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Depakote ER (Divalproex) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Depakote ER (Divalproex) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (137)
Death (1)
Life Threatening Events (4)
Disability (2)

Reports by Reaction Type

Convulsion (19)Tremor (15)Alopecia (12)Drug Ineffective (10)Dizziness (10)Nausea (10)Weight Increased (9)Vomiting (9)Weight Decreased (8)Headache (8)Fall (6)Off Label Use (6)

Below are a few examples of reports where side effects / adverse reactions may be related to Depakote ER (Divalproex). For a complete list or a specific selection of reports, please use the links above.

Possible Depakote ER side effects in male

Reported by a physician from United States on 2012-08-23

Patient: male, weighing 72.1 kg (158.7 pounds)

Reactions: Blood Pressure Increased, Rash

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 11 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 11 year old female, weighing 66.2 kg (145.7 pounds)

Reactions: Product Substitution Issue, Drug Ineffective, Crying

Drug(s) suspected as cause:
Depakote ER
    Dosage: 500 mg, 2xday, imd
    Indication: Autism

Depakote ER
    Dosage: 500 mg, 2xday, imd
    Indication: Attention Deficit / Hyperactivity Disorder



Possible Depakote ER side effects in 48 year old male

Reported by a pharmacist from United States on 2012-08-14

Patient: 48 year old male

Reactions: Homicide, Physical Assault

Drug(s) suspected as cause:
Depakote ER
    Indication: Mood Swings

Latuda
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2011-12-15
    End date: 2012-05-08



Possible Depakote ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Dysgeusia

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a pharmacist from United States on 2012-08-06

Patient: female

Reactions: Medication Residue

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: female, weighing 90.8 kg (199.8 pounds)

Reactions: Agitation, Vomiting, Nausea, Tachycardia, Vaginal Discharge, Drug Withdrawal Syndrome, Appetite Disorder, Poor Quality Sleep, Myalgia, Anxiety, Increased Tendency To Bruise, Vision Blurred, Gait Disturbance, DRY Eye, Feeling Drunk

Drug(s) suspected as cause:
Depakote ER
    Indication: Convulsion
    Start date: 2011-12-18
    End date: 2011-12-22

Depakote ER
    Dosage: one 500mg tab and one 250mg tab
    Administration route: Oral
    Start date: 2011-12-22
    End date: 2012-01-07

Other drugs received by patient: Indural; Phenobarbital TAB; Diazepam; Propranolol



Possible Depakote ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male, weighing 32.2 kg (70.9 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Drug Effect Decreased, Abnormal Behaviour

Drug(s) suspected as cause:
Depakote ER
    Start date: 2011-08-01
    End date: 2011-08-01

Depakote ER
    Dosage: one in morning and two in evening

Depakote ER
    Dosage: 2 in 1 day, (1 in am and 1 in pm)
    Indication: Bipolar Disorder
    Start date: 2011-08-01
    End date: 2011-08-01

Other drugs received by patient: Wellbutrin



Possible Depakote ER side effects in 57 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 57 year old female, weighing 54.5 kg (119.9 pounds)

Reactions: Accident, Head Injury, Neck Pain, Headache, Fall, Muscle Spasms, Inflammation

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 23 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 23 year old male, weighing 71.3 kg (156.8 pounds)

Reactions: Pain, Somnolence, Mental Impairment, Fatigue, Temporomandibular Joint Syndrome, Visual Impairment, Alopecia, Disturbance in Attention, Dizziness, Irritable Bowel Syndrome, Coordination Abnormal, Memory Impairment

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Feeling Abnormal

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a physician from United States on 2012-08-06

Patient: female, weighing 87.2 kg (191.8 pounds)

Reactions: Product Quality Issue, Back Pain, Nausea, Headache, Malaise, Diarrhoea, Hereditary Angioedema, Dizziness, Feeling Abnormal, Infusion Related Reaction

Drug(s) suspected as cause:
Cinryze
    Dosage: infused via central line over 10 minutes
    Indication: Hereditary Angioedema
    Start date: 2011-05-01
    End date: 2011-08-01

Depakote ER
    Administration route: Oral
    Indication: Headache
    End date: 2011-08-23

