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

Stem definitionDrug idCAS RN
vasodilators 522 72956-09-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • carvedilol
  • carvedilol phosphate
  • carvediol
  • carvedilol hydrochloride
  • carvedilol HCl
  • BM 14,190
A carbazole and propanol derivative that acts as a non-cardioselective beta blocker and vasodilator. It has blocking activity for ALPHA 1 ADRENERGIC RECEPTORS and, at higher doses, may function as a blocker of CALCIUM CHANNELS; it also has antioxidant properties. Carvedilol is used in the treatment of HYPERTENSION; ANGINA PECTORIS; and HEART FAILURE. It can also reduce the risk of death following MYOCARDIAL INFARCTION.
  • Molecular weight: 406.48
  • Formula: C24H26N2O4
  • CLOGP: 4.04
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 3
  • TPSA: 75.74
  • ALOGS: -4.96
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
37.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.03 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.80 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) 2.40 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 0.25 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1995 FDA SMITHKLINE BEECHAM

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
Cardiac failure congestive 1220.73 10.48 1063 96734 91370 63299855
Myocardial infarction 411.67 10.48 629 97168 99264 63291961
Hypotension 343.56 10.48 1060 96737 271544 63119681
Cardiac failure 337.57 10.48 540 97257 88602 63302623
Bradycardia 290.20 10.48 453 97344 72774 63318451
Drug ineffective 273.86 10.48 772 97025 1043993 62347232
Synovitis 228.99 10.48 15 97782 186903 63204322
Acute kidney injury 226.40 10.48 903 96894 262512 63128713
Systemic lupus erythematosus 216.38 10.48 32 97765 208886 63182339
Hyperkalaemia 210.09 10.48 332 97465 53871 63337354
Hand deformity 203.90 10.48 10 97787 159447 63231778
Joint swelling 203.22 10.48 127 97670 327539 63063686
Glossodynia 200.81 10.48 21 97776 178855 63212370
Acute myocardial infarction 194.99 10.48 244 97553 31880 63359345
Contraindicated product administered 194.39 10.48 48 97749 217600 63173625
Treatment failure 189.63 10.48 38 97759 199005 63192220
Infusion related reaction 187.25 10.48 72 97725 245449 63145776
Drug intolerance 172.35 10.48 134 97663 308527 63082698
Rheumatoid arthritis 169.25 10.48 90 97707 253729 63137496
Maternal exposure during pregnancy 165.37 10.48 66 97731 219996 63171229
Arthropathy 164.43 10.48 78 97719 234714 63156511
Cardiomyopathy 158.52 10.48 164 97633 17420 63373805
Death 154.04 10.48 1045 96752 373336 63017889
Gastrointestinal haemorrhage 153.50 10.48 367 97430 80809 63310416
Pericarditis 146.24 10.48 16 97781 131563 63259662
Lower respiratory tract infection 144.75 10.48 17 97780 132290 63258935
Therapeutic product effect decreased 143.40 10.48 59 97738 193128 63198097
Wound 141.91 10.48 38 97759 163225 63228000
Hepatic enzyme increased 138.92 10.48 69 97728 202259 63188966
Renal failure 137.24 10.48 446 97351 117206 63274019
Coronary artery disease 133.36 10.48 204 97593 32173 63359052
Pain 131.02 10.48 642 97155 739986 62651239
Alopecia 130.34 10.48 199 97598 337337 63053888
Ejection fraction decreased 129.76 10.48 166 97631 22166 63369059
Chronic kidney disease 128.51 10.48 242 97555 45156 63346069
Musculoskeletal stiffness 128.20 10.48 62 97735 184556 63206669
Atrial fibrillation 125.25 10.48 430 97367 116206 63275019
Hypersensitivity 122.44 10.48 163 97634 292522 63098703
Helicobacter infection 118.00 10.48 6 97791 92779 63298446
Syncope 117.62 10.48 423 97374 116962 63274263
Arthralgia 117.48 10.48 466 97331 569244 62821981
Dyspnoea 116.53 10.48 1540 96257 659773 62731452
Renal impairment 114.10 10.48 347 97450 88008 63303217
Discomfort 112.01 10.48 59 97738 167315 63223910
Off label use 111.62 10.48 598 97199 673864 62717361
Dehydration 101.40 10.48 531 97266 172823 63218402
Hypoglycaemia 101.31 10.48 260 97537 59805 63331420
Cerebrovascular accident 99.61 10.48 379 97418 107645 63283580
International normalised ratio increased 96.61 10.48 218 97579 46207 63345018
Oedema peripheral 94.50 10.48 556 97241 188955 63202270
Anaemia 93.25 10.48 771 97026 292659 63098566
Abdominal discomfort 90.23 10.48 228 97569 320657 63070568
Pulmonary oedema 89.94 10.48 235 97562 54638 63336587
Folliculitis 87.99 10.48 5 97792 70312 63320913
Product use issue 85.05 10.48 130 97667 220390 63170835
Blood creatinine increased 84.96 10.48 313 97484 87531 63303694
Cardiac disorder 82.64 10.48 217 97580 50599 63340626
Impaired healing 79.88 10.48 29 97768 102513 63288712
Drug interaction 79.25 10.48 614 97183 228517 63162708
Rash 77.53 10.48 526 97271 560345 62830880
Chest pain 76.52 10.48 582 97215 215377 63175848
Swelling 76.36 10.48 197 97600 275181 63116044
Hypertensive crisis 75.56 10.48 105 97692 15181 63376044
Exposure during pregnancy 75.33 10.48 77 97720 155470 63235755
Cardiac failure chronic 75.25 10.48 59 97738 4359 63386866
Blood glucose increased 70.81 10.48 286 97511 83470 63307755
Mental status changes 70.51 10.48 175 97622 39424 63351801
Cardiac arrest 68.91 10.48 304 97493 92241 63298984
Haemoglobin decreased 68.76 10.48 421 97376 145064 63246161
Atrioventricular block 66.55 10.48 70 97727 7577 63383648
Blood pressure decreased 65.67 10.48 235 97562 64787 63326438
Irritable bowel syndrome 64.71 10.48 23 97774 82389 63308836
Hypervolaemia 64.29 10.48 138 97659 28275 63362950
Cardiomegaly 64.25 10.48 105 97692 17509 63373716
Congestive cardiomyopathy 63.69 10.48 62 97735 6120 63385105
Sleep disorder due to general medical condition, insomnia type 61.57 10.48 5 97792 52212 63339013
Asthenia 59.03 10.48 873 96924 382731 63008494
Cardiogenic shock 58.90 10.48 102 97695 17830 63373395
Glomerular filtration rate decreased 58.62 10.48 87 97710 13354 63377871
Fluid retention 57.97 10.48 213 97584 59473 63331752
Dizziness 56.19 10.48 952 96845 428973 62962252
Completed suicide 55.78 10.48 400 97397 145273 63245952
Blister 55.53 10.48 71 97726 129743 63261482
Full blood count decreased 55.02 10.48 123 97674 25901 63365324
Cardioactive drug level increased 52.46 10.48 36 97761 2164 63389061
Mitral valve incompetence 51.20 10.48 101 97696 19493 63371732
Sinus bradycardia 50.74 10.48 85 97712 14466 63376759
Peritonitis bacterial 50.39 10.48 49 97748 4830 63386395
Drug abuse 49.32 10.48 25 97772 72493 63318732
Infection 49.27 10.48 184 97613 228989 63162236
Ischaemic cardiomyopathy 48.62 10.48 36 97761 2441 63388784
Unresponsive to stimuli 48.58 10.48 138 97659 33678 63357547
Blood loss anaemia 47.77 10.48 64 97733 8937 63382288
Arrhythmia 47.53 10.48 148 97649 37992 63353233
BRASH syndrome 47.14 10.48 20 97777 449 63390776
Drug hypersensitivity 47.09 10.48 283 97514 310404 63080821
Therapeutic product effect incomplete 46.96 10.48 75 97722 124981 63266244
Ill-defined disorder 46.16 10.48 35 97762 81720 63309505
Psoriatic arthropathy 45.79 10.48 44 97753 91476 63299749
Gastrointestinal tract mucosal pigmentation 45.45 10.48 21 97776 581 63390644
Mobility decreased 45.17 10.48 73 97724 121086 63270139
Gastrointestinal disorder 44.46 10.48 84 97713 131155 63260070
Plasma cell myeloma 44.44 10.48 139 97658 35766 63355459
Renal disorder 43.94 10.48 131 97666 32843 63358382
Blood potassium increased 43.82 10.48 91 97706 18218 63373007
Nasopharyngitis 43.77 10.48 222 97575 254035 63137190
Orthopnoea 43.59 10.48 51 97746 6210 63385015
Cardiac failure acute 43.50 10.48 63 97734 9460 63381765
Ischaemic stroke 42.69 10.48 89 97708 17868 63373357
Stomatitis 42.57 10.48 94 97703 138631 63252594
Coronary arterial stent insertion 42.28 10.48 35 97762 2794 63388431
Pregnancy 42.15 10.48 4 97793 36832 63354393
Condition aggravated 41.77 10.48 407 97390 401810 62989415
Glycosylated haemoglobin increased 41.34 10.48 71 97726 12327 63378898
Fall 41.21 10.48 840 96957 391494 62999731
Shock 41.03 10.48 103 97694 23360 63367865
Abortion spontaneous 40.95 10.48 11 97786 47184 63344041
Sinusitis 40.68 10.48 195 97602 226458 63164767
Ventricular arrhythmia 40.58 10.48 39 97758 3789 63387436
Blood urea increased 40.21 10.48 110 97687 26269 63364956
Urinary tract infection 40.11 10.48 601 97196 264083 63127142
Angina unstable 40.05 10.48 52 97745 7043 63384182
Hip arthroplasty 39.68 10.48 12 97785 47634 63343591
Pericardial effusion 39.66 10.48 119 97678 29939 63361286
Myocardial ischaemia 39.46 10.48 71 97726 12788 63378437
End stage renal disease 39.26 10.48 50 97747 6643 63384582
Fibromyalgia 38.70 10.48 40 97757 80380 63310845
Isosthenuria 38.26 10.48 12 97785 108 63391117
Angina pectoris 37.74 10.48 117 97680 29961 63361264
Red blood cell sedimentation rate increased 36.77 10.48 11 97786 43971 63347254
Loss of consciousness 36.68 10.48 309 97488 117812 63273413
Liver injury 36.68 10.48 24 97773 60496 63330729
Pulse absent 36.13 10.48 43 97754 5331 63385894
Calcium deficiency 35.84 10.48 22 97775 1092 63390133
Respiratory failure 35.17 10.48 273 97524 101585 63289640
Injection site pain 35.05 10.48 94 97703 129706 63261519
Intentional product use issue 35.01 10.48 92 97705 127800 63263425
Pyrexia 34.70 10.48 513 97284 469965 62921260
Implantable defibrillator insertion 34.16 10.48 16 97781 457 63390768
Hypovolaemia 34.13 10.48 60 97737 10613 63380612
Subdural haematoma 34.04 10.48 71 97726 14257 63376968
Extradural haematoma 33.74 10.48 25 97772 1697 63389528
Febrile neutropenia 33.35 10.48 84 97713 118365 63272860
Spinal epidural haematoma 33.09 10.48 21 97776 1106 63390119
Ventricular hypokinesia 32.62 10.48 38 97759 4606 63386619
Blood pressure increased 32.40 10.48 387 97410 161675 63229550
Decreased appetite 32.37 10.48 555 97242 250497 63140728
Atrioventricular block first degree 31.61 10.48 47 97750 7226 63383999
Left ventricular dysfunction 31.57 10.48 62 97735 11926 63379299
Blood glucose decreased 31.56 10.48 87 97710 20865 63370360
Ventricular tachycardia 31.14 10.48 84 97713 19895 63371330
Pyelitis 31.04 10.48 12 97785 210 63391015
Tricuspid valve incompetence 30.79 10.48 69 97728 14552 63376673
Serotonin syndrome 30.58 10.48 4 97793 28678 63362547
Blood pressure inadequately controlled 30.49 10.48 38 97759 4940 63386285
Pneumonia 30.28 10.48 919 96878 455848 62935377
Bladder hypertrophy 30.13 10.48 12 97785 228 63390997
Coronary artery occlusion 30.11 10.48 49 97748 8142 63383083
Myxoedema coma 29.22 10.48 14 97783 421 63390804
Distributive shock 29.19 10.48 21 97776 1362 63389863
Cerebral infarction 29.11 10.48 92 97705 23801 63367424
Migraine 28.54 10.48 74 97723 103272 63287953
Acute respiratory failure 28.53 10.48 117 97680 34368 63356857
Left ventricular hypertrophy 28.52 10.48 38 97759 5277 63385948
Inflammation 28.44 10.48 52 97745 82221 63309004
Electrocardiogram PR shortened 28.22 10.48 12 97785 271 63390954
Diarrhoea 28.02 10.48 1358 96439 714008 62677217
Arterial stenosis 27.75 10.48 15 97782 584 63390641
Dialysis 27.55 10.48 54 97743 10373 63380852
Upper gastrointestinal haemorrhage 27.14 10.48 77 97720 18775 63372450
Product use in unapproved indication 26.64 10.48 164 97633 178916 63212309
Aortic valve incompetence 26.46 10.48 39 97758 5949 63385276
Melaena 25.89 10.48 104 97693 30261 63360964
Chronic obstructive pulmonary disease 25.65 10.48 175 97622 62511 63328714
Cardio-respiratory arrest 25.50 10.48 169 97628 59790 63331435
Vessel puncture site haemorrhage 25.45 10.48 9 97788 121 63391104
Pleural effusion 25.40 10.48 237 97560 92973 63298252
Haemorrhage intracranial 24.62 10.48 60 97737 13359 63377866
Intracardiac thrombus 24.51 10.48 24 97773 2386 63388839
Left ventricular dilatation 24.49 10.48 13 97784 488 63390737
Anti-neutrophil cytoplasmic antibody positive vasculitis 24.27 10.48 26 97771 2873 63388352
Diastolic dysfunction 24.18 10.48 39 97758 6432 63384793
Product prescribing error 24.01 10.48 92 97705 26197 63365028
Gout 23.99 10.48 59 97738 13212 63378013
Blood pressure abnormal 23.78 10.48 64 97733 15134 63376091
Brain natriuretic peptide increased 23.10 10.48 34 97763 5179 63386046
Urticaria 23.04 10.48 155 97642 165647 63225578
Injection site reaction 23.01 10.48 34 97763 58490 63332735
Arteriosclerosis 22.89 10.48 49 97748 10017 63381208
Ventricular fibrillation 22.78 10.48 54 97743 11813 63379412
Loss of personal independence in daily activities 22.29 10.48 76 97721 97214 63294011
Product monitoring error 22.28 10.48 31 97766 4485 63386740
Hyperglycaemia 22.23 10.48 125 97672 41742 63349483
Atrioventricular block complete 22.12 10.48 43 97754 8208 63383017
Bursitis 22.03 10.48 15 97782 37026 63354199
Blood cholesterol increased 21.85 10.48 73 97724 93959 63297266
Bundle branch block left 21.69 10.48 39 97758 7020 63384205
Erythema 21.67 10.48 170 97627 175581 63215644
Atrial flutter 21.57 10.48 47 97750 9725 63381500
Hypertensive emergency 21.53 10.48 20 97777 1862 63389363
Pulmonary fibrosis 21.27 10.48 18 97779 39791 63351434
Femoral artery dissection 21.24 10.48 6 97791 36 63391189
Injection site erythema 21.14 10.48 62 97735 83112 63308113
Azotaemia 21.04 10.48 30 97767 4441 63386784
Nephrogenic anaemia 21.00 10.48 21 97776 2141 63389084
Labelled drug-drug interaction medication error 20.54 10.48 56 97741 13343 63377882
Genotype drug resistance test positive 20.50 10.48 11 97786 422 63390803
Pulseless electrical activity 19.93 10.48 39 97758 7482 63383743
Knee arthroplasty 19.88 10.48 33 97764 54173 63337052
Peripheral coldness 19.82 10.48 52 97745 12113 63379112
Lower gastrointestinal haemorrhage 19.81 10.48 40 97757 7850 63383375
Hyponatraemia 19.69 10.48 261 97536 111639 63279586
Chronic left ventricular failure 19.59 10.48 11 97786 462 63390763
Renal artery stenosis 19.39 10.48 19 97778 1890 63389335
Asthma 19.39 10.48 116 97681 127445 63263780
Pulmonary congestion 19.35 10.48 65 97732 17353 63373872
Renal injury 19.27 10.48 44 97753 9395 63381830
C-reactive protein increased 19.07 10.48 78 97719 94629 63296596
Platelet dysfunction 19.03 10.48 7 97790 106 63391119
Unevaluable event 19.01 10.48 140 97657 51246 63339979
Creatinine renal clearance increased 18.99 10.48 12 97785 627 63390598
Basal ganglia haemorrhage 18.74 10.48 12 97785 642 63390583
Torsade de pointes 18.70 10.48 54 97743 13297 63377928
Haematocrit decreased 18.65 10.48 114 97683 39226 63351999
Cognitive disorder 18.65 10.48 36 97761 55779 63335446
Sleep disorder 18.49 10.48 64 97733 81502 63309723
Device expulsion 18.40 10.48 16 97781 34906 63356319
Foot deformity 18.35 10.48 10 97787 27843 63363382
Therapy cessation 18.25 10.48 94 97703 30363 63360862
Diabetes mellitus inadequate control 18.20 10.48 58 97739 15068 63376157
Low cardiac output syndrome 18.01 10.48 10 97787 411 63390814
Renal hypoplasia 17.99 10.48 5 97792 28 63391197
Vascular stent stenosis 17.99 10.48 11 97786 542 63390683
Metabolic acidosis 17.95 10.48 125 97672 44944 63346281
Electrocardiogram QT shortened 17.92 10.48 7 97790 126 63391099
Thrombosis 17.82 10.48 165 97632 64590 63326635
Coronary artery bypass 17.68 10.48 20 97777 2349 63388876
Prescribed overdose 17.57 10.48 16 97781 34137 63357088
N-terminal prohormone brain natriuretic peptide increased 17.43 10.48 19 97778 2142 63389083
Sinus node dysfunction 17.18 10.48 28 97769 4657 63386568
Suicidal ideation 17.00 10.48 45 97752 62376 63328849
Epistaxis 16.94 10.48 179 97618 72546 63318679
Urine output decreased 16.91 10.48 47 97750 11323 63379902
Hypouricaemia 16.89 10.48 7 97790 148 63391077
Aortic dissection 16.72 10.48 18 97779 2000 63389225
Lethargy 16.58 10.48 145 97652 55862 63335363
Hypertensive encephalopathy 16.55 10.48 11 97786 627 63390598
Platelet count decreased 16.53 10.48 261 97536 115861 63275364
Vena cava injury 16.43 10.48 3 97794 0 63391225
Electrocardiogram ST segment 16.43 10.48 3 97794 0 63391225
Arthritis 16.29 10.48 108 97689 115813 63275412
Tendonitis 16.22 10.48 5 97792 19610 63371615
Mucocutaneous haemorrhage 16.19 10.48 6 97791 93 63391132
Pernicious anaemia 16.00 10.48 11 97786 663 63390562
Headache 15.99 10.48 805 96992 632436 62758789
Fear 15.92 10.48 57 97740 15709 63375516
Uraemic encephalopathy 15.88 10.48 8 97789 269 63390956
Embolic stroke 15.84 10.48 24 97773 3752 63387473
Joint stiffness 15.81 10.48 25 97772 41844 63349381
Hypophagia 15.73 10.48 92 97705 31167 63360058
Injection site swelling 15.62 10.48 31 97766 47541 63343684
Hospitalisation 15.62 10.48 200 97597 84881 63306344
Muscle spasticity 15.60 10.48 7 97790 21787 63369438
Wheezing 15.57 10.48 85 97712 95510 63295715
Pulmonary hypertension 15.40 10.48 104 97693 37019 63354206
Renin increased 15.38 10.48 7 97790 187 63391038
Hyphaema 15.30 10.48 8 97789 291 63390934
Toxic neuropathy 15.18 10.48 9 97788 419 63390806
Product dose omission issue 15.09 10.48 470 97327 233843 63157382
Urine albumin/creatinine ratio increased 15.05 10.48 8 97789 301 63390924
Herbal interaction 14.97 10.48 6 97791 116 63391109
Supraventricular extrasystoles 14.93 10.48 26 97771 4563 63386662
Occult blood positive 14.93 10.48 23 97774 3647 63387578
Hydrothorax 14.93 10.48 12 97785 919 63390306
Myelosuppression 14.91 10.48 9 97788 23694 63367531
Toxicity to various agents 14.90 10.48 492 97305 246758 63144467
Refractory anaemia with an excess of blasts 14.82 10.48 9 97788 438 63390787
Subdural haemorrhage 14.79 10.48 21 97776 3097 63388128
Electrocardiogram abnormal 14.71 10.48 39 97758 9140 63382085
Joint range of motion decreased 14.63 10.48 17 97780 32411 63358814
Lip dry 14.62 10.48 3 97794 15467 63375758
Type 2 diabetes mellitus 14.55 10.48 50 97747 63818 63327407
Transfusion 14.51 10.48 54 97743 15163 63376062
Drug dependence 14.44 10.48 10 97787 24473 63366752
Glomerulonephritis rapidly progressive 14.23 10.48 12 97785 983 63390242
Paraplegia 14.18 10.48 19 97778 2653 63388572
Presyncope 14.12 10.48 82 97715 27703 63363522
Angioedema 14.10 10.48 124 97673 47841 63343384
Metabolic encephalopathy 14.05 10.48 29 97768 5780 63385445
Hypokalaemia 13.91 10.48 231 97566 103573 63287652
Pulmonary arterial pressure increased 13.89 10.48 22 97775 3573 63387652
Cardiac operation 13.88 10.48 21 97776 3277 63387948
Dyspnoea exertional 13.85 10.48 148 97649 60154 63331071
Bone erosion 13.81 10.48 5 97792 17712 63373513
Renal atrophy 13.67 10.48 14 97783 1468 63389757
Blood potassium decreased 13.60 10.48 111 97686 41915 63349310
Catheterisation cardiac 13.60 10.48 25 97772 4578 63386647
Haematuria 13.51 10.48 84 97713 29073 63362152
Nephropathy 13.43 10.48 30 97767 6311 63384914
Adverse event 13.38 10.48 56 97741 67503 63323722
Basal cell carcinoma 13.37 10.48 14 97783 27977 63363248
Breast cancer recurrent 13.36 10.48 24 97773 4317 63386908
Carcinoembryonic antigen increased 13.34 10.48 15 97782 1750 63389475
Osteoarthritis 13.30 10.48 89 97708 95254 63295971
Peripheral vascular disorder 13.29 10.48 29 97768 6006 63385219
Grip strength decreased 13.28 10.48 9 97788 22278 63368947
Gastritis erosive 13.28 10.48 29 97768 6010 63385215
Vascular pseudoaneurysm 13.27 10.48 14 97783 1520 63389705
Blood sodium decreased 13.27 10.48 73 97724 24179 63367046
Live birth 13.19 10.48 12 97785 25618 63365607
Hepatotoxicity 13.17 10.48 23 97774 37018 63354207
Foetal exposure during pregnancy 13.13 10.48 18 97779 31944 63359281
Rhabdomyolysis 13.12 10.48 114 97683 43837 63347388
Hip fracture 13.09 10.48 84 97713 29390 63361835
Corneal disorder 13.00 10.48 15 97782 1799 63389426
Cardiac pacemaker insertion 12.94 10.48 23 97774 4103 63387122
Necrotising retinitis 12.91 10.48 8 97789 404 63390821
Obstructive airways disorder 12.83 10.48 8 97789 20691 63370534
Suspected suicide 12.73 10.48 30 97767 6538 63384687
Long QT syndrome 12.58 10.48 20 97777 3259 63387966
Gastrointestinal arteriovenous malformation 12.52 10.48 9 97788 583 63390642
Insulin-requiring type 2 diabetes mellitus 12.51 10.48 5 97792 96 63391129
Ventricular extrasystoles 12.45 10.48 43 97754 11644 63379581
Arterial occlusive disease 12.41 10.48 28 97769 5930 63385295
Transient ischaemic attack 12.37 10.48 100 97697 37653 63353572
Haemorrhage 12.30 10.48 146 97651 60876 63330349
Traumatic renal injury 12.29 10.48 3 97794 9 63391216
Hepatocellular carcinoma 12.26 10.48 16 97781 2178 63389047
Anticoagulation drug level above therapeutic 12.24 10.48 13 97784 1422 63389803
Carbohydrate antigen 15-3 increased 12.15 10.48 13 97784 1435 63389790
Intentional self-injury 12.10 10.48 13 97784 25674 63365551
Blood blister 12.08 10.48 15 97782 1943 63389282
Intercepted product dispensing error 12.01 10.48 5 97792 107 63391118
Oliguria 11.97 10.48 36 97761 9065 63382160
Electrocardiogram QRS complex shortened 11.96 10.48 8 97789 461 63390764
Breath sounds 11.92 10.48 5 97792 109 63391116
Haemorrhagic erosive gastritis 11.90 10.48 8 97789 465 63390760
Blood aldosterone abnormal 11.88 10.48 4 97793 46 63391179
Macular degeneration 11.86 10.48 12 97785 24364 63366861
Bronchiectasis 11.85 10.48 5 97792 16137 63375088
Epinephrine increased 11.83 10.48 3 97794 11 63391214
Oropharyngeal pain 11.82 10.48 91 97706 94396 63296829
Prothrombin time prolonged 11.81 10.48 37 97760 9527 63381698
Nodal rhythm 11.81 10.48 14 97783 1729 63389496
Cytomegalovirus infection 11.78 10.48 9 97788 20943 63370282
Hypochloraemia 11.77 10.48 15 97782 1994 63389231
Ischaemia 11.75 10.48 24 97773 4748 63386477
Extrapyramidal disorder 11.70 10.48 3 97794 13281 63377944
Electrocardiogram T wave inversion 11.69 10.48 20 97777 3461 63387764
Palpitations 11.64 10.48 241 97556 112529 63278696
Body temperature increased 11.56 10.48 25 97772 37167 63354058
Hypovolaemic shock 11.55 10.48 28 97769 6213 63385012
Cholestatic liver injury 11.53 10.48 17 97780 2593 63388632
Vitreous haemorrhage 11.53 10.48 15 97782 2035 63389190
Oral cavity fistula 11.52 10.48 9 97788 661 63390564
Quadriplegia 11.44 10.48 14 97783 1786 63389439
Arteriovenous fistula thrombosis 11.41 10.48 6 97791 221 63391004
Electrocardiogram QT prolonged 11.38 10.48 141 97656 59389 63331836
Leukopenia 11.37 10.48 71 97726 77219 63314006
Sedation 11.33 10.48 27 97770 38782 63352443
Gastric ulcer haemorrhage 11.29 10.48 24 97773 4884 63386341
Sinoatrial block 11.26 10.48 10 97787 878 63390347
Cardiac valve disease 11.21 10.48 22 97775 4230 63386995
Diarrhoea infectious 11.18 10.48 11 97786 1100 63390125
Bradyarrhythmia 11.16 10.48 15 97782 2100 63389125
Renal tubular injury 11.14 10.48 8 97789 517 63390708
Osteoporosis 11.06 10.48 48 97749 57290 63333935
Concomitant disease progression 11.06 10.48 15 97782 2119 63389106
