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Depakote (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 (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 (691)
Death (37)
Life Threatening Events (26)
Disability (54)

Reports by Reaction Type

Pain (119)Emotional Distress (119)Foetal Exposure During Pregnancy (118)Deformity (117)Anhedonia (116)Physical Disability (116)Injury (115)Anxiety (95)Convulsion (67)Loss of Employment (67)Spina Bifida (61)Neural Tube Defect (60)

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

Possible Depakote side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-25

Patient: female, weighing 72.6 kg (159.8 pounds)

Reactions: Liver Injury, Vomiting, Hepatic Fibrosis, Nausea, Hepatic Failure, non-Alcoholic Steatohepatitis, Hepatic Steatosis, Hepatic Enzyme Increased, Weight Increased, Hepatic Atrophy, Diarrhoea, Presyncope

Drug(s) suspected as cause:
Depakote

Other drugs received by patient: Lorepam



Possible Depakote side effects in 63 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-24

Patient: 63 year old male, weighing 72.6 kg (159.7 pounds)

Reactions: Off Label Use, Middle Insomnia, Bipolar Disorder, Pollakiuria

Drug(s) suspected as cause:
Depakote
    Indication: Depression
    Start date: 1995-01-01

Lorazepam
    Indication: Sleep Disorder

Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2010-01-01

Seroquel
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2010-01-01

Symbicort
    Dosage: 160/4.5 mcg, two times a day
    Indication: Asthma
    Start date: 2011-05-01

Other drugs received by patient: Wellbutrin; Generic Xanax; Generic Xanax



Possible Depakote side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male, weighing 9.9 kg (21.9 pounds)

Reactions: Convulsion

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in 64 year old male

Reported by a physician from United States on 2012-08-24

Patient: 64 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Drug Dose Omission, Drug Ineffective, Convulsion

Drug(s) suspected as cause:
Depakote
    Dosage: 500 mg, 2x/day
    Indication: Epilepsy

Dilantin
    Dosage: 100 mg, unk

Dilantin
    Dosage: 100 mg, 3x/day
    Indication: Epilepsy

Phenytoin Sodium
    Dosage: unk



Possible Depakote side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female, weighing 62.6 kg (137.7 pounds)

Reactions: Weight Increased, Alopecia, Heart Rate Increased, Nail Disorder

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in male

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

Patient: male

Reactions: Sudden Cardiac Death, Chest Pain

Adverse event resulted in: death

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

Fluoxetine HCL
    Indication: Product Used FOR Unknown Indication

Seroquel
    Indication: Product Used FOR Unknown Indication



Possible Depakote side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-23

Patient: female, weighing 64.0 kg (140.7 pounds)

Reactions: Product Substitution Issue, Vomiting, Convulsion

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in

Reported by a consumer/non-health professional from France on 2012-08-23

Patient:

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Abilify
    Administration route: Oral

Depakote
    Administration route: Oral

Diamicron
    Administration route: Oral

Glucophage
    Administration route: Oral

Januvia
    Administration route: Oral

Mediator
    Administration route: Oral

Metformin Hydrochloride
    Administration route: Oral

Repaglinide
    Administration route: Oral

Risperidone
    Administration route: Oral



Possible Depakote side effects in

Reported by a consumer/non-health professional from France on 2012-08-23

Patient:

Reactions: Portal Hypertension, Fatigue, Hypothermia, Anaemia, Epistaxis, Hepatic Cirrhosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Abilify
    Indication: Bipolar Disorder
    Start date: 1995-01-01
    End date: 2011-01-01

Depakote
    Dosage: 500 mg, unk
    Indication: Bipolar Disorder
    End date: 2006-01-01

Diamicron
    Dosage: 60 mg, unk
    Indication: Diabetes Mellitus
    End date: 2011-01-01

Glucophage
    Dosage: unk

Glucophage
    Administration route: Oral

Glucophage
    Indication: Diabetes Mellitus
    End date: 2011-01-01

Insulin
    Dosage: unk
    Start date: 2011-05-01

Mediator
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2006-01-01
    End date: 2006-01-01

Metformin Hydrochloride

Metformin Hydrochloride
    Dosage: unk
    Indication: Diabetes Mellitus
    End date: 2011-05-01

Repaglinide
    Dosage: unk
    Indication: Diabetes Mellitus
    Start date: 2011-05-01
    End date: 2011-01-01

Risperidone
    Indication: Bipolar Disorder
    End date: 2011-01-01

Sitagliptin Phosphate
    Dosage: unk
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2009-04-01
    End date: 2011-01-01



