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DEPAKOTE ER

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Depakote Er Adverse Events Reported to the FDA Over Time

How are Depakote Er adverse event reports trending over time?

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

Most Common Depakote Er Adverse Events Reported to the FDA

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

Convulsion
177 (3.15%)
Alopecia
156 (2.77%)
Medication Residue
138 (2.45%)
Tremor
125 (2.22%)
Weight Increased
114 (2.03%)
Somnolence
108 (1.92%)
Drug Level Decreased
91 (1.62%)
Nausea
84 (1.49%)
Fatigue
68 (1.21%)
Vomiting
67 (1.19%)
Diarrhoea
60 (1.07%)
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Ammonia Increased
59 (1.05%)
Dizziness
58 (1.03%)
Drug Ineffective
58 (1.03%)
Headache
57 (1.01%)
Fall
55 (.98%)
Product Substitution Issue
46 (.82%)
Pancreatitis
44 (.78%)
Insomnia
43 (.76%)
Depression
42 (.75%)
Confusional State
41 (.73%)
Feeling Abnormal
38 (.68%)
Mania
38 (.68%)
Anxiety
37 (.66%)
Platelet Count Decreased
37 (.66%)
Drug Level Increased
36 (.64%)
Weight Decreased
34 (.6%)
Asthenia
33 (.59%)
Abnormal Behaviour
32 (.57%)
Thrombocytopenia
32 (.57%)
Drug Dispensing Error
31 (.55%)
Lethargy
31 (.55%)
Rash
31 (.55%)
Agitation
30 (.53%)
Abdominal Pain
29 (.52%)
Dyskinesia
29 (.52%)
Hepatic Enzyme Increased
29 (.52%)
Oedema Peripheral
29 (.52%)
Abdominal Pain Upper
28 (.5%)
Pneumonia
28 (.5%)
White Blood Cell Count Decreased
28 (.5%)
Irritability
27 (.48%)
Amnesia
25 (.44%)
Anger
25 (.44%)
Gait Disturbance
25 (.44%)
Grand Mal Convulsion
25 (.44%)
Vision Blurred
25 (.44%)
Medication Error
24 (.43%)
Migraine
24 (.43%)
Wrong Technique In Drug Usage Proce...
24 (.43%)
Back Pain
23 (.41%)
Balance Disorder
23 (.41%)
Contusion
23 (.41%)
Pruritus
22 (.39%)
Death
21 (.37%)
Dyspnoea
21 (.37%)
Drug Interaction
20 (.36%)
Dysarthria
20 (.36%)
Hyperammonaemia
20 (.36%)
Pyrexia
20 (.36%)
Suicidal Ideation
20 (.36%)
Aggression
19 (.34%)
Drug Level Below Therapeutic
19 (.34%)
Malaise
19 (.34%)
Unevaluable Event
19 (.34%)
Chest Pain
18 (.32%)
Loss Of Consciousness
18 (.32%)
Memory Impairment
18 (.32%)
Condition Aggravated
17 (.3%)
Dehydration
17 (.3%)
Anticonvulsant Drug Level Below The...
16 (.28%)
Drug Exposure During Pregnancy
16 (.28%)
Head Injury
16 (.28%)
Petit Mal Epilepsy
16 (.28%)
Anaemia
15 (.27%)
Cholelithiasis
15 (.27%)
Decreased Appetite
15 (.27%)
Ill-defined Disorder
15 (.27%)
Liver Function Test Abnormal
15 (.27%)
Mental Status Changes
15 (.27%)
Nervousness
15 (.27%)
Anticonvulsant Drug Level Decreased
14 (.25%)
Ataxia
14 (.25%)
Cognitive Disorder
14 (.25%)
Constipation
14 (.25%)
Granulocytopenia
14 (.25%)
Mood Swings
14 (.25%)
Product Quality Issue
14 (.25%)
Abdominal Discomfort
13 (.23%)
Anorexia
13 (.23%)
Cough
13 (.23%)
Drug Toxicity
13 (.23%)
Dysphagia
13 (.23%)
Hallucination
13 (.23%)
Incorrect Dose Administered
13 (.23%)
Increased Appetite
13 (.23%)
Leukopenia
13 (.23%)
Muscle Spasms
13 (.23%)
Overdose
13 (.23%)
Speech Disorder
13 (.23%)
Bipolar Disorder
12 (.21%)

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

What are the most common Depakote Er 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 Er, 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 Er 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 Er According to Those Reporting Adverse Events

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

Bipolar Disorder
487
Drug Use For Unknown Indication
318
Convulsion
263
Product Used For Unknown Indication
136
Epilepsy
126
Affective Disorder
88
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Migraine
74
Bipolar I Disorder
49
Depression
48
Mania
32
Mood Swings
29
Schizophrenia
28
Schizoaffective Disorder
24
Drug Exposure During Pregnancy
21
Anxiety
20
Grand Mal Convulsion
17
Psychotic Disorder
14
Headache
13
Abnormal Behaviour
13
Mood Altered
12
Mental Disorder
11
Petit Mal Epilepsy
11
Drug Therapy
10
Migraine Prophylaxis
10
Attention Deficit/hyperactivity Dis...
9
Aggression
8
Complex Partial Seizures
7
Autism
7
Convulsion Prophylaxis
6
Dementia
5
Bipolar Ii Disorder
5
Agitation
5
Major Depression
5
Anger
4
Impulse-control Disorder
4
Dementia Alzheimers Type
4
Schizophrenia, Paranoid Type
4
Overdose
4
Post-traumatic Stress Disorder
4
Sleep Disorder
4
Intermittent Explosive Disorder
4
Parkinsons Disease
3
Thinking Abnormal
3
Moderate Mental Retardation
3
Schizoaffective Disorder Bipolar Ty...
3
Nausea
3
Panic Attack
3
Obsessive-compulsive Disorder
3
Nervous System Disorder
3
Infantile Spasms
3
Affect Lability
3

Drug Labels

LabelLabelerEffective
DepakotePhysicians Total Care, Inc.08-JUN-10
DepakoteRebel Distributors Corp17-DEC-10
DepakoteCardinal Health01-AUG-12
DepakoteerBryant Ranch Prepack13-FEB-13
DepakoteerAbbVie Inc.18-MAR-13

Depakote Er Case Reports

What Depakote Er 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 Er. 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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