CARBAMAZEPINE

Carbamazepine Adverse Events Reported to the FDA Over Time

How are Carbamazepine adverse event reports trending over time?

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

Most Common Carbamazepine Adverse Events Reported to the FDA

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

Convulsion	642 (2.15%)
Drug Interaction	417 (1.4%)
Pyrexia	397 (1.33%)
Drug Rash With Eosinophilia And Sys...	336 (1.13%)
Drug Exposure During Pregnancy	315 (1.06%)
Completed Suicide	304 (1.02%)
Somnolence	288 (.97%)
Hyponatraemia	244 (.82%)
Rash	236 (.79%)
Drug Toxicity	234 (.78%)
Grand Mal Convulsion	234 (.78%)
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Dizziness	223 (.75%)
Stevens-johnson Syndrome	221 (.74%)
Vomiting	221 (.74%)
Drug Ineffective	207 (.69%)
Condition Aggravated	200 (.67%)
Alanine Aminotransferase Increased	198 (.66%)
Confusional State	178 (.6%)
Fatigue	176 (.59%)
Nausea	176 (.59%)
Suicide Attempt	176 (.59%)
Overdose	175 (.59%)
Toxic Epidermal Necrolysis	170 (.57%)
Aspartate Aminotransferase Increase...	158 (.53%)
Drug Hypersensitivity	146 (.49%)
Fall	144 (.48%)
Coma	142 (.48%)
Loss Of Consciousness	138 (.46%)
Status Epilepticus	136 (.46%)
Epilepsy	135 (.45%)
Dyspnoea	129 (.43%)
Gamma-glutamyltransferase Increased	128 (.43%)
Headache	120 (.4%)
Gait Disturbance	119 (.4%)
Lymphadenopathy	116 (.39%)
Pneumonia	115 (.39%)
Cardiac Arrest	113 (.38%)
Anxiety	109 (.37%)
Asthenia	109 (.37%)
Depressed Level Of Consciousness	108 (.36%)
Malaise	105 (.35%)
Pruritus	104 (.35%)
Tachycardia	99 (.33%)
Maternal Drugs Affecting Foetus	98 (.33%)
Death	96 (.32%)
Skin Exfoliation	95 (.32%)
Ataxia	94 (.32%)
Diplopia	90 (.3%)
Anticonvulsant Drug Level Increased	89 (.3%)
Hypersensitivity	89 (.3%)
Drug Level Increased	87 (.29%)
Lethargy	86 (.29%)
Respiratory Arrest	86 (.29%)
Respiratory Failure	86 (.29%)
Electroencephalogram Abnormal	85 (.28%)
Hypotension	85 (.28%)
Abnormal Behaviour	83 (.28%)
Pain	83 (.28%)
Tremor	83 (.28%)
Eosinophilia	82 (.27%)
Rash Maculo-papular	82 (.27%)
Agitation	81 (.27%)
Petit Mal Epilepsy	80 (.27%)
Thrombocytopenia	80 (.27%)
Aggression	79 (.26%)
Memory Impairment	78 (.26%)
Depression	77 (.26%)
Cognitive Disorder	76 (.25%)
Balance Disorder	75 (.25%)
Multi-organ Failure	74 (.25%)
Myoclonus	74 (.25%)
Insomnia	73 (.24%)
Blood Alkaline Phosphatase Increase...	72 (.24%)
Coordination Abnormal	72 (.24%)
Dysarthria	72 (.24%)
Leukopenia	72 (.24%)
Renal Failure Acute	71 (.24%)
Treatment Noncompliance	70 (.23%)
Dysphagia	69 (.23%)
Intentional Overdose	69 (.23%)
Nystagmus	68 (.23%)
Cough	67 (.22%)
Diarrhoea	67 (.22%)
Leukocytosis	67 (.22%)
Syncope	67 (.22%)
Liver Disorder	65 (.22%)
Poisoning	65 (.22%)
Inappropriate Antidiuretic Hormone ...	64 (.21%)
Heart Rate Increased	63 (.21%)
Anaemia	62 (.21%)
Caesarean Section	62 (.21%)
Hypertension	61 (.2%)
Complex Partial Seizures	60 (.2%)
Disturbance In Attention	60 (.2%)
Bradycardia	59 (.2%)
Rash Generalised	59 (.2%)
Erythema	57 (.19%)
Hepatic Function Abnormal	56 (.19%)
Hepatitis	55 (.18%)
Oedema Peripheral	55 (.18%)
Sepsis	55 (.18%)

