capecitabine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 480 154361-50-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • capecitabine
  • capecitibine
  • capecytabine
  • capiibine
  • captabin
  • xeloda
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
  • Molecular weight: 359.35
  • Formula: C15H22FN3O6
  • CLOGP: 0.84
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 3
  • TPSA: 120.69
  • ALOGS: -3.16
  • ROTB: 7

  • 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) 26 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 171.93 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 30, 1998 FDA HOFFMANN LA ROCHE

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
Palmar-plantar erythrodysaesthesia syndrome 6654.46 13.01 2201 90435 18250 46575176
Disease progression 2750.83 13.01 1895 90741 89405 46504021
Diarrhoea 1971.50 13.01 3757 88879 555845 46037581
Malignant neoplasm progression 1698.82 13.01 1238 91398 63688 46529738
Metastases to liver 1137.92 13.01 620 92016 18965 46574461
Metastases to bone 956.68 13.01 532 92104 16944 46576482
Breast cancer metastatic 909.95 13.01 474 92162 13204 46580222
Death 886.51 13.01 2010 90626 333538 46259888
Mucosal inflammation 881.93 13.01 682 91954 38294 46555132
Metastases to lung 548.31 13.01 312 92324 10384 46583042
Metastases to central nervous system 544.99 13.01 316 92320 10905 46582521
Stomatitis 525.06 13.01 662 91974 67635 46525791
Breast cancer 406.27 13.01 476 92160 45042 46548384
Neuropathy peripheral 385.68 13.01 666 91970 90227 46503199
Vomiting 384.49 13.01 1843 90793 450951 46142475
Neutropenia 376.11 13.01 858 91778 142346 46451080
Metastases to lymph nodes 346.76 13.01 196 92440 6435 46586991
Drug ineffective 340.33 13.01 514 92122 677324 45916102
Skin exfoliation 335.57 13.01 369 92267 32569 46560857
Neoplasm progression 332.72 13.01 333 92303 26350 46567076
Dehydration 315.65 13.01 858 91778 158682 46434744
Skin fissures 297.26 13.01 187 92449 7493 46585933
Bone marrow failure 287.80 13.01 324 92312 29345 46564081
Gastrointestinal toxicity 287.64 13.01 150 92486 4181 46589245
Skin toxicity 267.11 13.01 135 92501 3519 46589907
Completed suicide 264.68 13.01 5 92631 145915 46447511
Neurotoxicity 246.48 13.01 210 92426 13507 46579919
Metastases to skin 244.71 13.01 95 92541 1285 46592141
Nausea 226.34 13.01 2214 90422 685240 45908186
Paronychia 225.42 13.01 130 92506 4436 46588990
Decreased appetite 221.94 13.01 865 91771 192971 46400455
Dry skin 217.91 13.01 333 92303 40683 46552743
Drug hypersensitivity 213.12 13.01 109 92527 243716 46349710
Haematotoxicity 196.34 13.01 139 92497 6794 46586632
Condition aggravated 194.89 13.01 123 92513 244929 46348497
Osteonecrosis of jaw 192.25 13.01 286 92350 34116 46559310
Arteriospasm coronary 189.23 13.01 107 92529 3514 46589912
Fall 178.78 13.01 235 92401 328862 46264564
Metastasis 174.44 13.01 108 92528 4204 46589222
Skin discolouration 173.11 13.01 265 92371 32415 46561011
Thrombocytopenia 169.10 13.01 594 92042 125987 46467439
Arthralgia 166.63 13.01 293 92343 364310 46229116
Enteritis 165.34 13.01 124 92512 6631 46586795
Laryngospasm 164.07 13.01 90 92546 2783 46590643
Joint swelling 161.03 13.01 64 92572 166009 46427417
Exposure during pregnancy 157.38 13.01 16 92620 108196 46485230
Tumour marker increased 154.28 13.01 93 92543 3448 46589978
Dihydropyrimidine dehydrogenase deficiency 153.59 13.01 35 92601 46 46593380
Maternal exposure during pregnancy 144.47 13.01 17 92619 102532 46490894
Pseudocirrhosis 138.66 13.01 52 92584 636 46592790
Psoriasis 137.44 13.01 4 92632 78600 46514826
Metastases to peritoneum 132.33 13.01 76 92560 2572 46590854
Contraindicated product administered 126.86 13.01 8 92628 79939 46513487
Cardiotoxicity 125.03 13.01 105 92531 6617 46586809
Drug interaction 121.84 13.01 134 92502 202960 46390466
Headache 116.65 13.01 521 92115 477831 46115595
Osteonecrosis 116.07 13.01 194 92442 25550 46567876
Asthenia 115.58 13.01 1030 91606 310045 46283381
Ascites 114.98 13.01 236 92400 36348 46557078
Sinusitis 114.76 13.01 57 92579 129711 46463715
Nail disorder 114.29 13.01 107 92529 7789 46585637
Metastatic neoplasm 113.38 13.01 77 92559 3516 46589910
Metastases to spine 110.31 13.01 68 92568 2626 46590800
Pleural effusion 108.72 13.01 387 92249 82565 46510861
Therapy cessation 107.38 13.01 191 92445 26438 46566988
Weight increased 106.00 13.01 102 92534 164371 46429055
Myelosuppression 105.04 13.01 101 92535 7602 46585824
Systemic lupus erythematosus 104.99 13.01 6 92630 65174 46528252
Breast cancer recurrent 102.92 13.01 75 92561 3836 46589590
Injection site pain 101.04 13.01 43 92593 107109 46486317
Lymphangiosis carcinomatosa 99.96 13.01 48 92588 1116 46592310
Metastases to pleura 99.63 13.01 47 92589 1049 46592377
Bronchitis 99.19 13.01 43 92593 105936 46487490
Depression 97.90 13.01 116 92520 169988 46423438
Overdose 97.65 13.01 40 92596 101939 46491487
Ejection fraction decreased 97.15 13.01 147 92489 17790 46575636
Hepatic function abnormal 96.54 13.01 212 92424 34209 46559217
PIK3CA-activated mutation 94.74 13.01 38 92598 563 46592863
Arthropathy 93.65 13.01 26 92610 84674 46508752
Onycholysis 93.04 13.01 46 92590 1142 46592284
Pneumonia 92.73 13.01 408 92228 375912 46217514
Treatment failure 88.33 13.01 37 92599 93050 46500376
Product use issue 87.62 13.01 39 92597 94605 46498821
Arthritis 84.98 13.01 24 92612 77292 46516134
Therapeutic product effect decreased 84.77 13.01 29 92607 82572 46510854
Bradycardia 84.05 13.01 15 92621 66283 46527143
Influenza 83.88 13.01 36 92600 89234 46504192
Intentional overdose 83.86 13.01 14 92622 64930 46528496
Musculoskeletal stiffness 83.71 13.01 45 92591 97948 46495478
Hepatic lesion 83.27 13.01 66 92570 3831 46589595
Non-cirrhotic portal hypertension 82.01 13.01 22 92614 77 46593349
Asthma 78.24 13.01 42 92594 91500 46501926
Blood bilirubin increased 77.78 13.01 194 92442 33990 46559436
Therapeutic product effect incomplete 77.54 13.01 29 92607 78124 46515302
Carcinoembryonic antigen increased 77.33 13.01 43 92593 1366 46592060
Intestinal obstruction 77.01 13.01 164 92472 25911 46567515
Plasma cell myeloma 75.15 13.01 3 92633 44475 46548951
Polyneuropathy 72.60 13.01 102 92534 11542 46581884
Hospice care 71.39 13.01 69 92567 5226 46588200
Somnolence 71.09 13.01 126 92510 156395 46437031
Febrile neutropenia 69.61 13.01 371 92265 94256 46499170
Feeling abnormal 69.06 13.01 88 92548 124972 46468454
Jaundice 68.06 13.01 166 92470 28679 46564747
Paraesthesia 67.91 13.01 432 92204 117005 46476421
General physical health deterioration 67.64 13.01 427 92209 115342 46478084
Fingerprint loss 67.04 13.01 15 92621 17 46593409
Pruritus 66.98 13.01 251 92385 242101 46351325
Suicidal ideation 66.79 13.01 15 92621 56367 46537059
Suicide attempt 66.50 13.01 14 92622 55022 46538404
Infusion site coldness 66.10 13.01 22 92614 184 46593242
Intentional product misuse 65.88 13.01 8 92628 47120 46546306
Abortion spontaneous 64.62 13.01 6 92630 43640 46549786
Hypotension 64.20 13.01 241 92395 232348 46361078
Ileus 63.41 13.01 106 92530 13958 46579468
Osteoarthritis 63.25 13.01 22 92614 62003 46531423
Injection site erythema 62.36 13.01 35 92601 74392 46519034
Metastases to chest wall 61.25 13.01 26 92610 448 46592978
Nail discolouration 60.90 13.01 44 92592 2220 46591206
Bone lesion 60.44 13.01 61 92575 4870 46588556
Urticaria 60.01 13.01 88 92548 117804 46475622
Neoplasm malignant 59.50 13.01 139 92497 23360 46570066
Leukopenia 58.73 13.01 280 92356 68063 46525363
Gamma-glutamyltransferase decreased 58.67 13.01 22 92614 269 46593157
Metastases to the mediastinum 58.31 13.01 25 92611 442 46592984
Chronic obstructive pulmonary disease 57.81 13.01 21 92615 57612 46535814
Acute kidney injury 57.80 13.01 256 92380 235599 46357827
Cardiac failure congestive 57.79 13.01 58 92578 91692 46501734
Hyperbilirubinaemia 57.17 13.01 86 92550 10352 46583074
Carbohydrate antigen 15-3 increased 55.69 13.01 30 92606 894 46592532
Gastrointestinal perforation 54.98 13.01 48 92588 3189 46590237
Metastases to meninges 53.09 13.01 38 92598 1889 46591537
Colon cancer metastatic 53.04 13.01 32 92604 1188 46592238
Hyperhidrosis 52.30 13.01 60 92576 89248 46504178
Bone pain 51.65 13.01 207 92429 46683 46546743
Fibromyalgia 51.44 13.01 6 92630 36457 46556969
Colitis 51.27 13.01 177 92459 37170 46556256
Bone disorder 51.27 13.01 119 92517 19914 46573512
Tooth extraction 50.25 13.01 80 92556 10113 46583313
Dysaesthesia pharynx 49.59 13.01 16 92620 120 46593306
Urinary tract infection 49.30 13.01 247 92389 220019 46373407
Intestinal perforation 49.20 13.01 82 92554 10769 46582657
Metastases to adrenals 49.02 13.01 25 92611 664 46592762
Chronic kidney disease 48.15 13.01 11 92625 40860 46552566
Portal hypertension 48.11 13.01 46 92590 3437 46589989
Blister 47.54 13.01 195 92441 44436 46548990
Pain 46.81 13.01 666 91970 476282 46117144
Hyperkalaemia 46.75 13.01 21 92615 50688 46542738
Insomnia 46.71 13.01 169 92467 164755 46428671
Blood glucose increased 45.95 13.01 45 92591 71968 46521458
Enterocolitis 44.49 13.01 58 92578 6110 46587316
Product dose omission issue 44.29 13.01 178 92458 168342 46425084
Nasal congestion 44.24 13.01 20 92616 48093 46545333
Neoplasm 44.22 13.01 56 92580 5732 46587694
Hypokalaemia 43.77 13.01 312 92324 87712 46505714
Ejection fraction 43.64 13.01 22 92614 570 46592856
Therapy change 43.32 13.01 52 92584 5038 46588388
Oxygen saturation decreased 43.23 13.01 44 92592 69120 46524306
Lymphoedema 43.02 13.01 68 92568 8544 46584882
Device related thrombosis 42.83 13.01 28 92608 1199 46592227
Erythema 42.57 13.01 452 92184 142368 46451058
Wrong technique in product usage process 42.23 13.01 28 92608 54394 46539032
Hypoaesthesia 42.12 13.01 390 92246 118479 46474947
Wheezing 42.06 13.01 27 92609 53359 46540067
Anxiety 41.87 13.01 202 92434 181755 46411671
Glossodynia 41.50 13.01 18 92618 44355 46549071
Drug reaction with eosinophilia and systemic symptoms 41.34 13.01 5 92631 29543 46563883
Foetal exposure during pregnancy 41.11 13.01 6 92630 30741 46562685
Agitation 41.02 13.01 30 92606 55385 46538041
Nasopharyngitis 40.88 13.01 162 92474 153836 46439590
Rhabdomyolysis 40.81 13.01 16 92620 41893 46551533
Angina bullosa haemorrhagica 40.58 13.01 14 92622 132 46593294
Pyogenic granuloma 40.47 13.01 17 92619 285 46593141
Debridement 40.39 13.01 28 92608 1322 46592104
Myocardial infarction 40.32 13.01 83 92553 97445 46495981
Peripheral sensory neuropathy 39.92 13.01 57 92579 6546 46586880
Loss of personal independence in daily activities 39.75 13.01 33 92603 57150 46536276
Mucosal toxicity 39.07 13.01 17 92619 312 46593114
Product use in unapproved indication 38.02 13.01 76 92560 90197 46503229
Fatigue 37.33 13.01 1518 91118 607179 45986247
Malignant ascites 36.54 13.01 23 92613 922 46592504
Abdominal lymphadenopathy 36.38 13.01 19 92617 531 46592895
Hepatic failure 36.38 13.01 147 92489 33269 46560157
Blood pressure fluctuation 36.26 13.01 8 92628 30440 46562986
Loss of consciousness 36.15 13.01 103 92533 108135 46485291
Lacrimation increased 36.06 13.01 90 92546 15771 46577655
Plantar erythema 35.84 13.01 15 92621 249 46593177
Skin hyperpigmentation 35.53 13.01 48 92588 5234 46588192
Osteolysis 35.14 13.01 34 92602 2578 46590848
Bone sequestrum 35.03 13.01 28 92608 1645 46591781
Hypoalbuminaemia 35.00 13.01 68 92568 10059 46583367
Migraine 34.91 13.01 53 92583 69973 46523453
Infusion site induration 34.77 13.01 21 92615 781 46592645
Cardiac output decreased 34.77 13.01 22 92614 890 46592536
Recurrent cancer 33.80 13.01 28 92608 1731 46591695
Brachiocephalic vein thrombosis 33.19 13.01 10 92626 58 46593368
Mobility decreased 33.05 13.01 43 92593 60551 46532875
Multiple sclerosis 32.77 13.01 5 92631 24786 46568640
Osteoporosis 32.73 13.01 20 92616 40588 46552838
Radiation necrosis 32.67 13.01 15 92621 314 46593112
Fluid overload 32.66 13.01 7 92629 27178 46566248
Proteinuria 32.58 13.01 89 92547 16464 46576962
Pulmonary arterial hypertension 32.57 13.01 6 92630 25922 46567504
Onychomadesis 32.52 13.01 34 92602 2829 46590597
Superior vena cava syndrome 32.51 13.01 18 92618 567 46592859
Jaw operation 32.38 13.01 20 92616 775 46592651
Periodontitis 32.06 13.01 37 92599 3439 46589987
Cataract 31.82 13.01 26 92610 45389 46548037
Subacute cutaneous lupus erythematosus 31.73 13.01 28 92608 1887 46591539
Colorectal cancer metastatic 31.60 13.01 19 92617 701 46592725
Atrial fibrillation 31.44 13.01 103 92533 103487 46489939
Swelling 31.15 13.01 134 92502 124377 46469049
Product quality issue 30.97 13.01 16 92620 35632 46557794
Abnormal behaviour 30.89 13.01 3 92633 21055 46572371
Heart rate increased 30.61 13.01 64 92572 74727 46518699
Injection site haemorrhage 30.25 13.01 3 92633 20706 46572720
Premature delivery 30.23 13.01 4 92632 22065 46571361
Invasive ductal breast carcinoma 29.84 13.01 48 92588 6120 46587306
Respiratory arrest 29.64 13.01 15 92621 33801 46559625
Exposed bone in jaw 29.34 13.01 34 92602 3174 46590252
Nervousness 29.20 13.01 10 92626 28465 46564961
Pericardial effusion 29.11 13.01 114 92522 25429 46567997
Performance status decreased 29.09 13.01 34 92602 3203 46590223
Nodular regenerative hyperplasia 28.90 13.01 13 92623 259 46593167
Metastases to ovary 28.79 13.01 14 92622 335 46593091
Abdominal pain 28.67 13.01 627 92009 229404 46364022
Anastomotic leak 28.66 13.01 15 92621 421 46593005
Sopor 28.63 13.01 3 92633 19825 46573601
Injection site bruising 28.10 13.01 18 92618 35618 46557808
Anastomotic fistula 27.98 13.01 7 92629 17 46593409
Hydronephrosis 27.87 13.01 56 92580 8489 46584937
Leukoencephalopathy 27.87 13.01 37 92599 3967 46589459
Gastric perforation 27.71 13.01 22 92614 1280 46592146
Hallucination 27.70 13.01 35 92601 49916 46543510
Disturbance in attention 27.66 13.01 14 92622 31546 46561880
Abdominal discomfort 27.60 13.01 181 92455 150984 46442442
Platelet count decreased 27.23 13.01 311 92325 99713 46493713
Lower respiratory tract infection 27.16 13.01 42 92594 55047 46538379
Unresponsive to stimuli 27.13 13.01 15 92621 32159 46561267
Pregnancy 27.02 13.01 10 92626 27127 46566299
Diabetes mellitus 26.82 13.01 36 92600 50029 46543397
Metastases to eye 26.69 13.01 10 92626 122 46593304
Post-traumatic neck syndrome 26.57 13.01 22 92614 1359 46592067
Injury 26.40 13.01 29 92607 43998 46549428
Myalgia 26.39 13.01 140 92496 122948 46470478
Accidental exposure to product 26.22 13.01 5 92631 21076 46572350
Vessel puncture site bruise 26.10 13.01 13 92623 328 46593098
Varices oesophageal 25.98 13.01 30 92606 2789 46590637
Pulmonary hypertension 25.98 13.01 20 92616 35973 46557453
Infusion related reaction 25.88 13.01 108 92528 101100 46492326
Lymphadenopathy 25.77 13.01 133 92503 33355 46560071
Lactic acidosis 25.56 13.01 18 92618 33891 46559535
Cardio-respiratory arrest 25.55 13.01 50 92586 59819 46533607
Ear infection 25.54 13.01 7 92629 23006 46570420
Cachexia 25.51 13.01 39 92597 4760 46588666
Electrocardiogram QT prolonged 25.43 13.01 39 92597 51286 46542140
Nail infection 25.34 13.01 24 92612 1772 46591654
Coronary artery disease 25.34 13.01 18 92618 33734 46559692
Mouth ulceration 25.30 13.01 113 92523 26719 46566707
Early satiety 25.23 13.01 17 92619 766 46592660
Pigmentation disorder 25.22 13.01 34 92602 3699 46589727
Vascular pain 25.18 13.01 16 92620 652 46592774
Irritability 25.13 13.01 13 92623 28933 46564493
Fluid retention 25.09 13.01 39 92597 51007 46542419
Cheilitis 24.96 13.01 35 92601 3953 46589473
Treatment noncompliance 24.87 13.01 14 92622 29717 46563709
Neoplasm recurrence 24.87 13.01 27 92609 2346 46591080
Dysaesthesia 24.73 13.01 31 92605 3140 46590286
Tooth erosion 24.61 13.01 14 92622 465 46592961
Tremor 24.52 13.01 132 92504 115507 46477919
Gallbladder disorder 24.38 13.01 3 92633 17495 46575931
Failure to anastomose 24.15 13.01 6 92630 14 46593412
Incorrect dose administered 24.15 13.01 33 92603 45517 46547909
Malignant pleural effusion 24.08 13.01 27 92609 2431 46590995
Adnexa uteri mass 23.77 13.01 14 92622 497 46592929
Wound 23.73 13.01 30 92606 42772 46550654
Therapy partial responder 23.43 13.01 37 92599 4645 46588781
Cardiac arrest 23.40 13.01 96 92540 90303 46503123
Gingival bleeding 23.33 13.01 63 92573 11576 46581850
Pulmonary embolism 23.30 13.01 323 92313 108262 46485164
Blood uric acid decreased 23.25 13.01 14 92622 518 46592908
Therapy interrupted 23.24 13.01 60 92576 10731 46582695
Staphylococcal infection 23.22 13.01 22 92614 35749 46557677
Diverticulitis 23.04 13.01 19 92617 33020 46560406
Hormone receptor positive breast cancer 22.98 13.01 13 92623 427 46592999
Arterial thrombosis 22.97 13.01 20 92616 1324 46592102
Dermatitis acneiform 22.95 13.01 34 92602 4036 46589390
Pneumatosis intestinalis 22.91 13.01 24 92612 2001 46591425
Hepatic atrophy 22.90 13.01 11 92625 256 46593170
Transaminases 22.86 13.01 8 92628 79 46593347
Caesarean section 22.76 13.01 3 92633 16600 46576826
Hyperaesthesia 22.71 13.01 49 92587 7807 46585619
Sequestrectomy 22.70 13.01 18 92618 1045 46592381
Pulpitis dental 22.61 13.01 16 92620 781 46592645
Tumour perforation 22.51 13.01 8 92628 83 46593343
Crying 22.42 13.01 7 92629 21134 46572292
Upper respiratory tract infection 22.32 13.01 59 92577 63497 46529929
Muscle swelling 22.29 13.01 12 92624 357 46593069
Hypophagia 22.27 13.01 116 92520 29190 46564236
Adverse event 22.22 13.01 21 92615 34163 46559263
Metastases to breast 22.14 13.01 11 92625 276 46593150
Ingrowing nail 22.12 13.01 24 92612 2084 46591342
Motion sickness 22.11 13.01 16 92620 809 46592617
Blood pressure systolic increased 22.07 13.01 15 92621 28772 46564654
Steatohepatitis 22.03 13.01 13 92623 463 46592963
Bone debridement 21.93 13.01 12 92624 369 46593057
Right ventricular failure 21.84 13.01 3 92633 16090 46577336
Oral pigmentation 21.76 13.01 5 92631 7 46593419
Radiation skin injury 21.57 13.01 16 92620 841 46592585
Breast cancer stage IV 21.56 13.01 12 92624 382 46593044
Haematoma 21.40 13.01 19 92617 31853 46561573
Angioedema 21.37 13.01 28 92608 39314 46554112
Vasodilatation 21.35 13.01 25 92611 2360 46591066
Hand-foot-and-mouth disease 21.32 13.01 8 92628 98 46593328
Acute respiratory failure 21.27 13.01 16 92620 29122 46564304
Cytomegalovirus infection 21.14 13.01 5 92631 18139 46575287
Disseminated intravascular coagulation 21.00 13.01 84 92552 18921 46574505
Lymphadenopathy mediastinal 20.94 13.01 25 92611 2409 46591017
Oral toxicity 20.90 13.01 4 92632 0 46593426
Inappropriate schedule of product administration 20.87 13.01 63 92573 64950 46528476
Cholangitis 20.76 13.01 35 92601 4639 46588787
Gingivitis 20.72 13.01 46 92590 7474 46585952
Nephrolithiasis 20.68 13.01 21 92615 33030 46560396
Blood creatinine decreased 20.60 13.01 35 92601 4669 46588757
Dental care 20.59 13.01 17 92619 1046 46592380
Body temperature decreased 20.58 13.01 66 92570 13343 46580083
Blood creatine phosphokinase increased 20.53 13.01 15 92621 27709 46565717
Tumour pain 20.42 13.01 18 92618 1211 46592215
Irritable bowel syndrome 20.36 13.01 4 92632 16511 46576915
Pneumocystis jirovecii pneumonia 20.33 13.01 3 92633 15245 46578181
Brain operation 20.27 13.01 12 92624 430 46592996
Seizure 20.17 13.01 152 92484 122902 46470524
Neutropenic sepsis 20.14 13.01 62 92574 12262 46581164
Depressed level of consciousness 20.06 13.01 40 92596 47529 46545897
Blood pressure increased 20.04 13.01 158 92478 126508 46466918
Asthenopia 19.96 13.01 22 92614 1944 46591482
Gait disturbance 19.95 13.01 188 92448 145075 46448351
Adenocarcinoma 19.91 13.01 24 92612 2335 46591091
Pharyngeal inflammation 19.69 13.01 13 92623 566 46592860
Dizziness 19.58 13.01 520 92116 339894 46253532
Mental disorder 19.58 13.01 10 92626 22415 46571011
Dysphagia 19.53 13.01 237 92399 77075 46516351
Dermatomyositis 19.46 13.01 22 92614 1999 46591427
Myopathy toxic 19.46 13.01 10 92626 270 46593156
Confusional state 19.45 13.01 213 92423 159679 46433747
Evans syndrome 19.41 13.01 9 92627 193 46593233
Breast cancer female 19.35 13.01 39 92597 5924 46587502
Toxic epidermal necrolysis 19.35 13.01 10 92626 22268 46571158
Triple negative breast cancer 19.33 13.01 8 92628 129 46593297
Constipation 19.32 13.01 467 92169 173630 46419796
Eosinophilia 19.27 13.01 7 92629 19210 46574216
Oncologic complication 19.22 13.01 8 92628 131 46593295
ECG signs of myocardial ischaemia 19.17 13.01 7 92629 79 46593347
Ataxia 19.09 13.01 66 92570 13864 46579562
Biliary obstruction 18.88 13.01 24 92612 2465 46590961
Toothache 18.87 13.01 74 92562 16518 46576908
Sedation 18.86 13.01 11 92625 22899 46570527
Hallucination, visual 18.81 13.01 6 92630 17867 46575559
Malaise 18.78 13.01 507 92129 330725 46262701
Stress 18.76 13.01 47 92589 51504 46541922
Delirium 18.72 13.01 28 92608 37200 46556226
Injection site swelling 18.70 13.01 32 92604 40295 46553131
Human epidermal growth factor receptor negative 18.67 13.01 4 92632 3 46593423
Radiation myelopathy 18.67 13.01 4 92632 3 46593423
Ankle fracture 18.62 13.01 4 92632 15507 46577919
Psychotic disorder 18.42 13.01 11 92625 22610 46570816
Hypersensitivity 18.39 13.01 200 92436 150121 46443305
Carbohydrate antigen 19-9 increased 18.38 13.01 8 92628 147 46593279
Eye pain 18.35 13.01 17 92619 27923 46565503
Subileus 18.27 13.01 26 92610 2977 46590449
Pulmonary mass 18.21 13.01 77 92559 17780 46575646
Infusion site haemorrhage 18.16 13.01 22 92614 2152 46591274
Increased liver stiffness 18.13 13.01 4 92632 4 46593422
Radiation fibrosis - lung 18.12 13.01 5 92631 20 46593406
Computerised tomogram abnormal 18.11 13.01 22 92614 2158 46591268
Hepatic cancer metastatic 18.09 13.01 10 92626 314 46593112
Brachial plexopathy 18.07 13.01 7 92629 94 46593332
Oral pain 18.06 13.01 97 92539 24700 46568726
Femoral artery embolism 18.05 13.01 6 92630 50 46593376
Chemical peritonitis 17.81 13.01 7 92629 98 46593328
Hypothalamo-pituitary disorder 17.80 13.01 13 92623 667 46592759
Pericardial effusion malignant 17.68 13.01 7 92629 100 46593326
Acute myeloid leukaemia 17.64 13.01 70 92566 15708 46577718
Joint injury 17.63 13.01 8 92628 19201 46574225
Insulinoma 17.62 13.01 7 92629 101 46593325
Skin disorder 17.53 13.01 89 92547 22174 46571252
Cerebrovascular accident 17.43 13.01 123 92513 100916 46492510
Herpangina 17.38 13.01 5 92631 24 46593402
Recall phenomenon 17.32 13.01 12 92624 566 46592860
Neutrophil count decreased 17.18 13.01 146 92490 43280 46550146
Eosinophil percentage increased 17.13 13.01 14 92622 849 46592577
Mucosal disorder 17.11 13.01 20 92616 1884 46591542
Radiation injury 16.82 13.01 11 92625 471 46592955
Anaphylactic reaction 16.67 13.01 52 92584 53060 46540366
Procedural pain 16.66 13.01 3 92633 13176 46580250
Sudden death 16.65 13.01 49 92587 9455 46583971
White blood cell count decreased 16.63 13.01 314 92322 111917 46481509
Tenderness 16.60 13.01 72 92564 16809 46576617
Ejection fraction abnormal 16.53 13.01 12 92624 610 46592816
Emotional distress 16.53 13.01 22 92614 30685 46562741
Stress cardiomyopathy 16.48 13.01 43 92593 7741 46585685
Anal erythema 16.46 13.01 8 92628 191 46593235
Diarrhoea haemorrhagic 16.43 13.01 42 92594 7467 46585959
Metastases to muscle 16.42 13.01 7 92629 122 46593304
Tachycardia 16.35 13.01 123 92513 99499 46493927
Central nervous system lesion 16.30 13.01 49 92587 9566 46583860
Gastrointestinal inflammation 16.25 13.01 30 92606 4271 46589155
Purulent discharge 16.17 13.01 32 92604 4798 46588628
Tumour invasion 16.11 13.01 7 92629 128 46593298
Iron deficiency anaemia 16.05 13.01 7 92629 17199 46576227
Accidental overdose 16.00 13.01 10 92626 20056 46573370
Colorectal cancer 16.00 13.01 14 92622 933 46592493
Product prescribing error 15.98 13.01 10 92626 20037 46573389
Rectal perforation 15.97 13.01 10 92626 397 46593029
Facial asymmetry 15.96 13.01 12 92624 644 46592782
Aggression 15.96 13.01 13 92623 22731 46570695
Small intestinal obstruction 15.92 13.01 69 92567 16103 46577323
Gastric cancer 15.85 13.01 24 92612 2905 46590521
Breast neoplasm 15.83 13.01 16 92620 1279 46592147
Peripheral motor neuropathy 15.83 13.01 17 92619 1459 46591967
Onychalgia 15.75 13.01 12 92624 657 46592769
Vulval disorder 15.72 13.01 12 92624 659 46592767
Abdominal wall mass 15.67 13.01 3 92633 0 46593426
Anxiety disorder due to a general medical condition 15.67 13.01 3 92633 0 46593426
Catheter site bruise 15.63 13.01 9 92627 306 46593120
Calcium ionised increased 15.63 13.01 7 92629 138 46593288
Tubulointerstitial nephritis 15.50 13.01 5 92631 14783 46578643
Perforation 15.50 13.01 14 92622 973 46592453
Hyperammonaemia 15.49 13.01 31 92605 4685 46588741
Gastrointestinal haemorrhage 15.48 13.01 90 92546 77283 46516143
Disease recurrence 15.36 13.01 75 92561 18396 46575030
Odynophagia 15.35 13.01 38 92598 6624 46586802
Epistaxis 15.33 13.01 195 92441 64110 46529316
Impaired healing 15.31 13.01 125 92511 36618 46556808
Enterocolitis haemorrhagic 15.23 13.01 17 92619 1523 46591903
Skin reaction 15.12 13.01 52 92584 10894 46582532
Restlessness 15.09 13.01 17 92619 25507 46567919
Influenza like illness 14.98 13.01 61 92575 57509 46535917
Hiccups 14.93 13.01 15 92621 1191 46592235
Renal hydrocele 14.91 13.01 4 92632 14 46593412
Seasonal allergy 14.90 13.01 4 92632 13330 46580096
Pelvic fluid collection 14.90 13.01 13 92623 863 46592563
Excessive granulation tissue 14.88 13.01 13 92623 864 46592562
Torsade de pointes 14.87 13.01 3 92633 12151 46581275
Lip pain 14.86 13.01 18 92618 1760 46591666
Foot deformity 14.83 13.01 6 92630 15419 46578007
Product complaint 14.77 13.01 3 92633 12098 46581328
Thyroid disorder 14.73 13.01 3 92633 12073 46581353
Bone fistula 14.71 13.01 6 92630 93 46593333
Fistula 14.71 13.01 42 92594 7968 46585458
Liver scan abnormal 14.70 13.01 5 92631 45 46593381
Hypovolaemic shock 14.61 13.01 32 92604 5151 46588275
Swelling face 14.58 13.01 55 92581 53004 46540422
Tumour marker abnormal 14.57 13.01 7 92629 163 46593263
Stridor 14.56 13.01 24 92612 3123 46590303
Mood swings 14.56 13.01 7 92629 16245 46577181
Mean cell haemoglobin decreased 14.55 13.01 23 92613 2889 46590537
Abdominal symptom 14.54 13.01 9 92627 350 46593076
Hepatitis 14.54 13.01 26 92610 32189 46561237
Vertebral column mass 14.53 13.01 7 92629 164 46593262
Sinus congestion 14.53 13.01 4 92632 13105 46580321
Hypoglycaemia 14.51 13.01 57 92579 54292 46539134
Small intestinal perforation 14.50 13.01 15 92621 1233 46592193
Rectal neoplasm 14.49 13.01 4 92632 16 46593410
Oropharyngeal pain 14.45 13.01 87 92549 74081 46519345
Vein disorder 14.42 13.01 27 92609 3886 46589540
Hypothyroidism 14.41 13.01 25 92611 31313 46562113
Pituitary tumour 14.41 13.01 13 92623 902 46592524
Gastrointestinal disorder 14.34 13.01 181 92455 59395 46534031
Respiratory disorder 14.25 13.01 20 92616 27280 46566146
Poisoning 14.20 13.01 5 92631 13989 46579437
Bile duct stenosis 14.19 13.01 14 92622 1087 46592339
Blood cholesterol increased 14.16 13.01 37 92599 39976 46553450
Corneal erosion 14.11 13.01 8 92628 264 46593162
Glomerular filtration rate decreased 14.07 13.01 3 92633 11691 46581735
Female genital tract fistula 14.05 13.01 24 92612 3215 46590211
Tongue discolouration 14.02 13.01 23 92613 2981 46590445
Sputum discoloured 13.97 13.01 4 92632 12774 46580652
International normalised ratio increased 13.95 13.01 47 92589 46836 46546590
Respiratory tract congestion 13.95 13.01 4 92632 12760 46580666
Peritoneal fluid analysis abnormal 13.94 13.01 4 92632 19 46593407
Restless legs syndrome 13.93 13.01 7 92629 15836 46577590
Back pain 13.92 13.01 314 92322 209725 46383701
Cognitive disorder 13.91 13.01 33 92603 36850 46556576
Medication error 13.91 13.01 25 92611 30886 46562540
Urinary incontinence 13.82 13.01 22 92614 28508 46564918
Syncope 13.81 13.01 137 92499 104666 46488760
Activated PI3 kinase delta syndrome 13.77 13.01 4 92632 20 46593406
Wrist fracture 13.74 13.01 3 92633 11500 46581926
Impaired work ability 13.73 13.01 4 92632 12632 46580794
Gastroenteropancreatic neuroendocrine tumour disease 13.73 13.01 5 92631 56 46593370
Wound treatment 13.72 13.01 7 92629 186 46593240
Acute hepatic failure 13.72 13.01 6 92630 14715 46578711
Ileus paralytic 13.71 13.01 28 92608 4295 46589131
Panic attack 13.67 13.01 12 92624 20230 46573196
Productive cough 13.66 13.01 53 92583 50662 46542764
Drug level increased 13.62 13.01 10 92626 18431 46574995
Brain neoplasm 13.61 13.01 26 92610 3798 46589628
Retroperitoneal neoplasm metastatic 13.61 13.01 4 92632 21 46593405
Neck pain 13.53 13.01 60 92576 55246 46538180
Dermatitis 13.52 13.01 60 92576 14148 46579278
Metastases to heart 13.49 13.01 5 92631 59 46593367
Renal vein thrombosis 13.48 13.01 8 92628 288 46593138
Granulocyte count decreased 13.48 13.01 12 92624 818 46592608
Venous thrombosis limb 13.47 13.01 22 92614 2841 46590585
Metastases to stomach 13.36 13.01 6 92630 119 46593307
Thrombosis 13.35 13.01 170 92466 55899 46537527
Extrapyramidal disorder 13.34 13.01 3 92633 11265 46582161
Bone cancer metastatic 13.32 13.01 6 92630 120 46593306
Dyschezia 13.31 13.01 16 92620 1552 46591874
Metastases to abdominal cavity 13.31 13.01 9 92627 408 46593018
Artificial menopause 13.31 13.01 4 92632 23 46593403
Vision blurred 13.27 13.01 98 92538 79610 46513816
Anastomotic complication 13.23 13.01 6 92630 122 46593304
Large intestine perforation 13.20 13.01 39 92597 7541 46585885
Brain cancer metastatic 13.06 13.01 5 92631 65 46593361
Herpes zoster 13.02 13.01 80 92556 67792 46525634
Gingival swelling 13.02 13.01 26 92610 3924 46589502

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
Palmar-plantar erythrodysaesthesia syndrome 2180.84 13.88 824 44037 14046 29893571
Diarrhoea 1302.71 13.88 2004 42857 332099 29575518
Disease progression 964.15 13.88 861 44000 79013 29828604
Death 517.82 13.88 1428 43433 355855 29551762
Mucosal inflammation 401.31 13.88 346 44515 30148 29877469
Arteriospasm coronary 353.96 13.88 137 44724 2481 29905136
Neuropathy peripheral 313.78 13.88 453 44408 70022 29837595
Vomiting 261.16 13.88 821 44040 218997 29688620
Dehydration 228.06 13.88 543 44318 122996 29784621
Nausea 208.70 13.88 937 43924 296020 29611597
Stomatitis 207.15 13.88 267 44594 37012 29870605
Anastomotic leak 198.76 13.88 62 44799 565 29907052
Metastases to liver 178.36 13.88 146 44715 11819 29895798
Neurotoxicity 178.18 13.88 152 44709 13030 29894587
Gastrointestinal perforation 168.44 13.88 90 44771 3526 29904091
Intestinal obstruction 168.13 13.88 174 44687 19038 29888579
Enteritis 157.18 13.88 107 44754 6538 29901079
Malignant neoplasm progression 153.37 13.88 336 44525 71951 29835666
Bone marrow failure 141.95 13.88 198 44663 29587 29878030
Drug ineffective 139.49 13.88 184 44677 340203 29567414
Completed suicide 134.54 13.88 3 44858 99489 29808128
Metastases to lung 134.04 13.88 104 44757 7791 29899826
Dihydropyrimidine dehydrogenase deficiency 133.76 13.88 29 44832 42 29907575
Decreased appetite 131.38 13.88 507 44354 149403 29758214
Colon cancer metastatic 117.04 13.88 55 44806 1630 29905987
Gastrointestinal toxicity 107.88 13.88 55 44806 1953 29905664
Neutropenia 96.83 13.88 415 44446 128125 29779492
Skin toxicity 95.62 13.88 60 44801 3189 29904428
Ileus 95.21 13.88 117 44744 15438 29892179
Abdominal pain 92.39 13.88 425 44436 135229 29772388
Anastomotic complication 86.47 13.88 28 44833 291 29907326
Headache 85.79 13.88 88 44773 182218 29725399
Pancreatic neuroendocrine tumour metastatic 84.28 13.88 24 44837 154 29907463
Pneumonia 82.05 13.88 244 44617 334062 29573555
Arthralgia 79.36 13.88 53 44808 135738 29771879
Cardiac failure congestive 77.48 13.88 16 44845 84391 29823226
Enterocolitis 76.16 13.88 70 44791 6617 29901000
Proteus infection 73.55 13.88 31 44830 705 29906912
Therapy cessation 71.15 13.88 100 44761 15037 29892580
Intestinal perforation 68.88 13.88 74 44787 8445 29899172
Metastases to peritoneum 67.62 13.88 37 44824 1520 29906097
Overdose 65.99 13.88 22 44839 84315 29823302
Tumour perforation 65.32 13.88 22 44839 261 29907356
Gastrointestinal anastomotic leak 63.99 13.88 23 44838 335 29907282
Carcinoembryonic antigen increased 63.69 13.88 27 44834 623 29906994
Skin exfoliation 63.66 13.88 120 44741 23052 29884565
Fall 62.04 13.88 111 44750 181761 29725856
Necrotising fasciitis 61.97 13.88 47 44814 3402 29904215
Dysphagia 61.64 13.88 206 44655 56492 29851125
Condition aggravated 56.75 13.88 74 44787 137792 29769825
Colon cancer 56.18 13.88 66 44795 8306 29899311
Haematotoxicity 55.97 13.88 57 44804 6113 29901504
Depression 55.97 13.88 33 44828 90404 29817213
Fingerprint loss 55.77 13.88 13 44848 31 29907586
Myelosuppression 54.67 13.88 61 44800 7261 29900356
Anxiety 53.93 13.88 34 44827 89837 29817780
Metastatic gastric cancer 53.17 13.88 17 44844 169 29907448
Neoplasm progression 51.58 13.88 95 44766 17928 29889689
Rectal perforation 51.56 13.88 20 44841 364 29907253
Subileus 50.95 13.88 40 44821 3047 29904570
Drug interaction 50.01 13.88 144 44717 199424 29708193
Stomal varices 49.99 13.88 12 44849 34 29907583
Cardiotoxicity 49.86 13.88 46 44815 4368 29903249
Gastric perforation 48.00 13.88 33 44828 2048 29905569
Induration 47.60 13.88 24 44837 832 29906785
Non-cirrhotic portal hypertension 47.27 13.88 17 44844 248 29907369
Thrombocytopenia 46.66 13.88 358 44503 136686 29770931
Metastases to lymph nodes 46.01 13.88 42 44819 3935 29903682
Faecal volume decreased 45.70 13.88 13 44848 83 29907534
Hiccups 45.33 13.88 63 44798 9371 29898246
Confusional state 44.42 13.88 84 44777 134750 29772867
Portal shunt 44.41 13.88 11 44850 37 29907580
Pulmonary embolism 43.94 13.88 232 44629 77903 29829714
Vascular pain 43.81 13.88 14 44847 139 29907478
Paraesthesia 43.60 13.88 179 44682 54148 29853469
Foetal exposure during pregnancy 43.52 13.88 3 44858 36868 29870749
Obstruction gastric 42.71 13.88 23 44838 915 29906702
Rectal cancer 42.10 13.88 31 44830 2145 29905472
Colitis 41.83 13.88 121 44740 30699 29876918
Dermatitis acneiform 41.80 13.88 47 44814 5642 29901975
Proteinuria 41.14 13.88 81 44780 16064 29891553
Prothrombin level decreased 40.34 13.88 24 44837 1158 29906459
Hallucination 39.78 13.88 12 44849 49047 29858570
Large intestine perforation 39.65 13.88 53 44808 7598 29900019
Peripheral ischaemia 39.07 13.88 44 44817 5290 29902327
Product dose omission issue 38.90 13.88 48 44813 91583 29816034
Mucosal disorder 38.88 13.88 26 44835 1541 29906076
Metastases to central nervous system 38.58 13.88 51 44810 7233 29900384
Hypokalaemia 38.41 13.88 163 44698 50029 29857588
Wound dehiscence 38.09 13.88 35 44826 3306 29904311
Protein urine 37.97 13.88 19 44842 648 29906969
Small intestinal obstruction 37.83 13.88 71 44790 13588 29894029
Neutropenic sepsis 37.63 13.88 64 44797 11345 29896272
Clostridial infection 37.54 13.88 36 44825 3589 29904028
Laryngospasm 37.52 13.88 24 44837 1319 29906298
Ventricular fibrillation 37.43 13.88 75 44786 15063 29892554
Device occlusion 37.39 13.88 46 44815 6074 29901543
Diaphragmatic spasm 37.32 13.88 11 44850 81 29907536
Psoriasis 37.09 13.88 9 44852 42497 29865120
Recall phenomenon 36.88 13.88 18 44843 581 29907036
Ascites 36.81 13.88 128 44733 35793 29871824
Aggression 35.98 13.88 6 44855 36901 29870716
Skin fissures 35.33 13.88 34 44827 3405 29904212
Focal nodular hyperplasia 35.28 13.88 12 44849 147 29907470
Influenza 34.49 13.88 11 44850 43387 29864230
Dysaesthesia pharynx 34.36 13.88 9 44852 40 29907577
Oesophagitis 33.38 13.88 60 44801 11111 29896506
Agitation 33.06 13.88 20 44841 54053 29853564
Anal prolapse 33.03 13.88 6 44855 0 29907617
Suicidal ideation 32.80 13.88 7 44854 36107 29871510
Metastasis 32.74 13.88 32 44829 3266 29904351
Cough 32.65 13.88 89 44772 125553 29782064
Insomnia 32.64 13.88 56 44805 93280 29814337
Oesophageal haemorrhage 32.62 13.88 21 44840 1167 29906450
Electrocardiogram QT prolonged 32.44 13.88 7 44854 35828 29871789
Skin discolouration 30.72 13.88 71 44790 15723 29891894
Rhabdomyolysis 30.62 13.88 30 44831 63550 29844067
Hypovolaemic shock 30.62 13.88 43 44818 6457 29901160
Intestinal dilatation 30.55 13.88 20 44841 1144 29906473
Hepatic lesion 30.33 13.88 30 44831 3106 29904511
Tumour marker increased 30.18 13.88 15 44846 504 29907113
Peritonitis 30.05 13.88 85 44776 21290 29886327
Drug hypersensitivity 30.02 13.88 35 44826 68484 29839133
Gastric cancer 29.90 13.88 37 44824 4913 29902704
Stoma site haemorrhage 29.57 13.88 18 44843 906 29906711
Arterial thrombosis 29.41 13.88 21 44840 1385 29906232
Drug reaction with eosinophilia and systemic symptoms 29.22 13.88 4 44857 28484 29879133
Dizziness 29.10 13.88 172 44689 194737 29712880
Asthma 29.05 13.88 9 44852 36165 29871452
Weight increased 28.99 13.88 42 44819 74871 29832746
Hyperfibrinolysis 28.88 13.88 6 44855 6 29907611
Proctalgia 28.56 13.88 34 44827 4338 29903279
Biliary obstruction 28.56 13.88 26 44835 2427 29905190
Tenderness 28.50 13.88 39 44822 5716 29901901
Portal hypertension 28.46 13.88 32 44829 3841 29903776
Colorectal cancer metastatic 28.22 13.88 18 44843 984 29906633
Abnormal behaviour 27.74 13.88 3 44858 25620 29881997
Asthenia 27.61 13.88 475 44386 220815 29686802
Large intestinal obstruction 26.95 13.88 20 44841 1400 29906217
Musculoskeletal stiffness 26.95 13.88 10 44851 35871 29871746
Chronic obstructive pulmonary disease 26.91 13.88 18 44843 46108 29861509
Rectal cancer metastatic 26.86 13.88 11 44850 232 29907385
Pigmentation disorder 26.63 13.88 23 44838 2003 29905614
Colon cancer recurrent 26.55 13.88 9 44852 109 29907508
Delirium 26.31 13.88 14 44847 40617 29867000
Oesophageal cancer metastatic 26.14 13.88 11 44850 249 29907368
Erythema 25.57 13.88 201 44660 77250 29830367
Pruritus 25.56 13.88 91 44770 118113 29789504
Seizure 25.39 13.88 70 44791 98405 29809212
Disseminated intravascular coagulation 25.36 13.88 82 44779 22089 29885528
Performance status decreased 24.59 13.88 30 44831 3927 29903690
Bronchitis 24.58 13.88 14 44847 39111 29868506
Myalgia 24.15 13.88 49 44812 76618 29830999
Bradycardia 24.13 13.88 38 44823 65488 29842129
Pelvic abscess 24.11 13.88 16 44845 936 29906681
Gastrointestinal stoma complication 24.08 13.88 18 44843 1274 29906343
Feeling abnormal 23.79 13.88 30 44831 56726 29850891
Dyspnoea 23.76 13.88 354 44507 332941 29574676
Injection site pain 23.52 13.88 8 44853 30302 29877315
Periportal sinus dilatation 23.41 13.88 6 44855 24 29907593
Gastroenteritis radiation 23.37 13.88 11 44850 327 29907290
Swelling of eyelid 23.28 13.88 11 44850 330 29907287
Splenorenal shunt 23.16 13.88 5 44856 7 29907610
General physical health deterioration 23.08 13.88 240 44621 99704 29807913
Hepatic infarction 23.04 13.88 9 44852 167 29907450
Joint swelling 22.78 13.88 22 44839 46924 29860693
Urticaria 22.75 13.88 29 44832 54577 29853040
Leukoencephalopathy 22.72 13.88 29 44832 3973 29903644
Treatment noncompliance 22.72 13.88 5 44856 25248 29882369
Fatigue 22.59 13.88 634 44227 320039 29587578
Metastases to the mediastinum 22.42 13.88 9 44852 180 29907437
Sinusitis 22.32 13.88 11 44850 33334 29874283
Leukopenia 22.11 13.88 152 44709 56007 29851610
Pancreatitis viral 22.05 13.88 5 44856 10 29907607
Anterior spinal artery syndrome 22.02 13.88 4 44857 0 29907617
Nephrotic syndrome 21.88 13.88 38 44823 6847 29900770
Polyneuropathy 21.74 13.88 52 44809 11771 29895846
Gastric dilatation 21.62 13.88 12 44849 507 29907110
Blood glucose increased 21.43 13.88 37 44824 61493 29846124
Colostomy 21.36 13.88 11 44850 399 29907218
Alanine aminotransferase increased 21.30 13.88 50 44811 74226 29833391
Gastrointestinal disorder 21.22 13.88 91 44770 28046 29879571
Coronary artery disease 21.13 13.88 26 44835 49686 29857931
Rectal tenesmus 21.03 13.88 12 44849 535 29907082
Change of bowel habit 20.83 13.88 15 44846 1002 29906615
Angioedema 20.62 13.88 13 44848 34371 29873246
Hyperbilirubinaemia 20.60 13.88 64 44797 16878 29890739
Pharyngeal ulceration 20.51 13.88 10 44851 322 29907295
Neutrophil count decreased 20.48 13.88 121 44740 42333 29865284
Peripheral embolism 20.47 13.88 14 44847 861 29906756
Chronic kidney disease 20.46 13.88 16 44845 37822 29869795
Cellulitis 20.38 13.88 24 44837 46760 29860857
Gastrointestinal mucosal necrosis 20.02 13.88 8 44853 158 29907459
Scrotal ulcer 19.98 13.88 10 44851 341 29907276
Somnolence 19.92 13.88 76 44785 96687 29810930
Irritability 19.87 13.88 5 44856 23045 29884572
Failure to anastomose 19.85 13.88 9 44852 245 29907372
Metastases to pelvis 19.59 13.88 9 44852 253 29907364
Incisional hernia 19.57 13.88 15 44846 1103 29906514
Gastrointestinal inflammation 19.56 13.88 23 44838 2896 29904721
Hypoglycaemia 19.31 13.88 29 44832 50952 29856665
Rash maculo-papular 19.23 13.88 7 44854 25411 29882206
Alopecia 19.14 13.88 68 44793 19207 29888410
Colorectal cancer 19.05 13.88 18 44843 1761 29905856
Nasopharyngitis 19.05 13.88 37 44824 58812 29848805
Balance disorder 19.02 13.88 16 44845 36477 29871140
Electrocardiogram ST segment elevation 18.90 13.88 28 44833 4414 29903203
Therapeutic product effect prolonged 18.83 13.88 9 44852 277 29907340
Pulmonary hypertension 18.76 13.88 3 44858 19033 29888584
Eosinophilia 18.74 13.88 5 44856 22155 29885462
Metastases to meninges 18.64 13.88 15 44846 1184 29906433
Subacute cutaneous lupus erythematosus 18.64 13.88 12 44849 667 29906950
Aortic thrombosis 18.54 13.88 12 44849 673 29906944
Hyperammonaemic encephalopathy 18.51 13.88 18 44843 1826 29905791
Therapy interrupted 18.49 13.88 28 44833 4501 29903116
Lactic acidosis 18.44 13.88 12 44849 31201 29876416
Pancreatic carcinoma 18.39 13.88 38 44823 7799 29899818
Mobility decreased 18.29 13.88 8 44853 25991 29881626
Nasal congestion 18.13 13.88 3 44858 18563 29889054
Intestinal ischaemia 18.05 13.88 35 44826 6862 29900755
Peripheral sensory neuropathy 18.02 13.88 32 44829 5869 29901748
Arthritis 17.99 13.88 7 44854 24394 29883223
Neoplasm malignant 17.83 13.88 63 44798 17751 29889866
Inappropriate schedule of product administration 17.71 13.88 20 44841 39708 29867909
Haematemesis 17.69 13.88 82 44779 26121 29881496
Portal vein dilatation 17.64 13.88 4 44857 8 29907609
Paraneoplastic dermatomyositis 17.64 13.88 4 44857 8 29907609
Ectropion 17.53 13.88 6 44855 75 29907542
Erectile dysfunction 17.51 13.88 3 44858 18099 29889518
Temperature intolerance 17.47 13.88 22 44839 2973 29904644
Anal erythema 17.46 13.88 6 44855 76 29907541
Therapeutic product effect decreased 17.42 13.88 11 44850 29065 29878552
Dry skin 17.23 13.88 73 44788 22381 29885236
Cognitive disorder 17.13 13.88 7 44854 23683 29883934
Myocardial infarction 17.09 13.88 114 44747 125511 29782106
Genital erythema 16.99 13.88 7 44854 150 29907467
Feeling cold 16.92 13.88 41 44820 9358 29898259
Idiosyncratic drug reaction 16.67 13.88 10 44851 490 29907127
Product use issue 16.64 13.88 27 44834 45989 29861628
Therapy change 16.57 13.88 20 44841 2589 29905028
Cataract 16.54 13.88 6 44855 21829 29885788
Urethral ulcer 16.52 13.88 3 44858 0 29907617
Gastrointestinal stoma necrosis 16.52 13.88 3 44858 0 29907617
Ileus paralytic 16.44 13.88 30 44831 5618 29901999
Hypotension 16.41 13.88 207 44654 200358 29707259
Injury 16.41 13.88 6 44855 21725 29885892
Hypoaesthesia 16.41 13.88 138 44723 54092 29853525
Influenza like illness 16.31 13.88 9 44852 25596 29882021
Biliary fistula 16.28 13.88 5 44856 43 29907574
Varices oesophageal 16.21 13.88 23 44838 3486 29904131
Cholangitis 16.20 13.88 36 44825 7766 29899851
Phrenic nerve paralysis 16.18 13.88 6 44855 96 29907521
Hospice care 16.05 13.88 26 44835 4426 29903191
Faeces pale 15.93 13.88 15 44846 1462 29906155
Nail bed inflammation 15.92 13.88 7 44854 177 29907440
Dysaesthesia 15.85 13.88 18 44843 2183 29905434
Wrong technique in product usage process 15.82 13.88 14 44847 31141 29876476
Perforation 15.81 13.88 7 44854 180 29907437
Atypical haemolytic uraemic syndrome 15.79 13.88 6 44855 103 29907514
Malignant ascites 15.76 13.88 9 44852 402 29907215
Tremor 15.63 13.88 59 44802 75304 29832313
Peripheral sensorimotor neuropathy 15.61 13.88 14 44847 1281 29906336
Cardiac failure 15.61 13.88 68 44793 83350 29824267
Wheezing 15.59 13.88 14 44847 30924 29876693
Acral peeling skin syndrome 15.52 13.88 5 44856 51 29907566
False negative investigation result 15.48 13.88 6 44855 109 29907508
Hepatic atrophy 15.46 13.88 7 44854 190 29907427
Metastases to adrenals 15.37 13.88 12 44849 906 29906711
Neutrophilia 15.25 13.88 22 44839 3385 29904232
Perineal ulceration 15.23 13.88 4 44857 18 29907599
Acute kidney injury 15.23 13.88 304 44557 273538 29634079
Arthropathy 15.19 13.88 6 44855 20721 29886896
COVID-19 15.18 13.88 4 44857 17874 29889743
Rectal discharge 15.09 13.88 6 44855 117 29907500
Interstitial lung disease 15.06 13.88 147 44714 60050 29847567
Respiratory arrest 15.03 13.88 13 44848 29245 29878372
Prostatic calcification 14.95 13.88 6 44855 120 29907497
Pelvic fluid collection 14.90 13.88 6 44855 121 29907496
Wound infection 14.86 13.88 30 44831 6055 29901562
Basal cell carcinoma 14.82 13.88 3 44858 16065 29891552
Contusion 14.78 13.88 15 44846 31265 29876352
Hepatocellular injury 14.77 13.88 10 44851 25461 29882156
Electromyogram abnormal 14.64 13.88 5 44856 62 29907555
Psychotic disorder 14.54 13.88 7 44854 21508 29886109
Pyogenic granuloma 14.54 13.88 7 44854 219 29907398
Duodenal perforation 14.48 13.88 13 44848 1191 29906426
Prostate cancer 14.44 13.88 9 44852 23948 29883669
Liver function test abnormal 14.44 13.88 15 44846 30935 29876682
Infusion site hypoaesthesia 14.44 13.88 3 44858 3 29907614
Portal vein pressure increased 14.44 13.88 3 44858 3 29907614
Varicose vein ruptured 14.42 13.88 4 44857 23 29907594
Upper respiratory tract infection 14.37 13.88 12 44849 27464 29880153
Haemolytic anaemia 14.25 13.88 40 44821 9970 29897647
Palmar erythema 14.23 13.88 7 44854 230 29907387
Metastases to eye 14.22 13.88 5 44856 68 29907549
Vasospasm 14.22 13.88 8 44853 347 29907270
Depressed mood 14.10 13.88 4 44857 17025 29890592
Weight decreased 14.04 13.88 310 44551 150611 29757006
Heart rate decreased 13.93 13.88 7 44854 20987 29886630

Pharmacologic Action:

SourceCodeDescription
ATC L01BC06 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 D009676 Noxae
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:50266 prodrugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Metastasis from malignant tumor of colon indication 314998002
Malignant tumor of stomach indication 363349007 DOID:10534
Metastatic Breast Carcinoma indication
Lymph Node Positive Colorectal Carcinoma indication
Malignant tumor of ovary off-label use 363443007 DOID:2394
Adenocarcinoma of pancreas off-label use 700423003 DOID:4074
Pancreatic Neuroendocrine Tumor off-label use
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Hyperbilirubinemia contraindication 14783006 DOID:2741
Infectious disease contraindication 40733004
Conduction disorder of the heart contraindication 44808001
Acute nephropathy contraindication 58574008
Stomatitis contraindication 61170000 DOID:9637
Dihydrouracil dehydrogenase (NADP^+^) deficiency contraindication 77365006 DOID:14218
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Severe diarrhea contraindication 409587002
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Palmar-Plantar Erythrodysesthesia contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.3 acidic
pKa2 12.91 acidic
pKa3 13.46 acidic
pKa4 0.75 Basic

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

External reference:

IDSource
4021099 VUID
N0000148555 NUI
D01223 KEGG_DRUG
4021099 VANDF
C0671970 UMLSCUI
CHEBI:31348 CHEBI
CHEMBL1773 ChEMBL_ID
DB01101 DRUGBANK_ID
D000069287 MESH_DESCRIPTOR_UI
7317 INN_ID
60953 PUBCHEM_CID
6799 IUPHAR_LIGAND_ID
6804DJ8Z9U UNII
194000 RXNORM
11693 MMSL
210675 MMSL
4344 MMSL
d04311 MMSL
007533 NDDF
108761006 SNOMEDCT_US
386906001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1100 TABLET, FILM COATED 150 mg ORAL NDA 29 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1101 TABLET, FILM COATED 500 mg ORAL NDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0272 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7473 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7474 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0378-2511 TABLET, FILM COATED 150 mg ORAL ANDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0378-2512 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16714-467 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16714-468 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-072 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-073 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 50268-154 TABLET 500 mg ORAL ANDA 21 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51079-510 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-095 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-096 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 53808-0411 TABLET, FILM COATED 500 mg ORAL NDA 24 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 54868-4143 TABLET, FILM COATED 150 mg ORAL NDA 30 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 54868-5260 TABLET, FILM COATED 500 mg ORAL NDA 30 sections
capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-496 TABLET 150 mg ORAL ANDA 26 sections
capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 55111-497 TABLET 500 mg ORAL ANDA 26 sections
Capecitabine Human Prescription Drug Label 1 59651-204 TABLET 150 mg ORAL ANDA 28 sections
Capecitabine Human Prescription Drug Label 1 59651-205 TABLET 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 59923-721 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 59923-722 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 60687-149 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Capecitabine Human Prescription Drug Label 1 62756-238 TABLET, FILM COATED 150 mg ORAL ANDA 30 sections
Capecitabine Human Prescription Drug Label 1 62756-239 TABLET, FILM COATED 500 mg ORAL ANDA 30 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 64980-276 TABLET, FILM COATED 150 mg ORAL ANDA 26 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 64980-277 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections