Tadalafil

What it is and how it works

Mechanism class: Phosphodiesterase 5 Inhibitors

Indications

Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) • the signs and symptoms of benign prostatic hyperplasia (BPH) • ED and the signs and symptoms of BPH (ED/BPH) If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks . Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown .

Dosage and administration (summary)

Do not split tadalafil tablets; entire dose should be taken. • Tadalafil tablets for use as needed: • ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose. Not to be taken more than once per day . • Tadalafil tablets for once daily use: • ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability .

Contraindications

• Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates . • History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA ® . • Administration with guanylate cyclase (GC) stimulators, such as riociguat .

Warnings and precautions

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil tablets, it is important to note the following: • Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status . • Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ).

Source: Tadalafil (Tadalafil) — US FDA prescribing information, 2025-08-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.