These highlights do not include all the information needed to use STENDRA safely and effectively. See full prescribing information for STENDRA. STENDRA® (avanafil) tablets, for oral use.
Initial U.S. Approval: 2012
Warnings and Precautions, Effects on the Eye (5.4) 08/2017
Dosage and Administration (2.1) 09/2014
Contraindications, Concomitant Guanylate Cyclase (GC)
Stimulators (4.3) 09/2015
STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (1)
Tablets: 50 mg, 100 mg, 200 mg (3)
Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact 866.928.6180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION and FDA approved patient labeling Revised: 12/2016
Do not take STENDRA if you take any medicines called “nitrates” or “guanylate cyclase stimulators”, as these combinations can cause your blood pressure to drop suddenly to unsafe levels. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
Tell all of your healthcare providers that you take STENDRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took STENDRA.
Stop sexual activity and get medical help right away if you experience 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.
Who should not take STENDRA?
Do not take STENDRA if you:
Before you take STENDRA, tell your healthcare provider if you:
STENDRA may affect the way other medicines work.
Tell your healthcare provider about all medicines you take, including any of the following:
Do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine, or 3 shots of whiskey). Drinking too much alcohol when taking STENDRA can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.
What are the possible side effects of STENDRA?
The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
Rare but serious side effects of STENDRA may include:
STENDRA does not protect against pregnancy or sexually transmitted diseases, including HIV.
How should I take STENDRA?
USE ONLY AS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL
These are not all the possible side effects of STENDRA. Talk to your healthcare provider or pharmacist for more information or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch.
Reference: 1. Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med. 2007;120(2): 151-157.