LEVETIRACETAM

Levetiracetam Adverse Events Reported to the FDA Over Time

How are Levetiracetam adverse event reports trending over time?

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

Most Common Levetiracetam Adverse Events Reported to the FDA

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

Convulsion	759 (6.89%)
Product Substitution Issue	249 (2.26%)
Drug Exposure During Pregnancy	242 (2.2%)
Grand Mal Convulsion	214 (1.94%)
Drug Ineffective	210 (1.91%)
Condition Aggravated	200 (1.81%)
Pregnancy	147 (1.33%)
Status Epilepticus	139 (1.26%)
Fatigue	132 (1.2%)
Abortion Spontaneous	126 (1.14%)
Thrombocytopenia	118 (1.07%)
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Somnolence	117 (1.06%)
Aggression	114 (1.03%)
Headache	101 (.92%)
Depression	93 (.84%)
Maternal Drugs Affecting Foetus	93 (.84%)
Dizziness	91 (.83%)
Fall	84 (.76%)
Drug Interaction	81 (.73%)
Confusional State	76 (.69%)
Myoclonus	74 (.67%)
Nausea	74 (.67%)
Complex Partial Seizures	68 (.62%)
Anxiety	62 (.56%)
Epilepsy	61 (.55%)
Gait Disturbance	59 (.54%)
Vomiting	59 (.54%)
Partial Seizures	58 (.53%)
Abnormal Behaviour	57 (.52%)
Irritability	57 (.52%)
Petit Mal Epilepsy	57 (.52%)
Encephalopathy	56 (.51%)
Abortion Induced	53 (.48%)
Drug Rash With Eosinophilia And Sys...	52 (.47%)
Therapeutic Response Unexpected Wit...	52 (.47%)
Tubulointerstitial Nephritis	52 (.47%)
Speech Disorder	50 (.45%)
Insomnia	49 (.44%)
Ataxia	48 (.44%)
Tremor	48 (.44%)
Agitation	47 (.43%)
Completed Suicide	47 (.43%)
Asthenia	45 (.41%)
Congenital Anomaly	45 (.41%)
Suicidal Ideation	45 (.41%)
Product Quality Issue	43 (.39%)
Delirium	39 (.35%)
Cardiac Arrest	38 (.34%)
Psychotic Disorder	38 (.34%)
Decreased Appetite	37 (.34%)
Rash	37 (.34%)
Balance Disorder	36 (.33%)
Drug Toxicity	36 (.33%)
Electroencephalogram Abnormal	36 (.33%)
Amnesia	34 (.31%)
Cognitive Disorder	34 (.31%)
Death	34 (.31%)
Depressed Level Of Consciousness	34 (.31%)
Movement Disorder	34 (.31%)
Muscle Twitching	34 (.31%)
Suicide Attempt	34 (.31%)
Vision Blurred	34 (.31%)
Anticonvulsant Drug Level Decreased	33 (.3%)
Leukopenia	33 (.3%)
Anger	32 (.29%)
Disorientation	32 (.29%)
Aphasia	31 (.28%)
Pancytopenia	31 (.28%)
Weight Decreased	31 (.28%)
Diarrhoea	30 (.27%)
Hyponatraemia	30 (.27%)
Loss Of Consciousness	30 (.27%)
Disturbance In Attention	29 (.26%)
Drug Effect Decreased	29 (.26%)
Developmental Delay	28 (.25%)
Feeling Abnormal	28 (.25%)
Pyrexia	28 (.25%)
White Blood Cell Count Decreased	28 (.25%)
Autism	27 (.24%)
Bradycardia	27 (.24%)
Cardio-respiratory Arrest	27 (.24%)
Pneumonia	27 (.24%)
Dyspnoea	26 (.24%)
No Therapeutic Response	26 (.24%)
Premature Baby	26 (.24%)
Metabolic Acidosis	25 (.23%)
Renal Failure Acute	25 (.23%)
Rhabdomyolysis	25 (.23%)
Abdominal Pain	24 (.22%)
Alanine Aminotransferase Increased	24 (.22%)
Dehydration	24 (.22%)
Hallucination	24 (.22%)
Lethargy	23 (.21%)
Neutropenia	23 (.21%)
Overdose	23 (.21%)
Hyperpyrexia	22 (.2%)
Pruritus	22 (.2%)
Aura	21 (.19%)
Coordination Abnormal	21 (.19%)
General Physical Health Deteriorati...	21 (.19%)
Hepatitis	21 (.19%)

