Flecainide


DB01195



General information:


Withdrawn ID: DB01195
Canonical SMILES:
Standard InChI:
Standard InChIKey:
ATC class(es): C01BC04
Molecular Formula: C17H20F6N2O3
Molweight: 414.343



Withdrawal information:


Withdrawn due to drug safety reasons:No
First approved: 1985



Side-effects:

Total reported cases (submitted by medical professionals) with Flecainide as primary suspect: 843


Reported final outcomes:
Hospitalization (initial or prolonged): 504
Life-Threatening condition: 185
Death: 155
Intervention required to prevent permanent impairment/damage: 12
Disability: 6
Congenital anomaly: 2


Reported side-effects:

Side-effect Case number
TOXICITY TO VARIOUS AGENTS261
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED156
HYPOTENSION99
VENTRICULAR TACHYCARDIA94
TACHYCARDIA91
BRADYCARDIA87
DRUG INEFFECTIVE84
CARDIAC ARREST83
ELECTROCARDIOGRAM QT PROLONGED79
OVERDOSE75
ATRIAL FIBRILLATION73
COMPLETED SUICIDE70
INTENTIONAL OVERDOSE60
ATRIAL FLUTTER60
SYNCOPE59
DIZZINESS45
DRUG INTERACTION43
BUNDLE BRANCH BLOCK RIGHT42
Atrioventricular block first degree40
ARRHYTHMIA40
Acute kidney injury37
ACCIDENTAL OVERDOSE37
BRUGADA SYNDROME35
DYSPNOEA34
CARDIO-RESPIRATORY ARREST33
VENTRICULAR FIBRILLATION31
TORSADE DE POINTES29
LOSS OF CONSCIOUSNESS29
ELECTROCARDIOGRAM ABNORMAL29
DRUG LEVEL INCREASED29
ASTHENIA28
PALPITATIONS25
MEDICATION ERROR25
CONFUSIONAL STATE25
SUICIDE ATTEMPT24
NAUSEA24
CARDIOGENIC SHOCK24
Foetal exposure during pregnancy23
DEATH22
CARDIAC FAILURE22
BUNDLE BRANCH BLOCK LEFT22
Mental status changes21
INCORRECT DOSE ADMINISTERED20
FATIGUE20
METABOLIC ACIDOSIS19
UNRESPONSIVE TO STIMULI18
SUPRAVENTRICULAR TACHYCARDIA18
LETHARGY18
ELECTROCARDIOGRAM PR PROLONGATION18
CARDIOTOXICITY18
Treatment failure17
SINUS BRADYCARDIA17
Pulseless electrical activity17
MALAISE16
CONDITION AGGRAVATED16
TACHYARRHYTHMIA15
Seizure15
DRUG LEVEL ABOVE THERAPEUTIC15
Defect conduction intraventricular15
SUPRAVENTRICULAR EXTRASYSTOLES14
STRESS CARDIOMYOPATHY14
SHOCK14
RENAL FAILURE14
Adverse drug reaction14
SOMNOLENCE13
FALL13
Conduction disorder13
VOMITING12
PULMONARY OEDEMA12
PRODUCT QUALITY ISSUE12
Hyperkalaemia12
Haemodynamic instability12
Exposure during pregnancy12
DEVICE MALFUNCTION12
ATRIAL TACHYCARDIA12
HYPONATRAEMIA11
Sinus tachycardia10
INTERSTITIAL LUNG DISEASE10
COUGH10
CHEST DISCOMFORT10
CARDIAC FAILURE CONGESTIVE10
ATRIOVENTRICULAR BLOCK10
SUDDEN CARDIAC DEATH9
PREMATURE BABY9
HYPOKALAEMIA9
DRUG TOXICITY9
Dehydration9
BUNDLE BRANCH BLOCK9
BLOOD PRESSURE DECREASED9
ATRIOVENTRICULAR BLOCK COMPLETE9
Accidental exposure to product9
VISION BLURRED8
Ventricular arrhythmia8
Tremor8
Presyncope8
PNEUMONIA ASPIRATION8
PHARMACEUTICAL PRODUCT COMPLAINT8
Off label use8
MYOCARDIAL ISCHAEMIA8
Hypophagia8
