Precautions for Men with Health Conditions

The most common side effects of vardenafil are listed below. These side effects may vary depending on the form of vardenafil prescribed. Tell your healthcare provider if you have any of these side effects that bother you.

Further information

355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do buy levitra no prescription not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

What is vardenafil, and what is it used for?

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, are ( printed page 27902) the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially approved on August 19, 2003. Levitra is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction.

Who should not take vardenafil?

In letters dated September 26, 2019, September 24, 2020, and September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, respectively, were being discontinued, and FDA moved the drug products to the “Discontinued Drug Product List” section of the Orange Book. Respira Therapeutics, Inc. submitted a citizen petition dated August 29, 2022 (Docket No. FDA-2022-P-2060), under 21 CFR 10.30, requesting that the Agency determine whether Levitra (vardenafil hydrochloride) oral tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. Stuffy or runny nose, or inflamed sinuses There may be other side effects of vardenafil that are not listed here.

Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at vardenafil levitra or by calling 800-FDA-1088.

What is Levitra?

This increases blood flow to the penis when aroused, making it easier to get and keep an erection. 2.5 mg, 5 mg, 10 mg, 20 mg oral tablets Vardenafil should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Do not remove an orally disintegrating tablet from the blister pack until ready to take it. Do not take if the blister pack is damaged or missing. In Canada, you can report side effects to Health Canada at or by calling 866-234-2345. While less common, the most serious side effects of vardenafil are described below, along with what to do if they happen. Vardenafil may cause allergic reactions, which can be serious. Stop taking vardenafil and get help right away if you have any of the following symptoms of a serious allergic reaction. Swelling of the face, lips, mouth, tongue, or throat Itching, skin rash, or pale red bumps on the skin called hives Vardenafil may cause an unwanted erection that is persistent, painful, and that may occur without sexual arousal. Permanent damage to the penis may occur if priapism is not treated quickly.

Stop taking vardenafil and get emergency help if you have any of the following symptoms of priapism.

Erection lasting for more than four hours Erection that is unrelated to sexual stimulation Vardenafil can cause mild, temporary vision changes such as seeing a blue tint, abnormal colors, blurry vision, or sensitivity to light.

• Levitra 5mg is a PDE5 inhibitor used to treat male erectile issues.
• The medication begins working within 30 minutes for many users.
• Always follow the dosage instructions provided by your healthcare provider.
• Use caution if you have a history of low blood pressure.
• Report any persistent side effects to your doctor promptly.

Though rare, some people have reported permanent vision loss.

• The effectiveness of Levitra 5mg depends on individual factors.
• Levitra 5mg is part of a broader ED treatment approach.
• Adhere strictly to your doctor’s prescribed dosage.
• Do not share your medication with others.
• Regular check-ups can help monitor treatment progress.

Stop taking vardenafil and get help right away if you have sudden vision loss in one or both eyes.

• Limit alcohol consumption while taking Levitra 5mg.
• Levitra 5mg effects typically last up to 4-6 hours.
• Do not take Levitra 5mg with nitrate medications.
• Store Levitra 5mg tablets in a cool, dry place.
• Possible side effects include headache and flushing.

Sudden hearing loss has been reported after taking vardenafil. This may occur along with dizziness and ringing in the ears. Stop taking vardenafil and get help right away if you have sudden hearing loss or suddenly have trouble hearing as well as usual.

About the Company

Although the citizen petition did not address the 5 mg and 10 mg strengths, those strengths have also been discontinued. On our own initiative, we have also determined whether those strengths were withdrawn for safety or effectiveness reasons. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale.

Does vardenafil interact with other medicines (drug interactions)?

We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin cost levitra costco procedures to withdraw approval of approved ANDAs that refer to these drug products.

How does vardenafil work (mechanism of action)?

Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Vardenafil is commonly used for erectile dysfunction, a condition where you have trouble getting or keeping an erection. Vardenafil may also be used for other conditions as determined by your healthcare provider. Vardenafil works by blocking an enzyme in the body called PDE5, which helps relax certain blood vessels. Vardenafil may cause a rare, dangerous heart rhythm problem called QT prolongation. Some people may have a higher risk of this, including people born with long QT syndrome and those taking certain medicines for heart rhythm problems. Tell your healthcare provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat. Vardenafil may cause a mild and temporary drop in blood pressure. You may be at a higher risk if you have certain health conditions or take blood pressure medicines.

Dosing & Uses

FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document. Requests that the FDA determine whether LEVITRA® (vardenafil HCl) 20 mg tablets approved under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc. has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.

Are you currently using Vardenafil (Levitra, Staxyn)?

2,287 as of 05/28/2026 at 10:15 am EDT This document is also available in the following formats: 2023-09365 as it appeared on Public Inspection on 05/02/2023 at 8:45 am. It was viewed 13 times while on Public Inspection. If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. Published Document: 2023-09365 (88 FR 27901) This document has been published in the Federal Register.

Are Levitra and Cialis the same?

Use the PDF linked in the document sidebar for the official electronic format. The Food and Drug Administration (FDA or Agency) has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. If you feel faint or dizzy, lie down. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.