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ROCURONIUM BROMIDE

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Rocuronium Bromide Adverse Events Reported to the FDA Over Time

How are Rocuronium Bromide adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Rocuronium Bromide, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rocuronium Bromide is flagged as the suspect drug causing the adverse event.

Most Common Rocuronium Bromide Adverse Events Reported to the FDA

What are the most common Rocuronium Bromide adverse events reported to the FDA?

Cardiac Arrest
104 (3.05%)
Hypotension
101 (2.96%)
Anaphylactic Reaction
91 (2.67%)
Neuromuscular Block Prolonged
78 (2.29%)
Anaphylactic Shock
74 (2.17%)
Drug Ineffective
66 (1.94%)
Bronchospasm
63 (1.85%)
Tachycardia
56 (1.64%)
Rhabdomyolysis
50 (1.47%)
Bradycardia
45 (1.32%)
Drug Rash With Eosinophilia And Sys...
37 (1.09%)
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Delayed Recovery From Anaesthesia
35 (1.03%)
Drug Effect Decreased
32 (.94%)
Blood Pressure Decreased
31 (.91%)
Anaesthetic Complication
30 (.88%)
Cardio-respiratory Arrest
30 (.88%)
Circulatory Collapse
30 (.88%)
Oxygen Saturation Decreased
29 (.85%)
Drug Interaction
28 (.82%)
Urticaria
25 (.73%)
Heart Rate Increased
24 (.7%)
Serotonin Syndrome
24 (.7%)
Respiratory Arrest
23 (.67%)
Procedural Complication
22 (.65%)
Ventricular Fibrillation
22 (.65%)
Erythema
21 (.62%)
Myoclonus
21 (.62%)
Asthenia
20 (.59%)
Hypoxia
20 (.59%)
Pulmonary Oedema
20 (.59%)
Ventricular Tachycardia
20 (.59%)
Apnoea
19 (.56%)
Dyspnoea
19 (.56%)
Endotracheal Intubation Complicatio...
19 (.56%)
Hypertension
19 (.56%)
Post Procedural Complication
19 (.56%)
Blood Pressure Increased
18 (.53%)
Stevens-johnson Syndrome
18 (.53%)
Agitation
17 (.5%)
Hyperthermia Malignant
17 (.5%)
Product Quality Issue
17 (.5%)
Pupillary Reflex Impaired
17 (.5%)
Renal Failure
17 (.5%)
Drug Exposure During Pregnancy
16 (.47%)
Staring
16 (.47%)
Atrial Fibrillation
15 (.44%)
Hyperhidrosis
15 (.44%)
No Therapeutic Response
15 (.44%)
Paralysis
15 (.44%)
Septic Shock
15 (.44%)
Acute Respiratory Distress Syndrome
14 (.41%)
Caesarean Section
14 (.41%)
Flushing
14 (.41%)
Mydriasis
14 (.41%)
Rash
14 (.41%)
Anuria
13 (.38%)
Blood Phosphorus Increased
13 (.38%)
Cough
13 (.38%)
Drug Hypersensitivity
13 (.38%)
Drug Toxicity
13 (.38%)
Skin Test Positive
13 (.38%)
Akathisia
12 (.35%)
Blood Calcium Increased
12 (.35%)
Cyanosis
12 (.35%)
Electrocardiogram St Segment Depres...
12 (.35%)
Electrocardiogram St Segment Elevat...
12 (.35%)
Hypoventilation
12 (.35%)
Muscle Twitching
12 (.35%)
Pleural Effusion
12 (.35%)
Restlessness
12 (.35%)
Speech Disorder
12 (.35%)
White Blood Cell Count Increased
12 (.35%)
C-reactive Protein Increased
11 (.32%)
Drug Effect Prolonged
11 (.32%)
Electrocardiogram Qt Prolonged
11 (.32%)
Electromechanical Dissociation
11 (.32%)
Extensor Plantar Response
11 (.32%)
Medication Error
11 (.32%)
Myocardial Infarction
11 (.32%)
Premature Baby
11 (.32%)
Torsade De Pointes
11 (.32%)
Unresponsive To Stimuli
11 (.32%)
Wheezing
11 (.32%)
Anaphylactoid Reaction
10 (.29%)
Arteriospasm Coronary
10 (.29%)
Glasgow Coma Scale Abnormal
10 (.29%)
Hypersensitivity
10 (.29%)
Maternal Drugs Affecting Foetus
10 (.29%)
Muscle Rigidity
10 (.29%)
Muscular Weakness
10 (.29%)
Respiratory Failure
10 (.29%)
Tongue Oedema
10 (.29%)
Blood Creatine Phosphokinase Increa...
9 (.26%)
Coma
9 (.26%)
Completed Suicide
9 (.26%)
Drug Effect Increased
9 (.26%)
Generalised Erythema
9 (.26%)
Hyperreflexia
9 (.26%)
Multi-organ Failure
9 (.26%)
Rash Erythematous
9 (.26%)
Respiratory Depression
9 (.26%)

