Clomiphene Side Effects

Some side effects of clomiphene may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to clomiphene: oral tablet

Along with its needed effects, clomiphene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clomiphene:

More common
  • Bloating
  • stomach or pelvic pain

Check with your doctor as soon as possible if any of the following side effects occur while taking clomiphene:

Less common or rare
  • Blurred vision
  • decreased or double vision or other vision problems
  • seeing flashes of light
  • sensitivity of eyes to light
  • yellow eyes or skin

Some side effects of clomiphene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Hot flashes
Less common or rare
  • Breast discomfort
  • dizziness or lightheadedness
  • headache
  • heavy menstrual periods or bleeding between periods
  • mental depression
  • nausea or vomiting
  • nervousness
  • restlessness
  • tiredness
  • trouble in sleeping

For Healthcare Professionals

Applies to clomiphene: compounding powder, oral tablet

General

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

Genitourinary

Very common (10% or more): Ovarian enlargement, ovarian hyperstimulation syndrome
Common (1% to 10%): Abnormal uterine bleeding (intermenstrual spotting, menorrhagia), multiple pregnancies, spontaneous abortions (ectopic pregnancies, hydatiform moles, fetus papyraceous)
Uncommon (0.1% to 1%): Stillbirths, increased urinary frequency/volume, vaginal dryness, priapism
Frequency not reported: Temporary sterility in males
Postmarketing reports: Endometriosis, ovarian cyst, ovarian hemorrhage, tubal pregnancy, uterine hemorrhage

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.

Ocular

Common (1% to 10%): Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Frequency not reported: Scintillations, heat waves, irreversible palinopsia (prolonged afterimages), shimmering of the peripheral field
Postmarketing reports: 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

Cardiovascular

Very common (10% or more): Vasomotor flushes
Postmarketing reports: Arrhythmias, chest pain, edema, hypertension, palpitations, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis.

Endocrine

Frequency not reported: Gynecomastia, thyroid disorders
Postmarketing reports: Thyroid disorders

Oncologic

Uncommon (0.1% to 1%): Leydig cell tumor of testis (in male treated for oligospermia)
Frequency not reported: Ovarian cancer, increased risk of borderline or invasive ovarian tumor
Postmarketing reports: Hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma, fibrocystic disease, breast carcinoma, endometrial carcinoma, astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess, luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma, hydatiform mole, choriocarcinoma, melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, insomnia, light-headedness, nervous tension, vertigo
Postmarketing reports: Migraine headache, paresthesia, seizure, stroke, syncope

Dermatologic

Uncommon (0.1% to 1%): Dermatitis, rash, hair loss, dry hair
Frequency not reported: Reversible alopecia, urticaria, acne, erythema nodosum, erythema multiforme
Postmarketing reports: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritis, urticaria

Gastrointestinal

Common (1% to 10%): Abdominal-pelvic discomfort/distention/bloating, nausea, vomiting
Uncommon (0.1% to 1%): Acute abdomen, constipation, diarrhea

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 medical 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.

Uncommon (0.1% to 1%): Deep vein thrombosis
Frequency not reported: Pituitary hemorrhage (with undiagnosed pituitary tumor)
Postmarketing reports: Leukocytosis

Hepatic

Postmarketing reports: Increased transaminases, hepatitis

Metabolic

Uncommon (0.1% to 1%): Increased appetite, weight gain/loss

Musculoskeletal

Postmarketing reports: Arthralgia, back pain, myalgia

Other

Common (1% to 10%): Breast discomfort
Uncommon (0.1% to 1%): Fatigue
Frequency not reported: Elevated levels of desmosterol (for prolonged therapy)
Postmarketing reports: Fever, tinnitus, weakness

Fetal/Neonatal Anomalies and Mortality:
Uncommon (0.1% to 1%): 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, neonatal death, fetal death/stillbirth
Postmarketing reports: Skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, joints; septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, coarctation of the aorta; down syndrome; ear abnormalities and deafness; cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele; hypospadias, cloacal exstrophy, lung tissue malformations; malformations of the eye and lens (cataract); neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia; neural tube defects (anencephaly, meningomyelocele), microcephaly, hydrocephalus; renal agenesis and renal dysgenesis; dwarfism, mental retardation

Psychiatric

Uncommon (0.1% to 1%): Depression
Postmarketing reports: Anxiety, irritability, mood changes, psychosis

Respiratory

Uncommon (0.1% to 1%): Pulmonary embolism (in male treated for infertility)

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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