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

Stem definitionDrug idCAS RN
uracil type antineoplastics 26 51-21-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • 5-fluorouracil
  • adrucil
  • fluoroblastin
  • fluorouracil
  • 5-FU
A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
  • Molecular weight: 130.08
  • Formula: C4H3FN2O2
  • CLOGP: -0.58
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 58.20
  • ALOGS: -1.35
  • ROTB: 0

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 12.20 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 92.25 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 28 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 26 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.64 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.12 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 25, 1962 FDA SPECTRUM PHARMS
Sept. 21, 2018 PMDA Kyowa Hakko Kirin Co., Ltd.

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
Neutropenia 1805.39 13.43 1584 72045 146381 50385114
Febrile neutropenia 974.83 13.43 936 72693 96731 50434764
Mucosal inflammation 914.68 13.43 624 73005 39518 50491977
Neuropathy peripheral 775.96 13.43 824 72805 95933 50435562
Diarrhoea 701.99 13.43 2155 71474 586321 49945174
Thrombocytopenia 566.77 13.43 807 72822 126866 50404629
Disease progression 562.74 13.43 695 72934 95171 50436324
Palmar-plantar erythrodysaesthesia syndrome 551.24 13.43 351 73278 19747 50511748
Leukopenia 509.10 13.43 557 73072 66971 50464524
Neurotoxicity 461.29 13.43 280 73349 14460 50517035
Dermatitis acneiform 451.55 13.43 183 73446 3874 50527621
Malignant neoplasm progression 424.05 13.43 509 73120 67615 50463880
Skin toxicity 416.69 13.43 171 73458 3742 50527753
Metastases to liver 375.40 13.43 277 73352 19827 50511668
Drug ineffective 367.40 13.43 393 73236 818940 49712555
Vomiting 344.75 13.43 1452 72177 459306 50072189
Bone marrow failure 335.66 13.43 296 73333 27328 50504167
Stomatitis 292.67 13.43 527 73102 100817 50430678
Metastases to lung 273.93 13.43 181 73448 10839 50520656
Acute myeloid leukaemia 259.80 13.43 198 73431 14876 50516619
Joint swelling 234.46 13.43 38 73591 245248 50286247
Neutrophil count decreased 233.94 13.43 311 73318 45715 50485780
Metastases to bone 218.91 13.43 193 73436 17802 50513693
Polyneuropathy 214.92 13.43 162 73467 11969 50519526
Nausea 214.34 13.43 1751 71878 703647 49827848
Neoplasm progression 213.41 13.43 237 73392 28920 50502575
Arthralgia 208.68 13.43 199 73430 438503 50092992
Gastrointestinal toxicity 208.58 13.43 112 73517 4565 50526930
Product dose omission issue 204.06 13.43 17 73612 183821 50347674
Metastasis 201.38 13.43 107 73522 4268 50527227
Posterior reversible encephalopathy syndrome 199.60 13.43 169 73460 14759 50516736
Haematotoxicity 199.44 13.43 131 73498 7764 50523731
Gastrointestinal perforation 197.17 13.43 94 73535 2967 50528528
Peripheral sensory neuropathy 195.42 13.43 121 73508 6470 50525025
Ejection fraction decreased 187.05 13.43 179 73450 18341 50513154
Second primary malignancy 185.14 13.43 119 73510 6795 50524700
Abdominal discomfort 184.69 13.43 54 73575 231587 50299908
Systemic lupus erythematosus 177.69 13.43 6 73623 140616 50390879
Cardiomyopathy 177.38 13.43 161 73468 15425 50516070
Paronychia 175.19 13.43 99 73530 4465 50527030
Arteriospasm coronary 173.14 13.43 89 73540 3313 50528182
Interstitial lung disease 169.53 13.43 289 73340 52887 50478608
Acute promyelocytic leukaemia 168.03 13.43 59 73570 825 50530670
Contraindicated product administered 164.66 13.43 14 73615 148944 50382551
Laryngospasm 162.40 13.43 79 73550 2609 50528886
Cardiotoxicity 161.62 13.43 110 73519 6917 50524578
Pain 158.90 13.43 383 73246 578520 49952975
Pulmonary embolism 158.33 13.43 412 73217 101292 50430203
Swelling 157.96 13.43 48 73581 200824 50330671
Weight increased 157.40 13.43 49 73580 201842 50329653
Disease recurrence 156.97 13.43 169 73460 19912 50511583
Sinusitis 155.10 13.43 30 73599 170528 50360967
Pyrexia 155.09 13.43 1014 72615 379189 50152306
Hyperammonaemia 150.99 13.43 91 73538 4633 50526862
Fall 150.97 13.43 159 73470 334773 50196722
Dehydration 150.63 13.43 526 73103 151923 50379572
Headache 145.42 13.43 327 73302 506208 50025287
Decreased appetite 144.53 13.43 627 73002 200296 50331199
Therapeutic product effect decreased 144.48 13.43 15 73614 136035 50395460
Anaemia 143.07 13.43 735 72894 251721 50279774
Arthropathy 141.00 13.43 29 73600 157877 50373618
Pemphigus 139.33 13.43 9 73620 120157 50411338
Myelosuppression 135.27 13.43 130 73499 13387 50518108
Nasopharyngitis 134.78 13.43 56 73573 192871 50338624
Abdominal pain 134.69 13.43 689 72940 235539 50295956
Metastases to lymph nodes 131.56 13.43 97 73532 6927 50524568
Wound 128.61 13.43 6 73623 105788 50425707
Neutropenic sepsis 124.76 13.43 127 73502 14020 50517475
Hypomagnesaemia 124.63 13.43 161 73468 22995 50508500
General physical health deterioration 122.58 13.43 470 73159 141964 50389531
Glossodynia 119.51 13.43 14 73615 115555 50415940
Drug hypersensitivity 118.92 13.43 114 73515 250896 50280599
Product use issue 116.96 13.43 36 73593 149439 50382056
Hypokalaemia 116.52 13.43 336 73293 87656 50443839
Injection site pain 115.93 13.43 13 73616 111011 50420484
Large intestine perforation 115.16 13.43 92 73537 7402 50524093
Enteritis 114.21 13.43 89 73540 6906 50524589
Paraesthesia 112.80 13.43 408 73221 119835 50411660
Proteinuria 111.38 13.43 129 73500 16468 50515027
Peripheral swelling 109.12 13.43 84 73545 205852 50325643
Pain in extremity 100.45 13.43 151 73478 272714 50258781
Musculoskeletal stiffness 98.62 13.43 32 73597 128449 50403046
Asthenia 98.23 13.43 796 72833 318246 50213249
Stress cardiomyopathy 94.72 13.43 84 73545 7803 50523692
Colorectal cancer metastatic 92.67 13.43 33 73596 482 50531013
Neutropenic colitis 91.61 13.43 52 73577 2365 50529130
Non-cirrhotic portal hypertension 90.36 13.43 25 73604 147 50531348
Contusion 87.77 13.43 27 73602 112156 50419339
Death 87.60 13.43 788 72841 324591 50206904
Portal hypertension 87.41 13.43 57 73572 3335 50528160
Hypertransaminasaemia 86.56 13.43 58 73571 3553 50527942
Ileus 85.72 13.43 101 73528 13128 50518367
Depression 85.68 13.43 69 73560 165354 50366141
Ascites 85.45 13.43 172 73457 35689 50495806
Maternal exposure during pregnancy 84.83 13.43 65 73564 159713 50371782
Focal nodular hyperplasia 82.49 13.43 30 73599 467 50531028
Intestinal perforation 81.55 13.43 88 73541 10391 50521104
Psoriasis 80.46 13.43 5 73624 68995 50462500
Discomfort 79.70 13.43 29 73600 108351 50423144
Extravasation 78.39 13.43 44 73585 1958 50529537
Cardiac failure 75.53 13.43 263 73366 75777 50455718
Hospitalisation 73.37 13.43 7 73622 67930 50463565
Hyperammonaemic encephalopathy 73.06 13.43 42 73587 1957 50529538
Injection site erythema 72.86 13.43 11 73618 74925 50456570
Left ventricular dysfunction 72.75 13.43 83 73546 10423 50521072
Condition aggravated 71.70 13.43 209 73420 296849 50234646
Influenza 71.03 13.43 21 73608 89517 50441978
Drug abuse 70.80 13.43 4 73625 59842 50471653
Drug intolerance 70.64 13.43 132 73497 218972 50312523
Pruritus 70.27 13.43 197 73432 283371 50248124
Arthritis 69.41 13.43 20 73609 86701 50444794
Insomnia 68.01 13.43 93 73536 174772 50356723
Dysarthria 67.05 13.43 160 73469 37243 50494252
Intestinal obstruction 67.02 13.43 130 73499 26253 50505242
Migraine 66.79 13.43 14 73615 75266 50456229
Hepatic enzyme increased 66.62 13.43 61 73568 137319 50394176
Enterocutaneous fistula 66.17 13.43 33 73596 1151 50530344
Haemolytic anaemia 65.34 13.43 74 73555 9218 50522277
Bronchitis 63.89 13.43 36 73593 104123 50427372
Loss of personal independence in daily activities 62.20 13.43 13 73616 70037 50461458
Peritonitis 61.41 13.43 93 73536 15393 50516102
Mobility decreased 61.17 13.43 20 73609 79928 50451567
Osteoarthritis 60.37 13.43 13 73616 68593 50462902
Pancytopenia 60.09 13.43 262 73367 83768 50447727
Helicobacter infection 59.80 13.43 3 73626 49699 50481796
Therapy partial responder 59.63 13.43 60 73569 6531 50524964
Suicidal ideation 59.04 13.43 6 73623 55379 50476116
Anxiety 58.11 13.43 106 73523 177500 50353995
Dihydropyrimidine dehydrogenase deficiency 57.82 13.43 15 73614 66 50531429
Drug interaction 57.74 13.43 128 73501 199493 50332002
Device related thrombosis 57.44 13.43 31 73598 1276 50530219
Rectal perforation 55.67 13.43 21 73608 364 50531131
Oesophageal fistula 55.20 13.43 16 73613 114 50531381
Leukoencephalopathy 54.04 13.43 45 73584 3838 50527657
Treatment failure 53.70 13.43 73 73556 137564 50393931
Deep vein thrombosis 53.51 13.43 230 73399 73074 50458421
Cholangitis 53.46 13.43 48 73581 4531 50526964
Disseminated intravascular coagulation 53.08 13.43 92 73537 17043 50514452
Pericarditis 53.05 13.43 24 73605 78665 50452830
Pneumonia 53.02 13.43 328 73301 378073 50153422
Dizziness 52.91 13.43 292 73337 346077 50185418
Lower respiratory tract infection 52.74 13.43 37 73592 95164 50436331
White blood cell count decreased 52.71 13.43 320 73309 116402 50415093
Intentional product misuse 52.69 13.43 4 73625 46730 50484765
Chronic obstructive pulmonary disease 51.59 13.43 8 73621 53427 50478068
Congestive cardiomyopathy 51.33 13.43 51 73578 5467 50526028
Gastrointestinal necrosis 51.19 13.43 37 73592 2561 50528934
Immune thrombocytopenia 50.56 13.43 64 73565 8953 50522542
Splenomegaly 50.15 13.43 66 73563 9594 50521901
Feeling abnormal 49.52 13.43 66 73563 125426 50406069
Suicide attempt 49.37 13.43 8 73621 51724 50479771
Subacute cutaneous lupus erythematosus 49.34 13.43 34 73595 2181 50529314
Chills 48.80 13.43 273 73356 96414 50435081
Carcinoembryonic antigen increased 48.68 13.43 29 73600 1445 50530050
Tumour perforation 48.64 13.43 14 73615 97 50531398
Breast cancer recurrent 48.62 13.43 42 73587 3766 50527729
Colony stimulating factor therapy 48.36 13.43 18 73611 300 50531195
Metastases to peritoneum 48.33 13.43 37 73592 2796 50528699
Breast cancer metastatic 48.02 13.43 67 73562 10297 50521198
Injury 47.98 13.43 7 73622 48918 50482577
Fluid retention 47.96 13.43 8 73621 50641 50480854
Agranulocytosis 47.78 13.43 100 73529 21321 50510174
Stress 47.72 13.43 10 73619 53783 50477712
Febrile bone marrow aplasia 47.36 13.43 52 73577 6259 50525236
Colitis 47.02 13.43 143 73486 38386 50493109
Gait disturbance 46.89 13.43 92 73537 149913 50381582
Metastases to pleura 46.56 13.43 27 73602 1279 50530216
Troponin I increased 46.32 13.43 31 73598 1895 50529600
Duodenal ulcer perforation 45.97 13.43 6 73623 45605 50485890
Female genital tract fistula 45.93 13.43 40 73589 3626 50527869
Haemolytic uraemic syndrome 45.63 13.43 33 73596 2286 50529209
Adverse drug reaction 45.56 13.43 12 73617 55210 50476285
Myocarditis 45.51 13.43 57 73572 7890 50523605
Myelodysplastic syndrome 45.26 13.43 80 73549 15052 50516443
Cholinergic syndrome 45.16 13.43 18 73611 364 50531131
Metastases to skin 45.13 13.43 27 73602 1356 50530139
Injection site reaction 45.01 13.43 9 73620 50023 50481472
Mucosal toxicity 44.53 13.43 17 73612 305 50531190
Sleep disorder 44.40 13.43 14 73615 57269 50474226
Malignant respiratory tract neoplasm 43.04 13.43 11 73618 45 50531450
Administration site extravasation 42.98 13.43 21 73608 700 50530795
Balance disorder 42.42 13.43 25 73604 70565 50460930
Epistaxis 42.39 13.43 195 73434 63759 50467736
Urticaria 41.76 13.43 78 73551 129483 50402012
Steatohepatitis 41.15 13.43 18 73611 463 50531032
Somnolence 41.11 13.43 104 73525 154881 50376614
Injection site swelling 40.91 13.43 6 73623 41767 50489728
Metastases to central nervous system 40.88 13.43 65 73564 11217 50520278
COVID-19 40.73 13.43 9 73620 46653 50484842
Short-bowel syndrome 40.71 13.43 17 73612 389 50531106
Asthma 40.59 13.43 42 73587 89295 50442200
Trichomegaly 40.14 13.43 10 73619 36 50531459
Embolism 39.93 13.43 50 73579 6918 50524577
Nodular regenerative hyperplasia 39.92 13.43 15 73614 257 50531238
Aortic thrombosis 39.44 13.43 22 73607 967 50530528
Memory impairment 38.73 13.43 35 73594 79325 50452170
Splenic artery thrombosis 38.01 13.43 10 73619 47 50531448
Factor VII deficiency 37.88 13.43 9 73620 25 50531470
Hypertensive crisis 37.37 13.43 68 73561 13086 50518409
Proctalgia 37.16 13.43 41 73588 4962 50526533
Septic shock 36.91 13.43 173 73456 57002 50474493
Aplasia 36.88 13.43 36 73593 3777 50527718
Hypophagia 36.77 13.43 106 73523 27622 50503873
Blister 36.76 13.43 42 73587 85376 50446119
Aortitis 36.43 13.43 20 73609 852 50530643
Subileus 36.39 13.43 31 73598 2728 50528767
Tumour ulceration 36.30 13.43 12 73617 138 50531357
Rash 36.20 13.43 435 73194 437036 50094459
Type 2 diabetes mellitus 35.93 13.43 4 73625 34371 50497124
Dermatitis 35.92 13.43 70 73559 14181 50517314
Cataract 35.88 13.43 12 73617 47288 50484207
Hyperbilirubinaemia 35.87 13.43 56 73573 9514 50521981
Wheezing 35.86 13.43 23 73606 62024 50469471
Cystitis radiation 35.69 13.43 10 73619 62 50531433
Dysaesthesia 35.63 13.43 35 73594 3700 50527795
Venous pressure jugular decreased 35.58 13.43 9 73620 35 50531460
Incorrect dose administered 35.50 13.43 13 73616 48401 50483094
Infusion related hypersensitivity reaction 35.29 13.43 10 73619 65 50531430
Overdose 34.89 13.43 57 73572 99670 50431825
Hormone receptor positive breast cancer 34.62 13.43 16 73613 470 50531025
Abortion spontaneous 34.61 13.43 9 73620 41763 50489732
Bladder tamponade 34.53 13.43 10 73619 71 50531424
Unevaluable event 34.40 13.43 12 73617 46054 50485441
White blood cell count abnormal 34.36 13.43 41 73588 5399 50526096
Nasal congestion 33.82 13.43 16 73613 51104 50480391
Large intestinal obstruction 33.43 13.43 25 73604 1824 50529671
Confusional state 33.36 13.43 148 73481 185780 50345715
Miller Fisher syndrome 32.95 13.43 10 73619 85 50531410
