Important Safety Information — Enclomiphene Citrate

Indications

Enclomiphene citrate is a selective estrogen receptor modulator (SERM) used off-label in men to support endogenous testosterone production. It works by blocking estrogen feedback at the pituitary gland, stimulating the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which in turn promote natural testosterone synthesis while preserving fertility.

Contraindications

Enclomiphene citrate should not be used in the following populations:

• Pregnant women or women who may become pregnant (treatment does not offer benefit and may pose risk to the fetus)
• Patients with uncontrolled thyroid or adrenal dysfunction
• Patients with an organic intracranial lesion such as a pituitary tumor
• Patients with known hypersensitivity to clomiphene citrate or any of its components
• Patients with liver disease or a history of liver dysfunction
• Patients with abnormal uterine bleeding of undetermined origin (in female patients)

Warnings and Precautions

• Visual disturbances: Patients may experience blurred vision, spots, flashes, or other visual symptoms. If visual disturbances occur, discontinue treatment and obtain a complete ophthalmological evaluation.
• Ovarian Hyperstimulation Syndrome (OHSS): In female patients, OHSS may occur. Early warning signs include abdominal pain, distension, nausea, vomiting, diarrhea, and weight gain. Severe cases may involve ascites, pleural effusion, acute abdomen, renal failure, or thrombosis.
• Multiple gestations: In female patients, there is a risk of multiple ovulations with resulting plural gestations.
• Liver function: Patients with pre-existing liver conditions should be monitored, as hepatic metabolism is involved in drug clearance.
• Nursing mothers: Caution should be exercised if administered to a nursing woman. It is not known whether enclomiphene is excreted in human milk.

Common Side Effects

• Hot flushes
• Mood changes
• Headache
• Nausea
• Abdominal discomfort or bloating
• Breast tenderness
• Fatigue

Serious Side Effects

Seek medical attention immediately if you experience any of the following:

• Visual disturbances (blurred vision, spots, flashes of light)
• Severe abdominal or pelvic pain
• Signs of allergic reaction (rash, difficulty breathing, swelling of face, lips, tongue, or throat)
• Signs of liver problems (yellowing of skin or eyes, dark urine, persistent nausea)
• Signs of blood clots (leg pain or swelling, sudden shortness of breath, chest pain)

Drug Interactions

Enclomiphene citrate has no listed severe drug interactions. However, it has moderate interactions with various medications. Inform your healthcare provider of all medications you are taking, including:

• Other hormone therapies or testosterone supplements
• Estrogen-containing medications
• Anti-estrogen therapies
• Herbal supplements that may affect hormone levels

Use in Specific Populations

• Pregnancy: Contraindicated. May cause fetal harm.
• Lactation: Use with caution. It is unknown whether enclomiphene is excreted in human milk.
• Pediatric use: Safety and effectiveness in pediatric patients have not been established.
• Hepatic impairment: Use with caution; monitor liver function.
• Renal impairment: No specific dose adjustment data available; consult your provider.