Hospice care 11.03 10.48 32 97765 7900 63383325
Sudden cardiac death 11.03 10.48 15 97782 2125 63389100
Peritonitis 11.02 10.48 54 97743 17100 63374125
Haemorrhoids 11.02 10.48 65 97732 22085 63369140
Right aortic arch 11.00 10.48 6 97791 238 63390987
Product residue present 10.99 10.48 21 97776 3958 63387267
Myocarditis infectious 10.92 10.48 3 97794 16 63391209
Aortic stenosis 10.92 10.48 24 97773 4996 63386229
Chemotherapeutic drug level increased 10.90 10.48 5 97792 136 63391089
Red blood cell count decreased 10.89 10.48 103 97694 40542 63350683
Retinopathy hypertensive 10.86 10.48 6 97791 244 63390981
Phaeochromocytoma crisis 10.79 10.48 6 97791 247 63390978
Cardiotoxicity 10.75 10.48 33 97764 8405 63382820
Hypercapnia 10.74 10.48 25 97772 5406 63385819
Coagulopathy 10.68 10.48 61 97736 20483 63370742
Subarachnoid haemorrhage 10.68 10.48 47 97750 14236 63376989
Photophobia 10.68 10.48 7 97790 17628 63373597
Ear pain 10.64 10.48 25 97772 36093 63355132
Viral titre decreased 10.62 10.48 3 97794 18 63391207
Night sweats 10.60 10.48 39 97758 48775 63342450
Sinus arrest 10.56 10.48 14 97783 1935 63389290
Exercise tolerance decreased 10.54 10.48 25 97772 5472 63385753
Paresis 10.50 10.48 16 97781 2514 63388711

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
Cardiac failure congestive 1129.91 10.90 1365 111201 81905 34762460
Cardiac failure 468.82 10.90 957 111609 90291 34754074
Hypotension 429.42 10.90 1625 110941 220024 34624341
Myocardial infarction 420.57 10.90 1088 111478 119997 34724368
Bradycardia 320.66 10.90 733 111833 74685 34769680
Off label use 190.62 10.90 703 111863 418821 34425544
Ejection fraction decreased 184.64 10.90 266 112300 18888 34825477
Drug abuse 180.50 10.90 48 112518 99048 34745317
Hyperkalaemia 174.79 10.90 556 112010 68833 34775532
Coronary artery disease 169.28 10.90 436 112130 47869 34796496
Acute myocardial infarction 167.19 10.90 464 112102 53255 34791110
Cardiac failure chronic 152.78 10.90 156 112410 7723 34836642
Syncope 137.29 10.90 621 111945 90830 34753535
Ischaemic cardiomyopathy 133.99 10.90 132 112434 6257 34838108
Mitral valve incompetence 131.73 10.90 199 112367 14744 34829621
Dizziness 131.07 10.90 1173 111393 217348 34627017
Dyspnoea 124.05 10.90 1798 110768 374984 34469381
Atrial fibrillation 118.96 10.90 737 111829 121656 34722709
Blood pressure decreased 118.20 10.90 400 112166 51115 34793250
Ventricular tachycardia 114.62 10.90 260 112306 26319 34818046
Febrile neutropenia 108.12 10.90 171 112395 136678 34707687
Neutropenia 104.99 10.90 217 112349 156561 34687804
Drug ineffective 104.58 10.90 955 111611 455796 34388569
Cardiomyopathy 101.54 10.90 189 112377 16619 34827746
Pyrexia 100.79 10.90 644 111922 332369 34511996
Chronic kidney disease 98.08 10.90 324 112242 40886 34803479
Cardiac failure acute 97.79 10.90 144 112422 10426 34833939
Foetal exposure during pregnancy 92.91 10.90 8 112558 38093 34806272
Gastrointestinal haemorrhage 92.41 10.90 543 112023 87934 34756431
Cardiac disorder 91.22 10.90 326 112240 42800 34801565
International normalised ratio increased 84.58 10.90 339 112227 46988 34797377
Blood potassium increased 77.48 10.90 167 112399 16328 34828037
Completed suicide 77.18 10.90 561 112005 97607 34746758
Cardiomegaly 74.47 10.90 158 112408 15280 34829085
BRASH syndrome 71.45 10.90 35 112531 511 34843854
Ventricular hypokinesia 70.15 10.90 88 112478 5464 34838901
Cerebrovascular accident 68.00 10.90 487 112079 84324 34760041
Tricuspid valve incompetence 66.94 10.90 116 112450 9644 34834721
Presyncope 65.65 10.90 171 112395 18888 34825477
Computerised tomogram coronary artery abnormal 65.13 10.90 25 112541 192 34844173
Bundle branch block left 65.00 10.90 88 112478 5891 34838474
Left ventricular dilatation 62.93 10.90 36 112530 731 34843634
Pulmonary oedema 62.67 10.90 311 112255 47218 34797147
Blood creatinine increased 62.58 10.90 521 112045 94455 34749910
Treatment failure 61.55 10.90 37 112529 46660 34797705
Congestive cardiomyopathy 60.56 10.90 96 112470 7414 34836951
Fluid retention 58.34 10.90 205 112361 26682 34817683
Renal impairment 57.82 10.90 510 112056 94003 34750362
Product use in unapproved indication 56.96 10.90 191 112375 117308 34727057
Oedema peripheral 56.87 10.90 613 111953 119199 34725166
Orthopnoea 55.32 10.90 75 112491 5028 34839337
Sinus bradycardia 53.87 10.90 125 112441 12838 34831527
Acute kidney injury 53.83 10.90 1323 111243 303665 34540700
Rheumatoid arthritis 49.41 10.90 31 112535 38207 34806158
Chest pain 49.23 10.90 624 111942 126138 34718227
Coronary arterial stent insertion 48.32 10.90 63 112503 4066 34840299
Mucosal inflammation 47.62 10.90 33 112533 38589 34805776
Coronary artery bypass 47.11 10.90 68 112498 4834 34839531
Product monitoring error 46.90 10.90 64 112502 4317 34840048
Toxicity to various agents 46.86 10.90 416 112150 199946 34644419
Intentional product use issue 46.00 10.90 76 112490 59740 34784625
N-terminal prohormone brain natriuretic peptide increased 45.94 10.90 50 112516 2665 34841700
Nipple swelling 45.92 10.90 22 112544 305 34844060
Cardiac arrest 45.15 10.90 491 112075 95668 34748697
N-terminal prohormone brain natriuretic peptide abnormal 45.14 10.90 19 112547 190 34844175
Hypoglycaemia 45.07 10.90 316 112250 54324 34790041
Leukopenia 44.59 10.90 84 112482 62772 34781593
Renal cyst haemorrhage 44.57 10.90 27 112539 612 34843753
Atrioventricular block 44.18 10.90 87 112479 7976 34836389
Malignant neoplasm progression 43.42 10.90 142 112424 87904 34756461
Suicidal ideation 42.93 10.90 40 112526 40348 34804017
Renal failure 41.84 10.90 621 111945 129936 34714429
Drug dependence 39.96 10.90 14 112552 24203 34820162
Therapeutic product effect incomplete 39.06 10.90 64 112502 50477 34793888
Left ventricular dysfunction 38.88 10.90 94 112472 9913 34834452
Agitation 38.73 10.90 79 112487 57320 34787045
Premature baby 38.70 10.90 8 112558 19625 34824740
Drug reaction with eosinophilia and systemic symptoms 38.38 10.90 30 112536 32982 34811383
Carotid arteriosclerosis 38.24 10.90 38 112528 1820 34842545
Angina pectoris 37.69 10.90 200 112366 31163 34813202
Rectal prolapse 37.47 10.90 22 112544 470 34843895
Blood loss anaemia 37.38 10.90 82 112484 8112 34836253
Asthenia 36.30 10.90 1040 111526 244211 34600154
Peritonitis bacterial 36.02 10.90 68 112498 6042 34838323
Conduction disorder 35.95 10.90 39 112527 2071 34842294
Nipple pain 35.19 10.90 27 112539 910 34843455
Diastolic dysfunction 35.10 10.90 68 112498 6159 34838206
Arthralgia 34.67 10.90 365 112201 169676 34674689
Carotid sinus syndrome 34.16 10.90 10 112556 28 34844337
Hyperparathyroidism secondary 34.00 10.90 33 112533 1535 34842830
Fall 33.88 10.90 874 111692 202011 34642354
Large intestine polyp 33.64 10.90 77 112489 7837 34836528
Blood pressure inadequately controlled 33.60 10.90 42 112524 2598 34841767
Pulmonary valve disease 33.34 10.90 18 112548 325 34844040
Cardioactive drug level increased 33.29 10.90 34 112532 1683 34842682
Rash 33.20 10.90 511 112055 222241 34622124
Glomerular filtration rate decreased 32.71 10.90 104 112462 12857 34831508
Suicide attempt 32.65 10.90 47 112519 39069 34805296
Aggression 32.35 10.90 47 112519 38917 34805448
Depression 32.26 10.90 182 112384 96916 34747449
Type V hyperlipidaemia 32.03 10.90 24 112542 780 34843585
Pulmonary hypertension 32.02 10.90 143 112423 20781 34823584
Hypervolaemia 31.91 10.90 137 112429 19572 34824793
Fractured coccyx 31.85 10.90 14 112552 157 34844208
Shock 31.70 10.90 158 112408 24021 34820344
Musculoskeletal stiffness 31.70 10.90 64 112502 46616 34797749
Death 31.63 10.90 1575 110991 396474 34447891
Dyspnoea exertional 31.51 10.90 243 112323 43036 34801329
Pericardial disease 31.35 10.90 19 112547 431 34843934
Pancytopenia 31.27 10.90 179 112387 94978 34749387
Orthostatic hypotension 30.95 10.90 165 112401 25754 34818611
Electrocardiogram abnormal 30.85 10.90 82 112484 9165 34835200
Blood urea increased 30.78 10.90 185 112381 30179 34814186
Intraductal papillary mucinous neoplasm 30.76 10.90 20 112546 515 34843850
Intentional self-injury 30.73 10.90 4 112562 13767 34830598
Neutrophil count decreased 30.66 10.90 75 112491 51029 34793336
Nodal rhythm 30.60 10.90 30 112536 1413 34842952
Thrombocytopenia 30.40 10.90 339 112227 155908 34688457
Sedation 30.06 10.90 15 112551 20991 34823374
Alanine aminotransferase increased 29.91 10.90 146 112420 80669 34763696
Drug resistance 29.58 10.90 24 112542 25903 34818462
Ventricular internal diameter abnormal 29.55 10.90 14 112552 189 34844176
Arrhythmia 29.47 10.90 207 112359 35601 34808764
Brain natriuretic peptide abnormal 29.38 10.90 17 112549 353 34844012
Jugular vein distension 29.06 10.90 21 112545 645 34843720
Mouth breathing 28.94 10.90 11 112555 82 34844283
Blood glucose decreased 28.77 10.90 101 112465 13136 34831229
Injection site pain 28.66 10.90 51 112515 38954 34805411
Cerebral infarction 28.29 10.90 168 112398 27287 34817078
Suspected suicide 28.18 10.90 53 112513 4695 34839670
Bradyarrhythmia 28.11 10.90 35 112531 2156 34842209
Sudden cardiac death 28.05 10.90 46 112520 3655 34840710
Nodal arrhythmia 28.04 10.90 23 112543 855 34843510
Vena cava injury 28.01 10.90 16 112550 324 34844041
Aortic valve incompetence 27.98 10.90 60 112506 5844 34838521
Infusion related reaction 27.96 10.90 83 112483 52974 34791391
Glycosylated haemoglobin increased 27.62 10.90 90 112476 11270 34833095
Generalised tonic-clonic seizure 27.58 10.90 17 112549 21157 34823208
Agranulocytosis 27.24 10.90 22 112544 23799 34820566
SARS-CoV-2 antibody test positive 27.24 10.90 17 112549 407 34843958
Myelosuppression 27.21 10.90 14 112552 19251 34825114
Cholestasis 27.12 10.90 28 112538 26920 34817445
Left ventricular hypertrophy 27.03 10.90 72 112494 8058 34836307
Dyspnoea at rest 26.91 10.90 46 112520 3782 34840583
Cardio-respiratory arrest 26.74 10.90 284 112282 54989 34789376
Myocardial necrosis 26.63 10.90 14 112552 239 34844126
Cytomegalovirus infection 26.48 10.90 27 112539 26108 34818257
Lower respiratory tract infection 26.42 10.90 38 112528 31599 34812766
Nephrogenic anaemia 26.28 10.90 34 112532 2177 34842188
Erythema 26.04 10.90 173 112393 88607 34755758
Sinus arrest 25.94 10.90 30 112536 1710 34842655
Cardiac discomfort 25.92 10.90 19 112547 597 34843768
Therapeutic drug monitoring analysis incorrectly performed 25.86 10.90 15 112551 313 34844052
Pulmonary arterial pressure abnormal 25.70 10.90 13 112553 204 34844161
Renal artery stenosis 25.68 10.90 34 112532 2227 34842138
Loss of personal independence in daily activities 25.65 10.90 42 112524 33137 34811228
Rales 25.58 10.90 80 112486 9803 34834562
Neuroleptic malignant syndrome 25.37 10.90 13 112553 17921 34826444
Diverticulum intestinal 25.27 10.90 46 112520 3975 34840390
Coma 25.14 10.90 70 112496 45608 34798757
Abdominal wall haemorrhage 24.99 10.90 17 112549 473 34843892
Vascular anastomotic haemorrhage 24.98 10.90 14 112552 273 34844092
Neutrophil count increased 24.91 10.90 12 112554 17134 34827231
Arteriosclerosis 24.88 10.90 90 112476 11878 34832487
Ventricular arrhythmia 24.85 10.90 55 112511 5473 34838892
Hypertensive crisis 24.68 10.90 73 112493 8678 34835687
Hepatic cytolysis 24.58 10.90 8 112558 14488 34829877
