# Solifenacin ```text DRUG INFORMATION ADULT - 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 - 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 - 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 CHILD - 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 - 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 - 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 RENAL IMPAIRMENT - 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 - 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 - 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 HEPATIC IMPAIRMENT - 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 - 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 - 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 PREGNANCY - 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 - Reproduction studies have been performed in mice, rats and rabbits. Source: US FDA label for solifenacin (Solifenacin Succinate), section 'pregnancy', retrieved 2026-08-29 - 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 BREASTFEEDING - 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 - 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 - 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)