nivolumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
human origin 4923 946414-94-4

Description:

MoleculeDescription

Synonyms:

  • nivolumab
  • opdivo
  • MDX-1106
  • ONO-4538
  • BMS-936558
  • nivolumab (genetical recombination)
A genetically engineered, fully humanized immunoglobulin G4 monoclonal antibody that binds to the PD-1 RECEPTOR, activating an immune response to tumor cells. It is used as monotherapy or in combination with IPILIMUMAB for the treatment of advanced malignant MELANOMA. It is also used in the treatment of advanced or recurring NON-SMALL CELL LUNG CANCER; RENAL CELL CARCINOMA; and HODGKIN'S LYMPHOMA.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 19, 2015 EMA Bristol-Myers Squibb
Dec. 22, 2014 FDA BRISTOL MYERS SQUIBB
July 4, 2014 PMDA Ono Pharmaceutical Co., Ltd

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
Malignant neoplasm progression 5470.44 16.51 2141 47620 79980 63359281
Death 1511.58 16.51 1650 48111 372731 63066530
Intentional product use issue 1230.99 16.51 922 48839 126970 63312291
Immune-mediated enterocolitis 1016.81 16.51 252 49509 1859 63437402
Pneumonitis 908.99 16.51 476 49285 34746 63404515
Hypophysitis 892.89 16.51 221 49540 1620 63437641
Colitis 890.86 16.51 524 49237 48004 63391257
Hypothyroidism 731.90 16.51 441 49320 42191 63397070
Fulminant type 1 diabetes mellitus 585.16 16.51 122 49639 353 63438908
Immune-mediated hepatitis 538.16 16.51 139 49622 1232 63438029
Adrenal insufficiency 522.30 16.51 263 49498 17652 63421609
Hyperthyroidism 480.01 16.51 233 49528 14440 63424821
Myocarditis 475.79 16.51 208 49553 10117 63429144
Immune-mediated lung disease 366.48 16.51 88 49673 558 63438703
Thyroiditis 361.04 16.51 116 49645 2350 63436911
Type 1 diabetes mellitus 360.60 16.51 129 49632 3661 63435600
Hepatic function abnormal 345.54 16.51 263 49498 36879 63402382
Hypopituitarism 339.34 16.51 93 49668 1055 63438206
Immune-mediated hepatic disorder 327.79 16.51 77 49684 438 63438823
Autoimmune colitis 322.90 16.51 77 49684 472 63438789
Autoimmune hepatitis 314.51 16.51 147 49614 8363 63430898
Diabetic ketoacidosis 268.79 16.51 179 49582 20326 63418935
Drug ineffective 259.15 16.51 264 49497 1044501 62394760
Adrenocorticotropic hormone deficiency 237.29 16.51 57 49704 362 63438899
Cholangitis 233.55 16.51 105 49656 5456 63433805
Myositis 229.59 16.51 122 49639 9144 63430117
Myasthenia gravis 226.43 16.51 97 49664 4484 63434777
Pemphigoid 202.84 16.51 104 49657 7240 63432021
Tumour pseudoprogression 198.20 16.51 46 49715 246 63439015
Metastases to central nervous system 197.77 16.51 125 49636 12980 63426281
Leukoderma 195.63 16.51 37 49724 51 63439210
Hepatitis 193.90 16.51 195 49566 39593 63399668
Secondary adrenocortical insufficiency 192.08 16.51 63 49698 1365 63437896
Pyrexia 191.80 16.51 802 48959 469676 62969585
Immune-mediated myocarditis 186.45 16.51 44 49717 256 63439005
Drug intolerance 185.73 16.51 15 49746 308646 63130615
Enterocolitis 179.42 16.51 98 49663 7760 63431501
Liver disorder 169.95 16.51 210 49551 53477 63385784
Drug hypersensitivity 166.73 16.51 23 49738 310664 63128597
Immune-mediated thyroiditis 164.26 16.51 35 49726 116 63439145
Cachexia 163.70 16.51 83 49678 5643 63433618
Pleural effusion 162.99 16.51 275 49486 92935 63346326
Joint swelling 162.92 16.51 30 49731 327636 63111625
Interstitial lung disease 162.89 16.51 221 49540 61687 63377574
Pain 157.34 16.51 211 49550 740417 62698844
Vitiligo 150.16 16.51 52 49709 1337 63437924
Lichenoid keratosis 144.76 16.51 54 49707 1729 63437532
Immune-mediated dermatitis 140.34 16.51 32 49729 156 63439105
Lymphocytic hypophysitis 138.27 16.51 33 49728 203 63439058
Encephalitis 134.73 16.51 85 49676 8795 63430466
Abdominal discomfort 132.99 16.51 43 49718 320842 63118419
Sepsis 128.34 16.51 334 49427 152789 63286472
Swelling 126.98 16.51 30 49731 275348 63163913
Systemic lupus erythematosus 126.03 16.51 10 49751 208908 63230353
Immune-mediated hypothyroidism 124.64 16.51 32 49729 276 63438985
Product dose omission issue 124.12 16.51 18 49743 234295 63204966
Uveitis 123.57 16.51 92 49669 12461 63426800
Pemphigus 122.39 16.51 5 49756 183721 63255540
Glossodynia 122.16 16.51 4 49757 178872 63260389
Arthropathy 122.16 16.51 19 49742 234773 63204488
Sinusitis 121.01 16.51 17 49744 226636 63212625
Immune-mediated nephritis 119.91 16.51 27 49734 123 63439138
Autoimmune thyroiditis 117.52 16.51 59 49702 3927 63435334
Synovitis 115.43 16.51 8 49753 186910 63252351
Prescribed underdose 111.90 16.51 127 49634 29562 63409699
Alopecia 108.72 16.51 65 49696 337471 63101790
Hypothalamo-pituitary disorder 108.50 16.51 35 49726 718 63438543
Immune-mediated uveitis 108.23 16.51 20 49741 22 63439239
Immune-mediated encephalitis 107.97 16.51 27 49734 207 63439054
Wound 106.90 16.51 5 49756 163258 63276003
Drug interaction 103.58 16.51 26 49735 229105 63210156
Immune-mediated hypophysitis 101.96 16.51 21 49740 56 63439205
Relapsing fever 101.35 16.51 25 49736 180 63439081
Exposure during pregnancy 101.08 16.51 5 49756 155542 63283719
Nasopharyngitis 100.25 16.51 37 49724 254220 63185041
Non-small cell lung cancer 96.65 16.51 50 49711 3545 63435716
Myasthenic syndrome 95.45 16.51 25 49736 235 63439026
Cytokine release syndrome 94.37 16.51 83 49678 14231 63425030
Meningitis aseptic 93.40 16.51 54 49707 4769 63434492
Peripheral swelling 93.20 16.51 46 49715 265896 63173365
Rash maculo-papular 90.20 16.51 118 49643 31778 63407483
Radiation pneumonitis 89.88 16.51 37 49724 1546 63437715
Cholangitis sclerosing 88.59 16.51 37 49724 1604 63437657
Nephritis 88.45 16.51 42 49719 2474 63436787
Discomfort 88.27 16.51 13 49748 167361 63271900
Cholestasis 88.11 16.51 112 49649 29322 63409939
Respiratory failure 86.11 16.51 223 49538 101635 63337626
Autoimmune myocarditis 84.85 16.51 19 49742 84 63439177
Decreased appetite 83.84 16.51 404 49357 250648 63188613
Treatment failure 83.59 16.51 26 49735 199017 63240244
Autoimmune nephritis 83.47 16.51 25 49736 397 63438864
Tubulointerstitial nephritis 83.39 16.51 90 49671 19813 63419448
Haemophagocytic lymphohistiocytosis 83.15 16.51 68 49693 10559 63428702
Toxicity to various agents 81.85 16.51 46 49715 247204 63192057
Vogt-Koyanagi-Harada disease 81.82 16.51 20 49741 138 63439123
Erythema multiforme 81.53 16.51 66 49695 10103 63429158
Autoimmune haemolytic anaemia 79.88 16.51 48 49713 4553 63434708
Acute kidney injury 78.85 16.51 411 49350 263004 63176257
Condition aggravated 78.76 16.51 121 49640 402096 63037165
Diarrhoea 78.40 16.51 880 48881 714486 62724775
Exposure via body fluid 74.16 16.51 25 49736 591 63438670
Maternal exposure during pregnancy 72.75 16.51 41 49720 220021 63219240
Disseminated intravascular coagulation 72.64 16.51 82 49679 18969 63420292
Pericardial effusion 72.57 16.51 103 49658 29955 63409306
Hyponatraemia 72.06 16.51 222 49539 111678 63327583
Hypersensitivity 71.92 16.51 74 49687 292611 63146650
Aspartate aminotransferase increased 71.57 16.51 193 49568 90084 63349177
Dizziness 70.07 16.51 145 49616 429780 63009481
Weight increased 66.28 16.51 64 49697 260728 63178533
Autoimmune pancreatitis 66.12 16.51 19 49742 259 63439002
Overdose 65.37 16.51 7 49754 115071 63324190
Therapeutic product effect incomplete 65.27 16.51 10 49751 125046 63314215
Serous retinal detachment 65.13 16.51 20 49741 347 63438914
Eosinophilic fasciitis 65.08 16.51 17 49744 158 63439103
Pain in extremity 64.59 16.51 100 49661 331386 63107875
Autoimmune dermatitis 64.41 16.51 16 49745 119 63439142
Thyroid disorder 62.53 16.51 68 49693 15094 63424167
Lipase increased 62.46 16.51 56 49705 9844 63429417
Product use in unapproved indication 61.03 16.51 290 49471 178790 63260471
Feeling abnormal 59.45 16.51 21 49740 148371 63290890
Encephalitis autoimmune 59.04 16.51 27 49734 1459 63437802
Musculoskeletal stiffness 58.74 16.51 36 49725 184582 63254679
Pancreatitis 58.55 16.51 123 49638 48932 63390329
Febrile neutropenia 58.54 16.51 215 49546 118234 63321027
Off label use 58.34 16.51 794 48967 673668 62765593
Immune-mediated adrenal insuficiency 56.74 16.51 13 49748 65 63439196
Embolism 56.48 16.51 48 49713 7858 63431403
Blood thyroid stimulating hormone increased 56.21 16.51 46 49715 7148 63432113
Immune-mediated arthritis 55.93 16.51 13 49748 70 63439191
Tumour pain 53.63 16.51 25 49736 1412 63437849
General physical health deterioration 53.30 16.51 304 49457 201098 63238163
Immune-mediated cholangitis 52.96 16.51 11 49750 31 63439230
Loss of personal independence in daily activities 52.58 16.51 7 49754 97283 63341978
Mobility decreased 52.34 16.51 15 49746 121144 63318117
Skin toxicity 51.95 16.51 37 49724 4677 63434584
Polyarthritis 51.75 16.51 51 49710 10095 63429166
Alanine aminotransferase increased 50.14 16.51 187 49574 103583 63335678
Blood corticotrophin decreased 49.56 16.51 16 49745 329 63438932
Cardiac tamponade 49.25 16.51 36 49725 4739 63434522
Immune-mediated myositis 49.00 16.51 23 49738 1320 63437941
Osteoarthritis 48.90 16.51 8 49753 95335 63343926
Fall 48.65 16.51 152 49609 392182 63047079
Enteritis 48.62 16.51 45 49716 8241 63431020
Drug-induced liver injury 48.17 16.51 101 49660 40121 63399140
Migraine 48.09 16.51 11 49750 103335 63335926
Immune-mediated adverse reaction 47.82 16.51 15 49746 280 63438981
Adverse event 47.21 16.51 138 49623 67421 63371840
Amylase increased 46.31 16.51 39 49722 6306 63432955
Psoriatic arthropathy 46.22 16.51 8 49753 91512 63347749
Tumour lysis syndrome 45.50 16.51 45 49716 8945 63430316
Hyperglycaemia 45.41 16.51 101 49660 41766 63397495
Immune-mediated encephalopathy 44.75 16.51 8 49753 6 63439255
Asthma 44.73 16.51 22 49739 127539 63311722
Anaemia 44.64 16.51 387 49374 293043 63146218
Lymphangiosis carcinomatosa 44.40 16.51 22 49739 1423 63437838
Immune-mediated pancreatitis 44.36 16.51 12 49749 129 63439132
Silent thyroiditis 43.91 16.51 11 49750 85 63439176
Ascites 43.89 16.51 98 49663 40630 63398631
Metastases to lung 43.78 16.51 52 49709 12698 63426563
Hypokalaemia 43.60 16.51 179 49582 103625 63335636
Blood pressure increased 43.24 16.51 38 49723 162024 63277237
Headache 43.18 16.51 305 49456 632936 62806325
Primary hypothyroidism 42.73 16.51 11 49750 96 63439165
Arthralgia 42.55 16.51 267 49494 569443 62869818
Metastases to meninges 42.23 16.51 26 49735 2576 63436685
Meningitis 42.15 16.51 39 49722 7138 63432123
Tumour haemorrhage 41.88 16.51 22 49739 1609 63437652
Adrenal disorder 41.06 16.51 22 49739 1675 63437586
Intentional overdose 40.88 16.51 5 49756 74147 63365114
Glucocorticoid deficiency 40.47 16.51 13 49748 263 63438998
Duodenitis 40.16 16.51 29 49732 3746 63435515
Lichen planus 39.58 16.51 24 49737 2314 63436947
Immune thrombocytopenia 39.50 16.51 45 49716 10511 63428750
Ill-defined disorder 39.46 16.51 8 49753 81747 63357514
Dermatitis 39.30 16.51 57 49704 16901 63422360
Rheumatoid arthritis 39.28 16.51 88 49673 253731 63185530
Contusion 39.05 16.51 36 49725 150008 63289253
Transaminases increased 39.01 16.51 80 49681 31287 63407974
Hypoalbuminaemia 38.65 16.51 47 49714 11758 63427503
Encephalopathy 38.38 16.51 90 49671 38530 63400731
Stress 38.36 16.51 4 49757 67163 63372098
Capillary leak syndrome 38.31 16.51 23 49738 2177 63437084
Adrenocortical insufficiency acute 38.27 16.51 21 49740 1677 63437584
Autoimmune arthritis 38.19 16.51 9 49752 52 63439209
Wheezing 37.48 16.51 14 49747 95581 63343680
Metastatic malignant melanoma 37.40 16.51 19 49742 1296 63437965
Guillain-Barre syndrome 37.12 16.51 28 49733 3865 63435396
Keratoacanthoma 36.93 16.51 14 49747 469 63438792
Suicide attempt 36.46 16.51 3 49758 60915 63378346
Hepatic failure 36.42 16.51 84 49677 35572 63403689
Urticaria 36.25 16.51 46 49715 165756 63273505
Pregnancy on contraceptive 36.19 16.51 18 49743 1174 63438087
Adverse drug reaction 36.07 16.51 9 49752 79705 63359556
Pancreatic failure 36.04 16.51 17 49744 986 63438275
Autoimmune hypothyroidism 35.49 16.51 11 49750 197 63439064
Thrombocytopenia 35.37 16.51 221 49540 150936 63288325
Diabetes mellitus 35.22 16.51 110 49651 55700 63383561
Wrong technique in product usage process 34.87 16.51 4 49757 62336 63376925
Anxiety 34.83 16.51 74 49687 217467 63221794
Pulmonary embolism 34.78 16.51 182 49579 116502 63322759
Immune-mediated gastritis 34.75 16.51 8 49753 41 63439220
Muscle spasms 34.47 16.51 43 49718 156107 63283154
Lithiasis 33.98 16.51 8 49753 46 63439215
Hypoaesthesia 33.52 16.51 50 49711 168343 63270918
Immune-mediated hyperthyroidism 33.25 16.51 9 49752 97 63439164
Cholecystitis 33.21 16.51 50 49711 15327 63423934
Drug eruption 33.14 16.51 71 49690 28623 63410638
Depression 33.02 16.51 65 49696 196427 63242834
Eagle Barrett syndrome 32.76 16.51 6 49755 6 63439255
Hepatocellular injury 31.91 16.51 68 49693 27313 63411948
Endocrine disorder 31.81 16.51 14 49747 691 63438570
Hypercalcaemia 31.47 16.51 69 49692 28253 63411008
Immune-mediated renal disorder 31.43 16.51 7 49754 30 63439231
Radiation skin injury 30.90 16.51 15 49746 928 63438333
Heart rate increased 30.48 16.51 18 49743 94220 63345041
Limbic encephalitis 30.48 16.51 11 49750 320 63438941
Suicidal ideation 30.35 16.51 6 49755 62415 63376846
Gastrooesophageal reflux disease 29.91 16.51 19 49742 95620 63343641
Impaired healing 29.90 16.51 22 49739 102520 63336741
Cortisol decreased 29.74 16.51 16 49745 1228 63438033
Dehydration 29.72 16.51 235 49526 173119 63266142
Eosinophilia 29.44 16.51 59 49702 22697 63416564
Pericarditis 29.29 16.51 36 49725 131543 63307718
Brain oedema 29.02 16.51 45 49716 14150 63425111
Eyelid ptosis 28.94 16.51 32 49729 7235 63432026
Cerebral microangiopathy 28.88 16.51 10 49751 257 63439004
Pneumonia 28.71 16.51 510 49251 456257 62983004
Immune-mediated neuropathy 28.61 16.51 6 49755 18 63439243
Nasal congestion 28.59 16.51 8 49753 65652 63373609
Oesophagitis 28.51 16.51 46 49715 14962 63424299
Hypoxia 28.24 16.51 107 49654 59685 63379576
Large intestine perforation 28.15 16.51 34 49727 8448 63430813
Gastrointestinal disorder 28.07 16.51 37 49724 131202 63308059
Toxic skin eruption 27.97 16.51 42 49719 12843 63426418
Haemolytic anaemia 27.91 16.51 37 49724 10088 63429173
Medication error 27.69 16.51 4 49757 52280 63386981
Insomnia 27.63 16.51 82 49679 215170 63224091
Catabolic state 27.62 16.51 7 49754 57 63439204
Adrenalitis 27.48 16.51 6 49755 23 63439238
Multiple sclerosis relapse 27.39 16.51 3 49758 48475 63390786
Demyelinating polyneuropathy 27.32 16.51 13 49748 769 63438492
Blood thyroid stimulating hormone decreased 27.07 16.51 25 49736 4565 63434696
Osteoporosis 26.87 16.51 6 49755 57332 63381929
Gastritis 26.82 16.51 77 49684 37226 63402035
Palmar-plantar erythrodysaesthesia syndrome 26.64 16.51 57 49704 22958 63416303
Fluid retention 26.50 16.51 7 49754 59679 63379582
Gait disturbance 26.34 16.51 66 49695 183112 63256149
Balance disorder 26.09 16.51 17 49744 84405 63354856
Influenza 26.08 16.51 28 49733 108694 63330567
Autoimmune neuropathy 26.02 16.51 6 49755 31 63439230
Iridocyclitis 25.98 16.51 19 49742 2503 63436758
Thyrotoxic crisis 25.92 16.51 13 49748 863 63438398
Hyperhidrosis 25.62 16.51 28 49733 107808 63331453
Peripheral sensory neuropathy 24.94 16.51 30 49731 7421 63431840
Oral mucosa erosion 24.93 16.51 14 49747 1169 63438092
Memory impairment 24.85 16.51 27 49734 104231 63335030
Mucosal inflammation 24.71 16.51 87 49674 46841 63392420
Blood alkaline phosphatase increased 24.67 16.51 82 49679 42885 63396376
Tremor 24.66 16.51 41 49720 132198 63307063
Immune-mediated oesophagitis 24.61 16.51 4 49757 0 63439261
Neutropenia 24.60 16.51 227 49534 174778 63264483
Systemic inflammatory response syndrome 24.57 16.51 26 49735 5595 63433666
Cardiomyopathy 24.45 16.51 47 49714 17537 63421724
Metastasis 24.44 16.51 25 49736 5172 63434089
Thoracic cavity drainage 24.39 16.51 7 49754 95 63439166
Cardiac failure congestive 24.25 16.51 22 49739 92411 63346850
Organising pneumonia 23.98 16.51 26 49735 5750 63433511
Blister 23.52 16.51 41 49720 129773 63309488
Tumour thrombosis 23.15 16.51 5 49756 18 63439243
Paraesthesia 23.00 16.51 56 49705 156910 63282351
Lower respiratory tract infection 22.88 16.51 43 49718 132264 63306997
Nephritis allergic 22.77 16.51 8 49753 215 63439046
Graft versus host disease 22.26 16.51 27 49734 6736 63432525
Abdominal pain upper 22.15 16.51 85 49676 206359 63232902
Thrombophlebitis migrans 22.10 16.51 7 49754 135 63439126
Blood creatine phosphokinase increased 22.06 16.51 63 49698 30367 63408894
Gait inability 22.06 16.51 7 49754 52952 63386309
Amnesia 22.02 16.51 8 49753 55577 63383684
Rhinorrhoea 21.96 16.51 12 49749 65565 63373696
Blood glucose increased 21.90 16.51 20 49741 83736 63355525
Autoimmune myositis 21.77 16.51 7 49754 142 63439119
Hepatobiliary disease 21.57 16.51 9 49752 389 63438872
Incorrect dose administered 21.54 16.51 10 49751 59958 63379303
Ileus 21.27 16.51 40 49721 14685 63424576
Haemoglobin decreased 21.24 16.51 52 49709 145433 63293828
Tracheal stenosis 21.07 16.51 7 49754 158 63439103
Paraparesis 21.06 16.51 16 49745 2232 63437029
Palpitations 20.99 16.51 35 49726 112735 63326526
Bradycardia 20.97 16.51 16 49745 73211 63366050
General physical condition abnormal 20.90 16.51 21 49740 4253 63435008
Heart rate decreased 20.89 16.51 5 49756 45555 63393706
Subacute cutaneous lupus erythematosus 20.86 16.51 17 49744 2626 63436635
Loss of consciousness 20.77 16.51 38 49723 118083 63321178
Pneumonia bacterial 20.76 16.51 31 49730 9434 63429827
Sleep disorder 20.71 16.51 20 49741 81546 63357715
Hepatotoxicity 20.66 16.51 70 49691 36971 63402290
Enterocolitis infectious 20.58 16.51 14 49747 1644 63437617
Ketoacidosis 20.48 16.51 21 49740 4357 63434904
Aspiration pleural cavity 20.31 16.51 11 49750 856 63438405
VIth nerve paralysis 20.27 16.51 11 49750 859 63438402
Orbital myositis 20.15 16.51 5 49756 37 63439224
Aplasia pure red cell 20.05 16.51 21 49740 4466 63434795
Tri-iodothyronine free decreased 19.86 16.51 8 49753 316 63438945
Electrocardiogram QT prolonged 19.78 16.51 11 49750 59519 63379742
Pneumothorax 19.66 16.51 41 49720 16220 63423041
Neutrophil count decreased 19.66 16.51 92 49669 56314 63382947
Gastroenteritis eosinophilic 18.98 16.51 6 49755 115 63439146
Dermatitis psoriasiform 18.82 16.51 15 49746 2244 63437017
Upper respiratory tract infection 18.73 16.51 22 49739 82025 63357236
Achromobacter infection 18.72 16.51 5 49756 51 63439210
Multiple organ dysfunction syndrome 18.64 16.51 91 49670 56661 63382600
Thyroid stimulating hormone deficiency 18.46 16.51 3 49758 0 63439261
Autoimmune retinopathy 18.46 16.51 3 49758 0 63439261
Antiacetylcholine receptor antibody positive 18.46 16.51 3 49758 0 63439261
Hepatic enzyme increased 18.22 16.51 89 49672 202239 63237022
Agranulocytosis 18.18 16.51 52 49709 25082 63414179
Generalised oedema 18.10 16.51 39 49722 15779 63423482
Platelet count decreased 18.05 16.51 154 49607 115968 63323293
Hydronephrosis 18.00 16.51 31 49730 10631 63428630
Transfusion 17.97 16.51 38 49723 15179 63424082
Oxygen saturation decreased 17.91 16.51 26 49735 88559 63350702
Tumour embolism 17.91 16.51 6 49755 139 63439122
Ear infection 17.90 16.51 4 49757 38209 63401052
Blood lactate dehydrogenase increased 17.88 16.51 49 49712 23067 63416194
Troponin increased 17.84 16.51 30 49731 10091 63429170
Acute polyneuropathy 17.83 16.51 7 49754 258 63439003
Type 3 diabetes mellitus 17.80 16.51 4 49757 18 63439243
Primary adrenal insufficiency 17.79 16.51 6 49755 142 63439119
KL-6 increased 17.76 16.51 5 49756 63 63439198
Lethargy 17.68 16.51 11 49750 55996 63383265
Optic neuritis 17.61 16.51 27 49734 8408 63430853
Thyroiditis subacute 17.43 16.51 7 49754 274 63438987
Liver function test increased 17.42 16.51 61 49700 32750 63406511
Blood corticotrophin increased 17.34 16.51 5 49756 69 63439192
Pericardial drainage 17.34 16.51 7 49754 278 63438983
Thyroxine free abnormal 17.30 16.51 4 49757 21 63439240
Agitation 17.19 16.51 13 49748 59744 63379517
Polymyositis 17.18 16.51 13 49748 1803 63437458
Pericardial excision 17.14 16.51 4 49757 22 63439239
Immune-mediated cytopenia 16.99 16.51 4 49757 23 63439238
Gamma-glutamyltransferase increased 16.98 16.51 62 49699 33969 63405292
Road traffic accident 16.83 16.51 4 49757 36628 63402633
Therapy partial responder 16.71 16.51 30 49731 10628 63428633
Rheumatic disorder 16.71 16.51 16 49745 3056 63436205
Metastases to bone 16.70 16.51 45 49716 20974 63418287
Intestinal perforation 16.66 16.51 32 49729 11931 63427330
Joint stiffness 16.63 16.51 6 49755 41863 63397398
Troponin T increased 16.55 16.51 11 49750 1243 63438018
Dermatitis acneiform 16.53 16.51 20 49741 4976 63434285

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
Malignant neoplasm progression 8424.76 14.16 4256 88367 83790 34780518
Immune-mediated enterocolitis 1397.76 14.16 448 92175 2351 34861957
Intentional product use issue 1361.18 14.16 1184 91439 58632 34805676
Hypothyroidism 1288.55 14.16 760 91863 20142 34844166
Pneumonitis 1205.94 14.16 873 91750 33005 34831303
Death 1180.82 14.16 2971 89652 395078 34469230
Adrenal insufficiency 1160.23 14.16 619 92004 13428 34850880
Colitis 1086.99 14.16 857 91766 36893 34827415
Hypophysitis 1028.03 14.16 338 92285 1948 34862360
Fulminant type 1 diabetes mellitus 918.31 14.16 250 92373 641 34863667
Hypopituitarism 701.80 14.16 254 92369 2028 34862280
Myocarditis 673.08 14.16 431 92192 13251 34851057
Pemphigoid 648.89 14.16 358 92265 8308 34856000
Interstitial lung disease 642.27 14.16 827 91796 64455 34799853
Hyperthyroidism 582.94 14.16 358 92265 10208 34854100
Thyroiditis 562.52 14.16 218 92405 2144 34862164
Adrenocorticotropic hormone deficiency 557.80 14.16 172 92451 775 34863533
Immune-mediated hepatitis 554.52 14.16 212 92411 2003 34862305
Type 1 diabetes mellitus 542.36 14.16 252 92371 4006 34860302
Immune-mediated lung disease 526.56 14.16 187 92436 1404 34862904
Myositis 524.80 14.16 352 92271 11718 34852590
Immune-mediated hepatic disorder 475.01 14.16 155 92468 868 34863440
Secondary adrenocortical insufficiency 464.68 14.16 167 92456 1303 34863005
Immune-mediated myocarditis 459.21 14.16 142 92481 647 34863661
Autoimmune hepatitis 416.62 14.16 212 92411 4148 34860160
Drug interaction 395.38 14.16 63 92560 225883 34638425
Autoimmune colitis 369.33 14.16 128 92495 886 34863422
Hepatic function abnormal 367.20 14.16 517 92106 43846 34820462
Prescribed underdose 360.91 14.16 249 92374 8684 34855624
Enterocolitis 343.90 14.16 232 92391 7794 34856514
Drug ineffective 341.73 14.16 427 92196 456324 34407984
Myasthenia gravis 327.35 14.16 213 92410 6727 34857581
Toxicity to various agents 316.18 14.16 72 92551 200290 34664018
Immune-mediated dermatitis 309.31 14.16 87 92536 262 34864046
Metastases to central nervous system 292.75 14.16 212 92411 7993 34856315
Hepatitis 276.78 14.16 329 92294 23575 34840733
Liver disorder 275.12 14.16 386 92237 32611 34831697
Diabetic ketoacidosis 268.50 14.16 283 92340 17749 34846559
Radiation pneumonitis 248.24 14.16 127 92496 2513 34861795
Vitiligo 235.01 14.16 90 92533 854 34863454
Lymphocytic hypophysitis 219.56 14.16 65 92558 247 34864061
Hypothalamo-pituitary disorder 216.96 14.16 82 92541 748 34863560
Cachexia 212.62 14.16 166 92457 7020 34857288
Prescribed overdose 204.57 14.16 192 92431 10455 34853853
Lichen planus 202.21 14.16 82 92541 917 34863391
Product dose omission issue 198.98 14.16 38 92585 119673 34744635
Pyrexia 197.36 14.16 1531 91092 331482 34532826
Tubulointerstitial nephritis 196.49 14.16 260 92363 20764 34843544
Encephalitis 191.63 14.16 157 92466 7120 34857188
Immune-mediated hypothyroidism 189.94 14.16 58 92565 251 34864057
Completed suicide 189.11 14.16 20 92603 98148 34766160
Overdose 187.70 14.16 14 92609 91045 34773263
Decreased appetite 177.87 14.16 891 91732 165501 34698807
Thyroid disorder 173.36 14.16 107 92516 3075 34861233
Cholangitis 173.32 14.16 160 92463 8529 34855779
Immune-mediated thyroiditis 171.95 14.16 45 92578 93 34864215
Diarrhoea 168.31 14.16 1672 90951 388240 34476068
Autoimmune thyroiditis 166.84 14.16 75 92548 1099 34863209
Tumour pseudoprogression 166.32 14.16 59 92564 441 34863867
Cholangitis sclerosing 165.25 14.16 79 92544 1342 34862966
Leukoderma 163.17 14.16 39 92584 44 34864264
Lung disorder 161.44 14.16 312 92311 34384 34829924
Immune-mediated adrenal insuficiency 159.89 14.16 44 92579 119 34864189
Immune-mediated hypophysitis 158.76 14.16 39 92584 54 34864254
General physical health deterioration 151.46 14.16 707 91916 127562 34736746
Hypercalcaemia 144.07 14.16 191 92432 15277 34849031
Adverse event 137.16 14.16 207 92416 18670 34845638
Uveitis 133.59 14.16 130 92493 7405 34856903
Immune-mediated nephritis 132.14 14.16 46 92577 323 34863985
Pulmonary toxicity 132.02 14.16 118 92505 6029 34858279
Adrenal disorder 131.74 14.16 62 92561 1015 34863293
Immune-mediated myositis 128.86 14.16 76 92547 2007 34862301
Immune-mediated encephalitis 126.47 14.16 40 92583 199 34864109
Drug hypersensitivity 124.70 14.16 30 92593 80499 34783809
Dizziness 123.03 14.16 246 92377 218275 34646033
Autoimmune nephritis 119.69 14.16 40 92583 244 34864064
Immune-mediated uveitis 116.04 14.16 28 92595 34 34864274
Nephritis 115.01 14.16 75 92548 2376 34861932
Pleural effusion 114.02 14.16 473 92150 81073 34783235
Tumour haemorrhage 111.30 14.16 79 92544 2883 34861425
Blood corticotrophin decreased 109.87 14.16 35 92588 179 34864129
Immune-mediated cholangitis 106.57 14.16 31 92592 109 34864199
Haemoglobin decreased 106.30 14.16 98 92525 120674 34743634
Autoimmune pancreatitis 101.91 14.16 37 92586 298 34864010
Immune thrombocytopenia 101.03 14.16 123 92500 9029 34855279
Rash 99.92 14.16 964 91659 221788 34642520
Skin disorder 98.98 14.16 149 92474 13406 34850902
Blood pressure increased 97.67 14.16 56 92567 88046 34776262
Intentional product misuse 96.91 14.16 6 92617 45605 34818703
Polyarthritis 95.22 14.16 86 92537 4454 34859854
Immune-mediated pancreatitis 94.04 14.16 28 92595 109 34864199
Palmar-plantar erythrodysaesthesia syndrome 90.60 14.16 161 92462 16634 34847674
Relapsing fever 90.60 14.16 29 92594 151 34864157
Encephalitis autoimmune 87.51 14.16 41 92582 664 34863644
Lipase increased 87.26 14.16 116 92507 9300 34855008
Erythema multiforme 87.08 14.16 111 92512 8538 34855770
Condition aggravated 86.84 14.16 243 92380 191953 34672355
Intentional overdose 86.41 14.16 8 92615 43666 34820642
Feeling abnormal 86.05 14.16 30 92593 63205 34801103
Immune-mediated adverse reaction 85.44 14.16 38 92585 542 34863766
Enteritis 84.36 14.16 106 92517 8036 34856272
Autoimmune haemolytic anaemia 80.51 14.16 78 92545 4418 34859890
Agitation 80.25 14.16 26 92597 57373 34806935
Cortisol decreased 80.07 14.16 45 92578 1082 34863226
Dermatomyositis 79.86 14.16 47 92576 1236 34863072
Suicidal ideation 78.32 14.16 8 92615 40380 34823928
Hyperglycaemia 77.84 14.16 256 92367 39224 34825084
Suicide attempt 77.83 14.16 7 92616 39109 34825199
Pain in extremity 77.65 14.16 135 92488 126378 34737930
Cardiac failure congestive 77.56 14.16 64 92559 83206 34781102
Aggression 77.45 14.16 7 92616 38957 34825351
Immune-mediated hyperthyroidism 76.86 14.16 20 92603 40 34864268
Blood thyroid stimulating hormone increased 76.53 14.16 74 92549 4181 34860127
International normalised ratio increased 76.52 14.16 16 92607 47311 34816997
Meningitis aseptic 75.47 14.16 65 92558 3159 34861149
Incorrect dose administered 73.67 14.16 10 92613 40505 34823803
Anxiety 72.73 14.16 94 92529 99334 34764974
Therapeutic product effect decreased 72.53 14.16 5 92618 34738 34829570
Autoimmune disorder 72.42 14.16 50 92573 1744 34862564
Adrenocortical insufficiency acute 70.32 14.16 47 92576 1553 34862755
Foetal exposure during pregnancy 70.24 14.16 9 92614 38092 34826216
Unevaluable event 70.10 14.16 4 92619 32586 34831722
Myasthenic syndrome 69.39 14.16 32 92591 499 34863809
Vogt-Koyanagi-Harada disease 68.61 14.16 20 92603 71 34864237
Immune-mediated arthritis 68.38 14.16 21 92602 93 34864215
Hyperhidrosis 67.06 14.16 61 92562 75631 34788677
Blood glucose increased 66.29 14.16 48 92575 66670 34797638
Dermatitis 66.19 14.16 102 92521 9366 34854942
Tri-iodothyronine free decreased 65.86 14.16 18 92605 47 34864261
Depression 65.80 14.16 97 92526 97001 34767307
Therapeutic product effect incomplete 65.36 14.16 26 92597 50515 34813793
Immune-mediated gastritis 65.00 14.16 17 92606 35 34864273
Pericardial effusion 63.79 14.16 176 92447 24486 34839822
Lichenoid keratosis 63.71 14.16 53 92570 2455 34861853
Sialoadenitis 63.27 14.16 31 92592 557 34863751
Fall 62.89 14.16 300 92323 202585 34661723
Thyroid function test abnormal 62.85 14.16 33 92590 690 34863618
Tumour pain 62.60 14.16 38 92585 1059 34863249
Muscle spasms 62.31 14.16 64 92559 74937 34789371
Joint swelling 62.27 14.16 41 92582 59849 34804459
Weight increased 62.01 14.16 94 92529 92939 34771369
Arthritis 61.55 14.16 203 92420 31143 34833165
Stress 61.55 14.16 5 92618 30342 34833966
Polymyalgia rheumatica 60.76 14.16 42 92581 1468 34862840
Non-small cell lung cancer 60.70 14.16 63 92560 3877 34860431
Endocrine disorder 60.52 14.16 25 92598 294 34864014
Rash maculo-papular 60.17 14.16 189 92434 28262 34836046
Silent thyroiditis 59.76 14.16 17 92606 54 34864254
Serous retinal detachment 59.16 14.16 30 92593 582 34863726
Peripheral swelling 58.44 14.16 70 92553 76471 34787837
Somnolence 58.29 14.16 130 92493 110986 34753322
Electrocardiogram QT prolonged 58.22 14.16 18 92605 40934 34823374
Eosinophilic fasciitis 58.20 14.16 18 92605 82 34864226
Immune-mediated renal disorder 58.13 14.16 20 92603 135 34864173
Drug intolerance 57.70 14.16 44 92579 59526 34804782
Hyponatraemia 57.66 14.16 396 92227 82295 34782013
Autoimmune arthritis 57.43 14.16 16 92607 46 34864262
Heart rate decreased 57.32 14.16 8 92615 31737 34832571
Metastases to bone 57.31 14.16 109 92514 11861 34852447
General physical condition abnormal 57.19 14.16 60 92563 3739 34860569
Immune-mediated cystitis 57.15 14.16 14 92609 19 34864289
Prostate cancer 57.14 14.16 17 92606 39632 34824676
Autoimmune myocarditis 57.05 14.16 22 92601 213 34864095
Coma 56.65 14.16 25 92598 45653 34818655
Bradycardia 56.49 14.16 70 92553 75348 34788960
Heart rate increased 56.48 14.16 26 92597 46317 34817991
Pneumothorax 56.23 14.16 143 92480 18949 34845359
Blood thyroid stimulating hormone decreased 55.60 14.16 44 92579 1897 34862411
Immune-mediated endocrinopathy 54.83 14.16 14 92609 25 34864283
Haemophagocytic lymphohistiocytosis 54.70 14.16 112 92511 12861 34851447
Blood pressure fluctuation 54.61 14.16 3 92620 25246 34839062
Wrong technique in product usage process 54.53 14.16 14 92609 35972 34828336
Coronary artery disease 54.52 14.16 30 92593 48275 34816033
Abdominal discomfort 54.46 14.16 47 92576 59788 34804520
Organising pneumonia 54.39 14.16 73 92550 5906 34858402
Pneumonia bacterial 54.26 14.16 106 92517 11766 34852542
Loss of personal independence in daily activities 54.08 14.16 11 92612 33168 34831140
Myocardial infarction 53.95 14.16 154 92469 120931 34743377
Rheumatic disorder 53.74 14.16 28 92595 576 34863732
Tumour associated fever 53.24 14.16 25 92598 407 34863901
Immune-mediated encephalopathy 51.99 14.16 12 92611 10 34864298
Haematocrit decreased 51.85 14.16 11 92612 32205 34832103
Nephrolithiasis 51.69 14.16 9 92614 30324 34833984
Drug-induced liver injury 50.72 14.16 180 92443 28652 34835656
Angioedema 50.37 14.16 18 92605 37356 34826952
Meningitis 50.05 14.16 63 92560 4784 34859524
Loss of consciousness 49.98 14.16 89 92534 82578 34781730
Amylase increased 49.97 14.16 70 92553 5898 34858410
Hallucination 49.93 14.16 38 92585 51460 34812848
Unresponsive to stimuli 49.66 14.16 7 92616 27562 34836746
Autoimmune neuropathy 49.56 14.16 14 92609 43 34864265
Drug dependence 49.09 14.16 4 92619 24213 34840095
Musculoskeletal stiffness 48.47 14.16 32 92591 46648 34817660
Nasopharyngitis 48.27 14.16 69 92554 69899 34794409
Primary adrenal insufficiency 48.18 14.16 14 92609 49 34864259
Insomnia 47.88 14.16 130 92493 103777 34760531
Palpitations 47.85 14.16 23 92600 39963 34824345
Asthma 47.41 14.16 27 92596 42629 34821679
Pancreatic enzymes increased 46.23 14.16 26 92597 626 34863682
Enterocolitis haemorrhagic 45.93 14.16 30 92593 953 34863355
Mobility decreased 45.11 14.16 12 92611 30116 34834192
Medication error 44.87 14.16 7 92616 25558 34838750
Hypotension 44.76 14.16 374 92249 221275 34643033
Drug-device incompatibility 44.42 14.16 9 92614 0 34864308
Drug level increased 43.83 14.16 4 92619 22092 34842216
Tremor 43.81 14.16 96 92527 82491 34781817
Diabetes mellitus 43.70 14.16 242 92381 46631 34817677
Primary hypothyroidism 43.58 14.16 13 92610 51 34864257
Embolism 43.45 14.16 76 92547 7753 34856555
Intracranial tumour haemorrhage 43.19 14.16 20 92603 315 34863993
Guillain-Barre syndrome 43.14 14.16 66 92557 6021 34858287
Autoimmune dermatitis 42.97 14.16 10 92613 9 34864299
Pneumonia aspiration 42.92 14.16 222 92401 41681 34822627
Autoimmune hypothyroidism 42.69 14.16 12 92611 36 34864272
Metastases to meninges 41.73 14.16 33 92590 1421 34862887
Cancer pain 41.66 14.16 43 92580 2629 34861679
Adrenalitis 41.51 14.16 10 92613 12 34864296
Abnormal behaviour 41.28 14.16 8 92615 24961 34839347
Blood corticotrophin increased 41.14 14.16 14 92609 91 34864217
Product prescribing error 40.87 14.16 6 92617 22921 34841387
Cardiac arrest 40.86 14.16 125 92498 96034 34768274
Cytomegalovirus enterocolitis 40.82 14.16 28 92595 966 34863342
Respiratory arrest 40.45 14.16 12 92611 28031 34836277
Drug eruption 40.08 14.16 130 92493 19768 34844540
Psychotic disorder 40.07 14.16 8 92615 24444 34839864
Adverse drug reaction 39.77 14.16 14 92609 29328 34834980
Metastases to pleura 39.74 14.16 21 92602 445 34863863
Dyskinesia 39.65 14.16 6 92617 22407 34841901
Nephrotic syndrome 39.37 14.16 70 92553 7233 34857075
Red blood cell count decreased 39.22 14.16 14 92609 29076 34835232
Disseminated intravascular coagulation 39.06 14.16 137 92486 21679 34842629
Metastases to lung 38.75 14.16 80 92543 9240 34855068
Eyelid ptosis 38.74 14.16 61 92562 5705 34858603
Epistaxis 38.66 14.16 59 92564 58192 34806116
Immune-mediated neuropathy 38.65 14.16 11 92612 35 34864273
Treatment failure 38.60 14.16 40 92583 46657 34817651
Wheezing 38.31 14.16 32 92591 41370 34822938
Drug withdrawal syndrome 38.26 14.16 4 92619 19830 34844478
Taste disorder 37.83 14.16 68 92555 7087 34857221
