Clomid Side Effects

Generic Name: clomiphene

Please note - some side effects for Clomid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Clomid - for the Consumer

Clomid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clomid:

Blurred vision or vision problems (spots or flashes); breast tenderness; dizziness; enlarged breasts; enlargement of the ovaries; flushing; headache; hot flashes; lightheadedness; mood change; nausea; pelvic pain or bloating; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)increased risk of cancer of the ovaries; over stimulation of the ovaries; spontaneous abortion.

Clomid Side Effects - for the Professional

Clomid

Clinical Trial Adverse Events

Clomid, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. Adverse experiences reported in patients treated with clomiphene citrate during clinical studies are shown in Table 2.

The following adverse events have been reported in fewer than 1% of patients in clinical trials: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.

Patients on prolonged Clomid therapy may show elevated serum levels of desmosterol. This is most likely due to a direct interference with cholesterol synthesis. However, the serum sterols in patients receiving the recommended dose of Clomid are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs. Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiphene may increase the risk of a borderline or invasive ovarian tumor.

Postmarketing Adverse Events

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.

Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus

Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope

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 loss of vision

Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis

Musculoskeletal: Arthralgia, back pain, myalgia

Hepatic: Transaminases increased, hepatitis

Neoplasms: Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abcess); 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); and neoplasms of offspring (neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia)

Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage

Body as a Whole: Fever, tinnitus, weakness

Other: Leukocytosis, thyroid disorder

The following fetal abnormalities have also been reported during postmarketing surveillance: delayed development; abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot, and joints; tissue malformations including imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, renal agenesis and dysgenesis, and malformations of the eye and lens (cataract), ear, lung, heart (ventricular septal defect and tetralogy of Fallot), and genitalia; as well as dwarfism, deafness, mental retardation, chromosomal disorders, and neural tube defects (including anencephaly).

Side Effects by Body System

General

At recommended dosages, clomiphene is generally well tolerated. Adverse reactions usually are mild, transient, and resolve when clomiphene is discontinued.

Genitourinary

Male sterility after high dose therapy may be due to hyalinization of the tubular membranes and damage to the spermatids. In general, clomiphene enhances spermatozoal motility and does not change the sperm to abnormal or immature forms.

Prolonged high dose therapy may result in temporary sterility in males. A case of priapism has been reported.

Ovarian hyperstimulation syndrome, menorrhagia, ovarian enlargement (13.6%), ovarian cysts, hot flashes, pelvic discomfort, heavier menses, increased urination, and breast discomfort (2.1%) have been reported.

There may be a sustained effect of clomiphene after cessation of therapy.

Ocular

Transient blurred vision, scotomata, flashes of light, vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary loss of vision, scintillations, and heat waves have occurred. Irreversible palinopsia (prolonged afterimages), shimmering of the peripheral field, and photophobia have been reported.

Cardiovascular

Vasomotor flushing occurs in about 10% of patients. Post-marketing surveillance has reported chest pain, arrhythmias, hypertension, palpitations, stroke, phlebitis, pulmonary embolism, shortness of breath, tachycardia, and thrombophlebitis.

Endocrine

Gynecomastia has been reported in males using clomiphene for infertility. Thyroid disorders occur rarely. Pituitary hemorrhage following treatment of primary infertility with clomiphene in a patient with a previously undiagnosed pituitary tumor has been reported.

Oncologic

Prolonged use of clomiphene may increase the risk of ovarian tumors (borderline or invasive).

Various liver, testicular, endometrial, breast, nervous system, ovary, renal, thyroid, bladder, and miscellaneous neoplasms have been reported in post-marketing surveys. A case of Leydig cell tumor of the testis has been associated with clomiphene therapy for oligospermia.

Nervous system

There have been cases of seizures reported after clomiphene therapy. Nervousness, headache (including migraine), paresthesias, insomnia, syncope, dizziness, depression, and fatigue have been reported.

Dermatologic

Reversible alopecia, urticaria, acne, erythema nodosum, erythema multiforme, and skin rashes have occurred, but the exact relationship to clomiphene therapy is undetermined.

Gastrointestinal

Gastric distress, nausea, vomiting, and bloating have been reported in about 6% of patients.

Hematologic

A 32-year-old woman receiving clomiphene citrate treatment for ovulation induction was admitted for complaints of swelling and pain in her right calf. Her medial history was unremarkable except for complications following an appendectomy three years prior which resulted in a deep vein thrombosis (DVT) and subsequent pulmonary embolism. The patient had been taking clomiphene two days prior to the development of the first DVT. Six months later, the treatment with clomiphene was renewed. The patient developed recurrent DVT following repeated standard clomiphene treatment.

One case of pulmonary embolism was reported in a male treated for infertility. A case of deep vein thrombosis following clomiphene citrate treatment also has been reported.
Leucocytosis occurs rarely.

Hepatic

Serum transaminase levels may increase. Hepatitis has occurred rarely.

Musculoskeletal

Myalgia and arthralgia may occur.

Psychiatric

Psychoses have been reported with clomiphene use. Anxiety, irritability, and mood changes have been noted in post-marketing surveillance.

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