{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "solifenacin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily (2.1).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily (2.1). Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4). Use of solifenacin succinate tablet is not recommended in patients with severe hepatic impairment (Child-Pugh C) (2.3).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of solifenacin succinate tablets in pediatric patients have not been established.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily (2.1). Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4). Use of solifenacin succinate tablet is not recommended in patients with severe hepatic impairment (Child-Pugh C) (2.3).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Solifenacin succinate tablets can be administered with or without food. 2.2 Dose Adjustment in Patients with Renal Impairment For patients with severe renal impairment (CL cr <30 mL/min), a daily dose of solifenacin succinate tablets greater than 5 mg is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.6)] .",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Multiple dose studies of solifenacin succinate tablets in elderly volunteers (65 to 80 years) showed that C max , AUC and t 1/2 values were 20 to 25% higher as compared to the younger volunteers (18 to 55 years). 8.6 Renal Impairment Solifenacin succinate tablets should be used with caution in patients with renal impairment.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4).",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Use of solifenacin succinate tablet is not recommended in patients with severe hepatic impairment (Child-Pugh C) (2.3). 2.1 Dosing Information The recommended dose of solifenacin succinate tablet is 5 mg once daily.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Solifenacin succinate tablets can be administered with or without food. 2.2 Dose Adjustment in Patients with Renal Impairment For patients with severe renal impairment (CL cr <30 mL/min), a daily dose of solifenacin succinate tablets greater than 5 mg is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.6)] .",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Reproduction studies have been performed in mice, rats and rabbits.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "After oral administration of 14 C-solifenacin succinate to lactating mice, radioactivity was detected in maternal milk.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "There were no adverse observations in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD].",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      },
      {
        "text": "Pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater revealed reduced body weights, postpartum pup mortality or delays in the onset of reflex and physical development during the lactation period.",
        "source": "US FDA label for solifenacin (Solifenacin Succinate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/solifenacin.json",
        "verbatim": true
      }
    ]
  }
}