Aspartate aminotransferase increased 37.81 14.16 308 92315 67475 34796833
Lymphangiosis carcinomatosa 37.68 14.16 26 92597 906 34863402
Headache 37.63 14.16 345 92278 200290 34664018
Aspiration pleural cavity 37.59 14.16 25 92598 819 34863489
Polymyositis 37.52 14.16 31 92592 1422 34862886
Hepatic failure 37.50 14.16 186 92437 34345 34829963
Treatment noncompliance 37.08 14.16 14 92609 28086 34836222
Cytokine release syndrome 37.01 14.16 139 92484 22738 34841570
Accidental overdose 36.54 14.16 5 92618 20135 34844173
Facial paralysis 36.52 14.16 85 92538 10649 34853659
Autoimmune thyroid disorder 36.26 14.16 8 92615 4 34864304
Thrombophlebitis migrans 35.90 14.16 15 92608 182 34864126
Pain 35.82 14.16 358 92265 204317 34659991
Balance disorder 35.71 14.16 33 92590 40621 34823687
Neutropenia 35.62 14.16 256 92367 156522 34707786
Prerenal failure 35.16 14.16 35 92588 2049 34862259
Sinusitis 34.75 14.16 35 92588 41367 34822941
Dermatitis psoriasiform 34.69 14.16 30 92593 1466 34862842
Metastases to lymph nodes 34.55 14.16 52 92571 4676 34859632
Paraesthesia 34.52 14.16 74 92549 64098 34800210
White blood cell count decreased 34.50 14.16 133 92490 95312 34768996
Iridocyclitis 34.07 14.16 31 92592 1621 34862687
Pleurodesis 33.07 14.16 9 92614 23 34864285
Gastrointestinal haemorrhage 32.82 14.16 122 92501 88355 34775953
Stomatitis 32.26 14.16 208 92415 42306 34822002
Morphoea 31.97 14.16 14 92609 192 34864116
Gait disturbance 31.84 14.16 117 92506 85023 34779285
Full blood count decreased 31.64 14.16 5 92618 18083 34846225
Injury 31.43 14.16 8 92615 20679 34843629
Superior vena cava syndrome 31.31 14.16 20 92603 611 34863697
Swelling 31.01 14.16 40 92583 42326 34821982
Hypertension 30.88 14.16 223 92400 136220 34728088
Sleep apnoea syndrome 30.60 14.16 8 92615 20313 34843995
Acquired tracheo-oesophageal fistula 30.47 14.16 11 92612 87 34864221
Inappropriate schedule of product administration 30.16 14.16 76 92547 62220 34802088
Chest discomfort 30.07 14.16 62 92561 54468 34809840
Blood urea increased 29.95 14.16 22 92601 30342 34833966
Stevens-Johnson syndrome 29.94 14.16 113 92510 18526 34845782
Glucocorticoid deficiency 29.86 14.16 15 92608 285 34864023
Confusional state 29.63 14.16 242 92381 143918 34720390
Limbic encephalitis 29.62 14.16 17 92606 426 34863882
Pituitary enlargement 29.52 14.16 8 92615 20 34864288
Tachycardia 29.45 14.16 120 92503 84652 34779656
Orthostatic hypotension 29.38 14.16 16 92607 25903 34838405
Metastases to skin 29.30 14.16 17 92606 435 34863873
Product quality issue 29.14 14.16 5 92618 17030 34847278
Cardiac tamponade 29.06 14.16 51 92572 5215 34859093
Premature baby 29.05 14.16 8 92615 19625 34844683
Intestinal perforation 28.93 14.16 70 92553 8990 34855318
Pallor 28.49 14.16 16 92607 25464 34838844
Metastases to liver 28.18 14.16 90 92533 13573 34850735
Contusion 28.01 14.16 33 92590 36331 34827977
Nasal congestion 27.99 14.16 13 92610 23044 34841264
Drug resistance 27.97 14.16 17 92606 25910 34838398
Transient acantholytic dermatosis 27.86 14.16 11 92612 114 34864194
Gastrointestinal perforation 27.54 14.16 42 92581 3821 34860487
Hypervolaemia 27.41 14.16 9 92614 19700 34844608
Blood corticotrophin abnormal 26.90 14.16 7 92616 14 34864294
Colitis microscopic 26.75 14.16 32 92591 2305 34862003
Bronchial fistula 26.62 14.16 12 92611 177 34864131
Cardiac disorder 26.44 14.16 46 92577 43080 34821228
Ill-defined disorder 26.34 14.16 3 92620 13906 34850402
White blood cell count increased 26.05 14.16 43 92580 41108 34823200
Myelitis 25.99 14.16 20 92603 827 34863481
Haematoma 25.97 14.16 18 92605 25587 34838721
Abdominal pain 25.84 14.16 293 92330 163325 34700983
Prostatic specific antigen increased 25.81 14.16 4 92619 14676 34849632
Optic neuritis 25.68 14.16 39 92584 3535 34860773
Therapy non-responder 25.63 14.16 40 92583 39106 34825202
Bile duct stenosis 25.51 14.16 23 92600 1188 34863120
Cholecystitis 25.41 14.16 74 92549 10614 34853694
Cardiomegaly 25.40 14.16 5 92618 15433 34848875
Infusion related reaction 25.35 14.16 233 92390 52824 34811484
Autoimmune lung disease 25.26 14.16 8 92615 40 34864268
Amnesia 25.23 14.16 20 92603 26543 34837765
Sleep disorder 25.23 14.16 28 92595 31660 34832648
Thrombosis 24.86 14.16 61 92562 50397 34813911
Pancytopenia 24.81 14.16 149 92474 95008 34769300
IgA nephropathy 24.68 14.16 23 92600 1240 34863068
Chest pain 24.60 14.16 216 92407 126546 34737762
Haemoptysis 24.58 14.16 168 92455 34838 34829470
Migraine 24.27 14.16 8 92615 17470 34846838
Road traffic accident 24.21 14.16 8 92615 17442 34846866
Immune-mediated cytopenia 24.20 14.16 7 92616 24 34864284
Pneumocystis jirovecii pneumonia 24.19 14.16 110 92513 19600 34844708
Memory impairment 24.09 14.16 49 92574 43269 34821039
Glomerular filtration rate decreased 24.03 14.16 3 92620 12958 34851350
Incorrect route of product administration 24.03 14.16 5 92618 14840 34849468
Skin hypopigmentation 23.88 14.16 13 92610 293 34864015
Extrapyramidal disorder 23.84 14.16 3 92620 12877 34851431
Obesity 23.83 14.16 3 92620 12875 34851433
Blood potassium decreased 23.51 14.16 9 92614 17906 34846402
Mechanical ileus 23.46 14.16 14 92609 378 34863930
Radiation necrosis 23.45 14.16 10 92613 128 34864180
Hyperlipidaemia 23.30 14.16 5 92618 14524 34849784
Iris adhesions 23.25 14.16 12 92611 242 34864066
Hypoglycaemia 23.22 14.16 71 92552 54569 34809739
Erectile dysfunction 23.02 14.16 13 92610 20624 34843684
Lip swelling 22.97 14.16 7 92616 16073 34848235
Gastrooesophageal reflux disease 22.75 14.16 41 92582 37883 34826425
Pancreatic failure 22.67 14.16 18 92605 780 34863528
Malignant pleural effusion 22.66 14.16 24 92599 1512 34862796
Melanoma recurrent 22.52 14.16 10 92613 142 34864166
Urticaria 22.48 14.16 87 92536 62290 34802018
Pericarditis 22.48 14.16 75 92548 11570 34852738
Blood triglycerides increased 22.45 14.16 5 92618 14154 34850154
Leukopenia 22.44 14.16 88 92535 62768 34801540
Dyspnoea exertional 22.37 14.16 51 92572 43228 34821080
Lactic acidosis 22.32 14.16 36 92587 34736 34829572
Large intestine perforation 22.30 14.16 61 92562 8442 34855866
Fluid retention 22.25 14.16 23 92600 26864 34837444
Infectious pleural effusion 22.22 14.16 30 92593 2440 34861868
Ventricular fibrillation 22.16 14.16 17 92606 22937 34841371
Transfusion 21.93 14.16 61 92562 8524 34855784
Syncope 21.89 14.16 147 92476 91304 34773004
Paranoia 21.88 14.16 3 92620 12065 34852243
Glomerulonephritis membranous 21.87 14.16 21 92602 1176 34863132
Gout 21.66 14.16 12 92611 19241 34845067
Hallucination, visual 21.64 14.16 10 92613 17781 34846527
Off label use 21.54 14.16 1336 91287 418188 34446120
Pancreatic toxicity 21.48 14.16 7 92616 39 34864269
Abdominal distension 21.45 14.16 81 92542 58411 34805897
Chronic gastritis 21.36 14.16 24 92599 1616 34862692
Paraneoplastic syndrome 21.36 14.16 15 92608 538 34863770
Sterile pyuria 21.33 14.16 7 92616 40 34864268
Generalised tonic-clonic seizure 21.33 14.16 15 92608 21159 34843149
Cryptitis 21.17 14.16 11 92612 225 34864083
Thyroxine free decreased 21.04 14.16 12 92611 297 34864011
Skin toxicity 21.00 14.16 42 92581 4742 34859566
Pericarditis malignant 20.77 14.16 7 92616 44 34864264
Pneumonia 20.72 14.16 1166 91457 361461 34502847
Autoimmune encephalopathy 20.63 14.16 7 92616 45 34864263
Upper respiratory tract infection 20.50 14.16 35 92588 33024 34831284
Full blood count abnormal 20.48 14.16 12 92611 18656 34845652
Intestinal metastasis 20.33 14.16 11 92612 245 34864063
Therapeutic response decreased 20.11 14.16 29 92594 29284 34835024
Cortisol increased 20.10 14.16 10 92613 186 34864122
Influenza 20.07 14.16 66 92557 49600 34814708
Coagulopathy 19.96 14.16 14 92609 19775 34844533
Burning sensation 19.93 14.16 12 92611 18382 34845926
Pleurocutaneous fistula 19.77 14.16 7 92616 52 34864256
Antinuclear antibody 19.74 14.16 4 92619 0 34864308
Optic perineuritis 19.74 14.16 4 92619 0 34864308
Blood pressure systolic increased 19.72 14.16 19 92604 22933 34841375
Physical deconditioning 19.63 14.16 21 92602 1338 34862970
Pulmonary sepsis 19.61 14.16 27 92596 2238 34862070
Thyroxine free abnormal 19.56 14.16 5 92618 9 34864299
Duodenitis 19.55 14.16 41 92582 4787 34859521
Therapy interrupted 19.50 14.16 6 92617 13691 34850617
Hepatotoxicity 19.40 14.16 110 92513 21375 34842933
Lung neoplasm malignant 19.34 14.16 11 92612 17384 34846924
Pericardial drainage 19.30 14.16 8 92615 95 34864213
Peripheral motor neuropathy 19.28 14.16 24 92599 1802 34862506
Appetite disorder 19.24 14.16 28 92595 2443 34861865
Diabetic ketoacidotic hyperglycaemic coma 19.14 14.16 9 92614 147 34864161
Osteoarthritis 19.04 14.16 16 92607 20626 34843682
Glomerulonephritis rapidly progressive 19.03 14.16 15 92608 643 34863665
Hypophonesis 18.89 14.16 5 92618 11 34864297
Flatulence 18.86 14.16 17 92606 21181 34843127
Swelling face 18.85 14.16 20 92603 23085 34841223
Hypertransaminasaemia 18.64 14.16 44 92579 5562 34858746
Cortisol abnormal 18.63 14.16 6 92617 32 34864276
Respiratory failure 18.62 14.16 397 92226 108175 34756133
Alanine aminotransferase increased 18.51 14.16 309 92314 80506 34783802
Chondritis 18.40 14.16 9 92614 161 34864147
Intestinal intraepithelial lymphocytes increased 18.40 14.16 9 92614 161 34864147
Obstructive airways disorder 18.40 14.16 9 92614 15485 34848823
Viral infection 18.40 14.16 12 92611 17611 34846697
Irritability 18.39 14.16 23 92600 24667 34839641
Muscle rigidity 18.19 14.16 3 92620 10515 34853793
Pulmonary sarcoidosis 18.13 14.16 14 92609 582 34863726
Seizure 18.06 14.16 184 92439 104673 34759635
Device malfunction 17.96 14.16 3 92620 10418 34853890
Oesophagitis 17.78 14.16 76 92547 13185 34851123
Metastasis 17.73 14.16 36 92587 4108 34860200
Renal disorder 17.72 14.16 122 92501 25358 34838950
Metastases to peritoneum 17.52 14.16 23 92600 1821 34862487
Radiation skin injury 17.40 14.16 15 92608 730 34863578
Hallucination, auditory 17.37 14.16 5 92618 11912 34852396
Hypoalbuminaemia 17.28 14.16 71 92552 12103 34852205
Coronary artery occlusion 17.12 14.16 4 92619 10958 34853350
Cerebrovascular accident 17.12 14.16 143 92480 84668 34779640
Achromotrichia acquired 16.98 14.16 4 92619 4 34864304
Autoimmune anaemia 16.98 14.16 4 92619 4 34864304
Biliary tract infection 16.97 14.16 14 92609 641 34863667
Scleroderma-like reaction 16.90 14.16 6 92617 45 34864263
Metastases to spine 16.90 14.16 27 92596 2557 34861751
Autoimmune myositis 16.83 14.16 8 92615 134 34864174
Myoclonus 16.82 14.16 9 92614 14716 34849592
Respiratory rate increased 16.72 14.16 3 92620 9891 34854417
Troponin increased 16.63 14.16 67 92556 11322 34852986
Oropharyngeal pain 16.63 14.16 44 92579 35441 34828867
Ileus 16.60 14.16 87 92536 16412 34847896
Neoplasm malignant 16.50 14.16 17 92606 19888 34844420
Pain in jaw 16.38 14.16 7 92616 13033 34851275
Blood thyroid stimulating hormone abnormal 16.05 14.16 11 92612 379 34863929
Hepatic steatosis 16.01 14.16 15 92608 18347 34845961
Sarcoidosis 15.98 14.16 28 92595 2860 34861448
Hospitalisation 15.96 14.16 87 92536 56815 34807493
Euthanasia 15.95 14.16 5 92618 24 34864284
Haemodynamic instability 15.85 14.16 3 92620 9520 34854788
Mania 15.82 14.16 3 92620 9508 34854800
Troponin T increased 15.81 14.16 25 92598 2346 34861962
Ventricular extrasystoles 15.81 14.16 6 92617 12002 34852306
Cardio-respiratory arrest 15.78 14.16 84 92539 55189 34809119
Hepatobiliary disease 15.77 14.16 11 92612 390 34863918
Chest tube insertion 15.73 14.16 7 92616 100 34864208
Lethargy 15.70 14.16 56 92567 41066 34823242
Pancreatic atrophy 15.62 14.16 12 92611 495 34863813
Muscle twitching 15.61 14.16 4 92619 10294 34854014
Skin cancer 15.61 14.16 4 92619 10293 34854015
Dysphagia 15.58 14.16 242 92381 62139 34802169
Synovitis 15.49 14.16 9 92614 14057 34850251
Pulmonary oedema 15.44 14.16 69 92554 47460 34816848
Chronic inflammatory demyelinating polyradiculoneuropathy 15.40 14.16 14 92609 731 34863577
Brain oedema 15.39 14.16 75 92548 13746 34850562
Ketosis-prone diabetes mellitus 15.37 14.16 4 92619 8 34864300
Arthropathy 15.34 14.16 30 92593 26877 34837431
Spinal cord compression 15.22 14.16 33 92590 3942 34860366
Rhinorrhoea 15.17 14.16 28 92595 25640 34838668
Serous retinopathy 15.13 14.16 7 92616 110 34864198
Limb injury 15.13 14.16 6 92617 11683 34852625
Squamous cell carcinoma of skin 15.07 14.16 5 92618 10876 34853432
Joint injury 15.03 14.16 3 92620 9170 34855138
Red blood cell sedimentation rate increased 15.01 14.16 3 92620 9159 34855149
Blood urine present 14.97 14.16 5 92618 10829 34853479
Neutrophil count increased 14.96 14.16 14 92609 17132 34847176
Disorientation 14.91 14.16 42 92581 33146 34831162
Blood pressure decreased 14.87 14.16 78 92545 51437 34812871
Dysuria 14.85 14.16 31 92592 27121 34837187
Blood pressure diastolic decreased 14.85 14.16 3 92620 9091 34855217
Renal tubular acidosis 14.85 14.16 24 92599 2295 34862013
Paraneoplastic retinopathy 14.81 14.16 3 92620 0 34864308
Myofascitis 14.81 14.16 3 92620 0 34864308
Laryngeal obstruction 14.81 14.16 3 92620 0 34864308
Glomerulonephritis 14.80 14.16 22 92601 1956 34862352
Opsoclonus myoclonus 14.80 14.16 6 92617 67 34864241
Haemorrhage 14.70 14.16 78 92545 51292 34813016
Rales 14.67 14.16 4 92619 9879 34854429
Abdominal pain upper 14.67 14.16 120 92503 71370 34792938
Diabetic hyperosmolar coma 14.66 14.16 11 92612 438 34863870
Depressed level of consciousness 14.64 14.16 61 92562 42780 34821528
Disease progression 14.62 14.16 200 92423 107877 34756431
Toxic neuropathy 14.59 14.16 12 92611 547 34863761
Hypoaesthesia 14.58 14.16 99 92524 61345 34802963
Atrioventricular block complete 14.55 14.16 56 92567 9263 34855045
Bladder cancer 14.55 14.16 13 92610 16265 34848043
Evans syndrome 14.51 14.16 9 92614 261 34864047
Neuritis 14.50 14.16 15 92608 919 34863389
Tracheal obstruction 14.49 14.16 6 92617 71 34864237
Respiratory depression 14.48 14.16 13 92610 16232 34848076
Thyroxine free increased 14.47 14.16 9 92614 262 34864046
Altered state of consciousness 14.40 14.16 107 92516 22786 34841522
Biliary obstruction 14.40 14.16 26 92597 2719 34861589
Haemodialysis 14.30 14.16 5 92618 10521 34853787
Microvillous inclusion disease 14.25 14.16 8 92615 192 34864116

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
Malignant neoplasm progression 12666.32 13.20 5550 124182 130440 79484216
Immune-mediated enterocolitis 2185.39 13.20 640 129092 4190 79610466
Pneumonitis 1910.05 13.20 1205 128527 59655 79555001
Hypothyroidism 1887.81 13.20 1133 128599 51259 79563397
Colitis 1768.89 13.20 1232 128500 72075 79542581
Hypophysitis 1753.41 13.20 522 129210 3644 79611012
Death 1668.64 13.20 3155 126577 563359 79051297
Adrenal insufficiency 1659.96 13.20 846 128886 27641 79587015
Intentional product use issue 1568.23 13.20 1561 128171 150551 79464105
Fulminant type 1 diabetes mellitus 1490.03 13.20 369 129363 1114 79613542
Myocarditis 1104.37 13.20 589 129143 21144 79593512
Hypopituitarism 1062.24 13.20 339 129393 3060 79611596
Immune-mediated hepatitis 1042.00 13.20 340 129392 3316 79611340
Hyperthyroidism 973.79 13.20 546 129186 21663 79592993
Interstitial lung disease 939.79 13.20 1033 128699 111567 79503089
Type 1 diabetes mellitus 902.66 13.20 361 129371 6558 79608098
Thyroiditis 900.60 13.20 323 129409 4282 79610374
Immune-mediated lung disease 881.91 13.20 268 129464 2022 79612634
Pemphigoid 831.75 13.20 434 129298 14881 79599775
Adrenocorticotropic hormone deficiency 822.51 13.20 227 129505 1158 79613498
Immune-mediated hepatic disorder 786.47 13.20 226 129506 1368 79613288
Myositis 753.81 13.20 439 129293 18729 79595927
Hepatic function abnormal 749.76 13.20 749 128983 72358 79542298
Autoimmune colitis 659.62 13.20 198 129534 1425 79613231
Immune-mediated myocarditis 657.23 13.20 183 129549 970 79613686
Secondary adrenocortical insufficiency 648.65 13.20 227 129505 2787 79611869
Autoimmune hepatitis 645.80 13.20 336 129396 11447 79603209
Myasthenia gravis 548.41 13.20 289 129443 10110 79604546
Enterocolitis 538.09 13.20 320 129412 14192 79600464
Diabetic ketoacidosis 518.69 13.20 436 129296 33686 79580970
Drug ineffective 496.14 13.20 621 129111 1080292 78534364
Immune-mediated dermatitis 460.43 13.20 120 129612 470 79614186
Liver disorder 440.93 13.20 566 129166 71851 79542805
Metastases to central nervous system 426.89 13.20 289 129443 16086 79598570
Prescribed underdose 425.80 13.20 366 129366 29148 79585508
Drug interaction 419.79 13.20 83 129649 415100 79199556
Cholangitis 415.36 13.20 259 129473 12517 79602139
Toxicity to various agents 414.39 13.20 90 129642 421450 79193206
Pyrexia 400.64 13.20 2164 127568 676545 78938111
Hepatitis 370.17 13.20 455 129277 55272 79559384
Cachexia 361.11 13.20 225 129507 10858 79603798
Leukoderma 360.57 13.20 78 129654 96 79614560
Hypothalamo-pituitary disorder 340.05 13.20 111 129621 1083 79613573
Tumour pseudoprogression 333.76 13.20 96 129636 583 79614073
Lymphocytic hypophysitis 331.59 13.20 92 129640 480 79614176
Vitiligo 331.52 13.20 126 129606 1983 79612673
Immune-mediated thyroiditis 325.22 13.20 79 129653 214 79614442
Completed suicide 320.48 13.20 20 129712 245747 79368909
Drug hypersensitivity 314.33 13.20 54 129678 298862 79315794
Immune-mediated hypothyroidism 313.71 13.20 91 129641 572 79614084
Radiation pneumonitis 304.64 13.20 142 129590 3791 79610865
Joint swelling 301.63 13.20 53 129679 288593 79326063
Drug intolerance 295.30 13.20 40 129692 264079 79350577
Decreased appetite 291.23 13.20 1215 128517 341203 79273453
Tubulointerstitial nephritis 289.86 13.20 334 129398 37901 79576755
Encephalitis 284.85 13.20 217 129515 14543 79600113
Pleural effusion 284.31 13.20 688 129044 144574 79470082
Immune-mediated hypophysitis 270.68 13.20 62 129670 117 79614539
Immune-mediated nephritis 263.97 13.20 77 129655 495 79614161
Product dose omission issue 255.24 13.20 47 129685 247490 79367166
Cholangitis sclerosing 254.44 13.20 111 129621 2526 79612130
Autoimmune thyroiditis 250.10 13.20 127 129605 4106 79610550
Diarrhoea 240.11 13.20 2332 127400 878157 78736499
Therapeutic product effect decreased 238.08 13.20 6 129726 163857 79450799
Uveitis 233.20 13.20 204 129528 16626 79598030
Pain 233.16 13.20 499 129233 703303 78911353
Overdose 228.57 13.20 19 129713 184187 79430469
Immune-mediated adrenal insuficiency 228.09 13.20 56 129676 161 79614495
Immune-mediated encephalitis 227.42 13.20 67 129665 448 79614208
Immune-mediated uveitis 222.82 13.20 48 129684 57 79614599
General physical health deterioration 213.32 13.20 950 128782 274288 79340368
Peripheral swelling 211.36 13.20 87 129645 269530 79345126
Abdominal discomfort 199.63 13.20 79 129653 250648 79364008
Swelling 199.47 13.20 53 129679 216658 79397998
Injection site pain 195.63 13.20 3 129729 129835 79484821
Lichen planus 195.42 13.20 94 129638 2697 79611959
Dizziness 191.55 13.20 353 129379 526088 79088568
Sinusitis 185.34 13.20 45 129687 195456 79419200
Immune-mediated myositis 184.62 13.20 97 129635 3370 79611286
Nasopharyngitis 183.27 13.20 92 129640 253789 79360867
Synovitis 183.05 13.20 17 129715 150717 79463939
Autoimmune nephritis 179.74 13.20 61 129671 678 79613978
Relapsing fever 178.93 13.20 53 129679 362 79614294
Condition aggravated 178.78 13.20 340 129392 500784 79113872
Lichenoid keratosis 175.73 13.20 99 129633 3958 79610698
Adrenal disorder 173.88 13.20 80 129652 2071 79612585
Tumour haemorrhage 173.77 13.20 99 129633 4045 79610611
Arthropathy 171.38 13.20 39 129693 177072 79437584
Thyroid disorder 168.19 13.20 157 129575 13922 79600734
Erythema multiforme 166.48 13.20 173 129559 17478 79597178
Pain in extremity 161.47 13.20 214 129518 364324 79250332
Autoimmune haemolytic anaemia 161.24 13.20 123 129609 8257 79606399
Hypercalcaemia 159.15 13.20 250 129482 38180 79576476
Meningitis aseptic 158.80 13.20 113 129619 6815 79607841
Non-small cell lung cancer 155.69 13.20 108 129624 6252 79608404
Immune-mediated cholangitis 155.45 13.20 41 129691 170 79614486
Hyperglycaemia 151.49 13.20 346 129386 69989 79544667
Musculoskeletal stiffness 151.48 13.20 48 129684 174960 79439696
Weight increased 151.33 13.20 137 129595 277249 79337407
Glossodynia 149.26 13.20 4 129728 103333 79511323
Blood pressure increased 147.47 13.20 80 129652 211280 79403376
Enteritis 146.73 13.20 148 129584 14435 79600221
Autoimmune pancreatitis 146.23 13.20 51 129681 619 79614037
Prescribed overdose 145.32 13.20 238 129494 37645 79577011
Feeling abnormal 144.46 13.20 40 129692 159159 79455497
Nephritis 143.48 13.20 88 129644 4126 79610530
Immune thrombocytopenia 142.48 13.20 160 129572 17645 79597011
Lipase increased 142.20 13.20 154 129578 16312 79598344
Exposure during pregnancy 142.16 13.20 5 129727 101127 79513529
Alopecia 141.50 13.20 102 129630 231253 79383403
Headache 140.88 13.20 567 129165 653205 78961451
Pericardial effusion 140.31 13.20 262 129470 45975 79568681
Vogt-Koyanagi-Harada disease 139.53 13.20 39 129693 210 79614446
Blood corticotrophin decreased 138.93 13.20 47 129685 517 79614139
Maternal exposure during pregnancy 136.28 13.20 28 129704 136510 79478146
Haemophagocytic lymphohistiocytosis 134.88 13.20 172 129560 21665 79592991
Cytokine release syndrome 133.83 13.20 223 129509 35775 79578881
Therapeutic product effect incomplete 133.45 13.20 33 129699 141612 79473044
Pulmonary toxicity 131.65 13.20 132 129600 12782 79601874
Myasthenic syndrome 131.25 13.20 50 129682 792 79613864
Rash maculo-papular 131.02 13.20 285 129447 55793 79558863
Treatment failure 128.78 13.20 58 129674 170428 79444228
Immune-mediated pancreatitis 128.11 13.20 38 129694 261 79614395
Lung disorder 127.03 13.20 352 129380 80205 79534451
Systemic lupus erythematosus 126.97 13.20 22 129710 121127 79493529
Intentional product misuse 126.23 13.20 7 129725 95158 79519498
Intentional overdose 125.88 13.20 13 129719 105947 79508709
Wound 124.20 13.20 20 129712 116159 79498497
Mobility decreased 124.14 13.20 24 129708 122151 79492505
Immune-mediated arthritis 121.50 13.20 34 129698 184 79614472
Serous retinal detachment 121.29 13.20 50 129682 984 79613672
Polyarthritis 121.24 13.20 123 129609 12079 79602577
Disseminated intravascular coagulation 118.77 13.20 211 129521 35631 79579025
Encephalitis autoimmune 115.98 13.20 62 129670 2232 79612424
Autoimmune myocarditis 115.48 13.20 38 129694 381 79614275
Hyponatraemia 115.12 13.20 583 129149 177265 79437391
Sepsis 114.77 13.20 791 128941 268637 79346019
Immune-mediated adverse reaction 114.35 13.20 46 129686 848 79613808
Eosinophilic fasciitis 112.50 13.20 34 129698 251 79614405
Fall 111.93 13.20 412 129320 487217 79127439
Loss of personal independence in daily activities 108.88 13.20 18 129714 102562 79512094
Discomfort 107.71 13.20 35 129697 125582 79489074
Respiratory failure 107.41 13.20 579 129153 180332 79434324
Adrenocortical insufficiency acute 107.33 13.20 65 129667 2978 79611678
Immune-mediated hyperthyroidism 106.72 13.20 29 129703 138 79614518
Hypersensitivity 106.10 13.20 164 129568 262075 79352581
Contusion 104.20 13.20 56 129676 148720 79465936
Aspartate aminotransferase increased 103.81 13.20 474 129258 138167 79476489
Dermatitis 102.92 13.20 149 129583 21172 79593484
Anxiety 102.87 13.20 153 129579 248359 79366297
Cortisol decreased 102.28 13.20 56 129676 2116 79612540
Blood thyroid stimulating hormone increased 102.23 13.20 101 129631 9607 79605049
Stress 102.15 13.20 7 129725 79605 79535051
Palmar-plantar erythrodysaesthesia syndrome 102.08 13.20 189 129543 32945 79581711
Suicide attempt 101.61 13.20 9 129723 82923 79531733
Acute kidney injury 101.10 13.20 1289 128443 518115 79096541
Tumour pain 99.30 13.20 56 129676 2243 79612413
Injury 98.89 13.20 7 129725 77489 79537167
Pneumothorax 98.07 13.20 170 129562 28153 79586503
Asthma 97.35 13.20 49 129683 135046 79479610
Immune-mediated encephalopathy 97.29 13.20 20 129712 15 79614641
Silent thyroiditis 97.21 13.20 28 129704 171 79614485
Helicobacter infection 96.07 13.20 4 129728 69700 79544956
Diabetes mellitus 95.69 13.20 313 129419 78077 79536579
Haemoglobin decreased 95.62 13.20 133 129599 221986 79392670
Blood pressure fluctuation 95.49 13.20 3 129729 67142 79547514
Immune-mediated gastritis 94.41 13.20 24 129708 83 79614573
Duodenal ulcer perforation 94.02 13.20 3 129729 66208 79548448
Migraine 93.65 13.20 15 129717 87478 79527178
Skin disorder 92.75 13.20 184 129548 33759 79580897
Pemphigus 92.25 13.20 24 129708 99558 79515098
Pneumonia bacterial 91.72 13.20 134 129598 19197 79595459
Product use issue 90.96 13.20 125 129607 209697 79404959
Embolism 90.91 13.20 113 129619 13869 79600787
Pneumonia 90.53 13.20 1542 128190 658704 78955952
Heart rate increased 89.71 13.20 42 129690 120682 79493974
Wheezing 89.17 13.20 39 129693 116625 79498031
Meningitis 88.72 13.20 93 129639 9489 79605167
General physical condition abnormal 87.81 13.20 78 129654 6485 79608171
Muscle spasms 85.28 13.20 95 129637 174635 79440021
Amylase increased 85.06 13.20 98 129634 11111 79603545
Immune-mediated renal disorder 84.75 13.20 25 129707 168 79614488
Irritable bowel syndrome 84.37 13.20 4 129728 62237 79552419
Drug-induced liver injury 84.32 13.20 268 129464 65849 79548807
Depression 82.59 13.20 141 129591 216649 79398007
Autoimmune arthritis 82.11 13.20 23 129709 125 79614531
Organising pneumonia 81.93 13.20 95 129637 10844 79603812
Palpitations 81.12 13.20 53 129679 126557 79488099
Osteoarthritis 80.95 13.20 21 129711 87288 79527368
Insomnia 80.71 13.20 174 129558 244996 79369660
Incorrect dose administered 80.10 13.20 14 129718 76616 79538040
Medication error 80.05 13.20 9 129723 68633 79546023
Suicidal ideation 79.68 13.20 14 129718 76326 79538330
Autoimmune dermatitis 79.64 13.20 23 129709 142 79614514
Ill-defined disorder 78.45 13.20 8 129724 65867 79548789
Wrong technique in product usage process 78.32 13.20 13 129719 73862 79540794
Hepatic failure 77.95 13.20 248 129484 60964 79553692
Cholestasis 77.53 13.20 223 129509 51886 79562770
Metastases to meninges 76.29 13.20 56 129676 3545 79611111
Dermatomyositis 75.98 13.20 56 129676 3567 79611089
Lymphangiosis carcinomatosa 75.95 13.20 46 129686 2108 79612548
Hyperhidrosis 75.43 13.20 81 129651 151411 79463245
Heart rate decreased 75.38 13.20 12 129720 70304 79544352
Cardiac tamponade 75.32 13.20 84 129648 9192 79605464
Agitation 75.16 13.20 34 129698 99681 79514975
Coma 74.80 13.20 35 129697 100614 79514042
Blood thyroid stimulating hormone decreased 74.62 13.20 67 129665 5649 79609007
Adverse drug reaction 74.25 13.20 10 129722 66382 79548274
Guillain-Barre syndrome 74.20 13.20 82 129650 8883 79605773
Sialoadenitis 73.83 13.20 44 129688 1957 79612699
Metastases to bone 73.58 13.20 138 129594 24289 79590367
Immune-mediated endocrinopathy 73.57 13.20 17 129715 34 79614622
Eyelid ptosis 73.00 13.20 90 129642 10954 79603702
Primary hypothyroidism 72.72 13.20 22 129710 163 79614493
Electrocardiogram QT prolonged 72.66 13.20 28 129704 90358 79524298
Tri-iodothyronine free decreased 71.84 13.20 26 129706 354 79614302
Nasal congestion 71.77 13.20 18 129714 76534 79538122
Immune-mediated cystitis 71.37 13.20 16 129716 26 79614630
Unevaluable event 70.98 13.20 5 129727 55580 79559076
Pneumonia aspiration 70.88 13.20 255 129477 66712 79547944
Endocrine disorder 70.24 13.20 32 129700 809 79613847
Metastases to lung 69.50 13.20 114 129618 18049 79596607
Cardiac failure congestive 68.85 13.20 78 129654 142324 79472332
Skin toxicity 68.73 13.20 76 129656 8238 79606418
Urticaria 68.22 13.20 123 129609 185078 79429578
Alanine aminotransferase increased 67.79 13.20 475 129257 162095 79452561
Autoimmune hypothyroidism 67.74 13.20 23 129709 256 79614400
Blood glucose increased 67.28 13.20 53 129679 114922 79499734
Paraesthesia 65.94 13.20 116 129616 176207 79438449
C-reactive protein abnormal 65.91 13.20 3 129729 48364 79566292
Immune-mediated neuropathy 65.43 13.20 16 129716 45 79614611
International normalised ratio increased 65.25 13.20 28 129704 84693 79529963
Pancreatitis 62.55 13.20 249 129483 68326 79546330
Tumour associated fever 62.16 13.20 30 129702 867 79613789
Red blood cell sedimentation rate increased 62.11 13.20 3 129729 45939 79568717
Primary adrenal insufficiency 61.09 13.20 20 129712 197 79614459
Abdominal pain upper 61.04 13.20 175 129557 223644 79391012
Anaemia 60.71 13.20 1039 128693 443976 79170680
Dermatitis psoriasiform 60.44 13.20 44 129688 2750 79611906
Multiple sclerosis relapse 59.96 13.20 4 129728 46529 79568127
Rash 59.41 13.20 1293 128439 577065 79037591
Duodenitis 59.35 13.20 69 129663 7898 79606758
Autoimmune neuropathy 59.13 13.20 17 129715 103 79614553
Polymyalgia rheumatica 58.87 13.20 53 129679 4484 79610172
Blood corticotrophin increased 58.79 13.20 19 129713 179 79614477
Impaired healing 58.48 13.20 35 129697 87620 79527036
Bradycardia 58.48 13.20 81 129651 135476 79479180
Lower respiratory tract infection 57.99 13.20 75 129657 129145 79485511
Cancer pain 57.90 13.20 56 129676 5189 79609467
Drug eruption 57.77 13.20 180 129552 43755 79570901
Thrombophlebitis migrans 57.17 13.20 23 129709 424 79614232
Loss of consciousness 57.09 13.20 117 129615 167826 79446830
Limbic encephalitis 56.84 13.20 28 129704 847 79613809
Aggression 56.22 13.20 8 129724 50950 79563706
Arthralgia 55.85 13.20 628 129104 571175 79043481
Pancreatic enzymes increased 55.60 13.20 32 129700 1333 79613323
Cholecystitis 55.45 13.20 116 129616 22096 79592560
Polymyositis 55.00 13.20 43 129689 2993 79611663
Ascites 54.79 13.20 256 129476 75306 79539350
Adrenalitis 54.70 13.20 13 129719 31 79614625
Unresponsive to stimuli 54.50 13.20 12 129720 55776 79558880
Haematocrit decreased 54.49 13.20 16 129716 61296 79553360
Drug-device incompatibility 54.23 13.20 10 129722 0 79614656
Balance disorder 53.64 13.20 49 129683 98808 79515848
Hypoaesthesia 53.60 13.20 134 129598 179218 79435438
Iridocyclitis 53.53 13.20 46 129686 3658 79610998
Rheumatic disorder 53.50 13.20 43 129689 3115 79611541
Blood pressure systolic increased 53.43 13.20 21 129711 66965 79547691
Memory impairment 53.14 13.20 62 129670 111672 79502984
Pancreatic failure 52.90 13.20 33 129699 1595 79613061
Cytomegalovirus enterocolitis 52.40 13.20 33 129699 1622 79613034
Nephrotic syndrome 52.35 13.20 77 129655 11097 79603559
Fluid retention 52.30 13.20 24 129708 69785 79544871
Oesophagitis 51.73 13.20 119 129613 24170 79590486
Drug dependence 51.11 13.20 4 129728 40765 79573891
Taste disorder 50.94 13.20 92 129640 15731 79598925
Gastrooesophageal reflux disease 50.49 13.20 57 129675 104189 79510467
Tremor 50.11 13.20 128 129604 169955 79444701
Folliculitis 50.05 13.20 14 129718 55366 79559290
Dehydration 49.86 13.20 620 129112 247567 79367089
Influenza 49.60 13.20 84 129648 129522 79485134
Respiratory arrest 49.38 13.20 16 129716 57534 79557122
Gait disturbance 49.03 13.20 173 129559 207333 79407323
Glucocorticoid deficiency 48.62 13.20 23 129709 635 79614021
Large intestine perforation 48.56 13.20 86 129646 14481 79600175
Angioedema 48.46 13.20 32 129700 76003 79538653
Somnolence 48.34 13.20 212 129520 238769 79375887
Hypertension 48.05 13.20 328 129404 330664 79283992
Blister 48.00 13.20 75 129657 119401 79495255
Metastases to lymph nodes 47.78 13.20 71 129661 10326 79604330
Red blood cell count decreased 47.60 13.20 17 129715 57496 79557160
Transaminases increased 47.28 13.20 188 129544 51555 79563101
Hypoalbuminaemia 47.20 13.20 106 129626 21191 79593465
Nephrolithiasis 47.19 13.20 14 129718 53277 79561379
Gastrointestinal perforation 47.14 13.20 54 129678 6083 79608573
Chest discomfort 47.05 13.20 96 129636 137948 79476708
Metastases to liver 46.88 13.20 126 129606 28188 79586468
Haemoptysis 46.85 13.20 198 129534 55801 79558855
Facial paralysis 46.83 13.20 105 129627 20967 79593689
Drug level increased 46.73 13.20 5 129727 39646 79575010
Intracranial tumour haemorrhage 46.72 13.20 21 129711 514 79614142
Localised infection 46.24 13.20 4 129728 37571 79577085
Hallucination 45.93 13.20 43 129689 85702 79528954
Sleep disorder 45.85 13.20 43 129689 85634 79529022
Stevens-Johnson syndrome 45.65 13.20 154 129578 39012 79575644
Metastasis 45.37 13.20 56 129676 6824 79607832
Pulmonary embolism 45.03 13.20 452 129280 171202 79443454
Oropharyngeal pain 44.55 13.20 68 129664 109285 79505371
Encephalopathy 44.30 13.20 222 129510 67175 79547481
Treatment noncompliance 44.03 13.20 15 129717 52253 79562403
Acquired tracheo-oesophageal fistula 43.99 13.20 14 129718 125 79614531
Demyelinating polyneuropathy 43.87 13.20 30 129702 1696 79612960
Amnesia 43.75 13.20 24 129708 63033 79551623
Morphoea 43.64 13.20 19 129713 430 79614226
Thyroid function test abnormal 43.43 13.20 38 129694 3096 79611560
Gastrointestinal disorder 43.36 13.20 83 129649 122122 79492534
Cardiac failure 43.19 13.20 413 129319 154429 79460227
Product prescribing error 43.05 13.20 10 129722 44803 79569853
Pain in jaw 42.97 13.20 11 129721 46140 79568516
Off label use 42.81 13.20 1843 127889 905372 78709284
Renal disorder 42.58 13.20 158 129574 41947 79572709
Rhinorrhoea 42.12 13.20 37 129695 76037 79538619
Hypervolaemia 42.07 13.20 9 129723 42681 79571975
Sopor 42.06 13.20 3 129729 33007 79581649
Drug withdrawal syndrome 41.90 13.20 4 129728 34714 79579942
Pneumocystis jirovecii pneumonia 41.65 13.20 132 129600 32376 79582280
Heart rate irregular 41.55 13.20 3 129729 32676 79581980
Ear infection 41.47 13.20 4 129728 34428 79580228
Radiation skin injury 41.45 13.20 27 129705 1407 79613249
Confusional state 41.40 13.20 325 129407 317672 79296984
Exposure via body fluid 41.12 13.20 17 129715 337 79614319
Dyskinesia 41.06 13.20 11 129721 44762 79569894
Product quality issue 40.73 13.20 4 129728 33936 79580720
Immune-mediated cytopenia 40.37 13.20 11 129721 53 79614603
Pancreatic toxicity 40.03 13.20 11 129721 55 79614601
Obesity 39.97 13.20 5 129727 35120 79579536
Nervousness 39.93 13.20 4 129728 33411 79581245
Osteoporosis 39.92 13.20 19 129713 54093 79560563
Ileus 39.79 13.20 113 129619 26098 79588558
Superior vena cava syndrome 39.78 13.20 25 129707 1224 79613432
Joint range of motion decreased 39.73 13.20 4 129728 33278 79581378
Rheumatoid arthritis 39.73 13.20 189 129543 208281 79406375
Bile duct stenosis 39.69 13.20 30 129702 1986 79612670
Incorrect route of product administration 39.68 13.20 5 129727 34924 79579732
Road traffic accident 39.53 13.20 11 129721 43653 79571003
Physical deconditioning 38.98 13.20 30 129702 2040 79612616
Upper respiratory tract infection 38.79 13.20 55 129677 91113 79523543
Brain oedema 38.43 13.20 109 129623 25154 79589502
Autoimmune lung disease 38.40 13.20 10 129722 39 79614617
Metastatic malignant melanoma 38.25 13.20 34 129698 2829 79611827
Oxygen saturation decreased 38.09 13.20 97 129635 128950 79485706
Autoimmune thyroid disorder 37.81 13.20 10 129722 42 79614614
Enterocolitis haemorrhagic 37.44 13.20 30 129702 2164 79612492
Troponin increased 37.39 13.20 91 129641 19164 79595492
Pituitary enlargement 36.90 13.20 11 129721 77 79614579
Epistaxis 36.78 13.20 79 129653 111436 79503220
Pleurodesis 36.73 13.20 10 129722 48 79614608
Febrile neutropenia 36.55 13.20 553 129179 230446 79384210
Glomerulonephritis membranous 36.21 13.20 26 129706 1590 79613066
Aspiration pleural cavity 36.20 13.20 26 129706 1591 79613065
Spinal cord compression 35.91 13.20 48 129684 6329 79608327
Accidental overdose 35.78 13.20 10 129722 39571 79575085
Pericarditis malignant 35.75 13.20 10 129722 54 79614602
Burning sensation 35.61 13.20 26 129706 58606 79556050
Blood corticotrophin abnormal 35.60 13.20 10 129722 55 79614601
Swelling face 35.52 13.20 38 129694 71174 79543482
Thyroxine free abnormal 35.43 13.20 9 129723 31 79614625
Sleep apnoea syndrome 35.32 13.20 8 129724 36470 79578186
Orthostatic hypotension 35.30 13.20 24 129708 56140 79558516
Abnormal behaviour 35.24 13.20 8 129724 36413 79578243
Psychotic disorder 34.67 13.20 12 129720 41390 79573266
Cardiac arrest 34.59 13.20 153 129579 171943 79442713
Intestinal perforation 34.52 13.20 83 129649 17343 79597313
Prerenal failure 34.43 13.20 36 129696 3662 79610994
Joint injury 34.38 13.20 5 129727 31330 79583326
Pulmonary sepsis 34.31 13.20 36 129696 3676 79610980
Sudden death 34.12 13.20 97 129635 22414 79592242
Troponin T increased 34.07 13.20 35 129697 3487 79611169
Joint stiffness 33.90 13.20 12 129720 40818 79573838
Myocardial infarction 33.88 13.20 169 129563 183960 79430696
Hepatobiliary disease 33.64 13.20 19 129713 763 79613893
Gastritis 33.62 13.20 161 129571 47832 79566824
Lactic acidosis 33.49 13.20 39 129693 70320 79544336
Malignant pleural effusion 33.44 13.20 34 129698 3346 79611310
Autoimmune myositis 33.34 13.20 14 129718 289 79614367
Glomerulonephritis 33.00 13.20 34 129698 3399 79611257
Blood pressure diastolic decreased 32.74 13.20 5 129727 30211 79584445
Dysphagia 32.69 13.20 323 129409 121813 79492843
Capillary leak syndrome 32.65 13.20 36 129696 3889 79610767
Blood alkaline phosphatase increased 32.62 13.20 196 129536 63468 79551188
Metastases to pleura 32.54 13.20 24 129708 1530 79613126
Biliary obstruction 32.37 13.20 39 129693 4635 79610021
Blood creatine phosphokinase increased 32.31 13.20 201 129531 65889 79548767
Dyspepsia 31.84 13.20 82 129650 108605 79506051
Blood potassium decreased 31.83 13.20 18 129714 46494 79568162
Full blood count abnormal 31.77 13.20 13 129719 40461 79574195
Blood glucose decreased 31.72 13.20 3 129729 26231 79588425
Coronary artery disease 31.48 13.20 36 129696 65438 79549218
Optic neuritis 31.47 13.20 56 129676 9464 79605192
Keratoacanthoma 31.00 13.20 20 129712 1025 79613631
Bursitis 30.69 13.20 10 129722 35834 79578822
Pallor 30.66 13.20 22 129710 50040 79564616
Autoimmune encephalopathy 30.59 13.20 10 129722 98 79614558
Bronchial fistula 30.51 13.20 12 129720 208 79614448
Neutrophil count decreased 30.48 13.20 259 129473 93700 79520956
Troponin I increased 30.33 13.20 38 129694 4700 79609956
Chronic gastritis 29.92 13.20 35 129697 4033 79610623
Gait inability 29.87 13.20 31 129701 58886 79555770
Psoriatic arthropathy 29.43 13.20 51 129681 77948 79536708
Gastric disorder 29.42 13.20 12 129720 37421 79577235
Pancreatic atrophy 29.26 13.20 16 129716 603 79614053
Lip swelling 29.22 13.20 15 129717 40896 79573760
Cortisol abnormal 29.15 13.20 9 129723 72 79614584
Therapy non-responder 29.12 13.20 67 129665 92238 79522418
Peripheral sensory neuropathy 29.03 13.20 65 129667 12968 79601688
Infectious pleural effusion 28.85 13.20 33 129699 3711 79610945
Blood calcium decreased 28.83 13.20 8 129724 31811 79582845
Therapeutic response decreased 28.77 13.20 40 129692 66813 79547843
Infection 28.73 13.20 253 129479 241459 79373197
Foot deformity 28.46 13.20 3 129729 24071 79590585
Chest pain 28.30 13.20 308 129424 281996 79332660
Dermatitis acneiform 28.30 13.20 55 129677 9938 79604718
Radiation necrosis 28.19 13.20 14 129718 431 79614225
Therapy interrupted 28.18 13.20 8 129724 31333 79583323
Hypokalaemia 28.11 13.20 358 129374 143682 79470974
Adverse event 28.11 13.20 181 129551 60033 79554623
Abdominal distension 28.08 13.20 100 129632 119550 79495106
Type 3 diabetes mellitus 28.04 13.20 8 129724 47 79614609
Inappropriate schedule of product administration 27.95 13.20 117 129615 133511 79481145
Full blood count decreased 27.81 13.20 5 129727 26814 79587842
IgA nephropathy 27.70 13.20 23 129709 1745 79612911
Tumour embolism 27.69 13.20 11 129721 196 79614460
Transfusion 27.68 13.20 87 129645 21243 79593413
Cerebral infarction 27.61 13.20 147 129585 45529 79569127
Malnutrition 27.58 13.20 90 129642 22412 79592244
Autoimmune disorder 27.57 13.20 74 129658 16538 79598118
Blood thyroid stimulating hormone abnormal 27.57 13.20 18 129714 942 79613714
Hepatotoxicity 27.54 13.20 160 129572 51192 79563464
Myasthenia gravis crisis 27.51 13.20 19 129713 1092 79613564
Myelitis 27.29 13.20 26 129706 2365 79612291
Thoracic cavity drainage 27.19 13.20 12 129720 281 79614375
Autoimmune retinopathy 27.05 13.20 6 129726 9 79614647
Arthritis 27.05 13.20 296 129436 114584 79500072
Swollen tongue 27.01 13.20 18 129714 42552 79572104
Tachycardia 26.85 13.20 174 129558 177594 79437062
Blood urea increased 26.68 13.20 24 129708 48766 79565890
Hepatocellular injury 26.64 13.20 150 129582 47443 79567213
Hallucination, visual 26.53 13.20 10 129722 32719 79581937
Peripheral motor neuropathy 26.50 13.20 30 129702 3337 79611319
Feeling hot 26.45 13.20 35 129697 59699 79554957
Extrapyramidal disorder 26.37 13.20 3 129729 22676 79591980
Metastases to peritoneum 26.31 13.20 34 129698 4338 79610318
Breast cancer 26.27 13.20 11 129721 33770 79580886
Panic attack 26.25 13.20 4 129728 24212 79590444
Pulmonary sarcoidosis 26.03 13.20 20 129712 1357 79613299
Hepatic cytolysis 25.89 13.20 100 129632 27051 79587605
Biliary tract infection 25.88 13.20 20 129712 1368 79613288
Meningoradiculitis 25.76 13.20 10 129722 167 79614489
Atrioventricular block complete 25.59 13.20 72 129660 16538 79598118
Inappropriate antidiuretic hormone secretion 25.17 13.20 97 129635 26216 79588440
Altered state of consciousness 25.12 13.20 139 129593 43683 79570973
Metastases to spine 25.05 13.20 33 129699 4291 79610365
Achromotrichia acquired 25.04 13.20 6 129726 15 79614641
Thyrotoxic crisis 25.04 13.20 19 129713 1265 79613391
Immunodeficiency 25.01 13.20 3 129729 21765 79592891
Hyperlipidaemia 24.72 13.20 6 129726 26087 79588569
Skin hypopigmentation 24.60 13.20 17 129715 978 79613678
Crying 24.54 13.20 4 129728 23039 79591617
Renal failure 24.42 13.20 461 129271 200507 79414149
Acute respiratory failure 24.22 13.20 173 129559 59368 79555288
Cholangitis acute 24.14 13.20 20 129712 1512 79613144
Chronic inflammatory demyelinating polyradiculoneuropathy 24.14 13.20 18 129714 1167 79613489
Acute polyneuropathy 24.09 13.20 13 129719 477 79614179
Prostate cancer 24.05 13.20 12 129720 33256 79581400
Limb injury 23.97 13.20 9 129723 29519 79585137
Polyneuropathy 23.90 13.20 90 129642 24061 79590595
Septic shock 23.87 13.20 305 129427 122496 79492160
Cryptitis 23.83 13.20 11 129721 287 79614369
Nausea 23.70 13.20 1295 128437 955901 78658755
Diabetic ketoacidotic hyperglycaemic coma 23.27 13.20 10 129722 219 79614437
Obstructive airways disorder 23.27 13.20 11 129721 31448 79583208
Pleurocutaneous fistula 23.12 13.20 7 129725 52 79614604
Hepatitis fulminant 23.09 13.20 42 129690 7220 79607436
Failure to thrive 23.02 13.20 56 129676 11788 79602868
Hypoxia 22.93 13.20 263 129469 102980 79511676
Performance status decreased 22.89 13.20 38 129694 6075 79608581
Chondritis 22.88 13.20 9 129723 156 79614500
Grip strength decreased 22.84 13.20 4 129728 21865 79592791
Device dislocation 22.67 13.20 7 129725 25963 79588693
Lower limb fracture 22.66 13.20 5 129727 23210 79591446
Hepatic enzyme increased 22.65 13.20 189 129543 182421 79432235
Hepatitis acute 22.62 13.20 66 129666 15476 79599180
Haemolytic anaemia 22.50 13.20 72 129660 17748 79596908
Respiratory rate increased 22.45 13.20 4 129728 21596 79593060
Generalised tonic-clonic seizure 22.38 13.20 23 129709 43887 79570769
Abortion spontaneous 22.32 13.20 10 129722 29497 79585159
Gamma-glutamyltransferase increased 22.32 13.20 159 129573 54521 79560135
Muscle spasticity 22.27 13.20 4 129728 21471 79593185
Acute motor axonal neuropathy 22.23 13.20 8 129724 107 79614549
Intestinal intraepithelial lymphocytes increased 22.12 13.20 9 129723 171 79614485
Toxic skin eruption 21.99 13.20 83 129649 22210 79592446
Endocrine toxicity 21.98 13.20 5 129727 9 79614647
Orbital myositis 21.98 13.20 9 129723 174 79614482
Glomerular filtration rate decreased 21.94 13.20 5 129727 22697 79591959
Myelitis transverse 21.89 13.20 21 129711 1926 79612730
Lethargy 21.82 13.20 64 129668 81228 79533428
Optic perineuritis 21.69 13.20 4 129728 0 79614656
Skin laceration 21.62 13.20 10 129722 28952 79585704
Renal tubular acidosis 21.58 13.20 28 129704 3586 79611070
White blood cell count decreased 21.53 13.20 199 129533 188089 79426567
Paraneoplastic syndrome 21.50 13.20 16 129716 1034 79613622
Viral infection 21.40 13.20 23 129709 42993 79571663
Torsade de pointes 21.38 13.20 3 129729 19309 79595347
Hallucination, auditory 21.15 13.20 4 129728 20689 79593967
Pregnancy on contraceptive 21.14 13.20 15 129717 900 79613756
Eye irritation 21.13 13.20 4 129728 20677 79593979
Intestinal metastasis 21.12 13.20 11 129721 375 79614281
Sterile pyuria 21.11 13.20 7 129725 72 79614584
Cerebral microangiopathy 21.11 13.20 10 129722 277 79614379
Mechanical ileus 21.08 13.20 15 129717 904 79613752
Muscle twitching 21.04 13.20 7 129725 24757 79589899
Tumour hyperprogression 20.95 13.20 9 129723 197 79614459
Foot fracture 20.93 13.20 5 129727 21976 79592680
Aplasia pure red cell 20.93 13.20 42 129690 7768 79606888
Pulmonary arterial hypertension 20.86 13.20 10 129722 28356 79586300
Hypersensitivity pneumonitis 20.83 13.20 28 129704 3711 79610945
Myofascitis 20.73 13.20 5 129727 13 79614643
Steroid diabetes 20.68 13.20 27 129705 3479 79611177
Non-cardiac chest pain 20.65 13.20 47 129685 9477 79605179
Tracheal stenosis 20.63 13.20 11 129721 394 79614262
Gastroenteritis eosinophilic 20.53 13.20 10 129722 295 79614361
Small intestinal perforation 20.41 13.20 26 129706 3271 79611385
Tumour lysis syndrome 20.30 13.20 85 129647 23854 79590802
Throat irritation 20.25 13.20 22 129710 40924 79573732
Cortisol increased 20.15 13.20 12 129720 533 79614123
Autoimmune uveitis 19.96 13.20 5 129727 16 79614640
Flushing 19.90 13.20 75 129657 88193 79526463
Depressed mood 19.88 13.20 30 129702 48450 79566206
Gastrointestinal toxicity 19.83 13.20 42 129690 8067 79606589
Hypophonesis 19.73 13.20 5 129727 17 79614639
Blood triglycerides increased 19.61 13.20 5 129727 21035 79593621
Transient acantholytic dermatosis 19.57 13.20 8 129724 154 79614502
Catabolic state 19.50 13.20 7 129725 93 79614563
Pericardial drainage 19.47 13.20 11 129721 442 79614214
Oesophageal prosthesis insertion 19.46 13.20 4 129728 3 79614653
Autoimmune blistering disease 19.46 13.20 4 129728 3 79614653
Gastroenteritis viral 19.45 13.20 8 129724 24823 79589833
Kidney transplant rejection 19.44 13.20 48 129684 10198 79604458
Depressed level of consciousness 19.36 13.20 86 129646 96566 79518090
Paranoia 19.35 13.20 4 129728 19428 79595228
Tumour thrombosis 19.29 13.20 8 129724 160 79614496
White blood cell count increased 19.14 13.20 60 129672 74573 79540083
Oesophageal fistula 19.12 13.20 11 129721 458 79614198
Autoimmune cholangitis 19.10 13.20 5 129727 20 79614636
Thyroxine free decreased 19.09 13.20 15 129717 1052 79613604
Cutaneous sarcoidosis 19.03 13.20 11 129721 462 79614194
Flatulence 18.95 13.20 25 129707 42699 79571957
Autoimmune anaemia 18.93 13.20 4 129728 4 79614652
Appetite disorder 18.83 13.20 40 129692 7699 79606957
Subacute cutaneous lupus erythematosus 18.83 13.20 26 129706 3535 79611121
Therapy cessation 18.78 13.20 20 129712 37542 79577114
Lymphadenopathy mediastinal 18.75 13.20 29 129703 4367 79610289
Hypertransaminasaemia 18.68 13.20 52 129680 11872 79602784
Chylothorax 18.59 13.20 13 129719 762 79613894
Melanoma recurrent 18.56 13.20 9 129723 263 79614393
Haemodynamic instability 18.55 13.20 3 129729 17379 79597277
Diabetic ketosis 18.46 13.20 11 129721 489 79614167
Lymphadenopathy 18.45 13.20 149 129583 53098 79561558
Pericarditis 18.41 13.20 97 129635 104139 79510517
Pulmonary tuberculosis 18.39 13.20 40 129692 7825 79606831
Enterocolitis infectious 18.35 13.20 23 129709 2846 79611810
Rales 18.18 13.20 5 129727 19996 79594660
Metastases to adrenals 18.18 13.20 16 129716 1314 79613342
Metastases to skin 18.14 13.20 18 129714 1721 79612935
Blood urine present 18.13 13.20 6 129726 21291 79593365
Blood bilirubin increased 18.13 13.20 176 129556 66056 79548600
Cardio-respiratory arrest 18.06 13.20 103 129629 108407 79506249
Thrombocytopenia 18.06 13.20 562 129170 264697 79349959
Haematoma 18.03 13.20 36 129696 52159 79562497
Muscle rigidity 18.01 13.20 5 129727 19877 79594779
Sarcoidosis 17.93 13.20 41 129691 8294 79606362
Pulmonary hypertension 17.63 13.20 32 129700 48048 79566608
Paraparesis 17.52 13.20 26 129706 3777 79610879
Basal cell carcinoma 17.48 13.20 21 129711 37354 79577302
Tracheal obstruction 17.39 13.20 8 129724 207 79614449
Immune-mediated oesophagitis 17.31 13.20 4 129728 8 79614648
VIth nerve paralysis 17.29 13.20 17 129715 1607 79613049
Gallbladder disorder 17.27 13.20 5 129727 19335 79595321
Dysstasia 17.25 13.20 12 129720 27734 79586922
Skin discolouration 17.21 13.20 25 129707 41009 79573647
Cytokine storm 17.21 13.20 14 129718 1032 79613624
Malignant peritoneal neoplasm 17.18 13.20 12 129720 702 79613954
Lithiasis 17.18 13.20 8 129724 213 79614443
Scleroderma-like reaction 17.16 13.20 7 129725 134 79614522
Eosinophil count increased 17.14 13.20 64 129668 17041 79597615
Seasonal allergy 17.14 13.20 3 129729 16403 79598253
Vaginal haemorrhage 17.13 13.20 7 129725 21810 79592846
Blood alkaline phosphatase abnormal 17.09 13.20 13 129719 869 79613787
Eye swelling 17.05 13.20 11 129721 26457 79588199
Microvillous inclusion disease 17.04 13.20 8 129724 217 79614439
Systemic inflammatory response syndrome 16.98 13.20 49 129683 11416 79603240
Metastases to pancreas 16.96 13.20 11 129721 569 79614087
Delusion 16.96 13.20 6 129726 20417 79594239
Mitral valve incompetence 16.92 13.20 13 129719 28552 79586104
Hypokinesia 16.89 13.20 5 129727 19055 79595601
Productive cough 16.86 13.20 80 129652 88251 79526405
Mydriasis 16.82 13.20 4 129728 17639 79597017
Creatinine renal clearance decreased 16.81 13.20 5 129727 18997 79595659
Cholelithiasis 16.79 13.20 38 129694 52626 79562030
Thrombosis 16.75 13.20 75 129657 84025 79530631
Thyroiditis subacute 16.66 13.20 9 129723 331 79614325
Sarcoid-like reaction 16.65 13.20 5 129727 36 79614620
Chest tube insertion 16.65 13.20 7 129725 145 79614511
Tendonitis 16.63 13.20 9 129723 23821 79590835
Complication associated with device 16.62 13.20 4 129728 17492 79597164
Cough 16.57 13.20 462 129270 366327 79248329
Restless legs syndrome 16.52 13.20 6 129726 20086 79594570
Gastrointestinal haemorrhage 16.51 13.20 157 129575 147562 79467094
Lymphocyte count abnormal 16.50 13.20 16 129716 1487 79613169
Tumour flare 16.34 13.20 14 129718 1109 79613547
Probiotic therapy 16.30 13.20 7 129725 153 79614503
Keratouveitis 16.27 13.20 3 129729 0 79614656
Immune-mediated cholestasis 16.27 13.20 3 129729 0 79614656
Paraneoplastic retinopathy 16.27 13.20 3 129729 0 79614656
Sciatica 16.26 13.20 18 129714 33204 79581452
Serous retinopathy 16.26 13.20 7 129725 154 79614502
Intervertebral disc degeneration 16.24 13.20 3 129729 15782 79598874
Renal vasculitis 16.21 13.20 11 129721 614 79614042
Ketoacidosis 16.20 13.20 38 129694 7816 79606840
Musculoskeletal discomfort 16.18 13.20 6 129726 19829 79594827
Neuritis 16.16 13.20 17 129715 1741 79612915
Blood pressure abnormal 16.16 13.20 4 129728 17165 79597491
Protein-losing gastroenteropathy 16.13 13.20 11 129721 619 79614037
Speech disorder 16.00 13.20 41 129691 54404 79560252
Osteopenia 15.94 13.20 5 129727 18359 79596297
Toxic neuropathy 15.88 13.20 13 129719 967 79613689
Infected neoplasm 15.79 13.20 9 129723 368 79614288
Prothrombin time prolonged 15.78 13.20 4 129728 16895 79597761
Abdominal pain 15.78 13.20 498 129234 389071 79225585
Skin ulcer 15.74 13.20 41 129691 54109 79560547
Psychomotor hyperactivity 15.71 13.20 4 129728 16845 79597811
Dermatitis bullous 15.71 13.20 55 129677 14190 79600466
Infective spondylitis 15.65 13.20 10 129722 504 79614152
Pathological fracture 15.58 13.20 45 129687 10492 79604164
Drug resistance 15.56 13.20 28 129704 42185 79572471
Apoptosis 15.55 13.20 10 129722 510 79614146
Petechiae 15.51 13.20 7 129725 20558 79594098
Spermatogenesis abnormal 15.48 13.20 4 129728 15 79614641
Sputum discoloured 15.48 13.20 8 129724 21735 79592921
Glycosylated haemoglobin increased 15.42 13.20 6 129726 19254 79595402
Cardiac disorder 15.40 13.20 55 129677 65702 79548954
Dyspnoea exertional 15.39 13.20 81 129651 86992 79527664
Paraesthesia oral 15.39 13.20 7 129725 20464 79594192
Proctitis 15.37 13.20 33 129699 6399 79608257
Pericardial excision 15.30 13.20 5 129727 49 79614607
Lung opacity 15.29 13.20 29 129703 5145 79609511
Mental disorder 15.28 13.20 17 129715 31285 79583371
Glomerulonephritis rapidly progressive 15.26 13.20 16 129716 1632 79613024
Urinary incontinence 15.20 13.20 27 129705 40882 79573774
Blood pressure decreased 15.19 13.20 97 129635 99369 79515287
Skin cancer 15.17 13.20 3 129729 15037 79599619
Coagulopathy 15.04 13.20 22 129710 35984 79578672
Cardiomyopathy 15.00 13.20 89 129643 28685 79585971
Papilloedema 14.92 13.20 32 129700 6201 79608455
Pharyngeal oedema 14.92 13.20 4 129728 16268 79598388
Tumour necrosis 14.91 13.20 17 129715 1905 79612751
Hepatic cirrhosis 14.90 13.20 21 129711 34885 79579771
Oesophageal stenosis 14.89 13.20 26 129706 4328 79610328
Blood lactate dehydrogenase increased 14.89 13.20 112 129620 39058 79575598
Hot flush 14.87 13.20 43 129689 54834 79559822
Platelet count increased 14.87 13.20 9 129723 22397 79592259
Right ventricular failure 14.82 13.20 10 129722 23487 79591169
Ear pain 14.82 13.20 19 129713 32850 79581806
Thyroiditis acute 14.77 13.20 7 129725 194 79614462
Neoplasm malignant 14.75 13.20 18 129714 31792 79582864
Oral mucosa erosion 14.73 13.20 17 129715 1930 79612726
Myoclonus 14.66 13.20 14 129718 27646 79587010
Hiatus hernia 14.60 13.20 10 129722 23302 79591354
Hypoparathyroidism 14.59 13.20 13 129719 1085 79613571
Acquired amegakaryocytic thrombocytopenia 14.56 13.20 4 129728 20 79614636
Breath sounds abnormal 14.52 13.20 4 129728 15980 79598676
Visual impairment 14.51 13.20 89 129643 92042 79522614
Evans syndrome 14.48 13.20 9 129723 432 79614224
Illness 14.47 13.20 34 129698 46477 79568179
Small intestinal haemorrhage 14.42 13.20 25 129707 4138 79610518
Giant cell arteritis 14.42 13.20 20 129712 2731 79611925
Axonal and demyelinating polyneuropathy 14.40 13.20 4 129728 21 79614635
Hypotension 14.38 13.20 578 129154 439739 79174917
Radiation associated pain 14.37 13.20 6 129726 122 79614534
Haemorrhage 14.36 13.20 88 129644 91030 79523626
Cutaneous nocardiosis 14.36 13.20 7 129725 207 79614449
Hypercholesterolaemia 14.34 13.20 10 129722 23085 79591571
Procedural pain 14.33 13.20 10 129722 23074 79591582
Aspartate aminotransferase abnormal 14.28 13.20 16 129716 1760 79612896
BRAF gene mutation 14.24 13.20 5 129727 62 79614594
Salivary duct inflammation 14.19 13.20 3 129729 3 79614653
Ocular hyperaemia 14.12 13.20 15 129717 28191 79586465
Eye pruritus 14.02 13.20 8 129724 20562 79594094
Hyperglycaemic hyperosmolar nonketotic syndrome 14.00 13.20 18 129714 2285 79612371
Hypothermia 13.92 13.20 10 129722 22736 79591920
Disease recurrence 13.92 13.20 32 129700 44077 79570579
Euthanasia 13.90 13.20 6 129726 133 79614523
Paraneoplastic neurological syndrome 13.89 13.20 5 129727 67 79614589
Pleurisy 13.84 13.20 43 129689 10432 79604224
Diabetic hyperosmolar coma 13.82 13.20 11 129721 786 79613870
Encephalomyelitis 13.79 13.20 7 129725 226 79614430
Lip dry 13.74 13.20 4 129728 15414 79599242
Bronchitis 13.70 13.20 141 129591 130503 79484153
IIIrd nerve paralysis 13.67 13.20 13 129719 1180 79613476
Thyroiditis chronic 13.54 13.20 4 129728 27 79614629
Respiratory depression 13.49 13.20 15 129717 27615 79587041
Multiple sclerosis 13.37 13.20 10 129722 22272 79592384
Metastases to abdominal cavity 13.34 13.20 10 129722 654 79614002

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FF01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
ATC L01XY03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000082082 Immune Checkpoint Inhibitors
FDA MoA N0000191259 Programmed Death Receptor-1-directed Antibody Interactions
FDA EPC N0000191260 Programmed Death Receptor-1 Blocking Antibody

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

DiseaseRelationSNOMED_IDDOID
Transitional cell carcinoma indication 27090000 DOID:2671
Squamous cell carcinoma of lung indication 254634000 DOID:3907
Non-small cell lung cancer indication 254637007 DOID:3908
Unresectable advanced or recurrent malignant pleural mesothelioma indication 254645002 DOID:7474
Head and neck cancer indication 255055008 DOID:11934
Unresectable, advanced or recurrent gastric cancer indication 276810009
Malignant tumor of stomach indication 363349007 DOID:10534
Malignant tumor of esophagus indication 363402007
Advanced melanoma with tumour cell PD-L1 expression below 1% indication 443493003
Metastatic malignant melanoma indication 443493003
Metastatic renal cell carcinoma indication 702392008
Microsatellite instability-high colorectal cancer indication 737058005
Classical Hodgkin lymphoma indication 762690000
Postoperative adjuvant therapy for urothelial carcinoma indication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Programmed cell death protein 1 Membrane receptor ANTIBODY BINDING Kd 9.14 IUPHAR SCIENTIFIC LITERATURE

External reference:

IDSource
31YO63LBSN UNII
D10316 KEGG_DRUG
4034032 VUID
N0000191289 NUI
4034032 VANDF
C3657270 UMLSCUI
CHEMBL2108738 ChEMBL_ID
DB09035 DRUGBANK_ID
D000077594 MESH_DESCRIPTOR_UI
9623 INN_ID
7335 IUPHAR_LIGAND_ID
1597876 RXNORM
231573 MMSL
30781 MMSL
d08324 MMSL
015839 NDDF
704191007 SNOMEDCT_US
704192000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 24 sections
OPDUALAG HUMAN PRESCRIPTION DRUG LABEL 2 0003-7125 INJECTION 12 mg INTRAVENOUS BLA 27 sections