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

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

Seizures	1434 (13.01%)
Neurological	867 (7.87%)
Therapeutic And Nontherapeutic Effe...	474 (4.3%)
Chemical Injury And Poisoning	395 (3.58%)
Product Quality Issues	314 (2.85%)
Epidermal And Dermal Conditions	294 (2.67%)
Gastrointestinal Signs	224 (2.03%)
Movement Disorders	215 (1.95%)
Anxiety Disorders	188 (1.71%)
Personality Disorders	165 (1.5%)
Injuries	164 (1.49%)
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Pregnancy, Labour, Delivery And Pos...	162 (1.47%)
Mental Impairment	157 (1.42%)
Cardiac Arrhythmias	152 (1.38%)
Respiratory	150 (1.36%)
Deliria	147 (1.33%)
Abortions And Stillbirth	144 (1.31%)
Suicidal And Self-injurious Behavio...	136 (1.23%)
Platelet	133 (1.21%)
Depressed Mood Disorders	131 (1.19%)
Medication Errors	125 (1.13%)
Muscle	116 (1.05%)
Hepatic And Hepatobiliary	111 (1.01%)
Headaches	110 (1%)
Toxicology And Therapeutic Drug Mon...	106 (.96%)
Mood Disorders	105 (.95%)
Infections - Pathogen Unspecified	103 (.93%)
Hematology Investigations	100 (.91%)
Sleep Disorders	92 (.83%)
Hepatobiliary	91 (.83%)
Appetite And General Nutritional	90 (.82%)
Vision	81 (.73%)
Disturbances In Thinking	80 (.73%)
White Blood Cell	78 (.71%)
Encephalopathies	75 (.68%)
Obstetric And Gynecological Therape...	74 (.67%)
Anemias Nonhemolytic And Marrow Dep...	72 (.65%)
Psychiatric And Behavioural Symptom...	72 (.65%)
Renal Disorders	71 (.64%)
Central Nervous System Vascular	67 (.61%)
Gastrointestinal Motility And Defec...	67 (.61%)
Musculoskeletal And Connective Tiss...	65 (.59%)
Electrolyte And Fluid Balance Condi...	63 (.57%)
Body Temperature Conditions	59 (.54%)
Gastrointestinal Tract Disorders Co...	56 (.51%)
Fatal Outcomes	54 (.49%)
Nephropathies	54 (.49%)
Urinary Tract Signs	54 (.49%)
Congenital And Hereditary	53 (.48%)
Physical Examination Topics	53 (.48%)
Cardiac And Vascular Disorders Cong...	50 (.45%)
Neurological, Special Senses And Ps...	50 (.45%)
Musculoskeletal And Connective Tiss...	47 (.43%)
Cardiac And Vascular Investigations	45 (.41%)
Renal And Urinary Tract Investigati...	44 (.4%)
Bacterial Infectious	43 (.39%)
Lifestyle Issues	43 (.39%)
Neonatal And Perinatal Conditions	42 (.38%)
Schizophrenia And Other Psychotic	41 (.37%)
Neurological Disorders Congenital	37 (.34%)
Therapeutic Procedures And Supporti...	37 (.34%)
Angiedema And Urticaria	34 (.31%)
Changes In Physical Activity	34 (.31%)
Sexual Dysfunctions, Disturbances A...	34 (.31%)
Allergic Conditions	32 (.29%)
Bone And Joint Injuries	29 (.26%)
Decreased And Nonspecific Blood Pre...	29 (.26%)
Water, Electrolyte And Mineral	28 (.25%)
Acid-base	27 (.24%)
Psychiatric	27 (.24%)
Skin Appendage Conditions	27 (.24%)
Exocrine Pancreas Conditions	24 (.22%)
Metabolic, Nutritional And Blood Ga...	24 (.22%)
Enzyme	23 (.21%)
Joint	23 (.21%)
Neuromuscular	23 (.21%)
Reproductive Tract And Breast Disor...	23 (.21%)
Cardiac Disorder Signs	21 (.19%)
Miscellaneous And Site Unspecified ...	21 (.19%)
Structural Brain	19 (.17%)
Coronary Artery	18 (.16%)
Bone Disorders	17 (.15%)
Lower Respiratory Tract Disorders	17 (.15%)
Oral Soft Tissue Conditions	17 (.15%)
Communication Disorders	16 (.15%)
Gastrointestinal Hemorrhages	16 (.15%)
Dental And Gingival Conditions	15 (.14%)
Neonatal Respiratory	15 (.14%)
Viral Infectious	15 (.14%)
Eye	14 (.13%)
Hypothalamus And Pituitary Gland	14 (.13%)
Legal Issues	14 (.13%)
Ocular Neuromuscular	14 (.13%)
Procedural And Device Related Injur...	14 (.13%)
Abdominal Hernias And Other Abdomin...	13 (.12%)
Protein And Chemistry Analyses	13 (.12%)
Gastrointestinal Inflammatory Condi...	12 (.11%)
Glucose Metabolism Disorders	12 (.11%)
Heart Failures	12 (.11%)
Musculoskeletal And Connective Tiss...	12 (.11%)
Sexual Function And Fertility	12 (.11%)

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