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Important Disclaimer
These statements have not been evaluated by the Food and Drug Administration (FDA). Compounded products are not FDA-approved and are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. The information provided is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting any new treatment.
Clinical Information
Evidence-based details for healthcare providers
Use exactly as directed by your healthcare provider. Do not change your dose, take extra capsules, or stop treatment without medical advice. If you miss a dose, take it when you remember unless it is close to your next dose. Do not take two doses at the same time. Your healthcare provider will decide how long you should use this medication and whether follow-up blood tests or exams are needed.
This capsule contains two medicines that work in different ways. Enclomiphene helps the brain send stronger signals to the body's hormone system, which can lead the testes to make more natural testosterone in men who are appropriate candidates. This effect is not immediate, and hormone changes may take several days to weeks, with symptom improvement often taking a few weeks or longer. Tadalafil relaxes blood vessels and improves blood flow, especially to the penis during sexual stimulation, which can help with erections. Tadalafil may start working within about 30 minutes to 2 hours, and its effects can last up to about 36 hours in some people. Patients may notice better erectile function sooner than hormone-related benefits, which usually take longer.
Do not use if you are allergic to enclomiphene, tadalafil, or any ingredient in the capsule. Do not use if you take nitrate medicines for chest pain, such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate, because tadalafil can cause a dangerous drop in blood pressure. Do not use if you take riociguat, a medicine for certain lung blood pressure conditions, for the same reason. Do not use if your healthcare provider has told you to avoid sexual activity because of heart problems. Do not use if you have had a recent heart attack, recent stroke, severe low blood pressure, uncontrolled high blood pressure, or serious heart rhythm problems unless your prescriber says it is safe. Do not use if you have certain serious eye conditions such as non-arteritic anterior ischemic optic neuropathy, or if you have sudden vision loss related to a PDE5 inhibitor. Do not use if you have severe liver disease or severe kidney disease unless specifically approved by your healthcare provider. This product is not for use in women, especially during pregnancy or breastfeeding, and it is not for children under 18 years of age. Do not use if you have a history of blood clots, certain hormone-sensitive conditions, or unexplained testicular problems unless your healthcare provider has evaluated you carefully.
This medication may interact with many common medicines. Major interaction: nitrates such as Nitrostat, Imdur, or Isordil can cause a severe and unsafe drop in blood pressure and must not be used with tadalafil. Major interaction: riociguat should not be used with tadalafil. Moderate to major interaction: alpha-blockers such as tamsulosin (Flomax), doxazosin, or terazosin and other blood pressure medicines may increase dizziness, fainting, or low blood pressure, so dose changes or monitoring may be needed. Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, and ritonavir can raise tadalafil levels and increase side effects. CYP3A4 inducers such as rifampin may lower tadalafil effect. Other erectile dysfunction medicines should not be combined unless your prescriber specifically tells you to do so. Alcohol can increase dizziness, headache, and low blood pressure risk, so limit or avoid heavy drinking. Enclomiphene may affect or be affected by other hormone-related treatments such as testosterone products, clomiphene, anastrozole, or fertility medicines, so tell your provider about all hormone therapies. Herbal products and supplements marketed for testosterone, sexual performance, or bodybuilding may increase side effects or make treatment harder to monitor.
Common side effects from tadalafil include headache, upset stomach, back pain, muscle aches, flushing, nasal congestion, and dizziness. These are often mild and may improve within a few hours to a few days. Less common side effects include heartburn, changes in blood pressure, and visual changes such as seeing a blue tint or blurred vision. Enclomiphene may cause headache, nausea, mood changes, irritability, hot flashes, trouble sleeping, or changes in hormone levels. Because enclomiphene is commonly used through compounding and does not have an FDA-approved label for this product, side effect rates are not well defined. Rare but serious effects need urgent medical care, including chest pain, fainting, sudden hearing loss, sudden vision loss, seizure, signs of a blood clot such as leg swelling or chest pain, or an erection lasting more than 4 hours. Seek emergency help right away if any serious symptom happens. Contact your healthcare provider promptly if side effects do not go away, become bothersome, or if you notice mood changes, severe headache, or major changes in vision.
Store at room temperature, ideally 68-77 degrees F (20-25 degrees C), in a tightly closed container. Protect from moisture, heat, and direct sunlight. Do not store in the bathroom, near a sink, or in a hot car. Keep out of reach of children and pets. Do not use after the beyond-use date on the label. Dispose of unused or expired capsules through a pharmacy take-back program when possible. If no take-back option is available, follow local pharmacy instructions for safe disposal.
Frequently Asked Questions
What is this compounded capsule used for?
This capsule is prescribed by some healthcare providers for men's health needs when they believe both ingredients may be helpful. Tadalafil is FDA-approved for erectile dysfunction, while enclomiphene in this compounded product is not FDA-approved as part of this capsule. Use it only for the reason your provider prescribed it.
How soon will I notice results?
Tadalafil may help with erections within about 30 minutes to 2 hours, but it still requires sexual stimulation to work. Enclomiphene-related hormone effects usually take longer, often several weeks before you notice changes in energy, mood, or other symptoms. Keep follow-up visits so your provider can check your response.
Can I take this with alcohol?
Small amounts of alcohol may be tolerated by some people, but drinking a lot can increase dizziness, headache, and low blood pressure risk. Heavy alcohol use can also make erections harder to achieve. It is best to limit alcohol and ask your healthcare provider what is safe for you.
What should I do if I miss a dose?
Take the missed dose when you remember unless it is almost time for your next dose. If it is close to your next dose, skip the missed dose and return to your normal schedule. Do not take two doses at once.
Can I use this if I take nitroglycerin or heart medicine?
Do not use this medication with nitroglycerin or other nitrate medicines because tadalafil can cause a dangerous drop in blood pressure. Some blood pressure drugs and alpha-blockers can also interact and may require close monitoring. Tell your prescriber about every heart medicine you take before starting this capsule.
Do I need lab work while taking this medication?
Your healthcare provider may order blood tests or other monitoring, especially if enclomiphene is being used to affect hormone levels. These checks may include testosterone-related labs and other tests based on your health history. Follow your provider's monitoring plan closely.
Is this medication safe for fertility?
Enclomiphene is sometimes chosen by prescribers when fertility is an important concern, but this does not mean it is right for everyone. Hormone-related treatment should be tailored to your medical history, symptoms, and lab results. Talk with your provider if you are trying to conceive now or in the near future.
When should I get emergency help?
Get emergency help right away if you have chest pain, fainting, sudden loss of vision or hearing, signs of an allergic reaction, or an erection lasting more than 4 hours. These problems are uncommon but serious. Do not wait to see if they go away on their own.
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