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breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin’s lymphoma, tongue carcinoma, bladder carcinoma) Psychiatric: Anxiety, irritability, mood changes, psychosis Visual disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary or prolonged loss of vision, possibly irreversible Metabolism disorders: Hypertriglyceridemia Other: Leukocytosis, thyroid disorder Careful attention should be given to selection of candidates for therapy; pelvic examination is necessary prior to treatment and before each subsequent course Uterine fibroids, pituitary or ovarian failure may occur Risk of ovarian enlargement & ovarian hyperstimulation syndrome (OHSS); transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, reported in association with OHSS, which is a medical event distinct from uncomplicated ovarian enlargement; death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred; if enlargement of ovary occurs, additional therapy should not be given until ovaries have returned to pretreatment size, and dosage or duration of next course should be reduced; ovarian enlargement and cyst formation associated with therapy usually regresses spontaneously within a few days or weeks after discontinuing treatment; potential benefit of subsequent therapy in these cases should exceed risk Potential for multiple births, especially at 100 mg dosage Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy Cases of pancreatitis reported Prolonged use of clomiphene citrate tablets USP may increase risk of a borderline or invasive ovarian tumor Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded Available human data from epidemiologic studies do not show apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly It is not known whether drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if drug is administered to a nursing woman; in some patients, therapy may reduce lactation Half-Life elimination: 5-7 days Onset: Within 5-10 days Peak plasma time 6.5 hours Bioavailability: Readily absorbed from GI tract Metabolism: Enterohepatically circulated Excretion: feces 37-51%; small amount in urine The above information is provided for general informational and educational purposes only. 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