Important Safety Information for Sildenafil (Viagra)
What are the most important things I need to know about VIAGRA® (sildenafil citrate) 25 mg, 50 mg, and 100 mg tablets and generic VIAGRA®?
Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate emergency medical attention.
- VIAGRA® and generic VIAGRA® can cause serious side effects. Serious, but rare, side effects include:
- an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, seek emergency medical attention 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). Stop taking VIAGRA and call your healthcare provider right away if you have any sudden vision loss
- 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 VIAGRA and contact a doctor right away
- VIAGRA® does not protect against sexually transmitted diseases, including HIV.
Who should not take VIAGRA® or generic VIAGRA®?
Do not take VIAGRA® or generic VIAGRA® if you:
- Take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
- Are allergic to sildenafil, as contained in VIAGRA® and REVATIO®, or any of the ingredients in VIAGRA® or generic VIAGRA® tablets.
- Are a women or a child
When should I call my primary provider?
Call your primary provider right away if you:
- Have an erection that lasts longer than 4 hours
- Experience a sudden loss of vision in one or both eyes
- Experience a sudden decrease in or loss of hearing
- Experience chest pain, dizziness, or nausea during sex
- Take too much Viagra or sildenafil citrate
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
What are the most common side effects of VIAGRA® and generic VIAGRA®?
The most common side effects are:
- 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
What should I tell my Roman-affiliated provider before taking VIAGRA® and generic VIAGRA®?
Before you take VIAGRA® or generic VIAGRA® , tell your healthcare provider if you:
- 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.
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VIAGRA may affect the way other medicines work, and other medicines may affect the way VIAGRA works, causing side effects.
Especially tell your healthcare provider if you take any of the following:
- 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 VIAGRA® 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
- VIAGRA® contains 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). VIAGRA® should not be used with REVATIO® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca tadalafil)
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What is the FDA-approved use of VIAGRA® and generic VIAGRA®?
VIAGRA® (sildenafil citrate) is prescription medicine used to treat erectile dysfunction (ED).
Roman-affiliated doctors may prescribe VIAGRA® or generic VIAGRA® for the treatment of premature ejaculation (PE), if they believe in their medical judgment that it is an appropriate course of treatment. While this is not an FDA-approved use of the drug, the American Urological Association has included the use of sildenafil citrate in the treatment of PE in its Guideline on the Pharmacologic Management of Premature Ejaculation.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see the full Prescribing Information for complete safety information.
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