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 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
Possible Depakote ER side effects in 20 year old female
Reported by a physician from United States on 2012-08-06
Patient: 20 year old female
Reactions: Weight Increased, Blood Prolactin Increased, Blood Testosterone Increased, Blood Thyroid Stimulating Hormone Decreased
Drug(s) suspected as cause:
Depakote ER
Other drugs received by patient: Unknown Concomitant Medications
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 47.2 kg (103.9 pounds)
Reactions: Hepatic Enzyme Increased
Drug(s) suspected as cause:
Depakote ER
Other drugs received by patient: Tylenol (Caplet); Multi-Vitamin; Naproxen; Olanzapine; Hydroxyzine
Possible Depakote ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female, weighing 57.7 kg (126.8 pounds)
Reactions: Dizziness, Headache
Drug(s) suspected as cause:
Depakote ER
Other drugs received by patient: Unknown Thyroid Medication
Possible Depakote ER side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female, weighing 77.2 kg (169.8 pounds)
Reactions: Dysmenorrhoea, Gingival Hypertrophy, Rash, Menorrhagia, Lymphoma
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: Medication Residue
Drug(s) suspected as cause:
Depakote ER
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