DIVALPROEX SODIUM

Divalproex Sodium Adverse Events Reported to the FDA Over Time

How are Divalproex Sodium adverse event reports trending over time?

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

Most Common Divalproex Sodium Adverse Events Reported to the FDA

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

Convulsion	776 (2.48%)
Tremor	449 (1.43%)
Weight Increased	397 (1.27%)
Somnolence	370 (1.18%)
Pain	360 (1.15%)
Alopecia	359 (1.15%)
Drug Ineffective	321 (1.03%)
Vomiting	288 (.92%)
Emotional Distress	287 (.92%)
Confusional State	286 (.91%)
Nausea	281 (.9%)
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Deformity	270 (.86%)
Physical Disability	269 (.86%)
Anxiety	245 (.78%)
Headache	245 (.78%)
Fatigue	235 (.75%)
Thrombocytopenia	232 (.74%)
Dizziness	229 (.73%)
Drug Interaction	227 (.73%)
Drug Level Decreased	225 (.72%)
Product Substitution Issue	217 (.69%)
Injury	215 (.69%)
Fall	214 (.68%)
Diarrhoea	211 (.67%)
Medication Residue	210 (.67%)
Drug Exposure During Pregnancy	208 (.66%)
Ammonia Increased	205 (.65%)
Anhedonia	205 (.65%)
Impaired Work Ability	204 (.65%)
Depression	199 (.64%)
Insomnia	195 (.62%)
Abnormal Behaviour	177 (.57%)
Hyperammonaemia	165 (.53%)
Coma	164 (.52%)
Pyrexia	162 (.52%)
Mania	161 (.51%)
Feeling Abnormal	160 (.51%)
Weight Decreased	153 (.49%)
Agitation	150 (.48%)
Lethargy	150 (.48%)
Rash	150 (.48%)
Pancreatitis	148 (.47%)
Overdose	147 (.47%)
Unevaluable Event	145 (.46%)
Loss Of Consciousness	144 (.46%)
Asthenia	142 (.45%)
Aggression	140 (.45%)
Suicide Attempt	140 (.45%)
Condition Aggravated	138 (.44%)
Platelet Count Decreased	138 (.44%)
Grand Mal Convulsion	133 (.42%)
Drug Level Increased	128 (.41%)
Spina Bifida	128 (.41%)
Suicidal Ideation	127 (.41%)
Amnesia	126 (.4%)
Gait Disturbance	126 (.4%)
Neutropenia	124 (.4%)
Dyspnoea	121 (.39%)
Neural Tube Defect	118 (.38%)
Malaise	117 (.37%)
Sedation	114 (.36%)
Memory Impairment	104 (.33%)
Dysarthria	103 (.33%)
White Blood Cell Count Decreased	102 (.33%)
Balance Disorder	97 (.31%)
Congenital Anomaly	96 (.31%)
Irritability	95 (.3%)
Abdominal Pain	94 (.3%)
Ill-defined Disorder	93 (.3%)
Oedema Peripheral	93 (.3%)
Quality Of Life Decreased	93 (.3%)
Dyskinesia	91 (.29%)
Intentional Overdose	90 (.29%)
Encephalopathy	88 (.28%)
Hallucination	87 (.28%)
Hepatic Enzyme Increased	86 (.27%)
Pneumonia	85 (.27%)
Anaemia	83 (.27%)
Disturbance In Attention	83 (.27%)
Multiple Injuries	83 (.27%)
Disorientation	82 (.26%)
Contusion	81 (.26%)
Mental Status Changes	81 (.26%)
Hypotension	80 (.26%)
Leukopenia	80 (.26%)
Medication Error	80 (.26%)
Vision Blurred	80 (.26%)
Death	78 (.25%)
Depressed Level Of Consciousness	78 (.25%)
Speech Disorder	78 (.25%)
Back Pain	76 (.24%)
Drug Toxicity	75 (.24%)
Activities Of Daily Living Impaired	74 (.24%)
Drug Level Below Therapeutic	74 (.24%)
Loss Of Employment	74 (.24%)
Abdominal Pain Upper	72 (.23%)
Chest Pain	71 (.23%)
Drug Dispensing Error	71 (.23%)
Constipation	70 (.22%)
Decreased Appetite	69 (.22%)
Bipolar Disorder	68 (.22%)

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

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

Neurological	2278 (7.28%)
Seizures	1085 (3.47%)
Gastrointestinal Signs	1031 (3.29%)
Movement Disorders	849 (2.71%)
Injuries	803 (2.57%)
Therapeutic And Nontherapeutic Effe...	797 (2.55%)
Lifestyle Issues	786 (2.51%)
Medication Errors	697 (2.23%)
Toxicology And Therapeutic Drug Mon...	695 (2.22%)
Hematology Investigations	672 (2.15%)
Anxiety Disorders	635 (2.03%)
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Physical Examination Topics	605 (1.93%)
Epidermal And Dermal Conditions	581 (1.86%)
Hepatobiliary	562 (1.8%)
Mood Disorders	543 (1.73%)
Skin Appendage Conditions	513 (1.64%)
Respiratory	500 (1.6%)
Product Quality Issues	496 (1.58%)
Depressed Mood Disorders	475 (1.52%)
Hepatic And Hepatobiliary	448 (1.43%)
Mental Impairment	426 (1.36%)
Deliria	406 (1.3%)
Infections - Pathogen Unspecified	370 (1.18%)
Chemical Injury And Poisoning	352 (1.12%)
Suicidal And Self-injurious Behavio...	347 (1.11%)
Gastrointestinal Motility And Defec...	333 (1.06%)
Headaches	329 (1.05%)
White Blood Cell	304 (.97%)
Sleep Disorders	303 (.97%)
Manic And Bipolar Mood Disorders	283 (.9%)
Muscle	275 (.88%)
Personality Disorders	275 (.88%)
Neurological Disorders Congenital	268 (.86%)
Exocrine Pancreas Conditions	260 (.83%)
Disturbances In Thinking	246 (.79%)
Platelet	243 (.78%)
Appetite And General Nutritional	238 (.76%)
Body Temperature Conditions	226 (.72%)
Electrolyte And Fluid Balance Condi...	225 (.72%)
Psychiatric	222 (.71%)
Musculoskeletal And Connective Tiss...	219 (.7%)
Cardiac Arrhythmias	210 (.67%)
Psychiatric And Behavioural Symptom...	207 (.66%)
Cardiac And Vascular Investigations	195 (.62%)
Urinary Tract Signs	183 (.58%)
Protein And Amino Acid Metabolism	180 (.57%)
Anemias Nonhemolytic And Marrow Dep...	177 (.57%)
Glucose Metabolism Disorders	170 (.54%)
Vision	169 (.54%)
Congenital And Hereditary	162 (.52%)
Encephalopathies	154 (.49%)
Renal Disorders	144 (.46%)
Metabolic, Nutritional And Blood Ga...	139 (.44%)
Investigations, Imaging And Histopa...	130 (.42%)
Lower Respiratory Tract Disorders	124 (.4%)
Decreased And Nonspecific Blood Pre...	118 (.38%)
Therapeutic Procedures And Supporti...	117 (.37%)
Joint	116 (.37%)
Fatal Outcomes	106 (.34%)
Central Nervous System Vascular	105 (.34%)
Economic And Housing Issues	102 (.33%)
Allergic Conditions	101 (.32%)
Changes In Physical Activity	101 (.32%)
Schizophrenia And Other Psychotic	96 (.31%)
Cardiac Disorder Signs	88 (.28%)
Neuromuscular	86 (.27%)
Dental And Gingival Conditions	80 (.26%)
Water, Electrolyte And Mineral	80 (.26%)
Lipid Analyses	78 (.25%)
Bacterial Infectious	76 (.24%)
Bone And Joint Injuries	76 (.24%)
Musculoskeletal And Connective Tiss...	76 (.24%)
Enzyme	72 (.23%)
Acid-base	71 (.23%)
Viral Infectious	70 (.22%)
Sexual Function And Fertility	69 (.22%)
Gastrointestinal Hemorrhages	68 (.22%)
Hearing	67 (.21%)
Salivary Gland Conditions	65 (.21%)
Sleep Disturbances	63 (.2%)
Angiedema And Urticaria	62 (.2%)
Cardiac And Vascular Disorders Cong...	62 (.2%)
Renal And Urinary Tract Investigati...	62 (.2%)
Vascular Hypertensive	62 (.2%)
Coronary Artery	61 (.19%)
Abortions And Stillbirth	60 (.19%)
Gastrointestinal	57 (.18%)
Protein And Chemistry Analyses	57 (.18%)
Vascular	56 (.18%)
Endocrine Investigations	53 (.17%)
Upper Respiratory Tract Disorders	52 (.17%)
Ocular Neuromuscular	51 (.16%)
Gallbladder	49 (.16%)
Inner Ear And Viiith Cranial Nerve	49 (.16%)
Oral Soft Tissue Conditions	49 (.16%)
Bronchial Disorders	46 (.15%)
Heart Failures	44 (.14%)
Skin Vascular Abnormalities	44 (.14%)
Communication Disorders	43 (.14%)
Gastrointestinal Conditions	43 (.14%)
Eye	42 (.13%)

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