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Avanafil (Stendra): Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Avanafil

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.

What are avanafil tablets?

Avanafil tablet is a prescription medicine used to treat erectile dysfunction (ED) in adult men.

Avanafil tablet is not for use in women or children.

It is not known if avanafil tablet is safe and effective in women or children under 18 years of age.

Do not take avanafil tablet if you:

  • take medicines called nitrates.
  • use street drugs called “poppers” such as amyl nitrite and butyl nitrite.
  • are allergic to avanafil or any of the ingredients in avanafil tablet. See the end of this leaflet for a complete list of ingredients in avanafil tablet.
  • take any medicines called guanylate cyclase stimulators.

Before you take avanafil tablet, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure.
  • have had heart surgery within the last 6 months.
  • have had a stroke.
  • have low blood pressure, or high blood pressure that is not controlled.
  • have a deformed penis shape.
  • have had an erection that lasted for more than 4 hours.
  • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia.
  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease.
  • have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).
  • have had a sudden decrease or loss of hearing.
  • have bleeding problems.
  • have or have had stomach ulcers.
  • have liver problems.
  • have kidney problems or are having kidney dialysis.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Avanafil tablet may affect the way other medicines work, and other medicines may affect the way avanafil tablet works causing side effects. Especially tell your healthcare provider if you take any of the following:

  • medicines called nitrates (see What is the most important information I should know about avanafil tablets?)
  • medicines called guanylate cyclase stimulators, such a riociguat or vericiguat (see What is the most important information I should know about avanafil tablets?)
  • medicines called HIV protease inhibitors.
  • some types of oral antifungal medicines, such as ketoconazole, and itraconozale.
  • some types of antibiotics, such as clarithromycin, telithromycin, or erythromycin.
  • medicines called alpha blockers. These include terazosin, tamsulosin HCl, doxazosin, prazosin HCl, alfuzosin HCl, dutasteride and tamsulosin HCl, or silodosin. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of avanafil tablet with alpha-blockers can lead to a drop in blood pressure or to fainting.
  • other medicines that treat high blood pressure.
  • other medicines or treatments for ED.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take avanafil tablets?

  • Take avanafil tablets exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much avanafil tablets to take and when to take it.
  • Take avanafil tablets 100 mg or 200 mg as early as 15 minutes before sexual activity or
  • Take avanafil tablets 50 mg as early as 30 minutes before sexual activity.
  • Do not take avanafil tablets more than 1 time a day.
  • Some form of sexual stimulation is needed for an erection to happen after taking avanafil tablets.
  • Your healthcare provider may change your dose if needed.
  • You should take the lowest dose of avanafil tablets that works for you. You and your healthcare provider should decide about the lowest dose of avanafil tablets that works for you.

  • Avanafil tablets may be taken with or without food.

  • If you take too much avanafil, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking avanafil tablets?

  • Do notdrink 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.

What are the possible side effects of avanafil tablets?

Avanafil tablets can cause serious side effects, including:

  • See “What is the most important information I should know about avanafil tablets?”
  • an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.
  • sudden vision loss in 1 or both eyes.Sudden vision loss in 1 or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors such as avanafil tablets, directly cause vision loss. Stop taking avanafil tablets and call your healthcare provider right away if you have sudden vision loss in 1 or both eyes.
  • sudden hearing decrease or hearing loss.Some people may also have ringing in their ears (tinnitus) or dizziness.

The most common side effects of avanafil tablets are:

  • headache
  • flushing
  • stuffy or runny nose
  • sore throat
  • back pain

These are not all of the possible side effects of avanafil tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

General information about the safe and effective use of avanafil tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use avanafil tablets for a condition for which it was not prescribed. Do not give avanafil tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about avanafil tablets that is written for health professionals.

What are the ingredients in avanafil tablets?

Active ingredient:avanafil

Inactive ingredients:fumaric acid, hydroxyl propyl cellulose, low-substituted hydroxyl propyl cellulose, magnesium stearate, mannitol and sodium bicarbonate.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited.

For more information, call 1-866-495-1995.

Manufactured for:

Camber Pharmaceuticals, Inc.,

Piscataway, NJ 08854

by: HETERO TM

Hetero Labs Limited

Jeedimetla, Hyderabad - 500 055, India.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 11/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 209266 · View the label on DailyMed

Revision date stated in the text: November 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Avanafil

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Phosphodiesterase 5 Inhibitor
Active ingredient Avanafil
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) HETERO LABS LTD V
FDA approval ANDA 209266Abbreviated New Drug Application (ANDA) – generic drug Approved June 14, 2024
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Stendra with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg – 30 in 1 bottle NDC 31722-440-30
50 mg – 100 in 1 bottle NDC 31722-440-01
100 mg – 30 in 1 bottle NDC 31722-441-30
100 mg – 100 in 1 bottle NDC 31722-441-01
200 mg – 30 in 1 bottle NDC 31722-442-30
200 mg – 100 in 1 bottle NDC 31722-442-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.