Directory of Drugs: Viagra - sildenafil citrate

FREQUENTLY ASKED QUESTIONS CONCERNING VIAGRA

This list of frequently asked questions and answers on Viagra has been developed by CDER's Drug Information Branch in response to the numerous telephone calls we have received. If you have other questions concerning Viagra or any other human drug products, please feel free to call Drug Information Branch (301) 827-4573.

1. What is Viagra for?

Viagra is approved for the treatment of men who have difficulty having and maintaining an erection (impotence).

2. When will Viagra be available to pharmacies?

It is our understanding that Viagra will be available to pharmacies in approximately one month. FDA has no control over when products are available in pharmacies after FDA approval for marketing. The decision of availability is completely up to the company marketing the product. For further information contact your pharmacist or Pfizer, Inc. directly.

3. How much will Viagra cost?

The FDA has no input into or legal control over the pricing of any drug product. At the present time, FDA is unaware of the price that Viagra will have when it is available in US pharmacies.

4. Will insurance cover the cost of Viagra?

The FDA has no input into or legal control over whether an insurance company does or does not cover the cost of drugs. Please call you insurance company if you have questions about whether your particular insurance provider will cover the cost of this product for you.

5. How does Viagra work?

An erection is the result of an increase in blood flow into certain internal areas of the penis. Viagra works by enhancing the effects of one of the chemicals the body normally releases into the penis during sexual arousal. This allows an increase of blood flow into the penis.

6. How do I take Viagra?

Viagra is taken orally as a once daily dose, one hour before sexual activity. For more detailed information consult with your health care provider.

7. How will Viagra be supplied?

Viagra will be available as oral tablets in 25mg, 50mg and 100mg strengths.

8. Will Viagra be prescription or OTC?

Viagra will be available by prescription only.

9. Are there any side effects with Viagra?

As with any drug products, there are side effects of the product in some people. The most commonly reported side effects in patients treated with Viagra during the testing of the product were: headache, flushing, stomach ache, and mild and temporary visual changes (color perception changes, light perception changes, and blurred vision).

10. Can Viagra be used with other treatment for impotence?

The safety and effectiveness of Viagra when used with other treatment for impotence has not been studied. The use of such treatments in combination with Viagra is not recommended at present.

11. What if I am taking other drugs?

Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter). In that way, you can receive the best advice for your own situation. At present, Viagra is not recommended for people taking nitroglycerin because the combination may lower blood pressure.

What is Viagra?

Viagra is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Viagra may help a man with ED get and keep an erection when he is sexually excited. Viagra must be used only under a doctor's care.

Viagra does not:

cure ED
increase a man's sexual desire
protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare professional about ways to guard against sexually transmitted diseases.
serve as a male form of birth control

Viagra is only for men with ED. Viagra is not for women or children. Viagra must be used only under a healthcare professional's care.

Who Should Not Take Viagra?

Do not take Viagra if you:

take any medicines called "nitrates"
use recreational drugs called "poppers" like amyl nitrate and butyl nitrate
have been told by your healthcare professional to not have sexual activity because of health problems

What are The Risks?

The following are the major possible risks and side effects of Viagra therapy. This list is not complete.

Viagra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines such as nitrates and alpha-blockers, and recreational drugs that contain nitrates called "poppers". A sudden drop in your blood pressure could cause you to become dizzy, faint, or have a heart attack or stroke.

Tell all your healthcare professionals that you take Viagra. If you need emergency medical care for a heart problem, it will be important for your healthcare professionals to know when you last took Viagra.

Viagra may uncommonly cause:

an erection that won't go away (priapism)
vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

Some common side effects with Viagra include:

headache
flushing
upset stomach
stuffy or runny nose
urinary tract infection
diarrhea

What Should I Tell My Healthcare Professional?

Tell your healthcare professional if you:

have or had heart problems
have low blood pressure or have high blood pressure that is not controlled
have had a stroke
have liver problems
have ever had severe vision loss
have kidney problems or require dialysis
have retinitis pigmentosa, a rare genetic (runs in families) eye disease
have stomach ulcers
have a bleeding problem
have a deformed penis shape or Peyronie's disease
have had an erection that lasted more than 4 hours
have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
are taking a medicine called a protease inhibitor for the treatment of HIV
are taking medicines called alpha blockers (alpha blockers are sometimes prescribed for prostate problems or high blood pressure)

Can Other Medicines or Food Affect Viagra?

Viagra and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them with you to show your healthcare professional. Continue reading ...

Viagra FDA Approved 1998
Patient Information Sheet Revised 07/2005