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SEVOFLURANE

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Sevoflurane Adverse Events Reported to the FDA Over Time

How are Sevoflurane adverse event reports trending over time?

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

Most Common Sevoflurane Adverse Events Reported to the FDA

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

Hyperthermia
237 (3.51%)
Cardiac Arrest
177 (2.62%)
Nausea
144 (2.13%)
Vomiting
141 (2.09%)
Bradycardia
129 (1.91%)
Hypotension
114 (1.69%)
Hyperthermia Malignant
108 (1.6%)
Rhabdomyolysis
103 (1.52%)
Torsade De Pointes
83 (1.23%)
Ventricular Tachycardia
83 (1.23%)
Blood Pressure Decreased
81 (1.2%)
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Drug Interaction
81 (1.2%)
Ventricular Fibrillation
81 (1.2%)
Electrocardiogram Qt Prolonged
70 (1.04%)
Pulmonary Oedema
66 (.98%)
Metabolic Acidosis
63 (.93%)
Tachycardia
54 (.8%)
Delayed Recovery From Anaesthesia
49 (.73%)
Hepatic Failure
48 (.71%)
Anaesthetic Complication
46 (.68%)
Drug Exposure During Pregnancy
46 (.68%)
Oxygen Saturation Decreased
45 (.67%)
Anaphylactic Shock
41 (.61%)
Unwanted Awareness During Anaesthes...
41 (.61%)
Pyrexia
39 (.58%)
Renal Failure
39 (.58%)
Dystonia
38 (.56%)
Blood Creatine Phosphokinase Increa...
37 (.55%)
Overdose
37 (.55%)
Procedural Complication
37 (.55%)
Agitation
36 (.53%)
Congenital Anomaly
36 (.53%)
Alanine Aminotransferase Increased
35 (.52%)
Cardiac Failure
35 (.52%)
Aspartate Aminotransferase Increase...
34 (.5%)
Ventricular Extrasystoles
34 (.5%)
Convulsion
33 (.49%)
Liver Disorder
33 (.49%)
Respiratory Failure
32 (.47%)
Atrial Fibrillation
31 (.46%)
Renal Failure Acute
31 (.46%)
Coagulopathy
30 (.44%)
Heart Rate Decreased
30 (.44%)
Post Procedural Complication
30 (.44%)
Shock
30 (.44%)
Arteriospasm Coronary
28 (.41%)
Erythema
28 (.41%)
Multi-organ Failure
28 (.41%)
Myotonia
28 (.41%)
Acute Pulmonary Oedema
27 (.4%)
Circulatory Collapse
27 (.4%)
Stress Cardiomyopathy
27 (.4%)
Extrasystoles
26 (.38%)
Heart Rate Increased
26 (.38%)
Blood Pressure Increased
25 (.37%)
Drug Ineffective
25 (.37%)
Myocardial Infarction
25 (.37%)
Anaphylactic Reaction
24 (.36%)
Apnoea
24 (.36%)
Haemoglobin Decreased
24 (.36%)
Hypoxia
24 (.36%)
Liver Function Test Abnormal
24 (.36%)
Panic Reaction
24 (.36%)
Pulse Absent
24 (.36%)
Long Qt Syndrome
23 (.34%)
Electrocardiogram St Segment Elevat...
22 (.33%)
Jaundice
22 (.33%)
Cardio-respiratory Arrest
21 (.31%)
Cyanosis
21 (.31%)
Operative Haemorrhage
21 (.31%)
Staring
21 (.31%)
Supraventricular Tachycardia
21 (.31%)
Acidosis
20 (.3%)
Coma
20 (.3%)
Hepatotoxicity
20 (.3%)
Catatonia
19 (.28%)
Hepatic Function Abnormal
19 (.28%)
Hepatic Necrosis
19 (.28%)
Hepatitis
19 (.28%)
Hyperkalaemia
19 (.28%)
Hypertension
19 (.28%)
Laryngeal Oedema
19 (.28%)
Sinus Tachycardia
19 (.28%)
Chills
18 (.27%)
Dyspnoea
18 (.27%)
Muscle Rigidity
18 (.27%)
Hypercapnia
17 (.25%)
Loss Of Consciousness
17 (.25%)
Respiratory Acidosis
17 (.25%)
Somnolence
17 (.25%)
Acute Hepatic Failure
16 (.24%)
Blood Creatinine Increased
16 (.24%)
Bronchospasm
16 (.24%)
Depressed Level Of Consciousness
16 (.24%)
Haemorrhage
16 (.24%)
Hepatitis Acute
16 (.24%)
Hypersensitivity
16 (.24%)
Respiratory Arrest
16 (.24%)
Urticaria
16 (.24%)
White Blood Cell Count Increased
16 (.24%)
Blood Bilirubin Increased
15 (.22%)

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

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

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

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

Anaesthesia
663
Maintenance Of Anaesthesia
477
General Anaesthesia
398
Induction Of Anaesthesia
181
Induction And Maintenance Of Anaest...
141
Drug Use For Unknown Indication
113
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Product Used For Unknown Indication
101
Drug Exposure During Pregnancy
34
Anaesthesia Procedure
33
Surgery
30
Foetal Exposure Timing Unspecified
18
Sedation
14
Tonsillectomy
9
Asthma
8
Accidental Exposure
8
Colonoscopy
7
Status Asthmaticus
6
Inhalation Therapy
4
Somnolence
4
Sedative Therapy
4
Postoperative Analgesia
4
Glaucoma Surgery
4
Circumcision
4
Analgesic Effect
4
Breast Operation
4
Tetanus
4
Appendicectomy
4
Spinal Operation
4
Maternal Exposure Timing Unspecifie...
4
Cardiac Operation
3
Hernia Repair
3
Ureteral Meatotomy
3
Sclerotherapy
3
Stupor
3
Adenoidectomy
2
Gastrectomy
2
Scoliosis Surgery
2
Anaphylactic Reaction
2
Urethral Meatotomy
2
Mitral Valve Incompetence
2
Abdominal Operation
2
Radical Prostatectomy
2
Bronchospasm
2
Suicide Attempt
2
Tooth Extraction
2
Lenticular Operation
2
Vomiting
2
Colostomy
2
Adenotonsillectomy
2
Ill-defined Disorder
2
Peritonitis
2

Drug Labels

LabelLabelerEffective
SevofluraneBaxter Healthcare Corporation14-DEC-11
SevofluranePiramal Critical Care Inc07-MAR-12
SevofluraneBaxter Healthcare Corporation30-MAY-12
UltaneAbbott Laboratories04-SEP-12
UltaneAbbott Laboratories04-SEP-12

Sevoflurane Case Reports

What Sevoflurane 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 Sevoflurane. 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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