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

Stem definitionDrug idCAS RN
beta-adrenoreceptor antagonists 1887 118457-14-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nebivolol
  • nebivolol hydrochloride
  • vasoxen
  • bystolic
  • nebivolol HCl
A cardioselective ADRENERGIC BETA-1 RECEPTOR ANTAGONIST (beta-blocker) that functions as a VASODILATOR through the endothelial L-arginine/ NITRIC OXIDE system. It is used to manage HYPERTENSION and chronic HEART FAILURE in elderly patients.
  • Molecular weight: 405.44
  • Formula: C22H25F2NO4
  • CLOGP: 3.50
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 70.95
  • ALOGS: -4
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 11 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 14 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 10 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 0.04 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MET,NTRK2,PDK2,PDK4,PRKDC,TEK,TGFBR1 18
kinase-selectivity-class AXL,EIF2AK3 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Dec. 17, 2007 FDA FOREST LABS

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
Acute kidney injury 350.27 11.30 535 36588 319852 90271472
Bradycardia 297.28 11.30 258 36865 83589 90507735
Hyponatraemia 242.51 11.30 286 36837 133252 90458072
Hypotension 180.52 11.30 406 36717 324991 90266333
Hypertensive crisis 177.25 11.30 103 37020 17681 90573643
Anaemia 161.96 11.30 409 36714 352393 90238931
Drug interaction 141.17 11.30 334 36789 276119 90315205
Systemic lupus erythematosus 133.82 11.30 3 37120 361893 90229431
Synovitis 117.23 11.30 4 37119 329748 90261576
Joint swelling 109.49 11.30 35 37088 503265 90088059
Syncope 108.76 11.30 195 36928 132468 90458856
Glossodynia 107.48 11.30 6 37117 321773 90269551
Treatment failure 92.03 11.30 9 37114 303919 90287405
Fall 91.45 11.30 415 36708 481395 90109929
Arthropathy 89.95 11.30 20 37103 366222 90225102
Maternal exposure during pregnancy 89.77 11.30 19 37104 360044 90231280
Infusion related reaction 82.11 11.30 34 37089 416746 90174578
Hyperkalaemia 81.50 11.30 116 37007 64848 90526476
Ischaemic stroke 80.07 11.30 69 37054 22097 90569227
Pericarditis 79.22 11.30 9 37114 270142 90321182
Sopor 77.64 11.30 71 37052 24573 90566751
Hypokalaemia 77.47 11.30 168 36955 130948 90460376
Cholestasis 72.94 11.30 82 37041 36217 90555107
Cardiac failure 70.13 11.30 145 36978 109351 90481973
Wound 65.94 11.30 21 37102 302959 90288365
Hypoglycaemia 64.16 11.30 108 37015 69740 90521584
Product prescribing error 63.84 11.30 70 37053 30075 90561249
Rhabdomyolysis 63.52 11.30 91 37032 51165 90540159
Atrial fibrillation 62.27 11.30 156 36967 133455 90457869
Pain 61.84 11.30 206 36917 996135 89595189
Rheumatoid arthritis 61.68 11.30 36 37087 362578 90228746
Contraindicated product administered 61.61 11.30 27 37096 320112 90271212
Dyspnoea 60.65 11.30 588 36535 880367 89710957
Swelling 60.18 11.30 50 37073 419008 90172316
Abdominal discomfort 59.17 11.30 65 37058 477263 90114061
Therapeutic product effect decreased 59.06 11.30 20 37103 277551 90313773
Acute motor-sensory axonal neuropathy 58.49 11.30 16 37107 359 90590965
Fibromyalgia 57.71 11.30 8 37115 206261 90385063
Hypomagnesaemia 57.62 11.30 72 37051 35516 90555808
Lip oedema 54.69 11.30 30 37093 4609 90586715
Traumatic coma 54.17 11.30 11 37112 61 90591263
Melaena 54.11 11.30 69 37054 34728 90556596
Hepatocellular injury 54.10 11.30 63 37060 28895 90562429
Impaired healing 53.19 11.30 15 37108 234184 90357140
Liver injury 51.74 11.30 5 37118 170562 90420762
Irritable bowel syndrome 51.56 11.30 11 37112 207437 90383887
Vertigo 51.37 11.30 98 37025 69713 90521611
Exposure during pregnancy 51.03 11.30 17 37106 238393 90352931
Angina pectoris 49.22 11.30 70 37053 39090 90552234
Renal failure 47.06 11.30 139 36984 130868 90460456
Discomfort 46.97 11.30 27 37096 274308 90317016
Mobility decreased 46.90 11.30 22 37101 250712 90340612
Arrhythmia 46.47 11.30 71 37052 42261 90549063
Ill-defined disorder 45.55 11.30 10 37113 184881 90406443
Lactic acidosis 44.98 11.30 77 37046 50386 90540938
Metabolic acidosis 44.51 11.30 81 37042 55595 90535729
Musculoskeletal stiffness 44.28 11.30 34 37089 296498 90294826
Neutropenia 43.49 11.30 195 36928 224709 90366615
Drug hypersensitivity 42.67 11.30 78 37045 463531 90127793
Type 2 diabetes mellitus 42.61 11.30 15 37108 203229 90388095
Dermatitis artefacta 42.39 11.30 9 37114 64 90591260
Blister 42.38 11.30 26 37097 254972 90336352
Therapeutic drug monitoring analysis not performed 42.05 11.30 17 37106 1312 90590012
Joint range of motion decreased 41.07 11.30 4 37119 135639 90455685
Systemic infection 40.66 11.30 25 37098 4750 90586574
Asthenia 39.45 11.30 362 36761 533389 90057935
Nasopharyngitis 37.89 11.30 68 37055 407036 90184288
Cerebellar ataxia 36.96 11.30 14 37109 908 90590416
Infection 36.92 11.30 57 37066 362037 90229287
Thrombocytopenia 36.68 11.30 176 36947 208549 90382775
Gastrointestinal disorder 36.36 11.30 31 37092 256656 90334668
Injury 35.85 11.30 18 37105 197331 90393993
Presyncope 35.83 11.30 54 37069 31751 90559573
Hypersensitivity 35.50 11.30 84 37039 454593 90136731
Drug intolerance 35.50 11.30 82 37041 447509 90143815
Atrioventricular block 35.04 11.30 29 37094 8786 90582538
Disorientation 35.04 11.30 64 37059 44050 90547274
Bursitis 34.78 11.30 6 37117 131648 90459676
Hypocalcaemia 34.32 11.30 62 37061 42306 90549018
Product use issue 33.57 11.30 52 37071 329867 90261457
Cardiac myxoma 33.51 11.30 10 37113 309 90591015
Drug ineffective 33.42 11.30 385 36738 1383913 89207411
Arthralgia 33.41 11.30 185 36938 778337 89812987
Alopecia scarring 33.20 11.30 9 37114 195 90591129
Stomatitis 32.27 11.30 39 37084 274659 90316665
Blood creatinine increased 32.14 11.30 103 37020 101283 90490041
Psoriatic arthropathy 31.82 11.30 28 37095 228307 90363017
Sinusitis 31.30 11.30 58 37065 343030 90248294
Cerebral haemorrhage 31.19 11.30 53 37070 34469 90556855
Blood pressure increased 30.90 11.30 161 36962 197056 90394268
Alopecia 30.83 11.30 102 37021 494969 90096355
Tongue oedema 30.56 11.30 22 37101 5432 90585892
Primary hyperaldosteronism 30.24 11.30 7 37116 77 90591247
Nodular melanoma 30.16 11.30 7 37116 78 90591246
Facial asymmetry 29.66 11.30 12 37111 928 90590396
Epistaxis 29.31 11.30 89 37034 85036 90506288
Haemorrhagic stroke 29.27 11.30 23 37100 6473 90584851
Miosis 29.24 11.30 27 37096 9457 90581867
Orthostatic hypotension 28.67 11.30 57 37066 41770 90549554
Sinus bradycardia 28.57 11.30 35 37088 16917 90574407
Leukopenia 28.09 11.30 98 37025 100612 90490712
Lip dry 28.03 11.30 4 37119 100951 90490373
Oedema peripheral 27.85 11.30 191 36932 257724 90333600
Respiratory failure 27.81 11.30 109 37014 118309 90473015
Wound infection 27.78 11.30 5 37118 106397 90484927
