VALPROATE SODIUM

Valproate Sodium Adverse Events Reported to the FDA Over Time

How are Valproate Sodium adverse event reports trending over time?

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

Most Common Valproate Sodium Adverse Events Reported to the FDA

What are the most common Valproate Sodium adverse events reported to the FDA?

Convulsion	438 (2.72%)
Drug Interaction	387 (2.4%)
Drug Exposure During Pregnancy	218 (1.35%)
Somnolence	184 (1.14%)
Drug Ineffective	160 (.99%)
Pyrexia	160 (.99%)
Vomiting	131 (.81%)
Fatigue	129 (.8%)
Confusional State	125 (.78%)
Thrombocytopenia	120 (.75%)
Neutropenia	114 (.71%)
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Epilepsy	113 (.7%)
Status Epilepticus	107 (.66%)
Tremor	107 (.66%)
Suicide Attempt	105 (.65%)
Overdose	104 (.65%)
Coma	103 (.64%)
Hyperammonaemia	95 (.59%)
Condition Aggravated	93 (.58%)
Encephalopathy	91 (.56%)
Grand Mal Convulsion	91 (.56%)
Alanine Aminotransferase Increased	82 (.51%)
Drug Level Decreased	82 (.51%)
Drug Toxicity	82 (.51%)
Foetal Anticonvulsant Syndrome	80 (.5%)
Hypotension	76 (.47%)
White Blood Cell Count Decreased	76 (.47%)
Agitation	73 (.45%)
Loss Of Consciousness	73 (.45%)
Hyponatraemia	71 (.44%)
Tachycardia	71 (.44%)
Aspartate Aminotransferase Increase...	70 (.43%)
Malaise	70 (.43%)
Aggression	68 (.42%)
Oedema Peripheral	66 (.41%)
Intentional Overdose	65 (.4%)
Platelet Count Decreased	65 (.4%)
Delirium	64 (.4%)
Dizziness	63 (.39%)
Fall	63 (.39%)
Psychotic Disorder	63 (.39%)
Dyspnoea	62 (.38%)
Weight Increased	60 (.37%)
Pneumonia	59 (.37%)
Hypothyroidism	58 (.36%)
Nausea	58 (.36%)
Abortion Spontaneous	57 (.35%)
Depression	56 (.35%)
Stevens-johnson Syndrome	56 (.35%)
Blood Creatine Phosphokinase Increa...	55 (.34%)
Diarrhoea	55 (.34%)
Gamma-glutamyltransferase Increased	55 (.34%)
Drug Level Increased	54 (.34%)
Rash	54 (.34%)
Drug Rash With Eosinophilia And Sys...	53 (.33%)
Headache	53 (.33%)
Pancytopenia	53 (.33%)
Gait Disturbance	52 (.32%)
Multiple Drug Overdose Intentional	52 (.32%)
Asthenia	51 (.32%)
Electroencephalogram Abnormal	49 (.3%)
Hypospadias	49 (.3%)
Myoclonus	49 (.3%)
Abnormal Behaviour	48 (.3%)
Anaemia	48 (.3%)
Anxiety	47 (.29%)
Cognitive Disorder	47 (.29%)
Developmental Delay	47 (.29%)
Disorientation	47 (.29%)
Hepatic Failure	47 (.29%)
Hypotonia	47 (.29%)
Congenital Anomaly	46 (.29%)
Dysmorphism	46 (.29%)
Hepatic Function Abnormal	46 (.29%)
Insomnia	46 (.29%)
Abdominal Pain	45 (.28%)
Sedation	45 (.28%)
Ammonia Increased	44 (.27%)
Hepatotoxicity	44 (.27%)
Maternal Drugs Affecting Foetus	44 (.27%)
Dysarthria	43 (.27%)
White Blood Cell Count Increased	43 (.27%)
Brain Oedema	42 (.26%)
Depressed Level Of Consciousness	42 (.26%)
Metabolic Acidosis	42 (.26%)
Neuroleptic Malignant Syndrome	42 (.26%)
Neutrophil Count Decreased	42 (.26%)
Leukopenia	41 (.25%)
Liver Function Test Abnormal	41 (.25%)
Ataxia	39 (.24%)
Balance Disorder	39 (.24%)
Restlessness	39 (.24%)
Sudden Unexplained Death In Epileps...	39 (.24%)
Pancreatitis	38 (.24%)
Rhabdomyolysis	38 (.24%)
Alopecia	37 (.23%)
Bradycardia	37 (.23%)
Hyperammonaemic Encephalopathy	37 (.23%)
Aphasia	36 (.22%)
Atrial Septal Defect	36 (.22%)
Cerebral Atrophy	36 (.22%)

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

What are the most common Valproate Sodium adverse events reported to the FDA?

