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KETAMINE

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Ketamine Adverse Events Reported to the FDA Over Time

How are Ketamine adverse event reports trending over time?

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

Most Common Ketamine Adverse Events Reported to the FDA

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

Drug Abuse
82 (2.1%)
Haematuria
71 (1.82%)
Renal Failure Acute
62 (1.59%)
Dilatation Intrahepatic Duct Acquir...
61 (1.56%)
Hepatotoxicity
60 (1.53%)
Drug Ineffective
54 (1.38%)
Liver Function Test Abnormal
51 (1.3%)
Cystitis
47 (1.2%)
Hypotension
47 (1.2%)
Hydronephrosis
46 (1.18%)
Anaphylactic Shock
40 (1.02%)
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Drug Interaction
40 (1.02%)
Venoocclusive Liver Disease
40 (1.02%)
Alanine Aminotransferase Increased
39 (1%)
Oliguria
38 (.97%)
Blood Alkaline Phosphatase Increase...
37 (.95%)
Bradycardia
36 (.92%)
Cardiac Arrest
32 (.82%)
Bladder Disorder
30 (.77%)
Lymphopenia
29 (.74%)
Stevens-johnson Syndrome
28 (.72%)
Acute Hepatic Failure
27 (.69%)
Pollakiuria
27 (.69%)
Completed Suicide
25 (.64%)
Cystitis Ulcerative
25 (.64%)
Multiple Drug Overdose
24 (.61%)
Aspergillosis
22 (.56%)
Circulatory Collapse
22 (.56%)
Contracted Bladder
22 (.56%)
Oxygen Saturation Decreased
22 (.56%)
Blood Creatinine Increased
21 (.54%)
Drug Toxicity
21 (.54%)
Bronchospasm
20 (.51%)
Confusional State
20 (.51%)
Drug Abuser
20 (.51%)
Pain
20 (.51%)
Blood Bilirubin Increased
19 (.49%)
Loss Of Consciousness
19 (.49%)
Nausea
19 (.49%)
Venoocclusive Disease
19 (.49%)
Apnoea
18 (.46%)
Drug Screen Positive
18 (.46%)
Dysuria
18 (.46%)
Micturition Urgency
18 (.46%)
Off Label Use
18 (.46%)
Pleural Effusion
18 (.46%)
Tachycardia
18 (.46%)
Toxic Epidermal Necrolysis
18 (.46%)
Accidental Death
17 (.43%)
Agitation
17 (.43%)
Cholestasis
17 (.43%)
Convulsion
17 (.43%)
Death
17 (.43%)
Medication Error
17 (.43%)
Product Quality Issue
17 (.43%)
Somnolence
17 (.43%)
Acute Pulmonary Oedema
16 (.41%)
Urge Incontinence
16 (.41%)
Depressed Level Of Consciousness
15 (.38%)
Generalised Erythema
15 (.38%)
Heart Rate Increased
15 (.38%)
Overdose
15 (.38%)
Rash
15 (.38%)
Septic Embolus
15 (.38%)
Vomiting
15 (.38%)
Brain Death
14 (.36%)
Brain Stem Syndrome
14 (.36%)
Delirium
14 (.36%)
Gamma-glutamyltransferase Increased
14 (.36%)
Hallucination
14 (.36%)
Hepatic Necrosis
14 (.36%)
Respiratory Failure
14 (.36%)
Constipation
13 (.33%)
Erythema
13 (.33%)
Respiratory Depression
13 (.33%)
Sedation
13 (.33%)
Septic Shock
13 (.33%)
Suicide Attempt
13 (.33%)
Cystitis Interstitial
12 (.31%)
Drug Rash With Eosinophilia And Sys...
12 (.31%)
Intentional Drug Misuse
12 (.31%)
Pyrexia
12 (.31%)
Sepsis
12 (.31%)
Toxic Skin Eruption
12 (.31%)
Anuria
11 (.28%)
Anxiety
11 (.28%)
Biopsy Bladder Abnormal
11 (.28%)
Face Oedema
11 (.28%)
Fall
11 (.28%)
Hypothyroidism
11 (.28%)
Pyuria
11 (.28%)
Rhabdomyolysis
11 (.28%)
Urinary Tract Disorder
11 (.28%)
Biliary Dilatation
10 (.26%)
Blood Pressure Increased
10 (.26%)
Cardiac Failure
10 (.26%)
Cardio-respiratory Arrest
10 (.26%)
Condition Aggravated
10 (.26%)
Dizziness
10 (.26%)
Hyponatraemia
10 (.26%)
Malaise
10 (.26%)

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

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

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

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

Drug Abuse
124
Pain
117
Anaesthesia
93
Sedation
77
Product Used For Unknown Indication
71
Induction Of Anaesthesia
70
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Drug Use For Unknown Indication
55
General Anaesthesia
47
Analgesic Therapy
42
Cancer Pain
28
Sedative Therapy
18
Drug Abuser
14
Complex Regional Pain Syndrome
14
Postoperative Analgesia
9
Ureteral Stent Removal
9
Ureteral Stent Insertion
9
Hepatic Necrosis
8
Anaesthesia Procedure
7
Stupor
7
Intubation
6
Analgesic Effect
6
Neuralgia
6
Surgery
5
Tooth Extraction
5
Status Asthmaticus
5
Bone Pain
4
Asthma
4
Post Herpetic Neuralgia
4
Procedural Pain
4
Substance Use
4
Suicide Attempt
4
Pain Management
3
Wisdom Teeth Removal
3
Musculoskeletal Pain
3
Arthralgia
3
Phantom Pain
3
Major Depression
3
Neck Pain
3
Endotracheal Intubation
3
Analgesic Intervention Supportive T...
2
Vascular Operation
2
Fracture Reduction
2
Anxiety
2
Chest Tube Insertion
2
Maintenance Of Anaesthesia
2
Premedication
2
Pain In Extremity
2
Neurosurgery
2
Poisoning
2
Colonoscopy
2
Prophylaxis
2

Drug Labels

LabelLabelerEffective
KetalarJHP Pharmaceuticals LLC13-MAR-12
Ketamine HydrochlorideJHP Pharmaceuticals, LLC10-APR-12
Ketamine HydrochloridePhysicians Total Care, Inc.23-APR-12
Ketamine HydrochlorideBedford Laboratories01-MAY-12
Ketamine HydrochlorideHospira, Inc.07-JUN-12
Ketamine HydrochlorideGeneral Injectables & Vaccines, Inc11-OCT-12
Ketamine HydrochlorideGeneral Injectables & Vaccines, Inc16-OCT-12
KetalarGeneral Injectables & Vaccines, Inc17-OCT-12
Ketamine HydrochlorideMylan Institutional LLC23-OCT-12
Ketamine HydrochlorideJHP Pharmaceuticals, LLC04-APR-13

Ketamine Case Reports

What Ketamine 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 Ketamine. 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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