Two medicines, side by side
Dutasteride vs tadalafil
Dutasteride and tadalafil are both labeled for enlarged prostate (bph). Drugs@FDA records approvals of dutasteride since 2001 and of tadalafil since 2003. Pharmacies paid $0.157 per dutasteride 0.5 mg capsule and $0.167 per tadalafil 20 mg tablet (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 tadalafil a phosphodiesterase 5 inhibitor.
Check it at the source: the dutasteride FDA label on DailyMed (effective September 11, 2025); the tadalafil FDA label on DailyMed (effective June 3, 2026).
Highlights of the dutasteride record
Dutasteride (Avodart) · label of September 11, 2025
Used for
From the label: indicationsDutasteride 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 tadalafil record
Tadalafil (Cialis) · label of June 3, 2026
Used for
From the label: indicationsCIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction CIALIS ® is indicated for the treatment […]
On the market
- Earliest approval on file
- November 21, 2003
- Generic labelers
- 49 labelers
- Pharmacy cost
- $0.167 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 12
Source: FDA drug labels via openFDA (Dutasteride label of September 11, 2025, Tadalafil label of June 3, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do dutasteride and tadalafil differ on the record?
In FDA's classes, dutasteride is a 5-alpha reductase inhibitor and tadalafil a phosphodiesterase 5 inhibitor.
How each works, in its label's words: Dutasteride, “Dutasteride inhibits the conversion of testosterone to DHT.”; Tadalafil, “Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.”
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 …”; Tadalafil, “Excretion – The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy …”
Generics: dutasteride since 2010; tadalafil since 2018 (Drugs@FDA).
| Dutasteride | Tadalafil | |
|---|---|---|
| Labeled for | Enlarged prostate (BPH) | Erectile dysfunction, Enlarged prostate (BPH), Pulmonary arterial hypertension |
| Pharmacologic class | 5-alpha Reductase Inhibitor | Phosphodiesterase 5 Inhibitor |
| 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. | Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. |
| 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 … | Excretion – The mean oral clearance for tadalafil is 2.5 L/hr and the mean terminal half-life is 17.5 hours in healthy subjects. |
| Earliest approval on file (Drugs@FDA) | November 20, 2001 | November 21, 2003 |
| First generic approved | December 21, 2010 | May 22, 2018 |
| Generic labelers (NDC) | 13 labelers | 49 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.157 per capsule (Dutasteride 0.5 mg capsule) | $0.167 per tablet (Tadalafil 20 mg tablet) |
| 12-month price change | -12% | -19% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 12 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,084 | 99,551 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to dutasteride
- every medicine labeled for the same conditions