sotalol ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
aromatic ring -CH(-OH)-CH2-NH-R 2464 3930-20-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • sotalol
  • DL-Sotalol
  • sotalol hydrochloride
  • sotylize
  • sotalol HCl
An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.
  • Molecular weight: 272.36
  • Formula: C12H20N2O3S
  • CLOGP: 0.23
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 78.43
  • ALOGS: -2.54
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 137 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 85 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.57 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.62 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.30 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.343 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.592 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.989 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.075 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 88.820 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 79.700 % High 1
herg hERG pIC50 4.344 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.466 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.373 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 88.450 % High 1
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK7,MAPKAPK2,NTRK2,PDK2,PRKDC,TEK,TGFBR1,ZAP70 25
kinase-selectivity-class GRK2,MAP2K6,PDK1,TEK 4
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.758 High 1
mh-clint Mouse hepatocyte intrinsic clearance 3.428 High 1
mppb Mouse plasma protein binding (% unbound) 92.110 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.714 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 89.910 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.600 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.830 % High 1
rppb Rat plasma protein binding (% unbound) 88.910 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 914.113 uM High 1

Approvals:

DateAgencyCompanyOrphan
Oct. 30, 1992 FDA COVIS PHARMA SARL

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 QT prolonged 414.84 16.25 220 16181 72236 90539810
Torsade de pointes 394.05 16.25 135 16266 15047 90596999
Atrial fibrillation 288.92 16.25 219 16182 133392 90478654
Ventricular tachycardia 193.96 16.25 93 16308 24615 90587431
Bradycardia 162.66 16.25 129 16272 83718 90528328
Drug interaction 153.77 16.25 218 16183 276235 90335811
Atrial tachycardia 116.40 16.25 43 16358 5947 90606099
Hypotension 110.26 16.25 205 16196 325192 90286854
International normalised ratio increased 98.63 16.25 76 16325 47240 90564806
Sinus bradycardia 95.49 16.25 51 16350 16901 90595145
Long QT syndrome 89.71 16.25 32 16369 4005 90608041
Arrhythmia 88.24 16.25 68 16333 42264 90569782
Palpitations 70.26 16.25 104 16297 136624 90475422
Hyponatraemia 67.79 16.25 101 16300 133437 90478609
Cardiospasm 64.25 16.25 24 16377 3422 90608624
Transient ischaemic attack 64.16 16.25 57 16344 43119 90568927
Palmoplantar keratoderma 63.84 16.25 24 16377 3483 90608563
Subarachnoid haemorrhage 63.81 16.25 40 16361 17864 90594182
Carotid artery occlusion 62.61 16.25 28 16373 6314 90605732
Cardio-respiratory arrest 59.51 16.25 65 16336 63075 90548971
Cerebral haematoma 59.15 16.25 24 16377 4265 90607781
Sleep terror 58.22 16.25 24 16377 4440 90607606
Pruritus genital 57.74 16.25 24 16377 4534 90607512
Cardiac arrest 57.06 16.25 82 16319 104853 90507193
Tension headache 55.09 16.25 27 16374 7482 90604564
Urinary incontinence 54.64 16.25 49 16352 37517 90574529
Hyperkalaemia 51.27 16.25 61 16340 64903 90547143
Inappropriate antidiuretic hormone secretion 51.16 16.25 36 16365 19469 90592577
Ischaemic stroke 49.25 16.25 37 16364 22129 90589917
Syncope 49.14 16.25 87 16314 132576 90479470
Systemic lupus erythematosus 47.74 16.25 5 16396 361891 90250155
