fluorouracil 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 ┬ÁM/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 1765.85 13.29 1610 75446 157575 53114435
Febrile neutropenia 954.93 13.29 953 76103 103983 53168027
Mucosal inflammation 934.15 13.29 646 76410 42138 53229872
Neuropathy peripheral 766.41 13.29 841 76215 102346 53169664
Diarrhoea 665.19 13.29 2192 74864 623354 52648656
Disease progression 597.96 13.29 736 76320 101184 53170826
Thrombocytopenia 546.88 13.29 826 76230 137901 53134109
Palmar-plantar erythrodysaesthesia syndrome 537.63 13.29 354 76702 21252 53250758
Leukopenia 482.34 13.29 562 76494 72901 53199109
Neurotoxicity 462.89 13.29 284 76772 15065 53256945
Malignant neoplasm progression 444.32 13.29 532 76524 71009 53201001
Dermatitis acneiform 439.04 13.29 184 76872 4286 53267724
Metastases to liver 432.57 13.29 309 76747 21187 53250823
Skin toxicity 403.73 13.29 169 76887 3924 53268086
Drug ineffective 360.37 13.29 392 76664 816853 52455157
Stomatitis 326.30 13.29 541 76515 97617 53174393
Vomiting 324.10 13.29 1496 75560 495643 52776367
Bone marrow failure 323.25 13.29 300 76756 29815 53242195
Neoplasm progression 317.19 13.29 296 76760 29623 53242387
Metastases to lung 298.96 13.29 195 76861 11509 53260501
Metastases to bone 258.20 13.29 218 76838 19110 53252900
Acute myeloid leukaemia 255.52 13.29 205 76851 16727 53255283
Neutrophil count decreased 221.53 13.29 312 76744 48786 53223224
Joint swelling 216.17 13.29 39 77017 234599 53037411
Product dose omission issue 215.60 13.29 16 77040 191604 53080406
Colorectal cancer metastatic 214.54 13.29 70 76986 777 53271233
Gastrointestinal perforation 205.81 13.29 100 76956 3319 53268691
Breast cancer 205.62 13.29 302 76754 49056 53222954
Posterior reversible encephalopathy syndrome 205.09 13.29 177 76879 15983 53256027
Gastrointestinal toxicity 204.66 13.29 111 76945 4651 53267359
Polyneuropathy 203.47 13.29 162 76894 13071 53258939
Metastasis 202.56 13.29 110 76946 4621 53267389
Peripheral sensory neuropathy 202.14 13.29 127 76929 7021 53264989
Haematotoxicity 200.28 13.29 131 76925 7766 53264244
Nausea 196.90 13.29 1804 75252 754287 52517723
Arthralgia 195.07 13.29 209 76847 439574 52832436
Second primary malignancy 194.90 13.29 124 76932 7008 53265002
Ejection fraction decreased 192.52 13.29 187 76869 19661 53252349
Completed suicide 184.27 13.29 3 77053 138198 53133812
Acute promyelocytic leukaemia 175.85 13.29 62 76994 885 53271125
Interstitial lung disease 173.43 13.29 307 76749 58315 53213695
Cardiomyopathy 173.29 13.29 165 76891 16923 53255087
Arteriospasm coronary 167.79 13.29 90 76966 3687 53268323
Abdominal discomfort 166.26 13.29 56 77000 221006 53051004
Cardiotoxicity 165.64 13.29 113 76943 7186 53264824
Fall 164.86 13.29 165 76891 358275 52913735
Headache 163.05 13.29 332 76724 536489 52735521
Laryngospasm 158.90 13.29 80 76976 2870 53269140
Paronychia 157.35 13.29 95 76961 4889 53267121
Hyperammonaemia 157.04 13.29 96 76960 5053 53266957
Weight increased 157.04 13.29 50 77006 204517 53067493
Pyrexia 156.31 13.29 1056 76000 402137 52869873
Systemic lupus erythematosus 154.90 13.29 6 77050 125408 53146602
Disease recurrence 153.83 13.29 170 76886 20776 53251234
Pain 150.51 13.29 399 76657 587999 52684011
Sinusitis 146.82 13.29 32 77024 168532 53103478
Contraindicated product administered 145.17 13.29 14 77042 135615 53136395
Dehydration 144.22 13.29 552 76504 167858 53104152
Metastases to lymph nodes 142.87 13.29 104 76952 7336 53264674
Pulmonary embolism 142.08 13.29 425 76631 114017 53157993
Swelling 132.62 13.29 55 77001 191050 53080960
Nasopharyngitis 132.39 13.29 56 77000 192239 53079771
Decreased appetite 131.21 13.29 636 76420 214338 53057672
General physical health deterioration 131.04 13.29 488 76568 146454 53125556
Anaemia 130.89 13.29 763 76293 275955 52996055
Drug hypersensitivity 130.19 13.29 115 76941 265127 53006883
Neutropenic sepsis 129.07 13.29 131 76925 14518 53257492
Myelosuppression 128.42 13.29 123 76933 12705 53259305
Therapeutic product effect decreased 124.41 13.29 17 77039 125638 53146372
Large intestine perforation 120.83 13.29 97 76959 7917 53264093
Injection site pain 120.57 13.29 12 77044 113379 53158631
Abdominal pain 119.94 13.29 704 76352 255199 53016811
Arthropathy 118.89 13.29 29 77027 141424 53130586
Proteinuria 116.35 13.29 137 76919 17931 53254079
Pemphigus 116.05 13.29 9 77047 104022 53167988
Hypomagnesaemia 115.33 13.29 160 76896 24651 53247359
Enteritis 114.13 13.29 91 76965 7355 53264655
Peripheral swelling 107.71 13.29 84 76972 206024 53065986
Product use issue 107.28 13.29 34 77022 139550 53132460
Wound 104.77 13.29 7 77049 91550 53180460
Psoriasis 104.76 13.29 5 77051 87084 53184926
Paraesthesia 104.22 13.29 412 76644 127103 53144907
Hypokalaemia 103.69 13.29 341 76715 96176 53175834
Depression 96.40 13.29 74 76982 182978 53089032
Pain in extremity 96.24 13.29 165 76891 284885 52987125
Stress cardiomyopathy 95.13 13.29 87 76969 8475 53263535
Glossodynia 91.54 13.29 17 77039 100274 53171736
Musculoskeletal stiffness 89.68 13.29 33 77023 123335 53148675
Death 87.51 13.29 843 76213 356389 52915621
Asthenia 86.23 13.29 815 76241 342775 52929235
Neutropenic colitis 85.94 13.29 51 77005 2542 53269468
Portal hypertension 85.26 13.29 58 76998 3670 53268340
Adenocarcinoma of colon 85.05 13.29 49 77007 2310 53269700
Contusion 83.26 13.29 28 77028 110704 53161306
Breast cancer metastatic 82.19 13.29 106 76950 15222 53256788
Ascites 82.10 13.29 179 76877 39556 53232454
Colon cancer 81.38 13.29 85 76971 9740 53262270
Ileus 81.10 13.29 104 76952 14851 53257159
Intestinal perforation 79.50 13.29 90 76966 11290 53260720
Maternal exposure during pregnancy 79.31 13.29 65 76991 155574 53116436
Hypertransaminasaemia 79.07 13.29 57 76999 3959 53268051
Drug abuse 78.04 13.29 4 77052 65522 53206488
Injection site erythema 77.52 13.29 10 77046 77239 53194771
Hospitalisation 76.84 13.29 7 77049 71005 53201005
Focal nodular hyperplasia 76.64 13.29 29 77027 511 53271499
Influenza 75.49 13.29 22 77034 95357 53176653
Insomnia 75.06 13.29 96 76960 186976 53085034
Hyperammonaemic encephalopathy 75.01 13.29 43 77013 2008 53270002
Pruritus 73.51 13.29 201 76855 293631 52978379
Extravasation 73.12 13.29 44 77012 2250 53269760
Anxiety 70.89 13.29 109 76947 196595 53075415
Intestinal obstruction 70.55 13.29 139 76917 28602 53243408
Breast cancer recurrent 70.54 13.29 54 77002 4111 53267899
Colon cancer metastatic 70.18 13.29 35 77021 1230 53270780
Drug interaction 69.46 13.29 132 76924 219197 53052813
Bronchitis 68.71 13.29 38 77018 111861 53160149
Left ventricular dysfunction 68.71 13.29 83 76973 11154 53260856
Condition aggravated 68.67 13.29 211 76845 296923 52975087
Migraine 68.50 13.29 16 77040 80401 53191609
Dysarthria 67.63 13.29 168 76888 40400 53231610
Dihydropyrimidine dehydrogenase deficiency 67.55 13.29 17 77039 65 53271945
Haemolytic anaemia 65.30 13.29 78 76978 10361 53261649
Pancytopenia 64.21 13.29 281 76775 90647 53181363
Arthritis 64.03 13.29 23 77033 87275 53184735
Non-cirrhotic portal hypertension 63.92 13.29 18 77038 115 53271895
Dizziness 63.59 13.29 299 76757 371960 52900050
Enterocutaneous fistula 63.38 13.29 33 77023 1271 53270739
Rectal perforation 63.27 13.29 24 77032 426 53271584
Metastases to pleura 62.56 13.29 33 77023 1306 53270704
Pneumonia 61.10 13.29 342 76714 406827 52865183
Osteoarthritis 60.08 13.29 14 77042 70472 53201538
Loss of personal independence in daily activities 59.25 13.29 14 77042 69801 53202209
Colorectal cancer 58.57 13.29 32 77024 1360 53270650
