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 Hosey CM, Chan R, 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 536.94 14.38 149 15447 5318 56271153
Atrial fibrillation 387.27 14.38 285 15311 108612 56167859
Electrocardiogram QT prolonged 259.65 14.38 171 15425 54417 56222054
Bradycardia 229.10 14.38 172 15424 67332 56209139
Drug interaction 195.06 14.38 264 15332 209491 56066980
Arrhythmia 194.23 14.38 121 15475 34962 56241509
Ventricular tachycardia 180.95 14.38 90 15506 16811 56259660
Toxicity to various agents 173.86 14.38 259 15337 224305 56052166
Cardiac arrest 170.54 14.38 161 15435 86153 56190318
Torsade de pointes 120.72 14.38 62 15534 12378 56264093
Atrial flutter 113.69 14.38 54 15542 9115 56267356
Atrioventricular block first degree 112.86 14.38 49 15547 6716 56269755
Bundle branch block right 101.39 14.38 41 15555 4706 56271765
Ventricular fibrillation 84.88 14.38 47 15549 10905 56265566
Device pacing issue 82.98 14.38 15 15581 64 56276407
Rheumatoid arthritis 75.11 14.38 9 15587 382595 55893876
Hypotension 70.21 14.38 189 15407 250319 56026152
Cardiogenic shock 69.96 14.38 48 15548 16277 56260194
Hyponatraemia 65.15 14.38 108 15488 102031 56174440
Rectal polyp 63.41 14.38 20 15576 1113 56275358
Ventricular dyssynchrony 58.32 14.38 10 15586 29 56276442
Device capturing issue 58.06 14.38 10 15586 30 56276441
Syncope 58.04 14.38 106 15490 108093 56168378
Thalamic infarction 55.96 14.38 15 15581 467 56276004
Brugada syndrome 55.40 14.38 14 15582 344 56276127
Stress cardiomyopathy 54.46 14.38 32 15564 8304 56268167
Sinus bradycardia 53.66 14.38 38 15558 13548 56262923
Injection site discomfort 53.09 14.38 25 15571 4135 56272336
Tachyarrhythmia 52.75 14.38 25 15571 4196 56272275
Defect conduction intraventricular 52.06 14.38 11 15585 118 56276353
Change of bowel habit 51.44 14.38 20 15576 2069 56274402
Sensitisation 49.01 14.38 20 15576 2348 56274123
Completed suicide 47.96 14.38 111 15485 133722 56142749
Acute kidney injury 46.09 14.38 159 15437 240604 56035867
Cardiac failure 46.01 14.38 82 15514 82011 56194460
Bundle branch block left 45.76 14.38 26 15570 6336 56270135
Pain 45.64 14.38 71 15525 663113 55613358
Palpitations 45.26 14.38 91 15505 99581 56176890
Intestinal haemorrhage 44.30 14.38 21 15575 3525 56272946
Conduction disorder 44.16 14.38 16 15580 1362 56275109
Cardio-respiratory arrest 41.45 14.38 63 15533 55258 56221213
Tachycardia 40.35 14.38 90 15506 105786 56170685
Contraindicated product administered 40.15 14.38 3 15593 186283 56090188
Sinoatrial block 39.44 14.38 13 15583 833 56275638
Cerebral venous thrombosis 39.06 14.38 16 15580 1897 56274574
Ventricular arrhythmia 38.75 14.38 19 15577 3435 56273036
Needle issue 38.16 14.38 26 15570 8712 56267759
Overdose 38.15 14.38 88 15508 105742 56170729
Drug intolerance 37.99 14.38 13 15583 264805 56011666
Urine odour abnormal 36.93 14.38 22 15574 5852 56270619
Tubulointerstitial nephritis 36.55 14.38 33 15563 16632 56259839
Atrioventricular block 36.18 14.38 23 15573 6864 56269607
Therapeutic product effect decreased 35.76 14.38 3 15593 169449 56107022
Intentional overdose 35.57 14.38 66 15530 68051 56208420
Frustration tolerance decreased 35.34 14.38 22 15574 6331 56270140
Bifascicular block 35.26 14.38 8 15588 122 56276349
Bradyarrhythmia 35.07 14.38 15 15581 1981 56274490
Polyp 34.13 14.38 21 15575 5921 56270550
Electrocardiogram PR prolongation 33.73 14.38 11 15585 682 56275789
Cutaneous T-cell lymphoma 33.28 14.38 13 15583 1362 56275109
Proctalgia 33.00 14.38 20 15576 5489 56270982
Duodenal ulcer 32.94 14.38 22 15574 7133 56269338
Furuncle 31.24 14.38 20 15576 6039 56270432
Infusion related reaction 30.40 14.38 10 15586 208921 56067550
Electrocardiogram abnormal 30.37 14.38 22 15574 8122 56268349
Urine abnormality 29.41 14.38 20 15576 6679 56269792
Thyroid disorder 29.39 14.38 27 15569 13911 56262560
Swelling 29.19 14.38 15 15581 239756 56036715
Bladder disorder 28.39 14.38 21 15575 8003 56268468
Wound 27.84 14.38 3 15593 138801 56137670
Systemic lupus erythematosus 27.31 14.38 8 15588 180070 56096401
Full blood count decreased 27.27 14.38 33 15563 23316 56253155
Heart rate decreased 26.08 14.38 43 15553 40384 56236087
Arthropathy 25.17 14.38 12 15584 200263 56076208
Ventricular extrasystoles 24.77 14.38 22 15574 10848 56265623
Metabolic acidosis 24.72 14.38 42 15554 40412 56236059
Supraventricular tachycardia 24.68 14.38 24 15572 13267 56263204
Peripheral coldness 24.53 14.38 22 15574 10989 56265482
Pulmonary alveolar haemorrhage 24.31 14.38 15 15581 4249 56272222
Bundle branch block 24.11 14.38 9 15587 833 56275638
Subarachnoid haemorrhage 23.96 14.38 22 15574 11325 56265146
Postoperative wound infection 23.55 14.38 20 15576 9293 56267178
Slow response to stimuli 22.93 14.38 9 15587 955 56275516
Intracranial haematoma 22.84 14.38 7 15589 354 56276117
Subdural haematoma 22.53 14.38 23 15573 13476 56262995
Device malfunction 22.52 14.38 25 15571 16111 56260360
Heart rate irregular 22.17 14.38 28 15568 20651 56255820
Pericardial haemorrhage 22.10 14.38 10 15586 1510 56274961
Medication error 22.07 14.38 41 15555 42294 56234177
Dermatitis exfoliative generalised 22.00 14.38 13 15583 3407 56273064
Drug-device interaction 21.53 14.38 5 15591 85 56276386
Arthralgia 20.45 14.38 71 15525 501598 55774873
Musculoskeletal stiffness 20.14 14.38 9 15587 155998 56120473
Dizziness 19.57 14.38 174 15422 375966 55900505
Pacemaker syndrome 19.50 14.38 3 15593 3 56276468
Cerebral haemorrhage 19.22 14.38 31 15565 28575 56247896
Blood glucose decreased 19.14 14.38 25 15571 19062 56257409
Tachycardia foetal 18.58 14.38 5 15591 158 56276313
Rash pustular 18.28 14.38 15 15581 6648 56269823
Drug-disease interaction 18.15 14.38 6 15590 388 56276083
Pericarditis 18.12 14.38 4 15592 108919 56167552
Mass 18.10 14.38 20 15576 12819 56263652
Extrasystoles 17.98 14.38 13 15583 4786 56271685
Mixed liver injury 17.85 14.38 12 15584 3932 56272539
Gallbladder disorder 17.84 14.38 23 15573 17311 56259160
Accidental overdose 17.78 14.38 25 15571 20436 56256035
Alopecia 17.73 14.38 34 15562 293424 55983047
Hepatic enzyme increased 17.68 14.38 13 15583 171371 56105100
Phospholipidosis 17.63 14.38 4 15592 61 56276410
Supraventricular extrasystoles 17.38 14.38 12 15584 4108 56272363
Musculoskeletal discomfort 17.34 14.38 22 15574 16296 56260175
Hypersensitivity 17.03 14.38 28 15568 256380 56020091
Hyperkalaemia 16.90 14.38 41 15555 50824 56225647
Cardiac ablation 16.78 14.38 8 15588 1359 56275112
Drug level above therapeutic 16.76 14.38 12 15584 4350 56272121
Sinus node dysfunction 16.58 14.38 12 15584 4422 56272049
Lung neoplasm malignant 16.23 14.38 22 15574 17374 56259097
Jaundice 16.23 14.38 28 15568 27266 56249205
Rash 16.16 14.38 76 15520 492971 55783500
Bicytopenia 16.10 14.38 9 15587 2124 56274347
Atrial tachycardia 15.69 14.38 9 15587 2232 56274239
Sinusitis 15.68 14.38 19 15577 197562 56078909
Exostosis 15.65 14.38 20 15576 14923 56261548
Cerebral congestion 15.60 14.38 3 15593 19 56276452
Therapeutic product effect incomplete 15.54 14.38 5 15591 106026 56170445
Anaemia macrocytic 15.40 14.38 10 15586 3093 56273378
Ischaemic stroke 15.26 14.38 21 15575 16821 56259650
Cholestasis 15.21 14.38 27 15569 26886 56249585
Gravitational oedema 14.80 14.38 7 15589 1168 56275303
Cerebral haematoma 14.78 14.38 10 15586 3313 56273158
Joint swelling 14.69 14.38 37 15559 289763 55986708
Blister 14.50 14.38 6 15590 108881 56167590
Electrocardiogram QT interval 14.44 14.38 4 15592 141 56276330
Unresponsive to stimuli 14.42 14.38 29 15567 31696 56244775
Weight increased 14.41 14.38 26 15570 229677 56046794

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 252.38 14.60 81 10028 4148 31683087
Bradycardia 185.73 14.60 163 9946 69164 31618071
Atrial fibrillation 180.72 14.60 201 9908 113582 31573653
Brugada syndrome 141.32 14.60 35 10074 683 31686552
Ventricular tachycardia 133.43 14.60 87 10022 23614 31663621
Atrial flutter 116.27 14.60 67 10042 14588 31672647
Electrocardiogram QT prolonged 66.83 14.60 71 10038 37916 31649319
Tachycardia foetal 62.43 14.60 16 10093 360 31686875
Toxicity to various agents 62.12 14.60 161 9948 181326 31505909
Hydrops foetalis 59.16 14.60 16 10093 446 31686789
Atrioventricular block first degree 58.60 14.60 31 10078 5706 31681529
Tachyarrhythmia 52.55 14.60 24 10085 3215 31684020
Hypotension 51.95 14.60 163 9946 204455 31482780
Tachycardia 49.73 14.60 88 10021 76119 31611116
Bundle branch block right 47.54 14.60 29 10080 6995 31680240
Cardiac arrest 47.11 14.60 94 10015 88968 31598267
Syncope 43.97 14.60 89 10020 85093 31602142
Electrocardiogram abnormal 43.96 14.60 29 10080 8007 31679228
Intentional overdose 42.65 14.60 59 10050 41330 31645905
Arrhythmia 40.00 14.60 51 10058 33026 31654209
Drug interaction 39.68 14.60 151 9958 208392 31478843
Cardiac flutter 38.16 14.60 16 10093 1746 31685489
Atrioventricular block complete 35.34 14.60 26 10083 8539 31678696
Supraventricular tachycardia 35.30 14.60 28 10081 10279 31676956
Interstitial lung disease 35.11 14.60 67 10042 61336 31625899
Ventricular fibrillation 32.71 14.60 35 10074 18813 31668422
Drug level increased 32.45 14.60 36 10073 20150 31667085
High frequency ablation 31.60 14.60 8 10101 171 31687064
Electrocardiogram PR prolongation 31.42 14.60 11 10098 735 31686500
Electrocardiogram QRS complex shortened 31.38 14.60 8 10101 176 31687059
Amaurosis 29.17 14.60 10 10099 627 31686608
Overdose 27.72 14.60 74 10035 84590 31602645
Electrocardiogram QRS complex abnormal 26.85 14.60 8 10101 318 31686917
Device pacing issue 26.83 14.60 5 10104 22 31687213
Pulseless electrical activity 24.60 14.60 19 10090 6708 31680527
Suicide attempt 24.24 14.60 43 10066 37205 31650030
Defect conduction intraventricular 23.29 14.60 7 10102 287 31686948
Atrioventricular block 23.20 14.60 19 10090 7296 31679939
Foetal exposure during pregnancy 22.61 14.60 44 10065 40832 31646403
Device capturing issue 21.15 14.60 3 10106 0 31687235
Splenic rupture 21.12 14.60 10 10099 1453 31685782
Atrial tachycardia 20.93 14.60 11 10098 1996 31685239
Bradyarrhythmia 20.51 14.60 11 10098 2080 31685155
Microcytic anaemia 20.49 14.60 11 10098 2084 31685151
Sinus bradycardia 20.19 14.60 22 10087 12065 31675170
Pelvic pain 20.17 14.60 11 10098 2150 31685085
Accidental overdose 20.16 14.60 27 10082 18323 31668912
Acute respiratory distress syndrome 19.52 14.60 31 10078 24509 31662726
Reflexes abnormal 18.26 14.60 6 10103 330 31686905
Peripheral T-cell lymphoma unspecified recurrent 17.96 14.60 4 10105 48 31687187
Completed suicide 17.93 14.60 67 10042 91447 31595788
Palpitations 17.65 14.60 36 10073 34547 31652688
Cardiogenic shock 17.41 14.60 28 10081 22380 31664855
Hypoglycaemic coma 17.19 14.60 10 10099 2211 31685024
Hypomania 17.13 14.60 10 10099 2225 31685010
Retinal vascular occlusion 17.00 14.60 5 10104 190 31687045
Eosinophilic pneumonia 16.51 14.60 11 10098 3086 31684149
Torsade de pointes 16.09 14.60 15 10094 6835 31680400
Shock haemorrhagic 16.09 14.60 18 10091 10159 31677076
Calcium ionised increased 15.95 14.60 3 10106 14 31687221
Ventricular dyssynchrony 15.62 14.60 3 10106 16 31687219
Vertigo 15.47 14.60 27 10082 23058 31664177
Pericardial effusion 14.73 14.60 26 10083 22397 31664838

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 682.54 14.49 212 22782 9594 70895856
Atrial fibrillation 473.39 14.49 426 22568 183922 70721528
Bradycardia 380.20 14.49 318 22676 124297 70781153
Ventricular tachycardia 303.80 14.49 173 22821 36250 70869200
Electrocardiogram QT prolonged 254.18 14.49 213 22781 83304 70822146
Atrial flutter 198.05 14.49 107 22887 20220 70885230
Arrhythmia 193.47 14.49 154 22840 55989 70849461
Toxicity to various agents 187.32 14.49 394 22600 381778 70523672
Brugada syndrome 186.73 14.49 48 22946 1075 70904375
Cardiac arrest 186.69 14.49 244 22750 159590 70745860
Drug interaction 164.95 14.49 374 22620 381067 70524383
Atrioventricular block first degree 138.12 14.49 70 22924 11603 70893847
Bundle branch block right 126.63 14.49 64 22930 10546 70894904
Torsade de pointes 111.92 14.49 71 22923 18045 70887405
Ventricular fibrillation 103.38 14.49 79 22915 27032 70878418
Tachyarrhythmia 101.90 14.49 47 22947 6335 70899115
Hypotension 101.07 14.49 324 22670 404057 70501393
Syncope 96.62 14.49 184 22810 165525 70739925
Device pacing issue 90.91 14.49 17 22977 75 70905375
Tachycardia 82.67 14.49 168 22826 158378 70747072
Intentional overdose 76.40 14.49 124 22870 98311 70807139
Device capturing issue 75.91 14.49 13 22981 30 70905420
Electrocardiogram abnormal 72.45 14.49 50 22944 14614 70890836
Cardiogenic shock 72.07 14.49 73 22921 36234 70869216
Rheumatoid arthritis 67.00 14.49 8 22986 291797 70613653
Sinus bradycardia 65.13 14.49 57 22937 23566 70881884
Overdose 63.91 14.49 158 22836 169587 70735863
Ventricular dyssynchrony 59.89 14.49 11 22983 43 70905407
Rectal polyp 58.85 14.49 21 22973 1459 70903991
Atrioventricular block 57.42 14.49 41 22953 12647 70892803
Completed suicide 55.68 14.49 181 22813 226954 70678496
Bundle branch block left 55.04 14.49 37 22957 10362 70895088
Bradyarrhythmia 53.56 14.49 26 22968 3927 70901523
Palpitations 50.31 14.49 111 22883 110642 70794808
Hyponatraemia 49.02 14.49 138 22856 159949 70745501
Electrocardiogram PR prolongation 48.29 14.49 18 22976 1416 70904034
Change of bowel habit 47.08 14.49 21 22973 2618 70902832
Injection site discomfort 46.64 14.49 25 22969 4644 70900806
Sensitisation 45.14 14.49 20 22974 2453 70902997
Stress cardiomyopathy 44.93 14.49 32 22962 9830 70895620
Defect conduction intraventricular 42.20 14.49 12 22982 397 70905053
Pain 39.74 14.49 91 22903 628725 70276725
Thalamic infarction 39.70 14.49 15 22979 1225 70904225
Drug level increased 38.37 14.49 53 22941 36416 70869034
Atrioventricular block complete 36.69 14.49 34 22960 15129 70890321
Intestinal haemorrhage 35.70 14.49 23 22971 5997 70899453
Thyroid disorder 35.44 14.49 31 22963 12801 70892649
Accidental overdose 33.93 14.49 49 22945 35072 70870378
Drug intolerance 32.91 14.49 16 22978 225671 70679779
Pulseless electrical activity 32.69 14.49 30 22964 13185 70892265
Ventricular arrhythmia 32.47 14.49 24 22970 7806 70897644
Cerebral venous thrombosis 32.45 14.49 16 22978 2499 70902951
Sinoatrial block 32.34 14.49 13 22981 1253 70904197
Cardio-respiratory arrest 31.99 14.49 88 22906 100589 70804861
Atrial tachycardia 31.87 14.49 18 22976 3702 70901748
Ventricular extrasystoles 31.42 14.49 34 22960 18192 70887258
Cardiac failure 31.26 14.49 110 22884 143431 70762019
Infusion related reaction 30.37 14.49 13 22981 197521 70707929
Bifascicular block 30.06 14.49 9 22985 358 70905092
Suicide attempt 29.87 14.49 74 22920 79436 70826014
Urine odour abnormal 29.67 14.49 20 22974 5623 70899827
Needle issue 29.40 14.49 26 22968 10889 70894561
Cardiac flutter 28.72 14.49 18 22976 4475 70900975
Frustration tolerance decreased 28.64 14.49 21 22973 6744 70898706
Therapeutic product effect decreased 28.13 14.49 6 22988 143012 70762438
High frequency ablation 27.56 14.49 8 22986 285 70905165
Polyp 27.55 14.49 21 22973 7149 70898301
Acute kidney injury 27.40 14.49 254 22740 474370 70431080
Bundle branch block 27.22 14.49 12 22982 1454 70903996
Interstitial lung disease 27.04 14.49 85 22909 104600 70800850
Bladder disorder 26.95 14.49 22 22972 8267 70897183
Swelling 26.54 14.49 14 22980 188525 70716925
Cutaneous T-cell lymphoma 26.43 14.49 14 22980 2539 70902911
Tubulointerstitial nephritis 26.09 14.49 42 22952 33034 70872416
International normalised ratio increased 26.08 14.49 71 22923 80655 70824795
Asthma 26.06 14.49 4 22990 120789 70784661
Electrocardiogram QRS complex abnormal 25.96 14.49 9 22985 574 70904876
Supraventricular tachycardia 25.96 14.49 32 22962 19678 70885772
Furuncle 25.81 14.49 20 22974 6978 70898472
Electrocardiogram QRS complex shortened 24.70 14.49 9 22985 664 70904786
Proctalgia 24.67 14.49 21 22973 8362 70897088
Pericardial haemorrhage 24.55 14.49 16 22978 4252 70901198
Amaurosis 23.96 14.49 10 22984 1060 70904390
Musculoskeletal stiffness 23.89 14.49 9 22985 147751 70757699
Urine abnormality 23.81 14.49 20 22974 7818 70897632
Conduction disorder 23.81 14.49 14 22980 3104 70902346
Medication error 23.55 14.49 55 22939 56857 70848593
Cardiac ablation 23.46 14.49 12 22982 2026 70903424
Subdural haematoma 22.83 14.49 37 22957 29261 70876189
Drug level above therapeutic 21.98 14.49 19 22975 7723 70897727
Hyperkalaemia 21.76 14.49 80 22914 106511 70798939
Loss of consciousness 21.71 14.49 104 22890 155612 70749838
Arthralgia 21.59 14.49 87 22907 503303 70402147
Peripheral coldness 21.49 14.49 25 22969 14475 70890975
Cardiotoxicity 21.49 14.49 22 22972 11048 70894402
Sinus node dysfunction 21.18 14.49 18 22976 7151 70898299
Dizziness 20.85 14.49 236 22758 463905 70441545
Nasopharyngitis 20.63 14.49 25 22969 222181 70683269
Device malfunction 20.47 14.49 28 22966 19056 70886394
Contraindicated product administered 20.46 14.49 9 22985 134603 70770847
Therapeutic product effect incomplete 19.89 14.49 7 22987 119875 70785575
Extrasystoles 19.78 14.49 17 22977 6857 70898593
Weight increased 19.73 14.49 30 22964 242301 70663149
Full blood count decreased 19.73 14.49 31 22963 23887 70881563
Hypoglycaemic coma 19.52 14.49 14 22980 4347 70901103
Slow response to stimuli 19.36 14.49 10 22984 1723 70903727
Postoperative wound infection 19.28 14.49 21 22973 11317 70894133
Unresponsive to stimuli 19.15 14.49 48 22946 51883 70853567
Pacemaker syndrome 19.03 14.49 3 22991 3 70905447
Membrane stabilising effect 19.03 14.49 3 22991 3 70905447
Duodenal ulcer 18.83 14.49 24 22970 15256 70890194
Subarachnoid haemorrhage 18.53 14.49 27 22967 19477 70885973
