TOPIRAMATE

Topiramate Adverse Events Reported to the FDA Over Time

How are Topiramate adverse event reports trending over time?

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

Most Common Topiramate Adverse Events Reported to the FDA

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

Convulsion	451 (2.7%)
Completed Suicide	255 (1.53%)
Product Substitution Issue	253 (1.52%)
Drug Ineffective	241 (1.44%)
Drug Exposure During Pregnancy	238 (1.43%)
Somnolence	187 (1.12%)
Drug Interaction	182 (1.09%)
Headache	178 (1.07%)
Confusional State	140 (.84%)
Weight Decreased	139 (.83%)
Paraesthesia	134 (.8%)
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Fatigue	131 (.79%)
Status Epilepticus	129 (.77%)
Memory Impairment	127 (.76%)
Depression	121 (.73%)
Metabolic Acidosis	117 (.7%)
Condition Aggravated	116 (.7%)
Dizziness	116 (.7%)
Maternal Drugs Affecting Foetus	115 (.69%)
Angle Closure Glaucoma	111 (.67%)
Migraine	105 (.63%)
Anxiety	98 (.59%)
Cardiac Arrest	95 (.57%)
Decreased Appetite	95 (.57%)
Overdose	93 (.56%)
Vomiting	92 (.55%)
Nausea	91 (.55%)
Dyspnoea	87 (.52%)
Speech Disorder	85 (.51%)
Suicidal Ideation	85 (.51%)
Abortion Spontaneous	84 (.5%)
Suicide Attempt	84 (.5%)
Drug Toxicity	83 (.5%)
Respiratory Arrest	83 (.5%)
Epilepsy	82 (.49%)
White Blood Cell Count Decreased	82 (.49%)
Insomnia	81 (.49%)
Vision Blurred	81 (.49%)
Grand Mal Convulsion	80 (.48%)
Aggression	78 (.47%)
Cardio-respiratory Arrest	77 (.46%)
Dysarthria	76 (.46%)
Neutropenia	75 (.45%)
Tremor	75 (.45%)
Disturbance In Attention	73 (.44%)
Myopia	73 (.44%)
Abnormal Behaviour	71 (.43%)
Death	70 (.42%)
Pyrexia	67 (.4%)
Asthenia	66 (.4%)
Balance Disorder	66 (.4%)
Road Traffic Accident	66 (.4%)
Intentional Overdose	63 (.38%)
Diplopia	61 (.37%)
Feeling Abnormal	61 (.37%)
Psychotic Disorder	60 (.36%)
Aphasia	58 (.35%)
Injury	58 (.35%)
Toothache	57 (.34%)
Cognitive Disorder	55 (.33%)
Off Label Use	55 (.33%)
Weight Increased	55 (.33%)
Tooth Infection	54 (.32%)
Coma	53 (.32%)
Gait Disturbance	53 (.32%)
Myoclonus	53 (.32%)
Rash	53 (.32%)
Scratch	53 (.32%)
Visual Acuity Reduced	52 (.31%)
Alopecia	51 (.31%)
Eosinophil Count Decreased	51 (.31%)
Loss Of Consciousness	51 (.31%)
Nephrolithiasis	50 (.3%)
Sepsis	50 (.3%)
Fall	49 (.29%)
Rhabdomyolysis	49 (.29%)
Choroidal Effusion	48 (.29%)
Platelet Count Decreased	47 (.28%)
Visual Impairment	47 (.28%)
Medication Error	46 (.28%)
Agitation	45 (.27%)
Lethargy	45 (.27%)
Pneumonia	45 (.27%)
Hallucination, Visual	43 (.26%)
Malaise	43 (.26%)
Hypoaesthesia	42 (.25%)
Congenital Anomaly	41 (.25%)
Mood Swings	41 (.25%)
Neutrophil Count Decreased	41 (.25%)
Amnesia	39 (.23%)
Disorientation	39 (.23%)
Irritability	39 (.23%)
Renal Failure	39 (.23%)
Unresponsive To Stimuli	39 (.23%)
Encephalopathy	38 (.23%)
Product Quality Issue	37 (.22%)
Tearfulness	37 (.22%)
Diarrhoea	36 (.22%)
Hallucination, Auditory	35 (.21%)
Hyperammonaemia	35 (.21%)
Poisoning	35 (.21%)

