ROCURONIUM BROMIDE

N/A

Manufactured by Fresenius Kabi USA, LLC

16,854 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ROCURONIUM BROMIDE

ROCURONIUM BROMIDE 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 ROCURONIUM BROMIDE include ANAPHYLACTIC REACTION, HYPOTENSION, DRUG INEFFECTIVE, ANAPHYLACTIC SHOCK, CARDIAC ARREST. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ROCURONIUM BROMIDE.

Top Adverse Reactions

ANAPHYLACTIC REACTION1,192 reports
HYPOTENSION1,064 reports
DRUG INEFFECTIVE1,023 reports
ANAPHYLACTIC SHOCK897 reports
CARDIAC ARREST635 reports
DRUG INTERACTION443 reports
BRADYCARDIA390 reports
TACHYCARDIA389 reports
OFF LABEL USE380 reports
BRONCHOSPASM343 reports
URTICARIA267 reports
RASH262 reports
RESPIRATORY FAILURE249 reports
HYPOXIA241 reports
OXYGEN SATURATION DECREASED240 reports
SEROTONIN SYNDROME223 reports
CIRCULATORY COLLAPSE211 reports
BLOOD PRESSURE DECREASED190 reports
CONDITION AGGRAVATED186 reports
FOETAL EXPOSURE DURING PREGNANCY186 reports
HYPERTHERMIA MALIGNANT186 reports
DYSPNOEA169 reports
ERYTHEMA165 reports
ACUTE KIDNEY INJURY157 reports
RENAL FAILURE153 reports
NEUROMUSCULAR BLOCK PROLONGED145 reports
PAIN145 reports
PREMATURE BABY144 reports
MATERNAL EXPOSURE DURING PREGNANCY142 reports
HYPERTENSION140 reports
PULMONARY OEDEMA135 reports
TOXICITY TO VARIOUS AGENTS133 reports
DRUG HYPERSENSITIVITY132 reports
ANGIOEDEMA127 reports
HYPERSENSITIVITY125 reports
RESPIRATORY ARREST123 reports
VENTRICULAR TACHYCARDIA123 reports
STRESS CARDIOMYOPATHY120 reports
DELAYED RECOVERY FROM ANAESTHESIA118 reports
OVERDOSE115 reports
SEPSIS114 reports
VENTRICULAR FIBRILLATION113 reports
HYPERKALAEMIA111 reports
HAEMODYNAMIC INSTABILITY110 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME109 reports
PNEUMONIA108 reports
ALANINE AMINOTRANSFERASE INCREASED107 reports
PRODUCT USE IN UNAPPROVED INDICATION107 reports
RHABDOMYOLYSIS107 reports
PULSELESS ELECTRICAL ACTIVITY106 reports
PYREXIA105 reports
EXPOSURE DURING PREGNANCY101 reports
RECURRENCE OF NEUROMUSCULAR BLOCKADE101 reports
RESPIRATORY DEPRESSION100 reports
RENAL IMPAIRMENT99 reports
DEATH98 reports
ANXIETY96 reports
METABOLIC ACIDOSIS95 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED93 reports
NAUSEA91 reports
SHOCK91 reports
CARDIO RESPIRATORY ARREST89 reports
PARALYSIS89 reports
HAEMORRHAGE88 reports
VOMITING88 reports
CONTRAINDICATED PRODUCT ADMINISTERED86 reports
HYPOVENTILATION86 reports
KOUNIS SYNDROME86 reports
PREMATURE DELIVERY81 reports
PRODUCT QUALITY ISSUE79 reports
AGITATION77 reports
APNOEA77 reports
FLUSHING77 reports
PROCEDURAL HYPOTENSION76 reports
RESPIRATORY ACIDOSIS75 reports
ATRIAL FIBRILLATION73 reports
PERIPHERAL SWELLING73 reports
TROPONIN INCREASED73 reports
HYPERHIDROSIS72 reports
BLOOD LACTATE DEHYDROGENASE INCREASED71 reports
ELECTROCARDIOGRAM QT PROLONGED71 reports
INJURY71 reports
PLEURAL EFFUSION71 reports
PNEUMOTHORAX71 reports
TOXIC ENCEPHALOPATHY71 reports
TREATMENT FAILURE71 reports
HEART RATE INCREASED70 reports
SEPTIC SHOCK70 reports
BLOOD POTASSIUM INCREASED69 reports
COMA69 reports
EMOTIONAL DISTRESS69 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS68 reports
ASTHENIA67 reports
RESPIRATORY DISTRESS67 reports
UNEVALUABLE EVENT67 reports
DRUG EFFECT DECREASED66 reports
ACUTE RESPIRATORY DISTRESS SYNDROME65 reports
AMYLASE INCREASED65 reports
ANAESTHETIC COMPLICATION65 reports
COUGH65 reports

Report Outcomes

Out of 10,765 classified reports for ROCURONIUM BROMIDE:

Serious 91.5%Non-Serious 8.5%

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

Female4,772 (51.5%)
Male4,440 (47.9%)
Unknown57 (0.6%)

Reports by Age

Age 49232 reports
Age 62192 reports
Age 71188 reports
Age 65185 reports
Age 60180 reports
Age 67176 reports
Age 68170 reports
Age 75159 reports
Age 55158 reports
Age 57157 reports
Age 59155 reports
Age 74155 reports
Age 64154 reports
Age 46153 reports
Age 63148 reports
Age 69146 reports
Age 73143 reports
Age 44140 reports
Age 58140 reports
Age 54137 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 ROCURONIUM BROMIDE?

This profile reflects 16,854 FDA FAERS reports that mention ROCURONIUM BROMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ROCURONIUM BROMIDE?

Frequently reported terms in FAERS include ANAPHYLACTIC REACTION, HYPOTENSION, DRUG INEFFECTIVE, ANAPHYLACTIC SHOCK, CARDIAC ARREST, DRUG INTERACTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ROCURONIUM BROMIDE?

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