Cardiac tamponade 18.37 14.49 18 22976 8577 70896873
Glossodynia 18.35 14.49 3 22991 86484 70818966
Microcytic anaemia 18.34 14.49 14 22980 4775 70900675
Cardioversion 18.23 14.49 10 22984 1944 70903506
Diarrhoea 17.98 14.49 165 22829 783176 70122274
Peripheral T-cell lymphoma unspecified recurrent 17.82 14.49 4 22990 49 70905401
Wound 17.74 14.49 5 22989 98727 70806723
Electrocardiogram T wave inversion 17.73 14.49 14 22980 5017 70900433
Hepatic enzyme increased 17.60 14.49 15 22979 156975 70748475
Heart rate decreased 17.54 14.49 52 22942 61963 70843487
Rectal haemorrhage 17.50 14.49 54 22940 65777 70839673
Haematoma 17.07 14.49 44 22950 48374 70857076
Cerebral haematoma 16.80 14.49 16 22978 7362 70898088
Rash 16.79 14.49 97 22897 510465 70394985
Ischaemic stroke 16.43 14.49 33 22961 30787 70874663
Vomiting 16.30 14.49 119 22875 592992 70312458
Lower respiratory tract infection 16.20 14.49 8 22986 111905 70793545
Reflexes abnormal 16.07 14.49 7 22987 825 70904625
Stomatitis 16.03 14.49 11 22983 128500 70776950
Unmasking of previously unidentified disease 15.99 14.49 9 22985 1838 70903612
Drug-device interaction 15.89 14.49 4 22990 82 70905368
Intracranial haematoma 15.89 14.49 7 22987 847 70904603
Sinusitis 15.74 14.49 19 22975 169176 70736274
Respiratory acidosis 15.70 14.49 18 22976 10263 70895187
Hypersensitivity 15.50 14.49 32 22962 229780 70675670
Mobility decreased 15.47 14.49 7 22987 102992 70802458
Mixed liver injury 15.09 14.49 14 22980 6235 70899215
Cerebral haemorrhage 15.08 14.49 45 22949 53819 70851631
Acute respiratory distress syndrome 15.07 14.49 38 22956 41216 70864234
Atrial conduction time prolongation 15 14.49 3 22991 20 70905430
Nausea 14.92 14.49 191 22803 851897 70053553
Dermatitis exfoliative generalised 14.78 14.49 14 22980 6400 70899050
Gallbladder disorder 14.67 14.49 23 22971 17689 70887761
Hypertensive crisis 14.56 14.49 24 22970 19238 70886212

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/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 A member 5 Ion channel BLOCKER Kd 4 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 0054-0011 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 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 42806-819 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 50090-5267 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 50090-6035 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 51407-019 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 53746-641 TABLET 50 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 53746-642 TABLET 100 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 53746-643 TABLET 150 mg ORAL ANDA 12 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 54868-5074 TABLET 50 mg ORAL ANDA 17 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 54868-5405 TABLET 100 mg ORAL ANDA 17 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 54868-5586 TABLET 150 mg ORAL ANDA 17 sections
Flecainide Acetate Human Prescription Drug Label 1 57237-063 TABLET 50 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 57237-064 TABLET 100 mg ORAL ANDA 18 sections
Flecainide Acetate Human Prescription Drug Label 1 57237-065 TABLET 150 mg ORAL ANDA 18 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 62559-380 TABLET 50 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 62559-381 TABLET 100 mg ORAL ANDA 19 sections
Flecainide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 62559-382 TABLET 150 mg ORAL ANDA 19 sections