Label: VARDENAFIL tablet, orally disintegrating
This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
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This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If you are a consumer or patient please visit this version.
Pregnancy Categories
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA).
Treatment & Diagnosis
(2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. (2.1)• The maximum recommended dosing frequency is one tablet per day. (2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. (2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should sex with tablet not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
| Drug Name | Dose Range | Duration of Action | Onset Time | Special Features |
|---|---|---|---|---|
| Vardenafil | 5-20 mg | 4-5 hours | 30-60 min | Fast onset, good for food timing |
| Sildenafil | 25-100 mg | 4-6 hours | 30-60 min | Well-studied, widespread use |
| Tadalafil | 2.5-20 mg | Up to 36 hours | 30-120 min | Long duration, daily options |
| Avanafil | 50-200 mg | 4-6 hours | 15-30 min | Fastest onset, fewer side effects |
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS.VARDENAFIL HYDROCHLORIDE orally disintegrating tabletsInitial U.S. Approval: 2003RECENT MAJOR CHANGESWarnings and Precautions (5.2) 4/2023INDICATIONS AND USAGE• Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).DOSAGE AND ADMINISTRATION• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). (2.1)• Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity.
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(2.1)• The maximum recommended dosing frequency is one tablet per day.
How To Get Vardenafil
• Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. • The maximum recommended dosing frequency is sex power tablet one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. • Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food.
Dosage Modifications
• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. • Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). • Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing.
Patient resources
• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. Adverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or • Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. (2.1)• Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. (2.1)• Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. (2.2)DOSAGE FORMS AND STRENGTHS• Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONS• Cardiovascular Effects: Patients should sex with tablet not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. (5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
(5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride orally disintegrating tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION.
- Vardenafil 10 mg enhances natural erectile response.
- The medication is prescription-only in most countries.
- Common brand names include Levitra and Staxyn.
- Do not crush or split the tablet unless instructed.
- Using more than the prescribed dose can increase risk.
- Vardenafil is a phosphodiesterase inhibitor.
- It is not intended for use by women.
- Possible side effects include nasal congestion and dizziness.
- Seek medical advice if you experience priapism.
- Keep out of reach of children.
(5.4, 6.2)• Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing.
- Vardenafil 10 mg is one of several ED treatment options.
- It is generally well-tolerated when used properly.
- Take care to follow your healthcare provider’s instructions.
- Possible interactions with antihypertensive drugs exist.
- Do not drive or operate machinery if feeling dizzy.
- Keep a record of any side effects experienced.
- The medication is not a cure for erectile dysfunction.
- Combining vardenafil with other ED drugs is dangerous.
- Take the tablet with a full glass of water.
- Consult your doctor for dose adjustments if needed.
(5.5, 6.2)• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. (2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets.
8.4 Pediatric Use
(5.1)• Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. (5.2, 7.2)• Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. (5.3)• Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride orally disintegrating tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION.
What is vardenafil used for?
(5.4, 6.2)• Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing. (5.5, 6.2)• Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil hydrochloride orally disintegrating tablets. (2.4, 5.6)• QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets.
Does vardenafil interact with other medicines (drug interactions)?
(5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. (7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. (7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (5.7, 12.2)• Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria. (5.12)ADVERSE REACTIONSAdverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or INTERACTIONS• Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives.
| Patient Type | Recommended Dose | Notes |
|---|---|---|
| Adult Men with ED | 10 mg | 1 hour before activity |
| Elderly Patients | 5-10 mg | Adjust based on tolerability |
| Patients with Liver Impairment | 5 mg | Lower dose recommended |
| Use with CYP3A4 inhibitors | 5 mg | To reduce adverse risk |
(7.1)• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations.
- Vardenafil 10 mg should not be used with certain medications.
- Grapefruit or grapefruit juice may have interactions.
- Inform your doctor about all health conditions before use.
- The medication may cause vision changes or sensitivity.
