Is tadalafil FDA-approved?

Yes, as specific products: Cialis, Adcirca, Alyq and Tadliq and generic tadalafil tablets are FDA-approved for the uses in their labels, and they're prescription only.

Checked 1 Nov 2026. The sources are below.

Tadalafil

Also: Cialis, Adcirca, Alyq, Tadliq, IC351, LY450190

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Cialis (tadalafil) tablets

    Oral

    Erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and ED with the signs and symptoms of BPH.

    Source: DailyMed label, checked 1 Nov 2026

  • Adcirca (tadalafil) tablets

    Oral

    Pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise ability.

    Source: DailyMed label, checked 1 Nov 2026

  • Alyq (tadalafil) tablets

    Oral

    Pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise ability (approved through an abbreviated new drug application, ANDA).

    Source: DailyMed label, checked 1 Nov 2026

  • Tadliq (tadalafil) oral suspension

    Oral

    Pulmonary arterial hypertension (PAH, WHO Group 1), to improve exercise ability.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic tadalafil tablets, from several manufacturers, with Cialis or Adcirca as the reference product

    Oral

    As stated on each product's label (approved through ANDAs).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above as "Prescription".

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add tadalafil in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell tadalafil or any other compound.

More sources

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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