Index of reports
> All Cases (600)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 600 Next >>
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 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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