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PRECEDEX

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Precedex Adverse Events Reported to the FDA Over Time

How are Precedex adverse event reports trending over time?

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

Most Common Precedex Adverse Events Reported to the FDA

What are the most common Precedex adverse events reported to the FDA?

Bradycardia
44 (3.88%)
Drug Rash With Eosinophilia And Sys...
38 (3.35%)
Hypotension
34 (3%)
Cardiac Arrest
31 (2.73%)
Drug Interaction
17 (1.5%)
Agitation
15 (1.32%)
Blood Pressure Decreased
14 (1.23%)
Condition Aggravated
13 (1.15%)
Respiratory Arrest
13 (1.15%)
Blood Pressure Increased
12 (1.06%)
Post Procedural Complication
12 (1.06%)
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Respiratory Depression
12 (1.06%)
Tachycardia
12 (1.06%)
Oxygen Saturation Decreased
11 (.97%)
Procedural Complication
11 (.97%)
Prothrombin Time Prolonged
11 (.97%)
Vomiting
11 (.97%)
Aspartate Aminotransferase Increase...
10 (.88%)
Blood Albumin Decreased
10 (.88%)
Convulsion
10 (.88%)
Depressed Level Of Consciousness
10 (.88%)
Hypertension
10 (.88%)
Atrioventricular Block Second Degre...
9 (.79%)
Cardiac Tamponade
9 (.79%)
Glossoptosis
9 (.79%)
Alanine Aminotransferase Increased
8 (.71%)
Heart Rate Increased
8 (.71%)
Off Label Use
8 (.71%)
Pyrexia
8 (.71%)
Restlessness
8 (.71%)
Sedation
8 (.71%)
White Blood Cell Count Decreased
8 (.71%)
Anxiety
7 (.62%)
Cardio-respiratory Arrest
7 (.62%)
Multi-organ Failure
7 (.62%)
Unresponsive To Stimuli
7 (.62%)
Ventricular Fibrillation
7 (.62%)
Apnoea
6 (.53%)
Blood Creatine Phosphokinase Increa...
6 (.53%)
Cerebral Infarction
6 (.53%)
Dyskinesia
6 (.53%)
Dyspnoea
6 (.53%)
Hypoxia
6 (.53%)
Idiopathic Pulmonary Fibrosis
6 (.53%)
Loss Of Consciousness
6 (.53%)
Lymphocyte Stimulation Test Positiv...
6 (.53%)
Pulse Absent
6 (.53%)
Renal Impairment
6 (.53%)
Respiratory Failure
6 (.53%)
Salivary Hypersecretion
6 (.53%)
Upper Airway Obstruction
6 (.53%)
Drug Withdrawal Syndrome
5 (.44%)
Erythema
5 (.44%)
Hepatic Function Abnormal
5 (.44%)
Hyperthermia
5 (.44%)
Musculoskeletal Stiffness
5 (.44%)
Myocardial Infarction
5 (.44%)
Neuroleptic Malignant Syndrome
5 (.44%)
Obstructive Airways Disorder
5 (.44%)
Pain
5 (.44%)
Platelet Count Decreased
5 (.44%)
Pulmonary Oedema
5 (.44%)
Renal Failure
5 (.44%)
Respiratory Acidosis
5 (.44%)
Torsade De Pointes
5 (.44%)
Unevaluable Event
5 (.44%)
Acidosis
4 (.35%)
Aspiration
4 (.35%)
Atelectasis
4 (.35%)
Bronchospasm
4 (.35%)
Cardiomegaly
4 (.35%)
Central Venous Pressure Increased
4 (.35%)
Coronary Artery Stenosis
4 (.35%)
Electrocardiogram Qt Prolonged
4 (.35%)
Electromechanical Dissociation
4 (.35%)
Feeling Abnormal
4 (.35%)
Grand Mal Convulsion
4 (.35%)
Hyperhidrosis
4 (.35%)
Hypoalbuminaemia
4 (.35%)
Injury
4 (.35%)
Liver Disorder
4 (.35%)
Medication Error
4 (.35%)
Metabolic Acidosis
4 (.35%)
Peripheral Circulatory Failure
4 (.35%)
Pneumonia
4 (.35%)
Sinus Arrhythmia
4 (.35%)
Swelling
4 (.35%)
Urticaria
4 (.35%)
Ventricular Extrasystoles
4 (.35%)
Aggression
3 (.26%)
Anaesthetic Complication
3 (.26%)
Anhedonia
3 (.26%)
Asthma
3 (.26%)
Blister
3 (.26%)
Blood Pressure Fluctuation
3 (.26%)
Bradyarrhythmia
3 (.26%)
Cardiac Failure
3 (.26%)
Cardiac Index Decreased
3 (.26%)
Cardiogenic Shock
3 (.26%)
Cardiovascular Insufficiency
3 (.26%)
Clonic Convulsion
3 (.26%)

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This graph shows the top adverse events submitted to the FDA for Precedex, 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 Precedex 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 Precedex

What are the most common Precedex adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Precedex, 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 Precedex 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 Precedex According to Those Reporting Adverse Events

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

Sedation
182
Sedative Therapy
70
Product Used For Unknown Indication
35
Drug Use For Unknown Indication
15
Analgesic Therapy
10
Maintenance Of Anaesthesia
9
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Agitation
6
Alcohol Withdrawal Syndrome
5
Anaesthesia
5
Ill-defined Disorder
4
Endotracheal Intubation
3
Mechanical Ventilation
3
General Anaesthesia
3
Cardiac Failure
3
Anxiety
2
Multiple Myeloma
2
Obesity Surgery
2
Postoperative Care
2
Sleep Apnoea Syndrome
2
Intubation
2
Coronary Artery Bypass
2
Echocardiogram
1
Autonomic Nervous System Imbalance
1
Histiocytosis Haematophagic
1
Nuclear Magnetic Resonance Imaging
1
Pain
1
Craniotomy
1
Blood Pressure Management
1
Intracranial Haematoma
1
Blood Pressure Increased
1
Heart Rate Increased
1
Perioperative Analgesia
1
Induction Of Anaesthesia
1
Blood Pressure Fluctuation
1
Postoperative Analgesia
1
Hypotension
1
Weaning Failure
1
Surgery
1
Extubation
1
Cardiac Operation
1

Drug Labels

LabelLabelerEffective
PrecedexHospira, Inc.13-MAR-13

Precedex Case Reports

What Precedex 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 Precedex. 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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