OXCARBAZEPINE

Oxcarbazepine Adverse Events Reported to the FDA Over Time

How are Oxcarbazepine adverse event reports trending over time?

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

Most Common Oxcarbazepine Adverse Events Reported to the FDA

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

Convulsion	311 (5.05%)
Hyponatraemia	132 (2.14%)
Completed Suicide	120 (1.95%)
Drug Interaction	109 (1.77%)
Drug Exposure During Pregnancy	78 (1.27%)
Dizziness	75 (1.22%)
Product Substitution Issue	74 (1.2%)
Condition Aggravated	69 (1.12%)
Drug Ineffective	69 (1.12%)
Rash	62 (1.01%)
Grand Mal Convulsion	61 (.99%)
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Somnolence	60 (.97%)
Fatigue	56 (.91%)
Diplopia	54 (.88%)
Vomiting	54 (.88%)
Pyrexia	51 (.83%)
Confusional State	49 (.8%)
Cardiac Arrest	48 (.78%)
Headache	47 (.76%)
Nausea	47 (.76%)
Asthenia	46 (.75%)
Fall	44 (.71%)
Respiratory Arrest	44 (.71%)
Feeling Abnormal	43 (.7%)
Anticonvulsant Drug Level Decreased	42 (.68%)
Therapeutic Response Unexpected Wit...	42 (.68%)
Aggression	41 (.67%)
Drug Toxicity	40 (.65%)
Ataxia	37 (.6%)
Epilepsy	35 (.57%)
Tremor	35 (.57%)
Balance Disorder	34 (.55%)
Cardio-respiratory Arrest	34 (.55%)
Agitation	33 (.54%)
Abnormal Behaviour	32 (.52%)
Drug Hypersensitivity	32 (.52%)
Gait Disturbance	30 (.49%)
Anxiety	28 (.45%)
Blood Sodium Decreased	28 (.45%)
Complex Partial Seizures	28 (.45%)
Inappropriate Antidiuretic Hormone ...	28 (.45%)
Stevens-johnson Syndrome	28 (.45%)
Depression	27 (.44%)
Insomnia	27 (.44%)
Weight Increased	26 (.42%)
Electroencephalogram Abnormal	25 (.41%)
Neurotoxicity	25 (.41%)
Alanine Aminotransferase Increased	23 (.37%)
Coma	23 (.37%)
Loss Of Consciousness	23 (.37%)
Multiple Drug Overdose	23 (.37%)
Suicide Attempt	22 (.36%)
Irritability	20 (.32%)
Partial Seizures	20 (.32%)
Dyskinesia	19 (.31%)
Malaise	18 (.29%)
Poisoning	18 (.29%)
Sudden Unexplained Death In Epileps...	18 (.29%)
Death	17 (.28%)
Depressed Level Of Consciousness	17 (.28%)
Intentional Overdose	17 (.28%)
Lethargy	17 (.28%)
Suicidal Ideation	17 (.28%)
Drug Level Decreased	16 (.26%)
Pain	16 (.26%)
Petit Mal Epilepsy	16 (.26%)
Product Quality Issue	16 (.26%)
Treatment Noncompliance	16 (.26%)
Aspartate Aminotransferase Increase...	15 (.24%)
Mania	15 (.24%)
Mood Altered	15 (.24%)
Nystagmus	15 (.24%)
Abasia	14 (.23%)
Caesarean Section	14 (.23%)
Disorientation	14 (.23%)
Dyspnoea	14 (.23%)
Encephalopathy	14 (.23%)
Hyperhidrosis	14 (.23%)
Lymphadenopathy	14 (.23%)
Medication Error	14 (.23%)
Myoclonus	14 (.23%)
Rash Erythematous	14 (.23%)
Speech Disorder	14 (.23%)
Status Epilepticus	14 (.23%)
Vision Blurred	14 (.23%)
Electrocardiogram Qt Prolonged	13 (.21%)
Hypotension	13 (.21%)
Incontinence	13 (.21%)
Intentional Drug Misuse	13 (.21%)
Leukocytosis	13 (.21%)
Memory Impairment	13 (.21%)
Overdose	13 (.21%)
Skin Exfoliation	13 (.21%)
Tachycardia	13 (.21%)
Unresponsive To Stimuli	13 (.21%)
Vertigo	13 (.21%)
Abdominal Pain	12 (.19%)
Bipolar Disorder	12 (.19%)
Drug Dispensing Error	12 (.19%)
Dysmorphism	12 (.19%)
Low Set Ears	12 (.19%)

