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flecainide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Class I antiarrhythmics, procainamide and lidocaine derivatives | 1176 | 54143-55-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
| 0.20 | g | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 12.07 µM/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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 10.116 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 1 | High | 1 | |
| rat-kpuu-brain | Rat brain Kpuu | 0.051 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 31, 1985 | FDA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Electrocardiogram QRS complex prolonged | 902.41 | 14.63 | 231 | 21119 | 7117 | 90599980 |
| Toxicity to various agents | 394.72 | 14.63 | 408 | 20942 | 287438 | 90319659 |
| Electrocardiogram QT prolonged | 381.11 | 14.63 | 228 | 21122 | 72228 | 90534869 |
| Bradycardia | 345.57 | 14.63 | 226 | 21124 | 83621 | 90523476 |
| Atrial fibrillation | 300.66 | 14.63 | 250 | 21100 | 133361 | 90473736 |
| Drug interaction | 300.53 | 14.63 | 347 | 21003 | 276106 | 90330991 |
| Ventricular tachycardia | 292.49 | 14.63 | 134 | 21216 | 24574 | 90582523 |
| Cardiac arrest | 247.79 | 14.63 | 202 | 21148 | 104733 | 90502364 |
| Arrhythmia | 206.43 | 14.63 | 127 | 21223 | 42205 | 90564892 |
| Atrial flutter | 181.72 | 14.63 | 75 | 21275 | 10683 | 90596414 |
| Torsade de pointes | 169.22 | 14.63 | 79 | 21271 | 15103 | 90591994 |
| Bundle branch block right | 156.75 | 14.63 | 56 | 21294 | 5397 | 90601700 |
| Atrioventricular block first degree | 135.88 | 14.63 | 57 | 21293 | 8454 | 90598643 |
| Cardiogenic shock | 128.48 | 14.63 | 77 | 21273 | 24391 | 90582706 |
| Syncope | 123.21 | 14.63 | 154 | 21196 | 132509 | 90474588 |
| Defect conduction intraventricular | 121.69 | 14.63 | 24 | 21326 | 212 | 90606885 |
| Device pacing issue | 119.88 | 14.63 | 21 | 21329 | 88 | 90607009 |
| Hypotension | 117.00 | 14.63 | 245 | 21105 | 325152 | 90281945 |
| Acute kidney injury | 93.49 | 14.63 | 222 | 21128 | 320165 | 90286932 |
| Hyponatraemia | 93.35 | 14.63 | 135 | 21215 | 133403 | 90473694 |
| Ventricular fibrillation | 89.14 | 14.63 | 50 | 21300 | 13994 | 90593103 |
| Completed suicide | 84.88 | 14.63 | 135 | 21215 | 144923 | 90462174 |
| Sinus bradycardia | 80.41 | 14.63 | 50 | 21300 | 16902 | 90590195 |
| Bundle branch block left | 78.59 | 14.63 | 38 | 21312 | 7847 | 90599250 |
| Change of bowel habit | 71.53 | 14.63 | 25 | 21325 | 2258 | 90604839 |
| Tachycardia | 71.46 | 14.63 | 131 | 21219 | 157542 | 90449555 |
| Rectal polyp | 71.32 | 14.63 | 21 | 21329 | 1092 | 90606005 |
| Brugada syndrome | 68.52 | 14.63 | 17 | 21333 | 458 | 90606639 |
| Cardio-respiratory arrest | 67.89 | 14.63 | 79 | 21271 | 63061 | 90544036 |
| Device capturing issue | 66.43 | 14.63 | 11 | 21339 | 30 | 90607067 |
| Ventricular dyssynchrony | 65.65 | 14.63 | 12 | 21338 | 67 | 90607030 |
| Infusion related reaction | 65.52 | 14.63 | 10 | 21340 | 416770 | 90190327 |
| Injection site discomfort | 63.38 | 14.63 | 30 | 21320 | 5910 | 90601187 |
| Cardiac failure | 62.79 | 14.63 | 101 | 21249 | 109395 | 90497702 |
| Bradyarrhythmia | 62.25 | 14.63 | 23 | 21327 | 2438 | 90604659 |
| Wound | 58.98 | 14.63 | 3 | 21347 | 302977 | 90304120 |
| Intentional overdose | 58.57 | 14.63 | 90 | 21260 | 93744 | 90513353 |
| Intestinal haemorrhage | 58.56 | 14.63 | 26 | 21324 | 4421 | 90602676 |
| Systemic lupus erythematosus | 58.47 | 14.63 | 8 | 21342 | 361888 | 90245209 |
| Conduction disorder | 58.23 | 14.63 | 20 | 21330 | 1715 | 90605382 |
| Atrioventricular block | 57.62 | 14.63 | 32 | 21318 | 8783 | 90598314 |
| Sensitisation | 56.88 | 14.63 | 25 | 21325 | 4150 | 90602947 |
| Tachyarrhythmia | 56.75 | 14.63 | 27 | 21323 | 5379 | 90601718 |
| Sinoatrial block | 55.90 | 14.63 | 17 | 21333 | 988 | 90606109 |
| Drug intolerance | 55.80 | 14.63 | 18 | 21332 | 447573 | 90159524 |
| Stress cardiomyopathy | 54.92 | 14.63 | 36 | 21314 | 13319 | 90593778 |
| Ventricular tachyarrhythmia | 53.89 | 14.63 | 12 | 21338 | 199 | 90606898 |
| Palpitations | 53.80 | 14.63 | 107 | 21243 | 136621 | 90470476 |
| Therapeutic product effect decreased | 53.24 | 14.63 | 3 | 21347 | 277568 | 90329529 |
| Electrocardiogram abnormal | 52.99 | 14.63 | 32 | 21318 | 10266 | 90596831 |
| Thalamic infarction | 52.68 | 14.63 | 14 | 21336 | 498 | 90606599 |
| Frustration tolerance decreased | 52.53 | 14.63 | 29 | 21321 | 7867 | 90599230 |
| Contraindicated product administered | 51.89 | 14.63 | 7 | 21343 | 320132 | 90286965 |
| Sinus node dysfunction | 50.69 | 14.63 | 25 | 21325 | 5387 | 90601710 |
| Swelling | 50.24 | 14.63 | 18 | 21332 | 419040 | 90188057 |
| Duodenal ulcer | 49.97 | 14.63 | 30 | 21320 | 9522 | 90597575 |
| Electrocardiogram PR prolongation | 49.61 | 14.63 | 15 | 21335 | 855 | 90606242 |
| Urine odour abnormal | 49.28 | 14.63 | 27 | 21323 | 7217 | 90599880 |
| Pericarditis | 48.66 | 14.63 | 4 | 21346 | 270147 | 90336950 |
| Rheumatoid arthritis | 48.07 | 14.63 | 13 | 21337 | 362601 | 90244496 |
| Overdose | 47.77 | 14.63 | 111 | 21239 | 157598 | 90449499 |
| Atrial conduction time prolongation | 47.26 | 14.63 | 8 | 21342 | 26 | 90607071 |
| Needle issue | 46.46 | 14.63 | 33 | 21317 | 13901 | 90593196 |
| Hepatic enzyme increased | 45.85 | 14.63 | 14 | 21336 | 360722 | 90246375 |
| Polyp | 45.23 | 14.63 | 26 | 21324 | 7618 | 90599479 |
| Musculoskeletal stiffness | 44.61 | 14.63 | 8 | 21342 | 296524 | 90310573 |
| Cerebral haemorrhage | 43.62 | 14.63 | 47 | 21303 | 34475 | 90572622 |
| Furuncle | 42.83 | 14.63 | 25 | 21325 | 7536 | 90599561 |
| Urine abnormality | 42.30 | 14.63 | 25 | 21325 | 7712 | 90599385 |
| Bifascicular block | 42.11 | 14.63 | 9 | 21341 | 122 | 90606975 |
| Arthropathy | 41.78 | 14.63 | 17 | 21333 | 366225 | 90240872 |
| Proctalgia | 40.96 | 14.63 | 25 | 21325 | 8173 | 90598924 |
| Pain | 40.96 | 14.63 | 111 | 21239 | 996230 | 89610867 |
| Ventricular arrhythmia | 40.59 | 14.63 | 20 | 21330 | 4301 | 90602796 |
| Cholestasis | 39.98 | 14.63 | 46 | 21304 | 36253 | 90570844 |
| Nodal arrhythmia | 39.79 | 14.63 | 14 | 21336 | 1289 | 90605808 |
| Thyroid disorder | 39.32 | 14.63 | 33 | 21317 | 17752 | 90589345 |
| Ventricular extrasystoles | 38.78 | 14.63 | 29 | 21321 | 13221 | 90593876 |
| Heart rate decreased | 38.68 | 14.63 | 55 | 21295 | 53450 | 90553647 |
| BRASH syndrome | 38.29 | 14.63 | 15 | 21335 | 1864 | 90605233 |
| Blister | 38.09 | 14.63 | 7 | 21343 | 254991 | 90352106 |
| Bladder disorder | 37.05 | 14.63 | 26 | 21324 | 10746 | 90596351 |
| Cutaneous T-cell lymphoma | 36.82 | 14.63 | 14 | 21336 | 1606 | 90605491 |
| Cerebral venous thrombosis | 35.19 | 14.63 | 15 | 21335 | 2313 | 90604784 |
| Mobility decreased | 35.14 | 14.63 | 8 | 21342 | 250726 | 90356371 |
| Lower respiratory tract infection | 35.12 | 14.63 | 8 | 21342 | 250651 | 90356446 |
| Irritable bowel syndrome | 34.91 | 14.63 | 4 | 21346 | 207444 | 90399653 |
| Accidental overdose | 34.86 | 14.63 | 38 | 21312 | 28235 | 90578862 |
| Hypersensitivity | 34.22 | 14.63 | 34 | 21316 | 454643 | 90152454 |
| Full blood count decreased | 33.33 | 14.63 | 38 | 21312 | 29651 | 90577446 |
| Peripheral coldness | 33.26 | 14.63 | 27 | 21323 | 13865 | 90593232 |
| Tubulointerstitial nephritis | 32.89 | 14.63 | 35 | 21315 | 25308 | 90581789 |
| Fibromyalgia | 32.27 | 14.63 | 5 | 21345 | 206264 | 90400833 |
| Hepatic cytolysis | 32.08 | 14.63 | 38 | 21312 | 30878 | 90576219 |
| Weight increased | 31.74 | 14.63 | 31 | 21319 | 417896 | 90189201 |
| Subdural haematoma | 30.98 | 14.63 | 28 | 21322 | 16617 | 90590480 |
| Stomatitis | 30.91 | 14.63 | 13 | 21337 | 274685 | 90332412 |
| Anticoagulation drug level abnormal | 30.74 | 14.63 | 7 | 21343 | 129 | 90606968 |
| Ill-defined disorder | 30.04 | 14.63 | 4 | 21346 | 184887 | 90422210 |
| Impaired healing | 29.90 | 14.63 | 9 | 21341 | 234190 | 90372907 |
| Alopecia | 29.86 | 14.63 | 44 | 21306 | 495027 | 90112070 |
| Postoperative wound infection | 29.86 | 14.63 | 25 | 21325 | 13401 | 90593696 |
| Pulseless electrical activity | 29.43 | 14.63 | 21 | 21329 | 8911 | 90598186 |
| Metabolic acidosis | 28.73 | 14.63 | 49 | 21301 | 55627 | 90551470 |
| Gallbladder disorder | 28.67 | 14.63 | 29 | 21321 | 19774 | 90587323 |
| Mass | 28.59 | 14.63 | 26 | 21324 | 15551 | 90591546 |
| Haemodynamic instability | 28.50 | 14.63 | 23 | 21327 | 11716 | 90595381 |
| Blood glucose decreased | 28.03 | 14.63 | 31 | 21319 | 23398 | 90583699 |
| Dermatitis exfoliative generalised | 27.80 | 14.63 | 17 | 21333 | 5576 | 90601521 |
| Rhythm idioventricular | 27.65 | 14.63 | 8 | 21342 | 391 | 90606706 |
| Hypertensive crisis | 27.51 | 14.63 | 27 | 21323 | 17757 | 90589340 |
| Type 2 diabetes mellitus | 27.46 | 14.63 | 7 | 21343 | 203237 | 90403860 |
| Device malfunction | 27.27 | 14.63 | 29 | 21321 | 20948 | 90586149 |
| Psoriatic arthropathy | 27.01 | 14.63 | 10 | 21340 | 228325 | 90378772 |
| Fall | 26.98 | 14.63 | 200 | 21150 | 481610 | 90125487 |
| Hyperkalaemia | 26.94 | 14.63 | 52 | 21298 | 64912 | 90542185 |
| Respiratory arrest | 26.71 | 14.63 | 36 | 21314 | 33275 | 90573822 |
| Drug-device interaction | 26.23 | 14.63 | 6 | 21344 | 113 | 90606984 |
| Heart rate irregular | 25.46 | 14.63 | 30 | 21320 | 24238 | 90582859 |
| Drug level above therapeutic | 24.72 | 14.63 | 16 | 21334 | 5793 | 90601304 |
| Bundle branch block | 24.58 | 14.63 | 9 | 21341 | 930 | 90606167 |
| Injection site mass | 24.33 | 14.63 | 28 | 21322 | 22062 | 90585035 |
| Musculoskeletal discomfort | 23.79 | 14.63 | 27 | 21323 | 20964 | 90586133 |
| Supraventricular tachycardia | 23.79 | 14.63 | 24 | 21326 | 16312 | 90590785 |
| Dizziness | 23.64 | 14.63 | 227 | 21123 | 589057 | 90018040 |
| Intracranial haematoma | 23.25 | 14.63 | 7 | 21343 | 393 | 90606704 |
| Tachycardia foetal | 23.22 | 14.63 | 6 | 21344 | 191 | 90606906 |
| Electrocardiogram QT interval | 23.10 | 14.63 | 6 | 21344 | 195 | 90606902 |
| C-reactive protein increased | 23.10 | 14.63 | 7 | 21343 | 181382 | 90425715 |
| Unresponsive to stimuli | 22.98 | 14.63 | 36 | 21314 | 38085 | 90569012 |
| Shock | 22.92 | 14.63 | 31 | 21319 | 28747 | 90578350 |
| Jaundice | 22.87 | 14.63 | 33 | 21317 | 32484 | 90574613 |
| Wheezing | 22.70 | 14.63 | 14 | 21336 | 238066 | 90369031 |
| Cardiac ablation | 22.56 | 14.63 | 10 | 21340 | 1694 | 90605403 |
| Hypokalaemia | 22.47 | 14.63 | 75 | 21275 | 131041 | 90476056 |
| Discomfort | 22.42 | 14.63 | 19 | 21331 | 274316 | 90332781 |
| Drug level increased | 22.25 | 14.63 | 30 | 21320 | 27732 | 90579365 |
| Sinusitis | 22.16 | 14.63 | 29 | 21321 | 343059 | 90264038 |
| Urinary incontinence | 21.99 | 14.63 | 35 | 21315 | 37531 | 90569566 |
| Pulmonary alveolar haemorrhage | 21.85 | 14.63 | 15 | 21335 | 5983 | 90601114 |
| Pericardial haemorrhage | 21.64 | 14.63 | 10 | 21340 | 1866 | 90605231 |
| Spinal epidural haematoma | 21.51 | 14.63 | 9 | 21341 | 1325 | 90605772 |
| Arthralgia | 21.13 | 14.63 | 103 | 21247 | 778419 | 89828678 |
| Cardiotoxicity | 20.88 | 14.63 | 19 | 21331 | 11370 | 90595727 |
| Lung neoplasm malignant | 20.64 | 14.63 | 27 | 21323 | 24246 | 90582851 |
| Presyncope | 20.53 | 14.63 | 31 | 21319 | 31774 | 90575323 |
| Extrasystoles | 20.26 | 14.63 | 14 | 21336 | 5643 | 90601454 |
| Subarachnoid haemorrhage | 20.24 | 14.63 | 23 | 21327 | 17881 | 90589216 |
| Cardiac failure acute | 20.13 | 14.63 | 19 | 21331 | 11910 | 90595187 |
| Bone disorder | 20.10 | 14.63 | 26 | 21324 | 23094 | 90584003 |
| Pacemaker syndrome | 19.98 | 14.63 | 3 | 21347 | 3 | 90607094 |
| Gait inability | 19.86 | 14.63 | 5 | 21345 | 146451 | 90460646 |
| Diffuse alveolar damage | 19.74 | 14.63 | 8 | 21342 | 1087 | 90606010 |
| Slow response to stimuli | 19.73 | 14.63 | 8 | 21342 | 1088 | 90606009 |
| Rash | 19.54 | 14.63 | 109 | 21241 | 795991 | 89811106 |
| Liver injury | 19.29 | 14.63 | 8 | 21342 | 170559 | 90436538 |
| Joint swelling | 19.18 | 14.63 | 58 | 21292 | 503242 | 90103855 |
| Dry mouth | 18.72 | 14.63 | 10 | 21340 | 184049 | 90423048 |
| Cerebral haematoma | 18.71 | 14.63 | 12 | 21338 | 4277 | 90602820 |
| Urticaria | 18.63 | 14.63 | 28 | 21322 | 312706 | 90294391 |
| Nasopharyngitis | 18.48 | 14.63 | 43 | 21307 | 407061 | 90200036 |
| Cardiac disorder | 18.27 | 14.63 | 41 | 21309 | 56831 | 90550266 |
| Renal failure | 18.23 | 14.63 | 70 | 21280 | 130937 | 90476160 |
| Adverse event | 18.01 | 14.63 | 3 | 21347 | 117415 | 90489682 |
| Rash pustular | 17.92 | 14.63 | 15 | 21335 | 8034 | 90599063 |
| Intentional product use issue | 17.74 | 14.63 | 15 | 21335 | 216877 | 90390220 |
| Therapeutic product effect incomplete | 17.66 | 14.63 | 12 | 21338 | 193884 | 90413213 |
| Coma | 17.62 | 14.63 | 47 | 21303 | 72585 | 90534512 |
| Atrioventricular block complete | 17.27 | 14.63 | 16 | 21334 | 9795 | 90597302 |
| Cutaneous vasculitis | 17.26 | 14.63 | 14 | 21336 | 7179 | 90599918 |
| Accelerated idioventricular rhythm | 16.89 | 14.63 | 4 | 21346 | 88 | 90607009 |
| Alkalosis | 16.79 | 14.63 | 6 | 21344 | 578 | 90606519 |
| Osteoarthritis | 16.68 | 14.63 | 13 | 21337 | 195717 | 90411380 |
| Haematemesis | 16.50 | 14.63 | 29 | 21321 | 33697 | 90573400 |
| International normalised ratio increased | 16.21 | 14.63 | 35 | 21315 | 47281 | 90559816 |
| Insomnia | 16.13 | 14.63 | 34 | 21316 | 333440 | 90273657 |
| Foetal death | 16.01 | 14.63 | 22 | 21328 | 20701 | 90586396 |
| Depression | 15.97 | 14.63 | 29 | 21321 | 300572 | 90306525 |
| Haemorrhage | 15.94 | 14.63 | 44 | 21306 | 69325 | 90537772 |
| Cardiac tamponade | 15.76 | 14.63 | 12 | 21338 | 5620 | 90601477 |
| Hepatocellular injury | 15.62 | 14.63 | 26 | 21324 | 28932 | 90578165 |
| Hallucination, visual | 15.61 | 14.63 | 23 | 21327 | 23069 | 90584028 |
| Gravitational oedema | 15.59 | 14.63 | 7 | 21343 | 1222 | 90605875 |
| Antisynthetase syndrome | 15.55 | 14.63 | 4 | 21346 | 125 | 90606972 |
| Hyperammonaemic encephalopathy | 15.49 | 14.63 | 9 | 21341 | 2690 | 90604407 |
| Product administered to patient of inappropriate age | 15.47 | 14.63 | 11 | 21339 | 4642 | 90602455 |
| Infection | 15.06 | 14.63 | 40 | 21310 | 362054 | 90245043 |
| Cardioactive drug level above therapeutic | 14.95 | 14.63 | 4 | 21346 | 146 | 90606951 |
| Ischaemic stroke | 14.87 | 14.63 | 22 | 21328 | 22144 | 90584953 |
| Cardioversion | 14.86 | 14.63 | 7 | 21343 | 1363 | 90605734 |
| Feeling abnormal | 14.71 | 14.63 | 78 | 21272 | 167157 | 90439940 |
| Asthenia | 14.69 | 14.63 | 191 | 21159 | 533560 | 90073537 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Electrocardiogram QRS complex prolonged | 403.57 | 15.26 | 125 | 13469 | 5698 | 42602043 |
| Bradycardia | 220.92 | 15.26 | 197 | 13397 | 85287 | 42522454 |
| Brugada syndrome | 175.81 | 15.26 | 45 | 13549 | 1008 | 42606733 |
| Ventricular tachycardia | 168.03 | 15.26 | 110 | 13484 | 30050 | 42577691 |
| Toxicity to various agents | 149.51 | 15.26 | 264 | 13330 | 228872 | 42378869 |
| Atrial flutter | 126.61 | 15.26 | 75 | 13519 | 17176 | 42590565 |
| Electrocardiogram QT prolonged | 118.73 | 15.26 | 108 | 13486 | 47837 | 42559904 |
| Atrial fibrillation | 113.85 | 15.26 | 178 | 13416 | 139415 | 42468326 |
| Atrioventricular block first degree | 98.79 | 15.26 | 46 | 13548 | 6445 | 42601296 |
| Bundle branch block right | 91.97 | 15.26 | 47 | 13547 | 8059 | 42599682 |
| Tachyarrhythmia | 69.72 | 15.26 | 31 | 13563 | 3901 | 42603840 |
| Sinus bradycardia | 63.37 | 15.26 | 46 | 13548 | 14807 | 42592934 |
| Hypotension | 62.40 | 15.26 | 202 | 13392 | 257429 | 42350312 |
| Electrocardiogram abnormal | 58.89 | 15.26 | 38 | 13556 | 10107 | 42597634 |
| Syncope | 58.77 | 15.26 | 110 | 13484 | 99296 | 42508445 |
| Cardiac arrest | 58.55 | 15.26 | 116 | 13478 | 109204 | 42498537 |
| Tachycardia | 57.46 | 15.26 | 110 | 13484 | 100977 | 42506764 |
| Drug interaction | 51.33 | 15.26 | 194 | 13400 | 266805 | 42340936 |
| Hydrops foetalis | 48.54 | 15.26 | 16 | 13578 | 889 | 42606852 |
| Atrioventricular block | 46.14 | 15.26 | 32 | 13562 | 9583 | 42598158 |
| Intentional overdose | 45.17 | 15.26 | 68 | 13526 | 51388 | 42556353 |
| Electrocardiogram QRS complex shortened | 43.77 | 15.26 | 11 | 13583 | 228 | 42607513 |
| Supraventricular tachycardia | 43.12 | 15.26 | 34 | 13560 | 12374 | 42595367 |
| Electrocardiogram PR prolongation | 42.97 | 15.26 | 15 | 13579 | 993 | 42606748 |
| Atrioventricular block complete | 41.35 | 15.26 | 32 | 13562 | 11332 | 42596409 |
| Gastric ischaemia | 39.67 | 15.26 | 8 | 13586 | 57 | 42607684 |
| Enzyme inhibition | 37.62 | 15.26 | 8 | 13586 | 76 | 42607665 |
| Overdose | 37.53 | 15.26 | 95 | 13499 | 105169 | 42502572 |
| Palmoplantar pustulosis | 35.84 | 15.26 | 11 | 13583 | 484 | 42607257 |
| Cardiac flutter | 35.16 | 15.26 | 16 | 13578 | 2124 | 42605617 |
| Cardiogenic shock | 34.01 | 15.26 | 49 | 13545 | 35591 | 42572150 |
| Shock haemorrhagic | 33.31 | 15.26 | 33 | 13561 | 16209 | 42591532 |
| Drug level increased | 32.61 | 15.26 | 41 | 13553 | 26159 | 42581582 |
| Splenic rupture | 32.49 | 15.26 | 14 | 13580 | 1633 | 42606108 |
| Arrhythmia | 32.18 | 15.26 | 51 | 13543 | 40266 | 42567475 |
| High frequency ablation | 31.30 | 15.26 | 8 | 13586 | 178 | 42607563 |
| Secondary hypogonadism | 30.85 | 15.26 | 11 | 13583 | 775 | 42606966 |
| Treatment failure | 30.57 | 15.26 | 64 | 13530 | 62560 | 42545181 |
| Interstitial lung disease | 30.26 | 15.26 | 73 | 13521 | 78389 | 42529352 |
| Inflammatory pain | 30.17 | 15.26 | 10 | 13584 | 565 | 42607176 |
| Ventricular fibrillation | 29.60 | 15.26 | 42 | 13552 | 30081 | 42577660 |
| Lymphostasis | 29.44 | 15.26 | 5 | 13589 | 11 | 42607730 |
| Endocarditis fibroplastica | 28.33 | 15.26 | 5 | 13589 | 15 | 42607726 |
| Completed suicide | 28.27 | 15.26 | 81 | 13513 | 96384 | 42511357 |
| Device capturing issue | 28.20 | 15.26 | 4 | 13590 | 0 | 42607741 |
| Ventricular arrhythmia | 28.04 | 15.26 | 20 | 13574 | 6259 | 42601482 |
| Device pacing issue | 27.85 | 15.26 | 6 | 13588 | 61 | 42607680 |
| Overflow diarrhoea | 27.67 | 15.26 | 6 | 13588 | 63 | 42607678 |
| Amaurosis | 26.36 | 15.26 | 10 | 13584 | 839 | 42606902 |
| Blood thyroid stimulating hormone increased | 26.30 | 15.26 | 18 | 13576 | 5274 | 42602467 |
| Accidental overdose | 25.65 | 15.26 | 38 | 13556 | 28292 | 42579449 |
| Microcytic anaemia | 24.38 | 15.26 | 14 | 13580 | 3021 | 42604720 |
| Electrocardiogram QRS complex abnormal | 24.05 | 15.26 | 8 | 13586 | 457 | 42607284 |
| Defect conduction intraventricular | 23.79 | 15.26 | 8 | 13586 | 473 | 42607268 |
| Product administered to patient of inappropriate age | 23.20 | 15.26 | 16 | 13578 | 4745 | 42602996 |
| Gastrointestinal ischaemia | 22.81 | 15.26 | 7 | 13587 | 308 | 42607433 |
| Extrasystoles | 22.55 | 15.26 | 15 | 13579 | 4194 | 42603547 |
| Ejection fraction decreased | 22.00 | 15.26 | 31 | 13563 | 22056 | 42585685 |
| Lentigo maligna | 21.25 | 15.26 | 7 | 13587 | 388 | 42607353 |
| Arrhythmia supraventricular | 20.93 | 15.26 | 10 | 13584 | 1483 | 42606258 |
| Pulseless electrical activity | 20.84 | 15.26 | 19 | 13575 | 8418 | 42599323 |
| Torsade de pointes | 20.54 | 15.26 | 19 | 13575 | 8575 | 42599166 |
| Pleurothotonus | 19.73 | 15.26 | 9 | 13585 | 1202 | 42606539 |
| Palpitations | 19.29 | 15.26 | 47 | 13547 | 50750 | 42556991 |
| Acute respiratory distress syndrome | 18.61 | 15.26 | 34 | 13560 | 30074 | 42577667 |
| Heart rate | 18.54 | 15.26 | 4 | 13590 | 41 | 42607700 |
| Peripheral T-cell lymphoma unspecified recurrent | 18.12 | 15.26 | 4 | 13590 | 46 | 42607695 |
| Bradyarrhythmia | 17.98 | 15.26 | 11 | 13583 | 2664 | 42605077 |
| Pneumonia | 17.72 | 15.26 | 72 | 13522 | 422077 | 42185664 |
| Tachycardia foetal | 17.38 | 15.26 | 6 | 13588 | 384 | 42607357 |
| Reflexes abnormal | 17.35 | 15.26 | 6 | 13588 | 386 | 42607355 |
| Suicide attempt | 16.81 | 15.26 | 42 | 13552 | 46058 | 42561683 |
| Bundle branch block left | 16.81 | 15.26 | 15 | 13579 | 6461 | 42601280 |
| Plantar fasciitis | 16.59 | 15.26 | 11 | 13583 | 3059 | 42604682 |
| Retinal vascular occlusion | 16.21 | 15.26 | 5 | 13589 | 224 | 42607517 |
| Foetal exposure during pregnancy | 16.11 | 15.26 | 42 | 13552 | 47269 | 42560472 |
| Hypomania | 16.06 | 15.26 | 10 | 13584 | 2498 | 42605243 |
| Pelvic pain | 16.01 | 15.26 | 11 | 13583 | 3243 | 42604498 |
| Ventricular dyssynchrony | 15.62 | 15.26 | 3 | 13591 | 16 | 42607725 |
| Calcium ionised increased | 15.32 | 15.26 | 3 | 13591 | 18 | 42607723 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Electrocardiogram QRS complex prolonged | 1136.53 | 13.70 | 325 | 30940 | 12696 | 110545338 |
| Bradycardia | 522.57 | 13.70 | 397 | 30868 | 155120 | 110402914 |
| Toxicity to various agents | 473.19 | 13.70 | 628 | 30637 | 479927 | 110078107 |
| Ventricular tachycardia | 454.58 | 13.70 | 240 | 31025 | 49769 | 110508265 |
| Electrocardiogram QT prolonged | 378.69 | 13.70 | 284 | 30981 | 108676 | 110449358 |
| Atrial fibrillation | 345.60 | 13.70 | 373 | 30892 | 229269 | 110328765 |
| Atrial flutter | 268.43 | 13.70 | 133 | 31132 | 24129 | 110533905 |
| Drug interaction | 263.57 | 13.70 | 491 | 30774 | 499692 | 110058342 |
| Cardiac arrest | 260.44 | 13.70 | 299 | 30966 | 196454 | 110361580 |
| Brugada syndrome | 239.12 | 13.70 | 61 | 31204 | 1527 | 110556507 |
| Bundle branch block right | 229.54 | 13.70 | 97 | 31168 | 12194 | 110545840 |
| Atrioventricular block first degree | 203.25 | 13.70 | 93 | 31172 | 14132 | 110543902 |
| Arrhythmia | 197.46 | 13.70 | 161 | 31104 | 69414 | 110488620 |
| Syncope | 180.78 | 13.70 | 253 | 31012 | 202283 | 110355751 |
| Hypotension | 160.83 | 13.70 | 414 | 30851 | 523435 | 110034599 |
| Torsade de pointes | 157.22 | 13.70 | 91 | 31174 | 22509 | 110535525 |
| Sinus bradycardia | 139.78 | 13.70 | 93 | 31172 | 29390 | 110528644 |
| Cardiogenic shock | 136.61 | 13.70 | 120 | 31145 | 57218 | 110500816 |
| Tachycardia | 127.18 | 13.70 | 229 | 31036 | 226416 | 110331618 |
| Device pacing issue | 125.75 | 13.70 | 24 | 31241 | 142 | 110557892 |
| Tachyarrhythmia | 121.13 | 13.70 | 55 | 31210 | 8206 | 110549828 |
| Electrocardiogram abnormal | 111.01 | 13.70 | 68 | 31197 | 18641 | 110539393 |
| Completed suicide | 105.51 | 13.70 | 220 | 31045 | 242161 | 110315873 |
| Ventricular fibrillation | 103.52 | 13.70 | 89 | 31176 | 41224 | 110516810 |
| Intentional overdose | 102.81 | 13.70 | 155 | 31110 | 132346 | 110425688 |
| Defect conduction intraventricular | 100.28 | 13.70 | 26 | 31239 | 695 | 110557339 |
| Atrioventricular block | 99.27 | 13.70 | 61 | 31204 | 16816 | 110541218 |
| Bundle branch block left | 92.58 | 13.70 | 53 | 31212 | 12835 | 110545199 |
| Device capturing issue | 92.14 | 13.70 | 15 | 31250 | 27 | 110558007 |
| Overdose | 87.83 | 13.70 | 200 | 31065 | 233594 | 110324440 |
| Bradyarrhythmia | 75.99 | 13.70 | 34 | 31231 | 4900 | 110553134 |
| Hyponatraemia | 71.76 | 13.70 | 177 | 31088 | 217476 | 110340558 |
| Acute kidney injury | 69.71 | 13.70 | 359 | 30906 | 635071 | 109922963 |
| Ventricular dyssynchrony | 66.99 | 13.70 | 13 | 31252 | 85 | 110557949 |
| Change of bowel habit | 64.98 | 13.70 | 26 | 31239 | 2843 | 110555191 |
| Rectal polyp | 64.74 | 13.70 | 22 | 31243 | 1518 | 110556516 |
| Electrocardiogram PR prolongation | 60.87 | 13.70 | 22 | 31243 | 1821 | 110556213 |
| Palpitations | 58.42 | 13.70 | 135 | 31130 | 159077 | 110398957 |
| Infusion related reaction | 57.68 | 13.70 | 18 | 31247 | 381144 | 110176890 |
| Cardio-respiratory arrest | 57.34 | 13.70 | 111 | 31154 | 115725 | 110442309 |
| Atrioventricular block complete | 55.94 | 13.70 | 46 | 31219 | 20036 | 110537998 |
| Ventricular arrhythmia | 55.63 | 13.70 | 35 | 31230 | 10052 | 110547982 |
| Injection site discomfort | 53.93 | 13.70 | 30 | 31235 | 6877 | 110551157 |
| Drug level increased | 53.92 | 13.70 | 67 | 31198 | 47652 | 110510382 |
| Sensitisation | 52.65 | 13.70 | 25 | 31240 | 4126 | 110553908 |
| Accidental overdose | 52.61 | 13.70 | 69 | 31196 | 51765 | 110506269 |
| Sinus node dysfunction | 51.42 | 13.70 | 32 | 31233 | 9015 | 110549019 |
| Swelling | 50.62 | 13.70 | 18 | 31247 | 351023 | 110207011 |
| BRASH syndrome | 49.00 | 13.70 | 23 | 31242 | 3700 | 110554334 |
| Drug intolerance | 48.94 | 13.70 | 27 | 31238 | 406485 | 110151549 |
| Wound | 48.42 | 13.70 | 5 | 31260 | 234432 | 110323602 |
| Glossodynia | 47.81 | 13.70 | 4 | 31261 | 222000 | 110336034 |
| Electrocardiogram QRS complex shortened | 47.78 | 13.70 | 15 | 31250 | 805 | 110557229 |
| Rheumatoid arthritis | 47.42 | 13.70 | 13 | 31252 | 299600 | 110258434 |
| Intestinal haemorrhage | 46.94 | 13.70 | 28 | 31237 | 7313 | 110550721 |
| Nodal arrhythmia | 46.73 | 13.70 | 19 | 31246 | 2165 | 110555869 |
| Sinoatrial block | 46.57 | 13.70 | 17 | 31248 | 1448 | 110556586 |
| Musculoskeletal stiffness | 46.48 | 13.70 | 11 | 31254 | 279811 | 110278223 |
| Cardiac failure | 46.15 | 13.70 | 137 | 31128 | 187489 | 110370545 |
| Pulseless electrical activity | 45.88 | 13.70 | 38 | 31227 | 16719 | 110541315 |
| Thyroid disorder | 45.46 | 13.70 | 38 | 31227 | 16931 | 110541103 |
| Stress cardiomyopathy | 43.60 | 13.70 | 36 | 31229 | 15770 | 110542264 |
| Duodenal ulcer | 42.81 | 13.70 | 39 | 31226 | 19475 | 110538559 |
| Frustration tolerance decreased | 42.48 | 13.70 | 28 | 31237 | 8703 | 110549331 |
| Systemic lupus erythematosus | 42.24 | 13.70 | 10 | 31255 | 254328 | 110303706 |
| Mobility decreased | 42.16 | 13.70 | 8 | 31257 | 237414 | 110320620 |
| Therapeutic product effect decreased | 41.79 | 13.70 | 9 | 31256 | 244307 | 110313727 |
| Urine odour abnormal | 41.57 | 13.70 | 26 | 31239 | 7389 | 110550645 |
| Ventricular extrasystoles | 41.56 | 13.70 | 41 | 31224 | 22600 | 110535434 |
| Conduction disorder | 41.22 | 13.70 | 21 | 31244 | 4034 | 110554000 |
| Gastric ischaemia | 40.63 | 13.70 | 8 | 31257 | 57 | 110557977 |
| Hepatic enzyme increased | 40.56 | 13.70 | 20 | 31245 | 320872 | 110237162 |
| Pain | 40.33 | 13.70 | 137 | 31128 | 954818 | 109603216 |
| Atrial conduction time prolongation | 39.49 | 13.70 | 8 | 31257 | 67 | 110557967 |
| Bifascicular block | 39.36 | 13.70 | 11 | 31254 | 393 | 110557641 |
| Hyperkalaemia | 39.11 | 13.70 | 105 | 31160 | 135691 | 110422343 |
| Extrasystoles | 38.84 | 13.70 | 26 | 31239 | 8292 | 110549742 |
| Lower respiratory tract infection | 37.63 | 13.70 | 11 | 31254 | 243095 | 110314939 |
| Suicide attempt | 37.17 | 13.70 | 87 | 31178 | 103307 | 110454727 |
| Anticoagulation drug level abnormal | 37.15 | 13.70 | 10 | 31255 | 310 | 110557724 |
| Fibromyalgia | 37.01 | 13.70 | 3 | 31262 | 170906 | 110387128 |
| Thalamic infarction | 36.80 | 13.70 | 14 | 31251 | 1338 | 110556696 |
| Cardiac ablation | 36.63 | 13.70 | 17 | 31248 | 2665 | 110555369 |
| Furuncle | 35.52 | 13.70 | 25 | 31240 | 8643 | 110549391 |
| Weight increased | 35.25 | 13.70 | 40 | 31225 | 419604 | 110138430 |
| Irritable bowel syndrome | 35.24 | 13.70 | 3 | 31262 | 164212 | 110393822 |
| Secondary hypogonadism | 34.99 | 13.70 | 12 | 31253 | 851 | 110557183 |
| Subdural haematoma | 34.65 | 13.70 | 47 | 31218 | 36407 | 110521627 |
| Polyp | 34.57 | 13.70 | 26 | 31239 | 9954 | 110548080 |
| Interstitial lung disease | 34.50 | 13.70 | 102 | 31163 | 139232 | 110418802 |
| Urine abnormality | 34.44 | 13.70 | 25 | 31240 | 9071 | 110548963 |
| Bladder disorder | 34.18 | 13.70 | 27 | 31238 | 11110 | 110546924 |
| Needle issue | 34.04 | 13.70 | 33 | 31232 | 17807 | 110540227 |
| Stomatitis | 33.91 | 13.70 | 17 | 31248 | 270225 | 110287809 |
| Enzyme inhibition | 33.81 | 13.70 | 8 | 31257 | 145 | 110557889 |
| Pericarditis | 33.75 | 13.70 | 10 | 31255 | 219104 | 110338930 |
| Cardiotoxicity | 33.68 | 13.70 | 32 | 31233 | 16849 | 110541185 |
| Heart rate decreased | 33.50 | 13.70 | 73 | 31192 | 82683 | 110475351 |
| Electrocardiogram QRS complex abnormal | 32.20 | 13.70 | 11 | 31254 | 771 | 110557263 |
| Blister | 32.19 | 13.70 | 12 | 31253 | 227364 | 110330670 |
| Contraindicated product administered | 32.09 | 13.70 | 15 | 31250 | 248252 | 110309782 |
| Nasopharyngitis | 31.61 | 13.70 | 39 | 31226 | 394322 | 110163712 |
| Hypersensitivity | 31.30 | 13.70 | 41 | 31224 | 403957 | 110154077 |
| Cerebral haemorrhage | 30.62 | 13.70 | 61 | 31204 | 64907 | 110493127 |
| Hypertensive crisis | 30.43 | 13.70 | 36 | 31229 | 24336 | 110533698 |
| Shock haemorrhagic | 30.36 | 13.70 | 38 | 31227 | 27209 | 110530825 |
| Proctalgia | 30.13 | 13.70 | 27 | 31238 | 13195 | 110544839 |
| International normalised ratio increased | 30.09 | 13.70 | 72 | 31193 | 86700 | 110471334 |
| Dizziness | 29.84 | 13.70 | 315 | 30950 | 697878 | 109860156 |
| Cholestasis | 29.71 | 13.70 | 60 | 31205 | 64458 | 110493576 |
| Palmoplantar pustulosis | 29.71 | 13.70 | 11 | 31254 | 975 | 110557059 |
| Cardiac flutter | 29.32 | 13.70 | 19 | 31246 | 5738 | 110552296 |
| Arthropathy | 29.30 | 13.70 | 23 | 31242 | 287499 | 110270535 |
| Loss of consciousness | 28.88 | 13.70 | 121 | 31144 | 196185 | 110361849 |
| Ill-defined disorder | 28.46 | 13.70 | 5 | 31260 | 156848 | 110401186 |
| Rhythm idioventricular | 28.30 | 13.70 | 10 | 31255 | 775 | 110557259 |
| Therapeutic product effect incomplete | 28.19 | 13.70 | 14 | 31251 | 223791 | 110334243 |
| Cerebral venous thrombosis | 27.76 | 13.70 | 15 | 31250 | 3247 | 110554787 |
| Ejection fraction decreased | 27.75 | 13.70 | 45 | 31220 | 40835 | 110517199 |
| Intentional product use issue | 27.66 | 13.70 | 18 | 31247 | 247888 | 110310146 |
| Peripheral coldness | 27.59 | 13.70 | 30 | 31235 | 18510 | 110539524 |
| Metabolic acidosis | 27.59 | 13.70 | 76 | 31189 | 99668 | 110458366 |
| Hepatic cytolysis | 27.53 | 13.70 | 53 | 31212 | 55000 | 110503034 |
| Alopecia | 27.25 | 13.70 | 38 | 31227 | 364715 | 110193319 |
| Cutaneous T-cell lymphoma | 27.25 | 13.70 | 15 | 31250 | 3369 | 110554665 |
| Electrocardiogram T wave inversion | 27.11 | 13.70 | 18 | 31247 | 5662 | 110552372 |
| Drug level above therapeutic | 27.08 | 13.70 | 24 | 31241 | 11564 | 110546470 |
| Endocarditis fibroplastica | 26.91 | 13.70 | 5 | 31260 | 25 | 110558009 |
| C-reactive protein increased | 26.90 | 13.70 | 14 | 31251 | 217905 | 110340129 |
| Impaired healing | 26.82 | 13.70 | 11 | 31254 | 196706 | 110361328 |
| High frequency ablation | 26.80 | 13.70 | 8 | 31257 | 362 | 110557672 |
| Cerebral haematoma | 26.69 | 13.70 | 22 | 31243 | 9610 | 110548424 |
| Wheezing | 26.54 | 13.70 | 20 | 31245 | 255210 | 110302824 |
| Bundle branch block | 26.42 | 13.70 | 12 | 31253 | 1791 | 110556243 |
| Bursitis | 26.23 | 13.70 | 3 | 31262 | 129915 | 110428119 |
| Gallbladder disorder | 26.15 | 13.70 | 31 | 31234 | 20998 | 110537036 |
| Haemodynamic instability | 25.63 | 13.70 | 32 | 31233 | 22856 | 110535178 |
| Supraventricular tachycardia | 25.54 | 13.70 | 33 | 31232 | 24389 | 110533645 |
| Atrial tachycardia | 25.51 | 13.70 | 21 | 31244 | 9157 | 110548877 |
| Lymphostasis | 25.47 | 13.70 | 5 | 31260 | 35 | 110557999 |
| Splenic rupture | 24.91 | 13.70 | 13 | 31252 | 2624 | 110555410 |
| Diffuse alveolar damage | 24.75 | 13.70 | 15 | 31250 | 4032 | 110554002 |
| Dry mouth | 24.45 | 13.70 | 13 | 31252 | 199935 | 110358099 |
| Cardiac failure acute | 24.35 | 13.70 | 32 | 31233 | 24046 | 110533988 |
| Postoperative wound infection | 24.34 | 13.70 | 26 | 31239 | 15727 | 110542307 |
| Blood cholesterol increased | 24.13 | 13.70 | 11 | 31254 | 184774 | 110373260 |
| Full blood count decreased | 24.09 | 13.70 | 37 | 31228 | 32062 | 110525972 |
| Ventricular tachyarrhythmia | 23.93 | 13.70 | 8 | 31257 | 525 | 110557509 |
| Unmasking of previously unidentified disease | 23.88 | 13.70 | 13 | 31252 | 2855 | 110555179 |
| Spinal epidural haematoma | 23.77 | 13.70 | 11 | 31254 | 1714 | 110556320 |
| Pericardial haemorrhage | 23.62 | 13.70 | 16 | 31249 | 5201 | 110552833 |
| Microcytic anaemia | 23.34 | 13.70 | 17 | 31248 | 6201 | 110551833 |
| Unresponsive to stimuli | 23.28 | 13.70 | 54 | 31211 | 63736 | 110494298 |
| Urticaria | 23.04 | 13.70 | 34 | 31231 | 318823 | 110239211 |
| Cardiac disorder | 22.98 | 13.70 | 60 | 31205 | 76220 | 110481814 |
| Fall | 22.89 | 13.70 | 266 | 30999 | 603216 | 109954818 |
| Vertigo | 22.85 | 13.70 | 65 | 31200 | 86805 | 110471229 |
| Type 2 diabetes mellitus | 22.45 | 13.70 | 11 | 31254 | 177221 | 110380813 |
| Mental status changes | 22.05 | 13.70 | 59 | 31206 | 76063 | 110481971 |
| Obesity | 21.95 | 13.70 | 3 | 31262 | 113348 | 110444686 |
| Inflammatory pain | 21.70 | 13.70 | 10 | 31255 | 1543 | 110556491 |
| Amaurosis | 21.48 | 13.70 | 10 | 31255 | 1579 | 110556455 |
| Drug hypersensitivity | 21.32 | 13.70 | 62 | 31203 | 454028 | 110104006 |
| Overflow diarrhoea | 21.29 | 13.70 | 6 | 31259 | 221 | 110557813 |
| Depression | 20.89 | 13.70 | 36 | 31229 | 317299 | 110240735 |
| Cardioversion | 20.66 | 13.70 | 11 | 31254 | 2312 | 110555722 |
| Shock | 20.26 | 13.70 | 46 | 31219 | 53542 | 110504492 |
| Insomnia | 20.20 | 13.70 | 45 | 31220 | 360545 | 110197489 |
| Sinusitis | 20.14 | 13.70 | 33 | 31232 | 296655 | 110261379 |
| Arrhythmia supraventricular | 20.13 | 13.70 | 11 | 31254 | 2435 | 110555599 |
| Device malfunction | 19.94 | 13.70 | 30 | 31235 | 25528 | 110532506 |
| Gastrointestinal ischaemia | 19.92 | 13.70 | 7 | 31258 | 534 | 110557500 |
| Migraine | 19.78 | 13.70 | 12 | 31253 | 171640 | 110386394 |
| Mass | 19.71 | 13.70 | 26 | 31239 | 19604 | 110538430 |
| Drug-device interaction | 19.64 | 13.70 | 5 | 31260 | 124 | 110557910 |
| Pacemaker syndrome | 19.44 | 13.70 | 3 | 31262 | 3 | 110558031 |
| Membrane stabilising effect | 19.44 | 13.70 | 3 | 31262 | 3 | 110558031 |
| Hypokalaemia | 19.17 | 13.70 | 102 | 31163 | 182346 | 110375688 |
| Rash | 19.01 | 13.70 | 145 | 31120 | 820819 | 109737215 |
| Condition aggravated | 18.85 | 13.70 | 126 | 31139 | 734710 | 109823324 |
| Tubulointerstitial nephritis | 18.77 | 13.70 | 45 | 31220 | 54239 | 110503795 |
| Colitis microscopic | 18.77 | 13.70 | 21 | 31244 | 13373 | 110544661 |
| Asthma | 18.76 | 13.70 | 26 | 31239 | 250265 | 110307769 |
| Haematoma | 18.66 | 13.70 | 47 | 31218 | 58429 | 110499605 |
| Discomfort | 18.52 | 13.70 | 20 | 31245 | 214687 | 110343347 |
| Psoriatic arthropathy | 18.50 | 13.70 | 17 | 31248 | 196744 | 110361290 |
| Joint swelling | 18.31 | 13.70 | 64 | 31201 | 442781 | 110115253 |
| Haemorrhage | 18.28 | 13.70 | 69 | 31196 | 106623 | 110451411 |
| Hypoglycaemic coma | 18.25 | 13.70 | 14 | 31251 | 5519 | 110552515 |
