LAMOTRIGINE

Lamotrigine Adverse Events Reported to the FDA Over Time

How are Lamotrigine adverse event reports trending over time?

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

Most Common Lamotrigine Adverse Events Reported to the FDA

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

Convulsion	993 (2.87%)
Drug Exposure During Pregnancy	778 (2.25%)
Rash	501 (1.45%)
Completed Suicide	480 (1.39%)
Drug Ineffective	466 (1.35%)
Drug Interaction	384 (1.11%)
Product Substitution Issue	374 (1.08%)
Pyrexia	373 (1.08%)
Dizziness	311 (.9%)
Somnolence	278 (.8%)
Vomiting	270 (.78%)
	Show More
Headache	264 (.76%)
Maternal Drugs Affecting Foetus	257 (.74%)
Condition Aggravated	245 (.71%)
Drug Rash With Eosinophilia And Sys...	244 (.7%)
Grand Mal Convulsion	244 (.7%)
Stevens-johnson Syndrome	230 (.66%)
Depression	226 (.65%)
Nausea	216 (.62%)
Fatigue	203 (.59%)
Tremor	194 (.56%)
Platelet Count Decreased	184 (.53%)
Abortion Spontaneous	179 (.52%)
Agitation	177 (.51%)
Epilepsy	170 (.49%)
Overdose	168 (.49%)
Cardiac Arrest	164 (.47%)
Therapeutic Response Unexpected Wit...	164 (.47%)
Confusional State	159 (.46%)
Drug Toxicity	158 (.46%)
Suicide Attempt	157 (.45%)
Insomnia	154 (.44%)
Haemoglobin Decreased	149 (.43%)
Tachycardia	145 (.42%)
Aggression	143 (.41%)
Anxiety	143 (.41%)
Intentional Overdose	142 (.41%)
Pruritus	142 (.41%)
Irritability	140 (.4%)
Feeling Abnormal	138 (.4%)
Fall	136 (.39%)
Balance Disorder	134 (.39%)
White Blood Cell Count Increased	128 (.37%)
Malaise	125 (.36%)
Status Epilepticus	124 (.36%)
Ataxia	123 (.36%)
Depressed Level Of Consciousness	121 (.35%)
Vision Blurred	121 (.35%)
Breast Abscess	116 (.34%)
Respiratory Arrest	116 (.34%)
Metastases To Spine	110 (.32%)
Suicidal Ideation	110 (.32%)
Mental Impairment	108 (.31%)
Product Quality Issue	108 (.31%)
Lymphadenopathy	107 (.31%)
Rash Maculo-papular	106 (.31%)
Rhabdomyolysis	106 (.31%)
Cardio-respiratory Arrest	105 (.3%)
Death	105 (.3%)
Ventricular Septal Defect	104 (.3%)
White Blood Cell Count Decreased	101 (.29%)
Atrial Septal Defect	100 (.29%)
Abnormal Behaviour	97 (.28%)
Hypotension	97 (.28%)
Rash Erythematous	97 (.28%)
Asthenia	95 (.27%)
Blood Creatine Phosphokinase Increa...	95 (.27%)
Breast Cancer	95 (.27%)
Thrombocytopenia	95 (.27%)
Loss Of Consciousness	94 (.27%)
Talipes	94 (.27%)
Psychomotor Hyperactivity	92 (.27%)
Diplopia	90 (.26%)
Diarrhoea	88 (.25%)
Multiple Drug Overdose Intentional	87 (.25%)
Rash Generalised	86 (.25%)
Aphasia	85 (.25%)
Alanine Aminotransferase Increased	84 (.24%)
Dyspnoea	84 (.24%)
Lethargy	84 (.24%)
Encephalopathy	83 (.24%)
Nystagmus	83 (.24%)
Pain	83 (.24%)
Toxic Epidermal Necrolysis	83 (.24%)
Metabolic Acidosis	82 (.24%)
Speech Disorder	82 (.24%)
Multi-organ Failure	79 (.23%)
Weight Decreased	77 (.22%)
Erythema	76 (.22%)
Pregnancy	76 (.22%)
Abortion Induced	75 (.22%)
Cognitive Disorder	75 (.22%)
Drug Hypersensitivity	75 (.22%)
Renal Failure	75 (.22%)
Coma	74 (.21%)
Disseminated Intravascular Coagulat...	74 (.21%)
General Physical Health Deteriorati...	74 (.21%)
Myoclonus	74 (.21%)
Premature Baby	74 (.21%)
Unresponsive To Stimuli	74 (.21%)
Blister	73 (.21%)

