Vardenafil

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA).
• Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA).
• ( 2.1 ) Vardenafil orally disintegrating tablet is 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 orally disintegrating tablet should be placed on the tongue where it will disintegrate.
• It should be taken without liquid.
• ( 2.1 ) Vardenafil orally disintegrating tablet may be taken with or without food.
• ( 2.2 )
• 2.1 General Vardenafil is available in 10 mg orally disintegrating tablets.
• Vardenafil orally disintegrating tablet is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA).
• Vardenafil orally disintegrating tablet provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA). [See Clinical Pharmacology ( 12.3 ).] Vardenafil orally disintegrating tablet should be taken orally, as needed, approximately 60 minutes before sexual activity.
• The maximum dosing frequency is one Vardenafil orally disintegrating tablet per day.
• Sexual stimulation is required for a response to treatment.
• Vardenafil orally disintegrating tablet should be placed on the tongue where it will disintegrate.
• The tablet should be taken without liquid.
• It should be taken immediately upon removal from the blister.
• Those patients who require a lower or higher dose of vardenafil need to be prescribed vardenafil film-coated tablets [see Patient Counseling Information ( 17)] .
• 2.2 Use with Food Vardenafil orally disintegrating tablet can be taken with or without food.
• 2.3 Use in Special Populations Hepatic Impairment:
• Do not use vardenafil orally disintegrating tablet in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment [see Warnings and Precautions ( 5.8 ) and Clinical Pharmacology ( 12.3)] .
• Renal Impairment:
• Do not use vardenafil orally disintegrating tablet in patients on renal dialysis [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.3 )].
• 2.4 Concomitant Medications Nitrates :
• Concomitant use with nitrates in any form is contraindicated [see Contraindications (4.1)] .
• Guanylate Cyclase (GC) Stimulators, such as riociguat:
• Concomitant use is contraindicated [see Contraindications ( 4.2 )].
• CYP3A4 Inhibitors:
• Do not use vardenafil orally disintegrating tablet with strong or moderate CYP3A4 inhibitors such as cobicistat ,ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin [see Warnings and Precautions ( 5.2) and Drug Interactions ( 7.2 )] .
• Alpha-Blockers:
• In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose.
• Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.
• In patients taking alpha-blockers, do not initiate vardenafil therapy with vardenafil orally disintegrating tablet.
• Lower doses of vardenafil film-coated tablets should be used as initial therapy in these patients [see Dosage and Administration ( 2.4)] .
• Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may change to vardenafil orally disintegrating tablet at the advice of their healthcare provider. [See Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7.1).] A time interval between dosing should be considered when vardenafil orally disintegrating tablet is prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology ( 12.2 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• The following serious adverse reactions with the use of vardenafil orally disintegrating tablet are discussed elsewhere in the labeling:
• Cardiovascular effects [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1) ] Priapism [see Warnings and Precautions ( 5.3) ] QT Prolongation [see Warnings and Precautions ( 5.7) ] Effects on eye [see Warnings and Precautions ( 5.4 )] Sudden hearing loss [see Warnings and Precautions ( 5.5 )] Adverse reactions reported by ≥ 2% of patients treated with vardenafil orally disintegrating tablet:
• Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 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 orally disintegrating tablet :
• Safety of vardenafil orally disintegrating tablet was evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials.
• In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥65 years old.
• Approximately 8% (n=29) were ≥75 years old.
• An integrated analysis of both studies included a total of 355 subjects that received vardenafil orally disintegrating tablet compared to 340 subjects that received placebo (mean age was 61.7, range 21.0 to 88.0; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other).
• The discontinuation rates due to adverse reactions were 1.4% for vardenafil orally disintegrating tablet compared to 0.6% for placebo.
• Table 1 below details the most frequently reported adverse reactions.
• Table 1:
• Adverse drug reactions reported by ≥2% of the patients treated with vardenafil orally disintegrating tablet and more frequent on drug than placebo in controlled trials Adverse Drug Reaction Vardenafil Orally Disintegrating Tablet (n=355) Placebo (n=340) Headache 14.4% 1.8% Flushing 7.6% 0.6% Nasal Congestion 3.1% 0.3% Dyspepsia 2.8% 0% Dizziness 2.3% 0% Back Pain 2% 0.3% Adverse drug reactions reported in the vardenafil orally disintegrating tablet placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.
• All Vardenafil Studies:
• Vardenafil film-coated tablets and vardenafil orally disintegrating tablet has been administered to over 17,000 men (mean age 54.5, 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.
• In the placebo-controlled clinical trials for vardenafil film-coated tablets and vardenafil orally disintegrating tablet, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.
• Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.
• The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil film-coated tablets and vardenafil orally disintegrating tablet.
• Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:
• Body as a whole:
• allergic edema and angioedema, feeling unwell, allergic reactions, chest pain Auditory:
• tinnitus, vertigo Cardiovascular:
• palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive:
• nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal:
• increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia Nervous:
• paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Respiratory:
• dyspnea, sinus congestion Skin and appendages:
• erythema, rash Ophthalmologic:
• visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis Urogenital:
• increase in erection, priapism
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation.
• 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.
• Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to:
• low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions ( 5.4) 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 )] .

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

12 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Vardenafil