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Avanafil

Avanafil is a PDE5 inhibitor tablet used to treat erectile dysfunction in adult males, available as the brand Stendra.

Brand name Stendra
Drug class Phosphodiesterase 5 Inhibitors
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Avanafil at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Avanafil (Stendra) treats erectile dysfunction by blocking an enzyme called PDE5, which helps the body’s natural erection response along, so it only works with sexual stimulation. It is a newer, less often prescribed cousin of sildenafil (Viagra), on the market since about 2012 and available as a generic. Most men tolerate it well, and the side effects people notice tend to be headache, a warm or flushed face, and a stuffy nose. Never take it with nitrate medicines for chest pain (such as nitroglycerin) or with riociguat, since together they can drop blood pressure to a life-threatening level.

Clinical pearls

  • It can be taken as early as about 15 minutes before sex, with or without food, at most once a day.
  • If chest pain starts during sex, tell emergency staff you took avanafil, since nitrates must wait at least 12 hours.
  • Clarithromycin, ketoconazole, itraconazole and ritonavir must not be combined with it, and diltiazem, verapamil or erythromycin lower the dose limit.
  • Alpha-blockers for prostate or blood pressure, or more than 3 drinks, can deepen its blood pressure drop, so stand up slowly.
How you get itPrescription only
Comes asTablet
Earliest FDA record2012
Companies listing it with the FDA1
FDA label last updatedJul 18, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Avanafil, written from its FDA label.

What Avanafil is used for

▾

Avanafil is a PDE5 inhibitor approved for use in adult males. Here is the full list of supported uses from the available product evidence:

  • Stendra (avanafil) oral tablets — treatment of erectile dysfunction (ED) in adult males.
  • Avanafil oral tablets (generic) — treatment of erectile dysfunction (ED) in adult males.

How Avanafil works

▾

When a man is sexually stimulated, the body releases nitric oxide in the erectile tissue of the penis. This triggers the production of a molecule called cGMP, which relaxes the smooth muscle and lets blood flow in to create an erection. An enzyme called PDE5 breaks cGMP down, limiting this response. Avanafil selectively blocks PDE5, allowing cGMP to build up and the natural erection process to continue. Because it relies on the body's own nitric oxide release, avanafil only works in the presence of sexual stimulation — it has no effect without it.

Avanafil dosage

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Avanafil tablets are taken by mouth on an as-needed basis — only when you plan to have sexual activity. Stendra can be taken as early as about 15 minutes before activity; do not take it more than once in a 24-hour period. The tablet may be taken with or without food, though eating a high-fat meal may slow the time it takes to start working.

  • Take only the dose your prescriber recommends — the lowest effective dose is preferred.
  • If you also take an alpha-blocker or certain other medications, your doctor may start you at a lower dose or advise you not to use avanafil at all.
  • Sexual stimulation is still required for the medication to work.

Dosing details from the FDA-approved label

From the Avanafil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Erectile Dysfunction
    • Starting dose 100 mg taken orally as needed as early as approximately 15 minutes before sexual activity
    • Based on individual efficacy and tolerability, may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity
    • Use the lowest dose that provides ben
    • Maximum: Once per day
    • May be taken with or without food; sexual stimulation is required for a response
  • Patients on stable alpha-blocker therapy
    • Initiate at the 50 mg dose
    • Patients should be stable on alpha-blocker therapy before starting
  • Patients taking concomitant moderate CYP3A4 inhibitors
    • Maximum recommended dose is 50 mg
    • Maximum: 50 mg, not to exceed once every 24 hours
    • Moderate inhibitors include erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil
  • Patients taking concomitant strong CYP3A4 inhibitors
    • Do not use
    • Strong inhibitors include ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • The starting dose is 100 mg taken as early as approximately 15 minutes before sexual activity, on an as needed basis ( 2.1 ) • Take avanafil tablet no more than once a day ( 2.1 ). • Based on efficacy and/or tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity or decreased to 50 mg taken approximately 30 minutes before sexual activity. Use the lowest dose that provides benefit ( 2.1 ). • Avanafil tablet may be taken with or without food ( 2.2 ) • Do not use avanafil tablet with strong CYP3A4 inhibitors ( 2.3 ) • If taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period ( 2.3 ). • In patients on stable alpha-blocker therapy, the recommended starting dose of avanafil tablet is 50 mg ( 2.3 ). 2.1 Erectile Dysfunction The recommended starting dose is 100 mg. Avanafil tablets should be taken orally as needed as early as approximately 15 minutes before sexual activity. Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity. The lowest dose that provides benefit should be used. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment. 2.2 Use with Food Avanafil tablets may be taken with or without food. 2.3 Concomitant Medications Nitrates Concomitant use of nitrates in any form is contraindicated [see Contraindications ( 4.1 )]. Alpha-Blockers If avanafil tablet is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with avanafil tablet, and avanafil tablet should be initiated at the 50 mg dose [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )]. CYP3A4 Inhibitors • For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use avanafil tablet [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.2 )].

