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LAMICTAL

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Lamictal Adverse Events Reported to the FDA Over Time

How are Lamictal adverse event reports trending over time?

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

Most Common Lamictal Adverse Events Reported to the FDA

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

Rash
3907 (5.21%)
Pyrexia
1605 (2.14%)
Convulsion
1510 (2.01%)
Drug Exposure During Pregnancy
1206 (1.61%)
Stevens-johnson Syndrome
1180 (1.57%)
Pruritus
920 (1.23%)
Drug Ineffective
855 (1.14%)
Headache
833 (1.11%)
Dizziness
825 (1.1%)
Nausea
742 (.99%)
Erythema
656 (.87%)
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Lymphadenopathy
577 (.77%)
Fatigue
574 (.76%)
Insomnia
560 (.75%)
Vomiting
547 (.73%)
Drug Interaction
534 (.71%)
Rash Generalised
456 (.61%)
Malaise
449 (.6%)
Tremor
448 (.6%)
Depression
447 (.6%)
Somnolence
436 (.58%)
Alanine Aminotransferase Increased
403 (.54%)
Anxiety
399 (.53%)
Drug Eruption
392 (.52%)
Alopecia
369 (.49%)
Drug Rash With Eosinophilia And Sys...
369 (.49%)
Aspartate Aminotransferase Increase...
356 (.47%)
Vision Blurred
356 (.47%)
Blister
352 (.47%)
Urticaria
351 (.47%)
Feeling Abnormal
332 (.44%)
C-reactive Protein Increased
328 (.44%)
Pain
326 (.43%)
Confusional State
322 (.43%)
Overdose
310 (.41%)
Dyspnoea
308 (.41%)
Toxic Epidermal Necrolysis
303 (.4%)
Skin Exfoliation
294 (.39%)
Suicidal Ideation
287 (.38%)
Hypersensitivity
282 (.38%)
Agitation
279 (.37%)
Fall
278 (.37%)
Rash Maculo-papular
278 (.37%)
Rash Erythematous
277 (.37%)
Amnesia
268 (.36%)
Aggression
264 (.35%)
Asthenia
264 (.35%)
Diarrhoea
262 (.35%)
Arthralgia
255 (.34%)
Grand Mal Convulsion
249 (.33%)
Epilepsy
242 (.32%)
Mania
242 (.32%)
Memory Impairment
242 (.32%)
Weight Increased
241 (.32%)
Irritability
237 (.32%)
Loss Of Consciousness
236 (.31%)
Suicide Attempt
233 (.31%)
Dysphagia
229 (.31%)
Mouth Ulceration
229 (.31%)
Rash Pruritic
223 (.3%)
Blood Lactate Dehydrogenase Increas...
219 (.29%)
Myalgia
219 (.29%)
Oedema Peripheral
215 (.29%)
Abortion Spontaneous
214 (.29%)
Balance Disorder
213 (.28%)
White Blood Cell Count Increased
212 (.28%)
Diplopia
206 (.27%)
Hepatic Function Abnormal
205 (.27%)
Disturbance In Attention
204 (.27%)
Gamma-glutamyltransferase Increased
204 (.27%)
Hepatic Enzyme Increased
204 (.27%)
Weight Decreased
204 (.27%)
Skin Disorder
199 (.27%)
White Blood Cell Count Decreased
198 (.26%)
Rash Macular
195 (.26%)
Swelling Face
195 (.26%)
Stomatitis
189 (.25%)
Adverse Event
185 (.25%)
Ill-defined Disorder
182 (.24%)
Product Quality Issue
179 (.24%)
Thrombocytopenia
175 (.23%)
Condition Aggravated
174 (.23%)
Gait Disturbance
166 (.22%)
Oropharyngeal Pain
166 (.22%)
Drug Hypersensitivity
163 (.22%)
Erythema Multiforme
163 (.22%)
Rash Papular
162 (.22%)
Toxic Skin Eruption
162 (.22%)
Coordination Abnormal
160 (.21%)
Speech Disorder
160 (.21%)
Face Oedema
159 (.21%)
Paraesthesia
158 (.21%)
Anger
155 (.21%)
Cough
154 (.21%)
Death
154 (.21%)
Hyperhidrosis
153 (.2%)
Conjunctivitis
152 (.2%)
Crying
145 (.19%)
Hallucination
145 (.19%)
Depressed Level Of Consciousness
144 (.19%)
Dyskinesia
143 (.19%)

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

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

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

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

Bipolar Disorder
7013
Epilepsy
4174
Drug Use For Unknown Indication
2437
Depression
1082
Convulsion
996
Product Used For Unknown Indication
739
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Bipolar I Disorder
257
Affective Disorder
226
Bipolar Ii Disorder
209
Partial Seizures
204
Ill-defined Disorder
179
Anxiety
132
Mood Swings
112
Complex Partial Seizures
83
Migraine
63
Major Depression
60
Grand Mal Convulsion
57
Drug Exposure During Pregnancy
46
Temporal Lobe Epilepsy
45
Schizoaffective Disorder
41
Mood Altered
38
Pain
37
Schizophrenia
35
Headache
33
Convulsion Prophylaxis
33
Migraine Prophylaxis
27
Attention Deficit/hyperactivity Dis...
25
Mental Disorder
25
Obsessive-compulsive Disorder
22
Myoclonic Epilepsy
22
Petit Mal Epilepsy
21
Post-traumatic Stress Disorder
20
Prophylaxis
20
Trigeminal Neuralgia
19
Neuropathy Peripheral
19
Borderline Personality Disorder
19
Mania
18
Panic Attack
17
Antidepressant Therapy
17
Insomnia
16
Status Epilepticus
16
Fibromyalgia
16
Neuralgia
15
Lennox-gastaut Syndrome
15
Simple Partial Seizures
14
Drug Therapy
13
Depressed Mood
13
Drug Dispensing Error
12
Autism
11
Personality Disorder
11
Foetal Exposure During Pregnancy
10

Drug Labels

LabelLabelerEffective
LamictalRebel Distributors Corp28-DEC-10
LamictalPD-Rx Pharmaceuticals, Inc.19-DEC-11
LamictalPhysicians Total Care, Inc.21-DEC-11
LamictalLake Erie Medical & Surgical Supply DBA Quality Care Products LLC12-JUN-12
LamictalGlaxoSmithKline LLC19-SEP-12
LamictalodtGlaxoSmithKline LLC19-SEP-12
LamictalxrGlaxoSmithKline LLC09-OCT-12

Lamictal Case Reports

What Lamictal 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 Lamictal. 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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