Cardiac failure 58.13 13.29 262 76794 85582 53186428
Suicidal ideation 57.98 13.29 9 77047 60502 53211508
Discomfort 57.78 13.29 33 77023 95439 53176571
Asthma 57.40 13.29 44 77012 108928 53163082
Hepatic enzyme increased 56.82 13.29 59 76997 126136 53145874
Device related thrombosis 56.67 13.29 31 77025 1321 53270689
Mobility decreased 56.09 13.29 20 77036 76251 53195759
Intentional product misuse 55.85 13.29 4 77052 49388 53222622
Leukoencephalopathy 55.07 13.29 47 77009 4177 53267833
Metastases to peritoneum 55.06 13.29 41 77015 2994 53269016
Chronic obstructive pulmonary disease 54.35 13.29 11 77045 61062 53210948
Febrile bone marrow aplasia 53.90 13.29 59 76997 7130 53264880
Feeling abnormal 53.66 13.29 70 76986 135231 53136779
Drug intolerance 53.29 13.29 138 76918 205355 53066655
Tumour perforation 52.59 13.29 15 77041 101 53271909
Carcinoembryonic antigen increased 52.58 13.29 31 77025 1526 53270484
Fluid retention 52.33 13.29 8 77048 54393 53217617
Metastases to central nervous system 51.95 13.29 75 76981 11982 53260028
Stress 51.39 13.29 10 77046 57074 53214936
Splenomegaly 51.04 13.29 69 76987 10370 53261640
White blood cell count decreased 50.96 13.29 331 76725 124144 53147866
Female genital tract fistula 50.57 13.29 44 77012 4014 53267996
Disseminated intravascular coagulation 50.38 13.29 97 76959 19622 53252388
Subacute cutaneous lupus erythematosus 49.82 13.29 35 77021 2333 53269677
Peritonitis 49.78 13.29 102 76954 21585 53250425
Metastases to skin 49.42 13.29 29 77027 1415 53270595
Gait disturbance 49.04 13.29 97 76959 158745 53113265
Cholangitis 48.16 13.29 47 77009 4966 53267044
Congestive cardiomyopathy 47.11 13.29 51 77005 6087 53265923
Immune thrombocytopenia 47.08 13.29 63 76993 9375 53262635
Colony stimulating factor therapy 46.81 13.29 18 77038 332 53271678
Chills 46.76 13.29 285 76771 104563 53167447
Myocarditis 46.09 13.29 59 76997 8409 53263601
Deep vein thrombosis 46.00 13.29 239 76817 82674 53189336
Injection site reaction 45.98 13.29 9 77047 51157 53220853
Therapy partial responder 45.20 13.29 50 77006 6113 53265897
Lower respiratory tract infection 45.09 13.29 39 77017 90942 53181068
Suicide attempt 44.96 13.29 14 77042 58154 53213856
Troponin I increased 44.73 13.29 31 77025 2022 53269988
Cholinergic syndrome 44.70 13.29 18 77038 377 53271633
Helicobacter infection 44.65 13.29 3 77053 39066 53232944
Treatment failure 44.48 13.29 73 76983 128330 53143680
Sleep disorder 44.04 13.29 15 77041 58855 53213155
Somnolence 43.97 13.29 112 76944 167622 53104388
Mucosal toxicity 43.32 13.29 17 77039 332 53271678
Urticaria 42.79 13.29 82 76974 135803 53136207
Gastrointestinal necrosis 42.66 13.29 35 77021 2945 53269065
Oesophageal fistula 42.18 13.29 13 77043 118 53271892
Injury 41.74 13.29 11 77045 50960 53221050
Injection site swelling 41.62 13.29 6 77050 42622 53229388
Overdose 41.43 13.29 57 76999 107679 53164331
Myelodysplastic syndrome 41.40 13.29 81 76975 16579 53255431
Agranulocytosis 41.33 13.29 100 76956 23649 53248361
Memory impairment 41.20 13.29 37 77019 84720 53187290
Malignant respiratory tract neoplasm 41.16 13.29 11 77045 56 53271954
Epistaxis 40.87 13.29 202 76854 68508 53203502
Haemolytic uraemic syndrome 40.75 13.29 32 77024 2529 53269481
Abortion spontaneous 40.27 13.29 9 77047 46626 53225384
Aortic thrombosis 40.18 13.29 23 77033 1071 53270939
Steatohepatitis 39.64 13.29 18 77038 511 53271499
Trichomegaly 39.58 13.29 10 77046 39 53271971
Adverse drug reaction 39.53 13.29 14 77042 53611 53218399
Splenic artery thrombosis 39.18 13.29 10 77046 41 53271969
Proctalgia 38.90 13.29 43 77013 5253 53266757
Short-bowel syndrome 38.71 13.29 17 77039 445 53271565
Incorrect dose administered 38.19 13.29 13 77043 51032 53220978
Balance disorder 37.98 13.29 30 77026 73177 53198833
Factor VII deficiency 37.95 13.29 9 77047 25 53271985
Nasal congestion 37.46 13.29 15 77041 53272 53218738
Embolism 37.30 13.29 50 77006 7453 53264557
White blood cell count abnormal 36.79 13.29 42 77014 5316 53266694
Pericarditis 36.54 13.29 24 77032 64382 53207628
Cataract 36.50 13.29 13 77043 49607 53222403
Metastases to spine 36.41 13.29 32 77024 2958 53269052
Unevaluable event 36.36 13.29 13 77043 49485 53222525
Hypophagia 36.28 13.29 113 76943 30949 53241061
Renal salt-wasting syndrome 36.16 13.29 13 77043 197 53271813
Colitis 36.13 13.29 137 76919 41415 53230595
Aplasia 36.03 13.29 37 77019 4155 53267855
Tumour ulceration 35.78 13.29 12 77044 146 53271864
Cystitis radiation 35.77 13.29 10 77046 62 53271948
Venous pressure jugular decreased 35.44 13.29 9 77047 36 53271974
Dysaesthesia 35.24 13.29 36 77020 4019 53267991
Dermatitis 35.07 13.29 72 76984 15254 53256756
Aortitis 35.02 13.29 19 77037 796 53271214
Rhabdomyolysis 34.98 13.29 10 77046 43913 53228097
Metastases to meninges 34.62 13.29 27 77029 2112 53269898
Type 2 diabetes mellitus 34.58 13.29 3 77053 31667 53240343
Wrong technique in product usage process 34.56 13.29 22 77034 60010 53212000
Nodular regenerative hyperplasia 34.26 13.29 14 77042 305 53271705
Septic shock 34.25 13.29 179 76877 62050 53209960
Hypertensive crisis 34.21 13.29 69 76987 14437 53257573
Bladder tamponade 34.01 13.29 10 77046 76 53271934
Osteonecrosis of jaw 33.79 13.29 122 76934 36024 53235986
Jugular vein thrombosis 33.38 13.29 30 77026 2856 53269154
Nephritis bacterial 33.28 13.29 8 77048 24 53271986
Atypical haemolytic uraemic syndrome 33.09 13.29 16 77040 525 53271485
Sepsis 33.01 13.29 340 76716 146089 53125921
Stridor 32.92 13.29 32 77024 3365 53268645
Small intestinal obstruction 32.88 13.29 75 76981 17072 53254938
Vena cava thrombosis 32.82 13.29 27 77029 2281 53269729
Organising pneumonia 32.78 13.29 39 77017 5157 53266853
Hyperbilirubinaemia 32.74 13.29 58 76998 11011 53260999
Neuromyotonia 32.73 13.29 9 77047 52 53271958
Subileus 32.49 13.29 31 77025 3185 53268825
Anastomotic leak 32.42 13.29 15 77041 445 53271565
Wheezing 32.32 13.29 28 77028 65247 53206763
Venous thrombosis 32.24 13.29 38 77018 4976 53267034
Heart rate decreased 32.16 13.29 7 77049 36940 53235070
COVID-19 32.09 13.29 7 77049 36881 53235129
Large intestinal obstruction 32.03 13.29 25 77031 1958 53270052
Miller Fisher syndrome 31.76 13.29 10 77046 98 53271912
Rash 31.66 13.29 454 76602 445737 52826273
Liver abscess 31.52 13.29 29 77027 2846 53269164
Confusional state 31.35 13.29 159 76897 194062 53077948
Hormone receptor positive breast cancer 31.23 13.29 15 77041 485 53271525
Metastases to the mediastinum 31.08 13.29 15 77041 490 53271520
Tumour haemorrhage 30.98 13.29 22 77034 1492 53270518
Ileal perforation 30.78 13.29 14 77042 399 53271611
Ocular toxicity 30.34 13.29 15 77041 517 53271493
Product quality issue 30.29 13.29 8 77048 37015 53234995
Malignant pleural effusion 30.23 13.29 27 77029 2550 53269460
Subclavian vein thrombosis 30.22 13.29 24 77032 1928 53270082
Skin fissures 30.07 13.29 49 77007 8696 53263314
Toxic leukoencephalopathy 30.06 13.29 16 77040 645 53271365
Venoocclusive liver disease 29.98 13.29 35 77021 4537 53267473
Duodenal ulcer perforation 29.95 13.29 7 77049 35176 53236834
Cough 29.76 13.29 233 76823 256660 53015350
Plasma cell myeloma 29.75 13.29 16 77040 47858 53224152
Drug withdrawal syndrome 29.68 13.29 3 77053 28019 53243991
Urinary tract infection 29.49 13.29 214 76842 239689 53032321
Fluid overload 29.42 13.29 3 77053 27828 53244182
Sedation 29.39 13.29 4 77052 29671 53242339
Upper respiratory tract infection 29.22 13.29 34 77022 69063 53202947
Thrombocytopenic purpura 29.15 13.29 20 77036 1283 53270727
Hepatic failure 28.64 13.29 115 76941 35691 53236319
