trastuzumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
humanized origin 4979 180288-69-1

Description:

MoleculeDescription

Synonyms:

  • trastuzumab-dkst
  • ogivri
  • trastuzumab
  • herceptin
  • trastuzumab (genetical recombination)
The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro, trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Aug. 28, 2000 EMA ROCHE REGISTRATION GMBH
Sept. 25, 1998 FDA GENENTECH
April 4, 2001 PMDA ROCHE JAPAN

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
Ejection fraction decreased 2866.37 13.99 1197 117599 21135 63349091
Myelosuppression 2561.85 13.99 1125 117671 22578 63347648
Disease progression 1737.40 13.99 1597 117199 121161 63249065
Metastases to central nervous system 1506.51 13.99 650 118146 12455 63357771
Palmar-plantar erythrodysaesthesia syndrome 1271.67 13.99 691 118105 22324 63347902
Diarrhoea 1265.09 13.99 3543 115253 711823 62658403
Cardiotoxicity 1227.17 13.99 495 118301 7943 63362283
Neuropathy peripheral 931.86 13.99 1105 117691 112562 63257664
Febrile neutropenia 743.06 13.99 1008 117788 117441 63252785
Drug ineffective 727.40 13.99 541 118255 1044224 62326002
Neutropenia 677.42 13.99 1191 117605 173814 63196412
Bone marrow failure 550.81 13.99 449 118347 28841 63341385
Metastases to bone 546.88 13.99 391 118405 20628 63349598
Mucosal inflammation 525.90 13.99 538 118258 46390 63323836
Metastases to liver 497.12 13.99 387 118409 23252 63346974
Metastases to lung 481.16 13.99 299 118497 12451 63357775
Chills 454.32 13.99 784 118012 112594 63257632
Polyneuropathy 441.91 13.99 298 118498 14291 63355935
Cardiac dysfunction 440.04 13.99 165 118631 2150 63368076
Rheumatoid arthritis 386.21 13.99 22 118774 253797 63116429
Left ventricular dysfunction 385.09 13.99 254 118542 11734 63358492
Malignant neoplasm progression 355.55 13.99 588 118208 81533 63288693
Breast cancer recurrent 355.23 13.99 170 118626 4171 63366055
Joint swelling 351.58 13.99 90 118706 327576 63042650
Interstitial lung disease 349.14 13.99 501 118295 61407 63308819
Drug hypersensitivity 343.73 13.99 80 118716 310607 63059619
Cardiac failure 336.97 13.99 601 118195 88541 63281685
Synovitis 328.37 13.99 4 118792 186914 63183312
Metastases to lymph nodes 327.39 13.99 199 118597 7959 63362267
Systemic lupus erythematosus 318.09 13.99 18 118778 208900 63161326
Condition aggravated 305.17 13.99 188 118608 402029 62968197
Arthropathy 292.45 13.99 45 118751 234747 63135479
Cardiomyopathy 290.08 13.99 250 118546 17334 63352892
Therapeutic product effect decreased 284.08 13.99 20 118776 193167 63177059
Abdominal discomfort 266.37 13.99 134 118662 320751 63049475
Peripheral sensory neuropathy 259.24 13.99 166 118630 7285 63362941
Completed suicide 256.35 13.99 3 118793 145670 63224556
Metastasis 253.91 13.99 144 118652 5053 63365173
Fall 250.12 13.99 220 118576 392114 62978112
Death 249.32 13.99 1367 117429 373014 62997212
Breast cancer metastatic 248.82 13.99 195 118601 11823 63358403
Metastases to skin 232.93 13.99 95 118701 1568 63368658
Pleural effusion 225.17 13.99 522 118274 92688 63277538
Neoplasm progression 218.92 13.99 304 118492 36124 63334102
Neutropenic sepsis 214.75 13.99 205 118591 16233 63353993
Treatment failure 208.87 13.99 57 118739 198986 63171240
Epistaxis 206.98 13.99 435 118361 72290 63297936
Sinusitis 206.20 13.99 83 118713 226570 63143656
Skin toxicity 204.74 13.99 121 118675 4593 63365633
Pneumonitis 204.32 13.99 289 118507 34933 63335293
Lymphoedema 198.48 13.99 169 118627 11523 63358703
Glossodynia 191.90 13.99 49 118747 178827 63191399
Neurotoxicity 186.98 13.99 193 118603 16797 63353429
Drug interaction 172.27 13.99 108 118688 229023 63141203
Computerised tomogram thorax abnormal 168.89 13.99 77 118719 1686 63368540
Pyrexia 168.63 13.99 1476 117320 469002 62901224
Nail disorder 167.52 13.99 161 118635 12854 63357372
Swelling 167.51 13.99 161 118635 275217 63095009
Product dose omission issue 165.99 13.99 118 118678 234195 63136031
Osteonecrosis of jaw 163.45 13.99 260 118536 34863 63335363
Onychoclasis 162.37 13.99 116 118680 6106 63364120
Onycholysis 161.61 13.99 73 118723 1563 63368663
Drug intolerance 158.73 13.99 207 118589 308454 63061772
Pain 156.18 13.99 785 118011 739843 62630383
Hypokalaemia 156.17 13.99 488 118308 103316 63266910
Weight increased 152.26 13.99 158 118638 260634 63109592
Wound 144.86 13.99 62 118734 163201 63207025
Neutrophil count decreased 141.80 13.99 321 118475 56085 63314141
Nausea 141.77 13.99 2312 116484 852159 62518067
Product use issue 139.89 13.99 124 118672 220396 63149830
Maternal exposure during pregnancy 139.29 13.99 124 118672 219938 63150288
Bone pain 135.18 13.99 309 118487 54332 63315894
Thrombocytopenia 132.99 13.99 598 118198 150559 63219667
Confusional state 130.46 13.99 150 118646 236230 63133996
Recall phenomenon 129.65 13.99 48 118748 602 63369624
Fibromyalgia 128.54 13.99 5 118791 80415 63289811
Decreased appetite 127.44 13.99 855 117941 250197 63120029
Anaemia 126.73 13.99 961 117835 292469 63077757
Vomiting 125.48 13.99 1597 117199 558020 62812206
Loss of personal independence in daily activities 124.85 13.99 17 118779 97273 63272953
Duodenal ulcer perforation 122.61 13.99 11 118785 87198 63283028
Lacrimation increased 122.18 13.99 171 118625 20460 63349766
Psoriasis 122.17 13.99 11 118785 86946 63283280
Ventricular hypokinesia 122.15 13.99 87 118709 4557 63365669
Therapeutic product effect incomplete 121.74 13.99 41 118755 125015 63245211
Drug abuse 121.33 13.99 3 118793 72515 63297711
Hepatic function abnormal 120.91 13.99 235 118561 36907 63333319
Haematotoxicity 120.70 13.99 116 118680 9260 63360966
Vascular device infection 120.66 13.99 104 118692 7208 63363018
Hyperpyrexia 119.17 13.99 78 118718 3554 63366672
Asthenia 118.84 13.99 1167 117629 382437 62987789
Pericardial effusion 117.77 13.99 206 118590 29852 63340374
Nail toxicity 117.08 13.99 38 118758 311 63369915
Toxicity to various agents 116.89 13.99 176 118620 247074 63123152
Musculoskeletal stiffness 115.65 13.99 105 118691 184513 63185713
Nail discolouration 115.28 13.99 69 118727 2681 63367545
Metastatic neoplasm 114.21 13.99 81 118715 4214 63366012
Mitral valve incompetence 113.95 13.99 161 118635 19433 63350793
Somnolence 112.67 13.99 101 118695 178584 63191642
Stomatitis 111.82 13.99 535 118261 138190 63232036
Exposure during pregnancy 110.53 13.99 78 118718 155469 63214757
Lymphangiosis carcinomatosa 110.41 13.99 54 118742 1391 63368835
Discomfort 109.92 13.99 91 118705 167283 63202943
Alveolitis 109.04 13.99 68 118728 2847 63367379
Acute myeloid leukaemia 108.88 13.99 147 118649 17000 63353226
Hospitalisation 108.85 13.99 15 118781 85066 63285160
Overdose 108.12 13.99 40 118756 115038 63255188
Hepatic enzyme increased 107.76 13.99 132 118664 202196 63168030
Dermatitis acneiform 107.62 13.99 83 118713 4913 63365313
Mobility decreased 107.47 13.99 46 118750 121113 63249113
Metastases to spine 107.15 13.99 70 118726 3179 63367047
Leukopenia 102.37 13.99 348 118448 76942 63293284
Paronychia 101.81 13.99 84 118712 5481 63364745
Inappropriate schedule of product administration 101.34 13.99 34 118762 103931 63266295
Hyperbilirubinaemia 99.14 13.99 114 118682 11200 63359026
Biopsy lung abnormal 99.03 13.99 28 118768 134 63370092
Dyspnoea 97.19 13.99 1756 117040 659557 62710669
Blood cholesterol increased 96.58 13.99 28 118768 94004 63276222
Nail dystrophy 95.04 13.99 44 118752 999 63369227
Injection site pain 95.00 13.99 63 118733 129737 63240489
