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Depakene (Valproic Acid) - Somnolence - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Somnolence (42)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) where reactions include somnolence. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 42   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 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 46 year old male

Reported by a physician from Korea, Republic of on 2012-08-09

Patient: 46 year old male

Reactions: Confusional State, Abnormal Behaviour, Cognitive Disorder, Memory Impairment, Disorientation, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Topamax
    Dosage: 50 mg
    Start date: 2012-01-01
    End date: 2012-01-01

Keppra
    Dosage: unknown dose
    Start date: 2012-01-01

Depakene
    Dosage: 1000 mg
    Start date: 2012-01-01

Oxcarbazepine
    Start date: 2012-04-12

Other drugs received by patient: Zobirax; Desamethasone; Zobirax; Desamethasone



Possible Depakene side effects in 52 year old male

Reported by a consumer/non-health professional from Netherlands on 2012-08-09

Patient: 52 year old male

Reactions: Drug Ineffective, Disturbance in Attention, Memory Impairment, Somnolence, Epilepsy, Tremor, Dysphemia

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-01

Depakene
    Administration route: Oral

Clobazam
    Administration route: Oral
    Indication: Epilepsy
    End date: 2011-07-01

Other drugs received by patient: Tamsulosin Hydrochloride; Azarga



Possible Depakene side effects in 52 year old male

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

Patient: 52 year old male

Reactions: Drug Ineffective, Disturbance in Attention, Somnolence, Epilepsy, Amnesia, Tremor, Dysphemia

Drug(s) suspected as cause:
Depakene
    Dosage: 300 mg milligram(s) 1 in 1 d, oral, 800 mg milligram(s), 2 in 1 d, oral
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-01

Onfi
    Dosage: 10 mg milligram(s), oral
    Administration route: Oral
    Indication: Epilepsy
    End date: 2011-07-01

Other drugs received by patient: Azarga (Azarga); Tamsulosin HCL



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from China on 2012-08-02

Patient: male

Reactions: Cognitive Disorder, Somnolence

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-01

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Cerebral Artery Embolism, Mass, Disorientation, Somnolence, Delirium, Benign Neoplasm

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Captopril; Phenytoin



Possible Depakene side effects in 3 year old male

Reported by a consumer/non-health professional from China on 2012-07-31

Patient: 3 year old male

Reactions: Drug Level Below Therapeutic, Drug Ineffective, Epilepsy, Muscle Twitching, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 58 year old female

Reported by a physician from Belgium on 2012-07-19

Patient: 58 year old female, weighing 99.0 kg (217.8 pounds)

Reactions: Confusional State, Sedation, Hyperammonaemia, Toxicity To Various Agents, Somnolence, Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Zestril; Levothyroxine Sodium; Angeliq; Redomex; Lamotrigine; Duragesic-100; Zantac; Novorapid; Clonazepam; Depakene; Lamotrigine; Sulfarlem S 25; Seroquel; Fenofibrate; Zocor; Calcium Carbonate; Abilify; D-Cure; Tenormin; Metformin HCL; Lantus



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-17

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Mass, Cerebral Artery Embolism, Disorientation, Delirium, Benign Neoplasm, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Phenytoin; Captopril



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-09

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Cerebral Artery Embolism, Mass, Disorientation, Delirium, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient: Phenytoin; Captopril



Possible Depakene side effects in 3 year old male

Reported by a consumer/non-health professional from China on 2012-06-13

Patient: 3 year old male

Reactions: Drug Level Below Therapeutic, Drug Ineffective, Muscle Twitching, Somnolence, Epilepsy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-06-08

Patient: 39 year old female

Reactions: Disturbance in Attention, Somnolence, Aggression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Lamotrigine
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Tegretol
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Depakene
    Dosage: extended release
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Other drugs received by patient: Diazepam; Polyethylene Glycol; Antiepileptics; Naproxen; Phenobarbital TAB



Possible Depakene side effects in female

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

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Intervertebral Disc Protrusion, Back Pain, Agitation, Weight Decreased, Somnolence, Tremor, Weight Increased, Daydreaming, Fibromyalgia, Alopecia, Memory Impairment, Mobility Decreased

Drug(s) suspected as cause:
Depakene
    Dosage: 2 tablets per day
    Administration route: Oral
    Indication: Convulsion

Depakote
    Indication: Traumatic Delivery

Depakene
    Indication: Traumatic Delivery

Depakote
    Dosage: 2 tablets per day
    Administration route: Oral
    Indication: Convulsion
    End date: 2009-01-01



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-05-31

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Daydreaming, Disturbance in Attention, Mental Retardation, Somnolence, Aggression

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tegretol-XR
    Dosage: 100-200 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Depakene
    Dosage: 600-750 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Lamictal
    Dosage: 75-100 mg
    Indication: Epilepsy
    Start date: 1975-03-01

