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

Stem definitionDrug idCAS RN
angiotensin II receptor antagonists, antihypertensive (non-peptidic) 2806 137862-53-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diovan
  • cardopan
  • valsartanin
  • valsartan
  • CGP 48933
  • CGP-48933
A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION. It has been approved in combination with sacubitril (under the name ENTRESTO) for the treatment of heart failure.
  • Molecular weight: 435.53
  • Formula: C24H29N5O3
  • CLOGP: 4.86
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 112.07
  • ALOGS: -4.28
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
80 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.18 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 13 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.50 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 23 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.49 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 22, 2000 PMDA Ciba-Geigy Japan
Dec. 23, 1996 FDA
Nov. 19, 2015 EMA Novartis Europharm Limited

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
Blood pressure inadequately controlled 376.61 9.70 187 111608 4193 50489136
Blood pressure increased 322.34 9.70 826 110969 132306 50361023
Pemphigus 222.97 9.70 10 111785 120156 50373173
Hyponatraemia 214.67 9.70 579 111216 95560 50397769
Macular degeneration 209.04 9.70 205 111590 14183 50479146
Off label use 201.05 9.70 472 111323 473954 50019375
Glossodynia 187.20 9.70 19 111776 115550 50377779
Systemic lupus erythematosus 184.94 9.70 42 111753 140580 50352749
Myocardial infarction 182.73 9.70 520 111275 88507 50404822
Hand deformity 174.57 9.70 12 111783 100187 50393142
Cardiac failure congestive 162.69 9.70 482 111313 83900 50409429
Hyperkalaemia 157.36 9.70 336 111459 47753 50445576
Oligohydramnios 155.53 9.70 117 111678 5633 50487696
Completed suicide 150.01 9.70 52 111743 131837 50361492
Oedema peripheral 139.61 9.70 704 111091 157257 50336072
Infusion related reaction 136.36 9.70 105 111690 169452 50323877
Cerebral infarction 132.96 9.70 199 111596 21405 50471924
Coronary artery disease 124.08 9.70 230 111565 29496 50463833
Acute kidney injury 123.20 9.70 894 110901 227164 50266165
Dizziness 119.50 9.70 1229 110566 345140 50148189
Maternal exposure during pregnancy 118.54 9.70 107 111688 159671 50333658
Alopecia 117.50 9.70 227 111568 244820 50248509
Product use issue 113.41 9.70 98 111697 149377 50343952
Contraindicated product administered 112.60 9.70 98 111697 148860 50344469
Pericarditis 110.70 9.70 20 111775 78669 50414660
Wound 108.32 9.70 49 111746 105745 50387584
Hypertensive crisis 103.00 9.70 136 111659 13018 50480311
Arthropathy 101.02 9.70 120 111675 157786 50335543
Blood creatinine increased 97.23 9.70 379 111416 75781 50417548
Therapeutic product effect decreased 95.18 9.70 96 111699 135954 50357375
Colitis microscopic 94.89 9.70 93 111702 6427 50486902
Renal failure 93.95 9.70 475 111320 106158 50387171
Glaucoma 92.99 9.70 142 111653 15544 50477785
Blood glucose increased 91.91 9.70 356 111439 70968 50422361
Diabetes mellitus 90.59 9.70 276 111519 48757 50444572
Pain 89.67 9.70 833 110962 578070 49915259
Cerebrovascular accident 89.27 9.70 430 111365 94250 50399079
Toxicity to various agents 86.06 9.70 216 111579 212283 50281046
Syncope 83.94 9.70 449 111346 102553 50390776
Treatment failure 83.41 9.70 109 111686 137528 50355801
Hypotension 82.22 9.70 838 110957 234631 50258698
Joint swelling 81.36 9.70 274 111521 245012 50248317
Duodenal ulcer perforation 80.79 9.70 5 111790 45606 50447723
Rash 77.71 9.70 607 111188 436864 50056465
Atrial fibrillation 76.52 9.70 434 111361 101311 50392018
Thyroid disorder 74.07 9.70 114 111681 12563 50480766
Drug ineffective 70.60 9.70 1332 110463 818001 49675328
Discomfort 68.61 9.70 83 111712 108297 50385032
Swelling 68.22 9.70 222 111573 200650 50292679
Cardiac failure 67.14 9.70 339 111456 75701 50417628
Blood pressure decreased 66.35 9.70 272 111523 55637 50437692
Product use in unapproved indication 65.87 9.70 96 111699 115723 50377606
Angina pectoris 63.74 9.70 163 111632 26025 50467304
Folliculitis 62.07 9.70 7 111788 39218 50454111
Blood urea increased 61.82 9.70 151 111644 23434 50469895
Drug intolerance 59.61 9.70 265 111530 218839 50274490
Bronchial haemorrhage 59.40 9.70 27 111768 493 50492836
Helicobacter infection 59.29 9.70 18 111777 49684 50443645
Muscle injury 57.79 9.70 7 111788 37104 50456225
Diabetes mellitus inadequate control 57.74 9.70 104 111691 13041 50480288
Bronchial neoplasm 57.54 9.70 25 111770 408 50492921
Synovitis 56.49 9.70 118 111677 123747 50369582
Rheumatoid factor positive 56.06 9.70 20 111775 49839 50443490
Fall 55.41 9.70 1043 110752 333889 50159440
Condition aggravated 54.14 9.70 409 111386 296649 50196680
Infection 54.08 9.70 198 111597 172756 50320573
Exposure during pregnancy 51.32 9.70 120 111675 120895 50372434
Rheumatoid arthritis 50.95 9.70 252 111543 202298 50291031
Nasal turbinate hypertrophy 50.00 9.70 26 111769 644 50492685
Hypertension 49.97 9.70 698 111097 210505 50282824
Diverticulitis 49.76 9.70 174 111621 33008 50460321
Fatigue 48.95 9.70 1191 110604 706410 49786919
Blood pressure diastolic decreased 46.73 9.70 110 111685 16671 50476658
Hyperuricaemia 45.61 9.70 54 111741 4626 50488703
Intentional product use issue 45.47 9.70 62 111733 76856 50416473
Total lung capacity increased 45.24 9.70 25 111770 702 50492627
Product prescribing error 44.47 9.70 124 111671 20837 50472492
Renal impairment 44.47 9.70 303 111492 75358 50417971
Death 44.43 9.70 482 111313 324897 50168432
Diverticulum intestinal 44.39 9.70 60 111735 5873 50487456
Bronchial disorder 44.34 9.70 29 111766 1113 50492216
Blister 43.64 9.70 76 111719 85342 50407987
Abortion spontaneous 43.28 9.70 19 111776 41753 50451576
Labile hypertension 43.14 9.70 21 111774 450 50492879
Fear of disease 42.78 9.70 26 111769 876 50492453
Haematoma 42.35 9.70 156 111639 30354 50462975
Mitral valve incompetence 41.75 9.70 108 111687 17363 50475966
Endometrial ablation 41.25 9.70 25 111770 838 50492491
Drug abuse 40.95 9.70 43 111752 59803 50433526
Asthenia 40.82 9.70 957 110838 318085 50175244
Drug hypersensitivity 40.04 9.70 358 111437 250652 50242677
Cardiovascular disorder 40.04 9.70 78 111717 10376 50482953
Transient ischaemic attack 40.03 9.70 159 111636 32051 50461278
Product dose omission issue 40.01 9.70 240 111555 183598 50309731
Obstructive airways disorder 38.69 9.70 98 111697 15554 50477775
Forced expiratory volume decreased 38.43 9.70 48 111747 4346 50488983
Neutropenia 38.40 9.70 182 111613 147783 50345546
Febrile neutropenia 38.16 9.70 101 111694 97566 50395763
Arthralgia 37.91 9.70 712 111083 437990 50055339
Blood uric acid increased 36.97 9.70 44 111751 3790 50489539
Dehydration 36.90 9.70 506 111289 151943 50341386
Tachyarrhythmia 36.16 9.70 45 111750 4060 50489269
Pulmonary hypoplasia 36.13 9.70 16 111779 274 50493055
Chest pain 36.10 9.70 570 111225 176312 50317017
Acute myocardial infarction 35.97 9.70 144 111651 29129 50464200
Rhonchi 35.63 9.70 34 111761 2273 50491056
Cardiomegaly 35.49 9.70 96 111699 15849 50477480
Chronic kidney disease 34.87 9.70 177 111618 39594 50453735
Pregnancy 34.76 9.70 11 111784 29566 50463763
Angioedema 34.67 9.70 170 111625 37506 50455823
Skin reaction 34.60 9.70 78 111717 11490 50481839
Sinusitis 34.36 9.70 228 111567 170330 50322999
Abdominal discomfort 34.10 9.70 337 111458 231304 50262025
Asthma 34.04 9.70 324 111471 89013 50404316
Lymphatic fistula 33.99 9.70 21 111774 729 50492600
Femoral hernia incarcerated 33.71 9.70 21 111774 740 50492589
Musculoskeletal stiffness 32.77 9.70 159 111636 128322 50365007
Pancreatic steatosis 32.24 9.70 22 111773 907 50492422
Brain stem stroke 32.03 9.70 14 111781 232 50493097
Blood sodium decreased 31.80 9.70 111 111684 21036 50472293
Lower respiratory tract infection 31.74 9.70 106 111689 95095 50398234
Blood pressure abnormal 31.70 9.70 80 111715 12667 50480662
Product impurity 31.46 9.70 9 111786 37 50493292
Ill-defined disorder 31.35 9.70 45 111750 54609 50438720
Arrhythmia 30.85 9.70 150 111645 32982 50460347
Angina unstable 30.66 9.70 54 111741 6652 50486677
Anaemia 30.65 9.70 752 111043 251704 50241625
Blood lactate dehydrogenase increased 30.56 9.70 104 111691 19458 50473871
Vascular resistance pulmonary decreased 30.17 9.70 10 111785 73 50493256
Arterial haemorrhage 30.03 9.70 26 111769 1531 50491798
Psoriatic arthropathy 29.77 9.70 36 111759 46996 50446333
Hip arthroplasty 29.74 9.70 15 111780 30414 50462915
Nervousness 29.29 9.70 130 111665 27521 50465808
Adverse drug reaction 29.25 9.70 48 111747 55174 50438155
COVID-19 29.23 9.70 36 111759 46626 50446703
Blood pressure systolic increased 29.16 9.70 155 111640 35294 50458035
Venous pressure jugular increased 29.10 9.70 17 111778 532 50492797
Recalled product administered 29.06 9.70 16 111779 446 50492883
Intentional overdose 28.94 9.70 59 111736 62445 50430884
Migraine 28.53 9.70 79 111716 75201 50418128
Hypochromic anaemia 28.12 9.70 26 111769 1670 50491659
Hepatic enzyme increased 27.98 9.70 183 111612 137197 50356132
Irritable bowel syndrome 27.91 9.70 44 111751 51397 50441932
Injection site reaction 27.91 9.70 42 111753 49990 50443339
Tricuspid valve incompetence 27.54 9.70 76 111719 12694 50480635
Injection site pain 27.39 9.70 139 111656 110885 50382444
Bradycardia 27.25 9.70 239 111556 64187 50429142
Antinuclear antibody negative 27.18 9.70 12 111783 204 50493125
Altered state of consciousness 27.10 9.70 108 111687 21802 50471527
Breast cancer 26.54 9.70 174 111621 42716 50450613
Gastrointestinal disorder 26.40 9.70 113 111682 94343 50398986
Hypokalaemia 26.38 9.70 304 111491 87688 50405641
Wound infection pseudomonas 26.07 9.70 22 111773 1251 50492078
Disease progression 26.00 9.70 116 111679 95750 50397579
Product contamination chemical 25.59 9.70 5 111790 0 50493329
Blood potassium increased 25.46 9.70 87 111708 16311 50477018
Thrombotic stroke 25.46 9.70 15 111780 477 50492852
Left-to-right cardiac shunt 25.42 9.70 10 111785 125 50493204
Hospitalisation 25.23 9.70 72 111723 67865 50425464
Impaired healing 25.16 9.70 75 111720 69711 50423618
Lymphocyte stimulation test positive 25.07 9.70 15 111780 491 50492838
Blood creatine phosphokinase increased 25.00 9.70 120 111675 26247 50467082
Product odour abnormal 24.96 9.70 20 111775 1057 50492272
Coombs positive haemolytic anaemia 24.85 9.70 13 111782 326 50493003
Hypertensive cardiomyopathy 24.80 9.70 11 111784 189 50493140
Bundle branch block left 24.49 9.70 47 111748 6183 50487146
Seroma 24.47 9.70 25 111770 1816 50491513
Stomatitis 24.36 9.70 128 111667 101216 50392113
Gastric ulcer haemorrhage 24.36 9.70 39 111756 4445 50488884
Drug resistance 24.29 9.70 6 111789 18983 50474346
Nasopharyngitis 24.24 9.70 291 111504 192636 50300693
Atrioventricular block complete 24.07 9.70 51 111744 7204 50486125
Hiatus hernia 23.97 9.70 92 111703 18252 50475077
Peripheral swelling 23.87 9.70 316 111479 205620 50287709
Sinus node dysfunction 23.71 9.70 36 111759 3919 50489410
Aortic valve stenosis 23.66 9.70 31 111764 2944 50490385
Hemiplegia 23.47 9.70 51 111744 7330 50485999
Rhabdomyolysis 23.34 9.70 157 111638 38870 50454459
Gamma-glutamyltransferase increased 23.33 9.70 128 111667 29495 50463834
Renal cyst 23.17 9.70 56 111739 8631 50484698
Dyschezia 23.08 9.70 24 111771 1780 50491549
Metastatic bronchial carcinoma 23.06 9.70 9 111786 110 50493219
Liver function test increased 23.03 9.70 14 111781 25592 50467737
Spinal osteoarthritis 22.97 9.70 76 111719 14016 50479313
Forced vital capacity decreased 22.93 9.70 18 111777 923 50492406
Coronary artery stenosis 22.88 9.70 37 111758 4252 50489077
Renal artery stenosis 22.76 9.70 23 111772 1649 50491680
Basal ganglion degeneration 22.60 9.70 13 111782 395 50492934
Concomitant disease progression 22.29 9.70 25 111770 2020 50491309
Gastrointestinal haemorrhage 22.28 9.70 254 111541 73067 50420262
Hypoglycaemia 22.26 9.70 198 111597 53383 50439946
Ventricular extrasystoles 22.10 9.70 62 111733 10454 50482875
Myocardial ischaemia 22.03 9.70 66 111729 11547 50481782
Injection site erythema 21.97 9.70 88 111707 74848 50418481
Coronary arterial stent insertion 21.81 9.70 28 111767 2606 50490723
Acral lentiginous melanoma 21.66 9.70 5 111790 6 50493323
Dementia Alzheimer's type 21.44 9.70 18 111777 1016 50492313
Tissue infiltration 21.37 9.70 14 111781 539 50492790
Live birth 21.35 9.70 5 111790 16403 50476926
Frustration tolerance decreased 21.32 9.70 42 111753 5632 50487697
Multiple sclerosis relapse 21.24 9.70 39 111756 42925 50450404
Hypochloraemia 21.23 9.70 22 111773 1625 50491704
Gastritis haemorrhagic 21.21 9.70 20 111775 1317 50492012
Complex regional pain syndrome 21.10 9.70 24 111771 1969 50491360
Ophthalmic vein thrombosis 20.76 9.70 9 111786 146 50493183
Neonatal seizure 20.70 9.70 12 111783 370 50492959
Pneumothorax traumatic 20.33 9.70 9 111786 154 50493175
Hepatic cyst 20.31 9.70 36 111759 4457 50488872
Herpes simplex reactivation 20.27 9.70 12 111783 385 50492944
Faecaloma 20.23 9.70 47 111748 7061 50486268
Impaired work ability 20.22 9.70 3 111792 13637 50479692
Lung diffusion test decreased 20.14 9.70 14 111781 595 50492734
Loss of consciousness 20.04 9.70 333 111462 104020 50389309
Colon cancer 20.02 9.70 53 111742 8638 50484691
Retrograde amnesia 19.89 9.70 12 111783 399 50492930
Ear infection 19.70 9.70 17 111778 25953 50467376
C-reactive protein increased 19.63 9.70 229 111566 66245 50427084
Coronary artery occlusion 19.62 9.70 48 111747 7455 50485874
Therapy interrupted 19.59 9.70 10 111785 20142 50473187
Monocyte count abnormal 19.52 9.70 9 111786 170 50493159
Psychotic disorder 19.51 9.70 12 111783 21800 50471529
Cough 19.47 9.70 683 111112 240581 50252748
Diabetic nephropathy 19.30 9.70 19 111776 1320 50492009
Multiple injuries 19.05 9.70 21 111774 1665 50491664
Suicidal ideation 18.91 9.70 61 111734 55324 50438005
Nephrogenic anaemia 18.85 9.70 21 111774 1684 50491645
Withdrawal hypertension 18.67 9.70 8 111787 126 50493203
Hypertensive heart disease 18.59 9.70 24 111771 2246 50491083
Ischaemic stroke 18.44 9.70 77 111718 15871 50477458
Rectal prolapse 18.42 9.70 21 111774 1728 50491601
Myalgia 18.41 9.70 381 111414 123938 50369391
Lacunar infarction 18.37 9.70 28 111767 3059 50490270
Peak expiratory flow rate decreased 18.24 9.70 13 111782 575 50492754
Neutrophil function disorder 18.22 9.70 5 111790 17 50493312
Cardiac failure chronic 18.01 9.70 30 111765 3533 50489796
No adverse event 17.95 9.70 29 111766 33549 50459780
Intestinal polyp 17.77 9.70 17 111778 1140 50492189
Feeling abnormal 17.74 9.70 382 111413 125110 50368219
Device dislocation 17.73 9.70 13 111782 21533 50471796
Iron deficiency anaemia 17.72 9.70 79 111716 16755 50476574
Cardiac failure acute 17.69 9.70 49 111746 8201 50485128
Urine albumin/creatinine ratio increased 17.68 9.70 9 111786 213 50493116
Monoplegia 17.64 9.70 26 111769 2757 50490572
Cardiac pacemaker insertion 17.46 9.70 30 111765 3623 50489706
Therapeutic drug monitoring analysis incorrectly performed 17.45 9.70 8 111787 149 50493180
Stenosis 17.45 9.70 17 111778 1166 50492163
Gastric cancer 17.43 9.70 27 111768 2991 50490338
Interstitial lung disease 17.43 9.70 187 111608 52989 50440340
Renin decreased 17.35 9.70 7 111788 94 50493235
Inguinal hernia 17.15 9.70 20 111775 1686 50491643
Glycosylated haemoglobin increased 17.11 9.70 57 111738 10549 50482780
Uterine enlargement 17.01 9.70 16 111779 1050 50492279
Aortic arteriosclerosis 16.90 9.70 37 111758 5345 50487984
Hypertensive emergency 16.85 9.70 19 111776 1544 50491785
Post-anoxic myoclonus 16.85 9.70 5 111790 24 50493305
Kyphosis 16.85 9.70 23 111772 2272 50491057
Transitional cell cancer of the renal pelvis and ureter 16.82 9.70 4 111791 6 50493323
Hyponatraemic syndrome 16.82 9.70 12 111783 532 50492797
Haemarthrosis 16.77 9.70 26 111769 2882 50490447
Arteriosclerosis 16.66 9.70 51 111744 9026 50484303
Infarction 16.60 9.70 23 111772 2305 50491024
Loss of personal independence in daily activities 16.54 9.70 89 111706 69961 50423368
Cardiac disorder 16.42 9.70 156 111639 42823 50450506
Intentional product misuse 16.29 9.70 51 111744 46683 50446646
Dyspnoea 16.22 9.70 1412 110383 546196 49947133
Gout 16.21 9.70 59 111736 11411 50481918
Ventricular hypertrophy 16.16 9.70 27 111768 3188 50490141
Anaphylactic reaction 16.14 9.70 63 111732 53992 50439337
Anaesthesia 16.11 9.70 10 111785 350 50492979
Drug ineffective for unapproved indication 16.06 9.70 14 111781 21267 50472062
Melaena 16.02 9.70 108 111687 26756 50466573
Breast neoplasm 15.96 9.70 17 111778 1296 50492033
Lipoedema 15.93 9.70 9 111786 264 50493065
Fear 15.86 9.70 69 111726 14480 50478849
Bronchitis 15.67 9.70 320 111475 103839 50389490
Bone marrow failure 15.59 9.70 23 111772 27601 50465728
Malaise 15.43 9.70 897 110898 334635 50158694
Carotid artery disease 15.40 9.70 18 111777 1521 50491808
Body height decreased 15.38 9.70 49 111746 8859 50484470
Coronary artery bypass 15.38 9.70 22 111773 2271 50491058
Intentional self-injury 15.37 9.70 17 111778 23095 50470234
Diapedesis 15.35 9.70 3 111792 0 50493329
Hypersensitivity 15.34 9.70 360 111435 214801 50278528
Angiotensin converting enzyme inhibitor foetopathy 15.27 9.70 5 111790 35 50493294
Multiple drug therapy 15.12 9.70 20 111775 1917 50491412
Palpitations 15.11 9.70 293 111502 94213 50399116
Nodal rhythm 14.95 9.70 18 111777 1569 50491760
Gastrointestinal stromal tumour 14.91 9.70 14 111781 917 50492412
Malignant neoplasm progression 14.76 9.70 89 111706 68035 50425294
Brain contusion 14.59 9.70 11 111784 531 50492798
Cranial sutures widening 14.48 9.70 4 111791 14 50493315
Incorrect route of product administration 14.43 9.70 12 111783 18654 50474675
Gingival ulceration 14.41 9.70 13 111782 809 50492520
Mydriasis 14.31 9.70 3 111792 10624 50482705
General physical health deterioration 14.30 9.70 414 111381 142020 50351309
Pyometra 14.27 9.70 6 111789 90 50493239
Blood pressure fluctuation 14.17 9.70 131 111664 35692 50457637
Pyrexia 14.16 9.70 691 111104 379512 50113817
Renal cell carcinoma 14.12 9.70 25 111770 3092 50490237
Product contamination 14.10 9.70 11 111784 559 50492770
Hyperlipidaemia 14.06 9.70 76 111719 17414 50475915
Device issue 14.06 9.70 14 111781 19958 50473371
Subarachnoid haemorrhage 14.04 9.70 54 111741 10722 50482607
Status epilepticus 14.04 9.70 6 111789 13400 50479929
Cataract 13.98 9.70 163 111632 47137 50446192
Coronary angioplasty 13.97 9.70 6 111789 95 50493234
Antiphospholipid syndrome 13.96 9.70 17 111778 1500 50491829
Blood aldosterone increased 13.89 9.70 7 111788 162 50493167
Visual acuity reduced 13.88 9.70 84 111711 20055 50473274
Left ventricular hypertrophy 13.75 9.70 32 111763 4813 50488516
Granuloma 13.69 9.70 32 111763 4826 50488503
Hepatic function abnormal 13.69 9.70 121 111674 32560 50460769
Bezold-Jarisch reflex 13.69 9.70 4 111791 18 50493311
Mobility decreased 13.62 9.70 112 111683 79836 50413493
Product taste abnormal 13.59 9.70 18 111777 1727 50491602
Chronic obstructive pulmonary disease 13.58 9.70 179 111616 53256 50440073
Injection site swelling 13.58 9.70 47 111748 41726 50451603
Gastroenteritis 13.53 9.70 93 111702 23188 50470141
Haematochezia 13.42 9.70 141 111654 39741 50453588
Mouth ulceration 13.36 9.70 26 111769 27998 50465331
Carpal tunnel syndrome 13.30 9.70 73 111722 16820 50476509
Fabry's disease 13.28 9.70 3 111792 3 50493326
Ulcer 13.28 9.70 15 111780 20185 50473144
Renal neoplasm 13.12 9.70 14 111781 1070 50492259
Diabetic retinopathy 13.09 9.70 20 111775 2190 50491139
Merycism 13.08 9.70 7 111788 184 50493145
Eructation 13.06 9.70 40 111755 7081 50486248
Arrhythmogenic right ventricular dysplasia 13.03 9.70 4 111791 22 50493307
Asthmatic crisis 13.00 9.70 17 111778 1611 50491718
Urticaria chronic 12.98 9.70 10 111785 499 50492830
Prosthesis implantation 12.97 9.70 5 111790 59 50493270
Brain natriuretic peptide increased 12.96 9.70 30 111765 4497 50488832
Renal cancer 12.85 9.70 26 111769 3554 50489775
Myelosuppression 12.71 9.70 7 111788 13510 50479819
Therapeutic product effect incomplete 12.67 9.70 135 111660 91380 50401949
Skin texture abnormal 12.67 9.70 9 111786 396 50492933
Respiration abnormal 12.67 9.70 32 111763 5070 50488259
Pulmonary thrombosis 12.59 9.70 41 111754 7500 50485829
Low density lipoprotein increased 12.57 9.70 34 111761 5612 50487717
Swollen tongue 12.51 9.70 107 111688 28523 50464806
Deafness 12.49 9.70 68 111727 15623 50477706
Sedation 12.45 9.70 31 111764 30579 50462750
Sinus arrest 12.44 9.70 17 111778 1681 50491648
Ischaemic cardiomyopathy 12.41 9.70 20 111775 2292 50491037
Stress cardiomyopathy 12.38 9.70 42 111753 7845 50485484
Neutropenic sepsis 12.35 9.70 8 111787 14139 50479190
Fixed eruption 12.27 9.70 12 111783 827 50492502
Metastases to bone 12.23 9.70 13 111782 17982 50475347
Bradycardia neonatal 12.18 9.70 12 111783 834 50492495
Cytomegalovirus infection 12.18 9.70 13 111782 17949 50475380
Cardiac myxoma 12.16 9.70 7 111788 213 50493116
Postural tremor 12.13 9.70 7 111788 214 50493115
Osteoarthritis 12.11 9.70 216 111579 68390 50424939
Upper-airway cough syndrome 12.10 9.70 44 111751 8506 50484823
Lymphostasis 12.07 9.70 3 111792 6 50493323
Therapeutic drug monitoring analysis not performed 12.06 9.70 11 111784 694 50492635
Marasmus 12.00 9.70 9 111786 431 50492898
Groin pain 11.95 9.70 45 111750 8846 50484483
Occult blood positive 11.93 9.70 24 111771 3267 50490062
Blood sodium increased 11.84 9.70 20 111775 2382 50490947
Ligament injury 11.82 9.70 13 111782 1028 50492301
Movement disorder 11.81 9.70 73 111722 17559 50475770
Hypertensive encephalopathy 11.77 9.70 10 111785 574 50492755
Gastritis 11.76 9.70 118 111677 32865 50460464
Heat illness 11.67 9.70 6 111789 145 50493184
Hypercholesterolaemia 11.63 9.70 54 111741 11649 50481680
Inflammatory marker increased 11.63 9.70 33 111762 5601 50487728
Microalbuminuria 11.57 9.70 8 111787 337 50492992
Multi-organ disorder 11.46 9.70 14 111781 1239 50492090
Duodenal ulcer 11.46 9.70 37 111758 6738 50486591
Hyperglycaemia 11.46 9.70 127 111668 36278 50457051
Therapy non-responder 11.40 9.70 66 111729 50956 50442373
Cutaneous lymphoma 11.38 9.70 6 111789 153 50493176
Cardiogenic shock 11.35 9.70 66 111729 15533 50477796
Affective disorder 11.34 9.70 31 111764 5150 50488179
Coronary artery restenosis 11.32 9.70 8 111787 349 50492980
Gastrointestinal cancer metastatic 11.27 9.70 5 111790 86 50493243
Cerebral haemorrhage 11.25 9.70 100 111695 26952 50466377
Product substitution issue 11.24 9.70 61 111734 13996 50479333
Ear pain 11.23 9.70 29 111766 28254 50465075
Perihepatic discomfort 11.21 9.70 3 111792 9 50493320
Knee arthroplasty 11.21 9.70 41 111754 35805 50457524
Seizure 11.18 9.70 188 111607 117686 50375643
Dyspnoea exertional 11.16 9.70 167 111628 51066 50442263
Erysipelas 11.10 9.70 36 111759 6572 50486757
Disease recurrence 11.06 9.70 17 111778 20064 50473265
Carotid artery stenosis 11.05 9.70 29 111766 4702 50488627
Pollakiuria 10.88 9.70 90 111705 23761 50469568
Therapy cessation 10.85 9.70 26 111769 25985 50467344
Pulmonary oedema 10.85 9.70 160 111635 48778 50444551
Hepatic cancer 10.84 9.70 23 111772 3252 50490077
Cell marker increased 10.76 9.70 7 111788 266 50493063
Infusion site pain 10.76 9.70 7 111788 12339 50480990
Cerebral arteriosclerosis 10.74 9.70 7 111788 267 50493062
Catheterisation cardiac 10.73 9.70 26 111769 4014 50489315
Skin ulcer 10.65 9.70 41 111754 35277 50458052
Atrioventricular block 10.61 9.70 35 111760 6443 50486886
Eye haemorrhage 10.59 9.70 38 111757 7297 50486032
Renal disorder 10.59 9.70 100 111695 27405 50465924
Dementia 10.57 9.70 66 111729 15931 50477398
Anuria 10.53 9.70 51 111744 11193 50482136
Hot flush 10.49 9.70 56 111739 44113 50449216
Overdose 10.48 9.70 156 111639 99571 50393758
Ankle fracture 10.47 9.70 65 111730 15657 50477672
Adverse reaction 10.44 9.70 3 111792 8583 50484746
Lymphocyte count decreased 10.42 9.70 27 111768 26280 50467049
Polyuria 10.38 9.70 37 111758 7084 50486245
Parkinson's disease 10.37 9.70 13 111782 1182 50492147
Duodenal polyp 10.36 9.70 5 111790 105 50493224
Oedema 10.35 9.70 215 111580 69966 50423363
Mood swings 10.32 9.70 12 111783 15942 50477387
Cutaneous listeriosis 10.32 9.70 4 111791 48 50493281
Neuropathy peripheral 10.29 9.70 151 111644 96606 50396723
Panniculitis 10.28 9.70 3 111792 8500 50484829
Blood chloride decreased 10.18 9.70 29 111766 4932 50488397
Acute phosphate nephropathy 10.18 9.70 3 111792 14 50493315
Mesothelioma malignant 10.17 9.70 4 111791 50 50493279
Clostridium difficile infection 10.16 9.70 26 111769 25413 50467916
Haemorrhage subcutaneous 10.16 9.70 20 111775 2681 50490648
Large intestinal ulcer haemorrhage 10.15 9.70 5 111790 110 50493219
Anxiety disorder 10.14 9.70 24 111771 3649 50489680
Breath sounds abnormal 10.11 9.70 39 111756 7753 50485576
Device related infection 10.09 9.70 19 111776 20716 50472613
Renal artery stent placement 10.07 9.70 5 111790 112 50493217
Liver disorder 10.01 9.70 126 111669 37096 50456233
Eczema 10.00 9.70 85 111710 22617 50470712
Meniere's disease 9.93 9.70 6 111789 200 50493129
Dysaesthesia 9.88 9.70 24 111771 3711 50489618
Caesarean section 9.86 9.70 12 111783 15627 50477702
Brain stem haemorrhage 9.86 9.70 10 111785 720 50492609
Carcinogenicity 9.85 9.70 3 111792 16 50493313
Hydrothorax 9.85 9.70 10 111785 721 50492608
Diverticulum 9.84 9.70 48 111747 10566 50482763
Inappropriate antidiuretic hormone secretion 9.82 9.70 56 111739 13087 50480242
Haematuria 9.80 9.70 93 111702 25520 50467809
Gait disturbance 9.79 9.70 415 111380 149590 50343739
Septic shock 9.78 9.70 80 111715 57095 50436234
Varicose vein ruptured 9.76 9.70 4 111791 56 50493273
Pigmentation disorder 9.76 9.70 24 111771 3740 50489589
Invasive ductal breast carcinoma 9.71 9.70 32 111763 5889 50487440

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
Off label use 217.69 10.35 293 78876 300507 29194851
Blood pressure inadequately controlled 209.54 10.35 110 79059 2276 29493082
Drug abuse 179.82 10.35 8 79161 79875 29415483
Blood pressure increased 171.84 10.35 510 78659 73293 29422065
Death 129.52 10.35 476 78693 341608 29153750
Blood creatinine increased 127.71 10.35 508 78661 84594 29410764
Cerebral infarction 115.76 10.35 224 78945 24451 29470907
Toxicity to various agents 111.77 10.35 183 78986 173478 29321880
Drug ineffective 97.81 10.35 572 78597 362598 29132760
Hyperkalaemia 97.34 10.35 373 78796 61019 29434339
Completed suicide 95.46 10.35 62 79107 90184 29405174
Myocardial infarction 87.81 10.35 550 78619 109746 29385612
Blood urea increased 87.13 10.35 216 78953 27896 29467462
Cardiac failure 72.44 10.35 410 78759 78877 29416481
Febrile neutropenia 71.45 10.35 119 79050 112121 29383237
Hypertensive crisis 69.39 10.35 95 79074 7753 29487605
Renal failure 66.23 10.35 543 78626 118056 29377302
Neutropenia 64.05 10.35 163 79006 131548 29363810
Dizziness 60.92 10.35 775 78394 188909 29306449
Product use in unapproved indication 59.17 10.35 88 79081 86787 29408571
Cerebrovascular accident 58.35 10.35 379 78790 76532 29418826
Fear of disease 55.60 10.35 22 79147 227 29495131
Syncope 52.85 10.35 386 78783 80985 29414373
Cardiac failure congestive 52.47 10.35 368 78801 76213 29419145
Angina pectoris 52.40 10.35 179 78990 27671 29467687
Product dose omission issue 48.61 10.35 117 79052 96266 29399092
Angioedema 48.17 10.35 191 78978 31724 29463634
Acute myocardial infarction 46.55 10.35 254 78915 48184 29447174
Treatment failure 45.38 10.35 21 79148 36918 29458440
Renal impairment 44.61 10.35 371 78798 80962 29414396
Interstitial lung disease 43.49 10.35 284 78885 57434 29437924
Sepsis 40.75 10.35 220 78949 142462 29352896
Hospitalisation 40.49 10.35 38 79131 45950 29449408
Blood pressure diastolic decreased 39.54 10.35 69 79100 6953 29488405
Blood lactic acid 39.33 10.35 19 79150 327 29495031
Blood creatine phosphokinase increased 38.29 10.35 212 78957 40432 29454926
Eosinophilic colitis 38.14 10.35 16 79153 194 29495164
Coronary artery disease 37.38 10.35 224 78945 43966 29451392
Cardiac failure chronic 37.01 10.35 64 79105 6403 29488955
Oxygen saturation increased 36.47 10.35 17 79152 269 29495089
Blood pressure decreased 35.62 10.35 226 78943 45251 29450107
Lymphocyte stimulation test positive 34.04 10.35 22 79147 679 29494679
Bundle branch block left 33.90 10.35 55 79114 5222 29490136
Product impurity 33.67 10.35 10 79159 38 29495320
Aortic aneurysm 33.58 10.35 60 79109 6160 29489198
Product use issue 33.20 10.35 54 79115 51390 29443968
Intentional product use issue 33.05 10.35 39 79130 42459 29452899
Gamma-glutamyltransferase increased 32.60 10.35 150 79019 26587 29468771
Arrhythmia 31.98 10.35 167 79002 31146 29464212
Blood glucose increased 31.76 10.35 268 78901 58716 29436642
Brain natriuretic peptide abnormal 31.60 10.35 16 79153 306 29495052
Fractured coccyx 31.49 10.35 13 79156 151 29495207
Sinus arrest 31.26 10.35 28 79141 1419 29493939
Glomerular filtration rate decreased 31.20 10.35 83 79086 11183 29484175
Hemiplegia 31.07 10.35 60 79109 6534 29488824
Arteriosclerosis 30.92 10.35 78 79091 10178 29485180
Drug dependence 30.70 10.35 9 79160 20972 29474386
Infusion related reaction 30.30 10.35 44 79125 43842 29451516
Disease progression 30.13 10.35 115 79054 81801 29413557
Mitral valve incompetence 30.05 10.35 91 79078 13202 29482156
Atrial fibrillation 29.83 10.35 422 78747 105224 29390134
Diabetes mellitus 29.39 10.35 195 78974 39636 29455722
N-terminal prohormone brain natriuretic peptide abnormal 29.07 10.35 13 79156 186 29495172
Cerebral haemorrhage 28.98 10.35 163 79006 31263 29464095
Lymphocyte count abnormal 28.79 10.35 19 79150 608 29494750
Hyponatraemia 28.70 10.35 292 78877 67341 29428017
Pulmonary arterial pressure abnormal 28.63 10.35 13 79156 193 29495165
Hypotension 28.49 10.35 701 78468 193653 29301705
Blood potassium increased 28.29 10.35 95 79074 14556 29480802
Pancreatic neoplasm 28.15 10.35 21 79148 820 29494538
Acute kidney injury 27.85 10.35 917 78252 264350 29231008
Left ventricular dilatation 27.64 10.35 19 79150 651 29494707
Clostridium difficile infection 27.44 10.35 5 79164 16136 29479222
Conduction disorder 27.34 10.35 29 79140 1811 29493547
Cell marker increased 27.33 10.35 16 79153 412 29494946
Blood triglycerides increased 27.28 10.35 86 79083 12748 29482610
Aggression 27.22 10.35 33 79136 35508 29459850
Shock 26.78 10.35 121 79048 21283 29474075
Pulmonary valve stenosis congenital 26.62 10.35 11 79158 128 29495230
Oedema peripheral 26.62 10.35 407 78762 103150 29392208
Blood uric acid increased 26.59 10.35 52 79117 5716 29489642
Thrombocytopenia 26.06 10.35 233 78936 134590 29360768
Painful respiration 25.93 10.35 23 79146 1151 29494207
Blood cholesterol increased 25.71 10.35 96 79073 15499 29479859
Gastric cancer 25.56 10.35 46 79123 4748 29490610
Blood thyroid stimulating hormone abnormal 25.47 10.35 13 79156 253 29495105
Suicidal ideation 24.77 10.35 34 79135 34682 29460676
Intentional overdose 24.34 10.35 41 79128 38487 29456871
Lung diffusion disorder 24.12 10.35 9 79160 78 29495280
Pneumonia 24.09 10.35 663 78506 319509 29175849
Cerebellar ischaemia 24.08 10.35 10 79159 118 29495240
Colon cancer 23.89 10.35 59 79110 7596 29487762
Breast discomfort 23.70 10.35 6 79163 10 29495348
Electrocardiogram QRS complex abnormal 23.68 10.35 13 79156 295 29495063
Urine albumin/creatinine ratio increased 23.29 10.35 10 79159 129 29495229
Walking aid user 23.24 10.35 24 79145 1453 29493905
Orthostatic intolerance 23.21 10.35 17 79152 645 29494713
Intentional self-injury 23.14 10.35 3 79166 12458 29482900
Microalbuminuria 23.07 10.35 17 79152 651 29494707
Agitation 23.01 10.35 66 79103 51238 29444120
Sedation 22.80 10.35 9 79160 17396 29477962
Bradycardia 22.64 10.35 272 78897 65357 29430001
Mucosal inflammation 22.48 10.35 31 79138 31564 29463794
Pemphigoid 22.17 10.35 57 79112 7524 29487834
COVID-19 22.13 10.35 39 79130 35975 29459383
Chronic kidney disease 22.06 10.35 170 78999 36246 29459112
Melaena 22.02 10.35 151 79018 31025 29464333
Atrioventricular block 21.99 10.35 54 79115 6928 29488430
Type 2 diabetes mellitus 21.89 10.35 83 79086 13498 29481860
Myocardial ischaemia 21.87 10.35 93 79076 15935 29479423
Chronic pigmented purpura 21.84 10.35 9 79160 104 29495254
Idiopathic pulmonary fibrosis 21.70 10.35 34 79135 3134 29492224
Goitre 21.58 10.35 23 79146 1444 29493914
Foetal exposure during pregnancy 21.43 10.35 36 79133 33831 29461527
Hyperglycaemia 21.29 10.35 161 79008 34126 29461232
Pancytopenia 21.17 10.35 133 79036 83035 29412323
Subacute hepatic failure 20.99 10.35 8 79161 74 29495284
Condition aggravated 20.94 10.35 271 78898 146024 29349334
Renal artery stenosis 20.85 10.35 26 79143 1935 29493423
Gastritis erosive 20.60 10.35 45 79124 5348 29490010
Aortic valve incompetence 20.50 10.35 43 79126 4970 29490388
Adrenal adenoma 20.46 10.35 12 79157 310 29495048
Hyperuricaemia 20.35 10.35 52 79117 6837 29488521
Chest injury 20.26 10.35 22 79147 1411 29493947
Blood lactate dehydrogenase increased 19.99 10.35 103 79066 19106 29476252
Drug resistance 19.91 10.35 17 79152 21523 29473835
Pulmonary hypoplasia 19.78 10.35 13 79156 413 29494945
Lateropulsion 19.70 10.35 4 79165 0 29495358
Ventricular hypokinesia 19.66 10.35 40 79129 4525 29490833
Vomiting 19.63 10.35 426 78743 211834 29283524
Deep vein thrombosis 19.57 10.35 83 79086 57316 29438042
Prostate cancer 19.45 10.35 126 79043 25401 29469957
Sprue-like enteropathy 19.40 10.35 13 79156 427 29494931
Gouty arthritis 19.34 10.35 18 79151 959 29494399
Synovitis 19.33 10.35 3 79166 10887 29484471
Patent ductus arteriosus 19.26 10.35 32 79137 3099 29492259
Rhythm idioventricular 19.23 10.35 11 79158 271 29495087
Dyslipidaemia 19.22 10.35 47 79122 6014 29489344
Drug ineffective for unapproved indication 19.21 10.35 7 79162 14207 29481151
Status epilepticus 19.10 10.35 3 79166 10791 29484567
Drug intolerance 19.04 10.35 66 79103 48313 29447045
Coronary arterial stent insertion 19.03 10.35 36 79133 3861 29491497
Cardiac failure acute 19.00 10.35 61 79108 9131 29486227
Pyonephrosis 18.73 10.35 7 79162 61 29495297
Coronary artery restenosis 18.65 10.35 18 79151 1004 29494354
Hypoparathyroidism 18.52 10.35 13 79156 461 29494897
Ventricular extrasystoles 18.16 10.35 66 79103 10516 29484842
Angioplasty 17.98 10.35 17 79152 924 29494434
Vertigo 17.96 10.35 110 79059 21751 29473607
Malignant neoplasm progression 17.83 10.35 120 79049 73739 29421619
Transient ischaemic attack 17.82 10.35 115 79054 23155 29472203
Coronary artery stenosis 17.81 10.35 57 79112 8516 29486842
Psychotic disorder 17.70 10.35 17 79152 20337 29475021
Lacunar infarction 17.59 10.35 29 79140 2790 29492568
Oscillopsia 17.44 10.35 6 79163 40 29495318
Osteoarthritis 17.42 10.35 95 79074 18008 29477350
Pyrexia 17.37 10.35 613 78556 287009 29208349
Neuropathy peripheral 17.35 10.35 115 79054 70912 29424446
Hypertrophic osteoarthropathy 17.29 10.35 7 79162 77 29495281
Brain stem infarction 17.13 10.35 18 79151 1112 29494246
Bundle branch block right 17.12 10.35 48 79121 6669 29488689
Quality of life decreased 17.01 10.35 31 79138 3231 29492127
Blood pressure abnormal 16.79 10.35 48 79121 6742 29488616
Intentional product misuse 16.73 10.35 43 79126 34618 29460740
Urticaria chronic 16.39 10.35 7 79162 89 29495269
Merycism 16.29 10.35 6 79163 50 29495308
Retinopathy 16.28 10.35 22 79147 1773 29493585
Nephrogenic anaemia 16.02 10.35 23 79146 1962 29493396
Liver function test increased 15.81 10.35 6 79163 11879 29483479
Chest pain 15.81 10.35 402 78767 111571 29383787
Leukopenia 15.79 10.35 85 79084 55118 29440240
Periarthritis calcarea 15.79 10.35 6 79163 55 29495303
Cardiac vein perforation 15.74 10.35 5 79164 25 29495333
Peripheral arterial occlusive disease 15.71 10.35 39 79130 5037 29490321
Surfactant protein increased 15.68 10.35 4 79165 7 29495351
Articular calcification 15.51 10.35 6 79163 58 29495300
Neurotoxicity 15.48 10.35 10 79159 14603 29480755
Bile duct cancer 15.47 10.35 13 79156 604 29494754
Pericardial haemorrhage 15.47 10.35 28 79141 2903 29492455
Disease recurrence 15.40 10.35 12 79157 15902 29479456
Diabetic nephropathy 15.35 10.35 22 79147 1873 29493485
Blood pressure systolic increased 15.28 10.35 87 79082 16758 29478600
Erectile dysfunction 15.03 10.35 91 79078 17918 29477440
Seizure 15.03 10.35 168 79001 92955 29402403
Myelosuppression 14.94 10.35 7 79162 12220 29483138
Septic shock 14.92 10.35 102 79067 62458 29432900
Cardiac pacemaker insertion 14.80 10.35 25 79144 2454 29492904
Angina unstable 14.79 10.35 63 79106 10802 29484556
Blepharochalasis 14.78 10.35 3 79166 0 29495358
Renal dysplasia 14.75 10.35 8 79161 177 29495181
Acquired C1 inhibitor deficiency 14.72 10.35 4 79165 10 29495348
Loss of consciousness 14.62 10.35 279 78890 73777 29421581
Dyspnoea 14.56 10.35 1038 78131 325694 29169664
Atrial thrombosis 14.51 10.35 22 79147 1971 29493387
Myoglobin blood increased 14.49 10.35 22 79147 1973 29493385
Fear 14.43 10.35 57 79112 9447 29485911
Generalised tonic-clonic seizure 14.41 10.35 18 79151 19121 29476237
Cytomegalovirus infection 14.39 10.35 25 79144 23190 29472168
Abnormal behaviour 14.25 10.35 25 79144 23102 29472256
Ischaemic stroke 14.15 10.35 82 79087 15895 29479463
Nausea 14.09 10.35 632 78537 288623 29206735
Immature granulocyte count increased 14.00 10.35 6 79163 77 29495281
Rheumatoid arthritis 13.95 10.35 42 79127 32110 29463248
Product substitution issue 13.92 10.35 55 79114 9117 29486241
Chest discomfort 13.90 10.35 186 78983 45797 29449561
Glycosylated haemoglobin increased 13.88 10.35 56 79113 9370 29485988
Abdominal tenderness 13.81 10.35 30 79139 3552 29491806
Bursitis 13.79 10.35 36 79133 4796 29490562
Serotonin syndrome 13.69 10.35 16 79153 17496 29477862
Adrenal cyst 13.66 10.35 6 79163 82 29495276
Hypertensive heart disease 13.59 10.35 22 79147 2085 29493273
Diabetic retinopathy 13.57 10.35 19 79150 1583 29493775
Carotid artery stenosis 13.48 10.35 34 79135 4435 29490923
Malabsorption 13.47 10.35 21 79148 1927 29493431
Colitis 13.43 10.35 41 79128 31207 29464151
Therapeutic product effect incomplete 13.29 10.35 57 79112 39248 29456110
Small intestine carcinoma 13.28 10.35 11 79158 501 29494857
Chest wall haematoma 13.28 10.35 7 79162 146 29495212
Lipid metabolism disorder 13.18 10.35 9 79160 305 29495053
Eyelid ptosis congenital 13.10 10.35 6 79163 91 29495267
Rales 13.02 10.35 47 79122 7463 29487895
Ejection fraction decreased 12.87 10.35 80 79089 15898 29479460
Dystonia 12.84 10.35 5 79164 9744 29485614
Legionella test positive 12.71 10.35 3 79166 3 29495355
Constipation 12.69 10.35 222 78947 113938 29381420
Bacteraemia 12.66 10.35 15 79154 16308 29479050
Hypocapnia 12.63 10.35 7 79162 162 29495196
Ejection fraction abnormal 12.61 10.35 13 79156 785 29494573
Graft versus host disease 12.58 10.35 5 79164 9623 29485735
Atrioventricular block first degree 12.58 10.35 37 79132 5282 29490076
