Important Safety Information for Sildenafil (Sildenafil)
Contraindications
- take medicines called nitrates (such as nitroglycerin)
- use street drugs called “poppers” such as amyl nitrate or amyl nitrite, and butyl nitrate
- take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)
- are allergic to sildenafil, as contained in Sildenafil and Revatio, or any of the ingredients in Sildenafil. See the end of this leaflet for a complete list of ingredients in Sildenafil.
What should I tell my healthcare provider before taking Sildenafil or generic Sildenafil?
To make sure Sildenafil is safe for you, tell your healthcare provider if you have any of the following before you take Sildenafil or generic Sildenafil:
- Have or have had heart problems such as a heart attack,irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
- Have had heart surgery within the last 6 months
- Have pulmonary hypertension
- 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 NAION
- Have bleeding problems
- Have or have had stomach or intestinal ulcers
- Have liver problems
- Have kidney problems or are having kidney dialysis
- Have any other medical conditions
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Sildenafil and generic Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil and generic Sildenafil works, causing side effects.
Drug Interactions
Tell your healthcare provider if you take any of the following because these drugs interact with Sildenafil and generic Sildenafil:
- Medicines called nitrates
- Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)
- Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), 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 Sildenafil or generic Sildenafil with alpha-blockers can lead to a drop in blood pressure or to fainting
- Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
- Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)
- Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
- Other medicines that treat high blood pressure
- Other medicines or treatments for ED
- Sildenafil and generic Sildenafil contain sildenafil, which is the same medicine found in another drug called Revatio®. Revatio® is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil and generic Sildenafil should not be used with Revatio® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])
- 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.
Sildenafil Side Effects
What are the possible side effects of Sildenafil and generic Sildenafil?
Sildenafil and generic Sildenafil can cause serious side effects. Rarely reported side effects include:
- 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 one or both eyes. Sudden vision loss in one 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 directly cause the vision loss. Stop taking Sildenafil 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. If you have these symptoms, stop taking Sildenafil or generic Sildenafil and contact a doctor right away.
The most common side effects of Sildenafil and generic Sildenafil are:
- headache
- flushing
- upset stomach
- abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
- stuffy or runny nose
- back pain
- muscle pain
- nausea
- dizziness
- Rash In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Sildenafil. Most, but not all, of these men had heart problems before taking Sildenafil. It is not known if Sildenafil caused these problems.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Sildenafil and generic Sildenafil. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Can Sildenafil have permanent effects?
Sildenafil does not have permanent effects on the body once it is broken down. It is only effective for as long as it is in the body. Sildenafil does not have permanent effects on the body once it is broken down. It is only effective for as long as it is in the body.
As you age, it is normal to see erectile function decrease. As a result, you may need more medication to see the same results. In some cases, erectile function may also worsen due to progression of the underlying disease that is causing ED (e.g., diabetes, vascular disease).
Sildenafil does not diminish in efficacy over time (i.e., you don’t need more because your body gets “used to it”).