Jugular vein thrombosis 32.94 13.43 29 73600 2667 50528828
Ocular toxicity 32.87 13.43 16 73613 529 50530966
Neuromyotonia 32.66 13.43 9 73620 52 50531443
Atypical haemolytic uraemic syndrome 32.54 13.43 16 73613 541 50530954
Nephritis bacterial 32.51 13.43 8 73621 27 50531468
Heart rate decreased 31.93 13.43 7 73622 36490 50495005
Liver abscess 31.90 13.43 28 73601 2565 50528930
Organising pneumonia 31.84 13.43 37 73592 4737 50526758
Venoocclusive liver disease 31.79 13.43 35 73594 4226 50527269
Sepsis 31.67 13.43 314 73315 132611 50398884
Metastases to meninges 31.66 13.43 25 73604 1977 50529518
Hepatic failure 31.46 13.43 111 73518 32172 50499323
Acute lymphocytic leukaemia 31.25 13.43 26 73603 2215 50529280
Rhabdomyolysis 31.22 13.43 9 73620 39018 50492477
Hydrothorax 31.18 13.43 17 73612 714 50530781
Sedation 30.91 13.43 4 73625 30606 50500889
Stridor 30.80 13.43 30 73599 3139 50528356
Cough 30.76 13.43 215 73414 241049 50290446
Hypertension 30.63 13.43 454 73175 210749 50320746
Anastomotic leak 30.58 13.43 14 73615 402 50531093
Venous thrombosis 30.44 13.43 35 73594 4431 50527064
Toxic leukoencephalopathy 30.36 13.43 16 73613 627 50530868
Wrong technique in product usage process 30.18 13.43 22 73607 55488 50476007
Osteonecrosis of jaw 30.13 13.43 110 73519 32416 50499079
Skin fissures 30.12 13.43 49 73580 8619 50522876
Thrombocytopenic purpura 29.83 13.43 20 73609 1226 50530269
Renal salt-wasting syndrome 29.82 13.43 12 73617 249 50531246
Vena cava thrombosis 29.33 13.43 24 73605 1997 50529498
Red blood cell sedimentation rate increased 29.33 13.43 4 73625 29412 50502083
Device related infection 29.19 13.43 81 73548 20654 50510841
Dysgeusia 29.07 13.43 123 73506 38793 50492702
Small intestinal obstruction 29.07 13.43 69 73560 15999 50515496
Nicotinic acid deficiency 29.07 13.43 8 73621 46 50531449
Metastases to reproductive organ 29.06 13.43 6 73623 6 50531489
Rash pustular 28.70 13.43 41 73588 6440 50525055
Cachexia 28.36 13.43 34 73595 4499 50526996
Malignant pleural effusion 28.34 13.43 25 73604 2305 50529190
Ileal perforation 28.31 13.43 13 73616 376 50531119
Upper respiratory tract infection 27.71 13.43 33 73596 65865 50465630
Dry skin 27.37 13.43 130 73499 43061 50488434
Encephalopathy 27.11 13.43 109 73520 33602 50497893
Acute abdomen 27.02 13.43 20 73609 1436 50530059
Conjunctival filtering bleb leak 26.97 13.43 6 73623 11 50531484
Intentional product use issue 26.87 13.43 44 73585 76874 50454621
ECG signs of myocardial ischaemia 26.57 13.43 8 73621 66 50531429
Gastrooesophageal reflux disease 26.44 13.43 44 73585 76384 50455111
Metastases to ovary 26.43 13.43 12 73617 338 50531157
Bradycardia 26.31 13.43 33 73596 64393 50467102
Emotional distress 26.11 13.43 5 73624 28658 50502837
Metastases to spine 26.03 13.43 26 73603 2805 50528690
Throat tightness 26.02 13.43 78 73551 20769 50510726
Metastases to the mediastinum 25.97 13.43 13 73616 457 50531038
Tumour necrosis 25.70 13.43 15 73614 719 50530776
Cardiac ventricular thrombosis 25.56 13.43 13 73616 473 50531022
Subclavian vein thrombosis 25.35 13.43 21 73608 1778 50529717
Aortic dissection 25.31 13.43 20 73609 1583 50529912
Acute interstitial pneumonitis 25.23 13.43 14 73615 609 50530886
Inferior vena cava stenosis 25.17 13.43 6 73623 17 50531478
Urinary tract infection 25.06 13.43 207 73422 223813 50307682
Therapy cessation 24.86 13.43 4 73625 26007 50505488
Soft tissue necrosis 24.81 13.43 12 73617 391 50531104
Blood creatine increased 24.77 13.43 33 73596 4854 50526641
Tumour lysis syndrome 24.51 13.43 41 73588 7380 50524115
Respiratory failure 24.50 13.43 221 73408 90960 50440535
Myocardial ischaemia 24.49 13.43 53 73576 11560 50519935
Osteonecrosis 24.20 13.43 80 73549 22437 50509058
Gastrointestinal stoma complication 24.19 13.43 19 73610 1491 50530004
Enterocolitis 24.02 13.43 38 73591 6529 50524966
Vision blurred 23.90 13.43 49 73580 78598 50452897
Pleural effusion 23.74 13.43 201 73428 81253 50450242
Nasal septum perforation 23.73 13.43 14 73615 685 50530810
Diaphragmatic paralysis 23.72 13.43 13 73616 552 50530943
Encapsulating peritoneal sclerosis 23.68 13.43 11 73618 327 50531168
Hepatic lesion 23.35 13.43 29 73600 3979 50527516
Hypocapnia 23.34 13.43 11 73618 338 50531157
Catabolic state 23.33 13.43 7 73622 57 50531438
Pregnancy 23.33 13.43 7 73622 29570 50501925
Electrocardiogram ST segment elevation 23.30 13.43 27 73602 3446 50528049
Gastric disorder 23.30 13.43 7 73622 29541 50501954
Product quality issue 23.11 13.43 8 73621 30850 50500645
Tonic clonic movements 22.98 13.43 17 73612 1220 50530275
Adverse event 22.95 13.43 18 73611 43745 50487750
Aortic intramural haematoma 22.91 13.43 7 73622 61 50531434
Stomatitis haemorrhagic 22.84 13.43 6 73623 28 50531467
Pelvic abscess 22.83 13.43 18 73611 1420 50530075
Tympanic membrane disorder 22.76 13.43 9 73620 178 50531317
Acute leukaemia 22.70 13.43 16 73613 1064 50530431
Ear infection 22.68 13.43 5 73624 25965 50505530
Oesophagitis 22.64 13.43 56 73573 13327 50518168
Platelet count decreased 22.57 13.43 235 73394 100491 50431004
Xerosis 22.26 13.43 13 73616 624 50530871
Type II hypersensitivity 22.19 13.43 5 73624 10 50531485
Cardiomyopathy acute 22.13 13.43 9 73620 192 50531303
Hypervolaemia 22.09 13.43 5 73624 25494 50506001
Adenocarcinoma of colon 22.02 13.43 21 73608 2141 50529354
Irritability 21.93 13.43 7 73622 28419 50503076
Gastrointestinal stoma output increased 21.92 13.43 9 73620 197 50531298
Recurrent cancer 21.67 13.43 19 73610 1738 50529757
Pulmonary alveolar haemorrhage 21.66 13.43 28 73601 3999 50527496
Portal vein thrombosis 21.61 13.43 21 73608 2191 50529304
Tumour haemorrhage 21.60 13.43 17 73612 1338 50530157
Amnesia 21.39 13.43 18 73611 42242 50489253
Depilation 21.29 13.43 5 73624 13 50531482
Nephrolithiasis 21.25 13.43 12 73617 34681 50496814
Left ventricular dilatation 21.21 13.43 11 73618 417 50531078
Recall phenomenon 21.17 13.43 12 73617 544 50530951
Blood pressure fluctuation 21.08 13.43 13 73616 35810 50495685
Radiation skin injury 21.02 13.43 14 73615 849 50530646
Aorto-oesophageal fistula 21.02 13.43 5 73624 14 50531481
Duodenal perforation 20.77 13.43 13 73616 708 50530787
Gait apraxia 20.76 13.43 5 73624 15 50531480
Myeloproliferative neoplasm 20.33 13.43 11 73618 455 50531040
Hyperkalaemia 20.30 13.43 24 73605 48065 50483430
K-ras gene mutation 20.29 13.43 5 73624 17 50531478
Rectal cancer recurrent 20.29 13.43 5 73624 17 50531478
Hypocalcaemia 20.22 13.43 85 73544 26731 50504764
Carbohydrate antigen 19-9 increased 20.20 13.43 8 73621 159 50531336
Chronic myeloid leukaemia 20.19 13.43 20 73609 2136 50529359
Oral pain 20.18 13.43 81 73548 24952 50506543
Coronary artery disease 20.13 13.43 9 73620 29717 50501778
Protein urine 20.10 13.43 12 73617 600 50530895
Acute coronary syndrome 20.02 13.43 43 73586 9331 50522164
Xerophthalmia 20.02 13.43 10 73619 350 50531145
Hallucination 20.01 13.43 23 73606 46634 50484861
Pigmentation disorder 19.98 13.43 26 73603 3738 50527757
Renal tubular disorder 19.90 13.43 21 73608 2416 50529079
Blood phosphorus decreased 19.84 13.43 26 73603 3763 50527732
Pelvic fluid collection 19.79 13.43 13 73616 770 50530725
Gait inability 19.71 13.43 15 73614 37012 50494483
Gastric varices haemorrhage 19.61 13.43 7 73622 103 50531392
Adenocarcinoma 19.59 13.43 21 73608 2460 50529035
Heart rate increased 19.58 13.43 53 73576 77197 50454298
Tumour marker increased 19.57 13.43 26 73603 3814 50527681
Dyskinesia 19.56 13.43 8 73621 27853 50503642
Visual impairment 19.53 13.43 44 73585 68231 50463264
Folliculitis 19.49 13.43 17 73612 39208 50492287
Gastrointestinal anastomotic leak 19.49 13.43 8 73621 175 50531320
Psychotic disorder 19.46 13.43 4 73625 21808 50509687
Foot fracture 19.41 13.43 3 73626 20088 50511407
Varices oesophageal 19.25 13.43 22 73607 2767 50528728
Wernicke's encephalopathy 19.09 13.43 5 73624 23 50531472
Fistula 19.07 13.43 39 73590 8179 50523316
Fistula of small intestine 18.91 13.43 9 73620 283 50531212
Vaginal fistula 18.91 13.43 10 73619 395 50531100
Oesophageal varices haemorrhage 18.78 13.43 14 73615 1016 50530479
Road traffic accident 18.78 13.43 6 73623 24346 50507149
Vesical fistula 18.73 13.43 6 73623 62 50531433
Colon cancer metastatic 18.66 13.43 14 73615 1026 50530469
No adverse event 18.65 13.43 13 73616 33565 50497930
Night sweats 18.65 13.43 13 73616 33561 50497934
Portal vein dilatation 18.59 13.43 5 73624 26 50531469
Aggression 18.57 13.43 4 73625 21112 50510383
Productive cough 18.53 13.43 30 73599 52664 50478831
Anastomotic complication 18.52 13.43 7 73622 122 50531373
Head injury 18.38 13.43 6 73623 24014 50507481
Osteoporosis 18.31 13.43 23 73606 44856 50486639
Erythema 18.27 13.43 307 73322 146107 50385388
Rib fracture 18.27 13.43 3 73626 19218 50512277
Retroperitoneal abscess 18.21 13.43 7 73622 128 50531367
Toxic cardiomyopathy 18.16 13.43 7 73622 129 50531366
Necrosis 18.15 13.43 28 73601 4708 50526787
Biliary tract infection 18.13 13.43 10 73619 430 50531065
Cardiac myxoma 18.07 13.43 8 73621 212 50531283
Blood pressure systolic increased 18.06 13.43 15 73614 35434 50496061
Neutrophil count abnormal 18.00 13.43 20 73609 2439 50529056
Multiple organ dysfunction syndrome 17.86 13.43 130 73499 50207 50481288
Chemical burns of eye 17.85 13.43 6 73623 73 50531422
Liver function test abnormal 17.80 13.43 23 73606 44316 50487179
Multiple sclerosis 17.79 13.43 4 73625 20489 50511006
Hyperpyrexia 17.67 13.43 22 73607 3027 50528468
Treatment noncompliance 17.66 13.43 11 73618 30139 50501356
Hepatic vein stenosis 17.58 13.43 5 73624 33 50531462
Ill-defined disorder 17.51 13.43 33 73596 54621 50476874
Splenic marginal zone lymphoma recurrent 17.44 13.43 4 73625 9 50531486
Marchiafava-Bignami disease 17.44 13.43 4 73625 9 50531486
Respiratory disorder 17.42 13.43 12 73617 31175 50500320
Anal inflammation 17.41 13.43 7 73622 145 50531350
Joint range of motion decreased 17.35 13.43 3 73626 18509 50512986
Illness 17.31 13.43 7 73622 24533 50506962
Blood glucose increased 17.28 13.43 50 73579 71274 50460221
Cutaneous tuberculosis 17.19 13.43 7 73622 150 50531345
Vasospasm 17.17 13.43 11 73618 624 50530871
Diabetes mellitus 17.17 13.43 28 73601 49005 50482490
Menopause 17.16 13.43 19 73610 2308 50529187
Dysphonia 17.14 13.43 106 73523 38786 50492709
Device issue 17.13 13.43 4 73625 19968 50511527
SAPHO syndrome 17.08 13.43 6 73623 84 50531411
Palpitations 17.07 13.43 75 73554 94431 50437064
Pulmonary artery thrombosis 16.98 13.43 11 73618 636 50530859
Pneumatosis intestinalis 16.96 13.43 18 73611 2085 50529410
Venous thrombosis limb 16.95 13.43 20 73609 2602 50528893
Intercepted product administration error 16.89 13.43 6 73623 87 50531408
Endocardial fibrosis 16.87 13.43 4 73625 11 50531484
Localised infection 16.82 13.43 8 73621 25477 50506018
Malignant peritoneal neoplasm 16.77 13.43 11 73618 650 50530845
International normalised ratio increased 16.70 13.43 23 73606 43129 50488366
Ocular vasculitis 16.64 13.43 5 73624 41 50531454
Endometrial dysplasia 16.61 13.43 4 73625 12 50531483
Vascular access site swelling 16.60 13.43 3 73626 0 50531495
Percussion test abnormal 16.60 13.43 3 73626 0 50531495
Dandy-Walker syndrome 16.58 13.43 6 73623 92 50531403
Tongue oedema 16.58 13.43 24 73605 3815 50527680
Proctitis 16.44 13.43 17 73612 1911 50529584
Monoparesis 16.41 13.43 15 73614 1449 50530046
Gastric perforation 16.36 13.43 15 73614 1455 50530040
Skin exfoliation 16.34 13.43 94 73535 33518 50497977
Blood creatine phosphokinase increased 16.32 13.43 9 73620 26358 50505137
Multiple-drug resistance 16.22 13.43 22 73607 3292 50528203
Withdrawal syndrome 16.17 13.43 3 73626 17587 50513908
Intravascular haemolysis 16.15 13.43 8 73621 275 50531220
Bursitis 16.13 13.43 6 73623 22129 50509366
Colon cancer recurrent 16.03 13.43 5 73624 47 50531448
Full blood count abnormal 15.97 13.43 7 73622 23381 50508114
Malignant neoplasm of pleura 15.94 13.43 5 73624 48 50531447
Portal shunt 15.93 13.43 4 73625 15 50531480
Cerebral infarction 15.91 13.43 68 73561 21536 50509959
Vitamin B1 deficiency 15.78 13.43 8 73621 289 50531206
T-cell type acute leukaemia 15.76 13.43 5 73624 50 50531445
Duodenal ulcer 15.54 13.43 32 73597 6743 50524752
Cardiogenic shock 15.51 13.43 54 73575 15545 50515950
Carbohydrate antigen 15-3 increased 15.51 13.43 13 73616 1119 50530376
Hypertensive encephalopathy 15.51 13.43 10 73619 574 50530921
Herpes zoster 15.47 13.43 52 73577 70734 50460761
Depressed mood 15.44 13.43 16 73613 34007 50497488
Herpes simplex encephalitis 15.41 13.43 8 73621 304 50531191
Anaemia of malignant disease 15.39 13.43 9 73620 433 50531062
Performance status decreased 15.32 13.43 21 73608 3174 50528321
Chemotherapy 15.29 13.43 14 73615 1355 50530140
Joint stiffness 15.23 13.43 13 73616 30295 50501200
Acute pulmonary oedema 15.14 13.43 33 73596 7234 50524261
Obesity 15.12 13.43 3 73626 16772 50514723
Surgery 15.12 13.43 13 73616 30192 50501303
Superior vena cava syndrome 15.11 13.43 10 73619 600 50530895
Thrombotic microangiopathy 15.10 13.43 37 73592 8754 50522741
Hypophosphataemia 15.08 13.43 36 73593 8378 50523117
Tendonitis 15.03 13.43 3 73626 16702 50514793
Gastrointestinal motility disorder 15.01 13.43 25 73604 4484 50527011
Hyperthermia 14.96 13.43 34 73595 7662 50523833
Bone marrow infiltration 14.92 13.43 9 73620 459 50531036
Pulmonary toxicity 14.85 13.43 28 73601 5534 50525961
Acute polyneuropathy 14.83 13.43 7 73622 216 50531279
Metastases to chest wall 14.74 13.43 9 73620 469 50531026
Nail disorder 14.74 13.43 39 73590 9669 50521826
Hydronephrosis 14.72 13.43 36 73593 8505 50522990
Red blood cell nucleated morphology present 14.68 13.43 4 73625 22 50531473
Anal fistula 14.65 13.43 19 73610 2723 50528772
Tumour obstruction 14.53 13.43 3 73626 3 50531492
