nivolumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:

DoseUnitRoute
17.10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

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 6055.76 16.24 2400 60670 104470 90460907
Death 1903.35 16.24 1937 61133 454614 90110763
Immune-mediated enterocolitis 1819.61 16.24 461 62609 4296 90561081
Hypothyroidism 1092.03 16.24 593 62477 52534 90512843
Pneumonitis 1014.68 16.24 531 62539 43639 90521738
Hypophysitis 982.26 16.24 248 62822 2272 90563105
Colitis 980.92 16.24 609 62461 69333 90496044
Intentional product use issue 902.20 16.24 922 62148 215970 90349407
Immune-mediated hepatitis 896.19 16.24 238 62832 2706 90562671
Fulminant type 1 diabetes mellitus 827.23 16.24 177 62893 701 90564676
Immune-mediated hepatic disorder 667.02 16.24 170 62900 1622 90563755
Immune-mediated lung disease 644.35 16.24 167 62903 1713 90563664
Hyperthyroidism 626.46 16.24 289 62781 18021 90547356
Myocarditis 594.44 16.24 256 62814 13550 90551827
Adrenal insufficiency 586.84 16.24 324 62746 29597 90535780
Type 1 diabetes mellitus 548.77 16.24 182 62888 4630 90560747
Thyroiditis 502.03 16.24 159 62911 3478 90561899
Immune-mediated myocarditis 450.69 16.24 117 62953 1208 90564169
Hepatic function abnormal 449.88 16.24 321 62749 45967 90519410
Diabetic ketoacidosis 428.96 16.24 246 62824 24161 90541216
Hypopituitarism 418.24 16.24 117 62953 1636 90563741
Immune-mediated hypothyroidism 390.11 16.24 108 62962 1450 90563927
Autoimmune colitis 385.14 16.24 93 62977 694 90564683
Autoimmune hepatitis 371.66 16.24 169 62901 10182 90555195
Immune-mediated dermatitis 349.83 16.24 89 62981 842 90564535
Immune-mediated hypophysitis 308.55 16.24 72 62998 455 90564922
Secondary adrenocortical insufficiency 297.96 16.24 96 62974 2222 90563155
Immune-mediated thyroiditis 295.29 16.24 69 63001 439 90564938
Adrenocorticotropic hormone deficiency 291.44 16.24 74 62996 694 90564683
Off label use 289.75 16.24 1518 61552 1100734 89464643
Pemphigoid 282.49 16.24 134 62936 8892 90556485
Cholangitis 272.89 16.24 122 62948 7060 90558317
Immune-mediated uveitis 262.51 16.24 50 63020 89 90565288
Immune-mediated adrenal insuficiency 252.59 16.24 71 62999 1011 90564366
Hepatitis 235.74 16.24 268 62802 70471 90494906
Interstitial lung disease 235.41 16.24 278 62792 76127 90489250
Metastases to central nervous system 233.63 16.24 148 62922 17394 90547983
Myasthenia gravis 231.11 16.24 107 62963 6718 90558659
Joint swelling 224.23 16.24 40 63030 503260 90062117
Drug intolerance 224.08 16.24 25 63045 447566 90117811
Enterocolitis 223.35 16.24 120 62950 10370 90555007
Cytokine release syndrome 222.40 16.24 172 62898 27801 90537576
Leukoderma 215.05 16.24 40 63030 58 90565319
Tumour pseudoprogression 213.29 16.24 57 63013 664 90564713
Systemic lupus erythematosus 210.05 16.24 10 63060 361886 90203491
Pyrexia 202.75 16.24 952 62118 659533 89905844
Immune-mediated nephritis 201.61 16.24 50 63020 422 90564955
Glossodynia 200.30 16.24 5 63065 321774 90243603
Pemphigus 200.05 16.24 6 63064 326858 90238519
Drug hypersensitivity 199.76 16.24 40 63030 463569 90101808
Abdominal discomfort 195.89 16.24 46 63024 477282 90088095
Pleural effusion 194.99 16.24 309 62761 111682 90453695
Synovitis 191.72 16.24 9 63061 329743 90235634
Arthropathy 189.61 16.24 18 63052 366224 90199153
Swelling 187.26 16.24 33 63037 419025 90146352
Myositis 186.69 16.24 146 62924 23982 90541395
Pain 183.83 16.24 256 62814 996085 89569292
Lichenoid keratosis 182.15 16.24 68 63002 2466 90562911
Drug ineffective 180.75 16.24 440 62630 1383858 89181519
Wound 180.34 16.24 7 63063 302973 90262404
Therapeutic product effect decreased 177.96 16.24 3 63067 277568 90287809
Immune-mediated encephalitis 175.79 16.24 46 63024 491 90564886
Uveitis 172.43 16.24 118 62952 15785 90549592
Immune-mediated cholangitis 171.92 16.24 40 63030 249 90565128
Metastatic malignant melanoma 171.56 16.24 58 63012 1566 90563811
Vitiligo 171.56 16.24 62 63008 2048 90563329
Cachexia 167.25 16.24 86 62984 6792 90558585
Sinusitis 167.09 16.24 21 63049 343067 90222310
Nasopharyngitis 159.70 16.24 43 63027 407061 90158316
Non-small cell lung cancer 158.74 16.24 72 62998 4309 90561068
Encephalitis 158.49 16.24 98 62972 11036 90554341
Sepsis 156.73 16.24 370 62700 179444 90385933
Thyroid disorder 153.81 16.24 115 62955 17670 90547707
Lymphocytic hypophysitis 149.74 16.24 36 63034 263 90565114
Immune-mediated myositis 148.96 16.24 58 63012 2363 90563014
Immune-mediated pancreatitis 146.29 16.24 37 63033 341 90565036
Exposure during pregnancy 143.61 16.24 5 63065 238405 90326972
Rash maculo-papular 141.30 16.24 158 62912 40775 90524602
Discomfort 140.59 16.24 14 63056 274321 90291056
Alopecia 138.32 16.24 87 62983 494984 90070393
Acute kidney injury 138.10 16.24 513 62557 319874 90245503
Tubulointerstitial nephritis 133.62 16.24 123 62947 25220 90540157
Fibromyalgia 129.10 16.24 3 63067 206266 90359111
Maternal exposure during pregnancy 128.64 16.24 45 63025 360018 90205359
Cholestasis 128.54 16.24 142 62928 36157 90529220
Nephritis 126.92 16.24 56 63014 3139 90562238
Diarrhoea 126.77 16.24 1098 61972 938092 89627285
Blood cholesterol increased 126.56 16.24 4 63066 208008 90357369
Irritable bowel syndrome 126.18 16.24 4 63066 207444 90357933
Respiratory failure 124.87 16.24 263 62807 118155 90447222
Peripheral swelling 124.76 16.24 66 63004 413040 90152337
Psoriatic arthropathy 121.42 16.24 10 63060 228325 90337052
Product dose omission issue 119.77 16.24 28 63042 291659 90273718
Autoimmune thyroiditis 118.74 16.24 65 63005 5828 90559549
Mobility decreased 118.10 16.24 17 63053 250717 90314660
Weight increased 115.93 16.24 74 62996 417853 90147524
Decreased appetite 113.11 16.24 540 62530 376000 90189377
Meningitis aseptic 112.93 16.24 66 63004 6707 90558670
Vogt-Koyanagi-Harada disease 109.66 16.24 30 63040 384 90564993
Blood thyroid stimulating hormone increased 109.00 16.24 72 62998 9083 90556294
Hypothalamo-pituitary disorder 107.66 16.24 45 63025 2207 90563170
Injection site pain 106.90 16.24 3 63067 173696 90391681
Treatment failure 106.81 16.24 39 63031 303889 90261488
Radiation pneumonitis 105.50 16.24 42 63028 1816 90563561
Aspartate aminotransferase increased 105.49 16.24 226 62844 102711 90462666
Palmar-plantar erythrodysaesthesia syndrome 105.10 16.24 113 62957 27910 90537467
Eosinophilic fasciitis 105.04 16.24 25 63045 174 90565203
Hyponatraemia 104.80 16.24 264 62806 133274 90432103
Autoimmune haemolytic anaemia 104.80 16.24 59 63011 5586 90559791
Hypersensitivity 102.76 16.24 99 62971 454578 90110799
Musculoskeletal stiffness 102.61 16.24 39 63031 296493 90268884
Myasthenic syndrome 101.95 16.24 28 63042 364 90565013
Wheezing 101.47 16.24 21 63049 238059 90327318
Immune-mediated arthritis 100.80 16.24 26 63044 261 90565116
Liver disorder 99.65 16.24 244 62826 121025 90444352
Haemophagocytic lymphohistiocytosis 99.43 16.24 84 62986 15375 90550002
Erythema multiforme 98.85 16.24 76 62994 12170 90553207
Pericardial effusion 98.77 16.24 125 62945 36708 90528669
Cholangitis sclerosing 98.25 16.24 42 63028 2179 90563198
Relapsing fever 98.02 16.24 25 63045 239 90565138
Condition aggravated 97.98 16.24 165 62905 595380 89969997
Blood corticotrophin decreased 97.31 16.24 29 63041 513 90564864
Asthma 95.98 16.24 25 63045 242135 90323242
Immune-mediated adverse reaction 95.83 16.24 32 63038 831 90564546
Glucocorticoid deficiency 95.62 16.24 29 63041 546 90564831
Lipase increased 94.19 16.24 71 62999 11040 90554337
Disseminated intravascular coagulation 93.62 16.24 94 62976 21444 90543933
Ill-defined disorder 93.23 16.24 10 63060 184881 90380496
Serous retinal detachment 92.83 16.24 29 63041 605 90564772
Osteoarthritis 92.79 16.24 13 63057 195717 90369660
Skin toxicity 92.27 16.24 58 63012 6721 90558656
Immune-mediated gastritis 89.53 16.24 22 63048 178 90565199
Migraine 89.43 16.24 13 63057 190379 90374998
Pericarditis 89.43 16.24 38 63032 270113 90295264
Impaired healing 89.41 16.24 26 63044 234173 90331204
Urticaria 88.58 16.24 54 63016 312680 90252697
Drug interaction 88.19 16.24 41 63029 276412 90288965
Autoimmune nephritis 86.40 16.24 25 63045 397 90564980
Hypoaesthesia 85.24 16.24 57 63013 314153 90251224
Overdose 83.57 16.24 7 63063 157702 90407675
Embolism 83.53 16.24 62 63008 9419 90555958
Therapeutic product effect incomplete 82.83 16.24 17 63053 193879 90371498
Pain in extremity 81.51 16.24 117 62953 450412 90114965
Exposure via body fluid 80.84 16.24 26 63044 598 90564779
Metastases to lung 77.36 16.24 74 62996 15917 90549460
Alanine aminotransferase increased 76.72 16.24 218 62852 118120 90447257
Anaemia 76.60 16.24 463 62607 352339 90213038
Adrenocortical insufficiency acute 76.47 16.24 37 63033 2564 90562813
Contusion 75.97 16.24 40 63030 251176 90314201
Blister 75.08 16.24 42 63028 254956 90310421
Autoimmune myocarditis 73.69 16.24 20 63050 248 90565129
Ascites 72.60 16.24 124 62946 47616 90517761
Dizziness 72.01 16.24 193 62877 589091 89976286
Hyperglycaemia 71.80 16.24 128 62942 50842 90514535
Immune-mediated hyperthyroidism 71.36 16.24 21 63049 355 90565022
Febrile neutropenia 70.15 16.24 256 62814 158093 90407284
Lower respiratory tract infection 69.97 16.24 44 63026 250615 90314762
Toxicity to various agents 69.36 16.24 59 63011 287787 90277590
Immune thrombocytopenia 68.93 16.24 64 63006 13262 90552115
Gait inability 68.77 16.24 10 63060 146446 90418931
Autoimmune dermatitis 68.39 16.24 17 63053 145 90565232
Autoimmune pancreatitis 67.47 16.24 20 63050 347 90565030
Encephalitis autoimmune 65.76 16.24 31 63039 2027 90563350
Tumour haemorrhage 65.25 16.24 31 63039 2063 90563314
Immune-mediated encephalopathy 65.10 16.24 12 63058 16 90565361
Memory impairment 64.85 16.24 28 63042 197216 90368161
Loss of personal independence in daily activities 62.29 16.24 10 63060 136095 90429282
Sleep disorder 62.16 16.24 30 63040 198000 90367377
Tumour pain 62.07 16.24 29 63041 1858 90563519
Bursitis 61.79 16.24 9 63061 131645 90433732
Amylase increased 61.75 16.24 46 63024 7026 90558351
Muscle spasms 60.22 16.24 52 63018 251831 90313546
Polyarthritis 60.20 16.24 69 63001 18281 90547096
Capillary leak syndrome 59.87 16.24 32 63038 2735 90562642
Prescribed underdose 59.54 16.24 149 62921 74870 90490507
Depression 59.49 16.24 73 62997 300528 90264849
Headache 58.81 16.24 356 62714 862390 89702987
Keratoacanthoma 57.84 16.24 20 63050 579 90564798
Feeling abnormal 57.80 16.24 22 63048 167213 90398164
Hypercholesterolaemia 57.79 16.24 3 63067 100889 90464488
Dehydration 57.64 16.24 278 62792 194169 90371208
Hepatic failure 57.54 16.24 101 62969 39627 90525750
Arthralgia 57.47 16.24 313 62757 778209 89787168
Hypokalaemia 57.24 16.24 211 62859 130905 90434472
Diabetes mellitus 56.99 16.24 134 62936 64741 90500636
Cardiac tamponade 56.85 16.24 40 63030 5592 90559785
Pancreatitis 56.80 16.24 140 62930 69686 90495691
Road traffic accident 56.40 16.24 5 63065 107621 90457756
Type 2 diabetes mellitus 56.27 16.24 36 63034 203208 90362169
Duodenitis 56.07 16.24 36 63034 4327 90561050
Insomnia 56.04 16.24 91 62979 333383 90231994
Eyelid ptosis 56.00 16.24 48 63022 8958 90556419
Guillain-Barre syndrome 54.24 16.24 36 63034 4576 90560801
Immune-mediated renal disorder 53.53 16.24 15 63055 211 90565166
Pulmonary embolism 53.36 16.24 206 62864 130614 90434763
Injection site erythema 53.22 16.24 4 63066 98498 90466879
Transaminases increased 53.15 16.24 94 62976 37098 90528279
Gastrooesophageal reflux disease 52.51 16.24 25 63045 166312 90399065
Enteritis 52.28 16.24 49 63021 10272 90555105
Injection site reaction 51.93 16.24 3 63067 92077 90473300
Stevens-Johnson syndrome 50.99 16.24 81 62989 29295 90536082
Liver injury 50.32 16.24 28 63042 170539 90394838
Immune-mediated oesophagitis 50.20 16.24 10 63060 25 90565352
Eosinophilia 49.98 16.24 79 62991 28454 90536923
Brain oedema 49.80 16.24 61 63009 17324 90548053
Dermatitis 49.69 16.24 69 63001 22151 90543226
Hepatotoxicity 49.66 16.24 103 62967 45739 90519638
Toxic skin eruption 49.54 16.24 58 63012 15716 90549661
Hypercalcaemia 49.53 16.24 87 62983 34153 90531224
Adrenal disorder 49.45 16.24 25 63045 1905 90563472
Abdominal pain upper 49.41 16.24 98 62972 332576 90232801
Hepatic cytolysis 49.26 16.24 82 62988 30834 90534543
Tumour lysis syndrome 49.07 16.24 49 63021 11103 90554274
Lichen planus 48.66 16.24 28 63042 2763 90562614
Primary hypothyroidism 48.52 16.24 13 63057 153 90565224
Silent thyroiditis 48.29 16.24 13 63057 156 90565221
Cholecystitis 47.54 16.24 59 63011 16981 90548396
Intentional overdose 47.48 16.24 5 63065 93829 90471548
Sciatica 47.41 16.24 7 63063 101375 90464002
Amnesia 47.40 16.24 9 63061 108496 90456881
Blood thyroid stimulating hormone decreased 47.15 16.24 36 63034 5704 90559673
Lymphangiosis carcinomatosa 46.80 16.24 23 63047 1649 90563728
Sarcoid-like reaction 45.99 16.24 13 63057 189 90565188
Adrenalitis 45.88 16.24 10 63060 44 90565333
Autoimmune hypothyroidism 45.75 16.24 14 63056 272 90565105
Rheumatoid arthritis 45.56 16.24 117 62953 362497 90202880
Neutropenia 45.51 16.24 290 62780 224614 90340763
Fall 45.42 16.24 177 62893 481633 90083744
Drug eruption 44.92 16.24 85 62985 35322 90530055
Anxiety 44.51 16.24 93 62977 309679 90255698
Hypoalbuminaemia 44.28 16.24 55 63015 15842 90549535
Wound infection 44.06 16.24 10 63060 106392 90458985
Inflammation 43.74 16.24 36 63034 178556 90386821
Peripheral venous disease 43.70 16.24 4 63066 83917 90481460
Ulcerative gastritis 43.58 16.24 10 63060 58 90565319
Haemolytic anaemia 43.56 16.24 47 63023 11650 90553727
Product quality issue 43.49 16.24 3 63067 79322 90486055
Hepatic enzyme increased 43.35 16.24 119 62951 360617 90204760
Pancreatic failure 43.19 16.24 21 63049 1471 90563906
Adverse drug reaction 42.64 16.24 14 63056 116687 90448690
Hepatocellular injury 42.43 16.24 74 62996 28884 90536493
Thrombocytopenia 42.14 16.24 269 62801 208456 90356921
Glomerulonephritis minimal lesion 42.13 16.24 14 63056 358 90565019
Lower limb fracture 41.83 16.24 5 63065 85008 90480369
Aplasia pure red cell 41.41 16.24 32 63038 5162 90560215
Metastases to meninges 41.16 16.24 28 63042 3707 90561670
Mucosal inflammation 41.14 16.24 110 62960 57515 90507862
Suicide attempt 40.91 16.24 3 63067 75396 90489981
Meningitis 40.55 16.24 39 63031 8442 90556935
Paraesthesia 40.47 16.24 70 63000 250256 90315121
Immune-mediated cystitis 40.35 16.24 9 63061 45 90565332
Osteoporosis 40.11 16.24 9 63061 96522 90468855
Blood creatine phosphokinase increased 39.89 16.24 79 62991 33944 90531433
Encephalopathy 39.78 16.24 95 62975 46349 90519028
Large intestine perforation 39.68 16.24 41 63029 9671 90555706
Stress 39.53 16.24 5 63065 81390 90483987
Medication error 39.23 16.24 6 63064 84646 90480731
Oesophagitis 39.22 16.24 54 63016 17195 90548182
Toxic epidermal necrolysis 38.71 16.24 76 62994 32452 90532925
Gait disturbance 38.44 16.24 77 62993 260419 90304958
Hypertransaminasaemia 38.20 16.24 51 63019 15774 90549603
Neoplasm progression 38.10 16.24 91 62979 44395 90520982
Thyrotoxic crisis 37.67 16.24 18 63052 1213 90564164
Confusional state 37.59 16.24 140 62930 386065 90179312
Polyneuropathy 37.31 16.24 56 63014 19285 90546092
Dyspepsia 37.24 16.24 50 63020 198110 90367267
Cortisol decreased 37.10 16.24 20 63050 1739 90563638
Gastrointestinal toxicity 36.95 16.24 39 63031 9428 90555949
Iridocyclitis 36.95 16.24 26 63044 3635 90561742
Immune-mediated endocrinopathy 36.92 16.24 10 63060 123 90565254
Pregnancy on contraceptive 36.80 16.24 18 63052 1277 90564100
Autoimmune arthritis 36.50 16.24 9 63061 74 90565303
Ileus 36.43 16.24 51 63019 16495 90548882
Gastritis 36.40 16.24 86 62984 41667 90523710
Peripheral sensory neuropathy 35.91 16.24 38 63032 9212 90556165
Suicidal ideation 34.76 16.24 5 63065 73850 90491527
Pulmonary fibrosis 34.16 16.24 16 63054 107487 90457890
Night sweats 34.03 16.24 24 63046 128742 90436635
Gastrointestinal disorder 33.65 16.24 81 62989 256606 90308771
Disease progression 33.57 16.24 205 62865 156410 90408967
Eagle Barrett syndrome 33.47 16.24 6 63064 6 90565371
Fluid retention 33.19 16.24 10 63060 88081 90477296
Limbic encephalitis 33.00 16.24 11 63059 284 90565093
Joint stiffness 32.99 16.24 7 63063 78035 90487342
Heart rate increased 32.63 16.24 19 63051 112883 90452494
Blood alkaline phosphatase increased 32.54 16.24 90 62980 47989 90517388
Paraparesis 32.32 16.24 22 63048 2916 90562461
Ear infection 32.21 16.24 5 63065 69770 90495607
Oral mucosa erosion 31.60 16.24 17 63053 1472 90563905
Multiple organ dysfunction syndrome 31.53 16.24 112 62958 68224 90497153
Adverse event 31.32 16.24 163 62907 117255 90448122
Wrong technique in product usage process 31.12 16.24 6 63064 71565 90493812
Autoimmune neuropathy 31.06 16.24 7 63063 37 90565340
Pulmonary toxicity 30.69 16.24 39 63031 11492 90553885
Foot deformity 30.64 16.24 3 63067 59648 90505729
Subacute cutaneous lupus erythematosus 30.60 16.24 23 63047 3559 90561818
Hepatitis G 30.60 16.24 8 63062 85 90565292
Pancreatic enzymes increased 30.58 16.24 14 63056 856 90564521
Nasal congestion 30.48 16.24 10 63060 83404 90481973
Radiation skin injury 30.40 16.24 15 63055 1085 90564292
Hypoxia 30.32 16.24 115 62955 72284 90493093
Nail disorder 30.27 16.24 3 63067 59064 90506313
Rhinorrhoea 29.88 16.24 12 63058 88304 90477073
Incorrect dose administered 29.67 16.24 9 63061 78921 90486456
Thrombophlebitis migrans 29.51 16.24 10 63060 272 90565105
Intestinal perforation 29.40 16.24 42 63028 13839 90551538
Septic shock 29.13 16.24 126 62944 84034 90481343
Morphoea 28.95 16.24 11 63059 419 90564958
Infusion related reaction 28.81 16.24 171 62899 416609 90148768
Cardiomyopathy 28.78 16.24 51 63019 20155 90545222
Cerebral microangiopathy 28.74 16.24 10 63060 295 90565082
Immune-mediated neuropathy 28.58 16.24 8 63062 112 90565265
Platelet count decreased 28.54 16.24 178 62892 136791 90428586
Blood pressure increased 28.49 16.24 59 63011 197158 90368219
Lymphadenopathy 28.36 16.24 83 62987 45692 90519685
General physical health deterioration 28.22 16.24 374 62696 354741 90210636
Lithiasis 27.92 16.24 7 63063 62 90565315
Troponin increased 27.85 16.24 40 63030 13241 90552136
Cardiac failure 27.83 16.24 150 62920 109346 90456031
Infection 27.50 16.24 144 62926 361950 90203427
Radiation necrosis 27.39 16.24 12 63058 661 90564716
Autoimmune myositis 27.31 16.24 10 63060 343 90565034
Balance disorder 27.12 16.24 17 63053 97063 90468314
VIth nerve paralysis 27.08 16.24 13 63057 885 90564492
Psoriasis 27.03 16.24 38 63032 147716 90417661
Gamma-glutamyltransferase increased 26.63 16.24 72 62998 37880 90527497
Blood lactate dehydrogenase increased 26.61 16.24 57 63013 25875 90539502
Upper respiratory tract infection 26.60 16.24 30 63040 128288 90437089
Demyelinating polyneuropathy 26.49 16.24 13 63057 929 90564448
Influenza 26.30 16.24 35 63035 139229 90426148
Therapeutic response decreased 26.07 16.24 15 63055 89714 90475663
Pneumonia bacterial 26.06 16.24 38 63032 12752 90552625
Hyperhidrosis 26.00 16.24 34 63036 136271 90429106
Multiple sclerosis relapse 25.92 16.24 3 63067 52302 90513075
Systemic inflammatory response syndrome 25.71 16.24 27 63043 6489 90558888
Immune-mediated cholestasis 25.70 16.24 6 63064 38 90565339
Therapy partial responder 25.62 16.24 51 63019 21992 90543385
Agranulocytosis 25.16 16.24 67 63003 34935 90530442
Skin disorder 25.12 16.24 69 63001 36637 90528740
Metastases to bone 24.96 16.24 55 63015 25450 90539927
Laryngitis 24.93 16.24 3 63067 50750 90514627
Troponin T increased 24.93 16.24 15 63055 1608 90563769
Nephrotic syndrome 24.75 16.24 28 63042 7311 90558066
Metastases to liver 24.75 16.24 59 63011 28748 90536629
Neutrophil count decreased 24.68 16.24 107 62963 71425 90493952
Hepatitis acute 24.63 16.24 34 63036 10853 90554524
Optic neuritis 24.61 16.24 32 63038 9646 90555731
Melanoma recurrent 24.59 16.24 8 63062 191 90565186
Catabolic state 24.59 16.24 6 63064 47 90565330
Hyperglycaemic hyperosmolar nonketotic syndrome 24.58 16.24 14 63056 1355 90564022
Hair colour changes 24.58 16.24 20 63050 3474 90561903
Type 3 diabetes mellitus 24.43 16.24 5 63065 15 90565362
Cytomegalovirus enterocolitis 24.40 16.24 12 63058 862 90564515
Atrioventricular block complete 24.27 16.24 32 63038 9779 90555598
Polymyalgia rheumatica 24.01 16.24 23 63047 4954 90560423
Organising pneumonia 23.97 16.24 28 63042 7569 90557808
Aspiration pleural cavity 23.86 16.24 12 63058 904 90564473
Autoimmune uveitis 23.74 16.24 5 63065 18 90565359
Lupus-like syndrome 23.72 16.24 3 63067 48843 90516534
Glomerulonephritis 23.68 16.24 17 63053 2453 90562924
Blood corticotrophin increased 23.48 16.24 7 63063 124 90565253
Metastasis 23.45 16.24 25 63045 6112 90559265
Engraftment syndrome 23.41 16.24 11 63059 714 90564663
Endocrine disorder 23.33 16.24 12 63058 948 90564429
Toxic erythema of chemotherapy 23.32 16.24 8 63062 226 90565151
Drug reaction with eosinophilia and systemic symptoms 23.19 16.24 74 62996 42684 90522693
Metastases to adrenals 23.12 16.24 12 63058 966 90564411
Dermatomyositis 23.10 16.24 19 63051 3351 90562026
Bacteraemia 22.87 16.24 49 63021 22251 90543126
Pneumonia 22.76 16.24 593 62477 637466 89927911
Ear pain 22.76 16.24 6 63064 57696 90507681
Blood bilirubin increased 22.46 16.24 74 62996 43396 90521981
Optic neuropathy 22.33 16.24 17 63053 2681 90562696
Heart rate decreased 22.20 16.24 5 63065 53500 90511877
Monoparesis 21.87 16.24 15 63055 2012 90563365
Pneumothorax 21.86 16.24 44 63026 19123 90546254
Thoracic cavity drainage 21.85 16.24 7 63063 159 90565218
Tracheal stenosis 21.75 16.24 8 63062 278 90565099
Musculoskeletal pain 21.68 16.24 55 63015 171196 90394181
Papilloedema 21.65 16.24 21 63049 4594 90560783
Metastases to peritoneum 21.57 16.24 20 63050 4135 90561242
Acquired tracheo-oesophageal fistula 21.42 16.24 4 63066 6 90565371
Chronic gastritis 21.37 16.24 19 63051 3722 90561655
Acute polyneuropathy 21.33 16.24 9 63061 452 90564925
Inappropriate antidiuretic hormone secretion 21.33 16.24 44 63026 19461 90545916
Cerebral infarction 21.28 16.24 53 63017 26543 90538834
Hydronephrosis 21.25 16.24 34 63036 12368 90553009
Polyserositis 21.08 16.24 10 63060 663 90564714
Coeliac disease 21.04 16.24 3 63067 44607 90520770
Joint dislocation 21.02 16.24 3 63067 44579 90520798
Dermatitis acneiform 21.02 16.24 24 63046 6330 90559047
Escherichia sepsis 21.01 16.24 23 63047 5793 90559584
Generalised oedema 20.86 16.24 43 63027 19010 90546367
Rheumatic disorder 20.86 16.24 18 63052 3390 90561987
Graft versus host disease 20.82 16.24 27 63043 8117 90557260
Renal failure 20.64 16.24 159 62911 130848 90434529
Nephritis allergic 20.64 16.24 8 63062 322 90565055
Palpitations 20.51 16.24 40 63030 136688 90428689
Enanthema 20.45 16.24 9 63061 501 90564876
Metastases to pancreas 20.43 16.24 8 63062 331 90565046
Dacryoadenitis acquired 20.38 16.24 4 63066 9 90565368
Tremor 20.33 16.24 48 63022 153125 90412252
Dermatitis psoriasiform 20.30 16.24 16 63054 2656 90562721
Tumour thrombosis 20.18 16.24 5 63065 42 90565335
Cancer pain 20.18 16.24 19 63051 4006 90561371
Hepatobiliary disease 20.06 16.24 9 63061 525 90564852
Central nervous system lesion 20.06 16.24 32 63038 11614 90553763
Tumour necrosis 20.05 16.24 11 63059 990 90564387
General physical condition abnormal 19.85 16.24 21 63049 5090 90560287
KL-6 increased 19.63 16.24 6 63064 116 90565261
Thyroiditis subacute 19.60 16.24 8 63062 369 90565008
Myasthenia gravis crisis 19.42 16.24 11 63059 1053 90564324
Autoimmune encephalopathy 19.40 16.24 5 63065 50 90565327
Oedema 19.21 16.24 73 62997 200222 90365155
Performance status decreased 19.19 16.24 19 63051 4261 90561116
Tri-iodothyronine free decreased 19.09 16.24 8 63062 395 90564982
Intracranial tumour haemorrhage 18.96 16.24 7 63063 246 90565131
Meningoradiculitis 18.95 16.24 6 63064 131 90565246
Malignant pleural effusion 18.84 16.24 16 63054 2948 90562429
Thyroid stimulating hormone deficiency 18.81 16.24 3 63067 0 90565377
Escherichia urinary tract infection 18.57 16.24 34 63036 13781 90551596
Electrocardiogram QT prolonged 18.49 16.24 14 63056 72442 90492935
Product use issue 18.48 16.24 144 62926 329775 90235602
Autoimmune retinopathy 18.46 16.24 4 63066 17 90565360
Illness 18.29 16.24 18 63052 81951 90483426
Ketoacidosis 18.29 16.24 21 63049 5574 90559803
Haemoglobin decreased 18.27 16.24 55 63015 161901 90403476
Pneumocystis jirovecii pneumonia 18.27 16.24 44 63026 21572 90543805
Rash morbilliform 18.27 16.24 18 63052 4011 90561366
Facial paralysis 18.12 16.24 36 63034 15498 90549879
Thyroxine free abnormal 18.10 16.24 4 63066 19 90565358
Achromobacter infection 18.07 16.24 5 63065 67 90565310
Bradycardia 18.04 16.24 19 63051 83828 90481549
Pericardial drainage 18.03 16.24 7 63063 283 90565094
Tumour associated fever 17.92 16.24 8 63062 461 90564916
Primary adrenal insufficiency 17.82 16.24 7 63063 292 90565085
Gastroenteritis eosinophilic 17.78 16.24 6 63064 161 90565216
Orbital myositis 17.54 16.24 5 63065 75 90565302
Transfusion 17.44 16.24 38 63032 17450 90547927
Cortisol abnormal 17.42 16.24 5 63065 77 90565300
Tumour embolism 17.41 16.24 6 63064 172 90565205
Drug-induced liver injury 17.35 16.24 115 62955 90203 90475174
Metastases to lymph nodes 17.29 16.24 30 63040 11659 90553718
Frequent bowel movements 17.29 16.24 9 63061 56926 90508451
Pathological fracture 17.27 16.24 27 63043 9633 90555744
Gastrointestinal perforation 17.18 16.24 18 63052 4314 90561063
Enterocolitis infectious 17.17 16.24 13 63057 2034 90563343
Hypertension 17.15 16.24 220 62850 457312 90108065
Infected seroma 17.13 16.24 5 63065 82 90565295
Blood thyroid stimulating hormone abnormal 17.13 16.24 10 63060 1014 90564363
Renal arteriosclerosis 17.12 16.24 6 63064 181 90565196
Pericardial excision 17.04 16.24 4 63066 26 90565351
Macular degeneration 16.90 16.24 3 63067 37967 90527410
Eosinophilic gastritis 16.74 16.24 3 63067 3 90565374
Troponin I increased 16.67 16.24 14 63056 2541 90562836
Polymyositis 16.45 16.24 13 63057 2166 90563211
Feeling hot 16.43 16.24 18 63052 77990 90487387
Respiratory distress 16.42 16.24 62 63008 38884 90526493
Chorioretinitis 16.26 16.24 9 63061 824 90564553

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 8836.36 13.75 4803 114901 103597 42398034
Immune-mediated enterocolitis 2187.34 13.75 758 118946 4919 42496712
Hypothyroidism 1551.23 13.75 1021 118683 31063 42470568
Adrenal insufficiency 1359.84 13.75 776 118928 18148 42483483
Death 1318.69 13.75 3571 116133 467614 42034017
Pneumonitis 1243.12 13.75 990 118714 40728 42460903
Fulminant type 1 diabetes mellitus 1241.03 13.75 352 119352 1022 42500609
Immune-mediated lung disease 1159.45 13.75 417 119287 3056 42498575
Intentional product use issue 1145.61 13.75 1200 118504 70633 42430998
Colitis 1093.22 13.75 963 118741 45609 42456022
Hypophysitis 1078.83 13.75 381 119323 2630 42499001
Immune-mediated hepatitis 930.82 13.75 363 119341 3411 42498220
Immune-mediated hepatic disorder 869.87 13.75 310 119394 2204 42499427
Pemphigoid 855.25 13.75 482 119222 10985 42490646
Interstitial lung disease 853.67 13.75 1076 118628 77386 42424245
Immune-mediated myocarditis 806.51 13.75 281 119423 1853 42499778
Hypopituitarism 797.97 13.75 299 119405 2492 42499139
Type 1 diabetes mellitus 768.28 13.75 353 119351 5134 42496497
Myocarditis 742.63 13.75 530 119174 18408 42483223
Thyroiditis 737.54 13.75 294 119410 2942 42498689
Hyperthyroidism 730.74 13.75 472 119232 13869 42487762
Adrenocorticotropic hormone deficiency 654.01 13.75 215 119489 1155 42500476
Immune-mediated dermatitis 634.75 13.75 206 119498 1055 42500576
Myositis 617.50 13.75 431 119273 14435 42487196
Secondary adrenocortical insufficiency 560.73 13.75 214 119490 1885 42499746
Hepatic function abnormal 542.68 13.75 696 119008 50871 42450760
Immune-mediated hypothyroidism 478.50 13.75 167 119537 1107 42500524
Drug interaction 473.03 13.75 89 119615 266910 42234721
Autoimmune hepatitis 463.89 13.75 253 119451 5392 42496239
Immune-mediated adrenal insuficiency 433.16 13.75 136 119568 613 42501018
Diabetic ketoacidosis 407.49 13.75 402 119302 21965 42479666
Drug ineffective 397.98 13.75 730 118974 629467 41872164
Hepatitis 397.28 13.75 435 119269 26865 42474766
Autoimmune colitis 392.07 13.75 140 119564 1001 42500630
Immune-mediated hypophysitis 391.42 13.75 110 119594 305 42501326
Enterocolitis 389.41 13.75 278 119426 9651 42491980
Liver disorder 378.13 13.75 510 119194 39134 42462497
Prescribed underdose 373.90 13.75 275 119429 10007 42491624
Toxicity to various agents 371.91 13.75 93 119611 229043 42272588
Palmar-plantar erythrodysaesthesia syndrome 347.51 13.75 355 119349 20227 42481404
Vitiligo 336.59 13.75 128 119576 1115 42500516
Metastases to central nervous system 304.27 13.75 244 119460 10111 42491520
Immune-mediated thyroiditis 290.21 13.75 91 119613 408 42501223
Radiation pneumonitis 287.82 13.75 148 119556 2785 42498846
Immune-mediated myositis 286.96 13.75 161 119543 3632 42497999
Immune-mediated cholangitis 272.68 13.75 88 119616 441 42501190
Hypothalamo-pituitary disorder 268.36 13.75 105 119599 995 42500636
Decreased appetite 266.53 13.75 1161 118543 191976 42309655
Immune-mediated uveitis 260.45 13.75 63 119641 70 42501561
Product dose omission issue 257.46 13.75 59 119645 154306 42347325
Lymphocytic hypophysitis 252.36 13.75 77 119627 309 42501322
Thyroid disorder 251.81 13.75 150 119554 3800 42497831
Prescribed overdose 238.49 13.75 234 119470 12693 42488938
Diarrhoea 238.00 13.75 2149 117555 458700 42042931
Immune-mediated encephalitis 236.04 13.75 83 119621 564 42501067
Overdose 227.58 13.75 18 119686 105246 42396385
Myasthenia gravis 225.84 13.75 252 119452 15885 42485746
Immune-mediated nephritis 218.33 13.75 81 119623 654 42500977
Cholangitis 214.53 13.75 203 119501 10524 42491107
Pyrexia 203.89 13.75 1839 117865 392203 42109428
Lichen planus 203.65 13.75 90 119614 1187 42500444
Cachexia 200.75 13.75 173 119531 7931 42493700
Tumour pseudoprogression 200.32 13.75 84 119620 966 42500665
Completed suicide 196.48 13.75 21 119683 96444 42405187
Cholangitis sclerosing 189.59 13.75 97 119607 1805 42499826
Pulmonary toxicity 187.00 13.75 171 119533 8484 42493147
Encephalitis 186.38 13.75 175 119529 8983 42492648
Tubulointerstitial nephritis 184.92 13.75 324 119380 31224 42470407
Immune-mediated renal disorder 181.47 13.75 63 119641 410 42501221
Leukoderma 180.91 13.75 44 119660 51 42501580
Uveitis 177.17 13.75 171 119533 9087 42492544
Immune-mediated arthritis 172.70 13.75 55 119649 262 42501369
Cytokine release syndrome 169.90 13.75 382 119322 44145 42457486
Autoimmune thyroiditis 167.38 13.75 84 119620 1498 42500133
Non-small cell lung cancer 165.15 13.75 126 119578 4848 42496783
Adverse event 158.74 13.75 258 119446 23382 42478249
Immune-mediated pancreatitis 158.35 13.75 52 119652 278 42501353
Immune-mediated adverse reaction 155.53 13.75 69 119635 919 42500712
General physical health deterioration 151.45 13.75 830 118874 150416 42351215
Drug hypersensitivity 148.63 13.75 47 119657 99342 42402289
Injection site pain 147.46 13.75 3 119701 57795 42443836
Intentional product misuse 144.48 13.75 7 119697 61893 42439738
Adrenal disorder 142.44 13.75 69 119635 1136 42500495
Nephritis 141.48 13.75 103 119601 3686 42497945
Immune-mediated hyperthyroidism 137.99 13.75 43 119661 188 42501443
Autoimmune nephritis 135.38 13.75 46 119658 278 42501353
Hypercalcaemia 134.96 13.75 207 119497 17851 42483780
Dizziness 133.32 13.75 316 119388 248938 42252693
Immune thrombocytopenia 133.23 13.75 161 119543 11055 42490576
Condition aggravated 129.05 13.75 344 119360 260410 42241221
Rash 123.67 13.75 1254 118450 275700 42225931
Haemoglobin decreased 121.13 13.75 116 119588 132355 42369276
Pleural effusion 120.16 13.75 566 119138 96600 42405031
Blood corticotrophin decreased 118.07 13.75 41 119663 267 42501364
Skin disorder 117.96 13.75 188 119516 16756 42484875
Lung disorder 117.36 13.75 348 119356 47575 42454056
Plasma cell myeloma 115.66 13.75 4 119700 47574 42454057
Intentional overdose 113.44 13.75 8 119696 51448 42450183
Immune-mediated cystitis 112.58 13.75 30 119674 63 42501568
Tumour haemorrhage 109.58 13.75 87 119617 3551 42498080
Blood thyroid stimulating hormone increased 109.36 13.75 102 119602 5190 42496441
Encephalitis autoimmune 108.39 13.75 60 119644 1317 42500314
Cortisol decreased 108.35 13.75 60 119644 1318 42500313
Anxiety 107.02 13.75 105 119599 118455 42383176
Off label use 106.95 13.75 2441 117263 635894 41865737
Polyarthritis 106.68 13.75 99 119605 5005 42496626
Incorrect dose administered 106.65 13.75 12 119692 52962 42448669
Lipase increased 105.36 13.75 139 119565 10427 42491204
Suicidal ideation 104.71 13.75 8 119696 48153 42453478
Feeling abnormal 104.32 13.75 33 119671 69753 42431878
Lichenoid keratosis 103.30 13.75 87 119617 3863 42497768
Stress 103.17 13.75 5 119699 44207 42457424
Autoimmune pancreatitis 102.23 13.75 40 119664 379 42501252
Erythema multiforme 102.20 13.75 133 119571 9844 42491787
Dermatomyositis 101.11 13.75 61 119643 1582 42500049
Agitation 100.53 13.75 28 119676 64286 42437345
Immune-mediated encephalopathy 100.12 13.75 26 119678 47 42501584
Taste disorder 99.82 13.75 133 119571 10074 42491557
Pericardial effusion 99.42 13.75 240 119464 29035 42472596
Somnolence 97.93 13.75 153 119551 140952 42360679
Pain in extremity 97.38 13.75 171 119533 150433 42351198
Loss of personal independence in daily activities 96.09 13.75 13 119691 49803 42451828
Immune-mediated endocrinopathy 94.96 13.75 25 119679 49 42501582
Foetal exposure during pregnancy 94.53 13.75 11 119693 47300 42454331
Haemophagocytic lymphohistiocytosis 93.87 13.75 177 119527 18045 42483586
Asthma 92.19 13.75 30 119674 62284 42439347
Immune-mediated gastritis 92.14 13.75 27 119677 91 42501540
Therapeutic product effect incomplete 90.41 13.75 43 119661 70896 42430735
Vogt-Koyanagi-Harada disease 89.90 13.75 30 119674 170 42501461
Therapeutic product effect decreased 89.55 13.75 5 119699 39145 42462486
Suicide attempt 88.99 13.75 12 119692 46088 42455543
Aggression 88.91 13.75 10 119694 44153 42457478
Relapsing fever 87.86 13.75 29 119675 158 42501473
Depression 86.95 13.75 111 119593 111252 42390379
Adrenocortical insufficiency acute 86.79 13.75 62 119642 2153 42499478
Blood thyroid stimulating hormone decreased 86.40 13.75 63 119641 2260 42499371
Meningitis aseptic 86.16 13.75 83 119621 4399 42497232
Cardiac failure congestive 85.41 13.75 69 119635 85533 42416098
Rash maculo-papular 84.94 13.75 265 119439 37238 42464393
Fall 84.63 13.75 355 119349 234165 42267466
Abdominal discomfort 83.77 13.75 54 119650 75201 42426430
International normalised ratio increased 83.08 13.75 17 119687 48151 42453480
Stomatitis 82.95 13.75 320 119384 50009 42451622
Myasthenic syndrome 79.32 13.75 41 119663 780 42500851
Coma 78.84 13.75 26 119678 53528 42448103
Hyperhidrosis 77.31 13.75 84 119620 90428 42411203
Blood pressure increased 77.10 13.75 104 119600 101824 42399807
Autoimmune myocarditis 76.92 13.75 29 119675 246 42501385
Electrocardiogram QT prolonged 76.57 13.75 20 119684 47925 42453706
Joint swelling 75.45 13.75 49 119655 67973 42433658
Pain 75.15 13.75 393 119311 244455 42257176
Hyperglycaemia 75.10 13.75 291 119413 45568 42456063
Autoimmune haemolytic anaemia 74.97 13.75 86 119618 5585 42496046
Dermatitis 74.86 13.75 126 119578 11749 42489882
Silent thyroiditis 74.44 13.75 22 119682 77 42501554
Pneumonia bacterial 74.19 13.75 147 119557 15545 42486086
Unevaluable event 73.68 13.75 6 119698 34282 42467349
Peripheral swelling 73.59 13.75 87 119617 90183 42411448
Metastases to lung 73.07 13.75 122 119582 11302 42490329
Bradycardia 72.28 13.75 80 119624 85404 42416227
Muscle spasms 72.23 13.75 81 119623 85963 42415668
Organising pneumonia 71.90 13.75 97 119607 7435 42494196
Sialoadenitis 71.06 13.75 38 119666 777 42500854
Weight increased 70.32 13.75 122 119582 107861 42393770
Enteritis 69.84 13.75 116 119588 10700 42490931
Musculoskeletal stiffness 69.15 13.75 38 119666 57727 42443904
Polymyalgia rheumatica 68.78 13.75 55 119649 2268 42499363
Prostate cancer 68.72 13.75 20 119684 44623 42457008
Drug intolerance 68.28 13.75 75 119629 80349 42421282
Wrong technique in product usage process 67.68 13.75 18 119686 42617 42459014
Tremor 67.32 13.75 105 119599 96824 42404807
Wheezing 67.09 13.75 35 119669 54746 42446885
Blood glucose increased 66.78 13.75 65 119639 73634 42427997
Metastases to bone 65.57 13.75 135 119569 14674 42486957
Medication error 65.51 13.75 8 119696 33146 42468485
Autoimmune disorder 65.49 13.75 55 119649 2432 42499199
Insomnia 65.45 13.75 147 119557 118106 42383525
Heart rate decreased 64.89 13.75 12 119692 36520 42465111
Stevens-Johnson syndrome 64.03 13.75 171 119533 22007 42479624
Tri-iodothyronine free decreased 64.02 13.75 18 119686 50 42501581
Heart rate increased 63.79 13.75 35 119669 53220 42448411
Disseminated intravascular coagulation 63.51 13.75 183 119521 24611 42477020
Amylase increased 63.23 13.75 86 119618 6643 42494988
Eosinophilic fasciitis 62.93 13.75 21 119683 119 42501512
Nasopharyngitis 62.21 13.75 87 119617 83909 42417722
Tumour associated fever 62.16 13.75 31 119673 545 42501086
Tumour pain 61.62 13.75 41 119663 1266 42500365
Nephrolithiasis 61.47 13.75 14 119690 36816 42464815
Pneumonia aspiration 61.32 13.75 291 119413 49787 42451844
Haematocrit decreased 60.87 13.75 12 119692 34896 42466735
Coronary artery disease 60.53 13.75 38 119666 53682 42447949
Rheumatic disorder 60.51 13.75 32 119672 639 42500992
Drug dependence 60.07 13.75 6 119698 29088 42472543
Autoimmune arthritis 59.69 13.75 20 119684 115 42501516
Nephrotic syndrome 59.67 13.75 96 119608 8622 42493009
Thyroid function test abnormal 59.41 13.75 32 119672 664 42500967
Hallucination 59.06 13.75 45 119659 57462 42444169
Headache 58.83 13.75 412 119292 238957 42262674
Myocardial infarction 58.67 13.75 167 119537 123842 42377789
Metastases to lymph nodes 58.41 13.75 78 119626 5920 42495711
Autoimmune dermatitis 58.40 13.75 16 119688 39 42501592
Inappropriate schedule of product administration 58.30 13.75 113 119591 95789 42405842
Drug level increased 57.96 13.75 4 119700 26196 42475435
Nightmare 57.81 13.75 3 119701 25009 42476622
Adrenalitis 57.80 13.75 15 119689 27 42501604
Mobility decreased 57.78 13.75 14 119690 35292 42466339
Glucocorticoid deficiency 57.69 13.75 29 119675 519 42501112
Cancer pain 57.43 13.75 60 119644 3507 42498124
Blood pressure fluctuation 57.02 13.75 5 119699 26903 42474728
Drug eruption 55.93 13.75 167 119537 22908 42478723
Palpitations 55.78 13.75 37 119667 50760 42450871
Accidental overdose 55.57 13.75 7 119697 28323 42473308
Serous retinal detachment 55.40 13.75 34 119670 910 42500721
Guillain-Barre syndrome 55.31 13.75 84 119620 7179 42494452
Endocrine disorder 55.30 13.75 25 119679 349 42501282
Swelling 55.03 13.75 44 119660 54841 42446790
Immune-mediated neuropathy 54.99 13.75 17 119687 72 42501559
Lymphangiosis carcinomatosa 54.94 13.75 35 119669 1002 42500629
Skin toxicity 54.55 13.75 79 119625 6470 42495161
Angioedema 53.72 13.75 26 119678 42451 42459180
Intracranial tumour haemorrhage 53.45 13.75 25 119679 379 42501252
Meningitis 52.71 13.75 73 119631 5736 42495895
Cytomegalovirus enterocolitis 52.55 13.75 38 119666 1345 42500286
Unresponsive to stimuli 52.29 13.75 12 119692 31391 42470240
Autoimmune neuropathy 51.09 13.75 15 119689 51 42501580
Metastases to pleura 51.06 13.75 28 119676 603 42501028
Adverse drug reaction 50.34 13.75 21 119683 37413 42464218
Aspartate aminotransferase increased 50.23 13.75 380 119324 76783 42424848
Incorrect route of product administration 50.21 13.75 5 119699 24300 42477331
Loss of consciousness 50.12 13.75 116 119588 92238 42409393
General physical condition abnormal 50.01 13.75 61 119643 4228 42497403
Radiation necrosis 49.81 13.75 21 119683 245 42501386
Red blood cell count decreased 49.72 13.75 15 119689 32700 42468931
Hypotension 49.33 13.75 474 119230 257157 42244474
Pneumothorax 49.33 13.75 162 119542 23381 42478250
Treatment failure 49.29 13.75 62 119642 62562 42439069
Hyponatraemia 49.28 13.75 468 119236 100994 42400637
Thrombophlebitis migrans 49.27 13.75 23 119681 347 42501284
Psychotic disorder 48.95 13.75 11 119693 29197 42472434
Autoimmune hypothyroidism 48.93 13.75 19 119685 176 42501455
Drug-device incompatibility 48.78 13.75 10 119694 0 42501631
Drug-induced liver injury 48.75 13.75 225 119479 38048 42463583
Blood corticotrophin increased 48.23 13.75 18 119686 148 42501483
Metastases to skin 48.17 13.75 26 119678 542 42501089
Product prescribing error 47.63 13.75 8 119696 26104 42475527
Cardiac arrest 47.56 13.75 153 119551 109167 42392464
Colitis microscopic 47.42 13.75 51 119653 3082 42498549
Autoimmune lung disease 46.84 13.75 15 119689 73 42501558
Metastases to meninges 46.82 13.75 41 119663 1920 42499711
Eyelid ptosis 46.48 13.75 74 119630 6587 42495044
Sleep disorder 46.44 13.75 40 119664 48055 42453576
Abnormal behaviour 46.31 13.75 9 119695 26442 42475189
Embolism 46.23 13.75 86 119618 8677 42492954
Therapy non-responder 46.13 13.75 49 119655 53310 42448321
Migraine 45.89 13.75 8 119696 25406 42476225
Dyskinesia 45.83 13.75 8 119696 25382 42476249
Immune-mediated oesophagitis 45.75 13.75 13 119691 38 42501593
Drug withdrawal syndrome 45.67 13.75 4 119700 21545 42480086
Autoimmune thyroid disorder 45.43 13.75 10 119694 4 42501627
Localised infection 45.39 13.75 3 119701 20370 42481261
Pancreatic enzymes increased 44.74 13.75 29 119675 856 42500775
Polymyositis 44.21 13.75 38 119666 1735 42499896
Acquired tracheo-oesophageal fistula 44.14 13.75 16 119688 120 42501511
Enterocolitis haemorrhagic 43.81 13.75 31 119673 1060 42500571
Gait disturbance 43.44 13.75 136 119568 97864 42403767
Full blood count abnormal 43.10 13.75 15 119689 29861 42471770
Facial paralysis 42.65 13.75 103 119601 12460 42489171
Lactic acidosis 42.07 13.75 39 119665 45222 42456409
Balance disorder 42.03 13.75 43 119661 47602 42454029
Treatment noncompliance 41.95 13.75 27 119677 37645 42463986
Paraesthesia 40.88 13.75 91 119613 73368 42428263
Diabetes mellitus 40.85 13.75 299 119405 59788 42441843
Hyperlipidaemia 40.58 13.75 6 119698 21510 42480121
Nasal congestion 40.56 13.75 16 119688 29485 42472146
Primary hypothyroidism 40.47 13.75 14 119690 90 42501541
Chest discomfort 40.38 13.75 73 119631 63543 42438088
Primary adrenal insufficiency 40.10 13.75 19 119685 297 42501334
Infusion related reaction 39.87 13.75 300 119404 60506 42441125
White blood cell count decreased 39.81 13.75 167 119537 110229 42391402
Respiratory arrest 39.77 13.75 15 119689 28409 42473222
Confusional state 38.94 13.75 293 119411 167304 42334327
Gout 38.93 13.75 15 119689 28040 42473591
Sleep apnoea syndrome 38.58 13.75 7 119697 21601 42480030
Neutropenia 38.54 13.75 366 119338 199065 42302566
Injury 38.22 13.75 8 119696 22308 42479323
Orthostatic hypotension 38.22 13.75 19 119685 30551 42471080
Epistaxis 37.83 13.75 82 119622 66744 42434887
Prerenal failure 37.52 13.75 40 119664 2393 42499238
Blood urea increased 37.21 13.75 23 119681 32770 42468861
Iridocyclitis 37.05 13.75 38 119666 2173 42499458
Arthritis 36.86 13.75 223 119481 41842 42459789
Dermatitis psoriasiform 36.52 13.75 37 119667 2085 42499546
Premature baby 36.32 13.75 10 119694 23143 42478488
Sinusitis 36.00 13.75 48 119656 47244 42454387
Hepatic failure 35.98 13.75 206 119498 37894 42463737
Abdominal distension 35.86 13.75 94 119610 71641 42429990
Sarcoid-like reaction 35.81 13.75 13 119691 98 42501533
Intestinal perforation 35.68 13.75 88 119616 10786 42490845
Overlap syndrome 35.57 13.75 18 119686 327 42501304
Bronchial fistula 35.48 13.75 16 119688 222 42501409
Therapeutic response decreased 35.47 13.75 31 119673 36981 42464650
Cholecystitis 35.34 13.75 98 119606 12890 42488741
Obesity 35.03 13.75 3 119701 16456 42485175
Extrapyramidal disorder 34.91 13.75 3 119701 16409 42485222
Aspiration pleural cavity 34.84 13.75 25 119679 874 42500757
Metastases to liver 34.79 13.75 113 119591 16213 42485418
Obstructive airways disorder 34.75 13.75 13 119691 24746 42476885
Ill-defined disorder 34.60 13.75 3 119701 16293 42485338
Endocrine toxicity 34.40 13.75 9 119695 17 42501614
Hepatic cytolysis 34.32 13.75 158 119546 26686 42474945
Full blood count decreased 33.94 13.75 8 119696 20552 42481079
Hypertransaminasaemia 33.88 13.75 78 119626 9149 42492482
Abdominal pain 33.70 13.75 357 119347 190114 42311517
Hepatotoxicity 33.57 13.75 150 119554 25017 42476614
Polyneuropathy 33.51 13.75 122 119582 18539 42483092
Pleurodesis 33.43 13.75 9 119695 20 42501611
Thrombosis 33.32 13.75 91 119613 68420 42433211
Ventricular fibrillation 32.99 13.75 22 119682 30101 42471530
Tachycardia 32.79 13.75 159 119545 100928 42400703
Hypervolaemia 32.70 13.75 12 119692 23113 42478518
Contusion 32.58 13.75 42 119662 41943 42459688
Seizure 32.34 13.75 202 119502 120359 42381272
White blood cell count increased 32.09 13.75 48 119656 45039 42456592
Cardiac disorder 32.09 13.75 55 119649 48877 42452754
Glomerulonephritis rapidly progressive 32.08 13.75 24 119680 896 42500735
Upper respiratory tract infection 31.90 13.75 43 119661 42130 42459501
Influenza 31.44 13.75 81 119623 62094 42439537
Hallucination, visual 31.29 13.75 10 119694 21010 42480621
Prostatic specific antigen increased 31.28 13.75 5 119699 16920 42484711
Viral infection 31.23 13.75 12 119692 22471 42479160
Lower respiratory tract infection 31.18 13.75 42 119662 41164 42460467
Chest pain 30.96 13.75 247 119457 139283 42362348
Amnesia 30.83 13.75 21 119683 28416 42473215
Therapy interrupted 30.70 13.75 12 119692 22238 42479393
Cardiac tamponade 30.59 13.75 61 119643 6479 42495152
Urticaria 30.56 13.75 106 119598 73930 42427701
Gastrointestinal haemorrhage 30.39 13.75 156 119548 97570 42404061
Erectile dysfunction 30.37 13.75 16 119688 24897 42476734
Gastrointestinal perforation 30.16 13.75 49 119655 4437 42497194
Drug resistance 30.10 13.75 31 119673 34217 42467414
Swollen tongue 30.05 13.75 11 119693 21220 42480411
Toxic epidermal necrolysis 29.56 13.75 151 119553 26599 42475032
Product quality issue 29.44 13.75 7 119697 17875 42483756
Physical deconditioning 29.34 13.75 35 119669 2370 42499261
Diabetic ketoacidotic hyperglycaemic coma 29.18 13.75 13 119691 175 42501456
Evans syndrome 29.17 13.75 17 119687 413 42501218
Impaired quality of life 29.07 13.75 3 119701 14174 42487457
Blood triglycerides increased 28.71 13.75 5 119699 15891 42485740
Paranoia 28.67 13.75 3 119701 14023 42487608
Fluid retention 28.50 13.75 28 119676 31591 42470040
Alanine aminotransferase increased 28.39 13.75 376 119328 88030 42413601
Bacterial infection 28.38 13.75 22 119682 27857 42473774
Stress cardiomyopathy 28.32 13.75 37 119667 2748 42498883
Atrioventricular block complete 28.25 13.75 83 119621 11281 42490350
Morphoea 28.13 13.75 14 119690 245 42501386
Tinnitus 28.01 13.75 24 119680 28914 42472717
Hypoglycaemia 27.99 13.75 81 119623 59773 42441858
Superior vena cava syndrome 27.98 13.75 20 119684 695 42500936
Burning sensation 27.91 13.75 12 119692 21001 42480630
Irritability 27.63 13.75 23 119681 28105 42473526
Optic neuritis 27.51 13.75 45 119659 4097 42497534
Cholestasis 27.35 13.75 172 119532 32707 42468924
Jaundice cholestatic 27.02 13.75 51 119653 5202 42496429
Cardiomegaly 26.75 13.75 7 119697 16759 42484872
Lip swelling 26.75 13.75 10 119694 19043 42482588
Rhinorrhoea 26.59 13.75 30 119674 31764 42469867
Blood potassium decreased 26.51 13.75 12 119692 20372 42481259
Type 3 diabetes mellitus 26.51 13.75 10 119694 85 42501546
Memory impairment 26.50 13.75 64 119640 50158 42451473
Swelling face 26.49 13.75 23 119681 27531 42474100
Limbic encephalitis 26.48 13.75 16 119688 416 42501215
Cerebrovascular accident 26.46 13.75 162 119542 96998 42404633
Tumour hyperprogression 26.45 13.75 12 119692 169 42501462
Malignant pleural effusion 26.44 13.75 30 119674 1925 42499706
Pneumocystis jirovecii pneumonia 26.35 13.75 140 119564 25041 42476590
Pancytopenia 26.31 13.75 208 119496 117535 42384096
Hallucination, auditory 26.14 13.75 5 119699 14859 42486772
Pulmonary sarcoidosis 25.97 13.75 20 119684 780 42500851
Immune-mediated cytopenia 25.95 13.75 12 119692 177 42501454
Joint injury 25.68 13.75 5 119699 14671 42486960
Neoplasm progression 25.57 13.75 154 119550 28846 42472785
Flatulence 25.41 13.75 20 119684 25132 42476499
Dermatitis bullous 25.22 13.75 66 119638 8390 42493241
Osteoarthritis 25.18 13.75 19 119685 24386 42477245
Pituitary enlargement 25.01 13.75 7 119697 19 42501612
Haemodynamic instability 24.88 13.75 3 119701 12554 42489077
Skin hypopigmentation 24.83 13.75 15 119689 390 42501241
Blood phosphorus increased 24.80 13.75 3 119701 12522 42489109
Rectal haemorrhage 24.79 13.75 65 119639 49541 42452090
Activated partial thromboplastin time prolonged 24.70 13.75 7 119697 15896 42485735
Pulmonary sepsis 24.68 13.75 38 119666 3286 42498345
Lethargy 24.55 13.75 60 119644 46830 42454801
Pallor 24.44 13.75 27 119677 28859 42472772
Syncope 24.41 13.75 171 119533 99235 42402396
Infectious pleural effusion 24.39 13.75 37 119667 3158 42498473
Iris adhesions 24.30 13.75 13 119691 266 42501365
Device malfunction 24.29 13.75 3 119701 12324 42489307
Biliary obstruction 24.10 13.75 37 119667 3192 42498439
Renal cell carcinoma 24.08 13.75 50 119654 5467 42496164
Metastases to spine 24.01 13.75 36 119668 3041 42498590
Blood pressure systolic increased 23.82 13.75 26 119678 27942 42473689
Delusion 23.80 13.75 6 119698 14728 42486903
Cryptitis 23.79 13.75 13 119691 278 42501353
Paraneoplastic syndrome 23.69 13.75 19 119685 787 42500844
Cortisol increased 23.61 13.75 12 119692 220 42501411
Bile duct stenosis 23.52 13.75 24 119680 1364 42500267
Blood corticotrophin abnormal 23.36 13.75 7 119697 26 42501605
Mechanical ileus 23.32 13.75 16 119688 520 42501111
Autoimmune encephalopathy 23.32 13.75 8 119696 50 42501581
IgA nephropathy 23.31 13.75 31 119673 2343 42499288
Productive cough 23.24 13.75 71 119633 51496 42450135
Melanoma recurrent 23.16 13.75 11 119693 173 42501458
Myasthenia gravis crisis 22.88 13.75 19 119685 827 42500804
Sudden death 22.85 13.75 100 119604 16529 42485102
Myelitis 22.80 13.75 21 119683 1051 42500580
Arteriosclerosis 22.76 13.75 11 119693 17978 42483653
Duodenitis 22.68 13.75 49 119655 5507 42496124
Giant cell arteritis 22.68 13.75 22 119682 1176 42500455
Renal tubular acidosis 22.65 13.75 33 119671 2717 42498914
Haematochezia 22.57 13.75 86 119618 58350 42443281
Oropharyngeal pain 22.56 13.75 54 119650 42456 42459175
Road traffic accident 22.21 13.75 13 119691 19080 42482551
Transient acantholytic dermatosis 22.11 13.75 12 119692 253 42501378
Appetite disorder 21.73 13.75 34 119670 2981 42498650
Immune-mediated cholestasis 21.46 13.75 5 119699 4 42501627
Keratoacanthoma 21.42 13.75 19 119685 905 42500726
Breath sounds abnormal 21.41 13.75 4 119700 12089 42489542
Thyroiditis subacute 21.41 13.75 8 119696 66 42501565
Glycosylated haemoglobin increased 21.39 13.75 5 119699 12919 42488712
Sterile pyuria 21.38 13.75 7 119697 37 42501594
Intestinal intraepithelial lymphocytes increased 21.34 13.75 11 119693 208 42501423
Intestinal metastasis 21.28 13.75 13 119691 345 42501286
Tumour embolism 21.12 13.75 9 119695 108 42501523
Autoimmune uveitis 20.94 13.75 5 119699 5 42501626
Micturition urgency 20.93 13.75 4 119700 11894 42489737
Hypogammaglobulinaemia 20.91 13.75 4 119700 11887 42489744
Salivary hypersecretion 20.76 13.75 3 119701 10940 42490691
Leukopenia 20.68 13.75 124 119580 74622 42427009
Neoplasm malignant 20.66 13.75 20 119684 22723 42478908
Pancreatic failure 20.65 13.75 20 119684 1067 42500564
Basal cell carcinoma 20.64 13.75 20 119684 22713 42478918
Oesophagitis 20.43 13.75 91 119613 15156 42486475
Respiratory depression 20.36 13.75 14 119690 18854 42482777
Thyroxine free decreased 20.35 13.75 12 119692 298 42501333
Large intestine perforation 20.32 13.75 66 119638 9470 42492161
Pulmonary oedema 20.19 13.75 79 119625 53193 42448438
Lymphadenopathy mediastinal 20.14 13.75 34 119670 3177 42498454
Hypoalbuminaemia 20.04 13.75 92 119612 15518 42486113
Bronchiectasis 19.94 13.75 13 119691 18006 42483625
Skin cancer 19.85 13.75 4 119700 11458 42490173
Generalised tonic-clonic seizure 19.84 13.75 27 119677 26352 42475279
Metastasis 19.79 13.75 42 119662 4663 42496968
Pancreatic toxicity 19.73 13.75 7 119697 49 42501582
Pain in jaw 19.71 13.75 8 119696 14494 42487137
Arthropathy 19.65 13.75 33 119671 29564 42472067
Coagulopathy 19.54 13.75 20 119684 22142 42479489
Antinuclear antibody 19.51 13.75 4 119700 0 42501631
Pleurocutaneous fistula 19.49 13.75 7 119697 51 42501580
Chondritis 19.45 13.75 10 119694 188 42501443
Biliary tract infection 19.32 13.75 17 119687 801 42500830
Muscle rigidity 19.31 13.75 5 119699 12054 42489577
Autoimmune cholangitis 19.30 13.75 6 119698 26 42501605
Glomerular filtration rate decreased 19.21 13.75 11 119693 16340 42485291
Meningoradiculitis 19.14 13.75 7 119697 54 42501577
Achromotrichia acquired 19.12 13.75 6 119698 27 42501604
Glomerulonephritis membranous 19.06 13.75 22 119682 1438 42500193
Squamous cell carcinoma of skin 19.04 13.75 6 119698 12720 42488911
Synovitis 18.97 13.75 10 119694 15557 42486074
Tracheal obstruction 18.92 13.75 7 119697 56 42501575
Metastatic malignant melanoma 18.86 13.75 28 119676 2345 42499286
Immune reconstitution inflammatory syndrome 18.74 13.75 3 119701 10140 42491491
Coronary artery occlusion 18.71 13.75 4 119700 10993 42490638
Haemorrhage 18.64 13.75 97 119607 60466 42441165
Hypophonesis 18.61 13.75 5 119699 11 42501620
Thyroxine free abnormal 18.61 13.75 5 119699 11 42501620
Pulmonary tuberculosis 18.56 13.75 45 119659 5456 42496175
Therapy cessation 18.56 13.75 18 119686 20432 42481199
Performance status decreased 18.55 13.75 41 119663 4679 42496952
Metastases to abdominal cavity 18.52 13.75 11 119693 277 42501354
Acute polyneuropathy 18.50 13.75 10 119694 209 42501422
Autoimmune myositis 18.40 13.75 15 119689 636 42500995
Metabolic acidosis 18.34 13.75 79 119625 51779 42449852
Drug level decreased 18.32 13.75 3 119701 9974 42491657
Disturbance in attention 18.30 13.75 35 119669 29831 42471800
Hepatitis fulminant 18.29 13.75 42 119662 4917 42496714
Dermatitis atopic 18.29 13.75 6 119698 12398 42489233
Low birth weight baby 18.27 13.75 3 119701 9952 42491679
End stage renal disease 18.25 13.75 12 119692 16546 42485085
Metastases to peritoneum 18.19 13.75 28 119676 2421 42499210
Red blood cell sedimentation rate increased 18.19 13.75 3 119701 9921 42491710
Pericardial drainage 18.14 13.75 8 119696 105 42501526
Peripheral sensory neuropathy 18.09 13.75 60 119644 8702 42492929
Serositis 18.00 13.75 11 119693 292 42501339
Anger 17.99 13.75 7 119697 13011 42488620
Immune-mediated neurological disorder 17.98 13.75 6 119698 34 42501597
Radiation associated pain 17.98 13.75 6 119698 34 42501597
Radiation skin injury 17.92 13.75 16 119688 769 42500862
Haematoma 17.91 13.75 32 119672 27991 42473640
Hypersensitivity pneumonitis 17.91 13.75 25 119679 1979 42499652
Pericarditis malignant 17.83 13.75 7 119697 67 42501564
Limb injury 17.72 13.75 9 119695 14296 42487335
Oesophageal carcinoma recurrent 17.69 13.75 6 119698 36 42501595
Non-small cell lung cancer recurrent 17.65 13.75 7 119697 69 42501562
Yersinia infection 17.56 13.75 7 119697 70 42501561
Eye irritation 17.54 13.75 5 119699 11313 42490318