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

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

Neurological	1442 (8.64%)
Seizures	862 (5.17%)
Therapeutic And Nontherapeutic Effe...	586 (3.51%)
Chemical Injury And Poisoning	487 (2.92%)
Suicidal And Self-injurious Behavio...	448 (2.68%)
Medication Errors	400 (2.4%)
Vision	395 (2.37%)
Respiratory	346 (2.07%)
Injuries	325 (1.95%)
Mental Impairment	324 (1.94%)
Hematology Investigations	322 (1.93%)
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Product Quality Issues	309 (1.85%)
Headaches	291 (1.74%)
Gastrointestinal Signs	284 (1.7%)
Infections - Pathogen Unspecified	284 (1.7%)
Cardiac Arrhythmias	263 (1.58%)
Epidermal And Dermal Conditions	249 (1.49%)
Depressed Mood Disorders	234 (1.4%)
Anxiety Disorders	225 (1.35%)
Physical Examination Topics	216 (1.29%)
Movement Disorders	213 (1.28%)
Musculoskeletal And Connective Tiss...	195 (1.17%)
Appetite And General Nutritional	185 (1.11%)
Mood Disorders	184 (1.1%)
Deliria	182 (1.09%)
Disturbances In Thinking	171 (1.02%)
Personality Disorders	164 (.98%)
Sleep Disorders	160 (.96%)
Ocular Structural Change, Deposit A...	157 (.94%)
Hepatic And Hepatobiliary	153 (.92%)
Acid-base	147 (.88%)
Hepatobiliary	138 (.83%)
Cardiac And Vascular Investigations	134 (.8%)
Ocular Infections, Irritations And ...	133 (.8%)
Skin Appendage Conditions	122 (.73%)
Muscle	121 (.73%)
Glaucoma And Ocular Hypertension	120 (.72%)
Abortions And Stillbirth	115 (.69%)
White Blood Cell	113 (.68%)
Renal Disorders	111 (.67%)
Psychiatric	107 (.64%)
Dental And Gingival Conditions	106 (.64%)
Lifestyle Issues	104 (.62%)
Body Temperature Conditions	100 (.6%)
Congenital And Hereditary	100 (.6%)
Electrolyte And Fluid Balance Condi...	99 (.59%)
Neuromuscular	96 (.58%)
Fatal Outcomes	94 (.56%)
Gastrointestinal Tract Disorders Co...	92 (.55%)
Metabolic, Nutritional And Blood Ga...	89 (.53%)
Gastrointestinal Motility And Defec...	84 (.5%)
Cardiac And Vascular Disorders Cong...	83 (.5%)
Urolithiases	83 (.5%)
Schizophrenia And Other Psychotic	82 (.49%)
Musculoskeletal And Connective Tiss...	81 (.49%)
Psychiatric And Behavioural Symptom...	80 (.48%)
Anterior Eye Structural Change, Dep...	78 (.47%)
Eye	77 (.46%)
Encephalopathies	76 (.46%)
Toxicology And Therapeutic Drug Mon...	76 (.46%)
Therapeutic Procedures And Supporti...	74 (.44%)
Urinary Tract Signs	70 (.42%)
Water, Electrolyte And Mineral	70 (.42%)
Decreased And Nonspecific Blood Pre...	67 (.4%)
Neonatal And Perinatal Conditions	55 (.33%)
Communication Disorders	53 (.32%)
Retina, Choroid And Vitreous Hemorr...	53 (.32%)
Tongue Conditions	52 (.31%)
Pregnancy, Labour, Delivery And Pos...	51 (.31%)
Bacterial Infectious	48 (.29%)
Cardiac Disorder Signs	48 (.29%)
Anemias Nonhemolytic And Marrow Dep...	47 (.28%)
Enzyme	46 (.28%)
Changes In Physical Activity	44 (.26%)
Neurological, Special Senses And Ps...	43 (.26%)
Bronchial Disorders	42 (.25%)
Joint	41 (.25%)
Reproductive Tract And Breast Disor...	41 (.25%)
Musculoskeletal And Connective Tiss...	40 (.24%)
Ocular Neuromuscular	40 (.24%)
Platelet	40 (.24%)
Renal And Urinary Tract Investigati...	40 (.24%)
Renal And Urinary Tract Disorders C...	39 (.23%)
Oral Soft Tissue Conditions	38 (.23%)
Central Nervous System Vascular	37 (.22%)
Dissociative	37 (.22%)
Protein And Amino Acid Metabolism	35 (.21%)
Bone Disorders	32 (.19%)
Nephropathies	32 (.19%)
Myocardial	30 (.18%)
Obstetric And Gynecological Therape...	30 (.18%)
Lower Respiratory Tract Disorders	29 (.17%)
Menstrual Cycle And Uterine Bleedin...	29 (.17%)
Allergic Conditions	28 (.17%)
Glucose Metabolism Disorders	28 (.17%)
Heart Failures	27 (.16%)
Increased Intracranial Pressure And...	27 (.16%)
Inner Ear And Viiith Cranial Nerve	27 (.16%)
Sexual Dysfunctions, Disturbances A...	27 (.16%)
Thyroid Gland	27 (.16%)
Neurological Disorders Congenital	25 (.15%)

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