-Johnson syndrome, skin rash, cellulitis, ecthyma, pyoderma, rash, urticaria^[Ref]

Other

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

Frequency not reported: Fatigue, abscess

Postmarketing reports: Generalized edema, peripheral edema^[Ref]

Musculoskeletal

Frequency not reported: Arthritis^[Ref]

Respiratory

Postmarketing reports: Epistaxis