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

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 4275.60 16.51 1748 43616 80373 63363285
Hypothyroidism 1261.39 16.51 613 44751 42019 63401639
Immune-mediated hypothyroidism 617.66 16.51 117 45247 191 63443467
Product use in unapproved indication 560.49 16.51 664 44700 178416 63265242
Immune-mediated hepatic disorder 540.41 16.51 114 45250 401 63443257
Immune-mediated adverse reaction 504.22 16.51 98 45266 197 63443461
Myocarditis 501.06 16.51 210 45154 10115 63433543
Hypertension 432.58 16.51 740 44624 278563 63165095
Immune-mediated enterocolitis 428.84 16.51 125 45239 1986 63441672
Palmar-plantar erythrodysaesthesia syndrome 399.00 16.51 232 45132 22783 63420875
Proteinuria 394.16 16.51 216 45148 18929 63424729
Thyroiditis 388.44 16.51 120 45244 2346 63441312
Immune-mediated myocarditis 358.74 16.51 74 45290 226 63443432
Hyperthyroidism 356.86 16.51 185 45179 14488 63429170
Pneumonitis 356.63 16.51 253 45111 34969 63408689
Colitis 354.95 16.51 287 45077 48241 63395417
Tumour pseudoprogression 343.18 16.51 71 45293 221 63443437
Immune-mediated hepatitis 326.97 16.51 92 45272 1279 63442379
Death 326.24 16.51 781 44583 373600 63070058
Immune-mediated lung disease 322.65 16.51 78 45286 568 63443090
Adrenal insufficiency 316.90 16.51 183 45181 17732 63425926
Tubulointerstitial nephritis 283.81 16.51 177 45187 19726 63423932
Immune-mediated dermatitis 282.01 16.51 56 45308 132 63443526
Platelet count decreased 274.58 16.51 375 44989 115747 63327911
Therapy partial responder 258.06 16.51 134 45230 10524 63433134
Hypophysitis 254.13 16.51 81 45283 1760 63441898
Type 1 diabetes mellitus 242.23 16.51 94 45270 3696 63439962
Hepatitis 236.73 16.51 209 45155 39579 63404079
Immune-mediated thyroiditis 226.63 16.51 45 45319 106 63443552
Hepatic function abnormal 220.76 16.51 195 45169 36947 63406711
Myelosuppression 209.76 16.51 157 45207 23546 63420112
Adrenocorticotropic hormone deficiency 201.12 16.51 49 45315 370 63443288
Interstitial lung disease 180.71 16.51 222 45142 61686 63381972
Immune-mediated pancreatitis 169.88 16.51 35 45329 106 63443552
Immune-mediated hyperthyroidism 167.63 16.51 33 45331 73 63443585
Blood thyroid stimulating hormone increased 167.16 16.51 88 45276 7106 63436552
Lichenoid keratosis 160.96 16.51 57 45307 1726 63441932
Pyrexia 160.84 16.51 713 44651 469765 62973893
Myositis 159.45 16.51 93 45271 9173 63434485
Vitiligo 158.85 16.51 53 45311 1336 63442322
Neutropenia 152.76 16.51 366 44998 174639 63269019
Joint swelling 151.46 16.51 26 45338 327640 63116018
Thrombocytopenia 143.78 16.51 327 45037 150830 63292828
Autoimmune colitis 136.20 16.51 38 45326 511 63443147
Immune-mediated arthritis 132.23 16.51 26 45338 57 63443601
Myasthenia gravis 129.59 16.51 64 45300 4517 63439141
Fulminant type 1 diabetes mellitus 127.61 16.51 35 45329 440 63443218
Drug ineffective 127.11 16.51 358 45006 1044407 62399251
Abdominal discomfort 125.20 16.51 37 45327 320848 63122810
Hepatic cytolysis 125.17 16.51 97 45267 15310 63428348
Nephritis 124.79 16.51 52 45312 2464 63441194
Pain 123.46 16.51 213 45151 740415 62703243
Decreased appetite 119.91 16.51 423 44941 250629 63193029
Immune-mediated gastritis 119.79 16.51 22 45342 27 63443631
Swelling 118.46 16.51 26 45338 275352 63168306
Renal impairment 118.05 16.51 220 45144 88135 63355523
Immune-mediated adrenal insuficiency 115.58 16.51 23 45341 55 63443603
Sinusitis 113.91 16.51 14 45350 226639 63217019
Autoimmune hypothyroidism 113.62 16.51 27 45337 181 63443477
Thyroid disorder 113.57 16.51 91 45273 15071 63428587
Neoplasm progression 113.38 16.51 135 45229 36293 63407365
Cholangitis 112.36 16.51 62 45302 5499 63438159
Fall 110.94 16.51 72 45292 392262 63051396
Arthropathy 109.83 16.51 18 45346 234774 63208884
Dizziness 109.71 16.51 88 45276 429837 63013821
Autoimmune thyroiditis 107.76 16.51 54 45310 3932 63439726
Nasopharyngitis 107.36 16.51 25 45339 254232 63189426
Therapeutic product effect decreased 104.65 16.51 9 45355 193178 63250480
Drug hypersensitivity 103.93 16.51 46 45318 310641 63133017
Synovitis 103.21 16.51 8 45356 186910 63256748
Autoimmune hepatitis 102.30 16.51 68 45296 8442 63435216
Maternal exposure during pregnancy 100.44 16.51 18 45346 220044 63223614
Hepatotoxicity 100.33 16.51 128 45236 36913 63406745
Gastrointestinal perforation 96.46 16.51 48 45316 3443 63440215
Dysphonia 95.05 16.51 142 45222 47472 63396186
Exposure during pregnancy 93.97 16.51 4 45360 155543 63288115
Hypopituitarism 93.47 16.51 34 45330 1114 63442544
Systemic lupus erythematosus 93.39 16.51 18 45346 208900 63234758
Condition aggravated 93.33 16.51 90 45274 402127 63041531
Wound 92.99 16.51 6 45358 163257 63280401
Glossodynia 92.48 16.51 10 45354 178866 63264792
Drug intolerance 90.87 16.51 54 45310 308607 63135051
Neuropathy peripheral 88.80 16.51 228 45136 113439 63330219
Headache 85.85 16.51 205 45159 633036 62810622
Acute kidney injury 85.76 16.51 394 44970 263021 63180637
Skin toxicity 85.59 16.51 49 45315 4665 63438993
Immune-mediated encephalitis 85.52 16.51 22 45342 212 63443446
Immune-mediated myositis 84.72 16.51 33 45331 1310 63442348
Immune-mediated nephritis 84.69 16.51 20 45344 130 63443528
Diarrhoea 82.20 16.51 825 44539 714541 62729117
Tumour associated fever 81.78 16.51 23 45341 319 63443339
Hypersensitivity 80.93 16.51 55 45309 292630 63151028
Discomfort 77.87 16.51 13 45351 167361 63276297
Inappropriate schedule of product administration 76.55 16.51 204 45160 103761 63339897
Eastern Cooperative Oncology Group performance status worsened 76.24 16.51 30 45334 1224 63442434
Secondary adrenocortical insufficiency 75.86 16.51 31 45333 1397 63442261
Immune-mediated hypophysitis 74.82 16.51 16 45348 61 63443597
Tumour hyperprogression 74.64 16.51 17 45347 92 63443566
Immune-mediated renal disorder 73.84 16.51 14 45350 23 63443635
Myasthenic syndrome 73.77 16.51 20 45344 240 63443418
Weight increased 72.10 16.51 49 45315 260743 63182915
Renal tubular necrosis 71.81 16.51 63 45301 11815 63431843
Product use issue 71.11 16.51 329 45035 220191 63223467
Adverse event 70.74 16.51 152 45212 67407 63376251
Drug interaction 70.39 16.51 38 45326 229093 63214565
Radiotherapy 69.58 16.51 21 45343 378 63443280
Contusion 69.03 16.51 12 45352 150032 63293626
Diabetic ketoacidosis 68.81 16.51 79 45285 20426 63423232
Cholecystitis 66.97 16.51 68 45296 15309 63428349
Immune-mediated neuropathy 66.63 16.51 12 45352 12 63443646
Troponin increased 63.85 16.51 55 45309 10066 63433592
Neutrophil count decreased 63.81 16.51 131 45233 56275 63387383
Alopecia 63.71 16.51 89 45275 337447 63106211
Peripheral swelling 63.39 16.51 58 45306 265884 63177774
Pancytopenia 63.24 16.51 182 45182 96751 63346907
Enterocolitis 62.79 16.51 49 45315 7809 63435849
Pemphigoid 61.31 16.51 47 45317 7297 63436361
Musculoskeletal stiffness 60.63 16.51 28 45336 184590 63259068
Off label use 60.03 16.51 740 44624 673722 62769936
Autoimmune nephritis 60.03 16.51 19 45345 403 63443255
Immune-mediated cholangitis 59.93 16.51 12 45352 30 63443628
Immune-mediated endocrinopathy 59.83 16.51 10 45354 3 63443655
Bronchitis 59.69 16.51 9 45355 124926 63318732
Cholestasis 59.04 16.51 88 45276 29346 63414312
Glucocorticoid deficiency 58.96 16.51 17 45347 259 63443399
Polymyalgia rheumatica 57.28 16.51 35 45329 3756 63439902
Treatment failure 55.52 16.51 37 45327 199006 63244652
Blood corticotrophin decreased 55.22 16.51 17 45347 328 63443330
Subacute cutaneous lupus erythematosus 54.86 16.51 30 45334 2613 63441045
Insomnia 53.63 16.51 45 45319 215207 63228451
Anaemia 53.59 16.51 376 44988 293054 63150604
Cardiac failure 53.03 16.51 162 45202 88980 63354678
Depression 52.85 16.51 38 45326 196454 63247204
Lichen planus 52.61 16.51 28 45336 2310 63441348
Infusion related reaction 52.29 16.51 59 45305 245462 63198196
Malaise 52.11 16.51 489 44875 415465 63028193
Lower respiratory tract infection 51.99 16.51 15 45349 132292 63311366
Posterior reversible encephalopathy syndrome 51.86 16.51 63 45301 17282 63426376
Intentional product use issue 51.18 16.51 14 45350 127878 63315780
Asthma 50.98 16.51 14 45350 127547 63316111
Mobility decreased 50.92 16.51 12 45352 121147 63322511
Febrile neutropenia 50.86 16.51 193 45171 118256 63325402
Migraine 50.40 16.51 7 45357 103339 63340319
Osteoarthritis 50.11 16.51 5 45359 95338 63348320
Autoimmune pancreatitis 50.07 16.51 15 45349 263 63443395
Autoimmune arthritis 49.89 16.51 11 45353 50 63443608
Rheumatoid arthritis 49.81 16.51 65 45299 253754 63189904
Influenza 49.34 16.51 9 45355 108713 63334945
Lymphocytic hypophysitis 48.04 16.51 14 45350 222 63443436
Pulmonary embolism 47.55 16.51 187 45177 116497 63327161
Radiation pneumonitis 47.42 16.51 23 45341 1560 63442098
Guillain-Barre syndrome 46.53 16.51 31 45333 3862 63439796
Cytokine release syndrome 46.10 16.51 54 45310 14260 63429398
Adrenal disorder 45.90 16.51 23 45341 1674 63441984
Immune-mediated neurological disorder 44.93 16.51 8 45356 7 63443651
Pericardial effusion 44.11 16.51 78 45286 29980 63413678
Overdose 43.49 16.51 14 45350 115064 63328594
Pericarditis 43.12 16.51 20 45344 131559 63312099
Eosinophilic fasciitis 42.90 16.51 12 45352 163 63443495
Small intestinal perforation 42.36 16.51 21 45343 1494 63442164
Mucosal inflammation 41.76 16.51 99 45265 46829 63396829
Large intestine perforation 41.56 16.51 40 45324 8442 63435216
Cortisol decreased 40.08 16.51 19 45345 1225 63442433
Encephalitis 40.01 16.51 40 45324 8840 63434818
No adverse event 39.76 16.51 90 45274 41315 63402343
Urogenital fistula 39.66 16.51 12 45352 218 63443440
Autoimmune myocarditis 39.19 16.51 10 45354 93 63443565
Pneumothorax 39.07 16.51 53 45311 16208 63427450
Pleural effusion 38.47 16.51 150 45214 93060 63350598
Muscle spasms 38.44 16.51 33 45331 156117 63287541
Cholangitis sclerosing 37.91 16.51 20 45344 1621 63442037
Acquired gene mutation 37.88 16.51 17 45347 966 63442692
Immune thrombocytopenia 37.68 16.51 42 45322 10514 63433144
Adrenocortical insufficiency acute 37.27 16.51 20 45344 1678 63441980
Rash maculo-papular 37.16 16.51 75 45289 31821 63411837
Liver disorder 37.14 16.51 103 45261 53584 63390074
Amylase increased 37.05 16.51 33 45331 6312 63437346
Aspartate aminotransferase increased 37.03 16.51 145 45219 90132 63353526
Pulmonary sarcoidosis 36.91 16.51 17 45347 1026 63442632
Hepatitis toxic 36.72 16.51 25 45339 3228 63440430
Uveitis 36.56 16.51 45 45319 12508 63431150
Dermatitis bullous 35.91 16.51 37 45327 8471 63435187
Wheezing 35.47 16.51 12 45352 95583 63348075
Hypothalamo-pituitary disorder 35.46 16.51 15 45349 738 63442920
Tumour haemorrhage 35.21 16.51 19 45345 1612 63442046
Toxicity to various agents 35.00 16.51 78 45286 247172 63196486
Loss of personal independence in daily activities 34.76 16.51 13 45351 97277 63346381
Hyperamylasaemia 34.60 16.51 13 45351 467 63443191
Hospice care 34.40 16.51 35 45329 7897 63435761
Female genital tract fistula 33.96 16.51 34 45330 7525 63436133
Myelitis transverse 33.85 16.51 17 45347 1243 63442415
Adrenalitis 33.78 16.51 7 45357 22 63443636
Suicidal ideation 33.52 16.51 3 45361 62418 63381240
Blood thyroid stimulating hormone decreased 33.21 16.51 27 45337 4563 63439095
Hyponatraemia 32.42 16.51 162 45202 111738 63331920
Polyarthritis 32.21 16.51 38 45326 10108 63433550
Hypertransaminasaemia 32.06 16.51 31 45333 6578 63437080
Gastrointestinal disorder 31.98 16.51 28 45336 131211 63312447
Metastases to central nervous system 31.92 16.51 43 45321 13062 63430596
Intestinal perforation 31.84 16.51 41 45323 11922 63431736
Cytokine storm 31.31 16.51 11 45353 325 63443333
Immune-mediated cystitis 31.22 16.51 5 45359 0 63443658
Immune-mediated uveitis 31.20 16.51 7 45357 35 63443623
Melanoma recurrent 30.58 16.51 9 45355 148 63443510
Thyrotoxic crisis 30.13 16.51 14 45350 862 63442796
Blister 30.08 16.51 29 45335 129785 63313873
Toxic epidermal necrolysis 30.02 16.51 60 45304 25274 63418384
Urticaria 29.97 16.51 45 45319 165757 63277901
Polyglandular autoimmune syndrome type II 29.84 16.51 7 45357 44 63443614
Periarticular thenar erythema with onycholysis 29.58 16.51 7 45357 46 63443612
Arthralgia 29.41 16.51 263 45101 569447 62874211
Metastases to meninges 29.38 16.51 20 45344 2582 63441076
Ascites 29.02 16.51 79 45285 40649 63403009
Metastases to adrenals 28.75 16.51 13 45351 752 63442906
EGFR gene mutation 28.74 16.51 10 45354 287 63443371
Alanine aminotransferase increased 28.50 16.51 148 45216 103622 63340036
Pain in extremity 28.39 16.51 131 45233 331355 63112303
Skin disorder 28.17 16.51 64 45300 29443 63414215
Knee arthroplasty 28.07 16.51 3 45361 54203 63389455
Meningitis aseptic 27.99 16.51 25 45339 4798 63438860
Intentional product misuse 27.72 16.51 5 45359 60912 63382746
Haemophagocytic lymphohistiocytosis 27.63 16.51 36 45328 10591 63433067
Folliculitis 27.56 16.51 8 45356 70309 63373349
Metastatic malignant melanoma 27.50 16.51 15 45349 1300 63442358
Diabetes mellitus 27.38 16.51 95 45269 55715 63387943
Impaired healing 27.33 16.51 20 45344 102522 63341136
Drug effective for unapproved indication 26.93 16.51 21 45343 3343 63440315
Cutaneous sarcoidosis 26.68 16.51 10 45354 357 63443301
Amputation stump pain 26.58 16.51 6 45358 31 63443627
Nephropathy toxic 26.04 16.51 33 45331 9446 63434212
Neurofibrosarcoma 25.91 16.51 8 45356 156 63443502
Hepatocellular injury 25.71 16.51 59 45305 27322 63416336
Hepatic failure 25.25 16.51 69 45295 35587 63408071
Radiation associated pain 25.03 16.51 7 45357 95 63443563
Cardiomyopathy 24.99 16.51 45 45319 17539 63426119
Autoimmune endocrine disorder 24.98 16.51 4 45360 0 63443658
Autoimmune cholangitis 24.83 16.51 5 45359 13 63443645
Taste disorder 24.79 16.51 39 45325 13623 63430035
Upper respiratory tract infection 24.60 16.51 14 45350 82033 63361625
Mixed deafness 24.30 16.51 5 45359 15 63443643
Erythema multiforme 24.21 16.51 33 45331 10136 63433522
Gastric perforation 24.09 16.51 15 45349 1664 63441994
Gastrooesophageal reflux disease 23.79 16.51 20 45344 95619 63348039
Malignant ascites 23.69 16.51 12 45352 894 63442764
Disseminated intravascular coagulation 23.64 16.51 46 45318 19005 63424653
Tumour pain 23.61 16.51 14 45350 1423 63442235
Dyspnoea 23.56 16.51 332 45032 660981 62782677
Morphoea 23.53 16.51 9 45355 340 63443318
Cancer pain 23.50 16.51 19 45345 3186 63440472
Cardiac failure congestive 23.40 16.51 19 45345 92414 63351244
Blood pressure abnormal 23.02 16.51 40 45324 15158 63428500
Stress cardiomyopathy 23.01 16.51 31 45333 9419 63434239
KL-6 increased 22.95 16.51 6 45358 62 63443596
Hyperhidrosis 22.83 16.51 26 45338 107810 63335848
Immune-mediated cytopenia 22.81 16.51 5 45359 22 63443636
Stomatitis 22.53 16.51 173 45191 138552 63305106
Neonatal respiratory depression 22.52 16.51 6 45358 67 63443591
Transaminases increased 22.51 16.51 61 45303 31306 63412352
Blood alkaline phosphatase abnormal 22.50 16.51 10 45354 555 63443103
Sarcoid-like reaction 22.45 16.51 5 45359 24 63443634
Blood corticotrophin increased 22.44 16.51 6 45358 68 63443590
Infection 22.43 16.51 86 45278 229087 63214571
Cardiac tamponade 22.42 16.51 22 45342 4753 63438905
Thyroid hormones decreased 22.33 16.51 9 45355 391 63443267
Renal arteriosclerosis 22.21 16.51 6 45358 71 63443587
Cerebral infarction 21.90 16.51 51 45313 23842 63419816
Tumour necrosis 21.86 16.51 11 45353 808 63442850
Positron emission tomogram abnormal 21.74 16.51 8 45356 271 63443387
Cortisol increased 21.72 16.51 9 45355 420 63443238
Oligodipsia 21.52 16.51 5 45359 30 63443628
Stevens-Johnson syndrome 21.51 16.51 52 45312 24898 63418760
Hip arthroplasty 21.49 16.51 4 45360 47642 63396016
Nasal congestion 21.47 16.51 10 45354 65650 63378008
Ileus 21.33 16.51 38 45326 14687 63428971
Thyroid hormones increased 20.97 16.51 9 45355 459 63443199
Silent thyroiditis 20.90 16.51 6 45358 90 63443568
BRAF V600E mutation positive 20.85 16.51 5 45359 35 63443623
Rash morbilliform 20.83 16.51 18 45346 3307 63440351
Ophthalmoplegia 20.81 16.51 13 45351 1451 63442207
Stress 20.80 16.51 11 45353 67156 63376502
Coma 20.75 16.51 10 45354 64354 63379304
Fistula 20.73 16.51 31 45333 10362 63433296
Adverse drug reaction 20.66 16.51 16 45348 79698 63363960
Circumstance or information capable of leading to medication error 20.39 16.51 19 45345 3851 63439807
Hypoaesthesia 20.04 16.51 58 45306 168335 63275323
Troponin T increased 20.03 16.51 12 45352 1242 63442416
Joint stiffness 20.03 16.51 3 45361 41866 63401792
Palpitations 19.99 16.51 31 45333 112739 63330919
General physical health deterioration 19.99 16.51 226 45138 201176 63242482
Aortic embolus 19.95 16.51 5 45359 43 63443615
Burning sensation 19.89 16.51 7 45357 54400 63389258
Unevaluable event 19.86 16.51 6 45358 51380 63392278
Drug eruption 19.79 16.51 55 45309 28639 63415019
Meningitis 19.74 16.51 25 45339 7152 63436506
Urinary tract infection enterococcal 19.71 16.51 16 45348 2697 63440961
Fluid retention 19.66 16.51 9 45355 59677 63383981
Wrong technique in product usage process 19.62 16.51 10 45354 62330 63381328
Lung adenocarcinoma recurrent 19.44 16.51 4 45360 12 63443646
Tremor 19.29 16.51 41 45323 132198 63311460
Renal failure 19.26 16.51 147 45217 117505 63326153
Autoimmune uveitis 19.20 16.51 4 45360 13 63443645
Inflammatory marker increased 19.09 16.51 24 45340 6815 63436843
Therapeutic product effect incomplete 18.89 16.51 38 45326 125018 63318640
Pain in jaw 18.89 16.51 4 45360 43492 63400166
Autoimmune dermatitis 18.88 16.51 6 45358 129 63443529
Ulcerative duodenitis 18.73 16.51 3 45361 0 63443658
Autoimmune pericarditis 18.73 16.51 3 45361 0 63443658
International normalised ratio increased 18.72 16.51 5 45359 46420 63397238
Metastases to lung 18.59 16.51 33 45331 12717 63430941
Anxiety 18.59 16.51 86 45278 217455 63226203
Autoimmune thyroid disorder 18.55 16.51 4 45360 16 63443642
Paraneoplastic syndrome 18.51 16.51 9 45355 614 63443044
Duodenal perforation 18.44 16.51 10 45354 857 63442801
Gait disturbance 18.40 16.51 68 45296 183110 63260548
Primary adrenal insufficiency 18.34 16.51 6 45358 142 63443516
Blood thyroid stimulating hormone abnormal 18.25 16.51 10 45354 874 63442784
Encephalitis autoimmune 18.16 16.51 12 45352 1474 63442184
Malignant pleural effusion 18.16 16.51 15 45349 2591 63441067
Rectal perforation 18.12 16.51 8 45356 437 63443221
Optic neuritis 18.04 16.51 26 45338 8409 63435249
Paraesthesia 18.00 16.51 55 45309 156911 63286747
Eyelid ptosis 17.94 16.51 24 45340 7243 63436415
Nephrotic syndrome 17.89 16.51 21 45343 5555 63438103
Febrile bone marrow aplasia 17.79 16.51 24 45340 7301 63436357
Therapeutic response decreased 17.73 16.51 11 45353 61514 63382144
Renal haemorrhage 17.64 16.51 10 45354 934 63442724
Cardiac dysfunction 17.56 16.51 14 45350 2301 63441357
Peritonitis 17.26 16.51 38 45326 17116 63426542
Haemolytic anaemia 17.13 16.51 28 45336 10097 63433561
Toxic skin eruption 17.08 16.51 32 45332 12853 63430805
Pancreatic failure 17.08 16.51 10 45354 993 63442665
Aplasia 17.04 16.51 18 45346 4241 63439417
Duodenitis 17.00 16.51 17 45347 3758 63439900
Cholecystitis acute 17.00 16.51 25 45339 8235 63435423
Chest pain 16.93 16.51 88 45276 215871 63227787
Loss of consciousness 16.91 16.51 37 45327 118084 63325574
Antinuclear antibody 16.84 16.51 8 45356 518 63443140
Peripheral motor neuropathy 16.82 16.51 12 45352 1669 63441989
Sarcoidosis 16.79 16.51 23 45341 7099 63436559
Road traffic accident 16.68 16.51 3 45361 36629 63407029
Bilirubin conjugated abnormal 16.66 16.51 3 45361 3 63443655
Pericarditis malignant 16.66 16.51 3 45361 3 63443655

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 3799.06 13.75 2042 48240 86004 34820645
Immune-mediated adverse reaction 869.78 13.75 195 50087 385 34906264
Immune-mediated hepatic disorder 794.12 13.75 202 50080 821 34905828
Pneumonitis 554.32 13.75 429 49853 33449 34873200
Immune-mediated enterocolitis 546.67 13.75 190 50092 2609 34904040
Interstitial lung disease 536.06 13.75 560 49722 64722 34841927
Immune-mediated myocarditis 521.02 13.75 137 50145 652 34905997
Immune-mediated lung disease 471.56 13.75 148 50134 1443 34905206
Product use in unapproved indication 458.05 13.75 694 49588 116805 34789844
Hypothyroidism 395.76 13.75 289 49993 20613 34886036
Tumour pseudoprogression 394.30 13.75 100 50182 400 34906249
Immune-mediated hepatitis 381.65 13.75 137 50145 2078 34904571
Therapy partial responder 367.30 13.75 207 50075 9409 34897240
Adrenal insufficiency 347.60 13.75 229 50053 13818 34892831
Colitis 336.98 13.75 339 49943 37411 34869238
Immune-mediated hypothyroidism 305.00 13.75 74 50208 235 34906414
Type 1 diabetes mellitus 267.35 13.75 128 50154 4130 34902519
Immune-mediated renal disorder 259.26 13.75 57 50225 98 34906551
Myasthenia gravis 255.85 13.75 146 50136 6794 34899855
Tubulointerstitial nephritis 237.29 13.75 215 50067 20809 34885840
Death 237.24 13.75 1163 49119 396886 34509763
Immune-mediated arthritis 230.48 13.75 49 50233 65 34906584
Product use issue 229.79 13.75 362 49920 62854 34843795
Myocarditis 229.52 13.75 176 50106 13506 34893143
Immune-mediated myositis 215.90 13.75 89 50193 1994 34904655
Adrenocorticotropic hormone deficiency 203.24 13.75 69 50213 878 34905771
Adverse event 199.32 13.75 186 50096 18691 34887958
Myositis 195.33 13.75 152 50130 11918 34894731
Hypophysitis 194.80 13.75 85 50197 2201 34904448
Myelosuppression 173.60 13.75 174 50108 19091 34887558
Neoplasm progression 169.95 13.75 188 50094 23112 34883537
Autoimmune hepatitis 166.83 13.75 94 50188 4266 34902383
Immune-mediated dermatitis 162.34 13.75 46 50236 303 34906346
Hyperthyroidism 155.82 13.75 126 50156 10440 34896209
Drug interaction 152.86 13.75 67 50215 225879 34680770
Hepatitis 145.98 13.75 176 50106 23728 34882921
Hepatic function abnormal 136.77 13.75 236 50046 44127 34862522
Pemphigoid 135.59 13.75 107 50175 8559 34898090
Tumour hyperprogression 132.53 13.75 30 50252 63 34906586
Immune-mediated thyroiditis 130.86 13.75 32 50250 106 34906543
Immune-mediated pancreatitis 126.01 13.75 31 50251 106 34906543
Thyroiditis 124.40 13.75 63 50219 2299 34904350
Off label use 123.28 13.75 1025 49257 418499 34488150
Vitiligo 120.96 13.75 47 50235 897 34905752
Eastern Cooperative Oncology Group performance status worsened 114.50 13.75 46 50236 962 34905687
Nephritis 113.62 13.75 60 50222 2391 34904258
Completed suicide 110.42 13.75 8 50274 98160 34808489
Autoimmune colitis 107.37 13.75 44 50238 970 34905679
Overdose 103.63 13.75 7 50275 91052 34815597
Fall 101.18 13.75 86 50196 202799 34703850
Decreased appetite 100.35 13.75 489 49793 165903 34740746
Pulmonary toxicity 92.10 13.75 74 50208 6073 34900576
Immune-mediated adrenal insuficiency 87.33 13.75 24 50258 139 34906510
Palmar-plantar erythrodysaesthesia syndrome 87.12 13.75 114 50168 16681 34889968
Immune-mediated nephritis 83.58 13.75 28 50254 341 34906308
Secondary adrenocortical insufficiency 82.69 13.75 41 50241 1429 34905220
Immune-mediated encephalitis 82.52 13.75 25 50257 214 34906435
Lichenoid keratosis 82.46 13.75 49 50233 2459 34904190
Cholangitis sclerosing 81.02 13.75 40 50242 1381 34905268
Dizziness 80.12 13.75 119 50163 218402 34688247
Haemophagocytic lymphohistiocytosis 79.96 13.75 96 50186 12877 34893772
Inappropriate schedule of product administration 78.51 13.75 232 50050 62064 34844585
Skin toxicity 76.84 13.75 60 50222 4724 34901925
Hypertransaminasaemia 76.67 13.75 64 50218 5542 34901107
Diabetic ketoacidosis 76.39 13.75 111 50171 17921 34888728
Immune-mediated gastritis 75.32 13.75 17 50265 35 34906614
Polymyalgia rheumatica 72.94 13.75 38 50244 1472 34905177
Immune thrombocytopenia 72.21 13.75 77 50205 9075 34897574
Immune-mediated cholangitis 72.17 13.75 20 50262 120 34906529
Thyroid disorder 71.77 13.75 49 50233 3133 34903516
Toxic epidermal necrolysis 71.76 13.75 119 50163 21527 34885122
Renal impairment 71.30 13.75 297 49985 94216 34812433
Hypopituitarism 70.92 13.75 43 50239 2239 34904410
Diarrhoea 68.52 13.75 858 49424 389054 34517595
Cholangitis 66.61 13.75 72 50210 8617 34898032
Immune-mediated cytopenia 66.54 13.75 14 50268 17 34906632
Immune-mediated hypophysitis 65.50 13.75 17 50265 76 34906573
Headache 65.35 13.75 118 50164 200517 34706132
Toxicity to various agents 64.23 13.75 119 50163 200243 34706406
Adrenal disorder 63.44 13.75 31 50251 1046 34905603
Blood thyroid stimulating hormone increased 61.16 13.75 50 50232 4205 34902444
Dysphonia 58.85 13.75 114 50168 23269 34883380
Proteinuria 57.18 13.75 99 50183 18543 34888106
Autoimmune hypothyroidism 55.16 13.75 13 50269 35 34906614
Eosinophilic fasciitis 54.85 13.75 15 50267 85 34906564
Pneumonia bacterial 54.58 13.75 76 50206 11796 34894853
Pericarditis malignant 54.38 13.75 13 50269 38 34906611
Insomnia 54.26 13.75 42 50240 103865 34802784
Fulminant type 1 diabetes mellitus 53.55 13.75 26 50256 865 34905784
Hepatotoxicity 53.16 13.75 104 50178 21381 34885268
Hypothalamo-pituitary disorder 52.24 13.75 25 50257 805 34905844
Organising pneumonia 52.00 13.75 53 50229 5926 34900723
Autoimmune arthritis 51.86 13.75 13 50269 49 34906600
Eyelid ptosis 51.77 13.75 52 50230 5714 34900935
Depression 51.02 13.75 39 50243 97059 34809590
Intentional product misuse 50.46 13.75 4 50278 45607 34861042
Hypotension 50.16 13.75 158 50124 221491 34685158
Agitation 49.44 13.75 11 50271 57388 34849261
Myasthenic syndrome 49.36 13.75 21 50261 510 34906139
Bradycardia 48.35 13.75 24 50258 75394 34831255
Cardiac failure congestive 48.32 13.75 30 50252 83240 34823409
Colitis microscopic 48.05 13.75 34 50248 2303 34904346
Subacute cutaneous lupus erythematosus 47.78 13.75 25 50257 977 34905672
Immune-mediated uveitis 46.92 13.75 12 50270 50 34906599
Autoimmune nephritis 46.80 13.75 17 50265 267 34906382
Encephalitis autoimmune 46.71 13.75 22 50260 683 34905966
Autoimmune myocarditis 46.06 13.75 16 50266 219 34906430
Stevens-Johnson syndrome 45.84 13.75 90 50192 18549 34888100
Rash 45.51 13.75 505 49777 222247 34684402
Tumour haemorrhage 45.10 13.75 36 50246 2926 34903723
Blood thyroid stimulating hormone abnormal 45.00 13.75 18 50264 372 34906277
Hepatic cytolysis 44.48 13.75 77 50205 14419 34892230
Electrocardiogram QT prolonged 44.18 13.75 4 50278 40948 34865701
Autoimmune thyroiditis 44.07 13.75 25 50257 1149 34905500
Drug hypersensitivity 44.04 13.75 31 50251 80498 34826151
Pain in extremity 43.34 13.75 72 50210 126441 34780208
Plasma cell myeloma 43.03 13.75 5 50277 42032 34864617
Hypersensitivity pneumonitis 41.87 13.75 27 50255 1568 34905081
Anxiety 41.62 13.75 49 50233 99379 34807270
Injection site pain 41.57 13.75 4 50278 39001 34867648
Hospitalisation 41.44 13.75 15 50267 56887 34849762
International normalised ratio increased 40.90 13.75 9 50273 47318 34859331
Nasopharyngitis 40.88 13.75 25 50257 69943 34836706
Encephalitis 40.25 13.75 51 50231 7226 34899423
Haemoglobin decreased 40.20 13.75 70 50212 120702 34785947
Prostate cancer 39.89 13.75 5 50277 39644 34867005
Aggression 38.99 13.75 5 50277 38959 34867690
Hallucination 38.49 13.75 13 50269 51485 34855164
Muscle spasms 38.28 13.75 31 50251 74970 34831679
Radiation pneumonitis 37.90 13.75 31 50251 2609 34904040
Enteritis 37.24 13.75 52 50230 8090 34898559
Autoimmune pancreatitis 37.06 13.75 15 50267 320 34906329
Hypersensitivity 36.80 13.75 21 50261 61014 34845635
Immune-mediated endocrinopathy 36.76 13.75 9 50273 30 34906619
Drug eruption 36.18 13.75 85 50197 19813 34886836
Liver disorder 36.07 13.75 117 50165 32880 34873769
Unevaluable event 35.65 13.75 3 50279 32587 34874062
Hyperhidrosis 35.36 13.75 34 50248 75658 34830991
Tremor 35.32 13.75 40 50242 82547 34824102
Immune-mediated neuropathy 35.28 13.75 9 50273 37 34906612
Syncope 35.22 13.75 48 50234 91403 34815246
Autoimmune lung disease 34.90 13.75 9 50273 39 34906610
Joint swelling 34.16 13.75 22 50260 59868 34846781
Pleural effusion 33.89 13.75 217 50065 81329 34825320
Pericardial effusion 33.11 13.75 94 50188 24568 34882081
Seizure 32.90 13.75 63 50219 104794 34801855
Musculoskeletal stiffness 32.83 13.75 13 50269 46667 34859982
Melanoma recurrent 32.32 13.75 11 50271 141 34906508
Pain 32.32 13.75 168 50114 204507 34702142
Taste disorder 31.69 13.75 45 50237 7110 34899539
Cancer pain 31.45 13.75 28 50254 2644 34904005
Lymphocytic hypophysitis 31.21 13.75 13 50269 299 34906350
Lung disorder 30.95 13.75 115 50167 34581 34872068
Malignant pleural effusion 30.78 13.75 22 50260 1514 34905135
Paraneoplastic neurological syndrome 30.60 13.75 8 50274 37 34906612
Mucosal inflammation 30.36 13.75 123 50159 38499 34868150
Urticaria 30.34 13.75 27 50255 62350 34844299
Condition aggravated 30.20 13.75 158 50124 192038 34714611
Lymphangiosis carcinomatosa 30.09 13.75 18 50264 914 34905735
Chest discomfort 29.80 13.75 21 50261 54509 34852140
Treatment noncompliance 29.63 13.75 3 50279 28097 34878552
Drug-induced liver injury 29.52 13.75 100 50182 28732 34877917
Radiation necrosis 29.40 13.75 10 50272 128 34906521
Drug ineffective 29.25 13.75 472 49810 456279 34450370
Cardiac arrest 29.11 13.75 59 50223 96100 34810549
Lichen planus 28.94 13.75 18 50264 981 34905668
Somnolence 28.92 13.75 74 50208 111042 34795607
Blood corticotrophin decreased 28.65 13.75 11 50271 203 34906446
Coma 28.57 13.75 15 50267 45663 34860986
Immune-mediated hyperthyroidism 28.32 13.75 8 50274 52 34906597
Myocardial infarction 28.27 13.75 85 50197 121000 34785649
Primary biliary cholangitis 28.11 13.75 11 50271 214 34906435
Bacterial diarrhoea 27.94 13.75 8 50274 55 34906594
Stress 27.83 13.75 5 50277 30342 34876307
Primary hypothyroidism 27.81 13.75 8 50274 56 34906593
Immune-mediated neurological disorder 27.73 13.75 5 50277 0 34906649
Tumour associated fever 27.15 13.75 13 50269 419 34906230
Metastases to central nervous system 27.04 13.75 45 50237 8160 34898489
Radiotherapy 26.98 13.75 13 50269 425 34906224
Pancytopenia 26.86 13.75 231 50051 94926 34811723
Miller Fisher syndrome 26.61 13.75 9 50273 113 34906536
Abdominal distension 26.48 13.75 27 50255 58465 34848184
Optic neuritis 26.32 13.75 29 50253 3545 34903104
Coronary artery disease 25.87 13.75 19 50263 48286 34858363
Hypertension 25.84 13.75 305 49977 136138 34770511
Flagellate dermatitis 25.66 13.75 8 50274 76 34906573
Loss of consciousness 25.64 13.75 50 50232 82617 34824032
Heart rate decreased 25.55 13.75 7 50275 31738 34874911
Autoimmune uveitis 25.38 13.75 5 50277 3 34906646
Upper respiratory tract infection 25.31 13.75 8 50274 33051 34873598
Autoimmune myositis 25.28 13.75 9 50273 133 34906516
Neutropenia 25.24 13.75 340 49942 156438 34750211
Dermatomyositis 24.85 13.75 18 50264 1265 34905384
KL-6 increased 24.59 13.75 7 50275 47 34906602
Dermatitis psoriasiform 24.54 13.75 19 50263 1477 34905172
Product dose omission issue 24.52 13.75 89 50193 119622 34787027
Hepatocellular injury 24.49 13.75 79 50203 22132 34884517
Cryptitis 24.17 13.75 10 50272 226 34906423
Stomatitis 24.15 13.75 123 50159 42391 34864258
Autoimmune haemolytic anaemia 24.06 13.75 31 50251 4465 34902184
Limbic encephalitis 23.87 13.75 12 50270 431 34906218
Intestinal intraepithelial lymphocytes increased 23.70 13.75 9 50273 161 34906488
Guillain-Barre syndrome 23.66 13.75 36 50246 6051 34900598
Respiratory failure 23.42 13.75 249 50033 108323 34798326
Latent autoimmune diabetes in adults 23.20 13.75 7 50275 59 34906590
Thrombocytopenia 23.19 13.75 334 49948 155913 34750736
Immune-mediated cystitis 23.09 13.75 6 50276 27 34906622
Chest pain 22.94 13.75 99 50183 126663 34779986
Gastrooesophageal reflux disease 22.92 13.75 13 50269 37911 34868738
Pericardial effusion malignant 22.91 13.75 6 50276 28 34906621
Silent thyroiditis 22.70 13.75 7 50275 64 34906585
Heart rate increased 22.60 13.75 20 50262 46323 34860326
Skin disorder 22.59 13.75 56 50226 13499 34893150
Body surface area decreased 22.59 13.75 5 50277 9 34906640
Tumour necrosis 22.54 13.75 17 50265 1271 34905378
Drug effective for unapproved indication 22.51 13.75 23 50259 2579 34904070
Pyrexia 22.42 13.75 632 49650 332381 34574268
Wrong technique in product usage process 22.24 13.75 12 50270 35974 34870675
Pneumocystis test positive 22.18 13.75 4 50278 0 34906649
Blood thyroid stimulating hormone decreased 22.18 13.75 20 50262 1921 34904728
Loss of personal independence in daily activities 22.11 13.75 10 50272 33169 34873480
Glomerulonephritis rapidly progressive 22.01 13.75 13 50269 645 34906004
Rash maculo-papular 21.88 13.75 90 50192 28361 34878288
Medication error 21.81 13.75 5 50277 25560 34881089
Meningitis aseptic 21.76 13.75 25 50257 3199 34903450
Apoptosis 21.75 13.75 11 50271 400 34906249
Cardiac tamponade 21.69 13.75 32 50250 5234 34901415
Transaminases increased 21.54 13.75 86 50196 26737 34879912
Paraneoplastic syndrome 21.36 13.75 12 50270 541 34906108
Sinusitis 21.26 13.75 17 50265 41385 34865264
Contusion 21.22 13.75 13 50269 36351 34870298
Trichoglossia 21.01 13.75 10 50272 318 34906331
Swelling 21.01 13.75 18 50264 42348 34864301
Thyroid function test abnormal 20.88 13.75 13 50269 710 34905939
Therapeutic product effect decreased 20.87 13.75 12 50270 34731 34871918
Metastases to skin 20.76 13.75 11 50271 441 34906208
Confusional state 20.72 13.75 122 50160 144038 34762611
Abdominal pain upper 20.68 13.75 45 50237 71445 34835204
Blood pressure systolic increased 20.58 13.75 4 50278 22948 34883701
Abdominal discomfort 20.52 13.75 34 50248 59801 34846848
Small intestinal perforation 20.27 13.75 20 50262 2151 34904498
Influenza 20.21 13.75 25 50257 49641 34857008
Mobility decreased 20.20 13.75 9 50273 30119 34876530
Dermatitis 20.07 13.75 43 50239 9425 34897224
Cortisol decreased 20.00 13.75 15 50267 1112 34905537
Haematoma 19.95 13.75 6 50276 25599 34881050
Injury 19.88 13.75 3 50279 20684 34885965
Autoimmune neuropathy 19.84 13.75 6 50276 51 34906598
Fluid retention 19.72 13.75 7 50275 26880 34879769
Autoimmune disorder 19.55 13.75 18 50264 1776 34904873
Respiratory arrest 19.41 13.75 8 50274 28035 34878614
Duodenitis 19.40 13.75 29 50253 4799 34901850
Adrenocortical insufficiency acute 19.30 13.75 17 50265 1583 34905066
Tumour embolism 19.25 13.75 6 50276 57 34906592
Right ventricular ejection fraction decreased 19.25 13.75 6 50276 57 34906592
Abnormal behaviour 19.19 13.75 6 50276 24963 34881686
Weight increased 19.16 13.75 69 50213 92964 34813685
Cortisol increased 19.05 13.75 8 50274 188 34906461
Asthma 18.95 13.75 20 50262 42636 34864013
Mixed liver injury 18.92 13.75 22 50260 2851 34903798
Nephrolithiasis 18.91 13.75 10 50272 30323 34876326
Microvillous inclusion disease 18.89 13.75 8 50274 192 34906457
Melaena 18.84 13.75 14 50268 35366 34871283
Angina pectoris 18.60 13.75 11 50271 31352 34875297
Ventricular fibrillation 18.59 13.75 5 50277 22949 34883700
Psychotic disorder 18.57 13.75 6 50276 24446 34882203
Non-small cell lung cancer stage III 18.53 13.75 4 50278 6 34906643
Lactic acidosis 18.20 13.75 14 50268 34758 34871891
Feeling hot 18.19 13.75 3 50279 19369 34887280
Tumour pain 18.14 13.75 14 50268 1083 34905566
Pneumocystis jirovecii pneumonia 18.14 13.75 66 50216 19644 34887005
Probiotic therapy 18.04 13.75 7 50275 133 34906516
Depressed level of consciousness 18.03 13.75 21 50261 42820 34863829
Pulmonary sarcoidosis 17.93 13.75 11 50271 585 34906064
Thyroid hormones increased 17.91 13.75 6 50276 73 34906576
Intentional product use issue 17.84 13.75 37 50245 59779 34846870
Blood pressure fluctuation 17.80 13.75 7 50275 25242 34881407
Lung lobectomy 17.77 13.75 5 50277 32 34906617
Peripheral swelling 17.66 13.75 54 50228 76487 34830162
Cholecystitis 17.65 13.75 44 50238 10644 34896005
Vascular access complication 17.63 13.75 9 50273 334 34906315
Myasthenia gravis crisis 17.42 13.75 11 50271 616 34906033
General physical health deterioration 17.38 13.75 270 50012 127999 34778650
Pancreatic failure 17.31 13.75 12 50270 786 34905863
Cutaneous sarcoidosis 17.18 13.75 7 50275 152 34906497
Atrioventricular block complete 17.14 13.75 40 50242 9279 34897370
Anaemia 17.13 13.75 448 49834 232887 34673762
Therapeutic product effect incomplete 17.07 13.75 29 50253 50512 34856137
Keratoacanthoma 17.05 13.75 11 50271 639 34906010
Tinnitus 17.03 13.75 4 50278 20114 34886535
Nasal congestion 16.91 13.75 6 50276 23051 34883598
Cachexia 16.83 13.75 34 50248 7152 34899497
Drug intolerance 16.81 13.75 38 50244 59532 34847117
Serotonin syndrome 16.80 13.75 4 50278 19929 34886720
Vomiting 16.75 13.75 253 50029 247368 34659281
Wheezing 16.68 13.75 21 50261 41381 34865268
Transitional cell carcinoma recurrent 16.66 13.75 4 50278 12 34906637
Acquired tracheo-oesophageal fistula 16.65 13.75 6 50276 92 34906557
Autoimmune cholangitis 16.64 13.75 3 50279 0 34906649
Overgrowth fungal 16.64 13.75 3 50279 0 34906649
Oesophagomediastinal fistula 16.64 13.75 3 50279 0 34906649
Arthropathy 16.58 13.75 9 50273 26898 34879751
Blood pressure increased 16.43 13.75 68 50214 88034 34818615
Palpitations 16.40 13.75 20 50262 39966 34866683
Weight abnormal 16.35 13.75 11 50271 686 34905963
Transitional cell carcinoma metastatic 16.28 13.75 5 50277 45 34906604
Blood corticotrophin increased 16.24 13.75 6 50276 99 34906550
Cardiac disorder 16.23 13.75 23 50259 43103 34863546
Dyskinesia 16.16 13.75 6 50276 22407 34884242
Pulmonary hypertension 16.13 13.75 5 50277 20919 34885730
Hypoglycaemia 16.12 13.75 34 50248 54606 34852043
Granulocyte count increased 16.12 13.75 9 50273 401 34906248
Thrombosis 16.09 13.75 30 50252 50428 34856221
Autoimmune encephalopathy 16.09 13.75 5 50277 47 34906602
Dysphagia 15.83 13.75 148 50134 62233 34844416
Endocrine ophthalmopathy 15.81 13.75 5 50277 50 34906599
Metabolic acidosis 15.75 13.75 24 50258 43656 34862993
Thrombophlebitis migrans 15.73 13.75 7 50275 190 34906459
Metastatic malignant melanoma 15.70 13.75 17 50265 2038 34904611
Melanosis 15.57 13.75 4 50278 17 34906632
Gliosis 15.50 13.75 7 50275 197 34906452
Chronic kidney disease 15.49 13.75 22 50260 41188 34865461
Biopsy 15.47 13.75 8 50274 305 34906344
Ophthalmoplegia 15.44 13.75 16 50266 1824 34904825
Neutrophil count decreased 15.44 13.75 126 50156 50978 34855671
Lung opacity 15.43 13.75 18 50264 2341 34904308
Immune-mediated encephalopathy 15.39 13.75 4 50278 18 34906631
Adrenalitis 15.39 13.75 4 50278 18 34906631
Disorientation 15.38 13.75 15 50267 33173 34873476
Recurrent cancer 15.27 13.75 14 50268 1373 34905276
Haemoglobin abnormal 15.16 13.75 23 50259 3857 34902792
Anti-thyroid antibody positive 15.07 13.75 5 50277 59 34906590
Laryngopharyngitis 15.05 13.75 4 50278 20 34906629
Lymph node abscess 15.05 13.75 4 50278 20 34906629
Catheter site rash 14.96 13.75 7 50275 214 34906435
Diffuse panbronchiolitis 14.56 13.75 3 50279 3 34906646
Immune-mediated oesophagitis 14.56 13.75 3 50279 3 34906646
Seronegative arthritis 14.49 13.75 12 50270 1027 34905622
Retroperitoneal lymphadenopathy 14.34 13.75 11 50271 843 34905806
Oesophageal carcinoma recurrent 14.16 13.75 4 50278 26 34906623
Systemic scleroderma 14.15 13.75 8 50274 365 34906284
Large intestine perforation 14.04 13.75 35 50247 8468 34898181
Balance disorder 14.03 13.75 23 50259 40631 34866018
Sleep disorder 13.92 13.75 15 50267 31673 34874976
Lymphadenectomy 13.88 13.75 8 50274 379 34906270
Platelet count abnormal 13.87 13.75 19 50263 2903 34903746
Treatment failure 13.83 13.75 29 50253 46668 34859981
Leukoderma 13.79 13.75 5 50277 78 34906571
Migraine 13.79 13.75 4 50278 17474 34889175
Febrile bone marrow aplasia 13.77 13.75 34 50248 8175 34898474

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 6632.62 13.52 3099 80664 132891 79527734
Hypothyroidism 1288.05 13.52 758 83005 51634 79608991
Immune-mediated hepatic disorder 1279.51 13.52 304 83459 1290 79659335
Immune-mediated adverse reaction 1203.47 13.52 260 83503 634 79659991
Immune-mediated enterocolitis 901.02 13.52 293 83470 4537 79656088
Immune-mediated myocarditis 833.03 13.52 202 83561 951 79659674
Immune-mediated hypothyroidism 831.87 13.52 182 83581 481 79660144
Immune-mediated lung disease 726.77 13.52 209 83554 2081 79658544
Pneumonitis 705.52 13.52 553 83210 60307 79600318
Interstitial lung disease 673.90 13.52 705 83058 111895 79548730
Product use in unapproved indication 655.13 13.52 1039 82724 249320 79411305
Immune-mediated hepatitis 646.46 13.52 213 83550 3443 79657182
Tumour pseudoprogression 637.12 13.52 147 83616 532 79660093
Myocarditis 620.76 13.52 347 83416 21386 79639239
Colitis 562.91 13.52 526 83237 72781 79587844
Therapy partial responder 541.49 13.52 294 83469 17103 79643522
Adrenal insufficiency 541.30 13.52 350 83413 28137 79632488
Type 1 diabetes mellitus 483.77 13.52 204 83559 6715 79653910
Tubulointerstitial nephritis 468.13 13.52 359 83404 37876 79622749
Hyperthyroidism 405.08 13.52 266 83497 21943 79638682
Thyroiditis 401.30 13.52 159 83604 4446 79656179
Immune-mediated dermatitis 388.78 13.52 96 83667 494 79660131
Adrenocorticotropic hormone deficiency 384.72 13.52 114 83649 1271 79659354
Hypophysitis 384.68 13.52 150 83613 4016 79656609
Death 372.81 13.52 1372 82391 565142 79095483
Myasthenia gravis 343.91 13.52 183 83580 10216 79650409
Immune-mediated thyroiditis 337.53 13.52 75 83688 218 79660407
Immune-mediated renal disorder 333.50 13.52 69 83694 124 79660501
Myositis 331.24 13.52 222 83541 18946 79641679
Immune-mediated arthritis 330.84 13.52 70 83693 148 79660477
Palmar-plantar erythrodysaesthesia syndrome 318.28 13.52 270 83493 32864 79627761
Hepatitis 315.42 13.52 339 83424 55388 79605237
Myelosuppression 306.94 13.52 288 83475 40008 79620617
Hepatic function abnormal 303.39 13.52 379 83384 72728 79587897
Proteinuria 298.24 13.52 258 83505 32244 79628381
Immune-mediated myositis 282.30 13.52 114 83649 3353 79657272
Hypertension 276.38 13.52 869 82894 330123 79330502
Neoplasm progression 274.38 13.52 304 83459 51378 79609247
Immune-mediated pancreatitis 271.32 13.52 63 83700 236 79660389
Vitiligo 241.96 13.52 89 83674 2020 79658605
Completed suicide 226.28 13.52 7 83756 245760 79414865
Autoimmune hepatitis 221.86 13.52 144 83619 11639 79648986
Decreased appetite 214.23 13.52 817 82946 341601 79319024
Drug interaction 203.22 13.52 91 83672 415092 79245533
Autoimmune colitis 203.00 13.52 73 83690 1550 79659075
Lichenoid keratosis 194.95 13.52 92 83671 3965 79656660
Immune-mediated gastritis 189.25 13.52 39 83724 68 79660557
Fall 187.57 13.52 143 83620 487486 79173139
Blood thyroid stimulating hormone increased 181.20 13.52 118 83645 9590 79651035
Joint swelling 180.57 13.52 41 83722 288605 79372020
Nephritis 179.57 13.52 88 83675 4126 79656499
Dizziness 176.34 13.52 176 83587 526265 79134360
Eastern Cooperative Oncology Group performance status worsened 175.39 13.52 70 83693 1995 79658630
Immune-mediated hyperthyroidism 171.95 13.52 39 83724 128 79660497
Pemphigoid 170.49 13.52 136 83627 15179 79645446
Cholangitis 169.68 13.52 126 83637 12650 79647975
Headache 169.50 13.52 266 83497 653506 79007119
Immune-mediated adrenal insuficiency 166.94 13.52 40 83723 177 79660448
Autoimmune hypothyroidism 166.84 13.52 42 83721 237 79660388
Hepatic cytolysis 163.92 13.52 171 83592 26980 79633645
Tumour hyperprogression 163.80 13.52 39 83724 167 79660458
Pain 163.60 13.52 307 83456 703495 78957130
Off label use 160.60 13.52 1553 82210 905662 78754963
Renal impairment 157.76 13.52 442 83321 157341 79503284
Fulminant type 1 diabetes mellitus 157.00 13.52 59 83704 1424 79659201
Product use issue 152.51 13.52 526 83237 209296 79451329
Neutropenia 152.28 13.52 652 83111 287058 79373567
Contraindicated product administered 150.60 13.52 3 83760 157535 79503090
Diabetic ketoacidosis 148.08 13.52 181 83582 33941 79626684
Thrombocytopenia 148.06 13.52 611 83152 264648 79395977
Nasopharyngitis 147.35 13.52 42 83721 253839 79406786
Secondary adrenocortical insufficiency 146.83 13.52 69 83694 2945 79657680
Immune-mediated encephalitis 145.70 13.52 43 83720 472 79660153
Drug hypersensitivity 143.85 13.52 67 83696 298849 79361776
Hypopituitarism 141.91 13.52 70 83693 3329 79657296
Platelet count decreased 139.71 13.52 486 83277 194178 79466447
Immune-mediated nephritis 136.99 13.52 42 83721 530 79660095
Skin toxicity 135.77 13.52 93 83670 8221 79652404
Autoimmune thyroiditis 135.76 13.52 73 83690 4160 79656465
Overdose 135.33 13.52 17 83746 184189 79476436
Inappropriate schedule of product administration 134.20 13.52 375 83388 133253 79527372
Pyrexia 131.92 13.52 1186 82577 677523 78983102
Sinusitis 130.03 13.52 24 83739 195477 79465148
Diarrhoea 127.65 13.52 1448 82315 879041 78781584
Immune-mediated cholangitis 122.39 13.52 31 83732 180 79660445
Immune-mediated hypophysitis 122.37 13.52 30 83733 149 79660476
Dysphonia 121.51 13.52 216 83547 56656 79603969
Cholangitis sclerosing 121.20 13.52 58 83705 2579 79658046
Hypersensitivity 116.86 13.52 65 83698 262174 79398451
Abdominal discomfort 116.35 13.52 59 83704 250668 79409957
Arthropathy 115.12 13.52 23 83740 177088 79483537
Injection site pain 114.95 13.52 5 83758 129833 79530792
Swelling 114.86 13.52 42 83721 216669 79443956
Therapeutic product effect decreased 113.62 13.52 18 83745 163845 79496780
Polymyalgia rheumatica 112.25 13.52 66 83697 4471 79656154
Drug intolerance 111.29 13.52 70 83693 264049 79396576
Haemophagocytic lymphohistiocytosis 108.25 13.52 124 83639 21713 79638912
Hypertransaminasaemia 106.02 13.52 93 83670 11831 79648794
Myasthenic syndrome 105.79 13.52 38 83725 804 79659821
Synovitis 105.78 13.52 16 83747 150718 79509907
Toxicity to various agents 105.76 13.52 175 83588 421365 79239260
Hepatotoxicity 102.03 13.52 189 83574 51163 79609462
Immune thrombocytopenia 101.89 13.52 109 83654 17696 79642929
Adverse event 101.80 13.52 207 83556 60007 79600618
Pulmonary toxicity 101.57 13.52 94 83669 12820 79647805
Toxic epidermal necrolysis 100.00 13.52 173 83590 44408 79616217
Tumour associated fever 99.76 13.52 37 83726 860 79659765
Intentional overdose 97.53 13.52 3 83760 105957 79554668
Autoimmune arthritis 97.11 13.52 24 83739 124 79660501
Maternal exposure during pregnancy 96.95 13.52 14 83749 136524 79524101
Condition aggravated 96.81 13.52 242 83521 500882 79159743
Insomnia 96.55 13.52 70 83693 245100 79415525
Thyroid disorder 96.53 13.52 95 83668 13984 79646641
Pancytopenia 94.91 13.52 385 83378 165360 79495265
Depression 94.75 13.52 55 83708 216735 79443890
Musculoskeletal stiffness 94.29 13.52 33 83730 174975 79485650
Contusion 93.23 13.52 21 83742 148755 79511870
Drug ineffective 90.34 13.52 716 83047 1080197 78580428
Radiotherapy 90.10 13.52 31 83732 575 79660050
Peripheral swelling 89.11 13.52 91 83672 269526 79391099
Weight increased 89.01 13.52 96 83667 277290 79383335
Autoimmune nephritis 87.79 13.52 32 83731 707 79659918
Pemphigus 87.61 13.52 4 83759 99578 79561047
Neuropathy peripheral 83.90 13.52 332 83431 140973 79519652
Tumour haemorrhage 83.84 13.52 53 83710 4091 79656534
Subacute cutaneous lupus erythematosus 83.39 13.52 50 83713 3511 79657114
Pleural effusion 82.82 13.52 337 83426 144925 79515700
Hypothalamo-pituitary disorder 82.77 13.52 35 83728 1159 79659466
Immune-mediated cytopenia 82.69 13.52 18 83745 46 79660579
Pain in extremity 81.85 13.52 162 83601 364376 79296249
Eosinophilic fasciitis 81.52 13.52 24 83739 261 79660364
Immune-mediated endocrinopathy 80.98 13.52 17 83746 34 79660591
Acute kidney injury 79.86 13.52 865 82898 518539 79142086
Immune-mediated uveitis 78.95 13.52 19 83744 86 79660539
Adrenal disorder 77.22 13.52 40 83723 2111 79658514
Mobility decreased 77.04 13.52 17 83746 122158 79538467
Blood corticotrophin decreased 76.72 13.52 27 83736 537 79660088
Lymphocytic hypophysitis 76.35 13.52 27 83736 545 79660080
Radiation pneumonitis 76.33 13.52 49 83714 3884 79656741
Anaemia 75.89 13.52 757 83006 444258 79216367
Autoimmune pancreatitis 75.85 13.52 28 83735 642 79659983
Pericardial effusion 75.85 13.52 157 83606 46080 79614545
Wound 75.66 13.52 15 83748 116164 79544461
Muscle spasms 74.00 13.52 46 83717 174684 79485941
Discomfort 72.43 13.52 21 83742 125596 79535029
Autoimmune myocarditis 72.41 13.52 24 83739 395 79660230
Immune-mediated neurological disorder 72.35 13.52 14 83749 14 79660611
Intentional product misuse 71.81 13.52 8 83755 95157 79565468
Intentional product use issue 71.73 13.52 35 83728 152077 79508548
Blood cholesterol increased 71.62 13.52 4 83759 83716 79576909
Eyelid ptosis 71.07 13.52 72 83691 10972 79649653
Pneumonia bacterial 68.86 13.52 93 83670 19238 79641387
Asthma 68.54 13.52 28 83735 135067 79525558
Systemic lupus erythematosus 68.49 13.52 21 83742 121128 79539497
Urticaria 67.68 13.52 57 83706 185144 79475481
Troponin increased 67.62 13.52 92 83671 19163 79641462
Immune-mediated neuropathy 66.90 13.52 15 83748 46 79660579
Pericarditis malignant 66.19 13.52 15 83748 49 79660576
Glossodynia 65.92 13.52 14 83749 103323 79557302
Injury 65.39 13.52 4 83759 77492 79583133
Cholecystitis 64.58 13.52 97 83666 22115 79638510
Migraine 64.41 13.52 8 83755 87485 79573140
Suicidal ideation 64.23 13.52 4 83759 76336 79584289
Bronchitis 63.22 13.52 29 83734 130615 79530010
Neutrophil count decreased 62.54 13.52 229 83534 93730 79566895
Guillain-Barre syndrome 62.40 13.52 61 83702 8904 79651721
Liver disorder 61.92 13.52 192 83571 72225 79588400
Glucocorticoid deficiency 61.83 13.52 24 83739 634 79659991
Gastrointestinal perforation 60.94 13.52 51 83712 6086 79654539
Influenza 60.83 13.52 30 83733 129576 79531049
Rash maculo-papular 59.85 13.52 161 83602 55917 79604708
Treatment failure 58.07 13.52 56 83707 170430 79490195
Enteritis 57.89 13.52 74 83689 14509 79646116
Lichen planus 57.23 13.52 36 83727 2755 79657870
Metastases to central nervous system 57.14 13.52 78 83685 16297 79644328
Loss of personal independence in daily activities 55.82 13.52 19 83744 102561 79558064
Hypotension 55.34 13.52 256 83507 440061 79220564
Mucosal inflammation 55.27 13.52 190 83573 75390 79585235
Lower respiratory tract infection 54.73 13.52 34 83729 129186 79531439
Renal tubular necrosis 54.63 13.52 96 83667 24943 79635682
Cardiac failure congestive 54.30 13.52 42 83721 142360 79518265
Medication error 53.79 13.52 5 83758 68637 79591988
Taste disorder 53.15 13.52 74 83689 15749 79644876
Blood thyroid stimulating hormone abnormal 53.09 13.52 24 83739 936 79659689
International normalised ratio increased 52.98 13.52 12 83751 84709 79575916
Stress 52.42 13.52 10 83753 79602 79581023
Wheezing 51.80 13.52 29 83734 116635 79543990
Bradycardia 51.66 13.52 40 83723 135517 79525108
Osteoarthritis 51.43 13.52 14 83749 87295 79573330
Hepatocellular injury 51.15 13.52 137 83626 47456 79613169
Pulmonary embolism 51.12 13.52 332 83431 171322 79489303
Encephalitis 51.04 13.52 70 83693 14690 79645935
Drug eruption 50.83 13.52 130 83633 43805 79616820
Organising pneumonia 50.68 13.52 60 83703 10879 79649746
Encephalitis autoimmune 50.61 13.52 31 83732 2263 79658362
Anxiety 50.27 13.52 117 83646 248395 79412230
Agitation 50.04 13.52 21 83742 99694 79560931
Cortisol decreased 49.58 13.52 30 83733 2142 79658483
Small intestinal perforation 49.43 13.52 35 83728 3262 79657363
Upper respiratory tract infection 49.41 13.52 17 83746 91151 79569474
Coma 49.23 13.52 22 83741 100627 79559998
Tremor 49.03 13.52 64 83699 170019 79490606
Cancer pain 48.83 13.52 42 83721 5203 79655422
Stevens-Johnson syndrome 48.57 13.52 119 83644 39047 79621578
Meningitis aseptic 47.96 13.52 47 83716 6881 79653744
Hyperhidrosis 46.83 13.52 54 83709 151438 79509187
Arthralgia 46.49 13.52 381 83382 571422 79089203
Amylase increased 46.27 13.52 58 83705 11151 79649474
Respiratory failure 46.23 13.52 337 83426 180574 79480051
Infusion related reaction 46.08 13.52 109 83654 230128 79430497
Syncope 44.45 13.52 75 83688 179374 79481251
Cholestasis 44.39 13.52 138 83625 51971 79608654
Immune-mediated cystitis 44.28 13.52 10 83753 32 79660593
Nasal congestion 43.75 13.52 13 83750 76539 79584086
KL-6 increased 43.62 13.52 13 83750 148 79660477
Cardiac tamponade 43.17 13.52 51 83712 9225 79651400
Heart rate increased 43.06 13.52 38 83725 120686 79539939
Autoimmune haemolytic anaemia 42.23 13.52 48 83715 8332 79652293
Pulmonary sarcoidosis 42.08 13.52 23 83740 1354 79659271
Alopecia 42.07 13.52 115 83648 231240 79429385
Malignant pleural effusion 41.91 13.52 32 83731 3348 79657277
Blood thyroid stimulating hormone decreased 41.87 13.52 40 83723 5676 79654949
Transaminases increased 41.31 13.52 134 83629 51609 79609016
Aspartate aminotransferase increased 41.18 13.52 268 83495 138373 79522252
Unevaluable event 41.12 13.52 5 83758 55580 79605045
Silent thyroiditis 40.90 13.52 13 83750 186 79660439
Polyarthritis 40.89 13.52 57 83706 12145 79648480
Blood pressure systolic increased 40.87 13.52 10 83753 66976 79593649
Cardiac arrest 40.74 13.52 74 83689 172022 79488603
Adrenocortical insufficiency acute 40.38 13.52 30 83733 3013 79657612
Enterocolitis 40.24 13.52 62 83701 14450 79646175
Abdominal pain upper 40.14 13.52 112 83651 223707 79436918
Hallucination 40.00 13.52 20 83743 85725 79574900
Skin disorder 39.85 13.52 101 83662 33842 79626783
Lymphangiosis carcinomatosa 39.75 13.52 26 83737 2128 79658497
Metastatic malignant melanoma 39.73 13.52 29 83734 2834 79657791
Febrile bone marrow aplasia 39.49 13.52 58 83705 12962 79647663
Gastrooesophageal reflux disease 39.42 13.52 31 83732 104215 79556410
Ophthalmoplegia 39.29 13.52 29 83734 2883 79657742
Aggression 39.17 13.52 4 83759 50954 79609671
Paraneoplastic neurological syndrome 38.92 13.52 10 83753 62 79660563
Plasma cell myeloma 38.88 13.52 5 83758 53254 79607371
Chest discomfort 38.71 13.52 53 83710 137991 79522634
Folliculitis 38.56 13.52 6 83757 55374 79605251
Adrenalitis 38.49 13.52 9 83754 35 79660590
Heart rate decreased 38.30 13.52 13 83750 70303 79590322
Therapeutic product effect incomplete 38.12 13.52 56 83707 141589 79519036
Autoimmune cholangitis 37.78 13.52 8 83755 17 79660608
Tumour necrosis 37.43 13.52 24 83739 1898 79658727
Chest pain 37.31 13.52 161 83602 282143 79378482
Palpitations 37.15 13.52 47 83716 126563 79534062
Alanine aminotransferase increased 37.13 13.52 295 83468 162275 79498350
Hypersensitivity pneumonitis 36.98 13.52 31 83732 3708 79656917
Melanoma recurrent 36.92 13.52 13 83750 259 79660366
Loss of consciousness 36.47 13.52 76 83687 167867 79492758
Diabetes mellitus 36.36 13.52 171 83592 78219 79582406
Pneumothorax 36.13 13.52 87 83676 28236 79632389
Large intestine perforation 35.94 13.52 59 83704 14508 79646117
Duodenitis 35.76 13.52 43 83720 7924 79652701
Autoimmune endocrine disorder 35.16 13.52 6 83757 0 79660625
Wrong technique in product usage process 34.81 13.52 17 83746 73858 79586767
Urogenital fistula 34.77 13.52 11 83752 155 79660470
Fluid retention 34.54 13.52 15 83748 69794 79590831
Feeling hot 34.40 13.52 10 83753 59724 79600901
Respiratory arrest 34.33 13.52 9 83754 57541 79603084
Knee arthroplasty 34.29 13.52 3 83760 43245 79617380
Somnolence 34.27 13.52 132 83631 238849 79421776
Confusional state 34.19 13.52 195 83568 317802 79342823
Paraesthesia 34.07 13.52 85 83678 176238 79484387
Electrocardiogram QT prolonged 34.02 13.52 27 83736 90359 79570266
Psoriatic arthropathy 33.75 13.52 20 83743 77979 79582646
Haemoglobin decreased 33.60 13.52 120 83643 221999 79438626
Primary hypothyroidism 33.59 13.52 11 83752 174 79660451
Serotonin syndrome 33.43 13.52 4 83759 45023 79615602
Burning sensation 33.42 13.52 10 83753 58622 79602003
Autoimmune uveitis 33.34 13.52 7 83756 14 79660611
Cutaneous sarcoidosis 33.24 13.52 14 83749 459 79660166
Rash 33.13 13.52 818 82945 577540 79083085
Blood corticotrophin increased 32.86 13.52 11 83752 187 79660438
Atrioventricular block complete 32.81 13.52 61 83702 16549 79644076
Product dose omission issue 32.81 13.52 141 83622 247396 79413229
Drug-induced liver injury 32.71 13.52 147 83616 65970 79594655
Swelling face 32.63 13.52 17 83746 71195 79589430
Rheumatoid arthritis 32.63 13.52 111 83652 208359 79452266
Depressed level of consciousness 32.61 13.52 32 83731 96620 79564005
Myelitis transverse 32.31 13.52 22 83741 1925 79658700
Pain in jaw 32.13 13.52 5 83758 46146 79614479
Hospitalisation 32.02 13.52 31 83732 94205 79566420
Hypoaesthesia 31.97 13.52 90 83673 179262 79481363
Latent autoimmune diabetes in adults 31.53 13.52 9 83754 87 79660538
Treatment noncompliance 31.51 13.52 8 83755 52260 79608365
Gait disturbance 31.46 13.52 112 83651 207394 79453231
Blood pressure abnormal 31.38 13.52 61 83702 17108 79643517
Malignant ascites 31.23 13.52 18 83745 1174 79659451
Optic neuritis 31.20 13.52 44 83719 9476 79651149
Sedation 31.17 13.52 8 83755 51887 79608738
Uveitis 31.01 13.52 60 83703 16770 79643855
Myocardial infarction 30.93 13.52 95 83668 184034 79476591
Limbic encephalitis 30.63 13.52 16 83747 859 79659766
Lactic acidosis 30.50 13.52 18 83745 70341 79590284
Blister 30.45 13.52 49 83714 119427 79541198
Hepatitis toxic 30.31 13.52 32 83731 5115 79655510
Multiple sclerosis relapse 30.30 13.52 6 83757 46527 79614098
Tumour ulceration 29.89 13.52 11 83752 250 79660375
Myasthenia gravis crisis 29.71 13.52 17 83746 1094 79659531
Pericardial effusion malignant 29.66 13.52 10 83753 174 79660451
Haematoma 29.58 13.52 9 83754 52186 79608439
General physical health deterioration 29.53 13.52 429 83334 274809 79385816
Pericarditis 29.24 13.52 40 83723 104196 79556429
Lung disorder 29.18 13.52 164 83599 80393 79580232
Prescribed overdose 29.05 13.52 3 83760 37880 79622745
Tumour pain 29.02 13.52 22 83741 2277 79658348
Dermatitis 28.83 13.52 67 83696 21254 79639371
Lung opacity 28.42 13.52 31 83732 5143 79655482
Glomerulonephritis rapidly progressive 28.25 13.52 19 83744 1629 79658996
Drug effective for unapproved indication 27.94 13.52 33 83730 5968 79654657
Metastases to meninges 27.91 13.52 26 83737 3575 79657050
Hyponatraemia 27.58 13.52 297 83466 177551 79483074
Autoimmune lung disease 27.44 13.52 7 83756 42 79660583
Acquired gene mutation 27.38 13.52 21 83742 2212 79658413
Thrombophlebitis migrans 27.36 13.52 12 83751 435 79660190
Impaired healing 27.35 13.52 31 83732 87624 79573001
Morphoea 27.31 13.52 12 83751 437 79660188
Dermatitis psoriasiform 27.29 13.52 23 83740 2771 79657854
Seizure 27.26 13.52 104 83659 188730 79471895
Body surface area decreased 27.16 13.52 7 83756 44 79660581
Bursitis 27.07 13.52 3 83760 35841 79624784
Thyroid function test abnormal 26.97 13.52 24 83739 3110 79657515
Oropharyngeal pain 26.80 13.52 46 83717 109307 79551318
Erythema multiforme 26.70 13.52 58 83705 17593 79643032
Dermatitis bullous 26.51 13.52 51 83712 14194 79646431
Febrile neutropenia 26.36 13.52 364 83399 230635 79429990
Periarticular thenar erythema with onycholysis 26.27 13.52 7 83756 51 79660574
Osteoporosis 26.19 13.52 12 83751 54100 79606525
Cardiac failure 26.10 13.52 263 83500 154579 79506046
Abdominal distension 26.09 13.52 54 83709 119596 79541029
Pancreatic failure 26.08 13.52 18 83745 1610 79659015
Intestinal intraepithelial lymphocytes increased 25.96 13.52 9 83754 171 79660454
Gastrointestinal disorder 25.94 13.52 56 83707 122149 79538476
Miller Fisher syndrome 25.77 13.52 10 83753 264 79660361
Road traffic accident 25.72 13.52 7 83756 43657 79616968
Meningitis 25.26 13.52 40 83723 9542 79651083
Paraneoplastic syndrome 25.26 13.52 15 83748 1035 79659590
Product quality issue 25.23 13.52 3 83760 33937 79626688
Cryptitis 24.95 13.52 10 83753 288 79660337
Immune-mediated oesophagitis 24.93 13.52 5 83758 7 79660618
Autoimmune myositis 24.79 13.52 10 83753 293 79660332
Vision blurred 24.64 13.52 46 83717 105852 79554773
Immune-mediated encephalopathy 24.61 13.52 6 83757 29 79660596
Disease progression 24.60 13.52 299 83464 184063 79476562
Pulmonary hypertension 24.32 13.52 10 83753 48070 79612555
Hyperpyrexia 24.32 13.52 31 83732 6061 79654564
Primary adrenal insufficiency 24.31 13.52 9 83754 208 79660417
Hyperamylasaemia 24.03 13.52 15 83748 1132 79659493
Metabolic acidosis 23.83 13.52 31 83732 82498 79578127
Intestinal perforation 23.82 13.52 55 83708 17371 79643254
Tumour cavitation 23.81 13.52 6 83757 34 79660591
Psychotic disorder 23.71 13.52 7 83756 41395 79619230
Posterior reversible encephalopathy syndrome 23.69 13.52 71 83692 26210 79634415
Cerebral infarction 23.69 13.52 103 83660 45573 79615052
Sarcoid-like reaction 23.66 13.52 6 83757 35 79660590
Lipase increased 23.65 13.52 53 83710 16413 79644212
Irritability 23.48 13.52 7 83756 41137 79619488
Vascular access complication 23.48 13.52 19 83744 2163 79658462
Gastrointestinal tube removal 23.44 13.52 4 83759 0 79660625
Amputation stump pain 23.38 13.52 6 83757 37 79660588
Mixed liver injury 23.33 13.52 34 83729 7544 79653081
Product administration error 23.22 13.52 3 83760 31843 79628782
Nephropathy toxic 23.18 13.52 60 83703 20359 79640266
Dyskinesia 23.16 13.52 9 83754 44764 79615861
Pneumocystis jirovecii pneumonia 23.13 13.52 81 83682 32427 79628198
Colitis microscopic 23.12 13.52 41 83722 10727 79649898
Abnormal behaviour 23.09 13.52 5 83758 36416 79624209
Swollen tongue 22.96 13.52 8 83755 42562 79618063
Mixed deafness 22.91 13.52 5 83758 13 79660612
Joint injury 22.73 13.52 3 83760 31332 79629293
Accidental exposure to product 22.72 13.52 3 83760 31319 79629306
Apoptosis 22.58 13.52 11 83752 509 79660116
Thyroid hormones increased 22.50 13.52 11 83752 513 79660112
Hip arthroplasty 22.48 13.52 5 83758 35751 79624874
Emotional distress 22.45 13.52 7 83756 39962 79620663
Aspartate aminotransferase abnormal 22.43 13.52 17 83746 1759 79658866
Transitional cell carcinoma metastatic 22.37 13.52 6 83757 45 79660580
Joint range of motion decreased 22.29 13.52 4 83759 33278 79627347
Dermatomyositis 22.19 13.52 23 83740 3600 79657025
Melanosis 22.14 13.52 6 83757 47 79660578
Cortisol increased 22.09 13.52 11 83752 534 79660091
Autoimmune encephalopathy 21.97 13.52 7 83756 101 79660524
Stomatitis 21.79 13.52 243 83520 146514 79514111
Coronary artery disease 21.71 13.52 22 83741 65452 79595173
C-reactive protein abnormal 21.50 13.52 12 83751 48355 79612270
Bacterial diarrhoea 21.49 13.52 8 83755 188 79660437
Restlessness 21.45 13.52 11 83752 46481 79614144
Autoimmune neuropathy 21.25 13.52 7 83756 113 79660512
Gamma-glutamyltransferase abnormal 20.98 13.52 11 83752 595 79660030
Cytokine release syndrome 20.87 13.52 84 83679 35914 79624711
Radiation associated pain 20.80 13.52 7 83756 121 79660504
EGFR gene mutation 20.70 13.52 10 83753 454 79660171
Pancreatitis 20.62 13.52 133 83630 68442 79592183
Lung adenocarcinoma recurrent 20.53 13.52 5 83758 24 79660601
Dyspepsia 20.52 13.52 53 83710 108634 79551991
Drug level increased 20.46 13.52 8 83755 39643 79620982
Neurofibrosarcoma 20.45 13.52 8 83755 216 79660409
Microvillous inclusion disease 20.41 13.52 8 83755 217 79660408
Right ventricular ejection fraction decreased 20.40 13.52 6 83757 65 79660560
Serous retinal detachment 20.36 13.52 13 83750 1021 79659604
Night sweats 20.32 13.52 15 83748 52080 79608545
Blood bilirubin increased 20.25 13.52 129 83634 66103 79594522
Cytokine storm 20.22 13.52 13 83750 1033 79659592
Sciatica 20.19 13.52 5 83758 33217 79627408
No adverse event 20.16 13.52 85 83678 37107 79623518
Thyrotoxic crisis 20.11 13.52 14 83749 1270 79659355
Oedema peripheral 20.03 13.52 169 83594 252119 79408506
Obesity 20.00 13.52 6 83757 35119 79625506
Nephrolithiasis 19.95 13.52 16 83747 53275 79607350
Oligodipsia 19.74 13.52 5 83758 29 79660596
Hyperglycaemia 19.69 13.52 134 83629 70201 79590424
Orthostatic hypotension 19.64 13.52 18 83745 56146 79604479
Sarcoidosis 19.55 13.52 33 83730 8302 79652323
Polyglandular autoimmune syndrome type II 19.46 13.52 5 83758 31 79660594
Therapeutic response decreased 19.42 13.52 25 83738 66828 79593797
Laryngopharyngitis 19.41 13.52 6 83757 78 79660547
Diffuse uveal melanocytic proliferation 19.40 13.52 4 83759 7 79660618
Haemoglobin abnormal 19.37 13.52 30 83733 7024 79653601
Probiotic therapy 19.27 13.52 7 83756 153 79660472
Sleep disorder 19.25 13.52 38 83725 85639 79574986
Autoimmune dermatitis 19.06 13.52 7 83756 158 79660467
Amnesia 18.92 13.52 23 83740 63034 79597591
Flagellate dermatitis 18.92 13.52 8 83755 265 79660360
Blood lactate dehydrogenase abnormal 18.83 13.52 8 83755 268 79660357
Breast cancer 18.83 13.52 6 83757 33775 79626850
Accidental overdose 18.81 13.52 9 83754 39572 79621053
Angina pectoris 18.79 13.52 16 83747 51716 79608909
Disorientation 18.73 13.52 23 83740 62753 79597872
Female genital tract fistula 18.67 13.52 27 83736 5948 79654677
SJS-TEN overlap 18.67 13.52 11 83752 748 79659877
Viral infection 18.65 13.52 11 83752 43005 79617620
Systemic scleroderma 18.63 13.52 13 83750 1184 79659441
Cancer fatigue 18.62 13.52 7 83756 169 79660456
Cachexia 18.60 13.52 38 83725 11045 79649580
Endocrine toxicity 18.44 13.52 4 83759 10 79660615
Ureteric dilatation 18.43 13.52 7 83756 174 79660451
Allergic colitis 18.35 13.52 5 83758 40 79660585
Joint stiffness 18.33 13.52 10 83753 40820 79619805
Ascites 18.28 13.52 139 83624 75423 79585202
Autoimmune retinopathy 18.16 13.52 4 83759 11 79660614
Physical deconditioning 18.11 13.52 16 83747 2054 79658571
Incorrect route of product administration 18.10 13.52 7 83756 34922 79625703
Adverse drug reaction 18.10 13.52 26 83737 66366 79594259
Radiation necrosis 18.09 13.52 9 83754 436 79660189
Renal tubular injury 18.00 13.52 14 83749 1505 79659120
Feeling abnormal 17.98 13.52 96 83667 159103 79501522
Transitional cell carcinoma recurrent 17.91 13.52 4 83759 12 79660613
Heart rate irregular 17.87 13.52 6 83757 32673 79627952
Infection 17.83 13.52 165 83598 241547 79419078
Pulmonary granuloma 17.77 13.52 16 83747 2105 79658520
Rhinorrhoea 17.74 13.52 33 83730 76041 79584584
Haemoptysis 17.70 13.52 110 83653 55889 79604736
Cardiac disorder 17.68 13.52 26 83737 65731 79594894
Autoimmune pericarditis 17.58 13.52 3 83760 0 79660625
Oesophagomediastinal fistula 17.58 13.52 3 83760 0 79660625
Ileus 17.53 13.52 64 83699 26147 79634478
Weight abnormal 17.47 13.52 14 83749 1572 79659053
Tumour rupture 17.46 13.52 9 83754 470 79660155
BRAF V600E mutation positive 17.45 13.52 5 83758 49 79660576
Neutrophil count abnormal 17.43 13.52 20 83743 3506 79657119
Trichoglossia 17.40 13.52 10 83753 649 79659976
Cardiomyopathy 17.37 13.52 68 83695 28706 79631919
Throat tightness 17.35 13.52 4 83759 27903 79632722
Neck pain 17.33 13.52 33 83730 75384 79585241
Eye pain 17.17 13.52 9 83754 37569 79623056
Blood alkaline phosphatase abnormal 17.14 13.52 11 83752 871 79659754
Memory impairment 17.13 13.52 60 83703 111674 79548951
Bilirubin conjugated abnormal 17.02 13.52 6 83757 120 79660505
Poisoning 17.01 13.52 3 83760 25269 79635356
Ketoacidosis 16.98 13.52 30 83733 7824 79652801
Chronic kidney disease 16.98 13.52 27 83736 66127 79594498
Cytomegalovirus enterocolitis 16.95 13.52 14 83749 1641 79658984
Nervousness 16.82 13.52 7 83756 33408 79627217
Malaise 16.79 13.52 651 83112 489218 79171407
Haematocrit decreased 16.72 13.52 24 83739 61288 79599337
Platelet count abnormal 16.72 13.52 23 83740 4839 79655786
Primary biliary cholangitis 16.71 13.52 12 83751 1143 79659482
Blood pressure fluctuation 16.67 13.52 28 83735 67117 79593508
Gallbladder enlargement 16.67 13.52 14 83749 1679 79658946
Full blood count abnormal 16.65 13.52 11 83752 40463 79620162
Pneumocystis test positive 16.64 13.52 4 83759 18 79660607
Balance disorder 16.59 13.52 51 83712 98806 79561819
Blood corticotrophin abnormal 16.54 13.52 5 83758 60 79660565
Back pain 16.37 13.52 223 83540 303957 79356668
Vogt-Koyanagi-Harada disease 16.27 13.52 7 83756 242 79660383
Unmasking of previously unidentified disease 16.23 13.52 15 83748 2042 79658583
Stress cardiomyopathy 16.11 13.52 36 83727 11130 79649495
Vascular purpura 16.04 13.52 18 83745 3080 79657545
Ischaemic stroke 15.89 13.52 73 83690 33058 79627567
Visual impairment 15.84 13.52 47 83716 92084 79568541
Lymphadenectomy 15.79 13.52 12 83751 1247 79659378
Feeding disorder 15.69 13.52 45 83718 16209 79644416
Circumstance or information capable of leading to medication error 15.62 13.52 20 83743 3928 79656697
Oxygen saturation decreased 15.60 13.52 76 83687 128971 79531654
Granulocyte count increased 15.57 13.52 12 83751 1273 79659352
Paraneoplastic dermatomyositis 15.51 13.52 5 83758 75 79660550
Superior vena cava stenosis 15.50 13.52 3 83760 3 79660622
Ulcerative duodenitis 15.50 13.52 3 83760 3 79660622
Cardio-respiratory arrest 15.50 13.52 60 83703 108450 79552175
Lymphadenopathy mediastinal 15.43 13.52 21 83742 4375 79656250
Vital functions abnormal 15.41 13.52 10 83753 807 79659818
Aortic embolus 15.39 13.52 5 83758 77 79660548
Dysphagia 15.39 13.52 196 83567 121940 79538685
Cataract 15.34 13.52 26 83737 62094 79598531
Rash morbilliform 15.29 13.52 25 83738 6125 79654500
Pancreatectomy 15.28 13.52 4 83759 27 79660598
Metastases to adrenals 15.20 13.52 12 83751 1318 79659307
Urinary tract infection enterococcal 15.14 13.52 18 83745 3277 79657348
Leukoderma 15.13 13.52 6 83757 168 79660457
Autoimmune blistering disease 15.04 13.52 3 83760 4 79660621
Septic shock 15.02 13.52 196 83567 122605 79538020
Anaphylactic reaction 14.93 13.52 42 83721 83701 79576924
Skin depigmentation 14.86 13.52 11 83752 1099 79659526
Antinuclear antibody 14.82 13.52 8 83755 459 79660166
Oesophageal fistula 14.79 13.52 8 83755 461 79660164
Pulse abnormal 14.75 13.52 18 83745 3366 79657259
Hospice care 14.57 13.52 33 83730 10291 79650334
Hepatic steatosis 14.54 13.52 11 83752 37727 79622898
Acute coronary syndrome 14.47 13.52 52 83711 21081 79639544
Acute polyneuropathy 14.46 13.52 8 83755 482 79660143
Angioedema 14.41 13.52 37 83726 75998 79584627
Gliosis 14.34 13.52 8 83755 490 79660135
Influenza like illness 14.29 13.52 34 83729 71673 79588952
Basal cell carcinoma 14.27 13.52 11 83752 37364 79623261
Herpes zoster 14.26 13.52 50 83713 93033 79567592
Troponin T increased 14.18 13.52 18 83745 3504 79657121
Tachycardia 14.14 13.52 119 83644 177649 79482976
Gastroduodenal ulcer 14.11 13.52 8 83755 506 79660119
Rheumatic disorder 14.10 13.52 17 83746 3141 79657484
Vanishing bile duct syndrome 14.09 13.52 13 83750 1765 79658860
Cystitis 14.03 13.52 21 83742 52711 79607914
Hypoglycaemia 13.98 13.52 57 83706 101537 79559088
Femur fracture 13.98 13.52 12 83751 38640 79621985
Benign mediastinal neoplasm 13.89 13.52 4 83759 40 79660585
Fungal infection 13.87 13.52 14 83749 41734 79618891
Renal failure 13.87 13.52 292 83471 200676 79459949
Respiratory disorder 13.84 13.52 16 83747 44840 79615785
Immunodeficiency 13.77 13.52 3 83760 21765 79638860
Gastric perforation 13.74 13.52 19 83744 4018 79656607
Tendonitis 13.70 13.52 4 83759 23826 79636799
Cheilitis 13.67 13.52 22 83741 5319 79655306
Myoclonus 13.59 13.52 6 83757 27654 79632971
Cholestatic liver injury 13.55 13.52 21 83742 4920 79655705

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
Advanced or recurrent cervical cancer indication 363354003 DOID:4362
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
HER2-negative breast cancer indication 767444009




🐶 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
DB09037 DRUGBANK_ID
1547545 RXNORM
228586 MMSL
30533 MMSL
d08287 MMSL
015666 NDDF
716125002 SNOMEDCT_US
763541003 SNOMEDCT_US
C3658706 UMLSCUI
9798 INN_ID
DPT0O3T46P UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3026 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 30 sections
KEYTRUDA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS BLA 30 sections