ROPIVACAINE HYDROCHLORIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

6,839 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ROPIVACAINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Fresenius Kabi USA, LLC. The most commonly reported adverse reactions for ROPIVACAINE HYDROCHLORIDE include DYSPNOEA, VOMITING, DRUG HYPERSENSITIVITY, PNEUMONIA, OEDEMA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROPIVACAINE HYDROCHLORIDE.

Top Adverse Reactions

DYSPNOEA506 reports
VOMITING503 reports
DRUG HYPERSENSITIVITY489 reports
PNEUMONIA486 reports
OEDEMA481 reports
ASTHMA467 reports
WHEEZING458 reports
PAIN213 reports
MALAISE189 reports
RESPIRATORY TRACT INFECTION170 reports
DRUG INEFFECTIVE168 reports
CHEST PAIN161 reports
COUGH150 reports
HYPOTENSION109 reports
NASAL OEDEMA104 reports
ANAPHYLACTIC SHOCK77 reports
HYPOAESTHESIA74 reports
CARDIAC ARREST69 reports
TACHYCARDIA54 reports
CONVULSION52 reports
BRADYCARDIA51 reports
ANAESTHETIC COMPLICATION41 reports
LOSS OF CONSCIOUSNESS41 reports
LOCAL ANAESTHETIC SYSTEMIC TOXICITY40 reports
NAUSEA39 reports
ANAPHYLACTIC REACTION38 reports
OFF LABEL USE38 reports
SOMNOLENCE36 reports
MATERNAL EXPOSURE DURING PREGNANCY35 reports
TOXICITY TO VARIOUS AGENTS35 reports
MUSCULAR WEAKNESS33 reports
RENAL FAILURE ACUTE33 reports
ERYTHEMA32 reports
HEADACHE31 reports
INCORRECT DOSE ADMINISTERED30 reports
MOVEMENT DISORDER30 reports
DIZZINESS29 reports
GRAND MAL CONVULSION29 reports
PYREXIA29 reports
MUSCULOSKELETAL PAIN28 reports
PARAESTHESIA28 reports
MEDICATION ERROR27 reports
PHRENIC NERVE PARALYSIS27 reports
GENERALISED TONIC CLONIC SEIZURE26 reports
OVERDOSE26 reports
RESPIRATORY DEPRESSION26 reports
BLOOD PRESSURE DECREASED25 reports
DYSPHAGIA25 reports
HAEMATURIA25 reports
NEUROTOXICITY25 reports
PRURITUS23 reports
TRACHEAL DEVIATION23 reports
OLIGURIA22 reports
POST PROCEDURAL COMPLICATION22 reports
RESPIRATORY FAILURE22 reports
CONFUSIONAL STATE21 reports
DRUG TOXICITY20 reports
EPILEPSY20 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED20 reports
HYPERTENSION20 reports
METABOLIC ACIDOSIS20 reports
OXYGEN SATURATION DECREASED20 reports
PARAPLEGIA20 reports
SUSPECTED PRODUCT QUALITY ISSUE20 reports
THERAPEUTIC PRODUCT EFFECT PROLONGED20 reports
ARTHROPATHY19 reports
CAESAREAN SECTION19 reports
CIRCULATORY COLLAPSE19 reports
MATERNAL EXPOSURE DURING DELIVERY19 reports
MOTOR DYSFUNCTION19 reports
RASH19 reports
STAPHYLOCOCCAL INFECTION19 reports
ASTHENIA18 reports
CAUDA EQUINA SYNDROME18 reports
CONSTIPATION18 reports
DELAYED RECOVERY FROM ANAESTHESIA18 reports
DRUG EXPOSURE DURING PREGNANCY18 reports
DYSKINESIA18 reports
CARDIO RESPIRATORY ARREST17 reports
CEREBRAL HAEMORRHAGE17 reports
CHEST DISCOMFORT17 reports
FALL17 reports
PLATELET COUNT DECREASED17 reports
BACK PAIN16 reports
BRONCHOSPASM16 reports
FOETAL EXPOSURE DURING PREGNANCY16 reports
MONOPLEGIA16 reports
SHOCK16 reports
SOPOR16 reports
URINARY RETENTION16 reports
AGITATION15 reports
ANURIA15 reports
ANXIETY15 reports
DRUG EFFECT DECREASED15 reports
EXPOSURE DURING PREGNANCY15 reports
INCORRECT ROUTE OF DRUG ADMINISTRATION15 reports
PARALYSIS15 reports
RESPIRATORY ARREST15 reports
SEIZURE15 reports
VENTRICULAR FIBRILLATION15 reports

Report Outcomes

Out of 2,221 classified reports for ROPIVACAINE HYDROCHLORIDE:

Serious 89.4%Non-Serious 10.6%

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

Female1,369 (73.1%)
Male495 (26.4%)
Unknown8 (0.4%)

Reports by Age

Age 65447 reports
Age 5437 reports
Age 7035 reports
Age 6733 reports
Age 4626 reports
Age 7223 reports
Age 3422 reports
Age 6122 reports
Age 1921 reports
Age 5021 reports
Age 6021 reports
Age 8321 reports
Age 2620 reports
Age 2920 reports
Age 3020 reports
Age 4920 reports
Age 5920 reports
Age 3319 reports
Age 4819 reports
Age 5319 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 ROPIVACAINE HYDROCHLORIDE?

This profile reflects 6,839 FDA FAERS reports that mention ROPIVACAINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROPIVACAINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DYSPNOEA, VOMITING, DRUG HYPERSENSITIVITY, PNEUMONIA, OEDEMA, ASTHMA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROPIVACAINE HYDROCHLORIDE?

Labeling and FAERS entries often list Fresenius Kabi USA, LLC in connection with ROPIVACAINE 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.