HYPERHIDROSIS8
ELECTROLYTE IMBALANCE8
ELECTROCARDIOGRAM T WAVE INVERSION8
EJECTION FRACTION DECREASED8
Device capturing issue8
DECREASED APPETITE8
BALANCE DISORDER8
ATAXIA8
ANAEMIA8
RESPIRATORY DISTRESS7
MUSCULAR WEAKNESS7
HYPOXIA7
HYPOTONIA7
HEART RATE IRREGULAR7
HEART RATE DECREASED7
HEADACHE7
GAIT DISTURBANCE7
DRUG DISPENSING ERROR7
DEVICE PACING ISSUE7
CIRCULATORY COLLAPSE7
Bradyarrhythmia7
BLOOD CREATININE INCREASED7
VENTRICULAR EXTRASYSTOLES6
VENTRICULAR DYSFUNCTION6
RENAL IMPAIRMENT6
PLEURAL EFFUSION6
MYOCLONUS6
Left ventricular dysfunction6
INTERNATIONAL NORMALISED RATIO INCREASED6
HYPOGLYCAEMIA6
ELECTROCARDIOGRAM ST SEGMENT ELEVATION6
ELECTROCARDIOGRAM QRS COMPLEX SHORTENED6
DIARRHOEA6
DEPRESSED LEVEL OF CONSCIOUSNESS6
CONVULSION6
Brain injury6
BLOOD POTASSIUM DECREASED6
ATRIOVENTRICULAR BLOCK SECOND DEGREE6
Acute respiratory distress syndrome6
Ventricular dyssynchrony5
TRANSIENT ISCHAEMIC ATTACK5
TACHYCARDIA FOETAL5
Subarachnoid haemorrhage5
Sinus rhythm5
Respiratory failure5
RESPIRATORY ARREST5
RENAL FAILURE ACUTE5
Pulmonary alveolar haemorrhage5
PRODUCT SUBSTITUTION ISSUE5
Product administration error5
Poisoning5
NODAL ARRHYTHMIA5
Neutropenia5
MULTI-ORGAN FAILURE5
Maternal exposure during pregnancy5
Liver injury5
INSOMNIA5
Hypoperfusion5
HYPERTENSION5
HYPERSENSITIVITY5
Heart rate increased5
GRAND MAL CONVULSION5
Generalised tonic-clonic seizure5
GENERAL PHYSICAL HEALTH DETERIORATION5
FEELING ABNORMAL5
Exposure via ingestion5
DYSGEUSIA5
DRUG HYPERSENSITIVITY5
Drug abuse5
Decreased activity5
CYANOSIS5
CONSTIPATION5
Coma5
Chest pain5
Cardiac failure acute5
CAESAREAN SECTION5
BLOOD PRESSURE SYSTOLIC INCREASED5
Bifascicular block5
ATRIOVENTRICULAR DISSOCIATION5
Visual impairment4
VESTIBULAR DISORDER4
Unmasking of previously unidentified disease4
TREATMENT NONCOMPLIANCE4
THROMBOCYTOPENIA4
THERAPEUTIC RESPONSE UNEXPECTED WITH DRUG SUBSTITUTION4
THERAPEUTIC RESPONSE DECREASED4
Systolic dysfunction4
Sopor4
Sinoatrial block4
Pulmonary toxicity4
Pulmonary hypertension4
PRURITUS4
Product preparation error4
NEUROTOXICITY4
EXTRASYSTOLES4
ELECTROCARDIOGRAM QRS COMPLEX ABNORMAL4
ELECTROCARDIOGRAM CHANGE4
DYSARTHRIA4
DISEASE RECURRENCE4
Diplopia4
Cognitive disorder4
CARDIAC DISORDER4
Agitation4
ABDOMINAL DISCOMFORT4
WRONG TECHNIQUE IN DRUG USAGE PROCESS3
Ventricular tachyarrhythmia3
URTICARIA3
Tubulointerstitial nephritis3
Transaminases increased3
Therapy non-responder3
SYSTEMIC LUPUS ERYTHEMATOSUS3
Respiratory tract oedema3
Respiratory disorder3
Pyrexia3
Product use issue3
Product dose omission3
Product dispensing error3
POISONING DELIBERATE3
PERIPHERAL COLDNESS3
PALLOR3
OEDEMA PERIPHERAL3
NODAL RHYTHM3
MYOCARDIAL INFARCTION3
Myalgia3
MITRAL VALVE INCOMPETENCE3
Miosis3
MEMORY IMPAIRMENT3
Low birth weight baby3
