TOLTERODINE TARTRATE

N/A

Manufactured by Viatris Specialty LLC

33,596 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TOLTERODINE TARTRATE

TOLTERODINE TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for TOLTERODINE TARTRATE include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TOLTERODINE TARTRATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,963 reports
FALL940 reports
FATIGUE895 reports
NAUSEA824 reports
DIZZINESS803 reports
HEADACHE744 reports
DIARRHOEA732 reports
PAIN690 reports
DRY MOUTH684 reports
ASTHENIA618 reports
CONSTIPATION617 reports
URINARY TRACT INFECTION593 reports
DYSPNOEA590 reports
ARTHRALGIA525 reports
WEIGHT DECREASED484 reports
GAIT DISTURBANCE475 reports
MALAISE457 reports
VOMITING453 reports
DEPRESSION441 reports
DEATH420 reports
BACK PAIN419 reports
PAIN IN EXTREMITY410 reports
RASH406 reports
INSOMNIA405 reports
HYPERTENSION400 reports
CONDITION AGGRAVATED395 reports
ANXIETY390 reports
PNEUMONIA385 reports
URINARY INCONTINENCE382 reports
CONFUSIONAL STATE360 reports
POLLAKIURIA351 reports
OFF LABEL USE343 reports
CEREBROVASCULAR ACCIDENT340 reports
PRURITUS324 reports
CHEST PAIN321 reports
OEDEMA PERIPHERAL321 reports
COUGH320 reports
MUSCLE SPASMS317 reports
WEIGHT INCREASED317 reports
FEELING ABNORMAL304 reports
MEMORY IMPAIRMENT304 reports
BALANCE DISORDER302 reports
DRUG HYPERSENSITIVITY297 reports
SOMNOLENCE295 reports
ABDOMINAL PAIN UPPER284 reports
VISION BLURRED282 reports
GASTROOESOPHAGEAL REFLUX DISEASE279 reports
PYREXIA279 reports
ABDOMINAL PAIN270 reports
DRUG INTERACTION265 reports
ALOPECIA264 reports
BLOOD PRESSURE INCREASED263 reports
TREMOR256 reports
ANAEMIA254 reports
MUSCULAR WEAKNESS254 reports
RENAL FAILURE253 reports
HYPOAESTHESIA247 reports
MYOCARDIAL INFARCTION244 reports
DECREASED APPETITE239 reports
MULTIPLE SCLEROSIS RELAPSE236 reports
HYPOTENSION223 reports
CHRONIC KIDNEY DISEASE217 reports
DEHYDRATION216 reports
PARAESTHESIA214 reports
JOINT SWELLING213 reports
HYPERSENSITIVITY211 reports
BLOOD GLUCOSE INCREASED210 reports
MYALGIA203 reports
MULTIPLE SCLEROSIS202 reports
FLUSHING199 reports
LOSS OF CONSCIOUSNESS198 reports
DYSPHAGIA196 reports
CARDIAC FAILURE CONGESTIVE195 reports
URINARY RETENTION194 reports
DRUG EFFECT DECREASED184 reports
DYSURIA181 reports
ATRIAL FIBRILLATION179 reports
DYSPEPSIA177 reports
CONTUSION176 reports
ABDOMINAL DISCOMFORT175 reports
DIABETES MELLITUS174 reports
NASOPHARYNGITIS170 reports
AMNESIA166 reports
ARTHRITIS166 reports
DRUG DOSE OMISSION163 reports
ERYTHEMA162 reports
BRONCHITIS160 reports
SINUSITIS160 reports
CYSTITIS159 reports
BLOOD CHOLESTEROL INCREASED158 reports
PALPITATIONS158 reports
NOCTURIA154 reports
MICTURITION URGENCY148 reports
URTICARIA148 reports
CHILLS147 reports
CHEST DISCOMFORT145 reports
PERIPHERAL SWELLING144 reports
ABDOMINAL DISTENSION142 reports
BLADDER DISORDER142 reports
OSTEOARTHRITIS142 reports

Report Outcomes

Out of 16,134 classified reports for TOLTERODINE TARTRATE:

Serious 62.2%Non-Serious 37.8%

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

Female11,976 (78.0%)
Male3,311 (21.6%)
Unknown72 (0.5%)

Reports by Age

Age 64248 reports
Age 67244 reports
Age 65240 reports
Age 63236 reports
Age 74234 reports
Age 56232 reports
Age 66230 reports
Age 72228 reports
Age 75228 reports
Age 60225 reports
Age 77217 reports
Age 58213 reports
Age 76213 reports
Age 80211 reports
Age 69207 reports
Age 68205 reports
Age 78201 reports
Age 62200 reports
Age 70200 reports
Age 73200 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 TOLTERODINE TARTRATE?

This profile reflects 33,596 FDA FAERS reports that mention TOLTERODINE TARTRATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TOLTERODINE TARTRATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, DIZZINESS, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures TOLTERODINE TARTRATE?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with TOLTERODINE TARTRATE. 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.