Enclomiphene Side Effects: What Is Reported and Where the Information Comes From

When a medication is FDA-approved, its side effects are set out in official labeling, based on studies the agency has reviewed. Enclomiphene has no such labeling, because it is not FDA-approved for any use. That does not mean nothing is known. It means the information comes from several partial sources, each with limits. This guide explains those sources, what each one suggests, and what to report to a provider. It is educational and does not replace medical advice.

Source 1: Studies of enclomiphene

Enclomiphene has been studied in clinical trials in men, but those studies were limited in size and length, and the application for approval was not approved.

Side effects reported in those studies include:

• Headache
• Nausea
• Hot flashes
• Dizziness

The limit. Smaller, shorter studies are less able to detect uncommon or long-term effects.

Source 2: A closely related approved medication

Enclomiphene is one of two components of an older FDA-approved medication that has been in use for decades for a different purpose. That medication's labeling lists:

• Visual symptoms, such as blurred vision, spots, or flashes
• Mood changes
• Hot flashes
• Headache
• Abdominal discomfort

The limit. That medication contains a second component and was studied mainly in women, so its labeling cannot be assumed to describe enclomiphene in men. It is a reason for caution, especially about vision.

Source 3: The drug class

Enclomiphene belongs to a class called selective estrogen receptor modulators. Some medications in this class carry warnings about blood clots.

The limit. A class warning does not establish the risk for one specific member. It is still a reason to tell your provider about any personal or family history of clots.

Source 4: Effects of the hormone changes themselves

Enclomiphene is intended to increase the body's own testosterone signaling. A portion of testosterone is converted to estrogen, so estrogen can rise as well. Changes in hormone levels can be associated with:

• Breast tenderness or swelling
• Acne or oily skin
• Mood or sleep changes
• Changes in blood counts, which is one reason providers order blood tests

What is not known

• How often each side effect occurs
• The effects of long-term use
• How any specific compounded product behaves, since compounded medications are not reviewed by the FDA for safety, effectiveness, or quality

Statements that enclomiphene has a better safety profile than other treatments are not supported by an approved label.

What to report promptly

Contact your provider before your next dose if you notice:

• Any change in vision
• Breast tenderness, swelling, or a lump
• Marked mood changes, irritability, or low mood
• Persistent headache or nausea

When to seek urgent care

• Sudden loss of vision
• Pain, swelling, or warmth in one leg
• Chest pain or sudden shortness of breath
• Yellowing of the skin or eyes, or dark urine
• Thoughts of self-harm. In the United States, call or text 988.

What monitoring usually involves

A provider who prescribes enclomiphene will generally:

• Order blood tests before starting, including testosterone and related hormones
• Repeat testing during treatment
• Ask about symptoms and side effects at follow-up
• Review whether to continue, adjust, or stop

What to tell your provider before starting

• Any eye condition or previous visual problems
• A personal or family history of blood clots
• Liver disease
• A history of hormone-sensitive cancer
• Every medication and supplement you take
• Whether you compete in a sport with drug testing, since enclomiphene is prohibited under anti-doping rules

What not to do

• Do not change the dose or schedule on your own
• Do not add other hormone-blocking products without a prescription
• Do not use enclomiphene obtained without a prescription
• Do not continue through a vision change while waiting to see if it passes

Care through Nu Image

Nu Image offers online evaluations and follow-up with licensed providers. The enclomiphene prescribed through Nu Image is a compounded medication and is not FDA-approved. Contact the care team about any side effect that concerns you.

This content is for educational purposes only and is not medical advice, diagnosis, or treatment. Enclomiphene is not approved by the FDA, and this is not a complete list of possible side effects. Compounded medications are not reviewed or approved by the FDA for safety, efficacy, or quality. Prescription products require an online consultation with a licensed healthcare provider, who will determine whether a prescription is appropriate.