capecitabine ๐Ÿถ 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 30, 1998 FDA HOFFMANN LA ROCHE
April 16, 2003 PMDA CHUGAI PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Palmar-plantar erythrodysaesthesia syndrome 7362.06 12.75 2375 99604 17723 50485422
Disease progression 3100.19 12.75 2091 99888 93775 50409370
Diarrhoea 2265.44 12.75 4140 97839 584336 49918809
Malignant neoplasm progression 2057.15 12.75 1426 100553 66698 50436447
Metastases to liver 1365.90 12.75 710 101269 19394 50483751
Metastases to bone 1163.86 12.75 615 101364 17380 50485765
Death 1072.35 12.75 2152 99827 323227 50179918
Mucosal inflammation 1023.45 12.75 759 101220 39383 50463762
Metastases to central nervous system 702.28 12.75 376 101603 10906 50492239
Metastases to lung 646.16 12.75 353 101626 10667 50492478
Breast cancer metastatic 536.75 12.75 306 101673 10058 50493087
Vomiting 471.96 12.75 2004 99975 458754 50044391
Neuropathy peripheral 455.52 12.75 749 101230 96008 50407137
Neutropenia 446.45 12.75 946 101033 147019 50356126
Drug ineffective 435.08 12.75 614 101365 818719 49684426
Neoplasm progression 426.55 12.75 400 101579 28757 50474388
Metastases to lymph nodes 400.70 12.75 221 101758 6803 50496342
Dehydration 394.84 12.75 917 101062 151532 50351613
Rheumatoid arthritis 391.25 12.75 3 101976 202547 50300598
Stomatitis 382.67 12.75 712 101267 100632 50402513
Skin exfoliation 355.71 12.75 387 101592 33225 50469920
Nausea 309.38 12.75 2448 99531 702950 49800195
Bone marrow failure 308.00 12.75 327 101652 27297 50475848
Joint swelling 296.31 12.75 66 101913 245220 50257925
Gastrointestinal toxicity 294.15 12.75 157 101822 4520 50498625
Skin fissures 293.09 12.75 195 101784 8473 50494672
Neurotoxicity 289.28 12.75 239 101740 14501 50488644
Skin toxicity 267.82 12.75 139 101840 3774 50499371
Metastases to skin 264.44 12.75 101 101878 1282 50501863
Contraindicated product administered 263.60 12.75 8 101971 148950 50354195
Paronychia 258.67 12.75 143 101836 4421 50498724
Maternal exposure during pregnancy 249.66 12.75 19 101960 159759 50343386
Systemic lupus erythematosus 247.21 12.75 8 101971 140614 50362531
Condition aggravated 244.81 12.75 148 101831 296910 50206235
Decreased appetite 242.94 12.75 922 101057 200001 50303144
Completed suicide 241.25 12.75 5 101974 131884 50371261
Arthralgia 229.40 12.75 331 101648 438371 50064774
Dry skin 224.43 12.75 350 101629 42841 50460304
Arthropathy 222.57 12.75 28 101951 157878 50345267
Arteriospasm coronary 221.86 12.75 117 101862 3285 50499860
Drug hypersensitivity 221.24 12.75 115 101864 250895 50252250
Osteonecrosis of jaw 220.60 12.75 299 101680 32227 50470918
Myelosuppression 220.15 12.75 197 101782 13320 50489825
Thrombocytopenia 218.89 12.75 659 101320 127014 50376131
Metastasis 207.42 12.75 122 101857 4253 50498892
Haematotoxicity 202.55 12.75 150 101829 7745 50495400
Breast cancer 198.84 12.75 330 101649 42560 50460585
Enteritis 191.00 12.75 138 101841 6857 50496288
Sinusitis 182.91 12.75 58 101921 170500 50332645
Exposure during pregnancy 181.84 12.75 17 101962 120998 50382147
Skin discolouration 179.36 12.75 272 101707 32485 50470660
Tumour marker increased 179.21 12.75 106 101873 3734 50499411
Therapeutic product effect decreased 178.08 12.75 30 101949 136020 50367125
Cardiotoxicity 174.67 12.75 131 101848 6896 50496249
Laryngospasm 174.02 12.75 92 101887 2596 50500549
Fall 167.77 12.75 260 101719 334672 50168473
Glossodynia 166.50 12.75 19 101960 115550 50387595
Dihydropyrimidine dehydrogenase deficiency 163.84 12.75 37 101942 44 50503101
Ascites 150.48 12.75 264 101715 35597 50467548
Metastases to peritoneum 144.91 12.75 83 101896 2750 50500395
Weight increased 143.20 12.75 118 101861 201773 50301372
Asthenia 142.37 12.75 1114 100865 317928 50185217
Pseudocirrhosis 142.34 12.75 52 101927 578 50502567
Pleural effusion 140.95 12.75 422 101557 81032 50422113
Product use issue 139.92 12.75 63 101916 149412 50353733
Metastases to pleura 139.70 12.75 63 101916 1243 50501902
Treatment failure 138.56 12.75 52 101927 137585 50365560
Therapy cessation 138.18 12.75 213 101766 25798 50477347
Osteonecrosis 137.73 12.75 197 101782 22320 50480825
Nail disorder 137.73 12.75 131 101848 9577 50493568
PIK3CA-activated mutation 133.10 12.75 53 101926 757 50502388
Musculoskeletal stiffness 130.24 12.75 48 101931 128433 50374712
Metastases to spine 129.12 12.75 77 101902 2754 50500391
Metastatic neoplasm 123.40 12.75 83 101896 3671 50499474
Psoriasis 120.94 12.75 4 101975 68996 50434149
Hepatic function abnormal 117.42 12.75 225 101754 32456 50470689
Wound 115.11 12.75 35 101944 105759 50397386
Lymphangiosis carcinomatosa 113.22 12.75 53 101926 1143 50502002
Swelling 112.30 12.75 144 101835 200728 50302417
Headache 111.60 12.75 584 101395 505951 49997194
Hepatic lesion 111.54 12.75 80 101899 3928 50499217
Drug interaction 108.62 12.75 146 101833 199475 50303670
Onycholysis 107.94 12.75 53 101926 1275 50501870
Breast cancer recurrent 105.96 12.75 76 101903 3732 50499413
Hospice care 105.81 12.75 90 101889 5682 50497463
Pain 104.56 12.75 711 101268 578192 49924953
Ejection fraction decreased 103.09 12.75 155 101824 18365 50484780
Injection site pain 100.47 12.75 49 101930 110975 50392170
Pericarditis 99.36 12.75 19 101960 78670 50424475
Blood bilirubin increased 98.83 12.75 207 101772 31831 50471314
Carbohydrate antigen 15-3 increased 97.49 12.75 47 101932 1085 50502060
Abdominal discomfort 96.79 12.75 201 101778 231440 50271705
Pruritus 96.48 12.75 274 101705 283294 50219851
Arthritis 95.59 12.75 28 101951 86693 50416452
Infusion related reaction 94.28 12.75 122 101857 169435 50333710
Overdose 90.26 12.75 44 101935 99683 50403462
Pneumonia 89.67 12.75 425 101554 377976 50125169
Discomfort 89.08 12.75 54 101925 108326 50394819
Carcinoembryonic antigen increased 88.54 12.75 48 101931 1426 50501719
Jaundice 87.71 12.75 176 101803 26253 50476892
Bone lesion 87.46 12.75 77 101902 5093 50498052
Depression 86.95 12.75 124 101855 165299 50337846
Bronchitis 86.87 12.75 51 101928 104108 50399037
Paraesthesia 86.62 12.75 474 101505 119769 50383376
Influenza 86.51 12.75 36 101943 89502 50413643
Hyperbilirubinaemia 85.55 12.75 101 101878 9469 50493676
Intestinal obstruction 84.35 12.75 173 101806 26210 50476935
Irritable bowel syndrome 83.55 12.75 5 101974 51436 50451709
Polyneuropathy 82.95 12.75 112 101867 12019 50491126
Lower respiratory tract infection 81.70 12.75 45 101934 95156 50407989
Intentional overdose 81.26 12.75 14 101965 62490 50440655
Bradycardia 80.40 12.75 16 101963 64410 50438735
Therapeutic product effect incomplete 80.38 12.75 42 101937 91473 50411672
Febrile neutropenia 75.78 12.75 393 101586 97274 50405871
Urticaria 74.32 12.75 91 101888 129470 50373675
Osteoarthritis 74.07 12.75 23 101956 68583 50434562
Abdominal lymphadenopathy 73.32 12.75 33 101946 648 50502497
Leukopenia 71.01 12.75 297 101682 67231 50435914
Nasopharyngitis 70.39 12.75 180 101799 192747 50310398
Asthma 70.00 12.75 47 101932 89290 50413855
Non-cirrhotic portal hypertension 69.66 12.75 22 101957 150 50502995
Duodenal ulcer perforation 69.58 12.75 6 101973 45605 50457540
Infusion site coldness 68.90 12.75 23 101956 191 50502954
Colitis 68.86 12.75 202 101777 38327 50464818
Dysaesthesia pharynx 68.64 12.75 21 101958 127 50503018
Ileus 68.39 12.75 107 101872 13122 50490023
Fibromyalgia 68.38 12.75 6 101973 44972 50458173
Metastases to meninges 67.57 12.75 45 101934 1957 50501188
Fingerprint loss 66.81 12.75 15 101964 17 50503128
Suicidal ideation 66.55 12.75 15 101964 55370 50447775
Bone pain 65.58 12.75 227 101752 47002 50456143
Metastases to the mediastinum 64.40 12.75 27 101952 443 50502702
Metastases to chest wall 63.97 12.75 27 101952 451 50502694
Neoplasm malignant 63.77 12.75 145 101834 23570 50479575
Injection site erythema 63.46 12.75 36 101943 74900 50428245
Hypokalaemia 63.43 12.75 347 101632 87645 50415500
Enterocolitis 63.21 12.75 72 101907 6495 50496650
Abortion spontaneous 62.36 12.75 6 101973 41766 50461379
Suicide attempt 62.18 12.75 14 101965 51718 50451427
Hypersensitivity 61.21 12.75 225 101754 214936 50288209
Gastrointestinal perforation 60.81 12.75 50 101929 3011 50500134
Gamma-glutamyltransferase decreased 60.49 12.75 23 101956 288 50502857
Mobility decreased 60.07 12.75 44 101935 79904 50423241
Bone disorder 59.99 12.75 123 101856 18629 50484516
Nail discolouration 58.76 12.75 44 101935 2310 50500835
Somnolence 58.54 12.75 142 101837 154843 50348302
Portal hypertension 58.34 12.75 51 101928 3341 50499804
Tooth extraction 57.85 12.75 81 101898 8994 50494151
Feeling abnormal 55.70 12.75 105 101874 125387 50377758
Loss of personal independence in daily activities 54.67 12.75 37 101942 70013 50433132
Insomnia 53.66 12.75 177 101802 174688 50328457
Therapy change 53.22 12.75 59 101920 5166 50497979
Chronic obstructive pulmonary disease 52.39 12.75 21 101958 53414 50449731
Product use in unapproved indication 52.20 12.75 96 101883 115723 50387422
Metastases to adrenals 51.39 12.75 26 101953 668 50502477
Hypotension 51.35 12.75 272 101707 235197 50267948
Plasma cell myeloma 51.00 12.75 3 101976 31319 50471826
Hepatic failure 50.90 12.75 162 101817 32121 50471024
Intestinal perforation 50.38 12.75 82 101897 10397 50492748
Hypoalbuminaemia 49.93 12.75 79 101900 9781 50493364
Product dose omission issue 49.20 12.75 197 101782 183641 50319504
Pulmonary embolism 49.00 12.75 362 101617 101342 50401803
Jaw operation 48.53 12.75 26 101953 754 50502391
Wheezing 48.12 12.75 33 101946 62014 50441131
General physical health deterioration 47.50 12.75 467 101512 141967 50361178
Chronic kidney disease 47.32 12.75 11 101968 39760 50463385
Nasal congestion 47.08 12.75 22 101957 51098 50452047
Cardiac failure congestive 46.57 12.75 61 101918 84321 50418824
Alopecia 46.52 12.75 296 101683 244751 50258394
Hepatic enzyme increased 46.44 12.75 133 101846 137247 50365898
Intentional product misuse 46.42 12.75 18 101961 46716 50456429
Erythema 46.39 12.75 475 101504 145939 50357206
Device related thrombosis 45.62 12.75 30 101949 1277 50501868
Abdominal pain 45.03 12.75 697 101282 235531 50267614
Skin hyperpigmentation 44.40 12.75 54 101925 5222 50497923
Neoplasm 44.03 12.75 57 101922 5871 50497274
Oxygen saturation decreased 43.53 12.75 50 101929 73198 50429947
Debridement 43.45 12.75 28 101951 1151 50501994
Lymphoedema 43.34 12.75 71 101908 9051 50494094
Leukoencephalopathy 43.31 12.75 46 101933 3837 50499308
Hyperhidrosis 43.14 12.75 71 101908 89355 50413790
Hypoaesthesia 42.79 12.75 418 101561 126839 50376306
