FDA label
What is tadalafil used for?
The FDA-approved uses of tadalafil, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for tadalafil lists 3 uses: Erectile Dysfunction; Benign Prostatic Hyperplasia; Erectile Dysfunction and Benign Prostatic Hyperplasia.
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Tadalafil, tablet, film coated
Indications and Usage, quoted from the label by Macleods Pharmaceuticals Limited (ANDA207244). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 4348b7db-e5b2-4e87-8cdd-674797a18890, version 4, effective September 17, 2025. NDC 33342-265, one of 164 listings for this product.
Questions
What is tadalafil used for?
The FDA label for tadalafil lists 3 uses: Erectile Dysfunction; Benign Prostatic Hyperplasia; Erectile Dysfunction and Benign Prostatic Hyperplasia.
What drug class is tadalafil?
FDA lists tadalafil in the Phosphodiesterase 5 Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Tadalafil
- Is Tadalafil a controlled substance?Federal schedule
- Generic for TadliqFDA Orange Book
- Generic for AdcircaFDA Orange Book
- Generic for CialisFDA Orange Book
- Phosphodiesterase 5 Inhibitors listFDA drug class
- NDC 0002-4462Tadalafil NDC record
- NDC 0002-4463Tadalafil NDC record
- NDC 0002-4464Tadalafil NDC record