Prescription medicine
Sildenafil Brand names: Viagra, Vybrique, Revatio
Sildenafil (Viagra) is a prescription medicine with an FDA approval on record since 1998. FDA's NDC Directory lists it from 60 generic labelers, and pharmacies paid $0.132 per sildenafil 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sildenafil FDA label on DailyMed (effective November 17, 2023, Viatris Specialty LLC); the NDA 20895 record on Drugs@FDA; every sildenafil label on DailyMed.
Highlights of the record
FDA label of November 17, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageVIAGRA is indicated for the treatment of erectile dysfunction.
Forms and strengths
- 20 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 0.8 mg/ml
- 10 mg/ml
- 10 mg/12.5ml
Film-coated tablet; tablet; powder for suspension; film; for suspension.
On the market
- Earliest approval on file
- March 27, 1998 Viagra, Viatris; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 49 first November 6, 2012; 38 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 65 of which 60 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- December 24, 2038 Liqrev oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.132 per tablet Sildenafil 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest December 7, 2020; 6 more by firms not listed as its makers
- FAERS reports
- 126,558 through July 30, 2026
What is sildenafil used for?
From the label: indications and usageVIAGRA is indicated for the treatment of erectile dysfunction. VIAGRA is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
Conditions named in the indications of sildenafil's FDA labels, with every medicine labeled for each:
From other sildenafil labelsPulmonary arterial hypertension: Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14) ].
FDA pharmacologic class: Phosphodiesterase 5 Inhibitor.
Source: FDA drug label (Viagra), Viatris Specialty LLC, effective November 17, 2023 (SPL set d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e), via openFDA; the full label on DailyMed
What does the patient leaflet for sildenafil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VIAGRA?VIAGRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VIAGRA if you take any other medicines called “nitrates”. Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take VIAGRA if you take medicines called guanylate cyclase stimulators which include: • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. Tell all your healthcare providers that you take VIAGRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took VIAGRA. Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex. VIAGRA does not protect you or your partner from getting sexually transmitted diseases, including HIV–the virus that causes AIDS.
From the patient leaflet: How should I store VIAGRA?Store VIAGRA at room temperature between 68°F to 77°F (20°C to 25°C). Keep VIAGRA and all medicines out of the reach of children.
Source: FDA drug label (Viagra), Viatris Specialty LLC, effective November 17, 2023 (SPL set d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e), via openFDA; the full label on DailyMed
Is there a generic for sildenafil (Viagra)?
The FDA approved the first generic sildenafil on November 6, 2012. 49 generic applications are approved; 38 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 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists sildenafil from 60 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Viagra tablets; a patent listed only for Liqrev oral suspension runs to December 24, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1998 earliest approval on file
- 2012 first generic approved
- 2038 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 sildenafil (Viagra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.132 per Sildenafil 100 mg tablet, down 11% from $0.148 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Sildenafil 100 mg tablet (generic)
- Viagra 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sildenafil 10 mg/mL oral suspension | Generic | $0.260 per mL | n/a | -58% |
| Sildenafil 100 mg tablet | Generic | $0.132 per tablet | $3.96 | -11% |
| Sildenafil 20 mg tablet | Generic | $0.051 per tablet | $1.53 | -30% |
| Sildenafil 25 mg tablet | Generic | $0.122 per tablet | $3.66 | +14% |
| Sildenafil 50 mg tablet | Generic | $0.107 per tablet | $3.20 | -4% |
| Viagra 100 mg tablet | Brand | $83.72 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $2,511.49 | +0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sildenafil been recalled?
The FDA's Enforcement Report lists 8 recalls naming sildenafil since 2013: 0 Class I (the most serious), 8 Class II, 0 Class III; 2 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of sildenafil 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 |
|---|---|---|---|
| August 3, 2026 | Class II | Shoolin Pharma Chem LLP not a listed maker | CGMP Deviations:Noted during FDA inspection |
| December 7, 2020 | Class II | AVKARE Inc. | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. |
| July 2, 2020 | Class II | MasterPharm LLC not a listed maker | Lack of Processing Controls (lack of assurance of conformity to specifications). |
| December 18, 2019 | Class II | MPRX, Inc. dba Medical Park Pharmacy not a listed maker | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components. |
| February 12, 2015 | Class II | Health Innovations Pharmacy, Inc not a listed maker | Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sildenafil label say about other medicines?
The sildenafil label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 38 other medicines name sildenafil. 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 |
|---|---|---|
| Amlodipine | drug interactions | Amlodipine When VIAGRA 100 mg was co-administered with amlodipine (5 mg or 10 mg) to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic [ see Warnings and Precautions (5.5), Clinical Pharmacology (12.2) ]. |
| Aspirin | warnings and precautions | In humans, VIAGRA has no effect on bleeding time when taken alone or with aspirin. |
| Bosentan | drug interactions | Moderate-to-Strong CYP3A Inducers Concomitant use of REVATIO with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. |
| Erythromycin | drug interactions | CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure ( 2.4 , 7.4 , 12.3 ) ▪ Ritonavir: |
| Heparin | warnings and precautions | In addition, the combination of heparin and VIAGRA had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans. |
| Itraconazole | drug interactions | CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure ( 2.4 , 7.4 , 12.3 ) ▪ Ritonavir: |
| Ketoconazole | drug interactions | CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure ( 2.4 , 7.4 , 12.3 ) ▪ Ritonavir: |
| Nitric oxide | contraindications | Consistent with its known effects on the nitric oxide/cGMP pathway [ see Clinical Pharmacology (12.1 , 12.2) ], VIAGRA was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either … |
| Riociguat | contraindications | Administration with guanylate cyclase (GC) stimulators, such as riociguat |
| Ritonavir | drug interactions | CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase VIAGRA exposure ( 2.4 , 7.4 , 12.3 ) ▪ Ritonavir: |
| Sodium nitroprusside | warnings and precautions | However, in vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). |
Other labels that name sildenafil
Source: FDA drug label (Viagra), Viatris Specialty LLC, effective November 17, 2023 (SPL set d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e), via openFDA; the full label on DailyMed
What do FAERS reports show for sildenafil?
The FDA Adverse Event Reporting System holds 126,558 reports that list sildenafil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,360 are coded as a death and 43,871 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 sildenafil?
4 other medicines are given the same way (oral) and in the same FDA class as sildenafil 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 | Pulmonary arterial hypertension, Erectile dysfunction | 50 labelers | $0.167 per tablet 20 mg tablet | No current entry |
| Vardenafil | Erectile dysfunction | 11 labelers | $2.79 per tablet 20 mg tablet | No current entry |
| Avanafil | Erectile dysfunction | 1 labeler | $50.00 per tablet 200 mg tablet | No current entry |
| Macitentan and tadalafil | Pulmonary arterial hypertension | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as sildenafil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sildenafil compare with medicines for the same use?
2 side-by-side pages set sildenafil beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sildenafil
- 4 medicines for the same use
- Other PDE5 inhibitors
- the pharmacologic class, with prices and generics
- Sildenafil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other