USE IN SPECIFIC POPULATIONS

has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document.

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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.

• Vardenafil 10mg is used primarily to improve erectile function in men.
• It’s important to avoid taking multiple doses in a 24-hour period.
• The tablet should be taken with water, not crushed or chewed.
• Potential side effects include headache, flushing, and indigestion.
• Rare but serious reactions include sudden vision or hearing loss.
• Consult your doctor immediately if adverse reactions occur.
• Men with certain health conditions should undergo evaluation before use.
• The drug works by relaxing blood vessels to increase blood flow.
• Avoid excessive alcohol consumption while on vardenafil.
• Store away from light, moisture, and away from children’s reach.

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. Use the PDF linked in the document sidebar for the official electronic format.

2.2 Use with Food

If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking vardenafil, call your doctor immediately. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of unneeded medications in a way so that pets, children, and other people cannot take them.

Does vardenafil interact with other medicines (drug interactions)?

Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information. Keep all medication out of sight and pills for men reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. 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.

Affordable men's sexual healthcare you can trust.

Talk to your doctor about eating grapefruit or drinking grapefruit juice while taking this medicine. erection that lasts longer than 4 hours sudden severe loss of vision (see below for more information) changes in color vision (seeing blue tinge on objects, difficulty telling the difference between blue and green, or difficulty seeing at night) swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs Call your doctor if you have any unusual problems while taking this medication. Some patients experienced a sudden loss of some or all of their vision after they took vardenafil or other medications that are similar to vardenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication.

What are the most common side effects of vardenafil?

If you experience a sudden loss of vision while you are taking vardenafil, call your doctor immediately. Do not take any more doses of vardenafil or similar medications such as sildenafil (Viagra) or tadalafil (Cialis) until you talk to your doctor. Some patients experienced a sudden decrease or loss of hearing after they took vardenafil or other medications that are similar to vardenafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and best pill for ed 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. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product.

• Vardenafil interacts with certain blood pressure medicines, affecting efficacy.
• The medication can be used by men of most adult age groups.
• Women who are pregnant or breastfeeding should not use vardenafil.
• It’s advisable to avoid grapefruit or grapefruit juice when on vardenafil.
• Always complete your prescribed course even if symptoms improve.
• Seek medical attention if you notice symptoms of allergic reaction.
• Vardenafil is not intended for use by individuals with recent stroke or heart attack.
• Sexual activity may be dangerous for some men with cardiovascular issues.
• The medication is not approved for use in women or children.
• Use caution when combining vardenafil with other erectile dysfunction drugs.

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 not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Tablets

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Usual Geriatric Dose for:

Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts. Enter a search term or FR citation e.g. 88 FR 38230 FR 78782024-13208USDA09/05/24RULE0503-AA39SORN Choosing an item from full text search results will bring you to those results. Pressing enter in the search box will also bring you to search results. Choosing an item from suggestions will bring you directly to the content. 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). 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.

7.3 Effects of Vardenafil on Other Drugs

Determination That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. 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. 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)).

What Is Vardenafil and How Does It Work?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking.

Visual disturbances

Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies. This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov. The documents posted on this site are XML renditions of published Federal Register documents. 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. 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.

• Vardenafil 10mg should be used only under medical supervision.
• Overdose may cause serious side effects like priapism or sudden vision loss.
• The medication is available by prescription and not for recreational use.
• Male patients with heart issues should consult a doctor before use.
• Vardenafil may interact with other medications like antibiotics or antifungals.
• Alcohol consumption can increase the risk of side effects when taking vardenafil.
• It’s important to follow the prescribed dosage strictly for safety.
• Use caution if you have liver or kidney problems while taking vardenafil.
• Women and children should avoid using vardenafil, as it's designed for men.
• Discuss all health conditions and medications with your healthcare provider first.

submitted a citizen petition dated August 29, 2022 (Docket No.

• Vardenafil HCl 10mg can be effective in treating erectile dysfunction symptoms.
• It’s important to avoid unprescribed or counterfeit versions of the drug.
• Consult a healthcare provider for proper diagnosis before starting treatment.
• Discontinue medication and seek medical help if serious side effects occur.
• The medication’s effects depend on proper timing and dosage adherence.
• It’s safe for most men but always needs individual health assessment.
• Mild side effects may diminish over time or with dose adjustment.
• Use caution with other medications that affect blood pressure or blood flow.
• Do not use vardenafil if you are allergic to similar medications like sildenafil.
• Always inform your doctor of any other medications you are taking.

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. Although the citizen petition did not address the 5 mg and 10 mg strengths, those strengths have also been discontinued.