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TEGRETOL

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Tegretol Adverse Events Reported to the FDA Over Time

How are Tegretol adverse event reports trending over time?

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

Most Common Tegretol Adverse Events Reported to the FDA

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

Convulsion
1259 (2.46%)
Pyrexia
926 (1.81%)
Dizziness
602 (1.17%)
Rash
578 (1.13%)
Somnolence
534 (1.04%)
Vomiting
501 (.98%)
Drug Interaction
449 (.88%)
Malaise
441 (.86%)
Drug Exposure During Pregnancy
417 (.81%)
Alanine Aminotransferase Increased
412 (.8%)
Fall
410 (.8%)
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Gamma-glutamyltransferase Increased
407 (.79%)
Nausea
390 (.76%)
Aspartate Aminotransferase Increase...
382 (.74%)
Headache
333 (.65%)
Hyponatraemia
331 (.65%)
Drug Rash With Eosinophilia And Sys...
320 (.62%)
Epilepsy
303 (.59%)
Drug Ineffective
299 (.58%)
Pain
293 (.57%)
Drug Eruption
288 (.56%)
Asthenia
283 (.55%)
Confusional State
269 (.52%)
Erythema
268 (.52%)
Pruritus
268 (.52%)
Fatigue
266 (.52%)
Blood Alkaline Phosphatase Increase...
262 (.51%)
Drug Level Increased
255 (.5%)
Stevens-johnson Syndrome
255 (.5%)
C-reactive Protein Increased
249 (.49%)
Platelet Count Decreased
246 (.48%)
Dyspnoea
245 (.48%)
Blood Lactate Dehydrogenase Increas...
242 (.47%)
Liver Disorder
238 (.46%)
Loss Of Consciousness
237 (.46%)
Feeling Abnormal
233 (.45%)
White Blood Cell Count Increased
222 (.43%)
Tremor
217 (.42%)
Diarrhoea
210 (.41%)
Lymphadenopathy
210 (.41%)
Haemoglobin Decreased
208 (.41%)
Suicide Attempt
206 (.4%)
Depression
205 (.4%)
White Blood Cell Count Decreased
205 (.4%)
Depressed Level Of Consciousness
199 (.39%)
Hepatic Function Abnormal
194 (.38%)
Anticonvulsant Drug Level Increased
192 (.37%)
Condition Aggravated
189 (.37%)
Dysphagia
180 (.35%)
Balance Disorder
175 (.34%)
Overdose
174 (.34%)
Anxiety
172 (.34%)
Intentional Overdose
171 (.33%)
Drug Toxicity
170 (.33%)
Gait Disturbance
169 (.33%)
Agitation
164 (.32%)
Blood Creatine Phosphokinase Increa...
161 (.31%)
Grand Mal Convulsion
161 (.31%)
Pneumonia
161 (.31%)
Weight Increased
159 (.31%)
Rash Generalised
158 (.31%)
Skin Exfoliation
157 (.31%)
Coma
150 (.29%)
Blood Creatinine Increased
146 (.28%)
Hypersensitivity
143 (.28%)
Vision Blurred
143 (.28%)
Urticaria
141 (.27%)
Weight Decreased
137 (.27%)
Altered State Of Consciousness
135 (.26%)
Abdominal Pain
132 (.26%)
Blood Glucose Increased
129 (.25%)
Lymphocyte Stimulation Test Positiv...
129 (.25%)
Oedema Peripheral
128 (.25%)
Hypotension
127 (.25%)
Amnesia
125 (.24%)
Blood Sodium Decreased
124 (.24%)
Hypertension
122 (.24%)
Diplopia
121 (.24%)
Insomnia
121 (.24%)
Speech Disorder
121 (.24%)
Aggression
120 (.23%)
Dyskinesia
120 (.23%)
Bradycardia
119 (.23%)
Memory Impairment
117 (.23%)
Hallucination
116 (.23%)
Decreased Appetite
113 (.22%)
Red Blood Cell Count Decreased
113 (.22%)
Blood Urea Increased
111 (.22%)
Cerebrovascular Accident
111 (.22%)
Thrombocytopenia
111 (.22%)
Death
110 (.21%)
Drug Hypersensitivity
110 (.21%)
Abnormal Behaviour
109 (.21%)
Dysarthria
108 (.21%)
Haematocrit Decreased
108 (.21%)
Constipation
107 (.21%)
Eosinophil Count Increased
104 (.2%)
Muscular Weakness
104 (.2%)
Hypoaesthesia
103 (.2%)
Chest Pain
102 (.2%)
Drug Level Decreased
102 (.2%)

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

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

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

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

Epilepsy
2723
Convulsion
1202
Trigeminal Neuralgia
609
Drug Use For Unknown Indication
319
Bipolar Disorder
278
Product Used For Unknown Indication
232
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Neuralgia
170
Depression
139
Pain
137
Partial Seizures
109
Bipolar I Disorder
95
Schizophrenia
87
Grand Mal Convulsion
84
Temporal Lobe Epilepsy
80
Affective Disorder
74
Complex Partial Seizures
67
Hypoaesthesia
54
Post Herpetic Neuralgia
49
Facial Neuralgia
44
Convulsion Prophylaxis
42
Neuropathy Peripheral
40
Ill-defined Disorder
38
Muscle Spasms
36
Mood Swings
36
Petit Mal Epilepsy
31
Headache
31
Personality Disorder
27
Diabetic Neuropathy
26
Post-traumatic Epilepsy
25
Facial Spasm
25
Mania
24
Status Epilepticus
24
Abnormal Behaviour
23
Psychotic Disorder
23
Migraine
23
Analgesic Therapy
22
Herpes Zoster
22
Pain In Extremity
20
Nerve Injury
20
Facial Pain
18
Mental Disorder
18
Drug Exposure During Pregnancy
18
Cancer Pain
17
Agitation
17
Restlessness
16
Nervous System Disorder
16
Aggression
15
Anxiety
15
Simple Partial Seizures
15
Mood Altered
15
Schizophrenia, Paranoid Type
14

Drug Labels

LabelLabelerEffective
TegretolPhysicians Total Care, Inc.17-MAR-11
TegretolxrPhysicians Total Care, Inc.17-MAR-11
TegretolxrNovartis Pharmaceuticals Corporation22-MAR-13
TegretolNovartis Pharmaceuticals Corporation22-MAR-13

Tegretol Case Reports

What Tegretol 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 Tegretol. 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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