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Trileptal (Oxcarbazepine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Trileptal (Oxcarbazepine) 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 (460)
Death (50)
Life Threatening Events (20)
Disability (7)

Reports by Reaction Type

Convulsion (88)Headache (37)Somnolence (35)Malaise (33)Nausea (31)Dizziness (30)Feeling Abnormal (27)Hyponatraemia (26)Vomiting (22)Pyrexia (21)Drug Ineffective (20)Death (20)

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

Possible Trileptal side effects in female

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

Patient: female

Reactions: Lower Limb Fracture

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Clonazepam; Atemperator



Possible Trileptal side effects in 53 year old male

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

Patient: 53 year old male

Reactions: Head Discomfort, Wrong Technique in Drug Usage Process, Pain, Headache, Somnolence, Malaise, Dizziness, Salivary Hypersecretion, Depression, Cough, Cardiac Murmur, Vomiting, Retching, Nausea, Restlessness, Self Injurious Behaviour, Dysgeusia, Sleep Disorder, Memory Impairment, Feeling Abnormal, Disability

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Clonazepam; Haldol



Possible Trileptal side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Migraine, Melas Syndrome, Cognitive Disorder, Cerebrovascular Accident, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Acetaminophen; Ibuprofen; Antiemetics



Possible Trileptal side effects in female

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

Patient: female, weighing 80.0 kg (176.0 pounds)

Reactions: Migraine, Weight Decreased, Epilepsy, Fall, Gastrointestinal Infection, Malaise, Dizziness, Depression, Pharyngitis

Drug(s) suspected as cause:
Clobazam
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Atonic Seizures

Trileptal
    Dosage: 600 mg,
    Administration route: Oral

Trileptal
    Dosage: 300 mg,
    Administration route: Oral
    Indication: Atonic Seizures

Trileptal
    Dosage: 1 tablet in morning and 1 tablet at night of each dosage form each (300 mg and 600 mg)
    Administration route: Oral

Trileptal
    Dosage: 1 tablet in morning and 1 tablet at night of each dosage form each (300 mg and 600 mg)
    Administration route: Oral

Trileptal
    Dosage: half tablet in morning and 1 tablet at night of each dosage form each (300 mg and 600 mg)
    Administration route: Oral



Possible Trileptal side effects in male

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

Patient: male

Reactions: Bladder Cancer

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Finasteride; Simvastatin; Donepezil HCL; Levothyroxine Sodium; Amlodipine Besylate; Aradois H; Motilium; Pramipexole Dihydrochloride; Solifenacin Succinate



Possible Trileptal side effects in female

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

Patient: female

Reactions: Trigeminal Nerve Disorder, VTH Nerve Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-22

Patient: male

Reactions: Cerebrovascular Accident

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-22

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-22

Patient: female

Reactions: Spinal Fracture, Procedural Site Reaction, Blood Pressure Fluctuation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Abdominal Pain, Headache, Oropharyngeal Pain, Pyrexia, Erythema, Cheilitis, Malaise, Cough, Epistaxis, Acne, Affective Disorder, Rhinitis Allergic, Ocular Hyperaemia, Dehydration, Vision Blurred, Chills, Conjunctivitis, Fatigue, Skin Lesion, Stevens-Johnson Syndrome, Pharyngeal Inflammation, Viral Infection, Vomiting, Kawasaki's Disease, Myopia, Urethritis, Rash, LIP Pain, Mucosal Inflammation, Oral Pain, Dysuria, DRY Eye, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Buspirone HCL; Acyclovir; Acetaminophen; Minocycline HCL; Buspar; Erythromycin; Famotidine; Seroquel



Possible Trileptal side effects in 79 year old male

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

Patient: 79 year old male

Reactions: Hyponatraemia, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pravastatin
    Dosage: 40 mg, qd
    End date: 2012-08-06

Trileptal
    Dosage: 2 df, daily
    Start date: 2012-07-26
    End date: 2012-08-06

Other drugs received by patient: Bisoprolol Fumarate; Clobazam; Potassium Chloride; Indapamide; Keppra



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-18

Patient: male

Reactions: Blood Pressure Increased, Dyspnoea, Ejaculation Failure, Swollen Tongue, Stress, Haematemesis, Therapeutic Response Decreased, Petit MAL Epilepsy, Nervousness

Drug(s) suspected as cause:
Exodus
    Dosage: unk ukn, unk

Tegretol
    Dosage: 400 mg, unk
    Administration route: Oral
    Indication: Convulsion

Tegretol
    Dosage: 400 mg, unk

Trileptal
    Dosage: 600 mg, 1 tablet in the morning and 1 tablet at night
    Administration route: Oral

Trileptal
    Dosage: 300 mg, 1 tablet in the evening
    Administration route: Oral

Trileptal
    Dosage: 600 mg, 1 tablet in the morning and 1 tablet at night
    Administration route: Oral
    Indication: Convulsion



Possible Trileptal side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Eye Discharge, Mouth Ulceration, Petechiae, Pyrexia, Oropharyngeal Pain, Transaminases Increased, Erythema, LIP Erosion, Dermatitis, Liver Function Test Abnormal, Skin Lesion, Oral Mucosa Erosion, Stevens-Johnson Syndrome, Cough, Blister, Swelling Face, Dysphagia, Rhinitis, Vaginal Discharge, Rash, Respiratory Distress, Eye Pain, Alopecia, Dysuria, Eye Swelling, Rash Maculo-Papular, Vaginal Lesion

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Nafcillin; Prednisolone; Propofol; Precedex; Benadryl



Possible Trileptal side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male

Reactions: Asthma, Tinnitus, Contusion, Tonsillar Hypertrophy, Urinary Incontinence, Pyrexia, Fall, Speech Disorder, Autism, Photophobia, Depression, Enteritis, Learning Disorder, Epistaxis, Stevens-Johnson Syndrome, Migraine, Speech Disorder Developmental, Excoriation, Haemoptysis, Hypoaesthesia, Joint Injury, Epilepsy, Enuresis, Developmental Coordination Disorder, Anxiety, Shigella Infection, Adenoidal Hypertrophy, Hallucination, Visual, Rash Maculo-Papular, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Keppra; Zonegran; Singulair; Claritin; Zofran



Possible Trileptal side effects in female

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

Patient: female, weighing 45.0 kg (99.0 pounds)

Reactions: Weight Decreased, Labyrinthitis, Head Injury, Wrist Fracture, Bladder Pain, Fall, Dyspepsia, Cough, Back Pain, White Blood Cell Count Decreased, Anaemia, Tremor, Arrhythmia, Syncope, Arthralgia, Renal Pain, Memory Impairment

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

Trileptal
    Dosage: 300 mg, daily
    Administration route: Oral
    Indication: Memory Impairment

Other drugs received by patient: Amlodipine Besylate



Possible Trileptal side effects in male

Reported by a physician from Brazil on 2012-08-16

Patient: male

Reactions: Sepsis, Lung Infection, Convulsion

Drug(s) suspected as cause:
Trileptal
    Dosage: 6 %, unk

Trileptal
    Dosage: 2 df, daily
    Administration route: Oral
    Indication: Convulsion

Other drugs received by patient: Motilium; Phenytoin; Ranitidine; Phenobarbital TAB; Furosemide



Possible Trileptal side effects in female

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

Patient: female

Reactions: Asthma, Abdominal Pain, Pruritus, Urticaria, Anaphylactic Reaction, Thalassaemia Beta, Pyrexia, Transaminases Increased, Lymphocytosis, Pharyngeal Oedema, Simplex Virus Test Positive, Dyspepsia, Back Pain, Anaemia, Nasal Congestion, Flushing, Rhinitis Allergic, Gastrointestinal Disorder, Polycystic Ovaries, LIP Swelling, Conjunctivitis, Bipolar II Disorder, Fatigue, Depression, Stevens-Johnson Syndrome, Migraine, Vomiting, Angioedema, Dyspnoea, Viral Infection, Nausea, Rash, Eosinophilia, Diarrhoea, Bronchitis, Blindness, DRY Eye

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Hydroxyzine; Acyclovir; Metformin Hydrochloride; Clotrimazole; Topamax



Possible Trileptal side effects in male

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

Patient: male

Reactions: Multi-Organ Failure, Hypovolaemic Shock, Clonus, Hyponatraemia, Gastroenteritis, Status Epilepticus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Hydrocortisone; Thyroid Hormones; Human Growth Hormone



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-15

Patient: male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Russian Federation on 2012-08-15

Patient: male

Reactions: Convulsion

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in female

Reported by a lawyer from United States on 2012-08-14

Patient: female, weighing 56.2 kg (123.7 pounds)

Reactions: Abdominal Pain, Pruritus, Vulval Ulceration, Urticaria, Pyrexia, Headache, Oral Candidiasis, Lymph Node Palpable, Hypoxia, Sputum Purulent, Proctalgia, Blister, Blood Gases Abnormal, Dysphagia, Stomatitis, Encephalomalacia, Coronary Artery Disease, Toxic Epidermal Necrolysis, Vaginal Discharge, Periorbital Oedema, Cachexia, Colonoscopy Abnormal, Acute Sinusitis, Rash Erythematous, Insomnia, Aspartate Aminotransferase Increased, Dehydration, Confusional State, Skin Exfoliation, Mouth Ulceration, Nuclear Magnetic Resonance Imaging Brain Abnormal, Hepatitis, Constipation, Death, Blood Calcium Decreased, Haematocrit Decreased, Chest Pain, Blood Sodium Decreased, Blood Glucose Increased, Vomiting, Blood Alkaline Phosphatase, Nausea, Alanine Aminotransferase Increased, Blood Potassium Increased, Facial Pain, Mucosal Inflammation, Haemoglobin Decreased, Oral Pain, Neoplasm Malignant, Respiratory Failure, Asthenia, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Dilantin
    Indication: Convulsion
    Start date: 2002-12-01

Trileptal
    Indication: Convulsion
    Start date: 2003-01-29
    End date: 2003-01-31

Other drugs received by patient: Ceftriaxone; Acyclovir; Triamcinolone; Nystatin; Gyne-Lotrimin; Pepcid; Fluconazole; Docusate; Neurontin



Possible Trileptal side effects in female

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

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Abilify

Adderall

Antidepressants

Beta Blocking Agents

Buspar

Darvocet-N 50

Daytrana

Depakote

Desyrel

Effexor

Elavil

Erythromycin

Lunesta

MAO Inhibitors

Neurontin

Pamelor

Paxil

Prozac

Reglan

Remeron

Requip

Ritalin

Seroquel

Sinequan

Skelaxin

Steroids NOS

Sumatriptan

Tegretol

Tizanidine Hydrochloride
    Indication: Migraine

Tofranil

Topamax

Trileptal

Valium
    Indication: Agitation

Wellbutrin

Zoloft

Zonegran

Zyprexa

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Trileptal side effects in male

Reported by a lawyer from United States on 2012-08-14

Patient: male, weighing 42.6 kg (93.8 pounds)

Reactions: Productive Cough, Platelet Count Increased, Pyrexia, Biopsy Skin Abnormal, Rash Pruritic, Herpes Zoster, Cheilitis, Upper Respiratory Tract Infection, White Blood Cell Count Increased, Epistaxis, Laceration, Respiratory Distress, Rhinitis Allergic, Joint Swelling, Vision Blurred, Rash Maculo-Papular, Keratitis, LIP Swelling, Skin Exfoliation, Pain, Constipation, Dermatitis Contact, Photophobia, Dizziness, Sinusitis, Stevens-Johnson Syndrome, Decreased Appetite, Oral Discharge, Iris Adhesions, Anxiety, Arthralgia, Eye Swelling, DRY Eye

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Concerta



Possible Trileptal side effects in male

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

Patient: male

Reactions: TIC, Dystonia

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Trileptal side effects in female

Reported by a physician from Costa Rica on 2012-08-13

Patient: female

Reactions: Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia, Apparent Life Threatening Event

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Trileptal

Other drugs received by patient: Valproate Sodium



Possible Trileptal side effects in 18 year old female

Reported by a physician from Switzerland on 2012-08-13

Patient: 18 year old female

Reactions: Major Depression, Somnolence, Hallucination, Suicidal Ideation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 500 mg, daily
    Administration route: Oral

Potiga
    Dosage: 400 mg, unk
    Administration route: Oral
    Start date: 2011-09-14
    End date: 2011-10-10

Trileptal
    Dosage: 900 mg, daily
    Administration route: Oral



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from Mexico on 2012-08-10

Patient: male

Reactions: Speech Disorder, Dysphagia, Brain Oedema, Paralysis

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Dystonia, TIC

Drug(s) suspected as cause:
Abilify
    Dosage: 40 mg, qd

Clonidine
    Dosage: 0.02 mg, bid

Clozaril
    Indication: Schizophrenia

Depakote
    Dosage: 125 mg, qd

Klonopin
    Dosage: 1 mg, qd (mrn)

Lithium Carbonate
    Dosage: 900 mg, qd

Metadate CD
    Dosage: 25 mg

Risperidone
    Dosage: 50 mg, bid

Seroquel
    Dosage: 25 mg, qd

Strattera
    Dosage: 50 mg, qd

Tegretol
    Dosage: 150 mg, tid

Trileptal
    Dosage: 25 mg, qd

Zoloft
    Dosage: 25 mg, qd

Other drugs received by patient: Zyprexa



Possible Trileptal side effects in female

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

Patient: female

Reactions: Dementia, Vertigo

Drug(s) suspected as cause:
Trileptal



Possible Trileptal side effects in female

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

Patient: female, weighing 31.0 kg (68.2 pounds)

Reactions: Insomnia, Paralysis, Convulsion

Drug(s) suspected as cause:
Oxcarbazepine
    Dosage: 7.5 ml, bid
    Indication: Convulsion

Trileptal
    Dosage: 5 ml, tid
    Indication: Convulsion

Trileptal
    Dosage: 7.5 ml, bid

Other drugs received by patient: Phenobarbital TAB; Lamotrigine; Levothyroxine Sodium; Clobazam; Phenytoin

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