Vardenafil is an active pharmaceutical ingredient in the Drugs Used In Erectile Dysfunction group (G04BE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 2, 2025[1]
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Vardenafil Tablets to be effective, sexual stimulation is required.
How to take
GB
CACanada· Health Canada
15 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS ................................................................................................... 9 DRUG INTERACTIONS .................................................................................................
12 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ...............................................................................................................
…….. 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 18 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................
USUnited States· FDA
4 products
Uses
USOfficial regulatory label· revised November 6, 2025[3]
1 INDICATIONS AND USAGE Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. Vardenafil hydrochloride tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.
( 1 )
How to take
US
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised January 20, 2025[4]
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required.
How to take
EU
Drug interactions
Known interactions involving Vardenafil. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 516. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02464209 · revised March 22, 2025
[3]FDA DailyMed · 083a3282-254f-40… · revised November 6, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/000475 · revised January 20, 2025
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology Use in adult men The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg.
The maximum recommended dosing frequency is once per day. Vardenafil Tablets can be taken with or without food. 2). Special populations Elderly (≥65 years old) Dose adjustments are not required in elderly patients. 8). Hepatic impairment A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B).
Based on tolerability and efficacy, the dose may subsequently be increased. 2). Renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance < 30 mL/min), a starting dose of 5 mg should be considered.
Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg. Paediatric population Vardenafil Tablets are not indicated for individuals below 18 years of age. There is no relevant indication for use of Vardenafil Tablets in children.
5). Method of administration For oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 2, 2025[1]
Summary of the safety profile The adverse reactions reported with Vardenafil Tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Tabulated list of adverse reactions Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4) Musculoskeletal Back pain and connective Increase in tissue disorders creatine phosphokinase Myalgia Increased muscle tone and cramping Renal and urinary disorders Haematuria System Organ Very Common Uncommon Rare Not known Class common (≥1/100 to (≥1/1,000 to (≥1/10,000 to (cannot be (≥1/10) <1/ 10) <1/100) <1/1,000) estimated from the available data) Reproductive Increase in Priapism Penile system and erection Haemorrhage breast Haematospermia disorders General disorders and administration site conditions Feeling unwell Chest pain Description of selected adverse reactions Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
7%) than younger patients (<65 years old). In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 2, 2025[1]
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. 3). 1). , aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack and cerebral haemorrhage); have been reported in temporal association with vardenafil.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Medicinal products for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
The safety and efficacy of combinations of Vardenafil Tablets with Vardenafil orodispersible tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. 8). Concomitant use of alpha-blockers The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha- blocker therapy. In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets.
Vardenafil may be administered at any time with tamsulosin or with alfuzosin. 5). In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 2, 2025[1]
1. 1). 4). g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]). The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: • severe hepatic impairment (Child-Pugh C), • end stage renal disease requiring dialysis, • hypotension (blood pressure < 90/50 mmHg), • recent history of stroke or myocardial infarction (within the last 6 months), • unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years. 5). 5).
This is not medical advice. Consult a qualified healthcare professional.
23 PART II: SCIENTIFIC INFORMATION .............................................................................. 25 PHARMACEUTICAL INFORMATION ......................................................................... 25 CLINICAL TRIALS…………………………………………………………………….
55 PART III: CONSUMER INFORMATION............................................................................. 56 Page 3 of 58 PrMYLAN-VARDENAFIL Vardenafil tablets 5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride trihydrate PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION TABLE 1: SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients oral Tablets / 5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride trihydrate Cellulose microcrystalline, crospovidone, silica (colloidal anhydrous), magnesium stearate.
The coating contains: hypromellose, titanium dioxide, macrogol, iron oxide yellow and iron oxide red. For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section. INDICATIONS AND CLINICAL USE MYLAN-VARDENAFIL (vardenafil tablets) is indicated for: Treatment of erectile dysfunction (difficulties or the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance).
Special Populations Pregnant and Nursing Women:
MYLAN-VARDENAFIL is not indicated for use in women. There are no trials of vardenafil tablets in pregnant women.
Pediatrics (< 18 years of age):
MYLAN-VARDENAFIL is not indicated for use in individuals less than 18 years old.
Geriatrics (≥ 65 years of age):
A starting dose of 5 mg MYLAN-VARDENAFIL should be considered in patients 65 years and older. On average, elderly males (65 years and over) had a 52% higher vardenafil AUC than younger males (18-45 years); however, this difference was not statistically significant.
