The most frequently reported adverse reactions were drowsiness, headache, dizziness, diplopia, nausea, vomiting, fatigue (more than 10% of patients).
In clinical studies, it has been shown that unwanted reactions are usually mild or moderate, are transient in nature and are observed mainly at the beginning of therapy.
The data below summarize the information on undesirable reactions (HP), registered during clinical trials, as well as data on the safety profile of the drug, obtained during its application in clinical practice. HP grouped in accordance with the classification of organs and systems of organs MedDRA, while listed in order of decreasing their importance. Criteria for assessing the incidence of adverse reactions: "very often" - ≥1/10, "often" - ≥1/100 - <1/10, "infrequently" - ≥1/1000 - <1/100, "rarely" - ≥1/10 000 - <1/1000, "very rarely" - <1/10 000 (including individual messages).
Violations from the blood and lymphatic system: infrequently, leukopenia; very rarely - suppression of bone marrow hematopoiesis, aplastic anemia, agranulocytosis, pancytopenia, thrombocytopenia, neutropenia.
Immune system disorders: very rarely - anaphylactic reactions, reactions, hypersensitivity (including reactions of multi-organ hypersensitivity), which are characterized by such phenomena as rash and fever. Possible damage to the circulatory and lymphatic systems (eosinophilia, thrombocytopenia, leukopenia, lymphadenopathy, splenomegaly), liver (hepatitis, changes in liver function),damage muscles and joints (myalgia, swelling in the joints, arthralgia), nervous system (hepatic encephalopathy), kidney (renal failure, interstitial nephritis, proteinuria), lungs (pulmonary edema, bronchospasm, bronchial asthma, interstitial inflammation, dyspnea), angioneurotic edema.
Disorders from the endocrine system: very rarely - hypothyroidism.
Disorders from the metabolism and nutrition: often - hyponatremia (more often observed in patients aged> 65 years); very rarely - clinically significant hyponatremia (sodium concentration <125 mmol / l) - as a rule, during the first 3 months of therapy with the drug; in some patients - more than 1 year after the start of treatment with Trileptal ®. This condition can lead to the development of such manifestations and symptoms as convulsive attacks, encephalopathy, decreased level of consciousness, confusion, visual impairment (including blurred vision), hypothyroidism, vomiting, nausea, folic acid deficiency.
Disorders of the psyche: often - agitation (including nervousness), emotional lability, confusion, depression, apathy.
Disturbances from the nervous system: very often - drowsiness (22.5%), headache (14.6%), dizziness (22.6%); often - ataxia, tremor, nystagmus, attention disturbance, amnesia.
Disturbances on the part of the organ of sight: very often - diplopia (13.9%); often - blurred vision, visual impairment.
Hearing disorders and labyrinthine disorders: often - systemic dizziness.
Heart Disease: very rarely - atrioventricular blockade, arrhythmias.
Vascular disorders: very rarely - hypertension.
Disorders from the gastrointestinal tract: very often - vomiting (11.1%), nausea (14.1%); often - diarrhea, abdominal pain, constipation; very rarely - pancreatitis.
Disturbances from the liver and bile ducts: very rarely - hepatitis.
Disturbances from the skin and subcutaneous tissues: often - rash, alopecia, acne; infrequently - hives; very rarely Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome caused by medication), angioedema, erythema multiforme, systemic lupus erythematosus.
General disorders and disorders at the site of administration: very often - a feeling of fatigue (12%); often - asthenia.
Laboratory and instrumental data: infrequently - increased activity "hepatic" enzymes, alkaline phosphatase; very rarely - increased activity of amylase, lipase.
In clinical studies conducted in children aged 1 month to 4 years, the most frequently observed drowsiness (in 11% of patients). With frequency ≥1% - <10% (often) there were ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremor, decreased appetite, increased concentration of uric acid in the blood.
Undesirable reactions identified in the postmarketing period on the basis of individual reports and cases described in the literature
Since the data on unwanted reactions in the postmarketing period were obtained on the basis of voluntary reports from a population of unknown numbers, it is impossible to estimate the frequency of their occurrence (the frequency is unknown). Undesirable reactions are classified according to organ systems, within each organ system, unwanted reactions are arranged in order of decreasing severity of their manifestation.
Disturbances from the skin and subcutaneous tissues
Drug rash with eosinophilia and systemic manifestations, acute generalized exanthematous pustulosis.
Disturbances from musculoskeletal and connective tissue
There have been reports of a decrease in bone mineral density, the detection of osteopenia, osteoporosis and fractures in patients receiving long-term treatment with Trileptal®. The mechanism of influence of oxcarbazepine on the metabolism of bone tissue is not clear.
Disorders from the metabolism and nutrition
Syndrome of inadequate secretion of antidiuretic hormone, manifested by lethargy, nausea, dizziness, decreased osmolality of the blood plasma, vomiting, headache, confusion and other symptoms from the nervous system.
Trauma, intoxication and complications of manipulation
A fall.
Disturbances from the nervous system
Violations of speech (including dysarthria), especially during the selection of a dose.