Important Safety Information: Enclomiphene Citrate | Compounded Oral Medication

What is this?

This Important Safety Information summarizes key warnings and precautions for Enclomiphene Citrate, a selective estrogen receptor modulator (SERM) used in men to support natural testosterone production by stimulating the body’s luteinizing hormone (LH) and follicle-stimulating hormone (FSH) pathways. It may be prescribed to support hormonal balance and fertility in appropriate patients.

This compounded formulation has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy and should only be used exactly as directed by a licensed healthcare provider. 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:

• Severe allergic reactions, including swelling of the face, lips, tongue, or throat

• Visual disturbances or changes in vision

• Mood changes or emotional instability

• Headaches or neurological symptoms

• Hormonal imbalance if improperly dosed

• Potential stimulation of hormone-sensitive conditions

Compounded medications may carry formulation or quality risks due to limited FDA oversight.

Who Should NOT Take Enclomiphene Citrate

Do not take this medication if you:

• Have a known allergy to enclomiphene citrate or any ingredient in the formulation

• Have a history of hormone-sensitive cancers

• Have uncontrolled liver disease

• Are pregnant or breastfeeding

• Have been advised to avoid fertility or hormone-stimulating medications

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

• Have liver disease or abnormal liver function tests

• Have a history of blood clots

• Have visual problems or migraines

• Have a history of mood disorders

• Take prescription, over the counter, or herbal medications

• Smoke, drink alcohol regularly, or use recreational drugs

• Are undergoing fertility evaluation or actively trying to conceive

Provide a complete list of all medications, supplements, and medical conditions to your provider.

Possible Side Effects

Common (mild to moderate):

• Headache

• Nausea

• Mood changes or irritability

• Mild visual disturbances

• Fatigue

• Gastrointestinal discomfort

Serious (seek medical care immediately):

• Rash, hives, swelling of the face or throat, difficulty breathing

• Sudden vision changes or visual blurring

• Severe mood changes or depression

• Signs of liver problems such as yellowing of the skin or eyes

• Chest pain or symptoms of blood clot

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

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

While Taking Enclomiphene Citrate

Tell your healthcare provider immediately if you:

• Develop visual disturbances

• Experience severe headaches

• Notice mood changes or emotional instability

• Develop unusual swelling or allergic symptoms

• Do not notice improvement in symptoms within the expected timeframe

It may take time for this medication to begin working and for hormone levels to adjust.

Pregnancy and Fertility

Enclomiphene Citrate is generally prescribed in men to support endogenous testosterone production and fertility preservation. It is not intended for use in women who are pregnant or breastfeeding. Use only under medical supervision when fertility is a treatment goal.

Overdose

Symptoms of overdose may include:

• Severe headache

• Visual disturbances

• Nausea or vomiting

• Mood instability

• Hormonal disruption

If overdose is suspected, seek emergency medical attention or contact Poison Control right away.

Missed Dosage

If you miss a scheduled dose:

• Take the missed dose when you remember unless it is near the time of your next scheduled dose

• Skip the missed dose if it is close to your next dose

• Do not double the next dose

• Contact your provider if you are unsure how to resume therapy

Storage

• Store as directed on your prescription label

• Keep at controlled room temperature unless otherwise instructed

• Protect from moisture and excessive heat

• Keep out of reach of children and pets

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains. Consult local medication take-back programs if available.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health and Wellness providers. Dosing and therapy schedules must be discussed directly with your provider to ensure safety and clinical appropriateness. Orders may be adjusted based on labs, symptoms, or fertility considerations.

Telemedicine Disclosure

This prescription may have been issued via telemedicine. If you experience concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This summary does not include all information about Enclomiphene Citrate and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.