Microvillous inclusion disease 17.53 13.75 10 119694 233 42501398
Oesophageal stenosis 17.51 13.75 25 119679 2021 42499610
COVID-19 17.50 13.75 225 119479 115723 42385908
Blood thyroid stimulating hormone abnormal 17.38 13.75 12 119692 394 42501237
Hypertension 17.37 13.75 348 119356 166856 42334775
Rhinitis 17.30 13.75 6 119698 11971 42489660
Gastrointestinal toxicity 17.29 13.75 36 119668 3943 42497688
Blood pressure diastolic decreased 17.20 13.75 4 119700 10371 42491260
Pericarditis 17.09 13.75 79 119625 13365 42488266
Respiratory failure 17.05 13.75 476 119228 127656 42373975
Ocular hyperaemia 17.02 13.75 12 119692 15951 42485680
Respiratory rate increased 16.94 13.75 5 119699 11057 42490574
Thyroxine free increased 16.93 13.75 11 119693 326 42501305
Hypomagnesaemia 16.92 13.75 34 119670 28454 42473177
Panic attack 16.90 13.75 5 119699 11040 42490591
Muscle twitching 16.84 13.75 6 119698 11774 42489857
Autoimmune anaemia 16.81 13.75 5 119699 18 42501613
Hyperadrenocorticism 16.79 13.75 9 119695 185 42501446
Dyspnoea exertional 16.77 13.75 78 119626 50070 42451561
Blood urine present 16.74 13.75 6 119698 11727 42489904
Chronic inflammatory demyelinating polyradiculoneuropathy 16.73 13.75 19 119685 1220 42500411
Myoclonus 16.70 13.75 14 119690 17051 42484580
Left ventricular hypertrophy 16.68 13.75 3 119701 9316 42492315
Hypertriglyceridaemia 16.60 13.75 4 119700 10122 42491509
Lymphoma 16.31 13.75 10 119694 14311 42487320
Mental status changes 16.25 13.75 62 119642 42053 42459578
Aortitis 16.24 13.75 14 119690 642 42500989
Retroperitoneal fibrosis 16.23 13.75 12 119692 440 42501191
Chronic gastritis 16.15 13.75 25 119679 2172 42499459
Dysuria 16.11 13.75 40 119664 31056 42470575
Hepatic steatosis 16.08 13.75 22 119682 21426 42480205
Hypercholesterolaemia 16.04 13.75 8 119696 12841 42488790
Eye pruritus 16.00 13.75 6 119698 11406 42490225
Neuritis cranial 15.86 13.75 4 119700 6 42501625
Chylothorax 15.85 13.75 18 119686 1156 42500475
Spinal cord compression 15.83 13.75 36 119668 4188 42497443
Cortisol abnormal 15.80 13.75 6 119698 52 42501579
Ventricular extrasystoles 15.74 13.75 9 119695 13381 42488250
Altered state of consciousness 15.73 13.75 138 119566 29121 42472510
Ulcerative keratitis 15.69 13.75 24 119680 2064 42499567
Tri-iodothyronine free increased 15.67 13.75 5 119699 24 42501607
Orbital myositis 15.63 13.75 8 119696 149 42501482
Chest tube insertion 15.53 13.75 7 119697 97 42501534
Opsoclonus myoclonus 15.53 13.75 7 119697 97 42501534
Eye swelling 15.53 13.75 7 119697 11913 42489718
Pneumonia 15.44 13.75 1381 118323 420768 42080863
Probiotic therapy 15.34 13.75 8 119696 155 42501476
Toxic neuropathy 15.34 13.75 13 119691 582 42501049
Cytomegalovirus viraemia 15.33 13.75 5 119699 10372 42491259
Respiratory symptom 15.30 13.75 6 119698 11100 42490531
Infection 15.29 13.75 222 119482 111846 42389785
Dysphagia 15.25 13.75 288 119416 72431 42429200
Dyspepsia 15.24 13.75 62 119642 41290 42460341
Renal disorder 15.22 13.75 136 119568 28844 42472787
Arteriosclerosis coronary artery 15.21 13.75 18 119686 18659 42482972
Neutrophil count increased 15.17 13.75 20 119684 19784 42481847
Hypoaesthesia 15.15 13.75 128 119576 71335 42430296
Serous retinopathy 15.14 13.75 9 119695 227 42501404
Disorientation 15.08 13.75 52 119652 36337 42465294
Haemodialysis 15.06 13.75 5 119699 10255 42491376
Prothrombin time prolonged 15.02 13.75 4 119700 9465 42492166
Lung neoplasm malignant 15.01 13.75 19 119685 19128 42482503
Metastatic renal cell carcinoma 14.96 13.75 24 119680 2150 42499481
Abdominal pain upper 14.92 13.75 154 119550 82455 42419176
Metastases to pancreas 14.91 13.75 11 119693 402 42501229
Torsade de pointes 14.88 13.75 3 119701 8591 42493040
Mental impairment 14.88 13.75 8 119696 12309 42489322
Xerophthalmia 14.85 13.75 8 119696 166 42501465
Chronic obstructive pulmonary disease 14.79 13.75 110 119594 63004 42438627
Hair colour changes 14.73 13.75 24 119680 2178 42499453
Pancreatic atrophy 14.63 13.75 12 119692 513 42501118
HER2 positive salivary gland cancer 14.63 13.75 3 119701 0 42501631
Myofascitis 14.63 13.75 3 119701 0 42501631
Embolic cerebellar infarction 14.63 13.75 3 119701 0 42501631
Extravasation 14.59 13.75 25 119679 2365 42499266
Skin laceration 14.43 13.75 11 119693 14047 42487584
Mitral valve incompetence 14.41 13.75 15 119689 16474 42485157
Rales 14.38 13.75 7 119697 11393 42490238
Bladder cancer 14.35 13.75 16 119688 17031 42484600
Angina pectoris 14.32 13.75 46 119658 32850 42468781
Scleroderma-like reaction 14.31 13.75 6 119698 69 42501562
Brachial plexopathy 14.31 13.75 6 119698 69 42501562
Hypersomnia 14.30 13.75 12 119692 14606 42487025
Pelvic inflammatory disease 14.26 13.75 4 119700 11 42501620
Haemoptysis 14.25 13.75 195 119509 45972 42455659
Tendonitis 14.21 13.75 5 119699 9889 42491742
Protein-losing gastroenteropathy 14.17 13.75 11 119693 434 42501197
Cholangitis acute 14.15 13.75 17 119687 1160 42500471
Transient ischaemic attack 14.12 13.75 48 119656 33691 42467940
Diabetic ketosis 14.12 13.75 9 119695 258 42501373
Pulmonary hypertension 14.11 13.75 28 119676 23541 42478090
Hospitalisation 14.08 13.75 137 119567 74193 42427438
Mania 14.04 13.75 6 119698 10541 42491090
Mental disorder 14.02 13.75 18 119686 18011 42483620
Metastases to kidney 13.95 13.75 10 119694 349 42501282
Subacute cutaneous lupus erythematosus 13.95 13.75 19 119685 1469 42500162
Vocal cord paralysis 13.95 13.75 17 119687 1177 42500454
Skin abrasion 13.86 13.75 3 119701 8172 42493459
Oesophagobronchial fistula 13.85 13.75 8 119696 191 42501440
Renal cancer metastatic 13.83 13.75 12 119692 555 42501076
Akathisia 13.83 13.75 6 119698 10445 42491186
Steroid diabetes 13.82 13.75 27 119677 2825 42498806
Depressed mood 13.81 13.75 28 119676 23356 42478275

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 14178.17 13.49 6357 162655 168210 110252077
Immune-mediated enterocolitis 3748.37 13.49 1134 167878 9051 110411236
Hypothyroidism 2629.90 13.49 1543 167469 71356 110348931
Death 2497.03 13.49 4090 164922 694779 109725508
Pneumonitis 2105.55 13.49 1363 167649 75168 110345119
Fulminant type 1 diabetes mellitus 2093.56 13.49 525 168487 1838 110418449
Adrenal insufficiency 1964.78 13.49 1058 167954 41332 110378955
Hypophysitis 1923.89 13.49 587 168425 4828 110415459
Immune-mediated lung disease 1859.12 13.49 569 168443 4734 110415553
Colitis 1840.70 13.49 1405 167607 100918 110319369
Immune-mediated hepatitis 1803.96 13.49 588 168424 6123 110414164
Immune-mediated hepatic disorder 1562.18 13.49 478 168534 3972 110416315
Type 1 diabetes mellitus 1362.63 13.49 515 168497 8532 110411755
Interstitial lung disease 1358.16 13.49 1349 167663 137985 110282302
Myocarditis 1341.95 13.49 732 168280 29323 110390964
Hyperthyroidism 1310.17 13.49 714 168298 28547 110391740
Immune-mediated myocarditis 1306.00 13.49 394 168618 3104 110417183
Hypopituitarism 1262.85 13.49 405 168607 3985 110416302
Thyroiditis 1210.99 13.49 434 168578 6139 110414148
Pemphigoid 1187.37 13.49 587 168425 19120 110401167
Hepatic function abnormal 1094.57 13.49 982 168030 88313 110331974
Intentional product use issue 1055.07 13.49 1577 167435 246329 110173958
Immune-mediated dermatitis 1048.00 13.49 302 168710 1988 110418299
Adrenocorticotropic hormone deficiency 999.64 13.49 288 168724 1894 110418393
Immune-mediated hypothyroidism 875.45 13.49 277 168735 2598 110417689
Secondary adrenocortical insufficiency 855.52 13.49 303 168709 4131 110416156
Diabetic ketoacidosis 854.98 13.49 622 168390 41436 110378851
Myositis 817.88 13.49 539 168473 30577 110389710
Autoimmune hepatitis 757.67 13.49 395 168617 14409 110405878
Autoimmune colitis 734.20 13.49 222 168790 1763 110418524
Immune-mediated hypophysitis 697.82 13.49 183 168829 798 110419489
Immune-mediated adrenal insuficiency 679.58 13.49 204 168808 1576 110418711
Enterocolitis 650.84 13.49 389 168623 18560 110401727
Immune-mediated thyroiditis 566.69 13.49 159 168853 937 110419350
Cholangitis 524.05 13.49 321 168691 16014 110404273
Immune-mediated uveitis 521.55 13.49 114 168898 170 110420117
Cytokine release syndrome 480.87 13.49 565 168447 69741 110350546
Metastases to central nervous system 471.71 13.49 341 168671 22476 110397811
Myasthenia gravis 471.18 13.49 333 168679 21178 110399109
Hepatitis 469.73 13.49 632 168380 89422 110330865
Vitiligo 469.70 13.49 176 168836 2841 110417446
Palmar-plantar erythrodysaesthesia syndrome 461.04 13.49 430 168582 40595 110379692
Immune-mediated cholangitis 460.51 13.49 129 168883 755 110419532
Immune-mediated myositis 456.93 13.49 212 168800 5974 110414313
Joint swelling 446.80 13.49 71 168941 442774 109977513
Pyrexia 441.05 13.49 2605 166407 895660 109524627
Immune-mediated nephritis 435.19 13.49 133 168879 1099 110419188
Drug hypersensitivity 429.50 13.49 86 168926 454004 109966283
Immune-mediated encephalitis 418.37 13.49 128 168884 1062 110419225
Drug interaction 416.10 13.49 124 168888 500059 109920228
Drug ineffective 410.16 13.49 1094 167918 1519446 108900841
Toxicity to various agents 401.80 13.49 118 168894 480437 109939850
Leukoderma 398.91 13.49 86 168926 115 110420172
Decreased appetite 394.31 13.49 1604 167408 474242 109946045
Tumour pseudoprogression 387.76 13.49 130 168882 1486 110418801
Drug intolerance 386.47 13.49 76 168936 406436 110013851
Lymphocytic hypophysitis 378.73 13.49 105 168907 588 110419699
Radiation pneumonitis 377.75 13.49 169 168843 4367 110415920
Cachexia 372.92 13.49 238 168774 12767 110407520
Diarrhoea 371.81 13.49 2989 166023 1136516 109283771
Tubulointerstitial nephritis 362.49 13.49 431 168581 53853 110366434
Liver disorder 359.19 13.49 719 168293 141524 110278763
Hypothalamo-pituitary disorder 357.38 13.49 142 168870 2704 110417583
Pleural effusion 354.17 13.49 816 168196 176893 110243394
Pain 350.26 13.49 576 168436 954379 109465908
Abdominal discomfort 345.50 13.49 88 168924 393770 110026517
Swelling 343.54 13.49 61 168951 350980 110069307
Synovitis 341.59 13.49 19 168993 274073 110146214
Therapeutic product effect decreased 335.04 13.49 8 169004 244308 110175979
Non-small cell lung cancer 334.06 13.49 186 168826 7749 110412538
Uveitis 327.31 13.49 269 168743 21441 110398846
Encephalitis 317.12 13.49 249 168763 18590 110401697
Systemic lupus erythematosus 303.92 13.49 22 168990 254316 110165971
Cholangitis sclerosing 303.23 13.49 135 168877 3447 110416840
Arthropathy 301.64 13.49 41 168971 287481 110132806
Glossodynia 301.63 13.49 8 169004 221996 110198291
Off label use 298.68 13.49 3548 165464 1496637 108923650
Nasopharyngitis 296.25 13.49 116 168896 394245 110026042
Peripheral swelling 295.14 13.49 124 168888 403910 110016377
Immune-mediated pancreatitis 293.86 13.49 87 168925 637 110419650
Completed suicide 289.52 13.49 21 168991 242360 110177927
Maternal exposure during pregnancy 283.00 13.49 30 168982 254853 110165434
Prescribed underdose 274.28 13.49 413 168599 64761 110355526
Immune-mediated arthritis 273.72 13.49 81 168931 592 110419695
Overdose 271.54 13.49 23 168989 233771 110186516
Wound 269.74 13.49 24 168988 234413 110185874
Sinusitis 268.52 13.49 62 168950 296626 110123661
Mobility decreased 266.03 13.49 27 168985 237395 110182892
Blood cholesterol increased 261.61 13.49 4 169008 184781 110235506
Duodenal ulcer perforation 255.27 13.49 3 169009 177697 110242590
Musculoskeletal stiffness 254.18 13.49 58 168954 279764 110140523
Helicobacter infection 253.09 13.49 5 169007 181872 110238415
Lichenoid keratosis 252.47 13.49 143 168869 6159 110414128
Thyroid disorder 251.09 13.49 208 168804 16761 110403526
Injection site pain 247.15 13.49 5 169007 177917 110242370
Autoimmune thyroiditis 247.04 13.49 142 168870 6292 110413995
Weight increased 242.31 13.49 173 168839 419471 110000816
Wheezing 241.85 13.49 48 168964 255182 110165105
Immune-mediated adverse reaction 238.79 13.49 92 168920 1608 110418679
Injury 238.53 13.49 7 169005 177258 110243029
Fibromyalgia 236.61 13.49 5 169007 170904 110249383
Immune-mediated renal disorder 235.86 13.49 74 168938 673 110419614
Condition aggravated 234.56 13.49 482 168530 734354 109685933
Pemphigus 233.78 13.49 27 168985 214543 110205744
Pulmonary toxicity 232.83 13.49 203 168809 17543 110402744
Exposure during pregnancy 231.38 13.49 5 169007 167419 110252868
Asthma 223.12 13.49 54 168958 250237 110170050
Alopecia 221.77 13.49 142 168870 364611 110055676
Pericardial effusion 220.30 13.49 348 168664 56869 110363418
Irritable bowel syndrome 219.09 13.49 7 169005 164208 110256079
Nephritis 218.79 13.49 129 168883 5997 110414290
Immune thrombocytopenia 217.30 13.49 217 168795 22277 110398010
Dizziness 216.05 13.49 466 168546 697727 109722560
Rash maculo-papular 215.26 13.49 398 168614 73824 110346463
Lichen planus 212.57 13.49 104 168908 3306 110416981
Product dose omission issue 210.09 13.49 115 168897 321667 110098620
Pain in extremity 209.54 13.49 262 168750 486856 109933431
Erythema multiforme 206.53 13.49 205 168807 20892 110399395
Immune-mediated hyperthyroidism 205.77 13.49 64 168948 564 110419723
Headache 204.97 13.49 679 168333 881698 109538589
Haemophagocytic lymphohistiocytosis 204.79 13.49 247 168765 31312 110388975
Lipase increased 204.54 13.49 193 168819 18479 110401808
Autoimmune nephritis 202.16 13.49 67 168945 737 110419550
Discomfort 202.10 13.49 41 168971 214666 110205621
Folliculitis 201.70 13.49 14 168998 167639 110252648
Tumour haemorrhage 199.35 13.49 115 168897 5130 110415157
Migraine 198.99 13.49 17 168995 171635 110248652
Ill-defined disorder 198.10 13.49 10 169002 156843 110263444
Adrenal disorder 197.38 13.49 89 168923 2343 110417944
Meningitis aseptic 191.52 13.49 142 168870 9728 110410559
Blood corticotrophin decreased 190.64 13.49 65 168947 785 110419502
Disseminated intravascular coagulation 190.12 13.49 273 168739 41013 110379274
Hyperglycaemia 188.78 13.49 408 168604 84682 110335605
Autoimmune haemolytic anaemia 187.26 13.49 144 168868 10423 110409864
Treatment failure 186.98 13.49 95 168917 277139 110143148
Therapeutic product effect incomplete 186.77 13.49 55 168957 223750 110196537
Osteoarthritis 184.62 13.49 29 168983 182594 110237693
Vogt-Koyanagi-Harada disease 181.96 13.49 58 168954 558 110419729
Hypercalcaemia 181.31 13.49 285 168727 46372 110373915
Blood thyroid stimulating hormone increased 180.37 13.49 150 168862 12151 110408136
Contusion 176.20 13.49 68 168944 233293 110186994
Relapsing fever 175.91 13.49 53 168959 415 110419872
C-reactive protein abnormal 174.92 13.49 5 169007 129690 110290597
Lower respiratory tract infection 173.61 13.49 77 168935 243029 110177258
Intentional product misuse 169.35 13.49 8 169004 132896 110287391
Hypersensitivity 163.74 13.49 227 168785 403771 110016516
Aspartate aminotransferase increased 163.35 13.49 577 168435 159359 110260928
Acute kidney injury 161.75 13.49 1581 167431 633849 109786438
Immune-mediated gastritis 161.03 13.49 46 168966 292 110419995
Immune-mediated encephalopathy 160.79 13.49 36 168976 64 110420223
Urticaria 159.73 13.49 151 168861 318706 110101581
Encephalitis autoimmune 157.59 13.49 86 168926 3442 110416845
Joint range of motion decreased 156.32 13.49 7 169005 121825 110298462
Immune-mediated cystitis 155.69 13.49 38 168974 115 110420172
Respiratory failure 154.81 13.49 696 168316 214636 110205651
Myasthenic syndrome 154.44 13.49 62 168950 1214 110419073
Intentional overdose 153.91 13.49 13 168999 132488 110287799
Eosinophilic fasciitis 153.72 13.49 46 168966 351 110419936
Loss of personal independence in daily activities 153.51 13.49 23 168989 149997 110270290
Autoimmune pancreatitis 152.58 13.49 55 168957 791 110419496
Muscle spasms 152.34 13.49 121 168891 278036 110142251
Anxiety 152.10 13.49 182 168830 344896 110075391
Feeling abnormal 151.52 13.49 44 168968 180667 110239620
Skin toxicity 150.99 13.49 133 168879 11650 110408637
Insomnia 150.78 13.49 198 168814 360392 110059895
Obesity 150.59 13.49 5 169007 113346 110306941
Bursitis 150.21 13.49 13 168999 129905 110290382
Adrenocortical insufficiency acute 149.46 13.49 90 168922 4350 110415937
General physical health deterioration 147.83 13.49 1134 167878 424161 109996126
Product use issue 147.64 13.49 155 168857 311540 110108747
Hyponatraemia 145.74 13.49 689 168323 216964 110203323
Depression 145.65 13.49 162 168850 317173 110103114
Enteritis 141.07 13.49 160 168852 18996 110401291
Cholestasis 140.41 13.49 307 168705 64211 110356076
Skin disorder 139.64 13.49 242 168770 42671 110377616
Sleep disorder 138.57 13.49 65 168947 198579 110221708
Serous retinal detachment 138.28 13.49 62 168950 1610 110418677
Sepsis 138.23 13.49 915 168097 326431 110093856
Metastases to lung 137.53 13.49 173 168839 22890 110397397
Hypoaesthesia 137.12 13.49 167 168845 314056 110106231
Pneumonia bacterial 136.37 13.49 184 168828 26077 110394210
Psoriatic arthropathy 136.31 13.49 65 168947 196696 110223591
Blister 136.11 13.49 90 168922 227286 110193001
Impaired healing 133.22 13.49 67 168945 196650 110223637
Autoimmune myocarditis 131.35 13.49 46 168966 605 110419682
Diabetes mellitus 129.84 13.49 390 168622 98991 110321296
Cortisol decreased 129.08 13.49 70 168942 2766 110417521
Stress 129.06 13.49 8 169004 105340 110314947
Polyarthritis 128.93 13.49 152 168860 18811 110401476
Glucocorticoid deficiency 127.90 13.49 53 168959 1129 110419158
Stevens-Johnson syndrome 127.89 13.49 245 168767 46656 110373631
Lip dry 127.59 13.49 6 169006 100077 110320210
Pneumonia aspiration 125.82 13.49 339 168673 80894 110339393
Injection site erythema 125.65 13.49 4 169008 94172 110326115
Paraesthesia 123.80 13.49 144 168868 276377 110143910
Amylase increased 123.18 13.49 122 168890 12397 110407890
Blood thyroid stimulating hormone decreased 122.51 13.49 96 168916 7143 110413144
Metastatic malignant melanoma 122.30 13.49 72 168940 3337 110416950
Dermatomyositis 122.27 13.49 79 168933 4327 110415960
Dermatitis 122.24 13.49 180 168832 27657 110392630
Immune-mediated endocrinopathy 122.18 13.49 31 168981 115 110420172
Abdominal pain upper 120.72 13.49 218 168794 348893 110071394
Medication error 120.58 13.49 11 169001 105355 110314932
Fall 119.79 13.49 495 168517 602987 109817300
Injection site reaction 118.07 13.49 4 169008 89066 110331221
Memory impairment 117.81 13.49 78 168934 196866 110223421
Alanine aminotransferase increased 115.97 13.49 572 168440 183201 110237086
Silent thyroiditis 115.51 13.49 35 168977 280 110420007
Gait inability 111.06 13.49 35 168977 136341 110283946
Road traffic accident 110.95 13.49 16 168996 107382 110312905
Pericarditis 110.59 13.49 103 168909 219011 110201276
Suicide attempt 110.15 13.49 14 168998 103380 110316907
Eyelid ptosis 109.69 13.49 118 168894 13209 110407078
Organising pneumonia 108.36 13.49 121 168891 14122 110406165
Gastrointestinal disorder 108.30 13.49 126 168886 241826 110178461
Guillain-Barre syndrome 108.13 13.49 106 168906 10638 110409649
Blood pressure increased 106.81 13.49 143 168869 258230 110162057
Embolism 106.51 13.49 128 168884 16161 110404126
Pneumothorax 105.80 13.49 192 168820 35093 110385194
Incorrect dose administered 105.77 13.49 16 168996 103625 110316662
Anaemia 105.68 13.49 1289 167723 545797 109874490
Red blood cell sedimentation rate increased 105.65 13.49 3 169009 78299 110341988
Grip strength decreased 104.88 13.49 4 169008 80170 110340117
Nephrotic syndrome 104.37 13.49 117 168895 13714 110406573
Hepatic failure 102.60 13.49 283 168729 68456 110351831
Hypercholesterolaemia 102.57 13.49 10 169002 90827 110329460
Tumour pain 102.09 13.49 61 168951 2906 110417381
Adverse drug reaction 101.74 13.49 19 168993 105540 110314747
Metastases to bone 100.87 13.49 176 168836 31196 110389091
Suicidal ideation 99.39 13.49 13 168999 93924 110326363
Meningitis 98.76 13.49 105 168907 11597 110408690
Autoimmune dermatitis 98.71 13.49 29 168983 206 110420081
Lymphangiosis carcinomatosa 98.56 13.49 56 168956 2426 110417861
Hepatic cytolysis 97.88 13.49 242 168770 54811 110365476
Confusional state 97.65 13.49 377 168635 468303 109951984
Heart rate increased 95.87 13.49 50 168962 143784 110276503
Peripheral venous disease 95.67 13.49 9 169003 84108 110336179
Blood pressure fluctuation 93.74 13.49 5 169007 74819 110345468
Polyneuropathy 91.96 13.49 171 168841 31841 110388446
Product quality issue 91.39 13.49 7 169005 77292 110342995
Autoimmune hypothyroidism 91.33 13.49 33 168979 478 110419809
Ascites 89.75 13.49 329 168683 92479 110327808
Cholecystitis 89.53 13.49 150 168862 25732 110394555
Sialoadenitis 89.50 13.49 54 168958 2619 110417668
Cardiac tamponade 89.37 13.49 98 168914 11209 110409078
Drug eruption 89.27 13.49 230 168782 53429 110366858
Haemoglobin decreased 88.95 13.49 152 168860 248575 110171712
Lower limb fracture 88.59 13.49 7 169005 75341 110344946
Amnesia 87.73 13.49 26 168986 105382 110314905
Palpitations 87.45 13.49 69 168943 159143 110261144
Polymyalgia rheumatica 87.15 13.49 75 168937 6367 110413920
Sciatica 86.18 13.49 18 168994 92381 110327906
Pulmonary embolism 85.96 13.49 592 168420 213882 110206405
Cancer pain 85.89 13.49 76 168936 6696 110413591
Autoimmune arthritis 84.59 13.49 27 168985 261 110420026
Nasal congestion 84.09 13.49 23 168989 98259 110322028
Arthralgia 83.69 13.49 775 168237 778857 109641430
Coma 83.06 13.49 38 168974 117831 110302456
Night sweats 82.94 13.49 51 168961 133932 110286355
Pneumonia 82.34 13.49 1834 167178 874880 109545407
General physical condition abnormal 82.26 13.49 78 168934 7512 110412775
Dyspepsia 81.68 13.49 103 168909 190862 110229425
Wrong technique in product usage process 81.50 13.49 17 168995 87331 110332956
Thrombophlebitis migrans 81.37 13.49 34 168978 740 110419547
Cytomegalovirus enterocolitis 81.37 13.49 48 168964 2233 110418054
Immune-mediated oesophagitis 81.10 13.49 20 168992 64 110420223
Electrocardiogram QT prolonged 80.16 13.49 33 168979 108927 110311360
Heart rate decreased 79.53 13.49 15 168997 82741 110337546
Gastrooesophageal reflux disease 79.16 13.49 95 168917 179881 110240406
Cardiac failure 78.83 13.49 524 168488 187102 110233185
Immune-mediated neuropathy 78.66 13.49 24 168988 197 110420090
Metastases to meninges 78.25 13.49 64 168948 5064 110415223
Incorrect route of product administration 78.06 13.49 5 169007 64056 110356231
Sarcoid-like reaction 77.33 13.49 26 168986 300 110419987
Agitation 77.28 13.49 38 168974 113013 110307274
Prescribed overdose 76.86 13.49 301 168711 87280 110333007
Primary hypothyroidism 76.86 13.49 25 168987 258 110420029
Duodenitis 76.70 13.49 82 168930 9114 110411173
Ear infection 76.13 13.49 5 169007 62727 110357560
Liver injury 75.53 13.49 71 168941 150342 110269945
Adrenalitis 74.57 13.49 19 168993 72 110420215
Blood corticotrophin increased 74.54 13.49 25 168987 286 110420001
Tumour associated fever 74.14 13.49 36 168976 1125 110419162
Blood creatine phosphokinase increased 74.01 13.49 263 168749 72814 110347473
Type 2 diabetes mellitus 73.32 13.49 98 168914 177134 110243153
Metastases to lymph nodes 73.04 13.49 102 168910 14930 110405357
Gait disturbance 72.99 13.49 202 168810 278006 110142281
Hyperhidrosis 71.14 13.49 110 168902 187188 110233099
Intracranial tumour haemorrhage 70.10 13.49 29 168983 615 110419672
Metastases to liver 69.85 13.49 162 168850 35224 110385063
Dermatitis psoriasiform 69.74 13.49 52 168960 3592 110416695
Dehydration 69.69 13.49 693 168319 278818 110141469
Keratoacanthoma 69.43 13.49 37 168975 1411 110418876
Autoimmune neuropathy 69.36 13.49 19 168993 101 110420186
Tri-iodothyronine free decreased 68.63 13.49 26 168986 433 110419854
Pancreatic enzymes increased 68.63 13.49 39 168973 1690 110418597
Rash 68.61 13.49 1690 167322 819274 109601013
Musculoskeletal pain 68.08 13.49 109 168903 182914 110237373
Facial paralysis 67.87 13.49 128 168884 24086 110396201
Hepatotoxicity 67.51 13.49 232 168780 63168 110357119
Oesophagitis 67.49 13.49 141 168871 28574 110391713
Iridocyclitis 67.21 13.49 60 168952 5348 110414939
Rheumatic disorder 65.97 13.49 50 168962 3541 110416746
Acquired tracheo-oesophageal fistula 65.79 13.49 20 168992 162 110420125
Unevaluable event 65.62 13.49 7 169005 59220 110361067
Fluid retention 65.53 13.49 31 168981 94276 110326011
Radiation necrosis 65.35 13.49 30 168982 824 110419463
Toxic epidermal necrolysis 65.21 13.49 213 168799 56514 110363773
Atrioventricular block complete 65.00 13.49 113 168899 19969 110400318
Osteoporosis 64.75 13.49 26 168986 87126 110333161
Polymyositis 64.54 13.49 50 168962 3658 110416629
Rhinorrhoea 63.65 13.49 39 168973 102627 110317660
Wound infection 63.59 13.49 34 168978 96431 110323856
Plasma cell myeloma 63.57 13.49 10 169002 62926 110357361
Sudden death 63.53 13.49 125 168887 24270 110396017
Transaminases increased 63.22 13.49 227 168785 63163 110357124
Rheumatoid arthritis 63.00 13.49 240 168772 299373 110120914
Pneumocystis jirovecii pneumonia 62.83 13.49 175 168837 42560 110377727
Hypertransaminasaemia 62.82 13.49 124 168888 24131 110396156
Pancreatic failure 62.37 13.49 41 168971 2313 110417974
Foot deformity 61.49 13.49 3 169009 48477 110371810
Therapy non-responder 61.07 13.49 91 168921 157216 110263071
Primary adrenal insufficiency 60.90 13.49 26 168986 598 110419689
Hepatic enzyme increased 60.62 13.49 268 168744 320624 110099663
Drug-device incompatibility 60.34 13.49 11 169001 0 110420287
Pancreatitis 60.30 13.49 293 168719 93240 110327047
Gastrointestinal perforation 59.58 13.49 65 168947 7391 110412896
International normalised ratio increased 59.56 13.49 29 168983 86743 110333544
Peripheral sensory neuropathy 59.48 13.49 98 168914 16582 110403705
Influenza 58.93 13.49 105 168907 168996 110251291
Joint stiffness 58.92 13.49 15 168997 67228 110353059
Inflammation 58.73 13.49 130 168882 193108 110227179
Multiple sclerosis relapse 58.14 13.49 5 169007 50235 110370052
Physical deconditioning 57.91 13.49 46 168966 3491 110416796
Morphoea 57.85 13.49 25 168987 593 110419694
Somnolence 57.66 13.49 246 168766 297203 110123084
Hypoalbuminaemia 57.58 13.49 133 168879 28841 110391446
Limbic encephalitis 57.53 13.49 27 168985 781 110419506
Endocrine disorder 57.53 13.49 30 168982 1094 110419193
Bradycardia 57.47 13.49 93 168919 155424 110264863
Autoimmune lung disease 57.41 13.49 19 168993 208 110420079
Cardiac failure congestive 57.03 13.49 89 168923 150911 110269376
Upper respiratory tract infection 57.02 13.49 70 168942 131258 110289029
Nail disorder 56.75 13.49 10 169002 57925 110362362
Blood pressure systolic increased 56.56 13.49 28 168984 82963 110337324
Angioedema 56.25 13.49 41 168971 98459 110321828
Capillary leak syndrome 56.19 13.49 52 168960 4856 110415431
Large intestine perforation 55.69 13.49 95 168917 16534 110403753
Intestinal perforation 55.37 13.49 108 168904 20836 110399451
Drug dependence 55.19 13.49 6 169006 50014 110370273
Balance disorder 55.10 13.49 58 168954 116502 110303785
Haemoptysis 54.53 13.49 235 168777 71119 110349168
Tremor 54.41 13.49 145 168867 202087 110218200
Onychomadesis 54.36 13.49 4 169008 45659 110374628
Haematocrit decreased 53.77 13.49 17 168995 66100 110354187
Chest discomfort 53.62 13.49 116 168896 173732 110246555
Abdominal distension 53.05 13.49 118 168894 174985 110245302
Therapeutic response decreased 52.76 13.49 42 168970 96457 110323830
Aggression 52.28 13.49 13 168999 59197 110361090
Nephrolithiasis 52.13 13.49 18 168994 66194 110354093
Malignant pleural effusion 52.04 13.49 46 168966 4047 110416240
Red blood cell count decreased 51.77 13.49 18 168994 65905 110354382
Ileus 51.40 13.49 132 168880 30597 110389690
Renal disorder 50.89 13.49 179 168833 49300 110370987
Type 3 diabetes mellitus 50.64 13.49 15 168997 110 110420177
Gastrointestinal toxicity 50.27 13.49 73 168939 11075 110409212
Blood glucose increased 50.13 13.49 78 168934 132418 110287869
Hypertension 50.03 13.49 518 168494 509566 109910721
Drug level increased 49.54 13.49 7 169005 47712 110372575
Autoimmune thyroid disorder 49.51 13.49 13 168999 57 110420230
Metastasis 49.27 13.49 62 168950 8205 110412082
Unresponsive to stimuli 49.10 13.49 18 168994 63772 110356515
Back injury 49.09 13.49 7 169005 47392 110372895
Biliary obstruction 48.91 13.49 51 168961 5507 110414780
Lactic acidosis 48.76 13.49 42 168970 92769 110327518
Cerebral infarction 48.63 13.49 182 168830 51656 110368631
Chest pain 48.54 13.49 356 168656 376019 110044268
Infection 48.46 13.49 339 168673 361861 110058426
Pulmonary sepsis 47.47 13.49 49 168963 5229 110415058
Hallucination 47.35 13.49 51 168961 101381 110318906
Endocrine toxicity 46.56 13.49 13 168999 75 110420212
Hypokalaemia 46.24 13.49 454 168558 181994 110238293
Renal failure 45.89 13.49 539 168473 226035 110194252
Drug-induced liver injury 45.49 13.49 327 168685 119740 110300547
Localised infection 45.43 13.49 6 169006 43042 110377245
Metastases to pleura 45.31 13.49 32 168980 2031 110418256
Gastritis 45.05 13.49 182 168830 53517 110366770
Accidental overdose 44.58 13.49 12 169000 51822 110368465
Sopor 44.09 13.49 3 169009 36543 110383744
Dysphagia 43.82 13.49 392 168620 153208 110267079
Immune-mediated cytopenia 43.76 13.49 17 168995 304 110419983
Pain in jaw 43.73 13.49 12 169000 51165 110369122
Mucosal inflammation 43.73 13.49 274 168738 95867 110324420
Oropharyngeal pain 43.62 13.49 88 168924 135188 110285099
Autoimmune myositis 43.60 13.49 24 168988 977 110419310
Drug withdrawal syndrome 43.46 13.49 4 169008 38050 110382237
Brain oedema 43.42 13.49 125 168887 30973 110389314
Loss of consciousness 43.38 13.49 154 168858 196152 110224135
Coeliac disease 43.31 13.49 7 169005 43180 110377107
Frequent bowel movements 43.04 13.49 28 168984 71362 110348925
Prerenal failure 43.03 13.49 43 168969 4416 110415871
Chylothorax 43.01 13.49 25 168987 1131 110419156
Bronchial fistula 43.00 13.49 16 168996 253 110420034
Full blood count abnormal 42.83 13.49 16 168996 56036 110364251
Hepatocellular injury 42.78 13.49 172 168840 50470 110369817
Neutrophil count decreased 42.75 13.49 324 168688 120617 110299670
Metastases to adrenals 42.67 13.49 28 168984 1575 110418712
Pulmonary fibrosis 42.63 13.49 56 168956 101986 110318301
Performance status decreased 42.52 13.49 54 168958 7212 110413075
Pulmonary sarcoidosis 42.47 13.49 29 168983 1743 110418544
Exposure via body fluid 42.38 13.49 17 168995 332 110419955
Feeling hot 42.32 13.49 46 168966 91060 110329227
Lupus-like syndrome 42.31 13.49 6 169006 40786 110379501
Inappropriate schedule of product administration 42.22 13.49 164 168848 203473 110216814
Metastatic renal cell carcinoma 42.21 13.49 33 168979 2447 110417840
Radiation skin injury 42.21 13.49 28 168984 1604 110418683
Altered state of consciousness 41.91 13.49 187 168825 57439 110362848
Myasthenia gravis crisis 41.86 13.49 29 168983 1785 110418502
Optic neuritis 41.79 13.49 67 168945 11080 110409207
Nervousness 41.75 13.49 4 169008 36847 110383440
Swollen tongue 41.69 13.49 20 168992 60342 110359945
Tumour hyperprogression 41.60 13.49 17 168995 349 110419938
Thyroid function test abnormal 41.14 13.49 37 168975 3330 110416957
Dermatitis bullous 41.11 13.49 86 168926 17443 110402844
Immune-mediated cholestasis 41.05 13.49 11 169001 53 110420234
Toxic skin eruption 40.77 13.49 113 168899 27402 110392885
Respiratory arrest 40.75 13.49 19 168993 58280 110362007
Aplasia pure red cell 40.71 13.49 61 168951 9517 110410770
Blood alkaline phosphatase increased 40.66 13.49 215 168797 70720 110349567
Thrombocytopenia 40.60 13.49 754 168258 348131 110072156
Burning sensation 40.58 13.49 28 168984 69184 110351103
Dyskinesia 40.48 13.49 14 168998 51432 110368855
Muscle spasticity 40.42 13.49 4 169008 35911 110384376
Swelling face 40.30 13.49 49 168963 92272 110328015
Laryngitis 40.09 13.49 8 169004 42403 110377884
Metastases to peritoneum 39.86 13.49 46 168966 5564 110414723
Psychotic disorder 39.84 13.49 14 168998 50923 110369364
Immunodeficiency 39.61 13.49 6 169006 38832 110381455
Superior vena cava syndrome 39.58 13.49 25 168987 1316 110418971
Sleep apnoea syndrome 39.58 13.49 7 169005 40440 110379847
Renal cell carcinoma 39.46 13.49 53 168959 7477 110412810
Autoimmune uveitis 39.18 13.49 9 169003 19 110420268
Lymphadenopathy 39.03 13.49 197 168815 63638 110356649
Joint injury 38.96 13.49 7 169005 39987 110380300
Diabetic ketoacidotic hyperglycaemic coma 38.83 13.49 15 168997 264 110420023
Troponin T increased 38.77 13.49 40 168972 4266 110416021
Product prescribing error 38.64 13.49 15 168997 51316 110368971
Tumour embolism 38.52 13.49 15 168997 270 110420017
Septic shock 38.47 13.49 389 168623 157139 110263148
Demyelinating polyneuropathy 38.44 13.49 30 168982 2219 110418068
Meningoradiculitis 38.30 13.49 14 168998 210 110420077
Bile duct stenosis 37.93 13.49 32 168980 2644 110417643
Neoplasm progression 37.86 13.49 197 168815 64398 110355889
Glomerulonephritis 37.39 13.49 41 168971 4689 110415598
Orthostatic hypotension 37.27 13.49 28 168984 66221 110354066
Haemolytic anaemia 37.22 13.49 92 168920 20828 110399459
Hepatitis fulminant 37.07 13.49 55 168957 8505 110411782
Glomerulonephritis rapidly progressive 36.68 13.49 29 168983 2186 110418101
Enterocolitis haemorrhagic 36.62 13.49 31 168981 2573 110417714
Thyrotoxic crisis 36.58 13.49 28 168984 2012 110418275
Infusion related reaction 36.56 13.49 389 168623 380773 110039514
Autoimmune encephalopathy 36.51 13.49 13 168999 180 110420107
Hypervolaemia 36.34 13.49 15 168997 49445 110370842
Spinal cord compression 36.33 13.49 51 168961 7501 110412786
Infectious pleural effusion 36.26 13.49 41 168971 4850 110415437
Troponin increased 36.24 13.49 114 168898 29652 110390635
Encephalopathy 36.23 13.49 230 168782 80825 110339462
Pleurodesis 36.22 13.49 10 169002 55 110420232
Aspiration pleural cavity 35.98 13.49 26 168986 1711 110418576
Sinus disorder 35.92 13.49 4 169008 32724 110387563
Blood pressure diastolic decreased 35.57 13.49 6 169006 35879 110384408
Pancreatic toxicity 35.46 13.49 11 169001 96 110420191
Dermatitis acneiform 35.44 13.49 67 168945 12628 110407659
Thyroxine free abnormal 35.34 13.49 9 169003 34 110420253
Inappropriate antidiuretic hormone secretion 35.28 13.49 123 168889 33728 110386559
Metastases to spine 34.95 13.49 42 168970 5301 110414986
Blood corticotrophin abnormal 34.94 13.49 10 169002 64 110420223
Glomerulonephritis membranous 34.84 13.49 27 168985 1976 110418311
Thyroiditis subacute 34.67 13.49 16 168996 445 110419842
Tumour necrosis 34.26 13.49 29 168983 2407 110417880
Lymphadenopathy mediastinal 34.08 13.49 42 168970 5442 110414845
Subacute cutaneous lupus erythematosus 33.90 13.49 40 168972 4954 110415333
Biliary tract infection 33.89 13.49 25 168987 1699 110418588
Treatment noncompliance 33.74 13.49 37 168975 72953 110347334
Abnormal behaviour 33.65 13.49 9 169003 39030 110381257
Metastases to skin 33.63 13.49 28 168984 2271 110418016
Achromotrichia acquired 33.61 13.49 8 169004 21 110420266
Hyperlipidaemia 33.39 13.49 7 169005 35841 110384446
Platelet count decreased 33.35 13.49 516 168496 229927 110190360
Extrapyramidal disorder 33.06 13.49 3 169009 28864 110391423
Body temperature decreased 32.82 13.49 8 169004 36927 110383360
Pericarditis malignant 32.68 13.49 10 169002 83 110420204
Troponin I increased 32.67 13.49 41 168971 5411 110414876
Gamma-glutamyltransferase increased 32.56 13.49 182 168830 61127 110359160
Hair colour changes 32.48 13.49 38 168974 4663 110415624
Eye irritation 32.28 13.49 6 169006 33446 110386841
Underdose 31.90 13.49 30 168982 63524 110356763
Pituitary enlargement 31.88 13.49 11 169001 138 110420149
Malnutrition 31.86 13.49 103 168909 27176 110393111
Hepatobiliary disease 31.85 13.49 20 168992 1042 110419245
Cholangitis acute 31.58 13.49 25 168987 1888 110418399
Illness 31.44 13.49 48 168964 82123 110338164
IgA nephropathy 31.36 13.49 31 168981 3142 110417145
Chronic gastritis 31.32 13.49 40 168972 5371 110414916
Autoimmune cholangitis 31.26 13.49 9 169003 59 110420228
Joint dislocation 31.19 13.49 7 169005 34183 110386104
VIth nerve paralysis 31.13 13.49 24 168988 1743 110418544
Ulcerative gastritis 30.92 13.49 11 169001 152 110420135
Obstructive airways disorder 30.80 13.49 16 168996 46133 110374154
Hallucination, visual 30.78 13.49 11 169001 39594 110380693
Retinitis 30.76 13.49 6 169006 32321 110387966
Renal tubular acidosis 30.74 13.49 37 168975 4678 110415609
Blood thyroid stimulating hormone abnormal 30.73 13.49 20 168992 1109 110419178
Ear pain 30.59 13.49 22 168990 53204 110367083
Cortisol abnormal 30.25 13.49 10 169002 109 110420178
Autoimmune retinopathy 29.95 13.49 8 169004 38 110420249
Rectal haemorrhage 29.94 13.49 89 168923 119744 110300543
Paraneoplastic neurological syndrome 29.85 13.49 11 169001 169 110420118
Orbital myositis 29.79 13.49 12 169000 237 110420050
Pancreatic atrophy 29.76 13.49 17 168995 744 110419543
Hepatitis acute 29.73 13.49 79 168933 18687 110401600
Melanoma recurrent 29.71 13.49 13 168999 318 110419969
Acute respiratory failure 29.68 13.49 207 168805 75053 110345234
Throat irritation 29.66 13.49 23 168989 53529 110366758
Acute polyneuropathy 29.62 13.49 17 168995 751 110419536
Evans syndrome 29.53 13.49 17 168995 755 110419532
Colitis microscopic 29.43 13.49 64 168948 13330 110406957
Chondritis 29.34 13.49 12 169000 247 110420040
Cardiomyopathy 29.23 13.49 115 168897 33410 110386877
Pulmonary tuberculosis 29.02 13.49 51 168961 9088 110411199
Blood potassium decreased 29.02 13.49 24 168988 54090 110366197
Product use in unapproved indication 28.95 13.49 495 168517 446882 109973405
Neuropathy peripheral 28.90 13.49 409 168603 178868 110241419
Giant cell arteritis 28.78 13.49 32 168980 3717 110416570
Chronic inflammatory demyelinating polyradiculoneuropathy 28.57 13.49 25 168987 2170 110418117
Pathological fracture 28.18 13.49 59 168953 11973 110408314
Febrile neutropenia 28.14 13.49 658 168354 316109 110104178
Paraneoplastic syndrome 27.60 13.49 20 168992 1322 110418965
Cryptitis 27.57 13.49 13 168999 380 110419907
Therapy partial responder 27.50 13.49 121 168891 36940 110383347
Blood lactate dehydrogenase increased 27.23 13.49 137 168875 44197 110376090
Hyperglycaemic hyperosmolar nonketotic syndrome 27.18 13.49 28 168984 2981 110417306
Hallucination, auditory 27.10 13.49 4 169008 26393 110393894
Cortisol increased 27.06 13.49 15 168997 619 110419668
Papilloedema 27.05 13.49 44 168968 7365 110412922
Protein-losing gastroenteropathy 27.02 13.49 17 168995 889 110419398
Thyroxine free decreased 26.97 13.49 19 168993 1201 110419086
Blood glucose decreased 26.97 13.49 6 169006 29482 110390805
Paraesthesia oral 26.77 13.49 9 169003 33662 110386625
Intestinal intraepithelial lymphocytes increased 26.65 13.49 11 169001 232 110420055
Glomerulonephritis minimal lesion 26.49 13.49 18 168994 1073 110419214
Oedema 26.38 13.49 200 168812 209776 110210511
Small intestinal perforation 26.37 13.49 33 168979 4343 110415944
Breast cancer 26.27 13.49 13 168999 38529 110381758
Intestinal metastasis 26.24 13.49 14 168998 535 110419752
Oxygen saturation decreased 26.18 13.49 137 168875 156845 110263442
Crying 26.04 13.49 4 169008 25624 110394663
Hypersensitivity pneumonitis 25.99 13.49 36 168976 5229 110415058
Abortion spontaneous 25.84 13.49 10 169002 34272 110386015
Thoracic cavity drainage 25.76 13.49 12 169000 341 110419946
Epistaxis 25.75 13.49 107 168905 130265 110290022
Pulmonary fistula 25.72 13.49 9 169003 118 110420169
Myelitis 25.66 13.49 28 168984 3185 110417102
Eye pruritus 25.65 13.49 9 169003 32766 110387521
Oesophageal carcinoma recurrent 25.57 13.49 8 169004 72 110420215
Proteinuria 25.53 13.49 125 168887 39893 110380394
Tumour lysis syndrome 25.52 13.49 104 168908 30697 110389590
Gastroenteritis viral 25.44 13.49 8 169004 31218 110389069
Coronary artery disease 25.43 13.49 44 168968 71646 110348641
Lip swelling 25.33 13.49 24 168988 50643 110369644
Paraparesis 25.25 13.49 33 168979 4533 110415754
Blood urea increased 25.24 13.49 28 168984 54929 110365358
Limb injury 25.19 13.49 13 168999 37623 110382664
Immune-mediated neurological disorder 25.00 13.49 8 169004 78 110420209
Cardiac arrest 24.91 13.49 187 168825 196566 110223721
Metastases to pancreas 24.81 13.49 15 168997 730 110419557
Full blood count decreased 24.80 13.49 9 169003 32090 110388197
Jaundice cholestatic 24.69 13.49 63 168949 14545 110405742
Sneezing 24.66 13.49 9 169003 31975 110388312
Blood calcium decreased 24.57 13.49 12 169000 35833 110384454
Failure to thrive 24.47 13.49 60 168952 13514 110406773
Therapy interrupted 24.44 13.49 24 168988 49798 110370489
Blood bilirubin increased 24.35 13.49 199 168813 75773 110344514
Atrial fibrillation 24.21 13.49 489 168523 229153 110191134
Torsade de pointes 24.21 13.49 3 169009 22597 110397690
White blood cell count increased 24.14 13.49 72 168940 96770 110323517
Skin hypopigmentation 24.03 13.49 19 168993 1432 110418855
Renal cancer metastatic 23.93 13.49 15 168997 779 110419508
Tracheal obstruction 23.75 13.49 10 169002 222 110420065
Pleurocutaneous fistula 23.67 13.49 7 169005 51 110420236
Paralysis recurrent laryngeal nerve 23.67 13.49 10 169002 224 110420063
Skin laceration 23.59 13.49 11 169001 33742 110386545
Cytokine storm 23.59 13.49 19 168993 1471 110418816
Breath sounds abnormal 23.58 13.49 5 169007 25399 110394888
Hepatic cirrhosis 23.54 13.49 42 168970 67584 110352703
Tumour thrombosis 23.41 13.49 11 169001 319 110419968
Lung disorder 23.37 13.49 396 168616 179651 110240636
Miosis 23.35 13.49 3 169009 21980 110398307
Peripheral motor neuropathy 23.33 13.49 30 168982 4056 110416231
Normal newborn 23.23 13.49 3 169009 21893 110398394
Myocardial infarction 23.18 13.49 185 168827 191898 110228389
Visual impairment 23.16 13.49 116 168896 134312 110285975
Chronic sinusitis 23.15 13.49 5 169007 25079 110395208
Abdominal pain 23.08 13.49 602 168410 512387 109907900
Cutaneous sarcoidosis 23.07 13.49 13 168999 554 110419733
Tachycardia 23.07 13.49 228 168784 226417 110193870
Lethargy 23.02 13.49 70 168942 93506 110326781
Skin haemorrhage 22.81 13.49 5 169007 24822 110395465
Hypoxia 22.72 13.49 300 168712 129215 110291072
Hepatitis G 22.65 13.49 8 169004 108 110420179
Eosinophilia 22.64 13.49 159 168853 57777 110362510
Renal cell carcinoma recurrent 22.57 13.49 7 169005 61 110420226
Prostate cancer 22.37 13.49 15 168997 37626 110382661
Viral infection 22.36 13.49 29 168983 53110 110367177
Pleurisy 22.32 13.49 54 168958 12062 110408225
Haemodynamic instability 22.31 13.49 4 169008 22884 110397403
Muscle twitching 22.12 13.49 9 169003 29926 110390361
Oesophageal stenosis 22.10 13.49 33 168979 5132 110415155
Microvillous inclusion disease 21.98 13.49 10 169002 269 110420018
Neck pain 21.94 13.49 105 168907 123025 110297262
Ulcer haemorrhage 21.88 13.49 4 169008 22567 110397720
Depressed mood 21.87 13.49 37 168975 60772 110359515
Appetite disorder 21.83 13.49 47 168965 9722 110410565
Foot fracture 21.81 13.49 6 169006 25540 110394747
Mechanical ileus 21.75 13.49 17 168995 1260 110419027
Steroid diabetes 21.67 13.49 33 168979 5221 110415066
Gastric disorder 21.63 13.49 12 169000 33345 110386942
Blood triglycerides increased 21.62 13.49 5 169007 23921 110396366
Non-small cell lung cancer recurrent 21.33 13.49 9 169003 201 110420086
Sterile pyuria 21.20 13.49 7 169005 76 110420211
Adverse event 21.20 13.49 257 168755 108552 110311735
Transfusion 21.10 13.49 86 168926 25386 110394901
Myelitis transverse 21.07 13.49 22 168990 2379 110417908
Oesophageal cancer metastatic 20.76 13.49 10 169002 307 110419980
Intentional dose omission 20.71 13.49 3 169009 20077 110400210
Diplopia 20.69 13.49 122 168890 41772 110378515
Pregnancy on contraceptive 20.68 13.49 15 168997 993 110419294
Kidney transplant rejection 20.57 13.49 52 168960 11935 110408352
Liver abscess 20.57 13.49 40 168972 7699 110412588
Non-cardiac chest pain 20.47 13.49 47 168965 10151 110410136
Therapy cessation 20.44 13.49 23 168989 44834 110375453
Thyroid stimulating hormone deficiency 20.38 13.49 6 169006 43 110420244
Taste disorder 20.27 13.49 170 168842 65217 110355070
Seasonal allergy 20.22 13.49 3 169009 19719 110400568
Adverse reaction 20.14 13.49 10 169002 29584 110390703
Apoptosis 20.10 13.49 13 168999 713 110419574
Acute motor axonal neuropathy 20.10 13.49 8 169004 153 110420134
Eye swelling 19.87 13.49 13 168999 33035 110387252
Encephalomyelitis 19.85 13.49 10 169002 339 110419948
Hypophonesis 19.82 13.49 5 169007 18 110420269
Basal cell carcinoma 19.78 13.49 24 168988 45246 110375041
Hyperadrenocorticism 19.72 13.49 12 169000 591 110419696
Ketoacidosis 19.71 13.49 46 168966 10041 110410246
Salivary duct inflammation 19.71 13.49 4 169008 3 110420284
Oesophageal squamous cell carcinoma recurrent 19.71 13.49 4 169008 3 110420284
Oesophageal prosthesis insertion 19.71 13.49 4 169008 3 110420284
Malignant peritoneal neoplasm 19.67 13.49 13 168999 740 110419547
Paranoia 19.58 13.49 5 169007 22369 110397918
Pericardial drainage 19.56 13.49 11 169001 467 110419820
Vaginal haemorrhage 19.42 13.49 7 169005 25067 110395220
Osteopenia 19.37 13.49 5 169007 22204 110398083
Diabetic ketosis 19.37 13.49 14 168998 922 110419365
Mydriasis 19.30 13.49 5 169007 22152 110398135
Probiotic therapy 19.28 13.49 8 169004 171 110420116
Small intestinal haemorrhage 19.04 13.49 29 168983 4589 110415698
Oesophageal fistula 19.04 13.49 11 169001 492 110419795
Serous retinopathy 19.00 13.49 9 169003 266 110420021
Eosinophil count increased 18.98 13.49 73 168939 20985 110399302
White blood cell count decreased 18.92 13.49 242 168770 229148 110191139
Empyema 18.89 13.49 32 168980 5538 110414749
Tracheal stenosis 18.88 13.49 12 169000 639 110419648
Restless legs syndrome 18.86 13.49 7 169005 24619 110395668
Pallor 18.83 13.49 36 168976 56431 110363856
Procedural pain 18.79 13.49 16 168996 35549 110384738
Gastroenteritis eosinophilic 18.77 13.49 10 169002 381 110419906
Stress cardiomyopathy 18.75 13.49 60 168952 15746 110404541
Macular degeneration 18.65 13.49 5 169007 21654 110398633
Drug level decreased 18.61 13.49 3 169009 18545 110401742
Cerebral microangiopathy 18.42 13.49 10 169002 396 110419891
Blood urine present 18.39 13.49 7 169005 24238 110396049
Dermatitis atopic 18.36 13.49 8 169004 25533 110394754
Autoimmune anaemia 18.34 13.49 5 169007 26 110420261
Biliary dilatation 18.21 13.49 25 168987 3600 110416687
Tinnitus 18.16 13.49 41 168971 60499 110359788
Yersinia infection 18.13 13.49 7 169005 123 110420164
Secondary hypogonadism 18.07 13.49 13 168999 850 110419437
Ocular hyperaemia 18.06 13.49 20 168992 39266 110381021
Keratitis 18.04 13.49 30 168982 5114 110415173
Urinary incontinence 18.00 13.49 29 168983 48558 110371729
Coordination abnormal 17.98 13.49 8 169004 25220 110395067
Bronchial injury 17.91 13.49 4 169008 7 110420280
Metastases to abdominal cavity 17.86 13.49 13 168999 865 110419422
Respiratory rate increased 17.80 13.49 8 169004 25075 110395212
KL-6 increased 17.78 13.49 9 169003 308 110419979
Gastric stenosis 17.76 13.49 8 169004 210 110420077
Oesophageal candidiasis 17.71 13.49 48 168964 11486 110408801
Disease progression 17.57 13.49 493 168519 243541 110176746
Skin cancer 17.57 13.49 3 169009 17781 110402506
Diabetic hyperosmolar coma 17.55 13.49 13 168999 889 110419398
Bacterial infection 17.50 13.49 27 168985 46009 110374278
Tendonitis 17.47 13.49 9 169003 26074 110394213
Transient acantholytic dermatosis 17.47 13.49 9 169003 320 110419967
Peritonitis 17.45 13.49 97 168915 32510 110387777
Pathogen resistance 17.42 13.49 3 169009 17669 110402618
Hydronephrosis 17.30 13.49 70 168942 20595 110399692
Mixed liver injury 17.30 13.49 49 168963 12030 110408257
Lung abscess 17.27 13.49 29 168983 4983 110415304
Dacryoadenitis acquired 17.24 13.49 4 169008 9 110420278
Dysstasia 17.23 13.49 15 168997 32971 110387316
Dermatitis exfoliative generalised 17.19 13.49 46 168966 10926 110409361
Chest tube insertion 17.16 13.49 7 169005 143 110420144
Premature delivery 17.16 13.49 13 168999 30619 110389668
Catabolic state 17.13 13.49 6 169006 79 110420208
Poor venous access 17.13 13.49 8 169004 24514 110395773
Hypoparathyroidism 17.11 13.49 16 168996 1514 110418773
Toxic neuropathy 17.10 13.49 14 168998 1109 110419178
Device dislocation 17.08 13.49 14 168998 31690 110388597
Myofascitis 16.96 13.49 5 169007 36 110420251
Sputum discoloured 16.79 13.49 11 169001 27934 110392353
Liver transplant rejection 16.72 13.49 25 168987 3893 110416394
Hypogammaglobulinaemia 16.61 13.49 5 169007 20071 110400216
Complication associated with device 16.61 13.49 5 169007 20068 110400219
Sensory loss 16.60 13.49 6 169006 21451 110398836
Panic attack 16.58 13.49 12 169000 28928 110391359
Muscle rigidity 16.54 13.49 8 169004 24023 110396264
Biliary tract disorder 16.51 13.49 17 168995 1809 110418478
Mental disorder 16.49 13.49 21 168991 38770 110381517
HER2 positive salivary gland cancer 16.46 13.49 3 169009 0 110420287
Food allergy 16.45 13.49 5 169007 19943 110400344
Pachymeningitis 16.43 13.49 10 169002 493 110419794
Gout 16.39 13.49 19 168993 36547 110383740
Platelet count increased 16.32 13.49 10 169002 26324 110393963
Pulmonary hypertension 16.08 13.49 38 168974 55182 110365105
Oesophagobronchial fistula 16.02 13.49 8 169004 266 110420021
Cough 15.99 13.49 561 168451 461080 109959207
Acquired amegakaryocytic thrombocytopenia 15.98 13.49 5 169007 45 110420242
Polyserositis 15.98 13.49 13 168999 1021 110419266
Systemic inflammatory response syndrome 15.92 13.49 50 168962 12993 110407294
Hepatitis cholestatic 15.92 13.49 61 168951 17505 110402782
Intervertebral disc degeneration 15.91 13.49 4 169008 18081 110402206
Flatulence 15.90 13.49 35 168977 52114 110368173
Thyroxine free increased 15.84 13.49 15 168997 1442 110418845
Infective spondylitis 15.81 13.49 10 169002 528 110419759
Eye pain 15.80 13.49 33 168979 50066 110370221
Productive cough 15.75 13.49 106 168906 114199 110306088
Spermatogenesis abnormal 15.73 13.49 4 169008 15 110420272
Renal vasculitis 15.69 13.49 11 169001 690 110419597
Vaginal discharge 15.68 13.49 4 169008 17904 110402383
Hyperphosphataemia 15.67 13.49 3 169009 16378 110403909
Ulcerative keratitis 15.66 13.49 27 168985 4739 110415548
Micturition urgency 15.65 13.49 5 169007 19315 110400972
Generalised tonic-clonic seizure 15.63 13.49 38 168974 54642 110365645
Product dispensing error 15.62 13.49 3 169009 16342 110403945
Lung squamous cell carcinoma metastatic 15.62 13.49 6 169006 104 110420183
Oral mucosa erosion 15.62 13.49 19 168993 2429 110417858
Autoimmune neutropenia 15.55 13.49 11 169001 700 110419587
Nephropathy toxic 15.55 13.49 83 168929 27395 110392892
Limb discomfort 15.50 13.49 24 168988 40830 110379457
Irritability 15.49 13.49 31 168981 47778 110372509
Nephritis allergic 15.49 13.49 13 168999 1066 110419221
Diverticulitis intestinal perforated 15.49 13.49 10 169002 547 110419740
Blood alkaline phosphatase abnormal 15.44 13.49 14 168998 1273 110419014
Pericardial excision 15.42 13.49 5 169007 51 110420236
Creatinine renal clearance decreased 15.42 13.49 7 169005 21808 110398479
Acute coronary syndrome 15.32 13.49 73 168939 23039 110397248
Bronchiectasis 15.27 13.49 20 168992 36473 110383814
Bladder tamponade 15.21 13.49 11 169001 725 110419562
Lithiasis 15.09 13.49 8 169004 302 110419985
Salivary hypersecretion 15.04 13.49 4 169008 17417 110402870
Respiratory depression 15.03 13.49 16 168996 31985 110388302
Myoclonus 14.95 13.49 17 168995 32981 110387306
Cutaneous nocardiosis 14.89 13.49 8 169004 310 110419977
Skin discolouration 14.89 13.49 33 168979 49013 110371274
Prothrombin time prolonged 14.84 13.49 4 169008 17257 110403030
Agranulocytosis 14.82 13.49 152 168860 61608 110358679
Autoimmune blistering disease 14.80 13.49 4 169008 20 110420267
Thyroiditis acute 14.74 13.49 7 169005 208 110420079
Bronchitis 14.74 13.49 161 168851 156871 110263416
Enterocolitis infectious 14.73 13.49 22 168990 3422 110416865
Blood pressure abnormal 14.63 13.49 8 169004 22416 110397871
Oligoarthritis 14.62 13.49 11 169001 770 110419517
Mucocutaneous disorder 14.56 13.49 7 169005 214 110420073
Myopathy 14.54 13.49 76 168936 24884 110395403
Rales 14.51 13.49 10 169002 24729 110395558
Cholelithiasis 14.51 13.49 49 168963 63373 110356914
Musculoskeletal discomfort 14.51 13.49 9 169003 23529 110396758
Pancreatic leak 14.49 13.49 4 169008 22 110420265
BRAF gene mutation 14.47 13.49 5 169007 63 110420224
Recall phenomenon 14.47 13.49 14 168998 1382 110418905
IIIrd nerve paralysis 14.46 13.49 14 168998 1383 110418904
Impaired insulin secretion 14.40 13.49 5 169007 64 110420223
Throat tightness 14.37 13.49 18 168994 33471 110386816
Malignant ascites 14.35 13.49 14 168998 1396 110418891
Scleroderma-like reaction 14.35 13.49 7 169005 221 110420066
Ileus paralytic 14.33 13.49 45 168967 11692 110408595
Cell death 14.27 13.49 29 168983 5762 110414525
Sarcoidosis 14.24 13.49 47 168965 12532 110407755
Enteritis infectious 14.10 13.49 23 168989 3859 110416428
Thinking abnormal 14.01 13.49 3 169009 15137 110405150
Erysipelas 13.87 13.49 48 168964 13110 110407177
Incorrect product administration duration 13.84 13.49 7 169005 20491 110399796
Respiratory disorder 13.84 13.49 59 168953 71323 110348964
Drug tolerance decreased 13.82 13.49 13 168999 27527 110392760
Pharyngeal oedema 13.76 13.49 4 169008 16424 110403863
Multiple organ dysfunction syndrome 13.72 13.49 316 168696 151394 110268893
Concomitant disease aggravated 13.68 13.49 4 169008 16360 110403927
Mood swings 13.68 13.49 9 169003 22803 110397484
Thyroiditis chronic 13.67 13.49 4 169008 28 110420259
HRD gene mutation assay positive 13.67 13.49 4 169008 28 110420259
Renal impairment 13.65 13.49 381 168631 188064 110232223
Cardiac disorder 13.61 13.49 65 168947 76215 110344072
Psychomotor hyperactivity 13.58 13.49 7 169005 20270 110400017

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/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
ATC L01FY02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Combinations of monoclonal antibodies and antibody drug conjugates
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000082082 Immune Checkpoint Inhibitors
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000191259 Programmed Death Receptor-1-directed Antibody Interactions
FDA EPC N0000191260 Programmed Death Receptor-1 Blocking Antibody
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs
atezolizumabavelumabcemiplimabdostarlimabdurvalumabpembrolizumabretifanlimabserplulimabsugemalimabtislelizumabtoripalimab
L01FY Combinations of monoclonal antibodies and antibody drug conjugates 3 drugs
pertuzumabrelatlimabtrastuzumab

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
CHEBI:231614 CHEBI
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 QVANTIG HUMAN PRESCRIPTION DRUG LABEL 2 0003-3120 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 27 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3734 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3756 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3772 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO HUMAN PRESCRIPTION DRUG LABEL 1 0003-3774 INJECTION 10 mg INTRAVENOUS BLA 31 sections
OPDIVO QVANTIG HUMAN PRESCRIPTION DRUG LABEL 2 0003-6120 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 27 sections
OPDIVO QVANTIG HUMAN PRESCRIPTION DRUG LABEL 2 0003-6120 INJECTION, SOLUTION 120 mg SUBCUTANEOUS BLA 27 sections
OPDUALAG HUMAN PRESCRIPTION DRUG LABEL 2 0003-7125 INJECTION 12 mg INTRAVENOUS BLA 28 sections