Before Using

Drug information provided by: Merative, Micromedex®

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Vardenafil is not indicated for use in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vardenafil in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amyl Nitrite
  • Bepridil
  • Cisapride
  • Dronedarone
  • Erythrityl Tetranitrate
  • Fluconazole
  • Isosorbide Dinitrate
  • Isosorbide Mononitrate
  • Ketoconazole
  • Lefamulin
  • Levoketoconazole
  • Mesoridazine
  • Nelfinavir
  • Nitroglycerin
  • Pentaerythritol Tetranitrate
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Propatyl Nitrate
  • Riociguat
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Adagrasib
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Bretylium
  • Bunazosin
  • Buprenorphine
  • Buserelin
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clothiapine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dapiprazole
  • Darunavir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexmedetomidine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxazosin
  • Doxepin
  • Droperidol
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Entrectinib
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Etrasimod
  • Famotidine
  • Fedratinib
  • Felbamate
  • Fexinidazole
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosnetupitant
  • Fostemsavir
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gepirone
  • Glasdegib
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imipramine
  • Indinavir
  • Inotuzumab Ozogamicin
  • Itraconazole
  • Ivabradine
  • Ivosidenib
  • Josamycin
  • Lapatinib
  • Larotrectinib
  • Lenacapavir
  • Lenvatinib
  • Leuprolide
  • Levofloxacin
  • Lofexidine
  • Lonafarnib
  • Lopinavir
  • Lorlatinib
  • Lumacaftor
  • Lumefantrine
  • Macimorelin
  • Mavacamten
  • Mefloquine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mibefradil
  • Mifepristone
  • Mirtazapine
  • Mizolastine
  • Mobocertinib
  • Moricizine
  • Moxifloxacin
  • Moxisylyte
  • Nafarelin
  • Nefazodone
  • Netupitant
  • Nilotinib
  • Nirmatrelvir
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Olutasidenib
  • Omaveloxolone
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Ozanimod
  • Pacritinib
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perphenazine
  • Phenobarbital
  • Phenoxybenzamine
  • Phentolamine
  • Pimavanserin
  • Pipamperone
  • Pirtobrutinib
  • Pitolisant
  • Ponesimod
  • Prajmaline
  • Prazosin
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Quizartinib
  • Ranolazine
  • Relugolix
  • Ribociclib
  • Risperidone
  • Ritlecitinib
  • Ritonavir
  • Saquinavir
  • Selpercatinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Silodosin
  • Simeprevir
  • Siponimod
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sparteine
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tamsulosin
  • Tedisamil
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Terazosin
  • Tetrabenazine
  • Tolazoline
  • Tolterodine
  • Toremifene
  • Trazodone
  • Triclabendazole
  • Trifluoperazine
  • Trimazosin
  • Trimipramine
  • Triptorelin
  • Trofinetide
  • Troleandomycin
  • Tucatinib
  • Urapidil
  • Vandetanib
  • Vemurafenib
  • Venlafaxine
  • Vericiguat
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormally shaped penis, including a curved penis and birth defects or
  • Age greater than 50 years or
  • Coronary artery disease or
  • Crowded disc or low cup to disc ratio in the eye (an eye disorder) or
  • Diabetes or
  • Hyperlipidemia (high fats in the blood) or
  • Hypertension (high blood pressure) or
  • Leukemia (cancer of the blood) or
  • Multiple myeloma (cancer of the blood) or
  • Non-arteritic anterior ischemic optic neuropathy (NAION; serious eye condition), history of or
  • Peyronie disease or
  • Sickle-cell anemia (blood disorder) or
  • Smoking—May increase the chance for a serious side effect in the eye called NAION.
  • Angina (severe chest pain), unstable or
  • Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or
  • Heart attack (within the last 6 months) or
  • Heart failure or
  • Heart rhythm problems or
  • Hypertension (high blood pressure), uncontrolled or
  • Hypotension (low blood pressure) or
  • Liver disease, severe or
  • Retinal disorders (eye problem) or
  • Retinitis pigmentosa (an inherited eye disorder) or
  • Stroke, history of—Should not be used in patients with these conditions.
  • Bleeding disorders or
  • Stomach ulcers—Chance of problems occurring may be increased. It is not known if the medicine is safe for use in these patients.
  • Fructose intolerance—The Staxyn® disintegrating tablet contains sorbitol, which can make this condition worse.
  • Hypotension (low blood pressure) or
  • QT prolongation (rare heart condition), or history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The Staxyn® disintegrating tablet contains aspartame, which can make this condition worse.

Portions of this document last updated: March 01, 2024

Copyright: © Merative US L.P. 1973, 2024. All rights reserved. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.