Fatigue 24.51 10.90 1442 111124 369211 34475154
Myocardial ischaemia 24.43 10.90 116 112450 17292 34827073
Lymphopenia 24.40 10.90 11 112555 16324 34828041
Gallbladder oedema 24.37 10.90 13 112553 229 34844136
Electrocardiogram QRS complex abnormal 24.11 10.90 15 112551 357 34844008
Intentional overdose 23.98 10.90 67 112499 43607 34800758
Angina unstable 23.70 10.90 87 112479 11566 34832799
Hepatocellular injury 23.60 10.90 22 112544 22189 34822176
Physical examination abnormal 23.56 10.90 14 112552 306 34844059
Heart rate decreased 23.53 10.90 179 112387 31566 34812799
Atrioventricular block first degree 23.42 10.90 57 112509 6035 34838330
Candida infection 23.39 10.90 14 112552 17701 34826664
Vomiting 23.33 10.90 613 111953 247008 34597357
Serotonin syndrome 23.31 10.90 18 112548 19915 34824450
Prostate cancer 23.15 10.90 59 112507 39590 34804775
Perineal cyst 22.94 10.90 13 112553 259 34844106
Blood iron decreased 22.92 10.90 52 112514 5261 34839104
Pulmonary embolism 22.89 10.90 182 112384 89564 34754801
Respiratory depression 22.65 10.90 12 112554 16233 34828132
Ventricular dysfunction 22.45 10.90 43 112523 3862 34840503
Aortic dilatation 22.32 10.90 25 112541 1376 34842989
Glomerular filtration rate abnormal 22.25 10.90 20 112546 843 34843522
Haemorrhage intracranial 22.19 10.90 106 112460 15840 34828525
Mitral valve disease 22.06 10.90 25 112541 1394 34842971
Blood glucose increased 21.99 10.90 319 112247 66399 34777966
Oxygen saturation increased 21.88 10.90 13 112553 284 34844081
Electrocardiogram Q wave abnormal 21.54 10.90 15 112551 434 34843931
Carotid artery stenosis 21.52 10.90 49 112517 4970 34839395
Oedema 21.18 10.90 233 112333 45508 34798857
Oesophageal discomfort 21.12 10.90 8 112558 59 34844306
Lymphadenopathy 21.11 10.90 37 112529 28426 34815939
Blood thyroid stimulating hormone abnormal 21.01 10.90 14 112552 376 34843989
Systolic dysfunction 20.99 10.90 34 112532 2674 34841691
Seizure 20.97 10.90 226 112340 104631 34739734
Dizziness postural 20.91 10.90 55 112511 6109 34838256
Aspergillus infection 20.36 10.90 7 112559 12247 34832118
Mitral valve calcification 20.31 10.90 16 112550 561 34843804
Atrioventricular block complete 20.16 10.90 71 112495 9248 34835117
Bone marrow failure 19.95 10.90 40 112526 29213 34815152
Bundle branch block 19.73 10.90 19 112547 875 34843490
Left atrial dilatation 19.64 10.90 28 112538 1968 34842397
Drug withdrawal syndrome 19.52 10.90 21 112545 19813 34824552
Full blood count decreased 19.49 10.90 112 112454 17976 34826389
Graft versus host disease 19.45 10.90 5 112561 10564 34833801
Torsade de pointes 19.25 10.90 59 112507 7150 34837215
Pneumocystis jirovecii pneumonia 19.25 10.90 21 112545 19689 34824676
Tumour lysis syndrome 19.20 10.90 16 112550 17043 34827322
Progressive multifocal leukoencephalopathy 19.20 10.90 4 112562 9760 34834605
Appendicitis 19.13 10.90 12 112554 14795 34829570
Vascular compression 19.07 10.90 13 112553 363 34844002
Psychotic disorder 18.85 10.90 31 112535 24421 34819944
Epilepsy 18.77 10.90 25 112541 21470 34822895
Extrapyramidal disorder 18.73 10.90 9 112557 12871 34831494
Concomitant disease progression 18.69 10.90 31 112535 2487 34841878
Ejection fraction abnormal 18.64 10.90 19 112547 938 34843427
Mitral valve thickening 18.52 10.90 13 112553 381 34843984
Drug hypersensitivity 18.43 10.90 168 112398 80361 34764004
Upper gastrointestinal haemorrhage 18.42 10.90 143 112423 25375 34818990
Pathogen resistance 18.41 10.90 4 112562 9478 34834887
Neutropenic sepsis 18.01 10.90 11 112555 13756 34830609
Osteonecrosis 17.99 10.90 13 112553 14877 34829488
End stage renal disease 17.89 10.90 66 112500 8795 34835570
Arterial spasm 17.87 10.90 8 112558 94 34844271
Hepatitis 17.79 10.90 31 112535 23873 34820492
Brain natriuretic peptide increased 17.70 10.90 49 112517 5610 34838755
Hepatojugular reflux 17.65 10.90 15 112551 586 34843779
Urticaria 17.57 10.90 123 112443 62254 34782111
Vascular graft 17.46 10.90 23 112543 1499 34842866
Bronchopulmonary aspergillosis 17.45 10.90 13 112553 14646 34829719
Pain 17.38 10.90 514 112052 204161 34640204
Helicobacter test false negative 17.28 10.90 7 112559 63 34844302
Disturbance in attention 17.25 10.90 36 112530 25909 34818456
Gingival hypertrophy 17.12 10.90 25 112541 1796 34842569
Multiple organ dysfunction syndrome 16.97 10.90 161 112405 76405 34767960
Therapy partial responder 16.85 10.90 5 112561 9611 34834754
Pulse waveform abnormal 16.74 10.90 4 112562 3 34844362
Migraine 16.66 10.90 19 112547 17459 34826906
Cerebral haemorrhage 16.65 10.90 179 112387 34758 34809607
Inflammation 16.60 10.90 42 112524 28253 34816112
Colitis 16.52 10.90 64 112502 37686 34806679
Tremor 16.51 10.90 178 112388 82409 34761956
Stenosis 16.50 10.90 22 112544 1451 34842914
Somnolence 16.48 10.90 255 112311 110861 34733504
Immune reconstitution inflammatory syndrome 16.40 10.90 4 112562 8755 34835610
Hypovolaemia 16.37 10.90 66 112500 9168 34835197
Hyperuricaemia 16.31 10.90 60 112506 7983 34836382
Mouth ulceration 16.31 10.90 9 112557 11901 34832464
Hallucination 16.30 10.90 98 112468 51400 34792965
Atrioventricular block second degree 16.26 10.90 37 112529 3751 34840614
Pulmonary renal syndrome 16.12 10.90 9 112557 174 34844191
Blood pressure systolic decreased 16.12 10.90 41 112525 4462 34839903
Ventricular extrasystoles 16.12 10.90 79 112487 11929 34832436
Rash maculo-papular 16.10 10.90 43 112523 28408 34815957
C-reactive protein increased 16.07 10.90 105 112461 53993 34790372
Implantable defibrillator insertion 16.05 10.90 16 112550 769 34843596
Low birth weight baby 16.04 10.90 3 112563 7902 34836463
Acute pulmonary oedema 15.93 10.90 56 112510 7287 34837078
Heart valve stenosis 15.89 10.90 7 112559 79 34844286
Cardiac pacemaker insertion 15.55 10.90 31 112535 2867 34841498
Sinus node dysfunction 15.54 10.90 39 112527 4210 34840155
Conjunctival scar 15.51 10.90 8 112558 131 34844234
Condition aggravated 15.50 10.90 486 112080 191710 34652655
Cardiogenic shock 15.41 10.90 142 112424 26476 34817889
Oral candidiasis 15.39 10.90 10 112556 12100 34832265
Blood 25-hydroxycholecalciferol decreased 15.33 10.90 10 112556 259 34844106
Substance abuse 15.29 10.90 3 112563 7638 34836727
Epstein-Barr virus infection 15.26 10.90 3 112563 7625 34836740
Aspartate aminotransferase increased 15.25 10.90 142 112424 67641 34776724
Intracardiac thrombus 14.99 10.90 28 112538 2468 34841897
Miosis 14.91 10.90 6 112560 9529 34834836
Anger 14.85 10.90 10 112556 11874 34832491
Infection 14.74 10.90 205 112361 90710 34753655
Delayed graft function 14.71 10.90 26 112540 2195 34842170
Disease progression 14.71 10.90 252 112314 107825 34736540
Abnormal behaviour 14.70 10.90 37 112529 24932 34819433
Coronary artery occlusion 14.63 10.90 72 112494 10890 34833475
Azotaemia 14.55 10.90 42 112524 4925 34839440
Dialysis 14.52 10.90 73 112493 11135 34833230
Stomatitis 14.48 10.90 79 112487 42435 34801930
Periodontitis 14.44 10.90 24 112542 1928 34842437
Osteonecrosis of jaw 14.43 10.90 22 112544 17867 34826498
Aortic arteriosclerosis 14.36 10.90 40 112526 4596 34839769
Heart rate abnormal 14.21 10.90 23 112543 1808 34842557
Cardioactive drug level above therapeutic 14.17 10.90 6 112560 61 34844304
Gravitational oedema 14.16 10.90 14 112552 666 34843699
Left atrial enlargement 14.16 10.90 16 112550 889 34843476
Hypoglycaemic unconsciousness 14.03 10.90 15 112551 783 34843582
Gastrointestinal endoscopic therapy 13.99 10.90 4 112562 10 34844355
Atrial flutter 13.98 10.90 92 112474 15482 34828883
Chronic left ventricular failure 13.96 10.90 13 112553 574 34843791
Subdural haematoma 13.95 10.90 113 112453 20308 34824057
Haemoglobin decreased 13.85 10.90 497 112069 120275 34724090
Cardioversion 13.74 10.90 16 112550 919 34843446
Haemophagocytic lymphohistiocytosis 13.60 10.90 13 112553 12960 34831405
Tachycardia induced cardiomyopathy 13.45 10.90 7 112559 117 34844248
Supraventricular tachycardia 13.42 10.90 71 112495 11046 34833319
Acute respiratory distress syndrome 13.41 10.90 41 112525 25928 34818437
Drug ineffective for unapproved indication 13.30 10.90 36 112530 23679 34820686
Lower gastrointestinal haemorrhage 13.27 10.90 63 112503 9389 34834976
Haematotoxicity 13.07 10.90 5 112561 8189 34836176
Uveitis 13.06 10.90 4 112562 7531 34836834
Occult blood 13.00 10.90 15 112551 853 34843512
Non-compaction cardiomyopathy 12.96 10.90 5 112561 39 34844326
Goitre 12.91 10.90 21 112545 1657 34842708
Acute generalised exanthematous pustulosis 12.87 10.90 3 112563 6773 34837592
Pulmonary arterial pressure increased 12.82 10.90 18 112548 1247 34843118
Intentional product misuse 12.81 10.90 90 112476 45521 34798844
Melaena 12.79 10.90 172 112394 35208 34809157
Injection site swelling 12.74 10.90 11 112555 11516 34832849
Atrial septal defect 12.67 10.90 4 112562 7388 34836977
Symblepharon 12.65 10.90 7 112559 133 34844232
Cytokine release syndrome 12.63 10.90 35 112531 22842 34821523
Injection site reaction 12.60 10.90 14 112552 13019 34831346
Bronchiectasis 12.58 10.90 8 112558 9793 34834572
Cardiac output decreased 12.56 10.90 15 112551 885 34843480
Hyperlipidaemia 12.54 10.90 85 112481 14444 34829921
Cardiac ventricular thrombosis 12.50 10.90 17 112549 1143 34843222
Polyp 12.47 10.90 34 112532 3858 34840507
Dilatation atrial 12.43 10.90 23 112543 2012 34842353
Muscle twitching 12.43 10.90 9 112557 10289 34834076
Defect conduction intraventricular 12.42 10.90 10 112556 362 34844003
Embolic stroke 12.41 10.90 37 112529 4417 34839948
Dehydration 12.35 10.90 524 112042 129445 34714920
Klebsiella infection 12.35 10.90 6 112560 8525 34835840
Gout 12.33 10.90 105 112461 19148 34825217
Loss of consciousness 12.30 10.90 351 112215 82316 34762049
Lymphocyte count decreased 12.20 10.90 35 112531 22587 34821778
Drug level decreased 12.17 10.90 5 112561 7841 34836524
Blood pressure abnormal 12.10 10.90 55 112511 8051 34836314
Echocardiogram abnormal 12.10 10.90 16 112550 1047 34843318
Procedural hypotension 12.09 10.90 15 112551 921 34843444
Transaminases increased 12.04 10.90 45 112521 26778 34817587
Hepatic enzyme increased 12.04 10.90 75 112491 39005 34805360
Neurotoxicity 11.96 10.90 25 112541 17985 34826380
Concomitant disease aggravated 11.96 10.90 43 112523 5658 34838707
Large intestinal haemorrhage 11.88 10.90 20 112546 1624 34842741
Eosinophilia 11.77 10.90 44 112522 26178 34818187
Low cardiac output syndrome 11.72 10.90 12 112554 596 34843769
Incarcerated hernia 11.70 10.90 7 112559 155 34844210
Tinnitus 11.69 10.90 30 112536 20088 34824277
Hydrothorax 11.66 10.90 11 112555 494 34843871
Hypophosphataemia 11.62 10.90 11 112555 11015 34833350
Spinal epidural haematoma 11.56 10.90 9 112557 310 34844055
Oesophageal carcinoma 11.40 10.90 8 112558 9296 34835069
Coagulation factor increased 11.30 10.90 5 112561 57 34844308
Toxic goitre 11.30 10.90 3 112563 5 34844360
Cardiac tamponade 11.29 10.90 40 112526 5226 34839139
Peripheral arterial occlusive disease 11.23 10.90 43 112523 5831 34838534
Periorbital haemorrhage 11.23 10.90 6 112560 106 34844259
Toe amputation 11.22 10.90 25 112541 2499 34841866
Cerebellar haemorrhage 11.20 10.90 19 112547 1552 34842813
Anxiety 11.03 10.90 240 112326 99188 34745177
Pulmonary fibrosis 11.03 10.90 27 112539 18369 34825996
Colitis ulcerative 10.92 10.90 23 112543 16497 34827868
Labile blood pressure 10.91 10.90 12 112554 647 34843718

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
Cardiac failure congestive 2277.21 10.04 2120 171306 140282 79430680
Myocardial infarction 890.24 10.04 1504 171922 182625 79388337
Cardiac failure 779.24 10.04 1288 172138 153554 79417408
Hypotension 708.50 10.04 2334 171092 437983 79132979
Bradycardia 657.03 10.04 1109 172317 134448 79436514
Hyperkalaemia 431.91 10.04 840 172586 113558 79457404
Acute myocardial infarction 398.10 10.04 649 172777 76387 79494575
Coronary artery disease 342.90 10.04 555 172871 64919 79506043
Acute kidney injury 281.92 10.04 2013 171413 517391 79053571
Synovitis 276.41 10.04 12 173414 150722 79420240
Ejection fraction decreased 274.50 10.04 357 173069 34220 79536742
Drug ineffective 274.41 10.04 1316 172110 1079597 78491365
Syncope 269.56 10.04 931 172495 178518 79392444
Gastrointestinal haemorrhage 240.93 10.04 788 172638 146931 79424031
Off label use 239.68 10.04 1088 172338 906127 78664835
Atrial fibrillation 234.98 10.04 952 172474 196934 79374028
Cardiac failure chronic 223.64 10.04 189 173237 10946 79560016
Rheumatoid arthritis 221.50 10.04 88 173338 208382 79362580
Joint swelling 212.43 10.04 189 173237 288457 79282505
Infusion related reaction 206.86 10.04 122 173304 230115 79340847
Death 206.64 10.04 2008 171418 564506 79006456
Dyspnoea 203.89 10.04 2795 170631 854230 78716732
Treatment failure 198.16 10.04 62 173364 170424 79400538
Drug intolerance 197.89 10.04 170 173256 263949 79307013
Cardiomyopathy 197.78 10.04 277 173149 28497 79542465
Hand deformity 194.82 10.04 7 173419 103912 79467050
Ischaemic cardiomyopathy 191.38 10.04 148 173278 7547 79563415
Chronic kidney disease 190.41 10.04 435 172991 65719 79505243
International normalised ratio increased 189.73 10.04 506 172920 84215 79486747
Drug abuse 182.35 10.04 63 173363 162628 79408334
Arthralgia 181.49 10.04 637 172789 571166 78999796
Renal impairment 180.07 10.04 750 172676 157033 79413929
Mitral valve incompetence 177.32 10.04 262 173164 28303 79542659
Systemic lupus erythematosus 170.64 10.04 29 173397 121120 79449842
Arthropathy 170.49 10.04 86 173340 177025 79393937
Blood creatinine increased 166.07 10.04 723 172703 154334 79416628
Renal failure 161.04 10.04 862 172564 200106 79370856
Ventricular tachycardia 155.76 10.04 306 173120 41629 79529333
Blood pressure decreased 155.31 10.04 523 172903 98943 79472019
Alopecia 152.29 10.04 167 173259 231188 79339774
Cerebrovascular accident 151.97 10.04 705 172721 154587 79416375
Lower respiratory tract infection 151.93 10.04 46 173380 129174 79441788
Therapeutic product effect decreased 151.19 10.04 84 173342 163779 79407183
Pain 151.18 10.04 905 172521 702897 78868065
Hypoglycaemia 148 10.04 522 172904 101072 79469890
Pulmonary oedema 147.60 10.04 475 172951 87779 79483183
Musculoskeletal stiffness 147.17 10.04 100 173326 174908 79396054
Maternal exposure during pregnancy 146.03 10.04 57 173369 136481 79434481
Cardiomegaly 144.23 10.04 228 173198 26124 79544838
Hepatic enzyme increased 143.60 10.04 112 173314 182498 79388464
Cardiac failure acute 143.35 10.04 191 173235 18738 79552224
Pericarditis 142.36 10.04 27 173399 104209 79466753
Oedema peripheral 141.18 10.04 986 172440 251302 79319660
Glossodynia 138.53 10.04 28 173398 103309 79467653
Cardiac disorder 134.54 10.04 380 173046 65377 79505585
Completed suicide 134.28 10.04 955 172471 244812 79326150
Contraindicated product administered 125.93 10.04 95 173331 157443 79413519
Hypersensitivity 123.77 10.04 239 173187 262000 79308962
BRASH syndrome 120.76 10.04 54 173372 963 79569999
Rash 119.21 10.04 753 172673 577605 78993357
Duodenal ulcer perforation 118.98 10.04 6 173420 66205 79504757
Discomfort 113.56 10.04 66 173360 125551 79445411
Dizziness 113.48 10.04 1689 171737 524752 79046210
Wound 112.40 10.04 56 173370 116123 79454839
Cardiac arrest 110.97 10.04 697 172729 171399 79399563
Sinus bradycardia 109.65 10.04 197 173229 25050 79545912
Helicobacter infection 109.21 10.04 12 173414 69692 79501270
Chest pain 108.68 10.04 1013 172413 281291 79289671
Congestive cardiomyopathy 106.80 10.04 130 173296 11650 79559312
Atrioventricular block 105.28 10.04 141 173285 13900 79557062
Tricuspid valve incompetence 104.37 10.04 168 173258 19544 79551418
Coronary arterial stent insertion 104.09 10.04 94 173332 5950 79565012
Febrile neutropenia 103.45 10.04 217 173209 230782 79340180
Drug interaction 100.59 10.04 1360 172066 413823 79157139
Blood potassium increased 98.44 10.04 205 173221 29070 79541892
Dehydration 95.71 10.04 891 172535 247296 79323666
Sinusitis 94.12 10.04 176 173250 195325 79375637
Drug hypersensitivity 93.94 10.04 334 173092 298582 79272380
Pyrexia 92.52 10.04 987 172439 677722 78893240
Ventricular hypokinesia 91.69 10.04 107 173319 9172 79561790
Bundle branch block left 91.55 10.04 119 173307 11394 79559568
Anaemia 88.98 10.04 1410 172016 443605 79127357
Muscle injury 88.55 10.04 4 173422 48557 79522405
Glomerular filtration rate decreased 85.92 10.04 167 173259 22535 79548427
Folliculitis 85.59 10.04 10 173416 55370 79515592
Shock 83.59 10.04 246 173180 43302 79527660
Nasopharyngitis 82.91 10.04 279 173147 253602 79317360
Presyncope 81.77 10.04 235 173191 40819 79530143
Angina pectoris 81.59 10.04 273 173153 51459 79519503
Left ventricular dilatation 80.71 10.04 42 173384 1059 79569903
Hypertensive crisis 78.86 10.04 153 173273 20617 79550345
Therapeutic product effect incomplete 78.86 10.04 116 173310 141529 79429433
Hypervolaemia 78.01 10.04 237 173189 42453 79528509
Product use in unapproved indication 77.14 10.04 282 173144 250077 79320885
Myocardial ischaemia 76.97 10.04 171 173255 25348 79545614
Injection site pain 76.60 10.04 102 173324 129736 79441226
Product monitoring error 75.46 10.04 95 173331 8811 79562151
Cardiogenic shock 75.01 10.04 231 173195 41683 79529279
Intentional product use issue 74.92 10.04 135 173291 151977 79418985
Infection 74.64 10.04 272 173154 241440 79329522
Computerised tomogram coronary artery abnormal 74.61 10.04 25 173401 193 79570769
Blood loss anaemia 73.88 10.04 126 173300 15372 79555590
Orthopnoea 73.76 10.04 100 173326 9973 79560989
Asthenia 72.70 10.04 1537 171889 510152 79060810
Coronary artery bypass 72.09 10.04 77 173349 5985 79564977
Fibromyalgia 71.91 10.04 25 173401 64315 79506647
N-terminal prohormone brain natriuretic peptide increased 70.42 10.04 68 173358 4687 79566275
Blood urea increased 70.42 10.04 250 173176 48540 79522422
Cerebral infarction 68.48 10.04 237 173189 45439 79525523
Cardioactive drug level increased 68.47 10.04 60 173366 3649 79567313
Fluid retention 68.28 10.04 317 173109 69492 79501470
Exposure during pregnancy 67.60 10.04 72 173354 101060 79469902
Impaired healing 67.32 10.04 55 173371 87600 79483362
Glycosylated haemoglobin increased 67.26 10.04 137 173289 19123 79551839
Haemoglobin decreased 67.24 10.04 759 172667 221360 79349602
Angina unstable 66.77 10.04 125 173301 16402 79554560
Arrhythmia 65.75 10.04 286 173140 60986 79509976
Mental status changes 65.44 10.04 304 173122 66655 79504307
Left ventricular dysfunction 64.42 10.04 135 173291 19226 79551736
Neutropenia 63.63 10.04 366 173060 287344 79283618
Irritable bowel syndrome 63.27 10.04 28 173398 62213 79508749
C-reactive protein abnormal 62.98 10.04 14 173412 48353 79522609
Peritonitis bacterial 62.63 10.04 90 173336 9477 79561485
Psoriatic arthropathy 62.35 10.04 47 173379 77952 79493010
Stomatitis 62.25 10.04 142 173284 146615 79424347
Ventricular arrhythmia 62.08 10.04 86 173340 8754 79562208
Product use issue 60.96 10.04 242 173184 209580 79361382
Sleep disorder due to general medical condition, insomnia type 60.06 10.04 11 173415 43545 79527417
Blood glucose increased 58.81 10.04 440 172986 114535 79456427
Red blood cell sedimentation rate increased 58.42 10.04 14 173412 45928 79525034
Renal cyst haemorrhage 58.31 10.04 29 173397 663 79570299
Diastolic dysfunction 57.04 10.04 92 173334 10719 79560243
Mobility decreased 56.16 10.04 113 173313 122062 79448900
Erythema 55.51 10.04 273 173153 223017 79347945
Haemorrhage intracranial 55.16 10.04 153 173273 26040 79544922
Inflammation 54.94 10.04 74 173352 93679 79477283
Upper gastrointestinal haemorrhage 54.63 10.04 206 173220 41174 79529788
Nipple swelling 54.61 10.04 22 173404 299 79570663
Gastrointestinal disorder 54.50 10.04 115 173311 122090 79448872
Migraine 54.44 10.04 66 173360 87427 79483535
Cardio-respiratory arrest 54.22 10.04 413 173013 108097 79462865
Swelling 53.84 10.04 265 173161 216446 79354516
Left ventricular hypertrophy 53.36 10.04 91 173335 11100 79559862
Subdural haematoma 53.26 10.04 170 173256 31264 79539698
Aortic valve incompetence 52.90 10.04 83 173343 9447 79561515
Arteriosclerosis 52.58 10.04 120 173306 18107 79552855
Blister 51.16 10.04 115 173311 119361 79451601
Atrioventricular block first degree 51.11 10.04 95 173331 12396 79558566
Hypovolaemia 49.41 10.04 115 173311 17576 79553386
Abdominal discomfort 49.18 10.04 331 173095 250396 79320566
Atrioventricular block complete 48.63 10.04 110 173316 16500 79554462
Electrocardiogram abnormal 48.07 10.04 110 173316 16627 79554335
Serotonin syndrome 47.79 10.04 19 173407 45008 79525954
Urticaria 47.44 10.04 224 173202 184977 79385985
N-terminal prohormone brain natriuretic peptide abnormal 47.31 10.04 19 173407 256 79570706
Fall 46.36 10.04 1388 172038 486241 79084721
Loss of personal independence in daily activities 46.19 10.04 96 173330 102484 79468478
Pulmonary hypertension 46.03 10.04 217 173209 47863 79523099
Ischaemic stroke 45.46 10.04 167 173259 32964 79537998
Nodal rhythm 44.87 10.04 44 173382 3091 79567871
Renal artery stenosis 44.57 10.04 46 173380 3436 79567526
Unresponsive to stimuli 44.40 10.04 239 173187 55549 79515413
Suicidal ideation 43.98 10.04 61 173365 76279 79494683
Leukopenia 43.75 10.04 120 173306 116393 79454569
Pregnancy 43.68 10.04 4 173422 26847 79544115
Nephrogenic anaemia 43.66 10.04 48 173378 3854 79567108
Drug dependence 43.60 10.04 17 173409 40752 79530210
Headache 43.27 10.04 1087 172339 652685 78918277
Blood pressure inadequately controlled 43.24 10.04 60 173366 6117 79564845
Carotid arteriosclerosis 43.19 10.04 40 173386 2616 79568346
Loss of consciousness 42.99 10.04 556 172870 167387 79403575
Vena cava injury 42.79 10.04 19 173407 333 79570629
Myelosuppression 42.77 10.04 17 173409 40279 79530683
End stage renal disease 42.76 10.04 87 173339 12133 79558829
Suspected suicide 42.73 10.04 80 173346 10496 79560466
Nipple pain 42.53 10.04 26 173400 900 79570062
Dialysis 42.04 10.04 111 173315 18351 79552611
Gastrointestinal tract mucosal pigmentation 41.98 10.04 27 173399 1023 79569939
Brain natriuretic peptide increased 41.95 10.04 72 173354 8828 79562134
Ventricular internal diameter abnormal 41.94 10.04 17 173409 235 79570727
Pulmonary valve disease 41.91 10.04 18 173408 290 79570672
Dyspnoea exertional 41.60 10.04 328 173098 86745 79484217
Hyperparathyroidism secondary 41.21 10.04 39 173387 2621 79568341
Spinal epidural haematoma 41.07 10.04 30 173396 1402 79569560
Injection site reaction 40.08 10.04 36 173390 54749 79516213
Torsade de pointes 39.87 10.04 112 173314 19200 79551762
Arthritis 39.72 10.04 123 173303 114757 79456205
Condition aggravated 39.40 10.04 811 172615 500313 79070649
Sedation 39.30 10.04 33 173393 51862 79519100
Melaena 38.82 10.04 246 173180 60644 79510318
Conduction disorder 38.57 10.04 42 173384 3337 79567625
Large intestine polyp 38.14 10.04 85 173341 12623 79558339
Implantable defibrillator insertion 38.00 10.04 25 173401 985 79569977
Sinus arrest 37.86 10.04 43 173383 3579 79567383
Asthma 37.85 10.04 158 173268 134937 79436025
Ventricular extrasystoles 37.51 10.04 111 173315 19593 79551369
Coronary artery occlusion 36.85 10.04 94 173332 15221 79555741
Blood glucose decreased 36.64 10.04 133 173293 26101 79544861
Liver injury 35.97 10.04 42 173384 56572 79514390
Osteoporosis 35.63 10.04 39 173387 54073 79516889
Sudden cardiac death 35.45 10.04 50 173376 5175 79565787
Bursitis 35.07 10.04 17 173409 35827 79535135
Type V hyperlipidaemia 34.89 10.04 24 173402 1019 79569943
Atrial flutter 34.87 10.04 115 173311 21510 79549452
Blood cholesterol increased 34.69 10.04 82 173344 83638 79487324
Sinus node dysfunction 34.60 10.04 61 173365 7640 79563322
Cerebral haemorrhage 34.32 10.04 229 173197 57444 79513518
Ventricular dysfunction 34.19 10.04 53 173373 5970 79564992
Isosthenuria 33.91 10.04 12 173414 111 79570851
Renal injury 33.80 10.04 97 173329 16830 79554132
Abortion spontaneous 33.78 10.04 11 173415 29496 79541466
Pericardial disease 33.58 10.04 19 173407 568 79570394
Pleural effusion 33.50 10.04 472 172954 144790 79426172
Ventricular fibrillation 33.47 10.04 148 173278 31778 79539184
Hip arthroplasty 33.43 10.04 18 173408 35738 79535224
Bradyarrhythmia 33.19 10.04 43 173383 4103 79566859
Brain natriuretic peptide abnormal 33.12 10.04 21 173405 776 79570186
Oropharyngeal pain 33.10 10.04 124 173302 109229 79461733
SARS-CoV-2 antibody test positive 32.91 10.04 17 173409 422 79570540
Lower gastrointestinal haemorrhage 32.78 10.04 93 173333 16032 79554930
Azotaemia 32.69 10.04 62 173364 8214 79562748
Nodal arrhythmia 32.57 10.04 30 173396 1948 79569014
Cytomegalovirus infection 32.44 10.04 27 173399 42617 79528345
Injection site swelling 32.11 10.04 33 173393 47099 79523863
Injection site erythema 32.08 10.04 77 173349 78120 79492842
Ill-defined disorder 31.06 10.04 60 173366 65815 79505147
Calcium deficiency 30.81 10.04 21 173405 878 79570084
Intraductal papillary mucinous neoplasm 30.63 10.04 20 173406 778 79570184
Anti-neutrophil cytoplasmic antibody positive vasculitis 30.36 10.04 39 173387 3690 79567272
Vascular anastomotic haemorrhage 30.17 10.04 14 173412 273 79570689
Osteoarthritis 29.81 10.04 94 173332 87215 79483747
Labelled drug-drug interaction medication error 29.61 10.04 129 173297 27521 79543441
Malignant neoplasm progression 29.49 10.04 174 173252 135816 79435146
Intentional self-injury 29.33 10.04 17 173409 32402 79538560
Stenosis 29.22 10.04 31 173395 2391 79568571
Physical examination abnormal 29.18 10.04 14 173412 295 79570667
Carotid artery stenosis 29.06 10.04 61 173365 8697 79562265
Intracardiac thrombus 29.01 10.04 41 173385 4252 79566710
Hyperuricaemia 28.99 10.04 73 173353 11726 79559236
Pericardial effusion 28.97 10.04 186 173240 46051 79524911
Embolic stroke 28.92 10.04 57 173369 7769 79563193
Wheezing 28.76 10.04 143 173283 116521 79454441
Full blood count decreased 28.62 10.04 125 173301 26694 79544268
Pulse absent 28.57 10.04 66 173360 10037 79560925
Plasma cell myeloma 28.46 10.04 206 173220 53053 79517909
Drug reaction with eosinophilia and systemic symptoms 28.18 10.04 61 173365 64183 79506779
Bone erosion 28.14 10.04 3 173423 17844 79553118
Abdominal wall haemorrhage 28.13 10.04 18 173408 676 79570286
Dyspnoea at rest 27.98 10.04 54 173372 7248 79563714
Perineal cyst 27.90 10.04 13 173413 256 79570706
Agitation 27.69 10.04 117 173309 99598 79471364
Poisoning deliberate 27.65 10.04 4 173422 18824 79552138
Orthostatic hypotension 27.62 10.04 213 173213 55951 79515011
Mouth breathing 27.61 10.04 11 173415 145 79570817
Foot deformity 27.51 10.04 9 173417 24065 79546897
Rheumatoid nodule 27.32 10.04 3 173423 17435 79553527
Epistaxis 27.19 10.04 366 173060 111149 79459813
Extradural haematoma 26.49 10.04 32 173394 2844 79568118
Femoral artery dissection 26.34 10.04 8 173418 43 79570919
Coma 26.19 10.04 121 173305 100528 79470434
Chronic left ventricular failure 26.10 10.04 20 173406 1006 79569956
Mucosal inflammation 26.07 10.04 81 173345 75499 79495463
Therapy cessation 25.98 10.04 155 173271 37407 79533555
Low cardiac output syndrome 25.77 10.04 20 173406 1025 79569937
Hypertensive emergency 25.68 10.04 31 173395 2754 79568208
Jugular vein distension 25.58 10.04 23 173403 1447 79569515
Cardiac tamponade 25.58 10.04 60 173366 9216 79561746
Bone marrow failure 25.47 10.04 45 173381 51062 79519900
Herpes zoster 25.37 10.04 110 173316 92973 79477989
Diverticulum intestinal 25.20 10.04 57 173369 8548 79562414
Acute respiratory failure 25.07 10.04 218 173208 59323 79511639
Extrapyramidal disorder 25.02 10.04 9 173417 22670 79548292
C-reactive protein increased 24.95 10.04 171 173255 128856 79442106
Product prescribing error 24.91 10.04 175 173251 44638 79526324
Progressive multifocal leukoencephalopathy 24.81 10.04 7 173419 20593 79550369
Sleep disorder 24.74 10.04 99 173327 85578 79485384
Pulmonary fibrosis 24.66 10.04 36 173390 44076 79526886
Electrocardiogram QRS complex abnormal 24.60 10.04 16 173410 618 79570344
Bronchiectasis 24.50 10.04 9 173417 22377 79548585
Depression 24.16 10.04 329 173097 216461 79354501
Cardiac discomfort 24.11 10.04 21 173405 1267 79569695
Cognitive disorder 24.08 10.04 75 173351 69851 79501111
Tenosynovitis 23.56 10.04 3 173423 15551 79555411
Rales 23.50 10.04 96 173330 19905 79551057
Knee arthroplasty 23.49 10.04 36 173390 43212 79527750
Aortic dilatation 23.30 10.04 24 173402 1788 79569174
Lip dry 23.29 10.04 3 173423 15415 79555547
Neutrophil count decreased 23.26 10.04 115 173311 93844 79477118
Acute pulmonary oedema 23.24 10.04 76 173350 14154 79556808
Peripheral coldness 23.18 10.04 82 173344 15888 79555074
Electrocardiogram PR shortened 23.04 10.04 12 173414 303 79570659
Pulmonary congestion 22.87 10.04 118 173308 26982 79543980
Myocardial necrosis 22.84 10.04 14 173412 487 79570475
Metabolic acidosis 22.71 10.04 277 173149 82252 79488710
Oral herpes 22.64 10.04 16 173410 27438 79543524
Pulseless electrical activity 22.56 10.04 75 173351 14085 79556877
Decreased appetite 22.36 10.04 934 172492 341484 79229478
Fear 22.35 10.04 101 173325 21885 79549077
Chronic obstructive pulmonary disease 22.35 10.04 284 173142 85135 79485827
Mitral valve thickening 22.24 10.04 13 173413 414 79570548
Carotid sinus syndrome 22.18 10.04 10 173416 182 79570780
Joint stiffness 22.17 10.04 34 173392 40796 79530166
Pyelitis 22.08 10.04 12 173414 331 79570631
Pulmonary renal syndrome 22.05 10.04 15 173411 625 79570337
Bundle branch block 22.05 10.04 22 173404 1578 79569384
Grip strength decreased 21.97 10.04 10 173416 21859 79549103
Supraventricular tachycardia 21.84 10.04 98 173328 21172 79549790
Pruritus 21.71 10.04 673 172753 393975 79176987
Benign prostatic hyperplasia 21.71 10.04 65 173361 11547 79559415
Respiratory failure 21.71 10.04 531 172895 180380 79390582
Pulmonary arterial pressure increased 21.67 10.04 37 173389 4518 79566444
Bladder hypertrophy 21.66 10.04 15 173411 644 79570318
Haematuria 21.61 10.04 237 173189 68599 79502363
Neuroleptic malignant syndrome 21.52 10.04 17 173409 27542 79543420
Haematochezia 21.51 10.04 288 173138 87357 79483605
Renal disorder 21.44 10.04 161 173265 41944 79529018
Device expulsion 21.42 10.04 15 173411 25846 79545116
Lymphadenopathy 21.39 10.04 53 173373 53194 79517768
Gastric ulcer haemorrhage 21.30 10.04 55 173371 8972 79561990
Left atrial enlargement 21.29 10.04 19 173407 1184 79569778
Abdominal pain 21.27 10.04 665 172761 388904 79182058
Vascular compression 21.09 10.04 14 173412 560 79570402
Gout 21.05 10.04 108 173318 24641 79546321
Hepatocellular injury 21.03 10.04 45 173381 47548 79523414
Dizziness postural 20.98 10.04 64 173362 11485 79559477
Cholestasis 20.83 10.04 52 173374 52057 79518905
Mitral valve disease 20.82 10.04 30 173396 3167 79567795
Blood pressure diastolic abnormal 20.54 10.04 8 173418 19194 79551768
Therapeutic drug monitoring analysis incorrectly performed 20.54 10.04 15 173411 701 79570261
Blood iron decreased 20.51 10.04 77 173349 15357 79555605
Concomitant disease progression 20.33 10.04 31 173395 3442 79567520
Blood pressure systolic increased 20.24 10.04 76 173350 66910 79504052
Myxoedema coma 20.15 10.04 15 173411 722 79570240
Lymphopenia 20.14 10.04 22 173404 30535 79540427
Peripheral vascular disorder 20.06 10.04 50 173376 7980 79562982
Helicobacter test false negative 19.95 10.04 7 173419 63 79570899
Acute coronary syndrome 19.95 10.04 95 173331 21038 79549924
Electrocardiogram Q wave abnormal 19.91 10.04 14 173412 616 79570346
Hydrothorax 19.89 10.04 20 173406 1448 79569514
Renal hypoplasia 19.87 10.04 5 173421 11 79570951
Cardiac pacemaker insertion 19.84 10.04 41 173385 5781 79565181
Mitral valve calcification 19.83 10.04 20 173406 1453 79569509
Impaired work ability 19.77 10.04 9 173417 19672 79551290
Blood pressure fluctuation 19.76 10.04 77 173349 67068 79503894
Activated partial thromboplastin time prolonged 19.75 10.04 72 173354 14156 79556806
Live birth 19.74 10.04 8 173418 18736 79552226
Hepatic cytolysis 19.67 10.04 18 173408 27133 79543829
Renal atrophy 19.65 10.04 22 173404 1803 79569159
Systolic dysfunction 19.62 10.04 32 173394 3763 79567199
Oesophageal varices haemorrhage 19.61 10.04 34 173392 4202 79566760
Neutrophil count increased 19.56 10.04 21 173405 29375 79541587
Hepatojugular reflux 19.55 10.04 14 173412 634 79570328
Gravitational oedema 19.51 10.04 22 173404 1817 79569145
Tendonitis 19.51 10.04 14 173412 23816 79547146
Paraesthesia 19.49 10.04 268 173158 176055 79394907
Basal ganglia haemorrhage 19.47 10.04 21 173405 1650 79569312
Procedural hypotension 19.44 10.04 23 173403 2000 79568962
Drug resistance 19.42 10.04 39 173387 42174 79528788
Rash maculo-papular 19.41 10.04 60 173366 56018 79514944
Therapy partial responder 19.03 10.04 7 173419 17390 79553572
Mania 18.90 10.04 8 173418 18252 79552710
Oxygen saturation increased 18.85 10.04 13 173413 554 79570408
Sleep disorder due to a general medical condition 18.85 10.04 4 173422 14273 79556689
Dilatation ventricular 18.85 10.04 33 173393 4111 79566851
Osteonecrosis 18.77 10.04 24 173402 31071 79539891
Pneumocystis jirovecii pneumonia 18.70 10.04 26 173400 32482 79538480
Cytokine release syndrome 18.58 10.04 31 173395 35967 79534995
Gastrointestinal arteriovenous malformation 18.56 10.04 16 173410 952 79570010
Vessel puncture site haemorrhage 18.53 10.04 9 173417 195 79570767
Drug tolerance decreased 18.50 10.04 3 173423 12975 79557987
Oedema 18.48 10.04 364 173062 119216 79451746
Joint effusion 18.47 10.04 8 173418 18006 79552956
Cardiac ventricular thrombosis 18.45 10.04 21 173405 1752 79569210
Aortic aneurysm 18.44 10.04 50 173376 8396 79562566
