cisplatin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antineoplastic agents, platinum derivatives 4392 15663-27-1

Description:

MoleculeDescription

Synonyms:

  • cisplatin
  • platinum diamminodichloride
  • cis-Platinum
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
  • Molecular weight: 300.05
  • Formula: Cl2H6N2Pt
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.53 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.30 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 4.75 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Dec. 19, 1978 FDA HQ SPCLT PHARMA

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
Febrile neutropenia 1070.56 15.52 853 51678 96814 50455779
Neutropenia 975.81 15.52 969 51562 146996 50405597
Thrombocytopenia 677.41 15.52 745 51786 126928 50425665
Malignant neoplasm progression 536.74 15.52 493 52038 67631 50484962
Bone marrow failure 476.59 15.52 318 52213 27306 50525287
Disease progression 471.26 15.52 538 51993 95328 50457265
Haematotoxicity 466.77 15.52 206 52325 7689 50544904
Mucosal inflammation 458.92 15.52 360 52171 39782 50512811
Vomiting 414.58 15.52 1229 51302 459529 50093064
Ototoxicity 404.75 15.52 113 52418 1014 50551579
Anaemia 368.99 15.52 810 51721 251646 50300947
Pancytopenia 328.41 15.52 420 52111 83610 50468983
Myelosuppression 291.04 15.52 179 52352 13338 50539255
Acute myeloid leukaemia 268.27 15.52 177 52354 14897 50537696
Nausea 266.83 15.52 1434 51097 703964 49848629
Dehydration 259.32 15.52 521 52010 151928 50400665
Leukopenia 255.09 15.52 332 52199 67196 50485397
Posterior reversible encephalopathy syndrome 248.13 15.52 168 52363 14760 50537833
Arthralgia 239.37 15.52 79 52452 438623 50113970
Second primary malignancy 233.78 15.52 123 52408 6791 50545802
Hypomagnesaemia 218.87 15.52 186 52345 22970 50529623
Off label use 214.15 15.52 1015 51516 473411 50079182
Joint swelling 194.89 15.52 16 52515 245270 50307323
Renal salt-wasting syndrome 185.36 15.52 45 52486 216 50552377
Hypokalaemia 179.36 15.52 325 52206 87667 50464926
Neutrophil count decreased 173.28 15.52 226 52305 45800 50506793
Deafness 171.17 15.52 137 52394 15554 50537039
Myelodysplastic syndrome 166.95 15.52 133 52398 14999 50537594
Diffuse large B-cell lymphoma recurrent 153.51 15.52 59 52472 1536 50551057
Gastrointestinal toxicity 151.88 15.52 81 52450 4596 50547997
Pain 150.40 15.52 231 52300 578672 49973921
Aortic thrombosis 149.23 15.52 51 52480 938 50551655
Neutropenic sepsis 142.68 15.52 118 52413 14029 50538564
Fall 138.04 15.52 89 52442 334843 50217750
Product dose omission issue 137.98 15.52 15 52516 183823 50368770
Metastases to lung 134.88 15.52 103 52428 10917 50541676
Abdominal discomfort 134.60 15.52 37 52494 231604 50320989
Platelet count decreased 134.06 15.52 312 52219 100414 50452179
Peripheral swelling 131.24 15.52 27 52504 205909 50346684
Metastases to central nervous system 130.56 15.52 102 52429 11180 50541413
Drug resistance 129.42 15.52 127 52404 18862 50533731
Arthropathy 129.03 15.52 9 52522 157897 50394696
Teratoma 125.36 15.52 29 52502 108 50552485
Neoplasm progression 123.71 15.52 152 52379 29005 50523588
Nephropathy toxic 120.78 15.52 85 52446 7944 50544649
Ovarian germ cell teratoma 118.40 15.52 25 52506 53 50552540
Drug ineffective 115.60 15.52 450 52081 818883 49733710
Contraindicated product administered 114.75 15.52 11 52520 148947 50403646
Pyrexia 114.07 15.52 729 51802 379474 50173119
Weight increased 114.03 15.52 34 52497 201857 50350736
Sepsis 113.26 15.52 349 52182 132576 50420017
Musculoskeletal stiffness 112.11 15.52 5 52526 128476 50424117
Acute kidney injury 110.48 15.52 499 52032 227559 50325034
Therapeutic product effect decreased 110.43 15.52 8 52523 136042 50416551
Urogenital fistula 109.57 15.52 26 52505 111 50552482
Pulmonary embolism 106.91 15.52 288 52243 101416 50451177
Hyponatraemia 105.88 15.52 277 52254 95862 50456731
Drug hypersensitivity 104.29 15.52 66 52465 250944 50301649
Product use in unapproved indication 104.20 15.52 310 52221 115509 50437084
Swelling 102.74 15.52 40 52491 200832 50351761
Diffuse large B-cell lymphoma refractory 101.77 15.52 39 52492 1007 50551586
Cardiotoxicity 100.18 15.52 72 52459 6955 50545638
Oesophagitis 99.68 15.52 94 52437 13289 50539304
Neurotoxicity 95.66 15.52 96 52435 14644 50537949
Pain in extremity 91.58 15.52 89 52442 272776 50279817
Nasopharyngitis 91.35 15.52 43 52488 192884 50359709
Headache 90.67 15.52 250 52281 506285 50046308
Hydronephrosis 87.70 15.52 72 52459 8469 50544124
Cardiomyopathy 87.64 15.52 94 52437 15492 50537101
Septic shock 85.97 15.52 186 52345 56989 50495604
Rash 85.87 15.52 206 52325 437265 50115328
Pruritus 85.68 15.52 101 52430 283467 50269126
Tumour lysis syndrome 85.66 15.52 67 52464 7354 50545239
Hypocalcaemia 84.72 15.52 121 52410 26695 50525898
White blood cell count decreased 80.19 15.52 285 52246 116437 50436156
Hypophagia 80.19 15.52 120 52411 27608 50524985
Renal failure 79.91 15.52 268 52263 106365 50446228
Disease recurrence 79.28 15.52 101 52430 19980 50532613
Metastases to lymph nodes 78.03 15.52 62 52469 6962 50545631
Arthritis 76.89 15.52 3 52528 86718 50465875
Condition aggravated 76.40 15.52 119 52412 296939 50255654
Neuropathy peripheral 75.00 15.52 246 52285 96511 50456082
Injection site pain 73.98 15.52 13 52518 111011 50441582
Insomnia 73.94 15.52 45 52486 174820 50377773
Metastases to liver 71.43 15.52 96 52435 20008 50532585
Wound 71.34 15.52 12 52519 105782 50446811
Renal tubular disorder 70.23 15.52 39 52492 2398 50550195
Teratoma benign 69.72 15.52 16 52515 57 50552536
Sinusitis 69.22 15.52 46 52485 170512 50382081
Contusion 68.79 15.52 16 52515 112167 50440426
Febrile bone marrow aplasia 68.60 15.52 55 52476 6256 50546337
Tinnitus 67.82 15.52 112 52419 28020 50524573
Ascites 64.93 15.52 126 52405 35735 50516858
Therapy partial responder 64.42 15.52 54 52477 6537 50546056
Asthma 62.81 15.52 9 52522 89328 50463265
Metastases to skin 62.63 15.52 30 52501 1353 50551240
Electrolyte imbalance 62.55 15.52 83 52448 17086 50535507
Migraine 62.31 15.52 4 52527 75276 50477317
Leukoencephalopathy 60.48 15.52 42 52489 3841 50548752
Renal tubular necrosis 60.13 15.52 63 52468 10105 50542488
Abdominal pain 59.90 15.52 435 52096 235793 50316800
Palmar-plantar erythrodysaesthesia syndrome 59.57 15.52 88 52443 20010 50532583
Gastrointestinal perforation 59.49 15.52 38 52493 3023 50549570
Muscle spasms 59.37 15.52 28 52503 125525 50427068
Radiation skin injury 59.12 15.52 25 52506 838 50551755
Drug intolerance 58.98 15.52 85 52446 219019 50333574
Hepatic enzyme increased 57.16 15.52 36 52495 137344 50415249
Diarrhoea 56.94 15.52 891 51640 587585 49965008
Pleural effusion 56.87 15.52 200 52331 81254 50471339
Deafness bilateral 56.76 15.52 27 52504 1199 50551394
Metastases to breast 56.37 15.52 18 52513 265 50552328
Decreased appetite 56.21 15.52 379 52152 200544 50352049
Oesophageal fistula 55.80 15.52 15 52516 115 50552478
Blister 54.77 15.52 11 52520 85407 50467186
Pericarditis 52.88 15.52 9 52522 78680 50473913
Ovarian cancer recurrent 52.07 15.52 23 52508 859 50551734
Polyneuropathy 51.05 15.52 63 52468 12068 50540525
Large intestine perforation 50.83 15.52 50 52481 7444 50545149
Myasthenia gravis crisis 50.80 15.52 18 52513 370 50552223
Metastases to bone 50.77 15.52 77 52454 17918 50534675
Blood creatinine increased 48.92 15.52 182 52349 75978 50476615
Urticaria 48.55 15.52 38 52493 129523 50423070
Osteoarthritis 48.02 15.52 7 52524 68599 50483994
Overdose 47.51 15.52 22 52509 99705 50452888
Injection site erythema 47.32 15.52 10 52521 74926 50477667
Loss of personal independence in daily activities 47.10 15.52 8 52523 70042 50482551
Gait disturbance 46.78 15.52 52 52479 149953 50402640
Renal impairment 46.27 15.52 178 52353 75483 50477110
Peripheral artery thrombosis 46 15.52 26 52505 1654 50550939
Suicidal ideation 45.66 15.52 3 52528 55382 50497211
Feeling abnormal 45.53 15.52 38 52493 125454 50427139
Infusion related reaction 45.39 15.52 66 52465 169491 50383102
Deep vein thrombosis 44.45 15.52 172 52359 73132 50479461
Depression 43.68 15.52 65 52466 165358 50387235
Fatigue 43.14 15.52 499 52032 707102 49845491
Haemoglobin decreased 43.04 15.52 252 52279 126964 50425629
Metastases to peritoneum 42.62 15.52 30 52501 2803 50549790
Mobility decreased 42.37 15.52 15 52516 79933 50472660
Bronchitis 42.35 15.52 28 52503 104131 50448462
Encephalopathy 42.16 15.52 102 52429 33609 50518984
Discomfort 41.61 15.52 31 52500 108349 50444244
Mesenteric abscess 41.19 15.52 11 52520 82 50552511
Inappropriate antidiuretic hormone secretion 41.06 15.52 59 52472 13084 50539509
Alopecia 40.72 15.52 125 52406 244922 50307671
Chemical peritonitis 40.29 15.52 11 52520 90 50552503
Somnolence 39.86 15.52 62 52469 154923 50397670
Cystitis haemorrhagic 39.68 15.52 32 52499 3670 50548923
Anastomotic leak 38.65 15.52 15 52516 401 50552192
Large intestinal ulcer perforation 38.37 15.52 10 52521 67 50552526
Ileus 37.88 15.52 57 52474 13172 50539421
Recall phenomenon 37.74 15.52 16 52515 540 50552053
Bicytopenia 37.54 15.52 24 52507 1912 50550681
Hospitalisation 37.30 15.52 12 52519 67925 50484668
Malignant transformation 37.26 15.52 14 52517 342 50552251
Performance status decreased 37.21 15.52 29 52502 3166 50549427
Wernicke's encephalopathy 36.97 15.52 8 52523 20 50552573
Ureteric rupture 36.26 15.52 7 52524 7 50552586
Nasal abscess 36.21 15.52 11 52520 136 50552457
Metastases to abdominal wall 36.19 15.52 10 52521 86 50552507
Cervix neoplasm 36.10 15.52 12 52519 202 50552391
Dermatitis 36.06 15.52 58 52473 14193 50538400
Gastric perforation 35.59 15.52 21 52510 1449 50551144
Fibromyalgia 35.47 15.52 3 52528 44975 50507618
Embryonal rhabdomyosarcoma 35.32 15.52 7 52524 9 50552584
Dizziness 35.24 15.52 213 52318 346156 50206437
Nephritis bacterial 35.19 15.52 8 52523 27 50552566
Cataract 35.09 15.52 4 52527 47296 50505297
Neutropenic colitis 34.99 15.52 25 52506 2392 50550201
Melanoderma 34.83 15.52 11 52520 156 50552437
Radiation injury 34.75 15.52 14 52517 414 50552179
Balance disorder 34.52 15.52 15 52516 70575 50482018
Unevaluable event 33.91 15.52 4 52527 46062 50506531
Asthenia 33.77 15.52 491 52040 318551 50234042
Exposure during pregnancy 33.47 15.52 46 52485 120969 50431624
Gastrointestinal fungal infection 33.45 15.52 12 52519 256 50552337
Haemophagocytic lymphohistiocytosis 33.41 15.52 43 52488 8590 50544003
Cerebral venous thrombosis 33.35 15.52 22 52509 1849 50550744
Injection site reaction 33.01 15.52 6 52525 50026 50502567
Malnutrition 32.44 15.52 53 52478 13136 50539457
Bladder perforation 32.32 15.52 10 52521 132 50552461
Chloroma 32.30 15.52 11 52520 200 50552393
Intentional product misuse 32.17 15.52 5 52526 46729 50505864
Varicella zoster virus infection 32.08 15.52 24 52507 2465 50550128
Cardiac tamponade 32.03 15.52 30 52501 4202 50548391
Injury 31.99 15.52 6 52525 48919 50503674
Nasal congestion 31.91 15.52 7 52524 51113 50501480
Adverse drug reaction 31.68 15.52 9 52522 55213 50497380
Metastases to adrenals 31.26 15.52 15 52516 679 50551914
Axillary vein thrombosis 30.67 15.52 12 52519 328 50552265
Maternal exposure during pregnancy 30.63 15.52 76 52455 159702 50392891
Enteritis 30.52 15.52 37 52494 6958 50545635
Pericardial effusion 30.48 15.52 76 52455 25513 50527080
Stress 30.43 15.52 9 52522 53784 50498809
Memory impairment 30.07 15.52 23 52508 79337 50473256
Vesical fistula 29.91 15.52 8 52523 60 50552533
Abortion spontaneous 29.84 15.52 4 52527 41768 50510825
Lower respiratory tract infection 29.67 15.52 33 52498 95168 50457425
Hypophosphataemia 29.61 15.52 40 52491 8374 50544219
White blood cell count abnormal 29.16 15.52 32 52499 5408 50547185
Haemolytic uraemic syndrome 29.09 15.52 22 52509 2297 50550296
Peripheral sensory neuropathy 28.98 15.52 35 52496 6556 50546037
Wrong technique in product usage process 28.43 15.52 11 52520 55499 50497094
Herpes simplex encephalitis 28.10 15.52 11 52520 301 50552292
Venoocclusive liver disease 28.10 15.52 28 52503 4233 50548360
Sinus polyp 27.90 15.52 11 52520 307 50552286
Enterocolitis infectious 27.86 15.52 18 52513 1460 50551133
Vena cava thrombosis 27.20 15.52 20 52511 2001 50550592
Acoustic stimulation tests abnormal 27.18 15.52 8 52523 88 50552505
Disseminated intravascular coagulation 27.18 15.52 57 52474 17078 50535515
Anxiety 27.12 15.52 94 52437 177512 50375081
Radiation pneumonitis 27.01 15.52 17 52514 1318 50551275
Thymus enlargement 26.86 15.52 8 52523 92 50552501
Tumour haemorrhage 26.77 15.52 17 52514 1338 50551255
Treatment failure 26.74 15.52 65 52466 137572 50415021
Alveolar soft part sarcoma 26.33 15.52 8 52523 99 50552494
Peripheral ischaemia 26.19 15.52 27 52504 4249 50548344
Respiratory symptom 26.15 15.52 21 52510 2393 50550200
Acquired gene mutation 25.88 15.52 14 52517 817 50551776
Female genital tract fistula 25.87 15.52 25 52506 3641 50548952
Intestinal perforation 25.63 15.52 42 52489 10437 50542156
Clostridium bacteraemia 25.54 15.52 9 52522 182 50552411
Gastrooesophageal reflux disease 25.49 15.52 25 52506 76403 50476190
Cytopenia 25.39 15.52 38 52493 8737 50543856
Adverse event 25.35 15.52 7 52524 43756 50508837
Fistula of small intestine 25.27 15.52 10 52521 282 50552311
Metastases to meninges 25.13 15.52 19 52512 1983 50550610
Blood cholesterol increased 25.05 15.52 13 52518 55202 50497391
Aortic embolus 25.03 15.52 6 52525 27 50552566
Metastases to abdominal cavity 25.02 15.52 11 52520 406 50552187
Respiratory failure 24.85 15.52 171 52360 91010 50461583
Wheezing 24.79 15.52 17 52514 62030 50490563
Hypoalbuminaemia 24.77 15.52 40 52491 9820 50542773
Chronic kidney disease 24.66 15.52 94 52437 39677 50512916
Dysphagia 24.56 15.52 151 52380 77367 50475226
Inappropriate schedule of product administration 24.54 15.52 23 52508 71808 50480785
Osteoporosis 24.51 15.52 8 52523 44871 50507722
Neoplasm recurrence 24.38 15.52 20 52511 2349 50550244
Amputation stump pain 24.35 15.52 6 52525 31 50552562
Impaired healing 24.25 15.52 22 52509 69764 50482829
Cerebellar haemangioma 24.21 15.52 7 52524 72 50552521
Drug clearance decreased 24.17 15.52 15 52516 1134 50551459
Influenza like illness 23.96 15.52 15 52516 57444 50495149
Metastasis 23.91 15.52 26 52505 4349 50548244
Jaw operation 23.90 15.52 13 52518 767 50551826
Suicide attempt 23.74 15.52 12 52519 51720 50500873
Neutrophil count abnormal 23.73 15.52 20 52511 2439 50550154
Arteriospasm coronary 23.63 15.52 23 52508 3379 50549214
Chronic obstructive pulmonary disease 23.62 15.52 13 52518 53422 50499171
Stem cell transplant 23.57 15.52 17 52514 1651 50550942
Multiple organ dysfunction syndrome 23.43 15.52 109 52422 50228 50502365
Oesophageal stenosis 23.07 15.52 21 52510 2837 50549756
Malignant peritoneal neoplasm 23.03 15.52 12 52519 649 50551944
Malaise 22.99 15.52 230 52301 335302 50217291
Bacteraemia 22.88 15.52 48 52483 14385 50538208
Embolism 22.83 15.52 32 52499 6936 50545657
Enterococcal sepsis 22.74 15.52 15 52516 1260 50551333
Radiation oesophagitis 22.44 15.52 9 52522 263 50552330
Ovarian vein thrombosis 22.44 15.52 6 52525 45 50552548
Acute myelomonocytic leukaemia 22.33 15.52 8 52523 170 50552423
Anti-Muellerian hormone level decreased 22.31 15.52 7 52524 97 50552496
Influenza 21.90 15.52 37 52494 89501 50463092
Femur fracture 21.69 15.52 6 52525 37458 50515135
Burning sensation 21.68 15.52 10 52521 45436 50507157
Fluid retention 21.43 15.52 13 52518 50636 50501957
Folliculitis 21.40 15.52 7 52524 39218 50513375
Proctitis 21.37 15.52 17 52514 1911 50550682
Oroticaciduria 21.25 15.52 4 52527 3 50552590
Blood magnesium decreased 21.16 15.52 40 52491 11120 50541473
Osteosarcoma metastatic 21.14 15.52 5 52526 21 50552572
Vascular compression 21.10 15.52 7 52524 117 50552476
Incorrect dose administered 21.08 15.52 12 52519 48402 50504191
Neck pain 21.03 15.52 17 52514 57050 50495543
Median nerve injury 20.95 15.52 5 52526 22 50552571
Blood glucose increased 20.85 15.52 26 52505 71298 50481295
Osteosarcoma 20.83 15.52 7 52524 122 50552471
Muscular weakness 20.80 15.52 42 52489 94971 50457622
Cervix carcinoma recurrent 20.77 15.52 5 52526 23 50552570
Hiccups 20.72 15.52 16 52515 1723 50550870
Maternal death affecting foetus 20.72 15.52 4 52527 4 50552589
Vision blurred 20.65 15.52 31 52500 78616 50473977
Failure to thrive 20.53 15.52 29 52502 6329 50546264
Therapy responder 20.50 15.52 9 52522 331 50552262
Ill-defined disorder 20.50 15.52 16 52515 54638 50497955
Pulmonary toxicity 20.43 15.52 27 52504 5535 50547058
Medulloblastoma recurrent 20.39 15.52 6 52525 66 50552527
Lymphopenia 20.32 15.52 48 52483 15573 50537020
Myalgia 20.21 15.52 64 52467 124255 50428338
Diabetes mellitus 20.17 15.52 13 52518 49020 50503573
Pulmonary vascular disorder 20.13 15.52 9 52522 346 50552247
Odynophagia 19.93 15.52 29 52502 6503 50546090
Tachycardia 19.90 15.52 174 52357 99589 50453004
Radiation proctitis 19.83 15.52 4 52527 6 50552587
Product quality issue 19.72 15.52 4 52527 30854 50521739
Superior sagittal sinus thrombosis 19.52 15.52 11 52520 696 50551897
Renal-limited thrombotic microangiopathy 19.45 15.52 4 52527 7 50552586
VIth nerve paresis 19.41 15.52 6 52525 79 50552514
Refeeding syndrome 19.38 15.52 5 52526 32 50552561
Blood sodium decreased 19.35 15.52 57 52474 21090 50531503
Radiation mucositis 19.25 15.52 5 52526 33 50552560
Leukaemic lymphoma 19.07 15.52 6 52525 84 50552509
Pain in jaw 19.05 15.52 8 52523 38420 50514173
Hypoaesthesia 18.98 15.52 68 52463 127189 50425404
Drug clearance increased 18.94 15.52 6 52525 86 50552507
Gastrointestinal necrosis 18.87 15.52 18 52513 2580 50550013
Salivary gland cancer 18.86 15.52 7 52524 165 50552428
Low cardiac output syndrome 18.84 15.52 8 52523 271 50552322
Stomatitis 18.80 15.52 174 52357 101170 50451423
Marchiafava-Bignami disease 18.78 15.52 4 52527 9 50552584
Purulent pericarditis 18.76 15.52 5 52526 37 50552556
Cardiac failure congestive 18.73 15.52 37 52494 84345 50468248
Pregnancy 18.56 15.52 4 52527 29573 50523020
Gastric disorder 18.53 15.52 4 52527 29544 50523049
Blood pressure fluctuation 18.51 15.52 7 52524 35816 50516777
Hypoglycaemia 18.48 15.52 17 52514 53564 50499029
Pelvic fluid collection 18.47 15.52 11 52520 772 50551821
Adrenocortical carcinoma 18.41 15.52 5 52526 40 50552553
Cerebral salt-wasting syndrome 18.30 15.52 5 52526 41 50552552
Hypoacusis 18.28 15.52 55 52476 20592 50532001
Gastroenteritis radiation 18.25 15.52 9 52522 433 50552160
Central obesity 18.17 15.52 12 52519 1010 50551583
Sinus tachycardia 18.08 15.52 56 52475 21298 50531295
Respiratory distress 18.03 15.52 71 52460 30418 50522175
Sweat gland tumour 17.99 15.52 6 52525 102 50552491
Tumour invasion 17.94 15.52 6 52525 103 50552490
Mucosal erosion 17.92 15.52 13 52518 1274 50551319
Hypoglossal nerve paresis 17.78 15.52 6 52525 106 50552487
Myasthenic syndrome 17.77 15.52 7 52524 195 50552398
Emphysematous cholecystitis 17.61 15.52 3 52528 0 50552593
Urinary tract toxicity 17.61 15.52 3 52528 0 50552593
Hypersensitivity 17.56 15.52 141 52390 215020 50337573
Acute respiratory distress syndrome 17.55 15.52 55 52476 21044 50531549
Transdifferentiation of neoplasm 17.48 15.52 4 52527 14 50552579
Tumour thrombosis 17.48 15.52 4 52527 14 50552579
Necrosis 17.41 15.52 23 52508 4713 50547880
Product use issue 17.30 15.52 88 52443 149387 50403206
Osteoradionecrosis 17.28 15.52 6 52525 116 50552477
Aorto-oesophageal fistula 17.27 15.52 4 52527 15 50552578
Ovarian failure 17.26 15.52 12 52519 1099 50551494
Ovarian disorder 17.19 15.52 10 52521 672 50551921
Hepatic lesion 17.16 15.52 21 52510 3987 50548606
Urogenital disorder 17.16 15.52 5 52526 53 50552540
Roseolovirus test positive 17.16 15.52 5 52526 53 50552540
Dry eye 17.04 15.52 6 52525 32089 50520504
Fanconi syndrome 17.02 15.52 12 52519 1124 50551469
Cytomegalovirus infection 17.00 15.52 49 52482 17913 50534680
Neurosensory hypoacusis 16.98 15.52 7 52524 220 50552373
Necrotising colitis 16.95 15.52 9 52522 506 50552087
Metastases to pelvis 16.78 15.52 8 52523 357 50552236
Cardiopulmonary failure 16.64 15.52 19 52512 3354 50549239
Sleep disorder 16.62 15.52 21 52510 57262 50495331
Melanosis 16.51 15.52 4 52527 19 50552574
Abdominal compartment syndrome 16.45 15.52 9 52522 537 50552056
Lip swelling 16.24 15.52 3 52528 24733 50527860
Blood pressure increased 16.20 15.52 77 52454 133055 50419538
Agitation 16.09 15.52 19 52512 53365 50499228
Stent malfunction 16.02 15.52 5 52526 68 50552525
Blood culture positive 15.96 15.52 21 52510 4287 50548306
Limb discomfort 15.89 15.52 3 52528 24354 50528239
Road traffic accident 15.89 15.52 3 52528 24349 50528244
Plasma cell leukaemia 15.86 15.52 11 52520 1004 50551589
Hypoxia 15.82 15.52 99 52432 51024 50501569
Eye pain 15.66 15.52 5 52526 28444 50524149
Granulocytopenia 15.63 15.52 23 52508 5208 50547385
VIth nerve disorder 15.54 15.52 3 52528 3 50552590
Metastases to pleura 15.52 15.52 12 52519 1294 50551299

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
Febrile neutropenia 1391.34 13.00 1567 74025 110673 29388262
Neutropenia 890.94 13.00 1366 74226 130345 29368590
Mucosal inflammation 759.36 13.00 636 74956 30959 29467976
Thrombocytopenia 534.54 13.00 1108 74484 133715 29365220
Malignant neoplasm progression 418.44 13.00 708 74884 73151 29425784
Pancytopenia 365.32 13.00 714 74878 82454 29416481
Dehydration 362.75 13.00 862 74730 113886 29385049
Bone marrow failure 342.98 13.00 386 75206 27063 29471872
Leukopenia 332.30 13.00 544 75048 54659 29444276
Disease progression 325.96 13.00 675 74917 81241 29417694
Vomiting 305.27 13.00 1209 74383 211051 29287884
Stomatitis 275.44 13.00 403 75189 36710 29462225
Myelosuppression 260.59 13.00 230 75362 11997 29486938
Neutropenic sepsis 258.77 13.00 225 75367 11502 29487433
Haematotoxicity 258.41 13.00 179 75413 6520 29492415
Nausea 249.88 13.00 1421 74171 287834 29211101
Acute myeloid leukaemia 240.78 13.00 252 75340 16261 29482674
Dysphagia 231.78 13.00 464 75128 54462 29444473
Neoplasm progression 217.65 13.00 253 75339 18359 29480576
Second primary malignancy 205.80 13.00 156 75436 6549 29492386
Anaemia 204.92 13.00 1034 74558 199917 29299018
Neutrophil count decreased 201.97 13.00 383 75209 43184 29455751
Product dose omission issue 189.73 13.00 15 75577 96368 29402567
Drug abuse 188.79 13.00 3 75589 79880 29419055
Pulmonary embolism 182.74 13.00 518 75074 76016 29422919
Off label use 171.53 13.00 1333 74259 299467 29199468
Aortic thrombosis 168.46 13.00 64 75528 617 29498318
Fall 166.38 13.00 126 75466 177052 29321883
Arthralgia 165.40 13.00 75 75517 139542 29359393
Nephropathy toxic 161.91 13.00 167 75425 10589 29488346
Renal salt-wasting syndrome 157.62 13.00 44 75548 134 29498801
Myelodysplastic syndrome 143.33 13.00 201 75391 17593 29481342
Pyrexia 139.86 13.00 1230 74362 286392 29212543
Drug interaction 129.62 13.00 190 75402 197195 29301740
Therapy partial responder 127.46 13.00 106 75486 5093 29493842
Decreased appetite 122.15 13.00 710 74882 144632 29354303
Hyponatraemia 116.46 13.00 409 75183 67224 29431711
Cardiotoxicity 114.80 13.00 96 75496 4648 29494287
Headache 111.77 13.00 170 75422 173837 29325098
Septic shock 110.03 13.00 381 75211 62179 29436756
Ototoxicity 109.22 13.00 61 75531 1504 29497431
Hypomagnesaemia 108.81 13.00 175 75417 17293 29481642
Overdose 107.51 13.00 35 75557 79784 29419151
Anastomotic leak 105.52 13.00 44 75548 552 29498383
Diffuse large B-cell lymphoma refractory 105.11 13.00 50 75542 872 29498063
Tumour lysis syndrome 104.69 13.00 152 75440 13732 29485203
Oesophagitis 102.50 13.00 139 75453 11784 29487151
White blood cell count decreased 101.38 13.00 452 75140 82910 29416025
Acute kidney injury 96.76 13.00 1069 74523 264198 29234737
Cardiac failure congestive 95.62 13.00 38 75554 76543 29422392
Arterial thrombosis 95.16 13.00 54 75538 1374 29497561
Weight increased 92.56 13.00 40 75552 76627 29422308
Rhabdomyolysis 92.51 13.00 21 75571 60787 29438148
Radiation skin injury 90.34 13.00 41 75551 639 29498296
Aorto-oesophageal fistula 90.12 13.00 22 75570 31 29498904
Hypophagia 89.93 13.00 178 75414 20694 29478241
Tinnitus 88.59 13.00 150 75442 15464 29483471
Febrile bone marrow aplasia 87.70 13.00 101 75491 7250 29491685
Depression 85.79 13.00 56 75536 85091 29413844
Odynophagia 84.16 13.00 80 75512 4590 29494345
Peripheral swelling 83.98 13.00 29 75563 63710 29435225
Gastric perforation 83.32 13.00 58 75534 2128 29496807
Muscle spasms 81.72 13.00 32 75560 65050 29433885
Inappropriate antidiuretic hormone secretion 81.43 13.00 119 75473 10813 29488122
Deafness 80.09 13.00 113 75479 9942 29488993
Sepsis 79.56 13.00 630 74962 142052 29356883
Vena cava thrombosis 77.43 13.00 42 75550 976 29497959
Peripheral ischaemia 76.16 13.00 79 75513 5040 29493895
Hospitalisation 75.99 13.00 13 75579 45975 29452960
Joint swelling 75.77 13.00 17 75575 49613 29449322
Anxiety 73.43 13.00 66 75526 85299 29413636
Peripheral artery thrombosis 73.25 13.00 53 75539 2069 29496866
Platelet count decreased 73.17 13.00 488 75104 104184 29394751
Metastases to lung 72.77 13.00 95 75497 7760 29491175
Product use in unapproved indication 72.58 13.00 424 75168 86451 29412484
Intentional product misuse 72.25 13.00 4 75588 34657 29464278
Metastases to central nervous system 71.98 13.00 90 75502 7041 29491894
Osteoradionecrosis 71.62 13.00 20 75572 61 29498874
Suicide attempt 70.90 13.00 4 75588 34106 29464829
Suicidal ideation 69.40 13.00 5 75587 34711 29464224
Nasopharyngitis 69.09 13.00 33 75559 59632 29439303
Insomnia 69.01 13.00 75 75517 88686 29410249
Myalgia 68.87 13.00 53 75539 73966 29424969
Musculoskeletal stiffness 67.94 13.00 8 75584 37450 29461485
Neutropenic colitis 67.22 13.00 53 75539 2358 29496577
Bacterial translocation 67.09 13.00 24 75568 192 29498743
Aplasia 66.46 13.00 66 75526 3997 29494938
Pain in extremity 66.01 13.00 113 75479 110320 29388615
Hypokalaemia 65.39 13.00 278 75314 49925 29449010
Death 65.06 13.00 561 75031 341523 29157412
Blood pressure increased 64.75 13.00 56 75536 73747 29425188
Splenic infarction 63.64 13.00 46 75546 1793 29497142
General physical health deterioration 62.77 13.00 464 75128 102393 29396542
Dermatitis 62.65 13.00 88 75504 7710 29491225
Gastrointestinal toxicity 61.92 13.00 48 75544 2083 29496852
Oesophageal fistula 61.60 13.00 22 75570 175 29498760
Psoriasis 60.69 13.00 6 75586 32221 29466714
Rheumatoid arthritis 57.98 13.00 7 75585 32145 29466790
Renal failure 57.70 13.00 508 75084 118091 29380844
Atypical haemolytic uraemic syndrome 57.49 13.00 20 75572 146 29498789
Portal venous gas 56.24 13.00 24 75568 320 29498615
Radiation pneumonitis 55.79 13.00 46 75546 2183 29496752
Pneumonitis 55.66 13.00 178 75414 27866 29471069
Inappropriate schedule of product administration 55.60 13.00 22 75570 44450 29454485
Asthma 54.98 13.00 10 75582 33839 29465096
Cardiac disorder 54.44 13.00 14 75578 37249 29461686
Condition aggravated 54.17 13.00 192 75400 146103 29352832
Thrombotic microangiopathy 54.09 13.00 87 75505 8594 29490341
Injection site pain 53.98 13.00 9 75583 32437 29466498
Acute respiratory distress syndrome 53.42 13.00 154 75438 22781 29476154
Hypocalcaemia 53.30 13.00 144 75448 20521 29478414
Tremor 52.99 13.00 66 75526 73472 29425463
Hiccups 52.82 13.00 87 75505 8766 29490169
Aggression 52.61 13.00 13 75579 35528 29463407
Electrolyte imbalance 52.03 13.00 99 75493 11175 29487760
Dizziness 51.94 13.00 279 75313 189405 29309530
Hepatitis B 51.73 13.00 67 75525 5430 29493505
Diffuse large B-cell lymphoma recurrent 51.64 13.00 47 75545 2550 29496385
Malignant transformation 51.47 13.00 30 75562 804 29498131
Oesophagobronchial fistula 50.75 13.00 18 75574 140 29498795
Neuropathy peripheral 50.71 13.00 333 75259 70694 29428241
Tumour necrosis 50.09 13.00 33 75559 1104 29497831
Pulmonary vascular disorder 50.09 13.00 26 75566 551 29498384
Deafness neurosensory 49.99 13.00 46 75546 2532 29496403
Gait disturbance 49.60 13.00 69 75523 73280 29425655
Wheezing 49.51 13.00 12 75580 33228 29465707
Radiation oesophagitis 49.31 13.00 23 75569 383 29498552
Metastases to liver 48.54 13.00 99 75493 11757 29487178
Vision blurred 48.40 13.00 21 75571 40155 29458780
Hallucination 48.38 13.00 27 75565 44685 29454250
Drug ineffective 47.88 13.00 648 74944 362522 29136413
Blood creatine phosphokinase increased 47.78 13.00 22 75570 40622 29458313
Bacteraemia 47.49 13.00 119 75473 16204 29482731
Ameloblastoma 47.25 13.00 15 75577 79 29498856
Deep vein thrombosis 47.15 13.00 279 75313 57120 29441815
Feeling abnormal 46.91 13.00 42 75550 54403 29444532
Hypertension 46.60 13.00 148 75444 116466 29382469
Pruritus 46.20 13.00 149 75443 116700 29382235
Heart rate decreased 45.98 13.00 5 75587 24907 29474028
Somnolence 45.96 13.00 108 75484 93847 29405088
Cytomegalovirus oesophagitis 45.72 13.00 22 75570 394 29498541
Mobility decreased 45.54 13.00 6 75586 25774 29473161
Oesophageal stenosis 45.52 13.00 35 75557 1500 29497435
Leukoencephalopathy 45.34 13.00 52 75540 3715 29495220
Renal infarct 44.80 13.00 31 75561 1126 29497809
Influenza 44.30 13.00 26 75566 41855 29457080
Wrong technique in product usage process 43.68 13.00 13 75579 31415 29467520
Azoospermia 43.25 13.00 21 75571 384 29498551
Coronary artery disease 43.22 13.00 30 75562 44160 29454775
Therapeutic product effect decreased 43.15 13.00 11 75581 29440 29469495
Renal impairment 43 13.00 355 75237 80978 29417957
Colitis 42.99 13.00 176 75416 31072 29467863
Osteosarcoma 42.84 13.00 17 75575 186 29498749
B-cell lymphoma recurrent 42.70 13.00 24 75568 599 29498336
Metastases to lymph nodes 42.64 13.00 52 75540 3965 29494970
Drug hypersensitivity 41.76 13.00 69 75523 68337 29430598
Intestinal ischaemia 41.60 13.00 67 75525 6625 29492310
COVID-19 41.55 13.00 20 75572 35994 29462941
Salivary gland cancer 41.40 13.00 18 75574 252 29498683
Radiation mucositis 41.09 13.00 15 75577 128 29498807
Memory impairment 40.95 13.00 21 75571 36449 29462486
Renal tubular disorder 40.88 13.00 53 75539 4299 29494636
Lymphopenia 40.78 13.00 100 75492 13433 29485502
Diarrhoea 40.73 13.00 1125 74467 331573 29167362
Alopecia 40.51 13.00 124 75468 18960 29479975
Urticaria 40.48 13.00 48 75544 54612 29444323
Carotid artery thrombosis 40.32 13.00 19 75573 324 29498611
Disease recurrence 40.14 13.00 110 75482 15804 29483131
Anastomotic complication 40.01 13.00 19 75573 330 29498605
Pulmonary arteriopathy 39.82 13.00 13 75579 76 29498859
Angioedema 39.54 13.00 16 75576 31899 29467036
Arthritis 39.34 13.00 8 75584 25011 29473924
Electrocardiogram QT prolonged 38.84 13.00 22 75570 36115 29462820
Foetal exposure during pregnancy 38.78 13.00 19 75573 33848 29465087
Pneumatosis intestinalis 38.57 13.00 44 75548 3125 29495810
Interstitial lung disease 38.42 13.00 266 75326 57452 29441483
Enteritis 38.20 13.00 65 75527 6726 29492209
Balance disorder 37.49 13.00 23 75569 36147 29462788
Embolism 37.47 13.00 65 75527 6831 29492104
Hypoglycaemia 37.38 13.00 41 75551 48305 29450630
Adverse drug reaction 37.11 13.00 8 75584 24012 29474923
Chemotherapy 37.05 13.00 21 75571 533 29498402
Blood stem cell transplant failure 36.76 13.00 19 75573 399 29498536
Blood pressure fluctuation 36.69 13.00 4 75588 19890 29479045
Prostate cancer 36.51 13.00 10 75582 25517 29473418
Tracheo-oesophageal fistula 36.25 13.00 19 75573 411 29498524
Influenza like illness 36.12 13.00 9 75583 24461 29474474
Large intestine perforation 35.69 13.00 66 75526 7290 29491645
Hypoacusis 35.69 13.00 99 75493 14324 29484611
Incorrect dose administered 35.56 13.00 20 75572 32964 29465971
Tumour perforation 35.51 13.00 16 75576 245 29498690
Blood sodium decreased 35.20 13.00 100 75492 14667 29484268
Bronchial fistula 35.05 13.00 14 75578 156 29498779
Neurosensory hypoacusis 34.80 13.00 7 75585 0 29498935
Teratoma 34.58 13.00 9 75583 19 29498916
Tumour haemorrhage 34.56 13.00 37 75555 2448 29496487
Empyema 34.53 13.00 39 75553 2740 29496195
Confusional state 34.45 13.00 189 75403 127688 29371247
Nephrolithiasis 34.27 13.00 11 75581 25323 29473612
Palmar-plantar erythrodysaesthesia syndrome 34.27 13.00 99 75493 14660 29484275
Metastasis 34.16 13.00 43 75549 3386 29495549
Respiratory failure 34.09 13.00 389 75203 96742 29402193
Chloroma 34.07 13.00 19 75573 467 29498468
Neoplasm recurrence 33.98 13.00 33 75559 1944 29496991
International normalised ratio increased 33.90 13.00 38 75554 44334 29454601
Unevaluable event 33.80 13.00 17 75575 29834 29469101
Progressive multifocal leukoencephalopathy 33.57 13.00 71 75521 8648 29490287
Cataract 33.48 13.00 8 75584 22370 29476565
Flagellate dermatitis 33.39 13.00 9 75583 23 29498912
Myocardial infarction 32.53 13.00 158 75434 110138 29388797
Osteoarthritis 32.49 13.00 4 75588 18099 29480836
Dyskinesia 32.42 13.00 6 75586 20055 29478880
Recall phenomenon 32.37 13.00 19 75573 516 29498419
Muscular weakness 32.23 13.00 69 75523 61983 29436952
Product prescribing error 32.19 13.00 4 75588 17972 29480963
Acquired gene mutation 31.56 13.00 26 75566 1232 29497703
Malaise 31.43 13.00 259 75333 159343 29339592
Rash 31.35 13.00 322 75270 189497 29309438
Depressed mood 31.13 13.00 3 75589 16445 29482490
Papillary thyroid cancer 30.89 13.00 19 75573 563 29498372
Pancreatitis 30.48 13.00 26 75566 34488 29464447
Abdominal discomfort 30.48 13.00 47 75545 47856 29451079
Blood glucose increased 30.29 13.00 66 75526 58918 29440017
Nasal congestion 29.76 13.00 6 75586 18873 29480062
Arterial occlusive disease 29.55 13.00 43 75549 3891 29495044
Osteosarcoma recurrent 29.53 13.00 8 75584 21 29498914
Liver function test abnormal 29.12 13.00 19 75573 28899 29470036
Pulmonary toxicity 29.10 13.00 48 75544 4842 29494093
Oedema peripheral 29.02 13.00 151 75441 103406 29395529
Toxicity to various agents 28.91 13.00 294 75298 173367 29325568
Serotonin syndrome 28.81 13.00 5 75587 17507 29481428
Hypophosphataemia 28.76 13.00 63 75529 7861 29491074
Bicytopenia 28.63 13.00 29 75563 1798 29497137
Pain 28.63 13.00 290 75302 171142 29327793
Sedation 28.57 13.00 5 75587 17400 29481535
Peritonitis 28.42 13.00 93 75499 14731 29484204
Chest discomfort 28.42 13.00 46 75546 45937 29452998
Mantle cell lymphoma recurrent 28.34 13.00 17 75575 481 29498454
Chronic obstructive pulmonary disease 28.20 13.00 38 75554 40917 29458018
Injury 28.12 13.00 7 75585 19039 29479896
Contusion 27.98 13.00 23 75569 31072 29467863
Erectile dysfunction 27.82 13.00 6 75586 18003 29480932
Drug resistance 27.81 13.00 119 75473 21421 29477514
Hepatic candidiasis 27.80 13.00 9 75583 51 29498884
Blood HIV RNA increased 27.46 13.00 22 75570 1002 29497933
Gout 27.45 13.00 5 75587 16906 29482029
Bradycardia 27.11 13.00 82 75510 65547 29433388
Extravasation 27.05 13.00 27 75565 1645 29497290
Gait inability 26.65 13.00 7 75585 18368 29480567
Back pain 26.54 13.00 153 75439 102131 29396804
Abnormal behaviour 26.44 13.00 13 75579 23114 29475821
Primitive neuroectodermal tumour 26.32 13.00 9 75583 62 29498873
Disseminated intravascular coagulation 26.27 13.00 111 75481 19869 29479066
Cerebral venous sinus thrombosis 26.24 13.00 15 75577 387 29498548
Cerebral ischaemia 26.22 13.00 50 75542 5653 29493282
Herpes zoster 26.10 13.00 23 75569 30029 29468906
Irritability 26.02 13.00 12 75580 22140 29476795
Blood creatinine increased 25.57 13.00 331 75261 84771 29414164
Enterocolitis 25.34 13.00 54 75538 6612 29492323
Arteriospasm coronary 25.29 13.00 32 75560 2533 29496402
Loss of personal independence in daily activities 25.23 13.00 17 75575 25423 29473512
Emotional distress 25.11 13.00 3 75589 13892 29485043
Dermatitis acneiform 25.07 13.00 48 75544 5443 29493492
Accidental overdose 24.96 13.00 7 75585 17586 29481349
Pneumothorax 24.84 13.00 93 75499 15749 29483186
Sleep disorder 24.59 13.00 16 75576 24370 29474565
Angina pectoris 24.57 13.00 21 75571 27829 29471106
Lymphadenopathy mediastinal 24.53 13.00 29 75563 2140 29496795
Radiation injury 24.49 13.00 15 75577 441 29498494
Fluid retention 24.38 13.00 15 75577 23545 29475390
Cerebral infarction 24.29 13.00 126 75466 24549 29474386
Refeeding syndrome 24.23 13.00 7 75585 25 29498910
Oesophageal perforation 24.13 13.00 18 75574 737 29498198
Lactic acidosis 24.11 13.00 25 75567 30222 29468713
Therapy cessation 24.08 13.00 4 75588 14458 29484477
Testicular malignant teratoma 23.97 13.00 6 75586 10 29498925
Refractory cancer 23.87 13.00 10 75582 127 29498808
Product administration error 23.73 13.00 4 75588 14306 29484629
Pharyngeal inflammation 23.55 13.00 13 75579 313 29498622
Diabetes mellitus 23.54 13.00 41 75551 39790 29459145
Retinal toxicity 23.53 13.00 14 75578 390 29498545
Sinusitis 23.52 13.00 32 75560 34318 29464617
Diaphragm muscle weakness 23.32 13.00 10 75582 135 29498800
Necrosis 23.00 13.00 44 75548 4986 29493949
Gastrooesophageal reflux disease 22.95 13.00 28 75564 31468 29467467
Blindness cortical 22.86 13.00 13 75579 332 29498603
Localised infection 22.61 13.00 4 75588 13812 29485123
Blood cholesterol increased 22.51 13.00 6 75586 15589 29483346
Granulocyte count decreased 22.49 13.00 16 75576 608 29498327
Road traffic accident 22.43 13.00 6 75586 15555 29483380
Haematoma 22.37 13.00 16 75576 23196 29475739
Oral candidiasis 22.13 13.00 69 75523 10653 29488282
Cholelithiasis 22.11 13.00 10 75582 18662 29480273
Hypochloraemia 22.09 13.00 15 75577 528 29498407
Agitation 21.98 13.00 63 75529 51241 29447694
Granulocyte-colony stimulating factor level increased 21.93 13.00 5 75587 4 29498931
Morphoea 21.80 13.00 10 75582 160 29498775
Gastrointestinal ischaemia 21.80 13.00 10 75582 160 29498775
Superior mesenteric artery syndrome 21.74 13.00 8 75584 70 29498865
Pleural effusion 21.73 13.00 280 75312 71628 29427307
Sleep apnoea syndrome 21.51 13.00 9 75583 17590 29481345
Myoclonus 21.46 13.00 4 75588 13305 29485630
Necrosis ischaemic 21.45 13.00 11 75581 227 29498708
Soft tissue disorder 21.43 13.00 16 75576 656 29498279
Performance status decreased 21.39 13.00 36 75556 3691 29495244
Coronary artery thrombosis 21.35 13.00 26 75566 1979 29496956
Labelled drug-drug interaction medication error 21.07 13.00 3 75589 12156 29486779
Blood glucose decreased 20.86 13.00 3 75589 12066 29486869
Wound 20.85 13.00 3 75589 12060 29486875
Extremity necrosis 20.78 13.00 23 75569 1580 29497355
Embolism arterial 20.67 13.00 14 75578 491 29498444
Choriocarcinoma 20.50 13.00 5 75587 7 29498928
Underdose 20.40 13.00 3 75589 11866 29487069
Vascular injury 20.34 13.00 11 75581 254 29498681
Neutrophil count abnormal 20.09 13.00 22 75570 1493 29497442
Hypoalbuminaemia 20.07 13.00 65 75527 10240 29488695
Metastases to peritoneum 20.03 13.00 22 75570 1498 29497437
Blood pressure systolic increased 19.98 13.00 9 75583 16836 29482099
Hyperammonaemic encephalopathy 19.90 13.00 25 75567 1965 29496970
Neurotoxicity 19.85 13.00 82 75510 14531 29484404
Full blood count decreased 19.83 13.00 8 75584 15984 29482951
Deafness bilateral 19.83 13.00 18 75574 973 29497962
Metastases to skin 19.80 13.00 12 75580 346 29498589
Palpitations 19.78 13.00 33 75559 32571 29466364
Iliac artery occlusion 19.67 13.00 9 75583 143 29498792
Product quality issue 19.63 13.00 8 75584 15887 29483048
Blood lactate dehydrogenase increased 19.54 13.00 99 75493 19110 29479825
Carotid artery dissection 19.51 13.00 9 75583 146 29498789
Adrenocortical carcinoma 19.50 13.00 6 75586 28 29498907
Mitral valve incompetence 19.40 13.00 5 75587 13288 29485647
Procedural vomiting 19.39 13.00 9 75583 148 29498787
Campylobacter test positive 19.32 13.00 6 75586 29 29498906
Hyperhidrosis 19.28 13.00 92 75500 64448 29434487
Failure to thrive 19.26 13.00 53 75539 7631 29491304
Speech disorder 19.24 13.00 19 75573 23497 29475438
Hot flush 19.17 13.00 7 75585 14863 29484072
Cell-mediated immune deficiency 19.16 13.00 6 75586 30 29498905
Transitional cell carcinoma recurrent 19.07 13.00 5 75587 11 29498924
Laryngeal pain 18.85 13.00 28 75564 2580 29496355
Medulloblastoma recurrent 18.85 13.00 7 75585 63 29498872
Transient ischaemic attack 18.81 13.00 19 75573 23251 29475684
Transformation to acute myeloid leukaemia 18.78 13.00 15 75577 680 29498255
EGFR gene mutation 18.66 13.00 8 75584 108 29498827
Loss of consciousness 18.55 13.00 112 75480 73944 29424991
Swelling 18.51 13.00 39 75553 35244 29463691
Haematochezia 18.48 13.00 42 75550 36941 29461994
Procedural nausea 18.47 13.00 7 75585 67 29498868
Psychotic disorder 18.38 13.00 15 75577 20339 29478596
Urinary tract infection 18.35 13.00 109 75483 72245 29426690
Chromaturia 18.33 13.00 5 75587 12797 29486138
Hepatitis B reactivation 18.28 13.00 31 75561 3198 29495737
Intestinal infarction 18.27 13.00 13 75579 494 29498441
Upper respiratory tract infection 18.20 13.00 26 75566 27323 29471612
Peripheral sensory neuropathy 18.01 13.00 44 75548 5895 29493040
Venous thrombosis 18.00 13.00 30 75562 3052 29495883
Meningitis tuberculous 17.99 13.00 14 75578 611 29498324
Visceral venous thrombosis 17.97 13.00 5 75587 15 29498920
Hypoaesthesia 17.91 13.00 73 75519 53394 29445541
Disturbance in attention 17.88 13.00 17 75575 21407 29477528
Hyperlipidaemia 17.88 13.00 5 75587 12585 29486350
Gastrointestinal perforation 17.85 13.00 32 75560 3451 29495484
Accidental exposure to product 17.84 13.00 3 75589 10750 29488185
Cerebral venous thrombosis 17.73 13.00 14 75578 624 29498311
Ureteric dilatation 17.67 13.00 8 75584 124 29498811
Drug clearance decreased 17.65 13.00 20 75572 1410 29497525
Oesophageal pain 17.64 13.00 15 75577 743 29498192
Haemoptysis 17.57 13.00 136 75456 30414 29468521
Dermatitis diaper 17.53 13.00 10 75582 257 29498678
Drug intolerance 17.53 13.00 64 75528 48315 29450620
Bronchitis 17.51 13.00 43 75549 36825 29462110
Fanconi syndrome 17.47 13.00 21 75571 1577 29497358
Mucosal toxicity 17.37 13.00 9 75583 190 29498745
Injection site erythema 17.28 13.00 7 75585 13949 29484986
Blood creatinine 17.22 13.00 6 75586 44 29498891
Dysstasia 17.21 13.00 3 75589 10471 29488464
Gastrointestinal anastomotic leak 17.19 13.00 11 75581 350 29498585
Visual impairment 17.18 13.00 31 75561 29677 29469258
Traumatic lung injury 17.17 13.00 18 75574 1162 29497773
Trigeminal nerve paresis 17.13 13.00 4 75588 4 29498931
Metastases to bone 17.12 13.00 60 75532 9838 29489097
B-cell lymphoma refractory 17 13.00 8 75584 136 29498799
Gingivitis ulcerative 16.99 13.00 6 75586 46 29498889
Chemotherapeutic drug level increased 16.91 13.00 9 75583 201 29498734
Human chorionic gonadotropin increased 16.86 13.00 5 75587 20 29498915
Metastases to meninges 16.86 13.00 18 75574 1187 29497748
Delusion 16.79 13.00 4 75588 11212 29487723
Lymphangiosis carcinomatosa 16.75 13.00 15 75577 797 29498138
Burning sensation 16.70 13.00 10 75582 15928 29483007
Movement disorder 16.67 13.00 3 75589 10234 29488701
Type 2 diabetes mellitus 16.51 13.00 7 75585 13574 29485361
Myelitis transverse 16.38 13.00 16 75576 949 29497986
Blister 16.38 13.00 16 75576 19890 29479045
Withdrawal syndrome 16.30 13.00 4 75588 10988 29487947
Thrombocytosis 16.16 13.00 30 75562 3323 29495612
Subcutaneous emphysema 16.01 13.00 16 75576 976 29497959
Swelling face 16.01 13.00 17 75575 20333 29478602
Wound evisceration 15.97 13.00 7 75585 100 29498835
Small cell lung cancer 15.93 13.00 21 75571 1731 29497204
Dementia 15.88 13.00 5 75587 11653 29487282
Rectal haemorrhage 15.87 13.00 41 75551 34508 29464427
Hypersomnia 15.78 13.00 4 75588 10750 29488185
Tumour thrombosis 15.78 13.00 6 75586 58 29498877
Eye pain 15.74 13.00 5 75587 11590 29487345
Hepatic enzyme increased 15.60 13.00 40 75552 33759 29465176
Testicular cancer metastatic 15.60 13.00 6 75586 60 29498875
Testicular germ cell cancer metastatic 15.60 13.00 6 75586 60 29498875
Ganglioneuroma 15.51 13.00 4 75588 8 29498927
Gene mutation 15.37 13.00 16 75576 1025 29497910
Blood magnesium decreased 15.35 13.00 39 75553 5355 29493580
Blastic plasmacytoid dendritic cell neoplasia 15.26 13.00 6 75586 64 29498871
Osteosarcoma metastatic 15.20 13.00 4 75588 9 29498926
Plasma cell leukaemia 15.02 13.00 14 75578 783 29498152
Immune-mediated hepatic disorder 15.01 13.00 10 75582 341 29498594
Hyperglycaemic hyperosmolar nonketotic syndrome 15 13.00 16 75576 1054 29497881
Blood triglycerides increased 15.00 13.00 7 75585 12827 29486108
Enterococcal bacteraemia 14.92 13.00 19 75573 1514 29497421
Carotid artery perforation 14.92 13.00 3 75589 0 29498935
Pharyngeal stenosis 14.92 13.00 3 75589 0 29498935
Plasma cell myeloma 14.87 13.00 47 75545 37068 29461867
Respiratory depression 14.86 13.00 8 75584 13515 29485420
Viral load increased 14.82 13.00 22 75570 2027 29496908
Eosinophilia 14.81 13.00 21 75571 22140 29476795
Hepatic steatosis 14.80 13.00 10 75582 14936 29483999
Dyspnoea exertional 14.77 13.00 46 75546 36444 29462491
Rib fracture 14.76 13.00 7 75585 12711 29486224
Cerebral haemorrhage 14.66 13.00 37 75555 31389 29467546
JC virus infection 14.63 13.00 21 75571 1876 29497059
Basal cell carcinoma 14.61 13.00 13 75579 16897 29482038
Thrombotic thrombocytopenic purpura 14.60 13.00 28 75564 3178 29495757
Laboratory test abnormal 14.52 13.00 15 75577 18170 29480765
Haemoperitoneum 14.44 13.00 19 75573 1563 29497372
Apparent mineralocorticoid excess 14.43 13.00 5 75587 36 29498899
Frequent bowel movements 14.43 13.00 3 75589 9236 29489699
White blood cell disorder 14.42 13.00 18 75574 1405 29497530
Infected neoplasm 14.41 13.00 6 75586 75 29498860
Metapneumovirus bronchiolitis 14.37 13.00 4 75588 12 29498923
Head injury 14.33 13.00 12 75580 16069 29482866
Diabetic ketoacidosis 14.32 13.00 12 75580 16061 29482874
Dropped head syndrome 14.27 13.00 7 75585 131 29498804
Treatment noncompliance 14.26 13.00 25 75567 24202 29474733
Sarcoma 14.24 13.00 10 75582 372 29498563
Penile vein thrombosis 14.13 13.00 4 75588 13 29498922
Cerebrovascular accident 14.13 13.00 127 75465 76784 29422151
Polyneuropathy 14.07 13.00 65 75527 12087 29486848
Malocclusion 14.06 13.00 6 75586 80 29498855
Eczema 14.03 13.00 9 75583 13817 29485118
Fistula of small intestine 13.94 13.00 10 75582 385 29498550
Laryngeal cancer stage IV 13.91 13.00 4 75588 14 29498921
Gastrointestinal haemorrhage 13.89 13.00 133 75459 79400 29419535
Paranoia 13.88 13.00 4 75588 9873 29489062
Therapeutic embolisation 13.85 13.00 9 75583 294 29498641
Osteomyelitis 13.81 13.00 9 75583 13700 29485235
Candida infection 13.80 13.00 76 75516 15149 29483786
Thrombophlebitis migrans 13.73 13.00 6 75586 85 29498850
Metastatic gastric cancer 13.59 13.00 7 75585 146 29498789
Focal nodular hyperplasia 13.50 13.00 7 75585 148 29498787
Torulopsis infection 13.49 13.00 4 75588 16 29498919
Optic atrophy 13.45 13.00 13 75579 761 29498174
Subdural haematoma 13.44 13.00 16 75576 18177 29480758
Fistula 13.44 13.00 36 75556 5103 29493832
Hip fracture 13.42 13.00 5 75587 10487 29488448
Chondrosarcoma 13.37 13.00 5 75587 46 29498889
Hemianopia 13.34 13.00 12 75580 641 29498294
Cellulitis 13.30 13.00 66 75526 45774 29453161
Oral pain 13.25 13.00 53 75539 9254 29489681
Tetany 13.20 13.00 12 75580 650 29498285
Abdominal wound dehiscence 13.19 13.00 6 75586 94 29498841
Tracheal stenosis 13.17 13.00 7 75585 156 29498779
Tooth disorder 13.13 13.00 4 75588 9525 29489410
Cytopenia 13.13 13.00 55 75537 9804 29489131
Laryngeal inflammation 13.12 13.00 4 75588 18 29498917
Decorticate posture 13.12 13.00 4 75588 18 29498917
Retinal ischaemia 13.00 13.00 9 75583 327 29498608

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
Febrile neutropenia 2189.66 12.76 2112 109007 185545 64202068
Neutropenia 1587.98 12.76 2005 109114 237619 64149994
Thrombocytopenia 1116.79 12.76 1633 109486 222168 64165445
Mucosal inflammation 1038.22 12.76 861 110258 61723 64325890
Malignant neoplasm progression 901.53 12.76 1040 110079 111831 64275782
Bone marrow failure 742.01 12.76 634 110485 47318 64340295
Pancytopenia 725.60 12.76 1054 110065 142255 64245358
Haematotoxicity 637.67 12.76 350 110769 12546 64375067
Disease progression 630.16 12.76 981 110138 140699 64246914
Leukopenia 509.66 12.76 743 110376 100499 64287114
Myelosuppression 509.40 12.76 381 110738 23449 64364164
Acute myeloid leukaemia 506.02 12.76 402 110717 27061 64360552
Anaemia 490.94 12.76 1599 109520 377081 64010532
Dehydration 470.70 12.76 1106 110013 215657 64171956
Vomiting 468.13 12.76 2031 109088 549086 63838527
Arthralgia 421.99 12.76 120 110999 442140 63945473
Second primary malignancy 402.59 12.76 256 110863 12081 64375532
Nausea 352.98 12.76 2434 108685 783366 63604247
Neutropenic sepsis 344.17 12.76 300 110819 22972 64364641
Off label use 324.96 12.76 2028 109091 630778 63756835
Aortic thrombosis 319.30 12.76 114 111005 1400 64386213
Renal salt-wasting syndrome 317.16 12.76 86 111033 378 64387235
Neutrophil count decreased 313.18 12.76 513 110606 76683 64310930
Fall 301.65 12.76 172 110947 416654 63970959
Ototoxicity 293.37 12.76 126 110993 2597 64385016
Neoplasm progression 273.39 12.76 345 110774 40619 64346994
Joint swelling 263.63 12.76 31 111088 215351 64172262
Hypomagnesaemia 262.59 12.76 323 110796 37053 64350560
Myelodysplastic syndrome 253.83 12.76 274 110845 27305 64360308
Rheumatoid arthritis 250.49 12.76 7 111112 164287 64223326
Pulmonary embolism 243.62 12.76 676 110443 145680 64241933
Product dose omission issue 243.45 12.76 26 111093 194721 64192892
Nephropathy toxic 241.46 12.76 217 110902 17297 64370316
Pyrexia 230.92 12.76 1698 109421 556946 63830667
Acute kidney injury 226.29 12.76 1434 109685 447806 63939807
Drug abuse 208.11 12.76 4 111115 132370 64255243
Peripheral swelling 208.10 12.76 52 111067 209101 64178512
Headache 202.47 12.76 378 110741 529089 63858524
Deafness 195.09 12.76 197 110922 18162 64369451
Weight increased 193.86 12.76 63 111056 213285 64174328
Cardiotoxicity 192.63 12.76 152 110967 10122 64377491
Pain 187.21 12.76 424 110695 553087 63834526
Tumour lysis syndrome 185.68 12.76 197 110922 19243 64368370
Platelet count decreased 183.96 12.76 671 110448 167040 64220573
Dysphagia 180.26 12.76 496 110623 106316 64281297
Sepsis 180.15 12.76 830 110289 229511 64158102
Posterior reversible encephalopathy syndrome 178.70 12.76 209 110910 22737 64364876
Decreased appetite 175.73 12.76 951 110168 280338 64107275
Stomatitis 175.17 12.76 499 110620 109106 64278507
Septic shock 174.36 12.76 486 110633 104951 64282662
Therapy partial responder 173.85 12.76 143 110976 10105 64377508
Metastases to lung 173.67 12.76 170 110949 15094 64372519
Musculoskeletal stiffness 171.89 12.76 10 111109 123196 64264417
Metastases to central nervous system 171.62 12.76 162 110957 13750 64373863
Anastomotic leak 171.25 12.76 64 111055 902 64386711
Arthropathy 168.21 12.76 10 111109 120957 64266656
Nasopharyngitis 162.74 12.76 67 111052 196006 64191607
Product use in unapproved indication 162.15 12.76 668 110451 175950 64211663
Drug hypersensitivity 160.81 12.76 106 111013 237709 64149904
Pain in extremity 158.60 12.76 173 110946 302912 64084701
Hypokalaemia 158.28 12.76 516 110603 121387 64266226
White blood cell count decreased 157.72 12.76 613 110506 157224 64230389
Tinnitus 155.09 12.76 239 110880 33894 64353719
Hyponatraemia 154.69 12.76 584 110535 147755 64239858
Diffuse large B-cell lymphoma recurrent 148.93 12.76 83 111036 3063 64384550
Oesophagitis 148.79 12.76 185 110934 21445 64366168
Overdose 145.12 12.76 47 111072 159519 64228094
Abdominal discomfort 140.80 12.76 69 111050 182253 64205360
Injection site pain 138.84 12.76 15 111104 111393 64276220
Radiation skin injury 134.96 12.76 59 111060 1271 64386342
Therapeutic product effect decreased 132.95 12.76 20 111099 115331 64272282
Renal failure 131.96 12.76 641 110478 181047 64206566
Teratoma 131.94 12.76 34 111085 117 64387496
Neuropathy peripheral 131.14 12.76 473 110646 117052 64270561
Drug resistance 129.91 12.76 224 110895 34878 64352735
Gastrointestinal toxicity 129.35 12.76 92 111027 5230 64382383
Insomnia 126.03 12.76 94 111025 197742 64189871
Condition aggravated 123.49 12.76 288 110831 372138 64015475
Pruritus 121.85 12.76 220 110899 312180 64075433
Hypophagia 120.36 12.76 232 110887 39355 64348258
Inappropriate antidiuretic hormone secretion 119.91 12.76 169 110950 22120 64365493
Peripheral artery thrombosis 119.89 12.76 71 111048 2944 64384669
Muscle spasms 117.29 12.76 48 111071 140975 64246638
Febrile bone marrow aplasia 116.34 12.76 119 111000 11136 64376477
Oesophageal fistula 116.01 12.76 36 111083 275 64387338
Swelling 115.79 12.76 66 111053 160152 64227461
Systemic lupus erythematosus 115.75 12.76 4 111115 77608 64310005
Metastases to lymph nodes 112.31 12.76 104 111015 8613 64379000
Aorto-oesophageal fistula 111.03 12.76 26 111093 52 64387561
Asthma 110.91 12.76 16 111103 95209 64292404
Hypocalcaemia 108.22 12.76 229 110890 41524 64346089
Diffuse large B-cell lymphoma refractory 108.04 12.76 48 111071 1076 64386537
Arthritis 107.78 12.76 10 111109 83804 64303809
Gastric perforation 107.25 12.76 70 111049 3453 64384160
Contusion 106.41 12.76 32 111087 113933 64273680
Ovarian germ cell teratoma 105.79 12.76 25 111094 53 64387560
Drug ineffective 105.53 12.76 934 110185 839313 63548300
Disease recurrence 104.91 12.76 192 110927 31318 64356295
Depression 102.16 12.76 99 111020 183192 64204421
Leukoencephalopathy 101.34 12.76 89 111030 6878 64380735
Intentional product misuse 100.42 12.76 6 111113 72289 64315324
Palmar-plantar erythrodysaesthesia syndrome 100.27 12.76 179 110940 28640 64358973
Deep vein thrombosis 99.74 12.76 402 110717 104780 64282833
Metastases to liver 99.57 12.76 161 110958 23780 64363833
Renal tubular disorder 98.34 12.76 82 111037 5905 64381708
Venoocclusive liver disease 96.53 12.76 102 111017 9913 64377700
Psoriasis 96.50 12.76 7 111112 71696 64315917
Contraindicated product administered 94.14 12.76 34 111085 107795 64279818
Drug interaction 93.32 12.76 316 110803 361767 64025846
Odynophagia 92.59 12.76 98 111021 9543 64378070
Wound 91.07 12.76 12 111107 76465 64311148
Peripheral ischaemia 91.02 12.76 91 111028 8287 64379326
Suicidal ideation 90.99 12.76 6 111113 66536 64321077
Pemphigus 90.97 12.76 3 111116 60698 64326915
Arterial thrombosis 90.85 12.76 55 111064 2375 64385238
Hypoacusis 90.43 12.76 161 110958 25706 64361907
Mobility decreased 89.97 12.76 19 111100 85821 64301792
Sinusitis 89.52 12.76 72 111047 145856 64241757
Hiccups 89.20 12.76 90 111029 8286 64379327
Dermatitis 88.65 12.76 131 110988 17898 64369715
Renal impairment 88.56 12.76 463 110656 134554 64253059
Gait disturbance 88.05 12.76 100 111019 172055 64215558
Neurotoxicity 87.49 12.76 164 110955 27240 64360373
Electrolyte imbalance 86.81 12.76 156 110963 25087 64362526
Radiation pneumonitis 86.63 12.76 60 111059 3268 64384345
Anxiety 86.06 12.76 135 110984 202514 64185099
Dizziness 85.94 12.76 415 110704 429748 63957865
Malignant transformation 85.52 12.76 41 111078 1100 64386513
Urogenital fistula 85.09 12.76 22 111097 77 64387536
Rash 83.91 12.76 456 110663 458093 63929520
Urticaria 83.91 12.76 78 111041 147239 64240374
Osteoarthritis 82.94 12.76 7 111112 63329 64324284
Teratoma benign 79.44 12.76 20 111099 61 64387552
Migraine 79.21 12.76 8 111111 62669 64324944
Bacteraemia 78.49 12.76 155 110964 26756 64360857
Feeling abnormal 78.16 12.76 69 111050 133533 64254080
Hospitalisation 78.10 12.76 17 111102 75190 64312423
Suicide attempt 78.04 12.76 14 111105 70993 64316620
Recall phenomenon 78.00 12.76 37 111082 969 64386644
Blood pressure increased 77.08 12.76 111 111008 172441 64215172
Blister 76.92 12.76 22 111097 80945 64306668
Somnolence 76.15 12.76 147 110972 203498 64184115
Cardiac failure congestive 75.72 12.76 68 111051 130512 64257101
Injection site erythema 75.59 12.76 15 111104 70785 64316828
Acute respiratory distress syndrome 74.97 12.76 190 110929 38745 64348868
Myalgia 74.91 12.76 98 111021 158519 64229094
Diarrhoea 74.19 12.76 1696 109423 721008 63666605
Osteoradionecrosis 73.55 12.76 20 111099 89 64387524
Stress 73.28 12.76 9 111110 60525 64327088
Bronchitis 72.72 12.76 49 111070 108694 64278919
Balance disorder 72.34 12.76 27 111092 83899 64303714
Nasal congestion 71.90 12.76 9 111110 59649 64327964
Enteritis 71.62 12.76 96 111023 11981 64375632
Hepatic enzyme increased 71.44 12.76 71 111048 129872 64257741
Wheezing 71.02 12.76 25 111094 80554 64307059
Pneumonitis 70.60 12.76 219 110900 50146 64337467
Drug intolerance 69.16 12.76 137 110982 187855 64199758
Deafness bilateral 68.95 12.76 42 111077 1834 64385779
Rhabdomyolysis 68.84 12.76 36 111083 91690 64295923
Pulmonary vascular disorder 68.47 12.76 33 111086 896 64386717
Large intestine perforation 68.43 12.76 96 111023 12508 64375105
Osteosarcoma 68.17 12.76 24 111095 282 64387331
Aplasia 67.34 12.76 71 111048 6882 64380731
Wrong technique in product usage process 66.83 12.76 15 111104 64959 64322654
Radiation oesophagitis 66.75 12.76 28 111091 543 64387070
Bicytopenia 66.63 12.76 53 111066 3569 64384044
Thrombotic microangiopathy 66.54 12.76 110 111009 16545 64371068
Injury 66.15 12.76 9 111110 55983 64331630
Hepatitis B 66.13 12.76 74 111045 7671 64379942
Blood creatinine increased 65.88 12.76 430 110689 135352 64252261
Cytomegalovirus oesophagitis 64.97 12.76 28 111091 582 64387031
Loss of personal independence in daily activities 64.68 12.76 22 111097 72432 64315181
Chloroma 64.23 12.76 29 111090 676 64386937
Hypophosphataemia 63.96 12.76 101 111018 14619 64372994
Inappropriate schedule of product administration 63.86 12.76 40 111079 92246 64295367
Neutropenic colitis 63.60 12.76 57 111062 4524 64383089
Bacterial translocation 63.55 12.76 25 111094 408 64387205
Pleural effusion 63.36 12.76 404 110715 126155 64261458
Influenza 62.33 12.76 55 111064 106476 64281137
Influenza like illness 61.97 12.76 15 111104 61687 64325926
Atypical haemolytic uraemic syndrome 61.58 12.76 28 111091 664 64386949
Portal venous gas 61.23 12.76 23 111096 329 64387284
Colitis 60.25 12.76 230 110889 58444 64329169
Electrocardiogram QT prolonged 59.89 12.76 31 111088 79417 64308196
Oesophageal stenosis 59.86 12.76 51 111068 3783 64383830
Metastases to skin 59.85 12.76 35 111084 1417 64386196
Discomfort 58.86 12.76 33 111086 80845 64306768
Injection site swelling 58.76 12.76 3 111116 41350 64346263
Bronchial fistula 58.59 12.76 19 111100 170 64387443
Metastases to breast 57.59 12.76 20 111099 225 64387388
Blood pressure fluctuation 57.49 12.76 10 111109 51861 64335752
Infusion related reaction 56.99 12.76 124 110995 164343 64223270
Renal tubular necrosis 56.98 12.76 121 110998 21989 64365624
Radiation injury 56.92 12.76 27 111092 707 64386906
Acquired gene mutation 56.91 12.76 38 111081 1948 64385665
Deafness neurosensory 56.31 12.76 62 111057 6312 64381301
Osteosarcoma metastatic 55.78 12.76 14 111105 42 64387571
Oesophagobronchial fistula 55.59 12.76 19 111100 203 64387410
Hypoglycaemia 55.55 12.76 44 111075 89848 64297765
Vena cava thrombosis 55.52 12.76 41 111078 2471 64385142
Pulmonary arteriopathy 55.46 12.76 16 111103 92 64387521
Memory impairment 55.44 12.76 40 111079 85642 64301971
Salivary gland cancer 54.94 12.76 22 111097 377 64387236
Metastasis 54.88 12.76 58 111061 5637 64381976
Exposure during pregnancy 54.67 12.76 33 111086 77642 64309971
Embolism 54.62 12.76 85 111034 12150 64375463
Disseminated intravascular coagulation 53.30 12.76 149 110970 32199 64355414
Ameloblastoma 53.09 12.76 15 111104 79 64387534
Renal infarct 52.50 12.76 39 111080 2372 64385241
Cataract 52.39 12.76 12 111107 51250 64336363
Vision blurred 52.39 12.76 47 111072 90269 64297344
Heart rate decreased 52.23 12.76 15 111104 55052 64332561
Tumour necrosis 52.13 12.76 34 111085 1675 64385938
Empyema 51.67 12.76 46 111073 3619 64383994
Anastomotic complication 51.39 12.76 21 111098 380 64387233
Malaise 50.56 12.76 438 110681 395809 63991804
Metastases to bone 50.55 12.76 110 111009 20325 64367288
Tremor 50.33 12.76 113 111006 148117 64239496
General physical health deterioration 50.25 12.76 556 110563 203869 64183744
Splenic infarction 50.18 12.76 43 111076 3214 64384399
Cardiomyopathy 50.13 12.76 125 110994 25231 64362382
Serotonin syndrome 49.67 12.76 5 111114 39277 64348336
Interstitial lung disease 49.53 12.76 313 110806 97419 64290194
Fibromyalgia 49.51 12.76 3 111116 35728 64351885
Osteoporosis 49.15 12.76 7 111112 42073 64345540
Arteriospasm coronary 48.01 12.76 53 111066 5412 64382201
Respiratory failure 48.01 12.76 456 110663 160727 64226886
Pulmonary toxicity 47.66 12.76 66 111053 8495 64379118
Tumour haemorrhage 47.58 12.76 43 111076 3450 64384163
Lymphopenia 47.11 12.76 123 110996 25534 64362079
Performance status decreased 47.08 12.76 52 111067 5312 64382301
Gastrointestinal perforation 46.61 12.76 52 111067 5372 64382241
Cerebral infarction 46.41 12.76 166 110953 40878 64346735
Gastrooesophageal reflux disease 46.18 12.76 45 111074 83098 64304515
Blood creatine phosphokinase increased 45.41 12.76 22 111097 58536 64329077
Fluid retention 45.31 12.76 23 111096 59583 64328030
Maternal exposure during pregnancy 44.48 12.76 60 111059 95824 64291789
Mantle cell lymphoma recurrent 44.15 12.76 20 111099 470 64387143
Radiation mucositis 43.91 12.76 15 111104 160 64387453
Sedation 43.81 12.76 9 111110 41453 64346160
Chronic obstructive pulmonary disease 43.62 12.76 35 111084 71013 64316600
Fatigue 43.61 12.76 971 110148 747759 63639854
Polyneuropathy 43.54 12.76 102 111017 19792 64367821
Blood cholesterol increased 43.32 12.76 16 111103 50050 64337563
Muscular weakness 43.29 12.76 97 111022 127241 64260372
Aggression 43.10 12.76 13 111106 46219 64341394
Blood sodium decreased 42.99 12.76 130 110989 29352 64358261
Peritonitis 42.95 12.76 117 111002 24906 64362707
Necrosis 42.53 12.76 61 111058 8110 64379503
Blood stem cell transplant failure 42.47 12.76 20 111099 515 64387098
B-cell lymphoma recurrent 42.27 12.76 23 111096 809 64386804
Drug withdrawal syndrome 42.25 12.76 3 111116 31288 64356325
Adverse drug reaction 42.00 12.76 13 111106 45451 64342162
Type 2 diabetes mellitus 41.32 12.76 5 111114 34015 64353598
Cerebral venous thrombosis 41.27 12.76 34 111085 2407 64385206
Drug clearance decreased 41.22 12.76 35 111084 2584 64385029
Palpitations 41.18 12.76 73 111046 104415 64283198
Burning sensation 41.11 12.76 17 111102 49647 64337966
Dermatitis acneiform 41.00 12.76 61 111058 8382 64379231
Hallucination 40.88 12.76 39 111080 72749 64314864
Cystitis haemorrhagic 40.84 12.76 59 111060 7897 64379716
Coronary artery disease 40.70 12.76 27 111092 60406 64327207
Tumour perforation 40.70 12.76 17 111102 326 64387287
Intestinal ischaemia 40.51 12.76 72 111047 11477 64376136
Hypoalbuminaemia 40.19 12.76 92 111027 17582 64370031
Pneumatosis intestinalis 39.66 12.76 47 111072 5182 64382431
Oedema peripheral 39.56 12.76 207 110912 210110 64177503
Nervousness 39.44 12.76 3 111116 29553 64358060
Red blood cell sedimentation rate increased 39.43 12.76 4 111115 31231 64356382
Pneumothorax 39.13 12.76 111 111008 24187 64363426
Cardiac disorder 38.87 12.76 24 111095 55792 64331821
Hypoaesthesia 38.83 12.76 117 111002 138991 64248622
Refeeding syndrome 38.61 12.76 11 111108 60 64387553
Incorrect dose administered 38.49 12.76 29 111090 60736 64326877
Hydronephrosis 38.37 12.76 79 111040 14046 64373567
Back pain 38.22 12.76 263 110856 249908 64137705
Adrenocortical carcinoma 38.02 12.76 11 111108 64 64387549
Lactic acidosis 38.01 12.76 30 111089 61380 64326233
Gastrointestinal anastomotic leak 37.70 12.76 17 111102 395 64387218
Neoplasm recurrence 37.68 12.76 39 111080 3700 64383913
Injection site reaction 37.00 12.76 17 111102 46647 64340966
Confusional state 36.77 12.76 281 110838 260863 64126750
Toxicity to various agents 36.68 12.76 425 110694 363088 64024525
Unevaluable event 36.16 12.76 21 111098 50468 64337145
Angioedema 36.05 12.76 32 111087 61789 64325824
Sleep disorder 35.92 12.76 30 111089 59679 64327934
Metastases to peritoneum 35.75 12.76 37 111082 3510 64384103
Myasthenia gravis crisis 35.63 12.76 21 111098 863 64386750
Gastrointestinal fungal infection 35.48 12.76 16 111103 372 64387241
Osteosarcoma recurrent 35.38 12.76 9 111110 29 64387584
Heart rate increased 35.33 12.76 73 111046 98602 64289011
Peripheral sensory neuropathy 34.96 12.76 67 111052 11311 64376302
Product prescribing error 34.59 12.76 9 111110 35260 64352353
Fanconi syndrome 34.49 12.76 31 111088 2470 64385143
Cholelithiasis 33.93 12.76 18 111101 45488 64342125
Road traffic accident 33.91 12.76 6 111113 30739 64356874
Blood pressure systolic increased 33.43 12.76 22 111097 49431 64338182
Large intestinal ulcer perforation 33.36 12.76 10 111109 67 64387546
Melanoderma 33.25 12.76 15 111104 349 64387264
Neurosensory hypoacusis 33.11 12.76 13 111106 211 64387402
Localised infection 33.02 12.76 6 111113 30155 64357458
Small cell lung cancer 32.84 12.76 31 111088 2630 64384983
Ureteric rupture 32.72 12.76 7 111112 7 64387606
Coronary artery thrombosis 32.72 12.76 32 111087 2837 64384776
Refractory cancer 32.45 12.76 13 111106 223 64387390
Abortion spontaneous 32.31 12.76 3 111116 25140 64362473
Mesenteric abscess 32.14 12.76 11 111108 118 64387495
Extremity necrosis 32.13 12.76 31 111088 2703 64384910
Haematoma 32.05 12.76 20 111099 46230 64341383
Blindness cortical 31.95 12.76 19 111100 794 64386819
Acoustic stimulation tests abnormal 31.88 12.76 8 111111 24 64387589
Wernicke's encephalopathy 31.88 12.76 8 111111 24 64387589
Cervix neoplasm 31.55 12.76 12 111107 178 64387435
Malnutrition 31.41 12.76 88 111031 19037 64368576
Irritability 31.36 12.76 12 111107 36734 64350879
Metastases to meninges 31.36 12.76 31 111088 2784 64384829
Plasma cell leukaemia 31.33 12.76 24 111095 1529 64386084
Eye pain 31.15 12.76 8 111111 31617 64355996
Ascites 31.05 12.76 198 110921 61803 64325810
Injection site haemorrhage 30.93 12.76 3 111116 24275 64363338
Throat irritation 30.86 12.76 9 111110 32702 64354911
Blood glucose increased 30.71 12.76 78 111041 97995 64289618
Cytopenia 30.30 12.76 76 111043 15395 64372218
Dyskinesia 30.23 12.76 15 111104 39373 64348240
Chemical peritonitis 30.13 12.76 13 111106 271 64387342
Nasal abscess 29.96 12.76 11 111108 147 64387466
Extravasation 29.96 12.76 32 111087 3148 64384465
Flagellate dermatitis 29.84 12.76 12 111107 208 64387405
Gait inability 29.81 12.76 18 111101 42350 64345263
Cerebral ischaemia 29.80 12.76 58 111061 9904 64377709
Myoclonus 29.76 12.76 4 111115 25114 64362499
Plasmacytoma 29.71 12.76 35 111084 3835 64383778
International normalised ratio increased 29.69 12.76 57 111062 79110 64308503
Visceral venous thrombosis 29.57 12.76 7 111112 15 64387598
Swelling face 29.54 12.76 35 111084 59131 64328482
Nephritis bacterial 29.53 12.76 8 111111 35 64387578
Gastric disorder 29.51 12.76 7 111112 29190 64358423
Accidental exposure to product 29.40 12.76 5 111114 26359 64361254
Product administration error 29.20 12.76 6 111113 27637 64359976
Progressive multifocal leukoencephalopathy 29.07 12.76 83 111036 18149 64369464
COVID-19 28.97 12.76 42 111077 65098 64322515
Emotional distress 28.77 12.76 13 111106 36025 64351588
Blood lactate dehydrogenase increased 28.64 12.76 123 110996 32955 64354658
Underdose 28.58 12.76 5 111114 25824 64361789
Limb discomfort 28.50 12.76 6 111113 27169 64360444
Musculoskeletal pain 28.38 12.76 61 111058 81233 64306380
Basal cell carcinoma 28.16 12.76 9 111110 30829 64356784
Hepatic candidiasis 28.11 12.76 9 111110 77 64387536
Myocardial infarction 28.02 12.76 169 110950 165652 64221961
Lymphadenopathy mediastinal 28.02 12.76 34 111085 3842 64383771
Blood magnesium decreased 27.96 12.76 69 111050 13836 64373777
Lip swelling 27.94 12.76 10 111109 31897 64355716
Femur fracture 27.75 12.76 12 111107 34123 64353490
Urinary tract infection 27.73 12.76 260 110859 231336 64156277
Oesophageal perforation 27.64 12.76 19 111100 1022 64386591
Metastases to adrenals 27.62 12.76 20 111099 1169 64386444
Cerebral venous sinus thrombosis 27.59 12.76 24 111095 1831 64385782
Joint stiffness 27.54 12.76 9 111110 30395 64357218
Labelled drug-drug interaction medication error 27.40 12.76 3 111116 22059 64365554
Swollen tongue 27.30 12.76 13 111106 34941 64352672
Limb injury 27.24 12.76 4 111115 23501 64364112
Agitation 27.11 12.76 71 111048 88296 64299317
Poisoning 27.11 12.76 3 111116 21876 64365737
Therapy cessation 27.09 12.76 11 111108 32478 64355135
EGFR gene mutation 27.04 12.76 13 111106 351 64387262
Pancreatitis 26.93 12.76 38 111081 59569 64328044
Papillary thyroid cancer 26.90 12.76 26 111093 2272 64385341
Failure to thrive 26.88 12.76 57 111062 10347 64377266
Enterocolitis 26.71 12.76 62 111057 11956 64375657
Hepatic steatosis 26.67 12.76 10 111109 30997 64356616
Blood glucose decreased 26.65 12.76 4 111115 23119 64364494
Cholangitis 26.55 12.76 58 111061 10744 64376869
Right ventricular failure 26.46 12.76 3 111116 21468 64366145
Testicular malignant teratoma 26.33 12.76 6 111113 10 64387603
Tracheal stenosis 26.26 12.76 12 111107 288 64387325
Nephrolithiasis 26.21 12.76 22 111097 43661 64343952
Tumour thrombosis 26.18 12.76 9 111110 98 64387515
Pericarditis 26.17 12.76 42 111077 62474 64325139
Erythropenia 26.03 12.76 13 111106 382 64387231
Device issue 25.91 12.76 4 111115 22644 64364969
Impaired healing 25.91 12.76 40 111079 60433 64327180
Blood HIV RNA increased 25.78 12.76 21 111098 1463 64386150
Hyperhidrosis 25.75 12.76 119 111000 124801 64262812
Diabetes mellitus 25.68 12.76 47 111072 66427 64321186
Superior mesenteric artery syndrome 25.66 12.76 10 111109 159 64387454
Dry eye 25.57 12.76 9 111110 29010 64358603
Pregnancy 25.50 12.76 3 111116 20862 64366751
Medulloblastoma recurrent 25.47 12.76 9 111110 107 64387506
Lower respiratory tract infection 25.39 12.76 81 111038 94533 64293080
Diaphragm muscle weakness 25.37 12.76 10 111109 164 64387449
Tracheo-oesophageal fistula 25.36 12.76 14 111105 507 64387106
Neutrophil count abnormal 25.29 12.76 28 111091 2868 64384745
Traumatic lung injury 25.24 12.76 25 111094 2251 64385362
Pain in jaw 25.11 12.76 20 111099 40735 64346878
Ovarian vein thrombosis 25.08 12.76 7 111112 35 64387578
Candida infection 25.06 12.76 114 111005 31305 64356308
Sleep apnoea syndrome 25.03 12.76 10 111109 29822 64357791
Liver function test abnormal 24.78 12.76 40 111079 59361 64328252
Hypersensitivity 24.62 12.76 218 110901 196234 64191379
Dysstasia 24.60 12.76 5 111114 23210 64364403
Hip fracture 24.58 12.76 8 111111 27091 64360522
Wound evisceration 24.53 12.76 9 111110 120 64387493
Necrotising colitis 24.52 12.76 17 111102 927 64386686
Death 24.43 12.76 639 110480 482066 63905547
Product use issue 24.40 12.76 157 110962 151558 64236055
Upper respiratory tract infection 24.27 12.76 56 111063 72729 64314884
Haemoptysis 24.17 12.76 156 110963 48892 64338721
Gout 24.01 12.76 4 111115 21409 64366204
Accidental overdose 23.97 12.76 14 111105 33543 64354070
Duodenal ulcer perforation 23.95 12.76 15 111104 34610 64353003
Granulocyte-colony stimulating factor level increased 23.90 12.76 5 111114 4 64387609
Melanosis 23.87 12.76 7 111112 43 64387570
Rib fracture 23.83 12.76 6 111113 24032 64363581
Intestinal perforation 23.73 12.76 69 111050 15244 64372369
Hepatic cirrhosis 23.44 12.76 8 111111 26290 64361323
Nightmare 23.36 12.76 4 111115 20989 64366624
Myeloid leukaemia 23.35 12.76 14 111105 594 64387019
Alpha 1 foetoprotein increased 23.25 12.76 15 111104 725 64386888
Blood pressure diastolic decreased 23.23 12.76 5 111114 22296 64365317
Sopor 23.21 12.76 11 111108 29650 64357963
Chest discomfort 23.11 12.76 112 111007 115994 64271619
Metastatic neoplasm 22.88 12.76 33 111086 4409 64383204
Device related infection 22.86 12.76 109 111010 30517 64357096
Stem cell transplant 22.70 12.76 29 111090 3452 64384161
Obesity 22.70 12.76 4 111115 20558 64367055
Herpes simplex encephalitis 22.66 12.76 14 111105 627 64386986
Encephalopathy 22.52 12.76 176 110943 58643 64328970
Multiple sclerosis 22.48 12.76 3 111116 18938 64368675
Dyspnoea 22.48 12.76 1011 110108 717663 63669950
Acne 22.42 12.76 6 111113 23075 64364538
Fistula of small intestine 22.38 12.76 14 111105 641 64386972
Haemophagocytic lymphohistiocytosis 22.33 12.76 74 111045 17535 64370078
Purulent pericarditis 22.28 12.76 7 111112 56 64387557
Sciatica 22.25 12.76 4 111115 20260 64367353
Fanconi syndrome acquired 22.17 12.76 24 111095 2397 64385216
Myelitis transverse 22.15 12.76 20 111099 1603 64386010
Lymphangiosis carcinomatosa 22.06 12.76 21 111098 1800 64385813
Crying 21.98 12.76 4 111115 20086 64367527
Product quality issue 21.90 12.76 12 111107 29787 64357826
Depressed mood 21.85 12.76 23 111096 40989 64346624
Haemoglobin decreased 21.82 12.76 464 110655 194599 64193014
Aortic embolus 21.75 12.76 7 111112 61 64387552
Chromaturia 21.74 12.76 6 111113 22605 64365008
Viral load increased 21.64 12.76 24 111095 2463 64385150
Tooth disorder 21.43 12.76 6 111113 22396 64365217
Gingivitis ulcerative 21.40 12.76 10 111109 253 64387360
Abnormal behaviour 21.35 12.76 16 111103 33606 64354007
Iliac artery occlusion 21.15 12.76 10 111109 260 64387353
Angina pectoris 21.11 12.76 28 111091 45053 64342560
Asthenia 21.09 12.76 920 110199 427124 63960489
Ear infection 21.07 12.76 7 111112 23397 64364216
Transitional cell carcinoma recurrent 21.03 12.76 5 111114 11 64387602
Prescribed underdose 21.03 12.76 3 111116 18012 64369601
Multiple organ dysfunction syndrome 20.99 12.76 267 110852 101146 64286467
Movement disorder 20.85 12.76 6 111113 21994 64365619
Acute promyelocytic leukaemia 20.73 12.76 18 111101 1370 64386243
Cerebellar haemangioma 20.72 12.76 7 111112 72 64387541
Iron deficiency anaemia 20.69 12.76 6 111113 21883 64365730
Mucosal toxicity 20.65 12.76 12 111107 480 64387133
Jaw operation 20.50 12.76 14 111105 745 64386868
Hyperlipidaemia 20.46 12.76 7 111112 22969 64364644
Metastases to abdominal cavity 20.45 12.76 12 111107 489 64387124
Amputation stump pain 20.44 12.76 6 111113 37 64387576
Carotid artery thrombosis 20.43 12.76 20 111099 1775 64385838
Blood culture positive 20.20 12.76 43 111076 7825 64379788
Varicella zoster virus infection 20.20 12.76 29 111090 3859 64383754
Apparent mineralocorticoid excess 20.17 12.76 6 111113 39 64387574
Transient ischaemic attack 20.13 12.76 28 111091 44154 64343459
Enterocolitis infectious 20.11 12.76 23 111096 2441 64385172
Rhinorrhoea 20.11 12.76 46 111073 59923 64327690
Conductive deafness 20.06 12.76 7 111112 80 64387533
Gastrointestinal necrosis 19.98 12.76 33 111086 4959 64382654
Granulocyte count decreased 19.97 12.76 17 111102 1259 64386354
Oral candidiasis 19.85 12.76 86 111033 23126 64364487
Surgery 19.83 12.76 12 111107 28201 64359412
Embryonal rhabdomyosarcoma 19.79 12.76 6 111113 42 64387571
Azoospermia 19.77 12.76 8 111111 141 64387472
Bradycardia 19.69 12.76 121 110998 118098 64269515
Subclavian vein thrombosis 19.57 12.76 22 111097 2292 64385321
Chemotherapy 19.45 12.76 18 111101 1489 64386124
Pharyngeal stenosis 19.45 12.76 5 111114 17 64387596
Hypersomnia 19.39 12.76 5 111114 19712 64367901
Hallucination, auditory 19.36 12.76 3 111116 16936 64370677
Frequent bowel movements 19.28 12.76 4 111115 18301 64369312
Renal tubular injury 19.27 12.76 16 111103 1145 64386468
Neoplasm malignant 19.26 12.76 89 111030 24599 64363014
Abdominal pain 19.26 12.76 688 110431 311687 64075926
Small intestinal perforation 19.25 12.76 23 111096 2557 64385056
Oroticaciduria 19.23 12.76 4 111115 3 64387610
Oesophageal squamous cell carcinoma metastatic 19.23 12.76 4 111115 3 64387610
Extrapyramidal disorder 19.15 12.76 5 111114 19547 64368066
Hepatitis B reactivation 19.14 12.76 32 111087 4857 64382756
Carotid artery dissection 19.13 12.76 10 111109 324 64387289
Renal tubular dysfunction 19.12 12.76 13 111106 687 64386926
Alveolar soft part sarcoma 19.10 12.76 7 111112 93 64387520
Dropped head syndrome 18.96 12.76 9 111110 236 64387377
Anti-Muellerian hormone level decreased 18.84 12.76 7 111112 97 64387516
Sinus polyp 18.82 12.76 11 111108 445 64387168
Thrombocytopenia neonatal 18.82 12.76 5 111114 20 64387593
Ileus 18.81 12.76 84 111035 22882 64364731
Retinal ischaemia 18.79 12.76 13 111106 707 64386906
Trigeminal nerve paresis 18.70 12.76 4 111115 4 64387609
Maternal death affecting foetus 18.70 12.76 4 111115 4 64387609
Chemotherapeutic drug level increased 18.63 12.76 10 111109 342 64387271
Liver abscess 18.62 12.76 33 111086 5247 64382366
Haemoperitoneum 18.60 12.76 28 111091 3887 64383726
Cystitis 18.50 12.76 28 111091 42647 64344966
Ureteric dilatation 18.49 12.76 8 111111 168 64387445
Agranulocytosis 18.47 12.76 121 110998 38108 64349505
Subcutaneous emphysema 18.45 12.76 18 111101 1591 64386022
Prescribed overdose 18.44 12.76 6 111113 20325 64367288
Herpes zoster 18.43 12.76 72 111047 79115 64308498
Testicular cancer metastatic 18.28 12.76 6 111113 56 64387557
Unresponsive to stimuli 18.27 12.76 37 111082 50356 64337257
Axillary vein thrombosis 18.19 12.76 12 111107 603 64387010
Dystonia 18.15 12.76 5 111114 18860 64368753
Pneumonia 18.12 12.76 1156 109963 558420 63829193
Metastases to pleura 18.09 12.76 16 111103 1248 64386365
Clostridium colitis 18.01 12.76 22 111097 2503 64385110
Testicular germ cell cancer metastatic 18.00 12.76 6 111113 59 64387554
Choriocarcinoma 17.91 12.76 6 111113 60 64387553
Amnesia 17.88 12.76 35 111084 48234 64339379
Pharyngeal inflammation 17.83 12.76 14 111105 925 64386688
Cervix carcinoma recurrent 17.81 12.76 4 111115 6 64387607
Disturbance in attention 17.76 12.76 27 111092 41047 64346566
Sweat gland tumour 17.70 12.76 11 111108 498 64387115
Osteomyelitis 17.68 12.76 13 111106 27574 64360039
Bone marrow disorder 17.59 12.76 23 111096 2802 64384811
Gastroenteritis viral 17.59 12.76 6 111113 19723 64367890
Mental disorder 17.56 12.76 12 111107 26433 64361180
Clostridium bacteraemia 17.52 12.76 9 111110 281 64387332
Acute myelomonocytic leukaemia 17.52 12.76 9 111110 281 64387332
Lymphadenopathy 17.49 12.76 139 110980 46547 64341066
Metastases to abdominal wall 17.48 12.76 7 111112 120 64387493
Gastrointestinal ischaemia 17.46 12.76 10 111109 389 64387224
Heart rate irregular 17.46 12.76 13 111106 27400 64360213
Recurrent cancer 17.45 12.76 21 111098 2352 64385261
Staphylococcal infection 17.43 12.76 148 110971 50530 64337083
Portal vein thrombosis 17.36 12.76 31 111088 4960 64382653
Retinopathy 17.34 12.76 25 111094 3340 64384273
Campylobacter test positive 17.32 12.76 6 111113 67 64387546
Morphoea 17.30 12.76 10 111109 396 64387217
Night sweats 17.28 12.76 22 111097 36024 64351589
Sarcomatoid carcinoma 17.15 12.76 5 111114 30 64387583
Immune-mediated hepatic disorder 17.10 12.76 11 111108 529 64387084
Breast cancer 17.10 12.76 15 111104 29133 64358480
Thrombophlebitis migrans 17.09 12.76 9 111110 296 64387317
Medication error 17.02 12.76 38 111081 49928 64337685
Median nerve injury 17.01 12.76 5 111114 31 64387582
Neck pain 16.98 12.76 52 111067 61481 64326132
Hypovolaemia 16.97 12.76 62 111057 15424 64372189
Laryngeal pain 16.95 12.76 33 111086 5635 64381978
Vertigo 16.91 12.76 49 111070 58962 64328651
Delusion 16.91 12.76 5 111114 18009 64369604
Primitive neuroectodermal tumour 16.88 12.76 5 111114 32 64387581
Muscle spasticity 16.84 12.76 4 111115 16665 64370948
Jugular vein occlusion 16.76 12.76 4 111115 9 64387604
Respiratory arrest 16.69 12.76 42 111077 52943 64334670
Eczema 16.60 12.76 16 111103 29704 64357909
Embolism venous 16.55 12.76 25 111094 3482 64384131
Venous thrombosis 16.53 12.76 35 111084 6346 64381267
Poor quality sleep 16.49 12.76 6 111113 18945 64368668
Vascular injury 16.47 12.76 14 111105 1035 64386578
Staphylococcal bacteraemia 16.37 12.76 47 111072 10308 64377305
Glaucoma 16.36 12.76 4 111115 16344 64371269
Device malfunction 16.36 12.76 5 111114 17628 64369985
Ganglioneuroma 16.31 12.76 7 111112 144 64387469
Embolism arterial 16.27 12.76 15 111104 1235 64386378
Gene mutation 16.26 12.76 19 111100 2063 64385550
Organising pneumonia 16.20 12.76 43 111076 9012 64378601
Oesophageal squamous cell carcinoma recurrent 16.10 12.76 3 111116 0 64387613
Mixed deafness 16.10 12.76 3 111116 0 64387613
Emphysematous cholecystitis 16.10 12.76 3 111116 0 64387613
Sepsis pasteurella 16.10 12.76 3 111116 0 64387613
Gastrointestinal haemorrhage 16.06 12.76 148 110971 132164 64255449
Delirium 16.05 12.76 63 111056 69131 64318482
Leukaemic lymphoma 16.03 12.76 6 111113 85 64387528
Paraneoplastic dermatomyositis 16.02 12.76 5 111114 39 64387574
Toxic leukoencephalopathy 16.01 12.76 13 111106 902 64386711
Oesophageal squamous cell carcinoma 15.97 12.76 10 111109 459 64387154
Ischaemic stroke 15.97 12.76 95 111024 28940 64358673
Ovarian cancer recurrent 15.96 12.76 9 111110 340 64387273
Metapneumovirus bronchiolitis 15.94 12.76 4 111115 12 64387601
Marchiafava-Bignami disease 15.94 12.76 4 111115 12 64387601
Hot flush 15.88 12.76 35 111084 46200 64341413
Staphylococcus test positive 15.84 12.76 32 111087 5613 64382000
Liver function test increased 15.80 12.76 18 111101 30952 64356661
Dementia 15.80 12.76 8 111111 20758 64366855
Meningitis tuberculous 15.77 12.76 14 111105 1097 64386516
Lung cancer metastatic 15.70 12.76 23 111096 3117 64384496
Laryngeal cancer stage IV 15.70 12.76 4 111115 13 64387600
Eye irritation 15.63 12.76 4 111115 15852 64371761
Restless legs syndrome 15.62 12.76 5 111114 17111 64370502
Abdominal pain upper 15.60 12.76 210 110909 174820 64212793
Proctitis 15.59 12.76 23 111096 3136 64384477
Rash pruritic 15.50 12.76 49 111070 57355 64330258
Retinal toxicity 15.48 12.76 15 111104 1315 64386298
Cytokine release syndrome 15.45 12.76 74 111045 20755 64366858
Metastases to retroperitoneum 15.40 12.76 9 111110 364 64387249
Skin ulcer 15.34 12.76 33 111086 43941 64343672
Myasthenic syndrome 15.33 12.76 11 111108 634 64386979
Pericardial effusion 15.33 12.76 118 111001 39136 64348477
Dyspnoea exertional 15.33 12.76 70 111049 73660 64313953
Sinus disorder 15.32 12.76 5 111114 16903 64370710
Pelvic fluid collection 15.28 12.76 11 111108 637 64386976
Uterine atrophy 15.26 12.76 4 111115 15 64387598
BRAF gene mutation 15.20 12.76 5 111114 47 64387566
Cell-mediated immune deficiency 15.19 12.76 6 111113 99 64387514
Necrosis ischaemic 15.19 12.76 13 111106 970 64386643
Granulocytopenia 15.19 12.76 46 111073 10394 64377219
Fistula 15.14 12.76 44 111075 9717 64377896
Metastases to thorax 15.09 12.76 7 111112 174 64387439
Vascular compression 15.06 12.76 8 111111 268 64387345
Noctiphobia 15.05 12.76 4 111115 16 64387597
Myositis 15.03 12.76 62 111057 16315 64371298
Sinus congestion 15.02 12.76 4 111115 15435 64372178
Cellulitis 15.01 12.76 97 111022 93560 64294053
Hypoxia 14.95 12.76 224 110895 87925 64299688
Muscle twitching 14.94 12.76 7 111112 18991 64368622
Kidney infection 14.93 12.76 6 111113 17832 64369781
Thrombocytosis 14.91 12.76 36 111083 7120 64380493
Procedural vomiting 14.90 12.76 11 111108 663 64386950
Endothelial dysfunction 14.84 12.76 7 111112 181 64387432
Blood loss anaemia 14.71 12.76 3 111116 13889 64373724
Renal-limited thrombotic microangiopathy 14.67 12.76 4 111115 18 64387595
Hypoglossal nerve paresis 14.66 12.76 6 111113 109 64387504
Eosinophilia 14.64 12.76 27 111092 38049 64349564
Fracture 14.61 12.76 7 111112 18748 64368865
Ovarian failure 14.60 12.76 10 111109 535 64387078
Diabetic ketoacidosis 14.53 12.76 18 111101 29827 64357786
Cerebral salt-wasting syndrome 14.51 12.76 6 111113 112 64387501
Dysphonia 14.43 12.76 37 111082 46345 64341268
Synovial sarcoma 14.34 12.76 5 111114 57 64387556
Depressed level of consciousness 14.28 12.76 82 111037 81354 64306259
Thymus enlargement 14.27 12.76 6 111113 117 64387496
Anaplastic lymphoma kinase gene mutation 14.23 12.76 6 111113 118 64387495
Upper limb fracture 14.19 12.76 4 111115 14862 64372751
Hernia 14.14 12.76 3 111116 13515 64374098
Pericardial fibrosis 14.03 12.76 5 111114 61 64387552
Carotid artery perforation 14.02 12.76 3 111116 3 64387610
Full blood count decreased 14.01 12.76 11 111108 22571 64365042
Mood altered 14.00 12.76 5 111114 15974 64371639
Intestinal infarction 13.98 12.76 14 111105 1277 64386336
Hyperglycaemic hyperosmolar nonketotic syndrome 13.95 12.76 16 111103 1703 64385910
Hyperammonaemic encephalopathy 13.85 12.76 25 111094 4033 64383580
Skin exfoliation 13.81 12.76 36 111083 44849 64342764
Haematochezia 13.81 12.76 63 111056 66310 64321303
Malignant pleural effusion 13.79 12.76 21 111098 2946 64384667
Stent malfunction 13.74 12.76 5 111114 65 64387548
Diabetes mellitus inadequate control 13.73 12.76 10 111109 21311 64366302
Fear 13.60 12.76 9 111110 20162 64367451
Enterococcal sepsis 13.54 12.76 19 111100 2475 64385138
Skin toxicity 13.53 12.76 33 111086 6569 64381044
Obstructive airways disorder 13.52 12.76 12 111107 23173 64364440
Retroperitoneal lymphadenopathy 13.50 12.76 12 111107 942 64386671
Thrombophlebitis 13.49 12.76 30 111089 5624 64381989
Enterococcal bacteraemia 13.48 12.76 19 111100 2486 64385127
Metastases to bladder 13.47 12.76 7 111112 224 64387389
VIth nerve paresis 13.44 12.76 6 111113 136 64387477
Culture urine positive 13.44 12.76 25 111094 4126 64383487
Thrombotic thrombocytopenic purpura 13.44 12.76 31 111088 5953 64381660
Coma 13.41 12.76 92 111027 87523 64300090
Procedural pain 13.34 12.76 5 111114 15503 64372110
Retroperitoneal neoplasm 13.32 12.76 4 111115 27 64387586
Body temperature decreased 13.31 12.76 15 111104 25913 64361700
Oral fungal infection 13.29 12.76 21 111098 3040 64384573
Epiphyses premature fusion 13.28 12.76 5 111114 72 64387541
Adenocarcinoma gastric 13.21 12.76 15 111104 1580 64386033
Hypothermia 13.19 12.76 9 111110 19847 64367766
Malignant peritoneal neoplasm 13.17 12.76 10 111109 629 64386984
Mydriasis 13.07 12.76 5 111114 15307 64372306
Gastroenteritis sapovirus 13.05 12.76 6 111113 146 64387467
Blood chloride decreased 13.05 12.76 35 111084 7381 64380232
Blastic plasmacytoid dendritic cell neoplasia 12.97 12.76 5 111114 77 64387536
Ecchymosis 12.97 12.76 4 111115 14018 64373595
Pulmonary artery thrombosis 12.92 12.76 13 111106 1193 64386420
Paranoia 12.89 12.76 6 111113 16346 64371267
Eye pruritus 12.86 12.76 3 111116 12656 64374957
Peritoneal sarcoma 12.81 12.76 3 111116 6 64387607
Stoma site dermatitis 12.81 12.76 3 111116 6 64387607
Mania 12.81 12.76 6 111113 16280 64371333

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XA01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Platinum compounds
FDA EXT N0000175073 Platinum-containing Compounds
FDA EPC N0000175413 Platinum-based Drug
MeSH PA D000970 Antineoplastic Agents
MeSH PA D003432 Cross-Linking Reagents
MeSH PA D007202 Indicators and Reagents
MeSH PA D011838 Radiation-Sensitizing Agents
CHEBI has role CHEBI:25435 mutagens
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:47868 photosensitising agent
CHEBI has role CHEBI:50684 cross-linking reagents
CHEBI has role CHEBI:50902 genotoxic agent
CHEBI has role CHEBI:61015 nephrotoxins
CHEBI has role CHEBI:68495 Type I cell-death inducers
CHEBI has role CHEBI:173085 ferroptosis inducers

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

DiseaseRelationSNOMED_IDDOID
Malignant tumor of ovary indication 363443007 DOID:2394
Ovarian Germ Cell Tumor Carcinoma indication
Testicular Germ Cell Tumor indication
Invasive Bladder Malignancy indication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
D(3) dopamine receptor GPCR Ki 5.95 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 5.37 CHEMBL
Canalicular multispecific organic anion transporter 1 Transporter WOMBAT-PK
Adenosine receptor A3 GPCR Ki 5.62 DRUG MATRIX
Multidrug resistance-associated protein 6 Transporter WOMBAT-PK
Multidrug resistance-associated protein 5 Transporter WOMBAT-PK
Epidermal growth factor receptor Kinase IC50 5.58 DRUG MATRIX
Tyrosine-protein kinase Lck Kinase IC50 4.64 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.32 DRUG MATRIX
C-X-C chemokine receptor type 2 GPCR Ki 5.02 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 5.03 DRUG MATRIX
C-C chemokine receptor type 2 GPCR Ki 5.15 DRUG MATRIX
Mitogen-activated protein kinase 3 Kinase IC50 5.34 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 5.22 DRUG MATRIX
Sodium/potassium-transporting ATPase subunit alpha-2 Ion channel IC50 5.03 DRUG MATRIX

External reference:

IDSource
D00275 KEGG_DRUG
4018139 VUID
N0000146476 NUI
4018139 VANDF
C0008838 UMLSCUI
CHEBI:27899 CHEBI
CPT PDB_CHEM_ID
CHEMBL1386 ChEMBL_ID
CHEMBL11359 ChEMBL_ID
CHEMBL2068237 ChEMBL_ID
DB00515 DRUGBANK_ID
5343 IUPHAR_LIGAND_ID
4426 INN_ID
Q20Q21Q62J UNII
5702198 PUBCHEM_CID
2555 RXNORM
31747 MMSL
4456 MMSL
d00195 MMSL
002641 NDDF
387318005 SNOMEDCT_US
57066004 SNOMEDCT_US
D002945 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CISplatin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9504 INJECTION 1 mg INTRAVENOUS ANDA 19 sections
CISplatin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9505 INJECTION 1 mg INTRAVENOUS ANDA 19 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 0703-5747 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 21 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 0703-5748 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 21 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 16729-288 INJECTION 1 mg INTRAVENOUS ANDA 26 sections
CISplatin HUMAN PRESCRIPTION DRUG LABEL 1 44567-509 INJECTION, SOLUTION 1 mg INTRAVENOUS NDA 19 sections
CISplatin HUMAN PRESCRIPTION DRUG LABEL 1 44567-510 INJECTION, SOLUTION 1 mg INTRAVENOUS NDA 19 sections
CISplatin HUMAN PRESCRIPTION DRUG LABEL 1 44567-511 INJECTION, SOLUTION 1 mg INTRAVENOUS NDA 19 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 44567-530 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 mg INTRAVENOUS NDA 26 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 63323-103 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 68001-283 INJECTION 1 mg INTRAVENOUS ANDA 26 sections
CISPLATIN Human Prescription Drug Label 1 68083-162 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
CISPLATIN Human Prescription Drug Label 1 68083-163 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 13 sections
Cisplatin HUMAN PRESCRIPTION DRUG LABEL 1 70860-206 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 21 sections