SOLIFENACIN SUCCINATE

N/A

Manufactured by Astellas Pharma US, Inc.

42,941 FDA adverse event reports analyzed

Last updated: 2026-04-14

About SOLIFENACIN SUCCINATE

SOLIFENACIN SUCCINATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. The most commonly reported adverse reactions for SOLIFENACIN SUCCINATE include DRUG INEFFECTIVE, DRY MOUTH, CONSTIPATION, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SOLIFENACIN SUCCINATE.

Top Adverse Reactions

DRUG INEFFECTIVE3,601 reports
DRY MOUTH1,615 reports
CONSTIPATION1,614 reports
FATIGUE1,275 reports
OFF LABEL USE1,236 reports
FALL1,226 reports
DIZZINESS1,033 reports
NAUSEA900 reports
HEADACHE859 reports
VISION BLURRED785 reports
URINARY TRACT INFECTION764 reports
DIARRHOEA725 reports
ASTHENIA662 reports
MALAISE655 reports
PAIN655 reports
GAIT DISTURBANCE605 reports
DYSPNOEA599 reports
CONFUSIONAL STATE515 reports
DEATH511 reports
INSOMNIA481 reports
PNEUMONIA481 reports
URINARY INCONTINENCE479 reports
PRURITUS471 reports
VOMITING471 reports
SOMNOLENCE468 reports
PAIN IN EXTREMITY462 reports
URINARY RETENTION444 reports
RASH436 reports
POLLAKIURIA427 reports
ARTHRALGIA426 reports
BACK PAIN407 reports
CONDITION AGGRAVATED393 reports
DEPRESSION379 reports
WEIGHT DECREASED368 reports
MEMORY IMPAIRMENT362 reports
COUGH361 reports
ABDOMINAL PAIN UPPER358 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION356 reports
BALANCE DISORDER344 reports
NOCTURIA343 reports
PYREXIA338 reports
MUSCLE SPASMS334 reports
FEELING ABNORMAL331 reports
DYSPEPSIA324 reports
ACUTE KIDNEY INJURY322 reports
DECREASED APPETITE321 reports
ALOPECIA314 reports
MULTIPLE SCLEROSIS RELAPSE309 reports
ANXIETY307 reports
HYPERTENSION306 reports
MUSCULAR WEAKNESS303 reports
OEDEMA PERIPHERAL296 reports
DRUG INTERACTION289 reports
HYPOTENSION279 reports
ABDOMINAL PAIN275 reports
TREATMENT NONCOMPLIANCE271 reports
DRY EYE266 reports
HYPOAESTHESIA266 reports
RENAL FAILURE265 reports
WEIGHT INCREASED265 reports
ABDOMINAL DISCOMFORT262 reports
CHEST PAIN261 reports
HALLUCINATION261 reports
BLOOD PRESSURE INCREASED260 reports
ANAEMIA255 reports
PERIPHERAL SWELLING250 reports
DEHYDRATION249 reports
CHRONIC KIDNEY DISEASE248 reports
TREMOR246 reports
DRUG DOSE OMISSION242 reports
NASOPHARYNGITIS242 reports
DYSURIA241 reports
LOSS OF CONSCIOUSNESS238 reports
GASTROOESOPHAGEAL REFLUX DISEASE225 reports
DRUG EFFECT INCOMPLETE224 reports
PARAESTHESIA224 reports
DYSPHAGIA222 reports
OVERDOSE213 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS213 reports
FLUSHING212 reports
VISUAL IMPAIRMENT210 reports
CYSTITIS205 reports
URTICARIA195 reports
BLOOD GLUCOSE INCREASED192 reports
CEREBROVASCULAR ACCIDENT191 reports
ATRIAL FIBRILLATION190 reports
AMNESIA188 reports
CONTUSION188 reports
ERYTHEMA188 reports
MULTIPLE SCLEROSIS180 reports
MYALGIA179 reports
HYPERSENSITIVITY178 reports
PRODUCT USE IN UNAPPROVED INDICATION178 reports
MICTURITION URGENCY172 reports
INTENTIONAL PRODUCT MISUSE169 reports
ABDOMINAL DISTENSION167 reports
SEPSIS166 reports
PRODUCT USE ISSUE164 reports
DRUG HYPERSENSITIVITY161 reports
HOT FLUSH159 reports

Report Outcomes

Out of 25,723 classified reports for SOLIFENACIN SUCCINATE:

Serious 50.1%Non-Serious 49.9%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female17,450 (70.5%)
Male7,175 (29.0%)
Unknown139 (0.6%)

Reports by Age

Age 75431 reports
Age 77426 reports
Age 71412 reports
Age 78409 reports
Age 76396 reports
Age 80393 reports
Age 72390 reports
Age 74385 reports
Age 70380 reports
Age 73379 reports
Age 82373 reports
Age 69372 reports
Age 65355 reports
Age 68355 reports
Age 83345 reports
Age 64332 reports
Age 79331 reports
Age 81325 reports
Age 63318 reports
Age 66308 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with SOLIFENACIN SUCCINATE?

This profile reflects 42,941 FDA FAERS reports that mention SOLIFENACIN SUCCINATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for SOLIFENACIN SUCCINATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DRY MOUTH, CONSTIPATION, FATIGUE, OFF LABEL USE, FALL. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures SOLIFENACIN SUCCINATE?

Labeling and FAERS entries often list Astellas Pharma US, Inc. in connection with SOLIFENACIN SUCCINATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.