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This graph shows the top adverse events submitted to the FDA for Rocuronium Bromide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rocuronium Bromide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Rocuronium Bromide

What are the most common Rocuronium Bromide adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Rocuronium Bromide, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rocuronium Bromide is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Rocuronium Bromide According to Those Reporting Adverse Events

Why are people taking Rocuronium Bromide, according to those reporting adverse events to the FDA?

Anaesthesia
190
Induction Of Anaesthesia
161
Neuromuscular Blocking Therapy
114
Muscle Relaxant Therapy
110
General Anaesthesia
106
Product Used For Unknown Indication
103
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Hypotonia
100
Drug Use For Unknown Indication
85
Endotracheal Intubation
53
Neuromuscular Blockade
52
Surgery
37
Anaesthesia Procedure
36
Intubation
22
Maintenance Of Anaesthesia
18
Induction And Maintenance Of Anaest...
15
Paralysis
13
Sensory Disturbance
11
Sedation
9
Preoperative Care
8
Relaxation Therapy
7
Drug Exposure During Pregnancy
5
Respiratory Disorder
3
Hernia
3
Sedative Therapy
3
Neuromuscular Blockade Reversal
3
Mechanical Ventilation
3
Ill-defined Disorder
3
Crohns Disease
2
Arrhythmia
2
Head And Neck Cancer
2
Supportive Care
2
Gastrointestinal Surgery
1
Thyroglossal Cyst Excision
1
Respiration Abnormal
1
Respiratory Failure
1
Adenoidectomy
1
Cervical Spinal Stenosis
1
Feeling Of Relaxation
1
Bronchoscopy
1
Colectomy
1
Therapeutic Hypothermia
1
Unwanted Awareness During Anaesthes...
1
Injury
1
Therapeutic Procedure
1
Anaesthetic Premedication
1
Spinal Cord Disorder
1
Splenectomy
1
Medical Device Removal
1
Ventriculo-peritoneal Shunt
1
Trismus
1
Allergy Test
1

Drug Labels

LabelLabelerEffective
Rocuronium BromideGeneraMedix Inc.17-FEB-09
RocuroniumAPP Pharmaceuticals, LLC30-APR-11
Rocuronium BromideHospira, Inc.05-JUL-11
Rocuronium BromideSagent Pharmaceuticals10-APR-12
Rocuronium BromideTeva Parenteral Medicines, Inc12-JUL-12
RocuroniumThe Medicines Company31-JUL-12
ZemuronOrganon USA Inc.16-AUG-12
Rocuronium BromideMylan Institutional LLC31-AUG-12
Rocuronium BromideSandoz Inc28-SEP-12
Rocuronium BromideX-GEN Pharmaceuticals, Inc.06-DEC-12
Rocuronium BromideMylan Institutional LLC31-MAR-13

Rocuronium Bromide Case Reports

What Rocuronium Bromide safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Rocuronium Bromide. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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