Enclomiphene

Enclomiphene is used to raise serum total testosterone levels while maintaining sperm counts in the normal range in men with secondary hypogonadism.

In 2015 the drug manufacturer received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene, which informed them that the application for the drug could not be approved in its present form.

Enclomiphene is available under the following different brand names: Androxal.

• 12.5-mg and 25-mg

Dosage Considerations – Should be Given as Follows:

• Use of 12.5-mg and 25-mg enclomiphene citrate significantly increased total T levels in hypogonadal men, with an efficacy that was comparable to topical testosterone. Increases in LH and FSH levels also were found with enclomiphene citrate treatment.

Common side effects of enclomiphene include:

• increased libido
• acne
• a temper if levels get too high

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Enclomiphene has no listed severe interactions with other drugs.

Enclomiphene has no listed serious interactions with other drugs.

Enclomiphene has moderate interactions with at least 71 different drugs.

Enclomiphene has mild interactions with at least 101 different drugs.

Warnings

This medication contains enclomiphene. Do not take Androxal if you are allergic to enclomiphene or any ingredients contained in this drug.

Contraindications

• No information available.

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Enclomiphene?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Enclomiphene?"

Cautions

• No information available.

Pregnancy and Lactation

Use of enclomiphene in pregnant women is contraindicated, as treatment does not offer benefit in this population.

It is not known whether enclomiphene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if enclomiphene is administered to a nursing woman. In some patients, therapy may reduce lactation.