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Avanafil side effects

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The most commonly reported side effects of avanafil (affecting 2% or more of users in clinical trials) include:

Common side effects

  • Headache
  • Flushing (face feels warm or red)
  • Stuffy nose (nasal congestion)
  • Nasopharyngitis (common cold-like symptoms)
  • Back pain

When to get medical help

  • Get emergency help right away if you have an erection lasting longer than 4 hours — this can permanently damage the penis if untreated.
  • Stop taking avanafil and call a doctor immediately if you experience sudden vision loss in one or both eyes.
  • Stop taking avanafil and seek prompt medical attention if you notice a sudden decrease or complete loss of hearing, which may be accompanied by ringing in the ears or dizziness.
  • Call emergency services right away if you develop chest pain during or after sex — do not take nitrates (like nitroglycerin) if you have recently taken avanafil.
  • Seek medical help if you feel severely dizzy, lightheaded, or faint, especially when standing up.

More serious reactions are rare but require immediate action: stop avanafil and get emergency help if you experience an erection lasting more than 4 hours, sudden vision loss in one or both eyes, or a sudden decrease or loss of hearing (with or without ringing in the ears or dizziness).

Avanafil warnings and precautions

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  • Nitrates — absolute prohibition: Combining avanafil with any nitrate medication (prescribed or recreational) can cause a life-threatening drop in blood pressure. This combination is strictly contraindicated. If you need emergency nitrate treatment after taking avanafil, at least 12 hours must pass and it must be given under close medical supervision.
  • Guanylate cyclase stimulators: Drugs like riociguat or vericiguat must not be used with avanafil — the blood pressure drop can be severe.
  • Cardiovascular risk: Sexual activity itself increases the heart's workload. Avanafil is not recommended for men whose heart condition makes sexual activity unsafe, or for those with recent heart attack, stroke, unstable angina, or very poorly controlled blood pressure.
  • Prolonged erection (priapism): An erection lasting more than 4 hours is a medical emergency — seek help immediately to prevent permanent damage.
  • Sudden vision or hearing loss: Stop avanafil and get medical care right away if this occurs.
  • Blood pressure effects: Avanafil lowers blood pressure modestly. The effect is amplified by alpha-blockers, other antihypertensives, and heavy alcohol use — potentially causing dizziness or fainting.

Avanafil interactions

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Avanafil can interact with a number of medications, foods, and substances. Key ones to be aware of:

  • Nitrates (e.g., nitroglycerin, isosorbide): Absolutely contraindicated — dangerous drop in blood pressure.
  • Guanylate cyclase stimulators (riociguat, vericiguat): Contraindicated — risk of severe low blood pressure.
  • Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, itraconazole, atazanavir, indinavir, nefazodone, nelfinavir, saquinavir, telithromycin): Do not use avanafil with these — they dramatically raise avanafil levels in the blood.
  • Moderate CYP3A4 inhibitors (erythromycin, diltiazem, fluconazole, verapamil, amprenavir, aprepitant, fosamprenavir): Require a lower maximum avanafil dose; follow your prescriber's guidance.
  • Alpha-blockers (used for prostate or blood pressure): Can cause a significant additive drop in blood pressure; avanafil should be started at the lowest dose and only after you are stable on the alpha-blocker.
  • Blood pressure medications (antihypertensives): Modest additional blood pressure lowering when combined with avanafil.
  • Alcohol (more than 3 units): Increases risk of dizziness, racing heart, and low blood pressure — especially when standing up quickly.
  • Grapefruit juice: Likely to increase avanafil blood levels; use with caution.

Interactions listed in the FDA-approved label

From the Avanafil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Nitrates: Avanafil was shown to potentiate the hypotensive effect of nitrates. Use with any form of organic nitrate is contraindicated; if nitrate is medically necessary in a life-threatening situation, at least 12 hours should elapse after the last avanafil dose, under close medical supervision with hemodynamic monitoring.
  • Alpha-blockers: Both are vasodilators with blood pressure-lowering effects; additive effect may lower blood pressure significantly, leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting). Caution is advised; patients should be stable on alpha-blocker therapy before starting avanafil, and avanafil should be initiated at 50 mg.
  • Antihypertensives (amlodipine, enalapril): Additional reductions in blood pressure of 3 to 5 mmHg occurred with a single 200 mg dose of avanafil compared with placebo.
  • Alcohol: Substantial consumption (e.g., greater than 3 units) with avanafil can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole, clarithromycin): Ketoconazole 400 mg daily increased avanafil AUC 13-fold and Cmax 3-fold and prolonged half-life to approximately 9 hours; ritonavir 600 mg twice daily increased Cmax approximately 2-fold and AUC approximately 13-fold. Do not use avanafil in patients taking strong CYP3A4 inhibitors.
  • Moderate CYP3A4 inhibitors (e.g., erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil): Erythromycin 500 mg twice daily increased avanafil Cmax approximately 2-fold and AUC approximately 3-fold and prolonged half-life to approximately 8 hours. Maximum recommended dose of avanafil is 50 mg, not to exceed once every 24 hours.
  • Grapefruit juice and other CYP3A4 inhibitors: Likely to increase avanafil exposure, although specific interactions have not been studied.
  • Weak CYP3A4 inhibitors: No in vivo drug-drug interaction studies with weak CYP3A4 inhibitors were conducted.
  • Amlodipine (CYP3A4 substrate): Amlodipine 5 mg daily increased avanafil Cmax by approximately 22% and AUC by approximately 70% and prolonged half-life to approximately 10 hrs; amlodipine Cmax and AUC decreased by approximately 9% and 4%.
  • Cytochrome P450 inducers: The effect of CYP inducers on avanafil pharmacokinetics was not evaluated. Concomitant use of avanafil and CYP inducers is not recommended.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol ( 7.1 ) • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure ( 7.2 ) 7.1 Potential for Pharmacodynamic Interactions with Avanafil Nitrates Administration of avanafil to patients who are using any form of organic nitrate, is contraindicated. In a clinical pharmacology trial, avanafil was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken avanafil, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 12 hours should elapse after the last dose of avanafil before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications ( 4.1 ), Dosage and Administration ( 2.3 ), and Clinical Pharmacology ( 12.2 )]. Alpha-Blockers Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including avanafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (e.g., dizziness, lightheadedness, fainting) [see Warnings and Precautions ( 5.6 ), Dosage and Administration ( 2.3 ), and Clinical Pharmacology ( 12.2 )]. Antihypertensives PDE5 inhibitors, including avanafil, are mild systemic vasodilators. 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).

