VALPROIC ACID

Valproic Acid Adverse Events Reported to the FDA Over Time

How are Valproic Acid adverse event reports trending over time?

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

Most Common Valproic Acid Adverse Events Reported to the FDA

What are the most common Valproic Acid adverse events reported to the FDA?

Convulsion	1593 (2.4%)
Drug Interaction	833 (1.26%)
Somnolence	775 (1.17%)
Drug Ineffective	739 (1.11%)
Drug Exposure During Pregnancy	641 (.97%)
Tremor	629 (.95%)
Vomiting	551 (.83%)
Completed Suicide	548 (.83%)
Thrombocytopenia	542 (.82%)
Pyrexia	536 (.81%)
Weight Increased	521 (.78%)
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Confusional State	518 (.78%)
Epilepsy	494 (.74%)
Alopecia	447 (.67%)
Fall	433 (.65%)
Pain	415 (.63%)
Nausea	409 (.62%)
Fatigue	377 (.57%)
Hyperammonaemia	375 (.56%)
Headache	367 (.55%)
Drug Level Decreased	361 (.54%)
Coma	359 (.54%)
Diarrhoea	350 (.53%)
Dizziness	342 (.52%)
Overdose	336 (.51%)
Loss Of Consciousness	331 (.5%)
Rash	308 (.46%)
Abnormal Behaviour	304 (.46%)
Suicide Attempt	300 (.45%)
Anxiety	296 (.45%)
Asthenia	296 (.45%)
Emotional Distress	295 (.44%)
Ammonia Increased	291 (.44%)
Depression	284 (.43%)
Platelet Count Decreased	284 (.43%)
Medication Residue	281 (.42%)
Agitation	279 (.42%)
Deformity	270 (.41%)
Physical Disability	270 (.41%)
Drug Level Increased	268 (.4%)
Weight Decreased	266 (.4%)
Condition Aggravated	261 (.39%)
Drug Toxicity	260 (.39%)
Intentional Overdose	257 (.39%)
Malaise	247 (.37%)
Encephalopathy	245 (.37%)
Neutropenia	244 (.37%)
Depressed Level Of Consciousness	242 (.36%)
Grand Mal Convulsion	242 (.36%)
Gait Disturbance	240 (.36%)
Aggression	239 (.36%)
Alanine Aminotransferase Increased	231 (.35%)
Pneumonia	229 (.35%)
Injury	228 (.34%)
Insomnia	227 (.34%)
Disorientation	222 (.33%)
Dyspnoea	222 (.33%)
Hyponatraemia	221 (.33%)
Abdominal Pain	214 (.32%)
Lethargy	212 (.32%)
Anaemia	211 (.32%)
Aspartate Aminotransferase Increase...	210 (.32%)
Impaired Work Ability	205 (.31%)
Anhedonia	204 (.31%)
Pancreatitis	201 (.3%)
Mania	198 (.3%)
Amnesia	197 (.3%)
Hypotension	195 (.29%)
Death	194 (.29%)
Feeling Abnormal	194 (.29%)
Balance Disorder	191 (.29%)
Unevaluable Event	190 (.29%)
Status Epilepticus	182 (.27%)
Disturbance In Attention	180 (.27%)
Renal Failure	175 (.26%)
Cognitive Disorder	172 (.26%)
Oedema Peripheral	171 (.26%)
Product Substitution Issue	168 (.25%)
Cardiac Arrest	166 (.25%)
Pancytopenia	165 (.25%)
Memory Impairment	164 (.25%)
White Blood Cell Count Decreased	164 (.25%)
Leukopenia	163 (.25%)
Pruritus	157 (.24%)
Tachycardia	156 (.24%)
Dysphagia	151 (.23%)
Hallucination	151 (.23%)
Sedation	150 (.23%)
Suicidal Ideation	149 (.22%)
Cardio-respiratory Arrest	147 (.22%)
Hepatic Enzyme Increased	147 (.22%)
Drug Level Below Therapeutic	144 (.22%)
Dysarthria	144 (.22%)
Spina Bifida	143 (.22%)
Rhabdomyolysis	141 (.21%)
Congenital Anomaly	140 (.21%)
Medication Error	140 (.21%)
Speech Disorder	139 (.21%)
Blood Creatine Phosphokinase Increa...	134 (.2%)
Dyskinesia	133 (.2%)
Cytolytic Hepatitis	132 (.2%)

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

What are the most common Valproic Acid adverse events reported to the FDA?

Neurological	4542 (6.84%)
Seizures	2829 (4.26%)
Therapeutic And Nontherapeutic Effe...	2029 (3.06%)
Epidermal And Dermal Conditions	1970 (2.97%)
Gastrointestinal Signs	1861 (2.8%)
Medication Errors	1610 (2.43%)
Movement Disorders	1488 (2.24%)
Hematology Investigations	1408 (2.12%)
Hepatobiliary	1334 (2.01%)
Hepatic And Hepatobiliary	1314 (1.98%)
Toxicology And Therapeutic Drug Mon...	1299 (1.96%)
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Respiratory	1262 (1.9%)
Chemical Injury And Poisoning	1216 (1.83%)
Injuries	1190 (1.79%)
Suicidal And Self-injurious Behavio...	1148 (1.73%)
Infections - Pathogen Unspecified	980 (1.48%)
Lifestyle Issues	930 (1.4%)
Physical Examination Topics	911 (1.37%)
Anxiety Disorders	907 (1.37%)
Mental Impairment	894 (1.35%)
Deliria	847 (1.28%)
Cardiac Arrhythmias	812 (1.22%)
Skin Appendage Conditions	747 (1.13%)
White Blood Cell	733 (1.1%)
Mood Disorders	705 (1.06%)
Body Temperature Conditions	697 (1.05%)
Depressed Mood Disorders	633 (.95%)
Product Quality Issues	621 (.94%)
Muscle	617 (.93%)
Platelet	599 (.9%)
Gastrointestinal Motility And Defec...	573 (.86%)
Electrolyte And Fluid Balance Condi...	564 (.85%)
Anemias Nonhemolytic And Marrow Dep...	555 (.84%)
Musculoskeletal And Connective Tiss...	506 (.76%)
Renal Disorders	484 (.73%)
Appetite And General Nutritional	455 (.69%)
Headaches	455 (.69%)
Encephalopathies	447 (.67%)
Sleep Disorders	447 (.67%)
Disturbances In Thinking	443 (.67%)
Cardiac And Vascular Investigations	431 (.65%)
Exocrine Pancreas Conditions	431 (.65%)
Protein And Amino Acid Metabolism	431 (.65%)
Personality Disorders	428 (.64%)
Neurological Disorders Congenital	425 (.64%)
Musculoskeletal And Connective Tiss...	414 (.62%)
Psychiatric	412 (.62%)
Urinary Tract Signs	389 (.59%)
Enzyme	381 (.57%)
Psychiatric And Behavioural Symptom...	374 (.56%)
Vision	353 (.53%)
Congenital And Hereditary	350 (.53%)
Lower Respiratory Tract Disorders	346 (.52%)
Manic And Bipolar Mood Disorders	343 (.52%)
Metabolic, Nutritional And Blood Ga...	323 (.49%)
Glucose Metabolism Disorders	318 (.48%)
Neuromuscular	296 (.45%)
Decreased And Nonspecific Blood Pre...	294 (.44%)
Fatal Outcomes	280 (.42%)
Oral Soft Tissue Conditions	271 (.41%)
Cardiac And Vascular Disorders Cong...	269 (.41%)
Central Nervous System Vascular	232 (.35%)
Water, Electrolyte And Mineral	210 (.32%)
Cardiac Disorder Signs	198 (.3%)
Allergic Conditions	197 (.3%)
Ocular Neuromuscular	197 (.3%)
Joint	195 (.29%)
Therapeutic Procedures And Supporti...	188 (.28%)
Acid-base	187 (.28%)
Changes In Physical Activity	185 (.28%)
Schizophrenia And Other Psychotic	184 (.28%)
Renal And Urinary Tract Investigati...	181 (.27%)
Protein And Chemistry Analyses	169 (.25%)
Viral Infectious	166 (.25%)
Bacterial Infectious	163 (.25%)
Investigations, Imaging And Histopa...	159 (.24%)
Obstetric And Gynecological Therape...	157 (.24%)
Bone And Joint Injuries	150 (.23%)
Ocular Infections, Irritations And ...	150 (.23%)
Abortions And Stillbirth	148 (.22%)
Coagulopathies And Bleeding Diathes...	148 (.22%)
Spleen, Lymphatic And Reticulendoth...	148 (.22%)
Hearing	141 (.21%)
Neurological, Special Senses And Ps...	140 (.21%)
Dental And Gingival Conditions	130 (.2%)
Gastrointestinal Hemorrhages	128 (.19%)
Increased Intracranial Pressure And...	128 (.19%)
Skin Vascular Abnormalities	124 (.19%)
Vascular Hypertensive	122 (.18%)
Vascular	119 (.18%)
Bone Disorders	118 (.18%)
Gastrointestinal	116 (.17%)
Neonatal And Perinatal Conditions	116 (.17%)
Sexual Function And Fertility	116 (.17%)
Upper Respiratory Tract Disorders	116 (.17%)
Bone, Calcium, Magnesium And Phosph...	113 (.17%)
Pleural	113 (.17%)
Renal And Urinary Tract Disorders C...	112 (.17%)
Musculoskeletal And Connective Tiss...	111 (.17%)
Salivary Gland Conditions	110 (.17%)
Endocrine Investigations	107 (.16%)

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