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What is Clomid?

Clomid stimulates the release of hormones necessary for ovulation to occur. It is mainly used for treating female infertility.

Clomid is used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient.

Clomid may also be used for purposes other than those listed in this medication guide.

Important information about Clomid

Use caution when driving, operating machinery, or performing other hazardous activities. Clomid may cause blurred vision or other visual side effects during or shortly after therapy. Notify your doctor immediately if you develop any visual side effects and use caution when performing hazardous activities, especially under conditions of variable lighting.

Clomid may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Who should not take Clomid?

Do not take Clomid without first talking to your doctor if you:

  • might be pregnant;

  • have a thyroid problem or another endocrine disorder;

  • have undiagnosed vaginal bleeding;

  • have endometriosis or endometrial carcinoma;

  • have uterine fibroids;

  • have liver disease;

  • have ovarian cysts or ovarian enlargement not due to polycystic ovarian syndrome; or

  • have any other serious or chronic medical illness.

You may not be able to take Clomid , or you may require a lower dose or special monitoring if you have any of the conditions listed above.

Do not take this medication if you are pregnant. Clomid is in the FDA pregnancy category X. This means that it is known to cause birth defects. It is not known whether Clomid pass into breast milk. Do not take Clomid without first talking to your doctor if you are breast-feeding a baby.

How should I take Clomid?

Use Clomid exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Take each dose with a full glass of water.

Clomid is usually taken in 5 day cycles. Follow your doctor's instructions.

Store Clomid at room temperature, away from direct light, moisture, and heat.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Clomid.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a clomiphene overdose include nausea, vomiting, flushing, blurred vision, visual spots or flashes, and abdominal pain.

What should I avoid while taking Clomid?

Use caution when driving, operating machinery, or performing other hazardous activities. Clomid may cause blurred vision or other visual side effects during or shortly after therapy. Notify your doctor immediately if you develop any visual side effects and use caution when performing hazardous activities, especially under conditions of variable lighting.

What are the possible side effects of Clomid?

Stop taking Clomid and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving Clomid. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;

  • flushing;

  • nausea, vomiting, or diarrhea;

  • breast tenderness or discomfort;

  • blurred vision or other visual disturbances;

  • headache; or

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Clomid may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Clomid?

There are no known interactions between Clomid and other medicines. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

For the Consumer

Applies to clomiphene: oral tablet

Along with its needed effects, clomiphene (the active ingredient contained in Clomid) 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
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  • 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
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  • dizziness or lightheadedness
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  • mental depression
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Applies to clomiphene: compounding powder, oral tablet

General

At recommended dosages, clomiphene (the active ingredient contained in Clomid) 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 (the active ingredient contained in Clomid) 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)