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Women who are pregnant must not use miltefosine. It may harm an unborn baby. Women of childbearing age must have a negative pregnancy test before starting treatment with this medication. To prevent pregnancy, use reliable forms of birth control during treatment and for 5 months after stopping miltefosine. Ask your doctor for more details.

Nausea, vomiting, diarrhea, stomach/abdominal pain, joint pain, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Take this medication with food to help reduce stomach/intestinal side effects. Drink plenty of fluids to avoid dehydration and kidney problems if vomiting or diarrhea occur. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, bloody/black/tarry stool, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, testicular pain/swelling. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.