Vidalista Black 80 mg contains tadalafil, a PDE‑5 inhibitor used to treat erectile dysfunction. Due to its potency—including effects lasting up to 36 hours—it carries serious health risks if not used under medical supervision (e.g., severe hypotension, vision loss, priapism). In most countries (like the USA and India), it’s classified as a prescription-only medication. This is because: Unsupervised use can interact with medications (notably nitrates and alpha‑blockers), causing potentially life-threatening drops in blood pressure. Safety concerns demand doctor oversight—liver, kidney, heart health, and current medications must be assessed before prescribing such a high-dose (80 mg) formulation . Regulations aim to prevent counterfeit or substandard products; OTC sale without prescription increases risk of exposure to fake or unsafe drugs . Community reports further confirm that retail pharmacies in places like the US will strictly refuse sales without a valid prescription. Some countries offer milder PDE‑5 inhibitors over the counter (e.g., 10 mg tadalafil in the UK as a Pharmacy (P) medicine), but high-dose 80 mg remains tightly controlled.