Neurological	1121 (6.96%)
Seizures	828 (5.14%)
Therapeutic And Nontherapeutic Effe...	661 (4.1%)
Epidermal And Dermal Conditions	485 (3.01%)
Movement Disorders	414 (2.57%)
Hematology Investigations	382 (2.37%)
Gastrointestinal Signs	370 (2.3%)
Chemical Injury And Poisoning	369 (2.29%)
Hepatobiliary	366 (2.27%)
Hepatic And Hepatobiliary	324 (2.01%)
Medication Errors	307 (1.91%)
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Infections - Pathogen Unspecified	303 (1.88%)
Respiratory	283 (1.76%)
Toxicology And Therapeutic Drug Mon...	273 (1.69%)
Musculoskeletal And Connective Tiss...	241 (1.5%)
White Blood Cell	238 (1.48%)
Deliria	236 (1.47%)
Cardiac Arrhythmias	218 (1.35%)
Body Temperature Conditions	207 (1.29%)
Mental Impairment	192 (1.19%)
Suicidal And Self-injurious Behavio...	188 (1.17%)
Encephalopathies	182 (1.13%)
Anxiety Disorders	176 (1.09%)
Anemias Nonhemolytic And Marrow Dep...	146 (.91%)
Platelet	142 (.88%)
Congenital And Hereditary	139 (.86%)
Muscle	138 (.86%)
Disturbances In Thinking	133 (.83%)
Neuromuscular	133 (.83%)
Electrolyte And Fluid Balance Condi...	130 (.81%)
Cardiac And Vascular Disorders Cong...	125 (.78%)
Renal Disorders	122 (.76%)
Enzyme	120 (.75%)
Skin Appendage Conditions	117 (.73%)
Physical Examination Topics	116 (.72%)
Personality Disorders	108 (.67%)
Protein And Amino Acid Metabolism	105 (.65%)
Injuries	103 (.64%)
Gastrointestinal Motility And Defec...	100 (.62%)
Thyroid Gland	100 (.62%)
Cardiac And Vascular Investigations	99 (.61%)
Decreased And Nonspecific Blood Pre...	99 (.61%)
Musculoskeletal And Connective Tiss...	99 (.61%)
Depressed Mood Disorders	97 (.6%)
Urinary Tract Signs	97 (.6%)
Abortions And Stillbirth	94 (.58%)
Mood Disorders	92 (.57%)
Sleep Disorders	90 (.56%)
Lifestyle Issues	83 (.52%)
Psychiatric	83 (.52%)
Schizophrenia And Other Psychotic	83 (.52%)
Vision	83 (.52%)
Neurological, Special Senses And Ps...	79 (.49%)
Fatal Outcomes	77 (.48%)
Acid-base	71 (.44%)
Changes In Physical Activity	69 (.43%)
Exocrine Pancreas Conditions	69 (.43%)
Appetite And General Nutritional	67 (.42%)
Metabolic, Nutritional And Blood Ga...	66 (.41%)
Lower Respiratory Tract Disorders	65 (.4%)
Water, Electrolyte And Mineral	64 (.4%)
Ocular Neuromuscular	62 (.38%)
Reproductive Tract And Breast Disor...	62 (.38%)
Musculoskeletal And Connective Tiss...	60 (.37%)
Headaches	58 (.36%)
Renal And Urinary Tract Investigati...	58 (.36%)
Bacterial Infectious	57 (.35%)
Gastrointestinal Tract Disorders Co...	57 (.35%)
Structural Brain	57 (.35%)
Psychiatric And Behavioural Symptom...	56 (.35%)
Increased Intracranial Pressure And...	54 (.34%)
Cardiac Disorder Signs	53 (.33%)
Glucose Metabolism Disorders	53 (.33%)
Manic And Bipolar Mood Disorders	53 (.33%)
Oral Soft Tissue Conditions	52 (.32%)
Product Quality Issues	52 (.32%)
Bone And Joint Injuries	48 (.3%)
Bone Disorders	44 (.27%)
Coagulopathies And Bleeding Diathes...	44 (.27%)
Pleural	42 (.26%)
Central Nervous System Vascular	41 (.25%)
Lipid Analyses	41 (.25%)
Protein And Chemistry Analyses	41 (.25%)
Allergic Conditions	40 (.25%)
Myocardial	40 (.25%)
Neurological Disorders Congenital	39 (.24%)
Obstetric And Gynecological Therape...	39 (.24%)
Ear And Labyrinthine Disorders Cong...	37 (.23%)
Nephropathies	37 (.23%)
Respiratory Disorders Congenital	37 (.23%)
Metabolism	36 (.22%)
Eye Disorders Congenital	34 (.21%)
Joint	34 (.21%)
Endocrine Investigations	31 (.19%)
Tissue	31 (.19%)
Viral Infectious	31 (.19%)
Cognitive And Attention Disorders	30 (.19%)
Hypothalamus And Pituitary Gland	30 (.19%)
Coronary Artery	29 (.18%)
Vascular	29 (.18%)
Breast	28 (.17%)

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