Common Oxcarbazepine Side Effects


The most commonly reported Oxcarbazepine side effects (click to view or check a box to report):

Convulsion (151)
Product Substitution Issue (61)
Hyponatraemia (61)
Dizziness (34)
Nausea (32)
Headache (32)
Vomiting (31)
Condition Aggravated (29)
Rash (27)
Confusional State (26)
Grand Mal Convulsion (25)
Fatigue (23)
Completed Suicide (23)
Diplopia (21)
Aggression (20)
Pyrexia (19)
Somnolence (18)
Tremor (17)
Asthenia (17)
Abnormal Behaviour (16)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Oxcarbazepine Side Effects Reported to FDA



Oxcarbazepine Side Effect Report#9958608
Toxicity To Various Agents, Ataxia
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: convulsion, who was treated with Oxcarbazepine Tablets, 300 Mg (dosage: NA, start time: NS), combined with:
  • Topiramate (100 Mg; Am)
  • Phenytoin (200 Mg; Am)
  • Quetiapine
  • Clonazepam
  • Valproic Acid
  • Carbamazepine
  • Lithium
and developed a serious reaction and side effect(s): Toxicity To Various Agents, Ataxia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine Tablets, 300 Mg treatment in female patients, resulting in Toxicity To Various Agents side effect. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9931049
Toxicity To Various Agents, Disorientation, Movement Disorder, Nausea, Vomiting, Mydriasis, Anion Gap Increased, Language Disorder, Overdose
This report suggests a potential Oxcarbazepine Toxicity To Various Agents side effect(s) that can have serious consequences. A 11-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: complex partial seizures and used Oxcarbazepine (dosage: 8 Df, (4800 Mg)) starting NS. After starting Oxcarbazepine the patient began experiencing various side effects, including: Toxicity To Various Agents, Disorientation, Movement Disorder, Nausea, Vomiting, Mydriasis, Anion Gap Increased, Language Disorder, OverdoseAdditional drugs used concurrently: NA.The patient was hospitalized. Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Oxcarbazepine Side Effect Report#9929329
Neuropathy Peripheral, Alopecia, Headache, Paraesthesia
This Neuropathy Peripheral problem was reported by a pharmacist from GB. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Oxcarbazepine (dosage: 750 Milligram Daily; 300mg In The Morning, 150mg Midday, 300mg At Night.). The following drugs were being taken at the same time:
  • Zonisamide (400 Milligram Daily;)
  • Pregabalin (250 Milligram Daily; 150mg In The Morning And 100mg At Night.)
When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Neuropathy Peripheral, Alopecia, Headache, ParaesthesiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neuropathy Peripheral, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9903085
Neuropathy Peripheral, Paraesthesia, Alopecia, Headache
This Neuropathy Peripheral side effect was reported by a health professional from GB. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oxcarbazepine (drug dosage: 750 Mg, Daily (300 Mg In The Morning, 150 Mg Midday And 300 Mg At Night)), which was initiated on NS. Concurrently used drugs:
  • Zonisamide (200 Mg, Bid)
  • Pregabalin (250 Mg, 150 Mg In The Morning And 100 Mg At Night)
.After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Neuropathy Peripheral, Paraesthesia, Alopecia, HeadacheThese side effects may potentially be related to Oxcarbazepine.
Oxcarbazepine Side Effect Report#9903000
Hallucination, Dizziness, Asthenia
This is a report of a 21-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: NA, who was treated with Oxcarbazepine (dosage: 600 Mg, Bid, start time:
Feb 09, 2014), combined with:
  • Sertraline (100 Mg, Bid)
  • Lexapro (20 Mg, Qd)
  • Lexapro
  • Seroquel Xro (50 Mg, Qd)
  • Seroquel Xro
and developed a serious reaction and side effect(s): Hallucination, Dizziness, Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in female patients, resulting in Hallucination side effect.
Oxcarbazepine Side Effect Report#9857529
Congestive Cardiomyopathy, Congenital Mitral Valve Incompetence, Congenital Tricuspid Valve Incompetence, Congenital Hydronephrosis, Patent Ductus Arteriosus, Cardiac Failure, Congenital Inguinal Hernia, Sepsis
This report suggests a potential Oxcarbazepine Congestive Cardiomyopathy side effect(s) that can have serious consequences. A male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Oxcarbazepine (dosage: NA) starting NS. After starting Oxcarbazepine the patient began experiencing various side effects, including: Congestive Cardiomyopathy, Congenital Mitral Valve Incompetence, Congenital Tricuspid Valve Incompetence, Congenital Hydronephrosis, Patent Ductus Arteriosus, Cardiac Failure, Congenital Inguinal Hernia, SepsisAdditional drugs used concurrently: NA. Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Congestive Cardiomyopathy, may still occur.
Oxcarbazepine Side Effect Report#9845283
Convulsion, Condition Aggravated, Product Substitution Issue
This Convulsion problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion,aura,post procedural complication. On NS this consumer started treatment with Oxcarbazepine (dosage: 2-3 Tablets Twice Daily Taken By Mouth?about 6 Weeks). The following drugs were being taken at the same time: NA. When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Convulsion, Condition Aggravated, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9797196
Stevens-johnson Syndrome
This Stevens-johnson Syndrome side effect was reported by a consumer or non-health professional from US. A 45-year-old female patient (weight:NA) experienced the following symptoms/conditions: trigeminal neuralgia,myoclonus.The patient was prescribed Oxcarbazepine (drug dosage: NA), which was initiated on
Dec 04, 2013. Concurrently used drugs: NA..After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Stevens-johnson SyndromeThese side effects may potentially be related to Oxcarbazepine. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9781674
Delusion Of Grandeur, Agitation, Irritability, Insomnia, Aggression, Delirium
This is a report of a 30-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: mania, who was treated with Oxcarbazepine (dosage: 900 Mg, Unk, start time: NS), combined with:
  • Olanzapine (20 Mg, For About 1 Year)
  • Haloperidol (30 Mg, Per Day)
  • Haloperidol (20 Mg Per Day)
  • Haloperidol (10 Mg, Unk)
  • Thiopentone
  • Succinylcholine
and developed a serious reaction and side effect(s): Delusion Of Grandeur, Agitation, Irritability, Insomnia, Aggression, Delirium after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in male patients, resulting in Delusion Of Grandeur side effect. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9752193
Product Substitution Issue
This report suggests a potential Oxcarbazepine Product Substitution Issue side effect(s) that can have serious consequences. A 19-year-old patient (weight: NA) from US was diagnosed with the following symptoms/conditions: rett^s disorder,diagnostic procedure and used Oxcarbazepine (dosage: 5 Cc Bid G-tube) starting 2005. After starting Oxcarbazepine the patient began experiencing various side effects, including: Product Substitution IssueAdditional drugs used concurrently: NA.The patient was hospitalized. Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Substitution Issue, may still occur.
Oxcarbazepine Side Effect Report#9748232
Atrioventricular Block Complete
This Atrioventricular Block Complete problem was reported by a health professional from TR. A 67-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Oxcarbazepine (dosage: NA). The following drugs were being taken at the same time: NA. When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Atrioventricular Block CompleteAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atrioventricular Block Complete, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9747659
Atrioventricular Block Complete
This Atrioventricular Block Complete side effect was reported by a health professional from TR. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oxcarbazepine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Atrioventricular Block CompleteThese side effects may potentially be related to Oxcarbazepine.
Oxcarbazepine Side Effect Report#9726446
Atrioventricular Block Complete
This is a report of a 67-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: partial seizures,hypertension, who was treated with Oxcarbazepine (dosage: 600 Mg, start time: NS), combined with:
  • Cilazapril/hydrochlorothiazide
and developed a serious reaction and side effect(s): Atrioventricular Block Complete after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in female patients, resulting in Atrioventricular Block Complete side effect. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9706646
Atrioventricular Block Complete
This report suggests a potential Oxcarbazepine Atrioventricular Block Complete side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: partial seizures and used Oxcarbazepine (dosage: 300 Mg, Bid) starting NS. After starting Oxcarbazepine the patient began experiencing various side effects, including: Atrioventricular Block CompleteAdditional drugs used concurrently: NA.The patient was hospitalized. Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atrioventricular Block Complete, may still occur.
Oxcarbazepine Side Effect Report#9676060
Atrioventricular Block Complete, Diastolic Dysfunction, Bradycardia, Fatigue, Headache
This Atrioventricular Block Complete problem was reported by a health professional from TR. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: partial seizures,hypertension. On NS this consumer started treatment with Oxcarbazepine (dosage: 300 Mg, Bid). The following drugs were being taken at the same time:
  • Hydrochlorothiazide W/cilazapril
When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Atrioventricular Block Complete, Diastolic Dysfunction, Bradycardia, Fatigue, HeadacheThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atrioventricular Block Complete, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9645534
Vision Blurred, Pruritus, Hallucination, Convulsion
This Vision Blurred side effect was reported by a consumer or non-health professional from US. A 15-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Oxcarbazepine (drug dosage: Qd X3day Bidthereafter), which was initiated on
Sep 26, 2013. Concurrently used drugs:
  • Concerta
  • Risperidone
  • Abilify
  • Zoloft
.After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Vision Blurred, Pruritus, Hallucination, ConvulsionThese side effects may potentially be related to Oxcarbazepine. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9645088
Convulsion, Product Substitution Issue
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: epilepsy, who was treated with Oxcarbazepine (dosage: 450 Mg, Am, Po, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Convulsion, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in female patients, resulting in Convulsion side effect.
Oxcarbazepine Side Effect Report#9637194
Tremor, Dizziness, Vision Blurred
This report suggests a potential Oxcarbazepine Tremor side effect(s) that can have serious consequences. A 37-year-old male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: epilepsy and used Oxcarbazepine (dosage: 600 Mg, Bid) starting
Oct 02, 2013. After starting Oxcarbazepine the patient began experiencing various side effects, including: Tremor, Dizziness, Vision BlurredAdditional drugs used concurrently:
  • Valproic Acid (3 Tablets/day)
  • Lamotrigine (1 Tablet/day)
Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tremor, may still occur.
Oxcarbazepine Side Effect Report#9627009
Psychotic Behaviour, Hallucinations, Mixed, Staring, Excessive Eye Blinking, Slow Response To Stimuli, Stereotypy, Petit Mal Epilepsy, Memory Impairment, No Therapeutic Response
This Psychotic Behaviour problem was reported by a health professional from US. A 44-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression,bipolar disorder. On NS this consumer started treatment with Oxcarbazepine (dosage: NA). The following drugs were being taken at the same time:
  • Lithium
  • Alprazolam
  • Levothyroxine
  • Aripirazole
When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Psychotic Behaviour, Hallucinations, Mixed, Staring, Excessive Eye Blinking, Slow Response To Stimuli, Stereotypy, Petit Mal Epilepsy, Memory Impairment, No Therapeutic ResponseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Psychotic Behaviour, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9586383
Obsessive-compulsive Disorder, Obsessive Thoughts, Depression, Suicide Attempt, Suicidal Ideation, Self-injurious Ideation, Hallucination, Auditory, Persecutory Delusion, Anxiety
This Obsessive-compulsive Disorder side effect was reported by a health professional from GR. A 42-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oxcarbazepine (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Obsessive-compulsive Disorder, Obsessive Thoughts, Depression, Suicide Attempt, Suicidal Ideation, Self-injurious Ideation, Hallucination, Auditory, Persecutory Delusion, AnxietyThese side effects may potentially be related to Oxcarbazepine. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9585928
Paranoia, Anxiety, Depression
This is a report of a 32-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Oxcarbazepine (dosage: 1 Pill, start time:
Sep 25, 2013), combined with:
  • Carbamazepine (1 Pill)
  • Oyster Calcium With Vitamin D
  • Fluticasone Nasal Spray
  • Risperidone
  • Trazodone
and developed a serious reaction and side effect(s): Paranoia, Anxiety, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in male patients, resulting in Paranoia side effect.
Oxcarbazepine Side Effect Report#9548398
Completed Suicide, Status Epilepticus, Grand Mal Convulsion
This report suggests a potential Oxcarbazepine Completed Suicide side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: epilepsy and used Oxcarbazepine (dosage: NA) starting NS. After starting Oxcarbazepine the patient began experiencing various side effects, including: Completed Suicide, Status Epilepticus, Grand Mal ConvulsionAdditional drugs used concurrently:
  • Clonazepam
  • Levetiracetam
  • Lamotrigine
  • Diazepam
  • Midazolam
  • Phenytoin
  • Levothyroxine (75 Ug, Unk)
  • Levothyroxine (100 Ug, Unk)
The patient was hospitalized. Although Oxcarbazepine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Oxcarbazepine Side Effect Report#9541931
Infection, Bone Marrow Failure, Red Blood Cell Count Decreased, Platelet Count Decreased, White Blood Cell Count Decreased, Reticulocyte Count Decreased
This Infection problem was reported by a health professional from CN. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: tic. On
Sep 14, 2012 this consumer started treatment with Oxcarbazepine (dosage: 0.3 G, Bid). The following drugs were being taken at the same time:
  • Valproic Acid (1200 Mg, Qd)
  • Phenobarbital (0.1 Mg, Qd)
  • Piperacillin W/sulbactam (5 G, Q8h)
  • Haemocoagulase (Unk Ukn, Unk)
  • Nifedipine (Unk Ukn, Unk)
  • Furosemide (Unk Ukn, Unk)
When using Oxcarbazepine, the patient experienced the following unwanted symptoms/side effects: Infection, Bone Marrow Failure, Red Blood Cell Count Decreased, Platelet Count Decreased, White Blood Cell Count Decreased, Reticulocyte Count DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Infection, may become evident only after a product is in use by the general population.
Oxcarbazepine Side Effect Report#9541894
Petit Mal Epilepsy, Staring, Excessive Eye Blinking, Memory Impairment, Dyskinesia, Stereotypy, Abnormal Behaviour, Psychotic Behaviour, Hallucination, Auditory
This Petit Mal Epilepsy side effect was reported by a health professional from US. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: bipolar disorder,psychotic disorder,petit mal epilepsy.The patient was prescribed Oxcarbazepine (drug dosage: Unk Ukn, Unk), which was initiated on NS. Concurrently used drugs:
  • Methylphenidate (Unk Ukn, Unk)
  • Valproic Acid (Unk Ukn, Unk)
  • Valproic Acid (Unk Ukn, Unk, Dose Adjustment)
  • Valproic Acid (Unk Ukn, Unk, Tapered)
  • Lithium (Unk Ukn, Unk)
  • Aripiprazole (Unk Ukn, Unk)
  • Levothyroxin (Unk Ukn, Unk)
  • Alprazolam (Unk Ukn, Unk)
.After starting to take Oxcarbazepine the consumer reported adverse symptoms, such as: Petit Mal Epilepsy, Staring, Excessive Eye Blinking, Memory Impairment, Dyskinesia, Stereotypy, Abnormal Behaviour, Psychotic Behaviour, Hallucination, AuditoryThese side effects may potentially be related to Oxcarbazepine. The patient was hospitalized.
Oxcarbazepine Side Effect Report#9528202
Septic Shock, Diarrhoea
This is a report of a 1.-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: convulsion, who was treated with Oxcarbazepine (dosage: 1 Ml, Bid, start time: NS), combined with:
  • Amato (25 Mg, Bid)
  • Diazepam (5 Mg, Bid)
and developed a serious reaction and side effect(s): Septic Shock, Diarrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oxcarbazepine treatment in female patients, resulting in Septic Shock side effect.


