eslicarbazepine acetate


EMA14



General information:


Withdrawn ID: EMA14
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): N03AF04
Molecular Formula: C17H16N2O3
Molweight: 296.326



Withdrawal information:


Withdrawn due to drug safety reasons:No



Side-effects:

Total reported cases (submitted by medical professionals) with eslicarbazepine acetate as primary suspect: 248


Reported final outcomes:
Hospitalization (initial or prolonged): 80
Life-Threatening condition: 15
Death: 11
Congenital anomaly: 5
Disability: 5


Reported side-effects:

Side-effect Case number
Seizure111
Off label use44
Hyponatraemia41
Drug ineffective32
Drug dose titration not performed22
Rash17
Dizziness16
Somnolence16
Pruritus13
Drug interaction12
Depression11
Nausea11
Suicidal ideation11
Generalised tonic-clonic seizure10
Overdose10
Anxiety9
Blood sodium decreased9
Dyspnoea9
Headache9
Vomiting9
Ataxia8
Drug reaction with eosinophilia and systemic symptoms8
Epilepsy8
Fatigue8
Leukopenia8
Agitation7
Confusional state7
Pain7
Balance disorder6
Condition aggravated6
Death6
Fall6
Gamma-glutamyltransferase increased6
Irritability6
Rash maculo-papular6
Bradycardia5
Inappropriate schedule of drug administration5
Insomnia5
Labelled drug-drug interaction medication error5
Loss of consciousness5
Malaise5
Neutropenia5
Partial seizures5
Product use in unapproved indication5
Simple partial seizures5
Swelling face5
Tremor5
Vertigo5
Abdominal pain4
Aggression4
Aphasia4
Cerebrovascular accident4
Cognitive disorder4
Decreased appetite4
Diplopia4
Gait disturbance4
Hyponatraemic seizure4
Paraesthesia4
Prescribed overdose4
Product dose omission issue4
Suicide attempt4
Thrombocytopenia4
Underdose4
Abortion spontaneous3
Amnesia3
Atrioventricular block complete3
Chills3
Cholestasis3
Congenital anomaly3
Coordination abnormal3
Disturbance in attention3
Dysphagia3
Memory impairment3
Nervousness3
No adverse event3
Peripheral swelling3
Petit mal epilepsy3
Product use issue3
Status epilepticus3
Tinnitus3
Toxic epidermal necrolysis3
Unresponsive to stimuli3
Vision blurred3
Weight fluctuation3
Weight increased3
Abnormal behaviour2
Anger2
Angioedema2
Asthenia2
Bradyphrenia2
Cardiac arrest2
Cardio-respiratory arrest2
Clumsiness2
Coma2
Convulsion2
Cough2
Cytopenia2
Delirium2
Dermatitis exfoliative2
Diarrhoea2
Drug dose omission2
Drug intolerance2
Eosinophilia2
Erythema2
Exposure during pregnancy2
Feeling abnormal2
Focal dyscognitive seizures2
Foetal exposure during pregnancy2
Hallucination2
Hallucination, auditory2
Hallucination, visual2
Hepatic cytolysis2
Hepatocellular injury2
Hypersensitivity2
Hypertonia2
Hypoaesthesia2
Hypochloraemia2
Hypokalaemia2
Lacrimation increased2
Liver function test abnormal2
Lymphadenopathy2
Mood altered2
Muscle rigidity2
Muscle twitching2
Myoclonus2
Neck pain2
Nocturia2
Pancreatitis2
Pancreatitis acute2
Pharyngeal oedema2
Pollakiuria2
Pregnancy2
Product dose omission2
Pulmonary embolism2
Pyrexia2
Road traffic accident2
Salivary hypersecretion2
Seizure cluster2
Skin lesion2
Sleep disorder2
Stress2
Sudden unexplained death in epilepsy2
Swelling2
Tachycardia2
Therapeutic product effect incomplete2
Therapy cessation2
Treatment noncompliance2
Urinary incontinence2
Wrong technique in product usage process2
Abdominal pain lower1
Accidental overdose1
Acne1
Acute pulmonary oedema1
Adams-Stokes syndrome1
Adrenal insufficiency1
Agranulocytosis1
Akathisia1
Alcohol withdrawal syndrome1
Alveolitis allergic1
Amylase increased1
Anaphylactic reaction1
Aneurysm1
Ankle fracture1
Anticonvulsant drug level below therapeutic1
Anticonvulsant drug level decreased1
Anticonvulsant drug level increased1
Anxiety disorder1
Aortic aneurysm rupture1
Arrhythmia1
Arthralgia1
Aspartate aminotransferase increased1
Asterixis1
Asthma1
Atonic seizures1
Attention deficit/hyperactivity disorder1
Back pain1
Behaviour disorder1
Blindness unilateral1
Blister1
Blood glucose increased1
Blood sodium increased1
Blood urea decreased1
Blood urea nitrogen/creatinine ratio decreased1
Bone marrow failure1
Bradyarrhythmia1
Brain operation1
Brief psychotic disorder, with postpartum onset1
C-reactive protein increased1
Cardiac failure1
Cerebellar atrophy1
Cerebellar syndrome1
Change of bowel habit1
Chest pain1
Choking sensation1
Clonus1
Completed suicide1
Complex partial seizures1
Conjoined twins1
Constipation1
Continuous haemodiafiltration1
Crying1
Cutaneous vasculitis1
Cyanosis1
Cytogenetic abnormality1
Cytotoxic lesions of corpus callosum1
