Important Safety Information
Clomiphene citrate is contraindicated in pregnancy (Pregnancy Category X), liver disease or history of liver dysfunction, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement not due to polycystic ovarian syndrome, and uncontrolled thyroid or adrenal dysfunction. The FDA label states 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 .
Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles).
Important
Non-Medical Use
Clomiphene citrate has no approved indication for male post-cycle therapy or performance enhancement. Non-medical use falls outside approved indications and carries health risks including visual disturbances, psychiatric effects, and hepatic injury. Product strength and laboratory verification do not establish safety for non-medical use.
Potential Adverse Effects
Visual symptoms: Blurring, spots, flashes, photophobia, diplopia, scotomata, and phosphenes have been reported. These symptoms increase in incidence with increasing total dose or therapy duration and may be irreversible, especially with increased dosage or duration. Patients should be warned that visual symptoms may render driving or operating machinery more hazardous.
Psychiatric effects: Anxiety, irritability, mood changes, and psychosis have been reported in postmarketing surveillance.
Hepatic effects: Transaminases increased and hepatitis have been reported.
Common adverse reactions: Abdominal-pelvic discomfort, distention, bloating, intermenstrual spotting, menorrhagia, and blurred vision were reported in clinical studies.
Other postmarketing reports: Cardiovascular effects (arrhythmia, chest pain, edema, hypertension, palpitation, pulmonary embolism, tachycardia, thrombophlebitis), central nervous system effects (migraine, paresthesia, seizure, stroke, syncope), dermatologic effects (acne, allergic reaction, urticaria), and musculoskeletal effects (arthralgia, back pain, myalgia) have been reported.
Conditions Requiring Medical Evaluation
Clomiphene citrate should not be used in patients with liver disease or a history of liver dysfunction. Pelvic examination is necessary prior to the first and each subsequent course of clomiphene citrate treatment. Patients with uterine fibroids should be cautioned due to the potential for further enlargement.
Monitoring During Therapy
Medically supervised clomiphene therapy involves determination of ovulation during each cycle. A basal body temperature graph or other appropriate tests may help determine if ovulation occurred. Long-term cyclic therapy is not recommended beyond a total of about six cycles.
Product Care
Storage & Handling
Store in a cool, dry place away from direct light and moisture. Keep the product in its original packaging and out of the reach of children.
Further Safety Information