Important Safety Information
Clomiphene is contraindicated in patients with known hypersensitivity to the drug, in pregnancy, and in patients with liver disease or abnormal uterine bleeding of undetermined etiology. The FDA labeling states that clomiphene should not be used in patients with ovarian cysts or enlargement except those with polycystic ovary syndrome.
Visual symptoms have been reported with clomiphene use and may be prolonged or irreversible, especially with increased dosage or duration of therapy. Patients should be advised that visual symptoms may render activities such as driving or operating machinery more hazardous than usual. If visual symptoms occur, clomiphene should be discontinued and complete ophthalmologic evaluation performed.
Important
Non-Medical Use
Clomiphene's approved indication is limited to the treatment of ovulatory dysfunction in women desiring pregnancy. Use for bodybuilding, post-cycle therapy, or performance enhancement falls outside approved medical indications. The FDA labeling specifically notes that there are no adequate or well-controlled studies demonstrating the effectiveness of clomiphene citrate in the treatment of male infertility, and that testicular tumors and gynecomastia have been reported in males using clomiphene.
Potential Adverse Effects
The most commonly reported adverse reactions in clinical trials include ovarian enlargement (13.6%), vasomotor flushes (10.4%), abdominal-pelvic discomfort (5.5%), nausea and vomiting (2.2%), and breast discomfort (2.1%). Visual symptoms including blurred vision, floaters, and photophobia have been reported at an incidence of approximately 1.5%.
Postmarketing reports have identified additional adverse reactions including arrhythmia, chest pain, edema, hypertension, pulmonary embolism, seizure, stroke, and psychiatric effects such as anxiety, irritability, mood changes, and psychosis. Hypertriglyceridemia and pancreatitis have also been reported.
In males, the FDA labeling notes that testicular tumors and gynecomastia have been reported with clomiphene use, though a cause-and-effect relationship has not been established.
Conditions Requiring Medical Evaluation
Clomiphene is not appropriate for everyone. Medical evaluation should consider liver function, as clomiphene is contraindicated in patients with liver disease. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene treatment.
Patients with uterine fibroids should be cautioned due to the potential for further enlargement of fibroids. Patients with pre-existing or family history of hyperlipidemia should have periodic monitoring of plasma triglycerides, as cases of hypertriglyceridemia have been reported.
Monitoring During Therapy
Medically supervised clomiphene therapy typically involves monitoring for ovulation and assessment of treatment response. For non-medical use, monitoring of testosterone and estrogen levels may help inform dosing decisions, though this should be done in consultation with healthcare professionals where possible.
Laboratory testing of the product itself, such as a published potency report, is separate from clinical monitoring of the person using clomiphene. No published laboratory report is available for this specific product.
Product Care
Storage & Handling
Store in the original packaging, protected from excessive heat, moisture and direct light. Keep all medications out of the reach of children. Follow the storage instructions provided with the product packaging.
Further Safety Information