LONG QT SYNDROME3
Livedo reticularis3
Irritability3
Hyporesponsive to stimuli3
Hepatotoxicity3
HEPATIC FUNCTION ABNORMAL3
HEPATIC FAILURE3
HALLUCINATION3
Foetal death3
FEELING HOT3
Feeding disorder3
ERYTHEMA3
Epigastric discomfort3
Dyspnoea exertional3
DYSKINESIA3
DRUG SCREEN POSITIVE3
Drug reaction with eosinophilia and systemic symptoms3
Drug eruption3
DRUG ADMINISTRATION ERROR3
Crying3
Compartment syndrome3
Cold sweat3
Cerebrovascular accident3
Cardiovascular insufficiency3
Cardiovascular disorder3
Cardiomyopathy3
Calcium ionised increased3
Bundle branch block bilateral3
Blood lactic acid increased3
Atrial conduction time prolongation3
ARTERIOSCLEROSIS CORONARY ARTERY3
ANXIETY3
ANURIA3
ACUTE MYOCARDIAL INFARCTION3
Wrong dose2
WHITE BLOOD CELL COUNT DECREASED2
WHEEZING2
VENTRICULAR HYPOKINESIA2
VENTRICULAR HYPERTROPHY2
Urinary tract infection2
TOXIC NEUROPATHY2
THERAPEUTIC AGENT TOXICITY2
Tachycardia induced cardiomyopathy2
Suicidal ideation2
Slow response to stimuli2
SKIN LESION2
Sinus node dysfunction2
SINUS ARREST2
Septic shock2
Sensory loss2
SELF-MEDICATION2
RHYTHM IDIOVENTRICULAR2
Rash2
RALES2
QRS AXIS ABNORMAL2
PULSE ABSENT2
PULMONARY HAEMORRHAGE2
Pulmonary fibrosis2
Product prescribing error2
PREMATURE LABOUR2
POTENTIATING DRUG INTERACTION2
POSTURE ABNORMAL2
POOR PERIPHERAL CIRCULATION2
POLLAKIURIA2
PNEUMONITIS2
PNEUMONIA2
Pneumocystis jirovecii infection2
Phospholipidosis2
Pericardial effusion2
PARANOIA2
Pain2
PACING THRESHOLD INCREASED2
Pacemaker syndrome2
Osteonecrosis2
Oscillopsia2
ORTHOSTATIC HYPOTENSION2
Organising pneumonia2
Oliguria2
OEDEMA2
Normal newborn2
Myocardial necrosis2
MYOCARDIAL DEPRESSION2
Muscle rigidity2
MULTIPLE DRUG OVERDOSE INTENTIONAL2
Metabolic alkalosis2
LUNG INFILTRATION2
Lung disorder2
Live birth2
LISTLESS2
Lip swelling2
Left ventricular hypertrophy2
Left ventricular failure2
Kidney transplant rejection2
INTENTIONAL SELF-INJURY2
Hyporeflexia2
HYPOMAGNESAEMIA2
HYPOKINESIA2
Hypertensive crisis2
HYPERGLYCAEMIA2
Hydrops foetalis2
Heterophoria2
Hepatic ischaemia2
Heart valve incompetence2
HAEMOGLOBIN DECREASED2
Gastrointestinal haemorrhage2
Food interaction2
Fluid overload2
EYE MOVEMENT DISORDER2
ELECTROCARDIOGRAM T WAVE ABNORMAL2
ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED2
Dysmetria2
DRY SKIN2
Drug resistance2
DRUG PRESCRIBING ERROR2
DRUG LEVEL DECREASED2
Drug half-life increased2
Drug dependence2
DISSEMINATED INTRAVASCULAR COAGULATION2
DISORIENTATION2
Diffuse alveolar damage2
DEPRESSION2
DELIRIUM2
Crepitations2
Coronary artery occlusion2
Coeliac disease2
CHOLECYSTECTOMY2
Choking2
Cardioversion2
Cardiac flutter2
Cardiac ablation2
BRASH syndrome2
BRAIN DEATH2
Bradycardia neonatal2
BLOOD PRESSURE INCREASED2
Blood potassium increased2
BLOOD GLUCOSE INCREASED2
