Vardenafil

DRUG INFORMATION

  ADULT
    - Vardenafil hydrochloride tablets are taken as needed: For most patients, the
      starting dose is 10 mg, up to once daily.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2.1 ) A starting dose of vardenafil hydrochloride tablets, 5 mg should be
      considered in patients ≥65 years of age.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2.3 , 8.6 ) 2.1 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.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - Vardenafil hydrochloride is not indicated for use in pediatric patients. Safety
      and efficacy have not been established in this population.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - 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. ( 2.1 ) A starting dose of vardenafil
      hydrochloride tablets, 5 mg should be considered in patients ≥65 years of age. (
      2.3 ) Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes
      before sexual activity.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - ( 2.1 ) A starting dose of vardenafil hydrochloride tablets, 5 mg should be
      considered in patients ≥65 years of age.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Renal Impairment: Do not use vardenafil hydrochloride tablets in patients on renal
      dialysis [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.7
      ) and Clinical Pharmacology ( 12.3 )] . 2.4 Concomitant Medications Nitrates:
      Concomitant use with nitrates and nitric oxide donors in any form is
      contraindicated [see Contraindications ( 4.1 )] .
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Renal Impairment: Do not use vardenafil hydrochloride tablets in patients on renal
      dialysis [see Warnings and Precautions ( 5.9 ), Use in Specific Populations ( 8.7
      ) and Clinical Pharmacology ( 12.3 )] .
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - ( 8.6 ) Do not use vardenafil hydrochloride in patients on renal dialysis.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - 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).
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The maximum dose in patients with moderate hepatic impairment should not exceed 10
      mg.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Hepatic Impairment: For patients with moderate hepatic impairment (Child-Pugh B),
      a starting dose of vardenafil hydrochloride tablets, 5 mg is recommended.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Vardenafil hydrochloride is not indicated for use in females.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - There are no data with the use of vardenafil hydrochloride in pregnant women to
      inform any drug-associated risks.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - In animal reproduction studies conducted in pregnant rats and rabbits, no adverse
      developmental outcomes were observed with oral administration of vardenafil during
      organogenesis at exposures for unbound vardenafil and its major metabolite at
      approximately 100 and 29 times, respectively, the maximum recommended human dose
      (MRHD) of 20 mg based on AUC (see Data) .
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Vardenafil hydrochloride is not indicated for use in females.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - There is no information on the presence of vardenafil and its major metabolite in
      human milk, the effects on the breastfed infant, or the effects on milk
      production.
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - Vardenafil is present in rat milk of lactating rats (see Data) .
      Source: US FDA label for vardenafil (Vardenafil Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29