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XYLOCAINE

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Xylocaine Adverse Events Reported to the FDA Over Time

How are Xylocaine adverse event reports trending over time?

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

Most Common Xylocaine Adverse Events Reported to the FDA

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

Convulsion
288 (1.63%)
Cardiac Arrest
208 (1.18%)
Dizziness
197 (1.12%)
Loss Of Consciousness
190 (1.08%)
Drug Toxicity
183 (1.04%)
Anaphylactic Shock
182 (1.03%)
Drug Ineffective
167 (.95%)
Dyspnoea
165 (.93%)
Hypotension
162 (.92%)
Overdose
159 (.9%)
Anaesthetic Complication
150 (.85%)
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Blood Pressure Decreased
147 (.83%)
Tachycardia
142 (.8%)
Nausea
135 (.76%)
Blood Pressure Increased
134 (.76%)
Drug Interaction
133 (.75%)
Pain
127 (.72%)
Shock
120 (.68%)
Bradycardia
119 (.67%)
Medication Error
114 (.65%)
Hypoaesthesia
111 (.63%)
Headache
105 (.59%)
Anaphylactic Reaction
99 (.56%)
Respiratory Arrest
91 (.52%)
Incorrect Route Of Drug Administrat...
90 (.51%)
Drug Hypersensitivity
88 (.5%)
Methaemoglobinaemia
88 (.5%)
Erythema
87 (.49%)
Grand Mal Convulsion
86 (.49%)
Confusional State
84 (.48%)
Hypertension
84 (.48%)
Post Procedural Complication
82 (.46%)
Vomiting
82 (.46%)
Septic Arthritis Staphylococcal
80 (.45%)
Cyanosis
79 (.45%)
Ventricular Tachycardia
79 (.45%)
Agitation
78 (.44%)
Malaise
78 (.44%)
Oxygen Saturation Decreased
78 (.44%)
Heart Rate Increased
77 (.44%)
Pyrexia
77 (.44%)
Depressed Level Of Consciousness
74 (.42%)
Syncope
74 (.42%)
Bronchospasm
73 (.41%)
Coma
73 (.41%)
Somnolence
73 (.41%)
Tremor
73 (.41%)
Ventricular Fibrillation
72 (.41%)
Angioedema
71 (.4%)
Off Label Use
71 (.4%)
Hypersensitivity
70 (.4%)
Palpitations
70 (.4%)
Urticaria
70 (.4%)
Anxiety
67 (.38%)
Cardio-respiratory Arrest
67 (.38%)
Hyperhidrosis
66 (.37%)
Drug Exposure During Pregnancy
65 (.37%)
Procedural Complication
65 (.37%)
Wrong Technique In Drug Usage Proce...
65 (.37%)
Pallor
64 (.36%)
Toxic Anterior Segment Syndrome
64 (.36%)
Oedema Peripheral
63 (.36%)
Asthenia
62 (.35%)
Musculoskeletal Pain
62 (.35%)
Heart Rate Decreased
58 (.33%)
Pain In Extremity
56 (.32%)
Paraesthesia
56 (.32%)
Visual Acuity Reduced
56 (.32%)
Fatigue
54 (.31%)
Injection Site Pain
52 (.29%)
Weight Decreased
52 (.29%)
Feeling Abnormal
50 (.28%)
Hypertensive Crisis
50 (.28%)
Rash
50 (.28%)
Burning Sensation
49 (.28%)
Death
49 (.28%)
Insomnia
49 (.28%)
Gait Disturbance
48 (.27%)
Pruritus
48 (.27%)
Circulatory Collapse
47 (.27%)
Muscular Weakness
47 (.27%)
Pulmonary Oedema
47 (.27%)
Restlessness
47 (.27%)
Unresponsive To Stimuli
47 (.27%)
Diplopia
45 (.25%)
Pulse Absent
45 (.25%)
Sinus Tachycardia
45 (.25%)
Ventricular Extrasystoles
45 (.25%)
Apnoea
44 (.25%)
Chondrolysis
44 (.25%)
Condition Aggravated
44 (.25%)
Fall
43 (.24%)
Mydriasis
43 (.24%)
Product Quality Issue
43 (.24%)
Accidental Overdose
42 (.24%)
Arthralgia
42 (.24%)
Hypoxia
42 (.24%)
Speech Disorder
42 (.24%)
Atrial Fibrillation
41 (.23%)
Dysarthria
40 (.23%)
Back Pain
39 (.22%)

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

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

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

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

Local Anaesthesia
951
Anaesthesia
609
Product Used For Unknown Indication
476
Drug Use For Unknown Indication
366
Pain
294
Epidural Anaesthesia
197
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Nerve Block
164
Back Pain
98
Stomatitis
86
Infiltration Anaesthesia
80
Musculoskeletal Pain
70
Post Herpetic Neuralgia
68
Induction Of Anaesthesia
67
Surgery
63
Ventricular Tachycardia
55
Neuralgia
54
Premedication
54
Cataract Operation
51
X-ray
48
Bronchoscopy
47
Analgesic Therapy
47
Arthralgia
37
General Anaesthesia
37
X-ray Limb
33
Arrhythmia
33
Ill-defined Disorder
32
Pain Management
32
Oral Pain
32
Analgesia
32
Anaesthesia Procedure
30
Prophylaxis
30
Rheumatoid Arthritis
29
Haemorrhoids
29
Epidural Test Dose
26
Proctalgia
25
Plastic Surgery
25
Mucosal Inflammation
25
Osteoarthritis
24
Endoscopy
23
Ingrowing Nail
21
Tooth Extraction
21
Pain In Extremity
21
Caesarean Section
21
Ventricular Extrasystoles
20
Ventricular Arrhythmia
17
Plantar Fasciitis
17
Periarthritis
17
Ventricular Fibrillation
16
Neuropathy Peripheral
15
Localised Osteoarthritis
15
Preoperative Care
15

Drug Labels

LabelLabelerEffective
XylocaineDentsply Pharmaceutical28-AUG-09
XylocaineAPP Pharmaceuticals, LLC19-NOV-09
XylocaineAPP Pharmaceuticals, LLC16-NOV-10
XylocaineRebel Distributors Corp22-DEC-10
XylocainempfAPP Pharmaceuticals, LLC14-JUL-11
XylocaineAPP Pharmaceuticals, LLC05-AUG-11
Xylocaine-mpfAPP Pharmaceuticals, LLC05-AUG-11
XylocaineGeneral Injectables & Vaccines, Inc21-SEP-11
XylocaineGeneral Injectables & Vaccines, Inc26-SEP-11
XylocaineGeneral Injectables & Vaccines, Inc28-SEP-11
XylocaineGeneral Injectables & Vaccines, Inc30-SEP-11
XylocaineGeneral Injectables & Vaccines, Inc25-OCT-11
XylocaineGeneral Injectables & Vaccines, Inc03-NOV-11
XylocaineGeneral Injectables & Vaccines, Inc18-NOV-11
Xylocaine General Injectables & Vaccines, Inc11-JAN-12
XylocainePhysicians Total Care, Inc.09-FEB-12
XylocainempfCardinal Health17-APR-12
XylocainempfCardinal Health26-APR-12
XylocaineCardinal Health26-APR-12
XylocaineAPP Pharmaceuticals, LLC04-MAY-12
XylocainempfAPP Pharmaceuticals, LLC04-MAY-12
XylocaineOak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)20-JUN-12
XylocaineCardinal Health16-JUL-12
XylocaineGeneral Injectables & Vaccines, Inc01-MAY-13

Xylocaine Case Reports

What Xylocaine 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 Xylocaine. 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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