) Page 4 of
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates, and therefore co-administration of MYLAN-VARDENAFIL (vardenafil tablets) with nitrates and nitric oxide donors is contraindicated.
In a patient prescribed MYLAN-VARDENAFIL (vardenafil tablets), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 24 hours should have elapsed after the last dose of MYLAN-VARDENAFIL (vardenafil tablets) before nitrate administration is considered.
In such circumstances, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring. Concomitant use of MYLAN-VARDENAFIL (vardenafil tablets) with medicinal products containing cobicistat, HIV protease inhibitors such as indinavir, ritonavir, saquinavir, or atazanavir, and combinations of these, ketoconazole, or itraconazole is contraindicated, as they are potent inhibitors of CYP3A4 (see WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION).
MYLAN-VARDENAFIL (vardenafil tablets) is contraindicated in patients with erectile dysfunction with a previous episode of non-arteritic anterior ischaemic optic neuropathy (NAION) (see WARNINGS AND PRECAUTIONS). The co-administration of PDE5 inhibitors, including MYLAN-VARDENAFIL, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may lead to potentially life-threatening episodes of symptomatic hypotension or syncope (see DRUG INTERACTIONS).
WARNINGS AND PRECAUTIONS General The evaluation of erectile dysfunction should include a determination of potential underlying causes, a medical assessment and the identification of appropriate treatment. Before prescribing MYLAN-VARDENAFIL (vardenafil tablets), it is important to note the following: Vardenafil tablets has not been administered to patients with bleeding disorders or significant active peptic ulceration.
Therefore MYLAN-VARDENAFIL should be Page 5 of 58 administered to these patients after careful benefit-risk assessment. In humans, vardenafil tablets has no effect on bleeding time alone or with acetylsalicyclic acid. In vitro studies with human platelets indicate that vardenafil tablets does not inhibit platelet aggregation induced by a variety of platelet agonists.
A small, concentration-dependent, enhancement of the anti-aggregation effects of a nitric oxide donor, nitroprusside, was observed with supra- therapeutic concentrations of vardenafil tablets in the presence of platelet agonists. The bleeding time in rats with a combination of heparin and vardenafil was not different from that observed with heparin alone.
However, this interaction has not been studied in humans. Treatment for erectile dysfunction should generally be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Vardenafil tablets has not been studied in patients with CNS disease (other than spinal cord injury), hypoactive sexual desire, or in patients who have undergone pelvic surgery (except nerve sparing prostatectomy), pelvic trauma, or radiotherapy.
Post-marketing reports of sudden loss of vision have occurred rarely, in temporal association with the use of PDE5 inhibitors. It is not clear whether these are related directly to the use of PDE5 inhibitors or to other factors. There may be an increased risk to patients who have already experienced Non-arteritic Anterior Ischemic Optic Neuropathy (NAION).
Cardiovascular Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, including uncontrolled hypertension (with BP > 140/90 mmHg), any treatment for erectile dysfunction, including MYLAN-VARDENAFIL generally should not be used.
Physicians are advised to consult the recommendations of the Princeton Consensus Panel (DeBusk et al. Am J Cardiol 2000;86:175-81). The following groups of patients with cardiovascular disease were not included in clinical trials: patients with a myocardial infarction or stroke within the last 6 months, patients with unstable angina pectoris or acute myocardial ischemia, patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg), uncontrolled hypertension (>170/110 mmHg), patients with symptomatic postural hypotension in the last six months.
MYLAN-VARDENAFIL has vasodilator properties which may result in mild and transient decreases in blood pressure. Patients with left ventricular outflow obstruction, eg, aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including Type 5 phosphodiesterase inhibitors.
Patients should be stable on alpha-blocker therapy before prescribing MYLAN-VARDENAFIL. Page 6 of 58 Patients receiving alpha-blocker therapy should be initiated at the lowest dose of 5 mg MYLAN- VARDENAFIL. Congenital and Acquired QT Prolongation In a study of the effect of vardenafil tablets on the QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil tablets produced minimal increases in QTc interval.
) In a post-marketing study evaluating the effect of combining vardenafil tablets with another drug of comparable QT effect (400 mg gatifloxacin), it was shown that the drug combination produced an additive QT effect […]
This is not medical advice. Consult a qualified healthcare professional.
2 DOSAGE AND ADMINISTRATION Vardenafil 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. 1 ) A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age.