Platelet count decreased 42.69 12.75 348 101631 100378 50402767
Lacrimation increased 42.51 12.75 101 101878 16891 50486254
Blood pressure fluctuation 42.44 12.75 10 101969 35813 50467332
Peripheral sensory neuropathy 42.27 12.75 59 101920 6532 50496613
Drug intolerance 41.91 12.75 264 101715 218840 50284305
Pyogenic granuloma 41.17 12.75 17 101962 268 50502877
Wrong technique in product usage process 41.11 12.75 31 101948 55479 50447666
Osteolysis 41.10 12.75 37 101942 2520 50500625
Migraine 40.95 12.75 55 101924 75225 50427920
Folliculitis 40.83 12.75 14 101965 39211 50463934
Nail infection 40.70 12.75 33 101946 1948 50501197
Angina bullosa haemorrhagica 40.56 12.75 14 101965 130 50503015
Blood uric acid decreased 40.38 12.75 22 101957 660 50502485
Drug reaction with eosinophilia and systemic symptoms 40.10 12.75 5 101974 28419 50474726
Pericardial effusion 39.97 12.75 128 101851 25461 50477684
Recurrent cancer 39.80 12.75 31 101948 1726 50501419
Performance status decreased 39.51 12.75 40 101939 3155 50499990
Bone sequestrum 39.48 12.75 28 101951 1350 50501795
Agitation 39.30 12.75 30 101949 53354 50449791
Mucosal toxicity 39.17 12.75 17 101962 305 50502840
Colon cancer metastatic 39.07 12.75 25 101954 1015 50502130
Disseminated intravascular coagulation 38.78 12.75 98 101881 17037 50486108
Plantar erythema 38.07 12.75 15 101964 208 50502937
Blood glucose increased 37.90 12.75 53 101926 71271 50431874
Urinary tract infection 37.37 12.75 281 101698 223739 50279406
Cardiac output decreased 37.24 12.75 23 101956 877 50502268
Rhabdomyolysis 37.19 12.75 16 101963 39011 50464134
Hyperkalaemia 36.73 12.75 26 101953 48063 50455082
Acute kidney injury 36.66 12.75 289 101690 227769 50275376
Cold dysaesthesia 36.14 12.75 8 101971 8 50503137
Osteoporosis 35.97 12.75 23 101956 44856 50458289
Ejection fraction 35.82 12.75 25 101954 1175 50501970
Malignant ascites 35.81 12.75 22 101957 831 50502314
Cataract 35.57 12.75 26 101953 47274 50455871
Infusion site induration 35.34 12.75 22 101957 851 50502294
Dysaesthesia 34.35 12.75 40 101939 3695 50499450
Pharyngeal inflammation 34.20 12.75 19 101960 593 50502552
Hypovolaemic shock 34.11 12.75 47 101932 5141 50498004
Anxiety 33.95 12.75 214 101765 177392 50325753
Necrotising oesophagitis 33.75 12.75 11 101968 84 50503061
Periodontitis 33.60 12.75 36 101943 3033 50500112
Eosinophil percentage increased 33.46 12.75 22 101957 936 50502209
Gingival bleeding 33.44 12.75 72 101907 11281 50491864
Mouth ulceration 33.24 12.75 128 101851 27896 50475249
Exposed bone in jaw 32.71 12.75 34 101945 2766 50500379
Blood creatinine decreased 32.59 12.75 45 101934 4931 50498214
Proteinuria 32.55 12.75 90 101889 16507 50486638
Blood cholesterol increased 32.47 12.75 38 101941 55177 50447968
Therapy partial responder 32.26 12.75 52 101927 6539 50496606
Nodular regenerative hyperplasia 31.91 12.75 14 101965 258 50502887
Drug ineffective for unapproved indication 31.91 12.75 3 101976 21278 50481867
Radiation necrosis 31.85 12.75 15 101964 328 50502817
Adverse event 31.70 12.75 25 101954 43738 50459407
Hiccups 31.64 12.75 27 101952 1712 50501433
Metastases to ovary 31.56 12.75 15 101964 335 50502810
Superior vena cava syndrome 31.54 12.75 18 101961 592 50502553
Premature delivery 31.42 12.75 5 101974 23658 50479487
Ear infection 31.26 12.75 7 101972 25963 50477182
Brachiocephalic vein thrombosis 31.20 12.75 10 101969 72 50503073
Onychomadesis 31.08 12.75 37 101942 3499 50499646
Contusion 30.76 12.75 119 101860 112064 50391081
Therapy interrupted 30.74 12.75 100 101879 20052 50483093
Tumour pain 30.72 12.75 23 101956 1207 50501938
Lymphadenopathy 30.38 12.75 141 101838 33358 50469787
Loss of consciousness 30.38 12.75 108 101871 104245 50398900
Accidental exposure to product 30.33 12.75 5 101974 23052 50480093
Sedation 30.05 12.75 12 101967 30598 50472547
Blood pressure systolic increased 30.05 12.75 17 101962 35432 50467713
Foetal exposure during pregnancy 29.83 12.75 9 101970 27350 50475795
Hydronephrosis 29.68 12.75 58 101921 8483 50494662
Toothache 29.63 12.75 88 101891 16806 50486339
Sopor 29.29 12.75 3 101976 19876 50483269
Confusional state 29.23 12.75 237 101742 185691 50317454
Pigmentation disorder 29.22 12.75 37 101942 3727 50499418
Hypophagia 29.16 12.75 122 101857 27606 50475539
Anastomotic leak 29.11 12.75 15 101964 401 50502744
Central nervous system lesion 28.89 12.75 61 101918 9428 50493717
Abnormal behaviour 28.88 12.75 3 101976 19655 50483490
Myocardial infarction 28.76 12.75 88 101891 88939 50414206
Malignant pleural effusion 28.50 12.75 29 101950 2301 50500844
Biliary sepsis 28.43 12.75 19 101960 831 50502314
Injury 28.42 12.75 34 101945 48891 50454254
Pregnancy 28.38 12.75 12 101967 29565 50473580
Cachexia 28.21 12.75 40 101939 4493 50498652
Injection site bruising 27.92 12.75 20 101959 36748 50466397
Subacute cutaneous lupus erythematosus 27.88 12.75 28 101951 2187 50500958
Anastomotic fistula 27.87 12.75 7 101972 17 50503128
Pulmonary mass 27.80 12.75 92 101887 18613 50484532
Human epidermal growth factor receptor negative 27.63 12.75 6 101973 5 50503140
Varices oesophageal 27.56 12.75 31 101948 2758 50500387
Peripheral swelling 27.35 12.75 274 101705 205662 50297483
Cheilitis 27.26 12.75 35 101944 3575 50499570
Bone debridement 27.02 12.75 12 101967 228 50502917
Nervousness 26.89 12.75 11 101968 27640 50475505
Stress cardiomyopathy 26.73 12.75 53 101926 7834 50495311
Sequestrectomy 26.72 12.75 18 101961 798 50502347
Hypervolaemia 26.72 12.75 9 101970 25490 50477655
Pancreatic fistula 26.63 12.75 6 101973 7 50503138
Asthenopia 26.54 12.75 26 101953 1971 50501174
Neoplasm recurrence 26.31 12.75 28 101951 2341 50500804
Colorectal cancer metastatic 26.10 12.75 15 101964 500 50502645
Constipation 26.06 12.75 522 101457 185186 50317959
Heart rate increased 25.94 12.75 75 101904 77175 50425970
Multiple sclerosis 25.75 12.75 5 101974 20488 50482657
Incorrect dose administered 25.69 12.75 36 101943 48378 50454767
Dermatitis acneiform 25.54 12.75 36 101943 4021 50499124
Pneumatosis intestinalis 25.41 12.75 26 101953 2077 50501068
Atrial fibrillation 25.35 12.75 112 101867 101633 50401512
Vessel puncture site bruise 25.21 12.75 13 101966 348 50502797
Early satiety 25.21 12.75 17 101962 755 50502390
Injection site haemorrhage 25.20 12.75 6 101973 21340 50481805
Tooth erosion 25.20 12.75 14 101965 437 50502708
White blood cell count decreased 25.18 12.75 352 101627 116370 50386775
Gastric perforation 25.08 12.75 22 101957 1448 50501697
Recall phenomenon 25.04 12.75 15 101964 541 50502604
Treatment noncompliance 24.79 12.75 15 101964 30135 50473010
Vascular pain 24.63 12.75 16 101963 667 50502478
Fluid retention 24.62 12.75 40 101939 50609 50452536
Respiratory arrest 24.57 12.75 15 101964 29994 50473151
Granulocyte count decreased 24.54 12.75 17 101962 789 50502356
Tumour perforation 24.48 12.75 9 101970 102 50503043
Product quality issue 24.48 12.75 16 101963 30842 50472303
Stridor 24.37 12.75 31 101948 3138 50500007
Limbal stem cell deficiency 24.37 12.75 6 101973 13 50503132
Ataxia 24.36 12.75 72 101907 13714 50489431
Steatohepatitis 24.35 12.75 14 101965 467 50502678
Adnexa uteri mass 24.33 12.75 14 101965 468 50502677
Hyperaesthesia 24.26 12.75 52 101927 8121 50495024
Hormone receptor positive breast cancer 24.22 12.75 14 101965 472 50502673
Unresponsive to stimuli 24.10 12.75 16 101963 30593 50472552
Failure to anastomose 24.06 12.75 6 101973 14 50503131
Pleural neoplasm 23.81 12.75 11 101968 230 50502915
Acute coronary syndrome 23.75 12.75 56 101923 9318 50493827
Oesophagitis 23.74 12.75 70 101909 13313 50489832
Vasodilatation 23.67 12.75 26 101953 2253 50500892
Arterial thrombosis 23.59 12.75 20 101959 1257 50501888
Ingrowing nail 23.55 12.75 24 101955 1908 50501237
Adenocarcinoma 23.54 12.75 27 101952 2454 50500691
Radiation skin injury 23.50 12.75 17 101962 846 50502299
Depressed level of consciousness 23.45 12.75 43 101936 51910 50451235
Pulmonary arterial hypertension 23.43 12.75 6 101973 20313 50482832
Neutrophil count decreased 23.40 12.75 166 101813 45860 50457285
Dysphagia 23.35 12.75 249 101730 77269 50425876
Brain operation 23.27 12.75 14 101965 509 50502636
Pulmonary hypertension 23.07 12.75 20 101959 33397 50469748
Metastases to eye 22.96 12.75 9 101970 123 50503022
Staphylococcal infection 22.61 12.75 23 101956 35593 50467552
Schistosomiasis 22.59 12.75 5 101974 5 50503140
Increased liver stiffness 22.59 12.75 5 101974 5 50503140
Hepatic atrophy 22.39 12.75 11 101968 265 50502880
Dental care 22.33 12.75 17 101962 915 50502230
Transaminases 22.30 12.75 8 101971 84 50503061
Joint injury 22.29 12.75 8 101971 21781 50481364
Nightmare 22.28 12.75 3 101976 16083 50487062
Motion sickness 22.26 12.75 16 101963 788 50502357
Cholangitis 22.24 12.75 36 101943 4543 50498602
Irritability 22.19 12.75 15 101964 28411 50474734
Blood lactate dehydrogenase increased 22.10 12.75 88 101891 19474 50483671
Fatigue 22.05 12.75 1682 100297 705919 49797226
Post-traumatic neck syndrome 21.97 12.75 23 101956 1887 50501258
Right ventricular failure 21.93 12.75 3 101976 15890 50487255
Pulpitis dental 21.75 12.75 16 101963 817 50502328
Vertebral column mass 21.73 12.75 9 101970 143 50503002
Oral pigmentation 21.68 12.75 5 101974 7 50503138
Brain neoplasm 21.60 12.75 32 101947 3741 50499404
Diverticulitis 21.56 12.75 21 101958 33161 50469984
Foot deformity 21.53 12.75 6 101973 19204 50483941
Muscle swelling 21.50 12.75 12 101967 378 50502767
Caesarean section 21.46 12.75 3 101976 15636 50487509
Nephrolithiasis 21.35 12.75 23 101956 34670 50468475
Dermatomyositis 21.32 12.75 24 101955 2137 50501008
Cytomegalovirus infection 21.30 12.75 5 101974 17957 50485188
Gingivitis 21.23 12.75 46 101933 7238 50495907
Body temperature decreased 21.20 12.75 77 101902 16318 50486827
Disturbance in attention 21.13 12.75 19 101960 31167 50471978
Inappropriate schedule of product administration 21.13 12.75 74 101905 71757 50431388
Breast neoplasm 21.10 12.75 19 101960 1294 50501851
Biliary obstruction 20.97 12.75 25 101954 2368 50500777
Epistaxis 20.95 12.75 209 101770 63745 50439400
Oral toxicity 20.84 12.75 4 101975 0 50503145
Radiation myelopathy 20.84 12.75 4 101975 0 50503145
Computerised tomogram abnormal 20.77 12.75 23 101956 2011 50501134
Myalgia 20.67 12.75 156 101823 124163 50378982
Lactic acidosis 20.66 12.75 22 101957 33333 50469812
No adverse event 20.64 12.75 127 101852 33451 50469694
Hand-foot-and-mouth disease 20.50 12.75 8 101971 108 50503037
Injection site swelling 20.29 12.75 33 101946 41740 50461405
