<ul>
	<li>Embryo-Fetal Toxicity. Do not use in pregnant women. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential.</li>
	<li>Reproductive effects. Miltefosine caused testicular atrophy and impaired fertility in male rats and impaired fertility in female rats. Advise patients of reproductive toxicities in animal studies and that the potential effects on human fertility have not been adequately evaluated.</li>
	<li>Renal Effects. Monitor serum creatinine during therapy and for 4 weeks after end of therapy.</li>
	<li>Hepatic Effects. Monitor transaminases and bilirubin during therapy.</li>
	<li>Gastrointestinal Effects. Encourage fluid intake.</li>
	<li>Thrombocytopenia. Monitor platelet count during therapy for visceral leishmaniasis.</li>
	<li>Absorption of Oral Contraceptives. Advise use of alternative method of contraception if vomiting and/or diarrhea occur.</li>
	<li>Stevens-Johnson syndrome. Discontinue miltefosine.</li>
</ul>