- Do not use vardenafil if you have liver or kidney issues.
- The pill helps achieve and maintain an erection.
- Follow prescribed dosage to avoid complications.
- Not effective as an aphrodisiac without sexual stimulation.
- Avoid using recreational drugs along with vardenafil.
- Regular medical check-ups are recommended during use.
(7.2)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2025 Warnings and Precautions (5.2) 4/2023 • Vardenafil hydrochloride orally disintegrating tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. • Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). • Vardenafil hydrochloride orally disintegrating tablets are taken as needed, orally, approximately 60 minutes before sexual activity. • The maximum recommended dosing frequency is sex power tablet one tablet per day. • Vardenafil hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. • Vardenafil hydrochloride orally disintegrating tablets may be taken with or without food. • Vardenafil hydrochloride orally disintegrating tablets 10 mg: White to off white, round, orally disintegrating tablets (not scored) (3) • Cardiovascular Effects: Patients should not use vardenafil hydrochloride orally disintegrating tablets if sex is inadvisable due to cardiovascular status. • Strong and Moderate CYP3A4 Inhibitors: Do not use vardenafil hydrochloride orally disintegrating tablets in patients taking strong or moderate CYP3A4 inhibitors. • Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. • Effects on the Eye: Patients should stop use of vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). • Sudden Hearing Loss: Patients should stop vardenafil hydrochloride orally disintegrating tablets and seek medical attention in the event of sudden decrease or loss in hearing. • Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. • QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride orally disintegrating tablets. • Phenylketonurics: Each vardenafil hydrochloride orally disintegrating tablet contain 1.403 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria.
8.7 Renal Impairment
• Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Phenylketonurics5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Orally Disintegrating Tablets7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 GeneralVardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets.
Related treatment guides
Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA) [see Clinical Pharmacology (12.3). ]Vardenafil hydrochloride orally disintegrating tablets should be taken orally, as needed, approximately 60 minutes before sexual activity.
What is vardenafil, and what is it used for?
Adverse reactions reported by ≥ 2% of patients treated with vardenafil hydrochloride orally disintegrating tablets: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or • Vardenafil hydrochloride orally disintegrating tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, and antihypertensives. • Do not use vardenafil hydrochloride orally disintegrating tablets with moderate or strong CYP3A4 inhibitors as coadministration will result in significant increases in plasma vardenafil concentrations. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 General2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular Effects5.2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors5.3 Risk of Priapism5.4 Effects on the Eye5.5 Sudden Hearing Loss5.6 Alpha-Blockers5.7 Congenital or Acquired QT Prolongation5.8 Hepatic Impairment5.9 Renal Impairment5.10 Combination with Other Erectile Dysfunction Therapies5.11 Effects on Bleeding5.12 Phenylketonurics5.14 Sexually Transmitted Disease6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride Orally Disintegrating Tablets7.2 Effect of Other Drugs on Vardenafil7.3 Effects of Vardenafil on Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Other Vardenafil Clinical Trials Using Film-Coated Tablets16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Recommended Storage17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed.
| Contraindication | Reason | Alternative Action |
|---|---|---|
| Use with Nitrates | Severe hypotension risk | Seek alternative ED treatment |
| Severe Liver Impairment | Reduced metabolism, increased risk | Dose adjustment or avoidance |
| Hypotension (<90/60 mm Hg) | Risk of significant blood pressure drop | Monitor blood pressure |
| Concomitant Potent CYP3A4 Inhibitors | Increased Vardenafil levels | Dose reduction |
2 DOSAGE AND ADMINISTRATION 2.1 GeneralVardenafil hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablets are not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). Vardenafil hydrochloride orally disintegrating tablets provide higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA) [see Clinical Pharmacology (12.3).
Generic vs Brand
]Vardenafil hydrochloride orally disintegrating tablets should be taken orally, as needed, approximately 60 minutes before sexual activity.
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