The most commonly reported adverse effects, which occur in >10% of patients, are drowsiness, headache, dizziness, diplopia, nausea, vomiting and feeling of weakness.
In clinical trials, adverse effects were for the most part mild to moderately severe and were transient, occuring primarily at the start of treatment.
The assessment of the adverse effect profile for each body system is based on the adverse events ascribed to Trileptal in clinical trials. Clinically significant reports from the post-marketing phase have also been taken into account.
Estimated Frequency in Accordance with CIOMS III Classification: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to <1/1000), very rare (<1/10,000).
Blood and Lymphatic System Disorders:
Uncommon: Leucopenia. Very Rare: Thrombocytopenia.
Metabolic and Nutritional Disturbances:
Common: Hyponatremia under special clinical circumstances, and more frequently in elderly patients (see Precautions).
In very rare cases, clinically significant hyponatremia (Na <125 mmol/L) may develop in patients being treated with Trileptal. It has usually occurred during the 1st 3 months, but there have been patients whose serum sodium levels did not fall <125 mmol/L until >1 year after the start of treatment (see Precautions). There have also been reports of symptomatic hyponatremia with seizures, disorientation, reduced perception, encephalopathy (see also Nervous System Disorders as follows), visual disturbances (eg, blurred vision), vomiting, nausea and folic acid deficiency.
Under special clinical circumstances, a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) may occur during treatment with Trileptal (see Precautions).
Common: Confusional state, depression, apathy, restlessness (eg, nervousness), affect lability.
Nervous System Disorders:
Very Common: Drowsiness (22.5%), headache (14.6%), lightheadedness (22.6%), dizziness (22.6%). Common: Ataxia, tremor, nystagmus, disturbances in attention, disturbances in memory.
Very Common: Diplopia (13.9%). Common: Blurred vision, disturbances of vision.
Very Rare: Arrhythmia, atrioventricular block.
Very Common: Nausea (14.1%), vomiting (11.1%). Common: Diarrhoea, constipation, abdominal pain. Very Rare: Pancreatitis and/or increase in lipase and/or amylase.
Uncommon: Elevated levels of transaminases and/or alkaline phosphatase. Very Rare: Hepatitis (see Precautions).
Common: Exanthema, alopecia and acne. Uncommon: Urticaria. Very rare: Angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis (drug-induced Lyell's syndrome) and erythema multiforme.
Very Common: Fatigue (12%). Common: Asthenia.
Very Common: Feeling of weakness (12%). Very Rare: Systemic lupus erythematosus, hypersensitivity (including multi-organ hypersensitivity) characterized by rash, fever. Other organs or systems may be affected eg, blood and lymphatic system (eg, eosinophilia, thrombocytopenia, leucopenia, lymphadenopathy, splenomegaly), liver (eg, abnormal liver function tests, hepatitis), muscles and joints (eg, joint swelling, myalgia, arthralgia), nervous system (eg, hepatic encephalopathy), kidney (eg, proteinuria, interstitial nephritis, renal failure), lungs (eg, dyspnea, pulmonary edema, asthma, bronchospasms, interstitial lung disease); angioedema and anaphylactic reactions (see Precautions).
In clinical studies in children aged from 1 month to <4 years, the most frequently reported adverse effect was drowsiness, which occurred in approximately 11% of patients. Adverse effects occurring with a frequency of ≥1% to <10% (common) were ataxia, excitation, vomiting, lethargy, fatigue, nystagmus, tremor, decreased appetite and increased blood uric acid.
Adverse Drug Reactions from Spontaneous Reports and Literature Cases (Frequency Not Known):
The following adverse drug reactions have been derived from post-marketing experience with Trileptal via spontaneous case reports and literature cases. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known. Adverse drug reactions are listed according to system organ classes in MedDRA. Within each system organ class, ADRs are presented in order of decreasing seriousness.
Immune System Disorders:
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Skin and Subcutaneous Tissue Disorders:
Acute Generalized Exanthematous Pustulosis (AGEP).
Musculoskeletal, Connective Tissue and Bone Disorders:
There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with Trileptal. The mechanism by which oxcarbazepine affects bone metabolism has not been identified.