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The appearance of Oxcarbazepine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Oxcarbazepine Side Effects for Women?

Women Side Effects Reports
Convulsion 77
Product Substitution Issue 31
Nausea 24
Headache 23
Vomiting 21
Hyponatraemia 20
Condition Aggravated 18
Diplopia 18
Dizziness 18
Confusional State 16

What are common Oxcarbazepine Side Effects for Men?

Men Side Effects Reports
Convulsion 74
Hyponatraemia 41
Product Substitution Issue 29
Dizziness 16
Rash 12
Somnolence 12
Condition Aggravated 11
Agitation 10
Confusional State 10
Pyrexia 10

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Oxcarbazepine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Oxcarbazepine Side Effects

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    Oxcarbazepine Safety Alerts, Active Ingredients, Usage Information

    NDC 0054-0097
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Oxcarbazepine
    Name Oxcarbazepine
    Dosage Form TABLET
    Route ORAL
    On market since 20071009
    Labeler Roxane Laboratories, Inc
    Active Ingredient(s) OXCARBAZEPINE
    Strength(s) 150
    Unit(s) mg/1
    Pharma Class Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]

    Oxcarbazepine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 680

    Oxcarbazepine safety alerts: 2013 2005

    Reported deaths: 69

    Reported hospitalizations: 195

    Trileptal (oxcarbazepine) Tablets and Oral Solution

    Audience: Neuropsychiatric healthcare professionals and consumers

    Novartis Pharmaceuticals and FDA notified healthcare professionals about revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for TRILEPTAL (oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated WARNINGS section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.

    [April 18, 2005 - Dear Healthcare Professional Letter - Novartis]
    [March 2005 - Label - FDA]

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