Two medicines, side by side
Tadalafil vs vardenafil
Tadalafil and vardenafil are both labeled for erectile dysfunction. Drugs@FDA records approvals of tadalafil since 2003 and of vardenafil since 2003. Pharmacies paid $0.167 per tadalafil 20 mg tablet and $2.79 per vardenafil HCl 20 mg tablet (NADAC, October 7, 2026). How each works, in its label's words: 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.”; Vardenafil, “Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles.”
Check it at the source: the tadalafil FDA label on DailyMed (effective June 3, 2026); the vardenafil FDA label on DailyMed (effective January 5, 2026).
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
Highlights of the vardenafil record
Vardenafil (Levitra) · label of January 5, 2026
Used for
From the label: indicationsVardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ) Vardenafil tablets are indicated for the treatment of erectile dysfunction.
On the market
- Earliest approval on file
- August 19, 2003
- Generic labelers
- 11 labelers
- Pharmacy cost
- $2.79 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Source: FDA drug labels via openFDA (Tadalafil label of June 3, 2026, Vardenafil label of January 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do tadalafil and vardenafil differ on the record?
How each works, in its label's words: 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.”; Vardenafil, “Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles.”
Both are in FDA's class phosphodiesterase 5 inhibitors.
Half-life, in each label's words: 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 …”; Vardenafil, “Excretion The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary …”
Generics: tadalafil since 2018; vardenafil since 2012 (Drugs@FDA).
| Tadalafil | Vardenafil | |
|---|---|---|
| Labeled for | Erectile dysfunction, Enlarged prostate (BPH), Pulmonary arterial hypertension | Erectile dysfunction |
| Pharmacologic class | Phosphodiesterase 5 Inhibitor | Phosphodiesterase 5 Inhibitor |
| How it works (label) | Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. | Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. |
| Half-life (label) | 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. | Excretion The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4 to 5 hours. |
| Earliest approval on file (Drugs@FDA) | November 21, 2003 | August 19, 2003 |
| First generic approved | May 22, 2018 | May 3, 2012 |
| Generic labelers (NDC) | 49 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.167 per tablet (Tadalafil 20 mg tablet) | $2.79 per tablet (Vardenafil HCl 20 mg tablet) |
| 12-month price change | -19% | +20% |
| Boxed warning | No | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 12 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 99,551 | 669 |
| 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 tadalafil
- every medicine labeled for the same conditions