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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 pharmacist from United States on 2012-08-06

Patient: male

Reactions: Antipsychotic Drug Level Increased

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 40 year old male

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

Patient: 40 year old male, weighing 95.3 kg (209.7 pounds)

Reactions: Impaired Driving Ability

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 48 year old male

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

Patient: 48 year old male, weighing 113.5 kg (249.7 pounds)

Reactions: Nausea

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 74.0 kg (162.8 pounds)

Reactions: Visual Impairment, Alopecia

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Lovastatin; Iron; Clonazepam; Metformin Hydrochloride; Lexapro; Nexium



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Depakote ER
    Administration route: Oral
    Start date: 2012-02-28

Depakote ER
    Administration route: Oral
    Indication: Convulsion
    End date: 2011-11-26

Depakote ER
    Administration route: Oral
    Start date: 2011-11-26
    End date: 2012-02-28



Possible Depakote ER side effects in 56 year old female

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

Patient: 56 year old female, weighing 54.5 kg (119.9 pounds)

Reactions: Abdominal Pain, Wrong Technique in Drug Usage Process, Somnolence, Off Label Use, Myalgia, Fatigue, DRY Mouth, Coordination Abnormal, Lethargy, LIP DRY, Stress, Tremor, Anxiety, Diarrhoea, Dermal Cyst, Vision Blurred

Drug(s) suspected as cause:
Depakote ER
    Start date: 2012-03-24
    End date: 2012-04-01

Depakote ER
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-04-03

Other drugs received by patient: Klonopin; Zoloft



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Product Counterfeit, Product Packaging Issue, Drug Ineffective, Counterfeit Drug Administered, Product LOT Number Issue, Drug Level Decreased

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Lamictal; Dilantin; Dilantin; Lamictal



Possible Depakote ER side effects in male

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

Patient: male

Reactions: White Blood Cell Count Decreased, Platelet Count Decreased

Drug(s) suspected as cause:
Depakote ER
    Indication: Product Used FOR Unknown Indication

Seroquel
    Indication: Product Used FOR Unknown Indication



Possible Depakote ER side effects in female

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

Patient: female

Reactions: Medication Residue

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

Depakote ER
    Indication: Vertigo CNS Origin

Other drugs received by patient: Effexor XR; Effexor XR



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Off Label Use, Fatigue, Wrong Technique in Drug Usage Process, Depressed Level of Consciousness, Somnolence

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Risperidone; Tenex



Possible Depakote ER side effects in male

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

Patient: male, weighing 63.6 kg (139.8 pounds)

Reactions: Paranoia, Parosmia, Delusion, Decreased Appetite

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Enbrel



Possible Depakote ER side effects in

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

Patient:

Reactions: Hepatic Enzyme Increased

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 79.9 kg (175.8 pounds)

Reactions: Weight Increased, Amenorrhoea, Polycystic Ovaries

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Singulair; Declined Full List



Possible Depakote ER side effects in female

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

Patient: female, weighing 49.0 kg (107.9 pounds)

Reactions: Alopecia, Feeling Abnormal, Tremor

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Wellbutrin; Zoloft



Possible Depakote ER side effects in female

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

Patient: female, weighing 54.0 kg (118.9 pounds)

Reactions: Rhinorrhoea

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Dilantin



Possible Depakote ER side effects in female

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

Patient: female

Reactions: Anxiety, Drug Dose Omission, Movement Disorder, Malaise, Hyperacusis, Nausea, Photophobia, Asthenia

Drug(s) suspected as cause:
Depakote ER
    Dosage: depakote
    Start date: 1989-01-01
    End date: 2008-01-01

Depakote ER
    Indication: Convulsion
    Start date: 2008-01-01



Possible Depakote ER side effects in female

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

Patient: female, weighing 65.4 kg (143.8 pounds)

Reactions: Weight Increased, Pruritus, Rash

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: at hour of sleep
    Administration route: Oral
    Indication: Headache
    Start date: 2011-10-05

Depakote ER
    Dosage: at hour of sleep
    Administration route: Oral
    Indication: Headache
    Start date: 2011-10-05
    End date: 2011-10-30

Other drugs received by patient: Maxalt



Possible Depakote ER side effects in 23 year old female

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

Patient: 23 year old female, weighing 77.2 kg (169.8 pounds)

Reactions: Weight Increased, Alopecia, Tremor

Drug(s) suspected as cause:
Depakote ER
    Indication: Bipolar Disorder
    Start date: 2003-12-18
    End date: 2009-10-03

Depakote ER
    Dosage: 1 tablet in am and 2 tablets in pm
    Administration route: Oral
    Start date: 2011-05-23

Other drugs received by patient: Unknown Birth Control Pill; Wellbutrin; Zoloft; Wellbutrin; Prozac; Inderal



Possible Depakote ER side effects in 23 year old male

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

Patient: 23 year old male, weighing 52.2 kg (114.9 pounds)

Reactions: Off Label Use, Drug Level Decreased

Drug(s) suspected as cause:
Depakote ER
    Dosage: three 500mg tablets and one 250mg tablet in am
    Start date: 2011-09-14

Depakote ER
    End date: 2011-08-13

Depakote ER
    Indication: Bipolar Disorder
    Start date: 2011-09-02
    End date: 2011-09-14

Depakote ER
    Indication: Intermittent Explosive Disorder
    Start date: 2011-08-13
    End date: 2011-09-02

Other drugs received by patient: Quetiapine; Fluticasone Furoate; Loratadine; Clonazepam; Montelucast; Multi-Vitamins; Ranitidine; Clorazepate Dipotassium



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 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 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 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

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