CYCLOBENZAPRINE HYDROCHLORIDE

N/A

Manufactured by Cephalon, LLC

32,882 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CYCLOBENZAPRINE HYDROCHLORIDE

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

Top Adverse Reactions

PAIN1,297 reports
HEADACHE979 reports
FATIGUE972 reports
DRUG INEFFECTIVE728 reports
CONSTIPATION680 reports
OFF LABEL USE663 reports
NAUSEA660 reports
BACK PAIN603 reports
FALL587 reports
RHEUMATOID ARTHRITIS494 reports
DYSPNOEA478 reports
DIARRHOEA466 reports
DRUG HYPERSENSITIVITY463 reports
HYPERSENSITIVITY457 reports
PRODUCT DOSE OMISSION ISSUE456 reports
ASTHMA455 reports
RASH448 reports
HYPERHIDROSIS439 reports
HYPERTENSION437 reports
UPPER RESPIRATORY TRACT INFECTION433 reports
HEPATIC ENZYME INCREASED414 reports
ARTHRALGIA406 reports
VOMITING401 reports
ERYTHEMA397 reports
PYREXIA386 reports
FLUID RETENTION375 reports
IMMUNODEFICIENCY374 reports
FOOD ALLERGY365 reports
HYPOTENSION362 reports
DIZZINESS357 reports
JOINT SWELLING356 reports
RASH ERYTHEMATOUS351 reports
BURSITIS344 reports
DRUG INTOLERANCE344 reports
PRODUCT USE ISSUE344 reports
PAIN IN EXTREMITY329 reports
OVERDOSE323 reports
COELIAC DISEASE318 reports
BALANCE DISORDER314 reports
TEMPERATURE REGULATION DISORDER309 reports
INFUSION RELATED REACTION306 reports
MOBILITY DECREASED305 reports
TOXICITY TO VARIOUS AGENTS292 reports
INFECTION291 reports
PNEUMONIA290 reports
WEIGHT DECREASED281 reports
COGNITIVE DISORDER277 reports
PRURITUS276 reports
COVID 19274 reports
ABDOMINAL PAIN UPPER271 reports
MALAISE269 reports
MIGRAINE269 reports
SEDATION267 reports
DEPRESSED LEVEL OF CONSCIOUSNESS265 reports
COUGH264 reports
SINUSITIS264 reports
ASTHENIA263 reports
URINARY TRACT INFECTION262 reports
HYPOAESTHESIA258 reports
CONTRAINDICATED PRODUCT ADMINISTERED255 reports
ORTHOSTATIC HYPOTENSION250 reports
INTENTIONAL PRODUCT MISUSE248 reports
BLOOD CALCIUM DECREASED246 reports
ANXIETY243 reports
SEDATION COMPLICATION241 reports
CREATININE RENAL CLEARANCE DECREASED240 reports
INSOMNIA237 reports
PRODUCT USE IN UNAPPROVED INDICATION237 reports
PRESCRIBED OVERDOSE236 reports
NASOPHARYNGITIS233 reports
PSORIASIS231 reports
MEMORY IMPAIRMENT227 reports
ILLNESS222 reports
THROMBOCYTOPENIA222 reports
CONDITION AGGRAVATED221 reports
DEPRESSION221 reports
EXPOSURE DURING PREGNANCY218 reports
MUSCLE SPASMS216 reports
WEIGHT INCREASED212 reports
GASTROOESOPHAGEAL REFLUX DISEASE211 reports
PARAESTHESIA210 reports
TREATMENT FAILURE206 reports
CHEST PAIN203 reports
DEATH197 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION194 reports
SOMNOLENCE192 reports
FEELING ABNORMAL186 reports
PERIPHERAL SWELLING185 reports
GAIT DISTURBANCE178 reports
ABDOMINAL PAIN166 reports
FOETAL DEATH164 reports
BLOOD PRESSURE INCREASED162 reports
ABDOMINAL DISCOMFORT160 reports
EYE PAIN156 reports
INJECTION SITE PAIN150 reports
ALOPECIA147 reports
DECREASED APPETITE147 reports
NECK PAIN139 reports
BRONCHITIS136 reports
INFLUENZA129 reports

Report Outcomes

Out of 7,993 classified reports for CYCLOBENZAPRINE HYDROCHLORIDE:

Serious 60.5%Non-Serious 39.5%

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

Female5,629 (76.5%)
Male1,714 (23.3%)
Unknown19 (0.3%)

Reports by Age

Age 58325 reports
Age 77279 reports
Age 43134 reports
Age 61133 reports
Age 60125 reports
Age 63124 reports
Age 62123 reports
Age 55116 reports
Age 57116 reports
Age 64114 reports
Age 50108 reports
Age 54108 reports
Age 51107 reports
Age 52107 reports
Age 56105 reports
Age 53102 reports
Age 66102 reports
Age 6798 reports
Age 5997 reports
Age 3695 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 CYCLOBENZAPRINE HYDROCHLORIDE?

This profile reflects 32,882 FDA FAERS reports that mention CYCLOBENZAPRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CYCLOBENZAPRINE HYDROCHLORIDE?

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

Who manufactures CYCLOBENZAPRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Cephalon, LLC in connection with CYCLOBENZAPRINE 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.