Oral pain 20.27 12.75 102 101877 24931 50478214
Coronary artery disease 20.27 12.75 18 101961 29708 50473437
Acute respiratory failure 20.15 12.75 17 101962 28765 50474380
ECG signs of myocardial ischaemia 20.09 12.75 7 101972 67 50503078
Hip arthroplasty 20.07 12.75 19 101960 30410 50472735
Crying 20.05 12.75 8 101971 20408 50482737
Hepatic cancer metastatic 20.01 12.75 11 101968 336 50502809
Lymphadenopathy mediastinal 20.00 12.75 25 101954 2486 50500659
Respiratory disorder 19.96 12.75 20 101959 31167 50471978
Type 2 diabetes mellitus 19.84 12.75 24 101955 34351 50468794
Congestive cardiomyopathy 19.82 12.75 38 101941 5480 50497665
Evans syndrome 19.75 12.75 9 101970 182 50502963
Gait disturbance 19.73 12.75 200 101779 149805 50353340
Subileus 19.67 12.75 26 101953 2733 50500412
Acute myeloid leukaemia 19.66 12.75 71 101908 15003 50488142
Metastases to stomach 19.66 12.75 9 101970 184 50502961
Prescribed overdose 19.58 12.75 3 101976 14597 50488548
Oncologic complication 19.50 12.75 8 101971 124 50503021
Blood pressure increased 19.43 12.75 173 101806 132959 50370186
Ankle fracture 19.41 12.75 4 101975 15718 50487427
Diabetes mellitus 19.23 12.75 44 101935 48989 50454156
Metastases to breast 19.21 12.75 10 101969 273 50502872
Cardio-respiratory arrest 19.07 12.75 51 101928 53841 50449304
Eosinophilia 18.83 12.75 7 101972 18645 50484500
Odynophagia 18.75 12.75 41 101938 6491 50496654
Hyperglycaemic hyperosmolar nonketotic syndrome 18.70 12.75 13 101966 607 50502538
Mucosal disorder 18.62 12.75 21 101958 1874 50501271
Paraneoplastic dermatomyositis 18.60 12.75 4 101975 3 50503142
Disease recurrence 18.56 12.75 85 101894 19996 50483149
Thrombosis 18.55 12.75 183 101796 55650 50447495
Diarrhoea haemorrhagic 18.53 12.75 45 101934 7630 50495515
Brain oedema 18.52 12.75 61 101918 12309 50490836
Eye pain 18.49 12.75 18 101961 28431 50474714
Metastases to thorax 18.39 12.75 9 101970 215 50502930
Hepatic neoplasm 18.31 12.75 20 101959 1722 50501423
Purulent discharge 18.30 12.75 32 101947 4300 50498845
Femoral artery embolism 18.28 12.75 6 101973 47 50503098
Pelvic fluid collection 18.14 12.75 14 101965 769 50502376
Angioedema 18.08 12.75 30 101949 37646 50465499
Radiation fibrosis - lung 18.04 12.75 5 101974 20 50503125
Medication error 18.03 12.75 28 101951 36076 50467069
Mental disorder 17.99 12.75 11 101968 21980 50481165
Carcinoid tumour pulmonary 17.99 12.75 11 101968 412 50502733
Chemical peritonitis 17.97 12.75 7 101972 94 50503051
Haematoma 17.93 12.75 21 101958 30489 50472656
Small intestinal obstruction 17.93 12.75 72 101907 15996 50487149
Neutropenic sepsis 17.92 12.75 66 101913 14081 50489064
Sudden death 17.87 12.75 49 101930 8942 50494203
Peripheral motor neuropathy 17.85 12.75 18 101961 1413 50501732
Product prescribing error 17.84 12.75 10 101969 20951 50482194
Dyschezia 17.74 12.75 20 101959 1784 50501361
Psychotic disorder 17.72 12.75 11 101968 21801 50481344
Carbohydrate antigen 19-9 increased 17.69 12.75 8 101971 159 50502986
Retroperitoneal neoplasm metastatic 17.66 12.75 5 101974 22 50503123
Calcium ionised increased 17.64 12.75 7 101972 99 50503046
Pericardial effusion malignant 17.58 12.75 7 101972 100 50503045
Pneumocystis jirovecii pneumonia 17.55 12.75 4 101975 14659 50488486
Hypothalamo-pituitary disorder 17.50 12.75 13 101966 674 50502471
Skin disorder 17.45 12.75 95 101884 23935 50479210
Tumour invasion 17.45 12.75 7 101972 102 50503043
Gallbladder disorder 17.38 12.75 6 101973 16736 50486409
Dysgeusia 17.31 12.75 136 101843 38780 50464365
Pneumonitis 17.14 12.75 110 101869 29400 50473745
Hallucination, visual 17.12 12.75 6 101973 16576 50486569
Vein disorder 17.08 12.75 31 101948 4288 50498857
Anaphylactic reaction 17.05 12.75 54 101925 54001 50449144
Joint range of motion decreased 16.99 12.75 8 101971 18504 50484641
Botryomycosis 16.98 12.75 5 101974 26 50503119
Gastroenteropancreatic neuroendocrine tumour disease 16.98 12.75 5 101974 26 50503119
Gastrointestinal inflammation 16.92 12.75 32 101947 4568 50498577
Brachial plexopathy 16.86 12.75 7 101972 112 50503033
Oral disorder 16.86 12.75 44 101935 7800 50495345
Dermatitis 16.82 12.75 65 101914 14186 50488959
Artificial menopause 16.82 12.75 5 101974 27 50503118
Enterocolitis haemorrhagic 16.80 12.75 17 101962 1340 50501805
Respiratory tract congestion 16.75 12.75 4 101975 14195 50488950
Anal erythema 16.74 12.75 8 101971 181 50502964
Premature baby 16.72 12.75 8 101971 18329 50484816
Herpangina 16.67 12.75 5 101974 28 50503117
C-reactive protein increased 16.66 12.75 73 101906 66401 50436744
Tubulointerstitial nephritis 16.59 12.75 5 101974 15206 50487939
Bone fistula 16.48 12.75 6 101973 66 50503079
Tremor 16.46 12.75 150 101829 114753 50388392
Excessive granulation tissue 16.41 12.75 13 101966 742 50502403
Hypertriglyceridaemia 16.37 12.75 35 101944 5456 50497689
Sinus congestion 16.35 12.75 4 101975 13967 50489178
Rectal perforation 16.34 12.75 10 101969 375 50502770
Hyperammonaemia 16.32 12.75 32 101947 4692 50498453
Anastomotic complication 16.31 12.75 7 101972 122 50503023
Hepatic cancer 16.25 12.75 26 101953 3249 50499896
Tongue discolouration 16.23 12.75 24 101955 2800 50500345
Thyroid disorder 16.12 12.75 3 101976 12674 50490471
Procedural pain 16.11 12.75 4 101975 13828 50489317
Delirium 16.03 12.75 33 101946 38159 50464986
Breast disorder 15.90 12.75 20 101959 2002 50501143
Radioisotope scan 15.85 12.75 4 101975 10 50503135
Renal vein thrombosis 15.83 12.75 9 101970 294 50502851
Myopathy toxic 15.78 12.75 10 101969 399 50502746
Impaired work ability 15.78 12.75 4 101975 13636 50489509
Bone cancer metastatic 15.76 12.75 7 101972 133 50503012
Sciatica 15.75 12.75 12 101967 21370 50481775
Blood creatine phosphokinase increased 15.66 12.75 18 101961 26349 50476796
Facial asymmetry 15.63 12.75 12 101967 654 50502491
Hyperchylomicronaemia 15.63 12.75 3 101976 0 50503145
Chemotherapy cardiotoxicity attenuation 15.63 12.75 3 101976 0 50503145
Metastases to muscle 15.62 12.75 7 101972 136 50503009
Metastases to abdominal cavity 15.61 12.75 10 101969 407 50502738
Hypermutation 15.60 12.75 5 101974 36 50503109
Perforation 15.59 12.75 14 101965 950 50502195
Hyperbaric oxygen therapy 15.48 12.75 5 101974 37 50503108
Cognitive disorder 15.43 12.75 42 101937 44081 50459064
Radiation injury 15.37 12.75 10 101969 418 50502727
Tenderness 15.28 12.75 76 101903 18489 50484656
Drug level increased 15.27 12.75 10 101969 19258 50483887
Catheter site bruise 15.21 12.75 9 101970 317 50502828
Restlessness 15.15 12.75 17 101962 25156 50477989
Ejection fraction abnormal 15.10 12.75 13 101966 834 50502311
Influenza like illness 15.08 12.75 62 101917 57397 50445748
Obstruction gastric 15.08 12.75 13 101966 836 50502309
Large intestine perforation 15.05 12.75 41 101938 7453 50495692
Liver scan abnormal 15.03 12.75 5 101974 41 50503104
Gram stain positive 15.03 12.75 5 101974 41 50503104
Upper respiratory tract infection 14.96 12.75 75 101904 65823 50437322
Vulval disorder 14.95 12.75 12 101967 698 50502447
Hepatotoxicity 14.90 12.75 100 101879 27126 50476019
Pulmonary thrombosis 14.89 12.75 41 101938 7500 50495645
Electrocardiogram QT prolonged 14.89 12.75 54 101925 51832 50451313
Pituitary tumour 14.86 12.75 13 101966 852 50502293
Cardiac arrest 14.85 12.75 103 101876 83548 50419597
Abdominal symptom 14.79 12.75 9 101970 334 50502811
Corneal erosion 14.78 12.75 8 101971 237 50502908
Neck pain 14.71 12.75 62 101917 57005 50446140
Ileus paralytic 14.68 12.75 28 101951 4022 50499123
Skin reaction 14.68 12.75 54 101925 11514 50491631
Venous thrombosis limb 14.67 12.75 22 101957 2600 50500545
Torsade de pointes 14.63 12.75 3 101976 11832 50491313
Fistula 14.59 12.75 43 101936 8175 50494970
Hypoglycaemia 14.57 12.75 57 101922 53524 50449621
Metastases to heart 14.53 12.75 5 101974 46 50503099
Extrapyramidal disorder 14.52 12.75 3 101976 11767 50491378
Mood swings 14.48 12.75 7 101972 15947 50487198
Hallucination 14.44 12.75 47 101932 46610 50456535
Restless legs syndrome 14.39 12.75 7 101972 15890 50487255
Iron deficiency anaemia 14.37 12.75 8 101971 16826 50486319
Accidental overdose 14.34 12.75 11 101968 19522 50483623
Mediastinal disorder 14.32 12.75 9 101970 354 50502791
Meningism 14.32 12.75 9 101970 354 50502791
Glomerular filtration rate decreased 14.31 12.75 3 101976 11649 50491496
Bile duct stenosis 14.28 12.75 14 101965 1062 50502083
Metastases to pelvis 14.28 12.75 9 101970 356 50502789
Swelling face 14.27 12.75 56 101923 52539 50450606
Ureteric obstruction 14.25 12.75 17 101962 1611 50501534
Blood iron decreased 14.25 12.75 3 101976 11612 50491533
Breast cancer female 14.24 12.75 38 101941 6824 50496321
Renal hydrocele 14.24 12.75 4 101975 17 50503128
Lip pain 14.20 12.75 17 101962 1617 50501528
Abdominal distension 14.19 12.75 216 101763 72687 50430458
Anaemia 14.15 12.75 633 101346 251823 50251322
Aggression 14.14 12.75 13 101966 21103 50482042
Limb injury 14.12 12.75 12 101967 20238 50482907
Metastases to bladder 14.12 12.75 7 101972 172 50502973
Keratitis 14.11 12.75 21 101958 2464 50500681
Wound treatment 14.05 12.75 7 101972 174 50502971
Pulmonary hilum mass 14.01 12.75 6 101973 104 50503041
Tumour excision 14.01 12.75 9 101970 368 50502777
Obstructive airways disorder 14.01 12.75 7 101972 15645 50487500
Product complaint 13.98 12.75 3 101976 11463 50491682
Hyperglycaemia 13.94 12.75 123 101856 36282 50466863
Hypothyroidism 13.89 12.75 30 101949 34095 50469050
Peritoneal fluid analysis abnormal 13.88 12.75 4 101975 19 50503126
Full blood count abnormal 13.85 12.75 16 101963 23372 50479773
Heavy menstrual bleeding 13.83 12.75 7 101972 15530 50487615
Small intestinal perforation 13.81 12.75 15 101964 1283 50501862
Weight decreased 13.80 12.75 561 101418 220684 50282461
Onychalgia 13.77 12.75 12 101967 783 50502362
Infusion site haemorrhage 13.76 12.75 23 101956 2981 50500164
Activated PI3 kinase delta syndrome 13.71 12.75 4 101975 20 50503125
Actinomycosis 13.60 12.75 13 101966 956 50502189
Metastases to kidney 13.59 12.75 7 101972 187 50502958
Sputum discoloured 13.57 12.75 5 101974 13390 50489755
Malignant peritoneal neoplasm 13.56 12.75 11 101968 650 50502495
Abdominal wall mass 13.55 12.75 3 101976 3 50503142
Anxiety disorder due to a general medical condition 13.55 12.75 3 101976 3 50503142
Macular degeneration 13.55 12.75 6 101973 14382 50488763
Stress 13.52 12.75 59 101920 53734 50449411
Dark circles under eyes 13.49 12.75 10 101969 517 50502628
Gingival swelling 13.47 12.75 26 101953 3769 50499376
Jaundice cholestatic 13.46 12.75 31 101948 5080 50498065
Feeling jittery 13.45 12.75 3 101976 11157 50491988
Lymphangitis 13.45 12.75 12 101967 808 50502337
Osteomyelitis 13.40 12.75 84 101895 22269 50480876
Rectal neoplasm 13.39 12.75 4 101975 22 50503123
Paraneoplastic syndrome 13.39 12.75 10 101969 523 50502622
Wound dehiscence 13.37 12.75 28 101951 4302 50498843
Mean cell haemoglobin decreased 13.33 12.75 24 101955 3299 50499846
Tumour haemorrhage 13.28 12.75 15 101964 1340 50501805
Kidney infection 13.21 12.75 11 101968 18735 50484410
Trismus 13.20 12.75 24 101955 3324 50499821
Head discomfort 13.20 12.75 3 101976 11016 50492129
Herpes zoster 13.15 12.75 86 101893 70700 50432445
Urinary incontinence 13.04 12.75 23 101956 28185 50474960
Radiotherapy 13.02 12.75 8 101971 302 50502843
Obesity 12.90 12.75 9 101970 16766 50486379
Subclavian vein thrombosis 12.90 12.75 17 101962 1782 50501363
Female genital tract fistula 12.87 12.75 25 101954 3641 50499504
Panic attack 12.84 12.75 12 101967 19330 50483815
Dizziness 12.81 12.75 569 101410 345800 50157345

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 2314.90 14.19 880 47570 13879 29512198
Diarrhoea 1355.98 14.19 2138 46312 330560 29195517
Disease progression 1070.21 14.19 960 47490 80956 29445121
Death 567.75 14.19 1521 46929 340563 29185514
Arteriospasm coronary 401.44 14.19 153 48297 2412 29523665
Mucosal inflammation 398.77 14.19 364 48086 31231 29494846
Neuropathy peripheral 333.74 14.19 491 47959 70536 29455541
Vomiting 260.10 14.19 850 47600 211410 29314667
Dehydration 251.79 14.19 570 47880 114178 29411899
Stomatitis 229.13 14.19 293 48157 36820 29489257
Nausea 227.39 14.19 1005 47445 288250 29237827
Anastomotic leak 208.91 14.19 65 48385 531 29525546
Enteritis 205.79 14.19 132 48318 6659 29519418
Gastrointestinal perforation 180.78 14.19 96 48354 3387 29522690
Metastases to liver 172.15 14.19 148 48302 11708 29514369
Neurotoxicity 168.07 14.19 160 48290 14453 29511624
Malignant neoplasm progression 167.45 14.19 372 48078 73487 29452590
Intestinal obstruction 161.61 14.19 178 48272 19099 29506978
Dihydropyrimidine dehydrogenase deficiency 155.56 14.19 34 48416 45 29526032
Drug ineffective 147.75 14.19 230 48220 362940 29163137
Metastases to lung 147.66 14.19 114 48336 7741 29518336
Decreased appetite 145.39 14.19 545 47905 144797 29381280
Bone marrow failure 139.23 14.19 197 48253 27252 29498825
Completed suicide 133.37 14.19 3 48447 90243 29435834
Anastomotic complication 126.27 14.19 39 48411 310 29525767
Gastrointestinal toxicity 122.78 14.19 63 48387 2068 29524009
Skin toxicity 113.50 14.19 73 48377 3698 29522379
Myelosuppression 109.62 14.19 117 48333 12110 29513967
Abdominal pain 102.44 14.19 466 47984 134891 29391186
Neutropenia 102.34 14.19 457 47993 131254 29394823
Ileus 102.14 14.19 122 48328 14280 29511797
Headache 90.55 14.19 91 48359 173916 29352161
Enterocolitis 90.28 14.19 80 48370 6586 29519491
Colon cancer metastatic 88.57 14.19 45 48405 1446 29524631
Therapy cessation 84.20 14.19 111 48339 14351 29511726
Pneumonia 82.78 14.19 260 48190 319912 29206165
Arthralgia 82.22 14.19 65 48385 139552 29386525
Metastases to peritoneum 76.36 14.19 41 48409 1479 29524598
Condition aggravated 73.26 14.19 79 48371 146216 29379861
Carcinoembryonic antigen increased 72.41 14.19 30 48420 594 29525483
Cardiac failure congestive 70.71 14.19 19 48431 76562 29449515
Intestinal perforation 70.06 14.19 76 48374 8010 29518067
Overdose 69.67 14.19 22 48428 79797 29446280
Gastrointestinal anastomotic leak 69.20 14.19 25 48425 336 29525741
Tumour perforation 69.09 14.19 23 48427 238 29525839
Proteus infection 65.73 14.19 31 48419 844 29525233
Fall 64.57 14.19 120 48330 177058 29349019
Skin exfoliation 64.02 14.19 125 48325 22520 29503557
Necrotising fasciitis 63.59 14.19 49 48401 3316 29522761
Dysphagia 62.42 14.19 215 48235 54711 29471366
Stomal varices 62.09 14.19 15 48435 39 29526038
Drug interaction 59.23 14.19 149 48301 197236 29328841
Cardiotoxicity 58.47 14.19 54 48396 4690 29521387
Neoplasm progression 57.88 14.19 107 48343 18505 29507572
Thrombocytopenia 56.39 14.19 396 48054 134427 29391650
Fingerprint loss 54.61 14.19 13 48437 31 29526046
Depression 53.50 14.19 37 48413 85110 29440967
Haematotoxicity 52.93 14.19 60 48390 6639 29519438
Colitis 52.12 14.19 140 48310 31108 29494969
Peritonitis 50.92 14.19 89 48361 14735 29511342
Subileus 50.60 14.19 40 48410 2810 29523267
Pulmonary embolism 49.46 14.19 252 48198 76282 29449795
Product dose omission issue 49.38 14.19 51 48399 96332 29429745
Rectal perforation 48.88 14.19 20 48430 383 29525694
Anxiety 48.64 14.19 41 48409 85324 29440753
Wound dehiscence 48.60 14.19 40 48410 2977 29523100
Induration 47.88 14.19 25 48425 851 29525226
Paraesthesia 47.22 14.19 194 48256 53651 29472426
Hiccups 47.03 14.19 65 48385 8788 29517289
Faecal volume decreased 46.51 14.19 14 48436 101 29525976
Metastases to lymph nodes 46.20 14.19 44 48406 3973 29522104
Portal hypertension 45.54 14.19 41 48409 3445 29522632
Confusional state 45.32 14.19 88 48362 127789 29398288
Obstruction gastric 45.20 14.19 24 48426 846 29525231
Dermatitis acneiform 44.78 14.19 50 48400 5441 29520636
Vascular pain 44.29 14.19 14 48436 121 29525956
Gastric perforation 43.88 14.19 33 48417 2153 29523924
Proteinuria 43.17 14.19 86 48364 15718 29510359
No adverse event 42.90 14.19 91 48359 17387 29508690
Non-cirrhotic portal hypertension 42.69 14.19 16 48434 240 29525837
Toxic leukoencephalopathy 41.24 14.19 16 48434 265 29525812
Cough 40.87 14.19 92 48358 126635 29399442
Prothrombin level decreased 40.81 14.19 24 48426 1034 29525043
Device occlusion 40.57 14.19 48 48402 5560 29520517
Pancreatic neuroendocrine tumour metastatic 40.42 14.19 12 48438 82 29525995
Recall phenomenon 40.33 14.19 19 48431 516 29525561
Diaphragmatic spasm 39.81 14.19 12 48438 87 29525990
Intentional product misuse 39.66 14.19 5 48445 34656 29491421
Hallucination 39.58 14.19 12 48438 44700 29481377
Portal shunt 39.40 14.19 10 48440 34 29526043
Aggression 38.62 14.19 6 48444 35535 29490542
Metastatic gastric cancer 38.59 14.19 13 48437 140 29525937
Small intestinal obstruction 38.01 14.19 73 48377 12988 29513089
Splenorenal shunt 37.80 14.19 8 48442 8 29526069
Large intestine perforation 37.57 14.19 53 48397 7303 29518774
Clostridial infection 37.53 14.19 36 48414 3279 29522798
Influenza 37.51 14.19 11 48439 41870 29484207
Mucosal disorder 37.49 14.19 26 48424 1494 29524583
Metastases to central nervous system 37.34 14.19 52 48398 7079 29518998
Hepatic lesion 37.17 14.19 35 48415 3115 29522962
Anal erythema 36.70 14.19 11 48439 78 29525999
Laryngospasm 36.43 14.19 24 48426 1266 29524811
Oesophageal haemorrhage 36.38 14.19 23 48427 1130 29524947
Foetal exposure during pregnancy 36.16 14.19 6 48444 33861 29492216
Weight increased 35.52 14.19 44 48406 76623 29449454
Hyperammonaemic encephalopathy 35.48 14.19 28 48422 1962 29524115
Agitation 35.38 14.19 20 48430 51284 29474793
Large intestinal obstruction 35.38 14.19 24 48426 1330 29524747
Focal nodular hyperplasia 34.52 14.19 12 48438 143 29525934
Hypokalaemia 34.32 14.19 168 48282 50035 29476042
Terminal ileitis 33.83 14.19 11 48439 105 29525972
Rhabdomyolysis 33.66 14.19 30 48420 60778 29465299
Neutropenic sepsis 33.46 14.19 65 48385 11662 29514415
Insomnia 33.27 14.19 59 48391 88702 29437375
Musculoskeletal stiffness 33.25 14.19 10 48440 37448 29488629
Suicidal ideation 33.21 14.19 8 48442 34708 29491369
Dizziness 33.19 14.19 179 48271 189505 29336572
Intestinal dilatation 33.09 14.19 21 48429 1039 29525038
Protein urine 33.08 14.19 19 48431 783 29525294
Skin discolouration 33.04 14.19 76 48374 15333 29510744
Ascites 32.94 14.19 133 48317 36486 29489591
Metastasis 32.84 14.19 34 48416 3395 29522682
Anal prolapse 32.50 14.19 6 48444 0 29526077
Stoma site haemorrhage 32.31 14.19 18 48432 699 29525378
Dysaesthesia pharynx 31.75 14.19 9 48441 51 29526026
Oesophagitis 31.51 14.19 64 48386 11859 29514218
Electrocardiogram QT prolonged 31.44 14.19 10 48440 36127 29489950
Hypovolaemic shock 31.38 14.19 44 48406 6028 29520049
Tumour marker increased 31.10 14.19 16 48434 528 29525549
Peripheral ischaemia 30.89 14.19 40 48410 5079 29520998
Colon cancer recurrent 30.80 14.19 10 48440 95 29525982
Skin fissures 30.79 14.19 35 48415 3884 29522193
Ventricular fibrillation 30.60 14.19 75 48375 15758 29510319
Joint swelling 30.58 14.19 22 48428 49608 29476469
Bradycardia 30.04 14.19 38 48412 65591 29460486
Pruritus 29.96 14.19 95 48355 116754 29409323
Hospice care 29.65 14.19 39 48411 5029 29521048
Polyneuropathy 29.50 14.19 63 48387 12089 29513988
Biliary obstruction 28.83 14.19 27 48423 2387 29523690
Therapy interrupted 28.34 14.19 50 48400 8336 29517741
Hyperbilirubinaemia 28.07 14.19 70 48380 14864 29511213
COVID-19 27.91 14.19 12 48438 36002 29490075
Psoriasis 27.89 14.19 9 48441 32218 29493859
Gastric dilatation 27.76 14.19 15 48435 548 29525529
Asthenia 27.45 14.19 500 47950 214750 29311327
Arterial thrombosis 27.43 14.19 21 48429 1407 29524670
Tenderness 27.40 14.19 40 48410 5687 29520390
Sinusitis 27.34 14.19 11 48439 34339 29491738
Abnormal behaviour 27.29 14.19 3 48447 23124 29502953
Gastrointestinal stoma necrosis 27.08 14.19 5 48445 0 29526077
Disseminated intravascular coagulation 26.99 14.19 83 48367 19897 29506180
Proctalgia 26.92 14.19 34 48416 4211 29521866
Gastroenteritis radiation 26.61 14.19 12 48438 294 29525783
Erythema 26.42 14.19 213 48237 75393 29450684
Pelvic abscess 26.15 14.19 17 48433 877 29525200
Rectal tenesmus 25.58 14.19 15 48435 643 29525434
Feeling abnormal 25.47 14.19 31 48419 54414 29471663
Product use issue 25.46 14.19 28 48422 51416 29474661
Chronic obstructive pulmonary disease 25.44 14.19 18 48432 40937 29485140
Asthma 25.11 14.19 12 48438 33837 29492240
Injection site pain 24.84 14.19 11 48439 32435 29493642
Gastrointestinal disorder 24.81 14.19 103 48347 28603 29497474
Pigmentation disorder 24.72 14.19 23 48427 2016 29524061
Dyspnoea 24.65 14.19 382 48068 326350 29199727
Rectal cancer metastatic 24.42 14.19 10 48440 192 29525885
Fatigue 24.38 14.19 685 47765 316136 29209941
Gastrointestinal stoma complication 24.21 14.19 18 48432 1154 29524923
Hyperfibrinolysis 23.96 14.19 6 48444 19 29526058
Performance status decreased 23.87 14.19 30 48420 3697 29522380
Myalgia 23.62 14.19 54 48396 73965 29452112
Pancreatitis viral 23.62 14.19 5 48445 5 29526072
Colostomy 23.41 14.19 12 48438 393 29525684
Bronchitis 23.17 14.19 16 48434 36852 29489225
Cholangitis 23.01 14.19 43 48407 7494 29518583
Seizure 22.97 14.19 77 48373 93046 29433031
Temperature intolerance 22.80 14.19 26 48424 2895 29523182
Cellulitis 22.63 14.19 25 48425 45815 29480262
Palmar erythema 22.48 14.19 10 48440 237 29525840
Colorectal cancer metastatic 22.36 14.19 13 48437 548 29525529
Inappropriate schedule of product administration 22.23 14.19 24 48426 44448 29481629
Drug reaction with eosinophilia and systemic symptoms 22.22 14.19 9 48441 27983 29498094
Leukoencephalopathy 22.05 14.19 29 48421 3738 29522339
Nasopharyngitis 22.04 14.19 40 48410 59625 29466452
Therapy change 21.77 14.19 24 48426 2574 29523503
Nephrotic syndrome 21.74 14.19 38 48412 6290 29519787
Hypoaesthesia 21.68 14.19 156 48294 53311 29472766
Swelling of eyelid 21.67 14.19 13 48437 581 29525496
Arthritis 21.63 14.19 7 48443 25012 29501065
Wheezing 21.46 14.19 14 48436 33226 29492851
Irritability 21.39 14.19 5 48445 22147 29503930
Chronic kidney disease 21.34 14.19 17 48433 36399 29489678
Therapeutic product effect decreased 21.00 14.19 11 48439 29440 29496637
Drug hypersensitivity 20.95 14.19 51 48399 68355 29457722
Nasal congestion 20.94 14.19 3 48447 18876 29507201
Hepatic infarction 20.89 14.19 9 48441 197 29525880
Urticaria 20.77 14.19 36 48414 54624 29471453
Rash maculo-papular 20.64 14.19 7 48443 24282 29501795
Neutrophil count decreased 20.58 14.19 132 48318 43435 29482642
Treatment noncompliance 20.55 14.19 7 48443 24220 29501857
Lactic acidosis 20.55 14.19 12 48438 30235 29495842
Failure to anastomose 20.52 14.19 9 48441 206 29525871
Incisional hernia 20.41 14.19 16 48434 1110 29524967
Blood pressure fluctuation 20.21 14.19 4 48446 19890 29506187
Delirium 19.98 14.19 21 48429 39376 29486701
Metastases to the mediastinum 19.98 14.19 9 48441 220 29525857
Change of bowel habit 19.94 14.19 15 48435 979 29525098
Balance disorder 19.83 14.19 18 48432 36152 29489925
Cataract 19.81 14.19 6 48444 22372 29503705
Somnolence 19.71 14.19 83 48367 93872 29432205
Erectile dysfunction 19.65 14.19 3 48447 18006 29508071
Pharyngeal ulceration 19.63 14.19 10 48440 323 29525754
Cognitive disorder 19.57 14.19 7 48443 23492 29502585
Therapeutic product effect prolonged 19.54 14.19 9 48441 232 29525845
Eosinophilia 19.51 14.19 6 48444 22155 29503922
Alanine aminotransferase increased 19.37 14.19 56 48394 70888 29455189
Gastrointestinal mucosal necrosis 19.23 14.19 8 48442 160 29525917
Gastrointestinal mucosal disorder 19.19 14.19 10 48440 339 29525738
Nail bed inflammation 19.14 14.19 8 48442 162 29525915
Gastrointestinal injury 19.06 14.19 10 48440 344 29525733
Prostate cancer 19.01 14.19 9 48441 25518 29500559
Hepatic atrophy 18.96 14.19 8 48442 166 29525911
Scrotal ulcer 18.87 14.19 10 48440 351 29525726
Coronary artery disease 18.79 14.19 27 48423 44163 29481914
Haematemesis 18.71 14.19 85 48365 24541 29501536
Tremor 18.69 14.19 60 48390 73478 29452599
Arthropathy 18.69 14.19 6 48444 21548 29504529
Alopecia 18.52 14.19 71 48379 19013 29507064
Metastases to pelvis 18.40 14.19 9 48441 266 29525811
Pulmonary hypertension 18.37 14.19 4 48446 18604 29507473
Peripheral sensory neuropathy 18.28 14.19 34 48416 5905 29520172
Electrocardiogram ST segment elevation 18.13 14.19 29 48421 4463 29521614
Basal cell carcinoma 18.04 14.19 3 48447 16907 29509170
Anterior spinal artery syndrome 18.01 14.19 4 48446 6 29526071
Wrong technique in product usage process 18.00 14.19 15 48435 31413 29494664
Leukopenia 17.92 14.19 153 48297 55050 29471027
Intestinal ischaemia 17.77 14.19 36 48414 6656 29519421
Peripheral embolism 17.75 14.19 14 48436 980 29525097
Aortic thrombosis 17.62 14.19 12 48438 669 29525408
Periportal sinus dilatation 17.54 14.19 5 48445 29 29526048
Product prescribing error 17.47 14.19 4 48446 17972 29508105
Ectropion 17.45 14.19 6 48444 69 29526008
Metastases to meninges 17.40 14.19 15 48435 1190 29524887
Dry skin 17.37 14.19 80 48370 23227 29502850
Gastrointestinal inflammation 17.37 14.19 23 48427 2985 29523092
Idiosyncratic drug reaction 17.32 14.19 10 48440 416 29525661
Dysaesthesia 17.29 14.19 19 48431 2031 29524046
Hypertriglyceridaemia 17.28 14.19 38 48412 7437 29518640
Feeling cold 17.19 14.19 43 48407 9148 29516929
Vasospasm 17.01 14.19 9 48441 315 29525762
Upper respiratory tract infection 17.01 14.19 12 48438 27337 29498740
Weight decreased 16.96 14.19 344 48106 150561 29375516
Metastases to eye 16.93 14.19 6 48444 76 29526001
Faeces pale 16.83 14.19 15 48435 1244 29524833
General physical health deterioration 16.80 14.19 249 48201 102608 29423469
Heart rate decreased 16.76 14.19 10 48440 24902 29501175
Oxygen saturation decreased 16.71 14.19 30 48420 44907 29481170
Neutrophilia 16.66 14.19 25 48425 3641 29522436
Blood glucose increased 16.51 14.19 46 48404 58938 29467139
Mobility decreased 16.45 14.19 11 48439 25769 29500308
Urethral ulcer 16.25 14.19 3 48447 0 29526077
Ileus paralytic 16.20 14.19 30 48420 5193 29520884
Metastatic neoplasm 16.19 14.19 21 48429 2671 29523406
Phrenic nerve paralysis 15.95 14.19 6 48444 91 29525986
Biliary fistula 15.94 14.19 5 48445 42 29526035
Scleroderma-like reaction 15.74 14.19 5 48445 44 29526033
Malignant ascites 15.73 14.19 9 48441 368 29525709
Liver injury 15.57 14.19 51 48399 12639 29513438
Cryptitis 15.54 14.19 5 48445 46 29526031
Genital erythema 15.54 14.19 7 48443 171 29525906
Prostatic calcification 15.54 14.19 6 48444 98 29525979
Muscular weakness 15.50 14.19 51 48399 62001 29464076
Rosacea 15.49 14.19 13 48437 994 29525083
Cardiac failure 15.44 14.19 72 48378 79215 29446862
Psychotic disorder 15.43 14.19 7 48443 20347 29505730
Ileal ulcer 15.36 14.19 10 48440 517 29525560
Depressed mood 15.32 14.19 4 48446 16444 29509633
Acute kidney injury 15.27 14.19 325 48125 264942 29261135
Pelvic fluid collection 15.27 14.19 6 48444 103 29525974
Interstitial lung disease 15.22 14.19 153 48297 57565 29468512
Liver function test abnormal 15.14 14.19 15 48435 28903 29497174
Subacute cutaneous lupus erythematosus 15.13 14.19 12 48438 847 29525230
Varices oesophageal 15.09 14.19 22 48428 3124 29522953
Acral peeling skin syndrome 15.08 14.19 5 48445 51 29526026
Hot flush 15.08 14.19 3 48447 14867 29511210
Pneumatosis intestinalis 14.96 14.19 22 48428 3147 29522930
Perforation 14.93 14.19 7 48443 188 29525889
Perineal ulceration 14.87 14.19 4 48446 18 29526059
Influenza like illness 14.87 14.19 11 48439 24459 29501618
Hypoglycaemia 14.84 14.19 36 48414 48310 29477767
Memory impairment 14.80 14.19 23 48427 36447 29489630
Pallor 14.77 14.19 8 48442 21016 29505061
Hypotension 14.68 14.19 227 48223 194127 29331950
Electromyogram abnormal 14.66 14.19 5 48445 56 29526021
Acute coronary syndrome 14.64 14.19 49 48401 12276 29513801
Prothrombin time ratio increased 14.61 14.19 6 48444 116 29525961
Metastases to adrenals 14.46 14.19 12 48438 903 29525174
Contusion 14.23 14.19 18 48432 31077 29495000
Wound complication 14.21 14.19 17 48433 1992 29524085

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 7023.15 12.64 2422 110811 26397 64359102
Diarrhoea 2639.72 12.64 4597 108636 718107 63667392
Disease progression 2633.21 12.64 2095 111138 139585 64245914
Mucosal inflammation 1075.98 12.64 886 112347 61698 64323801
Malignant neoplasm progression 1042.75 12.64 1132 112101 111739 64273760
Metastases to liver 912.67 12.64 552 112681 23389 64362110
Neuropathy peripheral 760.62 12.64 983 112250 116542 64268957
Metastases to bone 707.10 12.64 443 112790 19992 64365507
Death 566.41 12.64 1995 111238 480710 63904789
Metastases to lung 566.36 12.64 346 112887 14918 64370581
Arteriospasm coronary 561.91 12.64 246 112987 5219 64380280
Vomiting 516.44 12.64 2120 111113 548997 63836502
Stomatitis 472.31 12.64 756 112477 108849 64276650
Nausea 411.68 12.64 2565 110668 783235 63602264
Metastases to central nervous system 401.06 12.64 269 112964 13643 64371856
Dehydration 396.18 12.64 1048 112185 215715 64169784
Bone marrow failure 387.41 12.64 449 112784 47503 64337996
Neurotoxicity 383.17 12.64 345 112888 27059 64358440
Completed suicide 377.02 12.64 3 113230 224411 64161088
Neutropenia 362.78 12.64 1082 112151 238542 64146957
Breast cancer metastatic 357.61 12.64 197 113036 6972 64378527
Gastrointestinal toxicity 350.17 12.64 176 113057 5146 64380353
Drug ineffective 345.19 12.64 593 112640 839654 63545845
Metastases to lymph nodes 324.37 12.64 198 113035 8519 64376980
Myelosuppression 309.72 12.64 288 112945 23542 64361957
Enteritis 306.74 12.64 216 113017 11861 64373638
Skin toxicity 279.59 12.64 163 113070 6439 64379060
Rheumatoid arthritis 272.10 12.64 3 113230 164291 64221208
Decreased appetite 257.34 12.64 1076 112157 280213 64105286
Dihydropyrimidine dehydrogenase deficiency 246.90 12.64 55 113178 75 64385424
Skin exfoliation 242.08 12.64 344 112889 44541 64340958
Arthralgia 232.07 12.64 261 112972 441999 63943500
Neoplasm progression 228.40 12.64 319 112914 40645 64344854
Condition aggravated 222.63 12.64 196 113037 372230 64013269
Skin fissures 217.91 12.64 165 113068 10141 64375358
Thrombocytopenia 213.11 12.64 867 112366 222934 64162565
Cardiotoxicity 207.37 12.64 160 113073 10114 64375385
Gastrointestinal perforation 198.73 12.64 122 113111 5302 64380197
Joint swelling 195.61 12.64 67 113166 215315 64170184
Metastases to skin 177.83 12.64 74 113159 1378 64384121
Anastomotic leak 177.37 12.64 66 113167 900 64384599
Fall 177.02 12.64 287 112946 416539 63968960
Haematotoxicity 167.82 12.64 156 113077 12740 64372759
Laryngospasm 167.24 12.64 93 113140 3352 64382147
Skin discolouration 161.06 12.64 250 112983 35005 64350494
Dry skin 160.35 12.64 307 112926 50854 64334645
Drug interaction 157.76 12.64 245 112988 361838 64023661
Therapy cessation 156.33 12.64 236 112997 32253 64353246
Tumour marker increased 153.59 12.64 88 113145 3362 64382137
Paronychia 146.30 12.64 108 113125 6384 64379115
Asthenia 141.76 12.64 1256 111977 426788 63958711
Osteonecrosis of jaw 141.16 12.64 252 112981 39573 64345926
Intestinal obstruction 140.85 12.64 239 112994 36047 64349452
Overdose 140.79 12.64 52 113181 159514 64225985
Pseudocirrhosis 136.75 12.64 49 113184 596 64384903
Enterocolitis 136.73 12.64 135 113098 11883 64373616
Paraesthesia 133.35 12.64 528 112705 133994 64251505
Pneumonia 131.26 12.64 522 112711 559054 63826445
Metastases to peritoneum 130.50 12.64 80 113153 3467 64382032
Contraindicated product administered 126.75 12.64 19 113214 107810 64277689
Drug hypersensitivity 124.87 12.64 140 113093 237675 64147824
Arthropathy 123.80 12.64 30 113203 120937 64264562
Therapeutic product effect decreased 119.24 12.64 28 113205 115323 64270176
Sinusitis 118.30 12.64 54 113179 145874 64239625
Weight increased 118.25 12.64 120 113113 213228 64172271
Hospice care 116.53 12.64 101 113132 7524 64377975
Intentional overdose 115.07 12.64 12 113221 89932 64295567
Non-cirrhotic portal hypertension 114.84 12.64 38 113195 357 64385142
Carcinoembryonic antigen increased 114.65 12.64 59 113174 1814 64383685
Musculoskeletal stiffness 114.11 12.64 37 113196 123169 64262330
Maternal exposure during pregnancy 112.46 12.64 17 113216 95867 64289632
Headache 112.37 12.64 513 112720 528954 63856545
Anastomotic complication 110.30 12.64 37 113196 364 64385135
Cardiac failure congestive 109.51 12.64 46 113187 130534 64254965
Systemic lupus erythematosus 108.55 12.64 7 113226 77605 64307894
Metastasis 106.95 12.64 85 113148 5610 64379889
Nail disorder 105.85 12.64 101 113132 8523 64376976
Depression 105.13 12.64 100 113133 183191 64202308
Hepatic lesion 103.16 12.64 84 113149 5740 64379759
Portal hypertension 102.44 12.64 86 113147 6133 64379366
Product use issue 101.65 12.64 71 113162 151644 64233855
Breast cancer 98.91 12.64 181 113052 28967 64356532
Abdominal pain 98.82 12.64 908 112325 311467 64074032
Treatment failure 98.20 12.64 41 113192 116775 64268724
Colitis 97.20 12.64 274 112959 58400 64327099
Breast cancer recurrent 96.93 12.64 59 113174 2524 64382975
PIK3CA-activated mutation 96.87 12.64 36 113197 489 64385010
Lymphangiosis carcinomatosa 96.24 12.64 52 113181 1769 64383730
Exposure during pregnancy 95.27 12.64 12 113221 77663 64307836
Fingerprint loss 93.87 12.64 22 113211 43 64385456
Influenza 93.47 12.64 35 113198 106496 64279003
Ileus 91.42 12.64 153 113080 22813 64362686
Psoriasis 90.61 12.64 10 113223 71693 64313806
Dysaesthesia pharynx 89.81 12.64 27 113206 179 64385320
Suicide attempt 89.49 12.64 10 113223 70997 64314502
Bradycardia 86.49 12.64 50 113183 118169 64267330
Ascites 84.25 12.64 270 112963 61731 64323768
Polyneuropathy 82.50 12.64 135 113098 19759 64365740
Carbohydrate antigen 15-3 increased 81.08 12.64 38 113195 949 64384550
Hyperbilirubinaemia 80.08 12.64 138 113095 21067 64364432
Metastases to pleura 77.90 12.64 40 113193 1224 64384275
Onycholysis 76.49 12.64 43 113190 1583 64383916
Arthritis 76.14 12.64 26 113207 83788 64301711
Intentional product misuse 75.80 12.64 17 113216 72278 64313221
Injection site pain 73.47 12.64 53 113180 111355 64274144
Tumour perforation 72.50 12.64 26 113207 317 64385182
Metastatic neoplasm 72.29 12.64 61 113172 4381 64381118
Metastases to spine 71.91 12.64 56 113177 3587 64381912
Pruritus 71.42 12.64 294 112939 312106 64073393
Hypokalaemia 71.39 12.64 411 112822 121492 64264007
Bronchitis 71.37 12.64 52 113181 108691 64276808
Suicidal ideation 71.08 12.64 15 113218 66527 64318972
Infusion site coldness 70.68 12.64 23 113210 204 64385295
Chronic obstructive pulmonary disease 70.03 12.64 19 113214 71029 64314470
Hypotension 69.36 12.64 389 112844 380585 64004914
Rhabdomyolysis 68.23 12.64 38 113195 91688 64293811
Plasma cell myeloma 68.03 12.64 3 113230 46072 64339427
Pulmonary embolism 67.97 12.64 465 112768 145891 64239608
Bone lesion 66.56 12.64 62 113171 5075 64380424
Anxiety 64.93 12.64 164 113069 202485 64183014
Urticaria 63.72 12.64 100 113133 147217 64238282
Intestinal perforation 63.61 12.64 104 113129 15209 64370290
Electrocardiogram QT prolonged 63.43 12.64 30 113203 79418 64306081
Osteoarthritis 62.30 12.64 17 113216 63319 64322180
Confusional state 62.05 12.64 242 112991 260902 64124597
Product dose omission issue 61.31 12.64 159 113074 194588 64190911
Leukopenia 61.01 12.64 344 112889 100898 64284601
Stomal varices 60.78 12.64 15 113218 40 64385459
Glossodynia 60.65 12.64 19 113214 64677 64320822
Gamma-glutamyltransferase decreased 60.30 12.64 23 113210 337 64385162
Hypovolaemic shock 60.28 12.64 82 113151 10184 64375315
Fatigue 59.90 12.64 1728 111505 747002 63638497
Colon cancer metastatic 59.81 12.64 39 113194 1884 64383615
Insomnia 59.66 12.64 165 113068 197671 64187828
Recall phenomenon 59.59 12.64 31 113202 975 64384524
Nail discolouration 59.53 12.64 43 113190 2457 64383042
Feeling abnormal 59.40 12.64 89 113144 133513 64251986
Hypoaesthesia 59.35 12.64 433 112800 138675 64246824
Asthma 59.34 12.64 48 113185 95177 64290322
Osteonecrosis 59.20 12.64 144 113089 28085 64357414
Ejection fraction decreased 58.67 12.64 145 113088 28562 64356937
Acute kidney injury 57.13 12.64 509 112724 448731 63936768
Blood pressure fluctuation 56.84 12.64 11 113222 51860 64333639
Proteinuria 56.63 12.64 140 113093 27583 64357916
Drug reaction with eosinophilia and systemic symptoms 56.33 12.64 13 113220 54204 64331295
Agitation 55.75 12.64 44 113189 88323 64297176
Dysaesthesia 54.76 12.64 55 113178 4940 64380559
Gastrointestinal anastomotic leak 53.86 12.64 22 113211 390 64385109
Mobility decreased 53.83 12.64 43 113190 85797 64299702
Nasal congestion 53.33 12.64 19 113214 59639 64325860
Hepatic function abnormal 53.20 12.64 239 112994 64074 64321425
Subileus 53.10 12.64 54 113179 4923 64380576
Wheezing 52.26 12.64 39 113194 80540 64304959
Somnolence 52.10 12.64 183 113050 203462 64182037
Dermatitis acneiform 51.96 12.64 69 113164 8374 64377125
Performance status decreased 51.49 12.64 55 113178 5309 64380190
Gastric perforation 50.50 12.64 45 113188 3478 64382021
Therapy partial responder 50.08 12.64 75 113158 10173 64375326
Device related thrombosis 49.96 12.64 36 113197 2049 64383450
Wound 49.62 12.64 37 113196 76440 64309059
Chronic kidney disease 49.19 12.64 20 113213 57899 64327600
Metastases to the mediastinum 48.36 12.64 22 113211 512 64384987
Oesophagitis 48.23 12.64 113 113120 21517 64363982
Abdominal lymphadenopathy 48.20 12.64 28 113205 1098 64384401
Therapy change 48.20 12.64 58 113175 6376 64379123
Wrong technique in product usage process 48.20 12.64 27 113206 64947 64320552
Vascular pain 47.63 12.64 25 113208 801 64384698
Pain 47.58 12.64 685 112548 552826 63832673
Cytomegalovirus infection 47.47 12.64 5 113228 37194 64348305
Oxygen saturation decreased 47.05 12.64 72 113161 107104 64278395
Metastases to meninges 46.51 12.64 39 113194 2776 64382723
Hyperkalaemia 46.29 12.64 66 113167 101063 64284436
Injection site erythema 46.26 12.64 34 113199 70766 64314733
Subacute cutaneous lupus erythematosus 46.08 12.64 40 113193 2985 64382514
Irritable bowel syndrome 45.27 12.64 6 113227 37363 64348136
Coronary artery disease 44.99 12.64 25 113208 60408 64325091
Disseminated intravascular coagulation 44.96 12.64 142 113091 32206 64353293
Metastases to chest wall 44.78 12.64 19 113214 372 64385127
Varices oesophageal 44.72 12.64 50 113183 5080 64380419
Loss of consciousness 44.52 12.64 124 113109 148241 64237258
Lacrimation increased 44.40 12.64 99 113134 18247 64367252
Swelling 44.39 12.64 139 113094 160079 64225420
Delirium 44.22 12.64 34 113199 69160 64316339
Peripheral sensory neuropathy 44.21 12.64 75 113158 11303 64374196
Obstruction gastric 44.18 12.64 29 113204 1417 64384082
Skin hyperpigmentation 44.15 12.64 56 113177 6495 64379004
Jaw operation 43.85 12.64 23 113210 736 64384763
Peritonitis 43.54 12.64 119 113114 24904 64360595
Pericarditis 43.53 12.64 28 113205 62488 64323011
Erythema 43.47 12.64 511 112722 186559 64198940
Hiccups 43.38 12.64 63 113170 8313 64377186
Biliary obstruction 43.20 12.64 43 113190 3821 64381678
Myalgia 42.97 12.64 139 113094 158478 64227021
Fibromyalgia 42.66 12.64 6 113227 35725 64349774
Aggression 42.58 12.64 14 113219 46218 64339281
Blood bilirubin increased 42.55 12.64 207 113026 57346 64328153
Ejection fraction 42.26 12.64 27 113206 1259 64384240
Device occlusion 42.09 12.64 68 113165 9845 64375654
Infusion site induration 41.84 12.64 23 113210 810 64384689
Neutropenic sepsis 41.82 12.64 112 113121 23160 64362339
Mucosal disorder 41.70 12.64 38 113195 3024 64382475
Abnormal behaviour 41.70 12.64 5 113228 33617 64351882
Recurrent cancer 41.55 12.64 34 113199 2339 64383160
Leukoencephalopathy 41.44 12.64 56 113177 6911 64378588
Myocardial infarction 41.08 12.64 151 113082 165670 64219829
Sedation 41.02 12.64 11 113222 41451 64344048
Wound dehiscence 40.84 12.64 51 113182 5823 64379676
Proteus infection 40.82 12.64 29 113204 1614 64383885
Mucosal toxicity 40.59 12.64 19 113214 473 64385026
Drug level increased 40.23 12.64 6 113227 34190 64351309
Neutrophil count decreased 39.90 12.64 252 112981 76944 64308555
Toxic leukoencephalopathy 39.82 12.64 23 113210 892 64384607
General physical health deterioration 39.66 12.64 540 112693 203885 64181614
Lactic acidosis 39.46 12.64 30 113203 61380 64324119
Nasopharyngitis 39.08 12.64 194 113039 195879 64189620
Arterial thrombosis 38.78 12.64 33 113200 2397 64383102
Diaphragmatic spasm 38.76 12.64 12 113221 89 64385410
Unresponsive to stimuli 38.75 12.64 20 113213 50373 64335126
Pyogenic granuloma 38.72 12.64 18 113215 441 64385058
Prothrombin level decreased 38.71 12.64 27 113206 1459 64384040
Anastomotic fistula 38.64 12.64 12 113221 90 64385409
Tooth extraction 38.26 12.64 64 113169 9537 64375962
Pulmonary hypertension 38.12 12.64 14 113219 43125 64342374
Sleep apnoea syndrome 38.10 12.64 4 113229 29828 64355671
Eosinophilia 37.86 12.64 10 113223 38066 64347433
Acute coronary syndrome 37.85 12.64 96 113137 19214 64366285
Portal shunt 37.81 12.64 11 113222 64 64385435
Discomfort 37.79 12.64 52 113181 80826 64304673
Loss of personal independence in daily activities 37.60 12.64 43 113190 72411 64313088
Dysphagia 37.55 12.64 318 112915 106494 64279005
Depressed level of consciousness 37.41 12.64 53 113180 81383 64304116
Infusion related reaction 37.39 12.64 155 113078 164312 64221187
Biliary sepsis 37.32 12.64 26 113207 1402 64384097
Cold dysaesthesia 37.24 12.64 8 113225 8 64385491
Basal cell carcinoma 37.24 12.64 5 113228 30833 64354666
Necrotising fasciitis 36.65 12.64 46 113187 5280 64380219
Cholangitis 36.54 12.64 67 113166 10735 64374764
Hepatic enzyme increased 36.51 12.64 112 113121 129831 64255668
Platelet count decreased 36.29 12.64 452 112781 167259 64218240
Mouth ulceration 35.93 12.64 132 113101 32312 64353187
Hepatic failure 35.89 12.64 192 113041 55202 64330297
Irritability 35.88 12.64 10 113223 36736 64348763
Lymphoedema 35.50 12.64 63 113170 9842 64375657
Splenorenal shunt 35.47 12.64 8 113225 12 64385487
Drug ineffective for unapproved indication 35.41 12.64 6 113227 31127 64354372
Treatment noncompliance 35.35 12.64 16 113217 43466 64342033
Nervousness 35.20 12.64 5 113228 29551 64355948
Injury 35.16 12.64 28 113205 55964 64329535
Large intestine perforation 35.09 12.64 72 113161 12532 64372967
Hallucination 34.82 12.64 46 113187 72742 64312757
Duodenal ulcer perforation 34.61 12.64 9 113224 34616 64350883
Hypophagia 34.16 12.64 149 113084 39438 64346061
Product use in unapproved indication 33.91 12.64 177 113056 176441 64209058
Hepatic atrophy 33.90 12.64 16 113217 406 64385093
Induration 33.76 12.64 26 113207 1638 64383861
Hypertriglyceridaemia 33.57 12.64 66 113167 11139 64374360
Faecal volume decreased 33.49 12.64 12 113221 146 64385353
Hyperhidrosis 33.46 12.64 110 113123 124810 64260689
Blood uric acid decreased 33.35 12.64 22 113211 1084 64384415
Blood glucose increased 33.25 12.64 77 113156 97996 64287503
Small intestinal obstruction 33.24 12.64 104 113129 23469 64362030
Cataract 32.99 12.64 25 113208 51237 64334262
Nodular regenerative hyperplasia 32.97 12.64 20 113213 850 64384649
Granulocyte count decreased 32.81 12.64 23 113210 1253 64384246
Respiratory arrest 32.64 12.64 27 113206 52958 64332541
Adnexa uteri mass 32.63 12.64 14 113219 282 64385217
Dizziness 32.62 12.64 545 112688 429618 63955881
Bone disorder 32.51 12.64 83 113150 16676 64368823
Abdominal discomfort 32.12 12.64 188 113045 182134 64203365
Pigmentation disorder 32.00 12.64 40 113193 4572 64380927
Pharyngeal inflammation 31.57 12.64 20 113213 919 64384580
Rectal tenesmus 31.52 12.64 21 113212 1052 64384447
Lower respiratory tract infection 31.51 12.64 75 113158 94539 64290960
Therapeutic product effect incomplete 31.40 12.64 86 113147 103396 64282103
Hypervolaemia 31.26 12.64 14 113219 38271 64347228
Pneumatosis intestinalis 31.05 12.64 42 113191 5187 64380312
Metastases to ovary 30.90 12.64 13 113220 249 64385250
Urinary tract infection 30.88 12.64 259 112974 231337 64154162
Hypoalbuminaemia 30.70 12.64 84 113149 17590 64367909
Abortion spontaneous 30.54 12.64 4 113229 25139 64360360
Neoplasm malignant 30.39 12.64 104 113129 24584 64360915
Skin reaction 30.28 12.64 67 113166 12285 64373214
Pelvic fluid collection 30.11 12.64 17 113216 631 64384868
Debridement 29.96 12.64 24 113209 1602 64383897
Pancreatic neuroendocrine tumour metastatic 29.94 12.64 10 113223 97 64385402
Electrocardiogram ST segment elevation 29.74 12.64 49 113184 7210 64378289
Therapy interrupted 29.74 12.64 90 113143 19946 64365553
Cachexia 29.71 12.64 56 113177 9161 64376338
Emotional distress 29.71 12.64 13 113220 36025 64349474
Plantar erythema 29.42 12.64 13 113220 282 64385217
Jaundice 29.32 12.64 165 113068 48347 64337152
Metastases to eye 29.31 12.64 12 113221 214 64385285
Necrotising oesophagitis 29.12 12.64 17 113216 673 64384826
Asthenopia 29.05 12.64 26 113207 2021 64383478
Device issue 29.01 12.64 3 113230 22645 64362854
Bone pain 28.88 12.64 162 113071 47410 64338089
Clostridial infection 28.72 12.64 40 113193 5079 64380420
Product prescribing error 28.64 12.64 13 113220 35256 64350243
Pulmonary arterial hypertension 28.61 12.64 5 113228 25362 64360137
Syncope 28.59 12.64 161 113072 157474 64228025
Heart rate increased 28.47 12.64 84 113149 98591 64286908
Eosinophil percentage increased 28.35 12.64 22 113211 1402 64384097
Blood pressure systolic increased 28.30 12.64 27 113206 49426 64336073
Protein urine 27.98 12.64 21 113212 1273 64384226
Haematoma 27.96 12.64 24 113209 46226 64339273
Thrombosis 27.90 12.64 216 113017 70426 64315073
Anal erythema 27.90 12.64 11 113222 177 64385322
Constipation 27.83 12.64 561 112672 228776 64156723
Inappropriate schedule of product administration 27.77 12.64 77 113156 92209 64293290
Weight decreased 27.73 12.64 677 112556 285062 64100437
Psychotic disorder 27.68 12.64 13 113220 34565 64350934
Angioedema 27.64 12.64 41 113192 61780 64323719
Brachiocephalic vein thrombosis 27.59 12.64 10 113223 126 64385373
Malignant ascites 27.37 12.64 19 113214 1019 64384480
Neck pain 27.33 12.64 41 113192 61492 64324007
Pleural effusion 27.32 12.64 341 112892 126218 64259281
Prinzmetal angina 27.30 12.64 22 113211 1481 64384018
Focal nodular hyperplasia 27.23 12.64 16 113217 641 64384858
Fluid retention 27.17 12.64 39 113194 59567 64325932
Aortic thrombosis 27.16 12.64 22 113211 1492 64384007
Stress cardiomyopathy 27.10 12.64 54 113179 9203 64376296
Angina bullosa haemorrhagica 26.93 12.64 11 113222 195 64385304
Ectropion 26.87 12.64 13 113220 349 64385150
Gastrointestinal stoma necrosis 26.73 12.64 5 113228 0 64385499
Cryptitis 26.70 12.64 9 113224 90 64385409
Hyperfibrinolysis 26.62 12.64 7 113226 26 64385473
Acute respiratory failure 26.60 12.64 29 113204 49905 64335594
Tumour pain 26.34 12.64 24 113209 1909 64383590
Colorectal cancer metastatic 26.32 12.64 18 113215 942 64384557
Hypoglycaemia 26.31 12.64 76 113157 89816 64295683
Oesophageal haemorrhage 26.29 12.64 22 113211 1562 64383937
Vein disorder 26.07 12.64 34 113199 4053 64381446
Pulmonary mass 26.00 12.64 97 113136 23919 64361580
Stoma site haemorrhage 25.94 12.64 22 113211 1591 64383908
Tooth erosion 25.80 12.64 13 113220 382 64385117
Early satiety 25.78 12.64 19 113214 1120 64384379
Atrial fibrillation 25.76 12.64 185 113048 170904 64214595
Gastrointestinal inflammation 25.63 12.64 42 113191 6153 64379346
Respiratory depression 25.62 12.64 5 113228 23438 64362061
Medication error 25.55 12.64 30 113203 49936 64335563
Blood creatinine decreased 25.47 12.64 45 113188 7005 64378494
Venoocclusive liver disease 25.31 12.64 55 113178 9960 64375539
Nail infection 25.30 12.64 23 113210 1824 64383675
Bone sequestrum 25.29 12.64 19 113214 1153 64384346
Prescribed overdose 25.27 12.64 3 113230 20328 64365171
Disturbance in attention 25.21 12.64 21 113212 41053 64344446
Rectal perforation 25.08 12.64 16 113217 744 64384755
Onychomadesis 24.95 12.64 28 113205 2856 64382643
Vessel puncture site bruise 24.93 12.64 13 113220 411 64385088
Injection site haemorrhage 24.86 12.64 6 113227 24272 64361227
Accidental overdose 24.80 12.64 14 113219 33543 64351956
Post-traumatic neck syndrome 24.73 12.64 23 113210 1879 64383620
COVID-19 24.71 12.64 48 113185 65092 64320407
Metastases to pelvis 24.69 12.64 14 113219 524 64384975
Dysgeusia 24.56 12.64 154 113079 46893 64338606
Adverse event 24.48 12.64 20 113213 39469 64346030
Steatohepatitis 24.13 12.64 16 113217 795 64384704
Cardio-respiratory arrest 24.09 12.64 90 113143 98303 64287196
Extrapyramidal disorder 24.02 12.64 3 113230 19549 64365950
Upper respiratory tract infection 23.99 12.64 58 113175 72727 64312772
Vasodilatation 23.92 12.64 28 113205 2990 64382509
Hospitalisation 23.89 12.64 219 113014 74988 64310511
Cytokine release syndrome 23.72 12.64 4 113229 20825 64364674
Contusion 23.71 12.64 111 113122 113854 64271645
Tenderness 23.62 12.64 82 113151 19520 64365979
Restlessness 23.62 12.64 21 113212 39764 64345735
Hand-foot-and-mouth disease 23.47 12.64 10 113223 198 64385301
Acute myeloid leukaemia 23.41 12.64 103 113130 27360 64358139
Carbohydrate antigen 19-9 increased 23.37 12.64 12 113221 367 64385132
Human epidermal growth factor receptor negative 23.28 12.64 5 113228 5 64385494
Ileal ulcer 23.23 12.64 17 113216 991 64384508
Large intestinal obstruction 22.98 12.64 26 113207 2676 64382823
Dental care 22.98 12.64 15 113218 726 64384773
Cardiac output decreased 22.92 12.64 21 113212 1683 64383816
Osteoporosis 22.90 12.64 24 113209 42056 64343443
Tendonitis 22.87 12.64 4 113229 20278 64365221
Fistula 22.86 12.64 52 113181 9709 64375790
Right ventricular failure 22.60 12.64 5 113228 21466 64364033
Colon cancer recurrent 22.58 12.64 8 113225 94 64385405
Accidental exposure to product 22.55 12.64 9 113224 26355 64359144
Haemorrhage intracranial 22.41 12.64 7 113226 23877 64361622
Hyperammonaemia 22.36 12.64 52 113181 9852 64375647
Renal hydrocele 22.27 12.64 6 113227 25 64385474
Failure to anastomose 22.25 12.64 10 113223 226 64385273
Coma 22.20 12.64 79 113154 87536 64297963
Abdominal distension 22.17 12.64 262 112971 95732 64289767
Metastatic gastric cancer 21.90 12.64 11 113222 321 64385178
White blood cell count decreased 21.84 12.64 394 112839 157443 64228056
Hepatitis 21.60 12.64 29 113204 45553 64339946
Drug eruption 21.54 12.64 19 113214 36117 64349382
Cognitive disorder 21.41 12.64 40 113193 55047 64330452
Radiation myelopathy 21.39 12.64 4 113229 0 64385499
Poisoning 21.28 12.64 6 113227 21873 64363626
Peripheral ischaemia 21.16 12.64 46 113187 8332 64377167
Intestinal metastasis 21.14 12.64 10 113223 255 64385244
ECG signs of myocardial ischaemia 21.09 12.64 11 113222 348 64385151
Haemoglobin decreased 20.96 12.64 230 113003 194833 64190666
Eye pain 20.90 12.64 15 113218 31610 64353889
Gastrointestinal disorder 20.79 12.64 245 112988 89464 64296035
Febrile neutropenia 20.78 12.64 453 112780 187204 64198295
Limbal stem cell deficiency 20.76 12.64 6 113227 34 64385465
Toxicity to various agents 20.72 12.64 483 112750 363030 64022469
Neoplasm recurrence 20.65 12.64 29 113204 3710 64381789
Anal prolapse 20.59 12.64 7 113226 72 64385427
No adverse event 20.59 12.64 102 113131 28459 64357040
Osteolysis 20.56 12.64 25 113208 2778 64382721
Gastrointestinal mucosal necrosis 20.50 12.64 9 113224 192 64385307
Temperature intolerance 20.48 12.64 45 113188 8210 64377289
Periportal sinus dilatation 20.33 12.64 6 113227 37 64385462
Hyperammonaemic encephalopathy 20.26 12.64 30 113203 4028 64381471
Transaminases 20.25 12.64 7 113226 76 64385423
Hallucination, visual 20.02 12.64 12 113221 27822 64357677
Obstructive airways disorder 19.69 12.64 8 113225 23177 64362322
Oral pain 19.68 12.64 98 113135 27395 64358104
Intestinal dilatation 19.62 12.64 22 113211 2242 64383257
Rhinorrhoea 19.60 12.64 48 113185 59921 64325578
Disease recurrence 19.59 12.64 108 113125 31402 64354097
Injection site bruising 19.51 12.64 21 113212 36352 64349147
Hormone receptor positive breast cancer 19.41 12.64 10 113223 308 64385191
Hepatic infarction 19.38 12.64 14 113219 800 64384699
Infusion site hypoaesthesia 19.36 12.64 5 113228 17 64385482
Pancreatitis viral 19.36 12.64 5 113228 17 64385482
Stress 19.35 12.64 49 113184 60485 64325014
Sinus bradycardia 19.28 12.64 8 113225 22885 64362614
Generalised tonic-clonic seizure 19.25 12.64 25 113208 39832 64345667
Viral infection 19.24 12.64 21 113212 36119 64349380
Productive cough 19.23 12.64 65 113168 73138 64312361
Ventricular fibrillation 19.22 12.64 88 113145 23772 64361727
Infusion site haemorrhage 19.22 12.64 22 113211 2293 64383206
Exposed bone in jaw 19.19 12.64 27 113206 3460 64382039
Hypersplenism 19.06 12.64 11 113222 426 64385073
Bone debridement 18.87 12.64 11 113222 434 64385065
Hypoacusis 18.82 12.64 11 113222 25856 64359643
Incorrect dose administered 18.80 12.64 50 113183 60715 64324784
Metastases to breast 18.80 12.64 9 113224 236 64385263
Brain neoplasm 18.75 12.64 32 113201 4846 64380653
Dyskinesia 18.72 12.64 25 113208 39363 64346136
Vertebral column mass 18.70 12.64 8 113225 160 64385339
Metastases to adrenals 18.68 12.64 16 113217 1173 64384326
Gingival bleeding 18.65 12.64 63 113170 14791 64370708
Crying 18.65 12.64 6 113227 20084 64365415
Renal vein thrombosis 18.60 12.64 11 113222 446 64385053
Toothache 18.47 12.64 70 113163 17389 64368110
Computerised tomogram abnormal 18.46 12.64 25 113208 3091 64382408
Ear infection 18.43 12.64 9 113224 23395 64362104
Lymphadenopathy mediastinal 18.42 12.64 28 113205 3848 64381651
Pneumocystis jirovecii pneumonia 18.40 12.64 13 113220 27621 64357878
Metastases to stomach 18.36 12.64 9 113224 249 64385250
Hepatic cyst 18.36 12.64 33 113200 5207 64380292
Oral pigmentation 18.34 12.64 5 113228 22 64385477
Migraine 18.33 12.64 53 113180 62624 64322875
Incorrect route of product administration 18.28 12.64 9 113224 23289 64362210
Premature delivery 18.26 12.64 5 113228 18584 64366915
Panic attack 18.17 12.64 7 113226 20946 64364553
Metastases to thorax 18.13 12.64 8 113225 173 64385326
Pregnancy 18.05 12.64 7 113226 20858 64364641
Odynophagia 17.93 12.64 47 113186 9594 64375905
Tremor 17.89 12.64 170 113063 148060 64237439
Malignant pleural effusion 17.88 12.64 24 113209 2943 64382556
Peripheral motor neuropathy 17.86 12.64 24 113209 2946 64382553
Cerebrovascular accident 17.81 12.64 155 113078 137428 64248071
Congestive cardiomyopathy 17.80 12.64 49 113184 10295 64375204
Joint injury 17.80 12.64 9 113224 22938 64362561
International normalised ratio increased 17.74 12.64 75 113158 79092 64306407
C-reactive protein increased 17.71 12.64 96 113137 94813 64290686
Motion sickness 17.66 12.64 13 113220 765 64384734
Perineal ulceration 17.62 12.64 6 113227 62 64385437
Obesity 17.62 12.64 7 113226 20555 64364944
Head injury 17.57 12.64 19 113214 32823 64352676
Joint range of motion decreased 17.56 12.64 6 113227 19337 64366162
Prostatic calcification 17.54 12.64 6 113227 63 64385436
Mydriasis 17.31 12.64 3 113230 15309 64370190
Venous thrombosis limb 17.22 12.64 27 113206 3810 64381689
Herpangina 17.20 12.64 5 113228 29 64385470
Gastroenteropancreatic neuroendocrine tumour disease 17.20 12.64 5 113228 29 64385470
Sciatica 17.20 12.64 7 113226 20257 64365242
Sputum discoloured 17.17 12.64 5 113228 17851 64367648
Urinary incontinence 17.13 12.64 23 113210 36128 64349371
Perforation 17.13 12.64 15 113218 1133 64384366
Gastroenteritis radiation 17.11 12.64 12 113221 654 64384845
Diabetes mellitus inadequate control 17.09 12.64 8 113225 21313 64364186
Foot deformity 17.06 12.64 4 113229 16500 64368999
Staphylococcal infection 17.00 12.64 40 113193 50638 64334861
Lymphadenopathy 16.93 12.64 140 113093 46546 64338953
Device dislocation 16.89 12.64 8 113225 21170 64364329
Dyspnoea 16.89 12.64 1062 112171 717612 63667887
Hyperaesthesia 16.80 12.64 47 113186 9967 64375532
Gastric dilatation 16.79 12.64 15 113218 1163 64384336
Cough 16.78 12.64 403 112830 301745 64083754
Blood creatine phosphokinase increased 16.78 12.64 50 113183 58508 64326991
Enterocolitis haemorrhagic 16.75 12.64 19 113214 1961 64383538
Breast necrosis 16.67 12.64 6 113227 74 64385425
Pericardial effusion 16.61 12.64 122 113111 39132 64346367
Acute promyelocytic leukaemia 16.55 12.64 16 113217 1372 64384127
Respiratory tract congestion 16.54 12.64 4 113229 16161 64369338
Folliculitis 16.54 12.64 17 113216 30060 64355439
Hypoxia 16.54 12.64 89 113144 88060 64297439
Oropharyngeal pain 16.52 12.64 90 113143 88777 64296722
Myoclonus 16.48 12.64 12 113221 25106 64360393
Disorientation 16.48 12.64 47 113186 55781 64329718
Torsade de pointes 16.45 12.64 5 113228 17358 64368141
Blood pressure increased 16.40 12.64 209 113024 172343 64213156
Back pain 16.39 12.64 325 112908 249846 64135653
Dark circles under eyes 16.32 12.64 10 113223 433 64385066
Pancreatic fistula 16.31 12.64 6 113227 79 64385420
Seizure 16.29 12.64 201 113032 166691 64218808
Toxic epidermal necrolysis 16.27 12.64 25 113208 37141 64348358
Biliary fistula 16.18 12.64 6 113227 81 64385418
Restless legs syndrome 16.08 12.64 5 113228 17111 64368388
Hyperchylomicronaemia 16.04 12.64 3 113230 0 64385499
Dermatoglyphic anomaly 16.04 12.64 3 113230 0 64385499
Urethral ulcer 16.04 12.64 3 113230 0 64385499
Haemodialysis 16.03 12.64 5 113228 17072 64368427
Ataxia 16.01 12.64 79 113154 22005 64363494
Gallbladder disorder 15.96 12.64 5 113228 17025 64368474
Paraneoplastic dermatomyositis 15.93 12.64 5 113228 39 64385460
Product administration error 15.92 12.64 15 113218 27628 64357871
Hyperthyroidism 15.89 12.64 6 113227 18173 64367326
Dermatomyositis 15.85 12.64 22 113211 2784 64382715
Parkinsonism 15.85 12.64 3 113230 14370 64371129
Small intestinal perforation 15.74 12.64 21 113212 2559 64382940
Delusion 15.66 12.64 6 113227 18008 64367491
Tumour invasion 15.65 12.64 9 113224 346 64385153
Mental disorder 15.65 12.64 14 113219 26431 64359068
Liver injury 15.64 12.64 98 113135 29834 64355665
Mechanical ileus 15.60 12.64 11 113222 605 64384894
Bronchopulmonary aspergillosis 15.55 12.64 7 113226 19078 64366421
Vasospasm 15.51 12.64 13 113220 925 64384574
Lymphocyte count decreased 15.42 12.64 30 113203 40669 64344830
Hyperglycaemic hyperosmolar nonketotic syndrome 15.41 12.64 17 113216 1702 64383797
Epistaxis 15.39 12.64 250 112983 97881 64287618
Multiple sclerosis 15.35 12.64 7 113226 18934 64366565
Subdural haematoma 15.27 12.64 16 113217 28038 64357461
Dystonia 15.24 12.64 7 113226 18858 64366641
Calcium ionised increased 15.23 12.64 7 113226 167 64385332
Injection site swelling 15.23 12.64 31 113202 41322 64344177
Vulval disorder 15.23 12.64 10 113223 489 64385010
Terminal ileitis 15.22 12.64 11 113222 629 64384870
Colitis ischaemic 15.21 12.64 55 113178 13359 64372140
Hypermutation 15.20 12.64 5 113228 46 64385453
Fungal infection 15.03 12.64 23 113210 34228 64351271
Nail avulsion 15.03 12.64 6 113227 100 64385399
Liver scan abnormal 15.01 12.64 5 113228 48 64385451
Prostate cancer 15.01 12.64 8 113225 19787 64365712
Paranoia 14.97 12.64 5 113228 16347 64369152
Dermatitis 14.90 12.64 67 113166 17962 64367537
Mood swings 14.88 12.64 6 113227 17462 64368037
Rectal neoplasm 14.83 12.64 5 113228 50 64385449
Gastrointestinal injury 14.82 12.64 12 113221 813 64384686
Anhedonia 14.82 12.64 3 113230 13703 64371796
Acral peeling skin syndrome 14.74 12.64 5 113228 51 64385448
Memory impairment 14.73 12.64 89 113144 85593 64299906
Pharyngeal ulceration 14.71 12.64 12 113221 822 64384677
Glomerular filtration rate decreased 14.70 12.64 8 113225 19564 64365935
Chemical peritonitis 14.70 12.64 8 113225 276 64385223
Radiation fibrosis - lung 14.66 12.64 5 113228 52 64385447
Appendicitis noninfective 14.60 12.64 4 113229 18 64385481
Pulpitis dental 14.57 12.64 13 113220 1006 64384493
Liver abscess 14.51 12.64 30 113203 5250 64380249
Nail bed inflammation 14.49 12.64 10 113223 531 64384968
Femoral artery embolism 14.49 12.64 5 113228 54 64385445
Hyperbaric oxygen therapy 14.41 12.64 5 113228 55 64385444
Peritoneal fluid analysis abnormal 14.41 12.64 5 113228 55 64385444
Schistosomiasis 14.33 12.64 5 113228 56 64385443
Periodontitis 14.32 12.64 26 113207 4133 64381366
Hypothalamo-pituitary disorder 14.30 12.64 13 113220 1031 64384468
Proctalgia 14.21 12.64 37 113196 7522 64377977
Peripheral sensorimotor neuropathy 14.20 12.64 20 113213 2565 64382934
Tumour marker abnormal 14.20 12.64 7 113226 196 64385303
Diverticulitis 14.18 12.64 29 113204 38589 64346910
Administration site extravasation 14.14 12.64 13 113220 1046 64384453
Blood lactate dehydrogenase increased 14.11 12.64 103 113130 32975 64352524
Short-bowel syndrome 14.10 12.64 9 113224 419 64385080
Botryomycosis 14.09 12.64 5 113228 59 64385440
Acute hepatic failure 14.09 12.64 15 113218 26097 64359402
Increased liver stiffness 13.97 12.64 3 113230 3 64385496
Metaplastic breast carcinoma 13.97 12.64 3 113230 3 64385496
Abdominal fat apron 13.97 12.64 3 113230 3 64385496
Neutrophilia 13.87 12.64 34 113199 6660 64378839
Proctitis 13.86 12.64 22 113211 3137 64382362
Type 2 diabetes mellitus 13.85 12.64 24 113209 33996 64351503
Neoplasm 13.82 12.64 35 113198 6996 64378503
Onychoclasis 13.70 12.64 27 113206 4565 64380934
Ureteric obstruction 13.70 12.64 19 113214 2403 64383096
Brain operation 13.70 12.64 10 113223 581 64384918
Diabetes mellitus 13.67 12.64 65 113168 66409 64319090
Pituitary tumour 13.66 12.64 13 113220 1093 64384406
Hydronephrosis 13.61 12.64 55 113178 14070 64371429
Genital erythema 13.52 12.64 7 113226 218 64385281
Radioisotope scan 13.51 12.64 3 113230 4 64385495
Influenza like illness 13.49 12.64 59 113174 61643 64323856
Blood cholesterol increased 13.46 12.64 44 113189 50022 64335477
Skin disorder 13.46 12.64 89 113144 27591 64357908
Actinomycosis 13.44 12.64 12 113221 930 64384569
Electrolyte imbalance 13.40 12.64 83 113150 25160 64360339
Acute generalised exanthematous pustulosis 13.40 12.64 4 113229 14054 64371445
Skin burning sensation 13.39 12.64 45 113188 10538 64374961
Status epilepticus 13.39 12.64 11 113222 21652 64363847
Metastases to bladder 13.35 12.64 7 113226 224 64385275
Stoma complication 13.33 12.64 9 113224 461 64385038
Orthostatic hypotension 13.32 12.64 40 113193 46698 64338801
Uveitis 13.29 12.64 3 113230 12705 64372794
Uterine enlargement 13.28 12.64 11 113222 770 64384729
Amnesia 13.27 12.64 42 113191 48227 64337272
Limb injury 13.25 12.64 13 113220 23492 64362007
Adrenal insufficiency 13.19 12.64 12 113221 22475 64363024
Lung neoplasm malignant 13.12 12.64 11 113222 21437 64364062
Pleural neoplasm 13.12 12.64 7 113226 232 64385267
Cardiac arrest 13.05 12.64 191 113042 153873 64231626
Skin sensitisation 13.05 12.64 11 113222 789 64384710
Malignant peritoneal neoplasm 13.00 12.64 10 113223 629 64384870
Tumour excision 12.96 12.64 9 113224 483 64385016
Rash maculo-papular 12.87 12.64 41 113192 46985 64338514
Liver function test abnormal 12.86 12.64 57 113176 59344 64326155
Subclavian vein thrombosis 12.86 12.64 18 113215 2296 64383203
Fistula of small intestine 12.78 12.64 10 113223 645 64384854
Renal tubular necrosis 12.73 12.64 12 113221 22098 64363401
Dysphonia 12.73 12.64 131 113102 46251 64339248
Herpes zoster 12.71 12.64 84 113149 79103 64306396
Gastrointestinal oedema 12.70 12.64 18 113215 2322 64383177

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
007533 NDDF
108761006 SNOMEDCT_US
386906001 SNOMEDCT_US
4021099 VANDF

Pharmaceutical products:

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