Other drugs received by patient: Diazepam; Transipeg; Naproxen



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Netherlands on 2012-05-30

Patient: female, weighing 75.0 kg (165.0 pounds)

Reactions: Disturbance in Attention, Somnolence, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Tegretol-XR
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 1975-03-01

Other drugs received by patient: Diazepam; Transipeg; Naproxen



Possible Depakene side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-05-25

Patient: male

Reactions: Weight Decreased, Cerebral Disorder, Somnolence, Amnesia, Epilepsy, Convulsion, Food Aversion, Activities of Daily Living Impaired, Decreased Appetite

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy

Topiramate
    Administration route: Oral
    Indication: Epilepsy

Phenobarbital TAB
    Administration route: Oral

Phenobarbital TAB
    Administration route: Oral
    Indication: Epilepsy

Clonazepam
    Administration route: Oral
    Indication: Epilepsy

Depakene
    Administration route: Oral

Topiramate
    Administration route: Oral

Other drugs received by patient: Phenytoin; Frisium; Phenytoin; Dialodon



Possible Depakene side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-05-22

Patient: male

Reactions: Weight Decreased, Cerebral Disorder, Epilepsy, Somnolence, Amnesia, Convulsion, Food Aversion, Activities of Daily Living Impaired, Decreased Appetite

Drug(s) suspected as cause:
Phenobarbital TAB
    Administration route: Oral

Clonazepam
    Administration route: Oral
    Indication: Epilepsy

Topiramate
    Administration route: Oral
    Indication: Epilepsy

Depakene
    Administration route: Oral
    Indication: Epilepsy

Topiramate
    Administration route: Oral

Depakene
    Administration route: Oral

Phenobarbital TAB
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: Phenytoin; Dialodon; Phenytoin; Frisium



Possible Depakene side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Lithuania on 2012-05-17

Patient: 61 year old female

Reactions: Intentional Overdose, Dyskinesia, Coordination Abnormal, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Completed Suicide

Gabitril
    Administration route: Oral
    Indication: Completed Suicide



Possible Depakene side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-05-15

Patient: 49 year old female

Reactions: Renal Failure, Vomiting, Drug Ineffective, Pancytopenia, Hypercalcaemia, Somnolence, Thrombocytopenia

Drug(s) suspected as cause:
Depakene
    Dosage: 500 mg, unk
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-09-28
    End date: 2011-10-19

Haldol
    Dosage: 12.5 mg, unk
    Administration route: Oral
    Start date: 2011-10-29
    End date: 2011-10-29

Haldol
    Dosage: 10 mg, unk
    Administration route: Oral
    Start date: 2011-10-30
    End date: 2011-10-30

Haldol
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2011-11-01
    End date: 2011-11-01

Clozapine
    Dosage: 75 mg, unk
    Administration route: Oral
    End date: 2011-11-02

Haldol
    Dosage: 15 mg, unk
    Administration route: Oral
    Start date: 2011-10-20
    End date: 2011-10-28

Haldol
    Dosage: 2.5 mg, unk
    Administration route: Oral
    Start date: 2011-11-02
    End date: 2011-11-02

Zyprexa
    Dosage: 20 mg, unk
    Administration route: Oral
    Start date: 2011-10-07
    End date: 2011-11-01

Zyprexa
    Dosage: 20 mg, unk
    Administration route: Oral
    Start date: 2011-11-04
    End date: 2011-11-10

Clozapine
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-10-27

Haldol
    Dosage: 7.5 mg, unk
    Administration route: Oral
    Start date: 2011-10-31
    End date: 2011-10-31

Haldol
    Dosage: 7.5 mg, unk
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-10-08
    End date: 2011-10-19

Depakene
    Dosage: 1000 mg, unk
    Administration route: Oral
    Start date: 2011-10-20
    End date: 2011-11-10

Zyprexa
    Dosage: 15 mg, unk
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-09-28
    End date: 2011-10-06

Zyprexa
    Dosage: 10 mg, unk
    Administration route: Oral
    Start date: 2011-11-02
    End date: 2011-11-03

Other drugs received by patient: Diazepam; Cinacalcet Hydrochloride



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-04-30

Patient: male

Reactions: Somnolence

Drug(s) suspected as cause:
Depakene
    Dosage: 400mg daily
    Administration route: Oral
    Indication: Hydrocephalus
    Start date: 2012-01-01
    End date: 2012-03-29

Clonazepam
    Administration route: Oral
    Indication: Hydrocephalus
    Start date: 2012-01-01
    End date: 2012-03-29



Possible Depakene side effects in 61 year old female

Reported by a health professional (non-physician/pharmacist) from Lithuania on 2012-04-30

Patient: 61 year old female

Reactions: Intentional Overdose, Dyskinesia, Coordination Abnormal, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gabitril
    Administration route: Oral
    Indication: Completed Suicide

