Sildenafil

DRUG INFORMATION

  ADULT
    - • For most patients, the recommended dose is 50 mg taken, as needed, approximately
      1 hour before sexual activity.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'dosage and
      administration', retrieved 2026-08-29
    - However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours
      before sexual activity ( 2.1 ) • Based on effectiveness and toleration, may
      increase to a maximum of 100 mg or decrease to 25 mg ( 2.1 ) • Maximum recommended
      dosing frequency is once per day ( 2.1 ) 2.1 Dosage Information For most patients,
      the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual
      activity.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'dosage and
      administration', retrieved 2026-08-29
    - When sildenafil tablets is co-administered with an alpha-blocker, patients should
      be stable on alpha-blocker therapy prior to initiating sildenafil tablets
      treatment and sildenafil tablets should be initiated at 25 mg [see Warnings and
      Precautions (5.5) , Drug Interactions (7.2) , and Clinical Pharmacology (12.2) ].
      Source: US FDA label for sildenafil (SILDENAFIL), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Healthy elderly volunteers (65 years or over) had a reduced clearance of
      sildenafil resulting in approximately 84% and 107% higher plasma AUC values of
      sildenafil and its active N-desmethyl metabolite, respectively, compared to those
      seen in healthy young volunteers (18–45 years) [see Clinical Pharmacology (12.3)
      ].
      Source: US FDA label for sildenafil (SILDENAFIL), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in
      patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and
      patients with severe renal impairment (creatinine clearance <30 mL/minute) because
      administration of sildenafil tablets in these patients resulted in higher plasma
      levels of sildenafil [see Use in Specific Populations (8.5 , 8.6 , 8.7) and
      Clinical Pharmacology (12.3) ].
      Source: US FDA label for sildenafil (SILDENAFIL), section 'dosage and
      administration', retrieved 2026-08-29
    - • Geriatric use: Consider a starting dose of 25 mg ( 2.5 , 8.5 ) • Severe renal
      impairment: Consider a starting dose of 25 mg ( 2.5 , 8.6 ) • Hepatic impairment:
      Consider a starting dose of 25 mg ( 2.5 , 8.7 ) 8.1 Pregnancy Risk Summary
      Sildenafil tablets are not indicated for use in females.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'use in specific
      populations', retrieved 2026-08-29
    - However, since higher plasma levels may increase the incidence of adverse
      reactions, a starting dose of 25 mg should be considered in older subjects due to
      the higher systemic exposure [see Dosage and Administration (2.5) ]. 8.6 Renal
      Impairment No dose adjustment is required for mild (CLcr=50–80 mL/min) and
      moderate (CLcr=30–49 mL/min) renal impairment.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Dosage Adjustments in Special Populations Consider a starting dose of 25 mg in
      patients > 65 years, patients with hepatic impairment (e.g., cirrhosis), and
      patients with severe renal impairment (creatinine clearance <30 mL/minute) because
      administration of sildenafil tablets in these patients resulted in higher plasma
      levels of sildenafil [see Use in Specific Populations (8.5 , 8.6 , 8.7) and
      Clinical Pharmacology (12.3) ].
      Source: US FDA label for sildenafil (SILDENAFIL), section 'dosage and
      administration', retrieved 2026-08-29
    - • Geriatric use: Consider a starting dose of 25 mg ( 2.5 , 8.5 ) • Severe renal
      impairment: Consider a starting dose of 25 mg ( 2.5 , 8.6 ) • Hepatic impairment:
      Consider a starting dose of 25 mg ( 2.5 , 8.7 ) 8.1 Pregnancy Risk Summary
      Sildenafil tablets are not indicated for use in females.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'use in specific
      populations', retrieved 2026-08-29
    - A starting dose of 25 mg should be considered in patients with severe renal
      impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)
      ]. 8.7 Hepatic Impairment In volunteers with hepatic impairment (Child-Pugh Class
      A and B), sildenafil clearance was reduced, resulting in higher plasma exposure of
      sildenafil (47% for C max and 85% for AUC).
      Source: US FDA label for sildenafil (SILDENAFIL), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Sildenafil tablets are not indicated for use in females.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'pregnancy', retrieved
      2026-08-29
    - There are no data with the use of Sildenafil tablets in pregnant women to inform
      any drug-associated risks for adverse developmental outcomes.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'pregnancy', retrieved
      2026-08-29
    - Animal reproduction studies conducted with sildenafil did not show adverse
      developmental outcomes when administered during organogenesis in rats and rabbits
      at oral doses up to 16 and 32 times, respectively, the maximum recommended human
      dose (MRHD) of 100 mg/day on a mg/m 2 basis (see Data ).
      Source: US FDA label for sildenafil (SILDENAFIL), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Sildenafil tablets are not indicated for use in pediatric patients.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'nursing mothers',
      retrieved 2026-08-29
    - Safety and effectiveness have not been established in pediatric patients.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'nursing mothers',
      retrieved 2026-08-29
    - In the rat pre- and postnatal development study, the no observed adverse effect
      dose was 30 mg/kg/day given for 36 days, about 2 times the MRHD on a mg/m 2 basis
      in a 50 kg subject. 8.2 Lactation Risk Summary Sildenafil tablets are not
      indicated for use in females.
      Source: US FDA label for sildenafil (SILDENAFIL), section 'use in specific
      populations', retrieved 2026-08-29