STENDRA™ (avanafil) is a prescription medicine used to treat erectile dysfunction (ED).
STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information you should know about STENDRA?
STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take STENDRA if you take any medicines called “nitrates.” A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.
Tell all 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.
Do not take STENDRA if you:
- take nitrates, often prescribed for chest pain (angina), as this may cause a sudden, unsafe drop in blood pressure
- use street drugs called “poppers” such as amyl nitrate and butyl nitrate
- are allergic to avanafil or any of the ingredients in STENDRA
Before you take STENDRA, tell your healthcare provider 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 nonarteritic anterior ischemic optic neuropathy (NAION)
- have bleeding problems
- have or have had stomach ulcers
- have liver problems
- have kidney problems or are having kidney dialysis
- have any other medical condition
STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following:
- medicines called nitrates
- medicines called HIV protease inhibitors such as ritonavir (Norvir), indinavir (Crixivan), saquinavir (Fortavase or Invirase) or atazanavir (Reyataz) or some types of oral antifungal medicines, such as ketoconazole (Nizoral) and itraconazole (Sporanox)
- some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin
- medicines called alpha-blockers. These include Hytrin (terazosin), Flomax (tamsulosin HCl), Cardura (doxazosin), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA 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
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
The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.
STENDRA may uncommonly cause:
- an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away
- sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called nonarteritic anterior ischemic optic neuropathy (NAION). Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes
- sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness
STENDRA does not protect against sexually transmitted diseases, including HIV.
Please see full Prescribing Information and Patient Information for STENDRA tablets.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.