Carbamazepine (Carbamazepine) - Adverse Event Reports - Serious Event - Somnolence

Adverse event in 65 year old female receiving Carbamazepine

Reported by a individual with unspecified qualification from Italy on 2007-10-31

Patient: 65 year old female

Adverse reactions / side effects: Respiratory Rate Increased, Glossodynia, Ataxia, Somnolence, Diplopia, Oral Pain, Visual Disturbance, Anticonvulsant Drug Level Increased, Dizziness

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 300 mg tid
    Indication: Glossodynia

Carbamazepine
    Dosage: 200 mg tid
    Indication: Glossodynia

Adverse event in 24 year old male receiving Carbamazepine

Reported by a physician from Japan on 2007-10-22

Patient: 24 year old male

Adverse reactions / side effects: Agitation, Dysphagia, Abasia, Torticollis, Somnolence, Aggression, Incontinence, Aspartate Aminotransferase Increased, Salivary Hypersecretion, Neuroleptic Malignant Syndrome, Blood Pressure Fluctuation

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 400 mg, oral, 600 mg, oral
    Administration route: Oral

Zonegran
    Dosage: 160 mg, oral, gradual increase from 160mg to 300mg; oral, 300mg, oral
    Administration route: Oral
    Indication: Epilepsy

Other drugs received by patient: Risperidone; Clonazepam

Adverse event in 35 year old male receiving Carbamazepine

Reported by a pharmacist from United States on 2007-10-18

Patient: 35 year old male, weighing 90.0 kg (198.0 pounds)

Adverse reactions / side effects: Drug Level Increased, Somnolence, Aggression

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine

Adverse event in female receiving Carbamazepine

Reported by a health professional (non-physician/pharmacist) from France on 2007-10-17

Patient: female

Adverse reactions / side effects: Drug Level Above Therapeutic, Encephalopathy, Disorientation, Somnolence, Hallucination

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Administration route: Oral
    Indication: Epilepsy

Depakene
    Administration route: Oral
    Indication: Epilepsy
    End date: 2007-01-01

Depakene
    Administration route: Oral
    Start date: 2007-01-01

Other drugs received by patient: Levothyroxine Sodium

Adverse event in 24 year old male receiving Carbamazepine

Reported by a health professional (non-physician/pharmacist) from Japan on 2007-10-15

Patient: 24 year old male

Adverse reactions / side effects: Agitation, Blood Creatine Phosphokinase Increased, Abasia, Drug Interaction, Muscle Spasticity, Pyrexia, Hyperhidrosis, Muscle Rigidity, Somnolence, Labile Blood Pressure, Incontinence, Choreoathetosis, Neuroleptic Malignant Syndrome, Salivary Hypersecretion, Dysphagia, Torticollis, Aggression, Heart Rate Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 400 mg/day
    Indication: Partial Seizures

Carbamazepine
    Dosage: 600 mg/day

Zonisamide
    Dosage: 160 to 300 mg/day

Zonisamide
    Dosage: 300 mg/day

Other drugs received by patient: Risperidone; Clonazepam

Adverse event in 25 year old male receiving Carbamazepine

Reported by a consumer/non-health professional from Israel on 2007-10-01

Patient: 25 year old male, weighing 60.0 kg (132.0 pounds)

Adverse reactions / side effects: Blood Creatine Phosphokinase Increased, Pneumonia Aspiration, Intentional Overdose, Coma, Hypernatraemia, Somnolence, Loss of Consciousness, Gamma-Glutamyltransferase Increased, Thrombocytopenia, Vomiting, Mydriasis, Alanine Aminotransferase Increased, Convulsion, Anticonvulsant Drug Level Above Therapeutic, Sepsis, Sinus Tachycardia, Leukocytosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 20g per day
    Administration route: Oral
    Indication: Borderline Personality Disorder

Paroxetine
    Dosage: 400mg per day
    Administration route: Oral
    Indication: Borderline Personality Disorder

Other drugs received by patient: Lithium; Risperidone

Adverse event in 7 year old female receiving Carbamazepine

Reported by a individual with unspecified qualification from United States on 2007-07-27

Patient: 7 year old female

Adverse reactions / side effects: Irritability, Muscle Spasticity, Somnolence, Pharmaceutical Product Complaint, Oxygen Saturation Decreased, Lethargy

