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Important Safety Information

Enclomiphene Citrate

Compounded enclomiphene citrate (off-label)

About this product

Enclomiphene citrate is a selective estrogen receptor modulator (SERM) prescribed off-label by licensed providers to support endogenous testosterone production in men with secondary hypogonadism. Enclomiphene citrate is not currently FDA-approved as a standalone product and is dispensed as a compounded preparation through a state-licensed compounding pharmacy.

Important safety information

Enclomiphene/clomiphene-class medications may cause:

  • Visual disturbances, including blurring, spots or flashes (scintillating scotomata), reduced visual sharpness, or other visual symptoms. Stop and contact your provider if any visual changes occur.
  • Mood changes, including increased irritability, anxiety, or depression.
  • Headache, dizziness, lightheadedness.
  • Nausea, abdominal discomfort, or bloating.
  • Breast tenderness or gynecomastia.
  • Hot flashes.
  • Possible thromboembolic events (rare).
  • Possible liver enzyme elevations.

Do not use enclomiphene if you

  • Have liver disease or a history of liver dysfunction.
  • Have abnormal uterine bleeding of undetermined origin (not applicable to males but listed for the medication class).
  • Have ovarian cysts (not applicable to males but listed for the medication class).
  • Have known or suspected pregnancy (this medication is for adult males).
  • Have had a serious allergic reaction to enclomiphene, clomiphene, or any ingredient in the formulation.

Most common side effects

  • Headache
  • Nausea
  • Hot flashes
  • Mood changes
  • Visual disturbances (uncommon — stop and contact your provider)

Before starting enclomiphene, tell your provider if you

  • Have a history of liver disease, blood clots, stroke, or heart disease
  • Have a history of mental health conditions
  • Have prostate or testicular conditions
  • Are taking other prescription, over-the-counter, vitamin, or herbal products

Reporting side effects

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to the manufacturer or to your NowYou care team.

Important

This summary does not include all information about this medication. It is not a substitute for the full Prescribing Information or for talking with your healthcare provider. Please read the full Prescribing Information and Medication Guide before starting treatment, and discuss any questions with your provider.

This safety summary is provided for educational purposes and does not replace the full Prescribing Information, Medication Guide, or professional medical advice. Always discuss benefits, risks, and alternatives with your licensed provider.