Depakene
    Administration route: Oral
    Indication: Completed Suicide



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-04-09

Patient: female

Reactions: Syncope, Dyspnoea, Chest Pain, Somnolence

Drug(s) suspected as cause:
Trileptal
    Indication: Epilepsy

Depakote
    Administration route: Oral
    Indication: Syncope
    Start date: 2011-07-01
    End date: 2012-03-01

Depakene
    Administration route: Oral
    Indication: Syncope

Other drugs received by patient: Clobazam; Clobazam



Possible Depakene side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-03-29

Patient: female

Reactions: Dyspnoea, Syncope, Chest Pain, Somnolence

Drug(s) suspected as cause:
Depakote
    Administration route: Oral
    Indication: Syncope
    Start date: 2011-07-01
    End date: 2012-03-01

Trileptal
    Indication: Epilepsy

Depakene
    Administration route: Oral
    Indication: Syncope

Other drugs received by patient: Clobazam; Clobazam



Possible Depakene side effects in male

Reported by a physician from Japan on 2012-03-28

Patient: male

Reactions: Skin Exfoliation, Eye Discharge, Hyperthermia, Oropharyngeal Pain, Pyrexia, Erythema, Somnolence, LIP Erosion, Cheilitis, Malaise, Conjunctival Hyperaemia, Dizziness, Stevens-Johnson Syndrome, Erythema of Eyelid, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Rash Papular, Rash, Oral Mucosal Erythema, Aspartate Aminotransferase Increased, Epidermal Necrosis, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 25mg alternate days
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-06-16

Depakene
    Dosage: 400mg per day
    Administration route: Oral
    Indication: Bipolar I Disorder
    Start date: 2011-04-02
    End date: 2011-07-26

Lamictal
    Dosage: 50mg per day
    Administration route: Oral
    End date: 2011-07-19

Other drugs received by patient: Zolpidem; Flunitrazepam; Paxil; Sennoside; Allopurinol; U PAN; Lithium Carbonate; Desyrel



Possible Depakene side effects in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-20

Patient: 51 year old male

Reactions: Disorientation, Somnolence

Adverse event resulted in: hospitalization

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

Depakene
    Administration route: Oral

Depakene
    Administration route: Oral
    Indication: Epilepsy

Topiramate
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2011-07-01
    End date: 2011-09-01

Topiramate
    Administration route: Oral
    End date: 2011-07-01

Depakene
    Administration route: Oral



Possible Depakene side effects in 84 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-13

Patient: 84 year old female

Reactions: Confusional State, Orthostatic Hypotension, Drug Interaction, Dizziness, Fall, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Depakene

Other drugs received by patient possibly interacting with the suspect drug:
Depakene
    Administration route: Oral
    Start date: 2012-01-21

Lorazepam
    Dosage: daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-01-21

Other drugs received by patient: Oxazepam



Possible Depakene side effects in 23 year old female

Reported by a physician from Japan on 2012-03-07

Patient: 23 year old female

Reactions: Atelectasis, Pneumonia Aspiration, Intentional Overdose, Coma, Laceration, Pyrexia, Intentional Self-Injury, Somnolence, Suicidal Ideation, Anticonvulsant Drug Level Increased, Multiple Drug Overdose Intentional, Sputum Increased, Altered State of Consciousness, Medication Residue, Respiration Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lithium Carbonate
    Dosage: 5600 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-09-11

Depakene
    Dosage: 4200 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-09-11

Risperdal
    Dosage: 7 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-09-11

Tegretol
    Dosage: 4200 mg, daily
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-09-11

Other drugs received by patient: Alcohol



Possible Depakene side effects in 36 year old male

Reported by a pharmacist from Japan on 2012-03-01

Patient: 36 year old male

Reactions: Multiple Drug Overdose, Somnolence

Adverse event resulted in: hospitalization

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

Zonisamide
    Administration route: Oral

Seroquel
    Administration route: Oral

Mirtazapine
    Administration route: Oral

Depakene
    Administration route: Oral

Seroquel
    Administration route: Oral



Possible Depakene side effects in 29 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-02-28

Patient: 29 year old male

Reactions: Confusional State, Tachycardia, Pyrexia, Somnolence, Muscle Rigidity, Overdose, Gait Disturbance, Altered State of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nozinan
    Administration route: Oral
    Indication: Childhood Psychosis
    Start date: 2011-11-01

Lepticur

Clopixol
    Start date: 2011-11-01

Trimeprazine Tartrate
    Dosage: 30 drops daily
    Administration route: Oral
    Indication: Childhood Psychosis
    Start date: 2006-07-01

Trimeprazine Tartrate
    Dosage: 30 drops daily
    Administration route: Oral
    Start date: 2011-11-01

Tranxene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-23

Lepticur
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-07-01

Clopixol
    Indication: Childhood Psychosis
    Start date: 2009-07-01

Depakene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-13

Other drugs received by patient: Tercian; Loxapine HCL



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