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Depakene (Valproic Acid) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) 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 (600)
Death (38)
Life Threatening Events (66)
Disability (19)

Reports by Reaction Type

Convulsion (57)Pyrexia (46)Epilepsy (46)Somnolence (42)Thrombocytopenia (29)Drug Ineffective (27)Intentional Overdose (27)Suicide Attempt (27)Sopor (26)Confusional State (25)Foetal Exposure During Pregnancy (23)Rash (23)

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

Possible Depakene side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-27

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Vomiting, Dyspnoea, Hepatic Pain, Spinal Pain, Drug Ineffective, Nausea, Headache, Somnolence, Convulsion, Palpitations, Renal Pain, Hypertension, Decreased Appetite

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Zyprexa; Diazepam; Lithium Carbonate



Possible Depakene side effects in 34 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 34 year old male

Reactions: Intestinal Ischaemia, Ileus, Gastrointestinal Necrosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Dosage: 275 drops daily
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Quetiapine
    Dosage: daily
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01
    End date: 2012-06-25



Possible Depakene side effects in

Reported by a physician from Japan on 2012-08-24

Patient:

Reactions: Toxicity To Various Agents, Drug Dependence

Adverse event resulted in: hospitalization

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

Lorazepam
    Indication: Product Used FOR Unknown Indication

Luvox
    Indication: Product Used FOR Unknown Indication

Rohypnol
    Indication: Product Used FOR Unknown Indication



Possible Depakene side effects in male

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

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 3 year old male

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

Patient: 3 year old male

Reactions: Toothache, Pallor, Epilepsy, Fall

Drug(s) suspected as cause:
Depakene
    Dosage: 7-8 ml
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-06-01

Depakene
    Indication: Epilepsy
    Start date: 2012-07-01

Depakene
    Administration route: Oral
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Depakene side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: 34 year old female

Reactions: Drug Interaction, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient possibly interacting with the suspect drug:
Lamotrigine
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-06-04
    End date: 2012-06-18

Other drugs received by patient: Cetirizine



Possible Depakene side effects in

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

Patient:

Reactions: Drug Ineffective, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 3 year old male

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

Patient: 3 year old male

Reactions: Confusional State, Trismus, Epilepsy, Convulsion

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-03-01
    End date: 2012-08-01

Depakene
    Administration route: Oral
    Start date: 2012-08-01
    End date: 2012-08-15



Possible Depakene side effects in 41 year old female

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

Patient: 41 year old female, weighing 108.4 kg (238.5 pounds)

Reactions: Product Substitution Issue, Product Quality Issue, Anticonvulsant Drug Level Decreased, Convulsion

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in

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

Patient:

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 9 month old male

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

Patient: 9 month old male

Reactions: Arthropathy, Knee Deformity, Musculoskeletal Stiffness, Rash, Epilepsy

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Start date: 2012-08-01

Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-08-01



Possible Depakene side effects in 34 year old male

Reported by a physician from France on 2012-08-22

Patient: 34 year old male

Reactions: Intestinal Ischaemia, Gastrointestinal Necrosis, Intestinal Obstruction

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-25

Lepticur
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-05
    End date: 2012-06-25

Loxapine HCL
    Administration route: Oral
    Indication: Aggression
    Start date: 2012-06-14
    End date: 2012-06-25

Quetiapine Fumarate
    Dosage: drug reported as xeroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-06-05
    End date: 2012-06-25

Valium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-25



Possible Depakene side effects in

Reported by a physician from Japan on 2012-08-22

Patient:

Reactions: Multi-Organ Failure, Diarrhoea, Acute Respiratory Distress Syndrome, Hepatorenal Failure, Drug Rash With Eosinophilia and Systemic Symptoms, Convulsion, Disease Progression

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2006-11-11
    End date: 2009-09-07

Phenytoin Sodium CAP
    Indication: Status Epilepticus
    Start date: 2009-06-25
    End date: 2009-09-07

Tegretol
    Administration route: Oral
    Indication: Status Epilepticus
    Start date: 2009-06-25
    End date: 2009-09-07

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2010-06-11
    End date: 2010-10-05

Temodal
    Administration route: Oral
    Start date: 2008-02-21
    End date: 2008-02-25

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2009-09-28
    End date: 2010-05-04

Temodal
    Administration route: Oral
    Start date: 2007-11-29
    End date: 2007-12-03

Temodal
    Administration route: Oral
    Start date: 2008-04-17
    End date: 2008-04-21

Temodal
    Administration route: Oral
    Start date: 2008-10-02
    End date: 2008-10-06

Temodal
    Administration route: Oral
    Start date: 2008-10-30
    End date: 2008-11-03

Temodal
    Administration route: Oral
    Start date: 2010-02-08
    End date: 2010-02-12

Temodal
    Administration route: Oral
    Start date: 2010-03-08
    End date: 2010-03-12

Temodal
    Administration route: Oral
    Start date: 2010-06-11
    End date: 2010-06-15

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2007-01-25
    End date: 2009-05-18

Temodal
    Administration route: Oral
    Start date: 2007-03-22
    End date: 2007-03-26

Temodal
    Administration route: Oral
    Start date: 2007-06-14
    End date: 2007-06-18

Temodal
    Administration route: Oral
    Start date: 2007-08-09
    End date: 2007-08-13

Temodal
    Administration route: Oral
    Start date: 2007-10-04
    End date: 2007-10-08

Temodal
    Administration route: Oral
    Start date: 2009-12-14
    End date: 2009-12-18

Temodal
    Administration route: Oral
    Start date: 2008-05-15
    End date: 2008-05-19

Temodal
    Administration route: Oral
    Start date: 2009-10-26
    End date: 2009-10-30

Temodal
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2006-11-28
    End date: 2006-12-26

Temodal
    Administration route: Oral
    Start date: 2007-02-22
    End date: 2007-02-26

Temodal
    Administration route: Oral
    Start date: 2007-11-01
    End date: 2007-11-05

Temodal
    Administration route: Oral
    Start date: 2008-03-20
    End date: 2008-03-24

Temodal
    Administration route: Oral
    Start date: 2008-07-10
    End date: 2008-07-14

Temodal
    Administration route: Oral
    Start date: 2009-01-22
    End date: 2009-01-26

Temodal
    Administration route: Oral
    Start date: 2009-04-16
    End date: 2009-04-20

Temodal
    Administration route: Oral
    Start date: 2010-01-11
    End date: 2010-01-15

Temodal
    Administration route: Oral
    Start date: 2010-07-09
    End date: 2010-07-13

Temodal
    Administration route: Oral
    Start date: 2010-09-03
    End date: 2010-09-07

Temodal
    Administration route: Oral
    Start date: 2007-01-25
    End date: 2007-01-29

Temodal
    Administration route: Oral
    Start date: 2007-09-06
    End date: 2007-09-10

Temodal
    Administration route: Oral
    Start date: 2007-12-27
    End date: 2007-12-31

Temodal
    Administration route: Oral
    Start date: 2008-01-24
    End date: 2008-01-28

Temodal
    Administration route: Oral
    Start date: 2008-08-07
    End date: 2008-08-11

Temodal
    Administration route: Oral
    Start date: 2009-03-19
    End date: 2009-03-23

Temodal
    Administration route: Oral
    Start date: 2010-05-03
    End date: 2010-05-04

Temodal
    Administration route: Oral
    Start date: 2007-04-19
    End date: 2007-04-23

Temodal
    Administration route: Oral
    Start date: 2007-05-17
    End date: 2007-05-21

Temodal
    Administration route: Oral
    Start date: 2007-07-12
    End date: 2007-07-16

Temodal
    Administration route: Oral
    Start date: 2008-09-04
    End date: 2008-09-08

Temodal
    Administration route: Oral
    Start date: 2008-11-28
    End date: 2008-12-02

Temodal
    Administration route: Oral
    Start date: 2008-12-25
    End date: 2008-12-29

Temodal
    Administration route: Oral
    Start date: 2009-02-19
    End date: 2009-02-23

Temodal
    Administration route: Oral
    Start date: 2009-05-14
    End date: 2009-05-18

Temodal
    Administration route: Oral
    Start date: 2009-09-28
    End date: 2009-10-02

Temodal
    Administration route: Oral
    Start date: 2010-04-05
    End date: 2010-04-09

Temodal
    Administration route: Oral
    Start date: 2008-06-12
    End date: 2008-06-16

Temodal
    Administration route: Oral
    Start date: 2010-08-06
    End date: 2010-08-10

Temodal
    Administration route: Oral
    Start date: 2010-10-01
    End date: 2010-10-05

Other drugs received by patient: Depakene; Phenobarbital TAB; Betamethasone Sodium Phosphate; Kytril; Zonisamide; Diprivan; Isozol; Topiramate; Bacillus Subtilis (+) Lactobacillus Acidophilus (+) Streptococcus Faec



Possible Depakene side effects in female

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

Patient: female

Reactions: Hepatic Function Abnormal, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 24 year old male

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

Patient: 24 year old male

Reactions: Tongue Biting, Petit MAL Epilepsy, Gaze Palsy, Muscle Spasms

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

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

Patient: male

Reactions: Hyperthermia, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 900 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Escitalopram Oxalate
    Dosage: 10 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Seroquel
    Dosage: 600 mg
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01



Possible Depakene side effects in 6 year old female

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

Patient: 6 year old female

Reactions: Product Counterfeit, Fall, Epilepsy, Convulsion, Tremor

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2006-01-01
    End date: 2012-06-01

Depakene
    Dosage: 12 ml, oral solution, 3 times a day
    Administration route: Oral
    Start date: 2012-08-01

Depakene
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-07-31



Possible Depakene side effects in female

Reported by a physician from China on 2012-08-20

Patient: female

Reactions: Drug Eruption, Anaphylactoid Reaction, Swelling, Pyrexia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Penicillin



Possible Depakene side effects in 38 year old male

Reported by a physician from Spain on 2012-08-20

Patient: 38 year old male

Reactions: Oedema Peripheral, Pleural Effusion, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Start date: 2012-07-12
    End date: 2012-07-12

Depakene
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-07-11

Seroquel XR
    Administration route: Oral
    Indication: Mania
    Start date: 2012-07-04
    End date: 2012-07-17



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-20

Patient: female

Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Bilirubin Unconjugated Increased, Alanine Aminotransferase Increased, Hepatitis Cholestatic, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Bilirubin Conjugated Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

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

Patient: male

Reactions: Hepatic Function Abnormal, Alanine Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-16

Patient: male

Reactions: Somnolence, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01

Depakote
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-01-01
    End date: 2010-01-01

Other drugs received by patient: Lamotrigine; Clobazam



Possible Depakene side effects in male

Reported by a pharmacist from Italy on 2012-08-16

Patient: male

Reactions: Balance Disorder, Asthenia, Hypersomnia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Delorazepam (En)
    Dosage: 30 drop(s) ; daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-28
    End date: 2012-06-27

Depakene
    Dosage: 1000 mg daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-28
    End date: 2012-06-27

Tegretol
    Dosage: 800 milligram(s) daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-28
    End date: 2012-06-27



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-16

Patient: male

Reactions: Overdose, Depressed Level of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clobazam
    Indication: Suicidal Ideation

Clobazam
    Dosage: 30 dosage form, once
    Administration route: Oral
    Indication: Epilepsy

Depakene
    Dosage: unknown; once
    Administration route: Oral
    Indication: Epilepsy

Protecadin
    Dosage: unknown; once
    Administration route: Oral
    Indication: Epilepsy



Possible Depakene side effects in female

Reported by a physician from Japan on 2012-08-15

Patient: female

Reactions: Rash Generalised, Lymphocyte Stimulation Test Positive, Pyrexia, Rash, Drug Rash With Eosinophilia and Systemic Symptoms, Periproctitis, Anal Erosion, Generalised Erythema, Gamma-Glutamyltransferase Increased, Human Herpes Virus 6 Serology Positive, Anal Haemorrhage, White Blood Cell Count Increased, Toxic Skin Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 1000mg per day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2010-05-07

Lamictal
    Dosage: 50mg per day
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2010-05-10
    End date: 2010-06-25

Other drugs received by patient: Clobazam; Tegretol



Possible Depakene side effects in male

Reported by a physician from Italy on 2012-08-15

Patient: male

Reactions: Hyperthermia, Suicide Attempt

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Escitalopram
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Seroquel
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01



Possible Depakene side effects in 8 year old male

Reported by a consumer/non-health professional from China on 2012-08-14

Patient: 8 year old male

Reactions: Trismus, Epilepsy, Convulsion, Foaming AT Mouth, Loss of Consciousness

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Start date: 2011-06-01
    End date: 2012-03-01

Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-06-01
    End date: 2012-03-01

Depakene
    Dosage: 500 mg er tab daily
    Administration route: Oral
    Start date: 2012-03-01

Other drugs received by patient: Levetiracetam



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-14

Patient: female

Reactions: Diarrhoea, Melaena

Drug(s) suspected as cause:
Depakene
    Dosage: extended release, 1000 mg daily
    Administration route: Oral
    Start date: 2009-01-19
    End date: 2009-08-10

Depakene
    Dosage: extended release, 500 mg daily
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-14



Possible Depakene side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-14

Patient: male

Reactions: Femur Fracture, Physical Assault, Fall

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 6 year old female

Reported by a consumer/non-health professional from China on 2012-08-13

Patient: 6 year old female

Reactions: Product Counterfeit, Fall, Epilepsy, Tremor, Convulsion

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Start date: 2012-06-01

Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2006-01-01
    End date: 2012-06-01

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