Cialis (Tadalafil) Regulatory Status: US, EU, Canada, and UK Approval History

When did the FDA approve Cialis?

Cialis was approved on November 21, 2003, under NDA 021368, held by Lilly, as a type 1 new molecular entity [2]. The current label, effective June 3, 2026, carries three indications: erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and erectile dysfunction together with BPH [1].

Drugs@FDA lists the 5, 10 and 20 mg tablets as prescription and the 2.5 mg tablet as discontinued, with a Federal Register note that it was not discontinued or withdrawn for safety or effectiveness reasons [2]. The label gives a 2.5 mg once-daily starting dose for erectile dysfunction, which may be increased to 5 mg by response and tolerability [1].

What else is approved as tadalafil in the US?

The FDA approved Adcirca (tadalafil) on May 22, 2009, under NDA 022332, for pulmonary arterial hypertension [4]. Adcirca and Cialis are different products with different approved uses, but both are listed as 20 mg tablets [2][4]. The Cialis label says Cialis has not been studied with other PDE5 inhibitors or other ED treatments [1]. All 138 tadalafil drug labels in openFDA are prescription labels; none is over the counter.

What does the EMA list for Cialis?

The EMA lists Cialis as authorised in the European Union, available as 2.5, 5, 10 and 20 mg tablets and obtainable only with a prescription, for erectile dysfunction and the signs and symptoms of BPH [3].

Its dosing text differs from the US label. The EMA summary describes on-demand use as 10 mg taken at least 30 minutes before sexual activity, increased to 20 mg for men who do not respond, and says continuous daily use of 10 or 20 mg is not recommended; once-daily use is 5 mg, which can be lowered to 2.5 mg depending on tolerance [3]. The US label starts once-daily dosing at 2.5 mg and allows an increase to 5 mg [1].

What does the Cialis label contraindicate?

The Cialis label contraindicates any form of organic nitrate, guanylate cyclase stimulators such as riociguat, and known serious hypersensitivity to tadalafil [1]. The label says an erection lasting longer than 4 hours needs emergency care, and that sudden vision loss or a sudden decrease or loss of hearing calls for stopping Cialis and getting medical care [1].

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