Blood loss anaemia 27.70 11.30 27 37096 10113 90581211
Obesity 27.45 11.30 5 37118 105502 90485822
Pancreatitis acute 27.30 11.30 48 37075 32067 90559257
Osteoarthritis 27.27 11.30 24 37099 195706 90395618
Blood cholesterol increased 27.22 11.30 27 37096 207985 90383339
Haematoma 26.51 11.30 53 37070 38995 90552329
Electrolyte imbalance 26.30 11.30 40 37083 23705 90567619
Sprue-like enteropathy 26.12 11.30 11 37112 942 90590382
Labelled drug-drug interaction medication error 26.03 11.30 31 37092 14551 90576773
Lower respiratory tract infection 25.98 11.30 39 37084 250620 90340704
Myalgia 25.41 11.30 140 36983 174985 90416339
Angioedema 25.38 11.30 71 37052 64805 90526519
Chronic obstructive pulmonary disease 25.23 11.30 77 37046 73752 90517572
Erythrosis 24.93 11.30 6 37117 79 90591245
Hepatic enzyme increased 24.81 11.30 71 37052 360665 90230659
Diarrhoea 24.80 11.30 530 36593 938660 89652664
Renal impairment 24.72 11.30 97 37026 105324 90486000
Retroperitoneal haematoma 24.60 11.30 16 37107 3352 90587972
Walking disability 24.32 11.30 12 37111 1483 90589841
Nocturia 23.80 11.30 25 37098 10230 90581094
Resting tremor 23.56 11.30 10 37113 873 90590451
Suicide attempt 23.35 11.30 76 37047 75323 90516001
Cerebral haematoma 23.35 11.30 17 37106 4272 90587052
General physical health deterioration 23.29 11.30 235 36888 354880 90236444
Renin decreased 23.29 11.30 6 37117 106 90591218
Exercise tolerance decreased 22.32 11.30 21 37102 7530 90583794
Sciatica 22.08 11.30 7 37116 101375 90489949
Drug abuse 21.99 11.30 79 37044 82268 90509056
Interstitial lung disease 21.87 11.30 75 37048 76330 90514994
Peripheral venous disease 21.78 11.30 4 37119 83917 90507407
Rash 21.71 11.30 215 36908 795885 89795439
Faecaloma 21.70 11.30 24 37099 10407 90580917
Potentiating drug interaction 21.21 11.30 18 37105 5644 90585680
Atrioventricular block complete 21.15 11.30 23 37100 9788 90581536
Arterial spasm 20.84 11.30 5 37118 65 90591259
Agranulocytosis 20.82 11.30 45 37078 34957 90556367
Tremor 20.60 11.30 120 37003 153053 90438271
Therapeutic drug monitoring analysis incorrectly performed 20.54 11.30 7 37116 334 90590990
Microcytic anaemia 20.48 11.30 15 37108 3803 90587521
Cardiovascular insufficiency 20.46 11.30 11 37112 1624 90589700
Chronic pigmented purpura 20.37 11.30 6 37117 177 90591147
Gait inability 20.35 11.30 18 37105 146438 90444886
Somnolence 20.33 11.30 151 36972 208933 90382391
Electrocardiogram abnormal 20.23 11.30 23 37100 10275 90581049
Off label use 20.21 11.30 324 36799 1101928 89489396
C-reactive protein increased 20.00 11.30 27 37096 181362 90409962
Blood lactic acid increased 19.66 11.30 21 37102 8757 90582567
Blood aldosterone increased 19.58 11.30 6 37117 203 90591121
Intentional product use issue 19.47 11.30 37 37086 216855 90374469
Glomerular filtration rate decreased 19.43 11.30 29 37094 16903 90574421
Upper respiratory tract irritation 19.42 11.30 6 37117 209 90591115
Anuria 19.37 11.30 27 37096 14791 90576533
Rash maculo-papular 19.27 11.30 48 37075 40885 90550439
Autoimmune disorder 19.20 11.30 4 37119 76740 90514584
Peripheral ischaemia 19.17 11.30 17 37106 5650 90585674
Contusion 19.11 11.30 47 37076 251169 90340155
Hip arthroplasty 19.01 11.30 4 37119 76204 90515120
Drop attacks 18.98 11.30 8 37115 686 90590638
Hypoosmolar state 18.94 11.30 6 37117 227 90591097
Shock haemorrhagic 18.59 11.30 24 37099 12221 90579103
Eosinophilia 18.50 11.30 38 37085 28495 90562829
Sleep disorder 18.47 11.30 33 37090 197997 90393327
Peripheral swelling 18.31 11.30 97 37026 413009 90178315
Lower limb fracture 18.28 11.30 6 37117 85007 90506317
Gastrointestinal haemorrhage 17.99 11.30 79 37044 90169 90501155
Pulmonary fibrosis 17.79 11.30 11 37112 107492 90483832
International normalised ratio increased 17.74 11.30 51 37072 47265 90544059
Face oedema 17.47 11.30 33 37090 23285 90568039
Hyperammonaemia 17.24 11.30 17 37106 6458 90584866
Hypercholesterolaemia 17.15 11.30 10 37113 100882 90490442
Catheter site injury 17.15 11.30 6 37117 310 90591014
Elephantiasis 17.11 11.30 3 37120 6 90591318
Urine output increased 17.01 11.30 10 37113 1752 90589572
Drug reaction with eosinophilia and systemic symptoms 16.92 11.30 47 37076 42711 90548613
Cerebrovascular accident 16.75 11.30 97 37026 123436 90467888
N-terminal prohormone brain natriuretic peptide increased 16.71 11.30 12 37111 2950 90588374
Catheter site inflammation 16.52 11.30 8 37115 949 90590375
Hepatic cirrhosis 16.45 11.30 3 37120 63250 90528074
Inflammation 16.44 11.30 30 37093 178562 90412762
Palpitations 16.41 11.30 104 37019 136624 90454700
Intraventricular haemorrhage 16.27 11.30 11 37112 2458 90588866
Dry gangrene 16.20 11.30 7 37116 638 90590686
Gastrooesophageal reflux disease 16.17 11.30 27 37096 166310 90425014
Aeromonas infection 16.13 11.30 5 37118 176 90591148
Hypoaesthesia 16.12 11.30 70 37053 314140 90277184
Muscle rupture 16.08 11.30 12 37111 3129 90588195
Dysarthria 16.05 11.30 54 37069 54428 90536896
Pregnancy 16.01 11.30 3 37120 62044 90529280
Hypovolaemic shock 15.94 11.30 17 37106 7077 90584247
Electrocardiogram Q wave abnormal 15.92 11.30 5 37118 184 90591140
Taste disorder 15.83 11.30 3 37120 61543 90529781
Red blood cell sedimentation rate increased 15.81 11.30 7 37116 82588 90508736
Nasal mucosal erosion 15.67 11.30 4 37119 68 90591256
Hypochloraemia 15.67 11.30 11 37112 2611 90588713
Lipase increased 15.67 11.30 21 37102 11090 90580234
Intentional overdose 15.66 11.30 78 37045 93756 90497568
Coronavirus infection 15.66 11.30 15 37108 5500 90585824
Vasculitis 15.64 11.30 31 37092 22662 90568662
Colitis microscopic 15.60 11.30 21 37102 11138 90580186
Diffuse large B-cell lymphoma stage II 15.46 11.30 4 37119 72 90591252
Pulmonary embolism 15.38 11.30 99 37024 130721 90460603
Hepatic cytolysis 15.34 11.30 37 37086 30879 90560445
Toxic skin eruption 15.29 11.30 25 37098 15749 90575575
COVID-19 pneumonia 15.23 11.30 27 37096 18150 90573174
Hypotonia 15.21 11.30 21 37102 11405 90579919
Trigeminal neuralgia 15.20 11.30 13 37110 4118 90587206
Jaundice 15.17 11.30 38 37085 32479 90558845
Purpura 15.12 11.30 24 37099 14754 90576570
Inappropriate antidiuretic hormone secretion 15.11 11.30 28 37095 19477 90571847
Vascular encephalopathy 15.02 11.30 7 37116 763 90590561
Pallor 14.97 11.30 39 37084 34126 90557198
Adenocarcinoma metastatic 14.93 11.30 5 37118 226 90591098
Prescribed overdose 14.80 11.30 11 37112 97614 90493710
Hemiparesis 14.65 11.30 37 37086 31782 90559542
Cardiac failure acute 14.51 11.30 21 37102 11908 90579416
Adverse event 14.50 11.30 16 37107 117402 90473922
Acute myocardial infarction 14.45 11.30 39 37084 34851 90556473
Weight increased 14.44 11.30 106 37017 417821 90173503
Platelet disorder 14.34 11.30 10 37113 2349 90588975
Loss of personal independence in daily activities 14.26 11.30 21 37102 136084 90455240
Glycosylated haemoglobin increased 14.20 11.30 24 37099 15538 90575786
Frequent bowel movements 14.18 11.30 3 37120 56932 90534392
Adjustment disorder with depressed mood 14.11 11.30 3 37120 56750 90534574
Hallucination, visual 14.09 11.30 30 37093 23062 90568262
Abdominal wound dehiscence 14.08 11.30 5 37118 270 90591054
Loss of consciousness 14.04 11.30 102 37021 140136 90451188
Haematoma muscle 14.03 11.30 9 37114 1841 90589483
Disorganised speech 13.88 11.30 9 37114 1876 90589448
Degenerative bone disease 13.85 11.30 5 37118 283 90591041
Arthritis 13.77 11.30 30 37093 167285 90424039
Scar pain 13.74 11.30 5 37118 290 90591034
Hypersensitivity pneumonitis 13.67 11.30 12 37111 3936 90587388
Asthma 13.64 11.30 52 37071 242108 90349216
Product measured potency issue 13.55 11.30 4 37119 119 90591205
Mitral valve incompetence 13.44 11.30 29 37094 22495 90568829
Haemodynamic instability 13.32 11.30 20 37103 11719 90579605
Pulmonary hypertension 13.29 11.30 43 37080 42480 90548844
Peripheral artery stenosis 13.23 11.30 6 37117 614 90590710
Drug level above therapeutic 13.19 11.30 14 37109 5795 90585529
Tachycardia 13.19 11.30 110 37013 157563 90433761
Dizziness 13.15 11.30 325 36798 588959 90002365
Knee arthroplasty 13.10 11.30 9 37114 83173 90508151
Enuresis 13.09 11.30 11 37112 3403 90587921
Diaphragmatic disorder 13.03 11.30 6 37117 636 90590688
Road traffic accident 12.93 11.30 15 37108 107611 90483713
Joint stiffness 12.89 11.30 8 37115 78034 90513290
Intra-abdominal haematoma 12.82 11.30 9 37114 2135 90589189
Product use in unapproved indication 12.73 11.30 83 37040 336153 90255171
Psychotic behaviour 12.73 11.30 6 37117 670 90590654
Hypochromic anaemia 12.72 11.30 9 37114 2162 90589162
Palatal oedema 12.71 11.30 6 37117 673 90590651
Polyuria 12.69 11.30 18 37105 10022 90581302
Ductal adenocarcinoma of pancreas 12.69 11.30 4 37119 149 90591175
Arterial thrombosis 12.67 11.30 8 37115 1592 90589732
Bacterial diarrhoea 12.61 11.30 4 37119 152 90591172
Cardiorenal syndrome 12.58 11.30 7 37116 1105 90590219
Mucosal hyperaemia 12.50 11.30 3 37120 39 90591285
Chronic kidney disease 12.43 11.30 47 37076 50144 90541180
Erythema 12.38 11.30 146 36977 229100 90362224
Wrong schedule 12.33 11.30 5 37118 389 90590935
Dermatitis bullous 12.31 11.30 18 37105 10298 90581026
Withdrawal hypertension 12.30 11.30 4 37119 165 90591159
Wheezing 12.23 11.30 53 37070 238027 90353297
Chronic gastritis 12.22 11.30 11 37112 3730 90587594
Sinus node dysfunction 12.21 11.30 13 37110 5399 90585925
Bundle branch block right 12.13 11.30 13 37110 5440 90585884
Amnestic disorder 12.07 11.30 5 37118 411 90590913
Peripheral arterial occlusive disease 12.06 11.30 12 37111 4609 90586715
Dedifferentiated liposarcoma 11.98 11.30 3 37120 47 90591277
Poisoning deliberate 11.94 11.30 23 37100 16463 90574861
Cutaneous lupus erythematosus 11.86 11.30 10 37113 3108 90588216
Coronary artery occlusion 11.81 11.30 16 37107 8538 90582786
Coma scale abnormal 11.80 11.30 13 37110 5613 90585711
Anaphylactic shock 11.77 11.30 34 37089 31583 90559741
Renal hypertrophy 11.75 11.30 3 37120 51 90591273
Extrasystoles 11.74 11.30 13 37110 5644 90585680
Bradyarrhythmia 11.71 11.30 9 37114 2452 90588872
Lymphocele 11.70 11.30 6 37117 805 90590519
Polyneuropathy 11.66 11.30 25 37098 19316 90572008
Bronchospasm 11.61 11.30 26 37097 20683 90570641
Kidney transplant rejection 11.56 11.30 12 37111 4845 90586479
Sudden death 11.55 11.30 18 37105 10891 90580433
Hyperuricaemia 11.53 11.30 14 37109 6705 90584619

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
Acute kidney injury 218.54 11.76 681 30889 366656 42223109
Hyperkalaemia 175.89 11.76 255 31315 80203 42509562
Lactic acidosis 116.08 11.76 155 31415 45106 42544659
Bradycardia 107.85 11.76 212 31358 85272 42504493
Hypokalaemia 82.25 11.76 171 31399 71550 42518215
Hypoparathyroidism 67.74 11.76 24 31546 701 42589064
Hypertensive crisis 61.74 11.76 55 31515 10151 42579614
Syncope 59.27 11.76 185 31385 99221 42490544
Hypomagnesaemia 56.00 11.76 86 31484 28402 42561363
Cutaneous lupus erythematosus 53.38 11.76 21 31549 825 42588940
Death 53.00 11.76 176 31394 471009 42118756
Hypotension 51.10 11.76 346 31224 257285 42332480
Drug interaction 46.79 11.76 348 31222 266651 42323114
Hypocalcaemia 43.15 11.76 79 31491 30094 42559671
Ischaemic stroke 40.75 11.76 65 31505 22168 42567597
Angina pectoris 39.52 11.76 80 31490 32816 42556949
Anaemia 39.17 11.76 347 31223 279931 42309834
Cardiac failure 37.72 11.76 168 31402 106688 42483077
Cerebral haematoma 37.49 11.76 32 31538 5578 42584187
Melaena 37.13 11.76 86 31484 38660 42551105
Drug reaction with eosinophilia and systemic symptoms 36.67 11.76 90 31480 41985 42547780
Presyncope 35.07 11.76 61 31509 22326 42567439
Akinesia 34.53 11.76 22 31548 2450 42587315
Renal artery thrombosis 34.28 11.76 12 31558 338 42589427
Burnout syndrome 29.87 11.76 9 31561 155 42589610
Vascular purpura 29.41 11.76 19 31551 2167 42587598
Acute coronary syndrome 29.38 11.76 45 31525 14820 42574945
Cholestasis 29.36 11.76 71 31499 32808 42556957
Eosinophilia 29.33 11.76 71 31499 32828 42556937
Labelled drug-drug interaction medication error 29.16 11.76 46 31524 15536 42574229
Product monitoring error 29.09 11.76 25 31545 4398 42585367
Renal failure 28.40 11.76 193 31377 143533 42446232
Extrasystoles 28.11 11.76 24 31546 4185 42585580
Fungal endocarditis 27.47 11.76 11 31559 453 42589312
Blood lactic acid 26.90 11.76 10 31560 336 42589429
Cerebellar ischaemia 26.54 11.76 8 31562 138 42589627
Glomerular filtration rate abnormal 25.27 11.76 14 31556 1206 42588559
Hepatic function abnormal 25.19 11.76 4 31566 51563 42538202
Coma uraemic 24.93 11.76 6 31564 41 42589724
White blood cell count decreased 24.90 11.76 27 31543 110369 42479396
Cardiac failure chronic 24.77 11.76 33 31537 9568 42580197
Toxicity to various agents 24.69 11.76 87 31483 229049 42360716
Spinal osteoarthritis 24.19 11.76 31 31539 8655 42581110
Oral lichen planus 23.83 11.76 8 31562 198 42589567
Interstitial lung disease 23.74 11.76 118 31452 78344 42511421
Left ventricular false tendon 23.48 11.76 6 31564 54 42589711
Vertigo 23.35 11.76 67 31503 34280 42555485
Laryngeal cancer metastatic 23 11.76 6 31564 59 42589706
Inferior vena cava syndrome 22.82 11.76 6 31564 61 42589704
Lung diffusion test abnormal 22.73 11.76 6 31564 62 42589703
Shock haemorrhagic 22.55 11.76 42 31528 16200 42573565
Intercapillary glomerulosclerosis 22.48 11.76 6 31564 65 42589700
Enterobacter pneumonia 22.23 11.76 10 31560 551 42589214
Decreased ventricular preload 21.94 11.76 5 31565 26 42589739
Electrocardiogram abnormal 21.89 11.76 32 31538 10113 42579652
Agoraphobia 21.77 11.76 8 31562 260 42589505
Brief psychotic disorder with marked stressors 21.60 11.76 8 31562 266 42589499
Blood sodium abnormal 21.50 11.76 10 31560 595 42589170
Vitamin B12 decreased 21.30 11.76 14 31556 1644 42588121
Neurosis 20.75 11.76 7 31563 176 42589589
Idiopathic pulmonary fibrosis 20.59 11.76 21 31549 4583 42585182
Cerebellar syndrome 20.55 11.76 17 31553 2838 42586927
Hyponatraemia 20.48 11.76 137 31433 101325 42488440
Blood cholinesterase decreased 20.42 11.76 7 31563 185 42589580
Haematoma 20.36 11.76 56 31514 27967 42561798
Myelosuppression 20.08 11.76 3 31567 40458 42549307
Hepatocellular injury 19.94 11.76 50 31520 23628 42566137
Bundle branch block left 19.45 11.76 24 31546 6452 42583313
Lichen planus 19.43 11.76 12 31558 1265 42588500
Blood creatinine abnormal 19.20 11.76 17 31553 3112 42586653
Febrile neutropenia 19.01 11.76 72 31498 185631 42404134
Pemphigoid 18.95 11.76 32 31538 11435 42578330
Anticoagulation drug level increased 18.49 11.76 9 31561 593 42589172
Off label use 18.40 11.76 348 31222 637987 41951778
Folate deficiency 18.34 11.76 13 31557 1726 42588039
Enzyme induction 18.34 11.76 5 31565 59 42589706
Acetonaemia 18.32 11.76 7 31563 254 42589511
Platelet count decreased 18.21 11.76 48 31522 138533 42451232
Optic neuropathy 18.17 11.76 15 31555 2497 42587268
Blood urea abnormal 18.10 11.76 11 31559 1127 42588638
Potentiating drug interaction 17.88 11.76 23 31547 6445 42583320
Myalgia 17.77 11.76 127 31443 95953 42493812
Carbohydrate metabolism disorder 17.52 11.76 4 31566 21 42589744
Peripheral motor neuropathy 17.39 11.76 14 31556 2250 42587515
Erectile dysfunction 17.32 11.76 49 31521 24864 42564901
Bronchitis bacterial 17.31 11.76 10 31560 933 42588832
Tubulointerstitial nephritis 17.21 11.76 57 31513 31491 42558274
Infusion related reaction 17.19 11.76 12 31558 60794 42528971
Hypertensive nephropathy 16.97 11.76 8 31562 491 42589274
Left ventricle outflow tract obstruction 16.91 11.76 6 31564 176 42589589
Pemphigus 16.68 11.76 13 31557 1993 42587772
Dialysis device insertion 16.66 11.76 4 31566 27 42589738
Infective exacerbation of chronic obstructive airways disease 16.53 11.76 13 31557 2020 42587745
Ventricular internal diameter abnormal 16.42 11.76 6 31564 192 42589573
Metabolic acidosis 16.40 11.76 79 31491 51779 42537986
Craniocerebral injury 16.26 11.76 17 31553 3817 42585948
Pancreatitis acute 16.01 11.76 58 31512 33506 42556259
Electrocardiogram T wave amplitude decreased 15.74 11.76 7 31563 375 42589390
Electrocardiogram T wave abnormal 15.68 11.76 12 31558 1792 42587973
Metastatic bronchial carcinoma 15.42 11.76 7 31563 394 42589371
Electrolyte imbalance 15.34 11.76 37 31533 17064 42572701
Retinal disorder 15.29 11.76 10 31560 1165 42588600
Orthostatic intolerance 15.25 11.76 9 31561 874 42588891
Congestive cardiomyopathy 15.21 11.76 25 31545 8739 42581026
Blood pressure increased 15.12 11.76 128 31442 101800 42487965
Stress 14.96 11.76 7 31563 44205 42545560
Diabetic nephropathy 14.93 11.76 13 31557 2328 42587437
Dyspnoea 14.92 11.76 431 31139 442190 42147575
Blood creatine phosphokinase MB increased 14.75 11.76 12 31558 1958 42587807
Sepsis 14.69 11.76 87 31483 199247 42390518
Electrocardiogram QT prolonged 14.42 11.76 72 31498 47873 42541892
Renal ischaemia 14.28 11.76 11 31559 1659 42588106
Atrial enlargement 14.11 11.76 8 31562 721 42589044
Loss of personal independence in daily activities 13.86 11.76 10 31560 49806 42539959
Hydrocholecystis 13.83 11.76 7 31563 502 42589263
Sinus arrest 13.80 11.76 12 31558 2144 42587621
Haemorrhagic transformation stroke 13.60 11.76 11 31559 1780 42587985
Atrioventricular block 13.52 11.76 25 31545 9590 42580175
Drug ineffective 13.46 11.76 360 31210 629837 41959928
Transferrin saturation decreased 13.44 11.76 7 31563 533 42589232
Multiple organ dysfunction syndrome 13.21 11.76 33 31537 97002 42492763
Congenital inguinal hernia 13.20 11.76 5 31565 177 42589588
Musculoskeletal stiffness 13.16 11.76 14 31556 57751 42532014
Coma 13.10 11.76 76 31494 53478 42536287
Orthostatic hypotension 13.07 11.76 51 31519 30519 42559246
Cardioactive drug level decreased 13.01 11.76 4 31566 74 42589691
Funguria 13.01 11.76 4 31566 74 42589691
Alanine aminotransferase increased 12.88 11.76 29 31541 88377 42501388
Haemoglobinaemia 12.84 11.76 5 31565 191 42589574
Labelled drug-food interaction issue 12.81 11.76 4 31566 78 42589687
Epistaxis 12.74 11.76 89 31481 66737 42523028
Pain 12.71 11.76 118 31452 244730 42345035
Haemorrhagic stroke 12.69 11.76 21 31549 7381 42582384
Carcinogenicity 12.67 11.76 4 31566 81 42589684
Disease progression 12.65 11.76 59 31511 143597 42446168
Oesophagitis 12.63 11.76 32 31538 15215 42574550
Tachyarrhythmia 12.50 11.76 15 31555 3917 42585848
Cutaneous vasculitis 12.49 11.76 20 31550 6840 42582925
Dermatosis 12.38 11.76 6 31564 392 42589373
Albumin urine present 12.29 11.76 6 31564 398 42589367
Gingival discomfort 12.23 11.76 4 31566 91 42589674
Escherichia sepsis 12.21 11.76 18 31552 5729 42584036
Hypoglycaemia 12.17 11.76 81 31489 59773 42529992
Jealous delusion 12.16 11.76 6 31564 407 42589358
Traumatic haemothorax 12.15 11.76 6 31564 408 42589357
Oedema peripheral 12.12 11.76 154 31416 135922 42453843
Metabolic alkalosis 12.07 11.76 11 31559 2090 42587675
Intentional product misuse 12.00 11.76 17 31553 61883 42527882
Normocytic anaemia 11.96 11.76 14 31556 3563 42586202
Perioral dermatitis 11.94 11.76 5 31565 231 42589534
International normalised ratio fluctuation 11.93 11.76 9 31561 1315 42588450
Balance disorder 11.91 11.76 68 31502 47577 42542188
Drug hypersensitivity 11.89 11.76 36 31534 99353 42490412
Bacterial infection 11.87 11.76 3 31567 27876 42561889
Gastric ulcer 11.81 11.76 35 31535 18227 42571538
Drug abuse 11.79 11.76 39 31531 104732 42485033
Intentional product use issue 11.79 11.76 22 31548 71811 42517954
Nephritis allergic 11.78 11.76 7 31563 689 42589076

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
Acute kidney injury 606.03 10.99 1169 59039 634261 109894830
Bradycardia 359.34 10.99 433 59775 155084 110374007
Hyperkalaemia 264.08 10.99 347 59861 135449 110393642
Hypertensive crisis 236.97 10.99 154 60054 24218 110504873
Hyponatraemia 214.40 10.99 407 59801 217246 110311845
Hypotension 214.26 10.99 699 59509 523150 110005941
Drug interaction 195.19 10.99 657 59551 499526 110029565
Anaemia 194.77 10.99 697 59511 546389 109982702
Syncope 169.67 10.99 354 59854 202182 110326909
Lactic acidosis 160.34 10.99 224 59984 92587 110436504
Hypokalaemia 142.52 10.99 310 59898 182138 110346953
Synovitis 130.92 10.99 4 60204 274088 110255003
Systemic lupus erythematosus 120.44 10.99 4 60204 254334 110274757
Ischaemic stroke 115.55 10.99 127 60081 41136 110487955
Hypomagnesaemia 112.23 10.99 151 60057 60219 110468872
Infusion related reaction 103.56 10.99 39 60169 381123 110147968
Cholestasis 102.99 10.99 150 60058 64368 110464723
Maternal exposure during pregnancy 102.60 10.99 10 60198 254873 110274218
Joint swelling 102.18 10.99 57 60151 442788 110086303
Melaena 97.14 10.99 151 60057 68606 110460485
Cardiac failure 94.82 10.99 270 59938 187356 110341735
Arthropathy 93.50 10.99 21 60187 287501 110241590
Glossodynia 88.59 10.99 9 60199 221995 110307096
Helicobacter infection 82.26 10.99 4 60204 181873 110347218
Hypocalcaemia 82.00 10.99 136 60072 65230 110463861
Treatment failure 81.12 10.99 25 60183 277209 110251882
Pemphigus 79.92 10.99 11 60197 214559 110314532
Pericarditis 79.83 10.99 12 60196 219102 110309989
Fibromyalgia 79.81 10.99 3 60205 170906 110358185
Pain 76.86 10.99 265 59943 954690 109574401
Sopor 76.61 10.99 97 60111 36449 110492642
Vertigo 76.38 10.99 155 60053 86715 110442376
Angina pectoris 74.67 10.99 127 60081 62168 110466923
Fall 73.63 10.99 571 59637 602911 109926180
Presyncope 72.76 10.99 110 60098 48777 110480314
Hepatocellular injury 72.63 10.99 112 60096 50530 110478561
Folliculitis 71.82 10.99 5 60203 167648 110361443
Rheumatoid arthritis 71.36 10.99 37 60171 299576 110229515
Hypoglycaemia 70.65 10.99 179 60029 115925 110413166
Drug hypersensitivity 70.63 10.99 86 60122 454004 110075087
Renal failure 68.22 10.99 274 59934 226300 110302791
Exposure during pregnancy 66.24 10.99 7 60201 167417 110361674
Irritable bowel syndrome 64.63 10.99 7 60201 164208 110364883
Drug reaction with eosinophilia and systemic symptoms 64.62 10.99 140 60068 81955 110447136
Nasopharyngitis 64.21 10.99 72 60136 394289 110134802
Muscle injury 63.98 10.99 3 60205 140804 110388287
Atrial fibrillation 63.85 10.99 271 59937 229371 110299720
Musculoskeletal stiffness 63.09 10.99 37 60171 279785 110249306
Therapeutic product effect decreased 63.05 10.99 27 60181 244289 110284802
Dyspnoea 61.55 10.99 893 59315 1105979 109423112
Rhabdomyolysis 61.51 10.99 174 60034 120227 110408864
Cerebral haematoma 61.33 10.99 47 60161 9585 110519506
Metabolic acidosis 60.91 10.99 154 60054 99590 110429501
Cutaneous lupus erythematosus 57.48 10.99 31 60177 3457 110525634
Wound 57.24 10.99 28 60180 234409 110294682
Labelled drug-drug interaction medication error 57.07 10.99 75 60133 29227 110499864
Interstitial lung disease 55.88 10.99 185 60023 139149 110389942
Mobility decreased 55.52 10.99 30 60178 237392 110291699
Eosinophilia 55.29 10.99 107 60101 57829 110471262
Bursitis 55.28 10.99 4 60204 129914 110399177
Abdominal discomfort 52.79 10.99 83 60125 393775 110135316
Lower respiratory tract infection 52.22 10.99 34 60174 243072 110286019
Psoriatic arthropathy 51.97 10.99 21 60187 196740 110332351
Impaired healing 51.95 10.99 21 60187 196696 110332395
Ill-defined disorder 51.90 10.99 11 60197 156842 110372249
Sinusitis 50.69 10.99 52 60156 296636 110232455
Acute motor-sensory axonal neuropathy 48.30 10.99 16 60192 522 110528569
Arthralgia 47.90 10.99 240 59968 779392 109749699
Acute coronary syndrome 47.89 10.99 61 60147 23051 110506040
Atrioventricular block 47.34 10.99 52 60156 16825 110512266
Contraindicated product administered 46.54 10.99 40 60168 248227 110280864
Electrocardiogram abnormal 46.27 10.99 54 60154 18655 110510436
Joint range of motion decreased 45.94 10.99 6 60202 121826 110407265
Thrombocytopenia 45.77 10.99 336 59872 348549 110180542
C-reactive protein abnormal 45.22 10.99 8 60200 129687 110399404
Haematoma 45.19 10.99 99 60109 58377 110470714
Shock haemorrhagic 44.42 10.99 64 60144 27183 110501908
Stomatitis 44.33 10.99 49 60159 270193 110258898
Traumatic coma 43.92 10.99 10 60198 74 110529017
Blister 43.39 10.99 36 60172 227340 110301751
Product prescribing error 43.24 10.99 90 60118 51241 110477850
Haemorrhagic stroke 43.11 10.99 45 60163 13744 110515347
Discomfort 42.22 10.99 33 60175 214674 110314417
Pancreatitis acute 42.07 10.99 98 60110 60176 110468915
Epistaxis 41.91 10.99 161 60047 130211 110398880
Lip oedema 41.76 10.99 34 60174 7566 110521525
Alopecia 41.56 10.99 85 60123 364668 110164423
Liver injury 41.47 10.99 15 60193 150398 110378693
Hypoparathyroidism 41.25 10.99 19 60189 1511 110527580
Extrasystoles 41.11 10.99 35 60173 8283 110520808
Asthenia 41.02 10.99 563 59645 688436 109840655
Swelling 40.68 10.99 81 60127 350960 110178131
Orthostatic hypotension 40.14 10.99 102 60106 66147 110462944
Potentiating drug interaction 40.04 10.99 40 60168 11603 110517488
Electrolyte imbalance 39.84 10.99 72 60136 36956 110492135
Injury 39.15 10.99 24 60184 177241 110351850
Dermatitis artefacta 38.91 10.99 9 60199 72 110529019
Osteoarthritis 38.60 10.99 26 60182 182597 110346494
Myalgia 37.48 10.99 228 59980 222153 110306938
Cerebral haemorrhage 37.27 10.99 98 60110 64870 110464221
Renal impairment 36.85 10.99 201 60007 188244 110340847
Intentional product use issue 35.38 10.99 50 60158 247856 110281235
Sinus bradycardia 35.18 10.99 60 60148 29423 110499668
Drug ineffective 34.81 10.99 601 59607 1519939 109009152
Hypersensitivity 34.53 10.99 109 60099 403889 110125202
Cardiac failure chronic 34.39 10.99 40 60168 13771 110515320
Arrhythmia 34.02 10.99 99 60109 69476 110459615
Cardiac myxoma 33.97 10.99 10 60198 219 110528872
Anuria 33.73 10.99 53 60155 24288 110504803
Wound infection 33.52 10.99 6 60202 96459 110432632
Asthma 33.28 10.99 53 60155 250238 110278853
Product monitoring error 33.18 10.99 32 60176 8895 110520196
Hypoaesthesia 32.68 10.99 77 60131 314146 110214945
Renal artery thrombosis 32.48 10.99 12 60196 543 110528548
Therapeutic drug monitoring analysis not performed 31.37 10.99 17 60191 1914 110527177
Wheezing 31.22 10.99 57 60151 255173 110273918
Product use issue 31.14 10.99 78 60130 311617 110217474
Alopecia scarring 30.98 10.99 9 60199 188 110528903
Sprue-like enteropathy 30.56 10.99 16 60192 1680 110527411
Drug intolerance 30.47 10.99 116 60092 406396 110122695
Type 2 diabetes mellitus 30.33 10.99 31 60177 177201 110351890
Obesity 30.08 10.99 12 60196 113339 110415752
Hepatic function abnormal 30.08 10.99 6 60202 89289 110439802
Diarrhoea 29.47 10.99 820 59388 1138685 109390406
Blood creatinine increased 29.24 10.99 185 60023 182704 110346387
Blood loss anaemia 28.89 10.99 42 60166 17983 110511108
Pemphigoid 28.83 10.99 44 60164 19663 110509428
Infection 28.69 10.99 101 60107 362099 110166992
Kidney transplant rejection 28.65 10.99 34 60174 11953 110517138
General physical health deterioration 28.38 10.99 355 59853 424940 110104151
Retro-orbital neoplasm 27.78 10.99 7 60201 83 110529008
Lower limb fracture 27.72 10.99 4 60204 75344 110453747
Vascular purpura 27.58 10.99 20 60188 3751 110525340
Cerebellar ataxia 27.45 10.99 16 60192 2072 110527019
Hypotonia 27.16 10.99 38 60170 15707 110513384
Off label use 27.04 10.99 617 59591 1499568 109029523
Arthritis 26.81 10.99 31 60177 167555 110361536
Gait inability 26.75 10.99 21 60187 136355 110392736
Blood lactic acid 26.75 10.99 10 60198 468 110528623
N-terminal prohormone brain natriuretic peptide increased 26.72 10.99 24 60184 6097 110522994
Myelosuppression 26.70 10.99 9 60199 94331 110434760
Oedema peripheral 26.69 10.99 285 59923 328375 110200716
Coma uraemic 26.64 10.99 6 60202 42 110529049
Rash maculo-papular 26.64 10.99 95 60113 74127 110454964
Erectile dysfunction 26.54 10.99 41 60167 18515 110510576
Hypovolaemic shock 26.37 10.99 36 60172 14547 110514544
Facial asymmetry 26.01 10.99 12 60196 958 110528133
Left ventricular false tendon 25.94 10.99 6 60202 48 110529043
Loss of personal independence in daily activities 25.94 10.99 26 60182 149994 110379097
Jaundice 25.87 10.99 81 60127 59155 110469936
Glomerular filtration rate decreased 25.84 10.99 52 60156 28904 110500187
Infective exacerbation of chronic obstructive airways disease 25.83 10.99 18 60190 3172 110525919
Agranulocytosis 25.64 10.99 83 60125 61677 110467414
Systemic infection 25.39 10.99 29 60179 9790 110519301
Autoimmune disorder 25.23 10.99 3 60205 65480 110463611
Peripheral swelling 24.97 10.99 124 60084 403910 110125181
Cerebellar ischaemia 24.52 10.99 9 60199 400 110528691
Product use in unapproved indication 23.97 10.99 144 60064 447233 110081858
Peripheral venous disease 23.85 10.99 8 60200 84109 110444982
Blood pressure increased 23.82 10.99 230 59978 258143 110270948
Sleep disorder 23.72 10.99 45 60163 198599 110330492
Exercise tolerance decreased 23.67 10.99 31 60177 12036 110517055
Akinesia 23.58 10.99 18 60190 3649 110525442
Acute pulmonary oedema 23.54 10.99 37 60171 16959 110512132
Angioedema 23.41 10.99 111 60097 98389 110430702
Acute myocardial infarction 23.36 10.99 99 60109 83678 110445413
White blood cell count decreased 23.22 10.99 57 60151 229333 110299758
Sudden death 23.20 10.99 45 60163 24350 110504741
Gastrointestinal haemorrhage 23.17 10.99 162 60046 165356 110363735
Taste disorder 22.86 10.99 4 60204 65383 110463708
Faecaloma 22.83 10.99 34 60174 14874 110514217
Carbohydrate metabolism disorder 22.46 10.99 5 60203 33 110529058
Tongue oedema 22.40 10.99 25 60183 8231 110520860
Weight increased 21.99 10.99 136 60072 419508 110109583
Brief psychotic disorder with marked stressors 21.87 10.99 8 60200 352 110528739
Peripheral motor neuropathy 21.86 10.99 18 60190 4068 110525023
Chronic obstructive pulmonary disease 21.71 10.99 117 60091 109041 110420050
Blood creatinine abnormal 21.67 10.99 21 60187 5871 110523220
Urinary retention 21.53 10.99 85 60123 69598 110459493
C-reactive protein increased 21.39 10.99 55 60153 217864 110311227
Fungal endocarditis 21.35 10.99 10 60198 826 110528265
Sinus arrest 21.27 10.99 18 60190 4224 110524867
Red blood cell sedimentation rate increased 21.26 10.99 8 60200 78294 110450797
Intercapillary glomerulosclerosis 21.24 10.99 6 60202 113 110528978
Inflammation 21.18 10.99 46 60162 193192 110335899
Burnout syndrome 21.13 10.99 8 60200 388 110528703
Enterobacter pneumonia 21.10 10.99 9 60199 596 110528495
Inferior vena cava syndrome 21.09 10.99 6 60202 116 110528975
Blood urea abnormal 20.98 10.99 13 60195 1881 110527210
Retroperitoneal haematoma 20.96 10.99 21 60187 6110 110522981
Stress 20.94 10.99 16 60192 105332 110423759
Laryngeal cancer metastatic 20.62 10.99 5 60203 50 110529041
Bundle branch block left 20.61 10.99 30 60178 12858 110516233
Balance disorder 20.58 10.99 121 60087 116439 110412652
Renin decreased 20.58 10.99 6 60202 127 110528964
Cerebellar syndrome 20.48 10.99 21 60187 6281 110522810
Hepatic enzyme increased 20.10 10.99 98 60110 320794 110208297
Blepharospasm 19.97 10.99 3 60205 54848 110474243
Drug ineffective for unapproved indication 19.96 10.99 16 60192 102822 110426269
Primary hyperaldosteronism 19.94 10.99 7 60201 273 110528818
Walking disability 19.85 10.99 14 60194 2514 110526577
Haemorrhagic transformation stroke 19.73 10.99 15 60193 3022 110526069
Loss of consciousness 19.72 10.99 178 60030 196128 110332963
Decreased ventricular preload 19.71 10.99 5 60203 61 110529030
Chronic kidney disease 19.62 10.99 88 60120 76203 110452888
Supraventricular extrasystoles 19.46 10.99 23 60185 8050 110521041
Osteonecrosis of jaw 19.46 10.99 64 60144 47953 110481138
Blood cholesterol increased 19.43 10.99 45 60163 184740 110344351
Ventricular extrasystoles 19.42 10.99 40 60168 22601 110506490
Blood sodium abnormal 19.35 10.99 11 60197 1359 110527732
Bronchitis bacterial 18.83 10.99 12 60196 1824 110527267
Gastrointestinal disorder 18.80 10.99 68 60140 241884 110287207
Gastrooesophageal reflux disease 18.78 10.99 44 60164 179932 110349159
Dermatitis bullous 18.75 10.99 34 60174 17495 110511596
Frequent bowel movements 18.23 10.99 8 60200 71382 110457709
Lichen planus 18.20 10.99 15 60193 3395 110525696
Road traffic accident 18.13 10.99 19 60189 107379 110421712
Coronavirus infection 17.92 10.99 24 60184 9521 110519570
Migraine 17.88 10.99 42 60166 171610 110357481
Diabetic nephropathy 17.83 10.99 15 60193 3493 110525598
Face oedema 17.70 10.99 49 60159 33420 110495671
Renal tubular disorder 17.64 10.99 21 60187 7408 110521683
Rash 17.58 10.99 328 59880 820636 109708455
Neutropenia 17.53 10.99 294 59914 374326 110154765
Poisoning deliberate 17.49 10.99 42 60166 26289 110502802
Erythrosis 17.47 10.99 6 60202 219 110528872
Adverse drug reaction 17.45 10.99 19 60189 105540 110423551
Oral lichen planus 17.44 10.99 9 60199 918 110528173
Blood aldosterone increased 17.42 10.99 6 60202 221 110528870
Hyperlactacidaemia 17.37 10.99 22 60186 8264 110520827
Nail disorder 17.34 10.99 5 60203 57930 110471161
Therapeutic product effect incomplete 17.32 10.99 63 60145 223742 110305349
Arterial thrombosis 17.23 10.99 14 60194 3105 110525986
Contusion 17.21 10.99 67 60141 233294 110295797
Circulatory collapse 17.15 10.99 57 60151 42936 110486155
Cerebrovascular accident 17.01 10.99 162 60046 181122 110347969
Death 16.95 10.99 273 59935 698596 109830495
Ventricular internal diameter abnormal 16.92 10.99 6 60202 241 110528850
Mitral valve incompetence 16.85 10.99 48 60160 33281 110495810
Upper respiratory tract irritation 16.71 10.99 6 60202 250 110528841
Muscle rupture 16.60 10.99 16 60192 4444 110524647
Enzyme induction 16.55 10.99 5 60203 120 110528971
Sleep disorder due to a general medical condition 16.54 10.99 4 60204 52108 110476983
Back injury 16.35 10.99 3 60205 47396 110481695
Blood cholinesterase decreased 16.33 10.99 7 60201 469 110528622
Muscle mass 16.24 10.99 7 60201 476 110528615
Drug level increased 16.21 10.99 60 60148 47659 110481432
Nodular melanoma 16.05 10.99 6 60202 281 110528810
Glomerular filtration rate abnormal 15.99 10.99 12 60196 2371 110526720
Intracranial mass 15.97 10.99 12 60196 2376 110526715
Chronic pigmented purpura 15.90 10.99 6 60202 288 110528803
Palpitations 15.80 10.99 144 60064 159068 110370023
Catheter site injury 15.71 10.99 6 60202 298 110528793