| Bone disorder | 18.16 | 13.70 | 26 | 31239 | 21166 | 110536868 |
| Infection | 18.08 | 13.70 | 48 | 31217 | 362152 | 110195882 |
| Liver injury | 18.07 | 13.70 | 10 | 31255 | 150403 | 110407631 |
| Cardiac tamponade | 18.07 | 13.70 | 19 | 31246 | 11288 | 110546746 |
| Gait inability | 17.99 | 13.70 | 8 | 31257 | 136368 | 110421666 |
| Blood pressure systolic increased | 17.97 | 13.70 | 58 | 31207 | 82933 | 110475101 |
| Vomiting | 17.87 | 13.70 | 168 | 31097 | 910507 | 109647527 |
| Peripheral T-cell lymphoma unspecified recurrent | 17.87 | 13.70 | 4 | 31261 | 56 | 110557978 |
| Wound infection | 17.66 | 13.70 | 3 | 31262 | 96462 | 110461572 |
| Lactic acidosis | 17.57 | 13.70 | 62 | 31203 | 92749 | 110465285 |
| Pneumonia | 17.52 | 13.70 | 161 | 31104 | 876553 | 109681481 |
| Musculoskeletal discomfort | 17.48 | 13.70 | 27 | 31238 | 23511 | 110534523 |
| Ischaemic stroke | 17.38 | 13.70 | 37 | 31228 | 41226 | 110516808 |
| Alkalosis | 17.20 | 13.70 | 7 | 31258 | 799 | 110557235 |
| Sinus arrest | 16.84 | 13.70 | 12 | 31253 | 4230 | 110553804 |
| Coma | 16.82 | 13.70 | 72 | 31193 | 117797 | 110440237 |
| Blood glucose decreased | 16.76 | 13.70 | 30 | 31235 | 29458 | 110528576 |
| Dermatitis exfoliative generalised | 16.76 | 13.70 | 18 | 31247 | 10954 | 110547080 |
| Inflammation | 16.67 | 13.70 | 18 | 31247 | 193220 | 110364814 |
| Slow response to stimuli | 16.52 | 13.70 | 9 | 31256 | 1979 | 110556055 |
| Haematuria | 16.19 | 13.70 | 56 | 31209 | 82949 | 110475085 |
| Arthralgia | 16.08 | 13.70 | 142 | 31123 | 779490 | 109778544 |
| Potentiating drug interaction | 15.88 | 13.70 | 18 | 31247 | 11625 | 110546409 |
| Injection site reaction | 15.81 | 13.70 | 3 | 31262 | 89067 | 110468967 |
| Asthenia | 15.79 | 13.70 | 278 | 30987 | 688721 | 109869313 |
| Pruritus | 15.78 | 13.70 | 98 | 31167 | 581462 | 109976572 |
| Neovascular age-related macular degeneration | 15.69 | 13.70 | 6 | 31259 | 581 | 110557453 |
| Product administered to patient of inappropriate age | 15.59 | 13.70 | 15 | 31250 | 8021 | 110550013 |
| Medication error | 15.53 | 13.70 | 65 | 31200 | 105301 | 110452733 |
| Intracranial haematoma | 15.52 | 13.70 | 7 | 31258 | 1027 | 110557007 |
| Reflexes abnormal | 15.44 | 13.70 | 7 | 31258 | 1040 | 110556994 |
| Prescribed overdose | 15.44 | 13.70 | 3 | 31262 | 87578 | 110470456 |
| Subarachnoid haemorrhage | 15.35 | 13.70 | 29 | 31236 | 29673 | 110528361 |
| Product administration error | 15.25 | 13.70 | 33 | 31232 | 37184 | 110520850 |
| Acute respiratory distress syndrome | 15.17 | 13.70 | 41 | 31224 | 53157 | 110504877 |
| Lung neoplasm malignant | 15.02 | 13.70 | 31 | 31234 | 33811 | 110524223 |
| Plantar fasciitis | 14.87 | 13.70 | 12 | 31253 | 5089 | 110552945 |
| Lentigo maligna | 14.82 | 13.70 | 6 | 31259 | 676 | 110557358 |
| Injury | 14.75 | 13.70 | 17 | 31248 | 177248 | 110380786 |
| Respiratory arrest | 14.73 | 13.70 | 43 | 31222 | 58256 | 110499778 |
| Pleurothotonus | 14.61 | 13.70 | 9 | 31256 | 2489 | 110555545 |
| Neutrophil count decreased | 14.58 | 13.70 | 8 | 31257 | 120933 | 110437101 |
| Disease progression | 14.03 | 13.70 | 30 | 31235 | 244004 | 110314030 |
| Drug-disease interaction | 14.01 | 13.70 | 8 | 31257 | 1928 | 110556106 |
| Poisoning deliberate | 13.97 | 13.70 | 26 | 31239 | 26305 | 110531729 |
| Injection site mass | 13.94 | 13.70 | 25 | 31240 | 24588 | 110533446 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C01BC04 | CARDIOVASCULAR SYSTEM CARDIAC THERAPY ANTIARRHYTHMICS, CLASS I AND III Antiarrhythmics, class Ic |
| FDA EPC | N0000175426 | Antiarrhythmic |
| MeSH PA | D000889 | Anti-Arrhythmia Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D026941 | Sodium Channel Blockers |
| MeSH PA | D049990 | Membrane Transport Modulators |
| MeSH PA | D061567 | Voltage-Gated Sodium Channel Blockers |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:38070 | anti-arrhythmia drug |
Related Drugs by ATC class:
C01BC Antiarrhythmics, class Ic 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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 |
| 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 |
| K94FTS1806 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 50090-2233 | 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 | 50090-5306 | 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 | 50090-6810 | TABLET | 50 mg | ORAL | ANDA | 12 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 | 62135-660 | TABLET | 50 mg | ORAL | ANDA | 12 sections |
| Flecainide Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-661 | TABLET | 100 mg | ORAL | ANDA | 12 sections |
| Flecainide Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62135-662 | TABLET | 150 mg | ORAL | ANDA | 12 sections |
| Flecainide Acetate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 62559-380 | TABLET | 50 mg | ORAL | ANDA | 19 sections |