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

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

Neurological	2197 (7.37%)
Epidermal And Dermal Conditions	2102 (7.05%)
Seizures	1429 (4.79%)
Therapeutic And Nontherapeutic Effe...	842 (2.82%)
Chemical Injury And Poisoning	767 (2.57%)
Hepatobiliary	691 (2.32%)
Respiratory	683 (2.29%)
Gastrointestinal Signs	642 (2.15%)
Cardiac Arrhythmias	588 (1.97%)
Suicidal And Self-injurious Behavio...	557 (1.87%)
Hepatic And Hepatobiliary	543 (1.82%)
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Medication Errors	514 (1.72%)
Hematology Investigations	500 (1.68%)
Infections - Pathogen Unspecified	496 (1.66%)
Body Temperature Conditions	434 (1.45%)
Movement Disorders	403 (1.35%)
White Blood Cell	401 (1.34%)
Toxicology And Therapeutic Drug Mon...	399 (1.34%)
Electrolyte And Fluid Balance Condi...	359 (1.2%)
Mental Impairment	336 (1.13%)
Injuries	321 (1.08%)
Vision	277 (.93%)
Deliria	272 (.91%)
Cardiac And Vascular Investigations	263 (.88%)
Allergic Conditions	258 (.86%)
Anxiety Disorders	258 (.86%)
Musculoskeletal And Connective Tiss...	246 (.82%)
Lower Respiratory Tract Disorders	221 (.74%)
Physical Examination Topics	217 (.73%)
Skin Appendage Conditions	208 (.7%)
Renal Disorders	205 (.69%)
Neurological, Special Senses And Ps...	196 (.66%)
Oral Soft Tissue Conditions	192 (.64%)
Viral Infectious	191 (.64%)
Lifestyle Issues	185 (.62%)
Muscle	183 (.61%)
Enzyme	182 (.61%)
Depressed Mood Disorders	179 (.6%)
Personality Disorders	178 (.6%)
Urinary Tract Signs	177 (.59%)
Anemias Nonhemolytic And Marrow Dep...	174 (.58%)
Cardiac And Vascular Disorders Cong...	169 (.57%)
Mood Disorders	168 (.56%)
Neuromuscular	167 (.56%)
Disturbances In Thinking	165 (.55%)
Spleen, Lymphatic And Reticulendoth...	158 (.53%)
Metabolic, Nutritional And Blood Ga...	155 (.52%)
Musculoskeletal And Connective Tiss...	151 (.51%)
Water, Electrolyte And Mineral	148 (.5%)
Fatal Outcomes	144 (.48%)
Gastrointestinal Motility And Defec...	142 (.48%)
Renal And Urinary Tract Investigati...	141 (.47%)
Headaches	140 (.47%)
Decreased And Nonspecific Blood Pre...	131 (.44%)
Central Nervous System Vascular	129 (.43%)
Immunology And Allergy	124 (.42%)
Renal And Urinary Tract Disorders C...	118 (.4%)
Ocular Infections, Irritations And ...	117 (.39%)
Sleep Disorders	117 (.39%)
Ocular Neuromuscular	116 (.39%)
Bacterial Infectious	114 (.38%)
Appetite And General Nutritional	113 (.38%)
Neurological Disorders Congenital	110 (.37%)
Psychiatric	109 (.37%)
Obstetric And Gynecological Therape...	108 (.36%)
Myocardial	106 (.36%)
Platelet	106 (.36%)
Psychiatric And Behavioural Symptom...	105 (.35%)
Abortions And Stillbirth	95 (.32%)
Heart Failures	95 (.32%)
Protein And Chemistry Analyses	94 (.32%)
Changes In Physical Activity	92 (.31%)
Microbiology And Serology	88 (.3%)
Bone Disorders	86 (.29%)
Angiedema And Urticaria	84 (.28%)
Glucose Metabolism Disorders	81 (.27%)
Bone And Joint Injuries	80 (.27%)
Manic And Bipolar Mood Disorders	80 (.27%)
Skin Vascular Abnormalities	80 (.27%)
Hypothalamus And Pituitary Gland	76 (.25%)
Joint	76 (.25%)
Ocular Structural Change, Deposit A...	74 (.25%)
Eye	73 (.24%)
Pregnancy, Labour, Delivery And Pos...	71 (.24%)
Congenital And Hereditary	70 (.23%)
Encephalopathies	69 (.23%)
Vascular Hypertensive	67 (.22%)
Gastrointestinal Tract Disorders Co...	65 (.22%)
Product Quality Issues	65 (.22%)
Neonatal And Perinatal Conditions	64 (.21%)
Bronchial Disorders	61 (.2%)
Lipid Analyses	61 (.2%)
Schizophrenia And Other Psychotic	61 (.2%)
Cardiac Disorder Signs	59 (.2%)
Hematological And Lymphoid Tissue T...	58 (.19%)
Arteriosclerosis, Stenosis, Vascula...	57 (.19%)
Endocrine Investigations	57 (.19%)
Coagulopathies And Bleeding Diathes...	56 (.19%)
Pigmentation	56 (.19%)
Gastrointestinal Stenosis And Obstr...	55 (.18%)
Increased Intracranial Pressure And...	53 (.18%)

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