Malignant melanoma 12.57 10.35 45 79124 7116 29488242
Coronary artery occlusion 12.57 10.35 57 79112 10037 29485321
Tricuspid valve incompetence 12.47 10.35 50 79119 8344 29487014
Neutropenic sepsis 12.46 10.35 8 79161 11719 29483639
Hepatic calcification 12.44 10.35 9 79160 335 29495023
Costal cartilage fracture 12.43 10.35 8 79161 245 29495113
Cholangiocarcinoma 12.42 10.35 14 79155 936 29494422
Protein urine present 12.41 10.35 34 79135 4660 29490698
Renal cell carcinoma 12.40 10.35 34 79135 4662 29490696
Blood pressure systolic decreased 12.39 10.35 30 79139 3814 29491544
Pulmonary embolism 12.37 10.35 138 79031 76396 29418962
Tachycardia 12.33 10.35 129 79040 72281 29423077
Cardiovascular disorder 12.31 10.35 52 79117 8883 29486475
Erythema multiforme 12.30 10.35 47 79122 7670 29487688
Therapy non-responder 12.28 10.35 42 79127 30869 29464489
Extrasystoles 12.16 10.35 28 79141 3446 29491912
Adrenomegaly 12.14 10.35 9 79160 348 29495010
Atrioventricular block complete 12.12 10.35 48 79121 7963 29487395
Respiratory depression 12.10 10.35 11 79158 13512 29481846
Abdominal compartment syndrome 12.07 10.35 13 79156 826 29494532
Palpitations 12.06 10.35 137 79032 32467 29462891
Extrapyramidal disorder 12.05 10.35 7 79162 10824 29484534
Oedema neonatal 11.98 10.35 4 79165 24 29495334
Thrombotic stroke 11.98 10.35 8 79161 261 29495097
Lower respiratory tract infection 11.95 10.35 34 79135 26468 29468890
Loss of personal independence in daily activities 11.94 10.35 32 79137 25408 29469950
Choroidal detachment 11.92 10.35 9 79160 358 29495000
Malaise 11.76 10.35 531 78638 159071 29336287
Primary hyperaldosteronism 11.75 10.35 5 79164 63 29495295
Osteitis deformans 11.71 10.35 4 79165 26 29495332
Hepatic cancer 11.71 10.35 41 79128 6415 29488943
Nodal rhythm 11.70 10.35 16 79153 1304 29494054
Influenza 11.69 10.35 65 79104 41816 29453542
Electrocardiogram ST segment depression 11.69 10.35 21 79148 2164 29493194
Coronary angioplasty 11.68 10.35 9 79160 369 29494989
Genital candidiasis 11.68 10.35 5 79164 64 29495294
Dyspnoea exertional 11.61 10.35 149 79020 36341 29459017
Dyslalia 11.59 10.35 10 79159 482 29494876
Metamyelocyte count increased 11.51 10.35 9 79160 377 29494981
Pancreatitis chronic 11.51 10.35 20 79149 2008 29493350
Miscarriage of partner 11.50 10.35 3 79166 6 29495352
Lymphocyte count 11.47 10.35 5 79164 67 29495291
Ventricular hypertrophy 11.39 10.35 31 79138 4233 29491125
Neuromyopathy 11.34 10.35 13 79156 886 29494472
pH body fluid increased 11.28 10.35 5 79164 70 29495288
Ischaemic cardiomyopathy 11.27 10.35 37 79132 5601 29489757
Plasma cell myeloma 11.26 10.35 56 79113 37059 29458299
Hallucination 11.11 10.35 72 79097 44640 29450718
Carcinoid tumour 11.06 10.35 7 79162 208 29495150
Bladder cancer 11.02 10.35 55 79114 10072 29485286
Cardiac valve sclerosis 10.97 10.35 5 79164 75 29495283
Renal cyst 10.88 10.35 46 79123 7861 29487497
Emotional distress 10.84 10.35 69 79100 13826 29481532
Feeling cold 10.78 10.35 51 79118 9140 29486218
Small intestinal haemorrhage 10.78 10.35 19 79150 1930 29493428
Candida infection 10.77 10.35 15 79154 15210 29480148
Acute coronary syndrome 10.75 10.35 63 79106 12262 29483096
Hepatitis E antibody positive 10.74 10.35 6 79163 141 29495217
Renal failure neonatal 10.73 10.35 5 79164 79 29495279
Hepatic function abnormal 10.73 10.35 156 79013 39103 29456255
Joint stiffness 10.71 10.35 6 79163 9467 29485891
Adverse drug reaction 10.69 10.35 31 79138 23989 29471369
Bronchitis 10.68 10.35 148 79021 36720 29458638
Aortic aneurysm rupture 10.68 10.35 13 79156 944 29494414
Hypercholesterolaemia 10.66 10.35 43 79126 7195 29488163
Hypocalvaria 10.64 10.35 3 79166 9 29495349
Product residue present 10.64 10.35 22 79147 2517 29492841
Post streptococcal glomerulonephritis 10.59 10.35 4 79165 36 29495322
Concomitant disease progression 10.54 10.35 21 79148 2340 29493018
Aneurysm 10.45 10.35 17 79152 1617 29493741
Blood zinc decreased 10.41 10.35 3 79166 10 29495348
Injection site pain 10.40 10.35 48 79121 32398 29462960
Eczema 10.38 10.35 68 79101 13758 29481600

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
Blood pressure inadequately controlled 304.52 9.76 175 144955 5209 64348393
Off label use 287.31 9.76 624 144506 632182 63721420
Blood pressure increased 232.45 9.76 884 144246 171668 64181934
Completed suicide 230.93 9.76 108 145022 224306 64129296
Hyperkalaemia 225.53 9.76 616 144514 100513 64253089
Cardiac failure congestive 221.57 9.76 722 144408 129858 64223744
Myocardial infarction 213.91 9.76 838 144292 164983 64188619
Hyponatraemia 201.42 9.76 762 144368 147577 64206025
Cerebral infarction 176.45 9.76 325 144805 40719 64312883
Drug abuse 164.29 9.76 47 145083 132327 64221275
Toxicity to various agents 156.72 9.76 368 144762 363145 63990457
Coronary artery disease 153.96 9.76 387 144743 60046 64293556
Drug ineffective 141.79 9.76 1211 143919 839036 63514566
Hypertensive crisis 139.16 9.76 188 144942 18060 64335542
Acute kidney injury 135.41 9.76 1575 143555 447665 63905937
Blood creatinine increased 128.20 9.76 625 144505 135157 64218445
Renal failure 128.04 9.76 772 144358 180916 64172686
Death 127.93 9.76 605 144525 482100 63871502
Syncope 117.63 9.76 680 144450 156955 64196647
Hand deformity 116.35 9.76 6 145124 62765 64290837
Oedema peripheral 106.63 9.76 824 144306 209493 64144109
Febrile neutropenia 104.33 9.76 163 144967 187494 64166108
Infusion related reaction 103.23 9.76 131 144999 164336 64189266
Dizziness 95.98 9.76 1428 143702 428735 63924867
Systemic lupus erythematosus 95.46 9.76 28 145102 77584 64276018
Product use in unapproved indication 94.80 9.76 157 144973 176461 64177141
Cardiac failure 92.27 9.76 561 144569 131812 64221790
Product use issue 91.97 9.76 124 145006 151591 64202011
Glossodynia 90.00 9.76 18 145112 64678 64288924
Pemphigus 84.21 9.76 17 145113 60684 64292918
Atrial fibrillation 83.74 9.76 665 144465 170424 64183178
Acute myocardial infarction 83.10 9.76 344 144786 69374 64284228
Blood urea increased 82.92 9.76 253 144877 43900 64309702
Hypotension 82.32 9.76 1258 143872 379716 63973886
Cerebrovascular accident 82.32 9.76 561 144569 137022 64216580
Colitis microscopic 79.90 9.76 91 145039 7341 64346261
Angina pectoris 78.83 9.76 252 144878 44829 64308773
Renal impairment 78.09 9.76 546 144584 134471 64219131
Blood glucose increased 75.68 9.76 427 144703 97646 64255956
Alopecia 74.29 9.76 164 144966 165526 64188076
Pericarditis 72.53 9.76 25 145105 62491 64291111
Oligohydramnios 69.34 9.76 57 145073 3067 64350535
Mitral valve incompetence 66.54 9.76 165 144965 25373 64328229
Neutropenia 66.48 9.76 295 144835 239329 64114273
Angioedema 65.95 9.76 295 144835 61526 64292076
Joint swelling 63.53 9.76 259 144871 215123 64138479
Treatment failure 62.51 9.76 104 145026 116712 64236890
Condition aggravated 62.34 9.76 537 144593 371889 63981713
Arthropathy 61.72 9.76 111 145019 120856 64232746
Bundle branch block left 61.25 9.76 93 145037 9941 64343661
Maternal exposure during pregnancy 60.52 9.76 76 145054 95808 64257794
Cardiac failure chronic 58.34 9.76 86 145044 8955 64344647
Bronchial neoplasm 56.55 9.76 25 145105 418 64353184
Duodenal ulcer perforation 56.55 9.76 6 145124 34619 64318983
Intentional product use issue 54.73 9.76 81 145049 95283 64258319
Nasal turbinate hypertrophy 53.31 9.76 26 145104 549 64353053
Wound 53.26 9.76 56 145074 76421 64277181
Bradycardia 53.23 9.76 451 144679 117768 64235834
Interstitial lung disease 52.88 9.76 389 144741 97343 64256259
Pain 52.52 9.76 903 144227 552608 63800994
Labile hypertension 52.09 9.76 25 145105 509 64353093
Therapeutic product effect decreased 51.83 9.76 114 145016 115237 64238365
Product dose omission issue 51.47 9.76 244 144886 194503 64159099
Blood creatine phosphokinase increased 51.29 9.76 264 144866 58294 64295308
Product prescribing error 50.98 9.76 185 144945 35084 64318518
Intentional overdose 50.07 9.76 78 145052 89866 64263736
Product impurity 49.29 9.76 15 145115 78 64353524
Drug intolerance 47.67 9.76 239 144891 187753 64165849
Anaemia 46.90 9.76 1149 143981 377531 63976071
Glaucoma 46.21 9.76 109 145021 16239 64337363
Exposure during pregnancy 45.53 9.76 65 145065 77610 64275992
Total lung capacity increased 45.43 9.76 25 145105 683 64352919
Angina unstable 44.67 9.76 104 145026 15363 64338239
Diabetes mellitus inadequate control 44.63 9.76 127 145003 21194 64332408
Rheumatoid arthritis 44.49 9.76 204 144926 164090 64189512
Chest pain 44.41 9.76 762 144368 235218 64118384
Sleep disorder due to general medical condition, insomnia type 44.35 9.76 4 145126 26266 64327336
Melaena 43.19 9.76 236 144894 53312 64300290
Endometrial ablation 42.55 9.76 25 145105 776 64352826
Sinus arrest 42.31 9.76 43 145087 3047 64350555
Thyroid disorder 42.18 9.76 86 145044 11606 64341996
Contraindicated product administered 41.83 9.76 115 145015 107714 64245888
Blood pressure decreased 41.55 9.76 334 144796 85865 64267737
Synovitis 41.25 9.76 102 145028 98988 64254614
Hospitalisation 41.12 9.76 66 145064 75141 64278461
Blood lactate dehydrogenase increased 40.81 9.76 165 144965 32913 64320689
Transient ischaemic attack 40.66 9.76 202 144928 43980 64309622
Helicobacter infection 40.12 9.76 18 145112 38344 64315258
Chronic kidney disease 40.02 9.76 245 144885 57674 64295928
Obstructive airways disorder 39.07 9.76 128 145002 23057 64330545
Arteriosclerosis 38.67 9.76 100 145030 15777 64337825
Folliculitis 38.57 9.76 10 145120 30067 64323535
Infection 38.28 9.76 251 144879 184629 64168973
Coronary arterial stent insertion 37.97 9.76 55 145075 5637 64347965
Gamma-glutamyltransferase increased 37.92 9.76 212 144918 48298 64305304
Asthenia 37.48 9.76 1243 143887 426801 63926801
Bronchial haemorrhage 37.43 9.76 27 145103 1195 64352407
Blood lactic acid 37.21 9.76 19 145111 444 64353158
Forced expiratory volume decreased 36.86 9.76 60 145070 6807 64346795
Disease progression 36.55 9.76 179 144951 141501 64212101
Blood potassium increased 36.47 9.76 135 144995 25845 64327757
Tricuspid valve incompetence 36.29 9.76 102 145028 16901 64336701
Swelling 36.03 9.76 212 144918 160006 64193596
Ischaemic stroke 35.96 9.76 145 144985 28890 64324712
Foetal disorder 35.95 9.76 13 145117 124 64353478
Rash 35.80 9.76 773 144357 457776 63895826
Diverticulitis 35.14 9.76 176 144954 38442 64315160
Cerebral haemorrhage 34.60 9.76 215 144915 50875 64302727
N-terminal prohormone brain natriuretic peptide abnormal 34.59 9.76 15 145115 239 64353363
Myocardial ischaemia 34.48 9.76 123 145007 23128 64330474
Injection site pain 34.07 9.76 132 144998 111276 64242326
Cardiac failure acute 33.87 9.76 97 145033 16247 64337355
Aortic aneurysm 33.83 9.76 61 145069 7513 64346089
Arrhythmia 33.50 9.76 219 144911 52725 64300877
Diverticulum intestinal 33.45 9.76 60 145070 7360 64346242
Lymphatic fistula 33.43 9.76 21 145109 737 64352865
Femoral hernia incarcerated 33.35 9.76 21 145109 740 64352862
Drug hypersensitivity 33.33 9.76 358 144772 237457 64116145
Suicidal ideation 33.09 9.76 62 145068 66480 64287122
Abortion spontaneous 32.93 9.76 8 145122 25135 64328467
Drug resistance 32.93 9.76 19 145111 35083 64318519
Fear of disease 32.40 9.76 22 145108 883 64352719
Psoriatic arthropathy 32.08 9.76 30 145100 43251 64310351
Intentional product misuse 32.02 9.76 72 145058 72223 64281379
Arthralgia 31.84 9.76 755 144375 441505 63912097
Hyperglycaemia 31.46 9.76 240 144890 60728 64292874
Atrioventricular block complete 31.27 9.76 87 145043 14331 64339271
COVID-19 31.25 9.76 62 145068 65078 64288524
Rheumatoid factor positive 31.25 9.76 20 145110 34918 64318684
Dyspnoea 31.02 9.76 1942 143188 716732 63636870
Eosinophilic colitis 30.83 9.76 16 145114 387 64353215
Cardiovascular disorder 30.75 9.76 92 145038 15789 64337813
Lymphocyte stimulation test positive 30.64 9.76 23 145107 1083 64352519
Rhabdomyolysis 30.38 9.76 328 144802 91398 64262204
Pancreatic steatosis 30.26 9.76 22 145108 986 64352616
Pancreatic neoplasm 30.02 9.76 25 145105 1370 64352232
Bronchial disorder 30.00 9.76 30 145100 2085 64351517
Dehydration 29.94 9.76 668 144462 216095 64137507
Thrombotic stroke 29.86 9.76 19 145111 682 64352920
Hemiplegia 29.65 9.76 79 145051 12689 64340913
Coronary artery stenosis 29.65 9.76 73 145057 11175 64342427
Vascular resistance pulmonary decreased 29.64 9.76 10 145120 76 64353526
Diabetic retinopathy 29.24 9.76 34 145096 2805 64350797
Pemphigoid 28.80 9.76 79 145051 12907 64340695
Liver function test increased 28.71 9.76 17 145113 30953 64322649
Bronchitis 28.58 9.76 372 144758 108371 64245231
Atrioventricular block 28.57 9.76 75 145055 11940 64341662
Rhonchi 28.43 9.76 37 145093 3426 64350176
Hypertension 28.35 9.76 774 144356 258487 64095115
Cardiomegaly 28.31 9.76 117 145013 23567 64330035
Muscle injury 28.28 9.76 12 145118 26425 64327177
Blood uric acid increased 28.22 9.76 59 145071 8104 64345498
Status epilepticus 28.17 9.76 7 145123 21656 64331946
Fall 28.14 9.76 1176 143954 415650 63937952
Renal artery stenosis 28.01 9.76 34 145096 2935 64350667
Haematoma 27.87 9.76 189 144941 46061 64307541
Oxygen saturation increased 27.51 9.76 16 145114 487 64353115
Coronary artery occlusion 27.40 9.76 81 145049 13810 64339792
Stomatitis 27.39 9.76 140 144990 109465 64244137
Coronary artery restenosis 27.33 9.76 23 145107 1279 64352323
Discomfort 27.26 9.76 92 145038 80786 64272816
Device dislocation 27.23 9.76 7 145123 21171 64332431
Left ventricular dilatation 27.20 9.76 20 145110 912 64352690
Left-to-right cardiac shunt 27.06 9.76 10 145120 102 64353500
Disease recurrence 26.89 9.76 19 145111 31491 64322111
Ischaemic cardiomyopathy 26.72 9.76 52 145078 6786 64346816
Pregnancy 26.63 9.76 7 145123 20858 64332744
Renal cyst 26.43 9.76 75 145055 12495 64341107
Hypoglycaemia 26.41 9.76 314 144816 89578 64264024
Cell marker increased 26.36 9.76 17 145113 625 64352977
Drug ineffective for unapproved indication 26.27 9.76 19 145111 31114 64322488
Tachyarrhythmia 26.24 9.76 48 145082 5978 64347624
Sedation 26.01 9.76 33 145097 41429 64312173
Diabetes mellitus 26.00 9.76 246 144884 66228 64287374
Hip arthroplasty 25.71 9.76 8 145122 21343 64332259
Blood pressure systolic increased 25.69 9.76 195 144935 49258 64304344
Psychotic disorder 25.59 9.76 24 145106 34554 64319048
Intentional self-injury 25.47 9.76 17 145113 29027 64324575
Injection site reaction 25.46 9.76 41 145089 46623 64306979
Dyslipidaemia 25.45 9.76 61 145069 9181 64344421
Blister 25.35 9.76 95 145035 80872 64272730
Brain natriuretic peptide abnormal 25.24 9.76 17 145113 673 64352929
Myelosuppression 25.20 9.76 11 145119 23819 64329783
Blood sodium decreased 25.17 9.76 132 144998 29350 64324252
Arterial haemorrhage 25.15 9.76 28 145102 2203 64351399
Cytomegalovirus infection 25.05 9.76 28 145102 37171 64316431
Drug dependence 24.79 9.76 23 145107 33289 64320313
Ventricular hypertrophy 24.79 9.76 49 145081 6467 64347135
Lower respiratory tract infection 24.71 9.76 119 145011 94495 64259107
Clostridium difficile infection 24.60 9.76 27 145103 36136 64317466
Brain stem stroke 24.47 9.76 14 145116 413 64353189
Idiopathic pulmonary fibrosis 24.30 9.76 36 145094 3764 64349838
Haematochezia 24.18 9.76 242 144888 66131 64287471
Wound infection pseudomonas 24.09 9.76 23 145107 1510 64352092
Lacunar infarction 24.01 9.76 44 145086 5488 64348114
Colon cancer 23.91 9.76 73 145057 12666 64340936
Gastric cancer 23.71 9.76 48 145082 6445 64347157
Coronary angioplasty 23.66 9.76 13 145117 354 64353248
Sinusitis 23.65 9.76 212 144918 145716 64207886
Glomerular filtration rate decreased 23.64 9.76 97 145033 19475 64334127
Hyperuricaemia 23.61 9.76 63 145067 10128 64343474
Hypokalaemia 23.39 9.76 395 144735 121508 64232094
Orthostatic intolerance 23.26 9.76 23 145107 1577 64352025
Hepatic function abnormal 23.19 9.76 234 144896 64079 64289523
Musculoskeletal stiffness 23.16 9.76 172 144958 123034 64230568
Pyrexia 23.05 9.76 1025 144105 557619 63795983
Ventricular extrasystoles 22.88 9.76 89 145041 17440 64336162
Lung diffusion disorder 22.76 9.76 9 145121 112 64353490
Monoplegia 22.57 9.76 33 145097 3410 64350192
Nodal rhythm 22.50 9.76 30 145100 2844 64350758
Shock 22.29 9.76 155 144975 38085 64315517
Chronic pigmented purpura 22.21 9.76 10 145120 175 64353427
Hypochromic anaemia 22.15 9.76 27 145103 2341 64351261
Renal cell carcinoma 22.14 9.76 45 145085 6059 64347543
Adverse drug reaction 22.04 9.76 43 145087 45421 64308181
Eructation 21.47 9.76 57 145073 9134 64344468
Hypertensive heart disease 21.46 9.76 34 145096 3770 64349832
Septic shock 21.38 9.76 144 144986 105293 64248309
Electrocardiogram QRS complex abnormal 21.11 9.76 14 145116 540 64353062
Graft versus host disease 21.07 9.76 3 145127 13810 64339792
Bone marrow failure 21.03 9.76 48 145082 47904 64305698
Blood aldosterone increased 20.64 9.76 10 145120 208 64353394
Adrenomegaly 20.58 9.76 12 145118 367 64353235
Gastrointestinal disorder 20.53 9.76 118 145012 89591 64264011
Lateropulsion 20.40 9.76 4 145126 0 64353602
Bundle branch block right 20.37 9.76 60 145070 10209 64343393
Device issue 20.21 9.76 13 145117 22635 64330967
Respiratory arrest 20.17 9.76 57 145073 52928 64300674
Inguinal hernia 20.07 9.76 41 145089 5540 64348062
General physical health deterioration 20.03 9.76 602 144528 203823 64149779
Therapy interrupted 20.03 9.76 10 145120 20026 64333576
Prostate cancer 20.02 9.76 93 145037 19702 64333900
Vertigo 19.99 9.76 212 144918 58799 64294803
Chest injury 19.98 9.76 26 145104 2407 64351195
Migraine 19.98 9.76 73 145057 62604 64290998
Retrograde amnesia 19.96 9.76 13 145117 486 64353116
Venous pressure jugular increased 19.94 9.76 19 145111 1244 64352358
Neutropenic sepsis 19.90 9.76 14 145116 23258 64330344
Loss of consciousness 19.78 9.76 455 144675 147910 64205692
Atrial thrombosis 19.72 9.76 29 145101 3013 64350589
Impaired work ability 19.63 9.76 5 145125 15214 64338388
Gastric ulcer haemorrhage 19.53 9.76 51 145079 8092 64345510
Hepatic cyst 19.45 9.76 39 145091 5201 64348401
Rhythm idioventricular 19.41 9.76 13 145117 510 64353092
Neuropathy peripheral 19.36 9.76 170 144960 117355 64236247
Carotid artery stenosis 19.32 9.76 50 145080 7891 64345711
Decreased appetite 19.27 9.76 795 144335 280494 64073108
Adrenal adenoma 19.21 9.76 17 145113 1012 64352590
Carotid artery disease 19.16 9.76 24 145106 2139 64351463
Neurotoxicity 19.15 9.76 20 145110 27384 64326218
Cardio-respiratory arrest 19.15 9.76 136 144994 98257 64255345
Low density lipoprotein increased 19.11 9.76 49 145081 7691 64345911
Malabsorption 19.08 9.76 35 145095 4368 64349234
Glycosylated haemoglobin increased 19.04 9.76 79 145051 15940 64337662
Thrombocytopenia 18.98 9.76 372 144758 223429 64130173
Gastritis erosive 18.97 9.76 56 145074 9539 64344063
Skin reaction 18.88 9.76 66 145064 12286 64341316
Product substitution issue 18.87 9.76 85 145045 17776 64335826
Conduction disorder 18.81 9.76 28 145102 2940 64350662
Forced vital capacity decreased 18.79 9.76 20 145110 1496 64352106
Pulmonary arterial pressure abnormal 18.69 9.76 14 145116 657 64352945
Sepsis 18.60 9.76 386 144744 229955 64123647
Injection site erythema 18.51 9.76 89 145041 70711 64282891
Fatigue 18.44 9.76 1443 143687 747287 63606315
Brain contusion 18.36 9.76 18 145112 1221 64352381
Rectal prolapse 18.33 9.76 21 145109 1705 64351897
Cytopenia 18.27 9.76 6 145124 15465 64338137
Multiple sclerosis relapse 18.18 9.76 41 145089 41094 64312508
Concomitant disease progression 18.14 9.76 29 145101 3240 64350362
C-reactive protein increased 18.01 9.76 307 144823 94602 64259000
