Summary of the safety profile: The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea, vomiting and fatigue occurring in more than 10% of patients.
The safety profile is based on AEs from clinical trials assessed as related to Oxcarbazepine. In addition, clinically meaningful reports on adverse experiences from named patient programs and postmarketing experience were taken into account.
Adverse reactions are listed by MedDRA system organ class.
List of adverse reactions: Frequency estimate*: very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1 /100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000; unknown: cannot be estimated from the available data.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders: Uncommon: Leucopenia.
Very rare: Thrombocytopenia.
Unknown: Bone marrow depression, aplastic anemia, agranulocytosis, pancytopenia, neutropenia.
Immune system disorders: Very rare: Hypersensitivity#.
Unknown: Anaphylactic reactions.
Endocrine disorders: Common: Weight increased.
Metabolism and nutrition disorders: Common: Hyponatraemia†.
Unknown: Inappropriate ADH secretion like syndrome with signs and symptoms of lethargy, nausea, dizziness, decrease in serum (blood) osmolality, vomiting, headache, confusional state or other neurological signs and symptoms.
Psychiatric disorders: Common: Agitation (e.g. nervousness), affect lability, confusional state, depression, apathy..
Nervous system disorders: Very common: Somnolence, headache, dizziness.
Common: Ataxia, tremor, nystagmus, disturbance in attention, amnesia.
Unknown: Speech disorders (including dysarthria); more frequent during up titration of Oxcarbazepine dose.
Eye disorders: Very common: Diplopia.
Common: Vision blurred, visual disturbance.
Ear and labyrinth disorders: Common: Vertigo.
Cardiac disorders: Very rare: Atrioventricular block, arrhythmia.
Vascular disorders: Unknown: Hypertension.
Gastrointestinal disorders: Very common: Vomiting, nausea.
Common: Diarrhoea, abdominal pain, constipation.
Very rare: Pancreatitis and/or lipase and/or amylase increase.
Hepato-biliary disorders: Very rare: Hepatitis.
Skin and subcutaneous tissue disorders: Common: Rash, alopecia, acne.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema, erythema multiforme (see Precautions).
Unknown: Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)**, Acute Generalized Exanthematous Pustulosis (AGEP)**.
Musculoskeletal, connective tissue and bone disorders: Very rare: Systemic lupus erythematosus.
Unknown: There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with Oxcarbazepine. The mechanism by which Oxcarbazepine affects bone metabolism has not been identified.
General disorders and administration site conditions: Very common: Fatigue.
Investigations: Uncommon: Hepatic enzymes increased, blood alkaline phosphatase increased.
Unknown: Decrease in T4 (with unclear clinical significance).
Injury, poisoning and procedural complications: Unknown: Fall.
Description of selected adverse reactions: #Hypersensitivity (including multi-organ hypersensitivity) characterised by features such as rash, fever. Other organs or systems may be affected such as blood and lymphatic system (e.g. eosinophilia, thrombocytopenia, leucopenia, lymphadenopathy, splenomegaly), liver (e.g. hepatitis, abnormal liver function tests), muscles and joints (e.g. joint swelling, myalgia, arthralgia), nervous system (e.g. hepatic encephalopathy), kidneys (e.g. renal failure, nephritis interstitial, proteinuria), lungs (e.g. pulmonary oedema, asthma, bronchospasms, interstitial lung disease, dyspnea), angioedema.
†Serum sodium levels below 125 mmol/l have been observed in up to 2.7 % of oxcarbazepine treated patients with frequency common. In most cases, the hyponatraemia is asymptomatic and does not require adjustment of therapy.
Very rarely, the hyponatraemia is associated with signs and symptoms such as seizures, encephalopathy, depressed level of consciousness, confusion, (see also Nervous system disorders as previously mentioned for further undesirable effects), vision disorders (e.g. blurred vision), hypothyroidism, vomiting, and nausea can develop during oxcarbazepine use. Low serum sodium levels generally occurred during the first 3 months of treatment with oxcarbazepine, although there were patients who first developed a serum sodium level <125 mmol/l more than 1 year after initiation of therapy.
**Adverse reactions from spontaneous reports and literature cases (frequency not known): The following adverse reactions have been derived from post-marketing experience with oxcarbazepine 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 categorised as not known.
Pediatric population: Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.