TIZANIDINE HYDROCHLORIDE

N/A

Manufactured by Covis Pharma US, Inc

43,968 FDA adverse event reports analyzed

Last updated: 2026-04-14

About TIZANIDINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Covis Pharma US, Inc. The most commonly reported adverse reactions for TIZANIDINE HYDROCHLORIDE include FATIGUE, PAIN, NAUSEA, HEADACHE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TIZANIDINE HYDROCHLORIDE.

Top Adverse Reactions

FATIGUE1,468 reports
PAIN1,425 reports
NAUSEA1,410 reports
HEADACHE1,356 reports
DRUG INEFFECTIVE1,215 reports
FALL1,006 reports
DIZZINESS901 reports
DYSPNOEA836 reports
DIARRHOEA831 reports
ARTHRALGIA768 reports
DEPRESSION759 reports
VOMITING758 reports
ASTHENIA748 reports
BACK PAIN715 reports
ANXIETY675 reports
SOMNOLENCE652 reports
INSOMNIA616 reports
PAIN IN EXTREMITY616 reports
MUSCLE SPASMS605 reports
URINARY TRACT INFECTION602 reports
GAIT DISTURBANCE577 reports
OFF LABEL USE562 reports
WEIGHT DECREASED556 reports
PRODUCT DOSE OMISSION ISSUE555 reports
PNEUMONIA553 reports
MALAISE545 reports
PRURITUS527 reports
HYPOAESTHESIA513 reports
RASH487 reports
FEELING ABNORMAL481 reports
CONSTIPATION469 reports
HYPERTENSION465 reports
COUGH463 reports
CONDITION AGGRAVATED455 reports
PYREXIA438 reports
GASTROOESOPHAGEAL REFLUX DISEASE437 reports
DRUG HYPERSENSITIVITY422 reports
MIGRAINE419 reports
WEIGHT INCREASED417 reports
CHEST PAIN406 reports
COVID 19399 reports
MULTIPLE SCLEROSIS RELAPSE399 reports
TREMOR397 reports
SINUSITIS394 reports
MEMORY IMPAIRMENT393 reports
HYPOTENSION385 reports
LOSS OF CONSCIOUSNESS346 reports
PARAESTHESIA344 reports
INJECTION SITE PAIN341 reports
ABDOMINAL PAIN338 reports
BLOOD PRESSURE INCREASED330 reports
MYALGIA320 reports
MULTIPLE SCLEROSIS309 reports
CHRONIC KIDNEY DISEASE306 reports
MUSCULAR WEAKNESS303 reports
ABDOMINAL PAIN UPPER298 reports
NASOPHARYNGITIS295 reports
ACUTE KIDNEY INJURY288 reports
CONFUSIONAL STATE284 reports
HYPERHIDROSIS282 reports
DEHYDRATION281 reports
ABDOMINAL DISCOMFORT279 reports
BALANCE DISORDER278 reports
CHILLS278 reports
DECREASED APPETITE278 reports
BRONCHITIS276 reports
CONTUSION275 reports
ILLNESS275 reports
NECK PAIN272 reports
VISION BLURRED271 reports
RENAL FAILURE269 reports
DEATH262 reports
PERIPHERAL SWELLING257 reports
ALOPECIA253 reports
INFLUENZA253 reports
INFLUENZA LIKE ILLNESS253 reports
FLUSHING252 reports
COMA251 reports
ASTHMA244 reports
MUSCULOSKELETAL STIFFNESS238 reports
PNEUMONIA ASPIRATION236 reports
VISUAL IMPAIRMENT234 reports
ERYTHEMA232 reports
HYPERSENSITIVITY228 reports
OEDEMA PERIPHERAL225 reports
PRODUCT USE IN UNAPPROVED INDICATION219 reports
INFECTION214 reports
DYSPHAGIA213 reports
ANAEMIA212 reports
SEIZURE209 reports
DRUG WITHDRAWAL SYNDROME208 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION206 reports
MYOCARDIAL INFARCTION206 reports
DRUG INTERACTION203 reports
ARTHRITIS198 reports
SUICIDAL IDEATION198 reports
URTICARIA197 reports
HALLUCINATION196 reports
NEUROPATHY PERIPHERAL191 reports
CEREBROVASCULAR ACCIDENT188 reports

Report Outcomes

Out of 17,228 classified reports for TIZANIDINE HYDROCHLORIDE:

Serious 59.3%Non-Serious 40.7%

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

Female12,876 (78.4%)
Male3,533 (21.5%)
Unknown18 (0.1%)

Reports by Age

Age 64343 reports
Age 55322 reports
Age 58316 reports
Age 53312 reports
Age 57306 reports
Age 51303 reports
Age 60296 reports
Age 52295 reports
Age 54295 reports
Age 59289 reports
Age 49282 reports
Age 56278 reports
Age 61274 reports
Age 50268 reports
Age 45249 reports
Age 62248 reports
Age 48242 reports
Age 63238 reports
Age 46237 reports
Age 44223 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 TIZANIDINE HYDROCHLORIDE?

This profile reflects 43,968 FDA FAERS reports that mention TIZANIDINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for TIZANIDINE HYDROCHLORIDE?

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

Who manufactures TIZANIDINE HYDROCHLORIDE?

Labeling and FAERS entries often list Covis Pharma US, Inc in connection with TIZANIDINE HYDROCHLORIDE. 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.