Acute kidney injury 47.05 16.25 146 16255 320241 90291805
Ventricular arrhythmia 45.63 16.25 20 16381 4301 90607745
Anosmia 45.49 16.25 26 16375 9822 90602224
Hepatocellular injury 44.55 16.25 39 16362 28919 90583127
Immunisation 43.41 16.25 16 16385 2197 90609849
Atrioventricular block 42.68 16.25 24 16377 8791 90603255
Cardiac disorder 42.58 16.25 52 16349 56820 90555226
Presyncope 39.51 16.25 38 16363 31767 90580279
Joint swelling 39.42 16.25 21 16380 503279 90108767
Atrial flutter 38.25 16.25 24 16377 10734 90601312
Wound 37.93 16.25 5 16396 302975 90309071
Arthropathy 37.46 16.25 10 16391 366232 90245814
Heart rate increased 36.71 16.25 70 16331 112832 90499214
Infusion related reaction 36.31 16.25 15 16386 416765 90195281
Erythromelalgia 35.91 16.25 9 16392 332 90611714
Medical observation 35.35 16.25 8 16393 189 90611857
Bundle branch block left 34.24 16.25 20 16381 7865 90604181
Facial pain 33.81 16.25 24 16377 13158 90598888
Tachycardia 33.18 16.25 82 16319 157591 90454455
Localised oedema 33.10 16.25 18 16383 6176 90605870
Subdural haematoma 33.07 16.25 26 16375 16619 90595427
Fall 32.95 16.25 173 16228 481637 90130409
Apallic syndrome 32.55 16.25 10 16391 786 90611260
Ventricular fibrillation 32.44 16.25 24 16377 14020 90598026
Contraindicated product administered 32.25 16.25 9 16392 320130 90291916
Asthenia 32.06 16.25 185 16216 533566 90078480
Cardiogenic shock 31.85 16.25 30 16371 24438 90587608
Vasculitis 31.81 16.25 29 16372 22664 90589382
Drug intolerance 31.76 16.25 21 16380 447570 90164476
Mobility decreased 31.71 16.25 4 16397 250730 90361316
Rheumatoid arthritis 30.08 16.25 14 16387 362600 90249446
Hypersensitivity 30.07 16.25 23 16378 454654 90157392
Pain of skin 29.56 16.25 24 16377 16058 90595988
Gastrointestinal haemorrhage 29.38 16.25 56 16345 90192 90521854
Eye pruritus 29.30 16.25 31 16370 28996 90583050
Haematoma 28.09 16.25 35 16366 39013 90573033
Melaena 27.98 16.25 33 16368 34764 90577282
Blood cholesterol increased 27.09 16.25 3 16398 208009 90404037
Cardiac failure congestive 27.05 16.25 57 16344 98637 90513409
Infection 27.05 16.25 16 16385 362078 90249968
Sinus node dysfunction 26.92 16.25 15 16386 5397 90606649
Blindness 26.16 16.25 28 16373 26540 90585506
Blood glucose increased 26.10 16.25 55 16346 95191 90516855
Diplopia 26.07 16.25 29 16372 28685 90583361
Disturbance in attention 25.86 16.25 37 16364 47072 90564974
Product use issue 25.46 16.25 14 16387 329905 90282141
Myocardial infarction 25.41 16.25 58 16343 105914 90506132
Discomfort 25.33 16.25 9 16392 274326 90337720
Cardioactive drug level increased 25.06 16.25 11 16390 2373 90609673
Atrial rupture 25.05 16.25 5 16396 63 90611983
Nasal mucosal erosion 24.76 16.25 5 16396 67 90611979
Hepatic cytolysis 24.33 16.25 29 16372 30887 90581159
Hypokalaemia 24.28 16.25 65 16336 131051 90480995
Malaise 24.19 16.25 185 16216 585801 90026245
Tinnitus 23.88 16.25 34 16367 43068 90568978
Musculoskeletal stiffness 23.74 16.25 12 16389 296520 90315526
Supraventricular tachycardia 23.14 16.25 21 16380 16315 90595731
Nasopharyngitis 22.83 16.25 24 16377 407080 90204966
Electrocardiogram QRS complex prolonged 22.68 16.25 15 16386 7333 90604713
Fibromyalgia 22.31 16.25 5 16396 206264 90405782
Organising pneumonia 22.23 16.25 15 16386 7582 90604464
Lower respiratory tract infection 21.85 16.25 9 16392 250650 90361396
Urticaria 21.73 16.25 15 16386 312719 90299327
Cardiac ablation 21.67 16.25 9 16392 1695 90610351
Loss of consciousness 21.56 16.25 65 16336 140173 90471873
Pain 21.56 16.25 100 16301 996241 89615805
Muscle twitching 21.22 16.25 24 16377 24178 90587868
Hypoglycaemia 21.10 16.25 42 16359 69806 90542240
Therapeutic product effect decreased 21.10 16.25 12 16389 277559 90334487
Swelling 21.03 16.25 27 16374 419031 90193015
Ill-defined disorder 20.99 16.25 4 16397 184887 90427159
Anaemia macrocytic 20.92 16.25 12 16389 4560 90607486
Blister 20.89 16.25 10 16391 254988 90357058
Hepatic enzyme increased 20.52 16.25 21 16380 360715 90251331
Completed suicide 20.23 16.25 65 16336 144993 90467053
Psoriatic arthropathy 20.22 16.25 8 16393 228327 90383719
Inflammation 19.99 16.25 4 16397 178588 90433458
Renal failure 19.46 16.25 60 16341 130947 90481099
Stomatitis 19.32 16.25 13 16388 274685 90337361
Lip swelling 19.28 16.25 29 16372 38581 90573465
Sleep disorder 19.14 16.25 6 16395 198024 90414022
Sprue-like enteropathy 19.10 16.25 7 16394 946 90611100
Toxicity to various agents 18.71 16.25 102 16299 287744 90324302
Product administered by wrong person 18.55 16.25 4 16397 75 90611971
Type 2 diabetes mellitus 18.20 16.25 7 16394 203237 90408809
Dizziness 17.97 16.25 174 16227 589110 90022936
Failure to suspend medication 17.90 16.25 4 16397 89 90611957
Medication error 17.77 16.25 44 16357 84608 90527438
International normalised ratio abnormal 17.35 16.25 10 16391 3835 90608211
Cerebral haemorrhage 17.33 16.25 26 16375 34496 90577550
Sinusitis 17.31 16.25 22 16379 343066 90268980
Haemorrhagic stroke 17.06 16.25 12 16389 6484 90605562
Therapeutic product effect incomplete 16.83 16.25 7 16394 193889 90418157
Optic nerve infarction 16.62 16.25 3 16398 21 90612025
Noninfective gingivitis 16.57 16.25 8 16393 2145 90609901
Premature delivery 16.42 16.25 27 16374 38735 90573311
Asthma 16.31 16.25 12 16389 242148 90369898
Blood loss anaemia 16.29 16.25 14 16387 10126 90601920

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
Atrial fibrillation 225.06 14.42 257 14306 139336 42467436
Electrocardiogram QT prolonged 190.33 14.42 146 14417 47799 42558973
Bradycardia 154.03 14.42 167 14396 85317 42521455
Ventricular tachycardia 128.80 14.42 96 14467 30064 42576708
Torsade de pointes 97.60 14.42 51 14512 8543 42598229
Atrial flutter 65.01 14.42 51 14512 17200 42589572
Palpitations 59.74 14.42 80 14483 50717 42556055
Hypotension 56.80 14.42 205 14358 257426 42349346
Ventricular arrhythmia 51.31 14.42 30 14533 6249 42600523
Arrhythmia 51.28 14.42 66 14497 40251 42566521
Cardiogenic shock 47.94 14.42 60 14503 35580 42571192
BRASH syndrome 43.16 14.42 18 14545 1807 42604965
Atrial thrombosis 41.22 14.42 19 14544 2425 42604347
Drug interaction 40.22 14.42 189 14374 266810 42339962
Apallic syndrome 39.60 14.42 11 14552 316 42606456
Pacemaker generated rhythm 38.53 14.42 8 14555 62 42606710
International normalised ratio increased 36.76 14.42 62 14501 48106 42558666
Antiacetylcholine receptor antibody positive 35.53 14.42 8 14555 94 42606678
Staring 35.39 14.42 15 14548 1568 42605204
Cardiac ablation 34.86 14.42 14 14549 1276 42605496
Ischaemic stroke 34.08 14.42 40 14523 22193 42584579
Stenotrophomonas infection 33.75 14.42 19 14544 3685 42603087
Long QT syndrome 33.70 14.42 18 14545 3149 42603623
Tachycardia induced cardiomyopathy 32.25 14.42 8 14555 146 42606626
Treatment failure 32.10 14.42 68 14495 62556 42544216
Daydreaming 31.01 14.42 11 14552 712 42606060
Pallor 30.19 14.42 43 14520 28843 42577929
Petit mal epilepsy 28.67 14.42 17 14546 3633 42603139
Hyperthyroidism 27.48 14.42 29 14534 14312 42592460
Haemoptysis 27.05 14.42 53 14510 46114 42560658
Syncope 26.11 14.42 84 14479 99322 42507450
Loss of consciousness 26.06 14.42 80 14483 92274 42514498
Incontinence 25.31 14.42 20 14543 6810 42599962
Cardiac failure congestive 24.95 14.42 75 14488 85527 42521245
Gastrointestinal stoma output decreased 23.62 14.42 6 14557 121 42606651
Drug abuse 23.07 14.42 4 14559 104767 42502005
Pyrexia 22.47 14.42 65 14498 393977 42212795
Henoch-Schonlein purpura 22.26 14.42 12 14551 2138 42604634
Xanthopsia 22.10 14.42 6 14557 158 42606614
Sinus bradycardia 21.57 14.42 26 14537 14827 42591945
Cardiac disorder 21.53 14.42 50 14513 48882 42557890
Presyncope 21.47 14.42 32 14531 22355 42584417
Ejection fraction 20.55 14.42 6 14557 207 42606565
Cardiac amyloidosis 20.23 14.42 11 14552 1994 42604778
Dizziness 20.22 14.42 150 14413 249104 42357668
Electrocardiogram QRS complex shortened 19.86 14.42 6 14557 233 42606539
Rectal haemorrhage 18.95 14.42 48 14515 49558 42557214
Grandiosity 18.14 14.42 6 14557 314 42606458
Brugada syndrome 17.18 14.42 8 14555 1045 42605727
Supraventricular tachycardia 16.85 14.42 21 14542 12387 42594385
Heart rate abnormal 16.47 14.42 10 14553 2229 42604543
Dyspnoea 16.21 14.42 226 14337 442395 42164377
Dissociation 15.99 14.42 12 14551 3786 42602986
Blood pressure decreased 15.95 14.42 50 14513 58282 42548490
IgA nephropathy 15.93 14.42 10 14553 2364 42604408
Aphasia 15.77 14.42 29 14534 24054 42582718
Ventricular fibrillation 15.76 14.42 33 14530 30090 42576682
Loss of control of legs 15.58 14.42 7 14556 842 42605930
Heart rate irregular 15.47 14.42 23 14540 16027 42590745
Haematuria 15.31 14.42 49 14514 57750 42549022
Wolff-Parkinson-White syndrome 15.28 14.42 5 14558 253 42606519
Angiomyolipoma 15.25 14.42 4 14559 92 42606680
Poisoning deliberate 15.14 14.42 18 14545 10116 42596656
Cardiac failure 14.84 14.42 74 14489 106782 42499990
Pressure of speech 14.77 14.42 6 14557 563 42606209
Blood thyroid stimulating hormone increased 14.46 14.42 13 14550 5279 42601493

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 QT prolonged 546.44 12.68 338 26937 108622 110453402
Torsade de pointes 455.09 12.68 181 27094 22419 110539605
Atrial fibrillation 436.80 12.68 398 26877 229244 110332780
Bradycardia 304.12 12.68 274 27001 155243 110406781
Ventricular tachycardia 302.00 12.68 175 27100 49834 110512190
Drug interaction 181.26 12.68 388 26887 499795 110062229
Hypotension 148.51 12.68 369 26906 523480 110038544
Arrhythmia 123.02 12.68 116 27159 69459 110492565
International normalised ratio increased 120.76 12.68 127 27148 86645 110475379
Long QT syndrome 119.26 12.68 50 27225 7068 110554956
Palpitations 112.87 12.68 166 27109 159046 110402978
Atrial flutter 103.33 12.68 68 27207 24194 110537830
Ventricular arrhythmia 96.60 12.68 48 27227 10039 110551985
Cardiogenic shock 88.96 12.68 89 27186 57249 110504775
Ischaemic stroke 87.06 12.68 76 27199 41187 110520837
Sinus bradycardia 86.91 12.68 66 27209 29417 110532607
Syncope 72.96 12.68 157 27118 202379 110359645
Apallic syndrome 66.18 12.68 20 27255 1086 110560938
Acute kidney injury 64.22 12.68 318 26957 635112 109926912
Atrial tachycardia 63.13 12.68 35 27240 9143 110552881
Cerebral haematoma 61.55 12.68 35 27240 9597 110552427
Cardiac arrest 57.02 12.68 140 27135 196613 110365411
Atrial thrombosis 54.82 12.68 25 27250 4321 110557703
Loss of consciousness 50.97 12.68 134 27141 196172 110365852
Inappropriate antidiuretic hormone secretion 49.68 12.68 51 27224 33800 110528224
Cardiac disorder 47.59 12.68 75 27200 76205 110485819
Joint swelling 47.49 12.68 25 27250 442820 110119204
Cardiac failure congestive 46.48 12.68 110 27165 150890 110411134
Transient ischaemic attack 45.71 12.68 67 27208 63915 110498109
BRASH syndrome 45.65 12.68 21 27254 3702 110558322
Systemic lupus erythematosus 45.14 12.68 5 27270 254333 110307691
Cardio-respiratory arrest 44.23 12.68 92 27183 115744 110446280
Ventricular fibrillation 42.98 12.68 52 27223 41261 110520763
Cardiac ablation 42.13 12.68 18 27257 2664 110559360
Pacemaker generated rhythm 40.68 12.68 8 27267 66 110561958
Presyncope 40.56 12.68 55 27220 48832 110513192
Hyperthyroidism 39.21 12.68 42 27233 29219 110532805
Subdural haematoma 38.11 12.68 46 27229 36408 110525616
Sinus node dysfunction 37.65 12.68 25 27250 9022 110553002
Atrioventricular block 37.45 12.68 32 27243 16845 110545179
Gastrointestinal haemorrhage 37.01 12.68 107 27168 165411 110396613
Medical observation 36.54 12.68 9 27266 224 110561800
