Frequently Asked Questions and Answers for Viagra

This list of frequently asked questions and answers on Viagra has been developed by the Food and Drug Administration, CDER's Drug Information Branch and Arnot Ogden Medical Center, in response to the numerous telephone calls we have received.

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 is available to most pharmacies. 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 does 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. Does 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 long does it take for Viagra to be effective?

Viagra is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing on an empty stomach. The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.

When VIAGRA is taken with a high fat meal, the rate of effectiveness is reduced.

8. How is Viagra supplied?

Viagra is available as oral tablets in 25mg, 50mg and 100mg strengths. Viagra, a film-coated tablet, should be stored in a cool, dry place. We have received reports of people leaving Viagra in their vehicles, only to return to find the tablets melted together.

9. Is Viagra available over the counter?

Viagra is available by prescription only.

10. 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, urinary tract infection, diarrhea, dizziness, rash, and mild and temporary visual changes (color perception changes, light perception changes, and blurred vision). Stomach ache and abnormal vision were more common at 100 mg than at lower doses.

11. Is it true that 69 Americans taking the impotence pill Viagra, died between late March and July?

From the marketing of sildenafil citrate (Viagra) in late March through July 1998, during which more than 3.6 million outpatient prescriptions were dispensed, the FDA received reports of 123 patients who died after having been prescribed this drug. Twelve deaths concerned foreign patients and 30 concerned patients with unverifiable information (from hearsay, rumor, the media, or unidentifiable reporters). In addition, reporters stated that they did not know if the drug had been used for 12, leaving 69 U.S. patients who died after having taken Viagra. Of these, cause of death was unmentioned or unknown for 21, two patients had strokes, and 46 had cardiovascular events (21 with definite or suspected myocardial infarction, 17 with cardiac arrest, 4 with cardiac symptoms, 3 with coronary artery disease, and one with severe hypotension leading to cardiac arrest).

12. 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.

13. 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 commonly prescribed short- and long-acting nitrates because the combination may lower blood pressure.

A list of commonly prescribed short- and long-acting nitrates available in the United States:

Nitroglycerin

Deponit
Minitran
Nitrek
Nitro-Bid
Nitrocine
Nitro-Derm
Nitro Disc
Nitro-Dur
Nitrogard
Nitroglycerin
Nitroglycerin T/R
Nitroglyn
Nitrol Ointment
Nitrolan
Nitrolingual Spray
Nitrong
Nitropar
Nitropress
Nitroprex
Nitro S.A.
Nitrospan
Nitrostat
Nitro-Trans System
Nitro Transdermal
Nitro-Time
Transderm-Nitro
Tridil

Isosorbide Mononitrate

Imdur
ISMO
Isosorbide Mononitrate
Monoket

Isosorbide Nitrate

Dilatrate-SR
Iso-bid
Isordil
Isordil Tembids
Isosorbide Dinitrate
Isosorbide Dinitrate LA
Sorbitrate
Sorbitrate SA

Pentaerythritol Tetranitrate

Peritrate
Peritrate SA

Erythrityl Tetranitrate

Cardilate

Isosorbide Dinitrate/Phenobarbital

Isordil w/PB

Illicit Substances Containing Organic Nitrates

e.g., amyl nitrate or nitrite (It is known that amyl nitrate or nitrite is sometimes abused. In abused situations, amyl nitrate or nitrite may be known by various names, including "poppers.")