levitra Use Instructions

U. S. Food and Drug Administration


Questions and Answers for levitra (vardenafil)

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

levitra 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. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3. How is levitra different from the currently approved products for erectile dysfunction (ED)?

levitra is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of levitra to other products.

levitra is taken orally before sexual activity, not more than once daily. levitra may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5. Are there any side effects with levitra?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with levitra during the testing of the product were:

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking levitra and these usually go away by themselves within 48 hours. A small number of patients taking levitra also reported abnormal vision.

6. What important information should you know about levitra?

7. What should I talk to my doctor about when considering if levitra is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if levitra is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with levitra, levitra is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8. Who should not take levitra?

levitra should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) because the combination of these with levitra could significantly lower blood pressure and lead to fainting or even death in some men.

9. Can levitra be used with other treatments for impotence?

The safety and effectiveness of levitra when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with levitra is not recommended.

10. 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) that way, you can receive the best advice for your own situation. levitra is not recommended for people taking any form of nitroglycerin because the combination may lower blood pressure to an unsafe level.

11. How will levitra be supplied?

12. Will levitra be prescription or OTC (over-the-counter)?

13. When will levitra be available to pharmacies?

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 Eli Lilly and Company directly.

14. How can I report a serious side effect with levitra to FDA?

FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.

You can report an adverse event either online, by regular mail or by fax, using the contact information at the bottom of this page.

Related Information


12. Will levitra be prescription or OTC (over-the-counter)?


Questions and Answers for levitra (vardenafil)

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

levitra 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. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3. How is levitra different from the currently approved products for erectile dysfunction (ED)?

levitra is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of levitra to other products.

levitra is taken orally before sexual activity, not more than once daily. levitra may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5. Are there any side effects with levitra?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with levitra during the testing of the product were:

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking levitra and these usually go away by themselves within 48 hours. A small number of patients taking levitra also reported abnormal vision.

6. What important information should you know about levitra?

7. What should I talk to my doctor about when considering if levitra is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if levitra is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with levitra, levitra is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8. Who should not take levitra?

levitra should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) because the combination of these with levitra could significantly lower blood pressure and lead to fainting or even death in some men.

9. Can levitra be used with other treatments for impotence?

The safety and effectiveness of levitra when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with levitra is not recommended.

10. 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) that way, you can receive the best advice for your own situation. levitra is not recommended for people taking any form of nitroglycerin because the combination may lower blood pressure to an unsafe level.

11. How will levitra be supplied?

12. Will levitra be prescription or OTC (over-the-counter)?

13. When will levitra be available to pharmacies?

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 Eli Lilly and Company directly.

14. How can I report a serious side effect with levitra to FDA?

FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.

You can report an adverse event either online, by regular mail or by fax, using the contact information at the bottom of this page.


FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.


Related Information


levitra is not recommended for people taking any form of nitroglycerin because the combination may lower blood pressure to an unsafe level.




24.02.2023 01:47:25

2023-02-24 01:47:25


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