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Nitroprusside: (Contraindicated) Concomitant use of nitroprusside and vardenafil is contraindicated due to the risk of additive hypotension. A suitable time interval after vardenafil dosing for the safe administration of nitrates has not been determined. In addition, vardenafil may potentiate the nitric oxide-mediated platelet anti-aggregatory effect of nitroprusside. Ofloxacin: (Moderate) Concomitant use of ofloxacin and vardenafil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Olanzapine: (Moderate) Concomitant use of vardenafil and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Olanzapine; Fluoxetine: (Moderate) Concomitant use of vardenafil and fluoxetine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. (Moderate) Concomitant use of vardenafil and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients.

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Nicardipine: (Moderate) Vardenafil is metabolized by hepatic cytochrome P450 3A4 and to a lesser extent CYP2C9. Inhibitors of CYP3A4, such as nicardipine, can reduce vardenafil clearance. Increased systemic exposure to vardenafil may result in an increase in vardenafil-induced adverse effects. Nifedipine: (Moderate) Nifedipine can have additive hypotensive effects when administered with phosphodiesterase inhibitors (PDE 5 inhibitors). The patient should be monitored carefully and the dosage should be adjusted based on clinical response. Olanzapine; Samidorphan: (Moderate) Concomitant use of vardenafil and olanzapine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Ondansetron: (Major) Concomitant use of ondansetron and vardenafil increases the risk of QT/QTc prolongation and torsade de pointes (TdP).

Further information

If use of nilotinib and vardenafil oral tablets is required, do not exceed a single vardenafil oral tablet dose of 5 mg per 24-hour period. Nirmatrelvir; Ritonavir: (Major) Consider withholding vardenafil during receipt of ritonavir-boosted nirmatrelvir. Coadministration may increase vardenafil exposure resulting in increased toxicity. Nitrates: (Contraindicated) Coadministration of phosphodiesterase inhibitors with organic nitrates or nitrites in any dosage formulation is contraindicated. Nitroglycerin: (Contraindicated) Coadministration of phosphodiesterase inhibitors with organic nitrates or nitrites in any dosage formulation is contraindicated. Osilodrostat: (Moderate) Concomitant use of vardenafil and osilodrostat may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Osimertinib: (Major) Concomitant use of vardenafil and osimertinib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Oxaliplatin: (Major) Concomitant use of vardenafil and oxaliplatin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Ozanimod: (Major) In general, do not initiate ozanimod in patients taking vardenafil due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, seek advice from a cardiologist. Ozanimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays.

Medical uses

For example, in patients whose hypertension was controlled with nifedipine, vardenafil produced mean additional supine systolic/diastolic blood pressure reductions of 3 to 4 mmHg (age group 65 to 69 years) and 5 to 6 mmHg (age group 70 to 80 years) compared to placebo. Nilotinib: (Major) Avoid the concomitant use of nilotinib with other agents known to prolong the QT interval, such as vardenafil. Sudden death and QT prolongation have occurred in patients receiving nilotinib therapy. Also, nilotinib is a moderate CYP3A4 inhibitor and vardenafil is a primary CYP3A4 substrate; administering these drugs together may result in increased vardenafil concentrations. Do not use vardenafil orally disintegrating tablets with nilotinib due to increased vardenafil exposure. Ozanimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Pacritinib: (Major) Concomitant use of pacritinib and vardenafil increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Paliperidone: (Major) Concomitant use of vardenafil and paliperodone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Panobinostat: (Major) QT prolongation has been reported with panobinostat therapy in patients with multiple myeloma in a clinical trial; use of panobinostat with other agents that prolong the QT interval is not recommended. Obtain an electrocardiogram at baseline and periodically during treatment. Hold panobinostat if the QTcF increases to >= 480 milliseconds during therapy; permanently discontinue if QT prolongation does not resolve. Drugs with a possible risk for QT prolongation and torsade de pointes that should be used cautiously and with close monitoring with panobinostat include vardenafil. Pasireotide: (Moderate) Concomitant use of vardenafil and pasireotide may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Pazopanib: (Major) Concomitant use of vardenafil and pazopanib increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Pentamidine: (Major) Concomitant use of vardenafil and pentamidine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Perphenazine: (Minor) Use vardenafil with caution in combination with perphenazine due to increased risk of QT prolongation. Perphenazine is associated with a possible risk for QT prolongation.

Primary Outcome

Vardenafil is primarily metabolized by CYP3A4/5; nefazodone is a strong CYP3A4 inhibitor. Nelfinavir: (Major) Do not use vardenafil orally disintegrating tablets with nelfinavir due to increased vardenafil exposure; do not exceed a single dose of 2.5 mg per 24-hour period of vardenafil oral tablets. Vardenafil is primarily metabolized by CYP3A4/5; nelfinavir is a strong CYP3A4 inhibitor. Netupitant, Fosnetupitant; Palonosetron: (Major) Do not use vardenafil orally disintegrating tablets with netupitant due to increased vardenafil exposure; do not exceed a single dose of 5 mg per 24-hour period of vardenafil oral tablets. Vardenafil is primarily metabolized by CYP3A4/5; netupitant is a moderate CYP3A4 inhibitor. Perphenazine; Amitriptyline: (Minor) Use vardenafil with caution in combination with perphenazine due to increased risk of QT prolongation. Phenoxybenzamine: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of vardenafil. Phentolamine: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of vardenafil. Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Pimavanserin: (Major) Concomitant use of vardenafil and pimavanserin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Pimozide: (Contraindicated) Avoid concomitant use of vardenafil and pimozide due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation. Pitolisant: (Major) Concomitant use of vardenafil and pitolisant increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Ponesimod: (Major) In general, do not initiate ponesimod in patients taking vardenafil due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). Ponesimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ponesimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Posaconazole: (Contraindicated) The concurrent use of posaconazole with drugs that are associated with QT prolongation and are also CYP3A4 substrates, such as vardenafil, is contraindicated. Posaconazole is associated with QT prolongation, and vardenafil may cause QT prolongation at both therapeutic and supratherapeutic doses. Elevated plasma concentrations of vardenafil may also increase the risk for other vardenafil-related adverse events, such as prolonged erection or potential for syncope. Prazosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of vardenafil. Primaquine: (Moderate) Concomitant use of vardenafil and primaquine may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Procainamide: (Major) Vardenafil should be avoided in patients taking Class IA antiarrhythmics (disopyramide, procainamide, and quinidine). Prochlorperazine: (Minor) Use vardenafil with caution in combination with prochlorperazine due to increased risk of QT prolongation. Prochlorperazine is also associated with a possible risk for QT prolongation. Promethazine: (Moderate) Concomitant use of promethazine and vardenafil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Promethazine; Dextromethorphan: (Moderate) Concomitant use of promethazine and vardenafil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Promethazine; Phenylephrine: (Moderate) Concomitant use of promethazine and vardenafil may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Quetiapine: (Major) Concomitant use of vardenafil and quetiapine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Quinidine: (Major) Vardenafil should be avoided in patients taking Class IA antiarrhythmics (disopyramide, procainamide, and quinidine).