Daydreaming1
Decreased interest1
Deep vein thrombosis1
Delusion1
Dementia1
Demyelination1
Dental caries1
Depressed level of consciousness1
Depressive symptom1
Dermatitis allergic1
Diabetes mellitus1
Disability1
Discomfort1
Dissociation1
Drowning1
Drug administration error1
Drug effective for unapproved indication1
Drug resistance1
Drug screen false positive1
Drug screen positive1
Dry mouth1
Dysarthria1
Dyspepsia1
Dysstasia1
Dysuria1
Ear discomfort1
Ear pain1
Eczema1
Electrocardiogram QT prolonged1
Enanthema1
Encephalopathy1
Endotracheal intubation1
Eosinophil count increased1
Erythema multiforme1
Extra dose administered1
Eye pain1
Eyelid ptosis1
Facial pain1
Faecaloma1
Family stress1
Feeling drunk1
Femoral neck fracture1
Flatulence1
Fluid intake reduced1
Fontanelle bulging1
Frustration tolerance decreased1
Gastrointestinal tube insertion1
Gaze palsy1
General physical health deterioration1
Generalised erythema1
Gestational diabetes1
Haematochezia1
Haemorrhage1
Hashimoto's encephalopathy1
Heart rate increased1
Hemiparesis1
Hepatic enzyme increased1
Hepatic failure1
Hepatitis1
Hepatitis C1
Hepatitis C RNA1
Herpes zoster1
Hirsutism1
Hypercalcaemia1
Hyperlipidaemia1
Hypersomnia1
Hypertension1
Hypertensive crisis1
Hypertransaminasaemia1
Hyponatraemic encephalopathy1
Hypospadias1
Hypothyroidism1
Hypovolaemia1
Illness1
Impulse-control disorder1
Inappropriate antidiuretic hormone secretion1
Incoherent1
Incorrect dosage administered1
Incorrect route of drug administration1
Infection1
Initial insomnia1
Intentional product use issue1
Intentional self-injury1
Intentional underdose1
Intercepted drug administration error1
Jugular vein thrombosis1
Leg amputation1
Libido decreased1
Lip dry1
Lip swelling1
Lipase increased1
Livedo reticularis1
Liver disorder1
Liver function test increased1
Localised oedema1
Logorrhoea1
Lupus-like syndrome1
Madarosis1
Maternal exposure during breast feeding1
Maternal exposure during pregnancy1
Mental disorder1
Mental impairment1
Mental status changes1
Metabolic acidosis1
Metamorphopsia1
Migraine1
Mood swings1
Multimorbidity1
Multiple organ dysfunction syndrome1
Multiple-drug resistance1
Muscle tightness1
Muscular weakness1
Myoclonic epilepsy1
Necrosis1
Nephrolithiasis1
Nephrotic syndrome1
Neutrophil count decreased1
Nodal arrhythmia1
Normochromic normocytic anaemia1
Occipital neuralgia1
Ocular hyperaemia1
Odynophagia1
Oedema1
Oral mucosal blistering1
Oropharyngeal pain1
Palatal oedema1
Palpitations1
Pancytopenia1
Panic attack1
Parathyroid tumour benign1
Parotid gland enlargement1
Pericardial effusion1
Pharyngeal swelling1
Pharyngitis1
Physical assault1
Pigmentation disorder1
Pleural effusion1
Pneumonia1
Pneumonia staphylococcal1
Polycystic ovaries1
Polydactyly1
Porphyria acute1
Postictal psychosis1
Postictal state1
Potentiating drug interaction1
Prescription drug used without a prescription1
Presyncope1
Procedural haemorrhage1
Product availability issue1
Product label issue1
Product physical issue1
Product quality issue1
Product storage error1
Product substitution issue1
Productive cough1
Prostate cancer1
Proteinuria1
Prothrombin time prolonged1
Psychomotor hyperactivity1
Pupillary reflex impaired1
Rash erythematous1
Rash macular1
Rebound effect1
Renal impairment1
Respiratory disorder1
Respiratory failure1
Respiratory tract congestion1
Restlessness1
Resuscitation1
Rheumatoid arthritis1
Rhinitis1
Rhinorrhoea1
Sedation1
Self-injurious ideation1
Sepsis1
Sinoatrial block1
Sinus bradycardia1
Skeletal injury1
Skin abrasion1
Skin discolouration1
Skin exfoliation1
Skin oedema1
Skull fracture1
Slow response to stimuli1
Slow speech1
Spinal fracture1
Stevens-Johnson syndrome1
Subdural haematoma1
Supraventricular tachycardia1
Syncope1
Temperature intolerance1
Therapeutic product effect increased1
Therapeutic response unexpected1
Therapy interrupted1
Thirst decreased1
Throat irritation1
Thrombocytopenic purpura1
Thyroid disorder1
Tonic posturing1
Tooth erosion1
Tooth loss1
Toxic optic neuropathy1
Toxic skin eruption1
Toxicologic test abnormal1
Transaminases increased1
Trigeminal neuralgia1
Tuberculosis1
Urinary retention1
Urine abnormality1
Ventricular tachycardia1
Visual acuity reduced1
Visual field defect1
Visual impairment1
Vital capacity decreased1
Weight decreased1
White blood cell count decreased1
Withdrawal syndrome1
Wrong dose1
Wrong schedule1
Yawning1





Toxicity information:

Toxicity type: N/A



External links:

ChEBML: CHEMBL87992
DrugBank: DB09119