3 ) Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity. 1 ) The maximum recommended dosing frequency is one tablet per day. 1 ) Vardenafil hydrochloride tablets may be taken with or without food.
5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period. 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. 1 General Dose Information For 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 Use with Food Vardenafil hydrochloride tablets can be taken with or without food. 5) ].
Hepatic Impairment:
For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. 3) ] . 3) ].
2) ]. 2 ) ]. 5 mg in a 72-hour period. 5 mg in a 24-hour period.
No more than 5 mg in a 24-hour period. 5 mg in a 72 hour period.
Alpha-Blockers:
In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil. 5 mg when used concomitantly with certain CYP3A4 inhibitors).
2) ] .
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 26 reports total. [5]
Bradycardia 4
Poisoning Deliberate 4
Sopor 4
Toxicity To Various Agents 4
Vomiting 4
Drug Ineffective 3
Myalgia 3
Cardiac Dysfunction 2
Cardiac Fibrillation 2
Coronary Artery Disease 2
Cytokine Release Syndrome 2
Febrile Neutropenia 2
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised November 6, 2025[3]
7) ] Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.
1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Vardenafil hydrochloride tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.
1% for placebo. When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1 ).
Table 1:
Adverse Reactions Reported By ≥2% of Patients Treated with Vardenafil Hydrochloride Tablets and More Frequent on Drug than Placebo in Fixed and Flexible Flexible dose studies started all patients at vardenafil hydrochloride tablets 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy.
Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil Adverse Reaction Percentage of Patients Reporting Reactions Placebo N = 1199 Vardenafil Hydrochloride Tablets N = 2203 Headache 4% 15% Flushing 1% 11% Rhinitis 3% 9% Dyspepsia 1% 4% Accidental Injury All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury.
7% of patients on placebo. Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets.
5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.
8% for placebo. The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets. 2 Postmarketing Experience The following adverse reactions have been identified during post approval use of vardenafil hydrochloride tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Ophthalmologic:
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil.
4) and Patient Counseling Information (17) ] . Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience.
It is not possible to determine whether these events are related directly to the use of vardenafil.
Neurologic:
Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.
Otologic:
Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17) ] .
USOfficial regulatory label· Warnings and precautions· revised November 6, 2025[3]
5 WARNINGS AND PRECAUTIONS The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment. Before prescribing vardenafil hydrochloride tablets, it is important to note the following: Cardiovascular Effects : Patients should not use vardenafil hydrochloride tablets if sex is inadvisable due to cardiovascular status.
1 ) Risk of Priapism : In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. 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.
2 ) Sudden Hearing Loss : Patients should stop vardenafil hydrochloride tablets and seek medical attention in the event of sudden decrease or loss in hearing. 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). 6 ) QT Prolongation : Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using vardenafil hydrochloride tablets.
1 Cardiovascular Effects General Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatment for erectile dysfunction, including vardenafil hydrochloride tablets, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.
There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised November 6, 2025[3]
2) ] . Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined.
2 Guanylate Cyclase (GC) Stimulators Do not use vardenafil hydrochloride tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including vardenafil hydrochloride tablets may potentiate the hypotensive effects of GC stimulators.
This is not medical advice. Consult a qualified healthcare professional.
Posology Use in adult men The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg.
The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. 2). Special populations Elderly (>65 years old) Dose adjustments are not required in elderly patients. 8). Hepatic impairment A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B).
Based on tolerability and efficacy, the dose may subsequently be increased. 2). Renal impairment No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance <30 ml/min), a starting dose of 5 mg should be considered.
Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg. Paediatric population Levitra is not indicated for individuals below 18 years of age. There is no relevant indication for use of Levitra in children. 5).
Method of administration For oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised January 20, 2025[4]
Summary of the safety profile The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in 10% of patients is headache.
8 Tabulated list of adverse reactions Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 4) Musculoskele- tal and connective tissue disorders Back pain Increase in creatine phosphokinase Myalgia Increased muscle tone and cramping Renal and urinary disorders Haematuria Reproductive system and breast disorders Increase in erection Priapism Penile Haemorrhage Haematospermia General disorders and administra- tion site conditions Feeling unwell Chest pain Description of selected adverse reactions Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
7%) than younger patients (<65 years old). In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised January 20, 2025[4]
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. 3). 1). , aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Serious cardiovascular events including sudden death, tachycardia, myocardial infarction, ventricular tachy-arrythmia, angina pectoris, and cerebrovascular disorders (including transient ischaemic attack and cerebral haemorrhage), have been reported in temporal association with vardenafil.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Medicinal products for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
The safety and efficacy of combinations of Levitra film-coated tablets with Levitra orodispersible tablets or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
8). Concomitant use of alpha-blockers The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators. Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg film-coated tablets. Vardenafil may be administered at any time with tamsulosin or with alfuzosin.
