Serophene Side Effects

Generic Name: Clomiphene

Please note - some side effects for Serophene 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 Serophene - for the consumer

Serophene

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 Serophene:

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.

For the professional

Serophene

Clinical Trial Adverse Events. ClomiPHENE citrate, 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 clomiPHENE citrate 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 clomiPHENE citrate 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 clomiPHENE citrate.  The cause and effect relationship of the listed events to the administration of clomiPHENE citrate is not known.

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

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 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): 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

Fetal/Neonatal Anomalies: 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).

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