Urinary incontinence 36.34 12.68 52 27223 48535 110513489
Fall 35.23 12.68 262 27013 603220 109958804
Haemoptysis 34.98 12.68 63 27212 71291 110490733
Arthropathy 34.26 12.68 14 27261 287508 110274516
Heart rate increased 34.12 12.68 95 27180 143739 110418285
Subarachnoid haemorrhage 33.56 12.68 39 27236 29663 110532361
Mobility decreased 32.75 12.68 9 27266 237413 110324611
Haemorrhagic stroke 32.35 12.68 27 27248 13762 110548262
Pain 32.20 12.68 124 27151 954831 109607193
Impaired healing 32.19 12.68 5 27270 196712 110365312
Cardiospasm 31.60 12.68 18 27257 4949 110557075
Hyperkalaemia 31.53 12.68 89 27186 135707 110426317
Staring 31.41 12.68 15 27260 2877 110559147
Stenotrophomonas infection 31.40 12.68 19 27256 5839 110556185
Asthenia 31.00 12.68 282 26993 688717 109873307
Erythromelalgia 30.81 12.68 9 27266 434 110561590
Haematoma 30.43 12.68 53 27222 58423 110503601
Palmoplantar keratoderma 30.25 12.68 18 27257 5369 110556655
Antiacetylcholine receptor antibody positive 30.09 12.68 8 27267 272 110561752
Psoriatic arthropathy 30.02 12.68 6 27269 196755 110365269
Carotid artery occlusion 29.49 12.68 22 27253 9543 110552481
Tension headache 29.38 12.68 22 27253 9596 110552428
Stomatitis 29.33 12.68 15 27260 270227 110291797
Melaena 29.09 12.68 57 27218 68700 110493324
Daydreaming 29.05 12.68 11 27264 1191 110560833
Fibromyalgia 28.76 12.68 4 27271 170905 110391119
Irritable bowel syndrome 27.27 12.68 4 27271 164211 110397813
Pruritus genital 27.08 12.68 18 27257 6504 110555520
Asthma 27 12.68 14 27261 250277 110311747
Sleep terror 26.87 12.68 18 27257 6592 110555432
Sleep disorder 26.53 12.68 8 27267 198636 110363388
Rheumatoid arthritis 26.53 12.68 21 27254 299592 110262432
Hypersensitivity 26.06 12.68 37 27238 403961 110158063
Dizziness 25.66 12.68 274 27001 697919 109864105
Tachycardia 25.39 12.68 117 27158 226528 110335496
Hepatic enzyme increased 25.39 12.68 25 27250 320867 110241157
Cerebral haemorrhage 25.26 12.68 52 27223 64916 110497108
Hyponatraemia 24.86 12.68 113 27162 217540 110344484
Discomfort 24.70 12.68 11 27264 214696 110347328
Infusion related reaction 24.49 12.68 35 27240 381127 110180897
Rectal haemorrhage 24.44 12.68 75 27200 119758 110442266
Musculoskeletal stiffness 24.29 12.68 20 27255 279802 110282222
Hepatocellular injury 23.92 12.68 44 27231 50598 110511426
Atrial rupture 23.81 12.68 5 27270 59 110561965
Therapeutic product effect incomplete 23.43 12.68 13 27262 223792 110338232
Nasal mucosal erosion 23.22 12.68 5 27270 67 110561957
Helicobacter infection 23.09 12.68 8 27267 181869 110380155
Therapeutic product effect decreased 23.08 12.68 16 27259 244300 110317724
Pallor 22.91 12.68 46 27229 56421 110505603
Wound 22.61 12.68 15 27260 234422 110327602
Petit mal epilepsy 22.47 12.68 17 27258 7530 110554494
Blood cholesterol increased 22 12.68 9 27266 184776 110377248
Tachycardia induced cardiomyopathy 21.97 12.68 6 27269 226 110561798
Organising pneumonia 21.88 12.68 22 27253 14221 110547803
Heart rate irregular 21.79 12.68 34 27241 34240 110527784
Drug intolerance 21.78 12.68 42 27233 406470 110155554
Shock haemorrhagic 21.61 12.68 30 27245 27217 110534807
Ill-defined disorder 21.52 12.68 6 27269 156847 110405177
Completed suicide 21.41 12.68 117 27158 242264 110319760
Blister 21.33 12.68 15 27260 227361 110334663
Gastrointestinal stoma output decreased 21.16 12.68 6 27269 260 110561764
C-reactive protein increased 20.94 12.68 14 27261 217905 110344119
Blood loss anaemia 20.92 12.68 24 27251 18001 110544023
Nasopharyngitis 20.90 12.68 41 27234 394320 110167704
Hormone-refractory prostate cancer 20.81 12.68 8 27267 902 110561122
Urticaria 20.76 12.68 29 27246 318828 110243196
Medication error 20.61 12.68 65 27210 105301 110456723
Cardiac failure 20.38 12.68 96 27179 187530 110374494
Wheezing 20.05 12.68 20 27255 255210 110306814