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Avanafil

▾
  • Do not take avanafil if you use nitrate medications in any form (regularly or occasionally).
  • Do not take avanafil if you use guanylate cyclase stimulators such as riociguat or vericiguat.
  • Do not take avanafil if you have a known allergy to any ingredient in the tablet.
  • Tell your doctor if you have had a heart attack, stroke, dangerous heart rhythm, or coronary artery procedure in the past 6 months.
  • Tell your doctor if you have unstable angina, heart failure, or very low or very high resting blood pressure.
  • Tell your doctor if you have ever had sudden vision loss or a history of NAION (optic nerve-related vision loss).
  • Tell your doctor if you have a hereditary retinal eye disease such as retinitis pigmentosa — avanafil is not recommended in these patients.
  • Tell your doctor if you have a penile deformity (such as Peyronie's disease) or a blood condition that may predispose you to prolonged erections (e.g., sickle cell anemia, leukemia, multiple myeloma).
  • Tell your doctor if you have severe kidney disease or are on dialysis — avanafil has not been studied in this group and should not be used.
  • Tell your doctor if you have severe liver disease — avanafil is not recommended in this setting.
  • Avanafil is not indicated for use in women or children under 18.
  • Older adults may be more sensitive to the medication's effects; your prescriber will take this into account.

Avanafil overdose

▾

In studies, single doses much higher than the recommended maximum were given to healthy volunteers without causing life-threatening effects, but higher doses are associated with more side effects. If an overdose is suspected, standard supportive medical care should be sought immediately.

Because avanafil binds tightly to proteins in the blood and is not significantly cleared by the kidneys, dialysis is not expected to be helpful in removing it from the body.

What Avanafil does in the body

▾

Avanafil measurably improves erection hardness and duration when sexual stimulation is present, with effects observed in studies beginning as early as 20–40 minutes after dosing. It also modestly lowers blood pressure — a single high dose reduced systolic blood pressure by about 8 mmHg compared to placebo in healthy volunteers. This blood pressure effect is amplified when avanafil is combined with nitrates, alpha-blockers, other antihypertensives, or large amounts of alcohol, which is why those combinations require caution or are forbidden entirely.

How your body processes Avanafil

▾

Avanafil is rapidly absorbed after swallowing a tablet, reaching peak blood levels in about 30–45 minutes when taken on an empty stomach. Eating a high-fat meal slows absorption by roughly an hour but has minimal impact on overall drug exposure, so it can be taken with or without food. The drug is broken down mainly by the liver using an enzyme called CYP3A4, and has a half-life (the time for half the drug to leave the body) of approximately 5 hours. It is excreted mostly through the feces and to a lesser extent in the urine.

How to store Avanafil

▾

Store at controlled room temperature 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from light .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

144

Supplements & herbs that interact with Avanafil

144 supplements and herbal products have documented interactions with Avanafil in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 98
  • Minor · 41
Every supplement checked against Avanafil — ranked by severity The full interaction hub: 5 major · 98 moderate · 41 minor · every one linked to its full report. Check Avanafil against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Avanafil: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Avanafil — the kind of thing our pharmacy team would talk through with you at the counter.

How quickly does avanafil work, and how long does it last?

▾
Stendra (avanafil) is one of the faster-acting options in its class — it can start working as early as 15 minutes after you take it. That said, you still need sexual stimulation for it to do anything. Most of the drug is out of your system within about 5 hours. Take it when you actually plan to be intimate rather than hours in advance.

Can I take avanafil with my heart medication or blood pressure pills?

▾
It depends on which ones. If you take any nitrate medication — like nitroglycerin tablets, patches, or sprays — you absolutely cannot take avanafil. The combination can drop your blood pressure to a dangerous level. If you take alpha-blockers or other blood pressure medications, avanafil can still lower your blood pressure further, so your doctor may start you at the lowest dose. Always give your prescriber a full list of everything you take before starting avanafil.

Can I drink alcohol while taking avanafil?

▾
A drink or two is generally not a major concern, but drinking heavily — more than about 3 units — is a real problem. Both alcohol and avanafil lower blood pressure, and together they can cause dizziness, a racing heart, and lightheadedness, especially when you stand up. It's best to keep alcohol moderate on any day you plan to take avanafil.