Gastrointestinal toxicity 94.45 13.99 93 118703 7648 63362578
Product use in unapproved indication 93.08 13.99 119 118677 178961 63191265
Arthritis 92.19 13.99 51 118745 115870 63254356
Contusion 90.82 13.99 88 118708 149956 63220270
Cellulitis 89.86 13.99 347 118449 81611 63288615
Irritable bowel syndrome 89.44 13.99 22 118774 82390 63287836
Asthma 89.26 13.99 65 118731 127496 63242730
Erysipelas 89.15 13.99 91 118705 7814 63362412
Colitis 89.08 13.99 245 118551 48283 63321943
Dysgeusia 88.92 13.99 239 118557 46471 63323755
Radiation necrosis 88.62 13.99 32 118764 372 63369854
Onychomadesis 88.22 13.99 79 118717 5761 63364465
Breast pain 88.01 13.99 95 118701 8703 63361523
Pericarditis 87.04 13.99 71 118725 131508 63238718
Neutropenic infection 86.60 13.99 45 118751 1322 63368904
Dry skin 85.10 13.99 267 118529 56620 63313606
Osteoarthritis 84.87 13.99 36 118760 95307 63274919
White blood cell count decreased 83.05 13.99 494 118302 138610 63231616
Organising pneumonia 81.12 13.99 75 118721 5701 63364525
Suicide attempt 79.70 13.99 10 118786 60908 63309318
Platelet count decreased 79.63 13.99 428 118368 115694 63254532
Hot flush 79.19 13.99 243 118553 50916 63319310
Disease recurrence 78.92 13.99 167 118629 27863 63342363
Recurrent cancer 78.51 13.99 48 118748 1939 63368287
Radiation skin injury 77.36 13.99 37 118759 906 63369320
Injury 76.72 13.99 21 118775 73226 63297000
Hypertransaminasaemia 76.20 13.99 77 118719 6532 63363694
Osteonecrosis 75.96 13.99 152 118644 24378 63345848
Lung infiltration 75.60 13.99 113 118683 14350 63355876
Myalgia 74.81 13.99 500 118296 146029 63224197
Computerised tomogram thorax 74.55 13.99 29 118767 420 63369806
Migraine 74.49 13.99 51 118745 103295 63266931
Cough 73.41 13.99 854 117942 291889 63078337
Granulocyte count decreased 73.38 13.99 39 118757 1201 63369025
Oligohydramnios 73.09 13.99 74 118722 6292 63363934
Alanine aminotransferase increased 70.82 13.99 382 118414 103388 63266838
Injection site erythema 69.97 13.99 34 118762 83140 63287086
Aortitis 69.49 13.99 36 118760 1051 63369175
Device related infection 68.93 13.99 142 118654 23250 63346976
Dehydration 68.22 13.99 556 118240 172798 63197428
Madarosis 68.15 13.99 52 118744 3029 63367197
Breast neoplasm 68.13 13.99 39 118757 1393 63368833
Fatigue 66.91 13.99 2151 116645 885877 62484349
Constipation 66.90 13.99 679 118117 224264 63145962
Injection site swelling 66.86 13.99 6 118790 47566 63322660
Atelectasis 66.37 13.99 133 118663 21350 63348876
Mastitis 66.23 13.99 48 118748 2584 63367642
Bronchial polyp 66.07 13.99 18 118778 73 63370153
Multifocal micronodular pneumocyte hyperplasia 66.07 13.99 18 118778 73 63370153
Injection site bruising 65.65 13.99 3 118793 41907 63328319
Blister 64.64 13.99 89 118707 129725 63240501
Onychalgia 64.50 13.99 33 118763 938 63369288
Arthralgia 64.36 13.99 719 118077 568991 62801235
Systolic dysfunction 64.14 13.99 39 118757 1560 63368666
Mastectomy 63.38 13.99 39 118757 1594 63368632
Injection site pruritus 62.58 13.99 6 118790 45110 63325116
Metastases to meninges 62.18 13.99 46 118750 2556 63367670
Blood lactate dehydrogenase increased 61.95 13.99 135 118661 22981 63347245
Chest discomfort 60.23 13.99 382 118414 109587 63260639
Acute interstitial pneumonitis 58.91 13.99 28 118768 676 63369550
Impaired healing 58.78 13.99 63 118733 102479 63267747
Carcinoembryonic antigen increased 58.14 13.99 38 118758 1727 63368499
Tumour marker increased 58.02 13.99 58 118738 4857 63365369
Feeling abnormal 57.94 13.99 119 118677 148273 63221953
Adverse event 57.77 13.99 27 118769 67532 63302694
Urticaria 57.38 13.99 142 118654 165660 63204566
Hepatitis B reactivation 56.65 13.99 47 118749 3090 63367136
Second primary malignancy 56.41 13.99 72 118724 7881 63362345
Injection site reaction 55.54 13.99 20 118776 58504 63311722
Peripheral swelling 55.09 13.99 283 118513 265659 63104567
Alopecia areata 54.83 13.99 36 118760 1649 63368577
Aspartate aminotransferase increased 54.75 13.99 322 118474 89955 63280271
Radiation pneumonitis 54.40 13.99 35 118761 1548 63368678
Sedation 54.26 13.99 5 118791 38804 63331422
Hepatotoxicity 53.69 13.99 172 118624 36869 63333357
Agranulocytosis 53.37 13.99 134 118662 25000 63345226
Erythema 52.94 13.99 532 118264 175219 63195007
Incorrect dose administered 52.79 13.99 23 118773 59945 63310281
Blood bilirubin increased 52.51 13.99 171 118625 36969 63333257
Ventricular dysfunction 52.39 13.99 43 118753 2785 63367441
Nasal congestion 52.03 13.99 29 118767 65631 63304595
Drug reaction with eosinophilia and systemic symptoms 51.18 13.99 3 118793 33833 63336393
Invasive ductal breast carcinoma 50.95 13.99 64 118732 6894 63363332
Ejection fraction abnormal 50.57 13.99 35 118761 1750 63368476
Congestive cardiomyopathy 50.35 13.99 60 118736 6122 63364104
Nail infection 50.20 13.99 40 118756 2483 63367743
Wheezing 50.19 13.99 63 118733 95532 63274694
Axillary pain 49.52 13.99 36 118760 1947 63368279
Hyperfibrinogenaemia 49.00 13.99 12 118784 28 63370198
Hyperkalaemia 48.98 13.99 20 118776 54183 63316043
Transaminases increased 48.54 13.99 149 118647 31218 63339008
Lactic acidosis 48.38 13.99 7 118789 38280 63331946
Ear infection 48.25 13.99 7 118789 38206 63332020
Pulmonary embolism 47.92 13.99 378 118418 116306 63253920
Folliculitis 47.67 13.99 37 118759 70280 63299946
Gait disturbance 47.58 13.99 179 118617 182999 63187227
Bronchitis 47.25 13.99 102 118694 124833 63245393
Blood uric acid decreased 46.86 13.99 25 118771 776 63369450
Neoplasm recurrence 46.55 13.99 39 118757 2599 63367627
Skin fissures 45.84 13.99 79 118717 11309 63358917
Adverse drug reaction 45.65 13.99 49 118747 79665 63290561
Gait inability 45.54 13.99 21 118775 52938 63317288
Depression 45.40 13.99 201 118595 196291 63173935
Ascites 45.08 13.99 173 118623 40555 63329671
Suicidal ideation 44.71 13.99 31 118765 62390 63307836
Hair colour changes 44.68 13.99 41 118755 3086 63367140
Osteoporosis 44.46 13.99 26 118770 57312 63312914
Hallucination 43.74 13.99 24 118772 54793 63315433
Dermatitis 43.14 13.99 97 118699 16861 63353365
Type 2 diabetes mellitus 42.80 13.99 34 118762 63834 63306392
Metastases to pleura 42.39 13.99 30 118766 1555 63368671
Meibomian gland dysfunction 42.04 13.99 15 118781 168 63370058
Anxiety 41.44 13.99 238 118558 217303 63152923
Tachycardia 41.20 13.99 369 118427 117787 63252439
Pseudocirrhosis 41.17 13.99 22 118774 685 63369541
Dyspnoea exertional 41.13 13.99 222 118574 60080 63310146
Tonsillar disorder 40.88 13.99 26 118770 1127 63369099
Therapy interrupted 40.85 13.99 6 118790 32449 63337777
Peripheral motor neuropathy 40.81 13.99 30 118766 1651 63368575
Hydrothorax 40.70 13.99 24 118772 907 63369319
Foot deformity 40.56 13.99 3 118793 27850 63342376
Intentional product misuse 40.11 13.99 33 118763 60884 63309342
Plasma cell myeloma 40.11 13.99 9 118787 35896 63334330
Dermatomyositis 40.03 13.99 37 118759 2811 63367415
Therapy cessation 39.83 13.99 5 118791 30452 63339774
Toxic cardiomyopathy 39.79 13.99 14 118782 150 63370076
Breast disorder 39.76 13.99 35 118761 2495 63367731
Mouth ulceration 39.75 13.99 144 118652 32840 63337386
Hypoxia 39.35 13.99 218 118578 59574 63310652
Troponin I increased 39.32 13.99 33 118763 2205 63368021
Enterocolitis 39.09 13.99 60 118736 7798 63362428
Delirium 39.07 13.99 23 118773 50518 63319708
Lymphadenopathy 39.05 13.99 159 118637 38299 63331927
Cystitis noninfective 39.04 13.99 24 118772 979 63369247
Enterocolitis infectious 38.92 13.99 29 118767 1629 63368597
Acute respiratory distress syndrome 38.49 13.99 114 118682 23420 63346806
Blood alkaline phosphatase increased 38.48 13.99 171 118625 42796 63327430
Cardiac failure congestive 38.25 13.99 300 118496 92133 63278093
Bursitis 38.08 13.99 11 118785 37030 63333196
Sensory disturbance 37.95 13.99 81 118715 13591 63356635
Keratitis 37.87 13.99 39 118757 3383 63366843
Sleep apnoea syndrome 37.58 13.99 5 118791 29128 63341098
Blood creatinine decreased 37.45 13.99 49 118747 5496 63364730
Influenza 36.91 13.99 94 118702 108628 63261598
Neoplasm 36.42 13.99 56 118740 7289 63362937
Metastases to chest wall 36.08 13.99 19 118777 574 63369652
International normalised ratio increased 36.07 13.99 21 118775 46404 63323822
Wrong technique in product usage process 36.05 13.99 38 118758 62302 63307924
Aortic valve incompetence 36.00 13.99 50 118746 5938 63364288
Electrocardiogram QT prolonged 35.89 13.99 35 118761 59495 63310731
Capillary leak syndrome 35.71 13.99 31 118765 2169 63368057
Tumour pain 35.69 13.99 26 118770 1411 63368815
Paraesthesia 35.38 13.99 449 118347 156517 63213709
Product prescribing error 35.16 13.99 4 118792 26285 63343941
Jaw operation 34.74 13.99 21 118775 831 63369395
HER2 positive breast cancer 34.69 13.99 16 118780 360 63369866
Metastases to breast 34.47 13.99 15 118781 293 63369933
Hair texture abnormal 34.26 13.99 41 118755 4202 63366024
Central nervous system lesion 34.25 13.99 67 118729 10568 63359658
Dyskinesia 33.84 13.99 9 118787 31993 63338233
Performance status decreased 33.82 13.99 38 118758 3640 63366586
Sense of oppression 33.77 13.99 22 118774 994 63369232
Excessive eye blinking 33.71 13.99 24 118772 1256 63368970
Breast cancer 33.59 13.99 179 118617 48204 63322022
Eosinophil percentage increased 33.52 13.99 22 118774 1007 63369219
Breast mass 33.26 13.99 56 118740 7866 63362360
Chronic kidney disease 33.24 13.99 22 118774 45376 63324850
Left ventricular dilatation 33.20 13.99 17 118779 484 63369742
Therapy partial responder 32.94 13.99 66 118730 10592 63359634
Aggression 32.92 13.99 3 118793 23495 63346731
Pulmonary mass 32.81 13.99 105 118691 22491 63347735
Hepatic failure 32.76 13.99 143 118653 35513 63334713
Accidental overdose 32.59 13.99 3 118793 23306 63346920
Chronic obstructive pulmonary disease 32.18 13.99 42 118754 62644 63307582
Acute pulmonary oedema 32.06 13.99 56 118740 8102 63362124
Prescribed underdose 32.06 13.99 8 118788 29681 63340545
Intracranial pressure increased 31.95 13.99 44 118752 5183 63365043
Joint injury 31.87 13.99 8 118788 29564 63340662
Treatment noncompliance 31.78 13.99 15 118781 37310 63332916
Cataract 31.64 13.99 36 118760 57017 63313209
Hepatic lesion 31.60 13.99 42 118754 4783 63365443
Odynophagia 31.54 13.99 53 118743 7433 63362793
Ejection fraction 31.41 13.99 30 118766 2376 63367850
Unresponsive to stimuli 31.33 13.99 12 118784 33804 63336422
Basal cell carcinoma 31.30 13.99 7 118789 27984 63342242
Coma 31.16 13.99 45 118751 64319 63305907
Device issue 30.87 13.99 4 118792 23777 63346449
Breast inflammation 30.77 13.99 12 118784 175 63370051
Catheter site bruise 30.64 13.99 16 118780 475 63369751
Illness 30.57 13.99 28 118768 49031 63321195
Gastric disorder 30.34 13.99 16 118780 37353 63332873
Foetal exposure during pregnancy 30.19 13.99 11 118785 31951 63338275
Medication error 30.09 13.99 32 118764 52252 63317974
Hypoglycaemia 30.07 13.99 41 118755 60024 63310202
Cardiac disorder 29.99 13.99 180 118616 50636 63319590
Eastern Cooperative Oncology Group performance status worsened 29.59 13.99 22 118774 1232 63368994
Bone lesion 29.39 13.99 45 118751 5836 63364390
Malignant pleural effusion 29.38 13.99 30 118766 2576 63367650
Blood pressure fluctuation 29.38 13.99 26 118770 46291 63323935
Diabetes mellitus 29.06 13.99 37 118759 55773 63314453
Skin exfoliation 28.93 13.99 158 118638 42944 63327282
Seroma 28.63 13.99 27 118769 2104 63368122
Orthostatic hypotension 28.60 13.99 16 118780 36144 63334082
Nephrolithiasis 28.57 13.99 22 118774 41962 63328264
Pulmonary toxicity 28.57 13.99 58 118738 9397 63360829
Depressed level of consciousness 28.51 13.99 45 118751 62033 63308193
Perforation 28.46 13.99 21 118775 1162 63369064
Tumour marker abnormal 28.19 13.99 14 118782 373 63369853
Biliary sepsis 28.14 13.99 19 118777 912 63369314
Pneumonitis chemical 28.07 13.99 12 118784 224 63370002
Intercepted product preparation error 27.96 13.99 17 118779 680 63369546
Gamma-glutamyltransferase increased 27.92 13.99 132 118664 33899 63336327
Bladder irritation 27.54 13.99 12 118784 235 63369991
Retinal detachment 27.50 13.99 44 118752 5925 63364301
Vulvovaginal inflammation 27.48 13.99 18 118778 821 63369405
Rash pustular 27.35 13.99 49 118747 7233 63362993
Blood glucose increased 27.22 13.99 74 118722 83682 63286544
Cardio-respiratory arrest 27.03 13.99 44 118752 59915 63310311
Breast cellulitis 27.00 13.99 16 118780 610 63369616
Tumour lysis syndrome 26.99 13.99 55 118741 8935 63361291
Axillary vein thrombosis 26.68 13.99 13 118783 332 63369894
Swollen tongue 26.67 13.99 16 118780 34784 63335442
Hip arthroplasty 26.49 13.99 30 118766 47616 63322610
Flushing 26.42 13.99 235 118561 74852 63295374
Rhabdomyolysis 26.31 13.99 26 118770 43925 63326301
Breast oedema 26.24 13.99 8 118788 52 63370174
Vocal cord paralysis 26.03 13.99 26 118770 2175 63368051
Inflammation 25.76 13.99 74 118722 82199 63288027
Hiccups 25.73 13.99 26 118770 2205 63368021
Bone marrow infiltration 25.69 13.99 16 118780 668 63369558
Nasopharyngitis 25.49 13.99 329 118467 253928 63116298
Therapy non-responder 25.47 13.99 66 118730 75835 63294391
Red cell distribution width increased 25.44 13.99 59 118737 10465 63359761
Product quality issue 25.43 13.99 18 118778 35847 63334379
Frequent bowel movements 25.26 13.99 6 118790 23016 63347210
Osteolysis 25.25 13.99 29 118767 2845 63367381
Bile duct stenosis 25.18 13.99 20 118776 1236 63368990
Myocarditis 25.09 13.99 58 118738 10267 63359959
Secondary cerebellar degeneration 25.03 13.99 8 118788 62 63370164
Palmar erythema 24.92 13.99 23 118773 1744 63368482
Diastolic dysfunction 24.89 13.99 44 118752 6427 63363799
Hypervolaemia 24.84 13.99 11 118785 28402 63341824
Eosinophilia 24.83 13.99 6 118790 22750 63347476
Pruritus 24.82 13.99 502 118294 360951 63009275
Gastrointestinal haemorrhage 24.70 13.99 74 118722 81102 63289124
Infection 24.69 13.99 292 118504 228881 63141345
Calcium ionised increased 24.44 13.99 9 118787 111 63370115
Nail bed bleeding 24.33 13.99 12 118784 315 63369911
Hyperchlorhydria 24.08 13.99 23 118773 1821 63368405
Blood creatine increased 24.06 13.99 40 118756 5561 63364665
Full blood count abnormal 23.73 13.99 15 118781 31702 63338524
Nasal disorder 23.66 13.99 28 118768 2836 63367390
Respiratory arrest 23.66 13.99 16 118780 32629 63337597
Injection site haemorrhage 23.60 13.99 8 118788 24306 63345920
COVID-19 23.58 13.99 120 118676 112983 63257243
Dysuria 23.54 13.99 125 118671 33613 63336613
Vessel puncture site bruise 23.42 13.99 13 118783 437 63369789
Dysaesthesia 23.42 13.99 35 118761 4443 63365783
Vulvovaginal dryness 23.37 13.99 28 118768 2873 63367353
Hypersensitivity 23.36 13.99 396 118400 292289 63077937
Cardiac tamponade 23.11 13.99 36 118760 4739 63365487
Brachial plexopathy 22.97 13.99 9 118787 133 63370093
Asthenopia 22.96 13.99 25 118771 2312 63367914
Bone erosion 22.95 13.99 3 118793 17714 63352512
Disorientation 22.86 13.99 24 118772 39428 63330798
Vascular fragility 22.79 13.99 9 118787 136 63370090
Road traffic accident 22.71 13.99 21 118775 36611 63333615
Abnormal behaviour 22.70 13.99 6 118790 21420 63348806
Viral infection 22.64 13.99 20 118776 35643 63334583
Acute leukaemia 22.61 13.99 18 118778 1116 63369110
Acoustic stimulation tests abnormal 22.55 13.99 8 118788 88 63370138
Multicentric reticulohistiocytosis 22.48 13.99 5 118791 6 63370220
Metastases to the mediastinum 22.44 13.99 13 118783 475 63369751
Rhinorrhoea 22.44 13.99 204 118592 65373 63304853
Headache 22.21 13.99 964 117832 632277 62737949
Hyperaesthesia 22.12 13.99 52 118744 9306 63360920
Distichiasis 22.09 13.99 6 118790 24 63370202
Plantar erythema 22.06 13.99 10 118786 216 63370010
Sopor 22.02 13.99 7 118789 22157 63348069
Nodular regenerative hyperplasia 22.00 13.99 13 118783 493 63369733
Cytomegalovirus infection 21.95 13.99 6 118790 20946 63349280
Mental status changes 21.94 13.99 25 118771 39574 63330652
Mean platelet volume decreased 21.89 13.99 26 118770 2643 63367583
Kidney infection 21.85 13.99 8 118788 23168 63347058
Folate deficiency 21.79 13.99 25 118771 2450 63367776
Nail ridging 21.74 13.99 12 118784 399 63369827
Lymphangitis 21.60 13.99 16 118780 891 63369335
Sinus congestion 21.36 13.99 4 118792 18119 63352107
Tricuspid valve incompetence 21.28 13.99 68 118728 14553 63355673
Osteosclerosis 21.21 13.99 31 118765 3857 63366369
Physical capacity evaluation 21.13 13.99 4 118792 0 63370226
Embolism 20.98 13.99 46 118750 7860 63362366
Cardiac failure chronic 20.95 13.99 33 118763 4385 63365841
Lipoprotein increased 20.94 13.99 5 118791 10 63370216
Breast induration 20.84 13.99 6 118790 31 63370195
Osteitis condensans 20.84 13.99 6 118790 31 63370195
Joint range of motion decreased 20.81 13.99 18 118778 32410 63337816
Left ventricular enlargement 20.79 13.99 7 118789 65 63370161
Blood phosphorus decreased 20.76 13.99 33 118763 4420 63365806
Rectal haemorrhage 20.75 13.99 160 118636 48870 63321356
Upper respiratory tract infection 20.75 13.99 81 118715 81966 63288260
Hypercholesterolaemia 20.74 13.99 7 118789 21327 63348899
Fluid retention 20.72 13.99 51 118745 59635 63310591
Brain oedema 20.64 13.99 66 118730 14129 63356097
Sequestrectomy 20.64 13.99 15 118781 811 63369415
Dizziness 20.58 13.99 630 118166 429295 62940931
Superior vena cava syndrome 20.50 13.99 14 118782 685 63369541
Gallbladder disorder 20.49 13.99 5 118791 18837 63351389
Injection site rash 20.44 13.99 5 118791 18804 63351422
Multiple sclerosis 20.44 13.99 10 118786 24362 63345864
Bone sequestrum 20.43 13.99 19 118777 1455 63368771
Joint dislocation 20.43 13.99 5 118791 18795 63351431
Inflammatory carcinoma of the breast 20.33 13.99 7 118789 70 63370156
Toxic optic neuropathy 20.21 13.99 9 118787 186 63370040
Breast haemorrhage 20.13 13.99 9 118787 188 63370038
Cardiovascular disorder 20.07 13.99 58 118738 11754 63358472
Tooth extraction 20.01 13.99 53 118743 10211 63360015
Pustule 19.96 13.99 20 118776 1679 63368547
Dyschezia 19.90 13.99 23 118773 2271 63367955
Disability 19.70 13.99 5 118791 18342 63351884
Pneumocystis jirovecii pneumonia 19.67 13.99 73 118723 16841 63353385
Dysarthria 19.57 13.99 31 118765 42680 63327546
Hypothalamo-pituitary disorder 19.56 13.99 14 118782 739 63369487
Back pain 19.47 13.99 639 118157 263506 63106720
Cystoid macular oedema 19.36 13.99 19 118777 1556 63368670
Infusion site pain 19.30 13.99 4 118792 16865 63353361
Lipidosis 19.30 13.99 6 118790 42 63370184
Chromosomal mutation 19.27 13.99 5 118791 16 63370210
Peripheral venous disease 19.16 13.99 3 118793 15474 63354752
Hypoalbuminaemia 19.13 13.99 57 118739 11748 63358478
Transaminases 19.11 13.99 7 118789 85 63370141
Xerophthalmia 19.00 13.99 12 118784 514 63369712
Respiratory tract congestion 18.88 13.99 5 118791 17827 63352399
Corneal disorder 18.87 13.99 20 118776 1794 63368432
Blood magnesium decreased 18.86 13.99 61 118735 13137 63357089
Atrial thrombosis 18.83 13.99 20 118776 1798 63368428
Jaundice 18.81 13.99 106 118690 29145 63341081
Gingival bleeding 18.74 13.99 59 118737 12528 63357698
Myeloproliferative neoplasm 18.69 13.99 12 118784 529 63369697
Post-traumatic pain 18.57 13.99 11 118785 419 63369807
Protein total decreased 18.46 13.99 37 118759 5940 63364286
Coronary artery disease 18.42 13.99 20 118776 32357 63337869
Creatinine renal clearance decreased 18.39 13.99 4 118792 16304 63353922
Breast sarcoma 18.37 13.99 4 118792 4 63370222
Intentional product use issue 18.35 13.99 152 118644 127740 63242486
Myositis 18.22 13.99 48 118748 9218 63361008
Pleomorphic adenoma 18.21 13.99 5 118791 21 63370205
Congenital syphilitic osteochondritis 18.21 13.99 5 118791 21 63370205
Telangiectasia 18.17 13.99 15 118781 979 63369247
Mucosal dryness 18.15 13.99 24 118772 2720 63367506
Autonomic neuropathy 18.15 13.99 16 118780 1143 63369083
Hand dermatitis 18.12 13.99 9 118787 240 63369986
Device dislocation 18.10 13.99 13 118783 25692 63344534
Pericardial effusion malignant 18.08 13.99 7 118789 100 63370126
Bradycardia 18.07 13.99 73 118723 73154 63297072
Metastases to bone marrow 17.84 13.99 11 118785 451 63369775
Gingival pain 17.84 13.99 44 118752 8118 63362108
Leukaemia cutis 17.83 13.99 7 118789 104 63370122
Tremor 17.82 13.99 347 118449 131892 63238334
Hydrocephalus 17.81 13.99 34 118762 5266 63364960
Paralysis recurrent laryngeal nerve 17.79 13.99 6 118790 56 63370170
Sepsis 17.76 13.99 393 118403 152730 63217496
Sarcoid-like reaction 17.67 13.99 5 118791 24 63370202
Blood pressure systolic increased 17.66 13.99 39 118757 47358 63322868
Joint effusion 17.66 13.99 5 118791 17055 63353171
Sciatica 17.61 13.99 23 118773 34301 63335925
Emotional distress 17.55 13.99 21 118775 32528 63337698
Noninfective conjunctivitis 17.48 13.99 4 118792 6 63370220
Neutropenic colitis 17.36 13.99 25 118771 3070 63367156
Barotrauma 17.35 13.99 8 118788 180 63370046
Botryomycosis 17.34 13.99 5 118791 26 63370200
Spinal pain 17.24 13.99 59 118737 13080 63357146
Alopecia totalis 17.22 13.99 10 118786 367 63369859
Overflow diarrhoea 17.19 13.99 7 118789 115 63370111
Temperature intolerance 17.19 13.99 46 118750 8918 63361308
Breast ulceration 17.16 13.99 6 118790 63 63370163
Dilatation ventricular 17.13 13.99 22 118774 2423 63367803
Retracted nipple 17.10 13.99 4 118792 7 63370219
Chest wall abscess 17.08 13.99 6 118790 64 63370162
Gastritis 17.07 13.99 124 118672 37179 63333047
Gait apraxia 17.03 13.99 5 118791 28 63370198
Herpangina 17.03 13.99 5 118791 28 63370198
Gingival swelling 16.94 13.99 30 118766 4388 63365838
Therapeutic response unexpected 16.82 13.99 7 118789 18752 63351474
Hepatic cancer metastatic 16.81 13.99 10 118786 384 63369842
Cholangiectasis acquired 16.75 13.99 4 118792 8 63370218
Pleural disorder 16.74 13.99 12 118784 635 63369591
Underdose 16.71 13.99 16 118780 27440 63342786
Pituitary tumour 16.70 13.99 14 118782 934 63369292
Status epilepticus 16.65 13.99 4 118792 15229 63354997
Hypocalcaemia 16.63 13.99 109 118687 31604 63338622
Central nervous system neoplasm 16.60 13.99 5 118791 31 63370195
Thyroid disorder 16.54 13.99 4 118792 15158 63355068
Impaired work ability 16.53 13.99 6 118790 17469 63352757
Limb injury 16.52 13.99 14 118782 25463 63344763
Subclavian vein thrombosis 16.48 13.99 19 118777 1871 63368355
Hiatus hernia 16.45 13.99 10 118786 21584 63348642
Lymph node fibrosis 16.44 13.99 4 118792 9 63370217
Peripheral sensorimotor neuropathy 16.40 13.99 17 118779 1486 63368740
