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FDA Approves Cialis for Enlarged Prostate Treatment BPH

Author: U.S. Food and Drug Administration
Published: 2011/10/13 - Updated: 2026/01/19
Publication Details: Peer-Reviewed, Announcement
Category Topic: FDA - Related Publications

Page Content: Synopsis - Introduction - Main - Insights, Updates

Synopsis: This peer-reviewed announcement from the U.S. Food and Drug Administration provides authoritative guidance on the approved therapeutic uses of tadalafil (Cialis) for men experiencing benign prostatic hyperplasia, a condition where the prostate gland becomes enlarged and causes urinary symptoms. The information carries medical authority as it comes directly from the federal regulatory agency responsible for drug safety and effectiveness in the United States, making it a reliable reference for healthcare providers, patients, and caregivers. Men dealing with BPH symptoms - including difficulty starting urination, weak urine stream, and frequent nighttime urination - will find this particularly relevant, as the approval offers a treatment option that addresses both enlarged prostate and erectile dysfunction when these conditions occur together. The announcement details clinical trial results using standardized measurement tools like the International Prostate Symptom Score, while also noting important safety considerations regarding drug interactions with nitrates and alpha blockers - Disabled World (DW).

Introduction

The U.S. Food and Drug Administration approves Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

Main Content

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS). In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo. The improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function.

"BPH can have a big impact on a patient's quality of life," said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. "A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men."

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied for the treatment of BPH, and there is a risk of lowering blood pressure.

The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is manufactured by Indianapolis-based Eli Lilly and Co.

FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Insights, Analysis, and Developments

Editorial Note: The FDA's approval of Cialis for BPH represents a meaningful development for the millions of older men who face the dual challenge of managing both urinary symptoms and sexual health concerns. While eight other medications already existed for treating BPH symptoms alone, this approval fills a gap for patients who experience both conditions simultaneously - a common scenario in aging populations. The decision reflects careful evaluation of clinical evidence showing measurable symptom improvement, yet the warnings about potential blood pressure interactions serve as a reminder that even familiar medications require proper medical supervision when used for new indications. For men and their physicians, this expands the conversation about treatment options and quality of life, moving beyond single-symptom management toward more holistic approaches to age-related urological health - Disabled World (DW).

Attribution/Source(s): This peer reviewed publication was selected for publishing by the editors of Disabled World (DW) due to its relevance to the disability community. Originally authored by U.S. Food and Drug Administration and published on 2011/10/13, this content may have been edited for style, clarity, or brevity.

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APA: U.S. Food and Drug Administration. (2011, October 13 - Last revised: 2026, January 19). FDA Approves Cialis for Enlarged Prostate Treatment BPH. Disabled World (DW). Retrieved February 3, 2026 from www.disabled-world.com/medical/pharmaceutical/fda/cialis.php
MLA: U.S. Food and Drug Administration. "FDA Approves Cialis for Enlarged Prostate Treatment BPH." Disabled World (DW), 13 Oct. 2011, revised 19 Jan. 2026. Web. 3 Feb. 2026. <www.disabled-world.com/medical/pharmaceutical/fda/cialis.php>.
Chicago: U.S. Food and Drug Administration. "FDA Approves Cialis for Enlarged Prostate Treatment BPH." Disabled World (DW). Last modified January 19, 2026. www.disabled-world.com/medical/pharmaceutical/fda/cialis.php.

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