Prescription medicine
Avanafil First approved as Stendra
Avanafil (Stendra) is a prescription medicine with an FDA approval on record since 2012. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $50.00 per avanafil 200 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the avanafil FDA label on DailyMed (effective December 17, 2025, Camber Pharmaceuticals, Inc.); the NDA 202276 record on Drugs@FDA; every avanafil label on DailyMed.
Highlights of the record
FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAvanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males.
Forms and strengths
- 50 mg
- 100 mg
- 200 mg
Tablet.
On the market
- Earliest approval on file
- April 27, 2012 Stendra, Vivus Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 14, 2024; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $50.00 per tablet Avanafil 200 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 69 through July 30, 2026
What is avanafil used for?
From the label: indications and usageAvanafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males. Avanafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction
Conditions named in the indications of avanafil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Phosphodiesterase 5 Inhibitor.
Source: FDA drug label (Avanafil), ANDA209266 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective December 17, 2025 (SPL set 1d04e17d-7399-430a-a8bb-fa1912b155e9), via openFDA; the full label on DailyMed
What does the patient leaflet for avanafil 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 avanafil tablets?Avanafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take avanafil tablets if you take any 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 avanafil tablets if you take medicines called guanylate cyclase stimulators which include: • Riociguat and vericiguat, medicine that treat pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. Ask your healthcare provider or pharmacist if any of your medicines are nitrates or guanylate cyclase stimulators. Tell all your healthcare providers that you take avanafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took avanafil tablets. 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.
From the patient leaflet: What should I avoid while taking avanafil tablets?Do not drink too much alcohol when taking avanafil tablets (for example, 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking avanafil tablets can increase your chances of increasing your heart rate, lowering your blood pressure, dizziness or getting a headache.
From the patient leaflet: How should I store avanafil tablets?Store avanafil tablets at controlled room temperature 77°F (25°C). • Keep avanafil tablets out of the light. Keep avanafil tablets and all medicines out of the reach of children.
Source: FDA drug label (Avanafil), ANDA209266 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective December 17, 2025 (SPL set 1d04e17d-7399-430a-a8bb-fa1912b155e9), via openFDA; the full label on DailyMed
Is there a generic for avanafil (Stendra)?
The FDA approved the first generic avanafil on June 14, 2024. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists avanafil from 1 labeler 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.
- 2012 earliest approval on file
- 2024 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for avanafil (Stendra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $50.00 per Avanafil 200 mg tablet. 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.
- Avanafil 200 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Avanafil 200 mg tablet | Generic | $50.00 per tablet | $1,499.92 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the avanafil label say about other medicines?
The avanafil label names 19 other medicines in its interaction, contraindication or warning sections. The labels of 12 other medicines name avanafil. 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 | A clinical pharmacology trial was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medications (amlodipine and enalapril). |
| Aprepitant | drug interactions | Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. |
| Atazanavir | warnings and precautions | For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil [see Drug Interactions ( 7.2 )]. |
| Clarithromycin | drug interactions | Other potent inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir and telithromycin) would be expected to have similar effects. |
| Diltiazem | drug interactions | Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. |
| Enalapril | drug interactions | A clinical pharmacology trial was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medications (amlodipine and enalapril). |
| Erythromycin | drug interactions | CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure |
| Fluconazole | drug interactions | Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. |
| Fosamprenavir | drug interactions | Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. |
| Itraconazole | drug interactions | Other potent inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir and telithromycin) would be expected to have similar effects. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure |
| Nefazodone | warnings and precautions | For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil [see Drug Interactions ( 7.2 )]. |
| Nelfinavir | drug interactions | Other potent inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir and telithromycin) would be expected to have similar effects. |
| Nitric oxide | contraindications | Consistent with its known effects on the nitric oxide/cyclic guanosine monophosphate (cGMP) pathway, avanafil has been shown to potentiate the hypotensive effects of nitrates. |
Every other medicine the avanafil label names
| Medicine named | Section | What the label says |
|---|---|---|
| Riociguat | contraindications | Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat |
| Ritonavir | drug interactions | CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure |
| Sodium nitroprusside | warnings and precautions | In vitro studies with human platelets indicate that avanafil potentiates the anti-aggregatory effect of sodium nitroprusside (a nitric oxide [NO] donor). |
| Verapamil | drug interactions | Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects. |
| Vericiguat | contraindications | Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat |
Other labels that name avanafil
Source: FDA drug label (Avanafil), ANDA209266 (Hetero Labs Ltd V), as published by Camber Pharmaceuticals, Inc., effective December 17, 2025 (SPL set 1d04e17d-7399-430a-a8bb-fa1912b155e9), via openFDA; the full label on DailyMed
What do FAERS reports show for avanafil?
The FDA Adverse Event Reporting System holds 69 reports that list avanafil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 8 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.
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 avanafil?
3 other medicines are given the same way (oral) and in the same FDA class as avanafil 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 |
| Vardenafil | Erectile dysfunction | 11 labelers | $2.79 per tablet 20 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to avanafil
- 3 medicines for the same use
- Other PDE5 inhibitors
- the pharmacologic class, with prices and generics
- Avanafil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other