Ventricular hypokinesia 17.97 9.76 48 145082 7721 64345881
Blood triglycerides increased 17.89 9.76 87 145043 18779 64334823
Ophthalmic vein thrombosis 17.87 9.76 9 145121 204 64353398
Lipid metabolism disorder 17.73 9.76 10 145120 287 64353315
Fear 17.70 9.76 91 145039 20080 64333522
Pyonephrosis 17.64 9.76 7 145123 88 64353514
Irritable bowel syndrome 17.55 9.76 36 145094 37333 64316269
Product odour abnormal 17.55 9.76 17 145113 1136 64352466
Blood thyroid stimulating hormone abnormal 17.38 9.76 14 145116 732 64352870
Mucosal inflammation 17.35 9.76 77 145053 62507 64291095
Asthma 17.34 9.76 306 144824 94919 64258683
Peak expiratory flow rate decreased 17.26 9.76 13 145117 615 64352987
Basal ganglion degeneration 17.24 9.76 11 145119 397 64353205
Neutrophil function disorder 17.11 9.76 5 145125 22 64353580
Aortic arteriosclerosis 17.10 9.76 46 145084 7430 64346172
Gastrointestinal haemorrhage 17.09 9.76 404 144726 131908 64221694
Impaired healing 17.01 9.76 74 145056 60399 64293203
Infective pulmonary exacerbation of cystic fibrosis 17.00 9.76 3 145127 11793 64341809
Pneumothorax traumatic 17.00 9.76 9 145121 227 64353375
Seroma 16.95 9.76 22 145108 2032 64351570
Transplant rejection 16.93 9.76 9 145121 17392 64336210
Aortic valve stenosis 16.89 9.76 34 145096 4546 64349056
Myalgia 16.88 9.76 472 144658 158145 64195457
Haemorrhage subcutaneous 16.84 9.76 33 145097 4328 64349274
Pericardial haemorrhage 16.83 9.76 32 145098 4104 64349498
Uterine enlargement 16.81 9.76 14 145116 767 64352835
Periarthritis calcarea 16.80 9.76 6 145124 55 64353547
Hiatus hernia 16.80 9.76 89 145041 19868 64333734
Sinus node dysfunction 16.62 9.76 43 145087 6785 64346817
Cardiac vein perforation 16.59 9.76 5 145125 25 64353577
Post-anoxic myoclonus 16.59 9.76 5 145125 25 64353577
Seizure 16.49 9.76 270 144860 166622 64186980
Neoplasm progression 16.40 9.76 43 145087 40921 64312681
Gout 16.35 9.76 93 145037 21320 64332282
Renin decreased 16.29 9.76 7 145123 109 64353493
Immune reconstitution inflammatory syndrome 16.27 9.76 4 145126 12466 64341136
Malignant melanoma 16.26 9.76 65 145065 12899 64340703
Blood pressure abnormal 16.24 9.76 70 145060 14365 64339237
Toxic skin eruption 16.23 9.76 86 145044 19198 64334404
Hepatic cancer 16.21 9.76 45 145085 7403 64346199
Pancytopenia 16.16 9.76 226 144904 143083 64210519
Hypercholesterolaemia 16.12 9.76 73 145057 15300 64338302
Product monitoring error 16.11 9.76 37 145093 5417 64348185
Dyspnoea exertional 16.05 9.76 244 144886 73486 64280116
Blood alkaline phosphatase increased 15.83 9.76 195 144935 56084 64297518
Dementia Alzheimer's type 15.81 9.76 15 145115 977 64352625
Therapeutic drug monitoring analysis incorrectly performed 15.78 9.76 8 145122 184 64353418
Cardiac myxoma 15.78 9.76 7 145123 118 64353484
Nausea 15.72 9.76 1539 143591 784261 63569341
Tissue infiltration 15.69 9.76 12 145118 581 64353021
Altered state of consciousness 15.69 9.76 142 144988 37760 64315842
Hypertrophic osteoarthropathy 15.68 9.76 7 145123 120 64353482
Gouty arthritis 15.61 9.76 17 145113 1305 64352297
Coronary artery bypass 15.60 9.76 38 145092 5777 64347825
Erectile dysfunction 15.58 9.76 63 145067 12564 64341038
Microalbuminuria 15.57 9.76 14 145116 851 64352751
Pigmentation disorder 15.56 9.76 33 145097 4579 64349023
Aggression 15.30 9.76 53 145077 46179 64307423
Renal injury 15.24 9.76 72 145058 15357 64338245
Hypertensive emergency 15.19 9.76 22 145108 2254 64351348
Acute hepatic failure 15.15 9.76 22 145108 26090 64327512
Pyometra 15.15 9.76 6 145124 75 64353527
Somnolence 15.07 9.76 346 144784 203299 64150303
Aortic valve incompetence 15.05 9.76 47 145083 8254 64345348
Goitre 14.98 9.76 34 145096 4939 64348663
Subacute hepatic failure 14.93 9.76 8 145122 207 64353395
Mydriasis 14.78 9.76 8 145122 15304 64338298
Merycism 14.76 9.76 8 145122 212 64353390
Myoglobin blood increased 14.74 9.76 24 145106 2723 64350879
Acquired C1 inhibitor deficiency 14.64 9.76 4 145126 13 64353589
Left ventricular dysfunction 14.54 9.76 76 145054 16878 64336724
Haemophagocytic lymphohistiocytosis 14.53 9.76 11 145119 17598 64336004
Nephrotic syndrome 14.52 9.76 51 145079 9516 64344086
Hyperlipidaemia 14.51 9.76 95 145035 22881 64330721
Acral lentiginous melanoma 14.49 9.76 5 145125 41 64353561
Adrenal cyst 14.35 9.76 6 145124 87 64353515
Hypercreatininaemia 14.30 9.76 13 145117 802 64352800
Progressive multifocal leukoencephalopathy 14.28 9.76 12 145118 18220 64335382
Metastatic bronchial carcinoma 14.26 9.76 8 145122 227 64353375
Fractured coccyx 14.25 9.76 14 145116 952 64352650
Malignant neoplasm progression 14.19 9.76 174 144956 112697 64240905
Diverticulum intestinal haemorrhagic 14.19 9.76 26 145104 3243 64350359
Loss of personal independence in daily activities 14.17 9.76 100 145030 72354 64281248
Abdominal tenderness 14.16 9.76 50 145080 9355 64344247
Diastolic dysfunction 14.07 9.76 48 145082 8827 64344775
Painful respiration 14 9.76 25 145105 3056 64350546
Duodenal ulcer 14.00 9.76 67 145063 14368 64339234
Therapy partial responder 13.94 9.76 3 145127 10245 64343357
Macular degeneration 13.94 9.76 36 145094 5674 64347928
Articular calcification 13.93 9.76 6 145124 94 64353508
Nephrogenic anaemia 13.87 9.76 26 145104 3299 64350303
Hypochloraemia 13.87 9.76 20 145110 2041 64351561
Carotid artery occlusion 13.85 9.76 29 145101 3988 64349614
Mouth ulceration 13.81 9.76 33 145097 32411 64321191
Surfactant protein increased 13.80 9.76 4 145126 17 64353585
Abdominal discomfort 13.71 9.76 309 144821 182013 64171589
Staphylococcal infection 13.66 9.76 63 145067 50615 64302987
Costal cartilage fracture 13.65 9.76 8 145122 247 64353355
Accidental exposure to product 13.61 9.76 24 145106 26340 64327262
Anhedonia 13.57 9.76 64 145066 13642 64339960
Rhinitis 13.52 9.76 54 145076 10711 64342891
Venoocclusive liver disease 13.49 9.76 3 145127 10012 64343590
Lung diffusion test decreased 13.46 9.76 15 145115 1181 64352421
Hepatic calcification 13.39 9.76 9 145121 355 64353247
Anaphylactic reaction 13.31 9.76 95 145035 68569 64285033
Extrasystoles 13.30 9.76 39 145091 6619 64346983
Miscarriage of partner 13.22 9.76 3 145127 3 64353599
Faecaloma 13.19 9.76 50 145080 9678 64343924
Azotaemia 13.17 9.76 42 145088 7460 64346142
Recalled product administered 13.15 9.76 12 145118 744 64352858
Blood cholesterol increased 13.03 9.76 171 144959 49895 64303707
Cerebral arteriosclerosis 13.00 9.76 12 145118 755 64352847
Kyphosis 12.97 9.76 21 145109 2372 64351230
Dystonia 12.92 9.76 14 145116 18851 64334751
Iron deficiency anaemia 12.92 9.76 89 145041 21800 64331802
Hepatic enzyme increased 12.91 9.76 210 144920 129733 64223869
Transitional cell cancer of the renal pelvis and ureter 12.88 9.76 5 145125 59 64353543
Cognitive disorder 12.85 9.76 72 145058 55015 64298587
Epstein-Barr virus infection 12.84 9.76 6 145124 12482 64341120
Bezold-Jarisch reflex 12.67 9.76 4 145126 24 64353578
Nasopharyngitis 12.65 9.76 340 144790 195733 64157869
Erythema multiforme 12.52 9.76 69 145061 15632 64337970
Premature delivery 12.51 9.76 14 145116 18575 64335027
Emotional distress 12.46 9.76 130 145000 35908 64317694
Urticaria 12.44 9.76 245 144885 147072 64206530
Arrhythmogenic right ventricular dysplasia 12.40 9.76 4 145126 26 64353576
Peripheral swelling 12.39 9.76 367 144763 208786 64144816
Therapy non-responder 12.38 9.76 92 145038 65807 64287795
Device related infection 12.37 9.76 32 145098 30594 64323008
Infusion site pain 12.33 9.76 4 145126 10393 64343209
Anaesthesia 12.25 9.76 9 145121 410 64353192
Bladder cancer 12.18 9.76 53 145077 10921 64342681
Liver disorder 12.17 9.76 178 144952 53173 64300429
Immunodeficiency 12.16 9.76 11 145119 16113 64337489
Live birth 12.12 9.76 5 145125 11199 64342403
Electrocardiogram ST segment depression 12.12 9.76 29 145101 4360 64349242
Metastases to bone 12.07 9.76 17 145113 20418 64333184
Actinic keratosis 12.03 9.76 32 145098 5133 64348469
Renal artery stent placement 12.02 9.76 4 145126 29 64353573
Prerenal failure 11.98 9.76 24 145106 3198 64350404
Oedema 11.95 9.76 281 144849 91654 64261948
Gait disturbance 11.87 9.76 487 144643 171668 64181934
Withdrawal hypertension 11.83 9.76 8 145122 319 64353283
Hypersensitivity 11.81 9.76 344 144786 196108 64157494
Chronic obstructive pulmonary disease 11.78 9.76 225 144905 70823 64282779
Haemangioma 11.75 9.76 20 145110 2354 64351248
Sprue-like enteropathy 11.75 9.76 13 145117 1016 64352586
Neutrophil count decreased 11.70 9.76 114 145016 77082 64276520
Chronic leukaemia 11.70 9.76 3 145127 7 64353595
Hepatitis E antibody positive 11.68 9.76 6 145124 142 64353460
Putamen haemorrhage 11.66 9.76 9 145121 442 64353160
Aortic valve sclerosis 11.63 9.76 16 145114 1563 64352039
Eczema 11.62 9.76 110 145020 29610 64323992
Therapy cessation 11.61 9.76 36 145094 32453 64321149
Multiple injuries 11.59 9.76 24 145106 3275 64350327
Right ventricular failure 11.58 9.76 19 145111 21452 64332150
Basal ganglia haemorrhage 11.51 9.76 15 145115 1391 64352211
Cytomegalovirus viraemia 11.45 9.76 5 145125 10823 64342779
Cerebellar ischaemia 11.42 9.76 6 145124 149 64353453
Frustration tolerance decreased 11.40 9.76 35 145095 6090 64347512
Injection site swelling 11.39 9.76 51 145079 41302 64312300
Acute phosphate nephropathy 11.37 9.76 4 145126 35 64353567
Joint stiffness 11.36 9.76 33 145097 30371 64323231
Osteoarthritis 11.34 9.76 203 144927 63133 64290469
Activated partial thromboplastin time prolonged 11.34 9.76 58 145072 12773 64340829
Pulmonary oedema 11.33 9.76 244 144886 78430 64275172
Stenosis 11.33 9.76 17 145113 1798 64351804
Incorrect route of product administration 11.32 9.76 22 145108 23276 64330326
Panniculitis 11.29 9.76 3 145127 8876 64344726
Sudden cardiac death 11.28 9.76 29 145101 4558 64349044
Peripheral vascular disorder 11.27 9.76 39 145091 7222 64346380
Brain stem infarction 11.27 9.76 17 145113 1806 64351796
Body height decreased 11.23 9.76 40 145090 7514 64346088
Multiple drug therapy 11.17 9.76 19 145111 2235 64351367
Perihepatic discomfort 11.16 9.76 3 145127 9 64353593
Hepatobiliary cancer 11.16 9.76 3 145127 9 64353593
Bronchopulmonary aspergillosis 11.15 9.76 16 145114 19069 64334533
Hyponatraemic syndrome 11.15 9.76 11 145119 752 64352850
Low density lipoprotein decreased 11.13 9.76 13 145117 1077 64352525
Fibromyalgia 11.13 9.76 42 145088 35689 64317913
Anuria 11.13 9.76 77 145053 18887 64334715
Acute coronary syndrome 11.09 9.76 78 145052 19232 64334370
Cutaneous lymphoma 11.08 9.76 7 145123 248 64353354
Hypoxia 11.04 9.76 136 144994 88013 64265589
Large intestine polyp 11.02 9.76 51 145079 10786 64342816
Metamyelocyte count increased 10.97 9.76 10 145120 619 64352983
Arteriosclerosis coronary artery 10.92 9.76 66 145064 15463 64338139
Hepatitis E virus test positive 10.87 9.76 6 145124 165 64353437
Suspected suicide 10.86 9.76 3 145127 8651 64344951
Renal neoplasm 10.86 9.76 16 145114 1665 64351937
Mood swings 10.86 9.76 14 145116 17454 64336148
Aortic dissection 10.84 9.76 24 145106 3428 64350174
Angioplasty 10.83 9.76 16 145114 1669 64351933
Orthopnoea 10.82 9.76 45 145085 9089 64344513
Blood chloride decreased 10.80 9.76 39 145091 7377 64346225
Exercise tolerance decreased 10.77 9.76 40 145090 7670 64345932
Infarction 10.75 9.76 26 145104 3934 64349668
Post streptococcal glomerulonephritis 10.72 9.76 4 145126 42 64353560
Chest wall haematoma 10.69 9.76 8 145122 375 64353227
Rash maculo-papular 10.68 9.76 62 145068 46964 64306638
Small intestine carcinoma 10.62 9.76 11 145119 797 64352805
Left ventricular hypertrophy 10.62 9.76 46 145084 9460 64344142
Ear infection 10.61 9.76 23 145107 23381 64330221
Subdural haematoma 10.56 9.76 103 145027 27951 64325651
Protein urine present 10.51 9.76 44 145086 8912 64344690
Oscillopsia 10.46 9.76 6 145124 178 64353424
Haematocrit decreased 10.44 9.76 177 144953 54478 64299124
Skin texture abnormal 10.43 9.76 8 145122 389 64353213
Haemodialysis 10.41 9.76 70 145060 17007 64336595
Peripheral arterial occlusive disease 10.39 9.76 37 145093 6950 64346652
Blood phosphorus abnormal 10.37 9.76 7 145123 278 64353324
Brain stem haemorrhage 10.36 9.76 15 145115 1536 64352066
Laryngeal haemorrhage 10.32 9.76 4 145126 47 64353555
Subarachnoid haemorrhage 10.31 9.76 74 145056 18364 64335238
Aspergillus infection 10.31 9.76 13 145117 16366 64337236
Leukopenia 10.26 9.76 163 144967 101079 64252523
Cutaneous listeriosis 10.24 9.76 4 145126 48 64353554
Choroidal detachment 10.21 9.76 9 145121 533 64353069
Bacteraemia 10.21 9.76 29 145101 26882 64326720
Liver function test abnormal 10.19 9.76 85 145045 59316 64294286
Cardiac valve sclerosis 10.19 9.76 5 145125 107 64353495
Diabetic nephropathy 10.15 9.76 20 145110 2634 64350968
Incision site oedema 10.13 9.76 3 145127 14 64353588
Hallucination, auditory 10.10 9.76 14 145116 16925 64336677
Grip strength decreased 10.10 9.76 7 145123 11717 64341885
Sleep disorder due to a general medical condition 10.07 9.76 3 145127 8231 64345371
Lipoedema 10.05 9.76 6 145124 192 64353410
Cholangiocarcinoma 9.98 9.76 17 145113 2001 64351601
Aspartate aminotransferase increased 9.97 9.76 346 144784 119442 64234160
No adverse event 9.96 9.76 32 145098 28529 64325073
Gastrointestinal stromal tumour 9.95 9.76 14 145116 1397 64352205
Eosinophil count increased 9.94 9.76 60 145070 14052 64339550
Product complaint 9.85 9.76 53 145077 11901 64341701
Labelled drug-drug interaction medication error 9.83 9.76 84 145046 21978 64331624
Reaction to colouring 9.80 9.76 3 145127 16 64353586
Hypoparathyroidism 9.77 9.76 11 145119 876 64352726

FDA Adverse Event Reporting System (Pediatric)

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
Renal failure 38.31 28.83 19 294 254 84111

Pharmacologic Action:

SourceCodeDescription
ATC C09CA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
Angiotensin II receptor blockers (ARBs), plain
ATC C09DA03 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and diuretics
ATC C09DB01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DB08 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs) and calcium channel blockers
ATC C09DX01 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX02 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX04 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C09DX05 CARDIOVASCULAR SYSTEM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), COMBINATIONS
Angiotensin II receptor blockers (ARBs), other combinations
ATC C10BX10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Lipid modifying agents in combination with other drugs
FDA MoA N0000000070 Angiotensin 2 Receptor Antagonists
FDA EPC N0000175561 Angiotensin 2 Receptor Blocker
MeSH PA D047228 Angiotensin II Type 1 Receptor Blockers
MeSH PA D057911 Angiotensin Receptor Antagonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:61016 angiotensin receptor antagonists
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (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
Diabetic renal disease off-label use 127013003
Diastolic heart failure off-label use 418304008 DOID:9775
Nondiabetic Proteinuric Nephropathy off-label use
Anuria contraindication 2472002 DOID:2983
Hypercholesterolemia contraindication 13644009
Hyperkalemia contraindication 14140009
Secondary angle-closure glaucoma contraindication 21571006
Hypovolemia contraindication 28560003
Obstruction of bile duct contraindication 30144000
Dehydration contraindication 34095006
Hyperuricemia contraindication 35885006 DOID:1920
Angioedema contraindication 41291007 DOID:1558
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Sympathectomy contraindication 57071006
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Hypochloremic alkalosis contraindication 70134007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Hyponatremia contraindication 89627008
Gout contraindication 90560007 DOID:13189
Hypomagnesemia contraindication 190855004
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Neonatal hyperbilirubinemia contraindication 281610001
Pregnancy, function contraindication 289908002
Renal artery stenosis contraindication 302233006
Neutropenic disorder contraindication 303011007 DOID:1227
Azotemia contraindication 445009001
Severe Aortic Valve Stenosis 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 3.8 acidic
pKa2 4.44 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 8796331 Jan. 14, 2023 TREATMENT OF HEART FAILURE
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9388134 Nov. 8, 2026 TREATMENT OF HEART FAILURE
EQ 5MG BASE;80MG BYVALSON ALLERGAN N206302 June 3, 2016 DISCN TABLET ORAL 7838552 Oct. 4, 2027 METHOD OF TREATING HYPERTENSION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11135192 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9517226 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 9937143 Aug. 22, 2033 TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL 11058667 May 9, 2036 TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Oct. 1, 2022 NEW PATIENT POPULATION
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL April 1, 2023 PEDIATRIC EXCLUSIVITY
24MG;26MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
49MG;51MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
97MG;103MG ENTRESTO NOVARTIS PHARMS CORP N207620 July 7, 2015 RX TABLET ORAL Feb. 16, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
160MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
40MG DIOVAN NOVARTIS N021283 Aug. 14, 2002 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION
80MG DIOVAN NOVARTIS N021283 July 18, 2001 RX TABLET ORAL April 19, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Type-1 angiotensin II receptor GPCR ANTAGONIST Ki 5.33 CHEMBL CHEMBL
Platelet glycoprotein VI Unclassified Kd 4 CHEMBL
Type-1B angiotensin II receptor GPCR IC50 8.72 CHEMBL
Type-1A angiotensin II receptor GPCR IC50 8.47 CHEMBL
Angiotensin II receptor (AT-1) type-1 GPCR IC50 8.57 CHEMBL

External reference:

IDSource
D00400 KEGG_DRUG
4020986 VANDF
C0216784 UMLSCUI
CHEBI:9927 CHEBI
U35 PDB_CHEM_ID
CHEMBL1069 ChEMBL_ID
D000068756 MESH_DESCRIPTOR_UI
DB00177 DRUGBANK_ID
3937 IUPHAR_LIGAND_ID
7016 INN_ID
80M03YXJ7I UNII
60846 PUBCHEM_CID
216652 RXNORM
53010 MMSL
5663 MMSL
8844 MMSL
d04113 MMSL
006279 NDDF
108581009 SNOMEDCT_US
386876001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0314 TABLET, FILM COATED 80 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0315 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0358 TABLET 80 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0359 TABLET 160 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0360 TABLET 320 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0383 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 33 sections
Diovan HUMAN PRESCRIPTION DRUG LABEL 1 0078-0423 TABLET 40 mg ORAL NDA 33 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0471 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Diovan HCT HUMAN PRESCRIPTION DRUG LABEL 2 0078-0472 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0488 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0489 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0490 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HUMAN PRESCRIPTION DRUG LABEL 2 0078-0491 TABLET, FILM COATED 320 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0559 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 31 sections
Exforge HCT HUMAN PRESCRIPTION DRUG LABEL 3 0078-0560 TABLET, FILM COATED 160 mg ORAL NDA 31 sections