Important Enclomiphene Safety Information
Please carefully read the following safety information regarding your prescriptions of enclomiphene products:
Risks and Precautions:
- Stop taking enclomiphene and seek medical care if you experience sudden vision changes or loss of vision.
- Seek emergency medical care if you develop symptoms of a blood clot, such as leg swelling, chest pain, or sudden shortness of breath.
- Complete all recommended follow-up laboratory testing, as your provider may need to adjust your treatment based on your results.
Usage Guidelines:
- Take your medications exactly as prescribed by your healthcare provider.
- Do not share your medications with others.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.
Off Label:
Enclomiphene is dispensed through Ivím as a compounded medication and is not FDA-approved for any indication; it is used off-label as your provider determines. Compounded medications are permitted under federal law but are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or manufacturing quality.
For any questions or concerns regarding your medication, contact our support team immediately.
This statement does not replace individual medical advice provided by your healthcare professional. Always follow the specific instructions given by your provider.
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Important Enclomiphene Safety Information
Note regarding compounded medications
Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo FDA review for safety, effectiveness, or manufacturing quality. Your provider may recommend a compounded formulation of enclomiphene based on your individual medical evaluation.
What is enclomiphene used for?
Enclomiphene is prescribed to stimulate the body’s natural production of testosterone in men with secondary hypogonadism and may help preserve fertility. It is also used off-label in other hormone optimization protocols when deemed appropriate by your healthcare provider.
Who should not use enclomiphene?
You should not use enclomiphene if you:
- Have a known allergy to enclomiphene or clomiphene
- Have a history of breast or prostate cancer unless specifically directed by your treating specialist
Use with caution and only under close medical supervision if you have:
- Active liver disease
- Significant elevations in cholesterol or triglycerides
- A history of blood clots or cardiovascular disease
How should enclomiphene be administered?
Enclomiphene is an oral medication that can be taken with or without food. It should be taken around the same time each day.
What should I tell my provider before starting enclomiphene?
Medications to watch out for (interactions)
Please note this is not an exhaustive list.
Tell your provider if you use:
- Testosterone replacement therapy
- Other hormone replacement therapies
- Fertility medications
- Over-the-counter testosterone boosters
- Herbal hormone supplements
It is important to share your complete medical history with your provider, especially if you have a history of:
- Breast or prostate cancer
- Liver disease
- Kidney disease
- High cholesterol or triglycerides
- Blood clots
- Heart attack, stroke, or other cardiovascular disease
- Pituitary adenoma
- Uncontrolled thyroid disorders
- Uncontrolled adrenal disorders
What are the most serious side effects that I or a caregiver should monitor for?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
Vision changes
Although uncommon, enclomiphene may cause blurred vision, flashes of light, floaters, or other visual disturbances. Stop taking the medication and seek prompt medical evaluation if vision changes occur.
Blood clots (Thromboembolism)
Seek emergency medical care if you develop:
- Leg swelling or pain
- Chest pain
- Sudden shortness of breath
- Coughing up blood
These may be signs of a blood clot.
Elevated hematocrit
Enclomiphene may increase red blood cell production in some individuals. Excessively high hematocrit levels may increase the risk of clotting and require dose adjustment or discontinuation.
Elevated PSA or prostate concerns
Men receiving hormone therapy should undergo periodic prostate monitoring. Report urinary symptoms or significant PSA changes to your provider.
Serious allergic reactions
Stop using enclomiphene immediately if you experience swelling of the face, lips, tongue, or throat; severe rash or itching; difficulty breathing or swallowing; rapid heartbeat; or fainting.
Significant mood or behavioral changes
Contact your healthcare provider if you experience severe anxiety, depression, agitation, or other significant changes in mood or behavior.
What are the most common side effects of enclomiphene?
- Headache
- Nausea
- Increased libido
- Acne
- Mood changes
- Breast tenderness or enlargement (gynecomastia)
Most side effects are mild and improve with continued treatment or dose adjustment.
This information is not comprehensive. Please consult your healthcare provider for individualized medical advice.
Disclaimer
Enclomiphene is available as a compounded medication through licensed compounding pharmacies. Compounded medications are not FDA-approved but are prepared by pharmacists to meet individual patient needs based on a valid prescription. The safety, efficacy, and quality of compounded enclomiphene may vary depending on the pharmacy and formulation. Always consult with a licensed healthcare provider before starting any compounded therapy.
This document may include information about the use of medications, supplements, or therapies that are not approved by the U.S. Food and Drug Administration (FDA) for the specific indication discussed. Such “off-label” use is based on clinical judgment, emerging research, or standard-of-care guidelines and is intended to support safe, evidence-informed decision-making.