Cardiac amyloidosis 20.01 12.68 11 27264 2826 110559198
Disturbance in attention 19.97 12.68 46 27229 61949 110500075
Henoch-Schonlein purpura 19.96 12.68 12 27263 3645 110558379
Epistaxis 19.87 12.68 74 27201 130298 110431726
Supraventricular tachycardia 19.54 12.68 27 27248 24395 110537629
Hypoglycaemia 19.48 12.68 68 27207 116036 110445988
Cardioactive drug level increased 19.30 12.68 12 27263 3870 110558154
Lower respiratory tract infection 19.15 12.68 19 27256 243087 110318937
Xanthopsia 19.13 12.68 6 27269 369 110561655
Swelling 19.03 12.68 36 27239 351005 110211019
Infection 18.90 12.68 38 27237 362162 110199862
Immunisation 18.83 12.68 11 27264 3172 110558852
Haemorrhage intracranial 18.78 12.68 29 27246 28940 110533084
Anosmia 18.68 12.68 19 27256 12453 110549571
Acute pulmonary oedema 18.67 12.68 22 27253 16974 110545050
Sinusitis 18.31 12.68 28 27247 296660 110265364
International normalised ratio abnormal 18.22 12.68 14 27261 6343 110555681
Hypokalaemia 18.12 12.68 91 27184 182357 110379667
Haematuria 17.91 12.68 53 27222 82952 110479072
Bursitis 17.77 12.68 5 27270 129913 110432111
Localised oedema 17.49 12.68 16 27259 9207 110552817
Circulatory collapse 17.41 12.68 35 27240 42958 110519066
Incontinence 17.40 12.68 21 27254 16614 110545410
Musculoskeletal pain 17.26 12.68 12 27263 183011 110379013
Arthritis 17.16 12.68 10 27265 167576 110394448
Cerebrovascular accident 17.02 12.68 89 27186 181195 110380829
Gastrointestinal disorder 16.77 12.68 21 27254 241931 110320093
Arthralgia 16.77 12.68 118 27157 779514 109782510
Dyspnoea 16.60 12.68 373 26902 1106499 109455525
Grandiosity 16.57 12.68 6 27269 573 110561451
Junctional ectopic tachycardia 16.55 12.68 3 27272 15 110562009
Brugada syndrome 16.53 12.68 8 27267 1580 110560444
Left ventricular failure 16.42 12.68 17 27258 11372 110550652
Endodontic procedure 16.37 12.68 10 27265 3126 110558898
Cardioversion 16.36 12.68 9 27266 2314 110559710
IgA nephropathy 16.26 12.68 10 27265 3163 110558861
Type 2 diabetes mellitus 16.22 12.68 12 27263 177220 110384804
Depression 15.95 12.68 34 27241 317301 110244723
Myocardial infarction 15.81 12.68 91 27184 191992 110370032
Product administered by wrong person 15.79 12.68 4 27271 112 110561912
Contraindicated product administered 15.74 12.68 23 27252 248244 110313780
Blood pressure decreased 15.64 12.68 63 27212 115028 110446996
Toxicity to various agents 15.53 12.68 184 27091 480371 110081653
Penile pain 15.53 12.68 7 27268 1177 110560847
Liver injury 15.37 12.68 9 27266 150404 110411620
Inflammation 15.34 12.68 15 27260 193223 110368801
Adverse event 15.23 12.68 4 27271 108805 110453219
Malaise 15.09 12.68 241 27034 671578 109890446
Pressure of speech 14.74 12.68 7 27268 1325 110560699
Bundle branch block left 14.69 12.68 17 27258 12871 110549153
Noninfective gingivitis 14.65 12.68 8 27267 2029 110559995
Alopecia 14.53 12.68 44 27231 364709 110197315
Metastases to spleen 14.38 12.68 6 27269 838 110561186
Obesity 14.36 12.68 5 27270 113346 110448678
Loss of control of legs 14.31 12.68 8 27267 2124 110559900
Pericarditis 14.18 12.68 20 27255 219094 110342930
Venous pressure increased 14.09 12.68 3 27272 38 110561986
Loss of personal independence in daily activities 13.93 12.68 10 27265 150010 110412014
Facial pain 13.86 12.68 18 27257 15321 110546703
Prostate cancer recurrent 13.62 12.68 6 27269 956 110561068
Lactic acidosis 13.57 12.68 52 27223 92759 110469265
Intraventricular haemorrhage 13.37 12.68 11 27264 5496 110556528
Atrioventricular block first degree 13.34 12.68 17 27258 14208 110547816
Shock 13.30 12.68 36 27239 53552 110508472
Road traffic accident 13.16 12.68 5 27270 107393 110454631
Pemphigoid 13.16 12.68 20 27255 19687 110542337
Sprue-like enteropathy 13.14 12.68 7 27268 1689 110560335
Orthostatic hypotension 13.07 12.68 41 27234 66208 110495816
Off label use 12.97 12.68 277 26998 1499908 109062116
