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

Stem definitionDrug idCAS RN
humanized origin 4924 1374853-91-4

Description:

MoleculeDescription

Synonyms:

  • pembrolizumab
  • keytruda
  • lambrolizumab
  • SCH-900475
  • MK-3475
  • pembrolizumab (genetical recombination)
A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells. The ligands for PD-1 include programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs. Activated PD-1 negatively regulates T-cell activation and plays a key role in in tumor evasion from host immunity.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 28, 2016 PMDA MSD K.K.
July 17, 2015 EMA Merck Sharp & Dohme Limited
Sept. 4, 2014 FDA MERCK SHARP DOHME

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 2369.65 16.21 967 23054 67157 50513946
Product use in unapproved indication 636.42 16.21 488 23533 115331 50465772
Immune-mediated adverse reaction 496.64 16.21 89 23932 172 50580931
Immune-mediated lung disease 305.03 16.21 63 23958 324 50580779
Pneumonitis 273.89 16.21 172 23849 29338 50551765
Tumour pseudoprogression 256.50 16.21 50 23971 180 50580923
Hypothyroidism 246.34 16.21 170 23851 33955 50547148
Colitis 243.58 16.21 177 23844 38352 50542751
Immune-mediated enterocolitis 241.87 16.21 63 23958 997 50580106
Immune-mediated hepatitis 231.99 16.21 59 23962 845 50580258
Death 218.67 16.21 478 23543 324901 50256202
Immune-mediated hypothyroidism 194.79 16.21 33 23988 37 50581066
Tubulointerstitial nephritis 191.60 16.21 108 23913 15103 50566000
Hepatitis 190.86 16.21 141 23880 31312 50549791
Myocarditis 189.94 16.21 87 23934 7860 50573243
Immune-mediated hepatic disorder 163.13 16.21 32 23989 120 50580983
Hypophysitis 156.78 16.21 49 23972 1525 50579578
Immune-mediated myocarditis 147.18 16.21 27 23994 63 50581040
Autoimmune colitis 128.25 16.21 32 23989 422 50580681
Vitiligo 127.93 16.21 39 23982 1115 50579988
Type 1 diabetes mellitus 127.61 16.21 50 23971 3063 50578040
Therapy partial responder 126.37 16.21 62 23959 6529 50574574
Thyroiditis 125.88 16.21 43 23978 1779 50579324
Immune-mediated dermatitis 113.23 16.21 20 24001 34 50581069
Autoimmune hypothyroidism 108.04 16.21 22 23999 104 50580999
Off label use 105.27 16.21 474 23547 473952 50107151
Lichenoid keratosis 105.12 16.21 35 23986 1337 50579766
Immune-mediated thyroiditis 103.37 16.21 19 24002 45 50581058
Adrenal insufficiency 100.46 16.21 70 23951 14173 50566930
Immune-mediated arthritis 97.75 16.21 17 24004 25 50581078
Hyperthyroidism 95.75 16.21 64 23957 12111 50568992
Nephritis 94.78 16.21 36 23985 2026 50579077
Myasthenia gravis 94.76 16.21 42 23979 3510 50577593
Adverse event 92.62 16.21 109 23912 43654 50537449
Fulminant type 1 diabetes mellitus 91.71 16.21 23 23998 310 50580793
Autoimmune hepatitis 88.25 16.21 51 23970 7468 50573635
Adrenocorticotropic hormone deficiency 86.37 16.21 21 24000 247 50580856
Immune-mediated pancreatitis 85.07 16.21 16 24005 45 50581058
Myositis 83.19 16.21 50 23971 7870 50573233
Product use issue 76.49 16.21 198 23823 149277 50431826
Inappropriate schedule of product administration 75.60 16.21 128 23893 71703 50509400
Autoimmune thyroiditis 75.47 16.21 35 23986 3250 50577853
Drug hypersensitivity 75.40 16.21 14 24007 250996 50330107
Drug ineffective 66.59 16.21 186 23835 819147 49761956
Hepatic function abnormal 65.19 16.21 79 23942 32602 50548501
Immune-mediated hyperthyroidism 62.92 16.21 11 24010 17 50581086
Joint swelling 61.39 16.21 20 24001 245266 50335837
Renal tubular necrosis 60.32 16.21 45 23976 10123 50570980
Immune-mediated gastritis 59.88 16.21 9 24012 0 50581103
Fall 58.74 16.21 44 23977 334888 50246215
Cholestasis 58.32 16.21 66 23955 25335 50555768
Nasopharyngitis 57.40 16.21 11 24010 192916 50388187
Autoimmune arthritis 57.23 16.21 11 24010 36 50581067
Hepatotoxicity 56.24 16.21 67 23954 27159 50553944
Neoplasm progression 55.75 16.21 69 23952 29088 50552015
Immune-mediated nephritis 53.18 16.21 11 24010 57 50581046
Abdominal discomfort 52.72 16.21 22 23999 231619 50349484
Interstitial lung disease 51.03 16.21 91 23930 53085 50528018
Diabetic ketoacidosis 50.81 16.21 52 23969 17820 50563283
Immune-mediated myositis 50.77 16.21 19 24002 1026 50580077
Systemic lupus erythematosus 48.87 16.21 5 24016 140617 50440486
Dizziness 48.35 16.21 56 23965 346313 50234790
Lichen planus 48.33 16.21 22 23999 1957 50579146
Cholangitis 48.33 16.21 29 23992 4550 50576553
Drug intolerance 47.97 16.21 22 23999 219082 50362021
Blood thyroid stimulating hormone increased 47.83 16.21 32 23989 6060 50575043
Immune-mediated endocrinopathy 46.57 16.21 7 24014 0 50581103
Pemphigoid 46.31 16.21 31 23990 5876 50575227
Sinusitis 46.15 16.21 12 24009 170546 50410557
Exposure during pregnancy 45.65 16.21 3 24018 121012 50460091
Secondary adrenocortical insufficiency 45.58 16.21 18 24003 1125 50579978
Polymyalgia rheumatica 45.22 16.21 23 23998 2613 50578490
Acute kidney injury 44.53 16.21 220 23801 227838 50353265
Swelling 44.23 16.21 20 24001 200852 50380251
Tumour hyperprogression 43.96 16.21 10 24011 86 50581017
Uveitis 43.95 16.21 36 23985 9274 50571829
Metastases to central nervous system 43.81 16.21 39 23982 11243 50569860
Hypersensitivity 43.50 16.21 24 23997 215137 50365966
Condition aggravated 42.55 16.21 47 23974 297011 50284092
Hypopituitarism 42.45 16.21 16 24005 881 50580222
Drug effective for unapproved indication 41.83 16.21 20 24001 1989 50579114
Pyrexia 40.75 16.21 314 23707 379889 50201214
Lymphocytic hypophysitis 40.64 16.21 11 24010 203 50580900
Glossodynia 40.44 16.21 4 24017 115565 50465538
Subacute cutaneous lupus erythematosus 39.97 16.21 20 24001 2195 50578908
Therapeutic product effect decreased 39.94 16.21 8 24013 136042 50445061
Arthropathy 39.26 16.21 13 24008 157893 50423210
Autoimmune pancreatitis 39.25 16.21 11 24010 232 50580871
Autoimmune myocarditis 38.91 16.21 8 24013 40 50581063
Headache 38.76 16.21 118 23903 506417 50074686
Maternal exposure during pregnancy 38.27 16.21 14 24007 159764 50421339
Alopecia 38.23 16.21 36 23985 245011 50336092
Hepatocellular injury 38.17 16.21 54 23967 25893 50555210
Tumour associated fever 37.99 16.21 10 24011 165 50580938
Skin toxicity 36.74 16.21 23 23998 3890 50577213
Myasthenic syndrome 36.57 16.21 10 24011 192 50580911
Eastern Cooperative Oncology Group performance status worsened 36.18 16.21 13 24008 625 50580478
Autoimmune nephritis 35.99 16.21 11 24010 317 50580786
Pain 34.93 16.21 149 23872 578754 50002349
Synovitis 34.89 16.21 8 24013 123857 50457246
Glucocorticoid deficiency 34.62 16.21 10 24011 236 50580867
Drug interaction 33.95 16.21 27 23994 199594 50381509
Transaminases increased 33.89 16.21 53 23968 27771 50553332
Wound 33.73 16.21 5 24016 105789 50475314
Eosinophilic fasciitis 32.83 16.21 8 24013 95 50581008
Hepatitis toxic 32.77 16.21 19 24002 2797 50578306
Neutropenia 32.68 16.21 148 23873 147817 50433286
Overdose 31.14 16.21 5 24016 99722 50481381
Immune-mediated neuropathy 30.92 16.21 5 24016 3 50581100
Myelosuppression 30.81 16.21 35 23986 13482 50567621
Blood pressure abnormal 30.76 16.21 34 23987 12713 50568390
Thrombocytopenia 30.69 16.21 131 23890 127542 50453561
Discomfort 30.52 16.21 7 24014 108373 50472730
Rash maculo-papular 30.04 16.21 49 23972 26592 50554511
EGFR gene mutation 29.90 16.21 9 24012 246 50580857
Toxic epidermal necrolysis 29.86 16.21 43 23978 20949 50560154
Neurofibrosarcoma 29.54 16.21 8 24013 148 50580955
Hypertension 29.36 16.21 186 23835 211017 50370086
Amputation stump pain 29.02 16.21 6 24015 31 50581072
Pulmonary embolism 28.95 16.21 110 23911 101594 50479509
Bronchitis 28.80 16.21 7 24014 104152 50476951
Decreased appetite 28.59 16.21 178 23843 200745 50380358
Autoimmune dermatitis 28.41 16.21 6 24015 35 50581068
Cholangitis sclerosing 27.94 16.21 13 24008 1216 50579887
Thyroid disorder 27.51 16.21 32 23989 12645 50568458
Polyglandular autoimmune syndrome type II 27.22 16.21 6 24015 44 50581059
Rheumatoid arthritis 26.88 16.21 34 23987 202516 50378587
Immune-mediated hypophysitis 26.87 16.21 5 24016 13 50581090
Autoimmune endocrine disorder 26.61 16.21 4 24017 0 50581103
Toxicity to various agents 25.85 16.21 38 23983 212461 50368642
Immune-mediated cholangitis 25.65 16.21 5 24016 18 50581085
Diarrhoea 25.49 16.21 406 23615 588070 49993033
Palmar-plantar erythrodysaesthesia syndrome 25.47 16.21 39 23982 20059 50561044
Neonatal respiratory depression 25.47 16.21 6 24015 61 50581042
Aspartate aminotransferase increased 25.27 16.21 88 23933 77910 50503193
Contusion 24.94 16.21 11 24010 112172 50468931
Pericardial effusion 24.80 16.21 44 23977 25545 50555558
Pleural effusion 24.76 16.21 90 23931 81364 50499739
Weight increased 24.66 16.21 36 23985 201855 50379248
Metastases to adrenals 24.46 16.21 10 24011 684 50580419
Infusion related reaction 24.05 16.21 27 23994 169530 50411573
Thyroid hormones increased 24.04 16.21 8 24013 305 50580798
Rash pruritic 24.02 16.21 63 23958 47783 50533320
Oligodipsia 24.00 16.21 5 24016 27 50581076
Cutaneous sarcoidosis 23.79 16.21 8 24013 315 50580788
Meningitis aseptic 23.79 16.21 18 24003 4134 50576969
BRAF V600E mutation positive 23.41 16.21 5 24016 31 50581072
Immune thrombocytopenia 23.41 16.21 25 23996 8992 50572111
Immune-mediated encephalitis 23.27 16.21 6 24015 91 50581012
Neuropathy peripheral 23.02 16.21 99 23922 96658 50484445
Peripheral swelling 22.99 16.21 39 23982 205897 50375206
Liver disorder 22.92 16.21 53 23968 37169 50543934
Duodenitis 22.89 16.21 16 24005 3252 50577851
Febrile neutropenia 22.53 16.21 99 23922 97568 50483535
Rash morbilliform 22.46 16.21 15 24006 2831 50578272
Metastatic malignant melanoma 22.37 16.21 11 24010 1163 50579940
Serous retinal detachment 22.03 16.21 7 24014 230 50580873
No adverse event 21.99 16.21 49 23972 33529 50547574
Encephalitis 21.93 16.21 22 23999 7358 50573745
Tumour pain 21.88 16.21 11 24010 1219 50579884
Blood corticotrophin decreased 21.69 16.21 7 24014 242 50580861
Insomnia 21.53 16.21 31 23990 174834 50406269
Female genital tract fistula 21.24 16.21 16 24005 3650 50577453
Diabetes mellitus 21.08 16.21 61 23960 48972 50532131
Musculoskeletal stiffness 21.06 16.21 18 24003 128463 50452640
Radiation pneumonitis 21.03 16.21 11 24010 1324 50579779
Circumstance or information capable of leading to medication error 20.92 16.21 15 24006 3173 50577930
Migraine 20.92 16.21 5 24016 75275 50505828
Mobility decreased 20.90 16.21 6 24015 79942 50501161
Autoimmune uveitis 20.83 16.21 4 24017 13 50581090
Loss of personal independence in daily activities 20.80 16.21 4 24017 70046 50511057
Pancytopenia 20.78 16.21 87 23934 83943 50497160
Cytokine release syndrome 20.78 16.21 23 23998 8611 50572492
Radiation associated pain 20.63 16.21 5 24016 58 50581045
Dermatitis bullous 20.62 16.21 21 24000 7152 50573951
Stevens-Johnson syndrome 20.56 16.21 37 23984 21715 50559388
Enterocolitis 20.30 16.21 20 24001 6547 50574556
Antinuclear antibody 20.29 16.21 8 24013 498 50580605
Vesical fistula 20.25 16.21 5 24016 63 50581040
Immune-mediated adrenal insuficiency 19.96 16.21 3 24018 0 50581103
Respiratory failure 19.95 16.21 91 23930 91090 50490013
Alanine aminotransferase increased 19.95 16.21 89 23932 88270 50492833
Silent thyroiditis 19.57 16.21 5 24016 73 50581030
Influenza 19.55 16.21 9 24012 89529 50491574
Acquired gene mutation 19.54 16.21 9 24012 822 50580281
Asthma 19.48 16.21 9 24012 89328 50491775
Parathyroid tumour malignant 19.46 16.21 4 24017 20 50581083
Cardiomyopathy 19.41 16.21 30 23991 15556 50565547
Adenocarcinoma 19.40 16.21 13 24008 2468 50578635
Cholecystitis 19.13 16.21 28 23993 13843 50567260
Pulmonary sarcoidosis 19.12 16.21 9 24012 864 50580239
Posterior reversible encephalopathy syndrome 18.96 16.21 29 23992 14899 50566204
Depression 18.76 16.21 31 23990 165392 50415711
Pulmonary granuloma 18.56 16.21 10 24011 1278 50579825
Metastases to abdominal wall 18.54 16.21 5 24016 91 50581012
Melanoma recurrent 18.43 16.21 5 24016 93 50581010
Ophthalmoplegia 18.19 16.21 10 24011 1330 50579773
Large intestine perforation 18.10 16.21 20 24001 7474 50573629
Tumour haemorrhage 18.08 16.21 10 24011 1345 50579758
Vital functions abnormal 18.03 16.21 7 24014 418 50580685
Giant cell arteritis 17.85 16.21 11 24010 1809 50579294
Muscle spasms 17.79 16.21 20 24001 125533 50455570
Malignant pleural effusion 17.72 16.21 12 24009 2318 50578785
Optic neuritis 17.71 16.21 19 24002 6871 50574232
Guillain-Barre syndrome 17.59 16.21 14 24007 3463 50577640
Exposure via body fluid 17.51 16.21 7 24014 452 50580651
Infection 17.30 16.21 35 23986 172919 50408184
Polyarthritis 17.18 16.21 20 24001 7907 50573196
Immune-mediated encephalopathy 17.02 16.21 3 24018 5 50581098
Ototoxicity 16.94 16.21 9 24012 1118 50579985
Sarcoidosis 16.86 16.21 16 24005 5001 50576102
Urogenital fistula 16.78 16.21 5 24016 132 50580971
Achromotrichia acquired 16.67 16.21 3 24018 6 50581097
B-cell aplasia 16.45 16.21 4 24017 47 50581056
Autoimmune disorder 16.32 16.21 17 24004 5943 50575160
Pneumonia moraxella 16.30 16.21 4 24017 49 50581054

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 2646.45 14.80 1389 31527 72470 29469141
Immune-mediated adverse reaction 869.61 14.80 178 32738 269 29541342
Pneumonitis 464.31 14.80 323 32593 27721 29513890
Product use in unapproved indication 455.93 14.80 521 32395 86354 29455257
Immune-mediated hepatic disorder 378.41 14.80 86 32830 265 29541346
Immune-mediated lung disease 353.52 14.80 95 32821 673 29540938
Interstitial lung disease 350.56 14.80 374 32542 57344 29484267
Immune-mediated enterocolitis 346.11 14.80 111 32805 1542 29540069
Immune-mediated myocarditis 328.80 14.80 76 32840 258 29541353
Immune-mediated hepatitis 309.33 14.80 100 32816 1427 29540184
Myasthenia gravis 279.62 14.80 112 32804 3039 29538572
Tumour pseudoprogression 253.38 14.80 63 32853 313 29541298
Adrenal insufficiency 239.47 14.80 151 32765 10963 29530648
Adverse event 220.37 14.80 162 32754 15129 29526482
Hypothyroidism 214.66 14.80 162 32754 15744 29525867
Colitis 210.10 14.80 214 32702 31034 29510577
Immune-mediated hypothyroidism 194.61 14.80 39 32877 49 29541562
Type 1 diabetes mellitus 190.04 14.80 89 32827 3555 29538056
Myocarditis 178.31 14.80 125 32791 10831 29530780
Therapy partial responder 171.17 14.80 93 32823 5106 29536505
Adrenocorticotropic hormone deficiency 166.33 14.80 50 32866 552 29541059
Hypophysitis 164.37 14.80 67 32849 1903 29539708
Off label use 160.71 14.80 710 32206 300090 29241521
Autoimmune hepatitis 160.59 14.80 79 32837 3523 29538088
Product use issue 158.84 14.80 238 32678 51206 29490405
Immune-mediated arthritis 148.20 14.80 29 32887 29 29541582
Tubulointerstitial nephritis 145.10 14.80 135 32781 17508 29524103
Myositis 139.30 14.80 105 32811 10178 29531433
Immune-mediated myositis 138.83 14.80 56 32860 1547 29540064
Vitiligo 129.85 14.80 44 32872 732 29540879
Death 121.26 14.80 720 32196 341364 29200247
Autoimmune colitis 116.26 14.80 42 32874 851 29540760
Hyperthyroidism 114.61 14.80 87 32829 8521 29533090
Immune-mediated dermatitis 112.98 14.80 26 32890 86 29541525
Pemphigoid 110.72 14.80 81 32835 7500 29534111
Immune-mediated renal disorder 98.56 14.80 20 32896 28 29541583
Inappropriate schedule of product administration 98.29 14.80 177 32739 44295 29497316
Drug interaction 97.61 14.80 49 32867 197336 29344275
Hepatitis 91.09 14.80 114 32802 20669 29520942
Nephritis 89.74 14.80 45 32871 2091 29539520
Completed suicide 87.05 14.80 3 32913 90243 29451368
Immune-mediated pancreatitis 85.73 14.80 18 32898 33 29541578
Tumour hyperprogression 83.29 14.80 17 32899 25 29541586
Secondary adrenocortical insufficiency 76.63 14.80 33 32883 1078 29540533
Thyroiditis 76.27 14.80 39 32877 1889 29539722
Overdose 69.56 14.80 5 32911 79814 29461797
Neoplasm progression 68.97 14.80 94 32822 18518 29523093
Fall 68.51 14.80 58 32858 177120 29364491
Immune thrombocytopenia 68.09 14.80 62 32854 7815 29533796
Immune-mediated thyroiditis 67.59 14.80 15 32901 40 29541571
Polymyalgia rheumatica 67.56 14.80 31 32885 1180 29540431
Diabetic ketoacidosis 62.33 14.80 83 32833 15990 29525621
Eyelid ptosis 59.47 14.80 48 32868 5138 29536473
Immune-mediated nephritis 58.80 14.80 17 32899 162 29541449
Cholangitis sclerosing 58.54 14.80 27 32889 1040 29540571
Hepatic function abnormal 57.75 14.80 132 32784 39127 29502484
Fulminant type 1 diabetes mellitus 57.60 14.80 23 32893 618 29540993
Hypopituitarism 57.08 14.80 31 32885 1699 29539912
Organising pneumonia 56.36 14.80 46 32870 5002 29536609
Skin toxicity 54.40 14.80 40 32876 3731 29537880
Immune-mediated encephalitis 53.80 14.80 14 32902 86 29541525
Immune-mediated gastritis 52.72 14.80 10 32906 7 29541604
Haemophagocytic lymphohistiocytosis 51.50 14.80 61 32855 10443 29531168
Immune-mediated hypophysitis 51.12 14.80 11 32905 24 29541587
Subacute cutaneous lupus erythematosus 51.11 14.80 23 32893 836 29540775
Autoimmune hypothyroidism 48.61 14.80 11 32905 33 29541578
Eastern Cooperative Oncology Group performance status worsened 48.12 14.80 21 32895 709 29540902
Encephalitis autoimmune 47.78 14.80 19 32897 505 29541106
Pneumonia bacterial 47.04 14.80 55 32861 9288 29532323
Autoimmune thyroiditis 47.00 14.80 23 32893 1013 29540598
Eosinophilic fasciitis 46.79 14.80 12 32904 69 29541542
Autoimmune arthritis 45.97 14.80 11 32905 45 29541566
Immune-mediated cholangitis 45.40 14.80 11 32905 48 29541563
Immune-mediated uveitis 43.79 14.80 9 32907 14 29541597
Dizziness 42.92 14.80 92 32824 189592 29352019
Autoimmune pancreatitis 42.56 14.80 15 32901 282 29541329
Pericarditis malignant 42.35 14.80 9 32907 18 29541593
Myasthenic syndrome 41.49 14.80 16 32900 391 29541220
Toxicity to various agents 41.16 14.80 82 32834 173579 29368032
Autoimmune myocarditis 41.10 14.80 13 32903 172 29541439
Lymphocytic hypophysitis 40.62 14.80 13 32903 179 29541432
Lichenoid keratosis 40.60 14.80 27 32889 2143 29539468
Headache 40.53 14.80 83 32833 173924 29367687
Diarrhoea 40.01 14.80 554 32362 332144 29209467
Immune-mediated cytopenia 39.51 14.80 8 32908 11 29541600
Toxic epidermal necrolysis 38.48 14.80 71 32845 18082 29523529
Myelosuppression 38.28 14.80 57 32859 12170 29529441
Pleural effusion 38.23 14.80 170 32746 71738 29469873
Lung disorder 38.09 14.80 96 32820 30266 29511345
Hepatotoxicity 38.02 14.80 70 32846 17797 29523814
Pulmonary toxicity 37.47 14.80 36 32880 4854 29536757
Rash 37.23 14.80 348 32568 189471 29352140
Drug hypersensitivity 36.83 14.80 15 32901 68391 29473220
Decreased appetite 36.15 14.80 281 32635 145061 29396550
Colitis microscopic 35.58 14.80 23 32893 1740 29539871
Hepatocellular injury 35.26 14.80 75 32841 21168 29520443
Adrenal disorder 34.11 14.80 17 32899 779 29540832
Immune-mediated endocrinopathy 32.94 14.80 7 32909 14 29541597
Autoimmune nephritis 32.91 14.80 11 32905 175 29541436
Blood thyroid stimulating hormone abnormal 32.72 14.80 12 32904 254 29541357
Encephalitis 32.61 14.80 38 32878 6392 29535219
Hospitalisation 32.35 14.80 6 32910 45982 29495629
Primary biliary cholangitis 31.77 14.80 10 32906 130 29541481
Agitation 31.51 14.80 9 32907 51295 29490316
Drug-induced liver injury 30.93 14.80 72 32844 21583 29520028
Cholangitis 30.88 14.80 40 32876 7497 29534114
Bradycardia 29.88 14.80 18 32898 65611 29476000
Metastases to central nervous system 29.46 14.80 38 32878 7093 29534518
Electrocardiogram QT prolonged 29.45 14.80 3 32913 36134 29505477
Drug effective for unapproved indication 29.41 14.80 19 32897 1436 29540175
Depression 29.19 14.80 31 32885 85116 29456495
Hypothalamo-pituitary disorder 29.19 14.80 15 32901 734 29540877
Drug ineffective 28.92 14.80 262 32654 362908 29178703
Mucosal inflammation 28.85 14.80 89 32827 31506 29510105
Aggression 28.84 14.80 3 32913 35538 29506073
Hypotension 28.81 14.80 115 32801 194239 29347372
International normalised ratio increased 28.74 14.80 7 32909 44365 29497246
Thyroid disorder 28.71 14.80 24 32892 2698 29538913
Paraneoplastic neurological syndrome 28.63 14.80 7 32909 32 29541579
Haemoglobin decreased 28.47 14.80 48 32868 108327 29433284
Primary hypothyroidism 28.45 14.80 7 32909 33 29541578
Cardiac failure congestive 28.42 14.80 26 32890 76555 29465056
Melanoma recurrent 28.32 14.80 9 32907 121 29541490
Stevens-Johnson syndrome 28.26 14.80 59 32857 16438 29525173
Enteritis 27.76 14.80 36 32880 6755 29534856
Latent autoimmune diabetes in adults 26.76 14.80 7 32909 44 29541567
Autoimmune uveitis 26.66 14.80 5 32911 3 29541608
Hypertransaminasaemia 26.60 14.80 26 32890 3580 29538031
Silent thyroiditis 26.49 14.80 7 32909 46 29541565
Radiation pneumonitis 26.34 14.80 21 32895 2208 29539403
Radiation necrosis 25.78 14.80 8 32908 99 29541512
Mixed liver injury 25.70 14.80 20 32896 2031 29539580
Transaminases increased 25.69 14.80 69 32847 22593 29519018
Injection site pain 25.67 14.80 3 32913 32443 29509168
Intentional product misuse 25.53 14.80 4 32912 34657 29506954
Insomnia 25.51 14.80 37 32879 88724 29452887
Hypersensitivity 24.80 14.80 14 32902 52889 29488722
Optic neuritis 24.03 14.80 23 32893 3086 29538525
Pain in extremity 23.75 14.80 55 32861 110378 29431233
Condition aggravated 23.32 14.80 84 32832 146211 29395400
Anxiety 23.17 14.80 37 32879 85328 29456283
Unevaluable event 23.02 14.80 3 32913 29848 29511763
Lymphangiosis carcinomatosa 22.57 14.80 13 32903 799 29540812
Dermatitis 22.50 14.80 35 32881 7763 29533848
Syncope 22.34 14.80 35 32881 81336 29460275
Hallucination 22.18 14.80 11 32905 44701 29496910
Lichen planus 22.17 14.80 13 32903 826 29540785
Loss of consciousness 22.15 14.80 30 32886 74026 29467585
Chest discomfort 21.80 14.80 12 32904 45971 29495640
Bacterial diarrhoea 21.79 14.80 6 32910 47 29541564
Autoimmune disorder 21.62 14.80 16 32900 1507 29540104
Autoimmune neuropathy 21.57 14.80 6 32910 49 29541562
Respiratory failure 21.52 14.80 183 32733 96948 29444663
Pericardial effusion 21.50 14.80 62 32854 21146 29520465
Cancer pain 21.32 14.80 19 32897 2328 29539283
Metastatic malignant melanoma 21.24 14.80 17 32899 1798 29539813
Keratoacanthoma 21.07 14.80 11 32905 556 29541055
Muscle spasms 20.87 14.80 25 32891 65057 29476554
Joint swelling 20.71 14.80 15 32901 49615 29491996
Cardiac arrest 20.60 14.80 40 32876 85551 29456060
Blood thyroid stimulating hormone increased 20.35 14.80 21 32895 3084 29538527
Blood pressure increased 20.01 14.80 32 32884 73771 29467840
Tremor 19.83 14.80 32 32884 73506 29468105
Seizure 19.53 14.80 47 32869 93076 29448535
Dermatomyositis 19.51 14.80 13 32903 1035 29540576
Guillain-Barre syndrome 19.42 14.80 26 32890 5032 29536579
Paraneoplastic syndrome 19.30 14.80 10 32906 498 29541113
Cutaneous sarcoidosis 19.18 14.80 7 32909 146 29541465
Coma 19.13 14.80 10 32906 39440 29502171
Nasopharyngitis 19.05 14.80 23 32893 59642 29481969
Hypersensitivity pneumonitis 19.04 14.80 14 32902 1305 29540306
Pulmonary sarcoidosis 18.95 14.80 10 32906 517 29541094
Prostate cancer 18.68 14.80 3 32913 25524 29516087
Autoimmune haemolytic anaemia 18.29 14.80 22 32894 3826 29537785
Rash maculo-papular 18.21 14.80 64 32852 24225 29517386
Myocardial infarction 17.79 14.80 63 32853 110233 29431378
Abdominal distension 17.73 14.80 15 32901 45896 29495715
Lymph node abscess 17.68 14.80 4 32912 12 29541599
Transitional cell carcinoma recurrent 17.68 14.80 4 32912 12 29541599
Coronary artery disease 17.61 14.80 14 32902 44176 29497435
Musculoskeletal stiffness 17.43 14.80 10 32906 37448 29504163
Overgrowth fungal 17.41 14.80 3 32913 0 29541611
Autoimmune cholangitis 17.41 14.80 3 32913 0 29541611
Diffuse uveal melanocytic proliferation 17.41 14.80 3 32913 0 29541611
Non-small cell lung cancer stage III 17.41 14.80 3 32913 0 29541611
Treatment noncompliance 17.39 14.80 3 32913 24224 29517387
Meningitis aseptic 17.28 14.80 17 32899 2359 29539252
Immune-mediated encephalopathy 17.21 14.80 4 32912 14 29541597
Blood bilirubin increased 17.15 14.80 79 32837 33814 29507797
Drug eruption 17.03 14.80 49 32867 16692 29524919
Immune-mediated adrenal insuficiency 16.99 14.80 4 32912 15 29541596
Rheumatoid nodule 16.98 14.80 16 32900 2106 29539505
Pyrexia 16.90 14.80 429 32487 287193 29254418
Angina pectoris 16.89 14.80 5 32911 27845 29513766
Malignant pleural effusion 16.83 14.80 13 32903 1305 29540306
Tumour haemorrhage 16.64 14.80 17 32899 2468 29539143
Adrenalitis 16.59 14.80 4 32912 17 29541594
Hyperhidrosis 16.56 14.80 29 32887 64511 29477100
Urticaria 16.48 14.80 22 32894 54638 29486973
Anti-thyroid antibody positive 16.41 14.80 5 32911 58 29541553
Metastases to skin 16.40 14.80 8 32908 350 29541261
Nephrolithiasis 16.39 14.80 4 32912 25330 29516281
Haematoma 16.38 14.80 3 32913 23209 29518402
Dysphagia 16.38 14.80 111 32805 54815 29486796
Pancreatic failure 16.16 14.80 10 32906 701 29540910
Limbic encephalitis 16.11 14.80 8 32908 364 29541247
Systemic scleroderma 16.05 14.80 7 32909 236 29541375
Thyroid hormones increased 16.03 14.80 5 32911 63 29541548
Blood corticotrophin decreased 16.02 14.80 6 32910 135 29541476
Heart rate decreased 15.99 14.80 4 32912 24908 29516703
Liver disorder 15.79 14.80 67 32849 27682 29513929
Dysphonia 15.63 14.80 52 32864 19144 29522467
Tumour ulceration 15.23 14.80 5 32911 75 29541536
Cardiac tamponade 15.07 14.80 22 32894 4613 29536998

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 4133.99 14.17 1929 48756 110942 64337105
Immune-mediated adverse reaction 1204.02 14.17 241 50444 526 64447521
Product use in unapproved indication 711.15 14.17 781 49904 175837 64272210
Pneumonitis 636.85 14.17 430 50255 49935 64398112
Immune-mediated lung disease 596.13 14.17 147 50538 1055 64446992
Immune-mediated enterocolitis 558.42 14.17 165 50520 2491 64445556
Immune-mediated hepatic disorder 529.80 14.17 115 50570 425 64447622
Immune-mediated hepatitis 485.82 14.17 146 50539 2343 64445704
Immune-mediated myocarditis 469.02 14.17 101 50584 356 64447691
Tumour pseudoprogression 442.01 14.17 98 50587 409 64447638
Interstitial lung disease 430.92 14.17 454 50231 97278 64350769
Colitis 376.29 14.17 335 50350 58339 64389708
Hypothyroidism 372.51 14.17 285 50400 40172 64407875
Immune-mediated hypothyroidism 361.42 14.17 69 50616 103 64447944
Myocarditis 346.36 14.17 197 50488 16846 64431201
Myasthenia gravis 342.23 14.17 139 50546 5599 64442448
Adrenal insufficiency 327.83 14.17 210 50475 22277 64425770
Death 324.50 14.17 971 49714 481734 63966313
Type 1 diabetes mellitus 319.13 14.17 132 50553 5573 64442474
Tubulointerstitial nephritis 302.79 14.17 226 50459 30683 64417364
Hypophysitis 293.16 14.17 109 50576 3450 64444597
Therapy partial responder 268.01 14.17 140 50545 10108 64437939
Adrenocorticotropic hormone deficiency 255.55 14.17 70 50615 790 64447257
Immune-mediated arthritis 231.55 14.17 44 50641 63 64447984
Hepatitis 230.18 14.17 228 50457 45354 64402693
Vitiligo 229.59 14.17 76 50609 1692 64446355
Off label use 225.32 14.17 1037 49648 631769 63816278
Myositis 216.79 14.17 144 50541 16233 64431814
Autoimmune hepatitis 206.03 14.17 117 50568 9967 64438080
Autoimmune colitis 201.68 14.17 65 50620 1326 64446721
Immune-mediated dermatitis 200.93 14.17 42 50643 123 64447924
Immune-mediated myositis 177.46 14.17 70 50615 2608 64445439
Hyperthyroidism 173.71 14.17 131 50554 18048 64429999
Thyroiditis 173.22 14.17 75 50610 3549 64444498
Immune-mediated thyroiditis 159.87 14.17 33 50652 89 64447958
Immune-mediated pancreatitis 158.83 14.17 32 50653 73 64447974
Autoimmune hypothyroidism 157.28 14.17 35 50650 149 64447898
Adverse event 150.36 14.17 170 50515 39319 64408728
Inappropriate schedule of product administration 149.99 14.17 264 50421 92022 64356025
Fulminant type 1 diabetes mellitus 138.53 14.17 46 50639 1034 64447013
Pemphigoid 133.97 14.17 98 50587 12888 64435159
Nephritis 128.45 14.17 61 50624 3585 64444462
Drug interaction 122.57 14.17 66 50619 362017 64086030
Hepatic function abnormal 121.76 14.17 197 50488 64116 64383931
Product use issue 120.56 14.17 325 50360 151390 64296657
Secondary adrenocortical insufficiency 120.22 14.17 51 50634 2294 64445753
Diabetic ketoacidosis 119.64 14.17 132 50553 29713 64418334
Tumour hyperprogression 118.62 14.17 27 50658 130 64447917
Autoimmune thyroiditis 118.13 14.17 57 50628 3471 64444576
Fall 118.01 14.17 93 50592 416733 64031314
Neoplasm progression 116.27 14.17 152 50533 40812 64407235
Immune-mediated renal disorder 114.00 14.17 22 50663 36 64448011
Immune-mediated gastritis 111.82 14.17 20 50665 15 64448032
Drug hypersensitivity 105.98 14.17 28 50657 237787 64210260
Headache 103.81 14.17 160 50525 529307 63918740
Polymyalgia rheumatica 102.68 14.17 51 50634 3308 64444739
Autoimmune arthritis 96.64 14.17 22 50663 106 64447941
Lichenoid keratosis 94.23 14.17 48 50637 3286 64444761
Overdose 92.82 14.17 9 50676 159557 64288490
Immune thrombocytopenia 92.48 14.17 84 50601 14982 64433065
Immune-mediated nephritis 92.26 14.17 25 50660 270 64447777
Hypopituitarism 91.97 14.17 44 50641 2629 64445418
Joint swelling 91.07 14.17 28 50657 215354 64232693
Cholangitis sclerosing 86.14 14.17 38 50647 1881 64446166
Dizziness 84.23 14.17 130 50555 430033 64018014
Immune-mediated endocrinopathy 81.37 14.17 15 50670 16 64448031
Cholangitis 79.94 14.17 67 50618 10735 64437312
Lymphocytic hypophysitis 79.78 14.17 24 50661 386 64447661
Pleural effusion 79.20 14.17 249 50436 126310 64321737
Nasopharyngitis 78.49 14.17 28 50657 196045 64252002
Drug ineffective 75.67 14.17 372 50313 839875 63608172
Autoimmune pancreatitis 74.99 14.17 25 50660 569 64447478
Toxicity to various agents 73.91 14.17 107 50578 363406 64084641
Myasthenic syndrome 72.97 14.17 25 50660 620 64447427
Hepatocellular injury 71.62 14.17 128 50557 45107 64402940
Injection site pain 71.27 14.17 4 50681 111404 64336643
Skin toxicity 70.77 14.17 51 50634 6551 64441496
Hypersensitivity 70.61 14.17 33 50652 196419 64251628
Eyelid ptosis 70.33 14.17 59 50626 9466 64438581
Eastern Cooperative Oncology Group performance status worsened 70.21 14.17 29 50656 1219 64446828
Subacute cutaneous lupus erythematosus 69.71 14.17 38 50647 2987 64445060
Hepatotoxicity 69.68 14.17 118 50567 39844 64408203
Metastases to central nervous system 69.09 14.17 69 50616 13843 64434204
Immune-mediated cholangitis 67.34 14.17 16 50669 96 64447951
Haemophagocytic lymphohistiocytosis 67.33 14.17 76 50609 17533 64430514
Immune-mediated hypophysitis 66.97 14.17 14 50671 41 64448006
Eosinophilic fasciitis 66.80 14.17 18 50667 190 64447857
Autoimmune myocarditis 66.48 14.17 19 50666 253 64447794
Decreased appetite 65.94 14.17 412 50273 280877 64167170
Immune-mediated encephalitis 65.54 14.17 19 50666 267 64447780
Drug intolerance 63.91 14.17 34 50651 187958 64260089
Organising pneumonia 62.58 14.17 54 50631 9001 64439046
Toxic epidermal necrolysis 62.51 14.17 108 50577 37058 64410989
Abdominal discomfort 61.94 14.17 33 50652 182289 64265758
Sinusitis 61.61 14.17 19 50666 145909 64302138
Myelosuppression 60.84 14.17 84 50601 23746 64424301
Pain 59.47 14.17 229 50456 553282 63894765
Immune-mediated hyperthyroidism 58.79 14.17 12 50673 30 64448017
Intentional overdose 58.25 14.17 3 50682 89941 64358106
Pyrexia 57.59 14.17 681 50004 557963 63890084
Diarrhoea 57.45 14.17 840 49845 721864 63726183
Autoimmune nephritis 57.24 14.17 20 50665 527 64447520
Condition aggravated 55.82 14.17 132 50553 372294 64075753
Blood thyroid stimulating hormone increased 55.66 14.17 47 50638 7607 64440440
Immune-mediated uveitis 53.75 14.17 11 50674 28 64448019
Immune-mediated cytopenia 53.47 14.17 11 50674 29 64448018
Transaminases increased 53.24 14.17 112 50573 44482 64403565
Pneumonia bacterial 52.62 14.17 62 50623 14973 64433074
Arthropathy 52.43 14.17 15 50670 120952 64327095
Pericarditis malignant 48.99 14.17 10 50675 25 64448022
Pericardial effusion 48.51 14.17 100 50585 39154 64408893
Radiation pneumonitis 48.28 14.17 31 50654 3297 64444750
Enteritis 47.67 14.17 53 50632 12024 64436023
Swelling 47.48 14.17 34 50651 160184 64287863
Pulmonary toxicity 47.26 14.17 45 50640 8516 64439531
Encephalitis autoimmune 47.15 14.17 25 50660 1859 64446188
Rash maculo-papular 47.00 14.17 110 50575 46916 64401131
Therapeutic product effect decreased 46.95 14.17 16 50669 115335 64332712
Respiratory failure 46.12 14.17 249 50436 160934 64287113
Maternal exposure during pregnancy 45.20 14.17 10 50675 95874 64352173
Lichen planus 44.84 14.17 26 50659 2302 64445745
Depression 44.49 14.17 47 50638 183244 64264803
Peripheral swelling 44.00 14.17 60 50625 209093 64238954
Silent thyroiditis 43.36 14.17 12 50673 141 64447906
Pain in extremity 43.36 14.17 110 50575 302975 64145072
Metastatic malignant melanoma 42.73 14.17 26 50659 2515 64445532
Contusion 42.73 14.17 18 50667 113947 64334100
Insomnia 42.38 14.17 56 50629 197780 64250267
Musculoskeletal stiffness 42.28 14.17 22 50663 123184 64324863
Intentional product misuse 42.23 14.17 4 50681 72291 64375756
Thrombocytopenia 41.77 14.17 310 50375 223491 64224556
Hypothalamo-pituitary disorder 41.53 14.17 19 50666 1025 64447022
Tumour associated fever 41.42 14.17 16 50669 563 64447484
Lung disorder 41.27 14.17 123 50562 60577 64387470
Encephalitis 40.98 14.17 50 50635 12521 64435526
Suicidal ideation 40.74 14.17 3 50682 66539 64381508
Drug effective for unapproved indication 40.56 14.17 29 50656 3679 64444368
Uveitis 40.54 14.17 50 50635 12658 64435389
Stevens-Johnson syndrome 38.55 14.17 84 50601 34165 64413882
Alopecia 38.54 14.17 44 50641 165646 64282401
Immune-mediated neuropathy 38.38 14.17 8 50677 23 64448024
Synovitis 38.20 14.17 15 50670 99075 64348972
Meningitis aseptic 37.24 14.17 33 50652 5697 64442350
Loss of consciousness 37.19 14.17 37 50648 148328 64299719
Neutropenia 37.10 14.17 318 50367 239306 64208741
Acute kidney injury 37.07 14.17 526 50159 448714 63999333
Autoimmune endocrine disorder 36.90 14.17 6 50679 0 64448047
Glossodynia 36.69 14.17 4 50681 64692 64383355
Mobility decreased 36.54 14.17 11 50674 85829 64362218
Blood corticotrophin decreased 36.32 14.17 13 50672 368 64447679
Mucosal inflammation 36.27 14.17 120 50565 62464 64385583
International normalised ratio increased 35.84 14.17 9 50676 79158 64368889
Primary hypothyroidism 35.72 14.17 10 50675 123 64447924
Latent autoimmune diabetes in adults 35.63 14.17 9 50676 72 64447975
Muscle spasms 35.54 14.17 35 50650 140988 64307059
Autoimmune uveitis 35.37 14.17 7 50678 14 64448033
Liver disorder 35.22 14.17 107 50578 53244 64394803
Tumour haemorrhage 35.21 14.17 26 50659 3467 64444580
Hospitalisation 35.13 14.17 8 50677 75199 64372848
Glucocorticoid deficiency 34.98 14.17 14 50671 542 64447505
Autoimmune haemolytic anaemia 34.96 14.17 35 50650 7041 64441006
Cutaneous sarcoidosis 34.85 14.17 13 50672 415 64447632
Guillain-Barre syndrome 34.51 14.17 36 50649 7599 64440448
Urticaria 34.39 14.17 39 50646 147278 64300769
Blood thyroid stimulating hormone abnormal 34.22 14.17 15 50670 731 64447316
Asthma 34.18 14.17 16 50669 95209 64352838
Lymphangiosis carcinomatosa 34.18 14.17 20 50665 1801 64446246
Weight increased 34.05 14.17 73 50612 213275 64234772
Ophthalmoplegia 33.93 14.17 23 50662 2679 64445368
Tremor 33.79 14.17 40 50645 148190 64299857
Paraneoplastic neurological syndrome 33.25 14.17 8 50677 51 64447996
Hypertransaminasaemia 32.67 14.17 34 50651 7157 64440890
Diabetes mellitus 32.09 14.17 120 50565 66354 64381693
Drug-induced liver injury 31.87 14.17 96 50589 47547 64400500
Discomfort 31.58 14.17 12 50673 80866 64367181
Pulmonary embolism 31.54 14.17 210 50475 146146 64301901
Cholestasis 31.52 14.17 92 50593 44780 64403267
Chest discomfort 31.40 14.17 27 50658 116079 64331968
Systemic lupus erythematosus 31.17 14.17 11 50674 77601 64370446
Blood pressure abnormal 31.17 14.17 47 50638 14388 64433659
Pulmonary sarcoidosis 31.14 14.17 16 50669 1115 64446932
Adrenal disorder 30.96 14.17 18 50667 1602 64446445
Wound 30.44 14.17 11 50674 76466 64371581
Bradycardia 30.18 14.17 29 50656 118190 64329857
Malignant pleural effusion 29.72 14.17 22 50663 2945 64445102
Loss of personal independence in daily activities 29.57 14.17 10 50675 72444 64375603
Cardiac failure congestive 28.95 14.17 36 50649 130544 64317503
Serous retinal detachment 28.70 14.17 13 50672 685 64447362
Blood cholesterol increased 28.64 14.17 3 50682 50063 64397984
Cancer pain 28.63 14.17 25 50660 4232 64443815
Migraine 28.61 14.17 7 50678 62670 64385377
Palmar-plantar erythrodysaesthesia syndrome 28.34 14.17 67 50618 28752 64419295
Coma 28.10 14.17 17 50668 87598 64360449
Immune-mediated encephalopathy 27.89 14.17 6 50679 21 64448026
Rash 27.72 14.17 510 50175 458039 63990008
Melanoma recurrent 27.63 14.17 9 50676 190 64447857
Bronchitis 27.38 14.17 27 50658 108716 64339331
Stress 27.17 14.17 7 50678 60527 64387520
Renal tubular necrosis 26.93 14.17 56 50629 22054 64425993
Mixed liver injury 26.87 14.17 27 50658 5454 64442593
Adrenalitis 26.51 14.17 6 50679 28 64448019
Unevaluable event 26.51 14.17 4 50681 50485 64397562
Hypotension 26.44 14.17 183 50502 380791 64067256
Cardiac arrest 26.03 14.17 51 50634 154013 64294034
Optic neuritis 26.00 14.17 32 50653 8084 64439963
Syncope 25.93 14.17 53 50632 157582 64290465
Aggression 25.86 14.17 3 50682 46229 64401818
Agitation 25.84 14.17 19 50666 88348 64359699
Myasthenia gravis crisis 25.78 14.17 13 50672 871 64447176
Cytokine release syndrome 25.65 14.17 53 50632 20776 64427271
Pneumothorax 25.55 14.17 58 50627 24240 64423807
Autoimmune disorder 25.53 14.17 27 50658 5789 64442258
Haemoglobin decreased 25.46 14.17 74 50611 194989 64253058
Amputation stump pain 25.11 14.17 6 50679 37 64448010
Influenza 25.08 14.17 28 50657 106503 64341544
Hallucination 24.96 14.17 13 50672 72775 64375272
Immunisation reaction 24.84 14.17 6 50679 39 64448008
Nasal congestion 24.75 14.17 8 50677 59650 64388397
Pancreatic failure 24.71 14.17 15 50670 1445 64446602
Diffuse uveal melanocytic proliferation 24.60 14.17 4 50681 0 64448047
Immune-mediated neurological disorder 24.60 14.17 4 50681 0 64448047
Autoimmune dermatitis 24.45 14.17 6 50679 42 64448005
Polyarthritis 24.43 14.17 34 50651 9681 64438366
Heart rate increased 24.27 14.17 25 50660 98650 64349397
Cardiac tamponade 24.26 14.17 31 50654 8133 64439914
Hepatitis toxic 24.04 14.17 23 50662 4377 64443670
Tumour pain 23.19 14.17 16 50669 1917 64446130
Immune-mediated adrenal insuficiency 23.13 14.17 5 50680 18 64448029
Neurofibrosarcoma 23.10 14.17 8 50677 205 64447842
Atrioventricular block complete 23.07 14.17 41 50644 14377 64433670
Amylase increased 23.03 14.17 33 50652 9652 64438395
Large intestine perforation 23.01 14.17 38 50647 12566 64435481
Thyroid hormones increased 22.77 14.17 9 50676 337 64447710
Thyroid disorder 22.36 14.17 36 50649 11656 64436391
Dermatitis 22.35 14.17 46 50639 17983 64430064
EGFR gene mutation 22.33 14.17 9 50676 355 64447692
Duodenitis 22.28 14.17 27 50658 6714 64441333
Blood bilirubin increased 22.27 14.17 97 50588 57456 64390591
Dysphagia 22.24 14.17 152 50533 106660 64341387
Anxiety 22.22 14.17 83 50602 202566 64245481
Electrocardiogram QT prolonged 22.07 14.17 18 50667 79430 64368617
Aspartate aminotransferase increased 21.79 14.17 165 50520 119623 64328424
Heart rate decreased 21.78 14.17 8 50677 55059 64392988
Thyroid function test abnormal 21.60 14.17 18 50667 2861 64445186
Pulmonary granuloma 21.55 14.17 15 50670 1824 64446223
Haematoma 21.44 14.17 5 50680 46245 64401802
Therapeutic product effect incomplete 21.43 14.17 30 50655 103452 64344595
Hyperhidrosis 21.40 14.17 41 50644 124879 64323168
Cachexia 21.32 14.17 31 50654 9186 64438861
Vanishing bile duct syndrome 21.30 14.17 13 50672 1264 64446783
Adrenocortical insufficiency acute 21.27 14.17 17 50668 2548 64445499
Alanine aminotransferase increased 21.22 14.17 184 50501 138847 64309200
Oligodipsia 21.19 14.17 5 50680 29 64448018
Small intestinal perforation 21.18 14.17 17 50668 2563 64445484
Palpitations 20.94 14.17 31 50654 104457 64343590
Autoimmune neuropathy 20.92 14.17 6 50679 81 64447966
Upper respiratory tract infection 20.83 14.17 16 50669 72769 64375278
Radiation associated pain 20.78 14.17 6 50679 83 64447964
Taste disorder 20.77 14.17 31 50654 9402 64438645
Vital functions abnormal 20.75 14.17 10 50675 607 64447440
Blood thyroid stimulating hormone decreased 20.72 14.17 23 50662 5207 64442840
Osteoarthritis 20.72 14.17 12 50673 63324 64384723
Gait disturbance 20.55 14.17 68 50617 172087 64275960
Gastrooesophageal reflux disease 20.52 14.17 21 50664 83122 64364925
Autoimmune encephalopathy 20.46 14.17 6 50679 88 64447959
Cortisol decreased 20.40 14.17 14 50671 1663 64446384
Enterocolitis 20.30 14.17 35 50650 11983 64436064
Renal impairment 20.25 14.17 178 50507 134839 64313208
Hypoaesthesia 20.24 14.17 50 50635 139058 64308989
Autoimmune cholangitis 20.21 14.17 4 50681 8 64448039
Burning sensation 20.01 14.17 7 50678 49657 64398390
Tumour ulceration 19.91 14.17 7 50678 188 64447859
Hypersensitivity pneumonitis 19.79 14.17 18 50667 3214 64444833
Anaphylactic reaction 19.77 14.17 15 50670 68649 64379398
Paraneoplastic syndrome 19.75 14.17 11 50674 902 64447145
BRAF V600E mutation positive 19.68 14.17 5 50680 41 64448006
Depressed level of consciousness 19.61 14.17 21 50664 81415 64366632
Rheumatoid arthritis 19.54 14.17 65 50620 164229 64283818
Pancytopenia 19.50 14.17 185 50500 143124 64304923
Sarcoidosis 19.31 14.17 24 50661 6122 64441925
Haemoptysis 19.23 14.17 83 50602 48965 64399082
Systemic scleroderma 19.20 14.17 11 50674 952 64447095
Feeling hot 19.16 14.17 6 50679 45657 64402390
Transitional cell carcinoma recurrent 19.06 14.17 4 50681 12 64448035
Impaired healing 19.02 14.17 12 50673 60461 64387586
Wrong technique in product usage process 18.96 14.17 14 50671 64960 64383087
Drug eruption 18.93 14.17 67 50618 36069 64411978
Respiratory arrest 18.86 14.17 9 50676 52976 64395071
Serotonin syndrome 18.70 14.17 4 50681 39278 64408769
General physical health deterioration 18.70 14.17 244 50441 204181 64243866
Colitis microscopic 18.67 14.17 26 50659 7406 64440641
Bacterial diarrhoea 18.63 14.17 6 50679 122 64447925
Cholecystitis 18.60 14.17 45 50640 19591 64428456
Primary biliary cholangitis 18.60 14.17 11 50674 1010 64447037
Fluid retention 18.51 14.17 12 50673 59594 64388453
Gastrointestinal tube removal 18.45 14.17 3 50682 0 64448047
Swelling face 18.25 14.17 12 50673 59154 64388893
Blood pressure systolic increased 18.23 14.17 8 50677 49445 64398602
Lactic acidosis 18.22 14.17 13 50672 61397 64386650
Oropharyngeal pain 18.17 14.17 26 50659 88841 64359206
Ageusia 18.02 14.17 36 50649 13777 64434270
Multiple sclerosis relapse 18 14.17 5 50680 41130 64406917
Granulocyte count increased 18.00 14.17 10 50675 816 64447231
Dermatomyositis 17.92 14.17 16 50669 2790 64445257
Pain in jaw 17.75 14.17 5 50680 40750 64407297
Rash morbilliform 17.66 14.17 21 50664 5120 64442927
Cheilitis 17.63 14.17 20 50665 4636 64443411
Paraesthesia 17.57 14.17 51 50634 134471 64313576
Intentional product use issue 17.50 14.17 30 50655 95334 64352713
Myocardial infarction 17.48 14.17 69 50616 165752 64282295
Antinuclear antibody 17.31 14.17 8 50677 442 64447605
Somnolence 17.15 14.17 92 50593 203553 64244494
Abdominal pain upper 17.10 14.17 75 50610 174955 64273092
Angina pectoris 17.08 14.17 7 50678 45074 64402973
Lymphadenopathy mediastinal 17.03 14.17 18 50667 3858 64444189
Infusion related reaction 16.98 14.17 69 50616 164398 64283649
Keratoacanthoma 16.97 14.17 10 50675 912 64447135
Abdominal distension 16.89 14.17 31 50654 95963 64352084
Dyskinesia 16.84 14.17 5 50680 39383 64408664
Neutrophil count decreased 16.75 14.17 111 50574 77085 64370962
Autoimmune myositis 16.47 14.17 6 50679 179 64447868
Radiation necrosis 16.29 14.17 7 50678 325 64447722
Lung opacity 16.13 14.17 16 50669 3183 64444864
Acquired gene mutation 16.12 14.17 13 50672 1973 64446074
Treatment noncompliance 16.08 14.17 7 50678 43475 64404572
Chronic gastritis 15.96 14.17 16 50669 3224 64444823
Polyglandular autoimmune syndrome type II 15.95 14.17 4 50681 31 64448016
Cardiomyopathy 15.94 14.17 50 50635 25306 64422741
Urogenital fistula 15.89 14.17 5 50680 94 64447953
Pulmonary hypertension 15.87 14.17 7 50678 43132 64404915
Lipase increased 15.84 14.17 35 50650 14367 64433680
Vogt-Koyanagi-Harada disease 15.75 14.17 6 50679 203 64447844
Tumour rupture 15.73 14.17 7 50678 354 64447693
Infectious pleural effusion 15.71 14.17 15 50670 2847 64445200
Circumstance or information capable of leading to medication error 15.55 14.17 16 50669 3324 64444723
Adenocarcinoma 15.51 14.17 16 50669 3335 64444712
Treatment failure 15.46 14.17 44 50641 116772 64331275
Restlessness 15.37 14.17 6 50679 39779 64408268
Troponin increased 15.36 14.17 36 50649 15363 64432684
Acute polyneuropathy 15.29 14.17 7 50678 378 64447669
Hepatic cytolysis 15.29 14.17 34 50651 14015 64434032
Rash pruritic 15.27 14.17 87 50598 57317 64390730
Dermatitis psoriasiform 15.24 14.17 13 50672 2133 64445914
Neuritis cranial 15.16 14.17 3 50682 6 64448041
Stoma site dermatitis 15.16 14.17 3 50682 6 64448041
Weight fluctuation 15.16 14.17 25 50660 8257 64439790
Disorientation 15.07 14.17 13 50672 55815 64392232
Parathyroid tumour malignant 15.04 14.17 4 50681 40 64448007
Morphoea 14.94 14.17 7 50678 399 64447648
Scleroderma-like reaction 14.87 14.17 5 50680 117 64447930
Sedation 14.82 14.17 7 50678 41455 64406592
Nephrolithiasis 14.68 14.17 8 50677 43675 64404372
Hyperglycaemia 14.67 14.17 90 50595 60878 64387169
Lower respiratory tract infection 14.56 14.17 33 50652 94581 64353466
Melanosis 14.53 14.17 4 50681 46 64448001
Dry mouth 14.42 14.17 89 50596 60329 64387718
Intestinal perforation 14.41 14.17 35 50650 15278 64432769
Infusion site haemorrhage 14.39 14.17 13 50672 2302 64445745
Ketoacidosis 14.33 14.17 22 50663 6841 64441206
Lymph node abscess 14.30 14.17 4 50681 49 64447998
Limbic encephalitis 14.28 14.17 8 50677 663 64447384
Seizure 14.27 14.17 75 50610 166817 64281230
Metabolic acidosis 14.27 14.17 21 50664 70937 64377110
Product quality issue 14.26 14.17 3 50682 29796 64418251
Wheezing 14.19 14.17 26 50659 80553 64367494

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FF02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000082082 Immune Checkpoint Inhibitors
FDA MoA N0000191259 Programmed Death Receptor-1-directed Antibody Interactions
FDA EPC N0000191260 Programmed Death Receptor-1 Blocking Antibody

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

DiseaseRelationSNOMED_IDDOID
Unresectable urothelial carcinoma indication 27090000 DOID:2671
Non-small cell lung cancer indication 254637007 DOID:3908
Endometrial carcinoma progressing after chemotherapy indication 254878006 DOID:2871
Malignant tumor of head and/or neck indication 255056009
Squamous cell carcinoma of esophagus indication 276804009 DOID:3748
Metastatic malignant melanoma indication 443493003
Metastatic renal cell carcinoma indication 702392008
Triple negative breast neoplasms indication 706970001
Microsatellite instability-high colorectal cancer indication 737058005
Classical Hodgkin lymphoma indication 762690000




🐶 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 10 IUPHAR DRUG LABEL

External reference:

IDSource
D10574 KEGG_DRUG
4033703 VUID
N0000191088 NUI
4033703 VANDF
CHEMBL3137343 ChEMBL_ID
C582435 MESH_SUPPLEMENTAL_RECORD_UI
7499 IUPHAR_LIGAND_ID
9798 INN_ID
DB09037 DRUGBANK_ID
DPT0O3T46P UNII
1547545 RXNORM
228586 MMSL
30533 MMSL
d08287 MMSL
015666 NDDF
716125002 SNOMEDCT_US
763541003 SNOMEDCT_US
C3658706 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 29 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 29 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 29 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 29 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 29 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 29 sections