Possible Depakote side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Bedridden, Emphysema, Off Label Use, Lung Disorder, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin
    Dosage: 81 mg, prn
    Indication: Chest Pain

Atenolol
    Dosage: 25 mg, qd
    Administration route: Oral
    Indication: Hypertension

Ativan
    Dosage: 1 mg, tid
    Administration route: Oral
    Indication: Nervousness

Atropine Sulfate
    Dosage: 2.5 mg, qid
    Administration route: Oral
    Indication: Crohn's Disease

Depakote
    Dosage: 500 mg, bid
    Administration route: Oral
    Indication: Convulsion

Dilantin
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Convulsion

Furosemide
    Dosage: 40 mg, bid
    Administration route: Oral
    Indication: Diuretic Therapy

Generlac
    Dosage: 30 mg, prn
    Indication: Crohn's Disease

Humulin R
    Dosage: 24 units
    Indication: Diabetes Mellitus

Imdur
    Dosage: 30 mg, tid
    Indication: Cardiac Disorder

Lantus
    Dosage: 80 units in the moring and 90 units at night
    Indication: Diabetes Mellitus

Lantus
    Dosage: unk

Methocarbamol
    Indication: Neuropathy Peripheral

Methocarbamol
    Dosage: 750 mg, prn
    Administration route: Oral
    Indication: Muscle Spasms

Nitrostat
    Dosage: 0.4 mg, prn
    Indication: Chest Pain

Norvasc
    Administration route: Oral
    Indication: Palpitations

Potassium Chloride

Potassium Chloride (KV / 24)
    Dosage: 8 meq, qd
    Indication: Blood Potassium

Remeron
    Dosage: 30 mg, qd
    Administration route: Oral
    Indication: Insomnia

Tylenol
    Dosage: unk unk, qd
    Indication: Migraine

Zantac
    Dosage: 30 mg, tid
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Zocor
    Dosage: 40 mg, qd
    Administration route: Oral



Possible Depakote side effects in 36 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 36 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Speech Disorder, Pain, Nervous System Disorder, Memory Impairment, Epilepsy

Drug(s) suspected as cause:
Depakote
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2009-01-01

Dilantin
    Dosage: 200mg in morning and 300mg at night
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-01-15

Neurontin

Neurontin
    Dosage: unk, 3x/day
    Administration route: Oral
    Start date: 2003-01-01

Neurontin
    Indication: Migraine

Neurontin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Nerve Injury
    Start date: 2007-01-01

Other drugs received by patient: Percocet; Topamax; Amitriptyline; Amitriptyline; Estradiol



Possible Depakote side effects in

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

Patient:

Reactions: Bedridden, Emphysema, Amnesia, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Aspirin

Atenolol
    Administration route: Oral

Ativan
    Administration route: Oral

Depakote
    Administration route: Oral

Dilantin
    Administration route: Oral

Furosemide
    Administration route: Oral

Generlac

Humulin R

Isosorbide Mononitrate

Lantus
    Dosage: 80 iu, qam

Lantus
    Dosage: 90 df, qpm

Lomotil
    Administration route: Oral

Methocarbamol
    Administration route: Oral

Nitrostat

Norvasc
    Administration route: Oral

Potassium Chloride

Remeron
    Administration route: Oral

Tylenol W / Codeine NO. 3

Zantac

Zocor
    Administration route: Oral



Possible Depakote side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: male

Reactions: Abnormal Behaviour, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Equanil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Exelon
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-01

Tiapridal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Trimeprazine Tartrate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-10-24

Xanax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Polyethylene Glycol; Digoxin



Possible Depakote side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: White Blood Cell Count Decreased, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote

Keppra

Vimpat
    Indication: Convulsion



Possible Depakote side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-21

Patient: female

Reactions: Stress, Convulsion

Drug(s) suspected as cause:
Depakote
    Dosage: 1000mg daily
    Indication: Convulsion

Depakote
    Dosage: 1500mg daily



Possible Depakote side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: C-Reactive Protein Increased, Drug Interaction, Muscular Weakness, Rash Maculo-Papular, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Dosage: 750 mg, tid
    Administration route: Oral
    Indication: Bipolar Disorder

Lamotrigine
    Dosage: 50 mg, bid
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Quetiapine; Hydroxychloroquine Sulfate; Aspirin; Simvastatin; Venlafaxine



Possible Depakote side effects in male

Reported by a physician from United Kingdom on 2012-08-20

Patient: male

Reactions: Sudden Cardiac Death, Chest Pain

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakote
    Administration route: Oral

Fluoxetine HCL
    Administration route: Oral

Seroquel
    Administration route: Oral



Possible Depakote side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: Drug Interaction, Muscular Weakness, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Bipolar Disorder

Lamotrigine
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Simvastatin; Venlafaxine; Quetiapine; Aspirin; Hydroxychloroquine Sulfate



Possible Depakote side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-20

Patient: 59 year old female, weighing 83.5 kg (183.7 pounds)

Reactions: Drug Interaction, Muscular Weakness, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Bipolar Disorder

Lamotrigine
    Administration route: Oral
    Indication: Bipolar Disorder

Other drugs received by patient: Simvastatin; Quetiapine; Hydroxychloroquine Sulfate; Aspirin; Venlafaxine



Possible Depakote side effects in female

Reported by a lawyer from France on 2012-08-20

Patient: female

Reactions: Hepatic Cirrhosis

Drug(s) suspected as cause:
Abilify
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Depakote
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Diamicron
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Glucophage
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Mediator
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Metformin Hydrochloride
    Indication: Product Used FOR Unknown Indication

Repaglinide
    Dosage: unk
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-05-01

Risperidone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Sitagliptin Phosphate
    Indication: Product Used FOR Unknown Indication



Possible Depakote side effects in

Reported by a lawyer from United States on 2012-08-20

Patient:

Reactions: Blindness Congenital, Foetal Exposure During Pregnancy, Pain, Impaired Work Ability, Convulsion, Emotional Distress, Speech Disorder, Multiple Injuries, Unevaluable Event, Physical Disability

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: male

Reactions: Sudden Cardiac Death, Chest Pain

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakote
    Dosage: 1500 mg, unk
    Administration route: Oral

Fluoxetine HCL
    Dosage: 30 mg, unk
    Administration route: Oral

Seroquel



Possible Depakote side effects in 58 year old male

Reported by a physician from United States on 2012-08-17

Patient: 58 year old male

Reactions: Liver Injury, Hepatitis C, Bladder Neoplasm, Urethral Neoplasm, RED Blood Cell Count Decreased, Adverse Event, Cerebrovascular Accident

Drug(s) suspected as cause:
Depakote

Seroquel XR
    Administration route: Oral



Possible Depakote side effects in female

Reported by a lawyer from United States on 2012-08-17

Patient: female

Reactions: Economic Problem, Emotional Distress, Multiple Injuries, Pain, Unevaluable Event

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 38 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Depakote
    Indication: Convulsion

Lamictal
    Indication: Convulsion

Paxil
    Indication: Depression

Phenobarbital TAB
    Indication: Convulsion



Possible Depakote side effects in male

Reported by a lawyer from United States on 2012-08-16

Patient: male

Reactions: Neural Tube Defect, Spina Bifida, Foetal Exposure During Pregnancy, Pain, Deformity, Social Problem, Emotional Distress, Anhedonia, Loss of Employment, Congenital Anomaly, Injury, Physical Disability, Tension

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in female

Reported by a lawyer from United States on 2012-08-16

Patient: female

Reactions: Neural Tube Defect, Spina Bifida, Pain, Foetal Exposure During Pregnancy, Deformity, Emotional Distress, Social Problem, Anhedonia, Loss of Employment, Congenital Anomaly, Injury, Physical Disability, Tension

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in female

Reported by a lawyer from United States on 2012-08-16

Patient: female

Reactions: Neural Tube Defect, Spina Bifida, Foetal Exposure During Pregnancy, Pain, Deformity, Social Problem, Emotional Distress, Anhedonia, Loss of Employment, Congenital Anomaly, Injury, Tension, Physical Disability

Drug(s) suspected as cause:
Depakote



Possible Depakote side effects in 59 year old female

Reported by a physician from United Kingdom on 2012-08-16

Patient: 59 year old female

Reactions: C-Reactive Protein Increased, Muscular Weakness, Drug Interaction, Rash Maculo-Papular, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakote
    Indication: Bipolar Disorder

Lamotrigine
    Indication: Bipolar Disorder

Other drugs received by patient: Simvastatin; Hydroxychloroquine Sulfate; Quetiapine; Aspirin; Venlafaxine



Possible Depakote side effects in male

Reported by a lawyer from United States on 2012-08-16

Patient: male

Reactions: Neural Tube Defect, Maternal Drugs Affecting Foetus, Spina Bifida, Foetal Exposure During Pregnancy, Pain, Deformity, Social Problem, Emotional Distress, Anhedonia, Loss of Employment, Congenital Anomaly, Mental Disorder, Injury, Physical Disability, Tension

Drug(s) suspected as cause:
Depakote

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