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Carbamazepine

Other drugs received by patient: Risperdal; Topamax; Chloral Hydrate (Chloral Hydrate); Valium; Omnicef

Adverse event in 50 year old male receiving Carbamazepine

Reported by a physician from United Kingdom on 2007-07-20

Patient: 50 year old male, weighing 111.6 kg (245.5 pounds)

Adverse reactions / side effects: Alanine Aminotransferase Increased, Aphasia, Furuncle, Paralysis, Hemiparesis, Somnolence, Cerebral Haemorrhage, Disease Progression, Aspartate Aminotransferase Increased, Oedema

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 300mg twice per day
    Administration route: Oral
    Start date: 2005-12-01

Flucloxacillin
    Dosage: 1g four times per day
    Administration route: Oral
    Start date: 2007-05-15
    End date: 2007-05-29

Lapatinib
    Dosage: 1500mg per day
    Administration route: Oral
    Indication: Malignant Glioma
    Start date: 2007-04-17
    End date: 2007-05-31

Pazopanib
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Malignant Glioma
    Start date: 2007-04-17
    End date: 2007-05-31

Adverse event in 71 year old female receiving Carbamazepine

Reported by a individual with unspecified qualification from Poland on 2007-07-19

Patient: 71 year old female

Adverse reactions / side effects: Oral Intake Reduced, Contusion, Drug Ineffective, Bone Pain, Rales, Therapeutic Agent Toxicity, Coma, Drug Interaction, Cerebrovascular Disorder, Somnolence, Dizziness, Blood Sodium Decreased, Urinary Tract Infection, Anaemia, General Physical Health Deterioration, Muscle Twitching, Tremor, Hypotonia, Dehydration, Mental Disorder, Hyporeflexia, Bradycardia, Memory Impairment, Asthenia, Altered State of Consciousness, Mobility Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 1000 mg qd

Diclofenac Sodium
    Dosage: 200 mg qhs
    Indication: Bone Pain

Digoxin

Furosemide

Lithium Carbonate

Naproxen
    Dosage: 2000 mg qhs
    Indication: Bone Pain

Adverse event in 76 year old male receiving Carbamazepine

Reported by a individual with unspecified qualification from Singapore on 2007-07-18

Patient: 76 year old male

Adverse reactions / side effects: Therapeutic Response Unexpected With Drug Substitution, Drug Ineffective, Dizziness, Joint Injury, Facial Pain, Fall, Somnolence

Suspect drug(s):
Carbamazepine

Adverse event in 52 year old male receiving Carbamazepine

Reported by a individual with unspecified qualification on 2007-07-09

Patient: 52 year old male

Adverse reactions / side effects: Flushing, Multiple Drug Overdose Accidental, Pruritus, Scab, Coronary Artery Disease, Drug Dependence, Somnolence

Adverse event resulted in: death

Suspect drug(s):
Carbamazepine
    Dosage: unk, unk
    Indication: Drug USE FOR Unknown Indication

Diazepam
    Dosage: 10 mg, unk
    Indication: Drug USE FOR Unknown Indication

Oxycontin
    Dosage: unk, unk
    Indication: Headache
    Start date: 1998-07-28

Phenobarbital TAB
    Dosage: 32.4 mg, unk
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Depakote

Adverse event in 62 year old male receiving Carbamazepine

Reported by a individual with unspecified qualification from Singapore on 2007-07-05

Patient: 62 year old male

Adverse reactions / side effects: Drug Ineffective, Dizziness, Somnolence, Joint Injury, Facial Pain, Fall, Pharmaceutical Product Complaint

Suspect drug(s):
Carbamazepine

Adverse event in 12 year old female receiving Carbamazepine

Reported by a physician from Turkey on 2007-06-28

Patient: 12 year old female

Adverse reactions / side effects: Pupillary Reflex Impaired, Incorrect Dose Administered, Posture Abnormal, Treatment Noncompliance, Somnolence, Haemodialysis, Loss of Consciousness, Grand MAL Convulsion, Anticonvulsant Drug Level Above Therapeutic, Miosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine

Other drugs received by patient: Phenytoin

Adverse event in 50 year old male receiving Carbamazepine

Reported by a physician from United Kingdom on 2007-06-28

Patient: 50 year old male, weighing 111.6 kg (245.5 pounds)

Adverse reactions / side effects: Alanine Aminotransferase Increased, Aphasia, Furuncle, Paralysis, Hemiparesis, Somnolence, Cerebral Haemorrhage, Aspartate Aminotransferase Increased, Oedema, Thrombocytopenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 300mg twice per day
    Administration route: Oral
    Start date: 2005-12-01

Floxacillin Sodium
    Dosage: 1g four times per day
    Administration route: Oral
    Start date: 2007-05-15
    End date: 2007-05-29

Lapatinib
    Dosage: 1500mg per day
    Administration route: Oral
    Indication: Malignant Glioma
    Start date: 2007-04-17
    End date: 2007-05-31

Pazopanib
    Dosage: 800mg per day
    Administration route: Oral
    Indication: Malignant Glioma
    Start date: 2007-04-17
    End date: 2007-05-31

Adverse event in 25 year old female receiving Carbamazepine

Reported by a physician from Germany on 2007-06-27

Patient: 25 year old female

Adverse reactions / side effects: Tachycardia, Hypoglycaemia, Suicide Attempt, Multiple Drug Overdose, Somnolence

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Acetylsalicylic Acid (Acetylsalicylic Acid) 500 MG
    Dosage: (10000 mg 1x oral)
    Administration route: Oral
    Start date: 2007-06-13
    End date: 2007-06-13

Carbamazepine
    Dosage: (2000 mg 1x oral)
    Administration route: Oral
    Start date: 2007-06-13
    End date: 2007-06-13

Carbamazepine
    Dosage: (16000 mg 1x oral)
    Administration route: Oral
    Start date: 2007-06-13
    End date: 2007-06-13

Tavor / 00273201 / (Tavor) 1 MG
    Dosage: (75 mg 1x oral)
    Administration route: Oral
    Start date: 2007-06-13
    End date: 2007-06-13

Zyprexa
    Dosage: (210 mg 1x oral)
    Administration route: Oral
    Start date: 2007-06-13
    End date: 2007-06-13

Adverse event in 50 year old male receiving Carbamazepine

Reported by a individual with unspecified qualification from Canada on 2007-06-18

Patient: 50 year old male

Adverse reactions / side effects: Cytomegalovirus Antibody Positive, Hyperkeratosis, Blood Folate Increased, Biopsy Skin Abnormal, Treatment Noncompliance, Rash Pruritic, Balance Disorder, Oral Candidiasis, Dermatitis, Lymphocyte Count Decreased, Dysphagia, Mean Cell Volume Increased, Paraesthesia, Heart Rate Decreased, Rash Erythematous, Platelet Count Decreased, Hyporeflexia, Neutrophil Count Decreased, Immune Reconstitution Syndrome, Drug Level Increased, Pallor, Somnolence, Drug Toxicity, Fatigue, Gamma-Glutamyltransferase Increased, White Blood Cell Count Decreased, Rash Papular, Purpura, Rash, Haemoglobin Decreased, Reticulocyte Count Increased, Epidermal Necrosis, Bone Marrow Toxicity, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine

Other drugs received by patient: Tenofovir; Lamivudine; Lopinavir; Citalopram Hydrobromide; Dapsone; Fluconazole; Nelfinavir; Ritonavir

Adverse event in 22 year old male receiving Carbamazepine

Reported by a physician from Brazil on 2007-05-29

Patient: 22 year old male

Adverse reactions / side effects: Overdose, Hypotension, Dizziness, Suicide Attempt, Somnolence

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Haldol
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Adverse event in 41 year old male receiving Carbamazepine

Reported by a pharmacist from United States on 2007-05-24

Patient: 41 year old male, weighing 92.5 kg (203.5 pounds)

Adverse reactions / side effects: Depressed Level of Consciousness, Somnolence

Suspect drug(s):
Carbamazepine
    Dosage: 200 qam + 1000mg qpm (increased 1/26 for insomnia complaint)
    Indication: Headache

Carbamazepine
    Dosage: 200 qam + 1000mg qpm (increased 1/26 for insomnia complaint)
    Indication: Insomnia

Carbamazepine
    Dosage: 200 qam + 1000mg qpm (increased 1/26 for insomnia complaint)
    Indication: Pain

Adverse event in 68 year old male receiving Carbamazepine

Reported by a physician from United Kingdom on 2007-05-03

Patient: 68 year old male, weighing 110.0 kg (242.0 pounds)

Adverse reactions / side effects: Oral Intake Reduced, Confusional State, Body Temperature Increased, General Physical Health Deterioration, Purpura, Somnolence, Convulsion, Disease Progression, Staphylococcal Infection, Balance Disorder, Neutrophil Count Abnormal, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 100 mg; qd; po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-11-27

Dexamethasone TAB
    Dosage: 8 mg; qd; po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-10-16

Temozolomide (S-P) (Temozolomide)
    Dosage: 235 mg; qd; po
    Administration route: Oral
    Indication: Malignant Glioma
    Start date: 2006-10-30
    End date: 2006-11-19

Adverse event in 74 year old female receiving Carbamazepine

Reported by a individual with unspecified qualification from Germany on 2007-04-27

Patient: 74 year old female

Adverse reactions / side effects: Drug Toxicity, Somnolence

Adverse event resulted in: hospitalization

Suspect drug(s):
Enalapril (Formulation Unknown) (Generic) ( Enalapril)

Carbamazepine

Lamotrigine ( Formulation Unknown) (Generic) (Lamotrigine )

Lignocaine Hydrochloride (Formulation Unknown)(lidocaine Hcl)

Metoprolol Tartrate

Paracetamol ( Formulation Unknown) (Generic) (Acetaminophen)

Adverse event in 12 year old female receiving Carbamazepine

Reported by a physician from Turkey on 2007-04-04

Patient: 12 year old female

Adverse reactions / side effects: Grand MAL Convulsion, Pupillary Reflex Impaired, Overdose, Miosis, Somnolence, Treatment Noncompliance, Haemodialysis, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy

Phenytoin
    Indication: Epilepsy

Adverse event in 12 year old female receiving Carbamazepine

Reported by a individual with unspecified qualification from Turkey on 2007-03-22

Patient: 12 year old female

Adverse reactions / side effects: Grand MAL Convulsion, Drug Toxicity, Pupillary Reflex Impaired, Overdose, Miosis, Coordination Abnormal, Somnolence, Treatment Noncompliance, Haemodialysis, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine
    Dosage: 14 tablet once
    Indication: Epilepsy

Carbamazepine
    Indication: Epilepsy

Other drugs received by patient: Phenytoin

Adverse event in 12 year old female receiving Carbamazepine

Reported by a health professional (non-physician/pharmacist) from Turkey on 2007-02-27

Patient: 12 year old female

Adverse reactions / side effects: Grand MAL Convulsion, Overdose, Miosis, Anticonvulsant Drug Level Increased, Coordination Abnormal, Somnolence, Loss of Consciousness

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine

Other drugs received by patient: Phenytoin

Adverse event in 29 year old female receiving Carbamazepine

Reported by a health professional (non-physician/pharmacist) from United States on 2007-02-14

Patient: 29 year old female

Adverse reactions / side effects: Pupillary Reflex Impaired, Metabolic Acidosis, Mydriasis, Melas Syndrome, Status Epilepticus, Somnolence, Blood Lactic Acid Increased, Drug Exposure During Pregnancy, Mitochondrial Cytopathy, Hypotonia, Heart Rate Increased, Protein Total Increased, Hyporeflexia, Pregnancy Test Positive

Suspect drug(s):
Carbamazepine
    Dosage: 600 mg/day
    Indication: Convulsion

Carbamazepine
    Dosage: 1000 mg/day

Adverse event in 29 year old female receiving Carbamazepine

Reported by a health professional (non-physician/pharmacist) from Australia on 2007-01-23

Patient: 29 year old female

Adverse reactions / side effects: Ileostomy, Drug Level Increased, Bowel Sounds Abnormal, Intubation, Coma, Laparotomy, Intestinal Obstruction, Somnolence, Delirium, Respiratory Rate Decreased, Glasgow Coma Scale Abnormal, Overdose, Abdominal Distension, Blood Pressure Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbamazepine