Important Safety Information for Clomiphene

What is the FDA-approved use of clomiphene?

Clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women who want to become pregnant. The drug works by increasing the amount of hormones that support the growth and release of a mature egg (ovulation). 

Your Ro-affiliated provider may also recommend the use of clomiphene to increase testosterone levels in men with low testosterone.

Who should not use clomiphene?

Do not use clomiphene if: 

  • You have a known allergic reaction to clomiphene.

  • You have ever had problems with your liver.

  • You have any of these health problems: adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.

If you were assigned female at birth, you should not use clomiphene if: 

  • You have any of these health problems: endometriosis, endometrial cancer, enlarged ovaries or ovarian cysts, high levels of prolactin in the blood, or low levels of estrogen in the blood.

  • Your ovaries no longer make eggs, also called primary ovarian failure.

  • You have unexplained vaginal bleeding.

  • You are pregnant or may be pregnant.

How should I take clomiphene?

Clomiphene comes as a tablet and is taken by mouth. Take clomiphene exactly as directed by your Ro-affiliated provider, and don’t take more or less of it or take it more often than prescribed. Your dosage is based on your medical condition and response to therapy. 

Unless your provider tells you otherwise, you can continue your normal diet.

What should I tell my Ro-affiliated provider before using clomiphene?
  • It’s important to tell your Ro-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements. 

Withholding or providing inaccurate information about your health and medical history to obtain treatment may result in harm.

What are the most serious side effects that I or a caregiver should monitor for when taking clomiphene?

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

Clomiphene can cause rare, but potentially serious side effects: 

  • Visual symptoms: This medication can cause blurred eyesight, seeing spots or flashes, or double vision. These symptoms may show up or get worse in bright light. Most often, eyesight gets back to normal when the drug is stopped. Do not drive a car or operate machinery, especially in poor lighting, until you know how this medication affects you.

  • Increased triglyceride levels: Can occur with longer duration of treatment with clomiphene. You should be monitored for triglyceride levels if you have preexisting hyperlipidemia or family history of hyperlipidemia. 

If you were assigned female at birth, these serious side effects may occur:

  • Ovarian hyperstimulation syndrome (OHSS): Call your provider right away if you have severe stomach pain or bloating; a very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.

  • Ovarian cancer: In women, long-term use of clomiphene may increase the risk of ovarian cancer, but a causal relationship has not been determined yet. 

  • Multiple pregnancy: Clomiphene increases the chance of multiple pregnancy (twins or more). 

What are the most common side effects of clomiphene?
  • Flushing (feeling of warmth)

  • Abdominal pain and discomfort 

  • Nausea and vomiting

  • Breast discomfort

  • Visual symptoms

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.