Label: VARDENAFIL HYDROCHLORIDE tablet

Tell your doctor about all other medications you use for erectile dysfunction. This list is not complete and many other drugs may affect vardenafil.

Vardenafil Pharmacokinetics

Tell your doctor about all other medications you use for erectile dysfunction. This list is not complete and many other drugs may affect vardenafil. 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.

What should I do if I miss a dose of vardenafil?

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 TABLETS safely and effectively. See full prescribing information for VARDENAFIL HYDROCHLORIDE TABLETS.VARDENAFIL HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2003RECENT MAJOR CHANGESINDICATIONS AND USAGEVardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. 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.

Warnings & Precautions

( 5.3)Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Vardenafil hydrochloride 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. ( 5.4, 6.2)Sudden Hearing Loss: Patients should stop vardenafil hydrochloride 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 co-administered with alpha-blockers.

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In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). ( 2.4, 5.6)QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. ( 5.7, 12.2)Phenylketonurics: Contains Phenylalanine ( 5.13)ADVERSE REACTIONSMost common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or INTERACTIONSVardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VARDENAFIL HYDROCHLORIDE TABLETS safely and effectively.

• Vardenafil 10mg is one of the options for treating ED, alongside others like sildenafil.
• The pill should be taken as directed; do not split or crush it.
• It should not be taken by those with hypersensitivity to its components.
• Consult your healthcare provider before starting vardenafil if unsure about safety.
• The medication may improve quality of life and intimate relationships.
• Regular medical evaluation is important to ensure safe medication use.
• Not all men respond to vardenafil; some may require alternative treatments.
• Side effects like dizziness can impair your ability to operate machinery.
• Avoid using vardenafil if you are taking medications that contain nitrates.
• Always keep track of your medication usage and report adverse effects.

See full prescribing information for VARDENAFIL HYDROCHLORIDE TABLETS.VARDENAFIL HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2003RECENT MAJOR CHANGESINDICATIONS AND USAGEVardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. ( 1)DOSAGE AND ADMINISTRATIONVardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily.

5.10 Combination with Other Erectile Dysfunction Therapies

( 7.1)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 11/2025 Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. A starting dose of 5 mg vardenafil hydrochloride libido booster women tablets should be considered in patients ≥ 65 years of age. Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is one tablet per day.

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Vardenafil hydrochloride tablets may be taken with or without food. If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6) The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3, 8.6) Vardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3) Cardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability.

( 2.1)A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. ( 2.3)Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity.

• 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.

( 2.1)The maximum recommended dosing frequency is one tablet per day.

( 2.1)Vardenafil hydrochloride tablets may be taken with or without food. ( 2.2)If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6)The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3, 8.6)DOSAGE FORMS AND STRENGTHSVardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSCardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. ( 5.1)Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance.

• Vardenafil 10mg can help improve sexual confidence and satisfaction.
• Use it responsibly to maintain health and efficacy.
• Check for any medication allergies before use.
• Inform your doctor about all health conditions prior to starting.
• Do not take vardenafil if you have recent cardiovascular events.
• Avoid excessive alcohol, which can worsen side effects.
• Report any unexpected symptoms to your healthcare provider.
• Follow your doctor’s instructions for dosage and timing.
• Be aware of the medication’s interaction with other drugs.
• Proper storage ensures the medication’s effectiveness and safety.

( 5.3)Effects on the Eye: Patients should stop use of vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION).

Vardenafil hydrochloride 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. ( 5.4, 6.2)Sudden Hearing Loss: Patients should stop vardenafil hydrochloride 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 co-administered 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).

8.6 Hepatic Impairment

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 tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Sudden Hearing Loss: Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. ( 2.4, 5.6)QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. ( 5.7, 12.2)Phenylketonurics: Contains Phenylalanine ( 5.13)ADVERSE REACTIONSMost common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or INTERACTIONSVardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives.

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Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 General Dose InformationFor most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.2.3 Use in Specific PopulationsGeriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)].Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended. ( 7.1)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 11/2025 Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. A starting dose of 5 mg vardenafil hydrochloride libido booster women tablets should be considered in patients ≥ 65 years of age. Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. The maximum recommended dosing frequency is one tablet per day. Vardenafil hydrochloride tablets may be taken with or without food. If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6) The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3, 8.6) Vardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3) Cardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. 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 tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Sudden Hearing Loss: Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets. Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives.

Renal Dose Adjustments

( 1)DOSAGE AND ADMINISTRATIONVardenafil hydrochloride tablets are taken as needed: For most patients, the starting dose is 10 mg, up to once daily. Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability. ( 2.1)A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age. ( 2.3)Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. ( 2.1)The maximum recommended dosing frequency is one tablet per day.

What are the most common side effects of vardenafil?

( 2.1)Vardenafil hydrochloride tablets may be taken with or without food. ( 2.2)If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4, 5.2, 7.2): Ritonavir: No more than 2.5 mg in a 72-hour periodCobicistat: No more than 2.5 mg in a 72-hour periodIndinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour periodKetoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period.In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4, 5.6)The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B). The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. ( 2.3, 8.6)DOSAGE FORMS AND STRENGTHSVardenafil hydrochloride tablets 2.5 mg, 5 mg, 10 mg, 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSCardiovascular Effects: Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status. ( 5.1)Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. 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 General Dose Information2.2 Use with Food2.3 Use in Specific 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 Sexually Transmitted Disease5.13 Risks in Patients with Phenylketonuria6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride 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 Trials in a General Erectile Dysfunction Population14.2 Trial in Patients with ED and Diabetes Mellitus14.3 Trial in Patients with ED after Radical Prostatectomy16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

Drug Label Information

Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or Vardenafil hydrochloride tablets can potentiate the hypotensive effects of nitrates, alpha- blockers, and antihypertensives. 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 General Dose Information2.2 Use with Food2.3 Use in Specific 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 Sexually Transmitted Disease5.13 Risks in Patients with Phenylketonuria6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with Vardenafil Hydrochloride 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 Trials in a General Erectile Dysfunction Population14.2 Trial in Patients with ED and Diabetes Mellitus14.3 Trial in Patients with ED after Radical Prostatectomy16 HOW SUPPLIED/STORAGE AND HANDLING17 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 General Dose InformationFor most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.2.3 Use in Specific PopulationsGeriatrics: A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5)].Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended.