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Trileptal (Oxcarbazepine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Most Common Adverse Events in All Clinical Studies

Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs:   The most commonly observed (≥5%) adverse experiences seen in association with Trileptal® (oxcarbazepine) and substantially more frequent than in placebo-treated patients were: Dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait.

Approximately 23% of these 1,537 adult patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Dizziness (6.4%), diplopia (5.9%), ataxia (5.2%), vomiting (5.1%), nausea (4.9%), somnolence (3.8%), headache (2.9%), fatigue (2.1%), abnormal vision (2.1%), tremor (1.8%), abnormal gait (1.7%), rash (1.4%), hyponatremia (1.0%).

Monotherapy in Adults Not Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those in previously treated patients.

Approximately 9% of these 295 adult patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Dizziness (1.7%), nausea (1.7%), rash (1.7%), headache (1.4%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 4 Years Old and Above Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those seen in adults.

Approximately 11% of these 456 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Somnolence (2.4%), vomiting (2.0%), ataxia (1.8%), diplopia (1.3%), dizziness (1.3%), fatigue (1.1%), nystagmus (1.1%).

Monotherapy in Pediatric Patients 4 Years Old and Above Not Previously Treated with othe r AEDs :   The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those in adults.

Approximately 9.2% of 152 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated (≥1%) with discontinuation were rash (5.3%) and maculopapular rash (1.3%).

Adjunctive Therapy/Monotherapy in Pediatric Patients 1 Month to <4 Years Old Previously Treated or Not Previously Treated with other AEDs: The most commonly observed (≥5%) adverse experiences seen in association with Trileptal in these patients were similar to those seen in older children and adults except for infections and infestations which were more frequently seen in these younger children.

Approximately 11% of these 241 pediatric patients discontinued treatment because of an adverse experience. The adverse experiences most commonly associated with discontinuation were: Convulsions (3.7%), status epilepticus (1.2%), and ataxia (1.2%).

Incidence in Controlled Clinical Studies: The prescriber should be aware that the figures in Tables4, 5, 6 and 7 cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and nondrug factors to the adverse event incidences in the population studied.

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated with other AEDs: Table 4 lists treatment-emergent signs and symptoms that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of Trileptal. Table 5 lists treatment-emergent signs and symptoms in patients converted from other AEDs to either high dose Trileptal or low dose (300 mg) Trileptal. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables.

Table4: Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Adjunctive Therapy in Adults (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal® and Numerically More Frequent Than in the Placebo Group)
Oxcarbazepine Dosage (mg/day)
Body System/
Adverse Event
OXC 600
N=163

%
OXC 1200
N=171

%
OXC 2400
N=126

%
Placebo
N=166

%
Body as a Whole
      Fatigue1512157
      Asthenia6365
      Edema Legs2121
      Weight Increase1221
      Feeling Abnormal0120
Cardiovascular System
      Hypotension0120
Digestive System
      Nausea15252910
      Vomiting1325365
      Pain Abdominal1013115
      Diarrhea5676
      Dyspepsia5562
      Constipation2264
      Gastritis2121
Metabolic and Nutritional Disorders
      Hyponatremia3121
Musculoskeletal System
      Muscle Weakness1220
      Sprains and Strains0221
Nervous System
      Headache32282623
      Dizziness26324913
      Somnolence20283612
      Ataxia917315
      Nystagmus720265
      Gait Abnormal510171
      Insomnia4231
      Tremor38165
      Nervousness2421
      Agitation1121
      Coordination Abnormal1321
      EEG Abnormal0020
      Speech Disorder1130
      Confusion1121
      Cranial Injury NOS1021
      Dysmetria1230
      Thinking Abnormal0240
Respiratory System
      Rhinitis2454
Skin and Appendages
      Acne1220
Special Senses
      Diplopia1430405
      Vertigo612152
      Vision Abnormal614134
      Accommodation Abnormal0020
Table5: Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Monotherapy in Adults Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with 2400 mg/day of Trileptal® and Numerically More Frequent Than in the Low Dose Control Group)
Oxcarbazepine Dosage (mg/day)
Body System/
Adverse Event
2400
N=86

%
300
N=86

%
Body as a Whole
      Fatigue215
      Fever30
      Allergy20
      Edema Generalized21
      Pain Chest20
Digestive System
      Nausea227
      Vomiting155
      Diarrhea75
      Dyspepsia61
      Anorexia53
      Pain Abdominal53
      Mouth Dry30
      Hemorrhage Rectum20
      Toothache21
Hemic and Lymphatic System
      Lymphadenopathy20
Infections and Infestations
      Infection Viral75
      Infection20
Metabolic and Nutritional Disorders
      Hyponatremia50
      Thirst20
Nervous System
      Headache3115
      Dizziness288
      Somnolence195
      Anxiety75
      Ataxia71
      Confusion70
      Nervousness70
      Insomnia63
      Tremor63
      Amnesia51
      Convulsions Aggravated52
      Emotional Lability32
      Hypoesthesia31
      Coordination Abnormal21
      Nystagmus20
      Speech Disorder20
Respiratory System
      Upper Respiratory Tract Infection105
      Coughing50
      Bronchitis30
      Pharyngitis30
Skin and Appendages
      Hot Flushes21
      Purpura20
Special Senses
      Vision Abnormal142
      Diplopia121
      Taste Perversion50
      Vertigo30
      Earache21
      Ear Infection NOS20
Urogenital and Reproductive System
      Urinary Tract Infection51
      Micturition Frequency21
      Vaginitis20

Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with other AEDs: Table 6 lists treatment-emergent signs and symptoms in a controlled clinical study of monotherapy in adults not previously treated with other AEDs that occurred in at least 2% of adult patients with epilepsy treated with Trileptal or placebo and were numerically more common in the patients treated with Trileptal.

Table6: Treatment-Emergent Adverse Event Incidence in a Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal® and Numerically More Frequent Than in the Placebo Group)
Body System/
Adverse Event
Oxcarbazepine
N=55

%
Placebo
N=49

%
Body as a Whole
      Falling Down NOS40
Digestive System
      Nausea1612
      Diarrhea72
      Vomiting76
      Constipation50
      Dyspepsia54
Musculoskeletal System
      Pain Back42
Nervous System
      Dizziness226
      Headache1310
      Ataxia50
      Nervousness52
      Amnesia42
      Coordination Abnormal42
      Tremor40
Respiratory System
      Upper Respiratory Tract Infection70
      Epistaxis40
      Infection Chest40
      Sinusitis42
Skin and Appendages
      Rash42
Special Senses
      Vision Abnormal40

Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with other AEDs:   Table 7 lists treatment-emergent signs and symptoms that occurred in at least 2% of pediatric patients with epilepsy treated with Trileptal or placebo as adjunctive treatment and were numerically more common in the patients treated with Trileptal.

Table7: Treatment-Emergent Adverse Event Incidence in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients Previously Treated with Other AEDs (Events in at Least 2% of Patients Treated with Trileptal® and Numerically More Frequent Than in the Placebo Group)
Body System/
Adverse Event
Oxcarbazepine
N=171
%
Placebo
N=139
%
Body as a Whole
      Fatigue139
      Allergy20
      Asthenia21
Digestive System
      Vomiting3314
      Nausea195
      Constipation41
      Dyspepsia20
Nervous System
      Headache3119
      Somnolence3113
      Dizziness288
      Ataxia134
      Nystagmus91
      Emotional Lability84
      Gait Abnormal83
      Tremor64
      Speech Disorder31
      Concentration Impaired21
      Convulsions21
      Muscle Contractions Involuntary21
Respiratory System
      Rhinitis109
      Pneumonia21
Skin and Appendages
      Bruising42
      Sweating Increased30
Special Senses
      Diplopia171
      Vision Abnormal131
      Vertigo20

Other Events Observed in Association with the Administration of Trileptal

In the paragraphs that follow, the adverse events, other than those in the preceding tables or text, that occurred in a total of 565 children and 1,574 adults exposed to Trileptal and that are reasonably likely to be related to drug use are presented. Events common in the population, events reflecting chronic illness and events likely to reflect concomitant illness are omitted particularly if minor. They are listed in order of decreasing frequency. Because the reports cite events observed in open label and uncontrolled trials, the role of Trileptal in their causation cannot be reliably determined.

Body as a Whole:   Fever, malaise, pain chest precordial, rigors, weight decrease.

Cardiovascular System:   Bradycardia, cardiac failure, cerebral hemorrhage, hypertension, hypotension postural, palpitation, syncope, tachycardia.

Digestive System:   Appetite increased, blood in stool, cholelithiasis, colitis, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, mouth dry, pain biliary, pain right hypochondrium, retching, sialoadenitis, stomatitis, stomatitis ulcerative.

Hemic and Lymphatic System:   Leukopenia, thrombocytopenia.

Laboratory Abnormality:   Gamma-GT increased, hyperglycemia, hypocalcemia, hypoglycemia, hypokalemia, liver enzymes elevated, serum transaminase increased.

Musculoskeletal System:   Hypertonia muscle.

Nervous System:   Aggressive reaction, amnesia, anguish, anxiety, apathy, aphasia, aura, convulsions aggravated, delirium, delusion, depressed level of consciousness, dysphonia, dystonia, emotional lability, euphoria, extrapyramidal disorder, feeling drunk, hemiplegia, hyperkinesia, hyperreflexia, hypoesthesia, hypokinesia, hyporeflexia, hypotonia, hysteria, libido decreased, libido increased, manic reaction, migraine, muscle contractions involuntary, nervousness, neuralgia, oculogyric crisis, panic disorder, paralysis, paroniria, personality disorder, psychosis, ptosis, stupor, tetany.

Respiratory System:   Asthma, dyspnea, epistaxis, laryngismus, pleurisy.

Skin and Appendages:   Acne, alopecia, angioedema, bruising, dermatitis contact, eczema, facial rash, flushing, folliculitis, heat rash, hot flushes, photosensitivity reaction, pruritus genital, psoriasis, purpura, rash erythematous, rash maculopapular, vitiligo, urticaria.

Special Senses:   Accommodation abnormal, cataract, conjunctival hemorrhage, edema eye, hemianopia, mydriasis, otitis externa, photophobia, scotoma, taste perversion, tinnitus, xerophthalmia.

Surgical and Medical Procedures:   Procedure dental oral, procedure female reproductive, procedure musculoskeletal, procedure skin.

Urogenital and Reproductive System:    Dysuria, hematuria, intermenstrual bleeding, leukorrhea, menorrhagia, micturition frequency, pain renal, pain urinary tract, polyuria, priapism, renal calculus.

Other:   Systemic lupus erythematosus.

Post-Marketing and Other Experience

The following adverse events not seen in controlled clinical trials have been observed in named patient programs or post-marketing experience:

Body as a Whole: Multi-organ hypersensitivity disorders characterized by features such as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia and arthralgia (see PRECAUTIONS, Multi-Organ Hypersensitivity subsection).

Anaphylaxis (see WARNINGS, Anaphylactic Reactions and Angioedema subsection).

Skin and Appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (see WARNINGS, Serious Dermatological Reactions subsection).



REPORTS OF SUSPECTED TRILEPTAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Trileptal. The information is not vetted and should not be considered as verified clinical evidence.

Possible Trileptal side effects / adverse reactions in 41 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 41 year old male

Reactions: Anxiety, Therapeutic Response Decreased, Rhinorrhoea, Cerebrovascular Accident, Somnolence, Suicidal Ideation

Adverse event resulted in: hospitalization

Suspect drug(s):
Trileptal
    Dosage: unk ukn, unk
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Oxcarbazepine
    Dosage: unk ukn, unk

Other drugs received by patient: Loratadine; Nexium



Possible Trileptal side effects / adverse reactions in 51 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 51 year old female weighing 44.5 kg (97.8 pounds)

Reactions: Intervertebral Disc Protrusion, Bartholin's Cyst, Excoriation, Drug Ineffective, Urinary Tract Infection, Neck Injury, Laceration, Headache, Grand MAL Convulsion, Neck Pain, Dermal Cyst, Kidney Infection

Adverse event resulted in: hospitalization

Suspect drug(s):
Trileptal
    Dosage: 150 mg;bid
    Indication: Bipolar Disorder

Fentanyl
    Dosage: 1 patch;q72h;tder
    Indication: Pain
    Start date: 2009-01-01

Other drugs received by patient: Calcium Carbonate; Folic Acid; Adderall 5; Cymbalta; Dilantin; Women's 50+ Multivitamin; Nexium; Clonazepam; Promethazine; Unknown Muscle Relaxant; Lortab; Ropinirole; Cyclobenzaprine; Provigil



Possible Trileptal side effects / adverse reactions in 84 year old female

Reported by a physician from Costa Rica on 2011-10-04

Patient: 84 year old female

Reactions: Hypotension, Hypocalcaemia, Cerebellar Ataxia, Hyponatraemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Trileptal

Other drugs received by patient: Enalapril Maleate; Akatinol; Hydrochlorothiazide



See index of all Trileptal side effect reports >>

Drug label data at the top of this Page last updated: 2009-05-08

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