5). In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised January 20, 2025[4]
1. 1). 4). g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]). The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available: - severe hepatic impairment (Child-Pugh C), - end stage renal disease requiring dialysis, - hypotension (blood pressure <90/50 mmHg), - recent history of stroke or myocardial infarction (within the last 6 months), - unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years. 5). 5).
This is not medical advice. Consult a qualified healthcare professional.
3). 2). Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. 5). Effect on QTc interval Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone. 1). The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
g. g. amiodarone, sotalol). 8). If signs and symptoms suggestive of these reactions appear, vardenafil should be withdrawn immediately and should not be restarted in this patient at any time. Effect on vision Visual defects, including Central Serous Chorioretinopathy (CSCR) and cases of non-arteritic ischaemic optic neuropathy (NAION) have been reported in connection with the intake of Vardenafil Tablets and other PDE5 inhibitors.
8). 3). Effect on bleeding In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
In humans, vardenafil had no […]
Left Ventricular Outflow Obstruction Patients with left ventricular outflow obstruction, (for example, aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators including PDE5 inhibitors.
2) ] . While this normally would be expected to be of little consequence in most patients, prior to prescribing vardenafil hydrochloride tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.
2 Potential for Drug Interactions with Strong or Moderate CYP3A4 Inhibitors Concomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil.
2) ]. Long-term safety information is not available on the concomitant administration of vardenafil with HIV protease inhibitors. 3 Risk of Priapism There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds, including vardenafil.
In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Vardenafil hydrochloride tablets should be used with caution by patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or by patients who have conditions that may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
4 Effects on the Eye Physicians should advise patients to stop use of all phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil hydrochloride tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes.
Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.
8 cases per 100,000 in males aged ≥50. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period.
34). 20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. 2) ] . Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors.
Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including vardenafil hydrochloride tablets, should be used with caution in these patients and only when the anticipated benefits outweigh the risks.
Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population, however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including vardenafil hydrochloride tablets, for this uncommon condition.
Vardenafil hydrochloride tablets have not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.
5 Sudden Hearing Loss Physicians should advise patients to stop taking all PDE5 inhibitors, including vardenafil hydrochloride tablets, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil.
2) ]. 6 Alpha-Blockers Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including vardenafil hydrochloride tablets, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure lowering effects.
When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. 2) ] .
Consideration should be given to the following:
Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
4) ] . In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a PDE5 inhibitor.
Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. 2) ] , therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval.
2) ] . These observations should be considered in clinical decisions when prescribing vardenafil hydrochloride tablets to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil hydrochloride tablets.
8 Hepatic Impairment Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use vardenafil hydrochloride tablets in patients with severe (Child-Pugh C) hepatic impairment. 6) ]. 7) ]. 10 Combination with Other Erectile Dysfunction Therapies The safety and efficacy of vardenafil hydrochloride tablets used in combination with other treatments for erectile dysfunction have not been studied.
Therefore, the use of such combinations is not recommended. 11 Effects on Bleeding In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time. There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin.
Vardenafil hydrochloride tablets have not been administered to patients with bleeding disorders or significant active peptic ulceration. Therefore vardenafil hydrochloride tablets should be administered to these patients after careful benefit-risk assessment.
12 Sexually Transmitted Disease The use of vardenafil hydrochloride tablets offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.
13 Risks in Patients with Phenylketonuria Phenylalanine can be harmful to patients with phenylketonuria (PKU). Vardenafil hydrochloride tablets contain phenylalanine, a component of aspartame. 6 mg phenylalanine. Before prescribing vardenafil hydrochloride tablets in a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including vardenafil hydrochloride tablets.
3). 2). Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil. 5). Effect on QTc interval Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone. 1). The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at 5 any time in any given patient.
g. g. amiodarone, sotalol). 8). If signs and symptoms suggestive of these reactions appear, vardenafil should be withdrawn immediately and should not be restarted in this patient at any time. Effect on vision Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Levitra and other PDE5 inhibitors.
8). 3). Effect on bleeding In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
In humans vardenafil had no effect on bleeding […]