capecitabine 🐶 Veterinary Use | 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 µM/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
April 16, 2003 PMDA CHUGAI PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Palmar-plantar erythrodysaesthesia syndrome 7616.91 13.29 2432 104802 18633 56166200
Disease progression 3414.43 13.29 2251 104983 102922 56081911
Diarrhoea 2381.23 13.29 4292 102942 634215 55550618
Malignant neoplasm progression 2197.14 13.29 1497 105737 72090 56112743
Metastases to liver 1503.24 13.29 761 106473 20825 56164008
Metastases to bone 1243.28 13.29 648 106586 18860 56165973
Breast cancer metastatic 1203.06 13.29 588 106646 14881 56169952
Death 1194.89 13.29 2242 104992 339184 55845649
Mucosal inflammation 1090.11 13.29 791 106443 42019 56142814
Metastases to central nervous system 752.72 13.29 396 106838 11740 56173093
Rheumatoid arthritis 711.83 13.29 3 107231 382601 55802232
Metastases to lung 686.20 13.29 368 106866 11350 56173483
Neuropathy peripheral 513.03 13.29 793 106441 102100 56082733
Vomiting 500.77 13.29 2072 105162 496156 55688677
Breast cancer 498.38 13.29 537 106697 48296 56136537
Neoplasm progression 477.33 13.29 433 106801 31583 56153250
Neutropenia 471.04 13.29 973 106261 157194 56027639
Drug ineffective 438.78 13.29 674 106560 918315 55266518
Dehydration 432.34 13.29 942 106292 157883 56026950
Metastases to lymph nodes 414.71 13.29 226 107008 7197 56177636
Skin exfoliation 361.10 13.29 397 106837 36503 56148330
Joint swelling 344.86 13.29 67 107167 289733 55895100
Stomatitis 339.37 13.29 726 106508 120084 56064749
Nausea 330.13 13.29 2531 104703 761647 55423186
Bone marrow failure 318.66 13.29 328 106906 27958 56156875
Contraindicated product administered 317.09 13.29 8 107226 186278 55998555
Systemic lupus erythematosus 305.50 13.29 8 107226 180070 56004763
Gastrointestinal toxicity 304.46 13.29 173 107061 5983 56178850
Skin fissures 302.18 13.29 202 107032 9371 56175462
Neurotoxicity 299.10 13.29 245 106989 15550 56169283
Myelosuppression 295.92 13.29 254 106980 17201 56167632
Skin toxicity 287.64 13.29 146 107088 4007 56180826
Maternal exposure during pregnancy 283.77 13.29 20 107214 189533 55995300
Arteriospasm coronary 278.51 13.29 137 107097 3510 56181323
Arthropathy 275.80 13.29 30 107204 200245 55984588
Metastases to skin 275.60 13.29 104 107130 1354 56183479
Condition aggravated 275.02 13.29 158 107076 344740 55840093
Paronychia 269.92 13.29 148 107086 4770 56180063
Arthralgia 259.88 13.29 346 106888 501323 55683510
Decreased appetite 251.39 13.29 952 106282 218279 55966554
Thrombocytopenia 250.07 13.29 695 106539 135529 56049304
Metastasis 235.39 13.29 134 107100 4650 56180183
Osteonecrosis of jaw 230.97 13.29 301 106933 33057 56151776
Completed suicide 230.58 13.29 5 107229 133828 56051005
Dry skin 230.19 13.29 360 106874 46749 56138084
Drug hypersensitivity 222.23 13.29 124 107110 275081 55909752
Glossodynia 219.96 13.29 19 107215 152439 56032394
Therapeutic product effect decreased 217.23 13.29 32 107202 169420 56015413
Haematotoxicity 211.07 13.29 154 107080 8229 56176604
Enteritis 211.05 13.29 147 107087 7296 56177537
Sinusitis 195.93 13.29 66 107168 197515 55987318
Exposure during pregnancy 193.95 13.29 18 107216 136324 56048509
Skin discolouration 189.75 13.29 278 106956 34078 56150755
Cardiotoxicity 189.13 13.29 139 107095 7511 56177322
Tumour marker increased 184.12 13.29 110 107124 4183 56180650
Product use issue 179.55 13.29 65 107169 185976 55998857
Dihydropyrimidine dehydrogenase deficiency 175.51 13.29 39 107195 45 56184788
Treatment failure 174.08 13.29 54 107180 170338 56014495
Laryngospasm 172.80 13.29 92 107142 2792 56182041
Metastases to peritoneum 169.28 13.29 92 107142 2912 56181921
Ascites 167.08 13.29 275 106959 37269 56147564
Fall 162.03 13.29 270 106964 357240 55827593
Asthenia 159.89 13.29 1159 106075 341814 55843019
Metastases to pleura 159.02 13.29 69 107165 1313 56183520
Wound 158.89 13.29 35 107199 138769 56046064
PIK3CA-activated mutation 158.43 13.29 62 107172 896 56183937
Pleural effusion 157.59 13.29 437 106797 85043 56099790
Psoriasis 157.56 13.29 4 107230 92688 56092145
Therapy cessation 155.48 13.29 224 107010 27040 56157793
Musculoskeletal stiffness 153.09 13.29 53 107181 155954 56028879
Swelling 144.69 13.29 146 107088 239625 55945208
Pseudocirrhosis 144.31 13.29 52 107182 589 56184244
Weight increased 144.25 13.29 135 107099 229568 55955265
Osteonecrosis 141.64 13.29 197 107037 23018 56161815
Metastases to spine 139.78 13.29 81 107153 2908 56181925
Metastatic neoplasm 139.19 13.29 89 107145 3824 56181009
Nail disorder 136.61 13.29 137 107097 11314 56173519
Pericarditis 136.29 13.29 22 107212 108901 56075932
Pain 134.85 13.29 729 106505 662455 55522378
Breast cancer recurrent 131.03 13.29 87 107147 3988 56180845
Hospice care 130.05 13.29 102 107132 6078 56178755
Infusion related reaction 125.14 13.29 128 107106 208803 55976030
Hepatic function abnormal 122.43 13.29 229 107005 34329 56150504
Hepatic lesion 120.55 13.29 84 107150 4171 56180662
Abdominal discomfort 120.41 13.29 215 107019 277059 55907774
Discomfort 120.00 13.29 60 107174 141701 56043132
Lymphangiosis carcinomatosa 116.99 13.29 54 107180 1195 56183638
Headache 116.02 13.29 610 106624 558434 55626399
Onycholysis 114.73 13.29 55 107179 1329 56183504
Irritable bowel syndrome 109.18 13.29 5 107229 68453 56116380
Ejection fraction decreased 108.74 13.29 160 107074 19681 56165152
Pruritus 107.24 13.29 282 106952 316341 55868492
Blood bilirubin increased 107.09 13.29 212 107022 33142 56151691
Carbohydrate antigen 15-3 increased 106.86 13.29 51 107183 1220 56183613
Arthritis 106.79 13.29 29 107205 99823 56085010
Duodenal ulcer perforation 105.80 13.29 6 107228 68336 56116497
Drug interaction 101.92 13.29 151 107083 209604 55975229
Lower respiratory tract infection 101.11 13.29 46 107188 114748 56070085
Jaundice 94.36 13.29 179 107055 27115 56157718
Enterocolitis 94.08 13.29 90 107144 7014 56177819
Injection site pain 94.06 13.29 53 107181 117065 56067768
Bone lesion 94.02 13.29 80 107154 5350 56179483
Asthma 92.06 13.29 50 107184 112720 56072113
Intestinal obstruction 91.26 13.29 179 107055 27792 56157041
Depression 91.11 13.29 126 107108 179991 56004842
Overdose 90.75 13.29 44 107190 105786 56079047
Paraesthesia 90.66 13.29 489 106745 130025 56054808
Fibromyalgia 89.95 13.29 6 107228 59597 56125236
Carcinoembryonic antigen increased 89.81 13.29 49 107185 1563 56183270
Pneumonia 88.39 13.29 437 106797 406661 55778172
Polyneuropathy 87.58 13.29 116 107118 12934 56171899
Influenza 87.34 13.29 36 107198 95225 56089608
Hyperbilirubinaemia 86.31 13.29 102 107132 10133 56174700
Bronchitis 85.72 13.29 54 107180 112257 56072576
Intentional overdose 84.65 13.29 14 107220 68103 56116730
Urticaria 83.92 13.29 91 107143 144585 56040248
Leukopenia 82.67 13.29 310 106924 70630 56114203
Therapeutic product effect incomplete 82.28 13.29 50 107184 105981 56078852
Nasopharyngitis 81.64 13.29 188 107046 220771 55964062
Hypokalaemia 81.26 13.29 376 106858 94061 56090772
Osteoarthritis 80.96 13.29 26 107208 80270 56104563
Bradycardia 79.31 13.29 16 107218 67488 56117345
Non-cirrhotic portal hypertension 78.31 13.29 24 107210 156 56184677
Mobility decreased 77.77 13.29 46 107188 98945 56085888
Metastases to meninges 76.72 13.29 50 107184 2220 56182613
Plasma cell myeloma 75.73 13.29 3 107231 46643 56138190
Hypersensitivity 75.38 13.29 244 106990 256164 55928669
Febrile neutropenia 74.33 13.29 397 106837 105148 56079685
Abdominal lymphadenopathy 73.78 13.29 33 107201 677 56184156
Metastases to chest wall 73.48 13.29 30 107204 487 56184346
Bone pain 72.05 13.29 235 106999 49950 56134883
Ileus 71.85 13.29 109 107125 13773 56171060
Infusion site coldness 70.17 13.29 23 107211 191 56184642
Hepatic enzyme increased 69.81 13.29 138 107096 171246 56013587
Dysaesthesia pharynx 69.67 13.29 21 107213 128 56184705
Colitis 68.53 13.29 205 107029 41606 56143227
Alopecia 68.32 13.29 307 106927 293151 55891682
Suicide attempt 67.34 13.29 14 107220 57822 56127011
Fingerprint loss 67.19 13.29 15 107219 18 56184815
Product use in unapproved indication 65.84 13.29 104 107130 140718 56044115
Metastases to the mediastinum 65.49 13.29 27 107207 450 56184383
Suicidal ideation 65.15 13.29 15 107219 57727 56127106
Gastrointestinal perforation 63.45 13.29 51 107183 3148 56181685
Folliculitis 62.60 13.29 14 107220 54965 56129868
Bone disorder 62.46 13.29 124 107110 19419 56165414
Abortion spontaneous 61.59 13.29 6 107228 43747 56141086
Gamma-glutamyltransferase decreased 61.11 13.29 23 107211 297 56184536
Portal hypertension 60.96 13.29 52 107182 3489 56181344
Loss of personal independence in daily activities 60.88 13.29 40 107194 81329 56103504
Injection site erythema 59.42 13.29 37 107197 77411 56107422
Drug intolerance 58.69 13.29 282 106952 264536 55920297
Nail discolouration 58.66 13.29 44 107190 2452 56182381
Tooth extraction 58.56 13.29 81 107153 9412 56175421
Therapy change 57.06 13.29 61 107173 5427 56179406
Hepatic failure 56.60 13.29 166 107068 33320 56151513
Colorectal cancer metastatic 56.59 13.29 29 107205 812 56184021
Neoplasm malignant 56.57 13.29 145 107089 26910 56157923
Platelet count decreased 56.13 13.29 371 106863 106012 56078821
Colon cancer metastatic 55.21 13.29 32 107202 1149 56183684
Pulmonary embolism 54.96 13.29 371 106863 106753 56078080
Product dose omission issue 53.34 13.29 205 107029 204548 55980285
Insomnia 52.65 13.29 188 107046 191672 55993161
Erythema 52.47 13.29 490 106744 155449 56029384
Metastases to adrenals 51.73 13.29 26 107208 698 56184135
Blood cholesterol increased 51.23 13.29 38 107196 72541 56112292
Intestinal perforation 51.08 13.29 82 107152 10877 56173956
Chronic obstructive pulmonary disease 50.55 13.29 23 107211 57392 56127441
Hypoalbuminaemia 50.35 13.29 80 107154 10519 56174314
Pericardial effusion 50.10 13.29 139 107095 27036 56157797
Peripheral sensory neuropathy 50.05 13.29 64 107170 6892 56177941
Migraine 49.86 13.29 55 107179 86742 56098091
Feeling abnormal 49.85 13.29 113 107121 133489 56051344
Somnolence 49.74 13.29 153 107081 163260 56021573
Intentional product misuse 49.62 13.29 18 107216 51486 56133347
Wheezing 49.54 13.29 42 107192 74984 56109849
Device related thrombosis 48.42 13.29 33 107201 1580 56183253
Jaw operation 47.95 13.29 26 107208 819 56184014
Superior vena cava syndrome 47.83 13.29 24 107210 642 56184191
Skin hyperpigmentation 47.53 13.29 55 107179 5342 56179491
Chronic kidney disease 47.30 13.29 11 107223 42045 56142788
Blood pressure fluctuation 46.51 13.29 10 107224 40350 56144483
Neoplasm 46.23 13.29 59 107175 6342 56178491
Hypotension 45.99 13.29 284 106950 250224 55934609
Nasal congestion 45.98 13.29 25 107209 56345 56128488
Abdominal pain 45.93 13.29 720 106514 258085 55926748
Leukoencephalopathy 45.34 13.29 47 107187 4035 56180798
Pyogenic granuloma 45.20 13.29 18 107216 273 56184560
Disseminated intravascular coagulation 45.04 13.29 103 107131 17782 56167051
Debridement 44.72 13.29 28 107206 1159 56183674
Adverse event 44.53 13.29 25 107209 55351 56129482
Lacrimation increased 44.38 13.29 104 107130 18244 56166589
Lymphoedema 43.98 13.29 75 107159 10455 56174378
Anastomotic leak 43.73 13.29 20 107214 433 56184400
Nail infection 43.49 13.29 36 107198 2317 56182516
Osteoporosis 42.58 13.29 23 107211 52029 56132804
Osteolysis 42.20 13.29 37 107197 2576 56182257
Invasive ductal breast carcinoma 41.74 13.29 58 107176 6768 56178065
Hypoaesthesia 41.45 13.29 432 106802 141059 56043774
Angina bullosa haemorrhagica 41.33 13.29 14 107220 130 56184703
Mucosal toxicity 41.27 13.29 18 107216 347 56184486
Hyperhidrosis 40.72 13.29 73 107161 94015 56090818
Bone sequestrum 40.56 13.29 28 107206 1369 56183464
Drug reaction with eosinophilia and systemic symptoms 40.51 13.29 5 107229 30299 56154534
Recurrent cancer 40.26 13.29 31 107203 1797 56183036
Oxygen saturation decreased 40.25 13.29 55 107179 79012 56105821
Therapy partial responder 40.11 13.29 61 107173 7724 56177109
Performance status decreased 40.08 13.29 40 107194 3283 56181550
Blood uric acid decreased 39.59 13.29 22 107212 728 56184105
Contusion 39.24 13.29 120 107114 128310 56056523
Central nervous system lesion 39.18 13.29 69 107165 9869 56174964
Mouth ulceration 39.17 13.29 135 107099 29505 56155328
Wrong technique in product usage process 39.09 13.29 32 107202 58136 56126697
Cardiac failure congestive 38.92 13.29 67 107167 87653 56097180
Plantar erythema 38.89 13.29 15 107219 208 56184625
Malignant ascites 38.82 13.29 23 107211 861 56183972
Gingival bleeding 38.46 13.29 75 107159 11591 56173242
Cardiac output decreased 38.08 13.29 23 107211 892 56183941
Dysaesthesia 38.03 13.29 43 107191 4073 56180760
Injury 37.71 13.29 35 107199 59816 56125017
Ear infection 37.64 13.29 7 107227 31288 56153545
Agitation 37.44 13.29 31 107203 56005 56128828
Cataract 37.25 13.29 26 107208 51221 56133612
Metastases to ovary 36.92 13.29 17 107217 374 56184459
Hyperkalaemia 36.72 13.29 26 107208 50839 56133994
Cold dysaesthesia 36.59 13.29 8 107226 8 56184825
Rhabdomyolysis 36.24 13.29 16 107218 40642 56144191
Periodontitis 36.18 13.29 37 107197 3126 56181707
Multiple sclerosis 36.17 13.29 5 107229 27797 56157036
General physical health deterioration 36.07 13.29 488 106746 169522 56015311
Hiccups 35.88 13.29 30 107204 1958 56182875
Therapy interrupted 35.88 13.29 119 107115 25506 56159327
Exposed bone in jaw 35.68 13.29 35 107199 2813 56182020
Infusion site induration 35.50 13.29 22 107212 894 56183939
Anxiety 35.43 13.29 219 107015 192953 55991880
Human epidermal growth factor receptor negative 34.96 13.29 9 107225 27 56184806
Drug ineffective for unapproved indication 34.94 13.29 4 107230 25689 56159144
Acute coronary syndrome 34.92 13.29 65 107169 9703 56175130
Premature delivery 34.89 13.29 5 107229 27055 56157778
Hypovolaemic shock 34.88 13.29 47 107187 5326 56179507
Confusional state 34.64 13.29 243 106991 207912 55976921
Pharyngeal inflammation 34.54 13.29 19 107215 616 56184217
Proteinuria 34.51 13.29 92 107142 17478 56167355
Foetal exposure during pregnancy 34 13.29 11 107223 33812 56151021
Sedation 33.88 13.29 12 107222 34842 56149991
Type 2 diabetes mellitus 33.76 13.29 24 107210 46838 56137995
Blood glucose increased 33.70 13.29 57 107177 75094 56109739
Hydronephrosis 33.67 13.29 62 107172 9180 56175653
Eosinophil percentage increased 33.65 13.29 22 107212 982 56183851
Peripheral swelling 33.46 13.29 286 106948 234440 55950393
Necrotising oesophagitis 33.28 13.29 11 107223 94 56184739
Blood creatinine decreased 33.25 13.29 45 107189 5121 56179712
Malignant pleural effusion 32.74 13.29 31 107203 2385 56182448
Hypophagia 32.64 13.29 125 107109 28751 56156082
Lymphadenopathy 32.36 13.29 143 107091 35065 56149768
Granulocyte count decreased 32.15 13.29 21 107213 936 56183897
Blood pressure systolic increased 32.03 13.29 19 107215 40817 56144016
Acute kidney injury 31.84 13.29 299 106935 240464 55944369
Pulmonary arterial hypertension 31.72 13.29 6 107228 26497 56158336
Subacute cutaneous lupus erythematosus 31.56 13.29 30 107204 2319 56182514
Prescribed overdose 31.53 13.29 3 107231 22293 56162540
Urinary tract infection 31.25 13.29 300 106934 240213 55944620
Constipation 31.07 13.29 549 106685 201394 55983439
Pregnancy 31.05 13.29 12 107222 33021 56151812
Early satiety 30.99 13.29 20 107214 873 56183960
Gastric perforation 30.97 13.29 25 107209 1553 56183280
Tumour pain 30.88 13.29 23 107211 1268 56183565
Dysphagia 30.87 13.29 264 106970 81683 56103150
Radiation necrosis 30.86 13.29 15 107219 374 56184459
Accidental exposure to product 30.76 13.29 5 107229 24642 56160191
White blood cell count decreased 30.67 13.29 371 106863 125619 56059214
Stress cardiomyopathy 30.47 13.29 56 107178 8280 56176553
Pigmentation disorder 30.24 13.29 38 107196 4021 56180812
Neutrophil count decreased 30.15 13.29 180 107054 49642 56135191
Metastases to eye 29.81 13.29 11 107223 134 56184699
Brachiocephalic vein thrombosis 29.80 13.29 10 107224 90 56184743
Hormone receptor positive breast cancer 29.74 13.29 16 107218 496 56184337
Toothache 29.60 13.29 88 107146 17792 56167041
Breast neoplasm 29.58 13.29 23 107211 1353 56183480
Device issue 29.43 13.29 3 107231 21103 56163730
Ejection fraction 29.14 13.29 25 107209 1690 56183143
Congestive cardiomyopathy 29.14 13.29 45 107189 5774 56179059
Sopor 29.10 13.29 3 107231 20919 56163914
Onychomadesis 28.69 13.29 40 107194 4681 56180152
Biliary sepsis 28.53 13.29 19 107215 875 56183958
Nodular regenerative hyperplasia 28.42 13.29 15 107219 447 56184386
Anastomotic fistula 28.26 13.29 7 107227 17 56184816
Triple negative breast cancer 28.21 13.29 12 107222 217 56184616
Abnormal behaviour 27.96 13.29 3 107231 20269 56164564
Recall phenomenon 27.87 13.29 16 107218 564 56184269
Retroperitoneal neoplasm metastatic 27.86 13.29 8 107226 40 56184793
Varices oesophageal 27.86 13.29 31 107203 2885 56181948
Cheilitis 27.72 13.29 35 107199 3722 56181111
Bone debridement 27.67 13.29 12 107222 228 56184605
Sequestrectomy 27.58 13.29 18 107216 801 56184032
Loss of consciousness 27.48 13.29 111 107123 109238 56075595
Injection site bruising 27.40 13.29 20 107214 38501 56146332
Cachexia 27.29 13.29 40 107194 4902 56179931
Foot deformity 27.25 13.29 6 107228 23819 56161014
Oesophagitis 27.00 13.29 73 107161 13984 56170849
Pancreatic fistula 26.97 13.29 6 107228 7 56184826
Oral pigmentation 26.97 13.29 6 107228 7 56184826
Adnexa uteri mass 26.92 13.29 15 107219 499 56184334
Neoplasm recurrence 26.70 13.29 28 107206 2436 56182397
Dermatitis acneiform 26.69 13.29 37 107197 4307 56180526
Hyperaesthesia 26.55 13.29 54 107180 8603 56176230
Nervousness 26.52 13.29 11 107223 29004 56155829
Asthenopia 26.49 13.29 26 107208 2091 56182742
Hand-foot-and-mouth disease 26.44 13.29 10 107224 131 56184702
Joint injury 26.40 13.29 8 107226 25646 56159187
Arterial thrombosis 26.23 13.29 21 107213 1289 56183544
Brain operation 26.20 13.29 15 107219 526 56184307
Myocardial infarction 26.12 13.29 90 107144 92780 56092053
Pulmonary mass 25.98 13.29 92 107142 20378 56164455
Joint range of motion decreased 25.94 13.29 8 107226 25357 56159476
Thrombosis 25.93 13.29 198 107036 59229 56125604
Tooth erosion 25.93 13.29 14 107220 437 56184396
Pneumatosis intestinalis 25.32 13.29 26 107208 2207 56182626
Atrial fibrillation 25.24 13.29 114 107120 108783 56076050
Tumour perforation 24.97 13.29 9 107225 102 56184731
Ataxia 24.91 13.29 72 107162 14331 56170502
Steatohepatitis 24.87 13.29 14 107220 475 56184358
Vascular pain 24.84 13.29 16 107218 696 56184137
Stridor 24.79 13.29 31 107203 3264 56181569
Limbal stem cell deficiency 24.70 13.29 6 107228 13 56184820
Vasodilatation 24.49 13.29 26 107208 2295 56182538
Treatment noncompliance 24.45 13.29 16 107218 32607 56152226
Failure to anastomose 24.39 13.29 6 107228 14 56184819
Incorrect dose administered 24.36 13.29 39 107195 52508 56132325
Oral pain 24.32 13.29 107 107127 26186 56158647
Fluid retention 24.26 13.29 41 107193 54037 56130796
Hypervolaemia 24.24 13.29 10 107224 26448 56158385
Radiation skin injury 24.08 13.29 17 107217 862 56183971
Mucosal necrosis 23.90 13.29 7 107227 38 56184795
Adenocarcinoma 23.89 13.29 28 107206 2757 56182076
Vessel puncture site bruise 23.87 13.29 13 107221 413 56184420
Pulmonary hypertension 23.87 13.29 20 107214 35924 56148909
Epistaxis 23.72 13.29 213 107021 66810 56118023
No adverse event 23.69 13.29 134 107100 36240 56148593
Gingivitis 23.54 13.29 48 107186 7661 56177172
Unresponsive to stimuli 23.18 13.29 16 107218 31709 56153124
Medication error 23.04 13.29 28 107206 42307 56142526
Computerised tomogram abnormal 23.01 13.29 24 107210 2075 56182758
C-reactive protein increased 22.99 13.29 75 107159 78609 56106224
Schistosomiasis 22.87 13.29 5 107229 5 56184828
Increased liver stiffness 22.87 13.29 5 107229 5 56184828
Hepatic atrophy 22.86 13.29 11 107223 268 56184565
Transaminases 22.74 13.29 8 107226 84 56184749
Injection site haemorrhage 22.71 13.29 7 107227 22194 56162639
Hip arthroplasty 22.70 13.29 24 107210 38599 56146234
Pleural neoplasm 22.66 13.29 12 107222 360 56184473
Hepatic cancer metastatic 22.66 13.29 12 107222 360 56184473
Motion sickness 22.46 13.29 16 107218 823 56184010
Ingrowing nail 22.39 13.29 24 107210 2141 56182692
Post-traumatic neck syndrome 22.38 13.29 23 107211 1955 56182878
Dental care 22.24 13.29 17 107217 975 56183858
Nephrolithiasis 22.17 13.29 23 107211 37312 56147521
Blood lactate dehydrogenase increased 22.14 13.29 88 107146 20587 56164246
Metastases to breast 22.10 13.29 11 107223 289 56184544
Pulpitis dental 22.10 13.29 16 107218 844 56183989
Nightmare 21.95 13.29 3 107231 16823 56168010
Cytomegalovirus infection 21.79 13.29 5 107229 19291 56165542
Vertebral column mass 21.77 13.29 9 107225 151 56184682
Cholangitis 21.67 13.29 36 107198 4913 56179920
Respiratory arrest 21.65 13.29 16 107218 30609 56154224
Diverticulitis 21.39 13.29 22 107212 35830 56149003
Brain neoplasm 21.26 13.29 32 107202 4014 56180819
Heart rate increased 21.25 13.29 84 107150 83189 56101644
Respiratory disorder 21.22 13.29 20 107214 33937 56150896
Biliary obstruction 21.21 13.29 25 107209 2476 56182357
Right ventricular failure 21.18 13.29 3 107231 16376 56168457
Blood pressure increased 21.06 13.29 176 107058 145000 56039833
Chemotherapy cardiotoxicity attenuation 21.06 13.29 4 107230 0 56184833
Radiation myelopathy 21.06 13.29 4 107230 0 56184833
Oral toxicity 21.06 13.29 4 107230 0 56184833
Neuroendocrine breast tumour 20.90 13.29 6 107228 30 56184803
Fatigue 20.80 13.29 1757 105477 786795 55398038
Neutropenic sepsis 20.80 13.29 70 107164 15115 56169718
Brain oedema 20.73 13.29 64 107170 13207 56171626
Lactic acidosis 20.73 13.29 22 107212 35324 56149509
Breast disorder 20.70 13.29 24 107210 2335 56182498
Caesarean section 20.68 13.29 3 107231 16088 56168745
Product quality issue 20.66 13.29 18 107216 31718 56153115
Hyperglycaemic hyperosmolar nonketotic syndrome 20.64 13.29 14 107220 665 56184168
Disturbance in attention 20.53 13.29 19 107215 32521 56152312
Muscle swelling 20.50 13.29 12 107222 439 56184394
Oral disorder 20.49 13.29 47 107187 8128 56176705
ECG signs of myocardial ischaemia 20.48 13.29 7 107227 67 56184766
Purulent discharge 20.48 13.29 33 107201 4391 56180442
Pneumonitis 20.37 13.29 116 107118 31448 56153385
Lymphadenopathy mediastinal 20.18 13.29 25 107209 2608 56182225
Mucosal disorder 20.15 13.29 22 107212 2004 56182829
Metastases to stomach 20.15 13.29 9 107225 184 56184649
Body temperature decreased 20.14 13.29 78 107156 18030 56166803
Small intestinal obstruction 19.98 13.29 74 107160 16751 56168082
Angioedema 19.94 13.29 30 107204 41423 56143410
Diarrhoea haemorrhagic 19.90 13.29 46 107188 7997 56176836
Evans syndrome 19.84 13.29 9 107225 191 56184642
Obesity 19.74 13.29 9 107225 22439 56162394
Acute respiratory failure 19.67 13.29 18 107216 30976 56153857
COVID-19 19.61 13.29 75 107159 74983 56109850
Injection site swelling 19.58 13.29 33 107201 43545 56141288
Subileus 19.49 13.29 26 107208 2918 56181915
Eye pain 19.47 13.29 18 107216 30829 56154004
Coronary artery disease 19.41 13.29 18 107216 30778 56154055
Macular degeneration 19.27 13.29 6 107228 18902 56165931
Skin disorder 19.21 13.29 100 107134 26209 56158624
Sciatica 19.16 13.29 13 107221 25997 56158836
Odynophagia 19.12 13.29 41 107193 6777 56178056
Anaemia 19.11 13.29 655 106579 266856 55917977
Ankle fracture 19.03 13.29 4 107230 16399 56168434
Metastases to spleen 18.84 13.29 8 107226 144 56184689
Procedural pain 18.81 13.29 4 107230 16267 56168566
Acute myeloid leukaemia 18.79 13.29 73 107161 16899 56167934
Metastases to thorax 18.72 13.29 9 107225 219 56184614
Hepatic neoplasm 18.69 13.29 20 107214 1781 56183052
Femoral artery embolism 18.61 13.29 6 107228 47 56184786
Depressed level of consciousness 18.49 13.29 51 107183 56382 56128451
Carcinoid tumour pulmonary 18.37 13.29 11 107223 420 56184413
Disease recurrence 18.33 13.29 92 107142 23768 56161065
Radiation fibrosis - lung 18.32 13.29 5 107229 20 56184813
Myalgia 18.28 13.29 162 107072 131863 56052970
Dysgeusia 18.23 13.29 137 107097 40778 56144055
Dyschezia 18.13 13.29 21 107213 2042 56182791
Chemical peritonitis 18.09 13.29 7 107227 98 56184735
Dermatomyositis 17.96 13.29 24 107210 2698 56182135
Pericardial effusion malignant 17.96 13.29 7 107227 100 56184733
Cognitive disorder 17.95 13.29 42 107192 49091 56135742
Pelvic fluid collection 17.95 13.29 14 107220 827 56184006
Hypothalamo-pituitary disorder 17.94 13.29 13 107221 687 56184146
Sinus congestion 17.90 13.29 4 107230 15720 56169113
Calcium ionised increased 17.90 13.29 7 107227 101 56184732
Metastases to abdominal cavity 17.88 13.29 11 107223 441 56184392
Product prescribing error 17.88 13.29 11 107223 23175 56161658
Insulinoma 17.83 13.29 7 107227 102 56184731
Eosinophilia 17.73 13.29 8 107226 20069 56164764
Respiratory tract congestion 17.68 13.29 4 107230 15587 56169246
Haematoma 17.61 13.29 21 107213 31998 56152835
Weight decreased 17.60 13.29 591 106643 240123 55944710
Peripheral motor neuropathy 17.51 13.29 18 107216 1530 56183303
Tubulointerstitial nephritis 17.51 13.29 5 107229 16660 56168173
Sudden death 17.51 13.29 49 107185 9576 56175257
Delirium 17.49 13.29 34 107200 42483 56142350
Paraneoplastic dermatomyositis 17.41 13.29 4 107230 6 56184827
Anaphylactic reaction 17.39 13.29 56 107178 58939 56125894
Tumour marker abnormal 17.36 13.29 10 107224 355 56184478
Botryomycosis 17.25 13.29 5 107229 26 56184807
Brachial plexopathy 17.24 13.29 7 107227 112 56184721
Enterocolitis haemorrhagic 17.15 13.29 17 107217 1384 56183449
Mental disorder 17.12 13.29 12 107222 23592 56161241
Artificial menopause 17.10 13.29 5 107229 27 56184806
Gait disturbance 17.09 13.29 214 107020 163107 56021726
Psychotic disorder 17.05 13.29 12 107222 23546 56161287
Thyroid disorder 17.01 13.29 3 107231 13935 56170898
Oncologic complication 17.01 13.29 8 107226 185 56184648
Herpangina 16.94 13.29 5 107229 28 56184805
Abdominal distension 16.93 13.29 224 107010 77402 56107431
Prinzmetal angina 16.89 13.29 13 107221 753 56184080
Wound dehiscence 16.86 13.29 31 107203 4584 56180249
Anal erythema 16.85 13.29 8 107226 189 56184644
Bone fistula 16.81 13.29 6 107228 66 56184767
Neutrophil count abnormal 16.79 13.29 23 107211 2647 56182186
Gallbladder disorder 16.79 13.29 6 107228 17328 56167505
Vein disorder 16.76 13.29 31 107203 4606 56180227
Pulmonary thrombosis 16.72 13.29 43 107191 7994 56176839
Rectal perforation 16.67 13.29 10 107224 383 56184450
Dermatitis 16.63 13.29 65 107169 15092 56169741
Inappropriate schedule of product administration 16.62 13.29 92 107142 83295 56101538
Hyperammonaemia 16.58 13.29 32 107202 4908 56179925
Tongue discolouration 16.53 13.29 24 107210 2915 56181918
Anastomotic complication 16.49 13.29 7 107227 126 56184707
Premature baby 16.43 13.29 8 107226 19197 56165636
Jaundice cholestatic 16.42 13.29 34 107200 5485 56179348
Gastrointestinal inflammation 16.41 13.29 32 107202 4946 56179887
Bursitis 16.37 13.29 17 107217 27565 56157268
Carbohydrate antigen 19-9 increased 16.26 13.29 8 107226 205 56184628
Excessive granulation tissue 16.25 13.29 13 107221 797 56184036
Disability 16.09 13.29 5 107229 15775 56169058
Radioisotope scan 16.07 13.29 4 107230 10 56184823
Impaired work ability 16.01 13.29 4 107230 14568 56170265
Small intestinal perforation 16.01 13.29 16 107218 1315 56183518
Metastases to muscle 16.00 13.29 7 107227 136 56184697
Tumour invasion 15.90 13.29 7 107227 138 56184695
Hypermutation 15.87 13.29 5 107229 36 56184797
Hyperglycaemia 15.84 13.29 126 107108 38155 56146678
Metastases to thyroid 15.80 13.29 3 107231 0 56184833
Hyperchylomicronaemia 15.80 13.29 3 107231 0 56184833
Radiotherapy 15.76 13.29 9 107225 314 56184519
Hyperbaric oxygen therapy 15.76 13.29 5 107229 37 56184796
Drug level increased 15.75 13.29 10 107224 20715 56164118
Blood creatine phosphokinase increased 15.73 13.29 18 107216 27934 56156899
Upper respiratory tract infection 15.70 13.29 76 107158 71212 56113621
Colitis ulcerative 15.67 13.29 14 107220 24377 56160456
Bone cancer metastatic 15.59 13.29 7 107227 145 56184688
Staphylococcal infection 15.55 13.29 30 107204 37588 56147245
Catheter site bruise 15.48 13.29 9 107225 325 56184508
Hepatic cancer 15.43 13.29 28 107206 4099 56180734
Hallucination, visual 15.37 13.29 7 107227 17461 56167372
Pituitary tumour 15.32 13.29 13 107221 866 56183967
Liver scan abnormal 15.31 13.29 5 107229 41 56184792
Renal vein thrombosis 15.31 13.29 9 107225 332 56184501
Large intestine perforation 15.31 13.29 41 107193 7810 56177023
Perforation 15.29 13.29 14 107220 1032 56183801
Vulval disorder 15.25 13.29 12 107222 718 56184115
Hypertriglyceridaemia 15.21 13.29 34 107200 5782 56179051
Obstruction gastric 15.17 13.29 13 107221 878 56183955
Ileus paralytic 15.10 13.29 28 107206 4167 56180666
Gram stain positive 15.10 13.29 5 107229 43 56184790
Restlessness 15.09 13.29 17 107217 26569 56158264
Radiation injury 15.01 13.29 10 107224 461 56184372
Abdominal symptom 15.00 13.29 9 107225 345 56184488
Oestrogen receptor assay positive 14.95 13.29 10 107224 464 56184369
Infection 14.91 13.29 280 106954 199926 55984907
Rhinorrhoea 14.89 13.29 57 107177 56980 56127853
Colon cancer 14.84 13.29 46 107188 9515 56175318
Myopathy toxic 14.80 13.29 10 107224 472 56184361
Paresis 14.76 13.29 20 107214 2278 56182555
Facial asymmetry 14.73 13.29 12 107222 755 56184078
Lip pain 14.70 13.29 17 107217 1650 56183183
Mediastinal disorder 14.67 13.29 9 107225 359 56184474
Influenza like illness 14.64 13.29 63 107171 60925 56123908
Restless legs syndrome 14.59 13.29 7 107227 16940 56167893
Musculoskeletal chest pain 14.58 13.29 75 107159 19566 56165267
Hospitalisation 14.56 13.29 212 107022 74788 56110045
Torsade de pointes 14.50 13.29 3 107231 12437 56172396
Corneal erosion 14.47 13.29 8 107226 262 56184571
Renal hydrocele 14.46 13.29 4 107230 17 56184816
Venous thrombosis limb 14.46 13.29 22 107212 2787 56182046
Inflammation 14.43 13.29 75 107159 68996 56115837
Kidney infection 14.43 13.29 11 107223 20714 56164119
Joint dislocation 14.38 13.29 6 107228 15767 56169066
Wound treatment 14.38 13.29 7 107227 175 56184658
Extrapyramidal disorder 14.36 13.29 3 107231 12353 56172480
Pulmonary hilum mass 14.34 13.29 6 107228 104 56184729
Ureteric obstruction 14.33 13.29 17 107217 1695 56183138
Tumour excision 14.32 13.29 9 107225 375 56184458
Tenderness 14.30 13.29 76 107158 20079 56164754
Mood swings 14.29 13.29 7 107227 16740 56168093
Hallucination 14.25 13.29 47 107187 49102 56135731
Diabetes mellitus 14.23 13.29 52 107182 52683 56132150
Gastroenteropancreatic neuroendocrine tumour disease 14.17 13.29 5 107229 53 56184780
Crying 14.15 13.29 12 107222 21428 56163405
Fistula 14.11 13.29 43 107191 8812 56176021
Peritoneal fluid analysis abnormal 14.10 13.29 4 107230 19 56184814
Metastases to pelvis 14.07 13.29 9 107225 387 56184446
Accidental overdose 14.07 13.29 11 107223 20450 56164383
Metastases to bladder 14.06 13.29 7 107227 184 56184649
Limb injury 14.05 13.29 13 107221 22257 56162576
Activated PI3 kinase delta syndrome 13.93 13.29 4 107230 20 56184813
Pneumoperitoneum 13.92 13.29 15 107219 1346 56183487
Bile duct stenosis 13.92 13.29 14 107220 1160 56183673
Lymphangitis 13.85 13.29 12 107222 822 56184011
Hypoglycaemia 13.80 13.29 57 107177 55758 56129075
Sputum discoloured 13.75 13.29 5 107229 14287 56170546
Actinomycosis 13.73 13.29 13 107221 1000 56183833
Metastases to kidney 13.72 13.29 7 107227 194 56184639
Anxiety disorder due to a general medical condition 13.72 13.29 3 107231 3 56184830
Abdominal wall mass 13.72 13.29 3 107231 3 56184830
Dark circles under eyes 13.71 13.29 10 107224 534 56184299
Aggression 13.70 13.29 13 107221 21993 56162840
Paraneoplastic syndrome 13.69 13.29 10 107224 535 56184298
Tremor 13.68 13.29 156 107078 120933 56063900
Hypothyroidism 13.68 13.29 33 107201 38163 56146670
Glaucoma 13.68 13.29 8 107226 17321 56167512
Irritability 13.67 13.29 22 107212 29566 56155267
Onychalgia 13.67 13.29 12 107222 837 56183996
Obstructive airways disorder 13.61 13.29 8 107226 17274 56167559
Colitis ischaemic 13.55 13.29 46 107188 9974 56174859
Intracranial pressure increased 13.52 13.29 28 107206 4517 56180316
Gingival swelling 13.51 13.29 26 107208 3980 56180853
Heavy menstrual bleeding 13.49 13.29 7 107227 16202 56168631
Hypercalcaemia of malignancy 13.47 13.29 7 107227 202 56184631
Stress 13.45 13.29 62 107172 58848 56125985
Subclavian vein thrombosis 13.41 13.29 17 107217 1815 56183018
Herpes zoster 13.40 13.29 87 107147 75802 56109031
Product complaint 13.37 13.29 3 107231 11757 56173076

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 2382.10 14.62 905 49909 14578 31631952
Diarrhoea 1378.53 14.62 2197 48617 350212 31296318
Disease progression 1145.99 14.62 1032 49782 89432 31557098
Death 580.54 14.62 1564 49250 359005 31287525
Arteriospasm coronary 404.46 14.62 158 50656 2733 31643797
Mucosal inflammation 390.18 14.62 370 50444 34057 31612473
Neuropathy peripheral 374.59 14.62 530 50284 75119 31571411
Vomiting 254.50 14.62 862 49952 223111 31423419
Dehydration 252.38 14.62 576 50238 118535 31527995
Anastomotic leak 233.35 14.62 71 50743 547 31645983
Stomatitis 227.79 14.62 298 50516 39140 31607390
Nausea 224.05 14.62 1030 49784 306917 31339613
Enteritis 210.44 14.62 135 50679 6964 31639566
Metastases to liver 208.93 14.62 169 50645 12558 31633972
Neurotoxicity 186.73 14.62 176 50638 16050 31630480
Gastrointestinal perforation 181.76 14.62 97 50717 3535 31642995
Malignant neoplasm progression 172.62 14.62 387 50427 78611 31567919
Intestinal obstruction 160.10 14.62 181 50633 20429 31626101
Metastases to lung 157.97 14.62 121 50693 8301 31638229
Dihydropyrimidine dehydrogenase deficiency 156.29 14.62 34 50780 45 31646485
Decreased appetite 151.46 14.62 564 50250 152653 31493877
Myelosuppression 147.64 14.62 149 50665 14771 31631759
Gastrointestinal toxicity 143.50 14.62 71 50743 2203 31644327
Drug ineffective 141.93 14.62 262 50552 395311 31251219
Skin toxicity 140.64 14.62 86 50728 4073 31642457
Bone marrow failure 139.45 14.62 197 50617 27811 31618719
Completed suicide 132.24 14.62 3 50811 91511 31555019
Anastomotic complication 124.34 14.62 39 50775 336 31646194
Colon cancer metastatic 123.93 14.62 58 50756 1587 31644943
Enterocolitis 107.69 14.62 91 50723 7183 31639347
Ileus 100.80 14.62 123 50691 15046 31631484
Neutropenia 97.38 14.62 464 50350 139900 31506630
Abdominal pain 97.33 14.62 477 50337 145475 31501055
Pancreatic neuroendocrine tumour metastatic 96.93 14.62 28 50786 176 31646354
Headache 94.64 14.62 93 50721 183559 31462971
Arthralgia 91.10 14.62 66 50748 151358 31495172
Therapy cessation 85.66 14.62 113 50701 14942 31631588
Condition aggravated 84.54 14.62 83 50731 163926 31482604
Pneumonia 80.27 14.62 273 50541 335039 31311491
Metastases to peritoneum 76.55 14.62 42 50772 1618 31644912
Cardiac failure congestive 72.25 14.62 19 50795 79368 31567162
Carcinoembryonic antigen increased 71.94 14.62 30 50784 618 31645912
Tumour perforation 71.62 14.62 24 50790 260 31646270
Intestinal perforation 70.85 14.62 77 50737 8312 31638218
Cardiotoxicity 70.56 14.62 61 50753 4966 31641564
Overdose 70.27 14.62 24 50790 84640 31561890
Gastrointestinal anastomotic leak 69.00 14.62 25 50789 347 31646183
Wound dehiscence 67.59 14.62 49 50765 3089 31643441
Necrotising fasciitis 65.17 14.62 50 50764 3436 31643094
Fall 64.89 14.62 125 50689 185964 31460566
Proteus infection 64.26 14.62 31 50783 909 31645621
Thrombocytopenia 64.24 14.62 420 50394 142327 31504203
Skin exfoliation 63.68 14.62 127 50687 23747 31622783
Drug interaction 62.84 14.62 152 50662 208391 31438139
Dysphagia 61.60 14.62 218 50596 57458 31589072
Haematotoxicity 61.13 14.62 66 50748 7071 31639459
Stomal varices 60.84 14.62 15 50799 45 31646485
Neoplasm progression 59.14 14.62 112 50702 20160 31626370
Depression 56.66 14.62 38 50776 90777 31555753
Product dose omission issue 56.03 14.62 52 50762 105534 31540996
Colon cancer 55.85 14.62 69 50745 8544 31637986
Recall phenomenon 55.60 14.62 24 50790 540 31645990
Fingerprint loss 54.89 14.62 13 50801 31 31646499
Gastric perforation 53.48 14.62 38 50776 2321 31644209
Anxiety 52.99 14.62 41 50773 90992 31555538
Portal hypertension 51.87 14.62 45 50769 3680 31642850
Metastatic gastric cancer 51.86 14.62 17 50797 171 31646359
Proteinuria 50.62 14.62 94 50720 16669 31629861
Rectal perforation 50.43 14.62 21 50793 431 31646099
Peritonitis 50.16 14.62 89 50725 15238 31631292
Focal nodular hyperplasia 50.10 14.62 16 50798 147 31646383
Subileus 49.67 14.62 40 50774 2950 31643580
Rectal cancer 48.85 14.62 35 50779 2166 31644364
Metastases to lymph nodes 48.51 14.62 46 50768 4222 31642308
Hyperammonaemic encephalopathy 48.49 14.62 35 50779 2191 31644339
Colitis 47.88 14.62 141 50673 33746 31612784
Paraesthesia 47.58 14.62 197 50617 55874 31590656
Splenorenal shunt 47.46 14.62 10 50804 10 31646520
Induration 47.34 14.62 25 50789 891 31645639
Psoriasis 46.87 14.62 9 50805 46710 31599820
Pulmonary embolism 46.11 14.62 255 50559 81391 31565139
Hiccups 45.71 14.62 65 50749 9222 31637308
Dermatitis acneiform 45.36 14.62 51 50763 5716 31640814
Faecal volume decreased 45.22 14.62 14 50800 115 31646415
Foetal exposure during pregnancy 45.22 14.62 6 50808 40870 31605660
Obstruction gastric 45.13 14.62 24 50790 868 31645662
Vascular pain 44.49 14.62 14 50800 122 31646408
Cough 44.01 14.62 94 50720 134720 31511810
Hypovolaemic shock 43.90 14.62 53 50761 6409 31640121
No adverse event 43.72 14.62 97 50717 19528 31627002
Colorectal cancer metastatic 43.59 14.62 26 50788 1176 31645354
Toxic leukoencephalopathy 43.50 14.62 17 50797 294 31646236
Non-cirrhotic portal hypertension 42.43 14.62 16 50798 250 31646280
Prothrombin level decreased 40.77 14.62 24 50790 1059 31645471
Hallucination 40.54 14.62 12 50802 46398 31600132
Aggression 40.02 14.62 6 50808 37285 31609245
Metastases to central nervous system 39.90 14.62 55 50759 7581 31638949
Portal shunt 39.61 14.62 10 50804 34 31646496
Influenza 39.57 14.62 11 50803 44314 31602216
Rectal cancer metastatic 39.51 14.62 15 50799 239 31646291
Confusional state 39.46 14.62 98 50716 133236 31513294
Tumour marker increased 39.32 14.62 19 50795 559 31645971
Weight increased 39.29 14.62 45 50769 82902 31563628
Device occlusion 39.28 14.62 48 50766 5877 31640653
Intentional product misuse 38.73 14.62 7 50807 37944 31608586
Terminal ileitis 38.70 14.62 13 50801 142 31646388
Diaphragmatic spasm 38.50 14.62 12 50802 101 31646429
Skin fissures 38.38 14.62 41 50773 4339 31642191
Mucosal disorder 37.78 14.62 26 50788 1508 31645022
Hypokalaemia 37.69 14.62 178 50636 53396 31593134
Small intestinal obstruction 37.53 14.62 73 50741 13399 31633131
Agitation 37.52 14.62 20 50794 54149 31592381
Clostridial infection 37.29 14.62 36 50778 3379 31643151
Large intestine perforation 36.93 14.62 53 50761 7583 31638947
Anal erythema 36.58 14.62 11 50803 81 31646449
Laryngospasm 36.47 14.62 24 50790 1292 31645238
Hepatic lesion 36.40 14.62 35 50779 3268 31643262
Oesophageal haemorrhage 35.60 14.62 23 50791 1200 31645330
Musculoskeletal stiffness 35.53 14.62 11 50803 41314 31605216
Metastasis 35.48 14.62 36 50778 3588 31642942
Asthma 35.47 14.62 12 50802 42599 31603931
COVID-19 35.46 14.62 22 50792 54799 31591731
Rhabdomyolysis 35.29 14.62 30 50784 63551 31582979
Dizziness 35.16 14.62 182 50632 198965 31447565
Protein urine 34.75 14.62 20 50794 846 31645684
Insomnia 34.50 14.62 62 50752 94774 31551756
Suicidal ideation 34.49 14.62 8 50806 36398 31610132
Large intestinal obstruction 34.25 14.62 24 50790 1433 31645097
Prostate cancer 34.19 14.62 9 50805 37592 31608938
Rectal tenesmus 34.09 14.62 19 50795 755 31645775
Joint swelling 33.79 14.62 22 50792 53409 31593121
Pruritus 33.25 14.62 97 50717 125070 31521460
Polyneuropathy 33.20 14.62 68 50746 12954 31633576
Intestinal dilatation 33.13 14.62 21 50793 1060 31645470
Colon cancer recurrent 32.92 14.62 11 50803 118 31646412
Therapy interrupted 32.72 14.62 60 50754 10536 31635994
Anal prolapse 32.63 14.62 6 50808 0 31646530
Biliary obstruction 32.48 14.62 29 50785 2464 31644066
Bradycardia 32.41 14.62 38 50776 69289 31577241
Skin discolouration 32.35 14.62 77 50737 16230 31630300
Neutropenic sepsis 31.98 14.62 65 50749 12314 31634216
Dysaesthesia pharynx 31.95 14.62 9 50805 51 31646479
Stoma site haemorrhage 31.43 14.62 18 50796 754 31645776
Electrocardiogram QT prolonged 31.10 14.62 11 50803 37976 31608554
Oesophagitis 30.67 14.62 64 50750 12352 31634178
Peripheral ischaemia 30.48 14.62 40 50774 5260 31641270
Hospice care 30.40 14.62 41 50773 5535 31640995
Asthenia 30.23 14.62 517 50297 224238 31422292
Ascites 30.12 14.62 138 50676 40875 31605655
Electrocardiogram ST segment elevation 29.74 14.62 37 50777 4614 31641916
Sinusitis 29.41 14.62 11 50803 36685 31609845
Erythema 28.78 14.62 224 50590 80181 31566349
Hyperbilirubinaemia 28.72 14.62 72 50742 15678 31630852
Gastrointestinal disorder 28.61 14.62 111 50703 30549 31615981
Tenderness 28.45 14.62 41 50773 5887 31640643
Inappropriate schedule of product administration 28.17 14.62 24 50790 50799 31595731
Chronic obstructive pulmonary disease 28.02 14.62 19 50795 45147 31601383
Abnormal behaviour 27.58 14.62 3 50811 23825 31622705
Arterial thrombosis 27.37 14.62 21 50793 1443 31645087
Proctalgia 27.12 14.62 35 50779 4527 31642003
Disseminated intravascular coagulation 26.70 14.62 83 50731 20454 31626076
Product use issue 26.65 14.62 31 50783 56728 31589802
Gastroenteritis radiation 26.60 14.62 12 50802 301 31646229
Hypoaesthesia 26.46 14.62 167 50647 55855 31590675
Therapy change 26.44 14.62 27 50787 2711 31643819
Pelvic abscess 26.29 14.62 17 50797 888 31645642
Gastric dilatation 26.11 14.62 15 50799 632 31645898
Seizure 25.99 14.62 78 50736 99690 31546840
Feeling abnormal 25.84 14.62 32 50782 56970 31589560
Pigmentation disorder 25.82 14.62 24 50790 2148 31644382
Injection site pain 25.16 14.62 12 50802 34622 31611908
Peripheral sensorimotor neuropathy 25.15 14.62 20 50794 1448 31645082
Myalgia 25.08 14.62 54 50760 77204 31569326
Leukoencephalopathy 24.88 14.62 31 50783 3871 31642659
Bronchitis 24.40 14.62 16 50798 38701 31607829
Wound infection 24.35 14.62 40 50774 6435 31640095
Gastrointestinal stoma necrosis 24.34 14.62 6 50808 18 31646512
Nasopharyngitis 24.22 14.62 40 50774 63205 31583325
Gastrointestinal stoma complication 24.20 14.62 18 50796 1180 31645350
Temperature intolerance 24.11 14.62 27 50787 3012 31643518
Hyperfibrinolysis 24.09 14.62 6 50808 19 31646511
Arthritis 24.06 14.62 7 50807 27378 31619152
Drug reaction with eosinophilia and systemic symptoms 24.05 14.62 9 50805 30009 31616521
Cellulitis 23.89 14.62 25 50789 47993 31598537
Wheezing 23.88 14.62 14 50800 35972 31610558
Pancreatitis viral 23.73 14.62 5 50809 5 31646525
Gastric cancer 23.62 14.62 38 50776 6007 31640523
Blood pressure fluctuation 23.62 14.62 4 50810 22732 31623798
Fatigue 23.52 14.62 703 50111 334503 31312027
Performance status decreased 23.44 14.62 30 50784 3848 31642682
Ventricular fibrillation 23.42 14.62 75 50739 18773 31627757
Colostomy 23.05 14.62 12 50802 415 31646115
Dyspnoea 23.02 14.62 400 50414 343079 31303451
Therapeutic product effect decreased 22.90 14.62 11 50803 31611 31614919
Oesophageal cancer metastatic 22.72 14.62 11 50803 325 31646205
Ileus paralytic 22.52 14.62 35 50779 5373 31641157
Nasal congestion 22.52 14.62 3 50811 20378 31626152
Mucosal toxicity 22.38 14.62 10 50804 245 31646285
Urticaria 22.38 14.62 36 50778 57481 31589049
Gastrointestinal mucosal necrosis 22.30 14.62 9 50805 170 31646360
Chronic kidney disease 22.21 14.62 17 50797 37958 31608572
Cholangitis 21.91 14.62 43 50771 7943 31638587
Rash maculo-papular 21.83 14.62 7 50807 25712 31620818
Lactic acidosis 21.80 14.62 12 50802 31925 31614605
Treatment noncompliance 21.78 14.62 7 50807 25677 31620853
Irritability 21.74 14.62 5 50809 22884 31623646
Arthropathy 21.40 14.62 6 50808 24045 31622485
Palmar erythema 21.35 14.62 10 50804 274 31646256
Alanine aminotransferase increased 21.19 14.62 56 50758 74600 31571930
Neutrophil count decreased 21.10 14.62 137 50677 46257 31600273
Erectile dysfunction 20.85 14.62 3 50811 19232 31627298
Cognitive disorder 20.77 14.62 7 50807 24916 31621614
Failure to anastomose 20.71 14.62 9 50805 206 31646324
Hepatic infarction 20.67 14.62 9 50805 207 31646323
Somnolence 20.40 14.62 86 50728 99359 31547171
Eosinophilia 20.33 14.62 6 50808 23247 31623283
Heart rate decreased 20.22 14.62 10 50804 28256 31618274
Hypertriglyceridaemia 20.21 14.62 41 50773 7757 31638773
Change of bowel habit 20 14.62 15 50799 996 31645534
Scleroderma-like reaction 19.97 14.62 6 50808 44 31646486
Feeling cold 19.91 14.62 46 50768 9508 31637022
Incisional hernia 19.85 14.62 16 50798 1181 31645349
Oxygen saturation decreased 19.81 14.62 30 50784 49085 31597445
Pulmonary hypertension 19.80 14.62 4 50810 20037 31626493
Coronary artery disease 19.73 14.62 27 50787 46060 31600470
Tremor 19.72 14.62 60 50754 76360 31570170
Nephrotic syndrome 19.57 14.62 38 50776 6965 31639565
Metastases to the mediastinum 19.54 14.62 9 50805 237 31646293
Pharyngeal ulceration 19.48 14.62 10 50804 336 31646194
Wrong technique in product usage process 19.41 14.62 15 50799 33328 31613202
Therapeutic product effect prolonged 19.34 14.62 9 50805 243 31646287
Haematemesis 19.34 14.62 87 50727 25566 31620964
Basal cell carcinoma 19.33 14.62 3 50811 18176 31628354
Cataract 19.30 14.62 7 50807 23800 31622730
Nail bed inflammation 19.09 14.62 8 50806 167 31646363
Hepatic atrophy 18.91 14.62 8 50806 171 31646359
Gastrointestinal mucosal disorder 18.89 14.62 10 50804 358 31646172
Scrotal ulcer 18.82 14.62 10 50804 361 31646169
Upper respiratory tract infection 18.75 14.62 12 50802 29410 31617120
Drug hypersensitivity 18.73 14.62 57 50757 72542 31573988
Eosinophilic pneumonia chronic 18.65 14.62 9 50805 264 31646266
Gastrointestinal injury 18.64 14.62 10 50804 368 31646162
Ectropion 18.58 14.62 7 50807 109 31646421
Eczema impetiginous 18.27 14.62 5 50809 25 31646505
Metastases to pelvis 18.13 14.62 9 50805 281 31646249
Anterior spinal artery syndrome 18.09 14.62 4 50810 6 31646524
Venoocclusive liver disease 18.07 14.62 38 50776 7374 31639156
Laryngeal discomfort 18.02 14.62 8 50806 193 31646337
Gastrointestinal inflammation 18.02 14.62 24 50790 3201 31643329
Leukopenia 17.93 14.62 156 50658 57672 31588858
Cardiac failure 17.83 14.62 74 50740 85879 31560651
Peripheral embolism 17.71 14.62 14 50800 1005 31645525
Periportal sinus dilatation 17.65 14.62 5 50809 29 31646501
Therapy partial responder 17.60 14.62 35 50779 6527 31640003
Idiosyncratic drug reaction 17.44 14.62 10 50804 420 31646110
Aortic thrombosis 17.41 14.62 12 50802 698 31645832
Psychotic disorder 17.33 14.62 7 50807 22286 31624244
Peripheral sensory neuropathy 17.32 14.62 34 50780 6281 31640249
Varices oesophageal 17.22 14.62 24 50790 3342 31643188
Blood glucose increased 17.19 14.62 46 50768 61037 31585493
Dysaesthesia 17.11 14.62 19 50795 2100 31644430
Swelling of eyelid 17.09 14.62 13 50801 882 31645648
Metastases to eye 17.06 14.62 6 50808 76 31646454
Intestinal ischaemia 17.03 14.62 36 50778 7009 31639521
Delirium 17.00 14.62 25 50789 41396 31605134
Balance disorder 16.96 14.62 21 50793 37401 31609129
Vasospasm 16.86 14.62 9 50805 328 31646202
Pneumatosis intestinalis 16.84 14.62 25 50789 3686 31642844
Faeces pale 16.82 14.62 15 50799 1272 31645258
Dry skin 16.71 14.62 83 50731 25398 31621132
Metastases to meninges 16.70 14.62 15 50799 1284 31645246
Pancreatic neuroendocrine tumour 16.66 14.62 9 50805 336 31646194
Back pain 16.57 14.62 105 50709 109308 31537222
Hot flush 16.50 14.62 3 50811 16193 31630337
Hand-foot-genital syndrome 16.48 14.62 4 50810 11 31646519
Depressed mood 16.37 14.62 4 50810 17571 31628959
Urethral ulcer 16.31 14.62 3 50811 0 31646530
Alopecia 16.21 14.62 71 50743 20624 31625906
Interstitial lung disease 16.20 14.62 160 50654 61243 31585287
Neutrophilia 16.18 14.62 25 50789 3818 31642712
Liver injury 16.14 14.62 53 50761 13439 31633091
Biliary fistula 16.05 14.62 5 50809 42 31646488
Acute coronary syndrome 15.99 14.62 51 50763 12738 31633792
Metastatic neoplasm 15.95 14.62 21 50793 2770 31643760
Memory impairment 15.66 14.62 23 50791 38107 31608423
Breast cancer metastatic 15.65 14.62 5 50809 46 31646484
Neoplasm malignant 15.64 14.62 66 50748 18865 31627665
Contusion 15.54 14.62 18 50796 33010 31613520
Hyperammonaemia 15.51 14.62 31 50783 5802 31640728
Peritoneal disorder 15.49 14.62 8 50806 272 31646258
Prostatic calcification 15.45 14.62 6 50808 102 31646428
Weight decreased 15.40 14.62 350 50464 159602 31486928
Influenza like illness 15.37 14.62 11 50803 25426 31621104
Ileal ulcer 15.35 14.62 10 50804 529 31646001
Pancreatic carcinoma 15.35 14.62 39 50775 8561 31637969
Carcinoid tumour pulmonary 15.34 14.62 4 50810 16 31646514
Genital erythema 15.28 14.62 7 50807 182 31646348
Malignant ascites 15.27 14.62 9 50805 398 31646132
Acral peeling skin syndrome 15.19 14.62 5 50809 51 31646479
Cryptitis 15.19 14.62 5 50809 51 31646479
Phrenic nerve paralysis 15.18 14.62 6 50808 107 31646423
Haemoglobin decreased 15.15 14.62 112 50702 112563 31533967
Rosacea 15.08 14.62 13 50801 1054 31645476
Neck pain 15.08 14.62 9 50805 22901 31623629
Perineal ulceration 14.96 14.62 4 50810 18 31646512
Electromyogram abnormal 14.77 14.62 5 50809 56 31646474
Adenocarcinoma of colon 14.75 14.62 22 50792 3258 31643272
Hypotension 14.74 14.62 235 50579 204383 31442147
Hypoglycaemia 14.62 14.62 38 50776 50908 31595622

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Palmar-plantar erythrodysaesthesia syndrome 7261.29 12.49 2487 116849 27760 70781348
Disease progression 2917.71 12.49 2279 117057 154393 70654715
Diarrhoea 2723.89 12.49 4762 114574 778579 70030529
Malignant neoplasm progression 1134.06 12.49 1202 118134 120537 70688571
Mucosal inflammation 1116.75 12.49 920 118416 66930 70742178
Metastases to liver 1034.60 12.49 606 118730 25272 70783836
Neuropathy peripheral 847.01 12.49 1055 118281 125841 70683267
Breast cancer metastatic 770.41 12.49 365 118971 9781 70799327
Metastases to bone 747.36 12.49 467 118869 21909 70787199
Death 643.07 12.49 2099 117237 507962 70301146
Arteriospasm coronary 629.95 12.49 271 119065 5753 70803355
Metastases to lung 606.48 12.49 366 118970 16118 70792990
Vomiting 525.75 12.49 2178 117158 590933 70218175
Rheumatoid arthritis 473.66 12.49 3 119333 291802 70517306
Metastases to central nervous system 430.82 12.49 285 119051 14749 70794359
Stomatitis 428.04 12.49 772 118564 127739 70681369
Myelosuppression 426.40 12.49 375 118961 29770 70779338
Nausea 419.83 12.49 2653 116683 849435 69959673
Dehydration 417.80 12.49 1069 118267 225073 70584035
Neurotoxicity 409.85 12.49 365 118971 29461 70779647
Bone marrow failure 396.65 12.49 450 118886 48560 70760548
Gastrointestinal toxicity 389.29 12.49 198 119138 6207 70802901
Neutropenia 371.34 12.49 1111 118225 256045 70553063
Completed suicide 365.21 12.49 3 119333 227132 70581976
Drug ineffective 351.64 12.49 656 118680 939096 69870012
Metastases to lymph nodes 336.89 12.49 204 119132 9034 70800074
Enteritis 331.21 12.49 228 119108 12603 70796505
Skin toxicity 323.44 12.49 182 119154 7016 70802092
Breast cancer 279.87 12.49 313 119023 33236 70775872
Arthralgia 270.83 12.49 269 119067 503121 70305987
Neoplasm progression 265.09 12.49 353 118983 44875 70764233
Decreased appetite 260.72 12.49 1109 118227 303671 70505437
Condition aggravated 259.48 12.49 204 119132 427431 70381677
Dihydropyrimidine dehydrogenase deficiency 258.60 12.49 57 119279 77 70809031
Thrombocytopenia 246.10 12.49 922 118414 238188 70570920
Skin exfoliation 242.30 12.49 351 118985 48275 70760833
Cardiotoxicity 235.78 12.49 175 119161 10895 70798213
Joint swelling 233.78 12.49 68 119268 253143 70555965
Skin fissures 228.54 12.49 173 119163 11097 70798011
Anastomotic leak 216.97 12.49 77 119259 952 70808156
Gastrointestinal perforation 203.41 12.49 124 119212 5557 70803551
Metastases to skin 185.30 12.49 77 119259 1494 70807614
Haematotoxicity 183.17 12.49 165 119171 13509 70795599
Enterocolitis 177.66 12.49 159 119177 12907 70796201
Fall 176.11 12.49 298 119038 443798 70365310
Laryngospasm 166.08 12.49 93 119243 3550 70805558
Therapy cessation 163.26 12.49 240 119096 33436 70775672
Skin discolouration 161.10 12.49 252 119084 37073 70772035
Dry skin 161.10 12.49 316 119020 55615 70753493
Contraindicated product administered 160.58 12.49 19 119317 134593 70674515
Tumour marker increased 159.88 12.49 92 119244 3702 70805406
Asthenia 158.42 12.49 1312 118024 456354 70352754
Paronychia 157.79 12.49 115 119221 6959 70802149
Drug interaction 154.84 12.49 252 119084 381189 70427919
Arthropathy 154.58 12.49 32 119304 150025 70659083
Therapeutic product effect decreased 148.35 12.49 30 119306 142988 70666120
Intestinal obstruction 145.65 12.49 246 119090 38579 70770529
Osteonecrosis of jaw 144.90 12.49 253 119083 40749 70768359
Metastases to peritoneum 143.54 12.49 86 119250 3733 70805375
Systemic lupus erythematosus 142.17 12.49 7 119329 101895 70707213
Overdose 141.88 12.49 54 119282 169691 70639417
Pseudocirrhosis 138.34 12.49 49 119287 602 70808506
Hospice care 136.32 12.49 112 119224 8093 70801015
Paraesthesia 136.29 12.49 545 118791 144992 70664116
Sinusitis 134.61 12.49 58 119278 169137 70639971
Musculoskeletal stiffness 133.89 12.49 41 119295 147719 70661389
Maternal exposure during pregnancy 133.40 12.49 18 119318 115327 70693781
Psoriasis 127.64 12.49 10 119326 98423 70710685
Drug hypersensitivity 126.76 12.49 153 119183 262306 70546802
Pneumonia 126.52 12.49 545 118791 595687 70213421
Treatment failure 125.30 12.49 43 119293 144099 70665009
Weight increased 124.93 12.49 134 119202 242197 70566911
Non-cirrhotic portal hypertension 122.82 12.49 40 119296 373 70808735
Intentional overdose 122.22 12.49 12 119324 98423 70710685
Product use issue 121.91 12.49 76 119260 179861 70629247
Headache 118.61 12.49 538 118798 579867 70229241
Metastasis 117.70 12.49 91 119245 6023 70803085
Carcinoembryonic antigen increased 115.39 12.49 60 119276 1970 70807138
Breast cancer recurrent 113.11 12.49 66 119270 2727 70806381
Depression 112.97 12.49 101 119235 198873 70610235
Portal hypertension 112.87 12.49 91 119245 6401 70802707
Plasma cell myeloma 109.08 12.49 3 119333 73198 70735910
Anastomotic complication 107.58 12.49 37 119299 414 70808694
Exposure during pregnancy 105.55 12.49 12 119324 87705 70721403
Hepatic lesion 104.78 12.49 85 119251 6032 70803076
Nail disorder 104.08 12.49 107 119229 10317 70798791
PIK3CA-activated mutation 102.52 12.49 38 119298 536 70808572
Cardiac failure congestive 102.19 12.49 50 119286 135407 70673701
Lymphangiosis carcinomatosa 99.01 12.49 53 119283 1848 70807260
Suicide attempt 97.90 12.49 10 119326 79500 70729608
Influenza 96.95 12.49 35 119301 113665 70695443
Abdominal pain 96.20 12.49 938 118398 341189 70467919
Onycholysis 95.97 12.49 51 119285 1752 70807356
Fingerprint loss 94.14 12.49 22 119314 45 70809063
Colitis 93.02 12.49 277 119059 63537 70745571
Colon cancer metastatic 92.96 12.49 53 119283 2095 70807013
Polyneuropathy 91.58 12.49 144 119192 21271 70787837
Ileus 91.47 12.49 154 119182 24083 70785025
Dysaesthesia pharynx 90.82 12.49 27 119309 180 70808928
Arthritis 89.08 12.49 27 119309 97953 70711155
Ascites 88.96 12.49 283 119053 67264 70741844
Bradycardia 88.10 12.49 50 119286 124565 70684543
Hypokalaemia 87.95 12.49 445 118891 130743 70678365
Glossodynia 87.90 12.49 19 119317 86468 70722640
Metastases to pleura 83.76 12.49 42 119294 1276 70807832
Carbohydrate antigen 15-3 increased 83.18 12.49 39 119297 1019 70808089
Pruritus 82.57 12.49 301 119035 345259 70463849
Asthma 81.82 12.49 51 119285 120742 70688366
Hyperbilirubinaemia 80.69 12.49 140 119196 22428 70786680
Metastatic neoplasm 78.37 12.49 64 119272 4584 70804524
Intentional product misuse 77.87 12.49 19 119317 79576 70729532
Tumour perforation 75.70 12.49 27 119309 339 70808769
Recall phenomenon 74 12.49 36 119300 1023 70808085
Colorectal cancer metastatic 73.92 12.49 43 119293 1766 70807342
Metastases to spine 73.72 12.49 57 119279 3772 70805336
Wound 73.62 12.49 37 119299 98695 70710413
Hypovolaemic shock 73.55 12.49 91 119245 10746 70798362
Urticaria 73.54 12.49 100 119236 162949 70646159
Bronchitis 72.10 12.49 55 119281 117188 70691920
Infusion site coldness 71.64 12.49 23 119313 204 70808904
Suicidal ideation 71.31 12.49 15 119321 69581 70739527
Injection site pain 70.03 12.49 57 119279 117562 70691546
Anxiety 69.91 12.49 168 119168 220162 70588946
Pulmonary embolism 69.60 12.49 475 118861 155392 70653716
Chronic obstructive pulmonary disease 69.49 12.49 22 119314 77619 70731489
Pain 68.56 12.49 702 118634 628114 70180994
Leukopenia 68.30 12.49 357 118979 106203 70702905
Rhabdomyolysis 68.29 12.49 38 119298 95722 70713386
Osteoarthritis 68.19 12.49 20 119316 74127 70734981
Product dose omission issue 68.07 12.49 167 119169 217301 70591807
Bone lesion 67.80 12.49 63 119273 5367 70803741
Gastric perforation 65.32 12.49 53 119283 3762 70805346
Proteinuria 64.89 12.49 149 119187 29225 70779883
Intestinal perforation 64.65 12.49 105 119231 15939 70793169
Hypotension 64.56 12.49 407 118929 403974 70405134
Pericarditis 64.28 12.49 31 119305 84674 70724434
Blood pressure fluctuation 64.12 12.49 11 119325 59001 70750107
Irritable bowel syndrome 63.64 12.49 6 119330 50844 70758264
Swelling 62.84 12.49 140 119196 188399 70620709
Mobility decreased 62.46 12.49 49 119287 102950 70706158
Insomnia 62.27 12.49 175 119161 217631 70591477
Confusional state 61.96 12.49 257 119079 284141 70524967
Hypoaesthesia 61.93 12.49 457 118879 153282 70655826
Ejection fraction decreased 61.41 12.49 150 119186 30612 70778496
Wound dehiscence 60.67 12.49 63 119273 6145 70802963
Gamma-glutamyltransferase decreased 60.58 12.49 23 119313 348 70808760
Osteonecrosis 60.15 12.49 144 119192 29016 70780092
Stomal varices 59.87 12.49 15 119321 46 70809062
Electrocardiogram QT prolonged 59.75 12.49 33 119303 83484 70725624
Mucosal toxicity 59.64 12.49 26 119310 570 70808538
Feeling abnormal 59.54 12.49 92 119244 142227 70666881
Therapy partial responder 59.15 12.49 88 119248 12386 70796722
Fibromyalgia 58.99 12.49 6 119330 47868 70761240
Dysaesthesia 58.91 12.49 58 119278 5310 70803798
Fatigue 58.78 12.49 1807 117529 822512 69986596
Drug reaction with eosinophilia and systemic symptoms 58.43 12.49 13 119323 58000 70751108
Nail discolouration 58.11 12.49 43 119293 2663 70806445
Nasal congestion 58.08 12.49 19 119317 65653 70743455
Hepatic function abnormal 57.58 12.49 247 119089 67749 70741359
Duodenal ulcer perforation 56.71 12.49 9 119327 51103 70758005
Agitation 55.89 12.49 45 119291 93330 70715778
Discomfort 55.74 12.49 57 119279 105379 70703729
Metastases to meninges 54.61 12.49 44 119292 3092 70806016
Device related thrombosis 53.63 12.49 39 119297 2351 70806757
Hepatic enzyme increased 53.60 12.49 115 119221 156875 70652233
Infusion related reaction 53.34 12.49 163 119173 197371 70611737
Metastases to chest wall 53.26 12.49 22 119314 420 70808688
Therapy change 53.21 12.49 61 119275 6648 70802460
Wheezing 53.17 12.49 48 119288 94122 70714986
Pancreatic neuroendocrine tumour metastatic 53.13 12.49 17 119319 149 70808959
Subileus 52.81 12.49 54 119282 5173 70803935
Dermatitis acneiform 52.66 12.49 70 119266 8875 70800233
Gastrointestinal anastomotic leak 51.96 12.49 22 119314 448 70808660
Platelet count decreased 51.64 12.49 492 118844 177730 70631378
Acute kidney injury 51.60 12.49 530 118806 474094 70335014
Performance status decreased 51.46 12.49 55 119281 5546 70803562
Oesophagitis 51.25 12.49 116 119220 22536 70786572
Peripheral sensory neuropathy 51.18 12.49 81 119255 12029 70797079
Disseminated intravascular coagulation 51.01 12.49 148 119188 33450 70775658
Acute coronary syndrome 50.16 12.49 107 119229 19972 70789136
Nasopharyngitis 50.14 12.49 198 119138 222008 70587100
Chronic kidney disease 50.03 12.49 20 119316 61037 70748071
Skin hyperpigmentation 49.83 12.49 59 119277 6656 70802452
Subacute cutaneous lupus erythematosus 49.52 12.49 42 119294 3171 70805937
Cytomegalovirus infection 48.94 12.49 5 119331 39753 70769355
Metastases to the mediastinum 48.87 12.49 22 119314 522 70808586
Rectal cancer 48.83 12.49 42 119294 3232 70805876
Blood bilirubin increased 48.74 12.49 215 119121 59686 70749422
Neutrophil count decreased 48.18 12.49 272 119064 83284 70725824
Wrong technique in product usage process 47.92 12.49 28 119308 68670 70740438
Erythema 47.85 12.49 530 118806 199033 70610075
Varices oesophageal 47.68 12.49 52 119284 5365 70803743
Vascular pain 47.63 12.49 25 119311 837 70808271
Oxygen saturation decreased 47.05 12.49 77 119259 116352 70692756
Somnolence 46.83 12.49 195 119141 215411 70593697
Abdominal lymphadenopathy 46.51 12.49 28 119308 1226 70807882
Hyperkalaemia 46.42 12.49 67 119269 106524 70702584
Lacrimation increased 46.25 12.49 103 119233 19796 70789312
Hiccups 46.02 12.49 66 119270 8986 70800122
Sedation 46.01 12.49 11 119325 46720 70762388
Leukoencephalopathy 45.92 12.49 59 119277 7235 70801873
Neutropenic sepsis 45.29 12.49 117 119219 24713 70784395
Splenorenal shunt 45.16 12.49 10 119326 14 70809094
Coronary artery disease 44.57 12.49 25 119311 62711 70746397
Obstruction gastric 44.26 12.49 29 119307 1475 70807633
Toxic leukoencephalopathy 44.15 12.49 25 119311 975 70808133
Recurrent cancer 44.10 12.49 35 119301 2406 70806702
Dysphagia 44.06 12.49 333 119003 112501 70696607
Electrocardiogram ST segment elevation 43.99 12.49 59 119277 7545 70801563
Injection site erythema 43.82 12.49 35 119301 72889 70736219
Loss of personal independence in daily activities 43.65 12.49 47 119289 84863 70724245
Mucosal disorder 43.64 12.49 39 119297 3159 70805949
Myalgia 43.59 12.49 141 119195 167751 70641357
Peritonitis 43.40 12.49 119 119217 26040 70783068
Biliary obstruction 43.24 12.49 43 119293 3984 70805124
Jaw operation 43.12 12.49 23 119313 796 70808312
Abdominal discomfort 43.07 12.49 200 119136 214458 70594650
Aggression 42.87 12.49 14 119322 48432 70760676
COVID-19 42.68 12.49 70 119266 105687 70703421
Lower respiratory tract infection 42.49 12.49 77 119259 111836 70697272
Injury 42.20 12.49 29 119307 65216 70743892
Pyogenic granuloma 41.63 12.49 19 119317 466 70808642
Infusion site induration 41.45 12.49 23 119313 862 70808246
Drug level increased 41.42 12.49 6 119330 36463 70772645
Arterial thrombosis 41.31 12.49 34 119302 2462 70806646
Proteus infection 41.27 12.49 29 119307 1656 70807452
Abnormal behaviour 41.12 12.49 5 119331 34704 70774404
Focal nodular hyperplasia 40.99 12.49 21 119315 668 70808440
Delirium 40.98 12.49 39 119297 74575 70734533
Device occlusion 40.88 12.49 68 119268 10527 70798581
Product use in unapproved indication 40.63 12.49 195 119141 207283 70601825
Lactic acidosis 40.61 12.49 30 119306 64994 70744114
Sleep apnoea syndrome 40.56 12.49 4 119332 32709 70776399
Pulmonary hypertension 40.21 12.49 14 119322 46522 70762586
Mouth ulceration 39.94 12.49 138 119198 34211 70774897
Hepatic failure 39.66 12.49 197 119139 57428 70751680
Basal cell carcinoma 39.57 12.49 5 119331 33693 70775415
Rectal tenesmus 39.38 12.49 26 119310 1340 70807768
Metastatic gastric cancer 38.94 12.49 17 119319 374 70808734
Prothrombin level decreased 38.89 12.49 27 119309 1512 70807596
Necrotising fasciitis 38.46 12.49 47 119289 5479 70803629
Pulmonary arterial hypertension 38.27 12.49 5 119331 32850 70776258
Portal shunt 38.27 12.49 11 119325 64 70809044
Granulocyte count decreased 38.18 12.49 26 119310 1411 70807697
Myocardial infarction 38.04 12.49 154 119182 171491 70637617
Unresponsive to stimuli 37.90 12.49 20 119316 51911 70757197
Tooth extraction 37.84 12.49 64 119272 10043 70799065
Cold dysaesthesia 37.58 12.49 8 119328 8 70809100
Loss of consciousness 37.55 12.49 135 119201 155581 70653527
Diaphragmatic spasm 37.52 12.49 12 119324 105 70809003
Biliary sepsis 37.20 12.49 26 119310 1472 70807636
Lymphoedema 36.98 12.49 67 119269 11102 70798006
Eosinophilia 36.84 12.49 11 119325 40308 70768800
Anastomotic fistula 36.55 12.49 12 119324 115 70808993
Metastases to ovary 36.53 12.49 15 119321 282 70808826
Drug ineffective for unapproved indication 36.16 12.49 10 119326 38528 70770580
Metastases to eye 36.10 12.49 14 119322 225 70808883
Hypophagia 35.96 12.49 152 119184 41418 70767690
Nervousness 35.63 12.49 5 119331 31115 70777993
Ejection fraction 35.61 12.49 27 119309 1735 70807373
Hypertriglyceridaemia 35.54 12.49 68 119268 11743 70797365
Treatment noncompliance 35.40 12.49 17 119319 46557 70762551
Cholangitis 35.38 12.49 67 119269 11482 70797626
Adnexa uteri mass 35.31 12.49 15 119321 308 70808800
Hallucination 35.15 12.49 46 119290 76214 70732894
Large intestine perforation 34.92 12.49 72 119264 13123 70795985
Prescribed overdose 34.57 12.49 3 119333 27178 70781930
Therapy interrupted 34.56 12.49 106 119230 24696 70784412
Cataract 34.33 12.49 26 119310 55619 70753489
Jaundice 34.27 12.49 171 119165 49937 70759171
Hepatic atrophy 34.19 12.49 16 119320 416 70808692
Pigmentation disorder 34.18 12.49 42 119294 4924 70804184
Small intestinal obstruction 34.01 12.49 105 119231 24550 70784558
Thrombosis 33.75 12.49 230 119106 75175 70733933
Bone disorder 33.55 12.49 84 119252 17406 70791702
Depressed level of consciousness 33.33 12.49 60 119276 87371 70721737
Prinzmetal angina 33.24 12.49 25 119311 1587 70807521
Induration 33.24 12.49 26 119310 1750 70807358
Colon cancer 33.19 12.49 74 119262 14232 70794876
Pneumatosis intestinalis 33.02 12.49 45 119291 5842 70803266
Hyperammonaemic encephalopathy 32.91 12.49 39 119297 4404 70804704
General physical health deterioration 32.88 12.49 569 118767 235462 70573646
Pleural effusion 32.81 12.49 355 118981 132509 70676599
Faecal volume decreased 32.59 12.49 12 119324 166 70808942
Blood uric acid decreased 32.57 12.49 22 119314 1178 70807930
Blood pressure systolic increased 32.54 12.49 29 119307 57230 70751878
Therapeutic product effect incomplete 32.29 12.49 99 119237 119783 70689325
Adverse event 31.96 12.49 22 119314 49439 70759669
Protein urine 31.83 12.49 23 119313 1373 70807735
Pharyngeal inflammation 31.71 12.49 20 119316 952 70808156
Dizziness 31.33 12.49 571 118765 463570 70345538
Neoplasm malignant 31.21 12.49 113 119223 28661 70780447
Stress cardiomyopathy 31.19 12.49 58 119278 9804 70799304
Hypermutation 31.08 12.49 9 119327 54 70809054
Cachexia 31.03 12.49 58 119278 9842 70799266
Bone pain 31.00 12.49 168 119168 50654 70758454
Medication error 30.95 12.49 30 119306 56882 70752226
Abortion spontaneous 30.92 12.49 4 119332 26475 70782633
Cytokine release syndrome 30.90 12.49 4 119332 26463 70782645
Blood glucose increased 30.71 12.49 81 119255 102901 70706207
Invasive ductal breast carcinoma 30.48 12.49 43 119293 5766 70803342
Venoocclusive liver disease 30.33 12.49 60 119276 10618 70798490
Contusion 30.21 12.49 112 119224 127924 70681184
Debridement 30.20 12.49 24 119312 1653 70807455
Folliculitis 30.19 12.49 17 119319 42553 70766555
Respiratory arrest 29.84 12.49 28 119308 53905 70755203
Hypoalbuminaemia 29.77 12.49 85 119251 19037 70790071
Aortic thrombosis 29.51 12.49 23 119313 1540 70807568
Malignant ascites 29.44 12.49 20 119316 1081 70808027
Prostate cancer 29.40 12.49 8 119328 31155 70777953
Necrotising oesophagitis 29.27 12.49 17 119319 696 70808412
Plantar erythema 29.21 12.49 13 119323 300 70808808
Emotional distress 29.15 12.49 13 119323 37175 70771933
Urinary tract infection 28.98 12.49 273 119063 248496 70560612
Triple negative breast cancer 28.94 12.49 11 119325 167 70808941
Ectropion 28.84 12.49 14 119322 396 70808712
Eosinophil percentage increased 28.82 12.49 22 119314 1428 70807680
Nodular regenerative hyperplasia 28.79 12.49 21 119315 1272 70807836
Clostridial infection 28.79 12.49 40 119296 5289 70803819
Hand-foot-and-mouth disease 28.77 12.49 12 119324 235 70808873
Pelvic fluid collection 28.77 12.49 17 119319 719 70808389
Osteoporosis 28.73 12.49 24 119312 48883 70760225
Withdrawal syndrome 28.51 12.49 4 119332 24900 70784208
Nail infection 28.48 12.49 26 119310 2165 70806943
Asthenopia 28.43 12.49 26 119310 2170 70806938
Psychotic disorder 28.29 12.49 14 119322 37687 70771421
Hyperammonaemia 28.23 12.49 57 119279 10236 70798872
Haematoma 28.15 12.49 24 119312 48394 70760714
Weight decreased 27.98 12.49 702 118634 309786 70499322
Hypervolaemia 27.95 12.49 16 119320 39690 70769418
Angioedema 27.90 12.49 43 119293 66567 70742541
Anal erythema 27.86 12.49 11 119325 186 70808922
Stoma site haemorrhage 27.70 12.49 23 119313 1686 70807422
Irritability 27.49 12.49 15 119321 38210 70770898
Tumour pain 27.47 12.49 25 119311 2073 70807035
Constipation 27.46 12.49 586 118750 251852 70557256
Fluid retention 27.44 12.49 40 119296 63345 70745763
Acute respiratory failure 27.25 12.49 30 119306 53635 70755473
Pulmonary mass 27.20 12.49 101 119235 25932 70783176
Device issue 27.18 12.49 4 119332 24021 70785087
Hyperfibrinolysis 26.91 12.49 7 119329 26 70809082
Rectal perforation 26.87 12.49 17 119319 814 70808294
Angina bullosa haemorrhagica 26.78 12.49 11 119325 207 70808901
Skin reaction 26.45 12.49 67 119269 13982 70795126
Tooth erosion 26.29 12.49 13 119323 383 70808725
Upper respiratory tract infection 26.28 12.49 59 119277 79215 70729893
Oesophageal haemorrhage 26.26 12.49 22 119314 1633 70807475
Respiratory depression 26.17 12.49 5 119331 24826 70784282
Cryptitis 26.14 12.49 9 119327 101 70809007
Inappropriate schedule of product administration 26.08 12.49 93 119243 107462 70701646
Joint range of motion decreased 25.87 12.49 6 119330 26020 70783088
White blood cell count decreased 25.83 12.49 416 118920 169725 70639383
Bone sequestrum 25.82 12.49 19 119317 1167 70807941
Gastrointestinal inflammation 25.74 12.49 43 119293 6680 70802428
Product prescribing error 25.61 12.49 17 119319 38935 70770173
Hyperhidrosis 25.56 12.49 124 119212 131462 70677646
Blood creatinine decreased 25.50 12.49 45 119291 7304 70801804
Hypoglycaemia 25.36 12.49 78 119258 94286 70714822
Disturbance in attention 25.26 12.49 21 119315 42873 70766235
Dysgeusia 25.21 12.49 156 119180 49346 70759762
C-reactive protein increased 25.21 12.49 98 119238 110419 70698689
Neck pain 25.17 12.49 46 119290 66611 70742497
Obesity 25.02 12.49 7 119329 26764 70782344
Vein disorder 25.01 12.49 34 119302 4404 70804704
Heart rate increased 24.94 12.49 93 119243 106055 70703053
Accidental overdose 24.94 12.49 14 119322 35107 70774001
Blood cholesterol increased 24.92 12.49 44 119292 64560 70744548
Cognitive disorder 24.91 12.49 40 119296 60916 70748192
Post-traumatic neck syndrome 24.84 12.49 23 119313 1950 70807158
Early satiety 24.83 12.49 19 119317 1238 70807870
Congestive cardiomyopathy 24.77 12.49 56 119280 10870 70798238
Steatohepatitis 24.61 12.49 16 119320 803 70808305
Migraine 24.57 12.49 53 119283 72185 70736923
Extrapyramidal disorder 24.55 12.49 3 119333 20747 70788361
Vasodilatation 24.36 12.49 28 119308 3060 70806048
Metastases to pelvis 24.36 12.49 14 119322 562 70808546
Tendonitis 24.30 12.49 4 119332 22118 70786990
Hepatitis 24.23 12.49 29 119307 49951 70759157
Abdominal distension 24.16 12.49 276 119060 104393 70704715
Hospitalisation 23.92 12.49 228 119108 82340 70726768
Vessel puncture site bruise 23.75 12.49 13 119323 474 70808634
Peripheral sensorimotor neuropathy 23.73 12.49 26 119310 2696 70806412
Ear infection 23.68 12.49 9 119327 28327 70780781
Intestinal metastasis 23.65 12.49 11 119325 282 70808826
Gastrointestinal mucosal necrosis 23.65 12.49 10 119326 203 70808905
Temperature intolerance 23.56 12.49 48 119288 8675 70800433
Ileal ulcer 23.54 12.49 17 119319 1014 70808094
Human epidermal growth factor receptor negative 23.49 12.49 5 119331 5 70809103
Brachiocephalic vein thrombosis 23.42 12.49 10 119326 208 70808900
Oral pain 23.39 12.49 104 119232 28962 70780146
Cardiac output decreased 23.31 12.49 21 119315 1719 70807389
Accidental exposure to product 23.29 12.49 9 119327 28042 70781066
Injection site haemorrhage 23.26 12.49 7 119329 25520 70783588
Oral pigmentation 23.13 12.49 6 119330 22 70809086
Atrial fibrillation 22.90 12.49 199 119137 184149 70624959
Acute myeloid leukaemia 22.89 12.49 108 119228 30832 70778276
Syncope 22.82 12.49 174 119162 165535 70643573
Lymphadenopathy mediastinal 22.81 12.49 31 119305 4014 70805094
Carbohydrate antigen 19-9 increased 22.77 12.49 12 119324 405 70808703
Tenderness 22.76 12.49 83 119253 21127 70787981
Disease recurrence 22.73 12.49 124 119212 37479 70771629
Gastrointestinal stoma necrosis 22.72 12.49 6 119330 24 70809084
Failure to anastomose 22.66 12.49 10 119326 226 70808882
Coma 22.55 12.49 79 119257 91765 70717343
Renal hydrocele 22.52 12.49 6 119330 25 70809083
Drug eruption 22.45 12.49 20 119316 39476 70769632
Dental care 22.43 12.49 15 119321 790 70808318
Right ventricular failure 22.41 12.49 5 119331 22269 70786839
Rhinorrhoea 22.32 12.49 49 119287 66322 70742786
Hormone receptor positive breast cancer 22.31 12.49 11 119325 322 70808786
Eye pain 22.26 12.49 15 119321 34087 70775021
Peripheral ischaemia 22.26 12.49 47 119289 8711 70800397
Haemorrhage intracranial 22.20 12.49 7 119329 24770 70784338
Adenocarcinoma 22.14 12.49 29 119307 3624 70805484
Pericardial effusion 22.13 12.49 133 119203 41643 70767465
Foot deformity 22.11 12.49 4 119332 20651 70788457
Large intestinal obstruction 22.05 12.49 26 119310 2920 70806188
Restlessness 22.00 12.49 23 119313 42105 70767003
Neoplasm recurrence 21.92 12.49 30 119306 3911 70805197
Joint injury 21.77 12.49 9 119327 26923 70782185
Carcinoid tumour pulmonary 21.76 12.49 11 119325 340 70808768
Neuroendocrine breast tumour 21.64 12.49 6 119330 30 70809078
Small intestinal perforation 21.61 12.49 26 119310 2983 70806125
No adverse event 21.47 12.49 109 119227 32044 70777064
Mucosal necrosis 21.45 12.49 8 119328 115 70808993
ECG signs of myocardial ischaemia 21.44 12.49 11 119325 351 70808757
Stress 21.39 12.49 52 119284 67914 70741194
Exposed bone in jaw 21.24 12.49 28 119308 3521 70805587
Incorrect route of product administration 21.18 12.49 9 119327 26483 70782625
Multiple sclerosis 21.18 12.49 8 119328 25277 70783831
Gingival bleeding 21.13 12.49 65 119271 15167 70793941
Metastases to breast 21.02 12.49 10 119326 270 70808838
Premature delivery 21.00 12.49 5 119331 21299 70787809
Onychomadesis 20.99 12.49 30 119306 4071 70805037
Poisoning 20.98 12.49 6 119330 22616 70786492
Type 2 diabetes mellitus 20.92 12.49 26 119310 44054 70765054
Colon cancer recurrent 20.90 12.49 8 119328 124 70808984
Anal prolapse 20.88 12.49 7 119329 72 70809036
Limbal stem cell deficiency 20.86 12.49 6 119330 35 70809073
Hallucination, auditory 20.85 12.49 3 119333 18325 70790783
Pregnancy 20.81 12.49 7 119329 23774 70785334
Malignant pleural effusion 20.73 12.49 26 119310 3113 70805995
Fistula 20.60 12.49 52 119284 10829 70798279
Periportal sinus dilatation 20.58 12.49 6 119330 37 70809071
Transaminases 20.54 12.49 7 119329 76 70809032
Computerised tomogram abnormal 20.35 12.49 26 119310 3170 70805938
Sciatica 20.28 12.49 8 119328 24619 70784489
Incorrect dose administered 20.25 12.49 52 119284 66667 70742441
Intestinal dilatation 20.10 12.49 22 119314 2278 70806830
Rectal cancer metastatic 20.07 12.49 12 119324 519 70808589
Pneumocystis jirovecii pneumonia 19.95 12.49 13 119323 30069 70779039
Superior vena cava syndrome 19.76 12.49 16 119320 1132 70807976
Febrile neutropenia 19.60 12.49 466 118870 203852 70605256
Injection site bruising 19.60 12.49 21 119315 38011 70771097
Pancreatitis viral 19.57 12.49 5 119331 17 70809091
Terminal ileitis 19.55 12.49 13 119323 678 70808430
Productive cough 19.49 12.49 67 119269 78270 70730838
Toxicity to various agents 19.40 12.49 492 118844 381680 70427428
Bone debridement 19.22 12.49 11 119325 438 70808670
Obstructive airways disorder 19.14 12.49 10 119326 26103 70783005
Infusion site hypoaesthesia 19.14 12.49 5 119331 19 70809089
Hallucination, visual 19.02 12.49 13 119323 29324 70779784
Sinus bradycardia 18.93 12.49 8 119328 23615 70785493
Viral infection 18.91 12.49 22 119314 38369 70770739
Ventricular fibrillation 18.88 12.49 93 119243 27018 70782090
Hepatic infarction 18.85 12.49 14 119322 872 70808236
Hypersplenism 18.82 12.49 11 119325 456 70808652
Metastases to stomach 18.72 12.49 9 119327 249 70808859
Metastases to adrenals 18.66 12.49 16 119320 1226 70807882
Panic attack 18.52 12.49 7 119329 22112 70786996
Lymphadenopathy 18.48 12.49 143 119193 48648 70760460
Enterocolitis haemorrhagic 18.46 12.49 20 119316 2048 70807060
Metastases to thorax 18.45 12.49 8 119328 173 70808935
Aplastic anaemia 18.41 12.49 3 119333 16713 70792395
Vertebral column mass 18.41 12.49 8 119328 174 70808934
Eosinophilic pneumonia chronic 18.41 12.49 11 119325 475 70808633
Gastrointestinal disorder 18.39 12.49 264 119072 105163 70703945
Renal vein thrombosis 18.37 12.49 11 119325 477 70808631
Generalised tonic-clonic seizure 18.32 12.49 26 119310 41635 70767473
Blood pressure increased 18.24 12.49 216 119120 188301 70620807
Gastric cancer 18.23 12.49 44 119292 8911 70800197
Hyperglycaemic hyperosmolar nonketotic syndrome 18.18 12.49 19 119317 1867 70807241
Toothache 18.01 12.49 70 119266 18360 70790748
Acute promyelocytic leukaemia 17.93 12.49 17 119319 1485 70807623
Hepatic cyst 17.91 12.49 33 119303 5538 70803570
Brain neoplasm 17.87 12.49 32 119304 5254 70803854
Back pain 17.82 12.49 335 119001 270817 70538291
Cardio-respiratory arrest 17.78 12.49 98 119238 100579 70708529
Retroperitoneal neoplasm metastatic 17.71 12.49 5 119331 27 70809081
Prostatic calcification 17.70 12.49 6 119330 64 70809044
Dyskinesia 17.70 12.49 26 119310 41048 70768060
Respiratory tract congestion 17.68 12.49 4 119332 17649 70791459
Peripheral motor neuropathy 17.66 12.49 24 119312 3108 70806000
Haemoglobin decreased 17.64 12.49 241 119095 204918 70604190
Diabetes mellitus inadequate control 17.62 12.49 8 119328 22637 70786471
Motion sickness 17.60 12.49 13 119323 803 70808305
Odynophagia 17.59 12.49 47 119289 10128 70798980
Mydriasis 17.57 12.49 3 119333 16150 70792958
Perineal ulceration 17.54 12.49 6 119330 66 70809042
Sputum discoloured 17.48 12.49 5 119331 18846 70790262
Hypercalcaemia of malignancy 17.48 12.49 10 119326 398 70808710
Device dislocation 17.43 12.49 8 119328 22499 70786609
Peritoneal disorder 17.41 12.49 12 119324 664 70808444
Adenocarcinoma of colon 17.41 12.49 32 119304 5360 70803748
Herpangina 17.41 12.49 5 119331 29 70809079
Eczema impetiginous 17.41 12.49 5 119331 29 70809079
Hyperaesthesia 17.38 12.49 49 119287 10893 70798215
Gastroenteritis radiation 17.24 12.49 12 119324 675 70808433
Memory impairment 17.01 12.49 89 119247 92552 70716556
Osteolysis 16.93 12.49 25 119311 3494 70805614
Breast necrosis 16.92 12.49 6 119330 74 70809034
Blood creatine phosphokinase increased 16.92 12.49 50 119286 61213 70747895
Restless legs syndrome 16.88 12.49 5 119331 18423 70790685
Venous thrombosis limb 16.87 12.49 27 119309 4048 70805060
Ileus paralytic 16.72 12.49 42 119294 8719 70800389
Product administration error 16.72 12.49 15 119321 29508 70779600
Myoclonus 16.66 12.49 12 119324 26343 70782765
Hydronephrosis 16.65 12.49 60 119276 15182 70793926
Infusion site haemorrhage 16.53 12.49 22 119314 2793 70806315
Gastric dilatation 16.49 12.49 15 119321 1243 70807865
Hypoacusis 16.49 12.49 13 119323 27256 70781852
Dark circles under eyes 16.46 12.49 10 119326 445 70808663
Biliary fistula 16.43 12.49 6 119330 81 70809027
Perforation 16.42 12.49 15 119321 1250 70807858
Tremor 16.35 12.49 175 119161 155449 70653659
Head injury 16.35 12.49 20 119316 34121 70774987
Parkinsonism 16.33 12.49 3 119333 15322 70793786
Hand-foot-genital syndrome 16.29 12.49 4 119332 11 70809097
Disorientation 16.19 12.49 47 119289 57876 70751232
Urethral ulcer 16.17 12.49 3 119333 0 70809108
Dermatoglyphic anomaly 16.17 12.49 3 119333 0 70809108
Hyperchylomicronaemia 16.17 12.49 3 119333 0 70809108
Delusion 16.16 12.49 6 119330 19159 70789949
Toxic epidermal necrolysis 16.12 12.49 26 119310 39531 70769577
Drug intolerance 16.03 12.49 275 119061 225412 70583696
Brain operation 15.99 12.49 11 119325 607 70808501
Pancreatic fistula 15.91 12.49 6 119330 89 70809019
Gallbladder disorder 15.88 12.49 5 119331 17707 70791401
Hypoxia 15.87 12.49 92 119244 93252 70715856
Oropharyngeal pain 15.80 12.49 96 119240 96214 70712894
Radiation myelopathy 15.79 12.49 4 119332 13 70809095
Colitis ischaemic 15.74 12.49 56 119280 14081 70795027
International normalised ratio increased 15.71 12.49 76 119260 80650 70728458
Ataxia 15.71 12.49 79 119257 23138 70785970
Tumour invasion 15.69 12.49 9 119327 360 70808748
Seizure 15.68 12.49 208 119128 177754 70631354
Periodontitis 15.67 12.49 27 119309 4301 70804807
Lymphocyte count decreased 15.60 12.49 31 119305 43508 70765600
Vulval disorder 15.60 12.49 10 119326 490 70808618
Epistaxis 15.59 12.49 251 119085 102376 70706732
Vasospasm 15.46 12.49 13 119323 970 70808138
Bronchopulmonary aspergillosis 15.46 12.49 8 119328 20994 70788114
Haemodialysis 15.39 12.49 5 119331 17361 70791747
Liver abscess 15.35 12.49 31 119305 5568 70803540
Subdural haematoma 15.30 12.49 16 119320 29282 70779826
Calcium ionised increased 15.29 12.49 7 119329 173 70808935
Paranoia 15.29 12.49 5 119331 17283 70791825
Dystonia 15.27 12.49 7 119329 19699 70789409
Injection site swelling 15.23 12.49 31 119305 43126 70765982
Mental disorder 15.22 12.49 15 119321 28225 70780883
Liver scan abnormal 15.22 12.49 5 119331 48 70809060
Cough 15.16 12.49 424 118912 324953 70484155
Joint dislocation 15.16 12.49 3 119333 14528 70794580
Colitis ulcerative 15.08 12.49 21 119315 33902 70775206
Mood swings 14.96 12.49 6 119330 18280 70790828
Nail avulsion 14.95 12.49 6 119330 106 70809002
Acral peeling skin syndrome 14.95 12.49 5 119331 51 70809057
Fungal infection 14.92 12.49 25 119311 37442 70771666
Radiation fibrosis - lung 14.87 12.49 5 119331 52 70809056
Dysphonia 14.83 12.49 139 119197 49961 70759147
Amnesia 14.81 12.49 42 119294 52113 70756995
Nail bed inflammation 14.79 12.49 10 119326 536 70808572
Proctalgia 14.77 12.49 39 119297 8344 70800764
Appendicitis noninfective 14.77 12.49 4 119332 18 70809090
Chemical peritonitis 14.74 12.49 8 119328 287 70808821
Torsade de pointes 14.73 12.49 6 119330 18110 70790998
Post procedural diarrhoea 14.73 12.49 10 119326 540 70808568
Mechanical ileus 14.71 12.49 11 119325 692 70808416
Diverticulitis 14.71 12.49 30 119306 41704 70767404
Gastrointestinal injury 14.70 12.49 12 119324 859 70808249
Femoral artery embolism 14.70 12.49 5 119331 54 70809054
Anhedonia 14.69 12.49 3 119333 14210 70794898
Pulpitis dental 14.62 12.49 13 119323 1046 70808062
Hyperbaric oxygen therapy 14.61 12.49 5 119331 55 70809053
Paraneoplastic dermatomyositis 14.61 12.49 5 119331 55 70809053
Peritoneal fluid analysis abnormal 14.61 12.49 5 119331 55 70809053
Malignant peritoneal neoplasm 14.55 12.49 11 119325 704 70808404
Gastrointestinal oedema 14.53 12.49 19 119317 2371 70806737
Dermatitis 14.52 12.49 68 119268 19349 70789759
Orthostatic hypotension 14.45 12.49 42 119294 51701 70757407
Laryngeal discomfort 14.45 12.49 10 119326 557 70808551
Cardiac failure 14.45 12.49 163 119173 143378 70665730
Acute generalised exanthematous pustulosis 14.44 12.49 4 119332 15393 70793715
Skin disorder 14.42 12.49 94 119242 30263 70778845
Chemotherapy cardiotoxicity attenuation 14.42 12.49 4 119332 20 70809088
Neoplasm 14.40 12.49 37 119299 7787 70801321
Peripheral swelling 14.40 12.49 296 119040 236267 70572841
Metastases to spleen 14.39 12.49 10 119326 561 70808547
Rectal neoplasm 14.38 12.49 5 119331 58 70809050
Botryomycosis 14.30 12.49 5 119331 59 70809049
Crying 14.28 12.49 9 119327 21190 70787918
Pharyngeal ulceration 14.26 12.49 12 119324 896 70808212
Hypothalamo-pituitary disorder 14.24 12.49 13 119323 1082 70808026
Onychoclasis 14.15 12.49 28 119308 4956 70804152
Gastroenteropancreatic neuroendocrine tumour disease 14.15 12.49 5 119331 61 70809047
Scleroderma-like reaction 14.13 12.49 6 119330 123 70808985
Adenocarcinoma gastric 14.13 12.49 16 119320 1720 70807388
Heart rate decreased 14.13 12.49 55 119281 61960 70747148
Abdominal fat apron 14.09 12.49 3 119333 3 70809105
Metaplastic breast carcinoma 14.09 12.49 3 119333 3 70809105
Increased liver stiffness 14.09 12.49 3 119333 3 70809105
Schistosomiasis 14.07 12.49 5 119331 62 70809046
Adrenal insufficiency 14.03 12.49 13 119323 25182 70783926
Cerebrovascular accident 14.02 12.49 164 119172 143306 70665802
Herpes zoster 13.96 12.49 85 119251 85150 70723958
Insulinoma 13.91 12.49 6 119330 128 70808980
Electrolyte imbalance 13.90 12.49 85 119251 26776 70782332
Sinus congestion 13.73 12.49 6 119330 17367 70791741
Pituitary tumour 13.69 12.49 13 119323 1138 70807970
Dyspnoea 13.66 12.49 1113 118223 768947 70040161
Administration site extravasation 13.65 12.49 13 119323 1142 70807966
Bronchiectasis 13.64 12.49 5 119331 16092 70793016
Radioisotope scan 13.63 12.49 3 119333 4 70809104
Ureteric obstruction 13.63 12.49 19 119317 2520 70806588
Hypothyroidism 13.63 12.49 36 119300 45719 70763389
Influenza like illness 13.61 12.49 60 119276 65271 70743837
Limb injury 13.52 12.49 14 119322 25738 70783370
Lung neoplasm malignant 13.50 12.49 13 119323 24729 70784379
Kidney infection 13.46 12.49 8 119328 19447 70789661
Actinomycosis 13.44 12.49 12 119324 971 70808137
Genital erythema 13.40 12.49 7 119329 232 70808876
Cheilitis 13.37 12.49 27 119309 4850 70804258
Diffuse large B-cell lymphoma 13.35 12.49 3 119333 13299 70795809
Blood lactate dehydrogenase increased 13.32 12.49 103 119233 35024 70774084
Pelvic venous thrombosis 13.29 12.49 16 119320 1836 70807272
Nail toxicity 13.25 12.49 8 119328 352 70808756
Abdominal wall oedema 13.23 12.49 3 119333 5 70809103
Short-bowel syndrome 13.19 12.49 9 119327 490 70808618
Neutrophilia 13.14 12.49 34 119302 7187 70801921
Subclavian vein thrombosis 13.09 12.49 18 119318 2356 70806752
Metastases to bladder 13.08 12.49 7 119329 244 70808864
Pleural neoplasm 13.07 12.49 8 119328 361 70808747
Dermatomyositis 13.00 12.49 22 119314 3453 70805655
Tumour excision 13.00 12.49 9 119327 502 70808606
Hepatic cancer metastatic 12.97 12.49 11 119325 830 70808278
Hemianopia 12.97 12.49 15 119321 1650 70807458
Skin sensitisation 12.95 12.49 11 119325 832 70808276
Illness 12.86 12.49 21 119315 31770 70777338
Renal tubular necrosis 12.85 12.49 12 119324 23159 70785949
Sequestrectomy 12.84 12.49 11 119325 842 70808266
Haematemesis 12.79 12.49 132 119204 48665 70760443
Portal vein thrombosis 12.74 12.49 28 119308 5334 70803774
Rash maculo-papular 12.73 12.49 43 119293 50502 70758606
Haemolytic anaemia 12.70 12.49 59 119277 16735 70792373
Urinary incontinence 12.67 12.49 28 119308 37814 70771294
Pancreatic carcinoma metastatic 12.67 12.49 23 119313 3817 70805291
Proctitis 12.62 12.49 22 119314 3536 70805572
Miosis 12.61 12.49 4 119332 14097 70795011
Gastric disorder 12.58 12.49 23 119313 33299 70775809
Jaundice cholestatic 12.56 12.49 39 119297 9145 70799963
Congenital haematological disorder 12.51 12.49 4 119332 35 70809073
Skin burning sensation 12.50 12.49 45 119291 11381 70797727
Squamous cell carcinoma of skin 12.50 12.49 3 119333 12709 70796399

FDA Adverse Event Reporting System (Pediatric)

None

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 antineoplastic agents
CHEBI has role CHEBI:50266 Prodrugs

Drug Use | Suggest Off label Use Form| |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 717919005
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
194000 RXNORM
4021099 VANDF
C0671970 UMLSCUI
CHEBI:31348 CHEBI
CHEMBL1773 ChEMBL_ID
DB01101 DRUGBANK_ID
D000069287 MESH_DESCRIPTOR_UI
60953 PUBCHEM_CID
6799 IUPHAR_LIGAND_ID
7317 INN_ID
6804DJ8Z9U UNII
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 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 28 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 0054-0272 TABLET, FILM COATED 500 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 27 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16714-468 TABLET, FILM COATED 500 mg ORAL ANDA 27 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 51407-095 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
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-096 TABLET, FILM COATED 500 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-639 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-640 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