{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sildenafil",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• 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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "• 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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "• 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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Sildenafil tablets are not indicated for use in females.",
        "source": "US FDA label for sildenafil (SILDENAFIL), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Sildenafil tablets are not indicated for use in pediatric patients.",
        "source": "US FDA label for sildenafil (SILDENAFIL), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "Safety and effectiveness have not been established in pediatric patients.",
        "source": "US FDA label for sildenafil (SILDENAFIL), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sildenafil.json",
        "verbatim": true
      }
    ]
  }
}