Clomiphene Citrate | Capsules

Important Safety Information: Clomiphene Citrate | Capsules

What is this?

This Important Safety Information summarizes key warnings and precautions for clomiphene citrate tablets, USP, an oral prescription medication indicated for the treatment of ovulatory dysfunction in women who desire pregnancy  . Clomiphene works by stimulating the release of hormones necessary for ovulation. This summary does not include all available information. Always read your medication label and follow your provider’s instructions.

Most Serious Warnings

Product can cause:

• Ovarian Hyperstimulation Syndrome (OHSS), which may become serious and require medical treatment

• Visual disturbances, including blurred vision, spots, flashes, or other changes that may be prolonged or, in rare cases, irreversible

• Severe ovarian enlargement or ovarian cyst formation

• Multiple pregnancy, including twins or higher-order multiples

• Severe allergic reactions

• Blood clots, stroke, or pulmonary embolism

• Potential increased risk of borderline or invasive ovarian tumors with prolonged use

Who Should NOT Take Clomiphene Citrate

Do not take this medication if you:

• Are pregnant

• Have liver disease or a history of liver dysfunction

• Have abnormal uterine bleeding of unknown cause

• Have ovarian cysts or enlargement not due to polycystic ovary syndrome

• Have uncontrolled thyroid or adrenal disorders

• Have a pituitary tumor or other intracranial lesion

• Have a known hypersensitivity to clomiphene citrate or any of its ingredients 

Before Taking Clomiphene Citrate, Tell Your Healthcare Provider if You:

• Have a history of ovarian cysts or polycystic ovary syndrome

• Have uterine fibroids

• Have high triglycerides or a family history of lipid disorders

• Have a history of depression, mood changes, or neurological symptoms

• Have experienced visual changes in the past

• Have endometriosis

• Are taking any prescription, over the counter, or herbal medications

Possible Side Effects

Common (mild to moderate):

• Ovarian enlargement

• Hot flashes

• Abdominal or pelvic discomfort, bloating, or distention

• Nausea or vomiting

• Breast discomfort

• Headache

• Abnormal uterine bleeding or spotting 

Serious (seek medical care immediately):

• Severe abdominal or pelvic pain

• Rapid weight gain, swelling, or shortness of breath

• Visual disturbances such as blurred vision, flashing lights, floaters, or loss of vision

• Signs of a blood clot such as chest pain, leg swelling, warmth, redness, or sudden weakness

• Symptoms of stroke such as confusion, difficulty speaking, or severe headache

• Signs of a severe allergic reaction including rash, swelling of the face or throat, or difficulty breathing

While Taking Clomiphene Citrate

Tell your healthcare provider immediately if you:

• Develop visual changes of any kind

• Experience abdominal pain, swelling, or rapid weight gain

• Have shortness of breath or chest pain

• Notice abnormal vaginal bleeding

• Miss a menstrual period and suspect pregnancy

Pregnancy and Fertility

Clomiphene citrate is indicated to induce ovulation in women with ovulatory dysfunction who desire pregnancy  . It should not be used during pregnancy. If pregnancy is suspected, discontinue use and contact your provider immediately. There is an increased chance of multiple pregnancy when conception occurs with clomiphene therapy  .

Overdose

Symptoms of overdose may include nausea, vomiting, hot flashes, visual disturbances, and ovarian enlargement with abdominal or pelvic pain  . If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a dose, contact your healthcare provider for instructions. Do not double your next dose unless specifically directed by your provider.

Storage

• Store at controlled room temperature 15° to 30°C (59° to 86°F)

• Protect from heat, light, and excessive humidity

• Keep out of reach of children 

Provider Oversight

Clomiphene citrate treatment should be supervised by a healthcare provider experienced in managing gynecologic or endocrine disorders  . Therapy duration and dosing must follow established prescribing guidelines. Long-term cyclic therapy beyond recommended limits is not advised  .

Telemedicine Disclosure

If this prescription was issued via telemedicine, contact your prescribing clinician immediately if you experience concerning or severe symptoms, or seek emergency medical care as needed.

Disclaimer

This summary does not include all information about clomiphene citrate and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations.

Superior Health and Wellness

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.