Share/Embed Graph Export Data

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

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

Neurological	2469 (7.13%)
Epidermal And Dermal Conditions	2296 (6.63%)
Seizures	1739 (5.02%)
Chemical Injury And Poisoning	1342 (3.88%)
Therapeutic And Nontherapeutic Effe...	1296 (3.74%)
Hematology Investigations	831 (2.4%)
Suicidal And Self-injurious Behavio...	813 (2.35%)
Cardiac Arrhythmias	753 (2.18%)
Gastrointestinal Signs	728 (2.1%)
Medication Errors	710 (2.05%)
Infections - Pathogen Unspecified	697 (2.01%)
	Show More
Respiratory	631 (1.82%)
Movement Disorders	625 (1.81%)
Product Quality Issues	512 (1.48%)
Anxiety Disorders	501 (1.45%)
Body Temperature Conditions	424 (1.22%)
Musculoskeletal And Connective Tiss...	412 (1.19%)
Mental Impairment	397 (1.15%)
Muscle	370 (1.07%)
Hepatic And Hepatobiliary	351 (1.01%)
Cardiac And Vascular Disorders Cong...	347 (1%)
Injuries	341 (.99%)
Vision	337 (.97%)
Cardiac And Vascular Investigations	326 (.94%)
Depressed Mood Disorders	321 (.93%)
Hepatobiliary	317 (.92%)
Toxicology And Therapeutic Drug Mon...	301 (.87%)
Headaches	300 (.87%)
Abortions And Stillbirth	291 (.84%)
Mood Disorders	282 (.81%)
Sleep Disorders	272 (.79%)
White Blood Cell	269 (.78%)
Physical Examination Topics	250 (.72%)
Deliria	249 (.72%)
Personality Disorders	248 (.72%)
Gastrointestinal Tract Disorders Co...	232 (.67%)
Oral Soft Tissue Conditions	219 (.63%)
Psychiatric	217 (.63%)
Disturbances In Thinking	212 (.61%)
Neuromuscular	204 (.59%)
Renal Disorders	202 (.58%)
Lifestyle Issues	186 (.54%)
Fatal Outcomes	182 (.53%)
Musculoskeletal And Connective Tiss...	177 (.51%)
Skin Appendage Conditions	176 (.51%)
Pregnancy, Labour, Delivery And Pos...	170 (.49%)
Gastrointestinal Motility And Defec...	167 (.48%)
Electrolyte And Fluid Balance Condi...	166 (.48%)
Decreased And Nonspecific Blood Pre...	164 (.47%)
Allergic Conditions	157 (.45%)
Enzyme	157 (.45%)
Ocular Neuromuscular	153 (.44%)
Metabolic, Nutritional And Blood Ga...	151 (.44%)
Bacterial Infectious	149 (.43%)
Obstetric And Gynecological Therape...	144 (.42%)
Manic And Bipolar Mood Disorders	142 (.41%)
Neurological Disorders Congenital	138 (.4%)
Ocular Infections, Irritations And ...	133 (.38%)
Neonatal And Perinatal Conditions	132 (.38%)
Psychiatric And Behavioural Symptom...	131 (.38%)
Spleen, Lymphatic And Reticulendoth...	130 (.38%)
Appetite And General Nutritional	124 (.36%)
Anemias Nonhemolytic And Marrow Dep...	123 (.36%)
Breast Neoplasms Malignant And Unsp...	122 (.35%)
Lower Respiratory Tract Disorders	119 (.34%)
Angiedema And Urticaria	116 (.34%)
Metastases	110 (.32%)
Urinary Tract Signs	108 (.31%)
Platelet	105 (.3%)
Congenital And Hereditary	104 (.3%)
Joint	104 (.3%)
Coagulopathies And Bleeding Diathes...	102 (.29%)
Encephalopathies	96 (.28%)
Neonatal Respiratory	95 (.27%)
Acid-base	92 (.27%)
Protein And Chemistry Analyses	92 (.27%)
Renal And Urinary Tract Disorders C...	90 (.26%)
Schizophrenia And Other Psychotic	87 (.25%)
Changes In Physical Activity	86 (.25%)
Musculoskeletal And Connective Tiss...	86 (.25%)
Bone And Joint Injuries	84 (.24%)
Reproductive Tract And Breast Disor...	83 (.24%)
Glucose Metabolism Disorders	81 (.23%)
Eye	78 (.23%)
Cardiac Disorder Signs	75 (.22%)
Water, Electrolyte And Mineral	73 (.21%)
Exocrine Pancreas Conditions	71 (.21%)
Upper Respiratory Tract Disorders	71 (.21%)
Viral Infectious	71 (.21%)
Ocular Structural Change, Deposit A...	70 (.2%)
Bone Disorders	67 (.19%)
Vascular Hemorrhagic	67 (.19%)
Increased Intracranial Pressure And...	66 (.19%)
Structural Brain	66 (.19%)
Vascular	65 (.19%)
Communication Disorders	64 (.18%)
Inner Ear And Viiith Cranial Nerve	60 (.17%)
Anterior Eye Structural Change, Dep...	58 (.17%)
Leukemias	57 (.16%)
Tongue Conditions	57 (.16%)
Ocular Sensory Symptoms	56 (.16%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Lamotrigine, 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 Lamotrigine 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.