Other drugs received by patient: Excedrin Extra Strength Tablets; Ibuprofen; Topamax; Flexeril; Lortab; Benadryl; Prilosec; Excedrin Extra Strength Tablets; Ibuprofen; Neurontin; Kalbitor; Klonopin; Amitriptyline HCL; Tramadol HCL; Ibuprofen; Celexa; Lamictal; Klonopin



Possible Depakote ER side effects in male

Reported by a physician from United States on 2012-08-06

Patient: male

Reactions: Off Label Use

Drug(s) suspected as cause:
Depakote ER

Depakote ER
    Indication: Affective Disorder



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 136.2 kg (299.6 pounds)

Reactions: Body Temperature Decreased

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Armor Thyroid; Vitamin E; Iron; Metformin Hydrochloride; Selenium; L-Carnitine; Complete Omega 3; Vitamin D; Clonezepam; Folic Acid



Possible Depakote ER side effects in male

Reported by a pharmacist from United States on 2012-08-06

Patient: male

Reactions: Medication Residue

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient:

Reactions: Drug Dispensing Error

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient: male

Reactions: Hepatotoxicity, Liver Function Test Abnormal, Injection Site Reaction

Drug(s) suspected as cause:
Depakote ER
    Indication: Bipolar Disorder
    Start date: 2010-01-01
    End date: 2011-01-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2007-03-06



Possible Depakote ER side effects in

Reported by a physician from United States on 2012-08-06

Patient:

Reactions: Drug Level Decreased

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Amnesia

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in male

Reported by a pharmacist from United States on 2012-08-06

Patient: male

Reactions: Weight Increased

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in

Reported by a pharmacist from United States on 2012-08-06

Patient:

Reactions: Blood Uric Acid Increased

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male, weighing 68.1 kg (149.8 pounds)

Reactions: Weight Decreased, Pollakiuria, Asthenia, Fall, Suicidal Ideation

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Seroquel



Possible Depakote ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male, weighing 113.5 kg (249.7 pounds)

Reactions: Weight Increased, Decreased Activity, Tremor

Drug(s) suspected as cause:
Depakote ER
    Indication: Bipolar Disorder
    Start date: 2011-05-01

Depakote ER
    Start date: 2011-05-01

Depakote ER
    Indication: Bipolar I Disorder

Zyprexa
    Indication: Bipolar Disorder
    Start date: 2011-05-01

Other drugs received by patient: Triavil; Lithium Carbonate; Lithium Carbonate; Xanax; Provigil; Triavil



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Alopecia, Tremor

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Hydrochlorothiazde TAB; Paxil



Possible Depakote ER side effects in 54 year old male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 54 year old male, weighing 76.3 kg (167.8 pounds)

Reactions: Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Abilify
    Indication: Bipolar Disorder
    Start date: 2011-12-01

Depakote ER
    Dosage: 500mg in am, and 550mg and 250mg in pm
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-12-01

Other drugs received by patient: Depakote



Possible Depakote ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Diabetes Mellitus, Anticonvulsant Drug Level Below Therapeutic, Convulsion

Drug(s) suspected as cause:
Depakote ER
    Dosage: in morning
    Indication: Convulsion

Depakote ER
    Dosage: at night



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 45.4 kg (99.9 pounds)

Reactions: Dyskinesia, Facial Pain, Tremor

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 61.3 kg (134.8 pounds)

Reactions: Weight Decreased, Nausea, Arthralgia, Pain, Alopecia, Vision Blurred, Decreased Appetite

Drug(s) suspected as cause:
Depakote ER
    Indication: Bipolar Disorder
    Start date: 2011-06-01
    End date: 2011-10-01

Perphenazine
    Indication: Bipolar Disorder
    Start date: 2011-06-01
    End date: 2011-09-30



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 56.8 kg (124.9 pounds)

Reactions: Irritability

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in male

Reported by a pharmacist from United States on 2012-08-06

Patient: male

Reactions: Alopecia

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Dysphagia, Headache

Drug(s) suspected as cause:
Depakote
    Indication: Migraine Prophylaxis

Depakote ER
    Indication: Migraine Prophylaxis
    Start date: 1997-01-01

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