Oxcarbazepine Side Effects

Brand Names: Trileptal

Please note - some side effects for Oxcarbazepine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Oxcarbazepine - for the Consumer

Oxcarbazepine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oxcarbazepine:

Constipation; diarrhea; dizziness; drowsiness; headache; indigestion; mild stomach pain; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxcarbazepine:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, or tongue; unusual hoarseness); blood in the stool; chest pain; decreased coordination; decreased urination; difficulty concentrating or speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint or muscle pain, swelling, or weakness; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, behavior changes, suicidal thoughts or actions); new or worsening seizures; nosebleed; painful sores in the mouth or around the eyes; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; shortness of breath; swollen lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of low sodium levels (nausea, general body discomfort, headache, lack of energy, confusion, decreased consciousness, increased frequency or severity of seizures); tremor; trouble sleeping; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Oxcarbazepine Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oxcarbazepine Suspension:

Constipation; diarrhea; dizziness; drowsiness; headache; indigestion; mild stomach pain; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxcarbazepine Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, or tongue; unusual hoarseness); blood in stool; chest pain; decreased coordination; decreased urination; difficulty concentrating or speaking; double vision, changes in vision, or involuntary eye movement; dulled sense of touch; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint or muscle pain, swelling, or weakness; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, behavior changes, suicidal thoughts or actions); new or worsening seizures; nosebleed; painful sores in the mouth or around the eyes; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; shortness of breath; swollen lymph nodes; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of low sodium levels (nausea, general body discomfort, headache, lack of energy, confusion, decreased consciousness, increased frequency or severity of seizures); tremor; trouble sleeping; trouble walking; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Oxcarbazepine Side Effects - for the Professional

Oxcarbazepine

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 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 Oxcarbazepine 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 Oxcarbazepine 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 other AEDs

The most commonly observed (≥5%) adverse experiences seen in association with Oxcarbazepine 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 Oxcarbazepine 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 Tables 4, 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 Oxcarbazepine or placebo as adjunctive treatment and were numerically more common in the patients treated with any dose of Oxcarbazepine. Table 5 lists treatment-emergent signs and symptoms in patients converted from other AEDs to either high dose Oxcarbazepine or low dose (300 mg) Oxcarbazepine. Note that in some of these monotherapy studies patients who dropped out during a preliminary tolerability phase are not included in the tables.

Table 4: 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 Oxcarbazepine 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 5: 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 Oxcarbazepine 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 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 Oxcarbazepine or placebo and were numerically more common in the patients treated with Oxcarbazepine.

Table 6: 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 Oxcarbazepine 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 7 lists treatment-emergent signs and symptoms that occurred in at least 2% of pediatric patients with epilepsy treated with Oxcarbazepine or placebo as adjunctive treatment and were numerically more common in the patients treated with Oxcarbazepine.

Table 7: 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 Oxcarbazepine 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 Oxcarbazepine

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 Oxcarbazepine 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 Oxcarbazepine 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, dry mouth, duodenal ulcer, dysphagia, enteritis, eructation, esophagitis, flatulence, gastric ulcer, gingival bleeding, gum hyperplasia, hematemesis, hemorrhage rectum, hemorrhoids, hiccup, 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.

Anaphylaxis.

Digestive System: Pancreatitis and/or lipase and/or amylase increase.

Skin and Appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

The pattern of seizures following oxcarbazepine discontinuation suggests a rebound phenomenon rather than a loss of therapeutic efficacy.

Nervous system side effects have included dizziness (up to 49%), somnolence (up to 36%), headache (up to 32%), ataxia (up to 31%), nystagmus (up to 26%), abnormal gait (up to 17%), tremor (up to 16%), emotional lability (up to 8%), confusion (up to 7%), nervousness (up to 7%), anxiety (up to 7%), sedation (up to 6%), insomnia (up to 6%), amnesia (up to 5%), aggravated convulsions (up to 5%), abnormal thinking (up to 4%), abnormal coordination (up to 4%), tremor (up to 4%), hypoesthesia (up to 3%), speech disorder (up to 3%), dysmetria (up to 3%), abnormal coordination (up to 2%), confusion (up to 2%), cranial injury (up to 2%), agitation (up to 2%), impaired concentration (up to 2%), convulsions (up to 2%), and involuntary muscle contractions (up to 2%). Generalized tonic-clonic seizures following acute withdrawal have also been reported.

Dermatologic

Dermatologic side effects have included Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with oxcarbazepine use. The median time of onset for reported cases was 19 days. Rash (up to 4%), bruising (up to 4%), increased sweating (up to 3%), hot flushes (up to 2%), purpura (up to 2%), and acne (up to 2%) have also been reported.

These serious skin reactions may be life-threatening and some of the patients have required hospitalization with very rare reports of fatal outcome. Recurrence of the serious skin reactions following rechallenge with oxcarbazepine has also been reported. If a patient develops a skin rash while taking oxcarbazepine, consideration should be given to discontinuing oxcarbazepine and prescribing another antiepileptic medication.

General

Multi-organ hypersensitivity reactions are variable in expression and other organ system symptoms not noted may occur. If this reaction is suspected, oxcarbazepine should be discontinued and an alternative treatment should be started. Although there are no case reports to indicate cross sensitivity with other drugs that produce this syndrome, experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.

General side effects have included multi-organ hypersensitivity reactions that have been reported in close temporal association (median time to detection of 13 days) to the initiation of oxcarbazepine therapy in adult and pediatric patients. While there have been a limited number of reports, many of these cases resulted in hospitalization and some were considered life threatening. Signs and symptoms of this disorder were diverse. However, patients typically presented with fever and rash associated with organ system involvement. Other associated manifestations included lymphadenopathy, hepatitis, liver function test abnormalities, hematological abnormalities (including eosinophilia, thrombocytopenia, and neutropenia), pruritus, nephritis, oliguria, hepatorenal syndrome, arthralgia, and asthenia.

Fatigue (up to 21%), asthenia (up to 6%), falling down (up to 4%), fever (up to 3%), generalized edema (up to 2%), leg edema (up to 2%), allergy (up to 2%), increased weight (up to 2%), chest pain (up to 2%), and an abnormal feeling (up to 2%) have also been reported.

Ocular

Ocular side effects have included diplopia (up to 40%), abnormal vision (up to 14%), and abnormal accommodation (up to 2%).

Gastrointestinal

Gastrointestinal side effects have included vomiting (up to 36%), nausea (up to 29%), abdominal pain (up to 13%), diarrhea (up to 7%), dyspepsia (up to 6%), constipation (up to 6%), anorexia (up to 5%), dry mouth (up to 3%), gastritis (up to 2%), rectal hemorrhage (up to 2%), and toothache (up to 2%).

Other

Other side effects have included vertigo, taste perversion, earache, ear infection, pancreatitis and/or lipase and/or amylase increase, and folic acid deficiency.

Respiratory

Respiratory side effects have included upper respiratory tract infections (up to 10%), rhinitis (up to 10%), coughing (up to 5%), epistaxis (up to 4%), chest infection (4%), sinusitis (up to 4%), bronchitis (up to 3%), pharyngitis (up to 3%), and pneumonia (up to 2%).

Immunologic

Immunologic side effects have included viral infection (up to 7%) and infection (up to 2%).

Metabolic

Metabolic side effects have included hyponatremia (up to 23%) and thirst (up to 2%).

Genitourinary

Genitourinary side effects have included urinary tract infections (up to 5%), micturition frequency (up to 2%), and vaginitis (up to 2%).

Musculoskeletal

Musculoskeletal side effects have included back pain (up to 4%), muscle weakness (up to 2%), and sprains and strains (up to 2%).

Cardiovascular

Cardiovascular side effects have included hypotension (up to 2%).

Hematologic

Hematologic side effects have included lymphadenopathy (up to 2%). Hematologic side effects reported postmarketing have included bone marrow depression, agranulocytosis, aplastic anemia, pancytopenia,and neutropenia.

Endocrine

Endocrine side effects have included lower serum testosterone, lower free androgen indexes, and a high frequency of elevated levels of androstenedione.

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