What side effects should I actually expect versus which ones mean I should call for help?

▾
The most common ones are pretty manageable — headache, a flushed or warm face, a stuffy nose, and sometimes back pain. These usually pass on their own. What you should not ignore: an erection that lasts longer than 4 hours (go to the ER immediately — it can cause permanent damage), sudden vision loss in either eye, or a sudden drop in your hearing. Stop the medication right away and get medical help if any of those happen.

Do I need to take avanafil every day, or just when I need it?

▾
Avanafil is taken only when you plan to have sexual activity — it's not a daily pill. You take one tablet no more than once per day, roughly 15 minutes or so before activity. There's no need to take it on days when you don't need it, and skipping a day has no negative effect.

Are there any medications that can interfere with how well avanafil works or make it less safe?

▾
Yes, a few important ones. Certain antifungals, antibiotics, and HIV medications — like ketoconazole, clarithromycin, or ritonavir — block the liver enzyme that breaks down avanafil, which means the drug builds up much higher in your blood than intended. If you take any of these 'strong inhibitors,' avanafil should not be used at all. Others, like erythromycin, diltiazem, or verapamil, have a milder effect and require a lower dose limit. Grapefruit juice can also raise avanafil levels, so be cautious with that too. Always check with your pharmacist or prescriber.

Is Avanafil available over the counter?

▾
No. Avanafil is a prescription medicine: every Avanafil product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Avanafil first available?

▾
The earliest FDA record we hold for Avanafil is from 2012: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Avanafil was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Avanafil on HelloPharmacist

Detailed data & references for Avanafil Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Avanafil forms and strengths (how it comes)

Avanafil is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Stendra
How this form is used
What it may be used for
  • Stendra tablets are indicated for the treatment of erectile dysfunction in adult males.
  • Avanafil tablets are indicated for the treatment of erectile dysfunction in adult males.
Important instructions
  • Stendra tablets are taken by mouth as needed, as early as approximately 15 minutes before sexual activity, no more than once per day.
  • Avanafil tablets are taken by mouth as needed, as early as approximately 15 minutes before sexual activity, no more than once per day.
  • Both Stendra and avanafil tablets may be taken with or without food.
  • If you also take an alpha-blocker, Stendra and avanafil tablets should be started at the lowest available dose — follow your prescriber's instructions.
Available strengths 3 strengths
6 FDA-listed product records ⓘ

Avanafil on the U.S. market: products, makers and brands

How Avanafil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 3 Avanafil product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2012. Brand names on the directory include Stendra; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
3
FDA-listed product records ⓘ
2012
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Compare Avanafil products

A representative set of FDA-listed product records for Avanafil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
50 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
100 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →
200 mg Oral Camber Pharmaceuticals, Inc. ANDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Avanafil NDCs →

Avanafil recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Avanafil recalls since July 2021.

✅No Avanafil recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Avanafil RxCUI 1291301 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1291305 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 1291369 100 MG RxCUI 1291306 200 MG RxCUI 1291365

Look up RxCUI 1291301 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Avanafil costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 200 mg $50.00 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Avanafil brand names

Avanafil is sold under one brand name in the FDA directory — Stendra. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Stendra

Who makes Avanafil: manufacturers and labelers

One company lists Avanafil products with the FDA. By number of product records, the largest are Camber Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Camber Pharmaceuticals, Inc. 3

Avanafil drug class (RxNorm)

Avanafil belongs to the Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor
Drug family (ATC) Drugs used in erectile dysfunction
How it works Phosphodiesterase 5 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Avanafil page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 18, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Avanafil.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Avanafil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Metuchen Pharmaceuticals, LLC
Linked label effective
Jul 18, 2024
Composite sections available
22
Linked SPL Set ID
fa7d93e3-b69b-4e02-8146-89760cd8e9d6
Linked SPL Document ID
f44369fe-9831-437f-aa49-d1e833973371
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Metuchen Pharmaceuticals, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →