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TRILEPTAL

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Trileptal Adverse Events Reported to the FDA Over Time

How are Trileptal adverse event reports trending over time?

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

Most Common Trileptal Adverse Events Reported to the FDA

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

Convulsion
731 (3.47%)
Hyponatraemia
383 (1.82%)
Dizziness
329 (1.56%)
Somnolence
326 (1.55%)
Headache
286 (1.36%)
Nausea
260 (1.23%)
Drug Exposure During Pregnancy
247 (1.17%)
Vomiting
232 (1.1%)
Depression
227 (1.08%)
Pyrexia
204 (.97%)
Fall
202 (.96%)
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Malaise
182 (.86%)
Tremor
181 (.86%)
Fatigue
162 (.77%)
Drug Ineffective
157 (.75%)
Asthenia
156 (.74%)
Feeling Abnormal
150 (.71%)
Drug Interaction
143 (.68%)
Confusional State
136 (.65%)
Rash
131 (.62%)
Epilepsy
124 (.59%)
Agitation
119 (.56%)
Anxiety
112 (.53%)
Condition Aggravated
111 (.53%)
Blood Sodium Decreased
107 (.51%)
Pain
105 (.5%)
Speech Disorder
102 (.48%)
Death
100 (.47%)
Weight Increased
98 (.47%)
Dyspnoea
97 (.46%)
Gait Disturbance
97 (.46%)
Loss Of Consciousness
97 (.46%)
Suicide Attempt
95 (.45%)
Abdominal Pain
94 (.45%)
Pruritus
92 (.44%)
Memory Impairment
89 (.42%)
Grand Mal Convulsion
87 (.41%)
Insomnia
87 (.41%)
Vision Blurred
87 (.41%)
Alanine Aminotransferase Increased
86 (.41%)
Weight Decreased
84 (.4%)
Petit Mal Epilepsy
82 (.39%)
Nervousness
79 (.37%)
Amnesia
78 (.37%)
Aggression
77 (.37%)
Diplopia
72 (.34%)
Suicidal Ideation
72 (.34%)
Aspartate Aminotransferase Increase...
71 (.34%)
Coma
71 (.34%)
Syncope
70 (.33%)
Crying
68 (.32%)
Blood Pressure Increased
67 (.32%)
Gamma-glutamyltransferase Increased
67 (.32%)
Diarrhoea
66 (.31%)
Abnormal Behaviour
65 (.31%)
Dysphagia
65 (.31%)
Intentional Overdose
65 (.31%)
Hallucination
63 (.3%)
Disturbance In Attention
62 (.29%)
Balance Disorder
61 (.29%)
Caesarean Section
57 (.27%)
Leukopenia
57 (.27%)
Hypertension
56 (.27%)
Blood Alkaline Phosphatase Increase...
55 (.26%)
Tachycardia
55 (.26%)
Hypotension
54 (.26%)
Urinary Tract Infection
54 (.26%)
Anaemia
53 (.25%)
Sleep Disorder
53 (.25%)
Cholestasis
52 (.25%)
Irritability
52 (.25%)
Cerebrovascular Accident
51 (.24%)
Hyperhidrosis
51 (.24%)
Hypersensitivity
51 (.24%)
Surgery
51 (.24%)
C-reactive Protein Increased
50 (.24%)
Constipation
50 (.24%)
Cough
50 (.24%)
Stevens-johnson Syndrome
50 (.24%)
Pain In Extremity
49 (.23%)
Chest Pain
48 (.23%)
Visual Impairment
48 (.23%)
Hypoaesthesia
47 (.22%)
Paraesthesia
47 (.22%)
Thrombocytopenia
47 (.22%)
Abdominal Pain Upper
46 (.22%)
Oedema Peripheral
46 (.22%)
Lethargy
45 (.21%)
Visual Acuity Reduced
45 (.21%)
Abortion Spontaneous
44 (.21%)
Disorientation
44 (.21%)
Dyskinesia
44 (.21%)
Electroencephalogram Abnormal
44 (.21%)
Psychotic Disorder
44 (.21%)
Erythema
43 (.2%)
Muscle Spasms
43 (.2%)
Drug Toxicity
42 (.2%)
Neutropenia
42 (.2%)
Overdose
42 (.2%)
Skin Exfoliation
42 (.2%)
Inappropriate Antidiuretic Hormone ...
41 (.19%)

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

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

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

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

Epilepsy
1112
Convulsion
753
Bipolar Disorder
367
Affective Disorder
133
Partial Seizures
101
Drug Use For Unknown Indication
98
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Trigeminal Neuralgia
96
Product Used For Unknown Indication
74
Complex Partial Seizures
73
Depression
71
Neuralgia
54
Pain
40
Bipolar I Disorder
40
Mood Swings
30
Temporal Lobe Epilepsy
30
Simple Partial Seizures
25
Mood Altered
25
Anxiety
24
Neuropathy Peripheral
22
Schizoaffective Disorder
20
Petit Mal Epilepsy
17
Mental Disorder
16
Grand Mal Convulsion
16
Attention Deficit/hyperactivity Dis...
15
Convulsion Prophylaxis
15
Neuropathic Pain
14
Schizophrenia
13
Diabetic Neuropathy
12
Impulsive Behaviour
11
Multiple Sclerosis
11
Neuropathy
11
Bipolar Ii Disorder
10
Drug Exposure During Pregnancy
9
Trigeminal Nerve Disorder
9
Psychotic Disorder
9
Headache
8
Anger
8
Syncope
8
Abnormal Behaviour
8
Ill-defined Disorder
8
Status Epilepticus
8
Arrhythmia
7
Post Herpetic Neuralgia
7
Frontal Lobe Epilepsy
7
Impulse-control Disorder
7
Nervous System Disorder
7
Agitation
6
Migraine
6
Affect Lability
6
Cerebral Disorder
6
Parkinsons Disease
6

Drug Labels

LabelLabelerEffective
TrileptalPD-Rx Pharmaceuticals, Inc.17-MAR-11
TrileptalPhysicians Total Care, Inc.17-FEB-12
TrileptalNovartis Pharmaceuticals Corporation22-MAR-13

Trileptal Case Reports

What Trileptal 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 Trileptal. 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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