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 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 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 2012-08-06
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 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 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 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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