Atrial septal defect2
Arthralgia2
ARTERIOSCLEROSIS2
Apnoea2
ANGINA PECTORIS2
Altered state of consciousness2
ALKALOSIS2
Alcohol use2
Acute pulmonary oedema2
Acute lung injury2
ACIDOSIS2
ABDOMINAL PAIN UPPER2
Abdominal pain2
WHITE BLOOD CELL COUNT INCREASED1
WEIGHT INCREASED1
Weight bearing difficulty1
Vitreous detachment1
VISUAL DISTURBANCE1
Violence-related symptom1
VERTIGO1
VENTRICULAR FAILURE1
Ventricular asystole1
Venous oxygen saturation decreased1
Vasoplegia syndrome1
URINE SODIUM INCREASED1
Urine output increased1
Urine output decreased1
Ureterolithiasis1
Unevaluable event1
Trifascicular block1
TRI-IODOTHYRONINE FREE DECREASED1
Tongue neoplasm malignant stage unspecified1
Thyroid cancer1
Throat cancer1
Thinking abnormal1
Therapy partial responder1
Therapy change1
Therapeutic response unexpected1
Terminal state1
Tachypnoea1
TABLET PHYSICAL ISSUE1
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME1
Subdural haematoma1
Stomatitis1
Staring1
STAPHYLOCOCCAL INFECTION1
Speech disorder1
SOCIAL AVOIDANT BEHAVIOUR1
Sleep disorder1
SKIN REACTION1
SKIN EXFOLIATION1
Skin abrasion1
SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG1
SIGMOIDITIS1
SICK SINUS SYNDROME1
SEPSIS1
SELF INJURIOUS BEHAVIOUR1
Seizure like phenomena1
SCREAMING1
RIGHT ATRIAL DILATATION1
Resting tremor1
Respiratory acidosis1
Respiration abnormal1
RENAL TRANSPLANT1
RENAL FAILURE CHRONIC1
Reflexes abnormal1
RASH MORBILLIFORM1
RASH ERYTHEMATOUS1
RADIUS FRACTURE1
PYURIA1
Pupillary disorder1
PUPIL FIXED1
PULSE PRESSURE DECREASED1
Pulse abnormal1
Pulmonary embolism1
Pulmonary congestion1
Pulmonary artery stenosis1
PSYCHOMOTOR SKILLS IMPAIRED1
Prothrombin time shortened1
PROGESTERONE RECEPTOR ASSAY POSITIVE1
Product taste abnormal1
Product label issue1
Product contamination physical1
Product compounding quality issue1
PROCEDURAL COMPLICATION1
Prescription drug used without a prescription1
PREMATURE RUPTURE OF MEMBRANES1
Premature delivery1
PRE-ECLAMPSIA1
Post-anoxic myoclonus1
POOR QUALITY DRUG ADMINISTERED1
Poor feeding infant1
PO2 increased1
PLATELET COUNT DECREASED1
PLANTAR ERYTHEMA1
Petit mal epilepsy1
PETECHIAE1
Personality change1
PERITONEAL TUBERCULOSIS1
PERIPHERAL SENSORY NEUROPATHY1
Peripheral ischaemia1
Pericardial haemorrhage1
Pelvic pain1
PAROSMIA1
Parkinsonism1
Parkinson's disease1
Parathyroid tumour benign1
Pancytopenia1
PANCREATITIS ACUTE1
Pancreatitis1
PALMAR ERYTHEMA1
Pain in extremity1
PACING THRESHOLD DECREASED1
PACEMAKER COMPLICATION1
OXYGEN SATURATION IMMEASURABLE1
OXYGEN SATURATION DECREASED1
Oversensing1
Ototoxicity1
OESTROGEN RECEPTOR ASSAY POSITIVE1
NYSTAGMUS1
No therapeutic response1
No adverse event1
Neutrophilia1
NEUTROPHIL COUNT DECREASED1
NEUROPATHY PERIPHERAL1
NEUROLOGICAL SYMPTOM1
Neurological decompensation1
NEGATIVE CARDIAC INOTROPIC EFFECT1
Necrotising colitis1
Neck pain1
MYOCLONIC EPILEPSY1
MYCOSIS FUNGOIDES1
Musculoskeletal pain1
Muscle spasms1
MUSCLE DISORDER1
Multiple-drug resistance1
Multiple injuries1
MONOPLEGIA1
Mobility decreased1
METASTASES TO PERITONEUM1
Metastases to central nervous system1
METABOLIC ENCEPHALOPATHY1
Medical device complication1
MEAN ARTERIAL PRESSURE DECREASED1
MATERNAL DRUGS AFFECTING FOETUS1
Masked facies1
Mania1
Malignant neoplasm progression1
Macular hole1
LYMPHOCYTOSIS1
LOW DENSITY LIPOPROTEIN INCREASED1
LOW CARDIAC OUTPUT SYNDROME1
LEUKOCYTOSIS1
LEFT ATRIAL DILATATION1
LACTIC ACIDOSIS1
JUGULAR VEIN DISTENSION1
Joint swelling1
Jaw fracture1
Ischaemic stroke1
Interventional procedure1
Intercepted drug dispensing error1
Intentional product misuse1
Intentional drug misuse1
Insulinoma1
Infection1
INDUCED LABOUR1
Implant site haemorrhage1
Immune thrombocytopenic purpura1
Illusion1
Hypovolaemia1
Hypothermia1
Hypocalcaemia1
HYPOAESTHESIA1
Hypertonia1
HYPERTHERMIA1
Hypersomnia1
Hypernatraemia1
Hyperkinesia1
HYPERCAPNIA1
Humerus fracture1
Horner's syndrome1
HIGH DENSITY LIPOPROTEIN DECREASED1
Herbal interaction1
HEPATOJUGULAR REFLUX1
Hepatocellular injury1
Hepatic enzyme increased1
HEMIPARESIS1
HEART RATE ABNORMAL1
Heart injury1
Hallucination, visual1
HALLUCINATION, AUDITORY1
HAEMORRHAGE1
HAEMODIALYSIS1
Haematoma1
HAEMATOCHEZIA1
Haematemesis1
GLOMERULAR FILTRATION RATE DECREASED1
GASTROINTESTINAL STROMAL TUMOUR1
Gastrointestinal necrosis1
GASTRIC DISORDER1
GAMMA-GLUTAMYLTRANSFERASE INCREASED1
FRACTURED COCCYX1
Foetal hypokinesia1
FOETAL DISORDER1
Flushing1
FEELING COLD1
Feeding disorder neonatal1
FAILURE TO CAPTURE1
FACIAL BONES FRACTURE1
EYE SWELLING1
Eye disorder1
Extra dose administered1
Essential hypertension1
ERYTHEMA OF EYELID1
Erectile dysfunction1
Epilepsy1
EOSINOPHIL COUNT INCREASED1
Enteritis1
Emotional distress1
ELECTROCARDIOGRAM T WAVE PEAKED1
Electrocardiogram ST segment depression1
ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY1
Electrocardiogram QT interval1
Electrocardiogram QRS complex1
ELECTROCARDIOGRAM PACEMAKER SPIKE1
ELECTROCARDIOGRAM P WAVE ABNORMAL1
Ejection fraction abnormal1
Ejection fraction1
DYSPEPSIA1
Duplicate therapy error1
Drug-induced liver injury1
Drug level changed1
Drug level below therapeutic1
Drug intolerance1
DRUG EXPOSURE DURING PREGNANCY1
DRUG CLEARANCE DECREASED1
Diverticulum1
DIVERTICULITIS1
DILATATION VENTRICULAR1
Dilatation atrial1
DIET REFUSAL1
Diastolic dysfunction1
DIAPHRAGM MUSCLE WEAKNESS1
Device lead issue1
DEVICE BREAKAGE1
Developmental delay1
Dermatitis allergic1
DEPRESSED MOOD1
DELUSIONAL DISORDER, PERSECUTORY TYPE1
Delusion1
DEAFNESS UNILATERAL1
Deafness neurosensory1
CYTOLYTIC HEPATITIS1
Cystoid macular oedema1
CUTANEOUS LUPUS ERYTHEMATOSUS1
Crystal arthropathy1
CREATININE RENAL CLEARANCE DECREASED1
Coordination abnormal1
COOMBS POSITIVE HAEMOLYTIC ANAEMIA1
Contraindicated product administered1
CONJUNCTIVITIS1
Congestive cardiomyopathy1
Complication associated with device1
COMA SCALE ABNORMAL1
Colon cancer1
Colitis microscopic1
Chronic obstructive pulmonary disease1
Cholestasis of pregnancy1
CHOLECYSTITIS ACUTE1
CHOKING SENSATION1
CHEST X-RAY ABNORMAL1
CATHETER RELATED INFECTION1
CARDIOACTIVE DRUG LEVEL INCREASED1
CARDIOACTIVE DRUG LEVEL ABOVE THERAPEUTIC1
CARDIAC VENTRICULAR DISORDER1
Cardiac steatosis1
Cardiac pacemaker insertion1
Cardiac output decreased1
CARDIAC MURMUR1
Cardiac dysfunction1
Cardiac arrest neonatal1
CARCINOID SYNDROME1
Capillary disorder1
C-reactive protein increased1
Bronchiectasis1
BREAST CELLULITIS1
BREAST CANCER FEMALE1
Breast cancer1
BRAIN NATRIURETIC PEPTIDE INCREASED1
Bradypnoea1
BLOOD UREA INCREASED1
BLOOD THYROID STIMULATING HORMONE INCREASED1
BLOOD SODIUM INCREASED1
Blood pressure systolic decreased1
BLOOD PRESSURE IMMEASURABLE1
BLOOD PRESSURE FLUCTUATION1
BLOOD PRESSURE DIASTOLIC DECREASED1
Blood potassium abnormal1
BLOOD PH INCREASED1
Blood pH decreased1
BLOOD MAGNESIUM DECREASED1
BLOOD GLUCOSE DECREASED1
BLOOD CREATINE PHOSPHOKINASE INCREASED1
Blood creatine increased1
BLOOD BICARBONATE DECREASED1
BLOOD ALKALINE PHOSPHATASE INCREASED1
Bicuspid aortic valve1
Bezoar1
BENIGN PROSTATIC HYPERPLASIA1
Base excess decreased1
AUTONOMIC NEUROPATHY1
Atrioventricular conduction time shortened1
Aspartate aminotransferase increased1
ASCITES1
ARRHYTHMOGENIC RIGHT VENTRICULAR DYSPLASIA1
Aplasia1
Aortic valve incompetence1
Antiphospholipid syndrome1
Anticoagulation drug level below therapeutic1
Anger1
Anaphylactic shock1
Amniotic fluid volume decreased1
Ammonia increased1
Amaurosis1
Alveolitis1
Alopecia1
Alanine aminotransferase increased1
AKINESIA1
Agranulocytosis1
Agitated depression1
AGEUSIA1
Adverse reaction1
Adverse event1
ADRENOCORTICAL INSUFFICIENCY CHRONIC1
Acute respiratory failure1
Acute interstitial pneumonitis1
Acute generalised exanthematous pustulosis1
Activities of daily living impaired1
Accidental underdose1
Accidental exposure to product by child1
ACCIDENTAL EXPOSURE1
ACCIDENTAL DRUG INTAKE BY CHILD1
Abnormal behaviour1
Abdominal pain lower1
Abdominal compartment syndrome1





Filtered ChEMBL targets:

Target UniProtKB ID Activity in nm Target Name Target gene
P02545 1258.9 Prelamin-A/C LMNA_HUMAN
Q12809 3890.45 Potassium voltage-gated channel subfamily H member 2 KCNH2_HUMAN
Q14524 6500 Sodium channel protein type 5 subunit alpha SCN5A_HUMAN



Toxicity information:

Toxicity class: 4
Toxicity type: N/A
LD50: 584.5 mg/kg



External links:

ChEBML: CHEMBL652
DrugBank: DB01195