Important Tadalafil Safety Information
Please carefully read the following safety information regarding your prescriptions of tadalafil products:
Risks and Precautions:
- Tadalafil increases the risk of hypotension, or low blood pressure, especially when combined with certain medications
- You should seek emergency treatment if an erection lasts longer than 4 hours
- You should stop use and seek medical care if sudden loss of vision occurs in one or both eyes
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:
Tadalafil is dispensed through Ivím as a compounded medication and may be prescribed for both FDA-approved and off-label uses, 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.
——————————————————————————————————————
Important Tadalafil 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 safety, effectiveness, or manufacturing review by the FDA. Your Ivim Health provider may recommend certain doses of compounded medications based on your medical evaluation.
What is the FDA-approved use of tadalafil?
Tadalafil is FDA-approved for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hypertrophy (BPH), the combination of ED as well as BPH, and pulmonary arterial hypertension.
Who should not use tadalafil?
You should not take tadalafil if you are currently taking a class of medications called nitrates, if you have unstable angina, or you have a history of ischemic optic neuropathy.
How should tadalafil be administered?
Tadalafil is an oral medication. It may be available as a stand-alone medication that can be taken as needed before sexual activity or once daily. It may also be available in combination with enclomiphene to make once daily dosing easier. Current offerings through Ivím will vary.
What should I tell my IVIM provider before starting tadalafil?
Medications to watch out for (interactions):Please note, this is not an exhaustive list, and interactions are not limited to the following medications.
Isosorbide dinitrate
Isosorbide mononitrate
Nitroglycerin
Riociguat
Vericiguat
Itraconazole
Ketoconazole
Nicardipine
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a history of:
Hypersensitivity to tadalafil
Hypotension or low blood pressure
Multiple medications being used to lower blood pressure
Unstable angina
Chest pain
Use medications like tamsulosin
Chronic kidney disease
Chronic liver disease
Anatomic penile disorders
Spinal cord injury
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.
Priapism: Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) is an infrequent but dangerous side effect. In the event of an erection that persistslonger than 4 hours, you should seek immediate medical assistance.
Severe hypotension: Tadalafil may decrease blood pressure. When combined with other medications that do the same, there is a risk for dangerously low blood pressure that can cause dizziness, fainting, or chest discomfort. Any of these symptoms should prompt emergency evaluation.
Vision changes: Tadalafil can increase the risk of a condition called non-arteritic anterior ischemic optic neuropathy (NAION). If you experience sudden loss of vision in one or both eyes, you should seek immediate care.
Serious Allergic Reactions:Stop using tadalafil right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
What are the most common side effects of tadalafil?
- Headache
- Flushing
- Dyspepsia
- Myalgia
- Nasal congestion
- Dizziness
- Nausea
- Back pain
This information is not comprehensive. Please see full prescribing information for tadalafil for complete safety information.
Disclaimer: Tadalafil 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 tadalafil 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.
