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Two medicines, side by side

Dutasteride vs tamsulosin

Dutasteride and tamsulosin are both labeled for enlarged prostate (bph). Drugs@FDA records approvals of dutasteride since 2001 and of tamsulosin since 1997. Pharmacies paid $0.157 per dutasteride 0.5 mg capsule and $0.05 per tamsulosin HCl 0.4 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, dutasteride is a 5-alpha reductase inhibitor and tamsulosin an alpha-adrenergic blocker.

Check it at the source: the dutasteride FDA label on DailyMed (effective September 11, 2025); the tamsulosin FDA label on DailyMed (effective December 1, 2025).

Highlights of the dutasteride record

Dutasteride (Avodart) · label of September 11, 2025

Used for

From the label: indications

Dutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: ( 1.1 ) improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery. […]

On the market

Earliest approval on file
November 20, 2001
Generic labelers
13 labelers
Pharmacy cost
$0.157 per capsule

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the tamsulosin record

Tamsulosin (Flomax) · label of December 1, 2025

Used for

From the label: indications

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ]. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. […]

On the market

Earliest approval on file
April 15, 1997
Generic labelers
38 labelers
Pharmacy cost
$0.05 per capsule

Supply and safety

Shortage
No current entry
Recalls
3

Source: FDA drug labels via openFDA (Dutasteride label of September 11, 2025, Tamsulosin label of December 1, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do dutasteride and tamsulosin differ on the record?

In FDA's classes, dutasteride is a 5-alpha reductase inhibitor and tamsulosin an alpha-adrenergic blocker.

How each works, in its label's words: Dutasteride, “Dutasteride inhibits the conversion of testosterone to DHT.”; Tamsulosin, “The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic.”

Half-life, in each label's words: Dutasteride, “In this single-dose trial, dutasteride half-life increased with age (approximately 170 hours in men aged 20 to 49 …”; Tamsulosin, “Following intravenous or oral administration of an immediate-release formulation, the elimination half-life of …”

Generics: dutasteride since 2010; tamsulosin since 2010 (Drugs@FDA).

DutasterideTamsulosin
Labeled forEnlarged prostate (BPH)Enlarged prostate (BPH)
Pharmacologic class5-alpha Reductase Inhibitoralpha-Adrenergic Blocker
How it works (label)Dutasteride inhibits the conversion of testosterone to DHT. DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland.The symptoms associated with benign prostatic hyperplasia (BPH) are related to bladder outlet obstruction, which is comprised of two underlying components: static and dynamic.
Half-life (label)In this single-dose trial, dutasteride half-life increased with age (approximately 170 hours in men aged 20 to 49 years, approximately 260 hours in men aged 50 to 69 years, and approximately 300 hours in men older than …Following intravenous or oral administration of an immediate-release formulation, the elimination half-life of tamsulosin hydrochloride in plasma ranged from 5 to 7 hours.
Earliest approval on file (Drugs@FDA)November 20, 2001April 15, 1997
First generic approvedDecember 21, 2010March 2, 2010
Generic labelers (NDC)13 labelers38 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.157 per capsule (Dutasteride 0.5 mg capsule)$0.05 per capsule (Tamsulosin HCl 0.4 mg capsule)
12-month price change-12%-2%
Boxed warningNoNo
Shortage nowNo current entryNo current entry
Recalls recorded03
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)8,08420,287
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

Do their labels mention each other?

Dutasteride label, drug interactions

The administration of dutasteride in combination with tamsulosin or terazosin has no effect on the steady-state pharmacokinetics of either alpha-adrenergic antagonist.

Dutasteride label, warnings and precautions

Coadministration of dutasteride and tamsulosin resulted in similar changes to serum PSA as dutasteride monotherapy.

Source: FDA drug labels via openFDA

What next?

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