Rectal cancer 28.46 13.29 23 77033 1894 53270116
Nicotinic acid deficiency 28.29 13.29 8 77048 52 53271958
Hypertension 28.25 13.29 470 76586 224961 53047049
Blister 27.99 13.29 44 77012 78709 53193301
Bradycardia 27.91 13.29 37 77019 71019 53200991
No adverse event 27.69 13.29 11 77045 39254 53232756
Device related infection 27.64 13.29 84 76972 22702 53249308
Therapy cessation 27.23 13.29 4 77052 28021 53243989
Conjunctival filtering bleb leak 27.02 13.29 6 77050 11 53271999
Tumour lysis syndrome 26.91 13.29 44 77012 7830 53264180
Gastrooesophageal reflux disease 26.79 13.29 49 77007 82614 53189396
Metastases to reproductive organ 26.68 13.29 6 77050 12 53271998
Rectal cancer recurrent 26.64 13.29 7 77049 33 53271977
Cachexia 26.57 13.29 35 77021 5129 53266881
Emotional distress 26.41 13.29 7 77049 32310 53239700
Multiple sclerosis 26.10 13.29 4 77052 27149 53244861
Acute lymphocytic leukaemia 25.93 13.29 26 77030 2839 53269171
Hypocapnia 25.57 13.29 12 77044 368 53271642
Hydrothorax 25.49 13.29 15 77041 736 53271274
ECG signs of myocardial ischaemia 25.45 13.29 8 77048 78 53271932
Hepatic lesion 25.42 13.29 31 77025 4206 53267804
Pregnancy 25.33 13.29 7 77049 31434 53240576
Inferior vena cava stenosis 25.21 13.29 6 77050 17 53271993
Red blood cell sedimentation rate increased 25.07 13.29 5 77051 28052 53243958
Gastrointestinal stoma complication 24.87 13.29 20 77036 1636 53270374
Acute abdomen 24.85 13.29 20 77036 1638 53270372
Irritability 24.74 13.29 7 77049 30946 53241064
Tumour necrosis 24.68 13.29 15 77041 781 53271229
Dysgeusia 24.67 13.29 125 76931 42806 53229204
Encephalopathy 24.64 13.29 112 76944 36696 53235314
Blood creatine increased 24.59 13.29 33 77023 4924 53267086
Ear infection 24.47 13.29 4 77052 25896 53246114
Myocardial ischaemia 24.43 13.29 56 77000 12788 53259222
Full blood count decreased 24.37 13.29 3 77053 24026 53247984
Fistula 24.35 13.29 45 77011 8825 53263185
Throat tightness 24.28 13.29 79 76977 22137 53249873
Aortic dissection 24.20 13.29 20 77036 1700 53270310
Soft tissue necrosis 24.18 13.29 12 77044 417 53271593
Tympanic membrane disorder 23.97 13.29 9 77047 155 53271855
Cardiac ventricular thrombosis 23.93 13.29 13 77043 546 53271464
Gastric perforation 23.89 13.29 19 77037 1529 53270481
Acute leukaemia 23.86 13.29 17 77039 1159 53270851
Xerosis 23.62 13.29 14 77042 696 53271314
Metastases to ovary 23.54 13.29 11 77045 334 53271676
Diaphragmatic paralysis 23.44 13.29 13 77043 569 53271441
Dry skin 23.39 13.29 129 76927 45631 53226379
Vision blurred 23.32 13.29 56 77000 85548 53186462
Hallucination 23.30 13.29 26 77030 53812 53218198
Catabolic state 23.28 13.29 7 77049 58 53271952
Acute interstitial pneumonitis 23.23 13.29 14 77042 718 53271292
Electrocardiogram ST segment elevation 23.18 13.29 28 77028 3761 53268249
Aortic intramural haematoma 23.17 13.29 7 77049 59 53271951
Biliary tract infection 23.15 13.29 12 77044 458 53271552
Rash pustular 23.13 13.29 39 77017 7117 53264893
Amnesia 22.94 13.29 19 77037 45269 53226741
Stomatitis haemorrhagic 22.88 13.29 6 77050 28 53271982
Hyperkalaemia 22.61 13.29 27 77029 54229 53217781
Psychotic disorder 22.53 13.29 4 77052 24381 53247629
Radiation skin injury 22.51 13.29 15 77041 917 53271093
Nasal septum perforation 22.37 13.29 14 77042 768 53271242
Superior vena cava syndrome 22.20 13.29 13 77043 632 53271378
Tonic clonic movements 22.08 13.29 17 77039 1305 53270705
Gastric disorder 22.02 13.29 8 77048 30157 53241853
Pelvic abscess 21.90 13.29 18 77038 1518 53270492
Blood pressure fluctuation 21.82 13.29 12 77044 35458 53236552
Encapsulating peritoneal sclerosis 21.71 13.29 11 77045 400 53271610
Gastrointestinal stoma output increased 21.61 13.29 9 77047 206 53271804
Oesophagitis 21.58 13.29 58 76998 14619 53257391
Platelet count decreased 21.57 13.29 245 76811 107854 53164156
Heart rate increased 21.52 13.29 55 77001 82260 53189750
Fistula of small intestine 21.48 13.29 10 77046 301 53271709
Aggression 21.27 13.29 4 77052 23399 53248611
Diabetes mellitus 21.23 13.29 28 77028 53871 53218139
Pulmonary alveolar haemorrhage 21.13 13.29 29 77027 4421 53267589
Cardiomyopathy acute 21.10 13.29 9 77047 219 53271791
Coronary artery disease 21.03 13.29 11 77045 33426 53238584
Recurrent cancer 21.02 13.29 19 77037 1823 53270187
Duodenal perforation 20.98 13.29 14 77042 858 53271152
Intentional product use issue 20.89 13.29 46 77010 72448 53199562
Adenocarcinoma 20.87 13.29 22 77034 2547 53269463
Gait apraxia 20.80 13.29 5 77051 15 53271995
Administration site extravasation 20.74 13.29 13 77043 715 53271295
Dyskinesia 20.73 13.29 10 77046 31823 53240187
Tumour marker increased 20.66 13.29 27 77029 3926 53268084
Lymphangiosis carcinomatosa 20.65 13.29 16 77040 1240 53270770
Palpitations 20.64 13.29 77 76979 102271 53169739
Left ventricular dilatation 20.63 13.29 11 77045 445 53271565
Renal tubular disorder 20.60 13.29 23 77033 2840 53269170
Respiratory failure 20.59 13.29 229 76827 100283 53171727
Treatment noncompliance 20.58 13.29 11 77045 33024 53238986
Pleural effusion 20.58 13.29 207 76849 88372 53183638
Foot fracture 20.45 13.29 3 77053 21036 53250974
Carbohydrate antigen 19-9 increased 20.44 13.29 8 77048 155 53271855
Nephrolithiasis 20.43 13.29 14 77042 36733 53235277
Head injury 20.35 13.29 6 77050 25827 53246183
Portal vein dilatation 20.32 13.29 5 77051 17 53271993
K-ras gene mutation 20.32 13.29 5 77051 17 53271993
Neutrophil count abnormal 20.28 13.29 22 77034 2632 53269378
Osteonecrosis 20.18 13.29 84 76972 26491 53245519
Lymphadenopathy mediastinal 20.13 13.29 22 77034 2654 53269356
Recall phenomenon 20.08 13.29 12 77044 606 53271404
Pigmentation disorder 20.06 13.29 27 77029 4040 53267970
Pulmonary fistula 19.93 13.29 4 77052 3 53272007
Xerophthalmia 19.88 13.29 10 77046 358 53271652
Night sweats 19.85 13.29 13 77043 34934 53237076
Oral pain 19.74 13.29 84 76972 26753 53245257
Wound decomposition 19.69 13.29 5 77051 20 53271990
Drug level increased 19.64 13.29 3 77053 20418 53251592
Bone marrow infiltration 19.60 13.29 11 77045 493 53271517
Myeloproliferative neoplasm 19.56 13.29 11 77045 495 53271515
Gait inability 19.49 13.29 16 77040 38295 53233715
Blood glucose increased 19.23 13.29 53 77003 77308 53194702
Blood phosphorus decreased 19.20 13.29 27 77029 4210 53267800
Protein urine 18.99 13.29 12 77044 670 53271340
Oesophageal carcinoma 18.96 13.29 14 77042 1009 53271001
Liver function test abnormal 18.91 13.29 25 77031 48046 53223964
Visual impairment 18.84 13.29 49 77007 72863 53199147
Adverse event 18.69 13.29 19 77037 41042 53230968
Anal inflammation 18.68 13.29 7 77049 120 53271890
Multiple organ dysfunction syndrome 18.62 13.29 141 76915 55536 53216474
Chronic villitis of unknown etiology 18.51 13.29 4 77052 6 53272004
Osteoporosis 18.44 13.29 24 77032 46436 53225574
Eczema herpeticum 18.31 13.29 7 77049 127 53271883
Pelvic fluid collection 18.30 13.29 13 77043 882 53271128
Withdrawal syndrome 18.19 13.29 3 77053 19298 53252712
Herpes zoster 18.18 13.29 51 77005 73968 53198042
Vaginal fistula 18.17 13.29 10 77046 431 53271579
Depressed mood 18.12 13.29 16 77040 36948 53235062
Productive cough 18.05 13.29 34 77022 56695 53215315
Vesical fistula 18.04 13.29 6 77050 71 53271939
Illness 18.02 13.29 5 77051 22391 53249619
Localised infection 18.01 13.29 8 77048 26708 53245302
Depilation 17.78 13.29 4 77052 8 53272002
Dysaesthesia pharynx 17.68 13.29 7 77049 140 53271870
International normalised ratio increased 17.63 13.29 26 77030 47735 53224275
Hepatic vein stenosis 17.62 13.29 5 77051 33 53271977
Tongue oedema 17.59 13.29 26 77030 4241 53267769
Blood creatine phosphokinase increased 17.55 13.29 10 77046 28975 53243035
Cutaneous tuberculosis 17.54 13.29 7 77049 143 53271867
Blood pressure systolic increased 17.52 13.29 15 77041 35162 53236848
Toxic cardiomyopathy 17.50 13.29 7 77049 144 53271866
Splenic marginal zone lymphoma recurrent 17.47 13.29 4 77052 9 53272001
Portal shunt 17.47 13.29 4 77052 9 53272001
Retroperitoneal abscess 17.46 13.29 7 77049 145 53271865
Hypophosphataemia 17.42 13.29 39 77017 8766 53263244
Wernicke's encephalopathy 17.36 13.29 5 77051 35 53271975
Rib fracture 17.33 13.29 4 77052 20274 53251736
Hypermetabolism 17.32 13.29 7 77049 148 53271862
Vitamin B1 deficiency 17.27 13.29 8 77048 238 53271772
Hypocalcaemia 17.26 13.29 86 76970 29251 53242759
Performance status decreased 17.20 13.29 23 77033 3420 53268590
Chemical burns of eye 17.19 13.29 6 77050 83 53271927
Acute coronary syndrome 17.19 13.29 43 77013 10381 53261629
Enterocolitis 17.17 13.29 34 77022 7018 53264992
Device issue 17.12 13.29 5 77051 21653 53250357
Portal vein thrombosis 17.09 13.29 20 77036 2599 53269411
Ocular vasculitis 17.00 13.29 5 77051 38 53271972
Metastases to pelvis 16.97 13.29 9 77047 360 53271650
Metastases to chest wall 16.97 13.29 10 77046 492 53271518
Pulmonary toxicity 16.92 13.29 29 77027 5362 53266648
Mental disorder 16.91 13.29 7 77049 24369 53247641
Endocardial fibrosis 16.90 13.29 4 77052 11 53271999
Intercepted product administration error 16.87 13.29 6 77050 88 53271922
Menopause 16.86 13.29 19 77037 2371 53269639
Venous thrombosis limb 16.80 13.29 21 77035 2922 53269088
Road traffic accident 16.77 13.29 8 77048 25623 53246387
Eosinophilia 16.73 13.29 5 77051 21330 53250680
Surgery 16.70 13.29 13 77043 31951 53240059
Chemotherapy 16.70 13.29 15 77041 1427 53270583
Vasospasm 16.65 13.29 11 77045 663 53271347
Endometrial dysplasia 16.64 13.29 4 77052 12 53271998
Vascular access site swelling 16.63 13.29 3 77053 0 53272010
Neck pain 16.55 13.29 39 77017 59977 53212033
Chronic myeloid leukaemia 16.51 13.29 20 77036 2694 53269316
Hiatus hernia 16.51 13.29 4 77052 19616 53252394
Dandy-Walker syndrome 16.51 13.29 6 77050 94 53271916
Joint range of motion decreased 16.47 13.29 3 77053 17953 53254057
Erythema 16.36 13.29 318 76738 156651 53115359
SAPHO syndrome 16.33 13.29 6 77050 97 53271913
Hydronephrosis 16.29 13.29 39 77017 9157 53262853
Necrosis 16.24 13.29 28 77028 5203 53266807
Aorto-oesophageal fistula 16.17 13.29 4 77052 14 53271996
Pneumatosis intestinalis 16.09 13.29 18 77038 2228 53269782
Cerebral infarction 16.08 13.29 74 76982 24370 53247640
Colon cancer recurrent 16.07 13.29 5 77051 47 53271963
Skin exfoliation 16.02 13.29 98 76958 35985 53236025
Dry eye 15.97 13.29 15 77041 33629 53238381
Hyperpyrexia 15.93 13.29 22 77034 3372 53268638
Proctitis 15.85 13.29 17 77039 2008 53270002
Abdominal abscess 15.73 13.29 25 77031 4345 53267665
Intravascular haemolysis 15.61 13.29 8 77048 298 53271712
Restless legs syndrome 15.53 13.29 3 77053 17220 53254790
Blood count abnormal 15.50 13.29 5 77051 20310 53251700
Herpes simplex encephalitis 15.44 13.29 8 77048 305 53271705
Monoparesis 15.42 13.29 15 77041 1579 53270431
Gastroenteropancreatic neuroendocrine tumour disease 15.28 13.29 5 77051 56 53271954
Electrocardiogram QT prolonged 15.28 13.29 37 77019 56366 53215644
Phlebitis 15.27 13.29 30 77026 6157 53265853
Respiratory disorder 15.27 13.29 16 77040 34081 53237929
Multiple-drug resistance 15.23 13.29 21 77035 3214 53268796
Pulmonary artery thrombosis 15.21 13.29 11 77045 768 53271242
Marchiafava-Bignami disease 15.20 13.29 4 77052 19 53271991
Metastases to breast 15.18 13.29 8 77048 316 53271694
Anaemia of malignant disease 15.10 13.29 9 77047 452 53271558
Acute polyneuropathy 15.09 13.29 7 77049 209 53271801
Hypothyroidism 15.01 13.29 18 77038 36089 53235921
Myalgia 15.01 13.29 122 76934 133369 53138641
Hypoglycaemia 14.99 13.29 40 77016 58973 53213037
Small intestinal perforation 14.90 13.29 14 77042 1411 53270599
Metastases to neck 14.90 13.29 5 77051 61 53271949
Red blood cell nucleated morphology present 14.87 13.29 4 77052 21 53271989
Varices oesophageal 14.86 13.29 20 77036 2992 53269018
Periodontal disease 14.83 13.29 15 77041 1655 53270355
Obesity 14.82 13.29 3 77053 16659 53255351
Invasive ductal breast carcinoma 14.75 13.29 31 77025 6676 53265334
Bursitis 14.75 13.29 7 77049 22485 53249525
Respiratory arrest 14.73 13.29 16 77040 33524 53238486
Drug eruption 14.71 13.29 9 77047 25085 53246925
Oesophageal stenosis 14.70 13.29 20 77036 3024 53268986
Nail disorder 14.67 13.29 39 77017 9766 53262244
Inappropriate schedule of product administration 14.66 13.29 57 76999 74821 53197189
Ankle fracture 14.64 13.29 3 77053 16512 53255498
Intracardiac thrombus 14.59 13.29 18 77038 2471 53269539
Cardiac myxoma 14.58 13.29 7 77049 226 53271784
Accidental exposure to product 14.58 13.29 8 77048 23666 53248344
Tumour obstruction 14.55 13.29 3 77053 3 53272007
Percussion test abnormal 14.55 13.29 3 77053 3 53272007
Device dislocation 14.49 13.29 8 77048 23589 53248421
Dysphonia 14.47 13.29 107 76949 41831 53230179
Therapy interrupted 14.45 13.29 5 77051 19431 53252579
Oesophageal varices haemorrhage 14.44 13.29 13 77043 1240 53270770
Systolic dysfunction 14.39 13.29 14 77042 1473 53270537
Muscle spasms 14.34 13.29 125 76931 134670 53137340
Anal erosion 14.28 13.29 4 77052 25 53271985
Musculoskeletal pain 14.25 13.29 58 76998 75142 53196868
Cystitis 14.22 13.29 29 77027 46959 53225051
Duodenal obstruction 14.22 13.29 7 77049 239 53271771
T-cell type acute leukaemia 14.20 13.29 5 77051 71 53271939
Duodenal ulcer 14.20 13.29 33 77023 7603 53264407
Hypertensive encephalopathy 14.01 13.29 10 77046 684 53271326
Anal fistula 13.97 13.29 19 77037 2872 53269138
Extrasystoles 13.92 13.29 26 77030 5140 53266870
Vascular pain 13.86 13.29 10 77046 695 53271315
Malignant neoplasm of pleura 13.83 13.29 5 77051 77 53271933
Thrombotic microangiopathy 13.83 13.29 37 77019 9300 53262710
Cardiac arrest 13.81 13.29 79 76977 93588 53178422
Joint stiffness 13.80 13.29 14 77042 30269 53241741
Poor quality sleep 13.69 13.29 4 77052 17319 53254691
HER2 gene amplification 13.65 13.29 4 77052 30 53271980
Gastrointestinal motility disorder 13.64 13.29 25 77031 4871 53267139
Spinal cord compression 13.63 13.29 22 77034 3872 53268138
Rectal cancer metastatic 13.63 13.29 7 77049 262 53271748
Acute pulmonary oedema 13.55 13.29 34 77022 8221 53263789
Gingival atrophy 13.54 13.29 4 77052 31 53271979
Viral infection 13.53 13.29 16 77040 32279 53239731
Enterocolitis infectious 13.53 13.29 14 77042 1586 53270424
Limb injury 13.53 13.29 7 77049 21403 53250607
Nasal crusting 13.51 13.29 7 77049 267 53271743
Hepatic cytolysis 13.50 13.29 33 77023 7852 53264158
Metastases to abdominal wall 13.49 13.29 5 77051 83 53271927
Scintillating scotoma 13.42 13.29 6 77050 164 53271846
Lhermitte's sign 13.34 13.29 3 77053 6 53272004
Type II hypersensitivity 13.34 13.29 3 77053 6 53272004
Periportal sinus dilatation 13.34 13.29 3 77053 6 53272004
Optic disc hyperaemia 13.34 13.29 3 77053 6 53272004
Onycholysis 13.32 13.29 13 77043 1373 53270637
Product intolerance 13.32 13.29 4 77052 33 53271977

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 1226.92 13.95 1690 84888 140485 32286463
Diarrhoea 967.92 13.95 2621 83957 362181 32064767
Dermatitis acneiform 860.48 13.95 387 86191 5658 32421290
Mucosal inflammation 767.19 13.95 667 85911 32767 32394181
Neuropathy peripheral 761.78 13.95 980 85598 76002 32350946
Stomatitis 618.15 13.95 643 85935 39586 32387362
Disease progression 564.93 13.95 906 85672 85956 32340992
Skin toxicity 539.48 13.95 243 86335 3563 32423385
Arteriospasm coronary 501.05 13.95 212 86366 2648 32424300
Palmar-plantar erythrodysaesthesia syndrome 467.30 13.95 365 86213 15384 32411564
Paronychia 428.27 13.95 197 86381 3040 32423908
Metastases to liver 412.71 13.95 313 86265 12619 32414329
Thrombocytopenia 410.31 13.95 1086 85492 147213 32279735
Interstitial lung disease 403.23 13.95 664 85914 64337 32362611
Neurotoxicity 362.29 13.95 309 86269 14761 32412187
Leukopenia 343.36 13.95 592 85986 59530 32367418
Decreased appetite 286.84 13.95 1010 85568 159803 32267145
Nausea 286.09 13.95 1638 84940 319211 32107737
Vomiting 259.13 13.95 1275 85303 234282 32192666
Febrile neutropenia 254.96 13.95 798 85780 118768 32308180
Peripheral sensory neuropathy 251.63 13.95 177 86401 6337 32420611
Colorectal cancer metastatic 240.56 13.95 96 86482 1021 32425927
Cardiotoxicity 238.37 13.95 154 86424 4778 32422170
Drug ineffective 235.52 13.95 414 86164 383063 32043885
Hyperammonaemia 232.45 13.95 163 86415 5806 32421142
Gastrointestinal perforation 224.63 13.95 136 86442 3754 32423194
Completed suicide 218.40 13.95 6 86572 92511 32334437
Metastases to lung 217.55 13.95 180 86398 8237 32418711
Proteinuria 211.77 13.95 246 86332 17109 32409839
Gastrointestinal toxicity 205.37 13.95 105 86473 2064 32424884
Drug interaction 203.05 13.95 170 86408 218015 32208933
Bone marrow failure 202.46 13.95 321 86257 30083 32396865
Colorectal cancer 187.40 13.95 100 86478 2153 32424795
Hyperammonaemic encephalopathy 183.83 13.95 96 86482 1975 32424973
Arthralgia 183.31 13.95 83 86495 148365 32278583
Hypomagnesaemia 181.70 13.95 237 86341 18568 32408380
Polyneuropathy 175.94 13.95 196 86382 13019 32413929
Product dose omission issue 170.73 13.95 33 86545 102542 32324406
Dehydration 167.85 13.95 734 85844 128224 32298724
Neutrophil count decreased 163.50 13.95 377 86201 46762 32380186
Alopecia 162.27 13.95 236 86342 20494 32406454
General physical health deterioration 160.75 13.95 670 85908 114589 32312359
Intestinal obstruction 154.47 13.95 231 86347 20567 32406381
Skin reaction 150.73 13.95 116 86462 4776 32422172
Headache 141.92 13.95 189 86389 196008 32230940
Fall 140.91 13.95 190 86388 196011 32230937
Carcinoembryonic antigen increased 140.15 13.95 58 86520 682 32426266
Pneumatosis intestinalis 132.24 13.95 93 86485 3327 32423621
Portal hypertension 131.01 13.95 99 86479 3965 32422983
Abdominal pain 120.62 13.95 745 85833 148784 32278164
Portal venous gas 119.80 13.95 43 86535 332 32426616
Pulmonary embolism 117.86 13.95 488 86090 83171 32343777
Malignant neoplasm progression 117.83 13.95 467 86111 78029 32348919
Pyrexia 115.64 13.95 1330 85248 318638 32108310
Paraesthesia 115.02 13.95 382 86196 58562 32368386
Anxiety 113.33 13.95 57 86521 95948 32331000
Cardiac failure congestive 110.15 13.95 44 86534 84808 32342140
Rhabdomyolysis 109.05 13.95 23 86555 67242 32359706
Neoplasm progression 107.39 13.95 190 86388 19468 32407480
Myelosuppression 106.37 13.95 143 86435 11533 32415415
Myalgia 105.64 13.95 42 86536 81188 32345760
Haematotoxicity 105.14 13.95 109 86469 6667 32420281
Metastases to lymph nodes 104.75 13.95 90 86488 4338 32422610
Weight increased 102.83 13.95 47 86531 83616 32343332
Somnolence 102.50 13.95 76 86502 103721 32323227
Enteritis 102.37 13.95 111 86467 7150 32419798
Depression 101.22 13.95 67 86511 96993 32329955
Ileus 99.09 13.95 165 86413 16100 32410848
Chills 96.56 13.95 438 86140 77646 32349302
Hospitalisation 92.28 13.95 11 86567 48960 32377988
Asthma 90.67 13.95 7 86571 44058 32382890
Hiccups 89.85 13.95 121 86457 9774 32417174
Insomnia 89.73 13.95 81 86497 100267 32326681
Aggression 87.88 13.95 4 86574 39385 32387563
Psoriasis 87.81 13.95 10 86568 46113 32380835
Ileal perforation 86.94 13.95 42 86536 727 32426221
Rheumatoid arthritis 86.48 13.95 9 86569 44535 32382413
Death 86.30 13.95 631 85947 381886 32045062
Tumour necrosis 84.30 13.95 48 86530 1178 32425770
Large intestine perforation 84.07 13.95 106 86472 8024 32418924
Oesophageal fistula 82.94 13.95 28 86550 176 32426772
Rash pustular 82.05 13.95 85 86493 5194 32421754
Pain in extremity 81.39 13.95 119 86459 118782 32308166
Extravasation 81.23 13.95 55 86523 1848 32425100
Hallucination 79.34 13.95 21 86557 52598 32374350
Pelvic abscess 79.21 13.95 43 86535 959 32425989
Pneumonia 78.66 13.95 589 85989 354663 32072285
Small intestinal obstruction 78.56 13.95 138 86440 14058 32412890
Necrotising fasciitis 77.97 13.95 71 86507 3698 32423250
Anastomotic leak 77.61 13.95 37 86541 621 32426327
Colon cancer 76.84 13.95 106 86472 8760 32418188
Peritonitis 76.71 13.95 178 86400 22152 32404796
Electrocardiogram ST segment elevation 76.34 13.95 79 86499 4821 32422127
Anastomotic complication 76.11 13.95 31 86547 349 32426599
Overdose 75.81 13.95 72 86506 87005 32339943
Suicidal ideation 75.75 13.95 7 86571 38076 32388872
Leukoencephalopathy 74.38 13.95 72 86506 4053 32422895
Intentional product misuse 73.41 13.95 6 86572 36045 32390903
Peripheral swelling 72.83 13.95 46 86532 68299 32358649
Chronic obstructive pulmonary disease 72.48 13.95 20 86558 48733 32378215
Subileus 72.42 13.95 64 86514 3204 32423744
Septic shock 71.57 13.95 368 86210 68621 32358327
Small intestinal perforation 69.74 13.95 49 86529 1750 32425198
Aorto-oesophageal fistula 69.42 13.95 18 86560 35 32426913
Injection site pain 68.73 13.95 5 86573 33053 32393895
Focal nodular hyperplasia 68.61 13.95 23 86555 141 32426807
Ascites 68.40 13.95 249 86329 39942 32387006
Colon cancer metastatic 67.88 13.95 48 86530 1732 32425216
Dizziness 66.82 13.95 309 86269 209309 32217639
Hypokalaemia 66.55 13.95 307 86271 54787 32372161
Toxicity to various agents 66.34 13.95 247 86331 177794 32249154
Metastases to peritoneum 66.03 13.95 46 86532 1620 32425328
Joint swelling 65.22 13.95 28 86550 51707 32375241
Dermatitis 65.07 13.95 97 86481 8607 32418341
Disseminated intravascular coagulation 65.06 13.95 171 86407 23005 32403943
Device related infection 64.97 13.95 146 86432 17787 32409161
Influenza 64.55 13.95 21 86557 45993 32380955
Blood glucose increased 64.08 13.95 48 86530 65193 32361755
Cholinergic syndrome 63.55 13.95 30 86548 492 32426456
Intravascular haemolysis 63.52 13.95 29 86549 439 32426509
Confusional state 63.35 13.95 184 86394 142931 32284017
Adenocarcinoma of colon 63.10 13.95 61 86517 3428 32423520
Cholangitis 62.27 13.95 93 86485 8265 32418683
Therapy partial responder 61.99 13.95 71 86507 4859 32422089
Feeling abnormal 61.24 13.95 43 86535 60380 32366568
Dry skin 60.88 13.95 175 86403 24803 32402145
Administration site extravasation 60.02 13.95 29 86549 502 32426446
Intestinal perforation 59.44 13.95 94 86484 8781 32418167
Muscle spasms 59.24 13.95 60 86518 70358 32356590
Asthenia 58.12 13.95 916 85662 235028 32191920
Bradycardia 57.92 13.95 63 86515 71499 32355449
Coronary artery disease 57.89 13.95 30 86548 49676 32377272
Agitation 57.65 13.95 41 86537 57195 32369753
Tremor 56.92 13.95 80 86498 81197 32345751
Rectal cancer metastatic 55.61 13.95 23 86555 270 32426678
Wheezing 55.05 13.95 15 86563 36859 32390089
Sinusitis 54.34 13.95 15 86563 36545 32390403
Foetal exposure during pregnancy 54.25 13.95 21 86557 41280 32385668
Venous thrombosis 54.19 13.95 56 86522 3411 32423537
Tumour perforation 54.14 13.95 23 86555 290 32426658
Therapeutic product effect decreased 53.67 13.95 9 86569 31008 32395940
Acute coronary syndrome 53.33 13.95 116 86462 13825 32413123
Folliculitis 53.26 13.95 62 86516 4318 32422630
Myocardial infarction 53.14 13.95 165 86413 125511 32301437
Contusion 53.09 13.95 12 86566 33456 32393492
Rectal perforation 53.01 13.95 25 86553 409 32426539
Large intestinal obstruction 52.93 13.95 39 86539 1502 32425446
Product use issue 52.90 13.95 38 86540 52739 32374209
Incorrect dose administered 52.76 13.95 14 86564 35014 32391934
Stress 51.20 13.95 3 86575 23779 32403169
Disturbance in attention 51.13 13.95 3 86575 23750 32403198
Conjunctivitis 51.12 13.95 87 86491 8639 32418309
Oesophagitis 50.78 13.95 109 86469 12872 32414076
Electrocardiogram QT prolonged 50.69 13.95 21 86557 39620 32387328
Anastomotic fistula 50.59 13.95 15 86563 57 32426891
Incorrect drug administration rate 50.51 13.95 35 86543 1222 32425726
Epistaxis 49.84 13.95 286 86292 55569 32371379
Unevaluable event 49.51 13.95 14 86564 33572 32393376
Memory impairment 49.30 13.95 23 86555 40456 32386492
Mucosal toxicity 48.99 13.95 19 86559 186 32426762
Nasopharyngitis 48.54 13.95 59 86519 63728 32363220
Malignant ascites 48.41 13.95 23 86555 383 32426565
Subclavian vein thrombosis 47.43 13.95 30 86548 896 32426052
Rectal cancer 47.34 13.95 44 86534 2353 32424595
Injury 47.30 13.95 3 86575 22242 32404706
Hypoglycaemia 47.27 13.95 45 86533 54337 32372611
Carbohydrate antigen 19-9 increased 46.40 13.95 19 86559 217 32426731
Dysphonia 45.73 13.95 140 86438 20544 32406404
Fluid retention 45.29 13.95 8 86570 26542 32400406
Fistula 45.23 13.95 64 86514 5415 32421533
Treatment noncompliance 44.69 13.95 9 86569 27193 32399755
Colon cancer recurrent 44.64 13.95 16 86562 123 32426825
Vena cava thrombosis 44.62 13.95 31 86547 1087 32425861
Pulmonary artery thrombosis 44.46 13.95 26 86552 672 32426276
Hypertransaminasaemia 44.08 13.95 55 86523 4119 32422829
Musculoskeletal stiffness 43.82 13.95 25 86553 39239 32387709
Skin fissures 43.75 13.95 53 86525 3850 32423098
Irritability 43 13.95 7 86571 24647 32402301
Cytomegalovirus infection 42.73 13.95 8 86570 25456 32401492
Anal haemorrhage 42.14 13.95 39 86539 2074 32424874
Drug hypersensitivity 41.44 13.95 83 86495 73317 32353631
Hyperbilirubinaemia 41.07 13.95 122 86456 17608 32409340
Transdifferentiation of neoplasm 40.99 13.95 13 86565 65 32426883
Abnormal behaviour 40.97 13.95 10 86568 26456 32400492
Intestinal ischaemia 40.49 13.95 71 86507 7220 32419728
Aortic thrombosis 40.30 13.95 25 86553 721 32426227
Colon cancer stage III 40.18 13.95 16 86562 169 32426779
Hyperkalaemia 40.13 13.95 78 86500 69672 32357276
Enterovesical fistula 39.90 13.95 24 86554 654 32426294
Duodenal perforation 39.90 13.95 31 86547 1294 32425654
Acral peeling skin syndrome 39.79 13.95 12 86566 49 32426899
Cellulitis 39.78 13.95 45 86533 50185 32376763
Nicotinic acid deficiency 39.74 13.95 13 86565 73 32426875
Diabetes mellitus 39.71 13.95 37 86541 45136 32381812
Bacterial translocation 39.63 13.95 18 86560 269 32426679
Tumour lysis syndrome 39.47 13.95 106 86472 14441 32412507
Pelvic fluid collection 38.79 13.95 14 86564 110 32426838
Oesophagobronchial fistula 38.76 13.95 15 86563 146 32426802
Liver abscess 38.38 13.95 48 86530 3603 32423345
Cardiac disorder 38.35 13.95 33 86545 41833 32385115
Anal erythema 38.20 13.95 13 86565 84 32426864
Arthritis 37.75 13.95 12 86566 26680 32400268
International normalised ratio increased 37.68 13.95 45 86533 48990 32377958
Gait disturbance 37.30 13.95 101 86477 80307 32346641
Tumour haemorrhage 36.94 13.95 41 86537 2710 32424238
Proteus infection 36.68 13.95 25 86553 849 32426099
Acute abdomen 36.41 13.95 35 86543 1953 32424995
Venoocclusive liver disease 36.18 13.95 68 86510 7297 32419651
Odynophagia 36.09 13.95 55 86523 4976 32421972
Skin disorder 35.84 13.95 93 86485 12411 32414537
Vasospasm 35.80 13.95 18 86560 341 32426607
Psychotic disorder 35.05 13.95 9 86569 23011 32403937
Chronic kidney disease 34.83 13.95 33 86545 39942 32387006
Gastric perforation 34.78 13.95 36 86542 2197 32424751
Abdominal discomfort 34.68 13.95 54 86524 52570 32374378
Hallucination, visual 34.53 13.95 3 86575 17156 32409792
Respiratory arrest 34.32 13.95 17 86561 28891 32398057
Perforation 34.23 13.95 15 86563 205 32426743
Gastrointestinal necrosis 34.03 13.95 44 86534 3415 32423533
Laryngospasm 33.85 13.95 29 86549 1392 32425556
Aphthous ulcer 33.84 13.95 50 86528 4401 32422547
Blood creatine phosphokinase increased 33.61 13.95 43 86535 45433 32381515
Tumour marker increased 33.15 13.95 20 86558 548 32426400
White blood cell count decreased 33.10 13.95 380 86198 90818 32336130
Bronchitis 33.07 13.95 37 86541 41470 32385478
Cytomegalovirus oesophagitis 32.93 13.95 18 86560 407 32426541
Neutropenic sepsis 32.92 13.95 91 86487 12608 32414340
Portal vein thrombosis 32.88 13.95 45 86533 3690 32423258
Balance disorder 32.74 13.95 34 86544 39425 32387523
Oral pain 32.59 13.95 78 86500 9900 32417048
Induration 32.49 13.95 24 86554 928 32426020
Colitis 32.37 13.95 177 86401 33774 32393174
Acne 32.31 13.95 79 86499 10163 32416785
Nodular regenerative hyperplasia 32.23 13.95 22 86556 749 32426199
Influenza like illness 32.16 13.95 16 86562 27124 32399824
Subacute cutaneous lupus erythematosus 31.98 13.95 22 86556 759 32426189
Hypersensitivity 31.97 13.95 263 86315 57495 32369453
Stress cardiomyopathy 31.87 13.95 31 86547 1755 32425193
Hypophagia 31.80 13.95 136 86442 23487 32403461
Cachexia 31.69 13.95 63 86515 7046 32419902
Pain 31.62 13.95 333 86245 187223 32239725
Lung neoplasm malignant 31.56 13.95 3 86575 15960 32410988
Palmar erythema 31.50 13.95 15 86563 251 32426697
Biliary tract infection 31.19 13.95 19 86559 530 32426418
Renal disorder 31.14 13.95 14 86564 25169 32401779
Anaemia 31.03 13.95 797 85781 222827 32204121
Oesophageal stenosis 30.92 13.95 30 86548 1693 32425255
Pneumonitis 30.70 13.95 160 86418 29974 32396974
Catheter site thrombosis 30.60 13.95 9 86569 33 32426915
Oesophageal perforation 30.48 13.95 19 86559 553 32426395
Neutropenic colitis 30.45 13.95 36 86542 2549 32424399
Xerosis 30.32 13.95 19 86559 558 32426390
Rectal adenocarcinoma 30.04 13.95 22 86556 839 32426109
Recall phenomenon 30.02 13.95 19 86559 568 32426380
Cerebrovascular accident 30.01 13.95 123 86455 86197 32340751
Peritoneal neoplasm 29.80 13.95 9 86569 37 32426911
Jugular vein thrombosis 29.71 13.95 28 86550 1524 32425424
Nephrolithiasis 29.70 13.95 18 86560 27336 32399612
Pulmonary fibrosis 29.57 13.95 106 86472 16868 32410080
Hypovolaemic shock 29.56 13.95 60 86518 6812 32420136
Adverse drug reaction 29.53 13.95 16 86562 25845 32401103
Liver function test abnormal 29.48 13.95 25 86553 31922 32395026
Sciatic nerve palsy 29.42 13.95 9 86569 39 32426909
Eosinophilia 29.15 13.95 15 86563 24943 32402005
Enterocolitis 29.13 13.95 62 86516 7278 32419670
Left ventricular dysfunction 28.71 13.95 73 86505 9622 32417326
Head injury 28.69 13.95 6 86572 17657 32409291
Sedation 28.67 13.95 7 86571 18519 32408429
Stoma site haemorrhage 28.50 13.95 23 86555 1015 32425933
Dysphagia 28.37 13.95 269 86309 61207 32365741
Enterocutaneous fistula 28.18 13.95 21 86557 823 32426125
Subdural haematoma 28.16 13.95 9 86569 19944 32407004
Dihydropyrimidine dehydrogenase deficiency 28.11 13.95 10 86568 75 32426873
Colitis microscopic 28.05 13.95 30 86548 1902 32425046
Condition aggravated 28.03 13.95 272 86306 155389 32271559
Hypoalbuminaemia 28.00 13.95 82 86496 11740 32415208
Anaemia of malignant disease 27.91 13.95 16 86562 398 32426550
Device related thrombosis 27.63 13.95 22 86556 952 32425996
Emotional distress 27.62 13.95 5 86573 16301 32410647
Pneumonitis chemical 27.58 13.95 12 86566 161 32426787
Hepatic lesion 27.49 13.95 39 86539 3308 32423640
Splenomegaly 27.47 13.95 93 86485 14384 32412564
Sleep apnoea syndrome 27.43 13.95 8 86570 18806 32408142
Cough 27.41 13.95 237 86341 138580 32288368
Colitis ulcerative 27.27 13.95 6 86572 17045 32409903
Prostate cancer 27.11 13.95 20 86558 27386 32399562
Blood pressure increased 27.01 13.95 114 86464 79240 32347708
Proctalgia 26.87 13.95 46 86532 4588 32422360
Nail toxicity 26.86 13.95 8 86570 31 32426917
Blood pressure fluctuation 26.83 13.95 10 86568 20125 32406823
Drug level increased 26.72 13.95 10 86568 20070 32406878
PIK3CA-activated mutation 26.53 13.95 10 86568 90 32426858
Embolism 26.45 13.95 60 86518 7354 32419594
Haematoma 26.38 13.95 18 86560 25666 32401282
Toxic epidermal necrolysis 26.18 13.95 11 86567 20582 32406366
Urticaria 26.07 13.95 77 86501 59537 32367411
Vocal cord paralysis 26.06 13.95 21 86557 925 32426023
Mouth ulceration 25.97 13.95 78 86500 11323 32415625
Dyspnoea 25.77 13.95 751 85827 361294 32065654
Erythema 25.69 13.95 336 86242 82769 32344179
Cell-mediated cytotoxicity 25.56 13.95 8 86570 38 32426910
Nail disorder 25.53 13.95 28 86550 1826 32425122
Abdominal pain lower 25.49 13.95 69 86509 9444 32417504
Off label use 25.30 13.95 1026 85552 305294 32121654
Wrong technique in product usage process 25.03 13.95 34 86544 35025 32391923
Carbohydrate antigen 15-3 increased 25.02 13.95 9 86569 70 32426878
Varices oesophageal 24.83 13.95 39 86539 3622 32423326
Evans syndrome 24.78 13.95 13 86565 270 32426678
Pancreatic carcinoma metastatic 24.74 13.95 37 86541 3292 32423656
Nephrotic syndrome 24.70 13.95 58 86520 7271 32419677
Proctitis 24.57 13.95 31 86547 2347 32424601
Hepatitis B 24.52 13.95 53 86525 6288 32420660
Venous thrombosis limb 24.45 13.95 28 86550 1916 32425032
Trichomegaly 24.39 13.95 7 86571 23 32426925
Gastrointestinal ischaemia 24.37 13.95 12 86566 217 32426731
Diffuse alveolar damage 24.12 13.95 29 86549 2090 32424858
Fluid overload 24.12 13.95 11 86567 19610 32407338
Mobility decreased 24.11 13.95 24 86554 28385 32398563
Adenocarcinoma 24.09 13.95 27 86551 1804 32425144
Anal fissure 24.04 13.95 34 86544 2875 32424073
Gastrointestinal anastomotic leak 23.93 13.95 14 86564 362 32426586
Pulmonary oedema 23.87 13.95 55 86523 46212 32380736
Delirium 23.84 13.95 51 86527 43995 32382953
Gout 23.81 13.95 10 86568 18718 32408230
Deep vein thrombosis 23.79 13.95 267 86311 63446 32363502
Conjunctival filtering bleb leak 23.73 13.95 6 86572 10 32426938
Perforation bile duct 23.60 13.95 8 86570 51 32426897
Dysaesthesia pharynx 23.47 13.95 8 86570 52 32426896
Wound dehiscence 23.37 13.95 37 86541 3459 32423489
Blood cholesterol increased 23.36 13.95 9 86569 17748 32409200
Prothrombin level decreased 23.33 13.95 22 86556 1198 32425750
Hypertension 23.33 13.95 486 86092 131264 32295684
Abdominal abscess 23.30 13.95 41 86537 4180 32422768
Koebner phenomenon 23.21 13.95 8 86570 54 32426894
Protein urine 23.20 13.95 18 86560 750 32426198
Necrotising oesophagitis 22.90 13.95 16 86562 566 32426382
Retroperitoneal abscess 22.58 13.95 11 86567 194 32426754
Perineal disorder 22.49 13.95 8 86570 60 32426888
Herpes zoster 22.46 13.95 32 86546 32309 32394639
Hepatic atrophy 22.33 13.95 11 86567 199 32426749
Lower respiratory tract infection 22.29 13.95 27 86551 29216 32397732
Metastasis 22.13 13.95 37 86541 3620 32423328
Drug ineffective for unapproved indication 22.04 13.95 5 86573 13907 32413041
Soft tissue disorder 21.98 13.95 17 86561 705 32426243
Sepsis 21.97 13.95 566 86012 158268 32268680
Pneumoperitoneum 21.89 13.95 26 86552 1850 32425098
Myoclonus 21.74 13.95 6 86572 14623 32412325
Perioral dermatitis 21.66 13.95 9 86569 107 32426841
Anger 21.63 13.95 3 86575 11901 32415047
Pachymeningitis 21.58 13.95 9 86569 108 32426840
Hepatectomy 21.52 13.95 8 86570 69 32426879
Contraindicated product administered 21.49 13.95 12 86566 19064 32407884
Product prescribing error 21.37 13.95 13 86565 19704 32407244
Toxic erythema of chemotherapy 21.32 13.95 8 86570 71 32426877
Interventricular septum rupture 21.32 13.95 6 86572 18 32426930
Pseudocirrhosis 21.32 13.95 6 86572 18 32426930
Blood glucose decreased 21.17 13.95 5 86573 13529 32413419
Drug intolerance 21.17 13.95 66 86512 50169 32376779
Hepatitis C 21.13 13.95 5 86573 13513 32413435
Dyskinesia 21.13 13.95 19 86559 23584 32403364
Hypercreatininaemia 21.12 13.95 15 86563 545 32426403
Seizure 21.07 13.95 176 86402 103678 32323270
Rectosigmoid cancer 20.86 13.95 10 86568 170 32426778
Pancreatitis 20.79 13.95 44 86534 38107 32388841
Ectropion 20.75 13.95 8 86570 77 32426871
Type II hypersensitivity 20.62 13.95 6 86572 21 32426927
Accidental overdose 20.61 13.95 13 86565 19326 32407622
Heart rate decreased 20.58 13.95 22 86556 25178 32401770
Muscular weakness 20.49 13.95 102 86476 67827 32359121
Superior vena cava syndrome 20.44 13.95 15 86563 574 32426374
Premature baby 20.36 13.95 12 86566 18506 32408442
Erectile dysfunction 20.25 13.95 14 86564 19825 32407123
Haemoglobinuria 20.24 13.95 15 86563 583 32426365
Balanoposthitis 20.23 13.95 20 86558 1155 32425793
Anorectal discomfort 20.21 13.95 25 86553 1855 32425093
Loss of personal independence in daily activities 20.21 13.95 25 86553 26808 32400140
Cerebral vasoconstriction 20.19 13.95 11 86567 247 32426701
Underdose 20.11 13.95 5 86573 13064 32413884
Prinzmetal angina 19.95 13.95 18 86560 926 32426022
Diabetes mellitus inadequate control 19.81 13.95 6 86572 13762 32413186
NPM1 gene mutation 19.79 13.95 9 86569 135 32426813
Tubulointerstitial nephritis 19.73 13.95 14 86564 19563 32407385
Perihepatic abscess 19.72 13.95 8 86570 89 32426859
Microgenia 19.53 13.95 5 86573 9 32426939
Pulmonary infarction 19.45 13.95 20 86558 1211 32425737
Vision blurred 19.37 13.95 57 86521 44129 32382819
Clostridial infection 19.37 13.95 35 86543 3644 32423304
Stevens-Johnson syndrome 19.36 13.95 13 86565 18696 32408252
Ischiorectal hernia 19.19 13.95 5 86573 10 32426938
Hypersplenism 19.13 13.95 12 86566 353 32426595
COVID-19 19.11 13.95 35 86543 31980 32394968
Performance status decreased 19.09 13.95 37 86541 4061 32422887
Product quality issue 19.07 13.95 14 86564 19219 32407729
Paraesthesia oral 19.06 13.95 36 86542 3876 32423072
Intestinal strangulation 18.92 13.95 6 86572 30 32426918
Lymph node abscess 18.87 13.95 5 86573 11 32426937
Metastases to pelvis 18.82 13.95 11 86567 284 32426664
Peritonitis bacterial 18.80 13.95 5 86573 12491 32414457
Heart rate irregular 18.75 13.95 7 86571 14071 32412877
Gastrointestinal obstruction 18.75 13.95 16 86562 764 32426184
Osteoarthritis 18.72 13.95 15 86563 19704 32407244
Fistula of small intestine 18.63 13.95 12 86566 370 32426578
Respiratory depression 18.57 13.95 6 86572 13205 32413743
Portal vein embolisation 18.57 13.95 5 86573 12 32426936
Peritoneal haematoma 18.57 13.95 7 86571 63 32426885
Prostatic specific antigen increased 18.52 13.95 6 86572 13181 32413767
Unresponsive to stimuli 18.50 13.95 28 86550 27581 32399367
Pelvic venous thrombosis 18.30 13.95 14 86564 571 32426377
Eyelash changes 18.29 13.95 5 86573 13 32426935
Colony stimulating factor therapy 18.21 13.95 9 86569 164 32426784
Mental disorder 18.13 13.95 8 86570 14540 32412408
Myopathy 18.12 13.95 4 86574 11337 32415611
Guillain-Barre syndrome 18.10 13.95 43 86535 5431 32421517
Productive cough 18.05 13.95 40 86538 34076 32392872
Hyperlipidaemia 18.05 13.95 8 86570 14503 32412445
Radiation mucositis 18.02 13.95 8 86570 113 32426835
Colorectal cancer recurrent 18.01 13.95 6 86572 36 32426912
Oesophageal haemorrhage 17.98 13.95 19 86559 1188 32425760
Arthropathy 17.96 13.95 20 86558 22469 32404479
Thrombotic thrombocytopenic purpura 17.91 13.95 33 86545 3487 32423461
Febrile bone marrow aplasia 17.71 13.95 56 86522 8359 32418589
Adverse event 17.65 13.95 11 86567 16461 32410487
Hypersomnia 17.60 13.95 5 86573 11956 32414992
Treatment failure 17.55 13.95 50 86528 39113 32387835
Laboratory test abnormal 17.53 13.95 15 86563 19072 32407876
Bacteraemia 17.53 13.95 93 86485 17540 32409408
K-ras gene mutation 17.52 13.95 5 86573 16 32426932
Gastroenteritis radiation 17.50 13.95 11 86567 325 32426623
Haemorrhagic tumour necrosis 17.49 13.95 4 86574 3 32426945
Osteomyelitis 17.37 13.95 10 86568 15623 32411325
Bronchiolitis obliterans syndrome 17.37 13.95 9 86569 182 32426766
Product administration error 17.36 13.95 10 86568 15615 32411333
Acute respiratory distress syndrome 17.34 13.95 121 86457 25132 32401816
Nail ridging 17.22 13.95 6 86572 42 32426906
Acute cutaneous lupus erythematosus 17.17 13.95 7 86571 79 32426869
Primitive neuroectodermal tumour 17.17 13.95 7 86571 79 32426869
Bacterial colitis 17.10 13.95 6 86572 43 32426905
Refeeding syndrome 17.10 13.95 6 86572 43 32426905
Duodenal ulcer perforation 17.06 13.95 22 86556 1703 32425245
Visual impairment 17.04 13.95 39 86539 32849 32394099
Neoplasm recurrence 17.03 13.95 24 86554 2023 32424925
Enterocolitis haemorrhagic 17.02 13.95 17 86561 994 32425954
Heart rate increased 16.89 13.95 56 86522 41772 32385176
Toxic leukoencephalopathy 16.88 13.95 10 86568 265 32426683
Hepatic enzyme increased 16.80 13.95 47 86531 36990 32389958
Tetany 16.79 13.95 15 86563 762 32426186
Pancreatic neuroendocrine tumour metastatic 16.77 13.95 9 86569 196 32426752
Dysgeusia 16.76 13.95 121 86457 25410 32401538
Blood triglycerides increased 16.75 13.95 9 86569 14610 32412338
Rib fracture 16.74 13.95 8 86570 13881 32413067
Injection site reaction 16.72 13.95 5 86573 11564 32415384
Visceral venous thrombosis 16.66 13.95 5 86573 20 32426928
VIth nerve disorder 16.66 13.95 5 86573 20 32426928
Acute motor-sensory axonal neuropathy 16.64 13.95 8 86570 137 32426811
Pulmonary hypertension 16.62 13.95 18 86560 20476 32406472
Cerebral haemorrhage 16.59 13.95 43 86535 34704 32392244
Fixed eruption 16.52 13.95 19 86559 1306 32425642
Angioedema 16.50 13.95 46 86532 36243 32390705
Localised infection 16.47 13.95 10 86568 15177 32411771
Gastrointestinal inflammation 16.39 13.95 30 86548 3154 32423794
Mechanical ileus 16.35 13.95 10 86568 281 32426667
Hepatitis B surface antigen positive 16.33 13.95 8 86570 143 32426805
Eye pain 16.32 13.95 7 86571 12941 32414007
Second primary malignancy 16.30 13.95 48 86530 6893 32420055
Rectal ulcer 16.21 13.95 16 86562 922 32426026
Gastrointestinal stoma complication 16.21 13.95 19 86559 1333 32425615
Therapeutic response unexpected 16.17 13.95 3 86575 9609 32417339
B-cell small lymphocytic lymphoma 16.13 13.95 8 86570 147 32426801
Renal salt-wasting syndrome 16.13 13.95 8 86570 147 32426801
Oesophageal squamous cell carcinoma metastatic 16.08 13.95 4 86574 6 32426942
Stoma site pain 16.06 13.95 16 86562 933 32426015
Lymphangiosis carcinomatosa 16.06 13.95 16 86562 933 32426015
Product substitution issue 16.04 13.95 4 86574 10432 32416516
Hernia 15.94 13.95 3 86575 9512 32417436
Accidental exposure to product 15.90 13.95 5 86573 11197 32415751
Swelling face 15.89 13.95 22 86556 22483 32404465
Monocytopenia 15.89 13.95 7 86571 97 32426851
No adverse event 15.83 13.95 18 86560 20035 32406913
Peritoneal adhesions 15.82 13.95 7 86571 98 32426850
Hepatic artery occlusion 15.82 13.95 6 86572 55 32426893
Duodenal stenosis 15.73 13.95 9 86569 223 32426725
Suture rupture 15.55 13.95 11 86567 397 32426551
Road traffic accident 15.55 13.95 14 86564 17367 32409581
Jaundice 15.52 13.95 149 86429 34009 32392939
Radiation skin injury 15.50 13.95 14 86564 721 32426227
Inappropriate schedule of product administration 15.48 13.95 66 86512 45759 32381189
Injection site erythema 15.44 13.95 10 86568 14658 32412290
Neck pain 15.37 13.95 23 86555 22764 32404184
Pneumoretroperitoneum 15.36 13.95 6 86572 60 32426888
Intrahepatic portal hepatic venous fistula 15.35 13.95 4 86574 8 32426940
Bile duct stenosis 15.32 13.95 18 86560 1266 32425682
Tooth disorder 15.29 13.95 4 86574 10103 32416845
Oesophageal cancer metastatic 15.28 13.95 10 86568 317 32426631
Rectal abscess 15.20 13.95 16 86562 996 32425952
Blister 15.20 13.95 22 86556 22069 32404879
Rectal stenosis 15.08 13.95 8 86570 170 32426778
Electromyogram abnormal 15.02 13.95 6 86572 64 32426884
Aspergillus infection 15.01 13.95 6 86572 11568 32415380
Chimerism 15.00 13.95 9 86569 244 32426704
Vestibular neuronitis 14.96 13.95 8 86570 173 32426775
Temperature intolerance 14.95 13.95 29 86549 3186 32423762
Swelling 14.87 13.95 52 86526 38170 32388778
Catheter site extravasation 14.87 13.95 7 86571 114 32426834
Full blood count decreased 14.86 13.95 14 86564 16996 32409952
Cataract 14.82 13.95 26 86552 24157 32402791
Aplasia 14.80 13.95 35 86543 4407 32422541
Herpes simplex meningomyelitis 14.79 13.95 3 86575 0 32426948
Swollen tongue 14.77 13.95 9 86569 13630 32413318
Toxic cardiomyopathy 14.75 13.95 9 86569 252 32426696
Anaphylactic shock 14.74 13.95 79 86499 14955 32411993
Tumour fistulisation 14.74 13.95 4 86574 10 32426938
Tracheal stenosis 14.71 13.95 8 86570 179 32426769
Neurosarcoidosis 14.67 13.95 8 86570 180 32426768
Soft tissue swelling 14.66 13.95 10 86568 340 32426608
Pulmonary arterial hypertension 14.64 13.95 4 86574 9817 32417131
Laryngeal oedema 14.64 13.95 30 86548 3429 32423519
Cardiac arrest 14.63 13.95 176 86402 96600 32330348
Non-cirrhotic portal hypertension 14.62 13.95 9 86569 256 32426692
Radiation interaction 14.60 13.95 5 86573 33 32426915
Oedema peripheral 14.52 13.95 215 86363 113876 32313072
Astringent therapy 14.47 13.95 4 86574 11 32426937
Hepatic failure 14.45 13.95 152 86426 35528 32391420
Hepatitis B DNA increased 14.42 13.95 12 86566 553 32426395
Oral dysaesthesia 14.32 13.95 6 86572 73 32426875
Device related sepsis 14.28 13.95 25 86553 2538 32424410
Nasal congestion 14.26 13.95 20 86558 20331 32406617
Pigmentation disorder 14.22 13.95 23 86555 2189 32424759
Mania 14.22 13.95 4 86574 9628 32417320
Temperature difference of extremities 14.21 13.95 4 86574 12 32426936
Therapy cessation 14.20 13.95 13 86565 16000 32410948
Chemotherapy 14.18 13.95 12 86566 566 32426382
Intestinal mucosal hypertrophy 14.17 13.95 6 86572 75 32426873
Colonic fistula 14.16 13.95 10 86568 360 32426588
Abscess 14.09 13.95 61 86517 10589 32416359
Stress ulcer 14.03 13.95 6 86572 77 32426871
Metastatic neoplasm 13.99 13.95 27 86551 2954 32423994

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 cytostatic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35705 immunosuppressant
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:132992 radiosensitizers
CHEBI has role CHEBI:25435 mutagens
CHEBI has role CHEBI:77746 H. sapiens metabolites

Drug Use (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

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
3127006 SNOMEDCT_US
387172005 SNOMEDCT_US
4017806 VANDF

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
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 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
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 68001-266 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 24 sections
Fluorouracil HUMAN PRESCRIPTION DRUG LABEL 1 68001-266 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 24 sections