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ISOFLURANE

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Isoflurane Adverse Events Reported to the FDA Over Time

How are Isoflurane adverse event reports trending over time?

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

Most Common Isoflurane Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
35 (2.41%)
Cardiac Arrest
30 (2.07%)
Therapeutic Agent Toxicity
27 (1.86%)
Bradycardia
26 (1.79%)
Hypotension
26 (1.79%)
Drug Interaction
22 (1.52%)
Premature Baby
22 (1.52%)
Torsade De Pointes
22 (1.52%)
Tachycardia
21 (1.45%)
Post Procedural Complication
20 (1.38%)
Caesarean Section
18 (1.24%)
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Myotonia
18 (1.24%)
Dystonia
17 (1.17%)
Sinus Tachycardia
15 (1.03%)
Somnolence
15 (1.03%)
Ventricular Tachycardia
15 (1.03%)
Anaesthetic Complication
14 (.97%)
Ventricular Fibrillation
14 (.97%)
Convulsion
13 (.9%)
Heart Rate Increased
13 (.9%)
Oxygen Saturation Decreased
13 (.9%)
Blood Pressure Decreased
12 (.83%)
Myoclonus
12 (.83%)
Nuclear Magnetic Resonance Imaging ...
12 (.83%)
Pulmonary Hypertension
12 (.83%)
Acute Hepatic Failure
11 (.76%)
Hyperthermia Malignant
11 (.76%)
Abdominal Distension
10 (.69%)
Alanine Aminotransferase Increased
10 (.69%)
Aspartate Aminotransferase Increase...
10 (.69%)
Delayed Recovery From Anaesthesia
10 (.69%)
Electrocardiogram Qt Prolonged
10 (.69%)
Maternal Drugs Affecting Foetus
10 (.69%)
Nausea
10 (.69%)
Stridor
10 (.69%)
Tachypnoea
10 (.69%)
Blood Creatine Phosphokinase Increa...
9 (.62%)
Hepatic Necrosis
9 (.62%)
Premature Labour
9 (.62%)
Renal Impairment
9 (.62%)
Conversion Disorder
8 (.55%)
Death
8 (.55%)
Haemodynamic Instability
8 (.55%)
Hyperkalaemia
8 (.55%)
Incorrect Route Of Drug Administrat...
8 (.55%)
Metabolic Acidosis
8 (.55%)
Respiratory Arrest
8 (.55%)
Vomiting
8 (.55%)
Aphasia
7 (.48%)
Blood Lactate Dehydrogenase Increas...
7 (.48%)
Coma
7 (.48%)
Fall
7 (.48%)
Hepatomegaly
7 (.48%)
Loss Of Consciousness
7 (.48%)
No Therapeutic Response
7 (.48%)
Pulmonary Oedema
7 (.48%)
Activated Partial Thromboplastin Ti...
6 (.41%)
Agitation
6 (.41%)
Apnoea
6 (.41%)
Blood Potassium Increased
6 (.41%)
Coagulopathy
6 (.41%)
Confusional State
6 (.41%)
Depressed Level Of Consciousness
6 (.41%)
Disorientation
6 (.41%)
Electrocardiogram St Segment Depres...
6 (.41%)
Haemodialysis
6 (.41%)
Headache
6 (.41%)
Hydronephrosis
6 (.41%)
Overdose
6 (.41%)
Premature Rupture Of Membranes
6 (.41%)
Procedural Complication
6 (.41%)
Rhabdomyolysis
6 (.41%)
Tumour Lysis Syndrome
6 (.41%)
Urinoma
6 (.41%)
Blood Creatinine Increased
5 (.34%)
Deafness Neurosensory
5 (.34%)
Drug Toxicity
5 (.34%)
Electrocardiogram St Segment Elevat...
5 (.34%)
Gamma-glutamyltransferase Increased
5 (.34%)
Hypokalaemia
5 (.34%)
Migraine With Aura
5 (.34%)
Movement Disorder
5 (.34%)
Respiratory Acidosis
5 (.34%)
Restlessness
5 (.34%)
Supraventricular Extrasystoles
5 (.34%)
Arrhythmia
4 (.28%)
Blood Bilirubin Increased
4 (.28%)
Body Temperature Increased
4 (.28%)
Cardio-respiratory Arrest
4 (.28%)
Chills
4 (.28%)
Condition Aggravated
4 (.28%)
Cough
4 (.28%)
Electromechanical Dissociation
4 (.28%)
Heart Sounds Abnormal
4 (.28%)
Hemiparesis
4 (.28%)
Hypertension
4 (.28%)
Hypertensive Crisis
4 (.28%)
Hyperventilation
4 (.28%)
Hypocalcaemia
4 (.28%)
Hypocoagulable State
4 (.28%)
Hypoxia
4 (.28%)

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

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

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

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

Anaesthesia
161
Maintenance Of Anaesthesia
100
General Anaesthesia
95
Product Used For Unknown Indication
29
Drug Use For Unknown Indication
21
Varicose Vein Operation
12
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Sedation
7
Induction Of Anaesthesia
6
Anaesthesia Procedure
5
Drug Exposure During Pregnancy
4
Status Epilepticus
4
Catheterisation Cardiac
2
Gastrectomy
2
Maternal Exposure During Pregnancy
2
Accidental Exposure
2
Oral Surgery
2
Hip Arthroplasty
2
Nuclear Magnetic Resonance Imaging
1
Preoperative Care
1
Status Asthmaticus
1
Unevaluable Event
1
Prophylaxis
1
Heart Disease Congenital
1
Debridement
1
Ill-defined Disorder
1
Antibiotic Prophylaxis
1
Heart Transplant
1
Bronchospasm
1
Barotrauma
1
Vomiting
1
Perioperative Analgesia
1
Hot Flush
1
Anaesthesia Reversal
1
Caesarean Section
1
Maternal Exposure Timing Unspecifie...
1
Asthma
1
Hypotension
1
Renal Transplant
1
Induction And Maintenance Of Anaest...
1
Jaw Operation
1
Bile Duct Stent Insertion
1
Psoriasis
1

Drug Labels

LabelLabelerEffective
Isoflurane Piramal Critical Care Inc13-OCT-11
ForaneBaxter Healthcare Corporation15-DEC-11

Isoflurane Case Reports

What Isoflurane 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 Isoflurane. 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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