Prescription medicine
Vardenafil First approved as Levitra
Vardenafil (Levitra) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $2.79 per vardenafil HCl 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.); the NDA 21400 record on Drugs@FDA; every vardenafil label on DailyMed.
Highlights of the record
FDA label of January 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageVardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 11.85 mg
- 20 mg
Film-coated tablet; tablet; orally disintegrating tablet.
On the market
- Earliest approval on file
- August 19, 2003 Levitra, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first May 3, 2012; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 11 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- July 23, 2027 Levitra tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.79 per tablet Vardenafil HCl 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2018 0 Class I among all firms' recalls; latest February 19, 2018; 2 more by firms not listed as its makers
- FAERS reports
- 669 through July 30, 2026
What is vardenafil used for?
From the label: indications and usageVardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1 ) Vardenafil tablets are indicated for the treatment of erectile dysfunction.
Conditions named in the indications of vardenafil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Phosphodiesterase 5 Inhibitor.
Source: FDA drug label (VARDENAFIL), Zydus Pharmaceuticals USA Inc., effective January 5, 2026 (SPL set 5876e062-e604-42a7-99c3-5da30b8dac06), via openFDA; the full label on DailyMed
Is there a generic for vardenafil (Levitra)?
The FDA approved the first generic vardenafil on May 3, 2012. 8 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists vardenafil from 11 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Levitra tablets, the last expiring on July 23, 2027; a patent listed only for Staxyn tablets runs to December 23, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2003 earliest approval on file
- 2012 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for vardenafil (Levitra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.79 per Vardenafil HCl 20 mg tablet, up 20% from $2.32 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Vardenafil HCl 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Vardenafil HCl 10 mg ODT | Generic | $23.33 per unit | n/a | +21% |
| Vardenafil HCl 10 mg tablet | Generic | $2.87 per tablet | $86.00 | -4% |
| Vardenafil HCl 20 mg tablet | Generic | $2.79 per tablet | $83.78 | +20% |
| Vardenafil HCl 5 mg tablet | Generic | $7.10 per tablet | $212.99 | +48% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has vardenafil been recalled?
The FDA's Enforcement Report lists 3 recalls naming vardenafil since 2018: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of vardenafil and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2020 | Class II | MasterPharm LLC not a listed maker | Lack of Processing Controls (lack of assurance of conformity to specifications). |
| February 19, 2018 | Class II | Kalchem International, Inc. | cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the vardenafil label say about other medicines?
The vardenafil label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 27 other medicines name vardenafil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alfuzosin | drug interactions | Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. [See Dosage and Administration ( 2.4 ), Warnings and Precautions ( 5.6 ), and Clinical Pharmacology ( 12.2 ).] Antihypertensives Vardenafil may add to the blood pressure lowering effects of … |
| Amiodarone | warnings and precautions | Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil. |
| Aspirin | drug interactions | Aspirin Vardenafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets). |
| Cimetidine | drug interactions | Cimetidine (400 mg b.i.d.) had no effect on vardenafil bioavailability (AUC) and maximum concentration (C max ) of vardenafil when co-administered with 20 mg vardenafil in healthy volunteers. |
| Cobicistat | drug interactions | Consequently, it is recommended not to exceed a single 2.5 mg vardenafil dose in a 72-hour period when used in combination with ritonavir. [See Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.2 ).] Cobicistat with vardenafil can result in increased plasma concentrations, therefore it is recommended … |
| Dabigatran | drug interactions | While concomitant use of vardenafil did not significantly increase plasma concentrations of digoxin, a P-gp substrate, the effect on plasma concentrations of P-gp substrates that are more sensitive than digoxin (e.g. dabigatran) is not known. |
| Digoxin | drug interactions | While concomitant use of vardenafil did not significantly increase plasma concentrations of digoxin, a P-gp substrate, the effect on plasma concentrations of P-gp substrates that are more sensitive than digoxin (e.g. dabigatran) is not known. |
| Erythromycin | drug interactions | … period. [See Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5 ).] Moderate CYP3A4 inhibitors Erythromycin (500 mg t.i.d.) produced a 4-fold increase in vardenafil AUC and a 3-fold increase in C max when coadministered with vardenafil 5 mg in healthy volunteers. |
| Glyburide | drug interactions | Other interactions Vardenafil had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters). |
| Ketoconazole | drug interactions | In vivo studies Strong CYP3A4 inhibitors Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max ) when co-administered with vardenafil (5 mg) in healthy volunteers. |
| Moxifloxacin | warnings and precautions | In a study of the effect of vardenafil on QT interval in 59 healthy males [see Clinical Pharmacology ( 12.2 )], therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QT c interval. |
| Nifedipine | drug interactions | Nifedipine did not alter the plasma levels of vardenafil when taken in combination. |
| Nitric oxide | contraindications | CONTRAINDICATIONS Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat |
| Nitroglycerin | drug interactions | These effects were not observed when vardenafil 20 mg was taken 24 hours before the nitroglycerin (NTG). |
Every other medicine the vardenafil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Procainamide | warnings and precautions | Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using … |
| Quinidine | warnings and precautions | Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using … |
| Ranitidine | drug interactions | … warfarin, digoxin, an antacid based on magnesium-aluminum hydroxide, and ranitidine. |
| Riociguat | contraindications | CONTRAINDICATIONS Administration with nitrates and nitric oxide donors ( 2.4 , 4.1 ) Administration with guanylate cyclase (GC) stimulators, such as riociguat |
| Ritonavir | drug interactions | … and Administration ( 2.4 ) and Warnings and Precautions ( 5.2 ).] Ritonavir (600 mg b.i.d.) co-administered with vardenafil 5 mg resulted in a 49-fold increase in vardenafil AUC and a 13fold increase … |
| Sotalol | warnings and precautions | Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using … |
| Tamsulosin | drug interactions | Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. … |
| Terazosin | drug interactions | Clinical pharmacology studies have been conducted with co-administration of vardenafil with alfuzosin, terazosin or tamsulosin. … |
| Warfarin | drug interactions | Other interactions Vardenafil had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters). |
Other labels that name vardenafil
Source: FDA drug label (VARDENAFIL), Zydus Pharmaceuticals USA Inc., effective January 5, 2026 (SPL set 5876e062-e604-42a7-99c3-5da30b8dac06), via openFDA; the full label on DailyMed
What do FAERS reports show for vardenafil?
The FDA Adverse Event Reporting System holds 669 reports that list vardenafil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 53 are coded as a death and 243 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as vardenafil?
3 other medicines are given the same way (oral) and in the same FDA class as vardenafil or labeled mainly for the same use (erectile dysfunction), the same class first. Erectile dysfunction lists all 5 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tadalafil | Erectile dysfunction | 50 labelers | $0.167 per tablet 20 mg tablet | No current entry |
| Sildenafil | Erectile dysfunction | 59 labelers | $0.132 per tablet 100 mg tablet | No current entry |
| Avanafil | Erectile dysfunction | 1 labeler | $50.00 per tablet 200 mg tablet | No current entry |
Every medicine labeled for the same conditions as vardenafil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does vardenafil compare with medicines for the same use?
2 side-by-side pages set vardenafil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to vardenafil
- 3 medicines for the same use
- Other PDE5 inhibitors
- the pharmacologic class, with prices and generics
- Vardenafil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other