DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Trileptal (Oxcarbazepine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

Most Common Adverse Reactions in All Clinical Studies

Adjunctive Therapy/ Monotherapy in Adults Previously Treated with other AEDs: The most commonly observed (≥5%) adverse reactions seen in association with Trileptal 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 reactions 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 reactions 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 reactions 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 reactions 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 reactions 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 other AEDs : The most commonly observed (≥5%) adverse reactions 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 reactions 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 reactions 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 reaction 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 Tables 3, 4, 5 and 6 cannot be used to predict the frequency of adverse reactions 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 3 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 4 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.

Table 3  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
      Fatigue 15 12 15 7
      Asthenia 6 3 6 5
      Edema Legs 2 1 2 1
      Weight Increase 1 2 2 1
      Feeling Abnormal 0 1 2 0
Cardiovascular System
      Hypotension 0 1 2 0
Digestive System
      Nausea 15 25 29 10
      Vomiting 13 25 36 5
      Pain Abdominal 10 13 11 5
      Diarrhea 5 6 7 6
      Dyspepsia 5 5 6 2
      Constipation 2 2 6 4
      Gastritis 2 1 2 1
Metabolic and Nutritional Disorders
      Hyponatremia 3 1 2 1
Musculoskeletal System
      Muscle Weakness 1 2 2 0
      Sprains and Strains 0 2 2 1
Nervous System
      Headache 32 28 26 23
      Dizziness 26 32 49 13
      Somnolence 20 28 36 12
      Ataxia 9 17 31 5
      Nystagmus 7 20 26 5
      Gait Abnormal 5 10 17 1
      Insomnia 4 2 3 1
      Tremor 3 8 16 5
      Nervousness 2 4 2 1
      Agitation 1 1 2 1
      Coordination Abnormal 1 3 2 1
      EEG Abnormal 0 0 2 0
      Speech Disorder 1 1 3 0
      Confusion 1 1 2 1
      Cranial Injury NOS 1 0 2 1
      Dysmetria 1 2 3 0
      Thinking Abnormal 0 2 4 0
Respiratory System
      Rhinitis 2 4 5 4
Skin and Appendages
      Acne 1 2 2 0
Special   Senses
      Diplopia 14 30 40 5
      Vertigo 6 12 15 2
      Vision Abnormal 6 14 13 4
      Accommodation Abnormal 0 0 2 0
Table 4  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
      Fatigue 21 5
      Fever 3 0
      Allergy 2 0
      Edema Generalized 2 1
      Pain Chest 2 0
Digestive System
      Nausea 22 7
      Vomiting 15 5
      Diarrhea 7 5
      Dyspepsia 6 1
      Anorexia 5 3
      Pain Abdominal 5 3
      Mouth Dry 3 0
      Hemorrhage Rectum 2 0
      Toothache 2 1
Hemic and Lymphatic System
      Lymphadenopathy 2 0
Infections and Infestations
      Infection Viral 7 5
      Infection 2 0
Metabolic and Nutritional Disorders
      Hyponatremia 5 0
      Thirst 2 0
Nervous System
      Headache 31 15
      Dizziness 28 8
      Somnolence 19 5
      Anxiety 7 5
      Ataxia 7 1
      Confusion 7 0
      Nervousness 7 0
      Insomnia 6 3
      Tremor 6 3
      Amnesia 5 1
      Convulsions Aggravated 5 2
      Emotional Lability 3 2
      Hypoesthesia 3 1
      Coordination Abnormal 2 1
      Nystagmus 2 0
      Speech Disorder 2 0
Respiratory System
Upper Respiratory Tract Infection 10 5
      Coughing 5 0
      Bronchitis 3 0
      Pharyngitis 3 0
Skin and Appendages
      Hot Flushes 2 1
      Purpura 2 0
Special Senses
      Vision Abnormal 14 2
      Diplopia 12 1
      Taste Perversion 5 0
      Vertigo 3 0
      Earache 2 1
      Ear Infection NOS 2 0
Urogenital and Reproductive System
      Urinary Tract Infection 5 1
      Micturition Frequency 2 1
      Vaginitis 2 0

Controlled Clinical Study of Monotherapy in Adults Not Previously Treated with other AEDs: Table 5 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.

Table 5  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 NOS 4 0
Digestive System
      Nausea 16 12
      Diarrhea 7 2
      Vomiting 7 6
      Constipation 5 0
      Dyspepsia 5 4
Musculoskeletal System
      Pain Back 4 2
Nervous System
      Dizziness 22 6
      Headache 13 10
      Ataxia 5 0
      Nervousness 5 2
      Amnesia 4 2
      Coordination Abnormal 4 2
      Tremor 4 0
Respiratory System
Upper Respiratory Tract Infection 7 0
      Epistaxis 4 0
      Infection Chest 4 0
      Sinusitis 4 2
Skin and Appendages
      Rash 4 2
Special Senses
      Vision Abnormal 4 0

Controlled Clinical Studies of Adjunctive Therapy/ Monotherapy in Pediatric Patients Previously Treated with other AEDs: Table 6 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.

Table 6  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
      Fatigue 13 9
      Allergy 2 0
      Asthenia 2 1
Digestive System
      Vomiting 33 14
      Nausea 19 5
      Constipation 4 1
      Dyspepsia 2 0
Nervous System
      Headache 31 19
      Somnolence 31 13
      Dizziness 28 8
      Ataxia 13 4
      Nystagmus 9 1
      Emotional Lability 8 4
      Gait Abnormal 8 3
      Tremor 6 4
      Speech Disorder 3 1
      Concentration Impaired 2 1
      Convulsions 2 1
Muscle Contractions Involuntary 2 1
Respiratory System
      Rhinitis 10 9
      Pneumonia 2 1
Skin and Appendages
      Bruising 4 2
      Sweating Increased 3 0
Special Senses
      Diplopia 17 1
      Vision Abnormal 13 1
      Vertigo 2 0

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.

Hematologic and Lymphatic System: 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 Warnings and Precautions (5.8)]

Anaphylaxis : [see Warnings and Precautions (5.2)]

Digestive System: pancreatitis and/or lipase and/or amylase increase

Hem atolog ic and Lymphatic System s : aplastic anemia [see Warnings and Precautions (5.9)]

Skin and Appendages:  erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [see Warnings and Precautions (5.4)]



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: 2011-03-17

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015