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DEPAKOTE

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Depakote Adverse Events Reported to the FDA Over Time

How are Depakote adverse event reports trending over time?

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

Most Common Depakote Adverse Events Reported to the FDA

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

Convulsion
1083 (2.32%)
Drug Interaction
572 (1.23%)
Completed Suicide
541 (1.16%)
Tremor
519 (1.11%)
Somnolence
501 (1.07%)
Drug Ineffective
461 (.99%)
Weight Increased
429 (.92%)
Vomiting
394 (.84%)
Confusional State
380 (.81%)
Alopecia
379 (.81%)
Drug Exposure During Pregnancy
375 (.8%)
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Pain
371 (.79%)
Thrombocytopenia
356 (.76%)
Nausea
342 (.73%)
Fatigue
294 (.63%)
Emotional Distress
290 (.62%)
Headache
283 (.61%)
Fall
282 (.6%)
Dizziness
275 (.59%)
Anxiety
274 (.59%)
Hyperammonaemia
272 (.58%)
Overdose
271 (.58%)
Deformity
270 (.58%)
Physical Disability
270 (.58%)
Ammonia Increased
268 (.57%)
Pyrexia
265 (.57%)
Coma
263 (.56%)
Drug Level Decreased
263 (.56%)
Diarrhoea
257 (.55%)
Abnormal Behaviour
246 (.53%)
Medication Residue
246 (.53%)
Product Substitution Issue
242 (.52%)
Agitation
232 (.5%)
Depression
232 (.5%)
Drug Toxicity
229 (.49%)
Loss Of Consciousness
226 (.48%)
Injury
223 (.48%)
Grand Mal Convulsion
214 (.46%)
Insomnia
213 (.46%)
Condition Aggravated
211 (.45%)
Impaired Work Ability
207 (.44%)
Anhedonia
206 (.44%)
Rash
203 (.43%)
Lethargy
202 (.43%)
Suicide Attempt
196 (.42%)
Aggression
193 (.41%)
Platelet Count Decreased
193 (.41%)
Mania
191 (.41%)
Neutropenia
191 (.41%)
Drug Level Increased
185 (.4%)
Weight Decreased
181 (.39%)
Pancreatitis
179 (.38%)
Depressed Level Of Consciousness
176 (.38%)
Feeling Abnormal
176 (.38%)
Gait Disturbance
176 (.38%)
Intentional Overdose
175 (.37%)
Dyspnoea
171 (.37%)
Asthenia
168 (.36%)
Death
168 (.36%)
Encephalopathy
168 (.36%)
Hypotension
164 (.35%)
Unevaluable Event
153 (.33%)
Cardiac Arrest
149 (.32%)
Suicidal Ideation
148 (.32%)
Malaise
145 (.31%)
Pneumonia
145 (.31%)
Amnesia
144 (.31%)
Sedation
143 (.31%)
Abdominal Pain
142 (.3%)
Dysarthria
137 (.29%)
Epilepsy
137 (.29%)
Spina Bifida
135 (.29%)
Cardio-respiratory Arrest
134 (.29%)
White Blood Cell Count Decreased
134 (.29%)
Memory Impairment
130 (.28%)
Neural Tube Defect
129 (.28%)
Anaemia
127 (.27%)
Disorientation
125 (.27%)
Irritability
124 (.27%)
Mental Status Changes
121 (.26%)
Alanine Aminotransferase Increased
118 (.25%)
Respiratory Arrest
118 (.25%)
Balance Disorder
117 (.25%)
Dyskinesia
117 (.25%)
Hallucination
117 (.25%)
Medication Error
116 (.25%)
Oedema Peripheral
115 (.25%)
Aspartate Aminotransferase Increase...
113 (.24%)
Hepatic Enzyme Increased
113 (.24%)
Status Epilepticus
112 (.24%)
Tachycardia
112 (.24%)
Hyponatraemia
108 (.23%)
Congenital Anomaly
106 (.23%)
Disturbance In Attention
106 (.23%)
Leukopenia
106 (.23%)
Ill-defined Disorder
103 (.22%)
Multiple Drug Overdose
103 (.22%)
Vision Blurred
103 (.22%)
Speech Disorder
102 (.22%)
Metabolic Acidosis
99 (.21%)
Psychotic Disorder
98 (.21%)

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

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

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

Common Uses of Depakote According to Those Reporting Adverse Events

Why are people taking Depakote, according to those reporting adverse events to the FDA?

Bipolar Disorder
2177
Drug Use For Unknown Indication
2075
Convulsion
1768
Epilepsy
1380
Product Used For Unknown Indication
1026
Affective Disorder
516
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Drug Exposure During Pregnancy
415
Depression
355
Bipolar I Disorder
309
Migraine
282
Mania
246
Schizophrenia
227
Schizoaffective Disorder
213
Mood Swings
154
Maternal Exposure Timing Unspecifie...
133
Psychotic Disorder
120
Anxiety
105
Grand Mal Convulsion
99
Maternal Exposure During Pregnancy
98
Headache
94
Convulsion Prophylaxis
87
Abnormal Behaviour
85
Mood Altered
81
Petit Mal Epilepsy
71
Mental Disorder
70
Myoclonic Epilepsy
66
Complex Partial Seizures
60
Ill-defined Disorder
58
Drug Therapy
53
Partial Seizures
53
Agitation
48
Suicide Attempt
48
Intentional Overdose
48
Status Epilepticus
44
Attention Deficit/hyperactivity Dis...
44
Migraine Prophylaxis
42
Bipolar Ii Disorder
42
Aggression
40
Schizophrenia, Paranoid Type
36
Hypomania
35
Infantile Spasms
35
Post-traumatic Stress Disorder
32
Autism
26
Major Depression
26
Prophylaxis
25
Pain
23
Dementia
23
Sleep Disorder
23
Overdose
22
Dysthymic Disorder
18
Myoclonus
17

Drug Labels

LabelLabelerEffective
DepakotePhysicians Total Care, Inc.08-JUN-10
DepakoteRebel Distributors Corp17-DEC-10
DepakotePhysicians Total Care, Inc.03-JAN-11
DepakoteLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-NOV-11
DepakoteCardinal Health25-JUL-12
DepakoteCardinal Health01-AUG-12
DepakoteerBryant Ranch Prepack13-FEB-13
DepakoteAbbVie Inc.18-MAR-13
DepakoteerAbbVie Inc.18-MAR-13
DepakoteAbbVie Inc.09-APR-13

Depakote Case Reports

What Depakote safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Depakote. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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