Miltefosine Overview


Miltefosine is a prescription medication used to treat a tropical disease called leishmaniasis. Leishmaniasis is caused by Leishmania, a parasite transmitted to humans through sand fly bites. The exact way this medication works to kill the parasite is unknown.

Miltefosine comes in capsule form and is taken by mouth for 28 days in a row. It is taken 2 or 3 times daily, with food. Swallow miltefosine capsules whole.

Common side effects include nausea, vomiting and diarrhea.

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Miltefosine Cautionary Labels


Uses of Miltefosine

Miltefosine is prescription medicine used to treat certain types of leishmaniasis in patients 12 years of age and older: 

  • visceral leishmaniasis (affecting your internal organs)
  • cutaneous leishmaniasis (affecting your skin)
  • mucosal leishmaniasis (affecting your nose, mouth and throat)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.


Miltefosine Brand Names

Miltefosine may be found in some form under the following brand names:

Miltefosine Drug Class

Miltefosine is part of the drug class:

Side Effects of Miltefosine

Serious side effects have been reported. See "Precautions" section.

Common side effects include:

  • nausea
  • vomiting
  • diarrhea

Other side effects include abdominal pain, decreased appetite, dizziness, headache, sleepiness, skin itching, and abnormalities in liver or kidney tests.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of miltefosine. For more information, ask your healthcare provider.

You may report side effects to FDA at 1-800-FDA-1088.


Miltefosine Interactions

No drug interactions have been reported. However, you should tell your doctor and pharmacist about the medications you take including prescription and non-prescription medications, vitamins and herbal supplements. Not all drug interactions are known or reported and new interactions are continually reported.

Miltefosine Precautions

Miltefosine may cause serious side effects including:

  • Serious risks to pregnancy (see FDA Warning and Pregnancy Sections)
  • Fertility problems in male and female rats and abnormal menstrual cycle in female dogs. It is not known if miltefosine causes fertility problems in men or women.
  • Testicular pain and absent or decreased ejaculation
  • Kidney and liver problems
  • Stomach problems. Miltefosine can cause vomiting, diarrhea, and dehydration. Call your healthcare provider right away if you have severe vomiting and diarrhea that does not go away. Drink a lot of water to help prevent dehydration while you are having vomiting and diarrhea.
  • Decreased effectiveness of oral contraceptive pills. Vomiting and diarrhea may cause your birth control pills to be less effective at preventing pregnancy. Use an extra method of birth control, such as male condoms with spermicide, until you are no longer having vomiting and diarrhea.
  • Decrease in platelets (which are blood cells that help blood clot). 
  • Serious Skin Problems. miltefosine can cause a serious skin problem called Stevens-Johnson Syndrome. If you develop a skin rash with blisters while taking miltefosine, stop taking miltefosine right away and call your healthcare provider. 

Do not take miltefosine if you:

  • are pregnant
  • have Sjögren-Larsson-Syndrome
  • are allergic to miltefosine or any of the ingredients in miltefosine
  • are a woman who can become pregnant and have not had a pregnancy test. Women who can get pregnant must have a urine or blood pregnancy test before taking miltefosine.
  • are a woman who can become pregnant and you are not willing to use effective birth control during miltefosine treatment and for 5 months after treatment


Miltefosine Food Interactions

Medications can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of miltefosine, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before you take miltefosine, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems. Your healthcare provider should do blood tests to check your kidneys and liver before you start, during and after your treatment with miltefosine.
  • are pregnant or planning to become pregnant. Miltefosine may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if miltefosine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take miltefosine. You should avoid breastfeeding while you take miltefosine and for 5 months after you stop taking miltefosine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


Miltefosine and Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Miltefosine falls into category D.

Miltefosine may cause serious risks to pregnancy:

Do not take miltefosine if you are pregnant. If you take miltefosine during pregnancy, your baby is at risk for death or serious birth defects.

Women who can become pregnant should use effective birth control (contraception) during miltefosine treatment and for 5 months after stopping miltefosine treatment. Discuss with your healthcare provider which birth control method is right for you.

If you become pregnant while taking miltefosine, tell your healthcare provider right away. Talk to your healthcare provider about taking part in the miltefosine Pregnancy Registry. This is a study to learn how miltefosine affects pregnancy and babies.


Miltefosine and Lactation

Tell your healthcare provider if you are breastfeeding or plan to breastfeed.

It is not known if miltefosine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You and your healthcare provider will decide if the benefits outweigh the risk of using miltefosine.


Miltefosine Usage

  • Take miltefosine exactly as your healthcare provider tells you to.
  • Complete your full 28 day miltefosine treatment.
  • Take miltefosine capsules whole. Do not break, crush, dissolve, or chew miltefosine before swallowing. 
  • Take miltefosine with food to help reduce stomach problems.


Miltefosine Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on your weight.

The recommended dose for patients who weigh between 30 kg and 44 kg is one 50 mg capsule twice daily for 28 days.

The recommended dose for patients who weigh more than 44 kg is one 50 mg capsule three times daily for 28 days.


Miltefosine Overdose

If you take too much miltefosine call your doctor or poison control center right away.

Other Requirements

  • Store miltefosine at room temperature between 68°F to 77°F (20°C to 25°C).
  • Protect miltefosine from moisture.
  • Keep miltefosine and all medicines out of the reach of children. 



Miltefosine FDA Warning


Miltefosine may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer miltefosine 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



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