Tadalafil

Status

FDA-approved. FDA-approved labeling exists as Cialis for erectile dysfunction and for the signs and symptoms of benign prostatic hyperplasia, and as Adcirca for pulmonary arterial hypertension. Contraindicated with organic nitrates and with guanylate cyclase stimulators.

What it is

A long-acting PDE5 inhibitor approved for erectile function and prostate.

What published research measured

A phosphodiesterase type 5 inhibitor distinguished from the others in its class by pharmacokinetics: a half-life of about 17.5 hours, several times longer than sildenafil, which supports both on-demand use with a long window and continuous daily low-dose administration. Randomized trials support efficacy in erectile dysfunction, in benign prostatic hyperplasia — where it holds a separate approval and where the daily regimen improves urinary symptoms — and in pulmonary arterial hypertension. Back pain and myalgia appear more commonly with tadalafil than with the shorter-acting agents in the class. The nitrate contraindication is absolute and, because of the long half-life, persists considerably longer after a dose than it does with sildenafil.

Source

FDA labeling for Cialis and Adcirca, including the nitrate contraindication

Sources

• Half-life source for Tadalafil