Compounded preparations are not FDA-approved and have not undergone FDA review for safety, efficacy, or manufacturing consistency. Combinations with additional agents (e.g., tadalafil, oxytocin, bremelanotide) may involve off-label prescribing. Possible risks include headache, flushing, indigestion, dizziness, visual disturbances, blood pressure changes, and priapism requiring immediate medical attention. Sildenafil must not be used with nitrates due to the risk of severe hypotension. Patients with recent heart attack, unstable angina, severe cardiovascular disease, or severe liver or kidney impairment may not be candidates. No outcome is guaranteed. These products are offered under informed consent.
