Clomiphene

Clomiphene is a prescription medication used for the treatment of ovulatory failure.

• Clomiphene is available under the following different brand names: Clomid, Serophene

Adult dosage

Tablet

• 50mg

Treatment of Ovulatory Failure

Adult dosage

• 50 mg orally every day initially for 5 days
• Dosage can be increased to 100 mg only in patients who do not respond to the first course; lower doses of 12.5-25 mg once daily may be administered in women sensitive to the drug or who consistently develop large ovarian cysts

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Clomiphene include:

• flushing (warmth, redness, or tingly feeling),
• nausea,
• vomiting,
• bloating,
• breast pain or tenderness,
• headache, and
• breakthrough bleeding or spotting

Serious side effects of Clomiphene include:

• stomach pain,
• bloating,
• nausea,
• vomiting,
• diarrhea,
• rapid weight gain (especially in the face and midsection),
• little or no urination,
• pain while breathing,
• rapid heart rate, and
• shortness of breath

Rare side effects of Clomiphene include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Clomiphene has severe interactions with the following drug:
  • ospemifene
• Clomiphene has serious interactions with no other drugs.
• Clomiphene has moderate interactions with the following drug:
  • benazepril
• Clomiphene has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Pregnancy
• Liver disease or history of liver disease
• Undiagnosed abnormal uterine bleeding
• Uncontrolled thyroid or adrenal dysfunction
• Endometrial cancer
• Ovarian cysts not due to PCOS
• Presence of organic intracranial lesion, including pituitary tumor

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Clomiphene?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Clomiphene?”

Cautions

• Careful attention should be given to the selection of candidates for therapy; the pelvic examination is necessary before treatment and before each subsequent course
• Uterine fibroids, pituitary, or ovarian failure may occur
• Potential for multiple births, especially at 100 mg dosage
• Use should be supervised by a practitioner with training and thoroughly familiar with infertility problems and their management
• Risk of visual disturbance (like scotoma & photopsia); patients should be warned that visual symptoms may render activities such as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting; while the etiology of visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have complete ophthalmological evaluation carried out promptly
• Cases of hypertriglyceridemia reported; preexisting or family history of hyperlipidemia and use of higher than the recommended dose and/or longer duration of treatment are associated with risk of hypertriglyceridemia; periodic monitoring of plasma triglycerides is recommended in patients with a preexisting or family history of hyperlipidemia; pretreatment screening of triglyceride levels is recommended in patients initiating therapy
• Cases of pancreatitis reported
• Prolonged use of clomiphene citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor
• Presence of organic intracranial lesion, including pituitary tumor
• Ovarian enlargement may be accompanied by abdominal distention or abdominal pain and generally regresses without treatment within days or weeks of discontinuing therapy; withhold therapy if ovaries are abnormally enlarged until size returns to pretreatment size; reduce dose and duration of future cycles
• Ovarian hyperstimulation syndrome
  • Ovarian hyperstimulation syndrome is a rare exaggerated response to ovulation induction therapy
  • May begin within 24 hours of treatment but may become severe 7 to 10 days after therapy
  • Symptoms may include abdominal distention discomfort, nausea, diarrhea, vomiting
  • Severe symptoms may include severe abdominal pain ascites, hypotension, anuria/oliguria
  • Treatment is primarily symptomatic, including analgesics, fluid and electrolyte management, and prevention of thromboembolic complications

Pregnancy and Lactation

• Use in pregnant women is contraindicated, as treatment does not offer benefit in this population; to avoid inadvertent administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation and/or pregnancy occurs; patients should be evaluated carefully to exclude ovarian enlargement or ovarian cyst formation between each treatment cycle; the next course of therapy should be delayed until these conditions have been excluded
• human data from epidemiologic studies do not show any apparent cause and effect relationship between clomiphene citrate periconceptual exposure and an increased risk of overall birth defects, or any specific anomaly
• Lactation
  • It is not known whether the drug is excreted in human milk; because many drugs are excreted in human milk, caution should be exercised if the drug is administered to a nursing woman; in some patients, therapy may reduce lactation.