Drug ineffective for unapproved indication 18.32 10.04 54 173372 51184 79519778
Blood pressure abnormal 18.30 10.04 80 173346 17089 79553873
Aplastic anaemia 18.28 10.04 8 173418 17897 79553065
Therapeutic response decreased 18.22 10.04 79 173347 66774 79504188
Peripheral arterial occlusive disease 18.14 10.04 49 173377 8209 79562753
Rectal prolapse 18.08 10.04 23 173403 2155 79568807
Coronary artery stenosis 18.03 10.04 64 173362 12420 79558542
Uveitis 18.03 10.04 7 173419 16823 79554139
Internal haemorrhage 18.01 10.04 51 173375 8782 79562180
Pulmonary arterial pressure abnormal 17.86 10.04 14 173412 728 79570234
Fractured coccyx 17.81 10.04 16 173410 1006 79569956
Joint range of motion decreased 17.79 10.04 28 173398 33254 79537708
Vascular graft 17.74 10.04 22 173404 2009 79568953
Shunt occlusion 17.70 10.04 19 173407 1485 79569477
Hypoglycaemic unconsciousness 17.67 10.04 17 173409 1166 79569796
Haemophagocytic lymphohistiocytosis 17.65 10.04 13 173413 21824 79549138
Cardiac aneurysm 17.55 10.04 19 173407 1499 79569463
Multiple sclerosis relapse 17.40 10.04 48 173378 46485 79524477
Aortic dissection 17.39 10.04 32 173394 4143 79566819
Creatinine renal clearance increased 17.32 10.04 15 173411 898 79570064
Arterial spasm 17.24 10.04 8 173418 156 79570806
Fungal infection 17.20 10.04 41 173385 41707 79529255
Urine output decreased 17.00 10.04 81 173345 17941 79553021
Hepatorenal syndrome 16.99 10.04 32 173394 4217 79566745
Suicide attempt 16.99 10.04 108 173318 82824 79488138
Pericardial haemorrhage 16.93 10.04 33 173393 4462 79566500
Gastritis erosive 16.88 10.04 57 173369 10790 79560172
Left atrial dilatation 16.86 10.04 27 173399 3126 79567836
Sciatica 16.78 10.04 29 173397 33193 79537769
Aortic arteriosclerosis 16.75 10.04 50 173376 8868 79562094
Transfusion 16.71 10.04 91 173335 21239 79549723
Blood thyroid stimulating hormone abnormal 16.67 10.04 15 173411 945 79570017
Alanine aminotransferase increased 16.60 10.04 251 173175 162319 79408643
Vomiting 16.47 10.04 1236 172190 664592 78906370
Heart rate decreased 16.41 10.04 229 173197 70087 79500875
Ascites 16.41 10.04 243 173183 75319 79495643
Hepatocellular carcinoma 16.40 10.04 50 173376 8971 79561991
Mouth ulceration 16.39 10.04 37 173389 38357 79532605
Hyperglycaemia 16.39 10.04 229 173197 70106 79500856
Tinnitus 16.38 10.04 46 173380 44287 79526675
Large intestinal haemorrhage 16.37 10.04 25 173401 2780 79568182
Hepatotoxicity 16.35 10.04 57 173369 51295 79519667
Faeces discoloured 16.34 10.04 114 173312 29013 79541949
Immunodeficiency 16.29 10.04 14 173412 21754 79549208
Injection site pruritus 16.28 10.04 43 173383 42240 79528722
Glomerular filtration rate abnormal 16.28 10.04 19 173407 1629 79569333
Neutropenic sepsis 16.22 10.04 21 173405 27043 79543919
Small intestinal haemorrhage 16.21 10.04 31 173395 4132 79566830
Dilatation atrial 16.20 10.04 29 173397 3675 79567287
Epilepsy 16.15 10.04 41 173385 40819 79530143
Dyspnoea paroxysmal nocturnal 16.13 10.04 22 173404 2206 79568756
Immune reconstitution inflammatory syndrome 16.13 10.04 5 173421 13836 79557126
Lymphocyte count decreased 16.08 10.04 51 173375 47238 79523724
Psychotic disorder 16.02 10.04 42 173384 41360 79529602
Rhabdomyolysis 15.96 10.04 314 173112 102817 79468145
Haemodialysis 15.95 10.04 80 173346 18088 79552874
Electrocardiogram QRS complex shortened 15.92 10.04 13 173413 717 79570245
Haematocrit decreased 15.68 10.04 203 173223 61109 79509853
Blood 25-hydroxycholecalciferol decreased 15.55 10.04 10 173416 379 79570583
Unevaluable event 15.48 10.04 187 173239 55398 79515564
Electrocardiogram ST segment 15.40 10.04 3 173423 0 79570962
Pneumonia 15.36 10.04 1650 171776 658596 78912366
Rash erythematous 15.29 10.04 69 173357 57700 79513262
Panniculitis 15.28 10.04 4 173422 12367 79558595
Tremor 15.25 10.04 269 173157 169814 79401148
Colitis ulcerative 15.23 10.04 33 173393 34709 79536253
Night sweats 15.16 10.04 60 173366 52035 79518927
Conjunctival scar 15.12 10.04 8 173418 209 79570753
Aortic stenosis 15.01 10.04 43 173383 7452 79563510
Heart alternation 15.01 10.04 4 173422 12 79570950
Prescribed overdose 14.99 10.04 38 173388 37845 79533117
Arterial stenosis 14.93 10.04 17 173409 1419 79569543
Vitreous haemorrhage 14.89 10.04 28 173398 3685 79567277
Non-compaction cardiomyopathy 14.88 10.04 5 173421 39 79570923
Hypoxic-ischaemic encephalopathy 14.83 10.04 44 173382 7776 79563186
Blood pressure increased 14.81 10.04 581 172845 210779 79360183
Lacunar infarction 14.79 10.04 37 173389 5920 79565042
Delayed graft function 14.76 10.04 27 173399 3480 79567482
Cardiac output decreased 14.62 10.04 19 173407 1819 79569143
Dyslipidaemia 14.60 10.04 57 173369 11576 79559386
Ear pain 14.59 10.04 31 173395 32838 79538124
Hyperlipidaemia 14.56 10.04 102 173324 25991 79544971
Eye infection 14.45 10.04 4 173422 11916 79559046
Platelet dysfunction 14.38 10.04 10 173416 432 79570530
Oesophageal discomfort 14.38 10.04 9 173417 325 79570637
Intercepted product dispensing error 14.32 10.04 7 173419 154 79570808
Urinary tract infection 14.28 10.04 732 172694 273780 79297182
Gingival hypertrophy 14.26 10.04 25 173401 3117 79567845
Inappropriate antidiuretic hormone secretion 14.19 10.04 102 173324 26211 79544751
Metabolic encephalopathy 14.18 10.04 48 173378 9099 79561863
Peritonitis 14.16 10.04 107 173319 27929 79543033
Shunt thrombosis 14.11 10.04 7 173419 159 79570803
Vascular stent stenosis 14.08 10.04 17 173409 1510 79569452
Angioedema 14.04 10.04 238 173188 75797 79495165
International normalised ratio decreased 13.99 10.04 44 173382 8026 79562936
Cardioactive drug level above therapeutic 13.88 10.04 8 173418 248 79570714
Gangrene 13.86 10.04 47 173379 8917 79562045
Substance abuse 13.80 10.04 3 173423 10523 79560439
Subdural haemorrhage 13.79 10.04 36 173390 5912 79565050
Oliguria 13.75 10.04 71 173355 16238 79554724
Atrioventricular block second degree 13.74 10.04 41 173385 7271 79563691
Pathogen resistance 13.73 10.04 7 173419 14335 79556627
Hypophagia 13.69 10.04 155 173271 45212 79525750
Heart valve stenosis 13.65 10.04 7 173419 171 79570791
Troponin I increased 13.45 10.04 31 173395 4707 79566255
Haematoma 13.42 10.04 173 173253 52022 79518940
Coeliac disease 13.41 10.04 4 173422 11347 79559615
Diverticulum intestinal haemorrhagic 13.38 10.04 28 173398 3983 79566979
Traumatic renal injury 13.33 10.04 3 173423 3 79570959
Subarachnoid haemorrhage 13.28 10.04 95 173331 24370 79546592
Device inappropriate shock delivery 13.20 10.04 5 173421 57 79570905
Ankylosing spondylitis 13.20 10.04 5 173421 12200 79558762
Blood sodium increased 13.19 10.04 31 173395 4767 79566195
Sedation complication 13.10 10.04 9 173417 15660 79555302
Defect conduction intraventricular 13.05 10.04 10 173416 503 79570459
Distributive shock 13.01 10.04 22 173404 2665 79568297
Haemorrhage 12.97 10.04 274 173152 90844 79480118
Malaise 12.96 10.04 904 172522 488965 79081997
Electrocardiogram QT prolonged 12.93 10.04 272 173154 90114 79480848
Lower limb fracture 12.92 10.04 19 173407 23196 79547766
Haemorrhagic cerebral infarction 12.89 10.04 16 173410 1463 79569499
Anxiety 12.88 10.04 427 172999 248085 79322877
Fistula 12.87 10.04 6 173420 12934 79558028
Symblepharon 12.85 10.04 7 173419 194 79570768
Tachycardia induced cardiomyopathy 12.85 10.04 7 173419 194 79570768
Auditory disorder 12.84 10.04 10 173416 515 79570447
Electrocardiogram QRS complex prolonged 12.73 10.04 52 173374 10781 79560181
Schizophrenia 12.73 10.04 9 173417 15431 79555531
Cardiac murmur 12.73 10.04 68 173358 15756 79555206
Electrocardiogram T wave peaked 12.69 10.04 13 173413 962 79570000
Injection site urticaria 12.68 10.04 6 173420 12820 79558142
Gastrointestinal endoscopic therapy 12.54 10.04 5 173421 66 79570896
Haemothorax 12.54 10.04 33 173393 5445 79565517
Ear infection 12.52 10.04 36 173390 34396 79536566
Generalised tonic-clonic seizure 12.51 10.04 51 173375 43859 79527103
Vascular stent thrombosis 12.49 10.04 26 173400 3684 79567278
Hospice care 12.49 10.04 50 173376 10274 79560688
Pulmonary valve incompetence 12.48 10.04 18 173408 1902 79569060
Bundle branch block right 12.44 10.04 53 173373 11198 79559764
Iron deficiency anaemia 12.42 10.04 97 173329 25575 79545387
Agranulocytosis 12.40 10.04 53 173373 44977 79525985
Panic attack 12.36 10.04 21 173405 24195 79546767
Dry mouth 12.33 10.04 127 173299 87892 79483070
Periodontitis 12.31 10.04 29 173397 4467 79566495
Vascular pseudoaneurysm 12.29 10.04 25 173401 3485 79567477
Hypoglycaemic coma 12.27 10.04 30 173396 4730 79566232
Aggression 12.25 10.04 63 173363 50895 79520067
Brain contusion 12.20 10.04 15 173411 1358 79569604
Device breakage 12.18 10.04 4 173422 10671 79560291
Toxic goitre 12.04 10.04 4 173422 30 79570932
Hypertension 12.02 10.04 855 172571 330137 79240825
Miosis 12.00 10.04 10 173416 15779 79555183
Tumour lysis syndrome 12.00 10.04 21 173405 23918 79547044
Beta 2 microglobulin urine increased 11.99 10.04 6 173420 139 79570823
Hypoperfusion 11.98 10.04 21 173405 2618 79568344
Atrial enlargement 11.97 10.04 13 173413 1030 79569932
Pulmonary embolism 11.95 10.04 283 173143 171371 79399591
Haemorrhoids 11.92 10.04 106 173320 29022 79541940
Diabetes mellitus 11.90 10.04 238 173188 78152 79492810
Klebsiella infection 11.90 10.04 10 173416 15710 79555252
Blood potassium decreased 11.89 10.04 154 173272 46358 79524604
Haemorrhagic erosive gastritis 11.77 10.04 11 173415 728 79570234
Anticoagulation drug level above therapeutic 11.76 10.04 25 173401 3595 79567367
Pernicious anaemia 11.73 10.04 10 173416 586 79570376
Haemorrhagic transformation stroke 11.68 10.04 21 173405 2671 79568291
Left ventricular enlargement 11.68 10.04 11 173415 735 79570227
Pallor 11.66 10.04 163 173263 49899 79521063
Refractory anaemia with an excess of blasts 11.65 10.04 12 173414 894 79570068
Incorrect route of product administration 11.65 10.04 38 173388 34891 79536071
Varices oesophageal 11.64 10.04 34 173392 5957 79565005
Coagulation factor increased 11.62 10.04 5 173421 81 79570881
Duodenal ulcer 11.61 10.04 68 173358 16301 79554661
Renin increased 11.59 10.04 7 173419 237 79570725
Toe amputation 11.56 10.04 26 173400 3885 79567077
Muscle spasticity 11.54 10.04 18 173408 21457 79549505
Glomerulonephritis rapidly progressive 11.52 10.04 16 173410 1632 79569330
Injection site bruising 11.45 10.04 48 173378 40954 79530008
Diplopia 11.44 10.04 36 173390 33430 79537532
Drug withdrawal syndrome 11.42 10.04 38 173388 34680 79536282
Diabetes mellitus inadequate control 11.36 10.04 91 173335 24173 79546789
Red blood cell count decreased 11.35 10.04 182 173244 57331 79513631
Inspiratory capacity decreased 11.33 10.04 6 173420 157 79570805
Coagulopathy 11.31 10.04 124 173302 35882 79535080
Heart transplant 11.30 10.04 15 173411 1466 79569496
Ventricular hypertrophy 11.28 10.04 37 173389 6901 79564061
Personality change 11.28 10.04 4 173422 10166 79560796
Cardiac operation 11.27 10.04 30 173396 4982 79565980
Cardioversion 11.27 10.04 18 173408 2080 79568882
Eczema 11.26 10.04 48 173378 40770 79530192
Infective pulmonary exacerbation of cystic fibrosis 11.26 10.04 7 173419 12844 79558118
Chest discomfort 11.25 10.04 386 173040 137658 79433304
Respiratory tract infection 11.25 10.04 61 173365 48628 79522334
Genotype drug resistance test positive 11.16 10.04 14 173412 1294 79569668
Testicular swelling 11.14 10.04 14 173412 1296 79569666
Drug level decreased 11.10 10.04 9 173417 14393 79556569
Haemorrhage subcutaneous 11.04 10.04 29 173397 4780 79566182
Epinephrine increased 11.02 10.04 3 173423 10 79570952
Colitis 11.01 10.04 104 173322 73203 79497759
Rhinorrhoea 10.97 10.04 109 173317 75965 79494997
COVID-19 10.96 10.04 260 173166 157414 79413548
Ovarian cyst 10.94 10.04 7 173419 12648 79558314
Therapeutic response shortened 10.93 10.04 11 173415 15852 79555110
Neck pain 10.90 10.04 108 173318 75309 79495653
Skin necrosis 10.87 10.04 14 173412 18073 79552889
Sinoatrial block 10.80 10.04 14 173412 1337 79569625
Injection site mass 10.77 10.04 17 173409 20167 79550795
Hypovolaemic shock 10.74 10.04 54 173372 12222 79558740
Incarcerated hernia 10.73 10.04 8 173418 386 79570576
Blood cyanide increased 10.69 10.04 4 173422 44 79570918
Extrasystoles 10.69 10.04 38 173388 7381 79563581
Haemorrhagic stroke 10.68 10.04 50 173376 10996 79559966
Carbohydrate antigen 15-3 increased 10.67 10.04 13 173413 1166 79569796
Macroglossia 10.65 10.04 13 173413 1168 79569794
Body temperature increased 10.63 10.04 55 173371 44365 79526597
Pain in extremity 10.60 10.04 667 172759 363871 79207091
Weight increased 10.59 10.04 494 172932 276892 79294070
Musculoskeletal disorder 10.58 10.04 19 173407 21429 79549533
Thalamus haemorrhage 10.56 10.04 16 173410 1766 79569196
Aortic bruit 10.55 10.04 7 173419 280 79570682
Blood aldosterone abnormal 10.53 10.04 4 173422 46 79570916
Scrotal oedema 10.51 10.04 15 173411 1570 79569392
Left ventricular failure 10.49 10.04 45 173381 9536 79561426
Ventricular dyskinesia 10.48 10.04 8 173418 400 79570562
Echocardiogram abnormal 10.47 10.04 18 173408 2210 79568752
Cerebellar haemorrhage 10.47 10.04 21 173405 2899 79568063
Dry eye 10.46 10.04 43 173383 36888 79534074
Haematotoxicity 10.42 10.04 11 173415 15508 79555454
Hypophosphataemia 10.41 10.04 17 173409 19896 79551066
Dyskinesia 10.40 10.04 56 173370 44717 79526245
Complications of transplanted kidney 10.39 10.04 34 173392 6332 79564630
Chills 10.39 10.04 267 173159 159967 79410995
Breast cancer female 10.38 10.04 6 173420 11455 79559507
Traumatic haemothorax 10.30 10.04 9 173417 545 79570417
Blood parathyroid hormone decreased 10.30 10.04 5 173421 10531 79560431
Photophobia 10.30 10.04 18 173408 20510 79550452
Acute left ventricular failure 10.28 10.04 16 173410 1808 79569154
Osteopenia 10.25 10.04 15 173411 18349 79552613
Supraventricular extrasystoles 10.25 10.04 36 173390 6951 79564011
Aphthous ulcer 10.23 10.04 13 173413 16876 79554086
Blood sodium decreased 10.21 10.04 114 173312 33141 79537821
Cardiac amyloidosis 10.18 10.04 16 173410 1824 79569138
Laryngitis 10.08 10.04 12 173414 16027 79554935
Hypouricaemia 10.07 10.04 8 173418 424 79570538
Metastases to lymph nodes 10.07 10.04 5 173421 10392 79560570
Affect lability 10.05 10.04 6 173420 11253 79559709

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C07AG02 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS
Alpha and beta blocking agents
ATC C07FX06 CARDIOVASCULAR SYSTEM
BETA BLOCKING AGENTS
BETA BLOCKING AGENTS, OTHER COMBINATIONS
Beta blocking agents, other combinations
FDA MoA N0000000099 Adrenergic alpha-Antagonists
FDA MoA N0000009923 Adrenergic beta1-Antagonists
FDA MoA N0000009924 Adrenergic beta2-Antagonists
FDA EPC N0000175553 alpha-Adrenergic Blocker
FDA EPC N0000175556 beta-Adrenergic Blocker
CHEBI has role CHEBI:35530 beta-adrenergic blockers
CHEBI has role CHEBI:35554 cardiovascular agent
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders
MeSH PA D018663 Adrenergic Agents
MeSH PA D058668 Adrenergic alpha-1 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D000319 Adrenergic beta-Antagonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D000975 Antioxidants
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D020011 Protective Agents
MeSH PA D014665 Vasodilator Agents

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

DiseaseRelationSNOMED_IDDOID
Hypertensive disorder indication 38341003 DOID:10763
Chronic heart failure indication 48447003
Left ventricular cardiac dysfunction indication 429589006
Atrial fibrillation off-label use 49436004 DOID:0060224
Diastolic heart failure off-label use 418304008 DOID:9775
Prevention of Post Cardio-Thoracic Surgery Atrial Fibrillation off-label use
Bronchospasm contraindication 4386001
Complete atrioventricular block contraindication 27885002
Sick sinus syndrome contraindication 36083008 DOID:13884
Anaphylaxis contraindication 39579001
Low blood pressure contraindication 45007003
Sinus bradycardia contraindication 49710005
Hepatic failure contraindication 59927004
Chronic bronchitis contraindication 63480004 DOID:6132
Diabetes mellitus contraindication 73211009 DOID:9351
Prinzmetal angina contraindication 87343002
Pulmonary emphysema contraindication 87433001
Cardiogenic shock contraindication 89138009
Second degree atrioventricular block contraindication 195042002
Asthma contraindication 195967001 DOID:2841
Pregnancy, function contraindication 289908002
Peripheral vascular disease contraindication 400047006
Intraoperative floppy iris syndrome contraindication 418801006
Acutely Decompensated HF Requiring Parenteral Inotropic Therapy contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.13 acidic
pKa2 7.88 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF CONGESTIVE HEART FAILURE
10MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF HYPERTENSION
20MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF CONGESTIVE HEART FAILURE
20MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF HYPERTENSION
40MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF CONGESTIVE HEART FAILURE
40MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF HYPERTENSION
80MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF CONGESTIVE HEART FAILURE
80MG COREG CR WOODWARD N022012 Oct. 20, 2006 RX CAPSULE, EXTENDED RELEASE ORAL 7268156 June 27, 2023 TREATMENT OF HYPERTENSION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-2 adrenergic receptor GPCR ANTAGONIST Ki 9.90 IUPHAR CHEMBL
Beta-1 adrenergic receptor GPCR ANTAGONIST Ki 9.50 IUPHAR CHEMBL
D(1A) dopamine receptor GPCR Ki 6.13 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 7.31 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 7.40 DRUG MATRIX
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.46 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 6.93 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 6.27 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 8.48 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 6.93 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 7.82 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 7.22 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 6.15 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR ANTAGONIST Ki 8.66 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 7.37 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.71 DRUG MATRIX
Beta-3 adrenergic receptor GPCR ANTAGONIST Ki 9.40 IUPHAR
Alpha-2C adrenergic receptor GPCR Ki 7.89 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 6.17 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR ANTAGONIST Ki 9.05 DRUG MATRIX
Potassium channel subfamily K member 2 Ion channel IC50 5.80 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 5.47 CHEMBL
Potassium channel subfamily K member 10 Ion channel IC50 5.12 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.12 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.03 CHEMBL
Cytochrome P450 1B1 Enzyme IC50 5.96 CHEMBL
Toll-like receptor 4 Membrane receptor IC50 4.49 CHEMBL
Ryanodine receptor 2 Ion channel INHIBITOR IC50 4.80 IUPHAR
Amyloid beta A4 protein Unclassified IC50 4.52 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 8.71 DRUG MATRIX
5-hydroxytryptamine receptor 1B GPCR Ki 6.23 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 8.11 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 8.50 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 9.09 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 6.74 DRUG MATRIX

External reference:

IDSource
4021041 VUID
N0000148505 NUI
D00255 KEGG_DRUG
610309-89-2 SECONDARY_CAS_RN
20352 RXNORM
C0054836 UMLSCUI
CHEBI:3441 CHEBI
CVD PDB_CHEM_ID
CHEMBL723 ChEMBL_ID
CHEMBL1201167 ChEMBL_ID
D000077261 MESH_DESCRIPTOR_UI
DB01136 DRUGBANK_ID
2585 PUBCHEM_CID
551 IUPHAR_LIGAND_ID
5333 INN_ID
374779-41-6 SECONDARY_CAS_RN
0K47UL67F2 UNII
119032 MMSL
22339 MMSL
265288 MMSL
4363 MMSL
d03847 MMSL
108551001 SNOMEDCT_US
386870007 SNOMEDCT_US
426471008 SNOMEDCT_US
4021041 VANDF
4026028 VANDF
004167 NDDF
011844 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3370 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3370 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3371 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3371 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3372 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3372 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3373 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3373 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3383 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3383 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3385 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3385 CAPSULE, EXTENDED RELEASE 20 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3387 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3387 CAPSULE, EXTENDED RELEASE 40 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3388 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 26 sections
COREGCR HUMAN PRESCRIPTION DRUG LABEL 1 0007-3388 CAPSULE, EXTENDED RELEASE 80 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4139 TABLET, FILM COATED 3.13 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4139 TABLET, FILM COATED 3.13 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4140 TABLET, FILM COATED 6.25 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4140 TABLET, FILM COATED 6.25 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4141 TABLET, FILM COATED 12.50 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4141 TABLET, FILM COATED 12.50 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4142 TABLET, FILM COATED 25 mg ORAL NDA 26 sections
COREG HUMAN PRESCRIPTION DRUG LABEL 1 0007-4142 TABLET, FILM COATED 25 mg ORAL NDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0093-0051 TABLET, FILM COATED 3.13 mg ORAL ANDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0093-0135 TABLET, FILM COATED 6.25 mg ORAL ANDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0093-7295 TABLET, FILM COATED 12.50 mg ORAL ANDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0093-7296 TABLET, FILM COATED 25 mg ORAL ANDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3631 TABLET, FILM COATED 3.13 mg ORAL ANDA 26 sections
Carvedilol HUMAN PRESCRIPTION DRUG LABEL 1 0378-3631 TABLET, FILM COATED 3.13 mg ORAL ANDA 26 sections