Exostosis 15.66 10.99 3 60205 45953 110483138
Drug dependence 15.56 10.99 4 60204 50016 110479075
Liver disorder 15.47 10.99 34 60174 142209 110386882
Elephantiasis 15.40 10.99 3 60205 9 110529082
Hallucination, visual 15.35 10.99 52 60156 39553 110489538
Acetonaemia 15.18 10.99 7 60201 558 110528533
Renal artery stenosis 15.07 10.99 14 60194 3712 110525379
Trigeminal neuralgia 15.05 10.99 15 60193 4337 110524754
Tubulointerstitial nephritis 15.02 10.99 64 60144 54220 110474871
Blood creatine phosphokinase increased 14.99 10.99 79 60129 72998 110456093
Catheter site inflammation 14.99 10.99 9 60199 1231 110527860
Arterial spasm 14.95 10.99 5 60203 168 110528923
Urticaria 14.86 10.99 107 60101 318750 110210341
Dialysis device insertion 14.83 10.99 4 60204 63 110529028
Hydrocholecystis 14.81 10.99 7 60201 590 110528501
Folate deficiency 14.81 10.99 15 60193 4423 110524668
Palatal oedema 14.73 10.99 10 60198 1690 110527401
Adjustment disorder with depressed mood 14.67 10.99 3 60205 43880 110485211
Hip arthroplasty 14.66 10.99 6 60202 55807 110473284
Haemoglobinaemia 14.63 10.99 6 60202 360 110528731
Resting tremor 14.60 10.99 10 60198 1713 110527378
Nasal mucosal erosion 14.54 10.99 4 60204 68 110529023
Thoracic vertebral fracture 14.48 10.99 18 60190 6637 110522454
Congestive cardiomyopathy 14.48 10.99 27 60181 14192 110514899
Anaphylactic shock 14.43 10.99 61 60147 51485 110477606
Urine output increased 14.34 10.99 12 60196 2774 110526317
Subretinal fluid 14.32 10.99 9 60199 1335 110527756
Optic neuropathy 14.20 10.99 15 60193 4643 110524448
Lung diffusion test abnormal 14.19 10.99 6 60202 389 110528702
Contraindicated product prescribed 14.19 10.99 11 60197 2282 110526809
Body temperature increased 14.18 10.99 6 60202 54707 110474384
Anticoagulation drug level increased 14.16 10.99 8 60200 977 110528114
Adenocarcinoma metastatic 14.11 10.99 6 60202 394 110528697
Renal ischaemia 14.06 10.99 11 60197 2312 110526779
Knee arthroplasty 14.05 10.99 9 60199 64939 110464152
Coma 14.02 10.99 111 60097 117758 110411333
Cutaneous vasculitis 14.01 10.99 25 60183 12704 110516387
Hepatic mass 13.93 10.99 12 60196 2886 110526205
Blood creatine phosphokinase MB increased 13.91 10.99 12 60196 2891 110526200
Coronary artery stenosis 13.85 10.99 26 60182 13732 110515359
Hypoosmolar state 13.85 10.99 6 60202 413 110528678
Microcytic anaemia 13.82 10.99 17 60191 6201 110522890
Hypertensive nephropathy 13.77 10.99 8 60200 1030 110528061
Product measured potency issue 13.76 10.99 5 60203 216 110528875
Sinus rhythm 13.73 10.99 8 60200 1035 110528056
Electrocardiogram QT prolonged 13.73 10.99 104 60104 108856 110420235
Polyuria 13.67 10.99 30 60178 17708 110511383
Therapeutic drug monitoring analysis incorrectly performed 13.64 10.99 7 60201 705 110528386
Inappropriate antidiuretic hormone secretion 13.61 10.99 45 60163 33806 110495285
Agoraphobia 13.61 10.99 7 60201 709 110528382
Disorientation 13.55 10.99 75 60133 70596 110458495
Ear pain 13.53 10.99 6 60202 53220 110475871
Gastric ulcer 13.46 10.99 50 60158 39777 110489314
Dysarthria 13.38 10.99 85 60123 84036 110445055
Hypercholesterolaemia 13.27 10.99 18 60190 90819 110438272
Drop attacks 13.15 10.99 8 60200 1120 110527971
Jealous delusion 13.15 10.99 6 60202 467 110528624
Foot deformity 13.08 10.99 5 60203 48475 110480616
Gamma-glutamyltransferase increased 13.07 10.99 67 60141 61242 110467849
Altered state of consciousness 13.01 10.99 64 60144 57562 110471529
Atrial enlargement 13.00 10.99 8 60200 1143 110527948
Erythema 13.00 10.99 227 59981 291220 110237871
Hyperglycaemia 12.93 10.99 85 60123 85005 110444086
Bronchospasm 12.88 10.99 41 60167 30198 110498893
Language disorder 12.86 10.99 13 60195 3825 110525266
Breast pain 12.80 10.99 21 60187 9979 110519112
Dyspnoea at rest 12.73 10.99 19 60189 8327 110520764
Electrocardiogram T wave amplitude decreased 12.71 10.99 7 60201 814 110528277
Vascular encephalopathy 12.68 10.99 7 60201 817 110528274
Azotaemia 12.66 10.99 21 60187 10064 110519027
Orthostatic intolerance 12.66 10.99 10 60198 2131 110526960
Cardiovascular insufficiency 12.62 10.99 12 60196 3276 110525815
Hypertensive heart disease 12.61 10.99 14 60194 4582 110524509
Gastritis erosive 12.48 10.99 23 60185 11977 110517114
Diffuse large B-cell lymphoma stage II 12.40 10.99 4 60204 120 110528971
Blood potassium abnormal 12.39 10.99 13 60195 3992 110525099
Condition aggravated 12.39 10.99 305 59903 734531 109794560
Troponin increased 12.35 10.99 40 60168 29726 110499365
Labelled drug-food interaction issue 12.24 10.99 4 60204 125 110528966
Toxicity to various agents 12.22 10.99 186 60022 480369 110048722
International normalised ratio increased 12.18 10.99 85 60123 86687 110442404
Dedifferentiated liposarcoma 12.11 10.99 3 60205 33 110529058
Manufacturing materials contamination 12.03 10.99 3 60205 34 110529057
Musculoskeletal pain 11.98 10.99 55 60153 182968 110346123
Post stroke epilepsy 11.95 10.99 3 60205 35 110529056
Abdominal pain lower 11.94 10.99 46 60162 37237 110491854
Bundle branch block 11.92 10.99 9 60199 1794 110527297
Glycosylated haemoglobin increased 11.92 10.99 34 60174 23585 110505506
Colitis microscopic 11.89 10.99 24 60184 13370 110515721
Ear infection 11.88 10.99 10 60198 62722 110466369
Sciatica 11.87 10.99 20 60188 92379 110436712
Bradyarrhythmia 11.80 10.99 14 60194 4920 110524171
Duodenal ulcer 11.77 10.99 30 60178 19484 110509607
Febrile bone marrow aplasia 11.75 10.99 28 60180 17437 110511654
Neurosis 11.70 10.99 6 60202 604 110528487
Hyperuricaemia 11.68 10.99 25 60183 14506 110514585
Transient ischaemic attack 11.67 10.99 67 60141 63915 110465176
Hypochloraemia 11.66 10.99 12 60196 3606 110525485
Idiopathic pulmonary fibrosis 11.64 10.99 14 60194 4990 110524101
Aortic aneurysm 11.61 10.99 20 60188 9884 110519207
Leukopenia 11.59 10.99 128 60080 148663 110380428
Anti factor V antibody positive 11.58 10.99 3 60205 40 110529051
Sinus node dysfunction 11.58 10.99 19 60189 9028 110520063
Lipase increased 11.57 10.99 29 60179 18643 110510448
Night sweats 11.53 10.99 36 60172 133947 110395144
Tachyarrhythmia 11.46 10.99 18 60190 8243 110520848
Toxic skin eruption 11.44 10.99 37 60171 27478 110501613
Conjunctival haemorrhage 11.43 10.99 16 60192 6617 110522474
Pulmonary embolism 11.41 10.99 172 60036 214302 110314789
Therapeutic response decreased 11.39 10.99 22 60186 96477 110432614
Myocardial infarction 11.39 10.99 157 60051 191926 110337165
Dermatosis 11.31 10.99 7 60201 1011 110528080
Carcinogenicity 11.30 10.99 4 60204 160 110528931
Sinoatrial block 11.24 10.99 8 60200 1457 110527634
Developmental delay 11.24 10.99 8 60200 1457 110527634
Periorbital haematoma 11.22 10.99 7 60201 1025 110528066
Incorrect route of product administration 11.19 10.99 11 60197 64050 110465041
Blood pressure inadequately controlled 11.11 10.99 17 60191 7616 110521475
Vitamin B12 decreased 11.09 10.99 14 60194 5243 110523848
Escherichia sepsis 11.08 10.99 20 60188 10252 110518839
Malpositioned teeth 11.08 10.99 3 60205 48 110529043
Brain natriuretic peptide increased 11.06 10.99 21 60187 11188 110517903
Dry gangrene 11.02 10.99 7 60201 1057 110528034
Suicide attempt 11.02 10.99 95 60113 103299 110425792
Erysipelas 11.00 10.99 23 60185 13135 110515956

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C07AB12 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS
Beta blocking agents, selective
ATC C07BB12 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS AND THIAZIDES
Beta blocking agents, selective, and thiazides
ATC C07FB12 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents and calcium channel blockers
ATC C09BX07 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ACE INHIBITORS, COMBINATIONS
ACE inhibitors, other combinations
ATC C09DX05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX22 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000161 Adrenergic beta-Antagonists
FDA EPC N0000175556 beta-Adrenergic Blocker
MeSH PA D000318 Adrenergic beta-Agonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D014665 Vasodilator Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D058665 Adrenergic beta-1 Receptor Agonists
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35530 ฮฒ-adrenergic antagonist
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

C07AB Beta blocking agents, selective 13 drugs
acebutololatenololbetaxololbevantololbisoprololceliprololepanololesatenololesmolollandiololmetoprololpractolol show all 13 →
C07BB Beta blocking agents, selective, and thiazides 5 drugs
acebutololatenololbevantololbisoprololmetoprolol
C07FB Beta blocking agents and calcium channel blockers 6 drugs
amlodipineatenololbisoprololfelodipinemetoprololnifedipine
C09BX ACE inhibitors, other combinations 7 drugs
amlodipinebisoprololhydrochlorothiazideindapamideperindoprilramiprilzofenopril
C09DX Angiotensin II receptor blockers (ARBs), other combinations 10 drugs
aliskirenamlodipinecandesartan cilexetilhydrochlorothiazideindapamideirbesartanolmesartan medoxomilsacubitriltelmisartanvalsartan
C10BX Lipid modifying agents in combination with other drugs 14 drugs
acetylsalicylic acidamlodipineatorvastatincandesartan cilexetilfimasartanindapamidelisinoprilperindoprilpravastatinramiprilrosuvastatinsimvastatin show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure off-label use 48447003
Atrial fibrillation off-label use 49436004 DOID:0060224
Angina pectoris off-label use 194828000
Myocardial Reinfarction Prevention off-label use
Bronchospasm contraindication 4386001
Complete atrioventricular block contraindication 27885002
Sick sinus syndrome contraindication 36083008 DOID:13884
Bradycardia contraindication 48867003
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diabetes mellitus contraindication 73211009 DOID:9351
Cardiogenic shock contraindication 89138009
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Peripheral vascular disease contraindication 400047006




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 7.87 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 5MG BASE;80MG BYVALSON ABBVIE N206302 June 3, 2016 DISCN TABLET ORAL 7838552 Oct. 4, 2027 METHOD OF TREATING HYPERTENSION

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 8.50 WOMBAT-PK CHEMBL
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 7.50 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 8 WOMBAT-PK
Beta-3 adrenergic receptor GPCR ANTAGONIST Ki 5.66 IUPHAR

External reference:

IDSource
4027169 VUID
N0000179202 NUI
D05127 KEGG_DRUG
152520-56-4 SECONDARY_CAS_RN
4027169 VANDF
C0068475 UMLSCUI
CHEBI:64022 CHEBI
CHEMBL434394 ChEMBL_ID
CHEMBL1201731 ChEMBL_ID
D000068577 MESH_DESCRIPTOR_UI
DB04861 DRUGBANK_ID
71301 PUBCHEM_CID
7246 IUPHAR_LIGAND_ID
5969 INN_ID
030Y90569U UNII
236883 RXNORM
130026 MMSL
18486 MMSL
214248 MMSL
29969 MMSL
52690 MMSL
d05265 MMSL
007077 NDDF
007078 NDDF
318638009 SNOMEDCT_US
395808005 SNOMEDCT_US
734565001 SNOMEDCT_US
030Y90569U INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bystolic HUMAN PRESCRIPTION DRUG LABEL 1 0456-1402 TABLET 2.50 mg ORAL NDA 27 sections
Bystolic HUMAN PRESCRIPTION DRUG LABEL 1 0456-1405 TABLET 5 mg ORAL NDA 27 sections
Bystolic HUMAN PRESCRIPTION DRUG LABEL 1 0456-1410 TABLET 10 mg ORAL NDA 27 sections
Bystolic HUMAN PRESCRIPTION DRUG LABEL 1 0456-1420 TABLET 20 mg ORAL NDA 27 sections
NEBIVOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0904-7497 TABLET 2.50 mg ORAL ANDA 26 sections
NEBIVOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0904-7498 TABLET 5 mg ORAL ANDA 26 sections
NEBIVOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0904-7499 TABLET 10 mg ORAL ANDA 26 sections
NEBIVOLOL HUMAN PRESCRIPTION DRUG LABEL 1 0904-7500 TABLET 20 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 24689-159 TABLET 2.50 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 24689-160 TABLET 5 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 24689-161 TABLET 10 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 24689-162 TABLET 20 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 27241-179 TABLET 2.50 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 27241-180 TABLET 5 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 27241-181 TABLET 10 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 27241-182 TABLET 20 mg ORAL ANDA 26 sections
Nebivolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-375 TABLET 2.50 mg ORAL ANDA 24 sections
Nebivolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-376 TABLET 5 mg ORAL ANDA 24 sections
Nebivolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-377 TABLET 10 mg ORAL ANDA 24 sections
Nebivolol Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-378 TABLET 20 mg ORAL ANDA 24 sections
Nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 31722-585 TABLET 2.50 mg ORAL ANDA 25 sections
Nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 31722-586 TABLET 5 mg ORAL ANDA 25 sections
Nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 31722-587 TABLET 10 mg ORAL ANDA 25 sections
Nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 31722-588 TABLET 20 mg ORAL ANDA 25 sections
Nebivolol Human Prescription Drug Label 1 33342-457 TABLET 2.50 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 33342-458 TABLET 5 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 33342-459 TABLET 10 mg ORAL ANDA 26 sections
Nebivolol Human Prescription Drug Label 1 33342-460 TABLET 20 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 42291-871 TABLET 2.50 mg ORAL ANDA 26 sections
nebivolol HUMAN PRESCRIPTION DRUG LABEL 1 42291-872 TABLET 5 mg ORAL ANDA 26 sections