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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 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 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 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



Possible Depakote ER side effects in female

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

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Sinus Headache, Pain, Tension

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Hepatic Enzyme Increased

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

Depakote ER
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-01



Possible Depakote ER side effects in male

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

Patient: male, weighing 95.3 kg (209.7 pounds)

Reactions: Abdominal Pain Lower, Gastrointestinal Hypermotility, Diarrhoea, Flatulence, Gastrointestinal Sounds Abnormal, Eructation

Drug(s) suspected as cause:
Depakote
    Dosage: 1 tablet in am and 2 tablest in pm
    Indication: Epilepsy

Depakote ER
    Indication: Epilepsy

Depakote ER
    Indication: Epilepsy



Possible Depakote ER side effects in 36 year old male

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

Patient: 36 year old male, weighing 77.2 kg (169.8 pounds)

Reactions: Alopecia, Hair Growth Abnormal

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Synthroid



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Back Pain, Chest Pain

Drug(s) suspected as cause:
Depakote ER
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-23

Depakote ER
    Start date: 2012-06-23



Possible Depakote ER side effects in male

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

Patient: male, weighing 80.4 kg (176.8 pounds)

Reactions: Ear Discomfort, Tinnitus, Headache, Rash Macular, Rash Pruritic, Joint Swelling, Oedema Peripheral, Dizziness

Drug(s) suspected as cause:
Depakote ER
    Indication: Depression

Depakote ER
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2010-01-01
    End date: 2011-09-01



Possible Depakote ER side effects in 32 year old male

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

Patient: 32 year old male

Reactions: Nightmare

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in female

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

Patient: female

Reactions: Alopecia

Drug(s) suspected as cause:
Depakote ER



Possible Depakote ER side effects in 52 year old female

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

Patient: 52 year old female, weighing 51.3 kg (112.9 pounds)

Reactions: Clavicle Fracture, Headache, Tremor, Bone Loss, Balance Disorder, Alopecia, DRY Mouth, Gait Disturbance, Sinusitis

Drug(s) suspected as cause:
Depakote ER
    Indication: Intracranial Aneurysm

Depakote ER
    Administration route: Oral
    Indication: Convulsion



Possible Depakote ER side effects in 33 year old male

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

Patient: 33 year old male, weighing 86.3 kg (189.8 pounds)

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, weighing 99.9 kg (219.7 pounds)

Reactions: Swelling, Oedema Peripheral, Blood Magnesium Decreased

Drug(s) suspected as cause:
Depakote ER
    Indication: Mania

Depakote ER
    Administration route: Oral

Other drugs received by patient: Trileptal; Estradiol; Vesicare; Atenolol; Atenolol; Vitamin B Complex CAP; Depakote; Lutein; Magnesium; Vitamin B Complex CAP; Allopurinol; Lipitor; Magnesium; Lamictal; Geodon; Citracal + D



Possible Depakote ER side effects in female

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

Patient: female, weighing 88.5 kg (194.8 pounds)

Reactions: Vomiting, Chromaturia, Urine Odour Abnormal, Abdominal Pain Upper

Drug(s) suspected as cause:
Depakote ER
    Indication: Epilepsy
    Start date: 2012-05-07
    End date: 2012-05-22

Depakote ER
    Start date: 2012-05-01
    End date: 2012-05-06

Other drugs received by patient: Atenolol; Tegretol; Fluoxetine HCL



Possible Depakote ER side effects in male

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

Patient: male, weighing 86.3 kg (189.8 pounds)

Reactions: Agitation, Memory Impairment

Drug(s) suspected as cause:
Depakote ER
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-12-28
    End date: 2012-01-04

Depakote ER
    Administration route: Oral
    Indication: Fall
    Start date: 2012-01-04
    End date: 2012-01-11

Depakote ER
    Dosage: patient was tapered off tapered off medication
    Administration route: Oral
    Start date: 2012-01-11
    End date: 2012-01-27

Other drugs received by patient: Citalopram Hydrobromide; Metoprolol Tartrate; Phenytoin



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Hypertriglyceridaemia

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: Wrong Technique in Drug Usage Process, Unevaluable Event

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 male

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

Patient: male

Reactions: Thrombocytopenia

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Concerta



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

Other drugs received by patient: Magnesium Oxide; Iron; Calcium Citrate; Multi-Vitamin; Prilosec



Possible Depakote ER side effects in female

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

Patient: female, weighing 48.1 kg (105.9 pounds)

Reactions: Wrong Technique in Drug Usage Process, Rhabdomyolysis, Nausea, Rectal Ulcer, Incorrect Dose Administered, Compartment Syndrome, Nerve Compression, Abdominal Pain Upper, Malaise, Peroneal Nerve Palsy, Dehydration, Tendonitis, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote ER
    Dosage: two 500 mg capsules at bedtime
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Crohn's Disease
    Start date: 2009-03-01

Humira
    Start date: 2010-05-01

Klonopin
    Dosage: 2mg at bedtime

Klonopin
    Dosage: 2.5mg qpm
    Indication: Anxiety

Klonopin
    Dosage: prn
    Indication: Bipolar Disorder

Seroquel
    Dosage: 400mg qpm
    Indication: Product Used FOR Unknown Indication

Seroquel
    Dosage: 300mg at bedtime

Other drugs received by patient: Canasa; Pentasa; VFL #3; Dexilant; Mirapex; VFL #3; Flexeril; Vyvanse; Stool Softener



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
    Indication: Product Used FOR Unknown Indication

Depakote ER

Divalproex Sodium
    Indication: Product Used FOR Unknown Indication



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 59.0 kg (129.8 pounds)

Reactions: Blood Test Abnormal

Drug(s) suspected as cause:
Depakote ER

Other drugs received by patient: Lorazepam



Possible Depakote ER side effects in male

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

Patient: male

Reactions: Medication Residue

Drug(s) suspected as cause:
Depakote ER

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