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

Stem definitionDrug idCAS RN
humanized origin 5151 1380723-44-3

Description:

MoleculeDescription

Synonyms:

  • atezolizumab
  • tecentriq
  • RG7446
  • MPDL3280A
  • atezolizumab (genetical recombination)
A monoclonal antibody that targets programmed death-ligand 1 (CD274 ANTIGEN) and is used to treat urothelial carcinoma, the most common type of bladder cancer.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
57.10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Jan. 19, 2018 PMDA Chugai Pharmaceutical Co., Ltd.
May 18, 2016 FDA GENENTECH INC
Sept. 20, 2017 EMA Roche Registration GmbH

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
Disease progression 787.14 25.85 523 26742 156092 90445090
Hypothyroidism 644.66 25.85 316 26949 52811 90548371
Pneumonitis 548.57 25.85 267 26998 43903 90557279
Death 491.63 25.85 643 26622 455908 90145274
Febrile neutropenia 433.89 25.85 368 26897 157981 90443201
Anaemia 417.24 25.85 521 26744 352281 90248901
Neutrophil count decreased 368.47 25.85 243 27022 71289 90529893
Hyperthyroidism 331.81 25.85 144 27121 18166 90583016
Colitis 243.07 25.85 187 27078 69755 90531427
Interstitial lung disease 241.18 25.85 193 27072 76212 90524970
Myocarditis 232.04 25.85 103 27162 13703 90587479
Pyrexia 211.98 25.85 551 26714 659934 89941248
Neutropenia 194.80 25.85 286 26979 224618 90376564
Platelet count decreased 181.95 25.85 215 27050 136754 90464428
Immune-mediated hepatitis 181.32 25.85 57 27208 2887 90598295
Metastases to central nervous system 179.25 25.85 93 27172 17449 90583733
Adrenal insufficiency 177.04 25.85 111 27154 29810 90571372
Encephalitis 161.59 25.85 75 27190 11059 90590123
Hepatic function abnormal 161.28 25.85 124 27141 46164 90555018
Immune-mediated enterocolitis 158.21 25.85 58 27207 4699 90596483
Type 1 diabetes mellitus 150.21 25.85 56 27209 4756 90596426
Neutropenic sepsis 148.53 25.85 83 27182 18047 90583135
Thrombocytopenia 146.51 25.85 241 27024 208484 90392698
Proteinuria 139.28 25.85 87 27178 23204 90577978
Off label use 137.13 25.85 673 26592 1101579 89499603
Hypokalaemia 127.01 25.85 176 27089 130940 90470242
Joint swelling 126.43 25.85 6 27259 503294 90097888
Neuropathy peripheral 121.07 25.85 176 27089 136794 90464388
Pain 119.01 25.85 77 27188 996264 89604918
Hepatic failure 118.19 25.85 97 27168 39631 90561551
Drug intolerance 113.50 25.85 5 27260 447586 90153596
Mucosal inflammation 110.74 25.85 110 27155 57515 90543667
Ascites 106.62 25.85 99 27166 47641 90553541
Enterocolitis 105.40 25.85 55 27210 10435 90590747
Swelling 105.20 25.85 5 27260 419053 90182129
Thyroiditis 105.08 25.85 40 27225 3597 90597585
Embolism 104.77 25.85 53 27212 9428 90591754
Abdominal discomfort 104.66 25.85 11 27254 477317 90123865
Lymphocyte count decreased 103.05 25.85 85 27180 34965 90566217
Aspartate aminotransferase increased 102.40 25.85 140 27125 102797 90498385
Sepsis 101.87 25.85 189 27076 179625 90421557
Skin candida 100.14 25.85 32 27233 1709 90599473
Alanine aminotransferase increased 98.71 25.85 148 27117 118190 90482992
Rash maculo-papular 95.51 25.85 87 27178 40846 90560336
Cytokine release syndrome 95.37 25.85 74 27191 27899 90573283
Encephalitis autoimmune 90.95 25.85 31 27234 2027 90599155
Metastases to meninges 86.50 25.85 35 27230 3700 90597482
Systemic immune activation 86.14 25.85 16 27249 74 90601108
Metastases to liver 84.97 25.85 70 27195 28737 90572445
Weight increased 83.47 25.85 13 27252 417914 90183268
Drug ineffective 82.34 25.85 185 27080 1384113 89217069
Maternal exposure during pregnancy 82.34 25.85 7 27258 360056 90241126
Pleural effusion 80.76 25.85 131 27134 111860 90489322
White blood cell count decreased 80.42 25.85 164 27101 166945 90434237
Hyponatraemia 80.20 25.85 144 27121 133394 90467788
Fulminant type 1 diabetes mellitus 80.01 25.85 23 27242 855 90600327
Drug hypersensitivity 78.97 25.85 21 27244 463588 90137594
Autoimmune haemolytic anaemia 78.73 25.85 37 27228 5608 90595574
Constipation 76.55 25.85 221 27044 280174 90321008
Immune-mediated encephalitis 76.54 25.85 20 27245 517 90600665
Hypomagnesaemia 76.00 25.85 72 27193 35516 90565666
Autoimmune hepatitis 75.67 25.85 44 27221 10307 90590875
Myasthenia gravis 74.97 25.85 38 27227 6787 90594395
Product dose omission issue 74.76 25.85 3 27262 291684 90309498
Arthropathy 74.02 25.85 11 27254 366231 90234951
Cholangitis 73.14 25.85 38 27227 7144 90594038
Musculoskeletal stiffness 72.92 25.85 4 27261 296528 90304654
Pancytopenia 72.61 25.85 130 27135 120133 90481049
Treatment failure 72.04 25.85 5 27260 303923 90297259
Diarrhoea 70.55 25.85 503 26762 938687 89662495
Nasopharyngitis 70.16 25.85 18 27247 407086 90194096
Metastases to bone 69.07 25.85 59 27206 25446 90575736
Malignant neoplasm progression 69.02 25.85 119 27146 106751 90494431
Rheumatoid arthritis 68.61 25.85 13 27252 362601 90238581
Hyperglycaemia 67.57 25.85 80 27185 50890 90550292
Hepatitis 67.01 25.85 94 27171 70645 90530537
Peripheral sensory neuropathy 66.77 25.85 39 27226 9211 90591971
Myositis 65.72 25.85 56 27209 24072 90577110
Tubulointerstitial nephritis 65.34 25.85 57 27208 25286 90575896
Adrenocorticotropic hormone deficiency 65.02 25.85 19 27246 749 90600433
Drug interaction 64.22 25.85 5 27260 276448 90324734
Decreased appetite 63.93 25.85 253 27012 376287 90224895
Immune-mediated lung disease 62.80 25.85 23 27242 1857 90599325
Small intestinal obstruction 61.37 25.85 51 27214 21183 90579999
Haemophagocytic lymphohistiocytosis 59.55 25.85 44 27221 15415 90585767
Peripheral swelling 59.37 25.85 25 27240 413081 90188101
Encephalopathy 58.45 25.85 71 27194 46373 90554809
Therapy partial responder 57.68 25.85 50 27215 21993 90579189
Mobility decreased 56.95 25.85 5 27260 250729 90350453
Meningitis 56.62 25.85 34 27231 8447 90592735
Paraneoplastic neurological syndrome 56.06 25.85 10 27255 35 90601147
Sinusitis 55.69 25.85 17 27248 343071 90258111
Guillain-Barre syndrome 54.55 25.85 27 27238 4585 90596597
Blister 53.05 25.85 7 27258 254991 90346191
Neoplasm progression 52.75 25.85 66 27199 44420 90556762
Product use issue 52.38 25.85 17 27248 329902 90271280
Impaired healing 52.31 25.85 5 27260 234194 90366988
Condition aggravated 50.57 25.85 63 27202 595482 90005700
Blood cholesterol increased 50.53 25.85 3 27262 208009 90393173
Hypopituitarism 49.64 25.85 19 27246 1734 90599448
Urticaria 48.11 25.85 17 27248 312717 90288465
Nephritis 47.84 25.85 22 27243 3173 90598009
Skin toxicity 47.40 25.85 28 27237 6751 90594431
Nervous system disorder 46.69 25.85 44 27221 21549 90579633
Folliculitis 46.61 25.85 4 27261 204349 90396833
Contusion 45.43 25.85 10 27255 251206 90349976
Cholangitis sclerosing 45.28 25.85 19 27246 2202 90598980
Insomnia 45.05 25.85 22 27243 333452 90267730
Myelosuppression 44.61 25.85 67 27198 53524 90547658
Hypoxia 43.34 25.85 78 27187 72321 90528861
Acute kidney injury 43.31 25.85 201 27064 320186 90280996
Asthma 43.07 25.85 10 27255 242150 90359032
Tumour hyperprogression 42.75 25.85 10 27255 161 90601021
Hydronephrosis 42.68 25.85 33 27232 12369 90588813
Wheezing 42.01 25.85 10 27255 238070 90363112
Hypersensitivity 41.91 25.85 45 27220 454632 90146550
Hepatic encephalopathy 41.73 25.85 34 27231 13738 90587444
Osteoarthritis 41.61 25.85 5 27260 195725 90405457
Peripheral motor neuropathy 40.63 25.85 17 27248 1956 90599226
Oligoastrocytoma 40.07 25.85 7 27258 21 90601161
Metastases to lymph nodes 40.00 25.85 31 27234 11658 90589524
Immune-mediated myocarditis 39.82 25.85 15 27250 1310 90599872
Tumour haemorrhage 39.66 25.85 17 27248 2077 90599105
Pericardial effusion 39.50 25.85 52 27213 36781 90564401
Immune-mediated pancreatitis 39.41 25.85 11 27254 367 90600815
Dehydration 39.05 25.85 138 27127 194309 90406873
Toxicity to various agents 38.86 25.85 19 27246 287827 90313355
Erythema multiforme 38.73 25.85 31 27234 12215 90588967
Migraine 37.79 25.85 6 27259 190386 90410796
Activated PI3 kinase delta syndrome 37.72 25.85 8 27257 80 90601102
Adrenal disorder 37.65 25.85 16 27249 1914 90599268
Troponin increased 36.52 25.85 31 27234 13250 90587932
Amylase increased 36.29 25.85 24 27241 7048 90594134
Tumour inflammation 36.16 25.85 8 27257 99 90601083
Intentional product use issue 36.15 25.85 145 27120 216747 90384435
Transaminases increased 36.07 25.85 50 27215 37142 90564040
Metastases to lung 35.37 25.85 33 27232 15958 90585224
Small cell lung cancer 35.18 25.85 15 27250 1809 90599373
Diabetic ketoacidosis 35.17 25.85 40 27225 24367 90576815
Hepatic enzyme increased 35.17 25.85 34 27231 360702 90240480
Radiation pneumonitis 34.91 25.85 15 27250 1843 90599339
Palmar-plantar erythrodysaesthesia syndrome 33.90 25.85 42 27223 27981 90573201
Respiratory failure 33.87 25.85 95 27170 118323 90482859
Autoimmune nephritis 33.79 25.85 10 27255 412 90600770
Lichenoid keratosis 33.47 25.85 16 27249 2518 90598664
Pulmonary embolism 32.68 25.85 100 27165 130720 90470462
Blood creatinine increased 32.67 25.85 85 27180 101301 90499881
Musculoskeletal pain 32.66 25.85 6 27259 171245 90429937
Muscle spasms 31.97 25.85 18 27247 251865 90349317
Pericarditis 31.92 25.85 21 27244 270130 90331052
Polyneuropathy 31.85 25.85 34 27231 19307 90581875
Gastrointestinal disorder 31.64 25.85 19 27246 256668 90344514
Memory impairment 31.58 25.85 10 27255 197234 90403948
Hepatobiliary disease 31.47 25.85 10 27255 524 90600658
Drug-induced liver injury 31.47 25.85 78 27187 90240 90510942
Autoimmune colitis 31.46 25.85 11 27254 776 90600406
Hypophysitis 30.54 25.85 15 27250 2505 90598677
Enterocolitis infectious 30.35 25.85 14 27251 2033 90599149
Thrombotic microangiopathy 30.13 25.85 30 27235 15713 90585469
Gastrooesophageal reflux disease 29.31 25.85 7 27258 166330 90434852
Hepatic haemorrhage 29.30 25.85 10 27255 656 90600526
Inappropriate schedule of product administration 29.14 25.85 5 27260 149928 90451254
Arthralgia 29.08 25.85 128 27137 778394 89822788
Blood bilirubin increased 28.83 25.85 49 27216 43421 90557761
Autoimmune hypothyroidism 28.35 25.85 8 27257 278 90600904
Hepatotoxicity 28.22 25.85 50 27215 45792 90555390
Hospitalisation 27.90 25.85 3 27262 128097 90473085
Portal vein thrombosis 27.43 25.85 15 27250 3123 90598059
Metastases to pleura 27.28 25.85 13 27252 2031 90599151
Immune thrombocytopenia 26.63 25.85 26 27239 13300 90587882
Pulmonary toxicity 25.90 25.85 24 27241 11507 90589675

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
Disease progression 901.59 18.54 873 39013 142783 42438666
Hypothyroidism 499.42 18.54 333 39553 31751 42549698
Adrenal insufficiency 443.54 18.54 255 39631 18669 42562780
Proteinuria 440.46 18.54 272 39614 22711 42558738
Interstitial lung disease 410.39 18.54 433 39453 78029 42503420
Off label use 390.17 18.54 1391 38495 636944 41944505
Pneumonitis 380.62 18.54 314 39572 41404 42540045
Oesophageal varices haemorrhage 351.86 18.54 131 39755 3476 42577973
Death 297.02 18.54 1039 38847 470146 42111303
Hyperthyroidism 277.91 18.54 171 39715 14170 42567279
Ascites 275.37 18.54 301 39585 56377 42525072
Tumour haemorrhage 265.45 18.54 107 39779 3531 42577918
Colitis 237.86 18.54 254 39632 46318 42535131
Myocarditis 230.12 18.54 169 39717 18769 42562680
Hepatic function abnormal 230.08 18.54 262 39624 51305 42530144
Drug interaction 196.22 18.54 14 39872 266985 42314464
Encephalitis 187.14 18.54 113 39773 9045 42572404
Myositis 185.89 18.54 135 39751 14731 42566718
Immune-mediated enterocolitis 184.37 18.54 95 39791 5582 42575867
Myelosuppression 181.16 18.54 206 39680 40255 42541194
Metastases to central nervous system 159.79 18.54 107 39779 10248 42571201
Neutrophil count decreased 159.32 18.54 243 39643 63172 42518277
Liver disorder 143.22 18.54 181 39705 39463 42541986
Toxicity to various agents 138.33 18.54 24 39862 229112 42352337
Hepatic failure 137.72 18.54 174 39712 37926 42543523
Immune-mediated hepatitis 136.71 18.54 68 39818 3706 42577743
Pyrexia 133.45 18.54 722 39164 393320 42188129
Febrile neutropenia 133.27 18.54 429 39457 185274 42396175
Cholangitis 133.16 18.54 97 39789 10630 42570819
Varices oesophageal 130.19 18.54 69 39817 4296 42577153
Product dose omission issue 130.09 18.54 3 39883 154362 42427087
Hepatic encephalopathy 129.82 18.54 114 39772 16328 42565121
Nephritis 124.75 18.54 64 39822 3725 42577724
Type 1 diabetes mellitus 123.32 18.54 72 39814 5415 42576034
Therapy partial responder 121.71 18.54 120 39766 19901 42561548
Varicose vein ruptured 117.70 18.54 26 39860 85 42581364
Paraneoplastic neurological syndrome 114.30 18.54 25 39861 77 42581372
Tumour rupture 113.29 18.54 32 39854 337 42581112
Drug ineffective 111.69 18.54 268 39618 629929 41951520
Hypophysitis 108.32 18.54 54 39832 2957 42578492
Autoimmune hepatitis 105.99 18.54 66 39820 5579 42575870
Tumour thrombosis 104.04 18.54 27 39859 200 42581249
Portal vein thrombosis 103.04 18.54 60 39826 4489 42576960
Immune-mediated lung disease 95.45 18.54 52 39834 3421 42578028
Platelet count decreased 90.25 18.54 310 39576 138271 42443178
Enterocolitis 86.82 18.54 73 39813 9856 42571593
Hepatitis 86.68 18.54 117 39769 27183 42554266
Condition aggravated 85.74 18.54 71 39815 260683 42320766
Hypopituitarism 82.90 18.54 44 39842 2747 42578702
Blood bilirubin increased 81.80 18.54 144 39742 42108 42539341
Liver carcinoma ruptured 80.03 18.54 23 39863 259 42581190
Aspartate aminotransferase increased 79.25 18.54 203 39683 76960 42504489
Adrenocorticotropic hormone deficiency 78.74 18.54 34 39852 1336 42580113
Encephalitis autoimmune 78.58 18.54 34 39852 1343 42580106
Radiation pneumonitis 78.08 18.54 43 39843 2890 42578559
Alpha 1 foetoprotein increased 76.22 18.54 28 39858 714 42580735
Alanine aminotransferase increased 76.18 18.54 218 39668 88188 42493261
Metastases to bone 75.92 18.54 81 39805 14728 42566721
Neoplasm 73.71 18.54 55 39831 6250 42575199
Immune-mediated encephalitis 72.37 18.54 26 39860 621 42580828
Decreased appetite 72.00 18.54 364 39522 192773 42388676
Inappropriate schedule of product administration 70.40 18.54 5 39881 95897 42485552
Drug effective for unapproved indication 69.05 18.54 54 39832 6579 42574870
Metastases to lung 66.70 18.54 67 39819 11357 42570092
Hypertension 65.03 18.54 319 39567 166885 42414564
Tumour hyperprogression 61.52 18.54 17 39869 164 42581285
Autoimmune colitis 61.29 18.54 27 39859 1114 42580335
Nephrotic syndrome 60.06 18.54 56 39830 8662 42572787
Fulminant type 1 diabetes mellitus 59.56 18.54 28 39858 1346 42580103
Depression 58.33 18.54 16 39870 111347 42470102
Dizziness 57.81 18.54 90 39796 249164 42332285
Bleeding varicose vein 57.45 18.54 19 39867 351 42581098
Erythema multiforme 57.30 18.54 58 39828 9919 42571530
Secondary adrenocortical insufficiency 56.50 18.54 31 39855 2068 42579381
Hepatic rupture 56.22 18.54 13 39873 55 42581394
Anaemia 56.19 18.54 451 39435 279827 42301622
Product use in unapproved indication 56.04 18.54 54 39832 184402 42397047
Embolism 56.01 18.54 54 39832 8709 42572740
Somnolence 54.82 18.54 32 39854 141073 42440376
Tumour necrosis 54.79 18.54 28 39858 1616 42579833
Peripheral swelling 53.21 18.54 10 39876 90260 42491189
Hospitalisation 51.45 18.54 5 39881 74325 42507124
Pulmonary toxicity 50.96 18.54 51 39835 8604 42572845
Feeling abnormal 50.18 18.54 4 39882 69782 42511667
Cytokine release syndrome 49.74 18.54 121 39765 44406 42537043
Hyperhidrosis 49.32 18.54 12 39874 90500 42490949
Drug hypersensitivity 48.92 18.54 16 39870 99373 42482076
Nasopharyngitis 48.05 18.54 10 39876 83986 42497463
Immune-mediated myocarditis 47.94 18.54 28 39858 2106 42579343
Cerebral infarction 47.59 18.54 96 39790 31073 42550376
Drug-induced liver injury 47.08 18.54 108 39778 38165 42543284
Thyroiditis 46.49 18.54 32 39854 3204 42578245
Hyponatraemia 45.59 18.54 202 39684 101260 42480189
Hepatic lesion 45.51 18.54 36 39850 4458 42576991
Tremor 45.31 18.54 17 39869 96912 42484537
Headache 45.19 18.54 98 39788 239271 42342178
Tumour pseudoprogression 44.29 18.54 21 39865 1029 42580420
Fall 44.28 18.54 96 39790 234424 42347025
Neutropenic sepsis 44.14 18.54 64 39822 15882 42565567
Pneumonia 43.41 18.54 593 39293 421556 42159893
Polymyalgia rheumatica 43.20 18.54 27 39859 2296 42579153
Anxiety 43.12 18.54 29 39857 118531 42462918
Cholangitis sclerosing 42.84 18.54 25 39861 1877 42579572
Weight increased 42.63 18.54 24 39862 107959 42473490
Product use issue 42.16 18.54 10 39876 76741 42504708
Urinary occult blood 41.84 18.54 9 39877 25 42581424
Immune thrombocytopenia 41.73 18.54 52 39834 11164 42570285
Joint swelling 41.24 18.54 7 39879 68015 42513434
Blood thyroid stimulating hormone increased 40.38 18.54 36 39850 5256 42576193
Systemic immune activation 39.33 18.54 9 39877 36 42581413
Tumour fistulisation 39.27 18.54 11 39875 112 42581337
Gastrointestinal perforation 39.25 18.54 33 39853 4453 42576996
Paraneoplastic encephalomyelitis 38.70 18.54 8 39878 17 42581432
Skin disorder 38.42 18.54 62 39824 16882 42564567
Immune system disorder 38.16 18.54 37 39849 6007 42575442
Metastasis 37.88 18.54 33 39853 4672 42576777
Portal hypertension 37.39 18.54 33 39853 4754 42576695
Peripheral sensory neuropathy 36.47 18.54 43 39843 8719 42572730
Myasthenic syndrome 36.42 18.54 17 39869 804 42580645
Guillain-Barre syndrome 35.95 18.54 39 39847 7224 42574225
Stomatitis 35.71 18.54 116 39770 50213 42531236
Radiation necrosis 34.76 18.54 12 39874 254 42581195
Drug intolerance 34.53 18.54 16 39870 80408 42501041
Metastases to meninges 34.49 18.54 22 39864 1939 42579510
Asthma 34.46 18.54 8 39878 62306 42519143
Hepatic cirrhosis 34.11 18.54 64 39822 19638 42561811
Pharyngeal necrosis 34.07 18.54 9 39877 72 42581377
Haemophagocytic lymphohistiocytosis 33.83 18.54 61 39825 18161 42563288
Electrocardiogram QT prolonged 33.78 18.54 3 39883 47942 42533507
Tubulointerstitial nephritis 33.39 18.54 84 39802 31464 42549985
Haemoptysis 33.29 18.54 107 39779 46060 42535389
Gastric varices 32.83 18.54 15 39871 675 42580774
Neoplasm progression 32.58 18.54 79 39807 28921 42552528
Bradycardia 32.32 18.54 20 39866 85464 42495985
Thrombocytopenia 32.16 18.54 295 39591 189984 42391465
Immune-mediated hepatic disorder 31.80 18.54 23 39863 2491 42578958
Loss of consciousness 31.73 18.54 24 39862 92330 42489119
Haemobilia 31.71 18.54 13 39873 448 42581001
Pemphigoid 31.70 18.54 46 39840 11421 42570028
Neutropenia 31.62 18.54 305 39581 199126 42382323
Upper gastrointestinal haemorrhage 31.37 18.54 80 39806 30219 42551230
Hypoalbuminaemia 31.23 18.54 54 39832 15556 42565893
Myasthenia gravis 31.21 18.54 55 39831 16082 42565367
Infectious pleural effusion 31.09 18.54 25 39861 3170 42578279
Balance disorder 30.96 18.54 4 39882 47641 42533808
Incorrect dose administered 30.93 18.54 6 39880 52968 42528481
Autoimmune haemolytic anaemia 30.81 18.54 32 39854 5639 42575810
Musculoskeletal stiffness 30.80 18.54 8 39878 57757 42523692
Agitation 30.52 18.54 11 39875 64303 42517146
Dermatomyositis 30.31 18.54 19 39867 1624 42579825
Adrenal disorder 30.25 18.54 17 39869 1188 42580261
Tumour lysis syndrome 29.88 18.54 65 39821 22166 42559283
Abdominal discomfort 29.30 18.54 17 39869 75238 42506211
Sleep disorder 29.04 18.54 5 39881 48090 42533359
Metastases to adrenals 28.90 18.54 16 39870 1086 42580363
Skin toxicity 28.69 18.54 33 39853 6516 42574933
Plasma cell myeloma 28.61 18.54 5 39881 47573 42533876
Autoimmune thyroiditis 28.45 18.54 18 39868 1564 42579885
Lymphocyte count decreased 28.35 18.54 73 39813 27736 42553713
Cortisol decreased 28.13 18.54 17 39869 1361 42580088
Therapeutic product effect incomplete 27.65 18.54 16 39870 70923 42510526
Thrombophlebitis migrans 27.39 18.54 11 39875 359 42581090
Pneumothorax 27.38 18.54 65 39821 23478 42557971
Hyperbilirubinaemia 27.35 18.54 60 39826 20575 42560874
Palpitations 27.15 18.54 7 39879 50790 42530659
Blood glucose increased 26.82 18.54 18 39868 73681 42507768
Wrong technique in product usage process 26.72 18.54 4 39882 42631 42538818
Sinusitis 26.29 18.54 6 39880 47286 42534163
Prostate cancer 26.18 18.54 5 39881 44638 42536811
Cardiac failure congestive 26.03 18.54 25 39861 85577 42495872
Haemoglobin decreased 26.00 18.54 53 39833 132418 42449031
Blood corticotrophin decreased 25.76 18.54 10 39876 298 42581151
Limbic encephalitis 25.75 18.54 11 39875 421 42581028
Cardiac arrest 25.74 18.54 39 39847 109281 42472168
Hypertransaminasaemia 25.48 18.54 37 39849 9190 42572259
Pain 25.01 18.54 131 39755 244717 42336732
Infusion related reaction 25.01 18.54 118 39768 60688 42520761
Wheezing 24.94 18.54 10 39876 54771 42526678
Biliary tract infection 24.59 18.54 13 39873 805 42580644
Portal hypertensive gastropathy 24.51 18.54 13 39873 810 42580639
Disseminated intravascular coagulation 24.16 18.54 64 39822 24730 42556719
Drug reaction with eosinophilia and systemic symptoms 24.07 18.54 5 39881 42070 42539379
Small cell lung cancer recurrent 23.90 18.54 4 39882 0 42581449
Heart rate decreased 23.90 18.54 3 39883 36529 42544920
Tumour perforation 23.81 18.54 11 39875 508 42580941
Dermatitis 23.65 18.54 41 39845 11834 42569615
Cholecystitis 23.50 18.54 43 39843 12945 42568504
International normalised ratio increased 23.26 18.54 8 39878 48160 42533289
Large intestine perforation 23.15 18.54 36 39850 9500 42571949
Laryngeal haemorrhage 23.05 18.54 6 39880 45 42581404
Hypotension 23 18.54 144 39742 257487 42323962
Muscle spasms 22.98 18.54 28 39858 86016 42495433
Performance status decreased 22.76 18.54 25 39861 4695 42576754
Coronary artery disease 22.58 18.54 11 39875 53709 42527740
Hallucination 22.37 18.54 13 39873 57494 42523955
Heart rate increased 22.24 18.54 11 39875 53244 42528205
Transaminases increased 21.72 18.54 74 39812 32811 42548638
Blood pressure increased 21.55 18.54 39 39847 101889 42479560
Memory impairment 21.54 18.54 10 39876 50212 42531237
Oral fungal infection 21.54 18.54 16 39870 1805 42579644
Embolism arterial 21.43 18.54 12 39874 833 42580616
Portal vein embolism 21.13 18.54 4 39882 4 42581445
Alpha 1 foetoprotein decreased 21.13 18.54 4 39882 4 42581445
Lactic acidosis 21.04 18.54 8 39878 45253 42536196
Medication error 21.03 18.54 3 39883 33151 42548298
Device related bacteraemia 21.00 18.54 11 39875 668 42580781
Pyelonephritis 20.80 18.54 31 39855 7883 42573566
Angioedema 20.61 18.54 7 39879 42470 42538979
Haematocrit decreased 20.28 18.54 4 39882 34904 42546545
Therapeutic product effect decreased 19.79 18.54 6 39880 39144 42542305
Gastric varices haemorrhage 19.56 18.54 8 39878 274 42581175
Metastases to lymph nodes 19.48 18.54 26 39860 5972 42575477
Tumour pain 18.95 18.54 13 39873 1294 42580155
Primary hypothyroidism 18.83 18.54 6 39880 98 42581351
Pain in extremity 18.68 18.54 75 39811 150529 42430920
Primary adrenal insufficiency 18.68 18.54 8 39878 308 42581141
Pleural effusion 18.65 18.54 155 39731 97011 42484438
Paraneoplastic retinopathy 18.62 18.54 4 39882 11 42581438
Meningitis 18.59 18.54 25 39861 5784 42575665
Enteritis 18.55 18.54 35 39851 10781 42570668

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
Disease progression 1529.14 19.03 1209 63268 242825 110281997
Hypothyroidism 1140.90 19.03 640 63837 72259 110452563
Pneumonitis 825.56 19.03 529 63948 76002 110448820
Interstitial lung disease 703.23 19.03 610 63867 138724 110386098
Death 701.11 19.03 1366 63111 697503 109827319
Proteinuria 668.54 19.03 367 64110 39651 110485171
Hyperthyroidism 615.40 19.03 313 64164 28948 110495874
Adrenal insufficiency 613.87 19.03 354 64123 42036 110482786
Febrile neutropenia 566.32 19.03 804 63673 315963 110208859
Neutrophil count decreased 559.24 19.03 504 63973 120437 110404385
Myocarditis 470.08 19.03 264 64213 29791 110495031
Colitis 452.54 19.03 416 64061 101907 110422915
Anaemia 440.13 19.03 978 63499 546108 109978714
Ascites 423.45 19.03 384 64093 92424 110432398
Hepatic function abnormal 412.38 19.03 372 64105 88923 110435899
Off label use 378.30 19.03 1797 62680 1498388 109026434
Oesophageal varices haemorrhage 364.33 19.03 129 64348 4816 110520006
Immune-mediated enterocolitis 343.72 19.03 151 64326 10034 110514788
Platelet count decreased 341.25 19.03 536 63941 229907 110294915
Pyrexia 340.08 19.03 1221 63256 897044 109627778
Encephalitis 326.21 19.03 177 64300 18662 110506160
Tumour haemorrhage 301.66 19.03 114 64363 5131 110519691
Immune-mediated hepatitis 298.24 19.03 121 64356 6590 110518232
Metastases to central nervous system 281.73 19.03 172 64305 22645 110502177
Type 1 diabetes mellitus 260.33 19.03 120 64357 8927 110515895
Myositis 256.01 19.03 182 64295 30934 110493888
Hepatic failure 240.78 19.03 246 64231 68493 110456329
Drug interaction 235.71 19.03 14 64463 500169 110024653
Cholangitis 227.30 19.03 133 64344 16202 110508620
Joint swelling 209.84 19.03 12 64465 442833 110081989
Enterocolitis 209.08 19.03 133 64344 18816 110506006
Myelosuppression 199.19 19.03 260 64217 94080 110430742
Neutropenia 199.05 19.03 573 63904 374047 110150775
Therapy partial responder 190.16 19.03 164 64313 36897 110487925
Drug intolerance 180.99 19.03 15 64462 406497 110118325
Aspartate aminotransferase increased 179.48 19.03 329 64148 159607 110365215
Alanine aminotransferase increased 173.10 19.03 351 64126 183422 110341400
Neutropenic sepsis 172.00 19.03 143 64334 30603 110494219
Thrombocytopenia 170.38 19.03 518 63959 348367 110176455
Paraneoplastic neurological syndrome 168.45 19.03 35 64442 145 110524677
Drug ineffective 168.44 19.03 402 64075 1520138 109004684
Hepatic encephalopathy 165.55 19.03 135 64342 28121 110496701
Product dose omission issue 164.74 19.03 5 64472 321777 110203045
Immune-mediated lung disease 160.93 19.03 73 64404 5230 110519592
Toxicity to various agents 160.83 19.03 41 64436 480514 110044308
Pain 160.33 19.03 193 64284 954762 109570060
Drug hypersensitivity 159.34 19.03 35 64442 454055 110070767
Nephritis 156.95 19.03 75 64402 6051 110518771
Embolism 156.88 19.03 105 64372 16184 110508638
Nasopharyngitis 154.31 19.03 23 64454 394338 110130484
Hypophysitis 153.22 19.03 71 64406 5344 110519478
Condition aggravated 151.41 19.03 124 64353 734712 109790110
Encephalitis autoimmune 151.25 19.03 62 64415 3466 110521356
Peripheral swelling 150.42 19.03 27 64450 404007 110120815
Cytokine release syndrome 150.31 19.03 195 64282 70111 110454711
Abdominal discomfort 149.52 19.03 25 64452 393833 110130989
Autoimmune hepatitis 148.79 19.03 98 64379 14706 110510116
Varices oesophageal 148.20 19.03 76 64401 7139 110517683
Immune-mediated encephalitis 147.64 19.03 46 64431 1144 110523678
Portal vein thrombosis 146.87 19.03 75 64402 6983 110517839
Weight increased 143.91 19.03 34 64443 419610 110105212
Decreased appetite 141.83 19.03 601 63876 475245 110049577
Varicose vein ruptured 141.31 19.03 30 64447 141 110524681
Synovitis 141.24 19.03 4 64473 274088 110250734
Swelling 138.42 19.03 20 64457 351021 110173801
Hypopituitarism 135.02 19.03 61 64416 4329 110520493
Adrenocorticotropic hormone deficiency 134.86 19.03 50 64427 2132 110522690
Fulminant type 1 diabetes mellitus 134.58 19.03 51 64426 2312 110522510
Systemic lupus erythematosus 133.75 19.03 3 64474 254335 110270487
Lymphocyte count decreased 132.21 19.03 165 64312 57078 110467744
Thyroiditis 131.44 19.03 68 64409 6505 110518317
Metastases to bone 127.88 19.03 122 64355 31250 110493572
White blood cell count decreased 127.64 19.03 357 64120 229033 110295789
Musculoskeletal stiffness 125.41 19.03 10 64467 279812 110245010
Neuropathy peripheral 125.39 19.03 304 64173 178973 110345849
Arthropathy 124.18 19.03 12 64465 287510 110237312
Tumour rupture 123.26 19.03 35 64442 625 110524197
Contraindicated product administered 123.07 19.03 5 64472 248262 110276560
Therapeutic product effect decreased 120.84 19.03 5 64472 244311 110280511
Maternal exposure during pregnancy 120.37 19.03 7 64470 254876 110269946
Hyponatraemia 116.46 19.03 334 64143 217319 110307503
Liver disorder 115.72 19.03 256 64221 141987 110382835
Sepsis 115.52 19.03 436 64041 326910 110197912
Blood bilirubin increased 115.42 19.03 179 64298 75793 110449029
Product use issue 113.47 19.03 22 64455 311673 110213149
Peripheral sensory neuropathy 113.41 19.03 87 64390 16593 110508229
Radiation pneumonitis 111.55 19.03 54 64423 4482 110520340
Systemic immune activation 111.53 19.03 25 64452 158 110524664
Overdose 108.66 19.03 7 64470 233787 110291035
Discomfort 107.52 19.03 4 64473 214703 110310119
Pemphigus 107.44 19.03 4 64473 214566 110310256
Rheumatoid arthritis 107.28 19.03 22 64455 299591 110225231
Metastases to lung 104.24 19.03 95 64382 22968 110501854
Tumour hyperprogression 103.91 19.03 27 64450 339 110524483
Sinusitis 103.75 19.03 23 64454 296665 110228157
Erythema multiforme 103.46 19.03 91 64386 21006 110503816
Hypokalaemia 101.51 19.03 284 64193 182164 110342658
Tubulointerstitial nephritis 99.91 19.03 140 64337 54144 110470678
Hepatitis 99.38 19.03 184 64293 89870 110434952
Sleep disorder 98.45 19.03 4 64473 198640 110326182
Haemophagocytic lymphohistiocytosis 98.08 19.03 106 64371 31453 110493369
Treatment failure 97.93 19.03 21 64456 277213 110247609
Asthma 96.94 19.03 15 64462 250276 110274546
Tumour thrombosis 96.87 19.03 25 64452 305 110524517
Inappropriate schedule of product administration 94.92 19.03 6 64471 203631 110321191
Autoimmune haemolytic anaemia 94.34 19.03 65 64412 10502 110514320
Metastases to meninges 93.85 19.03 50 64427 5078 110519744
Pneumonia 93.31 19.03 848 63629 875866 109648956
Immune-mediated myocarditis 93.20 19.03 44 64433 3454 110521368
Mobility decreased 92.47 19.03 14 64463 237408 110287414
Liver carcinoma ruptured 92.03 19.03 24 64453 306 110524516
Wheezing 90.83 19.03 19 64458 255211 110269611
Pleural effusion 89.56 19.03 267 64210 177442 110347380
Guillain-Barre syndrome 88.71 19.03 63 64414 10681 110514141
Psoriatic arthropathy 88.23 19.03 7 64470 196754 110328068
Headache 87.52 19.03 246 64231 882131 109642691
Blister 87.20 19.03 14 64463 227362 110297460
Pulmonary toxicity 85.93 19.03 76 64401 17670 110507152
Autoimmune colitis 85.49 19.03 35 64442 1950 110522872
Cholangitis sclerosing 83.16 19.03 41 64436 3541 110521281
Dizziness 83.07 19.03 177 64300 698016 109826806
Myasthenia gravis 82.68 19.03 81 64396 21430 110503392
Neoplasm 82.41 19.03 61 64416 11026 110513796
Meningitis 81.67 19.03 62 64415 11640 110513182
Drug effective for unapproved indication 81.54 19.03 67 64410 14100 110510722
Nephrotic syndrome 80.84 19.03 66 64411 13765 110511057
Duodenal ulcer perforation 80.59 19.03 6 64471 177694 110347128
Tumour necrosis 78.59 19.03 35 64442 2401 110522421
Alpha 1 foetoprotein increased 77.05 19.03 26 64451 838 110523984
Constipation 75.29 19.03 409 64068 357377 110167445
Neoplasm progression 75.08 19.03 135 64342 64460 110460362
Skin toxicity 74.76 19.03 59 64418 11724 110513098
Hypertension 74.64 19.03 531 63946 509553 110015269
Immune thrombocytopenia 72.44 19.03 77 64400 22417 110502405
Adrenal disorder 72.29 19.03 33 64444 2399 110522423
Secondary adrenocortical insufficiency 72.16 19.03 40 64437 4394 110520428
Diarrhoea 72.11 19.03 995 63482 1138510 109386312
Urticaria 71.71 19.03 49 64428 318808 110206014
Rash maculo-papular 71.28 19.03 143 64334 74079 110450743
Contusion 70.51 19.03 24 64453 233337 110291485
Skin candida 70.49 19.03 32 64445 2296 110522526
Folliculitis 69.79 19.03 8 64469 167645 110357177
Migraine 69.46 19.03 9 64468 171643 110353179
Encephalopathy 69.44 19.03 149 64328 80906 110443916
Hypomagnesaemia 68.68 19.03 125 64352 60245 110464577
Depression 68.44 19.03 51 64426 317284 110207538
Somnolence 66.50 19.03 46 64431 297403 110227419
Pneumothorax 66.41 19.03 92 64385 35193 110489629
Cerebral infarction 66.30 19.03 113 64364 51725 110473097
Metastases to liver 66.21 19.03 92 64385 35294 110489528
Osteoarthritis 66.20 19.03 13 64464 182610 110342212
Arthralgia 64.23 19.03 236 64241 779396 109745426
Hospitalisation 64.07 19.03 5 64472 142488 110382334
Hepatic lesion 63.74 19.03 47 64430 8446 110516376
Muscle spasms 63.54 19.03 42 64435 278115 110246707
Skin disorder 62.23 19.03 99 64378 42814 110482008
Gastrointestinal perforation 62.21 19.03 44 64433 7412 110517410
Hypersensitivity 62.06 19.03 87 64390 403911 110120911
Drug-induced liver injury 62.00 19.03 182 64295 119885 110404937
Product use in unapproved indication 61.40 19.03 104 64373 447273 110077549
Hepatic enzyme increased 61.29 19.03 58 64419 320834 110203988
Tumour pseudoprogression 61.21 19.03 26 64451 1590 110523232
Memory impairment 59.94 19.03 20 64457 196924 110327898
Fall 59.92 19.03 168 64309 603314 109921508
Hyperhidrosis 58.81 19.03 18 64459 187280 110337542
Anxiety 58.49 19.03 69 64408 345009 110179813
Hypoalbuminaemia 58.25 19.03 78 64399 28896 110495926
Metastasis 58.14 19.03 44 64433 8223 110516599
Gait inability 58.05 19.03 6 64471 136370 110388452
Bleeding varicose vein 57.89 19.03 20 64457 693 110524129
Haemoptysis 57.52 19.03 128 64349 71226 110453596
Therapeutic product effect incomplete 56.46 19.03 30 64447 223775 110301047
Joint range of motion decreased 55.56 19.03 4 64473 121828 110402994
Malignant neoplasm progression 55.39 19.03 225 64252 174342 110350480
Blood thyroid stimulating hormone increased 54.28 19.03 50 64427 12251 110512571
Transaminases increased 53.69 19.03 116 64361 63274 110461548
Immune-mediated hepatic disorder 53.53 19.03 33 64444 4417 110520405
Portal hypertension 52.13 19.03 42 64435 8595 110516227
Insomnia 52.11 19.03 81 64396 360509 110164313
Hepatic rupture 52.02 19.03 13 64464 138 110524684
Hyperglycaemia 51.83 19.03 137 64340 84953 110439869
Tumour lysis syndrome 51.63 19.03 76 64401 30725 110494097
Metastases to adrenals 51.61 19.03 23 64454 1580 110523242
Pancytopenia 51.27 19.03 250 64227 209363 110315459
Acute kidney injury 51.25 19.03 581 63896 634849 109889973
Gastrooesophageal reflux disease 50.20 19.03 21 64456 179955 110344867
Impaired healing 50.17 19.03 26 64451 196691 110328131
Pain in extremity 49.53 19.03 134 64343 486984 110037838
Adverse drug reaction 49.51 19.03 3 64474 105556 110419266
Disseminated intravascular coagulation 48.89 19.03 87 64390 41199 110483623
Thrombophlebitis migrans 48.80 19.03 18 64459 756 110524066
Mucosal inflammation 47.98 19.03 144 64333 95997 110428825
Small intestinal obstruction 47.65 19.03 75 64402 32138 110492684
Metastases to lymph nodes 47.60 19.03 51 64426 14981 110509841
Pemphigoid 47.41 19.03 58 64419 19649 110505173
Cortisol decreased 47.29 19.03 26 64451 2810 110522012
Urinary occult blood 47.28 19.03 10 64467 46 110524776
Hypertransaminasaemia 46.79 19.03 64 64413 24191 110500631
Hepatobiliary disease 46.67 19.03 19 64458 1043 110523779
Medication error 46.53 19.03 4 64473 105362 110419460
Respiratory failure 46.49 19.03 248 64229 215084 110309738
Enteritis 45.47 19.03 56 64421 19100 110505722
Pericardial effusion 45.40 19.03 102 64375 57115 110467707
Hydronephrosis 45.21 19.03 58 64419 20607 110504215
Hyperbilirubinaemia 44.80 19.03 71 64406 30600 110494222
Bacteraemia 44.74 19.03 85 64392 42305 110482517
Tremor 44.23 19.03 32 64445 202200 110322622
Biliary tract infection 43.84 19.03 21 64456 1703 110523119
Pericarditis 43.74 19.03 38 64439 219076 110305746
Gastrointestinal disorder 43.59 19.03 46 64431 241906 110282916
Pyelonephritis 43.33 19.03 63 64414 25187 110499635
Cytopenia 43.01 19.03 69 64408 30047 110494775
Diabetic ketoacidosis 42.75 19.03 83 64394 41975 110482847
Tumour fistulisation 42.56 19.03 11 64466 135 110524687
Obesity 41.22 19.03 8 64469 113343 110411479
Infectious pleural effusion 41.12 19.03 29 64448 4862 110519960
Pulmonary embolism 40.97 19.03 239 64238 214235 110310587
Peripheral motor neuropathy 40.94 19.03 27 64450 4059 110520763
Limbic encephalitis 40.88 19.03 16 64461 792 110524030
Cholecystitis 40.72 19.03 62 64415 25820 110499002
Incorrect dose administered 40.59 19.03 6 64471 103635 110421187
Amylase increased 40.57 19.03 43 64434 12476 110512346
Polymyalgia rheumatica 40.32 19.03 32 64445 6410 110518412
Angioedema 40.24 19.03 5 64472 98495 110426327
Myasthenic syndrome 40.10 19.03 18 64459 1258 110523564
Large intestine perforation 40.10 19.03 49 64428 16580 110508242
Cardiac failure 39.75 19.03 215 64262 187411 110337411
Immune system disorder 39.60 19.03 44 64433 13457 110511365
Upper gastrointestinal haemorrhage 39.40 19.03 89 64388 50007 110474815
Paraesthesia 39.10 19.03 63 64414 276458 110248364
Lichenoid keratosis 38.79 19.03 31 64446 6271 110518551
Hypoaesthesia 38.69 19.03 78 64399 314145 110210677
Hypercholesterolaemia 38.65 19.03 4 64473 90833 110433989
Tumour pain 38.25 19.03 23 64454 2944 110521878
Rhinorrhoea 37.86 19.03 7 64470 102659 110422163
Palpitations 37.77 19.03 23 64454 159189 110365633
Dermatitis 37.34 19.03 62 64415 27775 110497047
Adverse event 36.89 19.03 9 64468 108800 110416022
Pharyngeal necrosis 36.87 19.03 9 64468 86 110524736
Dermatomyositis 36.75 19.03 26 64451 4380 110520442
Renal impairment 36.64 19.03 211 64266 188234 110336588
Blood creatinine increased 36.36 19.03 206 64271 182683 110342139
Feeling hot 36.32 19.03 5 64472 91101 110433721
Blood creatine phosphokinase increased 36.03 19.03 109 64368 72968 110451854
Dyspepsia 35.88 19.03 35 64442 190930 110333892
Fluid retention 35.71 19.03 6 64471 94301 110430521
Lipase increased 35.61 19.03 49 64428 18623 110506199
Immune-mediated pancreatitis 35.45 19.03 14 64463 710 110524112
Injection site reaction 35.25 19.03 5 64472 89065 110435757
Mesenteric vein thrombosis 35.24 19.03 19 64458 1976 110522846
Heart rate increased 35.22 19.03 20 64457 143814 110381008
Oligoastrocytoma 34.73 19.03 7 64470 24 110524798
Sciatica 34.72 19.03 6 64471 92393 110432429
Red blood cell sedimentation rate increased 34.50 19.03 3 64474 78299 110446523
Road traffic accident 34.29 19.03 10 64467 107388 110417434
Autoimmune thyroiditis 34.07 19.03 29 64448 6405 110518417
Laryngeal haemorrhage 33.93 19.03 8 64469 65 110524757
Night sweats 33.72 19.03 18 64459 133965 110390857
Septic shock 33.70 19.03 181 64296 157347 110367475
Bradycardia 33.50 19.03 25 64452 155492 110369330
Amnesia 33.32 19.03 10 64467 105398 110419424
Haemobilia 33.28 19.03 13 64464 640 110524182
Electrocardiogram QT prolonged 33.26 19.03 11 64466 108949 110415873
Portal hypertensive gastropathy 33.22 19.03 18 64459 1890 110522932
Radiation necrosis 33.21 19.03 14 64463 840 110523982
Gastric varices haemorrhage 32.88 19.03 12 64465 489 110524333
Gastric varices 32.82 19.03 14 64463 865 110523957
Swelling face 32.56 19.03 7 64470 92314 110432508
Confusional state 32.22 19.03 152 64325 468528 110056294
Osteoporosis 32.01 19.03 6 64471 87146 110437676
Heart rate decreased 31.93 19.03 5 64472 82751 110442071
Agitation 31.83 19.03 13 64464 113038 110411784
International normalised ratio increased 31.81 19.03 6 64471 86766 110438056
Asthenia 31.73 19.03 571 63906 688428 109836394
Product quality issue 31.39 19.03 4 64473 77295 110447527
Liver abscess 31.35 19.03 30 64447 7709 110517113
COVID-19 31.17 19.03 247 64230 244813 110280009
Tumour embolism 31.14 19.03 10 64467 275 110524547
Hepatotoxicity 30.72 19.03 94 64383 63306 110461516
Blood alkaline phosphatase increased 30.57 19.03 101 64376 70834 110453988
Gene mutation 30.39 19.03 21 64456 3408 110521414
Enterocolitis infectious 30.31 19.03 21 64456 3423 110521399
Blood pressure increased 30.23 19.03 66 64411 258307 110266515
Blood pressure fluctuation 30.08 19.03 4 64473 74820 110450002
Bile duct stenosis 30.06 19.03 19 64458 2657 110522165
Pancreatitis 30.00 19.03 121 64356 93412 110431410
Dry mouth 29.75 19.03 44 64433 199904 110324918
Loss of consciousness 29.40 19.03 43 64434 196263 110328559
Ileus 29.25 19.03 59 64418 30670 110494152
Palmar-plantar erythrodysaesthesia syndrome 29.10 19.03 70 64407 40955 110483867
Nervous system disorder 27.95 19.03 59 64418 31662 110493160
Lung adenocarcinoma 27.85 19.03 31 64446 9500 110515322
Febrile infection 27.64 19.03 22 64455 4426 110520396
Neck pain 27.55 19.03 19 64458 123111 110401711
Erysipelas 27.33 19.03 36 64441 13122 110511700
Tumour inflammation 27.31 19.03 7 64470 83 110524739
Biliary obstruction 27.30 19.03 24 64453 5534 110519288
Burning sensation 27.12 19.03 4 64473 69208 110455614
Paraneoplastic encephalomyelitis 26.82 19.03 8 64469 171 110524651
Tumour perforation 26.51 19.03 11 64466 634 110524188
Hallucination 26.46 19.03 13 64464 101419 110423403
Wrong technique in product usage process 26.34 19.03 9 64468 87339 110437483
Hepatic mass 26.28 19.03 18 64459 2880 110521942
Small intestinal perforation 25.82 19.03 21 64456 4355 110520467
Illness 25.60 19.03 8 64469 82163 110442659
Lactic acidosis 25.60 19.03 11 64466 92800 110432022
Musculoskeletal pain 25.58 19.03 42 64435 182981 110341841
Anaphylactic shock 25.52 19.03 77 64400 51469 110473353
Hypercalcaemia 25.30 19.03 72 64405 46585 110478237
Opportunistic infection 25.23 19.03 19 64458 3524 110521298
Cholangitis acute 25.10 19.03 15 64462 1898 110522924
Immune-mediated myositis 25.10 19.03 24 64453 6162 110518660
Cancer pain 25.09 19.03 25 64452 6747 110518075
Vision blurred 24.99 19.03 23 64454 128999 110395823
Febrile bone marrow aplasia 24.92 19.03 40 64437 17425 110507397
Hypoxia 24.50 19.03 144 64333 129371 110395451
Incorrect route of product administration 24.42 19.03 4 64473 64057 110460765
Influenza 24.39 19.03 38 64439 169063 110355759
Aggression 24.20 19.03 3 64474 59207 110465615
Blood glucose increased 24.07 19.03 25 64452 132471 110392351
Epistaxis 24.05 19.03 144 64333 130228 110394594
Joint stiffness 23.92 19.03 5 64472 67238 110457584
Pulmonary haemorrhage 23.90 19.03 38 64439 16418 110508404
Lymphangiosis carcinomatosa 23.90 19.03 16 64461 2466 110522356
Lymphoma transformation 23.82 19.03 10 64467 594 110524228
Gastric perforation 23.64 19.03 21 64456 4908 110519914
Hepatocellular carcinoma 23.64 19.03 29 64448 9851 110514971
Performance status decreased 23.62 19.03 25 64452 7241 110517581
Blood corticotrophin decreased 23.60 19.03 11 64466 839 110523983
Nasal congestion 23.59 19.03 14 64463 98268 110426554
Chest discomfort 23.28 19.03 41 64436 173807 110351015
Embolism arterial 22.91 19.03 14 64463 1845 110522977
Tumour cavitation 22.90 19.03 6 64471 78 110524744
Therapeutic response decreased 22.80 19.03 14 64463 96485 110428337
Type 2 diabetes mellitus 22.66 19.03 43 64434 177189 110347633
General physical health deterioration 22.66 19.03 361 64116 424934 110099888
Immune-mediated dermatitis 22.62 19.03 15 64462 2275 110522547
Device related bacteraemia 22.53 19.03 12 64465 1218 110523604
Protein urine 22.52 19.03 13 64464 1543 110523279
Tachycardia 22.51 19.03 63 64414 226582 110298240
Subileus 22.45 19.03 23 64454 6414 110518408
Peritonitis 22.45 19.03 55 64422 32552 110492270
Pneumonia bacterial 22.17 19.03 48 64429 26213 110498609
Small cell lung cancer 22.09 19.03 17 64460 3255 110521567
Thrombotic microangiopathy 22.05 19.03 51 64426 29098 110495724
Autoimmune hypothyroidism 21.97 19.03 9 64468 502 110524320
Renal disorder 21.81 19.03 71 64406 49408 110475414
Plasma cell myeloma 21.74 19.03 5 64472 62931 110461891
Hand dermatitis 21.72 19.03 10 64467 741 110524081
Serous retinal detachment 21.65 19.03 13 64464 1659 110523163
Small cell lung cancer recurrent 21.62 19.03 5 64472 37 110524785
Superior vena cava syndrome 21.56 19.03 12 64465 1329 110523493
Non-small cell lung cancer metastatic 21.46 19.03 12 64465 1340 110523482
Subacute cutaneous lupus erythematosus 21.45 19.03 20 64457 4974 110519848
Oral fungal infection 21.42 19.03 19 64458 4433 110520389
Stevens-Johnson syndrome 21.30 19.03 68 64409 46833 110477989
Blood pressure systolic increased 21.10 19.03 11 64466 82980 110441842
Immune-mediated neuropathy 21.09 19.03 7 64470 214 110524608
Urinary tract obstruction 20.84 19.03 20 64457 5157 110519665
Cardiac failure congestive 20.78 19.03 35 64442 150965 110373857
Coma 20.56 19.03 23 64454 117846 110406976
Paraneoplastic retinopathy 20.51 19.03 4 64473 11 110524811
Gait disturbance 20.43 19.03 88 64389 278120 110246702
Duodenal ulcer 20.43 19.03 39 64438 19475 110505347
Accidental overdose 20.30 19.03 3 64474 51831 110472991
Child-Pugh-Turcotte score increased 20.28 19.03 5 64472 50 110524772
Troponin increased 20.27 19.03 50 64427 29716 110495106
Immune-mediated cholangitis 20.17 19.03 10 64467 874 110523948
Alpha 1 foetoprotein decreased 20.01 19.03 4 64473 13 110524809
Polyneuropathy 19.95 19.03 52 64425 31960 110492862
Hepatic cytolysis 19.92 19.03 74 64403 54979 110469843
Autoimmune myocarditis 19.87 19.03 9 64468 642 110524180
COVID-19 pneumonia 19.83 19.03 57 64420 37086 110487736
Psychotic disorder 19.83 19.03 3 64474 50934 110473888
Abdominal pain upper 19.67 19.03 121 64356 348990 110175832
Protein induced by vitamin K absence or antagonist II increased 19.61 19.03 5 64472 58 110524764
Dehydration 19.58 19.03 249 64228 279262 110245560
Lung abscess 19.49 19.03 19 64458 4993 110519829
Primary hypothyroidism 19.40 19.03 7 64470 276 110524546
Autoimmune cholangitis 19.23 19.03 5 64472 63 110524759
Hepatic atrophy 19.22 19.03 8 64469 465 110524357

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FF05 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
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000082082 Immune Checkpoint Inhibitors
MeSH PA D000970 Antineoplastic Agents
FDA CS M0001352 Antibodies
FDA CS M0001357 Antibodies, Monoclonal
FDA CS M0556300 Antibodies, Monoclonal, Humanized
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:35610 antineoplastic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs
avelumabcemiplimabdostarlimabdurvalumabnivolumabpembrolizumabretifanlimabserplulimabsugemalimabtislelizumabtoripalimab

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

DiseaseRelationSNOMED_IDDOID
Transitional cell carcinoma indication 27090000 DOID:2671
Liver cell carcinoma indication 109841003 DOID:684
Germline BRCA-mutated, HER2-negative metastatic breast cancer indication 767444009
Metastatic non-small cell lung cancer indication 457721000124104
Extensive stage primary small cell carcinoma of lung indication 683991000119103




🐶 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 1 ligand 1 CD molecules ANTIBODY BINDING Kd 9.39 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
52CMI0WC3Y UNII
4035750 VANDF
C4055433 UMLSCUI
CHEBI:755740 CHEBI
CHEMBL3707227 ChEMBL_ID
D10773 KEGG_DRUG
DB11595 DRUGBANK_ID
9814 INN_ID
C000594389 MESH_SUPPLEMENTAL_RECORD_UI
7990 IUPHAR_LIGAND_ID
1792776 RXNORM
240980 MMSL
31671 MMSL
d08438 MMSL
016856 NDDF
719371003 SNOMEDCT_US
763505003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TECENTRIQ HUMAN PRESCRIPTION DRUG LABEL 1 50242-917 INJECTION, SOLUTION 1200 mg INTRAVENOUS BLA 31 sections
TECENTRIQ HUMAN PRESCRIPTION DRUG LABEL 1 50242-917 INJECTION, SOLUTION 1200 mg INTRAVENOUS BLA 31 sections
TECENTRIQ HUMAN PRESCRIPTION DRUG LABEL 1 50242-918 INJECTION, SOLUTION 840 mg INTRAVENOUS BLA 31 sections
TECENTRIQ HUMAN PRESCRIPTION DRUG LABEL 1 50242-918 INJECTION, SOLUTION 840 mg INTRAVENOUS BLA 31 sections
Tecentriq Hybreza HUMAN PRESCRIPTION DRUG LABEL 2 50242-933 INJECTION 1875 mg SUBCUTANEOUS BLA 31 sections
Tecentriq Hybreza HUMAN PRESCRIPTION DRUG LABEL 2 50242-933 INJECTION 1875 mg SUBCUTANEOUS BLA 31 sections