flecainide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
Class I antiarrhythmics, procainamide and lidocaine derivatives 1176 54143-55-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tambocor
  • flecainide
  • flecaine
  • flecainide acetate
A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.
  • Molecular weight: 414.35
  • Formula: C17H20F6N2O3
  • CLOGP: 4.15
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 59.59
  • ALOGS: -4.11
  • ROTB: 9

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 12.07 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 48.40 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 43 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.90 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.52 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 31, 1985 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Electrocardiogram QRS complex prolonged 589.81 14.77 162 16797 5776 63466287
Electrocardiogram QT prolonged 266.19 14.77 177 16782 59353 63412710
Atrial fibrillation 240.27 14.77 219 16740 116417 63355646
Bradycardia 237.60 14.77 179 16780 73048 63399015
Drug interaction 209.92 14.77 281 16678 228850 63243213
Toxicity to various agents 209.60 14.77 292 16667 246958 63225105
Ventricular tachycardia 198.66 14.77 100 16859 19879 63452184
Cardiac arrest 175.44 14.77 166 16793 92379 63379684
Arrhythmia 157.45 14.77 108 16851 38032 63434031
Atrial flutter 124.56 14.77 58 16901 9714 63462349
Torsade de pointes 115.86 14.77 61 16898 13290 63458773
Atrioventricular block first degree 114.41 14.77 50 16909 7223 63464840
Bundle branch block right 100.79 14.77 41 16918 4957 63467106
Ventricular fibrillation 82.96 14.77 47 16912 11820 63460243
Device pacing issue 80.45 14.77 15 16944 82 63471981
Rectal polyp 79.16 14.77 24 16935 1215 63470848
Hypotension 72.34 14.77 197 16762 272407 63199656
Syncope 69.96 14.77 118 16841 117267 63354796
Cardiogenic shock 69.79 14.77 49 16910 17883 63454180
Hyponatraemia 66.04 14.77 112 16847 111788 63360275
Change of bowel habit 65.71 14.77 24 16935 2169 63469894
Injection site discomfort 63.75 14.77 29 16930 4601 63467462
Bundle branch block left 63.37 14.77 33 16926 7026 63465037
Sinus bradycardia 61.89 14.77 42 16917 14509 63457554
Ventricular dyssynchrony 59.65 14.77 11 16948 56 63472007
Tachycardia 59.08 14.77 110 16849 118046 63354017
Device capturing issue 57.71 14.77 10 16949 33 63472030
Defect conduction intraventricular 56.31 14.77 12 16947 140 63471923
Thalamic infarction 56.20 14.77 15 16944 477 63471586
Intestinal haemorrhage 55.84 14.77 25 16934 3822 63468241
Sensitisation 55.60 14.77 24 16935 3362 63468701
Brugada syndrome 54.79 14.77 14 16945 374 63471689
Tachyarrhythmia 52.36 14.77 25 16934 4425 63467638
Stress cardiomyopathy 51.82 14.77 32 16927 9418 63462645
Cardiac failure 50.97 14.77 88 16871 89054 63383009
Needle issue 46.65 14.77 31 16928 10345 63461718
Urine odour abnormal 46.54 14.77 26 16933 6363 63465700
Contraindicated product administered 46.34 14.77 3 16956 217645 63254418
Completed suicide 45.48 14.77 112 16847 145561 63326502
Acute kidney injury 45.40 14.77 164 16795 263251 63208812
Cardio-respiratory arrest 44.98 14.77 67 16892 59892 63412171
Pain 44.91 14.77 81 16878 740547 62731516
Frustration tolerance decreased 44.37 14.77 26 16933 6962 63465101
Conduction disorder 43.75 14.77 16 16943 1451 63470612