Pulmonary fistula 14.53 13.43 3 73626 3 50531492
Haemolysis 14.50 13.43 29 73600 5987 50525508
Musculoskeletal pain 14.46 13.43 55 73574 72122 50459373
Intestinal ischaemia 14.44 13.43 31 73598 6726 50524769
Systolic dysfunction 14.43 13.43 14 73615 1458 50530037
Extrasystoles 14.42 13.43 25 73604 4630 50526865
Abdominal abscess 14.39 13.43 23 73606 3985 50527510
Enterocolitis infectious 14.38 13.43 14 73615 1464 50530031
Mental disorder 14.36 13.43 7 73622 21984 50509511
Spinal cord compression 14.32 13.43 22 73607 3687 50527808
Skin disorder 14.27 13.43 71 73558 23959 50507536
Dysphagia 14.25 13.43 174 73455 77344 50454151
Metastases to pelvis 14.23 13.43 8 73621 357 50531138
Dysaesthesia pharynx 14.18 13.43 6 73623 142 50531353
Metastases to neck 14.17 13.43 5 73624 71 50531424
Arterial thrombosis 14.15 13.43 13 73616 1264 50530231
Periodontal disease 14.13 13.43 14 73615 1496 50529999
Nasal crusting 14.12 13.43 7 73622 241 50531254
Anal erosion 14.12 13.43 4 73625 26 50531469
Accidental exposure to product 14.08 13.43 8 73621 23049 50508446
Scintillating scotoma 14.06 13.43 6 73623 145 50531350
Oesophageal stenosis 14.03 13.43 19 73610 2839 50528656
Restless legs syndrome 14.01 13.43 3 73626 15894 50515601
Small intestinal perforation 13.97 13.43 13 73616 1285 50530210
Gingival atrophy 13.86 13.43 4 73625 28 50531467
Neck pain 13.83 13.43 40 73589 57027 50474468
Therapy interrupted 13.81 13.43 6 73623 20146 50511349
Hepatic cytolysis 13.80 13.43 34 73595 8069 50523426
Ankle fracture 13.78 13.43 3 73626 15719 50515776
Onycholysis 13.72 13.43 13 73616 1315 50530180
Hypermetabolism 13.69 13.43 6 73623 155 50531340
Eosinophilia 13.68 13.43 5 73624 18647 50512848
Transaminases increased 13.65 13.43 78 73551 27746 50503749
HER2 gene amplification 13.62 13.43 4 73625 30 50531465
Product intolerance 13.62 13.43 4 73625 30 50531465
Enterobacter sepsis 13.58 13.43 7 73622 262 50531233
Dry eye 13.57 13.43 16 73613 32079 50499416
Drug ineffective for unapproved indication 13.56 13.43 7 73622 21274 50510221
Bronchospasm 13.56 13.43 50 73579 14804 50516691
Peripheral nerve injury 13.51 13.43 8 73621 394 50531101
Back pain 13.48 13.43 232 73397 219798 50311697
Thrombotic thrombocytopenic purpura 13.47 13.43 21 73608 3564 50527931

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
Neutropenia 1206.12 13.44 1661 81884 130050 29360932
Diarrhoea 947.84 13.44 2547 80998 330151 29160831
Dermatitis acneiform 861.39 13.44 383 83162 5108 29485874
Neuropathy peripheral 737.47 13.44 954 82591 70073 29420909
Mucosal inflammation 727.74 13.44 648 82897 30947 29460035
Stomatitis 583.01 13.44 617 82928 36496 29454486
Skin toxicity 549.91 13.44 250 83295 3521 29487461
Arteriospasm coronary 501.13 13.44 209 83336 2356 29488626
Disease progression 496.17 13.44 855 82690 81061 29409921
Palmar-plantar erythrodysaesthesia syndrome 445.47 13.44 354 83191 14405 29476577
Paronychia 437.62 13.44 198 83347 2755 29488227
Thrombocytopenia 424.23 13.44 1075 82470 133748 29357234
Interstitial lung disease 359.09 13.44 610 82935 57108 29433874
Neurotoxicity 344.67 13.44 304 83241 14309 29476673
Leukopenia 336.24 13.44 578 82967 54625 29436357
Metastases to liver 335.74 13.44 274 83271 11582 29479400
Decreased appetite 289.52 13.44 985 82560 144357 29346625
Nausea 268.60 13.44 1559 81986 287696 29203286
Febrile neutropenia 255.16 13.44 796 82749 111444 29379538
Peripheral sensory neuropathy 254.61 13.44 176 83369 5763 29485219
Vomiting 242.11 13.44 1211 82334 211049 29279933
Drug ineffective 229.46 13.44 424 83121 362746 29128236
Hyperammonaemia 229.18 13.44 162 83383 5501 29485481
Completed suicide 226.81 13.44 6 83539 90240 29400742
Cardiotoxicity 211.43 13.44 144 83401 4600 29486382
Proteinuria 210.22 13.44 241 83304 15563 29475419
Gastrointestinal toxicity 209.89 13.44 108 83437 2023 29488959
Gastrointestinal perforation 205.21 13.44 126 83419 3357 29487625
Bone marrow failure 194.68 13.44 308 83237 27141 29463841
Metastases to lung 194.41 13.44 168 83377 7687 29483295
Drug interaction 193.83 13.44 164 83381 197221 29293761
Arthralgia 184.20 13.44 82 83463 139535 29351447
Polyneuropathy 183.44 13.44 198 83347 11954 29479028
Hyperammonaemic encephalopathy 182.09 13.44 96 83449 1894 29489088
Hypomagnesaemia 178.21 13.44 233 83312 17235 29473747
General physical health deterioration 175.35 13.44 663 82882 102194 29388788
Product dose omission issue 174.26 13.44 31 83514 96352 29394630
Dehydration 171.73 13.44 710 82835 114038 29376944
Alopecia 163.62 13.44 234 83311 18850 29472132
Intestinal obstruction 153.12 13.44 228 83317 19049 29471933
Neutrophil count decreased 153.05 13.44 363 83182 43204 29447778
Skin reaction 150.74 13.44 114 83431 4303 29486679
Portal hypertension 137.07 13.44 98 83447 3388 29487594
Pneumatosis intestinalis 133.68 13.44 93 83452 3076 29487906
Fall 129.01 13.44 188 83357 176990 29313992
Headache 127.32 13.44 184 83361 173823 29317159
Carcinoembryonic antigen increased 125.77 13.44 52 83493 572 29490410
Abdominal pain 119.36 13.44 721 82824 134636 29356346
Enteritis 119.26 13.44 120 83425 6671 29484311
Pyrexia 118.82 13.44 1287 82258 286335 29204647
Myelosuppression 116.87 13.44 158 83387 12069 29478913
Portal venous gas 113.41 13.44 41 83504 303 29490679
Pulmonary embolism 108.45 13.44 466 83079 76068 29414914
Neoplasm progression 108.08 13.44 191 83354 18421 29472561
Paraesthesia 107.75 13.44 366 83179 53479 29437503
Rhabdomyolysis 106.78 13.44 21 83524 60787 29430195
Cardiac failure congestive 105.67 13.44 42 83503 76539 29414443
Myalgia 104.78 13.44 39 83506 73980 29417002
Anxiety 103.59 13.44 56 83489 85309 29405673
Malignant neoplasm progression 101.04 13.44 445 83100 73414 29417568
Haematotoxicity 100.82 13.44 109 83436 6590 29484392
Weight increased 99.48 13.44 46 83499 76621 29414361
Chills 98.61 13.44 431 83114 70869 29420113
Somnolence 97.12 13.44 74 83471 93881 29397101
Ileus 94.43 13.44 156 83389 14246 29476736
Peritonitis 93.76 13.44 158 83387 14666 29476316
Depression 91.98 13.44 64 83481 85083 29405899
Hospitalisation 91.84 13.44 11 83534 45977 29445005
Hiccups 87.04 13.44 116 83429 8737 29482245
Tumour necrosis 85.03 13.44 48 83497 1089 29489893
Rash pustular 84.40 13.44 84 83461 4607 29486375
Death 82.66 13.44 597 82948 341487 29149495
Extravasation 82.31 13.44 54 83491 1618 29489364
Oesophageal fistula 82.27 13.44 28 83517 169 29490813
Insomnia 80.68 13.44 79 83466 88682 29402300
Aggression 80.46 13.44 5 83540 35536 29455446
Anastomotic complication 76.89 13.44 31 83514 318 29490664
Toxicity to various agents 76.53 13.44 244 83301 173417 29317565
Pelvic abscess 75.81 13.44 41 83504 853 29490129
Ileal perforation 75.69 13.44 38 83507 674 29490308
Pain in extremity 75.64 13.44 122 83423 110311 29380671
Electrocardiogram ST segment elevation 74.55 13.44 77 83468 4415 29486567
Small intestinal obstruction 74.49 13.44 133 83412 12928 29478054
Overdose 73.74 13.44 70 83475 79749 29411233
Hypokalaemia 73.63 13.44 309 83236 49894 29441088
Large intestine perforation 73.27 13.44 97 83448 7259 29483723
Anastomotic leak 72.89 13.44 35 83510 561 29490421
Peripheral swelling 72.77 13.44 45 83500 63694 29427288
Suicidal ideation 72.64 13.44 7 83538 34709 29456273
Subileus 72.63 13.44 62 83483 2788 29488194
Intentional product misuse 72.50 13.44 7 83538 34654 29456328
Injection site pain 72.16 13.44 5 83540 32441 29458541
Septic shock 71.65 13.44 358 83187 62202 29428780
Hallucination 71.39 13.44 19 83526 44693 29446289
Metastases to lymph nodes 70.56 13.44 71 83474 3946 29487036
Asthma 70.37 13.44 7 83538 33842 29457140
Therapy partial responder 70.32 13.44 80 83465 5119 29485863
Pneumonia 70.11 13.44 574 82971 319598 29171384
Joint swelling 68.80 13.44 27 83518 49603 29441379
Focal nodular hyperplasia 68.55 13.44 23 83522 132 29490850
Aorto-oesophageal fistula 68.36 13.44 18 83527 35 29490947
Chronic obstructive pulmonary disease 68.10 13.44 16 83529 40939 29450043
Colorectal cancer metastatic 65.76 13.44 32 83513 529 29490453
Device related infection 65.73 13.44 140 83405 15496 29475486
Necrotising fasciitis 65.67 13.44 63 83482 3302 29487680
Intravascular haemolysis 65.42 13.44 29 83516 383 29490599
Disseminated intravascular coagulation 65.32 13.44 162 83383 19818 29471164
Leukoencephalopathy 65.10 13.44 66 83479 3701 29487281
Ascites 64.70 13.44 239 83306 36380 29454602
Dermatitis 64.45 13.44 94 83451 7704 29483278
Cholangitis 63.96 13.44 92 83453 7445 29483537
Psoriasis 63.63 13.44 8 83537 32219 29458763
Dizziness 62.74 13.44 299 83246 189385 29301597
Confusional state 62.57 13.44 171 83374 127706 29363276
Blood glucose increased 61.50 13.44 46 83499 58938 29432044
Influenza 61.06 13.44 21 83524 41860 29449122
Rheumatoid arthritis 61.06 13.44 9 83536 32143 29458839
Incorrect dose administered 60.90 13.44 10 83535 32974 29458008
Cholinergic syndrome 60.84 13.44 29 83516 457 29490525
Metastases to peritoneum 60.38 13.44 43 83502 1477 29489505
Feeling abnormal 60.01 13.44 40 83505 54405 29436577
Administration site extravasation 59.94 13.44 29 83516 473 29490509
Asthenia 59.13 13.44 894 82651 214356 29276626
Dry skin 59.07 13.44 172 83373 23135 29467847
Bradycardia 58.94 13.44 59 83486 65570 29425412
Therapeutic product effect decreased 58.90 13.44 7 83538 29444 29461538
Acute coronary syndrome 58.46 13.44 116 83429 12209 29478773
Muscle spasms 56.76 13.44 60 83485 65022 29425960
Folliculitis 56.15 13.44 62 83483 3838 29487144
Agitation 56.13 13.44 38 83507 51266 29439716
Sinusitis 55.97 13.44 14 83531 34336 29456646
Conjunctivitis 55.64 13.44 89 83456 7909 29483073
Venous thrombosis 55.10 13.44 55 83490 3027 29487955
Coronary artery disease 55.04 13.44 28 83517 44162 29446820
Wheezing 53.29 13.44 14 83531 33226 29457756
Small intestinal perforation 53.22 13.44 41 83504 1591 29489391
Product use issue 52.51 13.44 41 83504 51403 29439579
Contusion 51.99 13.44 12 83533 31083 29459899
Tremor 51.50 13.44 80 83465 73458 29417524
Electrocardiogram QT prolonged 51.18 13.44 19 83526 36118 29454864
Intestinal perforation 50.88 13.44 86 83459 8000 29482982
Rectal perforation 50.30 13.44 24 83521 379 29490603
Memory impairment 50.28 13.44 20 83525 36450 29454532
Tumour perforation 50.08 13.44 21 83524 240 29490742
Oesophagitis 49.24 13.44 106 83439 11817 29479165
Epistaxis 49.04 13.44 281 83264 51423 29439559
Nasopharyngitis 48.75 13.44 58 83487 59607 29431375
Stress 48.71 13.44 3 83542 21487 29469495
Large intestinal obstruction 48.54 13.44 36 83509 1318 29489664
Disturbance in attention 48.53 13.44 3 83542 21421 29469561
Mucosal toxicity 48.45 13.44 19 83526 180 29490802
Hypertransaminasaemia 47.94 13.44 55 83490 3551 29487431
Fistula 46.97 13.44 65 83480 5074 29485908
Anastomotic fistula 46.44 13.44 14 83531 53 29490929
Hypoglycaemia 46.29 13.44 41 83504 48305 29442677
Incorrect drug administration rate 46.09 13.44 33 83512 1143 29489839
Pulmonary artery thrombosis 46.09 13.44 26 83519 589 29490393
Foetal exposure during pregnancy 45.99 13.44 19 83526 33848 29457134
Hyperbilirubinaemia 45.59 13.44 118 83427 14816 29476166
Unevaluable event 45.22 13.44 14 83531 29837 29461145
Musculoskeletal stiffness 44.78 13.44 25 83520 37433 29453549
Myocardial infarction 43.75 13.44 162 83383 110134 29380848
Subclavian vein thrombosis 43.64 13.44 28 83517 807 29490175
Aortic thrombosis 43.63 13.44 26 83519 655 29490327
Bacterial translocation 43.53 13.44 18 83527 198 29490784
Dysphonia 43.32 13.44 136 83409 19060 29471922
Vena cava thrombosis 43.23 13.44 30 83515 988 29489994
Neutropenic colitis 43.05 13.44 43 83502 2368 29488614
Malignant ascites 42.68 13.44 21 83524 356 29490626
Irritability 42.53 13.44 6 83539 22146 29468836
Injury 42.16 13.44 3 83542 19043 29471939
Carbohydrate antigen 19-9 increased 42.02 13.44 17 83528 176 29490806
Duodenal perforation 41.42 13.44 31 83514 1151 29489831
Treatment noncompliance 41.20 13.44 9 83536 24218 29466764
Cytomegalovirus infection 40.77 13.44 8 83537 23207 29467775
Colon cancer recurrent 40.26 13.44 14 83531 91 29490891
Transdifferentiation of neoplasm 40.23 13.44 13 83532 65 29490917
Acral peeling skin syndrome 40.11 13.44 12 83533 44 29490938
Nicotinic acid deficiency 39.59 13.44 13 83532 69 29490913
Arthritis 39.24 13.44 11 83534 25008 29465974
Cellulitis 39.13 13.44 43 83502 45797 29445185
Venoocclusive liver disease 38.88 13.44 70 83475 6847 29484135
Skin disorder 38.81 13.44 95 83450 11523 29479459
Anal haemorrhage 38.79 13.44 37 83508 1925 29489057
Anal erythema 38.55 13.44 13 83532 76 29490906
Abnormal behaviour 38.51 13.44 9 83536 23118 29467864
Skin fissures 37.98 13.44 51 83494 3868 29487114
Intestinal ischaemia 37.97 13.44 68 83477 6624 29484358
Fluid retention 37.62 13.44 10 83535 23550 29467432
Anaemia 37.08 13.44 784 82761 200167 29290815
Drug hypersensitivity 36.88 13.44 87 83458 68319 29422663
Tumour haemorrhage 36.63 13.44 40 83505 2445 29488537
Pelvic fluid collection 35.97 13.44 13 83532 96 29490886
Nodular regenerative hyperplasia 35.93 13.44 23 83522 660 29490322
Hyperkalaemia 35.61 13.44 75 83470 61317 29429665
Abdominal discomfort 35.58 13.44 50 83495 47853 29443129
Balance disorder 35.44 13.44 30 83515 36140 29454842
Proteus infection 35.32 13.44 25 83520 850 29490132
Cardiac disorder 35.19 13.44 32 83513 37231 29453751
Perforation 35.12 13.44 15 83530 180 29490802
Laryngospasm 34.80 13.44 29 83516 1261 29489721
Liver abscess 34.76 13.44 45 83500 3293 29487689
Biliary tract infection 34.72 13.44 20 83525 472 29490510
Chronic kidney disease 34.72 13.44 31 83514 36385 29454597
Acute abdomen 34.64 13.44 33 83512 1714 29489268
Diabetes mellitus 34.40 13.44 37 83508 39794 29451188
Respiratory arrest 34.27 13.44 15 83530 25818 29465164
Hypersensitivity 34.05 13.44 261 83284 52642 29438340
Psychotic disorder 33.73 13.44 8 83537 20346 29470636
Dysphagia 33.71 13.44 268 83277 54658 29436324
White blood cell count decreased 33.69 13.44 372 83173 82990 29407992
Vasospasm 33.59 13.44 17 83528 307 29490675
Aphthous ulcer 33.56 13.44 49 83496 4019 29486963
Portal vein thrombosis 33.51 13.44 44 83501 3265 29487717
Prinzmetal angina 33.43 13.44 24 83521 835 29490147
Hypophagia 33.38 13.44 132 83413 20740 29470242
Hypoalbuminaemia 33.09 13.44 83 83462 10222 29480760
Enterovesical fistula 33.08 13.44 21 83524 594 29490388
Induration 33.01 13.44 24 83521 852 29490130
Gait disturbance 32.98 13.44 102 83443 73247 29417735
Tumour lysis syndrome 32.84 13.44 100 83445 13784 29477198
Odynophagia 32.53 13.44 52 83493 4618 29486364
Stoma site haemorrhage 32.50 13.44 22 83523 695 29490287
Oesophageal stenosis 32.37 13.44 30 83515 1505 29489477
Cytomegalovirus oesophagitis 32.30 13.44 18 83527 398 29490584
Hypovolaemic shock 32.30 13.44 60 83485 6012 29484970
International normalised ratio increased 32.28 13.44 47 83498 44325 29446657
Xerosis 32.15 13.44 19 83526 471 29490511
Oral pain 32.05 13.44 77 83468 9230 29481752
Gastric perforation 31.90 13.44 35 83510 2151 29488831
Pain 31.85 13.44 320 83225 171112 29319870
Oesophagobronchial fistula 31.28 13.44 13 83532 145 29490837
Type II hypersensitivity 30.97 13.44 9 83536 29 29490953
Stress cardiomyopathy 30.93 13.44 30 83515 1594 29489388
Jugular vein thrombosis 30.76 13.44 28 83517 1372 29489610
Blood pressure fluctuation 30.73 13.44 9 83536 19885 29471097
Enterocolitis 30.72 13.44 62 83483 6604 29484378
Recall phenomenon 30.61 13.44 19 83526 516 29490466
Hepatic lesion 30.54 13.44 41 83504 3109 29487873
Embolism 30.44 13.44 63 83482 6833 29484149
Cachexia 30.40 13.44 60 83485 6289 29484693
Adverse drug reaction 30.23 13.44 15 83530 24005 29466977
Catheter site thrombosis 30.08 13.44 9 83536 33 29490949
Bronchitis 29.93 13.44 36 83509 36832 29454150
Influenza like illness 29.73 13.44 16 83529 24454 29466528
Blood creatine phosphokinase increased 29.62 13.44 43 83502 40601 29450381
Peritoneal neoplasm 29.47 13.44 9 83536 36 29490946
Right ventricular ejection fraction decreased 29.47 13.44 9 83536 36 29490946
Pulmonary fibrosis 29.46 13.44 104 83441 15478 29475504
Condition aggravated 29.32 13.44 268 83277 146027 29344955
Prostate cancer 29.15 13.44 18 83527 25509 29465473
Sciatic nerve palsy 29.08 13.44 9 83536 38 29490944
Colitis microscopic 28.86 13.44 30 83515 1733 29489249
Pneumonitis chemical 28.70 13.44 12 83533 136 29490846
Palmar erythema 28.68 13.44 14 83531 233 29490749
Renal disorder 28.60 13.44 14 83531 22581 29468401
Sedation 28.53 13.44 7 83538 17398 29473584
Subdural haematoma 28.52 13.44 8 83537 18185 29472797
Vocal cord paralysis 28.50 13.44 22 83523 856 29490126
Perforation bile duct 28.47 13.44 8 83537 22 29490960
Colitis 28.43 13.44 168 83377 31080 29459902
Hypertension 28.39 13.44 475 83070 116139 29374843
Liver function test abnormal 28.31 13.44 24 83521 28894 29462088
Acne 28.29 13.44 73 83472 9147 29481835
Pneumonitis 28.29 13.44 155 83390 27889 29463093
Dihydropyrimidine dehydrogenase deficiency 28.25 13.44 10 83535 69 29490913
Neutropenic sepsis 28.24 13.44 85 83460 11642 29479340
Blood pressure increased 28.21 13.44 110 83435 73693 29417289
Nephrotic syndrome 28.15 13.44 58 83487 6270 29484712
Drug level increased 28.11 13.44 9 83536 18778 29472204
Venous thrombosis limb 28.01 13.44 29 83516 1667 29489315
Tumour marker increased 27.83 13.44 18 83527 526 29490456
Mouth ulceration 27.77 13.44 78 83467 10277 29480705
Device related thrombosis 27.42 13.44 22 83523 906 29490076
Colon cancer metastatic 27.38 13.44 27 83518 1464 29489518
Head injury 27.29 13.44 6 83539 16075 29474907
Gastrointestinal necrosis 27.28 13.44 38 83507 2984 29487998
Erythema 27.24 13.44 330 83215 75276 29415706
Gastrointestinal ischaemia 27.10 13.44 12 83533 158 29490824
Haematoma 27.02 13.44 16 83529 23196 29467786
Cough 26.78 13.44 229 83316 126498 29364484
Subacute cutaneous lupus erythematosus 26.75 13.44 21 83524 838 29490144
Nail toxicity 26.60 13.44 8 83537 30 29490952
Gastrointestinal anastomotic leak 26.35 13.44 15 83530 346 29490636
Dyspnoea 26.20 13.44 713 82832 326019 29164963
Eosinophilia 26.19 13.44 15 83530 22146 29468836
Enterocutaneous fistula 26.18 13.44 20 83525 766 29490216
Emotional distress 26.13 13.44 4 83541 13891 29477091
Abdominal pain lower 26.10 13.44 68 83477 8570 29482412
Cerebrovascular accident 26.09 13.44 120 83425 76791 29414191
Nephrolithiasis 26.08 13.44 20 83525 25314 29465668
Urticaria 26.02 13.44 74 83471 54586 29436396
PIK3CA-activated mutation 25.95 13.44 10 83535 90 29490892
Left ventricular dysfunction 25.80 13.44 69 83476 8833 29482149
Sepsis 25.73 13.44 555 82990 142127 29348855
Evans syndrome 25.48 13.44 13 83532 239 29490743
Sleep apnoea syndrome 25.34 13.44 9 83536 17590 29473392
Proctalgia 25.20 13.44 44 83501 4201 29486781
Cell-mediated cytotoxicity 25.09 13.44 8 83537 38 29490944
Anaemia of malignant disease 25.06 13.44 15 83530 381 29490601
Deep vein thrombosis 24.97 13.44 260 83285 57139 29433843
Pulmonary oedema 24.95 13.44 52 83493 42683 29448299
Toxic epidermal necrolysis 24.94 13.44 10 83535 18143 29472839
Prothrombin level decreased 24.91 13.44 22 83523 1036 29489946
Drug ineffective for unapproved indication 24.74 13.44 5 83540 14209 29476773
Carbohydrate antigen 15-3 increased 24.61 13.44 9 83536 69 29490913
Nail disorder 24.55 13.44 28 83517 1796 29489186
COVID-19 24.42 13.44 40 83505 35974 29455008
Proctitis 24.34 13.44 30 83515 2089 29488893
Loss of personal independence in daily activities 23.84 13.44 22 83523 25418 29465564
Trichomegaly 23.76 13.44 7 83538 24 29490958
Stoma site pain 23.71 13.44 16 83529 503 29490479
Renal salt-wasting syndrome 23.44 13.44 11 83534 167 29490815
Conjunctival filtering bleb leak 23.38 13.44 6 83539 10 29490972
Colitis ulcerative 23.28 13.44 4 83541 12765 29478217
Koebner phenomenon 23.27 13.44 8 83537 50 29490932
Off label use 23.26 13.44 1055 82490 299745 29191237
Varices oesophageal 23.25 13.44 36 83509 3110 29487872
Dysaesthesia pharynx 23.01 13.44 8 83537 52 29490930
Hypercreatininaemia 22.73 13.44 15 83530 454 29490528
Pachymeningitis 22.70 13.44 9 83536 88 29490894
Herpes zoster 22.68 13.44 31 83514 30021 29460961
Fistula of small intestine 22.53 13.44 14 83531 381 29490601
Myoclonus 22.52 13.44 5 83540 13304 29477678
Rectal tenesmus 22.49 13.44 17 83528 641 29490341
Mobility decreased 22.20 13.44 24 83521 25756 29465226
Gout 22.14 13.44 10 83535 16901 29474081
Rectal cancer metastatic 22.12 13.44 11 83534 191 29490791
Contraindicated product administered 22.11 13.44 12 83533 18254 29472728
Perineal disorder 22.03 13.44 8 83537 60 29490922
Hypervolaemia 22.01 13.44 11 83534 17534 29473448
Balanoposthitis 21.94 13.44 20 83525 982 29490000
Haemoglobinuria 21.88 13.44 16 83529 573 29490409
Abdominal abscess 21.88 13.44 39 83506 3785 29487197
Interventricular septum rupture 21.76 13.44 6 83539 15 29490967
Adverse event 21.71 13.44 8 83537 15283 29475699
Hepatitis B 21.70 13.44 48 83497 5449 29485533
Heart rate decreased 21.67 13.44 23 83522 24889 29466093
Blood glucose decreased 21.53 13.44 4 83541 12065 29478917
Cerebral vasoconstriction 21.42 13.44 11 83534 205 29490777
Lower respiratory tract infection 21.38 13.44 26 83519 26476 29464506
Febrile bone marrow aplasia 21.33 13.44 57 83488 7294 29483688
Delirium 21.31 13.44 50 83495 39347 29451635
Hepatectomy 21.26 13.44 8 83537 67 29490915
Ectropion 21.26 13.44 8 83537 67 29490915
Splenomegaly 21.24 13.44 84 83461 13195 29477787
Drug intolerance 21.23 13.44 68 83477 48311 29442671
Wrong technique in product usage process 21.22 13.44 35 83510 31393 29459589
Respiratory depression 21.10 13.44 6 83539 13517 29477465
Underdose 21.03 13.44 4 83541 11865 29479117
Unresponsive to stimuli 20.97 13.44 24 83521 25102 29465880
Pseudocirrhosis 20.97 13.44 6 83539 18 29490964
Toxic erythema of chemotherapy 20.96 13.44 8 83537 70 29490912
Pneumoperitoneum 20.92 13.44 24 83521 1549 29489433
Anger 20.79 13.44 3 83542 10887 29480095
Blood cholesterol increased 20.77 13.44 9 83536 15586 29475396
Perioral dermatitis 20.71 13.44 9 83536 113 29490869
Hepatic atrophy 20.62 13.44 10 83535 164 29490818
Swelling 20.54 13.44 43 83502 35240 29455742
Clostridial infection 20.51 13.44 35 83510 3280 29487702
Diffuse alveolar damage 20.43 13.44 27 83518 2016 29488966
NPM1 gene mutation 20.43 13.44 9 83536 117 29490865
Oesophageal perforation 20.42 13.44 17 83528 738 29490244
Anorectal discomfort 20.36 13.44 24 83521 1595 29489387
Vision blurred 20.16 13.44 53 83492 40123 29450859
Pulmonary infarction 20.15 13.44 20 83525 1093 29489889
Product prescribing error 20.08 13.44 13 83532 17963 29473019
Thrombotic thrombocytopenic purpura 20.04 13.44 34 83511 3172 29487810
Soft tissue disorder 20.01 13.44 16 83529 656 29490326
Premature baby 19.99 13.44 12 83533 17268 29473714
Seizure 19.78 13.44 168 83377 92955 29398027
Protein urine 19.53 13.44 17 83528 785 29490197
Perihepatic abscess 19.51 13.44 8 83537 86 29490896
Tubulointerstitial nephritis 19.38 13.44 13 83532 17630 29473352
Accidental overdose 19.27 13.44 13 83532 17580 29473402
Refeeding syndrome 19.26 13.44 6 83539 26 29490956
Microgenia 19.24 13.44 5 83540 9 29490973
Dyskinesia 19.21 13.44 17 83528 20044 29470938
Anal fissure 19.19 13.44 31 83514 2777 29488205
Device related sepsis 19.07 13.44 29 83516 2466 29488516
Pelvic venous thrombosis 19.06 13.44 14 83531 505 29490477
Osteoarthritis 19.01 13.44 14 83531 18089 29472893
Necrotising oesophagitis 18.99 13.44 14 83531 508 29490474
Ischiorectal hernia 18.90 13.44 5 83540 10 29490972
Paraesthesia oral 18.87 13.44 35 83510 3502 29487480
Prostatic specific antigen increased 18.83 13.44 6 83539 12558 29478424
Erectile dysfunction 18.82 13.44 14 83531 17995 29472987
Dysgeusia 18.78 13.44 119 83426 22555 29468427
Enterocolitis haemorrhagic 18.68 13.44 17 83528 833 29490149
Guillain-Barre syndrome 18.67 13.44 43 83502 5015 29485967
Arthropathy 18.63 13.44 20 83525 21534 29469448
Lymph node abscess 18.58 13.44 5 83540 11 29490971
Intestinal strangulation 18.57 13.44 6 83539 30 29490952
Peritoneal haematoma 18.57 13.44 7 83538 59 29490923
Cerebral haemorrhage 18.55 13.44 38 83507 31388 29459594
Jaundice 18.54 13.44 144 83401 29152 29461830
Superior vena cava syndrome 18.54 13.44 14 83531 527 29490455
Duodenal ulcer perforation 18.41 13.44 22 83523 1484 29489498
Heart rate irregular 18.39 13.44 7 83538 13110 29477872
Metastasis 18.38 13.44 34 83511 3395 29487587
Portal vein embolisation 18.28 13.44 5 83540 12 29490970
Accidental exposure to product 18.27 13.44 4 83541 10749 29480233
Retroperitoneal abscess 18.22 13.44 9 83536 154 29490828
Acute respiratory distress syndrome 18.16 13.44 119 83426 22816 29468166
Tetany 18.10 13.44 15 83530 647 29490335
Muscular weakness 18.09 13.44 102 83443 61950 29429032
Lymphoma 18.09 13.44 3 83542 9825 29481157
Primitive neuroectodermal tumour 18.07 13.44 7 83538 64 29490918
Eyelash changes 17.99 13.44 5 83540 13 29490969
Colony stimulating factor therapy 17.96 13.44 9 83536 159 29490823
Mental disorder 17.91 13.44 7 83538 12898 29478084
Bronchiolitis obliterans syndrome 17.86 13.44 9 83536 161 29490821
Diabetes mellitus inadequate control 17.83 13.44 6 83539 12128 29478854
Inappropriate schedule of product administration 17.82 13.44 65 83480 44407 29446575
Intentional product use issue 17.77 13.44 61 83484 42437 29448545
Oesophageal haemorrhage 17.77 13.44 19 83526 1134 29489848
Myopathy 17.73 13.44 4 83541 10529 29480453
Pancreatitis 17.72 13.44 45 83500 34469 29456513
Performance status decreased 17.58 13.44 35 83510 3692 29487290
Wound dehiscence 17.56 13.44 31 83514 2986 29487996
Gastrointestinal stoma complication 17.51 13.44 19 83526 1153 29489829
Visceral venous thrombosis 17.47 13.44 5 83540 15 29490967
Injection site reaction 17.39 13.44 5 83540 11183 29479799
Lymphangiosis carcinomatosa 17.37 13.44 16 83529 796 29490186
Neck pain 17.35 13.44 21 83524 21426 29469556
B-cell small lymphocytic lymphoma 17.32 13.44 8 83537 117 29490865
Hypersplenism 17.27 13.44 11 83534 313 29490669
Haemorrhagic tumour necrosis 17.26 13.44 4 83541 3 29490979
K-ras gene mutation 17.23 13.44 5 83540 16 29490966
Injection site erythema 17.14 13.44 9 83536 13947 29477035
Nail ridging 17.13 13.44 6 83539 40 29490942
Fixed eruption 17.12 13.44 19 83526 1183 29489799
Stevens-Johnson syndrome 17.01 13.44 13 83532 16484 29474498
Angioedema 16.86 13.44 41 83504 31874 29459108
Monocytopenia 16.85 13.44 7 83538 78 29490904
Acute cutaneous lupus erythematosus 16.77 13.44 7 83538 79 29490903
Acute motor-sensory axonal neuropathy 16.73 13.44 8 83537 127 29490855
Intrahepatic portal hepatic venous fistula 16.73 13.44 4 83541 4 29490978
Hepatic enzyme increased 16.64 13.44 45 83500 33754 29457228
Rectal ulcer 16.64 13.44 16 83529 841 29490141
Osteomyelitis 16.60 13.44 9 83536 13700 29477282
Product use in unapproved indication 16.59 13.44 161 83384 86714 29404268
Neoplasm recurrence 16.58 13.44 24 83521 1953 29489029
Product administration error 16.46 13.44 10 83535 14300 29476682
Swollen tongue 16.46 13.44 7 83538 12259 29478723
Hepatitis B surface antigen positive 16.40 13.44 8 83537 133 29490849
VIth nerve disorder 16.37 13.44 5 83540 20 29490962
Pulmonary toxicity 16.35 13.44 40 83505 4850 29486132
Metastases to pelvis 16.33 13.44 10 83535 265 29490717
Catheter site extravasation 16.31 13.44 7 83538 85 29490897
Bacteraemia 16.31 13.44 90 83455 16233 29474749
Radiation mucositis 16.29 13.44 8 83537 135 29490847
Blood triglycerides increased 16.17 13.44 8 83537 12826 29478156
Pancreatic neuroendocrine tumour metastatic 16.17 13.44 7 83538 87 29490895
Treatment failure 16.15 13.44 52 83493 36887 29454095
Toxic leukoencephalopathy 16.13 13.44 10 83535 271 29490711
Laryngeal oedema 16.06 13.44 30 83515 3018 29487964
Bacterial colitis 15.97 13.44 6 83539 50 29490932
Bile duct stenosis 15.94 13.44 18 83527 1142 29489840
Fatigue 15.92 13.44 1068 82477 315753 29175229
Rib fracture 15.92 13.44 8 83537 12710 29478272
Visual impairment 15.83 13.44 38 83507 29670 29461312
Colorectal cancer recurrent 15.81 13.44 5 83540 23 29490959
Product quality issue 15.79 13.44 13 83532 15882 29475100
Hepatic failure 15.77 13.44 147 83398 31365 29459617
Radiation skin injury 15.73 13.44 14 83531 666 29490316
Anaphylactic shock 15.73 13.44 77 83468 13259 29477723
Hyperlipidaemia 15.64 13.44 8 83537 12582 29478400
Laboratory test abnormal 15.58 13.44 17 83528 18168 29472814
Heart rate increased 15.54 13.44 57 83488 38881 29452101
Aplasia 15.50 13.44 35 83510 4028 29486954
Electromyogram abnormal 15.47 13.44 6 83539 55 29490927
Radiation interaction 15.47 13.44 5 83540 25 29490957
Respiratory alkalosis 15.46 13.44 20 83525 1463 29489519
Therapy cessation 15.43 13.44 11 83534 14451 29476531
Localised infection 15.42 13.44 10 83535 13806 29477176
Hyperthermia 15.36 13.44 60 83485 9370 29481612
Swelling face 15.35 13.44 21 83524 20329 29470653
Gastrointestinal obstruction 15.31 13.44 14 83531 690 29490292
Tracheal stenosis 15.30 13.44 8 83537 155 29490827
Tooth disorder 15.30 13.44 4 83541 9525 29481457
Pulmonary hypertension 15.28 13.44 18 83527 18590 29472392
Chimerism 15.27 13.44 9 83536 222 29490760
Sarcoidosis 15.20 13.44 27 83518 2613 29488369
Rectal abscess 15.20 13.44 16 83529 938 29490044
Road traffic accident 15.13 13.44 13 83532 15548 29475434
Therapeutic response unexpected 15.12 13.44 3 83542 8635 29482347
Pneumoretroperitoneum 15.10 13.44 6 83539 59 29490923
Cardiomyopathy 15.09 13.44 82 83463 14705 29476277
Neurosarcoidosis 14.98 13.44 8 83537 162 29490820
Eye pain 14.96 13.44 7 83538 11588 29479394
Limb injury 14.88 13.44 4 83541 9351 29481631
Periportal sinus dilatation 14.86 13.44 5 83540 29 29490953
Intestinal mucosal hypertrophy 14.84 13.44 6 83539 62 29490920
Vestibular neuronitis 14.81 13.44 8 83537 166 29490816
Nasal congestion 14.73 13.44 19 83526 18860 29472122
Rectal stenosis 14.72 13.44 8 83537 168 29490814
Klebsiella infection 14.72 13.44 50 83495 7299 29483683
Colorectal cancer 14.70 13.44 22 83523 1845 29489137
Oedema peripheral 14.69 13.44 205 83340 103352 29387630
Hypersomnia 14.65 13.44 6 83539 10748 29480234
Herpes simplex meningomyelitis 14.62 13.44 3 83542 0 29490982
Tumour fistulisation 14.51 13.44 4 83541 10 29490972
Faeces discoloured 14.45 13.44 10 83535 13341 29477641
Soft tissue swelling 14.44 13.44 10 83535 328 29490654
Product substitution issue 14.44 13.44 4 83541 9168 29481814
Hernia 14.42 13.44 3 83542 8355 29482627
Non-cirrhotic portal hypertension 14.42 13.44 9 83536 247 29490735
Productive cough 14.37 13.44 43 83502 31216 29459766
Rectal haemorrhage 14.32 13.44 155 83390 34394 29456588
Pneumomediastinum 14.27 13.44 21 83524 1735 29489247
Aspergillus infection 14.26 13.44 6 83539 10575 29480407
Astringent therapy 14.23 13.44 4 83541 11 29490971
Stress ulcer 14.12 13.44 6 83539 71 29490911
Suture rupture 14.10 13.44 10 83535 341 29490641
Rectal adenocarcinoma 14.09 13.44 14 83531 766 29490216
Peritoneal disorder 14.04 13.44 9 83536 259 29490723
Adenocarcinoma 14.03 13.44 20 83525 1605 29489377
Chemotherapy 14.01 13.44 12 83533 542 29490440
Peritoneal adhesions 14.00 13.44 7 83538 123 29490859
Axillary vein thrombosis 14.00 13.44 8 83537 186 29490796
Metapneumovirus bronchiolitis 13.98 13.44 4 83541 12 29490970
Temperature difference of extremities 13.98 13.44 4 83541 12 29490970
Cytokine release syndrome 13.97 13.44 10 83535 13109 29477873
Gastrointestinal inflammation 13.89 13.44 28 83517 2980 29488002
Night sweats 13.89 13.44 13 83532 14919 29476063
Duodenal stenosis 13.84 13.44 8 83537 190 29490792
Osteoradionecrosis 13.83 13.44 6 83539 75 29490907
Amnesia 13.69 13.44 27 83518 22616 29468366
Viral infection 13.65 13.44 13 83532 14797 29476185
Full blood count decreased 13.64 13.44 15 83530 15977 29475005
Portal shunt 13.60 13.44 5 83540 39 29490943
Blister 13.59 13.44 22 83523 19884 29471098
Hepatic pain 13.52 13.44 17 83528 1208 29489774
Encapsulating peritoneal sclerosis 13.52 13.44 12 83533 569 29490413
Oesophageal varices haemorrhage 13.50 13.44 26 83519 2676 29488306
Movement disorder 13.49 13.44 6 83539 10231 29480751
Oral dysaesthesia 13.48 13.44 6 83539 80 29490902
Bacteriuria 13.47 13.44 9 83536 278 29490704

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
Neutropenia 2707.94 12.49 2908 133101 236716 64126007
Neuropathy peripheral 1733.17 12.49 1650 134359 115875 64246848
Diarrhoea 1506.44 12.49 4100 131909 718604 63644119
Mucosal inflammation 1432.19 12.49 1130 134879 61454 64301269
Dermatitis acneiform 1263.57 12.49 523 135486 7920 64354803
Disease progression 1125.18 12.49 1438 134571 140242 64222481
Thrombocytopenia 952.28 12.49 1697 134312 222104 64140619
Palmar-plantar erythrodysaesthesia syndrome 912.32 12.49 633 135376 28186 64334537
Febrile neutropenia 836.76 12.49 1453 134556 186204 64176519
Skin toxicity 831.84 12.49 362 135647 6240 64356483
Leukopenia 753.75 12.49 996 135013 100246 64262477
Neurotoxicity 723.20 12.49 539 135470 26865 64335858
Stomatitis 715.82 12.49 1012 134997 108593 64254130
Arteriospasm coronary 628.28 12.49 281 135728 5184 64357539
Metastases to liver 563.69 12.49 440 135569 23501 64339222
Paronychia 534.14 12.49 265 135744 6227 64356496
Interstitial lung disease 497.89 12.49 804 135205 96928 64265795
Neoplasm progression 495.12 12.49 517 135492 40447 64322276
Bone marrow failure 485.06 12.49 551 135458 47401 64315322
Completed suicide 437.53 12.49 7 136002 224407 64138316
Vomiting 428.77 12.49 2288 133721 548829 63813894
Decreased appetite 419.69 12.49 1425 134584 279864 64082859
Drug ineffective 415.80 12.49 711 135298 839536 63523187
Metastases to lung 406.59 12.49 302 135707 14962 64347761
Gastrointestinal toxicity 399.00 12.49 204 135805 5118 64357605
Peripheral sensory neuropathy 398.14 12.49 266 135743 11112 64351611
Malignant neoplasm progression 398.11 12.49 791 135218 112080 64250643
Arthralgia 389.53 12.49 225 135784 442035 63920688
Nausea 385.32 12.49 2899 133110 782901 63579822
Polyneuropathy 358.26 12.49 313 135696 19581 64343142
Hyperammonaemia 354.89 12.49 235 135774 9669 64353054
Cardiotoxicity 351.83 12.49 237 135772 10037 64352686
Proteinuria 336.92 12.49 351 135658 27372 64335351
Neutrophil count decreased 335.78 12.49 592 135417 76604 64286119
Rheumatoid arthritis 305.01 12.49 9 136000 164285 64198438
Product dose omission issue 294.99 12.49 33 135976 194714 64168009
Joint swelling 285.78 12.49 54 135955 215328 64147395
General physical health deterioration 275.44 12.49 1002 135007 203423 64159300
Headache 266.60 12.49 442 135567 529025 63833698
Gastrointestinal perforation 260.52 12.49 155 135854 5269 64357454
Fall 259.88 12.49 298 135711 416528 63946195
Haematotoxicity 256.87 12.49 215 135794 12681 64350042
Hypomagnesaemia 255.37 12.49 353 135656 37023 64325700
Myelosuppression 254.87 12.49 282 135727 23548 64339175
Drug abuse 250.37 12.49 6 136003 132368 64230355
Hyperammonaemic encephalopathy 243.26 12.49 134 135875 3924 64358799
Weight increased 237.48 12.49 77 135932 213271 64149452
Pyrexia 233.83 12.49 1990 134019 556654 63806069
Dehydration 227.05 12.49 982 135027 215781 64146942
Enteritis 223.46 12.49 193 135816 11884 64350839
Portal hypertension 221.44 12.49 147 135862 6072 64356651
Drug interaction 221.15 12.49 263 135746 361820 64000903
Paraesthesia 213.89 12.49 697 135312 133825 64228898
Acute myeloid leukaemia 209.94 12.49 274 135735 27189 64335534
Sinusitis 205.85 12.49 31 135978 145897 64216826
Intestinal obstruction 203.24 12.49 312 135697 35974 64326749
Pulmonary embolism 201.74 12.49 723 135286 145633 64217090
Pain 180.76 12.49 583 135426 552928 63809795
Injection site pain 178.84 12.49 15 135994 111393 64251330
Therapeutic product effect decreased 178.56 12.49 18 135991 115333 64247390
Abdominal discomfort 174.56 12.49 83 135926 182239 64180484
Abdominal pain 172.36 12.49 1188 134821 311187 64051536
Peripheral swelling 171.85 12.49 115 135894 209038 64153685
Nasopharyngitis 169.06 12.49 102 135907 195971 64166752
Pain in extremity 168.60 12.49 236 135773 302849 64059874
Swelling 167.65 12.49 64 135945 160154 64202569
Metastases to lymph nodes 164.71 12.49 141 135868 8576 64354147
Extravasation 158.29 12.49 93 135916 3087 64359636
Depression 155.72 12.49 97 135912 183194 64179529
Asthenia 155.21 12.49 1479 134530 426565 63936158
Product use issue 153.18 12.49 64 135945 151651 64211072
Contusion 152.29 12.49 28 135981 113937 64248786
Anxiety 150.25 12.49 124 135885 202525 64160198
Ileus 148.07 12.49 211 135798 22755 64339968
Oesophageal fistula 145.95 12.49 45 135964 266 64362457
Contraindicated product administered 145.15 12.49 26 135983 107803 64254920
Arthropathy 144.91 12.49 38 135971 120929 64241794
Anaemia 144.51 12.49 1323 134686 377357 63985366
Drug hypersensitivity 140.54 12.49 177 135832 237638 64125085
Systemic lupus erythematosus 137.92 12.49 6 136003 77606 64285117
Therapy partial responder 137.67 12.49 137 135872 10111 64352612
Hypokalaemia 137.36 12.49 565 135444 121338 64241385
Posterior reversible encephalopathy syndrome 135.14 12.49 202 135807 22744 64339979
Chills 134.57 12.49 610 135399 136654 64226069
Focal nodular hyperplasia 134.29 12.49 51 135958 606 64362117
Musculoskeletal stiffness 130.91 12.49 48 135961 123158 64239565
Second primary malignancy 130.19 12.49 145 135864 12192 64350531
Carcinoembryonic antigen increased 129.49 12.49 68 135941 1805 64360918
Metastases to bone 127.72 12.49 185 135824 20250 64342473
Large intestine perforation 127.64 12.49 145 135864 12459 64350264
Hypertransaminasaemia 127.15 12.49 112 135897 7079 64355644
Insomnia 126.80 12.49 138 135871 197698 64165025
Administration site extravasation 126.67 12.49 56 135953 1003 64361720
Colorectal cancer metastatic 125.36 12.49 54 135955 906 64361817
Pneumatosis intestinalis 124.97 12.49 97 135912 5132 64357591
Laryngospasm 124.03 12.49 82 135927 3363 64359360
Ascites 121.64 12.49 346 135663 61655 64301068
Acute promyelocytic leukaemia 121.15 12.49 59 135950 1329 64361394
Intentional product misuse 120.95 12.49 8 136001 72287 64290436
Peritonitis 120.67 12.49 201 135808 24822 64337901
Influenza 119.25 12.49 38 135971 106493 64256230
Suicide attempt 118.37 12.49 8 136001 70999 64291724
Somnolence 117.78 12.49 154 135855 203491 64159232
Portal venous gas 116.25 12.49 39 135970 313 64362410
Leukoencephalopathy 116.23 12.49 105 135904 6862 64355861
Hospitalisation 115.69 12.49 12 135997 75195 64287528
Rhabdomyolysis 113.36 12.49 27 135982 91699 64271024
Arthritis 113.25 12.49 20 135989 83794 64278929
Venoocclusive liver disease 113.13 12.49 122 135887 9893 64352830
Psoriasis 111.45 12.49 11 135998 71692 64291031
Intestinal perforation 111.19 12.49 149 135860 15164 64347559
Ejection fraction decreased 110.59 12.49 209 135800 28498 64334225
Cardiomyopathy 108.28 12.49 193 135816 25163 64337560
Cholangitis 107.24 12.49 123 135886 10679 64352044
Hiccups 107.06 12.49 109 135900 8267 64354456
Dizziness 106.92 12.49 505 135504 429658 63933065
Electrocardiogram ST segment elevation 106.79 12.49 102 135907 7157 64355566
Subileus 105.41 12.49 86 135923 4891 64357832
Stress cardiomyopathy 104.97 12.49 113 135896 9144 64353579
Septic shock 104.38 12.49 470 135539 104967 64257756
Suicidal ideation 103.97 12.49 10 135999 66532 64296191
Neutropenic sepsis 103.07 12.49 180 135829 23092 64339631
Neutropenic colitis 103.06 12.49 82 135927 4499 64358224
Chronic obstructive pulmonary disease 102.70 12.49 14 135995 71034 64291689
Anastomotic leak 102.56 12.49 47 135962 919 64361804
Overdose 100.36 12.49 113 135896 159453 64203270
Skin reaction 100.29 12.49 127 135882 12225 64350498
Rash pustular 98.88 12.49 113 135896 9772 64352951
Tumour necrosis 98.51 12.49 55 135954 1654 64361069
Epistaxis 94.57 12.49 434 135575 97697 64265026
Maternal exposure during pregnancy 94.28 12.49 42 135967 95842 64266881
Injury 94.24 12.49 6 136003 55986 64306737
Wound 93.54 12.49 23 135986 76454 64286269
Injection site erythema 93.28 12.49 18 135991 70782 64291941
Asthma 93.18 12.49 42 135967 95183 64267540
Bronchitis 93.07 12.49 57 135952 108686 64254037
Cholinergic syndrome 92.60 12.49 42 135967 801 64361922
Pemphigus 92.56 12.49 10 135999 60691 64302032
Small intestinal obstruction 92.52 12.49 173 135836 23400 64339323
Pelvic abscess 91.94 12.49 54 135955 1791 64360932
Feeling abnormal 91.47 12.49 88 135921 133514 64229209
Aorto-oesophageal fistula 90.80 12.49 23 135986 55 64362668
Myalgia 90.62 12.49 121 135888 158496 64204227
Stress 89.73 12.49 11 135998 60523 64302200
Wheezing 89.72 12.49 29 135980 80550 64282173
Electrocardiogram QT prolonged 89.51 12.49 28 135981 79420 64283303
Non-cirrhotic portal hypertension 89.25 12.49 33 135976 362 64362361
Dermatitis 88.51 12.49 146 135863 17883 64344840
Migraine 86.79 12.49 14 135995 62663 64300060
White blood cell count decreased 86.08 12.49 599 135410 157238 64205485
Condition aggravated 85.72 12.49 449 135560 371977 63990746
Mucosal toxicity 85.69 12.49 34 135975 458 64362265
Nodular regenerative hyperplasia 85.12 12.49 40 135969 830 64361893
Hepatic enzyme increased 85.05 12.49 89 135920 129854 64232869
Pneumonia 84.09 12.49 765 135244 558811 63803912
Rectal perforation 83.91 12.49 38 135971 722 64362001
Osteoarthritis 83.66 12.49 16 135993 63320 64299403
Fluid retention 83.24 12.49 13 135996 59593 64303130
Device related infection 82.93 12.49 193 135816 30433 64332290
Glossodynia 82.02 12.49 18 135991 64678 64298045
Drug intolerance 81.83 12.49 171 135838 187821 64174902
Acute coronary syndrome 81.19 12.49 146 135863 19164 64343559
Dry skin 81.12 12.49 265 135744 50896 64311827
Ileal perforation 80.96 12.49 39 135970 857 64361866
Splenomegaly 80.94 12.49 140 135869 17821 64344902
Aggression 80.75 12.49 4 136005 46228 64316495
Mobility decreased 80.70 12.49 40 135969 85800 64276923
Aortic thrombosis 79.92 12.49 46 135963 1468 64361255
Confusional state 79.55 12.49 283 135726 260861 64101862
Tumour perforation 78.77 12.49 29 135980 314 64362409
Hyperbilirubinaemia 78.74 12.49 152 135857 21053 64341670
Intravascular haemolysis 76.35 12.49 35 135974 685 64362038
Device related thrombosis 75.96 12.49 50 135959 2035 64360688
Treatment failure 75.34 12.49 81 135928 116735 64245988
Bradycardia 75.11 12.49 83 135926 118136 64244587
Incorrect dose administered 74.85 12.49 18 135991 60747 64301976
Dihydropyrimidine dehydrogenase deficiency 74.75 12.49 22 135987 108 64362615
Blood cholesterol increased 74.45 12.49 9 136000 50057 64312666
Venous thrombosis 74.31 12.49 79 135930 6302 64356421
Disseminated intravascular coagulation 73.93 12.49 191 135818 32157 64330566
Metastases to peritoneum 72.42 12.49 60 135949 3487 64359236
Gait disturbance 72.09 12.49 160 135849 171995 64190728
Vena cava thrombosis 72.08 12.49 52 135957 2460 64360263
Lower respiratory tract infection 71.18 12.49 57 135952 94557 64268166
Enterocutaneous fistula 70.90 12.49 43 135966 1514 64361209
Colitis 70.06 12.49 277 135732 58397 64304326
Subacute cutaneous lupus erythematosus 69.88 12.49 55 135954 2970 64359753
Discomfort 69.75 12.49 42 135967 80836 64281887
Loss of personal independence in daily activities 69.26 12.49 33 135976 72421 64290302
Memory impairment 69.12 12.49 48 135961 85634 64277089
Large intestinal obstruction 68.69 12.49 52 135957 2650 64360073
Nicotinic acid deficiency 68.27 12.49 21 135988 123 64362600
Injection site swelling 67.93 12.49 5 136004 41348 64321375
Gastrointestinal necrosis 67.54 12.49 67 135942 4925 64357798
Necrotising fasciitis 67.51 12.49 69 135940 5257 64357466
Anastomotic complication 67.36 12.49 27 135982 374 64362349
Irritable bowel syndrome 66.02 12.49 3 136006 37366 64325357
Injection site reaction 65.57 12.49 10 135999 46654 64316069
Balance disorder 65.11 12.49 49 135960 83877 64278846
Left ventricular dysfunction 64.76 12.49 123 135886 16831 64345892
Cough 64.69 12.49 373 135636 301775 64060948
Hallucination 63.90 12.49 37 135972 72751 64289972
Pruritus 63.54 12.49 392 135617 312008 64050715
Liver abscess 62.60 12.49 66 135943 5214 64357509
Acute abdomen 62.35 12.49 50 135959 2774 64359949
Exposure during pregnancy 62.01 12.49 44 135965 77631 64285092
Urticaria 61.60 12.49 137 135872 147180 64215543
Deep vein thrombosis 60.78 12.49 405 135604 104777 64257946
Febrile bone marrow aplasia 60.52 12.49 95 135914 11160 64351563
Tumour lysis syndrome 59.91 12.49 129 135880 19311 64343412
Hypertension 59.40 12.49 820 135189 258441 64104282
Helicobacter infection 59.31 12.49 6 136003 38356 64324367
Tremor 58.64 12.49 142 135867 148088 64214635
Cardiac failure congestive 58.31 12.49 117 135892 130463 64232260
Hypophagia 58.28 12.49 200 135809 39387 64323336
Blister 58.17 12.49 51 135958 80916 64281807
Sedation 57.99 12.49 9 136000 41453 64321270
Colony stimulating factor therapy 57.65 12.49 26 135983 489 64362234
Emotional distress 57.41 12.49 5 136004 36033 64326690
Respiratory arrest 57.35 12.49 20 135989 52965 64309758
Embolism 57.28 12.49 97 135912 12138 64350585
Dysphonia 56.20 12.49 220 135789 46162 64316561
Sepsis 55.83 12.49 736 135273 229605 64133118
Blood pressure fluctuation 55.43 12.49 20 135989 51851 64310872
Treatment noncompliance 55.31 12.49 12 135997 43470 64319253
Dysgeusia 54.47 12.49 220 135789 46827 64315896
Heart rate decreased 54.31 12.49 24 135985 55043 64307680
Nasal congestion 54.28 12.49 29 135980 59629 64303094
Recall phenomenon 54.26 12.49 31 135978 975 64361748
Plasma cell myeloma 54.16 12.49 15 135994 46060 64316663
Coronary artery disease 54.08 12.49 30 135979 60403 64302320
Small intestinal perforation 53.42 12.49 44 135965 2536 64360187
Biliary tract infection 53.17 12.49 30 135979 921 64361802
Anastomotic fistula 53.17 12.49 16 135993 86 64362637
Haemolytic anaemia 52.33 12.49 109 135900 15944 64346779
Hepatic lesion 52.30 12.49 63 135946 5761 64356962
Intentional product use issue 52.18 12.49 75 135934 95289 64267434
Carbohydrate antigen 19-9 increased 51.74 12.49 22 135987 357 64362366
Pulmonary artery thrombosis 51.58 12.49 32 135977 1174 64361549
Duodenal perforation 51.50 12.49 38 135971 1862 64360861
Unevaluable event 51.40 12.49 21 135988 50468 64312255
Trichomegaly 51.24 12.49 15 135994 72 64362651
International normalised ratio increased 50.92 12.49 55 135954 79112 64283611
Intestinal ischaemia 50.71 12.49 89 135920 11460 64351263
Renal salt-wasting syndrome 50.60 12.49 23 135986 441 64362282
Skin fissures 49.97 12.49 83 135926 10223 64352500
Conjunctival filtering bleb leak 49.87 12.49 12 135997 21 64362702
Portal vein thrombosis 49.83 12.49 57 135952 4934 64357789
Toxicity to various agents 49.79 12.49 508 135501 363005 63999718
Oesophagitis 49.72 12.49 128 135881 21502 64341221
Muscle spasms 49.04 12.49 144 135865 140879 64221844
Blood glucose increased 49.01 12.49 82 135927 97991 64264732
Metastasis 48.54 12.49 60 135949 5635 64357088
Vasospasm 48.18 12.49 28 135981 910 64361813
Proctalgia 48.06 12.49 69 135940 7490 64355233
Red blood cell sedimentation rate increased 47.99 12.49 5 136004 31230 64331493
Hypoglycaemia 47.91 12.49 72 135937 89820 64272903
Fistula 47.85 12.49 79 135930 9682 64353041
Hyperkalaemia 47.42 12.49 88 135921 101041 64261682
Jugular vein thrombosis 47.41 12.49 49 135960 3782 64358941
Agitation 46.88 12.49 71 135938 88296 64274427
Steatohepatitis 46.47 12.49 26 135983 785 64361938
Skin disorder 46.25 12.49 146 135863 27534 64335189
Blood pressure increased 46.09 12.49 197 135812 172355 64190368
Enterocolitis 45.67 12.49 87 135922 11931 64350792
Oesophageal stenosis 45.59 12.49 48 135961 3786 64358937
Immune thrombocytopenia 45.31 12.49 99 135910 14967 64347756
Hypoalbuminaemia 45.27 12.49 109 135900 17565 64345158
Irritability 45.03 12.49 11 135998 36735 64325988
Dysarthria 44.67 12.49 245 135764 59161 64303562
Drug level increased 44.40 12.49 9 136000 34187 64328536
Dysphagia 44.07 12.49 380 135629 106432 64256291
Acral peeling skin syndrome 43.57 12.49 12 135997 44 64362679
Toxic leukoencephalopathy 43.55 12.49 26 135983 889 64361834
Pelvic fluid collection 43.30 12.49 23 135986 625 64362098
COVID-19 43.30 12.49 44 135965 65096 64297627
Congestive cardiomyopathy 43.21 12.49 78 135931 10266 64352457
Stoma site haemorrhage 43.13 12.49 32 135977 1581 64361142
Psychotic disorder 43.06 12.49 10 135999 34568 64328155
Adverse drug reaction 43.00 12.49 21 135988 45443 64317280
Subclavian vein thrombosis 42.84 12.49 37 135972 2277 64360446
Sleep apnoea syndrome 42.82 12.49 6 136003 29826 64332897
Underdose 42.78 12.49 3 136006 25826 64336897
Herpes zoster 42.61 12.49 63 135946 79124 64283599
Metastases to meninges 42.25 12.49 40 135969 2775 64359948
Hypervolaemia 42.22 12.49 14 135995 38271 64324452
Gastrooesophageal reflux disease 42.02 12.49 69 135940 83074 64279649
Odynophagia 41.95 12.49 74 135935 9567 64353156
Cellulitis 41.73 12.49 84 135925 93573 64269150
Gastric perforation 41.70 12.49 44 135965 3479 64359244
Metastases to skin 41.53 12.49 30 135979 1422 64361301
Myocardial infarction 41.47 12.49 194 135815 165627 64197096
Metastases to central nervous system 41.37 12.49 91 135918 13821 64348902
Drug ineffective for unapproved indication 40.82 12.49 8 136001 31125 64331598
Blood pressure systolic increased 40.82 12.49 27 135982 49426 64313297
Liver function test abnormal 40.78 12.49 39 135970 59362 64303361
Aplasia 40.63 12.49 61 135948 6892 64355831
Prinzmetal angina 40.60 12.49 30 135979 1473 64361250
Gastrointestinal anastomotic leak 40.49 12.49 19 135990 393 64362330
Venous thrombosis limb 40.31 12.49 45 135964 3792 64358931
Transdifferentiation of neoplasm 40.29 12.49 13 135996 91 64362632
Gastrointestinal stoma complication 40.02 12.49 35 135974 2191 64360532
Palpitations 39.83 12.49 102 135907 104386 64258337
Pulmonary fibrosis 39.73 12.49 146 135863 29732 64332991
Injection site haemorrhage 39.69 12.49 3 136006 24275 64338448
Bacterial translocation 39.59 12.49 19 135990 414 64362309
Tumour ulceration 39.36 12.49 15 135994 180 64362543
Conjunctivitis 39.33 12.49 113 135896 20241 64342482
Cachexia 39.14 12.49 70 135939 9147 64353576
Aortitis 39.14 12.49 26 135983 1075 64361648
Varices oesophageal 38.91 12.49 51 135958 5079 64357644
Nephrolithiasis 38.63 12.49 22 135987 43661 64319062
Proctitis 38.37 12.49 40 135969 3119 64359604
Full blood count abnormal 38.28 12.49 8 136001 29749 64332974
Anal haemorrhage 38.27 12.49 41 135968 3299 64359424
Withdrawal syndrome 38.13 12.49 3 136006 23489 64339234
Encapsulating peritoneal sclerosis 38.12 12.49 23 135986 802 64361921
Head injury 38.03 12.49 11 135998 32831 64329892
Enterovesical fistula 37.67 12.49 24 135985 923 64361800
Wrong technique in product usage process 37.66 12.49 49 135960 64925 64297798
Dyskinesia 37.55 12.49 18 135991 39370 64323353
Fistula of small intestine 37.54 12.49 21 135988 634 64362089
Type II hypersensitivity 37.12 12.49 10 135999 33 64362690
Troponin I increased 37.07 12.49 43 135966 3778 64358945
Short-bowel syndrome 36.78 12.49 18 135991 410 64362313
Agranulocytosis 36.74 12.49 169 135840 38060 64324663
Colon cancer recurrent 36.48 12.49 12 135997 90 64362633
Accidental exposure to product 36.25 12.49 6 136003 26358 64336365
Upper respiratory tract infection 36.23 12.49 61 135948 72724 64289999
Colon cancer metastatic 36.11 12.49 31 135978 1892 64360831
Nephrotic syndrome 36.03 12.49 69 135940 9498 64353225
Abnormal behaviour 35.86 12.49 13 135996 33609 64329114
Malignant ascites 35.66 12.49 24 135985 1014 64361709
Hepatic failure 35.50 12.49 219 135790 55175 64307548
Cytomegalovirus infection 35.46 12.49 17 135992 37182 64325541
K-ras gene mutation 35.43 12.49 10 135999 41 64362682
Product prescribing error 35.37 12.49 15 135994 35254 64327469
Dysaesthesia 35.34 12.49 48 135961 4947 64357776
Ocular toxicity 35.10 12.49 20 135989 626 64362097
Illness 35.06 12.49 3 136006 21935 64340788
Right ventricular ejection fraction decreased 35.05 12.49 10 135999 43 64362680
Hypovolaemic shock 34.99 12.49 71 135938 10195 64352528
Poisoning 34.94 12.49 3 136006 21876 64340847
Superior vena cava syndrome 34.90 12.49 24 135985 1051 64361672
Heart rate increased 34.85 12.49 100 135909 98575 64264148
Sleep disorder 34.63 12.49 45 135964 59664 64303059
Factor VII deficiency 34.57 12.49 9 136000 25 64362698
Xerosis 34.55 12.49 23 135986 954 64361769
Vision blurred 34.55 12.49 88 135921 90228 64272495
Miller Fisher syndrome 34.49 12.49 13 135996 151 64362572
Rib fracture 34.12 12.49 5 136004 24033 64338690
Eosinophilia 33.92 12.49 19 135990 38057 64324666
Atypical haemolytic uraemic syndrome 33.82 12.49 20 135989 672 64362051
Joint stiffness 33.73 12.49 11 135998 30393 64332330
Viral infection 33.72 12.49 17 135992 36123 64326600
Haemolytic uraemic syndrome 33.69 12.49 42 135967 3979 64358744
Off label use 33.36 12.49 1642 134367 631164 63731559
Splenic artery thrombosis 33.35 12.49 10 135999 53 64362670
Type 2 diabetes mellitus 33.28 12.49 15 135994 34005 64328718
Productive cough 33.17 12.49 65 135944 73138 64289585
C-reactive protein abnormal 33.14 12.49 10 135999 29037 64333686
Hepatitis B 33.12 12.49 59 135950 7686 64355037
Hypertensive crisis 33.05 12.49 99 135910 18149 64344574
Female genital tract fistula 32.90 12.49 34 135975 2624 64360099
Anal erythema 32.77 12.49 13 135996 175 64362548
Performance status decreased 32.70 12.49 48 135961 5316 64357407
Radiation skin injury 32.50 12.49 25 135984 1305 64361418
Sopor 32.44 12.49 11 135998 29650 64333073
Therapy cessation 32.29 12.49 14 135995 32475 64330248
Incorrect drug administration rate 32.26 12.49 34 135975 2685 64360038
Perineal disorder 32.23 12.49 8 136001 17 64362706
Oesophageal varices haemorrhage 32.17 12.49 39 135970 3590 64359133
Oral pain 32.17 12.49 129 135880 27364 64335359
Refeeding syndrome 32.17 12.49 10 135999 61 64362662
Rectal haemorrhage 32.14 12.49 232 135777 61585 64301138
Joint injury 32.05 12.49 5 136004 22942 64339781
Adverse event 32.00 12.49 22 135987 39467 64323256
Diabetes mellitus 31.91 12.49 57 135952 66417 64296306
Lung neoplasm malignant 31.53 12.49 4 136005 21444 64341279
Adenocarcinoma of colon 31.49 12.49 45 135964 4863 64357860
Cardiac disorder 31.42 12.49 43 135966 55773 64306950
Pulmonary toxicity 31.33 12.49 61 135948 8500 64354223
Neck pain 31.15 12.49 51 135958 61482 64301241
Thrombocytopenic purpura 31.08 12.49 30 135979 2132 64360591
Oesophageal perforation 30.90 12.49 22 135987 1019 64361704
Visual impairment 30.86 12.49 69 135940 74008 64288715
Cytomegalovirus oesophagitis 30.78 12.49 18 135991 592 64362131
Cataract 30.39 12.49 38 135971 51224 64311499
Blood creatine phosphokinase increased 30.15 12.49 48 135961 58510 64304213
Tumour haemorrhage 30.09 12.49 37 135972 3456 64359267
Cardiac arrest 29.89 12.49 196 135813 153868 64208855
Myoclonus 29.85 12.49 8 136001 25110 64337613
Road traffic accident 29.38 12.49 14 135995 30731 64331992
Crying 28.93 12.49 4 136005 20086 64342637
Tumour marker increased 28.85 12.49 36 135973 3414 64359309
Diaphragmatic paralysis 28.75 12.49 21 135988 1013 64361710
Mental disorder 28.59 12.49 10 135999 26435 64336288
Pneumonitis 28.52 12.49 193 135816 50172 64312551
Duodenal ulcer perforation 28.45 12.49 19 135990 34606 64328117
Toxic epidermal necrolysis 28.44 12.49 22 135987 37144 64325579
Hepatic atrophy 28.26 12.49 15 135994 407 64362316
Aphthous ulcer 28.25 12.49 75 135934 12831 64349892
Accidental overdose 28.13 12.49 18 135991 33539 64329184
Pregnancy 28.13 12.49 5 136004 20860 64341863
Nephritis bacterial 27.93 12.49 8 136001 35 64362688
Periportal sinus dilatation 27.93 12.49 8 136001 35 64362688
Pericarditis 27.91 12.49 56 135953 62460 64300263
Chronic myeloid leukaemia 27.88 12.49 35 135974 3339 64359384
Product quality issue 27.83 12.49 14 135995 29785 64332938
Hyperthermia 27.82 12.49 84 135925 15466 64347257
Induration 27.60 12.49 25 135984 1639 64361084
Metastases to the mediastinum 27.59 12.49 16 135993 518 64362205
Pancytopenia 27.57 12.49 440 135569 142869 64219854
White blood cell count abnormal 27.54 12.49 42 135967 4812 64357911
Portal shunt 27.53 12.49 9 136000 66 64362657
Chronic kidney disease 27.50 12.49 50 135959 57869 64304854
Nail disorder 27.46 12.49 58 135951 8566 64354157
Diffuse alveolar damage 27.44 12.49 34 135975 3201 64359522
Oesophagobronchial fistula 27.40 12.49 12 135997 210 64362513
Prescribed underdose 27.38 12.49 3 136006 18012 64344711
Osteoporosis 27.32 12.49 29 135980 42051 64320672
Kidney infection 27.03 12.49 3 136006 17835 64344888
Abdominal abscess 26.93 12.49 48 135961 6256 64356467
Ear infection 26.80 12.49 8 136001 23396 64339327
Cystitis radiation 26.78 12.49 10 135999 113 64362610
Night sweats 26.75 12.49 22 135987 36024 64326699
Multiple sclerosis 26.74 12.49 4 136005 18937 64343786
Cell-mediated cytotoxicity 26.74 12.49 8 136001 42 64362681
Haematoma 26.68 12.49 35 135974 46215 64316508
Organising pneumonia 26.66 12.49 59 135950 8996 64353727
Protein urine 26.65 12.49 22 135987 1272 64361451
Sciatic nerve palsy 26.64 12.49 9 136000 74 64362649
Metastases to chest wall 26.47 12.49 14 135995 377 64362346
Pigmentation disorder 26.29 12.49 40 135969 4572 64358151
Guillain-Barre syndrome 26.25 12.49 53 135956 7582 64355141
Balanoposthitis 26.22 12.49 18 135991 786 64361937
Hallucination, visual 26.11 12.49 13 135996 27821 64334902
Urinary tract infection 26.06 12.49 338 135671 231258 64131465
Erythema 26.04 12.49 546 135463 186524 64176199
Cystitis 25.97 12.49 31 135978 42644 64320079
Injection site mass 25.93 12.49 3 136006 17267 64345456
Proteus infection 25.92 12.49 24 135985 1619 64361104
Venous pressure jugular decreased 25.83 12.49 9 136000 82 64362641
Koebner phenomenon 25.71 12.49 8 136001 49 64362674
Chemotherapy 25.70 12.49 23 135986 1484 64361239
Extrapyramidal disorder 25.69 12.49 5 136004 19547 64343176
Back pain 25.68 12.49 372 135637 249799 64112924
Neuromyotonia 25.63 12.49 9 136000 84 64362639
VIth nerve disorder 25.56 12.49 7 136002 25 64362698
NPM1 gene mutation 25.52 12.49 10 135999 130 64362593
Pain in jaw 25.45 12.49 29 135980 40726 64321997
Gastric disorder 25.40 12.49 15 135994 29182 64333541
Amnesia 25.39 12.49 39 135970 48230 64314493
Joint range of motion decreased 25.30 12.49 5 136004 19338 64343385
Retroperitoneal abscess 25.24 12.49 13 135996 331 64362392
Limb injury 25.22 12.49 9 136000 23496 64339227
PIK3CA-activated mutation 25.20 12.49 15 135994 510 64362213
Metastases to pleura 25.01 12.49 21 135988 1243 64361480
Myocarditis 24.99 12.49 86 135923 16957 64345766
Adenocarcinoma 24.93 12.49 33 135976 3318 64359405
Musculoskeletal disorder 24.78 12.49 4 136005 17902 64344821
Muscle spasticity 24.77 12.49 3 136006 16666 64346057
Muscular weakness 24.70 12.49 162 135847 127176 64235547
Stridor 24.64 12.49 40 135969 4834 64357889
Ectropion 24.62 12.49 13 135996 349 64362374
Nervousness 24.58 12.49 16 135993 29540 64333183
Eye disorder 24.42 12.49 5 136004 18864 64343859
Hiatus hernia 24.40 12.49 6 136003 19951 64342772
Myopathy 24.36 12.49 4 136005 17676 64345047
Cerebral haemorrhage 24.35 12.49 44 135965 51046 64311677
Alopecia 24.18 12.49 487 135522 165203 64197520
Localised infection 24.18 12.49 17 135992 30144 64332579
Death 24.17 12.49 805 135204 481900 63880823
Musculoskeletal discomfort 24.02 12.49 3 136006 16274 64346449
Disturbance in attention 23.77 12.49 31 135978 41043 64321680
Toxic erythema of chemotherapy 23.73 12.49 11 135998 221 64362502
Gastrointestinal inflammation 23.73 12.49 45 135964 6150 64356573
Rectal tenesmus 23.69 12.49 19 135990 1054 64361669
Perforation bile duct 23.68 12.49 7 136002 35 64362688
Myelodysplastic syndrome 23.66 12.49 118 135891 27461 64335262
Gastrointestinal stoma output increased 23.64 12.49 11 135998 223 64362500
Platelet count decreased 23.51 12.49 490 135519 167221 64195502
Portal vein embolisation 23.50 12.49 6 136003 15 64362708
Mood altered 23.44 12.49 3 136006 15976 64346747
Radiation mucositis 23.36 12.49 10 135999 165 64362558
Anal erosion 23.20 12.49 7 136002 38 64362685
Evans syndrome 23.13 12.49 13 135996 396 64362327
Infusion related hypersensitivity reaction 23.09 12.49 10 135999 170 64362553
Nasal septum perforation 23.04 12.49 16 135993 712 64362011
Inappropriate schedule of product administration 23.04 12.49 108 135901 92178 64270545
Bacteraemia 22.99 12.49 115 135894 26796 64335927
Anger 22.99 12.49 3 136006 15738 64346985
Medication error 22.96 12.49 44 135965 49922 64312801
Cardio-respiratory arrest 22.92 12.49 118 135891 98275 64264448
Jaundice 22.91 12.49 178 135831 48334 64314389
Laryngeal oedema 22.84 12.49 48 135961 7065 64355658
Musculoskeletal pain 22.82 12.49 91 135918 81203 64281520
Oesophageal haemorrhage 22.81 12.49 22 135987 1562 64361161
Colitis ulcerative 22.76 12.49 10 135999 23018 64339705
Faeces discoloured 22.69 12.49 13 135996 25716 64337007
Movement disorder 22.64 12.49 9 136000 21991 64340732
Encephalopathy 22.57 12.49 206 135803 58613 64304110
Anal fistula 22.44 12.49 40 135969 5213 64357510
Biliary fistula 22.39 12.49 8 136001 79 64362644
Metastases to pelvis 22.32 12.49 14 135995 524 64362199
Astringent therapy 22.23 12.49 6 136003 20 64362703
Neoplasm recurrence 22.13 12.49 33 135976 3706 64359017
Device issue 22.13 12.49 10 135999 22638 64340085
Prothrombin level decreased 22.08 12.49 21 135988 1465 64361258
Full blood count decreased 22.02 12.49 10 135999 22572 64340151
Rectal cancer metastatic 22.00 12.49 13 135996 436 64362287
Oxygen saturation decreased 21.99 12.49 134 135875 107042 64255681
Pneumonitis chemical 21.98 12.49 12 135997 345 64362378
Dysaesthesia pharynx 21.80 12.49 10 135999 196 64362527
Wound dehiscence 21.67 12.49 42 135967 5832 64356891
Gout 21.64 12.49 9 136000 21404 64341319
Anaemia of malignant disease 21.61 12.49 15 135994 667 64362056
Interventricular septum rupture 21.58 12.49 6 136003 23 64362700
Gait inability 21.55 12.49 35 135974 42333 64320390
Necrotising colitis 21.45 12.49 17 135992 927 64361796
Eye pain 21.43 12.49 21 135988 31604 64331119
Blood glucose decreased 21.39 12.49 11 135998 23112 64339611
Subdural haematoma 20.97 12.49 17 135992 28037 64334686
Delusion 20.92 12.49 6 136003 18008 64344715
Angioedema 20.85 12.49 64 135945 61757 64300966
Anorectal discomfort 20.83 12.49 28 135981 2857 64359866
Anorectal disorder 20.82 12.49 23 135986 1916 64360807
Pancreatic neuroendocrine tumour metastatic 20.77 12.49 8 136001 99 64362624
Depressed mood 20.75 12.49 34 135975 40978 64321745
Gastrointestinal ischaemia 20.73 12.49 12 135997 387 64362336
Pulmonary arterial hypertension 20.73 12.49 14 135995 25353 64337370
Fungal infection 20.71 12.49 25 135984 34226 64328497
Microgenia 20.69 12.49 5 136004 9 64362714
Haemoglobinuria 20.64 12.49 15 135994 718 64362005
Pneumoperitoneum 20.63 12.49 27 135982 2684 64360039
Radiation interaction 20.57 12.49 7 136002 59 64362664
Ischiorectal hernia 20.35 12.49 5 136004 10 64362713
Sarcoidosis 20.35 12.49 42 135967 6104 64356619
Anal fissure 20.34 12.49 37 135972 4899 64357824
Breast cancer metastatic 20.31 12.49 46 135963 7123 64355600
Incorrect route of product administration 20.22 12.49 12 135997 23286 64339437
Acute respiratory distress syndrome 20.16 12.49 146 135863 38789 64323934
Respiratory disorder 20.14 12.49 28 135981 36083 64326640
Breast cancer recurrent 20.09 12.49 26 135983 2557 64360166
Pachymeningitis 20.07 12.49 10 135999 237 64362486
Pseudocirrhosis 20.00 12.49 14 135995 631 64362092
Thrombotic thrombocytopenic purpura 19.94 12.49 41 135968 5943 64356780
Acute interstitial pneumonitis 19.91 12.49 17 135992 1030 64361693
Pulmonary infarction 19.88 12.49 29 135980 3193 64359530
Tendonitis 19.75 12.49 9 136000 20273 64342450
Tympanic membrane disorder 19.73 12.49 9 136000 174 64362549
Rash pruritic 19.66 12.49 59 135950 57345 64305378
Intervertebral disc protrusion 19.59 12.49 9 136000 20182 64342541
Hepatectomy 19.59 12.49 9 136000 177 64362546
Spinal stenosis 19.53 12.49 3 136006 13928 64348795
Depilation 19.44 12.49 5 136004 13 64362710
Bronchiolitis obliterans syndrome 19.44 12.49 10 135999 254 64362469
Clostridial infection 19.38 12.49 37 135972 5082 64357641
Restless legs syndrome 19.33 12.49 6 136003 17110 64345613
No adverse event 19.31 12.49 19 135990 28542 64334181
Nail toxicity 19.28 12.49 11 135998 345 64362378
Soft tissue necrosis 19.19 12.49 14 135995 674 64362049
Renal disorder 19.15 12.49 28 135981 35337 64327386
Intracardiac thrombus 19.07 12.49 31 135978 3750 64358973
Vascular pain 19.04 12.49 15 135994 811 64361912
Nodule 19.04 12.49 7 136002 17940 64344783
Chimerism 19.02 12.49 10 135999 266 64362457
Vocal cord paralysis 18.92 12.49 23 135986 2123 64360600
Bile duct stenosis 18.87 12.49 21 135988 1763 64360960
Hydronephrosis 18.76 12.49 69 135940 14056 64348667
Hernia 18.75 12.49 3 136006 13515 64349208
Bursitis 18.74 12.49 11 135998 21474 64341249
Influenza like illness 18.66 12.49 67 135942 61635 64301088
Perihepatic abscess 18.58 12.49 8 136001 134 64362589
Metastases to spine 18.55 12.49 30 135979 3613 64359110
Scintillating scotoma 18.55 12.49 9 136000 201 64362522
Lip swelling 18.55 12.49 24 135985 31883 64330840
Dyspnoea 18.52 12.49 1286 134723 717388 63645335
Lymphadenopathy mediastinal 18.50 12.49 31 135978 3845 64358878
Visceral venous thrombosis 18.45 12.49 5 136004 17 64362706
Haemorrhage intracranial 18.45 12.49 14 135995 23870 64338853
Ventricular fibrillation 18.33 12.49 99 135910 23761 64338962
Creatinine renal clearance decreased 18.30 12.49 4 136005 14417 64348306
Foot deformity 18.26 12.49 6 136003 16498 64346225
Gait apraxia 18.23 12.49 5 136004 18 64362705
Chemotherapy cardiotoxicity attenuation 18.23 12.49 5 136004 18 64362705
Sinus congestion 18.19 12.49 5 136004 15434 64347289
Paraesthesia oral 18.16 12.49 65 135944 13066 64349657
Basal cell carcinoma 18.13 12.49 23 135986 30815 64331908
Swelling face 18.06 12.49 64 135945 59102 64303621
Peritoneal neoplasm 18.01 12.49 7 136002 89 64362634
Neonatal asphyxia 17.89 12.49 4 136005 4 64362719
Intrahepatic portal hepatic venous fistula 17.89 12.49 4 136005 4 64362719
Therapy interrupted 17.84 12.49 10 135999 20026 64342697
Thrombocytopenia neonatal 17.81 12.49 5 136004 20 64362703
Neutrophil count abnormal 17.77 12.49 26 135983 2870 64359853
Drug-induced liver injury 17.77 12.49 47 135962 47596 64315127
Catabolic state 17.73 12.49 7 136002 93 64362630
Cytokine release syndrome 17.70 12.49 11 135998 20818 64341905
Hormone receptor positive breast cancer 17.69 12.49 10 135999 308 64362415
Adrenal insufficiency 17.60 12.49 13 135996 22474 64340249
Inferior vena cava stenosis 17.58 12.49 6 136003 51 64362672
T-cell type acute leukaemia 17.48 12.49 8 136001 156 64362567
Hypocalcaemia 17.45 12.49 149 135860 41604 64321119
Tumour fistulisation 17.43 12.49 5 136004 22 64362701
Skin hyperpigmentation 17.42 12.49 41 135968 6510 64356213
Blood triglycerides increased 17.41 12.49 9 136000 18857 64343866
Necrosis 17.40 12.49 47 135962 8124 64354599
Cardiomyopathy acute 17.34 12.49 9 136000 233 64362490
Gastroenteritis radiation 17.33 12.49 13 135996 653 64362070
Hypersomnia 17.33 12.49 10 135999 19707 64343016
Intestinal strangulation 17.28 12.49 6 136003 54 64362669
Product substitution issue 17.27 12.49 8 136001 17853 64344870
Limbic encephalitis 17.25 12.49 13 135996 658 64362065
Hydrothorax 17.24 12.49 17 135992 1240 64361483
Gastrointestinal haemorrhage 17.21 12.49 187 135822 132125 64230598
Vaginal fistula 17.20 12.49 9 136000 237 64362486
Hypersplenism 17.20 12.49 11 135998 426 64362297
Colonic fistula 17.10 12.49 12 135997 543 64362180
Recurrent cancer 17.09 12.49 23 135986 2350 64360373
Hypercreatininaemia 17.09 12.49 14 135995 801 64361922
Carpal tunnel syndrome 17.08 12.49 6 136003 15822 64346901
Aortic dissection 17.00 12.49 28 135981 3424 64359299
Labelled drug-drug interaction medication error 16.95 12.49 13 135996 22049 64340674
Necrotising oesophagitis 16.93 12.49 13 135996 677 64362046
Endometrial dysplasia 16.91 12.49 5 136004 25 64362698
Rash macular 16.91 12.49 15 135994 23670 64339053
Ankle fracture 16.90 12.49 5 136004 14705 64348018
Hepatitis B surface antigen positive 16.89 12.49 8 136001 169 64362554
Lymphangiosis carcinomatosa 16.85 12.49 20 135989 1801 64360922
Dyspnoea exertional 16.84 12.49 89 135920 73641 64289082
Haemorrhagic infarction 16.68 12.49 13 135996 692 64362031
Metastases to ovary 16.67 12.49 9 136000 253 64362470
Mood swings 16.62 12.49 8 136001 17460 64345263
Oedema peripheral 16.60 12.49 328 135681 209989 64152734
Wernicke's encephalopathy 16.59 12.49 5 136004 27 64362696
Hypothyroidism 16.59 12.49 38 135971 40419 64322304
Osteopenia 16.59 12.49 6 136003 15534 64347189
Perineal abscess 16.47 12.49 11 135998 459 64362264
Prostatic calcification 16.46 12.49 6 136003 63 64362660
Hypocapnia 16.44 12.49 12 135997 578 64362145
Toxic cardiomyopathy 16.44 12.49 10 135999 354 64362369
Enterocolitis infectious 16.41 12.49 23 135986 2441 64360282
Perioral dermatitis 16.32 12.49 9 136000 264 64362459
Febrile infection 16.31 12.49 25 135984 2876 64359847
Mixed adenoneuroendocrine carcinoma 16.28 12.49 4 136005 8 64362715
Disability 16.23 12.49 3 136006 12169 64350554
Aortic intramural haematoma 16.22 12.49 7 136002 118 64362605
Miosis 16.20 12.49 4 136005 13262 64349461
Mydriasis 16.19 12.49 6 136003 15306 64347417
Splenic abscess 16.17 12.49 11 135998 473 64362250
Obstructive airways disorder 16.17 12.49 15 135994 23170 64339553
Viral hepatitis carrier 16.15 12.49 5 136004 30 64362693
Sneezing 16.09 12.49 6 136003 15245 64347478
Klebsiella infection 16.09 12.49 63 135946 13218 64349505
Mucosal ulceration 16.03 12.49 19 135990 1708 64361015
Hyperpyrexia 16.00 12.49 34 135975 5043 64357680
Cyst 15.96 12.49 3 136006 12024 64350699
Gallbladder disorder 15.90 12.49 8 136001 17022 64345701
Hyperlipidaemia 15.87 12.49 15 135994 22961 64339762
Glycosylated haemoglobin increased 15.76 12.49 7 136002 16012 64346711
Electrocardiogram ST segment depression 15.73 12.49 31 135978 4358 64358365
Peripheral sensorimotor neuropathy 15.57 12.49 23 135986 2562 64360161
Delirium 15.54 12.49 84 135925 69110 64293613
Cardiac ventricular thrombosis 15.52 12.49 17 135992 1403 64361320
Herpes simplex meningomyelitis 15.49 12.49 3 136006 0 64362723
Cholecystocholangitis 15.49 12.49 3 136006 0 64362723
Gastrointestinal obstruction 15.47 12.49 17 135992 1408 64361315
Peritoneal disorder 15.42 12.49 12 135997 637 64362086
Cholelithiasis 15.42 12.49 47 135962 45459 64317264
Soft tissue disorder 15.37 12.49 26 135983 3250 64359473
Liver function test increased 15.37 12.49 26 135983 30944 64331779
Therapy non-responder 15.36 12.49 79 135930 65820 64296903
Growth of eyelashes 15.32 12.49 7 136002 136 64362587
Ill-defined disorder 15.29 12.49 45 135964 44007 64318716
Lactic acidosis 15.25 12.49 72 135937 61338 64301385
Limb discomfort 15.23 12.49 21 135988 27154 64335569
Arterial thrombosis 15.18 12.49 22 135987 2408 64360315
Infectious pleural effusion 15.17 12.49 24 135985 2838 64359885
Metapneumovirus bronchiolitis 15.14 12.49 4 136005 12 64362711
Marchiafava-Bignami disease 15.14 12.49 4 136005 12 64362711
Throat tightness 15.11 12.49 92 135917 23068 64339655
COVID-19 pneumonia 15.04 12.49 8 136001 16496 64346227
Hyperleukocytosis 15.04 12.49 20 135989 2020 64360703
Tooth disorder 15.04 12.49 15 135994 22387 64340336
Pneumomediastinum 14.93 12.49 24 135985 2876 64359847
Ventricular hypokinesia 14.88 12.49 43 135966 7726 64354997
Nasal crusting 14.85 12.49 11 135998 542 64362181
Aspergillus infection 14.84 12.49 8 136001 16371 64346352
Drug eruption 14.77 12.49 34 135975 36102 64326621
Periodontal disease 14.71 12.49 18 135991 1673 64361050
Monocytopenia 14.65 12.49 7 136002 151 64362572
Thrombophlebitis 14.62 12.49 35 135974 5619 64357104
Pneumoretroperitoneum 14.60 12.49 6 136003 89 64362634
Respiratory alkalosis 14.55 12.49 28 135981 3869 64358854
Temperature difference of extremities 14.45 12.49 4 136005 15 64362708
Glomerular filtration rate decreased 14.45 12.49 12 135997 19560 64343163
Oral dysaesthesia 14.44 12.49 7 136002 156 64362567
Gastric varices haemorrhage 14.41 12.49 9 136000 334 64362389
Vitamin B1 deficiency 14.39 12.49 11 135998 569 64362154
Renal tubular disorder 14.35 12.49 36 135973 5951 64356772
Tissue injury 14.30 12.49 5 136004 46 64362677
Metastatic neoplasm 14.29 12.49 30 135979 4412 64358311
Sciatica 14.26 12.49 13 135996 20251 64342472
Duodenal varices 14.25 12.49 4 136005 16 64362707
Stevens-Johnson syndrome 14.18 12.49 32 135977 34217 64328506
Pulmonary alveolar haemorrhage 14.15 12.49 49 135960 9689 64353034
Tumour invasion 14.13 12.49 9 136000 346 64362377
Stomatitis haemorrhagic 14.13 12.49 6 136003 97 64362626
Lymph node abscess 14.12 12.49 5 136004 48 64362675
Dandy-Walker syndrome 14.12 12.49 5 136004 48 64362675
Colitis microscopic 14.10 12.49 41 135968 7391 64355332
Tetany 14.06 12.49 20 135989 2152 64360571
ECG signs of myocardial ischaemia 14.04 12.49 9 136000 350 64362373
Facial discomfort 14.03 12.49 5 136004 49 64362674
Hypercreatinaemia 14.02 12.49 8 136001 251 64362472
Cerebral vasoconstriction 14 12.49 15 135994 1207 64361516
Xerophthalmia 13.99 12.49 10 135999 466 64362257
Acute cutaneous lupus erythematosus 13.97 12.49 9 136000 353 64362370
Cerebrovascular accident 13.95 12.49 205 135804 137378 64225345
Capillary leak syndrome 13.95 12.49 25 135984 3272 64359451
Portal vein dilatation 13.94 12.49 5 136004 50 64362673
Peritoneal haematoma 13.93 12.49 7 136002 169 64362554
Hypertensive encephalopathy 13.91 12.49 13 135996 887 64361836
Intercepted product administration error 13.86 12.49 7 136002 171 64362552
Electrolyte imbalance 13.85 12.49 96 135913 25147 64337576
Dementia 13.83 12.49 14 135995 20752 64341971
Muscle rigidity 13.81 12.49 10 135999 17463 64345260
Eye swelling 13.75 12.49 16 135993 22265 64340458
Eastern Cooperative Oncology Group performance status worsened 13.74 12.49 15 135994 1233 64361490
Catheter site extravasation 13.70 12.49 9 136000 365 64362358
Tendon rupture 13.63 12.49 3 136006 10764 64351959
Head discomfort 13.63 12.49 4 136005 11830 64350893
Colorectal cancer recurrent 13.59 12.49 5 136004 54 64362669
Hepatitis B DNA increased 13.58 12.49 11 135998 619 64362104
Prostate cancer 13.58 12.49 13 135996 19782 64342941
Obstruction gastric 13.57 12.49 16 135993 1430 64361293
Hip arthroplasty 13.54 12.49 15 135994 21336 64341387
Left ventricular dilatation 13.53 12.49 13 135996 919 64361804
Diabetes mellitus inadequate control 13.50 12.49 15 135994 21306 64341417
Gastrointestinal fistula 13.47 12.49 11 135998 626 64362097
Bronchial fistula 13.46 12.49 7 136002 182 64362541
Procedural pain 13.44 12.49 8 136001 15500 64347223
Tooth infection 13.42 12.49 7 136002 14594 64348129
Lhermitte's sign 13.42 12.49 3 136006 3 64362720
Thrombotic microangiopathy 13.41 12.49 70 135939 16585 64346138
Dystonia 13.40 12.49 12 135997 18853 64343870
Pseudomembranous colitis 13.33 12.49 31 135978 4885 64357838
Mania 13.29 12.49 9 136000 16277 64346446
Purulent pericarditis 13.27 12.49 5 136004 58 64362665
Iatrogenic infection 13.27 12.49 5 136004 58 64362665
Respiratory depression 13.25 12.49 18 135991 23425 64339298
Sudden death 13.22 12.49 80 135929 20016 64342707
Rectal cancer recurrent 13.21 12.49 4 136005 22 64362701
Malignant pleural effusion 13.20 12.49 23 135986 2944 64359779
Catheter site thrombosis 13.19 12.49 7 136002 190 64362533
Systemic scleroderma 13.17 12.49 13 135996 950 64361773
Wrong rate 13.12 12.49 5 136004 60 64362663
Bladder tamponade 13.08 12.49 10 135999 517 64362206
Red blood cell nucleated morphology present 13.07 12.49 4 136005 23 64362700
Diverticulitis 13.00 12.49 40 135969 38578 64324145
Product administration error 13.00 12.49 24 135985 27619 64335104
Hypertrichosis 12.99 12.49 14 135995 1134 64361589
Oesophageal squamous cell carcinoma metastatic 12.96 12.49 3 136006 4 64362719
Pulmonary hypertension 12.94 12.49 47 135962 43092 64319631
Tracheal stenosis 12.93 12.49 8 136001 292 64362431
Procedural vomiting 12.93 12.49 11 135998 663 64362060
Pleural fistula 12.92 12.49 4 136005 24 64362699
Carbohydrate antigen 15-3 increased 12.90 12.49 13 135996 974 64361749
Pulmonary congestion 12.84 12.49 19 135990 23861 64338862
Rectal adenocarcinoma 12.84 12.49 15 135994 1328 64361395
Hepatic vein stenosis 12.83 12.49 5 136004 64 64362659
Blood pressure decreased 12.80 12.49 118 135891 86081 64276642
Ovarian failure 12.78 12.49 10 135999 535 64362188
Neutrophilia 12.77 12.49 37 135972 6657 64356066
Duodenal stenosis 12.74 12.49 11 135998 677 64362046
Blood pressure diastolic decreased 12.73 12.49 17 135992 22284 64340439
Blood potassium increased 12.72 12.49 22 135987 25958 64336765
Fixed eruption 12.70 12.49 19 135990 2140 64360583
Cardiogenic shock 12.66 12.49 114 135895 32313 64330410
Diverticulum 12.63 12.49 6 136003 13192 64349531
Rectal abscess 12.62 12.49 16 135993 1541 64361182
Pollakiuria 12.62 12.49 30 135979 31500 64331223
Angina pectoris 12.59 12.49 148 135861 44933 64317790
Stress ulcer 12.57 12.49 6 136003 129 64362594
Cutaneous tuberculosis 12.55 12.49 7 136002 210 64362513
Renal hydrocele 12.52 12.49 4 136005 27 64362696

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01BC02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
ATC L01BC52 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D009676 Noxae
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:132992 radiosensitizing agents
CHEBI has role CHEBI:25435 mutagens
CHEBI has role CHEBI:77746 Homo sapiens metabolite

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

DiseaseRelationSNOMED_IDDOID
Actinic keratosis indication 201101007 DOID:8866
Metastasis from malignant tumor of colon indication 314998002
Malignant tumor of stomach indication 363349007 DOID:10534
Malignant tumor of colon indication 363406005 DOID:219
Small intestine cancer indication 363509000 DOID:10154
Superficial basal cell carcinoma indication 403914000
Adenocarcinoma of pancreas indication 700423003 DOID:4074
Metastatic Breast Carcinoma indication
Carcinoid syndrome off-label use 35868009
Actinic cheilitis off-label use 46795000
Radiation dermatitis off-label use 49084001
Neoplasm of glans penis off-label use 126898002
Carcinoma of breast off-label use 254838004 DOID:3459
Malignant tumor of head and/or neck off-label use 255056009
Malignant tumor of cervix off-label use 363354003 DOID:4362
Malignant tumor of esophagus off-label use 363402007
Malignant tumor of anus off-label use 363490009 DOID:14110
Malignant tumor of urinary bladder off-label use 399326009 DOID:11054
Leukoplakia of oral mucosa off-label use 414603003
Pancreatic Neuroendocrine Tumor off-label use 717919005
Biliary Tract Malignancy off-label use
Metastatic Malignant Tumor of Anus off-label use
Nutritional disorder contraindication 2492009 DOID:374
Acute vomiting contraindication 23971007
Stomatitis contraindication 61170000 DOID:9637
Diarrhea contraindication 62315008
Acute infectious disease contraindication 63171007
Gastrointestinal hemorrhage contraindication 74474003
Dihydrouracil dehydrogenase (NADP^+^) deficiency contraindication 77365006 DOID:14218
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Superficial ulcer of skin contraindication 93448009
Secondary malignant neoplasm of bone marrow contraindication 94217008
Bleeding contraindication 131148009
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Pharyngitis contraindication 405737000 DOID:2275
Breastfeeding (mother) contraindication 413712001
Palmar-Plantar Erythrodysesthesia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.02 acidic

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
Thymidylate synthase Enzyme INHIBITOR WOMBAT-PK CHEMBL
Multidrug resistance-associated protein 5 Transporter WOMBAT-PK
ATP-binding cassette sub-family C member 11 Transporter WOMBAT-PK
Thymidylate synthase Enzyme IC50 7.70 CHEMBL
Uracil phosphoribosyltransferase Enzyme Ki 4.89 CHEMBL

External reference:

IDSource
4017806 VUID
N0000146166 NUI
D00584 KEGG_DRUG
202632 RXNORM
C0016360 UMLSCUI
CHEBI:46345 CHEBI
URF PDB_CHEM_ID
CHEMBL185 ChEMBL_ID
D005472 MESH_DESCRIPTOR_UI
DB00544 DRUGBANK_ID
4789 IUPHAR_LIGAND_ID
1421 INN_ID
U3P01618RT UNII
3385 PUBCHEM_CID
4694 MMSL
4745 MMSL
6969 MMSL
d00235 MMSL
002646 NDDF
4017806 VANDF
3127006 SNOMEDCT_US
387172005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Efudex HUMAN PRESCRIPTION DRUG LABEL 1 0187-3202 SOLUTION 0.50 g TOPICAL NDA 2 sections
Efudex HUMAN PRESCRIPTION DRUG LABEL 1 0187-3203 SOLUTION 1.25 g TOPICAL NDA 2 sections
Efudex HUMAN PRESCRIPTION DRUG LABEL 1 0187-3204 CREAM 2 g TOPICAL NDA 2 sections
Carac HUMAN PRESCRIPTION DRUG LABEL 1 0187-5200 CREAM 5 mg TOPICAL NDA 24 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 0378-4791 CREAM 5 mg TOPICAL NDA authorized generic 19 sections
Fluorouracil Cream HUMAN PRESCRIPTION DRUG LABEL 1 0378-8078 CREAM 5 mg TOPICAL NDA authorized generic 22 sections
Fluoroplex HUMAN PRESCRIPTION DRUG LABEL 1 16110-812 CREAM 10 mg TOPICAL NDA 23 sections
Fluoroplex HUMAN PRESCRIPTION DRUG LABEL 1 16110-812 CREAM 10 mg TOPICAL NDA 23 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 16714-178 CREAM 50 mg TOPICAL ANDA 20 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 16729-276 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 24 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 16729-276 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 24 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 16729-542 CREAM 50 mg TOPICAL ANDA 19 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 16729-542 CREAM 50 mg TOPICAL ANDA 19 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 21695-829 CREAM 50 mg TOPICAL ANDA 18 sections
fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 25021-215 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
TOLAK HUMAN PRESCRIPTION DRUG LABEL 1 28105-421 CREAM 0.04 g TOPICAL NDA 26 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 50090-4264 CREAM 50 mg TOPICAL ANDA 20 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 51672-4062 SOLUTION 20 mg TOPICAL ANDA 21 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 51672-4063 SOLUTION 50 mg TOPICAL ANDA 21 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 51672-4118 CREAM 50 mg TOPICAL ANDA 20 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 51862-362 CREAM 50 mg TOPICAL ANDA 20 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 52549-4118 CREAM 50 mg TOPICAL ANDA 21 sections
FLUOROURACIL Human Prescription Drug Label 1 54868-6293 CREAM 50 mg TOPICAL ANDA 18 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Fluorouracil Human Prescription Drug Label 1 63323-117 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
FLUOROURACIL Human Prescription Drug Label 1 66530-249 CREAM 50 mg TOPICAL ANDA 18 sections