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

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 1554.48 13.08 1475 70713 141729 46472145
Febrile neutropenia 872.47 13.08 893 71295 93734 46520140
Mucosal inflammation 831.98 13.08 596 71592 38380 46575494
Neuropathy peripheral 604.10 13.08 723 71465 90170 46523704
Diarrhoea 579.38 13.08 2034 70154 557568 46056306
Disease progression 533.81 13.08 681 71507 90619 46523255
Palmar-plantar erythrodysaesthesia syndrome 495.06 13.08 338 71850 20113 46593761
Thrombocytopenia 439.27 13.08 738 71450 125843 46488031
Leukopenia 436.42 13.08 533 71655 67810 46546064
Neurotoxicity 425.82 13.08 265 71923 13452 46600422
Stomatitis 409.36 13.08 516 71672 67781 46546093
Metastases to liver 380.19 13.08 283 71905 19302 46594572
Dermatitis acneiform 370.66 13.08 162 72026 3908 46609966
Malignant neoplasm progression 350.68 13.08 466 71722 64460 46549414
Drug ineffective 325.45 13.08 343 71845 677495 45936379
Bone marrow failure 309.68 13.08 300 71888 29369 46584505
Skin toxicity 305.57 13.08 137 72051 3517 46610357
Neoplasm progression 295.92 13.08 279 71909 26404 46587470
Metastases to lung 264.04 13.08 179 72009 10517 46603357
Vomiting 260.49 13.08 1381 70807 451413 46162461
Metastases to bone 237.64 13.08 205 71983 17271 46596603
Acute myeloid leukaemia 230.77 13.08 193 71995 15585 46598289
Neutrophil count decreased 213.60 13.08 298 71890 43128 46570746
Completed suicide 210.01 13.08 3 72185 145917 46467957
Posterior reversible encephalopathy syndrome 200.59 13.08 175 72013 14966 46598908
Product dose omission issue 200.34 13.08 16 72172 168504 46445370
Gastrointestinal toxicity 199.06 13.08 108 72080 4223 46609651
Breast cancer 198.48 13.08 295 71893 45223 46568651
Peripheral sensory neuropathy 195.92 13.08 124 72064 6479 46607395
Ejection fraction decreased 188.30 13.08 182 72006 17755 46596119
Metastasis 182.96 13.08 102 72086 4210 46609664
Gastrointestinal perforation 177.99 13.08 91 72097 3146 46610728
Polyneuropathy 177.69 13.08 146 72042 11498 46602376
Second primary malignancy 176.50 13.08 116 72072 6468 46607406
Haematotoxicity 175.83 13.08 118 72070 6815 46607059
Acute promyelocytic leukaemia 173.41 13.08 62 72126 859 46613015
Arthralgia 172.51 13.08 186 72002 364417 46249457
Fall 170.48 13.08 155 72033 328942 46284932
Pyrexia 168.35 13.08 1016 71172 347786 46266088
Joint swelling 164.90 13.08 29 72159 166044 46447830
Arteriospasm coronary 162.83 13.08 89 72099 3532 46610342
Colorectal cancer metastatic 160.63 13.08 55 72133 665 46613209
Cardiomyopathy 159.22 13.08 158 72030 15915 46597959
Cardiotoxicity 157.63 13.08 109 72079 6613 46607261
Hyperammonaemia 156.22 13.08 95 72093 4621 46609253
Headache 151.08 13.08 322 71866 478030 46135844
Laryngospasm 149.99 13.08 78 72110 2795 46611079
General physical health deterioration 148.06 13.08 454 71734 115315 46498559
Interstitial lung disease 146.40 13.08 283 71905 53666 46560208
Paronychia 146.19 13.08 90 72098 4476 46609398
Disease recurrence 140.95 13.08 158 72030 18313 46595561
Drug hypersensitivity 138.30 13.08 105 72083 243720 46370154
Nausea 135.15 13.08 1637 70551 685817 45928057
Neutropenic sepsis 134.93 13.08 128 72060 12196 46601678
Pulmonary embolism 130.69 13.08 417 71771 108168 46505706
Injection site pain 127.78 13.08 10 72178 107142 46506732
Metastases to lymph nodes 126.80 13.08 95 72093 6536 46607338
Dehydration 123.34 13.08 531 71657 159009 46454865
Weight increased 123.28 13.08 50 72138 164423 46449451
Proteinuria 116.84 13.08 136 72052 16417 46597457
Decreased appetite 114.02 13.08 596 71592 193240 46420634
Sinusitis 111.96 13.08 31 72157 129737 46484137
Abdominal discomfort 106.86 13.08 50 72138 151115 46462759
Nasopharyngitis 104.23 13.08 54 72134 153944 46459930
Hypomagnesaemia 104.10 13.08 149 72039 22061 46591813
Pain 103.10 13.08 385 71803 476563 46137311
Pain in extremity 101.34 13.08 152 72036 258528 46355346
Psoriasis 100.68 13.08 5 72183 78599 46535275
Depression 100.62 13.08 70 72118 170034 46443840
Abdominal pain 97.59 13.08 649 71539 229382 46384492
Anaemia 93.51 13.08 696 71492 255083 46358791
Paraesthesia 91.55 13.08 392 71796 117045 46496829
Large intestine perforation 91.23 13.08 83 72105 7497 46606377
Stress cardiomyopathy 89.34 13.08 83 72105 7701 46606173
Hypokalaemia 85.66 13.08 315 71873 87709 46526165
Systemic lupus erythematosus 83.94 13.08 4 72184 65176 46548698
Enteritis 83.33 13.08 75 72113 6680 46607194
Drug abuse 81.31 13.08 4 72184 63404 46550470
Peripheral swelling 81.01 13.08 75 72113 157996 46455878
Injection site erythema 80.73 13.08 10 72178 74417 46539457
Focal nodular hyperplasia 79.56 13.08 29 72159 426 46613448
Death 79.48 13.08 830 71358 334718 46279156
Contraindicated product administered 79.21 13.08 14 72174 79933 46533941
Adenocarcinoma of colon 78.39 13.08 46 72142 2094 46611780
Ileus 77.44 13.08 102 72086 13962 46599912
Colon cancer 77.14 13.08 83 72105 9186 46604688
Therapeutic product effect decreased 76.52 13.08 17 72171 82584 46531290
Influenza 75.73 13.08 22 72166 89248 46524626
Intestinal perforation 74.65 13.08 88 72100 10763 46603111
Neutropenic colitis 74.02 13.08 45 72143 2187 46611687
Extravasation 73.65 13.08 44 72144 2071 46611803
Hyperammonaemic encephalopathy 73.65 13.08 43 72145 1939 46611935
Portal hypertension 73.59 13.08 53 72135 3430 46610444
Anxiety 73.07 13.08 105 72083 181852 46432022
Hospitalisation 72.59 13.08 7 72181 63378 46550496
Drug interaction 72.30 13.08 127 72061 202967 46410907
Ascites 71.53 13.08 168 72020 36416 46577458
Myelosuppression 71.29 13.08 73 72115 7630 46606244
Bronchitis 70.44 13.08 38 72150 105941 46507933
Breast cancer recurrent 70.29 13.08 54 72134 3857 46610017
Musculoskeletal stiffness 69.86 13.08 32 72156 97961 46515913
Insomnia 69.40 13.08 92 72096 164832 46449042
Colon cancer metastatic 69.12 13.08 35 72153 1185 46612689
Breast cancer metastatic 68.90 13.08 95 72093 13583 46600291
Swelling 68.75 13.08 55 72133 124456 46489418
Migraine 67.78 13.08 13 72175 70013 46543861
Product use issue 67.32 13.08 31 72157 94613 46519261
Dihydropyrimidine dehydrogenase deficiency 66.61 13.08 17 72171 64 46613810
Left ventricular dysfunction 65.36 13.08 80 72108 10175 46603699
Pneumonia 64.59 13.08 331 71857 375989 46237885
Hypertransaminasaemia 64.53 13.08 49 72139 3439 46610435
Dizziness 64.48 13.08 289 71899 340125 46273749
Contusion 63.25 13.08 28 72160 87459 46526415
Metastases to pleura 60.80 13.08 31 72157 1065 46612809
Rectal perforation 60.40 13.08 23 72165 384 46613490
Arthritis 60.38 13.08 22 72166 77294 46536580
Arthropathy 59.84 13.08 28 72160 84672 46529202
Colorectal cancer 59.06 13.08 29 72159 918 46612956
Asthenia 58.09 13.08 735 71453 310340 46303534
Suicidal ideation 57.79 13.08 9 72179 56373 46557501
Feeling abnormal 57.62 13.08 65 72123 124995 46488879
Condition aggravated 57.32 13.08 191 71997 244861 46369013
Intentional product misuse 57.30 13.08 4 72184 47124 46566750
Osteoarthritis 56.97 13.08 13 72175 62012 46551862
Intestinal obstruction 56.81 13.08 125 72063 25950 46587924
Pruritus 55.93 13.08 190 71998 242162 46371712
Stress 55.72 13.08 7 72181 51544 46562330
Chronic obstructive pulmonary disease 55.15 13.08 11 72177 57622 46556252
Enterocutaneous fistula 55.12 13.08 30 72158 1180 46612694
Female genital tract fistula 54.47 13.08 43 72145 3196 46610678
Leukoencephalopathy 54.47 13.08 47 72141 3957 46609917
Pancytopenia 54.42 13.08 268 71920 84790 46529084
Subacute cutaneous lupus erythematosus 54.41 13.08 35 72153 1880 46611994
Carcinoembryonic antigen increased 53.50 13.08 31 72157 1378 46612496
Febrile bone marrow aplasia 52.85 13.08 59 72129 6803 46607071
Fluid retention 52.65 13.08 8 72180 51038 46562836
Device related thrombosis 51.98 13.08 29 72159 1198 46612676
Splenomegaly 51.39 13.08 69 72119 9619 46604255
Metastases to central nervous system 50.71 13.08 74 72114 11147 46602727
Cardiac failure 49.79 13.08 250 71938 79698 46534176
Dysarthria 48.73 13.08 148 72040 37350 46576524
Loss of personal independence in daily activities 48.66 13.08 14 72174 57169 46556705
Asthma 48.59 13.08 42 72146 91500 46522374
White blood cell count decreased 48.28 13.08 318 71870 111913 46501961
Disseminated intravascular coagulation 48.25 13.08 97 72091 18908 46594966
Congestive cardiomyopathy 47.26 13.08 51 72137 5662 46608212
Colony stimulating factor therapy 47.19 13.08 18 72170 302 46613572
Gait disturbance 47.12 13.08 96 72092 145167 46468707
Somnolence 47 13.08 108 72080 156413 46457461
Metastases to skin 46.22 13.08 28 72160 1352 46612522
Injection site reaction 46.06 13.08 9 72179 47840 46566034
Suicide attempt 45.87 13.08 14 72174 55022 46558852
Pemphigus 44.68 13.08 8 72180 45266 46568608
Mobility decreased 44.42 13.08 19 72169 60575 46553299
Metastases to peritoneum 44.20 13.08 35 72153 2613 46611261
Wound 43.48 13.08 7 72181 42795 46571079
Maternal exposure during pregnancy 43.32 13.08 57 72131 102492 46511382
Haemolytic anaemia 43.16 13.08 64 72124 9778 46604096
Overdose 42.76 13.08 57 72131 101922 46511952
Cholangitis 42.72 13.08 44 72144 4630 46609244
Myocarditis 42.40 13.08 56 72132 7683 46606191
Injection site swelling 42.33 13.08 6 72182 40321 46573553
Tumour perforation 41.49 13.08 12 72176 79 46613795
Peritonitis 41.44 13.08 96 72092 20618 46593256
Aortic thrombosis 40.75 13.08 23 72165 972 46612902
Cholinergic syndrome 40.67 13.08 17 72171 366 46613508
Malignant respiratory tract neoplasm 40.42 13.08 11 72177 56 46613818
Memory impairment 40.41 13.08 36 72152 77301 46536573
Abortion spontaneous 40.38 13.08 9 72179 43637 46570237
Steatohepatitis 40.28 13.08 18 72170 458 46613416
Chills 40.03 13.08 270 71918 95762 46518112
Haemolytic uraemic syndrome 39.35 13.08 32 72156 2482 46611392
Short-bowel syndrome 39.15 13.08 17 72171 403 46613471
Proctalgia 38.26 13.08 42 72146 4754 46609120
Troponin I increased 38.07 13.08 28 72160 1872 46612002
Balance disorder 37.51 13.08 27 72161 64494 46549380
Factor VII deficiency 37.34 13.08 9 72179 25 46613849
Injury 37.05 13.08 11 72177 44016 46569858
Embolism 36.59 13.08 50 72138 7088 46606786
Urticaria 36.48 13.08 80 72108 117812 46496062
Unevaluable event 36.28 13.08 13 72175 46162 46567712
Mucosal toxicity 36.27 13.08 15 72173 314 46613560
Rhabdomyolysis 36.14 13.08 10 72178 41899 46571975
Aortitis 35.95 13.08 19 72169 704 46613170
Incorrect dose administered 35.49 13.08 13 72175 45537 46568337
Wrong technique in product usage process 35.44 13.08 20 72168 54402 46559472
Renal salt-wasting syndrome 35.41 13.08 13 72175 195 46613679
Nasal congestion 35.40 13.08 15 72173 48098 46565776
Cataract 35.32 13.08 13 72175 45402 46568472
Immune thrombocytopenia 35.30 13.08 53 72135 8188 46605686
Cystitis radiation 35.09 13.08 10 72178 62 46613812
White blood cell count abnormal 34.28 13.08 41 72147 5091 46608783
Sleep disorder 33.78 13.08 15 72173 46780 46567094
Atypical haemolytic uraemic syndrome 33.62 13.08 16 72172 472 46613402
Bladder tamponade 33.57 13.08 10 72178 74 46613800
Nephritis bacterial 33.52 13.08 8 72180 21 46613853
Metastases to spine 33.40 13.08 30 72158 2664 46611210
Cough 33.23 13.08 214 71974 230035 46383839
Hypertensive crisis 32.80 13.08 68 72120 13547 46600327
Subileus 32.50 13.08 31 72157 2972 46610902
Organising pneumonia 32.47 13.08 39 72149 4863 46609011
Adverse drug reaction 32.37 13.08 14 72174 44348 46569526
Neuromyotonia 32.27 13.08 9 72179 51 46613823
Non-cirrhotic portal hypertension 31.95 13.08 10 72178 89 46613785
Deep vein thrombosis 31.88 13.08 222 71966 79551 46534323
Venous thrombosis 31.73 13.08 38 72150 4724 46609150
Product quality issue 31.70 13.08 8 72180 35640 46578234
Colitis 31.66 13.08 128 72060 37219 46576655
Urinary tract infection 31.64 13.08 205 71983 220061 46393813
Myelodysplastic syndrome 31.63 13.08 73 72115 15638 46598236
Treatment failure 31.48 13.08 60 72128 93027 46520847
Drug withdrawal syndrome 31.41 13.08 3 72185 27381 46586493
Large intestinal obstruction 31.37 13.08 25 72163 1884 46611990
Stridor 31.27 13.08 31 72157 3116 46610758
Hypertension 31.23 13.08 451 71737 195905 46417969
Fluid overload 31.13 13.08 3 72185 27182 46586692
Miller Fisher syndrome 31.09 13.08 10 72178 98 46613776
Venous pressure jugular decreased 30.96 13.08 8 72180 32 46613842
Skin fissures 30.93 13.08 48 72140 7632 46606242
Osteonecrosis of jaw 30.85 13.08 120 72068 34282 46579592
Trichomegaly 30.77 13.08 8 72180 33 46613841
Vena cava thrombosis 30.50 13.08 26 72162 2153 46611721
Gastrointestinal necrosis 30.33 13.08 29 72159 2789 46611085
Small intestinal obstruction 30.23 13.08 73 72115 16099 46597775
Agranulocytosis 30.18 13.08 89 72099 22096 46591778
Venoocclusive liver disease 30.11 13.08 35 72153 4216 46609658
Bradycardia 29.93 13.08 35 72153 66263 46547611
Liver abscess 29.83 13.08 28 72160 2631 46611243
Oesophageal fistula 29.81 13.08 10 72178 113 46613761
Malignant pleural effusion 29.74 13.08 27 72161 2431 46611443
Dermatitis 29.69 13.08 67 72121 14141 46599733
Tumour ulceration 29.66 13.08 10 72178 115 46613759
Plasma cell myeloma 29.46 13.08 16 72172 44462 46569412
Hypophagia 29.42 13.08 106 72082 29200 46584674
Dysaesthesia 29.25 13.08 30 72158 3141 46610733
Septic shock 29.24 13.08 171 72017 57722 46556152
Metastases to meninges 29.05 13.08 24 72164 1903 46611971
Hormone receptor positive breast cancer 29.02 13.08 14 72174 426 46613448
Nicotinic acid deficiency 28.73 13.08 8 72180 45 46613829
Epistaxis 28.73 13.08 184 72004 64121 46549753
Heart rate decreased 28.44 13.08 7 72181 31716 46582158
Thrombocytopenic purpura 28.41 13.08 20 72168 1248 46612626
Metastases to the mediastinum 28.23 13.08 14 72174 453 46613421
Upper respiratory tract infection 28.21 13.08 34 72154 63522 46550352
Glossodynia 27.91 13.08 17 72171 44356 46569518
Therapy cessation 27.86 13.08 4 72184 26625 46587249
Subclavian vein thrombosis 27.85 13.08 23 72165 1823 46612051
Rectal cancer 27.68 13.08 23 72165 1839 46612035
Device related infection 27.29 13.08 83 72105 20958 46592916
Hydrothorax 27.15 13.08 15 72173 608 46613266
Emotional distress 27.09 13.08 7 72181 30700 46583174
Electrocardiogram QT prolonged 26.68 13.08 24 72164 51301 46562573
Conjunctival filtering bleb leak 26.61 13.08 6 72182 11 46613863
No adverse event 26.28 13.08 10 72178 34221 46579653
Metastases to reproductive organ 26.27 13.08 6 72182 12 46613862
Rectal cancer recurrent 26.17 13.08 7 72181 33 46613841
Tumour lysis syndrome 26.09 13.08 43 72145 7193 46606681
Gastrooesophageal reflux disease 25.95 13.08 47 72141 74297 46539577
Wheezing 25.40 13.08 27 72161 53359 46560515
Drug intolerance 25.33 13.08 129 72059 146920 46466954
Multiple sclerosis 25.30 13.08 4 72184 24787 46589087
Hypocapnia 25.00 13.08 12 72176 361 46613513
Hyperbilirubinaemia 24.99 13.08 52 72136 10386 46603488
Ocular toxicity 24.94 13.08 13 72175 468 46613406
ECG signs of myocardial ischaemia 24.91 13.08 8 72180 78 46613796
Blood creatine increased 24.82 13.08 33 72155 4557 46609317
Inferior vena cava stenosis 24.81 13.08 6 72182 17 46613857
Irritability 24.78 13.08 7 72181 28939 46584935
Soft tissue necrosis 24.20 13.08 12 72176 388 46613486
Diabetes mellitus 24.18 13.08 25 72163 50040 46563834
Jugular vein thrombosis 24.16 13.08 25 72163 2645 46611229
Tumour necrosis 24.11 13.08 15 72173 760 46613114
Coronary artery disease 24.07 13.08 11 72177 33741 46580133
Hepatic enzyme increased 24.07 13.08 57 72131 81730 46532144
Hepatic failure 24.06 13.08 109 72079 33307 46580567
Hallucination 24.06 13.08 25 72163 49926 46563948
Full blood count decreased 24.04 13.08 3 72185 22208 46591666
Vision blurred 23.90 13.08 55 72133 79653 46534221
Palpitations 23.80 13.08 72 72116 95187 46518687
Encephalopathy 23.76 13.08 109 72079 33480 46580394
Hyperkalaemia 23.73 13.08 26 72162 50683 46563191
Xerosis 23.63 13.08 14 72174 649 46613225
Biliary tract infection 23.49 13.08 12 72176 414 46613460
Tympanic membrane disorder 23.49 13.08 9 72179 153 46613721
Acute lymphocytic leukaemia 23.37 13.08 25 72163 2748 46611126
Acute leukaemia 23.32 13.08 17 72171 1121 46612753
Anastomotic leak 23.23 13.08 12 72176 424 46613450
Acute interstitial pneumonitis 23.11 13.08 14 72174 676 46613198
Sepsis 23.05 13.08 316 71872 135698 46478176
Aplasia 22.95 13.08 28 72160 3548 46610326
Fistula 22.91 13.08 43 72145 7967 46605907
Ear infection 22.85 13.08 4 72184 23009 46590865
Catabolic state 22.81 13.08 7 72181 58 46613816
Therapy partial responder 22.80 13.08 32 72156 4650 46609224
Throat tightness 22.75 13.08 77 72111 20562 46593312
Sedation 22.71 13.08 4 72184 22906 46590968
Metastases to ovary 22.70 13.08 11 72177 338 46613536
Aortic intramural haematoma 22.70 13.08 7 72181 59 46613815
Gastrointestinal stoma complication 22.62 13.08 19 72169 1542 46612332
Hepatic lesion 22.60 13.08 29 72159 3868 46610006
Dry skin 22.59 13.08 124 72064 40892 46572982
Superior vena cava syndrome 22.55 13.08 13 72175 572 46613302
Aggression 22.48 13.08 4 72184 22740 46591134
Stomatitis haemorrhagic 22.48 13.08 6 72182 28 46613846
Cardiac ventricular thrombosis 22.35 13.08 12 72176 459 46613415
Psychotic disorder 22.31 13.08 4 72184 22617 46591257
Aortic dissection 22.29 13.08 19 72169 1573 46612301
Amnesia 22.20 13.08 19 72169 41612 46572262
Tumour haemorrhage 22.12 13.08 18 72170 1397 46612477
Xerophthalmia 21.90 13.08 10 72178 268 46613606
Nasal septum perforation 21.88 13.08 14 72174 745 46613129
Visual impairment 21.67 13.08 44 72144 66645 46547229
Gastrointestinal stoma output increased 21.60 13.08 9 72179 192 46613682
Myocardial ischaemia 21.16 13.08 55 72133 12694 46601180
Head injury 21.01 13.08 6 72182 24630 46589244
Device issue 20.90 13.08 3 72185 19977 46593897
Cardiomyopathy acute 20.90 13.08 9 72179 209 46613665
Type 2 diabetes mellitus 20.76 13.08 3 72185 19872 46594002
Cachexia 20.75 13.08 31 72157 4768 46609106
Hepatic vein stenosis 20.71 13.08 5 72183 14 46613860
Pregnancy 20.71 13.08 8 72180 27129 46586745
Tonic clonic movements 20.66 13.08 16 72172 1156 46612718
Red blood cell sedimentation rate increased 20.61 13.08 5 72183 22884 46590990
Oesophageal carcinoma 20.60 13.08 14 72174 825 46613049
Bone marrow infiltration 20.58 13.08 11 72177 417 46613457
Liver function test abnormal 20.49 13.08 25 72163 46462 46567412
Neutrophil count abnormal 20.49 13.08 22 72166 2428 46611446
Gait apraxia 20.46 13.08 5 72183 15 46613859
Pigmentation disorder 20.43 13.08 27 72161 3706 46610168
Foot fracture 20.35 13.08 3 72185 19579 46594295
Carbohydrate antigen 19-9 increased 20.30 13.08 8 72180 147 46613727
Duodenal perforation 20.30 13.08 14 72174 845 46613029
Gastric disorder 20.17 13.08 8 72180 26697 46587177
Platelet count decreased 20.17 13.08 240 71948 99784 46514090
Gait inability 20.11 13.08 15 72173 35188 46578686
Muscle spasms 20.08 13.08 110 72078 123003 46490871
Portal vein dilatation 19.99 13.08 5 72183 17 46613857
HER2 positive breast cancer 19.98 13.08 7 72181 91 46613783
Confusional state 19.92 13.08 155 72033 159737 46454137
International normalised ratio increased 19.85 13.08 26 72162 46857 46567017
Eczema herpeticum 19.84 13.08 7 72181 93 46613781
Heart rate increased 19.80 13.08 55 72133 74736 46539138
Blood glucose increased 19.78 13.08 52 72136 71961 46541913
Dyskinesia 19.75 13.08 10 72178 28915 46584959
Pulmonary fistula 19.66 13.08 4 72184 3 46613871
Blood phosphorus decreased 19.62 13.08 27 72161 3853 46610021
Herpes zoster 19.42 13.08 48 72140 67824 46546050
Wound decomposition 19.35 13.08 5 72183 20 46613854
Treatment noncompliance 19.25 13.08 11 72177 29720 46584154
Myeloproliferative neoplasm 19.17 13.08 11 72177 480 46613394
Protein urine 19.14 13.08 12 72176 616 46613258
Electrocardiogram ST segment elevation 19.11 13.08 26 72162 3669 46610205
Nodular regenerative hyperplasia 18.99 13.08 9 72179 263 46613611
Nephrolithiasis 18.99 13.08 14 72174 33037 46580837
Acute abdomen 18.87 13.08 17 72171 1515 46612359
Oesophagitis 18.79 13.08 55 72133 13596 46600278
Drug level increased 18.76 13.08 3 72185 18438 46595436
Recurrent cancer 18.74 13.08 18 72170 1741 46612133
Blood pressure fluctuation 18.69 13.08 12 72176 30436 46583438
Lymphangiosis carcinomatosa 18.61 13.08 15 72173 1149 46612725
Tumour marker increased 18.44 13.08 25 72163 3516 46610358
Withdrawal syndrome 18.34 13.08 3 72185 18131 46595743
Blood creatine phosphokinase increased 18.32 13.08 10 72178 27714 46586160
Chronic villitis of unknown etiology 18.24 13.08 4 72184 6 46613868
Dysgeusia 18.16 13.08 116 72072 40375 46573499
Cardiac arrest 18.12 13.08 75 72113 90324 46523550
Radiation skin injury 18.01 13.08 13 72175 844 46613030
Anal inflammation 17.95 13.08 7 72181 125 46613749
Myalgia 17.94 13.08 114 72074 122974 46490900
Pelvic fluid collection 17.76 13.08 13 72175 863 46613011
Proctitis 17.75 13.08 17 72171 1638 46612236
Vesical fistula 17.64 13.08 6 72182 71 46613803
Respiratory failure 17.60 13.08 224 71964 94592 46519282
Pelvic abscess 17.57 13.08 16 72172 1446 46612428
Splenic marginal zone lymphoma recurrent 17.51 13.08 4 72184 8 46613866
Recall phenomenon 17.51 13.08 11 72177 567 46613307
Diaphragmatic paralysis 17.40 13.08 11 72177 573 46613301
Device dislocation 17.36 13.08 6 72182 21796 46592078
Respiratory arrest 17.35 13.08 16 72172 33800 46580074
Rib fracture 17.35 13.08 4 72184 18950 46594924
Vitamin B1 deficiency 17.26 13.08 8 72180 222 46613652
Intercepted product administration error 17.20 13.08 6 72182 77 46613797
K-ras gene mutation 17.19 13.08 4 72184 9 46613865
Portal shunt 17.19 13.08 4 72184 9 46613865
Cutaneous tuberculosis 17.17 13.08 7 72181 141 46613733
Lymphadenopathy mediastinal 17.17 13.08 20 72168 2414 46611460
Gastric perforation 17.14 13.08 15 72173 1287 46612587
Osteonecrosis 17.08 13.08 82 72106 25662 46588212
Wernicke's encephalopathy 17.02 13.08 5 72183 35 46613839
Productive cough 16.87 13.08 33 72155 50682 46563192
Metastases to chest wall 16.87 13.08 10 72178 464 46613410
Depressed mood 16.82 13.08 16 72172 33303 46580571
Surgery 16.79 13.08 12 72176 28773 46585101
Ocular vasculitis 16.78 13.08 5 72183 37 46613837
Neck pain 16.71 13.08 38 72150 55268 46558606
Osteoporosis 16.70 13.08 23 72165 40585 46573289
Chemotherapy 16.65 13.08 15 72173 1337 46612537
Endocardial fibrosis 16.62 13.08 4 72184 11 46613863
Pneumatosis intestinalis 16.61 13.08 18 72170 2007 46611867
Localised infection 16.60 13.08 8 72180 23793 46590081
Lower respiratory tract infection 16.52 13.08 38 72150 55051 46558823
Mental disorder 16.48 13.08 7 72181 22418 46591456
Hiatus hernia 16.48 13.08 4 72184 18298 46595576
SAPHO syndrome 16.47 13.08 6 72182 88 46613786
Road traffic accident 16.47 13.08 8 72180 23683 46590191
Endometrial dysplasia 16.37 13.08 4 72184 12 46613862
Nail disorder 16.24 13.08 37 72151 7859 46606015
Multiple organ dysfunction syndrome 16.22 13.08 136 72052 51574 46562300
Hypocalcaemia 16.13 13.08 83 72105 26702 46587172
Dandy-Walker syndrome 16.11 13.08 6 72182 94 46613780
Tongue oedema 16.08 13.08 25 72163 3981 46609893
Adenocarcinoma 16.01 13.08 19 72169 2340 46611534
Dry eye 15.97 13.08 14 72174 30308 46583566
Blood count abnormal 15.92 13.08 4 72184 17874 46596000
Aorto-oesophageal fistula 15.90 13.08 4 72184 14 46613860
Eosinophilia 15.81 13.08 5 72183 19212 46594662
Menopause 15.81 13.08 18 72170 2121 46611753
Pulmonary toxicity 15.74 13.08 27 72161 4666 46609208
Hypophosphataemia 15.68 13.08 35 72153 7332 46606542
Small intestinal perforation 15.67 13.08 14 72174 1234 46612640
Metastases to neck 15.64 13.08 5 72183 48 46613826
Anaemia of malignant disease 15.64 13.08 9 72179 395 46613479
Performance status decreased 15.58 13.08 22 72166 3215 46610659
Metastases to breast 15.58 13.08 8 72180 279 46613595
Pulmonary fibrosis 15.57 13.08 67 72121 20025 46593849
Adverse event 15.48 13.08 18 72170 34166 46579708
Back pain 15.47 13.08 230 71958 209809 46404065
Vaginal fistula 15.47 13.08 9 72179 403 46613471
Colon cancer recurrent 15.46 13.08 5 72183 50 46613824
Hydronephrosis 15.36 13.08 38 72150 8507 46605367
Fistula of small intestine 15.32 13.08 8 72180 289 46613585
Hypermetabolism 15.24 13.08 6 72182 110 46613764
Agitation 15.23 13.08 40 72148 55375 46558499
Restless legs syndrome 15.20 13.08 3 72185 15840 46598034
Monoparesis 15.20 13.08 15 72173 1500 46612374
Hyperpyrexia 15.13 13.08 20 72168 2746 46611128
Herpes simplex encephalitis 15.12 13.08 8 72180 297 46613577
Hypoglycaemia 15.11 13.08 39 72149 54310 46559564
Enterocolitis 15.08 13.08 31 72157 6137 46607737
Left ventricular dilatation 15.07 13.08 8 72180 299 46613575
Night sweats 15.07 13.08 12 72176 27238 46586636
Systolic dysfunction 15.06 13.08 14 72174 1300 46612574
Carbohydrate antigen 15-3 increased 14.97 13.08 12 72176 912 46612962
Gastroenteropancreatic neuroendocrine tumour disease 14.95 13.08 5 72183 56 46613818
Facial discomfort 14.93 13.08 4 72184 19 46613855
Marchiafava-Bignami disease 14.93 13.08 4 72184 19 46613855
Acute coronary syndrome 14.90 13.08 42 72146 10162 46603712
Sopor 14.88 13.08 6 72182 19822 46594052
Red blood cell nucleated morphology present 14.76 13.08 4 72184 20 46613854
Ankle fracture 14.75 13.08 3 72185 15508 46598366
Multiple-drug resistance 14.73 13.08 19 72169 2546 46611328
Hypothyroidism 14.73 13.08 16 72172 31322 46582552
Off label use 14.72 13.08 723 71465 379118 46234756
Intracardiac thrombus 14.70 13.08 18 72170 2290 46611584
Oesophageal stenosis 14.67 13.08 20 72168 2829 46611045
Acute polyneuropathy 14.63 13.08 7 72181 209 46613665
Venous thrombosis limb 14.59 13.08 20 72168 2843 46611031
Skin exfoliation 14.55 13.08 94 72094 32844 46581030
Nasal crusting 14.54 13.08 7 72181 212 46613662
Anal erosion 14.44 13.08 4 72184 22 46613852
Percussion test abnormal 14.35 13.08 3 72185 3 46613871
Tumour obstruction 14.35 13.08 3 72185 3 46613871
Stoma site haemorrhage 14.33 13.08 12 72176 970 46612904
Blood pressure systolic increased 14.32 13.08 14 72174 28773 46585101
Cardiac myxoma 14.30 13.08 7 72181 220 46613654
Toxic cardiomyopathy 14.27 13.08 6 72182 131 46613743
Administration site extravasation 14.26 13.08 10 72178 620 46613254
Toxic encephalopathy 14.26 13.08 27 72161 5035 46608839
Joint range of motion decreased 14.23 13.08 3 72185 15121 46598753
Musculoskeletal pain 14.16 13.08 58 72130 70070 46543804
Pleural effusion 14.15 13.08 193 71995 82759 46531115
Discomfort 14.15 13.08 32 72156 46638 46567236
Skin disorder 14.12 13.08 70 72118 22193 46591681
Necrosis 14.10 13.08 26 72162 4754 46609120
Rash 14.05 13.08 432 71756 356080 46257794
Oesophageal varices haemorrhage 13.95 13.08 13 72175 1210 46612664
Periodontal disease 13.94 13.08 15 72173 1660 46612214
Cholelithiasis 13.90 13.08 24 72164 38657 46575217
T-cell type acute leukaemia 13.87 13.08 5 72183 71 46613803
Duodenal obstruction 13.82 13.08 7 72181 237 46613637
Chronic myeloid leukaemia 13.80 13.08 18 72170 2440 46611434
Portal vein thrombosis 13.74 13.08 18 72170 2449 46611425
Vascular pain 13.74 13.08 10 72178 658 46613216
Rash pustular 13.73 13.08 32 72156 6897 46606977
Erythema 13.73 13.08 303 71885 142517 46471357
Hypertensive encephalopathy 13.70 13.08 10 72178 661 46613213
Oral pain 13.67 13.08 75 72113 24722 46589152
Gallbladder disorder 13.62 13.08 5 72183 17493 46596381
Metastases to bone marrow 13.61 13.08 7 72181 245 46613629
Viral infection 13.60 13.08 16 72172 30219 46583655
Malignant neoplasm of pleura 13.56 13.08 5 72183 76 46613798
Metastases to abdominal wall 13.56 13.08 5 72183 76 46613798
Peripheral nerve injury 13.54 13.08 8 72180 369 46613505
Tremor 13.52 13.08 114 72074 115525 46498349
Systemic infection 13.43 13.08 10 72178 681 46613193
Spinal cord compression 13.43 13.08 22 72166 3662 46610212
Enterocolitis infectious 13.39 13.08 14 72174 1499 46612375
Pneumothorax spontaneous 13.37 13.08 9 72179 522 46613352
Accidental exposure to product 13.36 13.08 8 72180 21073 46592801
Bursitis 13.34 13.08 7 72181 19835 46594039
Red cell fragmentation syndrome 13.27 13.08 4 72184 31 46613843
Product intolerance 13.27 13.08 4 72184 31 46613843
Gingival atrophy 13.27 13.08 4 72184 31 46613843
Encapsulating peritoneal sclerosis 13.25 13.08 8 72180 384 46613490
Chronic kidney disease 13.24 13.08 27 72161 40844 46573030
Haemolysis 13.14 13.08 29 72159 6030 46607844
Optic disc hyperaemia 13.13 13.08 3 72185 6 46613868
Lhermitte's sign 13.13 13.08 3 72185 6 46613868
Periportal sinus dilatation 13.13 13.08 3 72185 6 46613868
Type II hypersensitivity 13.13 13.08 3 72185 6 46613868
Scintillating scotoma 13.13 13.08 6 72182 161 46613713
Pulmonary artery thrombosis 13.12 13.08 10 72178 706 46613168
Cerebral infarction 13.10 13.08 71 72117 23295 46590579

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 1137.12 13.60 1555 79062 126985 29744876
Diarrhoea 936.45 13.60 2466 78151 331637 29540224
Dermatitis acneiform 814.94 13.60 367 80250 5322 29866539
Mucosal inflammation 737.94 13.60 630 79987 29864 29841997
Neuropathy peripheral 706.73 13.60 908 79709 69567 29802294
Stomatitis 623.99 13.60 627 79990 36652 29835209
Disease progression 512.65 13.60 833 79784 79041 29792820
Arteriospasm coronary 486.51 13.60 203 80414 2415 29869446
Palmar-plantar erythrodysaesthesia syndrome 458.30 13.60 354 80263 14516 29857345
Skin toxicity 447.52 13.60 204 80413 3045 29868816
Paronychia 401.98 13.60 185 80432 2826 29869035
Thrombocytopenia 378.80 13.60 1010 79607 136034 29735827
Interstitial lung disease 378.06 13.60 622 79995 59575 29812286
Metastases to liver 366.84 13.60 284 80333 11681 29860180
Neurotoxicity 342.59 13.60 284 80333 12898 29858963
Leukopenia 315.14 13.60 552 80065 55607 29816254
Nausea 286.83 13.60 1561 79056 295396 29576465
Decreased appetite 281.05 13.60 964 79653 148946 29722915
Febrile neutropenia 252.74 13.60 744 79873 105949 29765912
Peripheral sensory neuropathy 249.03 13.60 170 80447 5731 29866130
Vomiting 244.00 13.60 1202 79415 218616 29653245
Completed suicide 239.42 13.60 6 80611 99486 29772375
Cardiotoxicity 224.77 13.60 143 80474 4271 29867590
Drug ineffective 224.66 13.60 357 80260 340030 29531831
Hyperammonaemia 214.11 13.60 151 80466 5369 29866492
Colorectal cancer metastatic 211.04 13.60 85 80532 917 29870944
Gastrointestinal perforation 206.48 13.60 126 80491 3490 29868371
Proteinuria 205.33 13.60 235 80382 15910 29855951
Bone marrow failure 204.86 13.60 321 80296 29464 29842397
Colorectal cancer 199.67 13.60 97 80520 1682 29870179
Metastases to lung 198.68 13.60 167 80450 7728 29864133
Gastrointestinal toxicity 194.34 13.60 99 80518 1909 29869952
Drug interaction 189.16 13.60 156 80461 199412 29672449
Hyperammonaemic encephalopathy 175.81 13.60 90 80527 1754 29870107
Dehydration 168.16 13.60 718 79899 122821 29749040
Arthralgia 164.45 13.60 80 80537 135711 29736150
Hypomagnesaemia 161.42 13.60 211 80406 16387 29855474
Polyneuropathy 158.69 13.60 177 80440 11646 29860215
Neutrophil count decreased 156.41 13.60 350 80267 42104 29829757
General physical health deterioration 150.21 13.60 599 80018 99345 29772516
Product dose omission issue 149.56 13.60 32 80585 91599 29780262
Intestinal obstruction 146.11 13.60 217 80400 18995 29852866
Alopecia 145.57 13.60 217 80400 19058 29852803
Carcinoembryonic antigen increased 132.97 13.60 54 80563 596 29871265
Headache 132.79 13.60 178 80439 182128 29689733
Fall 129.02 13.60 181 80436 181691 29690170
Abdominal pain 123.40 13.60 703 79914 134951 29736910
Skin reaction 122.77 13.60 100 80517 4425 29867436
Portal venous gas 122.13 13.60 42 80575 278 29871583
Pulmonary embolism 115.48 13.60 466 80151 77669 29794192
Pneumatosis intestinalis 114.68 13.60 78 80539 2612 29869249
Portal hypertension 114.48 13.60 90 80527 3783 29868078
Cardiac failure congestive 112.82 13.60 43 80574 84364 29787497
Rhabdomyolysis 106.21 13.60 21 80596 63559 29808302
Anxiety 104.17 13.60 56 80561 89815 29782046
Pyrexia 103.43 13.60 1228 79389 293261 29578600
Myalgia 100.89 13.60 40 80577 76627 29795234
Paraesthesia 100.22 13.60 348 80269 53979 29817882
Somnolence 92.29 13.60 75 80542 96688 29775173
Depression 91.47 13.60 66 80551 90371 29781490
Haematotoxicity 90.84 13.60 97 80520 6073 29865788
Weight increased 90.80 13.60 44 80573 74869 29796992
Neoplasm progression 90.54 13.60 169 80448 17854 29854007
Malignant neoplasm progression 88.98 13.60 408 80209 71879 29799982
Ileus 88.53 13.60 154 80463 15401 29856460
Pain in extremity 88.16 13.60 100 80517 110121 29761740
Psoriasis 87.92 13.60 7 80610 42499 29829362
Hospitalisation 87.10 13.60 9 80608 44310 29827551
Enteritis 84.93 13.60 97 80520 6548 29865313
Large intestine perforation 83.44 13.60 103 80514 7548 29864313
Hiccups 82.64 13.60 114 80503 9320 29862541
Oesophageal fistula 82.64 13.60 28 80589 176 29871685
Aggression 82.54 13.60 4 80613 36903 29834958
Ileal perforation 82.15 13.60 40 80577 697 29871164
Insomnia 81.01 13.60 79 80538 93257 29778604
Pelvic abscess 80.85 13.60 43 80574 909 29870952
Extravasation 80.30 13.60 54 80563 1774 29870087
Toxicity to various agents 80.29 13.60 229 80388 176954 29694907
Chills 79.39 13.60 395 80222 71943 29799918
Rheumatoid arthritis 79.35 13.60 9 80608 41188 29830673
Death 78.95 13.60 601 80016 356682 29515179
Necrotising fasciitis 78.71 13.60 69 80548 3380 29868481
Pneumonia 76.87 13.60 556 80061 333750 29538111
Intentional product misuse 76.76 13.60 4 80613 34663 29837198
Small intestinal obstruction 76.13 13.60 134 80483 13525 29858336
Colon cancer 76.11 13.60 103 80514 8269 29863592
Peritonitis 75.08 13.60 173 80444 21202 29850659
Suicidal ideation 74.54 13.60 6 80611 36108 29835753
Anastomotic complication 73.94 13.60 29 80588 290 29871571
Leukoencephalopathy 73.69 13.60 71 80546 3931 29867930
Hallucination 72.51 13.60 21 80596 49038 29822823
Overdose 72.47 13.60 72 80545 84265 29787596
Asthma 71.99 13.60 7 80610 36167 29835694
Aorto-oesophageal fistula 70.99 13.60 18 80599 30 29871831
Chronic obstructive pulmonary disease 69.55 13.60 19 80598 46107 29825754
Peripheral swelling 69.37 13.60 39 80578 61035 29810826
Electrocardiogram ST segment elevation 69.25 13.60 72 80545 4370 29867491
Subileus 68.93 13.60 61 80556 3026 29868835
Hypokalaemia 68.32 13.60 292 80325 49900 29821961
Colon cancer metastatic 67.45 13.60 47 80570 1638 29870223
Device related infection 66.83 13.60 144 80473 16871 29854990
Metastases to lymph nodes 66.61 13.60 67 80550 3910 29867951
Dermatitis 66.29 13.60 95 80522 8047 29863814
Blood glucose increased 66.08 13.60 42 80575 61488 29810373
Ascites 65.26 13.60 229 80388 35692 29836169
Focal nodular hyperplasia 65.11 13.60 22 80595 137 29871724
Small intestinal perforation 64.78 13.60 46 80571 1653 29870208
Septic shock 63.97 13.60 339 80278 63268 29808593
Anastomotic leak 63.85 13.60 32 80585 595 29871266
Injection site pain 62.66 13.60 5 80612 30305 29841556
Folliculitis 62.21 13.60 62 80555 3578 29868283
Confusional state 61.96 13.60 173 80444 134661 29737200
Dizziness 61.86 13.60 292 80325 194617 29677244
Influenza 61.57 13.60 20 80597 43378 29828483
Cholangitis 60.56 13.60 89 80528 7713 29864148
Coronary artery disease 60.53 13.60 29 80588 49683 29822178
Dry skin 60.22 13.60 164 80453 22290 29849571
Myocardial infarction 59.35 13.60 159 80458 125466 29746395
Cholinergic syndrome 58.34 13.60 28 80589 472 29871389
Joint swelling 57.75 13.60 27 80590 46919 29824942
Rash pustular 57.45 13.60 69 80548 4914 29866947
Tumour necrosis 57.11 13.60 36 80581 1057 29870804
Feeling abnormal 56.61 13.60 42 80575 56714 29815147
Muscle spasms 56.09 13.60 55 80562 64783 29807078
Intestinal perforation 56.02 13.60 90 80527 8429 29863432
Rectal cancer metastatic 56.00 13.60 22 80595 221 29871640
Disseminated intravascular coagulation 55.58 13.60 158 80459 22013 29849848
Agitation 55.25 13.60 39 80578 54034 29817827
Metastases to peritoneum 54.44 13.60 40 80577 1517 29870344
Adenocarcinoma of colon 54.29 13.60 55 80562 3237 29868624
Intravascular haemolysis 54.12 13.60 25 80592 385 29871476
Epistaxis 53.69 13.60 283 80334 52698 29819163
Incorrect drug administration rate 53.39 13.60 35 80582 1101 29870760
Venous thrombosis 53.28 13.60 54 80563 3180 29868681
Asthenia 53.09 13.60 863 79754 220427 29651434
Tumour perforation 52.76 13.60 22 80595 261 29871600
Tremor 52.33 13.60 76 80541 75287 29796574
Bradycardia 50.68 13.60 61 80556 65465 29806396
Anastomotic fistula 49.59 13.60 14 80603 42 29871819
Carbohydrate antigen 19-9 increased 49.44 13.60 19 80598 179 29871682
Anal haemorrhage 48.85 13.60 39 80578 1676 29870185
Contusion 48.84 13.60 12 80605 31268 29840593
Sinusitis 47.95 13.60 15 80602 33330 29838531
Malignant ascites 47.90 13.60 23 80594 388 29871473
Oesophagitis 47.89 13.60 98 80519 11073 29860788
Conjunctivitis 47.87 13.60 81 80536 7919 29863942
Therapeutic product effect decreased 47.71 13.60 10 80607 29066 29842795
Disturbance in attention 47.62 13.60 3 80614 22126 29849735
Fluid retention 46.80 13.60 6 80611 24992 29846869
Injury 46.60 13.60 3 80614 21728 29850133
Rectal perforation 46.31 13.60 22 80595 362 29871499
Unevaluable event 46.24 13.60 14 80603 31771 29840090
Subclavian vein thrombosis 46.02 13.60 29 80588 851 29871010
Incorrect dose administered 46.02 13.60 14 80603 31672 29840189
Vena cava thrombosis 45.87 13.60 31 80586 1027 29870834
Foetal exposure during pregnancy 45.66 13.60 21 80596 36850 29835011
Mucosal toxicity 45.54 13.60 18 80599 184 29871677
Fistula 45.02 13.60 62 80555 5060 29866801
Cardiac disorder 44.54 13.60 26 80591 39867 29831994
Dysphonia 44.21 13.60 132 80485 18900 29852961
Electrocardiogram QT prolonged 43.47 13.60 21 80596 35814 29836047
Memory impairment 43.28 13.60 23 80594 37151 29834710
Pulmonary artery thrombosis 42.89 13.60 25 80592 635 29871226
Treatment noncompliance 42.87 13.60 8 80609 25245 29846616
Stress 42.78 13.60 3 80614 20232 29851629
Administration site extravasation 42.72 13.60 21 80596 374 29871487
Wheezing 42.59 13.60 15 80602 30923 29840938
Hypoglycaemia 42.10 13.60 45 80572 50936 29820925
Large intestinal obstruction 41.97 13.60 33 80584 1387 29870474
Cytomegalovirus oesophagitis 41.90 13.60 18 80599 231 29871630
Transdifferentiation of neoplasm 41.01 13.60 13 80604 64 29871797
Product use issue 41.00 13.60 38 80579 45978 29825883
Bacterial translocation 40.96 13.60 18 80599 245 29871616
Rectal cancer 40.81 13.60 39 80578 2137 29869724
Acral peeling skin syndrome 40.68 13.60 12 80605 44 29871817
Proteus infection 40.37 13.60 25 80592 711 29871150
Drug hypersensitivity 40.24 13.60 77 80540 68442 29803419
Nicotinic acid deficiency 40.05 13.60 13 80604 70 29871791
Irritability 39.79 13.60 7 80610 23043 29848818
Myelosuppression 39.72 13.60 71 80546 7251 29864610
Abnormal behaviour 39.68 13.60 10 80607 25613 29846248
Tumour haemorrhage 39.45 13.60 41 80576 2487 29869374
Aortic thrombosis 39.44 13.60 24 80593 661 29871200
Colon cancer recurrent 39.32 13.60 14 80603 104 29871757
Acute coronary syndrome 39.29 13.60 102 80515 13471 29858390
Nasopharyngitis 39.25 13.60 61 80556 58788 29813073
Cytomegalovirus infection 39.14 13.60 8 80609 23666 29848195
Liver abscess 38.97 13.60 46 80571 3216 29868645
Intestinal ischaemia 38.86 13.60 68 80549 6829 29865032
Skin fissures 38.63 13.60 47 80570 3392 29868469
Odynophagia 38.59 13.60 54 80563 4473 29867388
Enterovesical fistula 38.37 13.60 23 80594 616 29871245
Pelvic fluid collection 38.32 13.60 14 80603 113 29871748
Musculoskeletal stiffness 37.82 13.60 25 80592 35856 29836005
Therapy partial responder 37.55 13.60 48 80569 3643 29868218
International normalised ratio increased 37.38 13.60 44 80573 47695 29824166
Hyperkalaemia 37.19 13.60 76 80541 65934 29805927
Hyperbilirubinaemia 37.01 13.60 115 80502 16827 29855034
Gastric perforation 36.59 13.60 36 80581 2045 29869816
Off label use 36.50 13.60 903 79714 248387 29623474
Skin disorder 36.49 13.60 90 80527 11518 29860343
Perforation 36.42 13.60 15 80602 172 29871689
Oesophagobronchial fistula 36.14 13.60 14 80603 135 29871726
Venoocclusive liver disease 35.72 13.60 64 80553 6549 29865312
Respiratory arrest 35.71 13.60 17 80600 29241 29842620
Diabetes mellitus 35.64 13.60 36 80581 41829 29830032
Duodenal perforation 35.63 13.60 28 80589 1176 29870685
Stress cardiomyopathy 35.37 13.60 31 80586 1518 29870343
Cellulitis 34.66 13.60 45 80572 46739 29825122
Tumour marker increased 34.63 13.60 20 80597 499 29871362
Subacute cutaneous lupus erythematosus 34.57 13.60 22 80595 657 29871204
Induration 34.55 13.60 24 80593 832 29871029
Hypertransaminasaemia 34.10 13.60 47 80570 3838 29868023
Abdominal discomfort 34.06 13.60 49 80568 48742 29823119
Gastrointestinal necrosis 33.82 13.60 43 80574 3246 29868615
Hypersensitivity 33.72 13.60 255 80362 53773 29818088
Oesophageal perforation 33.63 13.60 19 80598 454 29871407
Arthritis 33.30 13.60 12 80605 24389 29847472
White blood cell count decreased 33.28 13.60 359 80258 83588 29788273
Renal disorder 33.21 13.60 11 80606 23573 29848288
Laryngospasm 32.94 13.60 28 80589 1315 29870546
Pain 32.70 13.60 302 80315 172339 29699522
Blood creatine phosphokinase increased 32.66 13.60 42 80575 43806 29828055
Influenza like illness 32.62 13.60 14 80603 25591 29846270
Hallucination, visual 32.37 13.60 3 80614 16110 29855751
Left ventricular dysfunction 32.36 13.60 72 80545 8619 29863242
Psychotic disorder 32.17 13.60 9 80608 21506 29850355
Gait disturbance 32.09 13.60 99 80518 74678 29797183
Chronic kidney disease 31.68 13.60 33 80584 37805 29834056
Acne 31.63 13.60 75 80542 9361 29862500
Neutropenic sepsis 31.26 13.60 84 80533 11325 29860536
Colitis microscopic 30.95 13.60 30 80587 1673 29870188
Oesophageal stenosis 30.88 13.60 29 80588 1554 29870307
Enterocutaneous fistula 30.67 13.60 21 80596 711 29871150
Stoma site haemorrhage 30.65 13.60 23 80594 901 29870960
Portal vein thrombosis 30.55 13.60 42 80575 3422 29868439
Tumour lysis syndrome 30.53 13.60 90 80527 12795 29859066
Vasospasm 30.05 13.60 16 80601 339 29871522
Hypertension 30.03 13.60 476 80141 120878 29750983
Hypophagia 29.95 13.60 129 80488 22107 29849754
Lung neoplasm malignant 29.91 13.60 3 80614 15129 29856732
Peritoneal neoplasm 29.70 13.60 9 80608 37 29871824
Bronchitis 29.63 13.60 37 80580 39088 29832773
Recall phenomenon 29.48 13.60 19 80598 580 29871281
Liver function test abnormal 29.46 13.60 24 80593 30926 29840935
Nephrolithiasis 29.39 13.60 15 80602 24795 29847066
Oral pain 29.32 13.60 73 80544 9396 29862465
Balance disorder 29.25 13.60 33 80584 36460 29835401
Hepatic lesion 29.14 13.60 39 80578 3097 29868764
Anal fissure 29.04 13.60 34 80583 2357 29869504
Hypovolaemic shock 29.02 13.60 58 80559 6442 29865419
Proctitis 28.71 13.60 32 80585 2102 29869759
Dysphagia 28.59 13.60 255 80362 56443 29815418
Subdural haematoma 28.25 13.60 8 80609 18964 29852897
Cerebrovascular accident 28.25 13.60 122 80495 83355 29788506
Acute abdomen 28.13 13.60 29 80588 1742 29870119
Mouth ulceration 27.95 13.60 77 80540 10532 29861329
Dyspnoea 27.87 13.60 684 79933 332611 29539250
Nodular regenerative hyperplasia 27.79 13.60 20 80597 734 29871127
Hypoalbuminaemia 27.75 13.60 79 80538 11013 29860848
Catheter site thrombosis 27.63 13.60 8 80609 27 29871834
Head injury 27.62 13.60 6 80611 17014 29854847
Aphthous ulcer 27.57 13.60 44 80573 4097 29867764
Colitis 27.44 13.60 159 80458 30661 29841200
Jugular vein thrombosis 27.43 13.60 26 80591 1410 29870451
Proctalgia 27.14 13.60 45 80572 4327 29867534
Drug level increased 26.85 13.60 8 80609 18346 29853515
Nail toxicity 26.77 13.60 8 80609 31 29871830
Emotional distress 26.75 13.60 5 80612 15760 29856101
Pneumonitis 26.67 13.60 145 80472 27309 29844552
Urticaria 26.60 13.60 68 80549 54538 29817323
Device related thrombosis 26.53 13.60 20 80597 789 29871072
PIK3CA-activated mutation 26.42 13.60 10 80607 90 29871771
Anaemia of malignant disease 26.35 13.60 16 80601 439 29871422
Cough 26.34 13.60 214 80403 125428 29746433
Pancreatitis 26.11 13.60 36 80581 36454 29835407
Biliary tract infection 26.09 13.60 16 80601 447 29871414
Anaemia 25.95 13.60 738 79879 207254 29664607
Seizure 25.90 13.60 157 80460 98318 29773543
Dihydropyrimidine dehydrogenase deficiency 25.86 13.60 9 80608 62 29871799
Hepatitis B 25.71 13.60 53 80564 6019 29865842
Nephrotic syndrome 25.59 13.60 57 80560 6828 29865033
Carbohydrate antigen 15-3 increased 25.38 13.60 9 80608 66 29871795
Sleep apnoea syndrome 25.30 13.60 7 80610 16850 29855011
Protein urine 25.29 13.60 18 80599 649 29871212
Toxic erythema of chemotherapy 24.97 13.60 8 80609 41 29871820
Gastrointestinal ischaemia 24.91 13.60 12 80605 204 29871657
Pneumonitis chemical 24.88 13.60 11 80606 152 29871709
Nail disorder 24.67 13.60 27 80590 1738 29870123
Anal erythema 24.60 13.60 9 80608 73 29871788
Adenocarcinoma 24.57 13.60 27 80590 1746 29870115
Adverse drug reaction 24.56 13.60 16 80601 23129 29848732
Pneumoperitoneum 24.52 13.60 26 80591 1614 29870247
Splenomegaly 24.52 13.60 86 80531 13394 29858467
Enterocolitis 24.45 13.60 55 80562 6632 29865229
Injection site erythema 24.32 13.60 4 80613 13830 29858031
Neutropenic colitis 24.28 13.60 30 80587 2200 29869661
Rectal adenocarcinoma 24.22 13.60 19 80598 796 29871065
Sedation 24.20 13.60 7 80610 16366 29855495
Eosinophilia 23.95 13.60 15 80602 22145 29849716
Soft tissue disorder 23.76 13.60 17 80600 618 29871243
Prothrombin level decreased 23.73 13.60 22 80595 1160 29870701
Conjunctival filtering bleb leak 23.66 13.60 6 80611 10 29871851
Deep vein thrombosis 23.63 13.60 258 80359 60243 29811618
Haematoma 23.52 13.60 18 80599 23935 29847926
Perforation bile duct 23.52 13.60 8 80609 51 29871810
Koebner phenomenon 23.52 13.60 8 80609 51 29871810
Fluid overload 23.44 13.60 11 80606 19081 29852780
Abdominal pain lower 23.32 13.60 64 80553 8734 29863127
Pulmonary fibrosis 22.81 13.60 94 80523 15796 29856065
Embolism 22.73 13.60 55 80562 6954 29864907
Cachexia 22.65 13.60 53 80564 6558 29865303
Perineal disorder 22.52 13.60 8 80609 59 29871802
Retroperitoneal abscess 22.47 13.60 11 80606 194 29871667
Xerosis 22.43 13.60 15 80602 488 29871373
Venous thrombosis limb 22.37 13.60 26 80591 1788 29870073
Drug intolerance 22.37 13.60 56 80561 45235 29826626
Necrotising oesophagitis 22.24 13.60 14 80603 410 29871451
Pachymeningitis 22.11 13.60 9 80608 100 29871761
Blood cholesterol increased 22.06 13.60 9 80608 16961 29854900
Pseudocirrhosis 22.05 13.60 6 80611 15 29871846
Wrong technique in product usage process 22.02 13.60 31 80586 31124 29840737
Abdominal abscess 21.94 13.60 39 80578 3965 29867896
Erythema 21.94 13.60 311 80306 77140 29794721
Metastasis 21.90 13.60 35 80582 3263 29868598
Diabetes mellitus inadequate control 21.75 13.60 4 80613 12758 29859103
Superior vena cava syndrome 21.74 13.60 14 80603 427 29871434
Cell-mediated cytotoxicity 21.67 13.60 7 80610 37 29871824
Colitis ulcerative 21.65 13.60 6 80611 14428 29857433
Rectosigmoid cancer 21.65 13.60 10 80607 154 29871707
Perioral dermatitis 21.64 13.60 9 80608 106 29871755
Blood pressure fluctuation 21.62 13.60 10 80607 17493 29854368
Balanoposthitis 21.55 13.60 20 80597 1056 29870805
Bacteraemia 21.52 13.60 91 80526 15469 29856392
Blood pressure increased 21.46 13.60 110 80507 71818 29800043
Hepatectomy 21.43 13.60 8 80609 69 29871792
Mobility decreased 21.40 13.60 23 80594 25976 29845885
Condition aggravated 21.26 13.60 253 80364 137613 29734248
Interventricular septum rupture 21.25 13.60 6 80611 18 29871843
Pulmonary oedema 21.23 13.60 55 80562 43920 29827941
Gout 21.22 13.60 10 80607 17305 29854556
Prostate cancer 21.08 13.60 20 80597 23937 29847924
Peritoneal adhesions 21.08 13.60 7 80610 41 29871820
Delirium 21.04 13.60 49 80568 40582 29831279
Ectropion 21.04 13.60 8 80609 73 29871788
Toxic epidermal necrolysis 21.02 13.60 11 80606 17929 29853932
Herpes zoster 20.96 13.60 30 80587 29913 29841948
Muscular weakness 20.93 13.60 94 80523 63551 29808310
Hepatitis C 20.74 13.60 5 80612 13200 29858661
Cataract 20.69 13.60 17 80600 21818 29850043
Anorectal discomfort 20.68 13.60 25 80592 1792 29870069
Hyperlipidaemia 20.45 13.60 6 80611 13901 29857960
Blood glucose decreased 20.39 13.60 5 80612 13048 29858813
Sepsis 20.38 13.60 527 80090 145868 29725993
Vestibular neuronitis 20.31 13.60 8 80609 81 29871780
Stevens-Johnson syndrome 20.23 13.60 11 80606 17545 29854316
Wound dehiscence 20.22 13.60 34 80583 3307 29868554
Acute respiratory distress syndrome 20.19 13.60 120 80497 23352 29848509
Anger 20.03 13.60 3 80614 11117 29860744
Prinzmetal angina 20.03 13.60 18 80599 911 29870950
Vocal cord paralysis 19.97 13.60 17 80600 800 29871061
Guillain-Barre syndrome 19.93 13.60 43 80574 5040 29866821
Metastases to pelvis 19.93 13.60 11 80606 251 29871610
Hepatic atrophy 19.90 13.60 10 80607 187 29871674
Stoma site pain 19.75 13.60 16 80601 702 29871159
Vision blurred 19.66 13.60 53 80564 41763 29830098
Perihepatic abscess 19.64 13.60 8 80609 89 29871772
Pancreatic carcinoma metastatic 19.59 13.60 33 80584 3214 29868647
Clostridial infection 19.47 13.60 35 80582 3590 29868271
Lower respiratory tract infection 19.47 13.60 26 80591 26688 29845173
Drug ineffective for unapproved indication 19.45 13.60 3 80614 10877 29860984
Pelvic venous thrombosis 19.40 13.60 14 80603 516 29871345
Full blood count decreased 19.38 13.60 9 80608 15708 29856153
Bacterial colitis 19.19 13.60 6 80611 28 29871833
Ischiorectal hernia 19.14 13.60 5 80612 10 29871851
Myoclonus 19.11 13.60 6 80611 13306 29858555
Varices oesophageal 19 13.60 34 80583 3475 29868386
Accidental overdose 18.90 13.60 13 80604 18262 29853599
Intestinal strangulation 18.85 13.60 6 80611 30 29871831
Lymph node abscess 18.82 13.60 5 80612 11 29871850
Product quality issue 18.57 13.60 14 80603 18760 29853101
Erectile dysfunction 18.55 13.60 13 80604 18089 29853772
Colorectal cancer recurrent 18.53 13.60 6 80611 32 29871829
Radiation mucositis 18.53 13.60 8 80609 104 29871757
Peritoneal haematoma 18.49 13.60 7 80610 63 29871798
Peritonitis bacterial 18.49 13.60 4 80613 11374 29860487
Dyskinesia 18.32 13.60 19 80598 21815 29850046
Thrombotic thrombocytopenic purpura 18.31 13.60 33 80584 3392 29868469
Underdose 18.30 13.60 5 80612 12136 29859725
Radiation skin injury 18.19 13.60 15 80602 675 29871186
Contraindicated product administered 18.16 13.60 12 80605 17219 29854642
Colony stimulating factor therapy 18.12 13.60 9 80608 164 29871697
Fixed eruption 18.11 13.60 19 80598 1165 29870696
Oesophageal haemorrhage 18.06 13.60 19 80598 1169 29870692
Gastrointestinal inflammation 18.06 13.60 30 80587 2889 29868972
Pancreatic neuroendocrine tumour metastatic 17.88 13.60 9 80608 169 29871692
Hypercreatininaemia 17.88 13.60 13 80604 485 29871376
Treatment failure 17.82 13.60 42 80575 34637 29837224
Rib fracture 17.79 13.60 6 80611 12714 29859147
Visceral venous thrombosis 17.71 13.60 5 80612 15 29871846
Mental disorder 17.70 13.60 7 80610 13442 29858419
Acute cutaneous lupus erythematosus 17.67 13.60 7 80610 72 29871789
Refeeding syndrome 17.67 13.60 6 80611 38 29871823
Nail ridging 17.67 13.60 6 80611 38 29871823
K-ras gene mutation 17.47 13.60 5 80612 16 29871845
Portal vein embolisation 17.45 13.60 4 80613 3 29871858
Gastrointestinal obstruction 17.37 13.60 15 80602 720 29871141
Enterocolitis haemorrhagic 17.36 13.60 17 80600 960 29870901
Oesophageal cancer metastatic 17.30 13.60 10 80607 250 29871611
Performance status decreased 17.30 13.60 35 80582 3922 29867939
Duodenal ulcer perforation 17.21 13.60 22 80595 1670 29870191
Adverse event 17.12 13.60 10 80607 15331 29856530
Primitive neuroectodermal tumour 17.10 13.60 7 80610 79 29871782
Premature baby 17.09 13.60 12 80605 16679 29855182
Dysaesthesia pharynx 17.04 13.60 6 80611 43 29871818
Unresponsive to stimuli 17.02 13.60 28 80589 26391 29845470
Pulmonary infarction 16.98 13.60 18 80599 1117 29870744
Inferior vena cava dilatation 16.97 13.60 9 80608 189 29871672
Tubulointerstitial nephritis 16.87 13.60 14 80603 17877 29853984
COVID-19 16.84 13.60 14 80603 17864 29853997
Tetany 16.83 13.60 15 80602 751 29871110
Viral infection 16.80 13.60 10 80607 15175 29856686
Acute motor-sensory axonal neuropathy 16.77 13.60 8 80609 133 29871728
Gastrointestinal anastomotic leak 16.75 13.60 11 80606 347 29871514
Gastrointestinal stoma complication 16.74 13.60 19 80598 1273 29870588
Myopathy 16.64 13.60 4 80613 10582 29861279
Pulmonary hypertension 16.62 13.60 16 80601 19020 29852841
VIth nerve disorder 16.61 13.60 5 80612 20 29871841
Road traffic accident 16.54 13.60 13 80604 17058 29854803
Osteoarthritis 16.52 13.60 15 80602 18334 29853527
Lymphangiosis carcinomatosa 16.49 13.60 16 80601 893 29870968
Anaphylactic shock 16.46 13.60 78 80539 13915 29857946
Renal salt-wasting syndrome 16.45 13.60 8 80609 139 29871722
Rectal abscess 16.45 13.60 16 80601 896 29870965
Hypersomnia 16.43 13.60 5 80612 11311 29860550
Fistula of small intestine 16.37 13.60 11 80606 361 29871500
B-cell small lymphocytic lymphoma 16.30 13.60 8 80609 142 29871719
Prostatic specific antigen increased 16.21 13.60 6 80611 11998 29859863
Duodenal stenosis 16.20 13.60 9 80608 208 29871653
Diffuse alveolar damage 16.18 13.60 23 80594 1933 29869928
Swelling face 16.11 13.60 20 80597 21184 29850677
Oesophageal squamous cell carcinoma metastatic 16.03 13.60 4 80613 6 29871855
Cerebral haemorrhage 15.98 13.60 41 80576 32846 29839015
Product prescribing error 15.89 13.60 13 80604 16720 29855141
Blood triglycerides increased 15.83 13.60 9 80608 14008 29857853
Monocytopenia 15.81 13.60 7 80610 97 29871764
Osteomyelitis 15.78 13.60 10 80607 14671 29857190
Periportal sinus dilatation 15.71 13.60 5 80612 25 29871836
Product use in unapproved indication 15.67 13.60 125 80492 73568 29798293
Hepatic artery occlusion 15.66 13.60 6 80611 56 29871805
Pigmentation disorder 15.56 13.60 23 80594 2003 29869858
Accidental exposure to product 15.56 13.60 4 80613 10111 29861750
Paraesthesia oral 15.55 13.60 32 80585 3629 29868232
Visual impairment 15.53 13.60 37 80580 30401 29841460
Neoplasm recurrence 15.51 13.60 22 80595 1845 29870016
Heart rate increased 15.40 13.60 53 80564 38668 29833193
Product substitution issue 15.37 13.60 4 80613 10031 29861830
Neurosarcoidosis 15.35 13.60 8 80609 162 29871699
Hepatic enzyme increased 15.33 13.60 43 80574 33451 29838410
Intrahepatic portal hepatic venous fistula 15.31 13.60 4 80613 8 29871853
Oral dysaesthesia 15.30 13.60 6 80611 60 29871801
Pneumoretroperitoneum 15.30 13.60 6 80611 60 29871801
Arthropathy 15.28 13.60 20 80597 20707 29851154
Injection site reaction 15.18 13.60 5 80612 10755 29861106
Rectal stenosis 15.17 13.60 8 80609 166 29871695
Product administration error 15.17 13.60 10 80607 14367 29857494
Heart rate irregular 15.15 13.60 7 80610 12252 29859609
Respiratory depression 15.12 13.60 6 80611 11497 29860364
Angioedema 15.11 13.60 45 80572 34339 29837522
Obstructive airways disorder 15.10 13.60 3 80614 9056 29862805
Tracheal stenosis 15.04 13.60 8 80609 169 29871692
Rectal ulcer 15.04 13.60 15 80602 866 29870995
Device related sepsis 14.93 13.60 24 80593 2248 29869613
Gastroenteritis radiation 14.88 13.60 10 80607 328 29871533
Dysgeusia 14.87 13.60 116 80501 24685 29847176
Laboratory test abnormal 14.84 13.60 15 80602 17427 29854434
Jaundice 14.80 13.60 143 80474 32343 29839518
No adverse event 14.80 13.60 15 80602 17404 29854457
Chemotherapy 14.79 13.60 12 80605 528 29871333
Abscess 14.77 13.60 60 80557 10018 29861843
Herpes simplex meningomyelitis 14.76 13.60 3 80614 0 29871861
Pneumomediastinum 14.73 13.60 21 80596 1770 29870091
Heart rate decreased 14.73 13.60 21 80596 20973 29850888
Tumour fistulisation 14.70 13.60 4 80613 10 29871851
Vascular device infection 14.57 13.60 21 80596 1788 29870073
Radiation interaction 14.55 13.60 5 80612 33 29871828
Non-cirrhotic portal hypertension 14.53 13.60 9 80608 256 29871605
Device infusion issue 14.52 13.60 12 80605 542 29871319
Swelling 14.47 13.60 49 80568 35926 29835935
Astringent therapy 14.42 13.60 4 80613 11 29871850
Cardiac ventricular thrombosis 14.41 13.60 14 80603 783 29871078
Evans syndrome 14.38 13.60 9 80608 261 29871600
Limbic encephalitis 14.25 13.60 9 80608 265 29871596
Stress ulcer 14.25 13.60 6 80611 73 29871788
Axillary vein thrombosis 14.24 13.60 8 80609 189 29871672
Drug-induced liver injury 14.22 13.60 22 80595 21252 29850609
Hernia 14.22 13.60 3 80614 8683 29863178
Sarcoidosis 14.21 13.60 26 80591 2703 29869158
Trichomegaly 14.17 13.60 4 80613 12 29871849
Temperature difference of extremities 14.17 13.60 4 80613 12 29871849
Oedema peripheral 14.17 13.60 200 80417 105632 29766229
Swollen tongue 14.16 13.60 9 80608 13183 29858678
Eye pain 14.15 13.60 7 80610 11782 29860079
Fatigue 14.14 13.60 1023 79594 319650 29552211
Intestinal mucosal hypertrophy 14.11 13.60 6 80611 75 29871786
Rectal haemorrhage 14.10 13.60 150 80467 34789 29837072
Productive cough 14.05 13.60 38 80579 29915 29841946
Bacteriuria 14.05 13.60 9 80608 272 29871589
Procedural vomiting 14.02 13.60 7 80610 129 29871732
Aspergillus infection 13.97 13.60 5 80612 10209 29861652
Hyperthermia 13.91 13.60 59 80558 10040 29861821
Localised infection 13.90 13.60 10 80607 13727 29858134
Suture rupture 13.82 13.60 10 80607 370 29871491
Necrotising colitis 13.76 13.60 15 80602 961 29870900
Anal fistula 13.70 13.60 32 80585 3954 29867907
Pulmonary arterial hypertension 13.70 13.60 4 80613 9297 29862564
Neck pain 13.68 13.60 22 80595 20922 29850939
Hepatic failure 13.66 13.60 146 80471 33897 29837964

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

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
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
Biliary Tract Malignancy off-label use
Metastatic Malignant Tumor of Anus off-label use
Pancreatic Neuroendocrine Tumor 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
ATP-binding cassette sub-family C member 11 Transporter WOMBAT-PK
Multidrug resistance-associated protein 5 Transporter WOMBAT-PK
Thymidylate synthase Enzyme IC50 7.70 CHEMBL
Uracil phosphoribosyltransferase Unclassified Ki 4.89 CHEMBL

External reference:

IDSource
4017806 VUID
N0000146166 NUI
D00584 KEGG_DRUG
C0016360 UMLSCUI
CHEBI:46345 CHEBI
URF PDB_CHEM_ID
CHEMBL185 ChEMBL_ID
3385 PUBCHEM_CID
DB00544 DRUGBANK_ID
D005472 MESH_DESCRIPTOR_UI
4789 IUPHAR_LIGAND_ID
1421 INN_ID
U3P01618RT UNII
202632 RXNORM
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 19 sections
Efudex HUMAN PRESCRIPTION DRUG LABEL 1 0187-3203 SOLUTION 1.25 g TOPICAL NDA 19 sections
Efudex HUMAN PRESCRIPTION DRUG LABEL 1 0187-3204 CREAM 2 g TOPICAL NDA 19 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 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 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 50742-423 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 23 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 50742-481 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 23 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 50742-482 INJECTION, SOLUTION 2.50 g INTRAVENOUS ANDA 24 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 50742-483 INJECTION, SOLUTION 5 g INTRAVENOUS ANDA 24 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 21 sections
FLUOROURACIL HUMAN PRESCRIPTION DRUG LABEL 1 51862-362 CREAM 50 mg TOPICAL ANDA 21 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