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

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

Seizures	509 (8.27%)
Neurological	499 (8.1%)
Therapeutic And Nontherapeutic Effe...	282 (4.58%)
Epidermal And Dermal Conditions	245 (3.98%)
Suicidal And Self-injurious Behavio...	177 (2.87%)
Chemical Injury And Poisoning	157 (2.55%)
Electrolyte And Fluid Balance Condi...	150 (2.44%)
Cardiac Arrhythmias	142 (2.31%)
Gastrointestinal Signs	141 (2.29%)
Movement Disorders	126 (2.05%)
Medication Errors	125 (2.03%)
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Respiratory	115 (1.87%)
Toxicology And Therapeutic Drug Mon...	105 (1.71%)
Product Quality Issues	98 (1.59%)
Vision	88 (1.43%)
Anxiety Disorders	86 (1.4%)
Injuries	84 (1.36%)
Hepatobiliary	78 (1.27%)
Deliria	74 (1.2%)
Hematology Investigations	64 (1.04%)
Personality Disorders	60 (.97%)
Body Temperature Conditions	55 (.89%)
Cardiac And Vascular Investigations	52 (.84%)
Headaches	51 (.83%)
Water, Electrolyte And Mineral	51 (.83%)
Psychiatric	50 (.81%)
Musculoskeletal And Connective Tiss...	48 (.78%)
Infections - Pathogen Unspecified	46 (.75%)
Physical Examination Topics	46 (.75%)
Mental Impairment	45 (.73%)
Sleep Disorders	45 (.73%)
Fatal Outcomes	43 (.7%)
Muscle	43 (.7%)
Allergic Conditions	42 (.68%)
Mood Disorders	41 (.67%)
White Blood Cell	40 (.65%)
Depressed Mood Disorders	39 (.63%)
Lifestyle Issues	39 (.63%)
Psychiatric And Behavioural Symptom...	39 (.63%)
Hepatic And Hepatobiliary	37 (.6%)
Disturbances In Thinking	36 (.58%)
Neuromuscular	36 (.58%)
Lower Respiratory Tract Disorders	35 (.57%)
Bone And Joint Injuries	34 (.55%)
Urinary Tract Signs	34 (.55%)
Manic And Bipolar Mood Disorders	33 (.54%)
Neurological, Special Senses And Ps...	33 (.54%)
Hypothalamus And Pituitary Gland	29 (.47%)
Musculoskeletal And Connective Tiss...	29 (.47%)
Skin Appendage Conditions	29 (.47%)
Schizophrenia And Other Psychotic	28 (.45%)
Endocrine Investigations	27 (.44%)
Bone Disorders	24 (.39%)
Changes In Physical Activity	24 (.39%)
Renal Disorders	23 (.37%)
Cardiac Disorder Signs	22 (.36%)
Obstetric And Gynecological Therape...	22 (.36%)
Ear And Labyrinthine Disorders Cong...	21 (.34%)
Angiedema And Urticaria	20 (.32%)
Appetite And General Nutritional	20 (.32%)
Cardiac And Vascular Disorders Cong...	20 (.32%)
Encephalopathies	20 (.32%)
Enzyme	20 (.32%)
Ocular Infections, Irritations And ...	20 (.32%)
Oral Soft Tissue Conditions	20 (.32%)
Decreased And Nonspecific Blood Pre...	19 (.31%)
Inner Ear And Viiith Cranial Nerve	19 (.31%)
Myocardial	18 (.29%)
Congenital And Hereditary	17 (.28%)
Gastrointestinal Motility And Defec...	17 (.28%)
Spleen, Lymphatic And Reticulendoth...	17 (.28%)
Anemias Nonhemolytic And Marrow Dep...	16 (.26%)
Glucose Metabolism Disorders	16 (.26%)
Ocular Neuromuscular	16 (.26%)
Pregnancy, Labour, Delivery And Pos...	16 (.26%)
Skin Vascular Abnormalities	16 (.26%)
Therapeutic Procedures And Supporti...	16 (.26%)
Abortions And Stillbirth	15 (.24%)
Musculoskeletal And Connective Tiss...	15 (.24%)
Protein And Chemistry Analyses	15 (.24%)
Central Nervous System Vascular	14 (.23%)
Gastrointestinal	14 (.23%)
Gastrointestinal Tract Disorders Co...	14 (.23%)
Microbiology And Serology	14 (.23%)
Upper Respiratory Tract Disorders	14 (.23%)
Bacterial Infectious	13 (.21%)
Metabolic, Nutritional And Blood Ga...	13 (.21%)
Joint	12 (.19%)
Neonatal And Perinatal Conditions	12 (.19%)
Nervous System, Skull And Spine The...	12 (.19%)
Renal And Urinary Tract Disorders C...	12 (.19%)
Renal And Urinary Tract Investigati...	12 (.19%)
Acid-base	11 (.18%)
Communication Disorders	11 (.18%)
Investigations, Imaging And Histopa...	11 (.18%)
Placental, Amniotic And Cavity Diso...	11 (.18%)
Vascular Hypertensive	11 (.18%)
Gastrointestinal Hemorrhages	10 (.16%)
Tongue Conditions	10 (.16%)
Cranial Nerve Disorders	9 (.15%)
Eye	9 (.15%)

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