FESOTERODINE FUMARATE

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

22,165 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FESOTERODINE FUMARATE

FESOTERODINE FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for FESOTERODINE FUMARATE include DRUG INEFFECTIVE, DRY MOUTH, FALL, CONSTIPATION, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FESOTERODINE FUMARATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,662 reports
DRY MOUTH822 reports
FALL529 reports
CONSTIPATION505 reports
FATIGUE505 reports
OFF LABEL USE505 reports
URINARY RETENTION502 reports
PAIN440 reports
HEADACHE415 reports
DIZZINESS393 reports
MALAISE333 reports
CONFUSIONAL STATE325 reports
NAUSEA322 reports
DIARRHOEA321 reports
CONDITION AGGRAVATED319 reports
RASH319 reports
URINARY TRACT INFECTION308 reports
SOMNOLENCE296 reports
WEIGHT DECREASED291 reports
GAIT DISTURBANCE278 reports
ASTHENIA271 reports
PAIN IN EXTREMITY263 reports
DEPRESSION257 reports
PYREXIA248 reports
CEREBROVASCULAR ACCIDENT247 reports
DYSPNOEA245 reports
ABDOMINAL DISCOMFORT244 reports
ARTHRITIS233 reports
VISION BLURRED223 reports
POLLAKIURIA222 reports
DYSURIA218 reports
INSOMNIA214 reports
URINARY INCONTINENCE209 reports
ARTHRALGIA201 reports
INTENTIONAL PRODUCT USE ISSUE200 reports
VOMITING199 reports
PALPITATIONS196 reports
VERTIGO195 reports
COVID 19193 reports
RECTAL HAEMORRHAGE191 reports
FEELING ABNORMAL188 reports
COLITIS ULCERATIVE186 reports
BACK PAIN185 reports
PRODUCT USE IN UNAPPROVED INDICATION185 reports
DEATH184 reports
STRESS180 reports
MIGRAINE178 reports
DRUG EFFECT INCOMPLETE177 reports
MEMORY IMPAIRMENT174 reports
FREQUENT BOWEL MOVEMENTS173 reports
HYPERTENSION173 reports
PULMONARY EMBOLISM168 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION164 reports
DYSGEUSIA163 reports
SWOLLEN TONGUE160 reports
PNEUMONIA159 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES156 reports
PRURITUS156 reports
HAEMATOCHEZIA154 reports
ABDOMINAL PAIN UPPER153 reports
ECZEMA143 reports
TINNITUS143 reports
DEEP VEIN THROMBOSIS142 reports
DRUG INTERACTION141 reports
COUGH140 reports
MEDICATION ERROR138 reports
NIGHTMARE138 reports
DRUG HYPERSENSITIVITY137 reports
TUBULOINTERSTITIAL NEPHRITIS135 reports
ACCIDENTAL OVERDOSE133 reports
BLOOD PRESSURE INCREASED129 reports
CARDIAC MURMUR129 reports
GINGIVAL PAIN129 reports
BRONCHIECTASIS128 reports
ANXIETY126 reports
IMPAIRED WORK ABILITY126 reports
SYSTEMIC LUPUS ERYTHEMATOSUS126 reports
BURNS SECOND DEGREE124 reports
CATARRH124 reports
HYPOPNOEA124 reports
LOSS OF CONSCIOUSNESS124 reports
PAROSMIA122 reports
RHINITIS122 reports
ADVERSE DRUG REACTION120 reports
DYSPHAGIA120 reports
STEROID DEPENDENCE120 reports
BALANCE DISORDER116 reports
CHEST PAIN114 reports
HYPOTENSION114 reports
RENAL FAILURE110 reports
MUSCLE SPASMS109 reports
DRY EYE108 reports
IMPAIRED QUALITY OF LIFE108 reports
ABDOMINAL PAIN107 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE106 reports
OEDEMA PERIPHERAL105 reports
MUSCULAR WEAKNESS104 reports
CYSTITIS103 reports
OROPHARYNGEAL PAIN103 reports
HYPOACUSIS100 reports

Report Outcomes

Out of 10,687 classified reports for FESOTERODINE FUMARATE:

Serious 55.9%Non-Serious 44.1%

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

Female6,579 (68.2%)
Male2,994 (31.0%)
Unknown76 (0.8%)

Reports by Age

Age 75236 reports
Age 73207 reports
Age 71206 reports
Age 77201 reports
Age 82195 reports
Age 78179 reports
Age 74169 reports
Age 72168 reports
Age 70164 reports
Age 80158 reports
Age 81156 reports
Age 69154 reports
Age 53152 reports
Age 83149 reports
Age 68146 reports
Age 76146 reports
Age 79146 reports
Age 84143 reports
Age 64139 reports
Age 66134 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 FESOTERODINE FUMARATE?

This profile reflects 22,165 FDA FAERS reports that mention FESOTERODINE FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FESOTERODINE FUMARATE?

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

Who manufactures FESOTERODINE FUMARATE?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with FESOTERODINE FUMARATE. 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.