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Cialis ® (tadalafil) tablets
2.5 mg, 5 mg, 10mg, 20 mg tablets
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What are the approved indications for Cialis® (tadalafil)?
Cialis has been approved for the treatment of ED, signs and symptoms of BPH, and both ED and signs and symptoms of BPH.
Approved Indications
The Food and Drug Administration has approved tadalafil for
- use as needed for the treatment of erectile dysfunction (ED) in November 2003
- once-daily use for the treatment of ED in January 2008
- once-daily use for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in October 2011, and
- once-daily use for the treatment of both ED and signs and symptoms of BPH in October 2011.1,2
Enclosed Prescribing Information
References
1Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2Drugs@FDA: FDA-approved drugs. US Food and Drug Administration. Accessed January 8, 2024. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021368
Date of Last Review: January 08, 2024