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The purpose and risks of Clomid therapy should be presented to the patient before starting treatment. Blurred vision, Headache, Abnormal uterine bleeding, Breast discomfort and tenderness, Pelvic pain, Swelling of pelvic area. Inform the patient that there is an increased chance of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy, when conception occurs in relation to Clomid therapy. Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of clomiphene citrate. Oral administration of Clomid to male rats at doses of 0.3 or 1 mg/kg/day caused decreased fertility, while higher doses caused temporary infertility.

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Clomid Adverse Reactions

It is not known whether Clomid is excreted in human milk. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. The following adverse experiences were reported spontaneously with Clomid. The cause and effect relationship of the listed events to the administration of Clomid is not known. The acute oral LD 50 of Clomid is 1700 mg/kg in mice and 5750 mg/kg in rats. Clomid should not be administered during pregnancy. Clomid may cause fetal harm in animals Although no causative evidence of a deleterious effect of Clomid therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population To avoid inadvertent Clomid administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs.

Clomid Overdosage

Clomid, at recommended dosages, is generally well tolerated. Toxic effects accompanying acute overdosage of Clomid have not been reported. Neonatal death and fetal death/stillbirth in infants with birth defects have also been reported at a rate of less than 1%. The overall incidence of reported birth anomalies from pregnancies associated with maternal Clomid ingestion during clinical studies was within the range of that reported for the general population.

Clomiphene Contraindications

The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle. Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries. These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens.

In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day. No permanent malformations were observed in those studies. The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with Clomid during clinical trials. Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate. Following injection of clomiphene citrate 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract.

Each of the following fetal abnormalities were reported at a rate of less than 1% (experiences are listed in order of decreasing frequency): Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum.