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 16, 2003 PMDA CHUGAI PHARMACEUTICAL CO., LTD.
April 30, 1998 FDA HOFFMANN LA ROCHE
Nov. 19, 2012 EMA medac Gesellschaft für klinische Spezialpräparate mbH

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 8018.66 13.54 2544 110902 20471 63355105
Disease progression 3732.96 13.54 2462 110984 120296 63255280
Diarrhoea 2558.45 13.54 4554 108892 710812 62664764
Malignant neoplasm progression 2393.09 13.54 1606 111840 80515 63295061
Metastases to liver 1636.21 13.54 813 112633 22826 63352750
Metastases to bone 1390.06 13.54 701 112745 20318 63355258
Death 1261.37 13.54 2332 111114 372049 63003527
Mucosal inflammation 1124.62 13.54 815 112631 46113 63329463
Metastases to central nervous system 854.34 13.54 433 113013 12672 63362904
Metastases to lung 815.82 13.54 416 113030 12334 63363242
Breast cancer metastatic 604.49 13.54 334 113112 11684 63363892
Neoplasm progression 569.06 13.54 492 112954 35936 63339640
Neuropathy peripheral 546.06 13.54 832 112614 112835 63262741
Vomiting 517.32 13.54 2170 111276 557447 62818129
Neutropenia 510.39 13.54 1028 112418 173977 63201599
Dehydration 459.31 13.54 979 112467 172375 63203201
Rheumatoid arthritis 436.38 13.54 3 113443 253816 63121760
Metastases to lymph nodes 427.57 13.54 233 113213 7925 63367651
Drug ineffective 411.41 13.54 780 112666 1043985 62331591
Myelosuppression 375.91 13.54 323 113123 23380 63352196
Joint swelling 365.87 13.54 71 113375 327595 63047981
Nausea 355.49 13.54 2671 110775 851800 62523776
Skin exfoliation 354.76 13.54 411 113035 42691 63332885
Contraindicated product administered 350.48 13.54 8 113438 217640 63157936
Systemic lupus erythematosus 335.15 13.54 8 113438 208910 63166666
Neurotoxicity 331.12 13.54 261 113185 16729 63358847
Stomatitis 329.34 13.54 750 112696 137975 63237601
Bone marrow failure 328.49 13.54 329 113117 28961 63346615
Arteriospasm coronary 321.09 13.54 152 113294 3816 63371760
Maternal exposure during pregnancy 314.26 13.54 20 113426 220042 63155534
Arthropathy 311.07 13.54 30 113416 234762 63140814
Skin fissures 300.67 13.54 210 113236 11178 63364398
Metastases to skin 293.89 13.54 111 113335 1552 63374024
Condition aggravated 293.57 13.54 178 113268 402039 62973537
Gastrointestinal toxicity 288.15 13.54 177 113269 7564 63368012
Arthralgia 285.70 13.54 360 113086 569350 62806226
Skin toxicity 284.71 13.54 148 113298 4566 63371010
Paronychia 275.26 13.54 153 113293 5412 63370164
Thrombocytopenia 273.87 13.54 737 112709 150420 63225156
Metastasis 262.86 13.54 145 113301 5052 63370524
Decreased appetite 254.00 13.54 1003 112443 250049 63125527
Glossodynia 244.59 13.54 20 113426 178856 63196720
Osteonecrosis of jaw 243.40 13.54 307 113139 34816 63340760
Breast cancer 236.05 13.54 357 113089 48026 63327550
Completed suicide 235.82 13.54 5 113441 145668 63229908
Drug hypersensitivity 235.78 13.54 131 113315 310556 63065020
Therapeutic product effect decreased 232.82 13.54 34 113412 193153 63182423
Tumour marker increased 231.87 13.54 131 113315 4784 63370792
Cardiotoxicity 230.73 13.54 159 113287 8279 63367297
Haematotoxicity 229.26 13.54 165 113281 9211 63366365
Enteritis 219.21 13.54 153 113293 8133 63367443
Dry skin 215.20 13.54 374 113072 56513 63319063
Exposure during pregnancy 210.97 13.54 18 113428 155529 63220047
Product use issue 200.11 13.54 72 113374 220448 63155128
Ascites 199.35 13.54 301 113145 40427 63335149
Sinusitis 198.99 13.54 78 113368 226575 63149001
Treatment failure 196.54 13.54 56 113390 198987 63176589
Asthenia 193.38 13.54 1259 112187 382345 62993231
Dihydropyrimidine dehydrogenase deficiency 188.21 13.54 41 113405 45 63375531
Skin discolouration 187.18 13.54 281 113165 37547 63338029
PIK3CA-activated mutation 184.66 13.54 70 113376 989 63374587
Wound 182.80 13.54 35 113411 163228 63212348
Laryngospasm 182.67 13.54 95 113351 2933 63372643
Pleural effusion 179.37 13.54 465 112981 92745 63282831
Metastases to peritoneum 176.73 13.54 97 113349 3345 63372231
Therapy cessation 175.18 13.54 243 113203 30214 63345362
Metastases to pleura 170.32 13.54 74 113372 1511 63374065
Hospice care 170.12 13.54 129 113317 7803 63367773
Swelling 165.58 13.54 149 113297 275229 63100347
Musculoskeletal stiffness 159.61 13.54 65 113381 184553 63191023
Fall 159.39 13.54 286 113160 392048 62983528
Pericarditis 158.85 13.54 23 113423 131556 63244020
Infusion related reaction 152.24 13.54 129 113317 245392 63130184
Pseudocirrhosis 150.06 13.54 54 113392 653 63374923
Metastatic neoplasm 149.21 13.54 94 113352 4201 63371375
Osteonecrosis 147.53 13.54 200 113246 24330 63351246
Abdominal discomfort 144.15 13.54 219 113227 320666 63054910
Nail disorder 141.87 13.54 144 113302 12871 63362705
Metastases to spine 140.96 13.54 82 113364 3167 63372409
Hepatic function abnormal 140.19 13.54 244 113202 36898 63338678
Psoriasis 136.84 13.54 4 113442 86953 63288623
Weight increased 134.30 13.54 161 113285 260631 63114945
Pain 133.43 13.54 778 112668 739850 62635726
Discomfort 132.08 13.54 67 113379 167307 63208269
Duodenal ulcer perforation 130.39 13.54 6 113440 87203 63288373
Hyperbilirubinaemia 128.50 13.54 128 113318 11186 63364390
Lymphangiosis carcinomatosa 128.21 13.54 59 113387 1386 63374190
Headache 126.74 13.54 642 112804 632599 62742977
Ejection fraction decreased 126.66 13.54 177 113269 22155 63353421
Irritable bowel syndrome 125.43 13.54 5 113441 82407 63293169
Breast cancer recurrent 123.89 13.54 84 113362 4257 63371319
Carcinoembryonic antigen increased 122.87 13.54 61 113385 1704 63373872
Hepatic lesion 122.76 13.54 87 113359 4738 63370838
Arthritis 121.26 13.54 29 113417 115892 63259684
Onycholysis 121.22 13.54 59 113387 1577 63373999
Pruritus 119.46 13.54 296 113150 361157 63014419
Fibromyalgia 118.73 13.54 6 113440 80414 63295162
Enterocolitis 118.33 13.54 104 113342 7754 63367822
Carbohydrate antigen 15-3 increased 115.72 13.54 55 113391 1393 63374183
Blood bilirubin increased 114.97 13.54 224 113222 36916 63338660
Lower respiratory tract infection 112.04 13.54 48 113398 132259 63243317
Jaundice 106.29 13.54 189 113257 29062 63346514
Non-cirrhotic portal hypertension 102.01 13.54 31 113415 210 63375366
Intestinal obstruction 96.42 13.54 187 113259 30712 63344864
Asthma 96.30 13.54 54 113392 127507 63248069
Urticaria 95.69 13.54 93 113353 165709 63209867
Polyneuropathy 95.50 13.54 124 113322 14465 63361111
Pneumonia 94.71 13.54 457 112989 456310 62919266
Bone lesion 92.92 13.54 80 113366 5801 63369775
Bronchitis 92.73 13.54 54 113392 124881 63250695
Nasopharyngitis 92.17 13.54 198 113248 254059 63121517
Osteoarthritis 91.89 13.54 28 113418 95315 63280261
Therapeutic product effect incomplete 91.48 13.54 55 113391 125001 63250575
Influenza 91.16 13.54 40 113406 108682 63266894
Depression 90.18 13.54 132 113314 196360 63179216
Drug interaction 89.38 13.54 171 113275 228960 63146616
Overdose 89.37 13.54 47 113399 115031 63260545
Hypokalaemia 89.27 13.54 395 113051 103409 63272167
Mobility decreased 87.63 13.54 54 113392 121105 63254471
Intentional overdose 87.10 13.54 14 113432 74138 63301438
Paraesthesia 86.76 13.54 528 112918 156438 63219138
Injection site pain 85.65 13.54 64 113382 129736 63245840
Leukopenia 85.47 13.54 318 113128 76972 63298604
Hypersensitivity 84.42 13.54 256 113190 292429 63083147
Dysaesthesia pharynx 82.91 13.54 24 113422 134 63375442
Hepatic enzyme increased 82.45 13.54 147 113299 202181 63173395
Metastases to chest wall 81.54 13.54 33 113413 560 63375016
Bradycardia 81.28 13.54 16 113430 73211 63302365
Folliculitis 80.98 13.54 14 113432 70303 63305273
Metastases to meninges 80.64 13.54 53 113393 2549 63373027
Product use in unapproved indication 78.61 13.54 124 113322 178956 63196620
Bone pain 78.14 13.54 245 113201 54396 63321180
Hepatic failure 78.13 13.54 187 113259 35469 63340107
Alopecia 75.06 13.54 329 113117 337207 63038369
Colitis 74.43 13.54 223 113223 48305 63327271
Abdominal lymphadenopathy 74.28 13.54 33 113413 712 63374864
Ileus 73.70 13.54 110 113336 14615 63360961
Blood cholesterol increased 73.61 13.54 38 113408 93994 63281582
Loss of personal independence in daily activities 72.26 13.54 42 113404 97248 63278328
Infusion site coldness 71.40 13.54 23 113423 193 63375383
Febrile neutropenia 70.29 13.54 406 113040 118043 63257533
Platelet count decreased 68.89 13.54 398 113048 115724 63259852
Fingerprint loss 68.14 13.54 15 113431 18 63375558
Therapy change 67.58 13.54 68 113378 6013 63369563
Metastases to the mediastinum 66.56 13.54 27 113419 461 63375115
Suicidal ideation 66.48 13.54 15 113431 62406 63313170
Suicide attempt 66.18 13.54 14 113432 60904 63314672
Gastrointestinal perforation 64.52 13.54 52 113394 3439 63372137
Gamma-glutamyltransferase decreased 62.55 13.54 23 113423 297 63375279
Abortion spontaneous 62.50 13.54 6 113440 47189 63328387
Bone disorder 61.63 13.54 125 113321 21201 63354375
Wheezing 60.69 13.54 49 113397 95546 63280030
Tooth extraction 60.67 13.54 83 113363 10181 63365395
Product dose omission issue 60.58 13.54 215 113231 234098 63141478
Portal hypertension 60.43 13.54 52 113394 3767 63371809
Nail discolouration 59.58 13.54 45 113401 2705 63372871
Migraine 59.57 13.54 58 113388 103288 63272288
Drug intolerance 58.12 13.54 319 113127 308342 63067234
Device related thrombosis 56.88 13.54 37 113409 1748 63373828
Skin hyperpigmentation 56.46 13.54 61 113385 5860 63369716
Neoplasm malignant 56.39 13.54 148 113298 29713 63345863
Peripheral sensory neuropathy 56.22 13.54 68 113378 7383 63368193
Hypoalbuminaemia 55.97 13.54 86 113360 11719 63363857
Pericardial effusion 55.77 13.54 148 113298 29910 63345666
Pulmonary embolism 54.93 13.54 377 113069 116307 63259269
Feeling abnormal 54.19 13.54 115 113331 148277 63227299
Intestinal perforation 53.73 13.54 85 113361 11878 63363698
Nasal congestion 53.71 13.54 25 113421 65635 63309941
Injection site erythema 53.59 13.54 42 113404 83132 63292444
Adverse event 53.32 13.54 27 113419 67532 63308044
Recurrent cancer 53.28 13.54 37 113409 1950 63373626
Chronic obstructive pulmonary disease 52.64 13.54 23 113423 62663 63312913
Plasma cell myeloma 51.99 13.54 3 113443 35902 63339674
Metastases to adrenals 51.95 13.54 26 113420 739 63374837
Blood pressure fluctuation 51.65 13.54 10 113436 46307 63329269
Type 2 diabetes mellitus 51.20 13.54 25 113421 63843 63311733
Superior vena cava syndrome 51.17 13.54 25 113421 674 63374902
Lymphoedema 49.67 13.54 81 113365 11611 63363965
Jaw operation 49.31 13.54 26 113420 826 63374750
Erythema 49.09 13.54 505 112941 175246 63200330
Prescribed overdose 49.00 13.54 3 113443 34150 63341426
Intentional product misuse 48.60 13.54 24 113422 60893 63314683
Leukoencephalopathy 48.41 13.54 49 113397 4364 63371212
Mucosal toxicity 48.39 13.54 20 113426 359 63375217
Debridement 48.28 13.54 29 113417 1189 63374387
Lacrimation increased 48.24 13.54 111 113335 20520 63355056
Chronic kidney disease 48.16 13.54 11 113435 45387 63330189
Hyperhidrosis 47.93 13.54 74 113372 107762 63267814
Therapy interrupted 47.76 13.54 147 113299 32308 63343268
Insomnia 47.68 13.54 210 113236 215042 63160534
Disseminated intravascular coagulation 47.33 13.54 105 113341 18946 63356630
Injury 47.18 13.54 37 113409 73210 63302366
Anastomotic leak 47.14 13.54 21 113425 456 63375120
Abdominal pain 47.04 13.54 761 112685 292695 63082881
Neoplasm 45.86 13.54 61 113385 7284 63368292
Nail infection 45.40 13.54 37 113409 2486 63373090
Ear infection 45.35 13.54 7 113439 38206 63337370
Osteoporosis 45.12 13.54 23 113423 57315 63318261
Pyogenic granuloma 44.99 13.54 18 113428 296 63375280
Contusion 44.82 13.54 129 113317 149915 63225661
Central nervous system lesion 44.26 13.54 73 113373 10562 63365014
Subacute cutaneous lupus erythematosus 43.89 13.54 37 113409 2606 63372970
Osteolysis 43.19 13.54 38 113408 2836 63372740
Drug reaction with eosinophilia and systemic symptoms 43.01 13.54 5 113441 33831 63341745
Somnolence 42.87 13.54 169 113277 178516 63197060
Angina bullosa haemorrhagica 42.21 13.54 14 113432 130 63375446
Drug ineffective for unapproved indication 40.98 13.54 6 113440 34057 63341519
Bone sequestrum 40.82 13.54 28 113418 1446 63374130
Lymphadenopathy 40.65 13.54 156 113290 38302 63337274
Gingival bleeding 40.27 13.54 77 113369 12510 63363066
Therapy partial responder 40.18 13.54 70 113376 10588 63364988
Mouth ulceration 40.09 13.54 140 113306 32844 63342732
Pharyngeal inflammation 40.00 13.54 21 113425 661 63374915
Dysphagia 39.79 13.54 283 113163 88302 63287274
Plantar erythema 39.63 13.54 15 113431 211 63375365
Congestive cardiomyopathy 39.61 13.54 52 113394 6130 63369446
Blood uric acid decreased 39.55 13.54 22 113424 779 63374797
Wrong technique in product usage process 39.51 13.54 32 113414 62308 63313268
Colon cancer metastatic 39.50 13.54 25 113421 1126 63374450
Oxygen saturation decreased 39.16 13.54 61 113385 88524 63287052
Performance status decreased 38.82 13.54 40 113406 3638 63371938
Acute coronary syndrome 38.82 13.54 67 113379 10059 63365517
Neutrophil count decreased 38.58 13.54 201 113245 56205 63319371
Metastases to ovary 38.45 13.54 18 113428 440 63375136
Cardiac output decreased 38.16 13.54 23 113423 949 63374627
Cataract 37.79 13.54 28 113418 57025 63318551
Hypotension 37.61 13.54 309 113137 272295 63103281
Confusional state 37.32 13.54 258 113188 236122 63139454
Dysaesthesia 37.31 13.54 43 113403 4435 63371141
Cold dysaesthesia 37.10 13.54 8 113438 8 63375568
Anxiety 37.09 13.54 232 113214 217309 63158267
Malignant ascites 37.03 13.54 22 113424 884 63374692
Constipation 37.02 13.54 586 112860 224357 63151219
Periodontitis 36.82 13.54 37 113409 3266 63372310
Exposed bone in jaw 36.79 13.54 35 113411 2890 63372686
Pulmonary sarcoidosis 36.66 13.54 23 113423 1020 63374556
Hiccups 36.57 13.54 31 113415 2200 63373376
Sedation 36.31 13.54 12 113434 38797 63336779
Malignant pleural effusion 36.28 13.54 33 113413 2573 63373003
Prescribed underdose 36.25 13.54 5 113441 29684 63345892
Hypovolaemic shock 36.18 13.54 50 113396 6191 63369385
Blood creatinine decreased 36.08 13.54 47 113399 5498 63370078
Cardiac failure congestive 35.98 13.54 69 113377 92364 63283212
Neoplasm recurrence 35.94 13.54 33 113413 2605 63372971
Human epidermal growth factor receptor negative 35.53 13.54 9 113437 27 63375549
Peripheral swelling 35.53 13.54 304 113142 265638 63109938
COVID-19 35.44 13.54 95 113351 113008 63262568
Stridor 34.95 13.54 37 113409 3473 63372103
Premature delivery 34.92 13.54 6 113440 30275 63345301
Anastomotic fistula 34.59 13.54 9 113437 31 63375545
Eosinophil percentage increased 34.44 13.54 22 113424 1007 63374569
Blood pressure systolic increased 34.43 13.54 21 113425 47376 63328200
Joint range of motion decreased 34.12 13.54 8 113438 32420 63343156
Hypophagia 34.02 13.54 128 113318 31131 63344445
White blood cell count decreased 33.88 13.54 389 113057 138715 63236861
Nodular regenerative hyperplasia 33.78 13.54 17 113429 489 63375087
Pregnancy 33.41 13.54 12 113434 36824 63338752
Hypoaesthesia 33.33 13.54 453 112993 167940 63207636
Proteinuria 33.24 13.54 92 113354 19053 63356523
Gastric perforation 33.15 13.54 26 113420 1653 63373923
Granulocyte count decreased 33.04 13.54 23 113423 1217 63374359
Hyperkalaemia 32.90 13.54 29 113417 54174 63321402
Accidental exposure to product 32.57 13.54 5 113441 27400 63348176
Breast neoplasm 32.29 13.54 24 113422 1408 63374168
Tumour pain 32.21 13.54 24 113422 1413 63374163
Hyperaesthesia 32.12 13.54 59 113387 9299 63366277
Oesophagitis 32.11 13.54 78 113368 14930 63360646
General physical health deterioration 31.76 13.54 521 112925 200881 63174695
Medication error 31.71 13.54 28 113418 52256 63323320
Hand-foot-and-mouth disease 31.50 13.54 12 113434 172 63375404
Foetal exposure during pregnancy 31.49 13.54 9 113437 31953 63343623
Radiation necrosis 31.23 13.54 15 113431 389 63375187
Foot deformity 31.08 13.54 6 113440 27847 63347729
Infusion site induration 31.01 13.54 22 113424 1200 63374376
Vocal cord paralysis 30.90 13.54 28 113418 2173 63373403
Colorectal cancer metastatic 30.71 13.54 17 113429 596 63374980
Brachiocephalic vein thrombosis 30.33 13.54 10 113436 91 63375485
Thrombosis 30.32 13.54 209 113237 64546 63311030
Hydronephrosis 30.22 13.54 62 113384 10600 63364976
Early satiety 30.17 13.54 20 113426 976 63374600
Toothache 30.16 13.54 89 113357 19110 63356466
Hormone receptor positive breast cancer 29.79 13.54 16 113430 528 63375048
Joint injury 29.75 13.54 8 113438 29564 63346012
Pigmentation disorder 29.69 13.54 39 113407 4600 63370976
Epistaxis 29.61 13.54 227 113219 72498 63303078
Breast disorder 29.42 13.54 29 113417 2501 63373075
Varices oesophageal 29.26 13.54 32 113414 3116 63372460
Stress cardiomyopathy 29.24 13.54 57 113389 9393 63366183
Device issue 29.05 13.54 4 113442 23777 63351799
Biliary sepsis 28.94 13.54 19 113427 912 63374664
Sopor 28.87 13.54 3 113443 22161 63353415
Blood glucose increased 28.84 13.54 67 113379 83689 63291887
Radiation skin injury 28.72 13.54 19 113427 924 63374652
Mucosal necrosis 28.54 13.54 8 113438 39 63375537
Agitation 28.52 13.54 39 113407 59718 63315858
Injection site bruising 28.50 13.54 20 113426 41890 63333686
Sequestrectomy 28.50 13.54 18 113428 808 63374768
Obesity 28.48 13.54 9 113437 29943 63345633
Retroperitoneal neoplasm metastatic 28.37 13.54 8 113438 40 63375536
Dermatomyositis 28.32 13.54 30 113416 2818 63372758
Sciatica 28.18 13.54 13 113433 34311 63341265
Bone debridement 28.17 13.54 12 113434 233 63375343
Treatment noncompliance 27.87 13.54 16 113430 37309 63338267
Abnormal behaviour 27.65 13.54 3 113443 21423 63354153
Cachexia 27.55 13.54 42 113404 5684 63369892
Pancreatic fistula 27.35 13.54 6 113440 7 63375569
Rhabdomyolysis 27.30 13.54 23 113423 43928 63331648
C-reactive protein increased 27.13 13.54 83 113363 94624 63280952
Recall phenomenon 27.13 13.54 16 113430 634 63374942
Cheilitis 26.98 13.54 35 113411 4078 63371498
Onychomadesis 26.92 13.54 42 113404 5798 63369778
Acute kidney injury 26.92 13.54 321 113125 263094 63112482
Loss of consciousness 26.89 13.54 114 113332 118007 63257569
Vascular pain 26.84 13.54 17 113429 767 63374809
Odynophagia 26.71 13.54 48 113398 7438 63368138
Pulpitis dental 26.58 13.54 18 113428 910 63374666
Pneumonitis 26.54 13.54 129 113317 35093 63340483
Brain oedema 26.43 13.54 70 113376 14125 63361451
Adnexa uteri mass 26.29 13.54 15 113431 558 63375018
Tooth erosion 26.15 13.54 14 113432 459 63375117
Bursitis 26.09 13.54 17 113429 37024 63338552
Dermatitis acneiform 25.97 13.54 38 113408 4958 63370618
Incorrect dose administered 25.84 13.54 42 113404 59926 63315650
Pulmonary mass 25.82 13.54 94 113352 22502 63353074
Asthenopia 25.73 13.54 26 113420 2311 63373265
Multiple sclerosis 25.66 13.54 6 113440 24366 63351210
Arterial thrombosis 25.62 13.54 21 113425 1422 63374154
Hepatic cancer metastatic 25.61 13.54 13 113433 381 63375195
Metastases to eye 25.59 13.54 10 113436 154 63375422
Fluid retention 25.53 13.54 42 113404 59644 63315932
Brain operation 25.44 13.54 15 113431 594 63374982
Oral pigmentation 25.40 13.54 6 113440 12 63375564
Ataxia 25.38 13.54 72 113374 15123 63360453
Vasodilatation 25.19 13.54 26 113420 2369 63373207
Limbal stem cell deficiency 25.08 13.54 6 113440 13 63375563
Gingivitis 25.06 13.54 50 113396 8379 63367197
Pneumatosis intestinalis 25.03 13.54 26 113420 2387 63373189
Nervousness 25.02 13.54 12 113434 30967 63344609
Tumour perforation 24.85 13.54 9 113437 111 63375465
Respiratory disorder 24.84 13.54 20 113426 39062 63336514
Failure to anastomose 24.78 13.54 6 113440 14 63375562
Hand dermatitis 24.73 13.54 11 113435 238 63375338
Intracranial pressure increased 24.67 13.54 38 113408 5189 63370387
Fatigue 24.59 13.54 1872 111574 886156 62489420
Hypervolaemia 24.53 13.54 10 113436 28403 63347173
Oral pain 24.34 13.54 108 113338 28286 63347290
Tongue discolouration 24.23 13.54 29 113417 3114 63372462
Nightmare 23.99 13.54 3 113443 19191 63356385
Vessel puncture site bruise 23.98 13.54 13 113433 437 63375139
Bone marrow infiltration 23.83 13.54 15 113431 669 63374907
Blood lactate dehydrogenase increased 23.80 13.54 93 113353 23023 63352553
Weight decreased 23.69 13.54 655 112791 276143 63099433
Nephrolithiasis 23.68 13.54 24 113422 41960 63333616
Myocardial infarction 23.61 13.54 95 113351 99798 63275778
Hepatic atrophy 23.38 13.54 11 113435 272 63375304
Procedural pain 23.33 13.54 5 113441 21564 63354012
Ejection fraction 23.31 13.54 25 113421 2381 63373195
Transaminases 23.24 13.54 8 113438 84 63375492
Product quality issue 23.24 13.54 18 113428 35847 63339729
Computerised tomogram abnormal 23.20 13.54 24 113422 2193 63373383
Increased liver stiffness 23.19 13.54 5 113441 5 63375571
Schistosomiasis 23.19 13.54 5 113441 5 63375571
Unresponsive to stimuli 23.17 13.54 16 113430 33800 63341776
Evans syndrome 23.11 13.54 10 113436 202 63375374
Muscle swelling 23.05 13.54 13 113433 473 63375103
Neutrophil count abnormal 22.81 13.54 27 113419 2865 63372711
Acute myeloid leukaemia 22.79 13.54 75 113371 17072 63358504
Post-traumatic neck syndrome 22.70 13.54 23 113423 2051 63373525
Disturbance in attention 22.50 13.54 21 113425 38168 63337408
Metastases to breast 22.50 13.54 11 113435 297 63375279
Brain neoplasm 22.40 13.54 33 113413 4333 63371243
Adenocarcinoma 22.38 13.54 27 113419 2923 63372653
Cytomegalovirus infection 22.38 13.54 5 113441 20947 63354629
Atrial fibrillation 22.20 13.54 120 113326 116516 63259060
Steatohepatitis 22.19 13.54 14 113432 627 63374949
Delirium 22.15 13.54 35 113411 50506 63325070
Metastases to spleen 22.01 13.54 9 113437 157 63375419
Macular degeneration 22.01 13.54 8 113438 24368 63351208
Injection site haemorrhage 21.92 13.54 8 113438 24306 63351270
Diverticulitis 21.87 13.54 23 113423 39534 63336042
Urinary tract infection 21.82 13.54 337 113109 264347 63111229
Device malfunction 21.82 13.54 3 113443 17854 63357722
Dental care 21.79 13.54 17 113429 1072 63374504
Blood pressure increased 21.74 13.54 185 113261 161877 63213699
Respiratory arrest 21.64 13.54 16 113430 32629 63342947
Inflammation 21.56 13.54 75 113371 82198 63293378
Lactic acidosis 21.46 13.54 22 113424 38265 63337311
Hyperglycaemia 21.33 13.54 138 113308 41729 63333847
Chemotherapy cardiotoxicity attenuation 21.32 13.54 4 113442 0 63375576
Motion sickness 21.28 13.54 16 113430 955 63374621
Neuroendocrine breast tumour 21.28 13.54 6 113440 30 63375546
Ingrowing nail 21.22 13.54 24 113422 2425 63373151
Pulmonary hypertension 21.19 13.54 21 113425 37102 63338474
Neutropenic sepsis 21.05 13.54 71 113375 16367 63359209
ECG signs of myocardial ischaemia 20.92 13.54 7 113439 67 63375509
Hip arthroplasty 20.87 13.54 33 113413 47613 63327963
Injection site swelling 20.79 13.54 33 113413 47539 63328037
Right ventricular failure 20.74 13.54 3 113443 17185 63358391
Vertebral column mass 20.70 13.54 9 113437 184 63375392
Pleural neoplasm 20.56 13.54 11 113435 360 63375216
Infection 20.55 13.54 287 113159 228886 63146690
Purulent discharge 20.53 13.54 33 113413 4673 63370903
Caesarean section 20.49 13.54 3 113443 17029 63358547
HER2 positive breast cancer 20.42 13.54 11 113435 365 63375211
Metastases to spinal cord 20.37 13.54 8 113438 125 63375451
Hepatic neoplasm 20.33 13.54 21 113425 1915 63373661
Epilepsy 20.30 13.54 99 113347 26966 63348610
Cholangitis 20.28 13.54 36 113410 5525 63370051
Acute respiratory failure 20.27 13.54 19 113427 34466 63341110
Large intestine perforation 20.23 13.54 46 113400 8436 63367140
No adverse event 20.19 13.54 135 113311 41270 63334306
Anaemia 20.19 13.54 676 112770 292754 63082822
Lymphadenopathy mediastinal 20.17 13.54 25 113421 2783 63372793
Mucosal disorder 20.08 13.54 22 113424 2147 63373429
Sinus congestion 20.02 13.54 4 113442 18119 63357457
Product prescribing error 20.01 13.54 11 113435 26278 63349298
Oral disorder 20 13.54 47 113399 8807 63366769
Prinzmetal angina 19.96 13.54 14 113432 750 63374826
Eosinophilia 19.66 13.54 8 113438 22748 63352828
Illness 19.64 13.54 36 113410 49023 63326553
Ankle fracture 19.60 13.54 4 113442 17851 63357725
Respiratory tract congestion 19.57 13.54 4 113442 17828 63357748
Metastases to muscle 19.54 13.54 8 113438 140 63375436
Eye pain 19.50 13.54 19 113427 33835 63341741
Pulmonary arterial hypertension 19.40 13.54 8 113438 22569 63353007
Biliary obstruction 19.38 13.54 25 113421 2896 63372680
Angioedema 19.37 13.54 35 113411 47930 63327646
Hyperchlorhydria 19.36 13.54 20 113426 1824 63373752
Folate deficiency 19.35 13.54 23 113423 2452 63373124
Disease recurrence 19.24 13.54 100 113346 27930 63347646
Subileus 19.23 13.54 26 113420 3153 63372423
Invasive ductal breast carcinoma 19.18 13.54 40 113406 6918 63368658
Metastases to stomach 19.12 13.54 9 113437 223 63375353
Small intestinal obstruction 19.06 13.54 74 113372 18263 63357313
Bronchiectasis 19.06 13.54 3 113443 16139 63359437
Femoral artery embolism 18.99 13.54 6 113440 47 63375529
Cognitive disorder 18.93 13.54 45 113401 55770 63319806
Tubulointerstitial nephritis 18.89 13.54 6 113440 19897 63355679
Weight fluctuation 18.88 13.54 49 113397 9770 63365806
Excessive granulation tissue 18.87 13.54 14 113432 819 63374757
Coronary artery disease 18.85 13.54 18 113428 32359 63343217
Small intestinal perforation 18.81 13.54 18 113428 1497 63374079
Depressed level of consciousness 18.80 13.54 53 113393 62025 63313551
Gamma-glutamyltransferase abnormal 18.65 13.54 10 113436 329 63375247
Metastases to thorax 18.61 13.54 9 113437 237 63375339
Haematoma 18.42 13.54 21 113425 34799 63340777
Pericardial effusion malignant 18.39 13.54 7 113439 100 63375476
Disability 18.38 13.54 5 113441 18342 63357234
Catheter site inflammation 18.34 13.54 14 113432 855 63374721
Metastases to abdominal cavity 18.31 13.54 11 113435 451 63375125
Diarrhoea haemorrhagic 18.29 13.54 46 113400 8996 63366580
Necrotising oesophagitis 18.29 13.54 11 113435 452 63375124
Pelvic fluid collection 18.24 13.54 14 113432 862 63374714
Upper respiratory tract infection 18.17 13.54 80 113366 81967 63293609
Metastases to pelvis 18.12 13.54 11 113435 460 63375116
Chemical peritonitis 18.08 13.54 7 113439 105 63375471
Radiation fibrosis - lung 18.07 13.54 5 113441 23 63375553
Hyperammonaemia 17.97 13.54 33 113413 5199 63370377
Carcinoid tumour pulmonary 17.97 13.54 11 113435 467 63375109
Body temperature decreased 17.96 13.54 78 113368 20241 63355335
Psychotic disorder 17.84 13.54 12 113434 25700 63349876
Hypothalamo-pituitary disorder 17.83 13.54 13 113433 740 63374836
Rhinorrhoea 17.71 13.54 59 113387 65518 63310058
Blood lactate dehydrogenase abnormal 17.70 13.54 10 113436 365 63375211
Oral toxicity 17.66 13.54 4 113442 6 63375570
Calcium ionised increased 17.62 13.54 7 113439 113 63375463
Radiation injury 17.61 13.54 11 113435 484 63375092
Myalgia 17.59 13.54 172 113274 146357 63229219
Botryomycosis 17.57 13.54 5 113441 26 63375550
Abdominal distension 17.53 13.54 234 113212 86381 63289195
Sensory disturbance 17.46 13.54 59 113387 13613 63361963
Blood alkaline phosphatase increased 17.42 13.54 134 113312 42833 63332743
Enterocolitis haemorrhagic 17.41 13.54 17 113429 1449 63374127
Artificial menopause 17.41 13.54 5 113441 27 63375549
Dyschezia 17.41 13.54 21 113425 2273 63373303
Tumour marker abnormal 17.41 13.54 10 113436 377 63375199
Paresis 17.33 13.54 22 113424 2508 63373068
Gallbladder disorder 17.32 13.54 6 113440 18836 63356740
Pulmonary thrombosis 17.32 13.54 44 113402 8658 63366918
Ileus paralytic 17.30 13.54 30 113416 4521 63371055
Hypertriglyceridaemia 17.27 13.54 36 113410 6223 63369353
Joint dislocation 17.26 13.54 6 113440 18794 63356782
Herpangina 17.26 13.54 5 113441 28 63375548
Peripheral motor neuropathy 17.23 13.54 18 113428 1663 63373913
Bone fistula 17.18 13.54 6 113440 66 63375510
Colitis ischaemic 17.17 13.54 50 113396 10658 63364918
Impaired work ability 17.07 13.54 5 113441 17470 63358106
Oncologic complication 17.04 13.54 8 113438 197 63375379
Gastroenteropancreatic neuroendocrine tumour disease 16.97 13.54 5 113441 30 63375546
Sudden death 16.95 13.54 49 113397 10400 63365176
Wound dehiscence 16.94 13.54 31 113415 4872 63370704
Anaphylactic reaction 16.82 13.54 61 113385 66039 63309537
Premature baby 16.79 13.54 8 113438 20727 63354849
Anal erythema 16.78 13.54 8 113438 204 63375372
Skin disorder 16.74 13.54 100 113346 29407 63346169
Hyperglycaemic hyperosmolar nonketotic syndrome 16.74 13.54 14 113432 975 63374601
Obstructive airways disorder 16.74 13.54 8 113438 20691 63354885
Autoimmune disorder 16.62 13.54 5 113441 17172 63358404
Drug level increased 16.61 13.54 10 113436 22726 63352850
Gait disturbance 16.56 13.54 229 113217 182949 63192627
Metastases to kidney 16.53 13.54 8 113438 211 63375365
Blood bilirubin abnormal 16.52 13.54 14 113432 993 63374583
Brachial plexopathy 16.48 13.54 7 113439 135 63375441
Anastomotic complication 16.48 13.54 7 113439 135 63375441
Amnesia 16.43 13.54 48 113398 55537 63320039
Metastases to bladder 16.43 13.54 8 113438 214 63375362
Dysgeusia 16.41 13.54 141 113305 46569 63329007
Gastrointestinal inflammation 16.34 13.54 33 113413 5579 63369997
Hallucination, visual 16.32 13.54 7 113439 19291 63356285
Radioisotope scan 16.32 13.54 4 113442 10 63375566
Incorrect route of product administration 16.29 13.54 15 113431 27437 63348139
Cytokine release syndrome 16.15 13.54 3 113443 14311 63361265
Influenza like illness 16.14 13.54 63 113383 66761 63308815
Malignant peritoneal neoplasm 16.13 13.54 12 113434 705 63374871
Rectal perforation 16.11 13.54 10 113436 435 63375141
Hypermutation 16.07 13.54 5 113441 37 63375539
Hyperbaric oxygen therapy 16.07 13.54 5 113441 37 63375539
Hospitalisation 16.05 13.54 227 113219 84854 63290722
Sleep disorder 16.03 13.54 83 113363 81483 63294093
Tumour invasion 16.02 13.54 7 113439 145 63375431
Actinomycosis 16.01 13.54 14 113432 1036 63374540
Metastases to thyroid 15.99 13.54 3 113443 0 63375576
Hyperchylomicronaemia 15.99 13.54 3 113443 0 63375576
Dermatoglyphic anomaly 15.99 13.54 3 113443 0 63375576
Vein disorder 15.89 13.54 31 113415 5110 63370466
Staphylococcal infection 15.87 13.54 31 113415 41225 63334351
Gastric varices haemorrhage 15.84 13.54 7 113439 149 63375427
Kidney infection 15.83 13.54 11 113435 23165 63352411
Heart rate increased 15.78 13.54 101 113345 94137 63281439
Hallucination 15.73 13.54 48 113398 54769 63320807
Dermatitis 15.69 13.54 66 113380 16892 63358684
Bone erosion 15.68 13.54 6 113440 17711 63357865
Liver scan abnormal 15.52 13.54 5 113441 42 63375534
Thyroid disorder 15.44 13.54 4 113442 15158 63360418
Gram stain positive 15.41 13.54 5 113441 43 63375533
Sputum discoloured 15.39 13.54 5 113441 16342 63359234
Memory impairment 15.36 13.54 116 113330 104142 63271434
Sepsis 15.32 13.54 370 113076 152753 63222823
Neutropenic colitis 15.31 13.54 23 113423 3072 63372504
Bone cancer metastatic 15.31 13.54 7 113439 162 63375414
Restless legs syndrome 15.24 13.54 7 113439 18524 63357052
Pituitary tumour 15.19 13.54 13 113433 935 63374641
Blood phosphorus decreased 15.19 13.54 28 113418 4425 63371151
Carbohydrate antigen 19-9 increased 15.15 13.54 8 113438 255 63375321
Mediastinal disorder 15.14 13.54 9 113437 362 63375214
Sinus disorder 15.06 13.54 13 113433 24540 63351036
Limb injury 15.02 13.54 14 113432 25463 63350113
Musculoskeletal chest pain 15.02 13.54 76 113370 21007 63354569
Pleural disorder 14.94 13.54 11 113435 636 63374940
Keratitis 14.93 13.54 24 113422 3398 63372178
Paraneoplastic dermatomyositis 14.91 13.54 4 113442 16 63375560
Musculoskeletal pain 14.90 13.54 100 113346 92177 63283399
Facial asymmetry 14.90 13.54 12 113434 793 63374783
Mood swings 14.84 13.54 7 113439 18241 63357335
Oestrogen receptor assay positive 14.83 13.54 10 113436 502 63375074
Full blood count abnormal 14.83 13.54 21 113425 31696 63343880
Renal hydrocele 14.71 13.54 4 113442 17 63375559
Cancer pain 14.71 13.54 23 113423 3182 63372394
Left ventricular dysfunction 14.67 13.54 51 113395 11937 63363639
Pulmonary hilum mass 14.66 13.54 6 113440 105 63375471
Torsade de pointes 14.64 13.54 3 113443 13348 63362228
Perforation 14.58 13.54 14 113432 1169 63374407
Extrapyramidal disorder 14.53 13.54 3 113443 13281 63362295
Radiotherapy 14.53 13.54 9 113437 390 63375186
Myopathy toxic 14.52 13.54 10 113436 520 63375056
Cardiac murmur 14.52 13.54 4 113442 14548 63361028
Abdominal symptom 14.51 13.54 9 113437 391 63375185
Renal vein thrombosis 14.47 13.54 9 113437 393 63375183
Respiratory tract infection 14.43 13.54 33 113413 41450 63334126
Venous thrombosis limb 14.38 13.54 22 113424 2986 63372590
Peritoneal fluid analysis abnormal 14.35 13.54 4 113442 19 63375557
Lip pain 14.32 13.54 17 113429 1809 63373767
Nail avulsion 14.28 13.54 7 113439 190 63375386
Hypoglycaemia 14.27 13.54 57 113389 60008 63315568
Glaucoma 14.26 13.54 8 113438 18897 63356679
Tumour excision 14.25 13.54 9 113437 404 63375172
Activated PI3 kinase delta syndrome 14.19 13.54 4 113442 20 63375556
Wound treatment 14.18 13.54 7 113439 193 63375383
Tumour haemorrhage 14.16 13.54 16 113430 1615 63373961
Corneal erosion 14.09 13.54 8 113438 295 63375281
Obstruction gastric 14.07 13.54 13 113433 1034 63374542
Vulval disorder 14.06 13.54 12 113434 860 63374716
Rectal cancer recurrent 14.02 13.54 4 113442 21 63375555
Ureteric obstruction 14.00 13.54 17 113429 1853 63373723
Anxiety disorder due to a general medical condition 13.91 13.54 3 113443 3 63375573
Bile duct stenosis 13.87 13.54 14 113432 1242 63374334
Skin sensitisation 13.85 13.54 12 113434 877 63374699
Subclavian vein thrombosis 13.85 13.54 17 113429 1873 63373703
Electrocardiogram QT prolonged 13.82 13.54 57 113389 59473 63316103
Hepatic cancer 13.80 13.54 27 113419 4460 63371116
Protein total decreased 13.80 13.54 32 113414 5945 63369631
Product complaint 13.79 13.54 3 113443 12806 63362770
Ocular icterus 13.76 13.54 24 113422 3632 63371944
Dark circles under eyes 13.75 13.54 10 113436 567 63375009
Aggression 13.75 13.54 13 113433 23485 63352091
Faeces soft 13.72 13.54 31 113415 5661 63369915
Blood phosphorus increased 13.65 13.54 22 113424 3123 63372453
Lymphangitis 13.65 13.54 12 113434 895 63374681
Pulmonary fibrosis 13.58 13.54 32 113414 39777 63335799

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 2434.82 14.46 929 52707 15866 34887429
Diarrhoea 1383.32 14.46 2271 51365 387641 34515654
Disease progression 1220.83 14.46 1134 52502 106943 34796352
Death 589.70 14.46 1629 52007 396420 34506875
Arteriospasm coronary 485.22 14.46 186 53450 3196 34900099
Neuropathy peripheral 398.58 14.46 561 53075 82702 34820593
Mucosal inflammation 388.22 14.46 381 53255 38241 34865054
Vomiting 260.38 14.46 902 52734 246719 34656576
Stomatitis 256.36 14.46 321 53315 42193 34861102
Dehydration 255.22 14.46 594 53042 129375 34773920
Anastomotic leak 243.58 14.46 73 53563 558 34902737
Enteritis 233.01 14.46 149 53487 7993 34895302
Nausea 232.88 14.46 1083 52553 338825 34564470
Myelosuppression 217.98 14.46 203 53433 19062 34884233
Malignant neoplasm progression 208.44 14.46 434 53202 87612 34815683
Neurotoxicity 198.43 14.46 187 53449 17823 34885472
Metastases to liver 192.46 14.46 163 53473 13500 34889795
Gastrointestinal perforation 182.94 14.46 98 53538 3765 34899530
Dihydropyrimidine dehydrogenase deficiency 171.69 14.46 37 53599 49 34903246
Intestinal obstruction 166.57 14.46 190 53446 22632 34880663
Decreased appetite 164.82 14.46 595 53041 165797 34737498
Metastases to lung 162.59 14.46 126 53510 9194 34894101
Gastrointestinal toxicity 160.52 14.46 80 53556 2639 34900656
Skin toxicity 153.10 14.46 94 53542 4690 34898605
Bone marrow failure 146.96 14.46 202 53434 29051 34874244
Enterocolitis 143.27 14.46 110 53526 7916 34895379
Drug ineffective 136.13 14.46 314 53322 456437 34446858
Completed suicide 136.08 14.46 3 53633 98165 34805130
Anastomotic complication 123.07 14.46 39 53597 366 34902929
Neutropenia 104.09 14.46 496 53140 156282 34747013
Colon cancer metastatic 101.80 14.46 50 53586 1597 34901698
Tumour perforation 101.29 14.46 32 53604 297 34902998
Abdominal pain 98.90 14.46 504 53132 163114 34740181
Ileus 98.43 14.46 124 53512 16375 34886920
Arthralgia 97.84 14.46 71 53565 169970 34733325
Condition aggravated 96.12 14.46 92 53544 192104 34711191
Headache 95.81 14.46 100 53536 200535 34702760
Therapy cessation 95.64 14.46 124 53512 16849 34886446
Cardiotoxicity 87.04 14.46 71 53565 5577 34897718
Stomal varices 85.12 14.46 21 53615 67 34903228
Metastases to peritoneum 85.12 14.46 46 53590 1798 34901497
Pneumonia 81.43 14.46 285 53351 362342 34540953
Thrombocytopenia 76.72 14.46 455 53181 155792 34747503
Carcinoembryonic antigen increased 74.11 14.46 31 53605 674 34902621
Overdose 73.56 14.46 24 53612 91035 34812260
Gastrointestinal anastomotic leak 73.04 14.46 27 53609 417 34902878
Wound dehiscence 71.73 14.46 51 53585 3260 34900035
Cardiac failure congestive 68.95 14.46 21 53615 83249 34820046
Intestinal perforation 68.75 14.46 77 53559 8983 34894312
Drug interaction 66.45 14.46 156 53480 225790 34677505
Fall 66.35 14.46 132 53504 202753 34700542
Neoplasm progression 66.05 14.46 124 53512 23176 34880119
Portal hypertension 64.57 14.46 52 53584 4010 34899285
Skin exfoliation 64.51 14.46 135 53501 27297 34875998
Necrotising fasciitis 64.21 14.46 50 53586 3672 34899623
Dysphagia 64.05 14.46 226 53410 62155 34841140
Proteus infection 60.76 14.46 31 53605 1075 34902220
Product dose omission issue 60.13 14.46 57 53579 119654 34783641
Haematotoxicity 59.39 14.46 68 53568 8126 34895169
Depression 59.18 14.46 38 53598 97060 34806235
Anxiety 57.80 14.46 41 53595 99387 34803908
Gastric perforation 57.34 14.46 40 53596 2480 34900815
Toxic leukoencephalopathy 57.04 14.46 22 53614 384 34902911
Terminal ileitis 56.85 14.46 19 53617 214 34903081
Proteinuria 56.34 14.46 102 53534 18540 34884755
Recall phenomenon 56.33 14.46 24 53612 547 34902748
Hyperammonaemic encephalopathy 55.49 14.46 38 53598 2286 34901009
Fingerprint loss 55.45 14.46 13 53623 31 34903264
Colitis 54.60 14.46 154 53482 37596 34865699
Non-cirrhotic portal hypertension 53.70 14.46 19 53617 257 34903038
Rectal perforation 53.47 14.46 22 53614 458 34902837
Metastases to lymph nodes 51.87 14.46 49 53587 4679 34898616
Focal nodular hyperplasia 50.79 14.46 16 53620 147 34903148
COVID-19 50.56 14.46 28 53608 77522 34825773
Peritonitis 50.04 14.46 90 53546 16275 34887020
Hiccups 49.67 14.46 69 53567 10013 34893282
Paraesthesia 49.17 14.46 212 53424 63960 34839335
Subileus 48.79 14.46 40 53596 3163 34900132
Splenorenal shunt 47.90 14.46 10 53626 10 34903285
Intentional product misuse 46.90 14.46 7 53629 45604 34857691
Induration 46.90 14.46 25 53611 950 34902345
Cough 46.24 14.46 101 53535 150039 34753256
Dermatitis acneiform 45.93 14.46 52 53584 6137 34897158
Faecal volume decreased 45.72 14.46 14 53622 116 34903179
Pulmonary embolism 45.68 14.46 264 53372 89482 34813813
Hepatic lesion 45.64 14.46 41 53595 3671 34899624
Hallucination 44.44 14.46 12 53624 51486 34851809
Therapy interrupted 44.03 14.46 77 53559 13620 34889675
Influenza 43.95 14.46 11 53625 49655 34853640
Weight increased 43.62 14.46 47 53589 92986 34810309
Hypovolaemic shock 43.45 14.46 54 53582 7031 34896264
Obstruction gastric 43.25 14.46 24 53612 989 34902306
Metastases to central nervous system 43.21 14.46 58 53578 8147 34895148
Pruritus 42.50 14.46 97 53539 141884 34761411
Vascular pain 42.02 14.46 14 53622 156 34903139
Confusional state 41.15 14.46 101 53535 144059 34759236
Prothrombin level decreased 40.84 14.46 24 53612 1104 34902191
Dizziness 40.49 14.46 185 53451 218336 34684959
Pancreatic neuroendocrine tumour metastatic 40.23 14.46 12 53624 90 34903205
Portal shunt 40.05 14.46 10 53626 34 34903261
Aggression 40.02 14.46 6 53630 38958 34864337
Oesophageal haemorrhage 39.89 14.46 25 53611 1293 34902002
Oesophagitis 39.36 14.46 72 53564 13189 34890106
Electrocardiogram ST segment elevation 38.86 14.46 44 53592 5194 34898101
Foetal exposure during pregnancy 38.83 14.46 6 53630 38095 34865200
Large intestinal obstruction 38.80 14.46 26 53610 1509 34901786
Device occlusion 38.72 14.46 49 53587 6496 34896799
Diaphragmatic spasm 38.71 14.46 12 53624 104 34903191
No adverse event 38.65 14.46 99 53537 22828 34880467
Joint swelling 38.49 14.46 22 53614 59868 34843427
Agitation 38.47 14.46 20 53616 57379 34845916
Mucosal disorder 38.35 14.46 27 53609 1699 34901596
Musculoskeletal stiffness 38.22 14.46 12 53624 46668 34856627
Hospice care 37.99 14.46 50 53586 6890 34896405
Metastatic gastric cancer 37.85 14.46 13 53623 160 34903135
Tumour marker increased 37.75 14.46 19 53617 640 34902655
Hypokalaemia 37.66 14.46 183 53453 58031 34845264
Suicidal ideation 37.62 14.46 8 53628 40380 34862915
Rhabdomyolysis 37.17 14.46 30 53606 68133 34835162
Small intestinal obstruction 37.11 14.46 75 53561 14791 34888504
Clostridial infection 36.79 14.46 36 53600 3591 34899704
Laryngospasm 36.62 14.46 25 53611 1496 34901799
Gastrointestinal disorder 36.56 14.46 125 53511 33823 34869472
Anal erythema 36.26 14.46 11 53625 88 34903207
Insomnia 36.19 14.46 65 53571 103842 34799453
Inappropriate schedule of product administration 35.78 14.46 26 53610 62270 34841025
Stoma site haemorrhage 35.05 14.46 20 53616 870 34902425
Prostate cancer 34.66 14.46 9 53627 39640 34863655
Polyneuropathy 34.65 14.46 73 53563 14823 34888472
Metastasis 34.53 14.46 37 53599 4107 34899188
Large intestine perforation 34.36 14.46 53 53583 8450 34894845
Protein urine 34.35 14.46 20 53616 904 34902391
Venoocclusive liver disease 34.09 14.46 51 53585 7915 34895380
Colon cancer recurrent 33.91 14.46 11 53625 112 34903183
Skin fissures 33.73 14.46 41 53595 5218 34898077
Psoriasis 33.57 14.46 9 53627 38803 34864492
Bradycardia 33.28 14.46 40 53596 75378 34827917
Sinusitis 33.26 14.46 11 53625 41391 34861904
Rectal tenesmus 33.16 14.46 19 53617 833 34902462
Biliary obstruction 33.12 14.46 30 53606 2715 34900580
Anal prolapse 32.89 14.46 6 53630 0 34903295
Asthenia 32.69 14.46 543 53093 244708 34658587
Electrocardiogram QT prolonged 32.69 14.46 11 53625 40941 34862354
Dysaesthesia pharynx 32.19 14.46 9 53627 52 34903243
Asthma 31.46 14.46 13 53623 42643 34860652
Intestinal dilatation 31.03 14.46 21 53615 1239 34902056
Hypoaesthesia 30.76 14.46 180 53456 61264 34842031
Skin discolouration 30.02 14.46 77 53559 17768 34885527
Peripheral ischaemia 29.64 14.46 40 53596 5647 34897648
Therapy partial responder 29.54 14.46 53 53583 9563 34893732
Neutropenic sepsis 29.20 14.46 65 53571 13702 34889593
Ascites 29.12 14.46 145 53491 46426 34856869
Chronic obstructive pulmonary disease 28.64 14.46 20 53616 48898 34854397
Injection site pain 28.59 14.46 12 53624 38993 34864302
Wound infection 28.43 14.46 44 53592 7035 34896260
Therapy change 28.37 14.46 29 53607 3048 34900247
Rectal cancer metastatic 28.01 14.46 11 53625 202 34903093
Nasopharyngitis 27.91 14.46 40 53596 69928 34833367
Neutrophil count decreased 27.74 14.46 153 53483 50951 34852344
Disseminated intravascular coagulation 27.71 14.46 85 53551 21731 34881564
Abnormal behaviour 27.68 14.46 3 53633 24966 34878329
Hyperbilirubinaemia 27.64 14.46 72 53564 16771 34886524
Leukopenia 27.59 14.46 178 53458 62678 34840617
Arterial thrombosis 27.55 14.46 21 53615 1494 34901801
Pneumatosis intestinalis 27.49 14.46 32 53604 3891 34899404
Leukoencephalopathy 27.26 14.46 33 53603 4182 34899113
Wheezing 26.90 14.46 15 53621 41387 34861908
Cellulitis 26.81 14.46 25 53611 52926 34850369
Erythema 26.78 14.46 230 53406 88550 34814745
Cheilitis 26.65 14.46 25 53611 2366 34900929
Fatigue 26.55 14.46 750 52886 369903 34533392
Gastroenteritis radiation 26.49 14.46 12 53624 318 34902977
Proctalgia 26.46 14.46 38 53598 5685 34897610
Pelvic abscess 26.40 14.46 17 53619 922 34902373
Feeling abnormal 26.37 14.46 35 53601 63200 34840095
Product use issue 26.36 14.46 35 53601 63181 34840114
Myalgia 26.35 14.46 56 53580 84054 34819241
Bronchitis 26.13 14.46 16 53620 41947 34861348
Drug reaction with eosinophilia and systemic symptoms 26.12 14.46 9 53627 33003 34870292
Pigmentation disorder 25.97 14.46 25 53611 2444 34900851
Blood pressure fluctuation 25.67 14.46 4 53632 25245 34878050
Gastrointestinal mucosal necrosis 25.54 14.46 10 53626 182 34903113
Dysaesthesia 25.50 14.46 24 53612 2281 34901014
Hypertriglyceridaemia 25.24 14.46 46 53590 8402 34894893
Ileus paralytic 25.10 14.46 38 53598 5959 34897336
Seizure 25.05 14.46 80 53556 104777 34798518
Nasal congestion 24.99 14.46 3 53633 23054 34880241
Therapeutic product effect decreased 24.96 14.46 11 53625 34732 34868563
Tenderness 24.96 14.46 41 53595 6893 34896402
Gastric dilatation 24.95 14.46 15 53621 720 34902575
Peripheral sensorimotor neuropathy 24.61 14.46 20 53616 1562 34901733
Gastrointestinal stoma necrosis 24.60 14.46 6 53630 18 34903277
Somnolence 24.36 14.46 88 53548 111028 34792267
Hyperfibrinolysis 24.35 14.46 6 53630 19 34903276
Cognitive disorder 24.17 14.46 7 53629 28686 34874609
Aortic thrombosis 24.16 14.46 15 53621 763 34902532
Pancreatitis viral 23.95 14.46 5 53631 5 34903290
Chronic kidney disease 23.92 14.46 17 53619 41193 34862102
Arthropathy 23.72 14.46 6 53630 26901 34876394
Lactic acidosis 23.46 14.46 12 53624 34760 34868535
Treatment noncompliance 23.40 14.46 7 53629 28093 34875202
Gastrointestinal stoma complication 23.33 14.46 18 53618 1304 34901991
Performance status decreased 22.95 14.46 30 53606 4107 34899188
Heart rate decreased 22.89 14.46 10 53626 31735 34871560
Eosinophilia 22.83 14.46 6 53630 26216 34877079
Irritability 22.77 14.46 5 53631 24685 34878610
Alanine aminotransferase increased 22.74 14.46 57 53579 80758 34822537
Mucosal toxicity 22.58 14.46 10 53626 251 34903044
Temperature intolerance 22.47 14.46 27 53609 3395 34899900
Colorectal cancer metastatic 22.31 14.46 14 53622 726 34902569
Ectropion 22.04 14.46 8 53628 117 34903178
Varices oesophageal 22.03 14.46 28 53608 3727 34899568
Pharyngeal ulceration 22.01 14.46 11 53625 365 34902930
Dyspnoea 21.95 14.46 427 53209 376355 34526940
Cholangitis 21.88 14.46 44 53592 8645 34894650
Urticaria 21.73 14.46 39 53597 62338 34840957
Acute promyelocytic leukaemia 21.66 14.46 12 53624 493 34902802
Erectile dysfunction 21.60 14.46 3 53633 20634 34882661
Tumour necrosis 21.56 14.46 17 53619 1271 34902024
Colostomy 21.48 14.46 12 53624 501 34902794
Failure to anastomose 21.09 14.46 9 53627 206 34903089
Hepatic infarction 20.93 14.46 9 53627 210 34903085
Palmar erythema 20.90 14.46 10 53626 301 34902994
Nephrotic syndrome 20.85 14.46 39 53597 7264 34896031
Wrong technique in product usage process 20.68 14.46 15 53621 35971 34867324
Oxygen saturation decreased 20.26 14.46 32 53604 53786 34849509
Basal cell carcinoma 20.25 14.46 3 53633 19655 34883640
Change of bowel habit 20.17 14.46 15 53621 1028 34902267
Interstitial lung disease 20.14 14.46 170 53466 65112 34838183
Scleroderma-like reaction 20.12 14.46 6 53630 45 34903250
Electrolyte imbalance 20.05 14.46 58 53578 14354 34888941
Upper respiratory tract infection 20.04 14.46 13 53623 33046 34870249
Coronary artery disease 19.87 14.46 27 53609 48278 34855017
Pulmonary hypertension 19.78 14.46 4 53632 20920 34882375
Tremor 19.73 14.46 63 53573 82524 34820771
Back pain 19.71 14.46 108 53528 121681 34781614
Perforation 19.58 14.46 9 53627 247 34903048
Idiosyncratic drug reaction 19.57 14.46 11 53625 465 34902830
Therapeutic product effect prolonged 19.41 14.46 9 53627 252 34903043
Gastrointestinal wall thickening 19.32 14.46 17 53619 1481 34901814
Nail bed inflammation 19.29 14.46 8 53628 170 34903125
Cataract 19.28 14.46 8 53628 26178 34877117
Hepatic atrophy 19.08 14.46 8 53628 175 34903120
Gastrointestinal mucosal disorder 19.01 14.46 10 53626 370 34902925
Incisional hernia 18.99 14.46 16 53620 1314 34901981
Drug hypersensitivity 18.84 14.46 62 53574 80467 34822828
Blood glucose increased 18.81 14.46 47 53589 66671 34836624
Psychotic disorder 18.77 14.46 7 53629 24445 34878850
Gastrointestinal inflammation 18.76 14.46 25 53611 3486 34899809
Haematemesis 18.55 14.46 88 53548 27623 34875672
Balance disorder 18.53 14.46 21 53615 40633 34862662
Eczema impetiginous 18.49 14.46 5 53631 25 34903270
Metastases to the mediastinum 18.48 14.46 9 53627 282 34903013
Eosinophilic pneumonia chronic 18.36 14.46 9 53627 286 34903009
Anterior spinal artery syndrome 18.27 14.46 4 53632 6 34903289
Blood lactic acid increased 18.06 14.46 35 53601 6693 34896602
Hot flush 18.06 14.46 3 53633 18063 34885232
Memory impairment 18.04 14.46 24 53612 43294 34860001
Feeling cold 17.99 14.46 46 53590 10593 34892702
Laryngeal discomfort 17.98 14.46 8 53628 203 34903092
Peripheral sensory neuropathy 17.95 14.46 35 53601 6725 34896570
Sedation 17.92 14.46 5 53631 21001 34882294
Peripheral embolism 17.91 14.46 14 53622 1034 34902261
Metastases to pelvis 17.75 14.46 9 53627 308 34902987
Contusion 17.45 14.46 18 53618 36346 34866949
Disturbance in attention 17.44 14.46 9 53627 25936 34877359
Treatment failure 17.36 14.46 28 53608 46669 34856626
Metastases to eye 17.31 14.46 6 53630 76 34903219
Gastrointestinal injury 17.20 14.46 10 53626 451 34902844
Muscular weakness 17.14 14.46 56 53580 72841 34830454
Hyperammonaemia 16.94 14.46 33 53603 6334 34896961
Ventricular fibrillation 16.93 14.46 75 53561 22879 34880416
Pallor 16.89 14.46 9 53627 25471 34877824
Arthritis 16.83 14.46 14 53622 31332 34871963
Scrotal ulcer 16.76 14.46 10 53626 473 34902822
Neck pain 16.73 14.46 9 53627 25340 34877955
Hand-foot-genital syndrome 16.66 14.46 4 53632 11 34903284
Hypoglycaemia 16.59 14.46 37 53599 54603 34848692
Adenocarcinoma metastatic 16.59 14.46 5 53631 39 34903256
Depressed level of consciousness 16.58 14.46 25 53611 42816 34860479
Vasospasm 16.53 14.46 9 53627 357 34902938
Acute coronary syndrome 16.48 14.46 52 53584 13493 34889802
Urethral ulcer 16.44 14.46 3 53633 0 34903295
Faeces pale 16.27 14.46 15 53621 1388 34901907
Pelvic fluid collection 16.17 14.46 7 53629 166 34903129
Cardiac failure 15.83 14.46 79 53557 91169 34812126
Metastases to meninges 15.82 14.46 15 53621 1439 34901856
Phimosis 15.71 14.46 12 53624 856 34902439
Intestinal ischaemia 15.64 14.46 36 53600 7758 34895537
Neutrophilia 15.62 14.46 25 53611 4112 34899183
Peritoneal disorder 15.59 14.46 8 53628 281 34903014
Duodenal perforation 15.48 14.46 14 53622 1264 34902031
Metastatic neoplasm 15.48 14.46 21 53615 2979 34900316
Acral peeling skin syndrome 15.41 14.46 5 53631 51 34903244
Liver injury 15.33 14.46 54 53582 14824 34888471
False negative investigation result 15.17 14.46 7 53629 194 34903101
Perineal ulceration 15.13 14.46 4 53632 18 34903277
Swelling of eyelid 15.12 14.46 13 53623 1098 34902197
Accidental overdose 15.07 14.46 6 53630 20134 34883161
Urinary tract infection 15.05 14.46 72 53564 84009 34819286
Electromyogram abnormal 14.99 14.46 5 53631 56 34903239
Prostatic calcification 14.94 14.46 6 53630 117 34903178
Phrenic nerve paralysis 14.90 14.46 6 53630 118 34903177
Blood pressure increased 14.88 14.46 77 53559 88025 34815270
Biliary fistula 14.83 14.46 5 53631 58 34903237
Hypotension 14.83 14.46 245 53391 221404 34681891
Malignant ascites 14.80 14.46 9 53627 441 34902854
Mouth ulceration 14.75 14.46 46 53590 11864 34891431
Respiratory arrest 14.48 14.46 13 53623 28030 34875265

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 7642.36 12.86 2609 124613 30525 79586641
Disease progression 3274.06 12.86 2551 124671 181811 79435355
Diarrhoea 2852.81 12.86 5037 122185 875452 78741714
Malignant neoplasm progression 1258.15 12.86 1305 125917 134685 79482481
Mucosal inflammation 1132.18 12.86 949 126273 74631 79542535
Metastases to liver 1055.66 12.86 622 126600 27692 79589474
Neuropathy peripheral 884.76 12.86 1108 126114 140197 79476969
Metastases to bone 818.27 12.86 501 126721 23926 79593240
Arteriospasm coronary 757.70 12.86 314 126908 6402 79610764
Metastases to lung 703.26 12.86 409 126813 17754 79599412
Death 671.21 12.86 2204 125018 564310 79052856
Myelosuppression 572.25 12.86 491 126731 39805 79577361
Vomiting 545.15 12.86 2300 124922 663528 78953638
Metastases to central nervous system 513.23 12.86 322 126900 16053 79601113
Neurotoxicity 449.05 12.86 390 126832 32128 79585038
Nausea 444.73 12.86 2822 124400 954374 78662792
Stomatitis 435.76 12.86 814 126408 145943 79471223
Dehydration 417.76 12.86 1096 126126 247091 79370075
Breast cancer metastatic 407.07 12.86 221 127001 8381 79608785
Neutropenia 402.85 12.86 1188 126034 286522 79330644
Bone marrow failure 402.48 12.86 451 126771 50656 79566510
Gastrointestinal toxicity 382.80 12.86 208 127014 7901 79609265
Completed suicide 375.07 12.86 3 127219 245764 79371402
Metastases to lymph nodes 355.14 12.86 216 127006 10181 79606985
Enteritis 341.20 12.86 239 126983 14344 79602822
Skin toxicity 339.86 12.86 194 127028 8120 79609046
Neoplasm progression 338.55 12.86 415 126807 51267 79565899
Drug ineffective 325.18 12.86 785 126437 1080128 78537038
Rheumatoid arthritis 315.89 12.86 3 127219 208467 79408699
Arthralgia 293.73 12.86 288 126934 571515 79045651
Condition aggravated 282.96 12.86 231 126991 500893 79116273
Dihydropyrimidine dehydrogenase deficiency 282.80 12.86 62 127160 88 79617078
Decreased appetite 281.29 12.86 1186 126036 341232 79275934
Thrombocytopenia 276.70 12.86 991 126231 264268 79352898
Cardiotoxicity 271.09 12.86 194 127028 12045 79605121
Joint swelling 255.49 12.86 72 127150 288574 79328592
Skin exfoliation 245.69 12.86 367 126855 54733 79562433
Enterocolitis 235.31 12.86 191 127031 14321 79602845
Skin fissures 231.07 12.86 181 127041 12892 79604274
Anastomotic leak 226.03 12.86 79 127143 986 79616180
Gastrointestinal perforation 205.75 12.86 126 127096 6011 79611155
Metastases to skin 201.87 12.86 83 127139 1656 79615510
Haematotoxicity 197.98 12.86 178 127044 15341 79601825
Asthenia 187.24 12.86 1426 125796 510263 79106903
Tumour marker increased 183.55 12.86 103 127119 4169 79612997
Arthropathy 181.10 12.86 32 127190 177079 79440087
Fall 179.01 12.86 315 126907 487314 79129852
Contraindicated product administered 173.54 12.86 23 127199 157515 79459651
Laryngospasm 173.45 12.86 97 127125 3900 79613266
Hospice care 171.87 12.86 138 127084 10186 79606980
Therapy cessation 170.03 12.86 252 126970 37310 79579856
Paronychia 166.60 12.86 121 127101 7687 79609479
Systemic lupus erythematosus 163.19 12.86 7 127215 121142 79496024
Therapeutic product effect decreased 162.42 12.86 32 127190 163831 79453335
Metastases to peritoneum 160.10 12.86 95 127127 4277 79612889
Non-cirrhotic portal hypertension 159.01 12.86 50 127172 437 79616729
Skin discolouration 155.98 12.86 254 126968 40780 79576386
Maternal exposure during pregnancy 155.11 12.86 18 127204 136520 79480646
Intestinal obstruction 152.41 12.86 258 126964 42762 79574404
Carcinoembryonic antigen increased 151.79 12.86 73 127149 2136 79615030
Osteonecrosis of jaw 151.51 12.86 258 126964 42968 79574198
Drug interaction 146.22 12.86 275 126947 414908 79202258
Dry skin 145.81 12.86 330 126892 67665 79549501
Treatment failure 144.44 12.86 46 127176 170440 79446726
Overdose 143.61 12.86 57 127165 184149 79433017
Pseudocirrhosis 142.62 12.86 50 127172 630 79616536
Sinusitis 137.54 12.86 70 127152 195431 79421735
Pneumonia 136.72 12.86 566 126656 659680 78957486
Musculoskeletal stiffness 136.68 12.86 54 127168 174954 79442212
Drug hypersensitivity 136.09 12.86 166 127056 298750 79318416
Paraesthesia 135.45 12.86 599 126623 175724 79441442
Metastasis 134.17 12.86 101 127121 6779 79610387
Product use issue 133.48 12.86 85 127137 209737 79407429
Headache 126.47 12.86 575 126647 653197 78963969
Intentional overdose 125.40 12.86 12 127210 105948 79511218
Portal hypertension 124.72 12.86 98 127124 7010 79610156
Weight increased 120.07 12.86 160 127062 277226 79339940
Depression 119.55 12.86 102 127120 216688 79400478
Exposure during pregnancy 118.25 12.86 12 127210 101120 79516046
Breast cancer 114.93 12.86 199 127023 33582 79583584
PIK3CA-activated mutation 113.81 12.86 41 127181 562 79616604
Hepatic lesion 113.68 12.86 92 127130 6867 79610299
Hyperbilirubinaemia 113.13 12.86 166 127056 24352 79592814
Nail disorder 111.56 12.86 115 127107 11737 79605429
Breast cancer recurrent 109.83 12.86 65 127157 2912 79614254
Lymphangiosis carcinomatosa 109.36 12.86 58 127164 2096 79615070
Anastomotic complication 108.01 12.86 37 127185 433 79616733
Psoriasis 106.40 12.86 10 127212 89577 79527589
Influenza 106.22 12.86 37 127185 129569 79487597
Colitis 105.41 12.86 306 126916 73001 79544165
Dysaesthesia pharynx 104.21 12.86 30 127192 187 79616979
Tumour perforation 104.04 12.86 35 127187 386 79616780
Glossodynia 102.76 12.86 20 127202 103317 79513849
Onycholysis 99.89 12.86 54 127168 2029 79615137
Polyneuropathy 99.34 12.86 155 127067 23996 79593170
Ascites 98.80 12.86 305 126917 75257 79541909
Pruritus 97.55 12.86 314 126908 394334 79222832
Cardiac failure congestive 97.16 12.86 53 127169 142349 79474817
Abdominal pain 96.73 12.86 998 126224 388571 79228595
Suicide attempt 96.54 12.86 10 127212 82922 79534244
Fingerprint loss 95.30 12.86 22 127200 45 79617121
Hypokalaemia 94.18 12.86 467 126755 143573 79473593
Metastases to pleura 93.77 12.86 47 127175 1507 79615659
Arthritis 92.09 12.86 34 127188 114846 79502320
Bradycardia 90.26 12.86 52 127170 135505 79481661
Ileus 89.94 12.86 155 127067 26056 79591110
Wound 88.82 12.86 37 127185 116142 79501024
Carbohydrate antigen 15-3 increased 87.24 12.86 41 127181 1138 79616028
Asthma 84.15 12.86 56 127166 135039 79482127
Leukopenia 82.83 12.86 387 126835 116126 79501040
Urticaria 81.98 12.86 105 127117 185096 79432070
Intentional product misuse 81.79 12.86 25 127197 95140 79522026
Stomal varices 81.64 12.86 21 127201 79 79617087
Pericarditis 81.63 12.86 32 127190 104204 79512962
Bronchitis 80.25 12.86 55 127167 130589 79486577
Product dose omission issue 80.15 12.86 172 127050 247365 79369801
Fibromyalgia 79.65 12.86 6 127216 64334 79552832
Swelling 78.44 12.86 141 127081 216570 79400596
Osteoarthritis 76.74 12.86 22 127200 87287 79529879
Irritable bowel syndrome 76.49 12.86 6 127216 62235 79554931
Therapy partial responder 76.26 12.86 115 127107 17282 79599884
Anxiety 76.11 12.86 178 127044 248334 79368832
Suicidal ideation 75.42 12.86 15 127207 76325 79540841
Pain 75.28 12.86 739 126483 703063 78914103
Metastatic neoplasm 74.72 12.86 63 127159 4979 79612187
Hypovolaemic shock 74.62 12.86 95 127127 12181 79604985
Duodenal ulcer perforation 74.50 12.86 9 127213 66202 79550964
Hepatic function abnormal 74.20 12.86 271 126951 72836 79544330
Recall phenomenon 73.39 12.86 36 127186 1101 79616065
Chronic obstructive pulmonary disease 72.40 12.86 23 127199 85396 79531770
Metastases to spine 72.40 12.86 58 127164 4266 79612900
Ejection fraction decreased 72.09 12.86 166 127056 34411 79582755
Plasma cell myeloma 71.96 12.86 3 127219 53256 79563910
Infusion site coldness 71.68 12.86 23 127199 216 79616950
Gastric perforation 71.56 12.86 56 127166 3981 79613185
Blood pressure fluctuation 71.12 12.86 11 127211 67134 79550032
Proteinuria 68.83 12.86 157 127065 32345 79584821
Colon cancer metastatic 68.60 12.86 43 127179 2138 79615028
Infusion related reaction 68.05 12.86 168 127054 230069 79387097
Nasal congestion 67.82 12.86 19 127203 76533 79540633
Pulmonary embolism 67.39 12.86 487 126735 171167 79445999
Dysaesthesia 66.67 12.86 63 127159 5785 79611381
COVID-19 66.11 12.86 93 127129 157581 79459585
Bone lesion 66.02 12.86 63 127159 5856 79611310
Mobility decreased 65.48 12.86 59 127163 122116 79495050
Platelet count decreased 65.11 12.86 532 126690 194132 79423034
Intestinal perforation 65.04 12.86 107 127115 17319 79599847
Oesophagitis 64.93 12.86 129 127093 24160 79593006
Muscle injury 64.74 12.86 3 127219 48558 79568608
Confusional state 64.13 12.86 275 126947 317722 79299444
Wound dehiscence 63.90 12.86 65 127157 6530 79610636
Feeling abnormal 63.71 12.86 97 127125 159102 79458064
Discomfort 63.43 12.86 64 127158 125553 79491613
Wheezing 62.93 12.86 56 127166 116608 79500558
Fatigue 62.72 12.86 1932 125290 927795 78689371
Drug reaction with eosinophilia and systemic symptoms 62.68 12.86 13 127209 64231 79552935
Electrocardiogram QT prolonged 62.58 12.86 33 127189 90353 79526813
Hepatic enzyme increased 62.38 12.86 123 127099 182487 79434679
Neutrophil count decreased 62.36 12.86 306 126916 93653 79523513
Subacute cutaneous lupus erythematosus 62.27 12.86 49 127173 3512 79613654
Dermatitis acneiform 61.80 12.86 78 127144 9915 79607251
Hepatic failure 61.35 12.86 226 126996 60986 79556180
Rhabdomyolysis 61.25 12.86 45 127177 103086 79514080
Osteonecrosis 61.25 12.86 146 127076 30949 79586217
Gamma-glutamyltransferase decreased 61.00 12.86 23 127199 361 79616805
Mucosal toxicity 60.81 12.86 26 127196 574 79616592
Device related thrombosis 60.49 12.86 43 127179 2640 79614526
Nail discolouration 60.22 12.86 45 127177 2986 79614180
Nasopharyngitis 59.92 12.86 206 127016 253675 79363491
Metastases to chest wall 59.84 12.86 25 127197 520 79616646
Skin hyperpigmentation 58.40 12.86 65 127157 7238 79609928
Hypoaesthesia 58.28 12.86 487 126735 178865 79438301
Abdominal discomfort 58.12 12.86 205 127017 250522 79366644
Injection site pain 58.08 12.86 73 127149 129765 79487401
Insomnia 57.81 12.86 199 127023 244971 79372195
Hypotension 57.37 12.86 439 126783 439878 79177288
Peripheral sensory neuropathy 56.91 12.86 86 127136 12947 79604219
Gastrointestinal anastomotic leak 56.29 12.86 24 127198 526 79616640
Therapy change 56.00 12.86 64 127158 7335 79609831
Recurrent cancer 55.79 12.86 41 127181 2652 79614514
Loss of personal independence in daily activities 55.61 12.86 49 127173 102531 79514635
Toxic leukoencephalopathy 55.57 12.86 30 127192 1124 79616042
Metastases to meninges 55.45 12.86 46 127176 3555 79613611
Varices oesophageal 54.35 12.86 57 127165 5934 79611232
Disseminated intravascular coagulation 53.82 12.86 152 127070 35690 79581476
Acute coronary syndrome 53.82 12.86 110 127112 21023 79596143
Dysphagia 53.51 12.86 356 126866 121780 79495386
Terminal ileitis 53.18 12.86 27 127195 890 79616276
Blood bilirubin increased 53.07 12.86 228 126994 66004 79551162
Electrocardiogram ST segment elevation 52.66 12.86 66 127156 8331 79608835
Injury 52.62 12.86 29 127193 77467 79539699
Chronic kidney disease 52.30 12.86 20 127202 66134 79551032
Subileus 51.66 12.86 54 127168 5600 79611566
Hiccups 50.80 12.86 71 127151 9960 79607206
Vascular pain 50.34 12.86 26 127196 889 79616277
Lacrimation increased 50.30 12.86 111 127111 22366 79594800
Neutropenic sepsis 50.02 12.86 124 127098 26940 79590226
Cytomegalovirus infection 50.00 12.86 5 127217 42639 79574527
Performance status decreased 49.90 12.86 55 127167 6058 79611108
Wrong technique in product usage process 49.65 12.86 28 127194 73847 79543319
Lower respiratory tract infection 49.55 12.86 81 127141 129139 79488027
Leukoencephalopathy 49.21 12.86 62 127160 7867 79609299
Venoocclusive liver disease 49.04 12.86 76 127146 11695 79605471
Oxygen saturation decreased 48.45 12.86 82 127140 128965 79488201
Prescribed overdose 48.44 12.86 3 127219 37880 79579286
Agitation 47.87 12.86 53 127169 99662 79517504
Metastases to the mediastinum 47.58 12.86 22 127200 588 79616578
Acute kidney injury 47.16 12.86 566 126656 518838 79098328
Somnolence 46.74 12.86 209 127013 238772 79378394
Abdominal lymphadenopathy 46.28 12.86 28 127194 1306 79615860
Splenorenal shunt 45.69 12.86 10 127212 14 79617152
Hyperkalaemia 45.48 12.86 70 127152 114328 79502838
Peritonitis 44.17 12.86 121 127101 27915 79589251
Mucosal disorder 44.08 12.86 40 127182 3488 79613678
Jaw operation 44.01 12.86 23 127199 806 79616360
Coronary artery disease 43.73 12.86 25 127197 65449 79551717
Sleep apnoea syndrome 43.50 12.86 4 127218 36474 79580692
Hypertriglyceridaemia 43.26 12.86 75 127147 12665 79604501
Anastomotic fistula 43.21 12.86 14 127208 136 79617030
Drug level increased 43.14 12.86 6 127216 39645 79577521
Erythema 43.11 12.86 545 126677 222745 79394421
Pneumatosis intestinalis 42.88 12.86 52 127170 6345 79610821
Myalgia 42.86 12.86 152 127070 185489 79431677
Cytokine release syndrome 42.78 12.86 4 127218 35994 79581172
Lactic acidosis 42.69 12.86 30 127192 70329 79546837
Aggression 42.69 12.86 14 127208 50944 79566222
Basal cell carcinoma 42.25 12.86 5 127217 37370 79579796
Sedation 42.19 12.86 15 127207 51880 79565286
Lymphoedema 42.05 12.86 73 127149 12340 79604826
Pyogenic granuloma 41.50 12.86 19 127203 496 79616670
Obstruction gastric 41.37 12.86 29 127193 1741 79615425
Abnormal behaviour 40.85 12.86 5 127217 36416 79580750
Arterial thrombosis 40.84 12.86 34 127188 2640 79614526
Blood cholesterol increased 40.74 12.86 44 127178 83676 79533490
Medication error 40.69 12.86 30 127192 68612 79548554
Eosinophilia 40.64 12.86 11 127211 45334 79571832
Delirium 40.60 12.86 45 127177 84582 79532584
Focal nodular hyperplasia 40.58 12.86 21 127201 721 79616445
Device occlusion 40.48 12.86 70 127152 11796 79605370
Therapy interrupted 40.48 12.86 126 127096 31215 79585951
Pleural effusion 40.25 12.86 381 126841 144881 79472285
Biliary obstruction 39.80 12.86 43 127179 4631 79612535
Hallucination 39.62 12.86 47 127175 85698 79531468
Mouth ulceration 39.52 12.86 143 127079 38251 79578915
Treatment noncompliance 39.37 12.86 17 127205 52251 79564915
Injection site erythema 39.28 12.86 40 127182 78157 79539009
Pulmonary hypertension 38.91 12.86 14 127208 48066 79569100
Portal shunt 38.71 12.86 11 127211 65 79617101
Folliculitis 38.66 12.86 20 127202 55360 79561806
Prothrombin level decreased 38.58 12.86 27 127195 1617 79615549
Granulocyte count decreased 38.53 12.86 28 127194 1780 79615386
Rectal tenesmus 38.12 12.86 27 127195 1648 79615518
Drug ineffective for unapproved indication 38.06 12.86 17 127205 51221 79565945
Cold dysaesthesia 38.01 12.86 8 127214 8 79617158
Unresponsive to stimuli 37.69 12.86 21 127201 55767 79561399
Tooth extraction 37.69 12.86 65 127157 10930 79606236
Therapeutic product effect incomplete 37.56 12.86 109 127113 141536 79475630
Diaphragmatic spasm 37.56 12.86 12 127210 111 79617055
Prinzmetal angina 37.48 12.86 27 127195 1693 79615473
Thrombosis 37.35 12.86 246 126976 83854 79533312
Large intestine perforation 37.30 12.86 76 127146 14491 79602675
Infusion site induration 37.27 12.86 23 127199 1112 79616054
Hyperammonaemic encephalopathy 37.27 12.86 42 127180 4740 79612426
Necrotising fasciitis 37.06 12.86 47 127175 6003 79611163
Jaundice 37.01 12.86 176 127046 53173 79563993
Dizziness 36.97 12.86 604 126618 525837 79091329
Proteus infection 36.72 12.86 29 127193 2089 79615077
Pharyngeal inflammation 36.72 12.86 22 127200 1008 79616158
Biliary sepsis 36.65 12.86 26 127196 1591 79615575
Blood pressure systolic increased 36.30 12.86 32 127190 66954 79550212
Hypophagia 36.21 12.86 156 127066 45211 79571955
Product use in unapproved indication 35.76 12.86 243 126979 250116 79367050
Depressed level of consciousness 35.74 12.86 62 127160 96590 79520576
Cataract 35.73 12.86 28 127194 62092 79555074
Contusion 35.56 12.86 120 127102 148656 79468510
Aortic thrombosis 35.55 12.86 26 127196 1669 79615497
Ectropion 35.15 12.86 16 127206 412 79616754
Pigmentation disorder 34.98 12.86 44 127178 5574 79611592
Adverse event 34.82 12.86 27 127195 60187 79556979
Hepatic atrophy 34.69 12.86 16 127206 425 79616741
Metastases to ovary 34.64 12.86 15 127207 342 79616824
Congestive cardiomyopathy 34.46 12.86 65 127157 11715 79605451
Cholangitis 34.32 12.86 68 127154 12708 79604458
Nervousness 34.21 12.86 6 127216 33409 79583757
Joint range of motion decreased 34.02 12.86 6 127216 33276 79583890
Hypoalbuminaemia 33.63 12.86 92 127130 21205 79595961
Cachexia 33.48 12.86 62 127160 11021 79606145
Nodular regenerative hyperplasia 33.46 12.86 23 127199 1338 79615828
Abortion spontaneous 33.22 12.86 4 127218 29503 79587663
Adnexa uteri mass 33.22 12.86 15 127207 379 79616787
Pulmonary sarcoidosis 33.21 12.86 23 127199 1354 79615812
Bone pain 33.10 12.86 176 127046 55566 79561600
Small intestinal obstruction 32.81 12.86 107 127115 27165 79590001
Bone disorder 32.64 12.86 85 127137 19028 79598138
Obesity 32.47 12.86 8 127214 35117 79582049
Migraine 32.47 12.86 56 127166 87437 79529729
Hyperhidrosis 32.38 12.86 128 127094 151364 79465802
Induration 32.29 12.86 26 127196 1926 79615240
COVID-19 pneumonia 32.26 12.86 4 127218 28845 79588321
Blood uric acid decreased 32.22 12.86 22 127200 1266 79615900
Hand-foot-and-mouth disease 32.13 12.86 14 127208 324 79616842
Faecal volume decreased 32.08 12.86 12 127210 184 79616982
Myocardial infarction 31.94 12.86 168 127054 183961 79433205
Metastases to eye 31.87 12.86 13 127209 254 79616912
Osteoporosis 31.62 12.86 24 127198 54088 79563078
Hypermutation 31.41 12.86 9 127213 55 79617111
Type 2 diabetes mellitus 31.30 12.86 27 127195 57095 79560071
White blood cell count decreased 31.15 12.86 447 126775 187841 79429325
Hyperammonaemia 30.96 12.86 60 127162 11033 79606133
Prescribed underdose 30.88 12.86 5 127217 29509 79587657
Ejection fraction 30.88 12.86 27 127195 2242 79614924
Protein urine 30.87 12.86 23 127199 1519 79615647
Constipation 30.81 12.86 628 126594 282422 79334744
Colorectal cancer metastatic 30.62 12.86 21 127201 1217 79615949
Stoma site haemorrhage 30.60 12.86 25 127197 1891 79615275
Respiratory arrest 30.58 12.86 28 127194 57522 79559644
Pelvic fluid collection 30.52 12.86 18 127204 801 79616365
Debridement 30.49 12.86 24 127198 1721 79615445
Cheilitis 30.38 12.86 40 127182 5301 79611865
Psychotic disorder 30.34 12.86 14 127208 41388 79575778
Oesophageal haemorrhage 30.22 12.86 24 127198 1743 79615423
Weight decreased 30.20 12.86 761 126461 354437 79262729
Prostate cancer 29.95 12.86 8 127214 33260 79583906
Sciatica 29.88 12.86 8 127214 33214 79583952
Loss of consciousness 29.82 12.86 152 127070 167791 79449375
Angioedema 29.76 12.86 47 127175 75988 79541178
Ear infection 29.66 12.86 9 127213 34423 79582743
Plantar erythema 29.60 12.86 13 127209 307 79616859
Nail infection 29.58 12.86 27 127195 2372 79614794
Stress cardiomyopathy 29.48 12.86 59 127163 11107 79606059
Fluid retention 29.42 12.86 41 127181 69768 79547398
Disturbance in attention 29.09 12.86 23 127199 50778 79566388
Eosinophil percentage increased 28.97 12.86 22 127200 1496 79615670
Hypervolaemia 28.94 12.86 16 127206 42674 79574492
Pancreatic neuroendocrine tumour metastatic 28.89 12.86 10 127212 121 79617045
Odynophagia 28.89 12.86 59 127163 11268 79605898
Rectal perforation 28.86 12.86 18 127204 887 79616279
Blood glucose increased 28.67 12.86 91 127131 114884 79502282
Tumour pain 28.59 12.86 26 127196 2273 79614893
Emotional distress 28.55 12.86 14 127208 39955 79577211
Metastases to pelvis 28.55 12.86 16 127206 646 79616520
Clostridial infection 28.27 12.86 40 127182 5674 79611492
C-reactive protein increased 28.22 12.86 108 127114 128919 79488247
Respiratory depression 28.20 12.86 5 127217 27625 79589541
Upper respiratory tract infection 28.12 12.86 65 127157 91103 79526063
Hypoglycaemia 27.80 12.86 77 127145 101517 79515649
Acute myeloid leukaemia 27.63 12.86 110 127112 30775 79586391
Anal erythema 27.59 12.86 11 127211 202 79616964
Cognitive disorder 27.58 12.86 43 127179 69883 79547283
Device issue 27.47 12.86 5 127217 27103 79590063
Asthenopia 27.39 12.86 26 127196 2401 79614765
Angina bullosa haemorrhagica 27.20 12.86 11 127211 210 79616956
General physical health deterioration 27.15 12.86 602 126620 274636 79342530
Acute promyelocytic leukaemia 27.12 12.86 21 127201 1470 79615696
Withdrawal syndrome 27.11 12.86 5 127217 26849 79590317
Skin reaction 26.97 12.86 71 127151 15997 79601169
Gastrointestinal mucosal necrosis 26.77 12.86 11 127211 219 79616947
Hyperfibrinolysis 26.68 12.86 7 127215 29 79617137
Malignant ascites 26.64 12.86 19 127203 1173 79615993
Tooth erosion 26.58 12.86 13 127209 395 79616771
Blood creatinine decreased 26.48 12.86 46 127176 7779 79609387
Pulmonary mass 26.45 12.86 104 127118 28930 79588236
Tumour necrosis 26.41 12.86 23 127199 1899 79615267
Gastrointestinal inflammation 26.39 12.86 45 127177 7499 79609667
Neoplasm recurrence 26.23 12.86 33 127189 4181 79612985
Bone sequestrum 26.11 12.86 19 127203 1210 79615956
Acute respiratory failure 26.07 12.86 34 127188 59507 79557659
Haematoma 25.87 12.86 27 127195 52168 79564998
Small intestinal perforation 25.77 12.86 29 127193 3268 79613898
Extrapyramidal disorder 25.72 12.86 3 127219 22676 79594490
Lymphadenopathy 25.64 12.86 159 127063 53088 79564078
Joint injury 25.57 12.86 9 127213 31326 79585840
Accidental exposure to product 25.55 12.86 9 127213 31313 79585853
Illness 25.47 12.86 22 127200 46489 79570677
Foot deformity 25.36 12.86 4 127218 24070 79593096
Disease recurrence 25.33 12.86 138 127084 43971 79573195
Rhinorrhoea 25.31 12.86 52 127170 76022 79541144
Accidental overdose 25.19 12.86 16 127206 39565 79577601
Mucosal necrosis 25.07 12.86 9 127213 122 79617044
Tendonitis 25.02 12.86 4 127218 23826 79593340
Carbohydrate antigen 19-9 increased 24.97 12.86 13 127209 452 79616714
Hormone receptor positive breast cancer 24.83 12.86 12 127210 355 79616811
Vasodilatation 24.83 12.86 28 127194 3163 79614003
Memory impairment 24.78 12.86 93 127129 111641 79505525
Post-traumatic neck syndrome 24.72 12.86 23 127199 2071 79615095
Haemophagocytic lymphohistiocytosis 24.49 12.86 3 127219 21834 79595332
Peripheral sensorimotor neuropathy 24.43 12.86 27 127195 2983 79614183
Neoplasm malignant 24.33 12.86 108 127114 31702 79585464
Restlessness 24.25 12.86 23 127199 46469 79570697
Eye pain 24.18 12.86 15 127207 37563 79579603
Hospitalisation 24.05 12.86 243 126979 93993 79523173
Dysgeusia 24.03 12.86 165 127057 57012 79560154
Device malfunction 23.92 12.86 3 127219 21445 79595721
Vessel puncture site bruise 23.79 12.86 13 127209 499 79616667
Drug eruption 23.79 12.86 21 127201 43914 79573252
Human epidermal growth factor receptor negative 23.75 12.86 5 127217 5 79617161
Xeroderma 23.55 12.86 11 127211 301 79616865
Malignant pleural effusion 23.52 12.86 28 127194 3352 79613814
Coma 23.49 12.86 82 127140 100567 79516599
Early satiety 23.45 12.86 19 127203 1420 79615746
Urinary tract infection 23.41 12.86 303 126919 274209 79342957
Pulmonary arterial hypertension 23.40 12.86 8 127214 28358 79588808
Incorrect dose administered 23.34 12.86 55 127167 76575 79540591
Cardiac output decreased 23.28 12.86 21 127201 1817 79615349
Necrotising oesophagitis 23.18 12.86 17 127205 1096 79616070
Failure to anastomose 23.17 12.86 10 127212 226 79616940
Pregnancy 23.16 12.86 7 127215 26844 79590322
Oral pigmentation 23.04 12.86 6 127216 24 79617142
Ileal ulcer 22.95 12.86 17 127205 1113 79616053
Poisoning 22.89 12.86 6 127216 25266 79591900
Pericardial effusion 22.85 12.86 139 127083 46098 79571068
Renal hydrocele 22.84 12.86 6 127216 25 79617141
Gastrointestinal stoma necrosis 22.84 12.86 6 127216 25 79617141
Hallucination, auditory 22.82 12.86 3 127219 20690 79596476
Injection site haemorrhage 22.75 12.86 8 127214 27862 79589304
HER2 positive breast cancer 22.71 12.86 11 127211 327 79616839
Peripheral ischaemia 22.64 12.86 48 127174 9409 79607757
Steatohepatitis 22.63 12.86 16 127206 974 79616192
Obstructive airways disorder 22.50 12.86 11 127211 31448 79585718
Product prescribing error 22.42 12.86 23 127199 44790 79572376
Right ventricular failure 22.42 12.86 5 127217 23492 79593674
Large intestinal obstruction 22.41 12.86 27 127195 3272 79613894
Vocal cord paralysis 22.38 12.86 24 127198 2563 79614603
Vein disorder 22.35 12.86 34 127188 5148 79612018
Haemorrhage intracranial 22.29 12.86 7 127215 26186 79590980
Oral pain 22.12 12.86 105 127117 31693 79585473
Lymphadenopathy mediastinal 22.09 12.86 31 127191 4365 79612801
Productive cough 21.96 12.86 70 127152 88261 79528905
Dermatomyositis 21.96 12.86 28 127194 3595 79613571
Neuroendocrine breast tumour 21.95 12.86 6 127216 30 79617136
ECG signs of myocardial ischaemia 21.88 12.86 11 127211 355 79616811
Temperature intolerance 21.80 12.86 48 127174 9657 79607509
Abdominal distension 21.79 12.86 289 126933 119361 79497805
Brachiocephalic vein thrombosis 21.77 12.86 10 127212 263 79616903
Dermatoglyphic anomaly 21.77 12.86 4 127218 0 79617166
Metastatic gastric cancer 21.71 12.86 11 127211 361 79616805
Bone marrow infiltration 21.70 12.86 14 127208 732 79616434
Blood lactate dehydrogenase abnormal 21.67 12.86 10 127212 266 79616900
Viral infection 21.61 12.86 22 127200 42994 79574172
Toxicity to various agents 21.55 12.86 510 126712 421030 79196136
Gingival bleeding 21.54 12.86 66 127156 16210 79600956
Superior vena cava syndrome 21.44 12.86 17 127205 1232 79615934
Exposed bone in jaw 21.38 12.86 28 127194 3692 79613474
Dental care 21.36 12.86 15 127207 903 79616263
Intestinal metastasis 21.33 12.86 11 127211 375 79616791
Anal prolapse 21.25 12.86 7 127215 72 79617094
Metastases to breast 21.23 12.86 10 127212 279 79616887
Blood pressure increased 21.22 12.86 225 126997 211135 79406031
Hallucination, visual 21.15 12.86 13 127209 32716 79584450
Colon cancer recurrent 21.13 12.86 8 127214 127 79617039
Amnesia 21.07 12.86 43 127179 63014 79554152
Limbal stem cell deficiency 21.04 12.86 6 127216 36 79617130
Heart rate increased 21.01 12.86 110 127112 120614 79496552
Epistaxis 20.99 12.86 271 126951 111244 79505922
Atrial fibrillation 20.96 12.86 208 127014 197678 79419488
Transaminases 20.91 12.86 7 127215 76 79617090
Pneumocystis jirovecii pneumonia 20.88 12.86 13 127209 32495 79584671
Bursitis 20.81 12.86 16 127206 35828 79581338
Portal vein thrombosis 20.70 12.86 35 127187 5792 79611374
Injection site bruising 20.56 12.86 21 127201 40981 79576185
Hyperaesthesia 20.51 12.86 54 127168 12168 79604998
Premature delivery 20.46 12.86 6 127216 23461 79593705
Inappropriate schedule of product administration 20.43 12.86 127 127095 133501 79483665
Hepatitis 20.37 12.86 36 127186 55691 79561475
Device dislocation 20.28 12.86 8 127214 25962 79591204
Tenderness 20.19 12.86 83 127139 23559 79593607
Computerised tomogram abnormal 20.10 12.86 26 127196 3387 79613779
Sputum discoloured 20.01 12.86 5 127217 21738 79595428
Stress 19.86 12.86 63 127159 79549 79537617
Ileus paralytic 19.85 12.86 46 127176 9574 79607592
Pancreatitis viral 19.83 12.86 5 127217 17 79617149
Incorrect route of product administration 19.77 12.86 16 127206 34913 79582253
Panic attack 19.68 12.86 7 127215 24209 79592957
Bone debridement 19.63 12.86 11 127211 444 79616722
Respiratory tract congestion 19.54 12.86 4 127218 19950 79597216
Perforation 19.47 12.86 17 127205 1409 79615757
Gastrointestinal disorder 19.36 12.86 288 126934 121917 79495249
Phimosis 19.36 12.86 12 127210 585 79616581
Sinus bradycardia 19.35 12.86 8 127214 25239 79591927
Onychomadesis 19.31 12.86 32 127190 5210 79611956
Breast disorder 19.24 12.86 20 127202 2061 79615105
Dyskinesia 19.16 12.86 26 127196 44747 79572419
Hepatic infarction 19.11 12.86 14 127208 901 79616265
Bronchiectasis 19.02 12.86 6 127216 22380 79594786
Brain neoplasm 18.86 12.86 33 127189 5613 79611553
Cardio-respiratory arrest 18.81 12.86 99 127123 108411 79508755
Aplastic anaemia 18.81 12.86 3 127219 17902 79599264
Neck pain 18.59 12.86 60 127162 75357 79541809
Sleep disorder 18.55 12.86 72 127150 85605 79531561
Metastases to adrenals 18.45 12.86 16 127206 1314 79615852
Adenocarcinoma metastatic 18.45 12.86 8 127214 183 79616983
Back pain 18.44 12.86 358 126864 303822 79313344
Mydriasis 18.43 12.86 3 127219 17640 79599526
Enterocolitis haemorrhagic 18.36 12.86 20 127202 2174 79614992
Eosinophilic pneumonia chronic 18.30 12.86 11 127211 507 79616659
Oropharyngeal pain 18.28 12.86 101 127121 109252 79507914
Colitis ischaemic 18.24 12.86 60 127162 15299 79601867
Intestinal dilatation 18.18 12.86 22 127200 2678 79614488
Metastases to stomach 18.12 12.86 9 127213 283 79616883
Diabetes mellitus inadequate control 18.10 12.86 8 127214 24256 79592910
Syncope 18.02 12.86 191 127031 179258 79437908
Toxic epidermal necrolysis 17.98 12.86 27 127195 44554 79572612
Retroperitoneal neoplasm metastatic 17.97 12.86 5 127217 27 79617139
Cryptitis 17.94 12.86 9 127213 289 79616877
Hypercalcaemia of malignancy 17.88 12.86 10 127212 402 79616764
No adverse event 17.87 12.86 111 127111 37081 79580085
Perineal ulceration 17.85 12.86 6 127216 66 79617100
Metastases to thorax 17.83 12.86 8 127214 199 79616967
Head injury 17.78 12.86 20 127202 37349 79579817
Restless legs syndrome 17.77 12.86 5 127217 20087 79597079
Toothache 17.76 12.86 71 127151 19899 79597267
Gastric dilatation 17.72 12.86 16 127206 1386 79615780
Peripheral swelling 17.69 12.86 313 126909 269304 79347862
Eczema impetiginous 17.67 12.86 5 127217 29 79617137
Herpangina 17.67 12.86 5 127217 29 79617137
Fistula 17.62 12.86 53 127169 12887 79604279
Pneumonitis 17.53 12.86 161 127061 60699 79556467
Product administration error 17.51 12.86 15 127207 31831 79585335
Nail avulsion 17.49 12.86 7 127215 130 79617036
Joint dislocation 17.43 12.86 3 127219 16936 79600230
Generalised tonic-clonic seizure 17.32 12.86 27 127195 43883 79573283
Renal vein thrombosis 17.31 12.86 11 127211 560 79616606
Peripheral motor neuropathy 17.30 12.86 24 127198 3343 79613823
Gastric varices haemorrhage 17.18 12.86 10 127212 434 79616732
Multiple sclerosis 17.18 12.86 7 127215 22275 79594891
Dysphonia 17.17 12.86 152 127070 56720 79560446
Gastroenteritis radiation 17.16 12.86 12 127210 718 79616448
Vertebral column mass 17.12 12.86 8 127214 219 79616947
Stridor 17.09 12.86 31 127191 5422 79611744
Peritoneal disorder 17.08 12.86 12 127210 723 79616443
Hepatic cyst 17.07 12.86 33 127189 6056 79611110
Hypersplenism 17.02 12.86 11 127211 577 79616589
Parkinsonism 16.93 12.86 3 127219 16581 79600585
Paranoia 16.88 12.86 5 127217 19427 79597739
Breast necrosis 16.87 12.86 6 127216 79 79617087
Infusion site hypoaesthesia 16.87 12.86 5 127217 35 79617131
Mechanical ileus 16.84 12.86 13 127209 906 79616260
Dermatitis 16.77 12.86 73 127149 21248 79595918
Motion sickness 16.76 12.86 13 127209 912 79616254
Gallbladder disorder 16.76 12.86 5 127217 19335 79597831
Injection site swelling 16.73 12.86 31 127191 47101 79570065
Prostatic calcification 16.54 12.86 6 127216 84 79617082
Myoclonus 16.51 12.86 12 127210 27648 79589518
Febrile neutropenia 16.50 12.86 484 126738 230515 79386651
Hand-foot-genital syndrome 16.50 12.86 4 127218 11 79617155
Vasospasm 16.46 12.86 14 127208 1120 79616046
Delusion 16.43 12.86 6 127216 20417 79596749
Respiratory disorder 16.37 12.86 29 127193 44827 79572339
Hypoxia 16.37 12.86 97 127125 103146 79514020
Urethral ulcer 16.33 12.86 3 127219 0 79617166
Dark circles under eyes 16.33 12.86 10 127212 477 79616689
Splenomegaly 16.28 12.86 71 127151 20683 79596483
Venous thrombosis limb 16.14 12.86 27 127195 4430 79612736
Metastases to spleen 16.11 12.86 11 127211 633 79616533
Hypersensitivity 16.09 12.86 308 126914 261931 79355235
Weight fluctuation 16.07 12.86 48 127174 11627 79605539
Dystonia 16.05 12.86 7 127215 21392 79595774
Lymphocyte count decreased 16.01 12.86 32 127190 47257 79569909
Radiation myelopathy 16.00 12.86 4 127218 13 79617153
Ischaemia 15.99 12.86 38 127184 8037 79609129
Gastroenteropancreatic neuroendocrine tumour disease 15.97 12.86 5 127217 43 79617123
Periodontitis 15.96 12.86 27 127195 4469 79612697
Hyperglycaemic hyperosmolar nonketotic syndrome 15.89 12.86 19 127203 2284 79614882
Subdural haematoma 15.88 12.86 16 127206 31418 79585748
Acute generalised exanthematous pustulosis 15.81 12.86 4 127218 17250 79599916
Brain operation 15.79 12.86 11 127211 654 79616512
Hand dermatitis 15.78 12.86 9 127213 376 79616790
Hyperchlorhydria 15.76 12.86 18 127204 2061 79615105
Sinus congestion 15.75 12.86 6 127216 19890 79597276
Mood swings 15.73 12.86 6 127216 19874 79597292
Biliary fistula 15.64 12.86 6 127216 99 79617067
Bronchopulmonary aspergillosis 15.63 12.86 8 127214 22286 79594880
Hypoacusis 15.63 12.86 15 127207 30135 79587031
Diverticulitis 15.62 12.86 31 127191 45905 79571261
Pancreatic fistula 15.58 12.86 6 127216 100 79617066
Irritability 15.57 12.86 26 127196 41118 79576048
Tumour invasion 15.46 12.86 9 127213 391 79616775
International normalised ratio increased 15.42 12.86 76 127146 84645 79532521
Lung neoplasm malignant 15.39 12.86 13 127209 27779 79589387
Liver scan abnormal 15.39 12.86 5 127217 49 79617117
Drug intolerance 15.36 12.86 313 126909 263806 79353360
Metastases to bladder 15.34 12.86 8 127214 279 79616887
Cough 15.26 12.86 457 126765 366332 79250834
Acral peeling skin syndrome 15.21 12.86 5 127217 51 79617115
Nail bed inflammation 15.21 12.86 10 127212 540 79616626
Peripheral coldness 15.19 12.86 58 127164 15912 79601254
Ventricular fibrillation 15.16 12.86 95 127127 31831 79585335
Procedural pain 15.15 12.86 9 127213 23075 79594091
Kidney infection 15.09 12.86 8 127214 21843 79595323
Malignant peritoneal neoplasm 15.08 12.86 11 127211 703 79616463
Therapy non-responder 15.02 12.86 86 127136 92219 79524947
Torsade de pointes 15.00 12.86 6 127216 19306 79597860
Chemical peritonitis 14.98 12.86 8 127214 293 79616873
Appendicitis noninfective 14.98 12.86 4 127218 18 79617148
Femoral artery embolism 14.96 12.86 5 127217 54 79617112
Limb injury 14.95 12.86 15 127207 29513 79587653
Radiation fibrosis - lung 14.88 12.86 5 127217 55 79617111
Peritoneal fluid analysis abnormal 14.88 12.86 5 127217 55 79617111
Ataxia 14.82 12.86 79 127143 24960 79592206
Liver abscess 14.81 12.86 31 127191 6023 79611143
Cerebral infarction 14.80 12.86 124 127098 45552 79571614
Schistosomiasis 14.79 12.86 5 127217 56 79617110
Blood alkaline phosphatase increased 14.75 12.86 161 127061 63503 79553663
Electrolyte imbalance 14.73 12.86 92 127130 30789 79586377
Hyperbaric oxygen therapy 14.71 12.86 5 127217 57 79617109
Adenocarcinoma 14.69 12.86 24 127198 3862 79613304
Blood creatine phosphokinase increased 14.66 12.86 55 127167 66035 79551131
Osteolysis 14.65 12.86 26 127196 4472 79612694
Rectal neoplasm 14.64 12.86 5 127217 58 79617108
Chemotherapy cardiotoxicity attenuation 14.63 12.86 4 127218 20 79617146
Proctalgia 14.61 12.86 42 127180 9959 79607207
Pharyngeal ulceration 14.60 12.86 13 127209 1106 79616060
Actinomycosis 14.60 12.86 13 127209 1106 79616060
Anhedonia 14.56 12.86 3 127219 14895 79602271
Botryomycosis 14.56 12.86 5 127217 59 79617107
Breast neoplasm 14.55 12.86 12 127210 920 79616246
Axonal and demyelinating polyneuropathy 14.47 12.86 4 127218 21 79617145
Angina pectoris 14.47 12.86 136 127086 51596 79565570
Oesophageal varices haemorrhage 14.46 12.86 25 127197 4211 79612955
Folate deficiency 14.43 12.86 22 127200 3338 79613828
Laryngeal discomfort 14.42 12.86 10 127212 590 79616576
Insulinoma 14.31 12.86 6 127216 126 79617040
Metaplastic breast carcinoma 14.25 12.86 3 127219 3 79617163
Increased liver stiffness 14.25 12.86 3 127219 3 79617163
Abdominal fat apron 14.25 12.86 3 127219 3 79617163
Calcium ionised increased 14.24 12.86 7 127215 215 79616951
Vulval disorder 14.15 12.86 10 127212 608 79616558
Nephrolithiasis 14.13 12.86 41 127181 53250 79563916
Pleural disorder 14.10 12.86 12 127210 961 79616205
Head discomfort 14.01 12.86 3 127219 14499 79602667
Haemolytic anaemia 14.00 12.86 61 127161 17759 79599407
Respiratory tract infection 14.00 12.86 36 127186 48653 79568513
Gastrointestinal injury 13.99 12.86 12 127210 971 79616195
Tongue discolouration 13.99 12.86 23 127199 3720 79613446
Enterovesical fistula 13.98 12.86 13 127209 1169 79615997
Gastrointestinal oedema 13.96 12.86 19 127203 2599 79614567
Herpes zoster 13.95 12.86 89 127133 92994 79524172
Haematemesis 13.93 12.86 136 127086 52128 79565038
Scleroderma-like reaction 13.93 12.86 6 127216 135 79617031
Hydronephrosis 13.91 12.86 60 127162 17394 79599772
Rectal cancer recurrent 13.89 12.86 4 127218 25 79617141
Hypothalamo-pituitary disorder 13.87 12.86 13 127209 1181 79615985
Skin sensitisation 13.86 12.86 12 127210 983 79616183
Colorectal cancer recurrent 13.85 12.86 5 127217 69 79617097
Miosis 13.83 12.86 4 127218 15785 79601381
Formication 13.81 12.86 27 127195 4996 79612170
Radioisotope scan 13.79 12.86 3 127219 4 79617162
Hyperchylomicronaemia 13.79 12.86 3 127219 4 79617162
Gastrointestinal wall thickening 13.74 12.86 19 127203 2638 79614528
Cytomegalovirus enterocolitis 13.70 12.86 15 127207 1640 79615526
Pallor 13.65 12.86 38 127184 50024 79567142
Metastases to muscle 13.65 12.86 8 127214 352 79616814
Orthostatic hypotension 13.62 12.86 45 127177 56119 79561047
Pituitary tumour 13.62 12.86 13 127209 1209 79615957
Vasculitis 13.59 12.86 12 127210 25090 79592076
Blood lactate dehydrogenase increased 13.59 12.86 108 127114 39062 79578104
Nail toxicity 13.59 12.86 8 127214 355 79616811
Haemodialysis 13.54 12.86 6 127216 18162 79599004
Periportal sinus dilatation 13.53 12.86 6 127216 145 79617021
Duodenal perforation 13.50 12.86 17 127205 2155 79615011
Fungal infection 13.50 12.86 29 127193 41719 79575447
Paraneoplastic dermatomyositis 13.47 12.86 5 127217 75 79617091
Radiation injury 13.46 12.86 11 127211 832 79616334
Coagulopathy 13.45 12.86 101 127121 35905 79581261
Muscle swelling 13.44 12.86 11 127211 834 79616332
Ureteric obstruction 13.42 12.86 19 127203 2697 79614469
Abdominal wall oedema 13.39 12.86 3 127219 5 79617161
Acute hepatic failure 13.39 12.86 17 127205 30096 79587070
Post procedural diarrhoea 13.38 12.86 10 127212 664 79616502
Squamous cell carcinoma of skin 13.36 12.86 3 127219 14030 79603136
Subclavian vein thrombosis 13.36 12.86 18 127204 2439 79614727
Staphylococcal infection 13.26 12.86 48 127174 58247 79558919
Sequestrectomy 13.25 12.86 11 127211 851 79616315
Influenza like illness 13.24 12.86 64 127158 71643 79545523
Urinary tract stoma complication 13.17 12.86 5 127217 80 79617086
Hemianopia 13.17 12.86 15 127207 1713 79615453
Night sweats 13.15 12.86 41 127181 52054 79565112
Skin disorder 13.12 12.86 96 127126 33847 79583319
Hepatitis cholestatic 13.11 12.86 3 127219 13849 79603317
Seizure 13.10 12.86 217 127005 188617 79428549
Onychoclasis 13.00 12.86 28 127194 5550 79611616
Gastric disorder 12.96 12.86 25 127197 37408 79579758

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
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
108761006 SNOMEDCT_US
386906001 SNOMEDCT_US
4021099 VANDF
007533 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1100 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1100 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1101 TABLET, FILM COATED 500 mg ORAL NDA 36 sections
Xeloda HUMAN PRESCRIPTION DRUG LABEL 1 0004-1101 TABLET, FILM COATED 500 mg ORAL NDA 36 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0271 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0272 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0272 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0272 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0272 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7473 TABLET, FILM COATED 150 mg ORAL ANDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7473 TABLET, FILM COATED 150 mg ORAL ANDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7474 TABLET, FILM COATED 500 mg ORAL ANDA 29 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 0093-7474 TABLET, FILM COATED 500 mg ORAL ANDA 29 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 31 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-072 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-073 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections
CAPECITABINE HUMAN PRESCRIPTION DRUG LABEL 1 16729-073 TABLET, FILM COATED 500 mg ORAL ANDA 31 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 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-095 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-095 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Capecitabine HUMAN PRESCRIPTION DRUG LABEL 1 51407-096 TABLET, FILM COATED 500 mg ORAL ANDA 31 sections