Polyp 43.36 14.77 25 16934 6496 63465567
Proctalgia 42.16 14.77 24 16935 6086 63465977
Duodenal ulcer 41.86 14.77 26 16933 7730 63464333
Palpitations 40.96 14.77 92 16867 112678 63359385
Rheumatoid arthritis 40.73 14.77 9 16950 253810 63218253
Furuncle 40.56 14.77 24 16935 6542 63465521
Therapeutic product effect decreased 40.14 14.77 3 16956 193184 63278879
Sinoatrial block 39.29 14.77 13 16946 875 63471188
Urine abnormality 39.08 14.77 24 16935 6995 63465068
Cerebral venous thrombosis 38.37 14.77 16 16943 2058 63470005
Tubulointerstitial nephritis 38.20 14.77 36 16923 19867 63452196
Electrocardiogram PR prolongation 37.73 14.77 12 16947 712 63471351
Ventricular arrhythmia 37.55 14.77 19 16940 3809 63468254
Atrioventricular block 37.19 14.77 24 16935 7623 63464440
Infusion related reaction 36.87 14.77 10 16949 245511 63226552
Thyroid disorder 36.17 14.77 31 16928 15131 63456932
Bladder disorder 36.10 14.77 25 16934 8921 63463142
Intentional overdose 35.75 14.77 68 16891 74084 63397979
Drug intolerance 35.68 14.77 19 16940 308642 63163421
Bifascicular block 35.49 14.77 8 16951 123 63471940
Overdose 35.39 14.77 88 16871 114990 63357073
Bradyarrhythmia 34.76 14.77 15 16944 2100 63469963
Cutaneous T-cell lymphoma 33.69 14.77 13 16946 1367 63470696
Swelling 33.25 14.77 16 16943 275362 63196701
Wound 32.63 14.77 3 16956 163260 63308803
Systemic lupus erythematosus 32.33 14.77 8 16951 208910 63263153
Ventricular extrasystoles 32.25 14.77 26 16933 11661 63460402
Full blood count decreased 31.84 14.77 37 16922 25987 63446076
Peripheral coldness 31.33 14.77 26 16933 12139 63459924
Postoperative wound infection 29.50 14.77 24 16935 10901 63461162
Arthropathy 29.33 14.77 13 16946 234779 63237284
Electrocardiogram abnormal 28.74 14.77 22 16937 9157 63462906
Heart rate decreased 28.71 14.77 47 16912 45513 63426550
Musculoskeletal stiffness 25.05 14.77 9 16950 184609 63287454
Mass 24.37 14.77 24 16935 13976 63458087
Blood glucose decreased 24.32 14.77 29 16930 20923 63451140
Subdural haematoma 23.90 14.77 24 16935 14304 63457759
Bundle branch block 23.78 14.77 9 16950 898 63471165
Pulmonary alveolar haemorrhage 23.56 14.77 15 16944 4653 63467410
Gallbladder disorder 23.40 14.77 27 16932 18815 63453248
Electrocardiogram QT interval 23.31 14.77 6 16953 165 63471898
Device malfunction 22.87 14.77 26 16933 17831 63454232
Musculoskeletal discomfort 22.74 14.77 26 16933 17941 63454122
Slow response to stimuli 22.65 14.77 9 16950 1023 63471040
Hepatic enzyme increased 22.57 14.77 13 16946 202315 63269748
Cerebral haemorrhage 22.55 14.77 34 16925 30695 63441368
Metabolic acidosis 22.55 14.77 42 16917 45027 63427036
Pericarditis 22.48 14.77 4 16955 131575 63340488
Intracranial haematoma 22.21 14.77 7 16952 403 63471660
Subarachnoid haemorrhage 22.15 14.77 23 16936 14260 63457803
Cutaneous vasculitis 21.91 14.77 15 16944 5254 63466809
Pericardial haemorrhage 21.84 14.77 10 16949 1609 63470454
Drug-device interaction 21.39 14.77 5 16954 91 63471972
Exostosis 21.19 14.77 25 16934 17837 63454226
Dermatitis exfoliative generalised 21.15 14.77 13 16946 3794 63468269
Jaundice 20.95 14.77 32 16927 29219 63442844
Lung neoplasm malignant 20.88 14.77 26 16933 19607 63452456
Hypersensitivity 20.49 14.77 29 16930 292656 63179407
Shock 20.19 14.77 28 16931 23435 63448628
Cardiac failure acute 19.77 14.77 18 16941 9505 63462558
Heart rate irregular 19.66 14.77 27 16932 22394 63449669
Pacemaker syndrome 19.61 14.77 3 16956 3 63472060
Alopecia 19.41 14.77 38 16921 337498 63134565
Injection site mass 18.72 14.77 24 16935 18632 63453431
Dizziness 18.68 14.77 186 16773 429739 63042324
Supraventricular tachycardia 18.65 14.77 21 16938 14250 63457813
Hypokalaemia 18.15 14.77 65 16894 103739 63368324
Presyncope 17.96 14.77 29 16930 27756 63444307
Arthralgia 17.81 14.77 85 16874 569625 62902438
Rash pustular 17.59 14.77 15 16944 7267 63464796
Extrasystoles 17.56 14.77 13 16946 5147 63466916
Unresponsive to stimuli 17.52 14.77 32 16927 33784 63438279
Accidental overdose 17.40 14.77 26 16933 23283 63448780
Sinusitis 17.35 14.77 21 16938 226632 63245431
Medication error 17.14 14.77 41 16918 52243 63419820
Weight increased 17.13 14.77 27 16932 260765 63211298
Neovascular age-related macular degeneration 16.99 14.77 5 16954 228 63471835
Antisynthetase syndrome 16.85 14.77 4 16955 78 63471985
Drug-disease interaction 16.65 14.77 6 16953 522 63471541
Blister 16.50 14.77 7 16952 129807 63342256
Drug level increased 16.46 14.77 25 16934 22711 63449352
Cardiac ablation 16.43 14.77 8 16951 1477 63470586
Sinus node dysfunction 16.38 14.77 12 16947 4673 63467390
Mobility decreased 16.27 14.77 6 16953 121153 63350910
Mixed liver injury 16.27 14.77 12 16947 4723 63467340
Bone disorder 16.22 14.77 24 16935 21302 63450761
Urinary incontinence 16.22 14.77 30 16929 31984 63440079
Rash 16.20 14.77 86 16873 560785 62911278
Hyperkalaemia 16.18 14.77 41 16918 54162 63417901
Drug level above therapeutic 16.11 14.77 12 16947 4793 63467270
Discomfort 15.68 14.77 13 16946 167361 63304702
Hepatocellular injury 15.59 14.77 27 16932 27354 63444709
Coma 15.51 14.77 45 16914 64319 63407744
Lower respiratory tract infection 15.48 14.77 8 16951 132299 63339764
Hyperammonaemic encephalopathy 15.30 14.77 9 16950 2425 63469638
Limb discomfort 15.25 14.77 28 16931 29688 63442375
Nodal arrhythmia 15.12 14.77 7 16952 1156 63470907
Bicytopenia 15.06 14.77 9 16950 2496 63469567
Cerebral congestion 14.89 14.77 3 16956 26 63472037
Gravitational oedema 14.83 14.77 7 16952 1207 63470856
Ischaemic stroke 14.81 14.77 21 16938 17936 63454127

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Electrocardiogram QRS complex prolonged 287.58 14.80 92 10741 4802 34941296
Bradycardia 189.70 14.80 169 10664 75249 34870849
Brugada syndrome 158.54 14.80 39 10794 762 34945336
Atrial fibrillation 113.32 14.80 163 10670 122230 34823868
Ventricular tachycardia 112.64 14.80 81 10752 26498 34919600
Atrial flutter 106.42 14.80 64 10769 15510 34930588
Toxicity to various agents 67.97 14.80 174 10659 200188 34745910
Electrocardiogram QT prolonged 65.83 14.80 72 10761 40880 34905218
Atrioventricular block first degree 57.68 14.80 31 10802 6061 34940037
Hypotension 56.93 14.80 174 10659 221475 34724623
Tachyarrhythmia 50.74 14.80 24 10809 3584 34942514
Syncope 49.68 14.80 96 10737 91355 34854743
Hydrops foetalis 49.67 14.80 16 10817 851 34945247
Bundle branch block right 49.04 14.80 30 10803 7486 34938612
Cardiac arrest 48.68 14.80 98 10735 96061 34850037
Tachycardia 44.83 14.80 88 10745 84684 34861414
Electrocardiogram PR prolongation 41.19 14.80 14 10819 881 34945217
Electrocardiogram abnormal 41.02 14.80 29 10804 9218 34936880
Intentional overdose 38.58 14.80 57 10776 43617 34902481
Drug interaction 38.53 14.80 155 10678 225791 34720307
Cardiac flutter 37.82 14.80 16 10817 1837 34944261
Atrioventricular block 37.43 14.80 26 10807 8037 34938061
Interstitial lung disease 34.77 14.80 68 10765 65214 34880884
Atrioventricular block complete 34.05 14.80 26 10807 9293 34936805
High frequency ablation 31.61 14.80 8 10825 176 34945922
Electrocardiogram QRS complex shortened 31.23 14.80 8 10825 185 34945913
Ventricular fibrillation 31.17 14.80 37 10796 22917 34923181
Drug level increased 30.63 14.80 36 10797 22060 34924038
Sinus bradycardia 30.41 14.80 28 10805 12935 34933163
Supraventricular tachycardia 30.02 14.80 26 10807 11091 34935007
Amaurosis 28.64 14.80 10 10823 682 34945416
Overdose 26.63 14.80 75 10758 90984 34855114
Defect conduction intraventricular 26.04 14.80 8 10825 364 34945734
Electrocardiogram QRS complex abnormal 26.04 14.80 8 10825 364 34945734
Overflow diarrhoea 24.77 14.80 5 10828 37 34946061
Splenic rupture 23.99 14.80 11 10822 1530 34944568
Pulseless electrical activity 23.91 14.80 19 10814 7192 34938906
Arrhythmia 23.72 14.80 41 10792 35767 34910331
Device pacing issue 23.61 14.80 5 10828 48 34946050
Suicide attempt 22.36 14.80 42 10791 39074 34907024
Lentigo maligna 21.94 14.80 7 10826 361 34945737
Gastrointestinal ischaemia 20.93 14.80 6 10827 214 34945884
Palpitations 20.49 14.80 41 10792 39945 34906153
Bradyarrhythmia 20.32 14.80 11 10822 2180 34943918
Accidental overdose 20.29 14.80 28 10805 20112 34925986
Microcytic anaemia 19.38 14.80 11 10822 2389 34943709
Device capturing issue 19.16 14.80 3 10830 3 34946095
Pelvic pain 19.05 14.80 11 10822 2469 34943629
Heart rate 18.93 14.80 4 10829 38 34946060
Acute respiratory distress syndrome 18.88 14.80 31 10802 25938 34920160
Tachycardia foetal 18.31 14.80 6 10827 337 34945761
Reflexes abnormal 18.26 14.80 6 10827 340 34945758
Peripheral T-cell lymphoma unspecified recurrent 18.23 14.80 4 10829 46 34946052
Hypomania 16.89 14.80 10 10823 2349 34943749
Pleurothotonus 16.89 14.80 8 10825 1197 34944901
Retinal vascular occlusion 16.82 14.80 5 10828 203 34945895
Hypoglycaemic coma 16.62 14.80 10 10823 2421 34943677
Vertigo 16.60 14.80 29 10804 25507 34920591
Shock haemorrhagic 16.57 14.80 19 10814 11335 34934763
Completed suicide 16.38 14.80 67 10766 98101 34847997
Foetal exposure during pregnancy 15.97 14.80 36 10797 38065 34908033
Torsade de pointes 15.81 14.80 15 10818 7194 34938904
Ventricular dyssynchrony 15.71 14.80 3 10830 16 34946082
BRASH syndrome 15.58 14.80 6 10827 540 34945558
Eosinophilic pneumonia 15.57 14.80 11 10822 3490 34942608
Panic reaction 15.36 14.80 8 10825 1467 34944631
Calcium ionised increased 15.14 14.80 3 10830 20 34946078

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Electrocardiogram QRS complex prolonged 736.79 13.40 228 24634 10605 79708921
Bradycardia 385.96 13.40 327 24535 135230 79584296
Ventricular tachycardia 300.41 13.40 178 24684 41757 79677769
Atrial fibrillation 289.91 13.40 332 24530 197554 79521972
Electrocardiogram QT prolonged 261.03 13.40 220 24642 90166 79629360
Toxicity to various agents 212.94 13.40 430 24432 421110 79298416
Atrial flutter 209.70 13.40 112 24750 21513 79698013
Brugada syndrome 203.41 13.40 52 24810 1186 79718340
Cardiac arrest 192.26 13.40 252 24610 171844 79547682
Drug interaction 173.19 13.40 392 24470 414791 79304735
Arrhythmia 146.40 13.40 134 24728 61138 79658388
Atrioventricular block first degree 142.02 13.40 72 24790 12419 79707107
Bundle branch block right 128.35 13.40 65 24797 11186 79708340
Torsade de pointes 115.26 13.40 73 24789 19239 79700287
Syncope 113.72 13.40 202 24660 179247 79540279
Hypotension 107.39 13.40 341 24521 439976 79279550
Tachycardia 99.87 13.40 190 24672 177578 79541948
Tachyarrhythmia 99.74 13.40 47 24815 6915 79712611
Ventricular fibrillation 98.87 13.40 81 24781 31845 79687681
Device pacing issue 84.94 13.40 17 24845 119 79719407
Sinus bradycardia 84.42 13.40 67 24795 25180 79694346
Device capturing issue 75.54 13.40 13 24849 33 79719493
Bundle branch block left 74.96 13.40 46 24816 11467 79708059
Atrioventricular block 73.77 13.40 49 24813 13992 79705534
Intentional overdose 73.22 13.40 124 24738 105836 79613690
Rectal polyp 72.22 13.40 25 24837 1652 79717874
Electrocardiogram abnormal 68.25 13.40 50 24812 16687 79702839
Cardiogenic shock 67.45 13.40 74 24788 41840 79677686
Ventricular dyssynchrony 61.42 13.40 12 24850 73 79719453
Overdose 60.55 13.40 159 24703 184047 79535479
Change of bowel habit 60.13 13.40 25 24837 2732 79716794
Injection site discomfort 56.46 13.40 29 24833 5137 79714389
Bradyarrhythmia 53.34 13.40 26 24836 4120 79715406
Sensitisation 52.55 13.40 24 24838 3287 79716239
Completed suicide 52.30 13.40 182 24680 245585 79473941
Electrocardiogram PR prolongation 50.86 13.40 19 24843 1564 79717962
Defect conduction intraventricular 48.77 13.40 14 24848 499 79719027
Palpitations 48.64 13.40 116 24746 126494 79593032
Hyponatraemia 47.13 13.40 142 24720 177706 79541820
Intestinal haemorrhage 45.24 13.40 27 24835 6399 79713127
Drug level increased 44.06 13.40 58 24804 39593 79679933
Stress cardiomyopathy 42.49 13.40 32 24830 11134 79708392
Thyroid disorder 42.07 13.40 35 24827 14044 79705482
Thalamic infarction 39.50 13.40 15 24847 1292 79718234
Pain 38.80 13.40 103 24759 703699 79015827
Rheumatoid arthritis 38.26 13.40 9 24853 208461 79511065
Urine odour abnormal 38.14 13.40 24 24838 6249 79713277
Atrioventricular block complete 37.08 13.40 35 24827 16575 79702951
Frustration tolerance decreased 36.58 13.40 25 24837 7477 79712049
Needle issue 36.00 13.40 31 24831 13037 79706489
Cardio-respiratory arrest 34.95 13.40 93 24769 108417 79611109
Cardiac failure 34.95 13.40 117 24745 154725 79564801
Polyp 34.83 13.40 25 24837 8082 79711444
Bladder disorder 34.28 13.40 26 24836 9139 79710387
Furuncle 34.08 13.40 24 24838 7530 79711996
Ventricular extrasystoles 33.82 13.40 36 24826 19668 79699858
Infusion related reaction 33.36 13.40 15 24847 230222 79489304
Therapeutic product effect decreased 32.28 13.40 6 24856 163857 79555669
Proctalgia 32.27 13.40 26 24836 9975 79709551
Urine abnormality 32.26 13.40 24 24838 8195 79711331
Sinoatrial block 32.01 13.40 13 24849 1338 79718188
Pulseless electrical activity 31.92 13.40 30 24832 14130 79705396
Cerebral venous thrombosis 31.67 13.40 16 24846 2737 79716789
Drug intolerance 31.38 13.40 22 24840 264097 79455429
Accidental overdose 30.94 13.40 49 24813 39532 79679994
Bifascicular block 30.35 13.40 9 24853 360 79719166
Swelling 30.04 13.40 15 24847 216696 79502830
Interstitial lung disease 29.90 13.40 90 24772 112510 79607016
Musculoskeletal stiffness 29.39 13.40 9 24853 174999 79544527
Electrocardiogram QRS complex shortened 28.06 13.40 10 24852 720 79718806
Cardiac flutter 27.75 13.40 18 24844 4936 79714590
Acute kidney injury 27.67 13.40 265 24597 519139 79200387
High frequency ablation 27.61 13.40 8 24854 295 79719231
Peripheral coldness 27.09 13.40 29 24833 15941 79703585
Tubulointerstitial nephritis 26.72 13.40 45 24817 38190 79681336
Bundle branch block 26.67 13.40 12 24850 1588 79717938
International normalised ratio increased 26.66 13.40 72 24790 84649 79634877
Ventricular arrhythmia 26.46 13.40 22 24840 8818 79710708
Cutaneous T-cell lymphoma 26.19 13.40 14 24848 2689 79716837
Conduction disorder 25.90 13.40 15 24847 3364 79716162
Cardiotoxicity 25.82 13.40 25 24837 12214 79707312
Cardiac ablation 25.64 13.40 13 24849 2240 79717286
Suicide attempt 25.61 13.40 70 24792 82862 79636664
Electrocardiogram QRS complex abnormal 25.57 13.40 9 24853 625 79718901
Hyperkalaemia 25.41 13.40 86 24776 114312 79605214
Loss of consciousness 24.83 13.40 111 24751 167832 79551694
Duodenal ulcer 24.78 13.40 28 24834 16341 79703185
Subdural haematoma 24.68 13.40 39 24823 31395 79688131
Postoperative wound infection 24.61 13.40 25 24837 12936 79706590
Pericardial haemorrhage 24.37 13.40 16 24846 4479 79715047
Full blood count decreased 23.49 13.40 35 24827 26784 79692742
Extrasystoles 23.33 13.40 19 24843 7400 79712126
Amaurosis 23.31 13.40 10 24852 1181 79718345
Nasopharyngitis 23.17 13.40 27 24835 253854 79465672
Weight increased 22.73 13.40 32 24830 277354 79442172
Medication error 22.26 13.40 59 24803 68583 79650943
Glossodynia 22.11 13.40 3 24859 103334 79616192
Atrial tachycardia 21.87 13.40 18 24844 7115 79712411
Contraindicated product administered 21.69 13.40 11 24851 157527 79561999
Heart rate decreased 21.36 13.40 59 24803 70257 79649269
Wound 21.34 13.40 5 24857 116174 79603352
Unresponsive to stimuli 21.28 13.40 51 24811 55737 79663789
Gallbladder disorder 21.03 13.40 28 24834 19312 79700214
Sinus node dysfunction 20.67 13.40 18 24844 7683 79711843
Drug level above therapeutic 20.66 13.40 19 24843 8704 79710822
Hepatic enzyme increased 20.66 13.40 16 24846 182594 79536932
Dizziness 20.34 13.40 252 24610 526189 79193337
Shock 20.17 13.40 43 24819 43505 79676021
Lower respiratory tract infection 19.38 13.40 8 24854 129212 79590314
Mobility decreased 19.25 13.40 7 24855 122168 79597358
Asthma 19.25 13.40 9 24853 135086 79584440
Slow response to stimuli 19.24 13.40 10 24852 1815 79717711
Pacemaker syndrome 19.14 13.40 3 24859 3 79719523
Membrane stabilising effect 19.14 13.40 3 24859 3 79719523
Supraventricular tachycardia 18.97 13.40 28 24834 21242 79698284
Hypoglycaemic coma 18.91 13.40 14 24848 4746 79714780
Hypersensitivity 18.87 13.40 33 24829 262206 79457320
Cardiac disorder 18.82 13.40 54 24808 65703 79653823
Device malfunction 18.79 13.40 28 24834 21420 79698106
Nodal arrhythmia 18.48 13.40 10 24852 1968 79717558
Peripheral T-cell lymphoma unspecified recurrent 18.13 13.40 4 24858 47 79719479
Cardioversion 17.93 13.40 10 24852 2088 79717438
Cardiac tamponade 17.81 13.40 18 24844 9258 79710268
Arthralgia 17.80 13.40 105 24757 571698 79147828
Overflow diarrhoea 17.73 13.40 5 24857 167 79719359
Stomatitis 17.72 13.40 12 24850 146745 79572781
Exostosis 17.71 13.40 24 24838 16834 79702692
Cutaneous vasculitis 17.68 13.40 17 24845 8235 79711291
Microcytic anaemia 17.63 13.40 14 24848 5260 79714266
Musculoskeletal discomfort 17.53 13.40 26 24836 19809 79699717
Electrocardiogram T wave inversion 17.41 13.40 14 24848 5358 79714168
Neovascular age-related macular degeneration 17.31 13.40 6 24856 398 79719128
Poisoning deliberate 17.10 13.40 25 24837 18803 79700723
Mass 17.05 13.40 24 24838 17448 79702078
Splenic rupture 16.57 13.40 10 24852 2419 79717107
Sinusitis 16.56 13.40 22 24840 195479 79524047
Therapeutic product effect incomplete 16.55 13.40 12 24850 141633 79577893
Blood pressure systolic increased 16.34 13.40 52 24810 66934 79652592
Cerebral haematoma 16.33 13.40 16 24846 7926 79711600
C-reactive protein increased 16.33 13.40 10 24852 129017 79590509
Cerebral haemorrhage 16.16 13.40 47 24815 57626 79661900
Gastrointestinal ischaemia 16.09 13.40 6 24856 491 79719035
Haematoma 16.06 13.40 44 24818 52151 79667375
Subarachnoid haemorrhage 16.05 13.40 28 24834 24437 79695089
Lung neoplasm malignant 15.93 13.40 30 24832 27762 79691764
Drug-device interaction 15.78 13.40 4 24858 88 79719438
Rectal haemorrhage 15.75 13.40 56 24806 76244 79643282
Ischaemic stroke 15.67 13.40 33 24829 33098 79686428
Haemorrhage 15.61 13.40 63 24799 91055 79628471
Discomfort 15.53 13.40 10 24852 125607 79593919
Intracranial haematoma 15.51 13.40 7 24855 933 79718593
Reflexes abnormal 15.49 13.40 7 24855 936 79718590
Unmasking of previously unidentified disease 15.42 13.40 9 24853 2048 79717478
Bone disorder 15.40 13.40 24 24838 19089 79700437
Lentigo maligna 15.38 13.40 6 24856 556 79718970
Hypertensive crisis 15.25 13.40 25 24837 20745 79698781
Coma 15.23 13.40 67 24795 100582 79618944
Mixed liver injury 15.09 13.40 15 24847 7563 79711963
Rash 15.07 13.40 112 24750 578246 79141280
Respiratory acidosis 15.02 13.40 18 24844 11182 79708344
Alopecia 14.99 13.40 31 24831 231324 79488202
Arthropathy 14.93 13.40 20 24842 177091 79542435
Heart rate 14.93 13.40 4 24858 110 79719416
Blood glucose decreased 14.65 13.40 28 24834 26206 79693320
Vertigo 14.52 13.40 51 24811 69031 79650495
Systemic lupus erythematosus 14.50 13.40 10 24852 121139 79598387
Injection site mass 14.43 13.40 24 24838 20160 79699366
Acute respiratory distress syndrome 14.41 13.40 38 24824 44029 79675497
Hypokalaemia 14.17 13.40 85 24777 143955 79575571
Atrial conduction time prolongation 14.13 13.40 3 24859 29 79719497
Dermatitis exfoliative generalised 13.81 13.40 14 24848 7227 79712299
Vomiting 13.76 13.40 137 24725 665691 79053835

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C01BC04 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
ANTIARRHYTHMICS, CLASS I AND III
Antiarrhythmics, class Ic
FDA EPC N0000175426 Antiarrhythmic
CHEBI has role CHEBI:38070 antiarrhythmic agent
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Atrial fibrillation indication 49436004 DOID:0060224
Paroxysmal atrial fibrillation indication 282825002
Paroxysmal atrial flutter indication 427665004
Prevention of Paroxysmal Supraventricular Tachycardia indication
Life-Threatening Ventricular Tachycardia indication
Cardioversion of Atrial Fibrillation off-label use
Hyperkalemia contraindication 14140009
Myocardial infarction contraindication 22298006 DOID:5844
Complete atrioventricular block contraindication 27885002
Sick sinus syndrome contraindication 36083008 DOID:13884
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Second degree atrioventricular block contraindication 195042002
Disease of liver contraindication 235856003 DOID:409
Smokes tobacco daily contraindication 449868002
Right Bundle Branch Block with Left Hemiblock contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.78 acidic
pKa2 8.94 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 5.19 CHEMBL CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.41 CHEMBL
Sodium channel protein type 4 subunit alpha Ion channel Ki 4.75 WOMBAT-PK
Potassium voltage-gated channel subfamily A member 5 Ion channel BLOCKER Kd 4 IUPHAR
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 Ion channel IC50 2.77 WOMBAT-PK
Potassium voltage-gated channel subfamily A member 7 Ion channel BLOCKER Kd 5.10 IUPHAR
Potassium voltage-gated channel subfamily D member 2 Ion channel IC50 5 CHEMBL
Potassium voltage-gated channel subfamily C member 1 Ion channel BLOCKER IC50 4 IUPHAR

External reference:

IDSource
D00638 KEGG_DRUG
54143-56-5 SECONDARY_CAS_RN
4018822 VANDF
4019757 VANDF
C0016229 UMLSCUI
CHEBI:75984 CHEBI
K4D PDB_CHEM_ID
CHEMBL652 ChEMBL_ID
CHEMBL398673 ChEMBL_ID
CHEMBL1200822 ChEMBL_ID
D005424 MESH_DESCRIPTOR_UI
DB01195 DRUGBANK_ID
3356 PUBCHEM_CID
2560 IUPHAR_LIGAND_ID
4096 INN_ID
K94FTS1806 UNII
152403 RXNORM
2279 MMSL
43018 MMSL
4730 MMSL
d00234 MMSL
000628 NDDF
004483 NDDF
372751001 SNOMEDCT_US
46576005 SNOMEDCT_US
8886003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0010 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0010 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0011 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0011 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0012 TABLET 150 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0012 TABLET 150 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-817 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-817 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-818 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-818 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-819 TABLET 150 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 42806-819 TABLET 150 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-1132 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 50090-2233 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2968 TABLET 100 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-2968 TABLET 100 mg ORAL ANDA 19 sections
Flecainide Acetate Human Prescription Drug Label 1 50090-5267 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 50090-5267 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 50090-5306 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 50090-5306 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50090-6035 TABLET 50 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50268-320 TABLET 50 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50268-321 TABLET 100 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 50268-322 TABLET 150 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-018 TABLET 50 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-018 TABLET 50 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-019 TABLET 100 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-019 TABLET 100 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-020 TABLET 150 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 51407-020 TABLET 150 mg ORAL ANDA 19 sections