Joint range of motion decreased 12.86 12.68 7 27268 121825 110440199
Product use issue 12.85 12.68 37 27238 311658 110250366
Right ventricular failure 12.82 12.68 23 27252 25931 110536093
Auricular haematoma 12.81 12.68 3 27272 60 110561964
Pericardial effusion 12.79 12.68 37 27238 57180 110504844
Overdose 12.75 12.68 100 27175 233694 110328330
Acquired haemophilia 12.75 12.68 8 27267 2623 110559401

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C07AA07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS
Beta blocking agents, non-selective
ATC C07BA07 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS AND THIAZIDES
Beta blocking agents, non-selective, and thiazides
ATC C07FX02 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
FDA MoA N0000000161 Adrenergic beta-Antagonists
FDA PE N0000008330 Cardiac Rhythm Alteration
FDA EPC N0000175426 Antiarrhythmic
MeSH PA D000319 Adrenergic beta-Antagonists
MeSH PA D000889 Anti-Arrhythmia Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D013565 Sympatholytics
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D018674 Adrenergic Antagonists
CHEBI has role CHEBI:35530 ฮฒ-adrenergic antagonist
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:38070 anti-arrhythmia drug
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

C07AA Beta blocking agents, non-selective 13 drugs
alprenololbopindololbupranololcarteololcloranololmepindololnadololoxprenololpenbutololpindololpropranololtertatolol show all 13 →
C07BA Beta blocking agents, non-selective, and thiazides 5 drugs
metipranololnadololoxprenololpropranololtimolol
C07FX Beta blocking agents, other combinations 6 drugs
acetylsalicylic acidbisoprololcarvedilolivabradinemetoprololpropranolol

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

DiseaseRelationSNOMED_IDDOID
Atrial fibrillation indication 49436004 DOID:0060224
Life-Threatening Ventricular Tachycardia indication
Bronchospasm contraindication 4386001
Complete atrioventricular block contraindication 27885002
Torsades de pointes contraindication 31722008
Sick sinus syndrome contraindication 36083008 DOID:13884
Anaphylaxis contraindication 39579001
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Sinus bradycardia contraindication 49710005
Diabetes mellitus contraindication 73211009 DOID:9351
Cardiogenic shock contraindication 89138009
Prolonged QT interval contraindication 111975006
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Asthma contraindication 195967001 DOID:2841
Impaired renal function disorder contraindication 197663003
Pregnancy, function contraindication 289908002
Congenital long QT syndrome contraindication 442917000




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 9.95 acidic
pKa2 9.22 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 12403109 Aug. 14, 2028 DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 10206895 April 1, 2034 INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 10206895 April 1, 2034 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 12290495 April 1, 2034 INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 12290495 April 1, 2034 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 11850222 Nov. 19, 2034 INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 11850222 Nov. 19, 2034 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
5MG/ML (5MG/ML) SOTYLIZE AZURITY N205108 Oct. 22, 2014 RX SOLUTION ORAL 9724297 Aug. 31, 2035 SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10512620 Aug. 14, 2038 DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10512620 Aug. 14, 2038 INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 11696902 Aug. 14, 2038 DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 12390431 Aug. 14, 2038 DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10799138 April 5, 2039 INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 10799138 April 5, 2039 USE FOR LOADING DOSE IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM OR FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYCARDIA
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 12569183 April 5, 2039 METHOD OF ADMINISTERING SOTALOL IV/SWITCH
150MG/10ML (15MG/ML) SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC N022306 July 2, 2009 RX SOLUTION INTRAVENOUS 11583216 Aug. 21, 2039 INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 6.10 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 6.90 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel BLOCKER Ki 4 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR Kd 6.24 CHEMBL
Beta-2 adrenergic receptor GPCR IC50 5.30 CHEMBL

External reference:

IDSource
4020814 VUID
N0000148334 NUI
D01026 KEGG_DRUG
959-24-0 SECONDARY_CAS_RN
4020779 VANDF
4020814 VANDF
C0037707 UMLSCUI
CHEBI:63622 CHEBI
CHEMBL471 ChEMBL_ID
CHEMBL1700 ChEMBL_ID
DB00489 DRUGBANK_ID
D013015 MESH_DESCRIPTOR_UI
5253 PUBCHEM_CID
7297 IUPHAR_LIGAND_ID
2350 INN_ID
A6D97U294I UNII
1593726 RXNORM
230116 MMSL
31427 MMSL
5503 MMSL
d00371 MMSL
003453 NDDF
004111 NDDF
125691000 SNOMEDCT_US
372911006 SNOMEDCT_US
96301002 SNOMEDCT_US
A6D97U294I INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1060 TABLET 120 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1061 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1062 TABLET 160 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-1063 TABLET 240 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7143 TABLET 80 mg ORAL ANDA 25 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-661 TABLET 80 mg ORAL ANDA 24 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-662 TABLET 120 mg ORAL ANDA 24 sections
Sotalol HUMAN PRESCRIPTION DRUG LABEL 1 10135-663 TABLET 160 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-715 TABLET 80 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-716 TABLET 120 mg ORAL ANDA 24 sections
Sotalol HydrochlorideAF HUMAN PRESCRIPTION DRUG LABEL 1 10135-717 TABLET 160 mg ORAL ANDA 24 sections
SOTALOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 11788-051 TABLET 80 mg ORAL ANDA 22 sections
SOTALOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 11788-052 TABLET 120 mg ORAL ANDA 22 sections
SOTALOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 11788-053 TABLET 160 mg ORAL ANDA 22 sections
SOTALOL HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 11788-054 TABLET 240 mg ORAL ANDA 22 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-397 TABLET 80 mg ORAL ANDA 19 sections
SOTYLIZE HUMAN PRESCRIPTION DRUG LABEL 1 24338-530 SOLUTION 5 mg ORAL NDA 31 sections
Sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-121 TABLET 80 mg ORAL ANDA 27 sections
Sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-122 TABLET 120 mg ORAL ANDA 27 sections
Sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-123 TABLET 160 mg ORAL ANDA 27 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-1299 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7796 TABLET 80 mg ORAL ANDA 27 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-724 TABLET 80 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-725 TABLET 120 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51655-450 TABLET 240 mg ORAL ANDA 25 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 53217-011 TABLET 80 mg ORAL ANDA 21 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-4435 TABLET 80 mg ORAL ANDA 19 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5549 TABLET 160 mg ORAL ANDA 19 sections
sotalol hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5614 TABLET 120 mg ORAL ANDA 19 sections
Sotalol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 55154-8179 TABLET 80 mg ORAL ANDA 27 sections