Macular degeneration 16.30 13.99 13 118783 24363 63345863
Bone disorder 16.26 13.99 81 118715 21245 63348981
Respiratory depression 16.23 13.99 3 118793 13712 63356514
Entropion 16.22 13.99 6 118790 75 63370151
Neuromyopathy 16.22 13.99 12 118784 667 63369559
Hepatic neoplasm 16.11 13.99 19 118777 1917 63368309
Nasal crusting 16.10 13.99 9 118787 307 63369919
Toxic neuropathy 16.05 13.99 10 118786 418 63369808
Immunodeficiency 15.96 13.99 9 118787 20245 63349981
Pneumonia aspiration 15.89 13.99 25 118771 34515 63335711
Rotator cuff syndrome 15.87 13.99 3 118793 13499 63356727
Simple mastectomy 15.85 13.99 3 118793 0 63370226
Multiple gated acquisition scan abnormal 15.85 13.99 3 118793 0 63370226
Inflammatory carcinoma of breast stage IV 15.85 13.99 3 118793 0 63370226
Globulinuria 15.85 13.99 3 118793 0 63370226
Metastases to the respiratory system 15.85 13.99 3 118793 0 63370226
Left atrial volume increased 15.85 13.99 3 118793 0 63370226
Colitis ischaemic 15.76 13.99 50 118746 10658 63359568
Apical granuloma 15.73 13.99 5 118791 38 63370188
Lymphopenia 15.70 13.99 72 118724 18255 63351971
Acute hepatic failure 15.70 13.99 72 118724 18255 63351971
Eye swelling 15.69 13.99 13 118783 23905 63346321
Catheter site inflammation 15.65 13.99 13 118783 856 63369370
Nervousness 15.65 13.99 21 118775 30958 63339268
Bronchospasm 15.64 13.99 69 118727 17211 63353015
Fear 15.63 13.99 5 118791 15761 63354465
Arachnoid cyst 15.62 13.99 8 118788 228 63369998
Pneumothorax 15.54 13.99 66 118730 16195 63354031
Scintillating scotoma 15.53 13.99 7 118789 149 63370077
Gamma-glutamyltransferase abnormal 15.51 13.99 9 118787 330 63369896
Irritability 15.49 13.99 22 118774 31672 63338554
Glaucoma 15.49 13.99 8 118788 18897 63351329
Cardiac failure acute 15.45 13.99 46 118750 9477 63360749
Mouth swelling 15.43 13.99 30 118766 4710 63365516
Intervertebral disc protrusion 15.41 13.99 13 118783 23696 63346530
Acral peeling skin syndrome 15.37 13.99 4 118792 13 63370213
Skin laceration 15.32 13.99 12 118784 22696 63347530
Stress 15.32 13.99 69 118727 67098 63303128
Metabolic acidosis 15.26 13.99 39 118757 45030 63325196
Vaginal prolapse 15.23 13.99 10 118786 458 63369768
Rash follicular 15.19 13.99 5 118791 43 63370183
Gram stain positive 15.19 13.99 5 118791 43 63370183
Lip dry 15.17 13.99 5 118791 15465 63354761
Oral pain 15.14 13.99 98 118698 28296 63341930
Dacryostenosis acquired 15.08 13.99 11 118785 598 63369628
Spider naevus 15.08 13.99 7 118789 160 63370066
Essential thrombocythaemia 15.08 13.99 7 118789 160 63370066
Duodenal ulcer 15.07 13.99 40 118756 7716 63362510
SAPHO syndrome 15.05 13.99 6 118790 93 63370133
Nasal ulcer 15.00 13.99 20 118776 2284 63367942
Bone cancer metastatic 15.00 13.99 7 118789 162 63370064
Product administration error 14.91 13.99 12 118784 22385 63347841
Laboratory test abnormal 14.90 13.99 17 118779 26895 63343331
Oropharyngeal candidiasis 14.78 13.99 14 118782 1097 63369129
Hallucination, auditory 14.76 13.99 3 118793 12821 63357405
Dyspnoea at rest 14.75 13.99 27 118769 4052 63366174
Blood lactate dehydrogenase abnormal 14.67 13.99 9 118787 366 63369860
Amnesia 14.62 13.99 54 118742 55531 63314695
Skin disorder 14.62 13.99 100 118696 29407 63340819
Dandy-Walker syndrome 14.60 13.99 6 118790 101 63370125
Extravasation 14.55 13.99 20 118776 2352 63367874
Foot fracture 14.48 13.99 14 118782 23900 63346326
Autoimmune disorder 14.47 13.99 7 118789 17170 63353056
Blood bilirubin decreased 14.41 13.99 12 118784 793 63369433
Dystonia 14.39 13.99 4 118792 13815 63356411
Hernia 14.35 13.99 3 118793 12571 63357655
Corneal bleeding 14.35 13.99 4 118792 18 63370208
Cerebrovascular accident 14.33 13.99 131 118665 107893 63262333
Merycism 14.30 13.99 8 118788 273 63369953
Vena cava thrombosis 14.27 13.99 19 118777 2168 63368058
Lethargy 14.26 13.99 164 118632 55843 63314383
Catheter site pain 14.25 13.99 29 118767 4706 63365520
Flatulence 14.25 13.99 27 118769 34675 63335551
Poisoning 14.21 13.99 4 118792 13696 63356530
Ocular vasculitis 14.18 13.99 5 118791 54 63370172
Therapeutic response decreased 14.15 13.99 63 118733 61462 63308764
Adenocarcinoma gastric 14.10 13.99 10 118786 520 63369706
Vulvovaginal candidiasis 14.08 13.99 23 118773 3152 63367074

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
Disease progression 259.64 23.82 193 6548 107884 34842306
Myelosuppression 210.79 23.82 93 6648 19172 34931018
Off label use 143.98 23.82 274 6467 419250 34530940
Palmar-plantar erythrodysaesthesia syndrome 112.81 23.82 58 6683 16737 34933453
Delusion of grandeur 107.51 23.82 28 6713 1132 34949058
Oligohydramnios 104.31 23.82 22 6719 346 34949844
Rhinalgia 90.78 23.82 24 6717 1029 34949161
Death 76.40 23.82 207 6534 397842 34552348
Affective disorder 71.05 23.82 28 6713 4332 34945858
Pulmonary hypoplasia 66.00 23.82 16 6725 481 34949709
Lymphocyte count abnormal 60.66 23.82 18 6723 1180 34949010
Bone marrow failure 58.41 23.82 47 6694 29206 34920984
Metastases to central nervous system 56.98 23.82 29 6712 8176 34942014
Neuropathy peripheral 56.92 23.82 75 6666 83188 34867002
Therapy partial responder 55.42 23.82 30 6711 9586 34940604
Anastomotic complication 53.58 23.82 13 6728 392 34949798
Schizophrenia 52.65 23.82 28 6713 8638 34941552
Alopecia 52.63 23.82 41 6700 24314 34925876
Carbohydrate antigen 15-3 increased 48.57 23.82 9 6732 69 34950121
Intentional product use issue 47.37 23.82 58 6683 59758 34890432
Tidal volume decreased 46.99 23.82 8 6733 35 34950155
Ejection fraction decreased 45.23 23.82 34 6707 19120 34931070
Hallucination, auditory 44.35 23.82 28 6713 11889 34938301
SARS-CoV-2 test positive 44.22 23.82 22 6719 5911 34944279
Diarrhoea 43.72 23.82 169 6572 389743 34560447
Extrapyramidal disorder 42.36 23.82 28 6713 12852 34937338
Neutrophil count increased 41.75 23.82 31 6710 17115 34933075
Mucosal inflammation 38.19 23.82 42 6699 38580 34911610
Metastases to lung 37.46 23.82 23 6718 9297 34940893
Gastric perforation 36.95 23.82 15 6726 2505 34947685
Onycholysis 36.49 23.82 11 6730 761 34949429
Metastases to liver 36.20 23.82 26 6715 13637 34936553
Lymphocyte count decreased 36.19 23.82 32 6709 22590 34927600
Nasal discomfort 35.73 23.82 13 6728 1615 34948575
Foetal growth abnormality 35.10 23.82 6 6735 27 34950163
Incorrect dose administered 33.21 23.82 40 6701 40475 34909715
Leukopenia 33.08 23.82 50 6691 62806 34887384
Drug interaction 32.67 23.82 3 6738 225943 34724247
Metastases to bone 32.22 23.82 23 6718 11947 34938243
Paranasal sinus discomfort 31.40 23.82 10 6731 830 34949360
Neutropenia 31.26 23.82 83 6658 156695 34793495
Anastomotic leak 29.86 23.82 9 6732 622 34949568
Metastases to meninges 29.65 23.82 11 6730 1443 34948747
Obstruction gastric 29.56 23.82 10 6731 1003 34949187
Rectal polyp 28.70 23.82 9 6732 710 34949480
Renal hypoplasia 28.46 23.82 6 6735 94 34950096
Lymphoedema 27.36 23.82 14 6727 3989 34946201
Psychotic disorder 26.64 23.82 28 6713 24424 34925766
Platelet count decreased 26.55 23.82 66 6675 119651 34830539
Hepatic lesion 25.42 23.82 13 6728 3699 34946491
Breast cancer metastatic 24.52 23.82 5 6736 66 34950124
Foetal growth restriction 24.15 23.82 13 6728 4104 34946086

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
Myelosuppression 2403.91 13.91 1104 94566 39192 79609526
Ejection fraction decreased 1874.74 13.91 887 94783 33690 79615028
Diarrhoea 998.02 13.91 2796 92874 877693 78771025
Disease progression 968.22 13.91 1148 94522 183214 79465504
Palmar-plantar erythrodysaesthesia syndrome 904.66 13.91 538 95132 32596 79616122
Metastases to central nervous system 895.91 13.91 423 95247 15952 79632766
Cardiotoxicity 724.78 13.91 334 95336 11905 79636813
Neuropathy peripheral 720.06 13.91 867 94803 140438 79508280
Bone marrow failure 497.12 13.91 444 95226 50663 79598055
Drug ineffective 449.85 13.91 384 95286 1080529 78568189
Metastases to bone 420.52 13.91 297 95373 24130 79624588
Metastases to liver 390.03 13.91 301 95369 28013 79620705
Febrile neutropenia 384.87 13.91 853 94817 230146 79418572
Polyneuropathy 384.45 13.91 280 95390 23871 79624847
Mucosal inflammation 363.85 13.91 451 95219 75129 79573589
Metastases to lung 362.65 13.91 242 95428 17921 79630797
Chills 351.23 13.91 663 95007 159571 79489147
Neutropenia 345.75 13.91 937 94733 286773 79361945
Cardiac dysfunction 343.09 13.91 143 95527 3981 79644737
Breast cancer recurrent 287.91 13.91 115 95555 2862 79645856
Left ventricular dysfunction 262.65 13.91 204 95466 19157 79629561
Metastases to lymph nodes 255.75 13.91 158 95512 10239 79638479
Breast cancer metastatic 232.86 13.91 139 95531 8463 79640255
Drug interaction 230.44 13.91 105 95565 415078 79233640
Rheumatoid arthritis 211.49 13.91 9 95661 208461 79440257
Condition aggravated 209.95 13.91 176 95494 500948 79147770
Cardiomyopathy 203.85 13.91 210 95460 28564 79620154
Fall 203.36 13.91 172 95498 487457 79161261
Lymphoedema 202.27 13.91 146 95524 12267 79636451
Neutropenic sepsis 199.87 13.91 202 95468 26862 79621856
Interstitial lung disease 197.65 13.91 425 95245 112175 79536543
Nausea 194.43 13.91 1873 93797 955323 78693395
Malignant neoplasm progression 188.82 13.91 468 95202 135522 79513196
Drug hypersensitivity 181.35 13.91 66 95604 298850 79349868
Neoplasm progression 180.69 13.91 264 95406 51418 79597300
Drug abuse 179.85 13.91 3 95667 162688 79486030
Computerised tomogram thorax abnormal 178.37 13.91 77 95593 2342 79646376
Peripheral sensory neuropathy 178.24 13.91 138 95532 12895 79635823
Metastases to skin 178.03 13.91 70 95600 1669 79647049
Toxicity to various agents 175.31 13.91 149 95521 421391 79227327
Joint swelling 168.01 13.91 68 95602 288578 79360140
Synovitis 165.71 13.91 3 95667 150731 79497987
Contraindicated product administered 162.48 13.91 6 95664 157532 79491186
Onycholysis 155.87 13.91 67 95603 2016 79646702
Stomatitis 155.38 13.91 457 95213 146300 79502418
Cardiac failure 153.40 13.91 471 95199 154371 79494347
Osteonecrosis of jaw 152.83 13.91 222 95448 43004 79605714
Epistaxis 146.63 13.91 376 95294 111139 79537579
Therapeutic product effect decreased 135.72 13.91 18 95652 163845 79484873
Product dose omission issue 135.03 13.91 64 95606 247473 79401245
Hyperpyrexia 133.36 13.91 86 95584 6006 79642712
Hypokalaemia 133.32 13.91 428 95242 143612 79505106
Confusional state 130.18 13.91 114 95556 317883 79330835
Metastasis 128.55 13.91 88 95582 6792 79641926
Pleural effusion 124.92 13.91 421 95249 144841 79503877
Arthropathy 121.98 13.91 31 95639 177080 79471638
Vomiting 117.42 13.91 1267 94403 664561 78984157
Vascular device infection 115.46 13.91 97 95573 10179 79638539
Pneumonitis 115.20 13.91 237 95433 60623 79588095
Nail toxicity 114.60 13.91 34 95636 329 79648389
Recall phenomenon 113.70 13.91 45 95625 1092 79647626
Bone pain 111.37 13.91 222 95448 55520 79593198
Biopsy lung abnormal 110.36 13.91 28 95642 140 79648578
Nail disorder 109.32 13.91 100 95570 11752 79636966
Nail dystrophy 108.02 13.91 42 95628 971 79647747
Skin toxicity 107.13 13.91 85 95585 8229 79640489
Abdominal discomfort 106.11 13.91 87 95583 250640 79398078
Systemic lupus erythematosus 106.05 13.91 11 95659 121138 79527580
Lacrimation increased 104.67 13.91 132 95538 22345 79626373
Alveolitis 104.01 13.91 64 95606 4116 79644602
Decreased appetite 99.31 13.91 727 94943 341691 79307027
Fatigue 99.09 13.91 1614 94056 928113 78720605
Lymphangiosis carcinomatosa 97.77 13.91 49 95621 2105 79646613
Paronychia 96.71 13.91 78 95592 7730 79640988
Cellulitis 96.32 13.91 319 95351 108741 79539977
Nail discolouration 92.65 13.91 53 95617 2978 79645740
Neurotoxicity 92.44 13.91 151 95519 32367 79616351
Gastrointestinal toxicity 92.05 13.91 77 95593 8032 79640686
Treatment failure 91.53 13.91 45 95625 170441 79478277
Pyrexia 90.88 13.91 1226 94444 677483 78971235
Overdose 89.64 13.91 55 95615 184151 79464567
Alopecia 89.43 13.91 528 95142 230827 79417891
Oligohydramnios 89.41 13.91 54 95616 3358 79645360
Metastases to meninges 89.26 13.91 55 95615 3546 79645172
Somnolence 89.20 13.91 93 95577 238888 79409830
Sinusitis 88.88 13.91 63 95607 195438 79453280
Computerised tomogram thorax 87.07 13.91 29 95641 421 79648297
Madarosis 85.66 13.91 49 95621 2753 79645965
Dyspnoea 85.42 13.91 1472 94198 855553 78793165
Dysgeusia 84.86 13.91 202 95468 56975 79591743
Psoriasis 84.22 13.91 6 95664 89581 79559137
Neutrophil count decreased 84.01 13.91 276 95394 93683 79555035
Weight increased 82.70 13.91 128 95542 277258 79371460
Loss of personal independence in daily activities 80.91 13.91 13 95657 102567 79546151
Onychoclasis 80.52 13.91 61 95609 5517 79643201
Erysipelas 80.13 13.91 81 95589 10769 79637949
Inappropriate schedule of product administration 80.13 13.91 30 95640 133598 79515120
Metastases to spine 80.06 13.91 55 95615 4269 79644449
Metastatic neoplasm 79.18 13.91 58 95612 4984 79643734
Pericardial effusion 78.18 13.91 172 95498 46065 79602653
Mastitis 77.03 13.91 42 95628 2149 79646569
Hyperkalaemia 76.89 13.91 21 95649 114377 79534341
Mitral valve incompetence 76.31 13.91 129 95541 28436 79620282
White blood cell count decreased 76.17 13.91 435 95235 187853 79460865
Ventricular hypokinesia 75.44 13.91 73 95597 9206 79639512
Product use in unapproved indication 74.18 13.91 116 95554 250243 79398475
Multifocal micronodular pneumocyte hyperplasia 74.00 13.91 18 95652 73 79648645
Bronchial polyp 73.62 13.91 18 95652 75 79648643
Invasive ductal breast carcinoma 73.27 13.91 59 95611 5833 79642885
Aortitis 70.52 13.91 35 95635 1472 79647246
Hypertransaminasaemia 70.32 13.91 79 95591 11845 79636873
Anaemia 69.25 13.91 827 94843 444188 79204530
Rhabdomyolysis 69.19 13.91 19 95651 103112 79545606
Pain 69.00 13.91 528 95142 703274 78945444
Suicide attempt 68.91 13.91 9 95661 82923 79565795
Hot flush 67.96 13.91 181 95489 54696 79594022
Acute myeloid leukaemia 67.78 13.91 128 95542 30757 79617961
Granulocyte count decreased 67.31 13.91 36 95634 1772 79646946
Dermatitis acneiform 67.30 13.91 71 95599 9922 79638796
Tumour marker increased 66.76 13.91 49 95621 4223 79644495
Alopecia areata 66.66 13.91 36 95634 1807 79646911
Therapy partial responder 65.37 13.91 92 95578 17305 79631413
Fibromyalgia 64.48 13.91 3 95667 64337 79584381
Drug reaction with eosinophilia and systemic symptoms 64.36 13.91 3 95667 64241 79584477
Product use issue 64.28 13.91 95 95575 209727 79438991
Haematotoxicity 64.24 13.91 86 95584 15433 79633285
Cough 63.95 13.91 697 94973 366092 79282626
Hospitalisation 63.90 13.91 17 95653 94219 79554499
Leukopenia 63.75 13.91 293 95377 116220 79532498
Colitis 63.44 13.91 213 95457 73094 79575624
Breast pain 63.42 13.91 63 95607 8202 79640516
Hyperbilirubinaemia 63.22 13.91 109 95561 24409 79624309
Therapeutic product effect incomplete 62.61 13.91 47 95623 141598 79507120
Device related infection 60.75 13.91 130 95540 34164 79614554
Atelectasis 60.30 13.91 125 95545 32132 79616586
Lactic acidosis 60.01 13.91 7 95663 70352 79578366
Platelet count decreased 59.63 13.91 419 95251 194245 79454473
Hepatic function abnormal 58.54 13.91 207 95463 72900 79575818
Mastectomy 57.63 13.91 28 95642 1124 79647594
Radiation skin injury 57.48 13.91 30 95640 1404 79647314
Disease recurrence 57.18 13.91 148 95522 43961 79604757
Onychalgia 56.40 13.91 26 95644 926 79647792
Arthritis 56.29 13.91 34 95636 114846 79533872
Hair texture abnormal 56.28 13.91 41 95629 3493 79645225
Acute interstitial pneumonitis 56.04 13.91 28 95642 1195 79647523
Mobility decreased 56 13.91 39 95631 122136 79526582
Organising pneumonia 55.37 13.91 67 95603 10872 79637846
Chest discomfort 55.20 13.91 318 95352 137726 79510992
Neutropenic infection 54.95 13.91 35 95635 2392 79646326
Drug intolerance 53.35 13.91 152 95518 263967 79384751
Myalgia 53.06 13.91 393 95277 185248 79463470
Myocardial infarction 52.93 13.91 87 95583 184042 79464676
Cardio-respiratory arrest 51.94 13.91 33 95637 108477 79540241
Delusion of grandeur 51.87 13.91 28 95642 1404 79647314
Asthenia 51.53 13.91 881 94789 510808 79137910
Hepatic enzyme increased 50.90 13.91 88 95582 182522 79466196
Duodenal ulcer perforation 50.86 13.91 9 95661 66202 79582516
International normalised ratio increased 50.81 13.91 19 95651 84702 79564016
Acute kidney injury 50.66 13.91 390 95280 519014 79129704
Carcinoembryonic antigen increased 50.37 13.91 32 95638 2177 79646541
Asthma 49.90 13.91 53 95617 135042 79513676
Hair colour changes 49.73 13.91 41 95629 4191 79644527
Tonsillar disorder 49.37 13.91 26 95644 1240 79647478
Gastrointestinal haemorrhage 49.13 13.91 63 95607 147656 79501062
Paraesthesia 49.10 13.91 371 95299 175952 79472766
Musculoskeletal stiffness 49.09 13.91 84 95586 174924 79473794
Delirium 49.07 13.91 20 95650 84607 79564111
Injury 48.85 13.91 16 95654 77480 79571238
Axillary pain 48.68 13.91 31 95639 2118 79646600
Swelling 48.09 13.91 119 95551 216592 79432126
Infusion related reaction 47.98 13.91 454 95216 229783 79418935
Osteonecrosis 47.37 13.91 111 95559 30984 79617734
Contusion 45.90 13.91 67 95603 148709 79500009
Meibomian gland dysfunction 45.80 13.91 15 95655 206 79648512
Hallucination 45.45 13.91 23 95647 85722 79562996
Pseudocirrhosis 44.80 13.91 20 95650 660 79648058
Breast neoplasm 44.67 13.91 22 95648 910 79647808
Sedation 44.67 13.91 5 95665 51890 79596828
Recurrent cancer 44.61 13.91 32 95638 2661 79646057
Feeling abnormal 44.11 13.91 77 95593 159122 79489596
Plasma cell myeloma 43.72 13.91 6 95664 53253 79595465
Blood uric acid decreased 43.38 13.91 24 95646 1264 79647454
Dry skin 43.30 13.91 179 95491 67816 79580902
Bradycardia 42.86 13.91 60 95610 135497 79513221
Carbohydrate antigen 15-3 increased 42.56 13.91 23 95647 1156 79647562
Wound 42.43 13.91 46 95624 116133 79532585
Discomfort 42.37 13.91 53 95617 125564 79523154
Orthostatic hypotension 42.35 13.91 8 95662 56156 79592562
Metastases to chest wall 42.33 13.91 18 95652 527 79648191
Product prescribing error 42.12 13.91 3 95667 44810 79603908
Hyperfibrinogenaemia 42.04 13.91 12 95658 100 79648618
Hypoglycaemia 42.02 13.91 36 95634 101558 79547160
Drug ineffective for unapproved indication 41.53 13.91 6 95664 51232 79597486
Nasal congestion 41.38 13.91 20 95650 76532 79572186
Arthralgia 41.23 13.91 463 95207 571340 79077378
Injection site reaction 40.90 13.91 8 95662 54777 79593941
Injection site pain 40.52 13.91 58 95612 129780 79518938
Hydrothorax 40.45 13.91 24 95646 1444 79647274
Breast mass 40.26 13.91 45 95625 6709 79642009
Intentional product misuse 40.25 13.91 33 95637 95132 79553586
Erythema 40.10 13.91 427 95243 222863 79425855
Second primary malignancy 39.92 13.91 66 95604 14284 79634434
Electrocardiogram QT prolonged 39.92 13.91 30 95640 90356 79558362
Hepatotoxicity 39.90 13.91 144 95526 51208 79597510
Unresponsive to stimuli 39.89 13.91 9 95661 55779 79592939
Blood creatinine decreased 39.72 13.91 48 95622 7777 79640941
Cytomegalovirus infection 39.66 13.91 3 95667 42641 79606077
Constipation 39.64 13.91 516 95154 282534 79366184
Wheezing 39.58 13.91 49 95621 116615 79532103
Blood cholesterol increased 39.33 13.91 26 95644 83694 79565024
Central nervous system lesion 39.25 13.91 63 95607 13305 79635413
Agranulocytosis 39.09 13.91 131 95539 44899 79603819
Keratitis 38.95 13.91 36 95634 4286 79644432
Glossodynia 38.76 13.91 40 95630 103297 79545421
Nail infection 38.58 13.91 28 95642 2371 79646347
Medication error 38.55 13.91 17 95653 68625 79580093
Chronic obstructive pulmonary disease 38.18 13.91 28 95642 85391 79563327
Blood lactate dehydrogenase increased 37.66 13.91 118 95552 39052 79609666
Depression 37.30 13.91 134 95536 216656 79432062
Osteoarthritis 37.27 13.91 30 95640 87279 79561439
Injection site erythema 37.12 13.91 24 95646 78173 79570545
Dyskinesia 36.86 13.91 5 95665 44768 79603950
Enterocolitis 36.74 13.91 64 95606 14448 79634270
Metastases to pleura 36.66 13.91 23 95647 1531 79647187
Injection site pruritus 36.58 13.91 4 95666 42279 79606439
Sensory disturbance 36.24 13.91 65 95605 15012 79633706
Accidental overdose 36.21 13.91 3 95667 39578 79609140
HER2 positive breast cancer 35.99 13.91 14 95656 324 79648394
Temperature intolerance 35.98 13.91 51 95619 9654 79639064
Vulvovaginal dryness 35.87 13.91 26 95644 2198 79646520
Hepatic lesion 35.84 13.91 43 95627 6916 79641802
Radiation necrosis 35.57 13.91 15 95655 430 79648288
Coronary artery disease 35.55 13.91 17 95653 65457 79583261
Odynophagia 35.49 13.91 55 95615 11272 79637446
Mental status changes 35.43 13.91 18 95652 66941 79581777
Ejection fraction 35.40 13.91 26 95644 2243 79646475
Adverse event 35.28 13.91 14 95656 60200 79588518
Bladder irritation 35.23 13.91 13 95657 259 79648459
Eosinophilia 35.19 13.91 6 95664 45339 79603379
Flushing 35.05 13.91 203 95467 88065 79560653
Onychomadesis 34.86 13.91 37 95633 5205 79643513
Acoustic stimulation tests abnormal 34.75 13.91 8 95662 24 79648694
Cystitis noninfective 34.58 13.91 21 95649 1319 79647399
Dermatitis 34.56 13.91 78 95592 21243 79627475
Anxiety 34.44 13.91 167 95503 248345 79400373
Coma 34.43 13.91 42 95628 100607 79548111
Respiratory arrest 34.35 13.91 13 95657 57537 79591181
Blood pressure fluctuation 34.13 13.91 19 95651 67126 79581592
Blister 33.81 13.91 57 95613 119419 79529299
Skin fissures 33.55 13.91 58 95612 13015 79635703
Suicidal ideation 32.87 13.91 26 95644 76314 79572404
Breast disorder 32.81 13.91 24 95646 2057 79646661
Irritable bowel syndrome 32.53 13.91 17 95653 62224 79586494
Dehydration 32.48 13.91 447 95223 247740 79400978
Gait inability 32.45 13.91 15 95655 58902 79589816
Jaw operation 32.25 13.91 17 95653 812 79647906
Rhinalgia 32.22 13.91 25 95645 2342 79646376
Pulmonary mass 32.20 13.91 92 95578 28942 79619776
Eosinophil percentage increased 32.17 13.91 21 95649 1497 79647221
Diabetes mellitus 32.14 13.91 28 95642 78362 79570356
Pericarditis 32.09 13.91 47 95623 104189 79544529
Catheter site bruise 31.88 13.91 14 95656 444 79648274
Chronic kidney disease 31.82 13.91 20 95650 66134 79582584
Sense of oppression 31.57 13.91 21 95649 1545 79647173
Depressed level of consciousness 31.33 13.91 42 95628 96610 79552108
Thrombocytopenia 31.24 13.91 469 95201 264790 79383928
Congestive cardiomyopathy 31.20 13.91 53 95617 11727 79636991
Vascular fragility 31.18 13.91 10 95660 128 79648590
Perforation 30.89 13.91 20 95650 1406 79647312
Gait disturbance 30.79 13.91 136 95534 207370 79441348
Troponin I increased 30.73 13.91 33 95637 4705 79644013
Tumour pain 30.69 13.91 24 95646 2275 79646443
Cardiac arrest 30.52 13.91 105 95565 171991 79476727
Migraine 30.47 13.91 36 95634 87457 79561261
Dysarthria 30.44 13.91 22 95648 67600 79581118
Neoplasm recurrence 30.28 13.91 31 95639 4183 79644535
Disorientation 30.16 13.91 19 95651 62757 79585961
Enterocolitis infectious 30.02 13.91 26 95644 2843 79645875
Excessive eye blinking 30.00 13.91 21 95649 1680 79647038
Exposure during pregnancy 29.79 13.91 47 95623 101085 79547633
Wrong technique in product usage process 29.56 13.91 27 95643 73848 79574870
Asthenopia 29.54 13.91 24 95646 2403 79646315
Mouth ulceration 29.27 13.91 107 95563 38287 79610431
Treatment noncompliance 29.26 13.91 13 95657 52255 79596463
Systolic dysfunction 29.25 13.91 29 95641 3766 79644952
Therapy cessation 29.08 13.91 5 95665 37557 79611161
Death 28.79 13.91 886 94784 565628 79083090
Mean platelet volume decreased 28.62 13.91 25 95645 2765 79645953
Corneal disorder 28.61 13.91 23 95647 2268 79646450
Capillary leak syndrome 28.43 13.91 29 95641 3896 79644822
Hyperchlorhydria 28.39 13.91 22 95648 2057 79646661
Anastomotic complication 28.36 13.91 13 95657 457 79648261
Urticaria 28.32 13.91 120 95550 185081 79463637
Tachycardia 28.28 13.91 332 95338 177436 79471282
Blood glucose increased 28.02 13.91 60 95610 114915 79533803
Ear infection 27.98 13.91 4 95666 34428 79614290
Abnormal behaviour 27.86 13.91 5 95665 36416 79612302
Lung infiltration 27.78 13.91 75 95595 22837 79625881
Impaired healing 27.50 13.91 39 95631 87616 79561102
Off label use 27.40 13.91 1340 94330 905875 78742843
Vessel puncture site bruise 27.30 13.91 13 95657 499 79648219
Red cell distribution width increased 27.24 13.91 58 95612 15184 79633534
Tumour marker abnormal 27.19 13.91 11 95659 283 79648435
Back pain 27.10 13.91 514 95156 303666 79345052
Nasal discomfort 26.80 13.91 33 95637 5450 79643268
Aortic valve incompetence 26.74 13.91 44 95626 9486 79639232
Dyspepsia 26.57 13.91 222 95448 108465 79540253
Osteoporosis 26.52 13.91 16 95654 54096 79594622
Breast cancer 26.47 13.91 95 95575 33686 79615032
Osteosclerosis 26.36 13.91 28 95642 3943 79644775
Blood alkaline phosphatase increased 26.31 13.91 148 95522 63516 79585202
Biliary sepsis 26.30 13.91 19 95651 1598 79647120
Dizziness 26.23 13.91 459 95211 525982 79122736
Nephrolithiasis 25.78 13.91 16 95654 53275 79595443
Nasal disorder 25.77 13.91 27 95643 3742 79644976
Metabolic acidosis 25.61 13.91 37 95633 82492 79566226
Lymphocyte count abnormal 25.22 13.91 18 95652 1485 79647233
Maternal exposure during pregnancy 25.10 13.91 82 95588 136456 79512262
Renal failure 25.06 13.91 140 95530 200828 79447890
Papilloedema 24.97 13.91 34 95636 6199 79642519
Breast inflammation 24.93 13.91 9 95661 168 79648550
Lymphadenopathy 24.86 13.91 128 95542 53119 79595599
Basal cell carcinoma 24.85 13.91 7 95663 37368 79611350
Bone lesion 24.80 13.91 33 95637 5886 79642832
Swollen tongue 24.77 13.91 10 95660 42560 79606158
Subdural haematoma 24.74 13.91 4 95666 31430 79617288
Vulvovaginal candidiasis 24.73 13.91 22 95648 2492 79646226
Multicentric reticulohistiocytosis 24.70 13.91 5 95665 6 79648712
Therapy interrupted 24.64 13.91 4 95666 31337 79617381
Peripheral motor neuropathy 24.61 13.91 25 95645 3342 79645376
Adverse drug reaction 24.56 13.91 26 95644 66366 79582352
Lymphocyte count decreased 24.44 13.91 117 95553 47172 79601546
Renal impairment 24.26 13.91 102 95568 157681 79491037
Sopor 24.26 13.91 5 95665 33005 79615713
Eastern Cooperative Oncology Group performance status worsened 24.25 13.91 20 95650 2045 79646673
Road traffic accident 24.23 13.91 11 95659 43653 79605065
Cerebrovascular accident 24.12 13.91 100 95570 155192 79493526
Breast cellulitis 24.09 13.91 11 95659 383 79648335
Performance status decreased 23.97 13.91 33 95637 6080 79642638
Emotional distress 23.90 13.91 9 95661 39960 79608758
Infection 23.74 13.91 181 95489 241531 79407187
Pulmonary embolism 23.61 13.91 312 95358 171342 79477376
Vulvovaginal inflammation 23.55 13.91 12 95658 534 79648184
Osteitis condensans 23.48 13.91 6 95664 31 79648687
Blood creatine phosphokinase increased 23.22 13.91 27 95643 66063 79582655
Palmar erythema 23.16 13.91 19 95651 1928 79646790
Lipoprotein increased 23.15 13.91 5 95665 10 79648708
Dermatomyositis 23.09 13.91 25 95645 3598 79645120
Influenza 23.03 13.91 79 95591 129527 79519191
Gastrointestinal disorder 23.00 13.91 236 95434 121969 79526749
Calcium ionised increased 22.95 13.91 9 95661 213 79648505
Respiratory depression 22.95 13.91 3 95667 27627 79621091
Cystoid macular oedema 22.88 13.91 19 95651 1961 79646757
Folate deficiency 22.85 13.91 24 95646 3336 79645382
Pneumonia aspiration 22.84 13.91 28 95642 66939 79581779
Frequent bowel movements 22.72 13.91 4 95666 29535 79619183
Neutrophil count increased 22.47 13.91 82 95588 29314 79619404
Illness 22.45 13.91 14 95656 46497 79602221
Post-traumatic pain 22.45 13.91 11 95659 450 79648268
Pneumonitis chemical 22.20 13.91 11 95659 461 79648257
Lipidosis 22.19 13.91 6 95664 40 79648678
Dysaesthesia 22.08 13.91 31 95639 5817 79642901
Acute pulmonary oedema 21.89 13.91 51 95619 14179 79634539
Lymphangitis 21.66 13.91 16 95654 1392 79647326
Bursitis 21.55 13.91 8 95662 35836 79612882
Rash pustular 21.33 13.91 44 95626 11267 79637451
Folliculitis 21.26 13.91 21 95649 55359 79593359
Alopecia totalis 21.07 13.91 10 95660 381 79648337
Xerophthalmia 21.06 13.91 12 95658 669 79648049
Blood lactate dehydrogenase abnormal 21.05 13.91 9 95661 267 79648451
Nail bed bleeding 20.98 13.91 12 95658 674 79648044
Pulmonary hypoplasia 20.71 13.91 6 95664 53 79648665
Hypoxia 20.69 13.91 202 95468 103041 79545677
Metastases to breast 20.66 13.91 9 95661 280 79648438
Limb injury 20.64 13.91 5 95665 29523 79619195
Pustule 20.48 13.91 18 95652 2007 79646711
Distichiasis 20.42 13.91 5 95665 21 79648697
Hypervolaemia 20.40 13.91 13 95657 42677 79606041
Poisoning 20.38 13.91 3 95667 25269 79623449
Left ventricular dilatation 20.37 13.91 14 95656 1087 79647631
Sinus bradycardia 20.36 13.91 3 95667 25244 79623474
Hypotension 20.32 13.91 389 95281 439928 79208790
Barotrauma 20.30 13.91 8 95662 192 79648526
Hypoaesthesia 20.28 13.91 315 95355 179037 79469681
Vaginal prolapse 20.16 13.91 9 95661 297 79648421
Encephalopathy 20.15 13.91 31 95639 67366 79581352
Breast sarcoma 20.14 13.91 4 95666 4 79648714
Urinary retention 20.04 13.91 23 95647 56607 79592111
Mouth swelling 19.83 13.91 30 95640 6021 79642697
Radiation pneumonitis 19.76 13.91 24 95646 3909 79644809
Bronchitis 19.75 13.91 85 95585 130559 79518159
Metastases to the mediastinum 19.54 13.91 11 95659 599 79648119
Subclavian vein thrombosis 19.35 13.91 19 95651 2438 79646280
Viral infection 19.35 13.91 14 95656 43002 79605716
Hypothalamo-pituitary disorder 19.35 13.91 14 95656 1180 79647538
Ulcerative keratitis 19.33 13.91 23 95647 3666 79645052
Tidal volume decreased 19.29 13.91 6 95664 69 79648649
Pancreatitis 19.14 13.91 33 95637 68542 79580176
Angioedema 19.10 13.91 39 95631 75996 79572722
Foot deformity 19.09 13.91 3 95667 24071 79624647
Herpangina 19.09 13.91 5 95665 29 79648689
Blood magnesium decreased 18.97 13.91 53 95617 16459 79632259
Metastases to bone marrow 18.97 13.91 12 95658 810 79647908
Intracranial pressure increased 18.89 13.91 35 95635 8287 79640431
Joint injury 18.83 13.91 7 95663 31328 79617390
Osteolysis 18.73 13.91 25 95645 4473 79644245
Transaminases 18.69 13.91 6 95664 77 79648641
Gait apraxia 18.67 13.91 5 95665 32 79648686
Inflammatory carcinoma of the breast 18.67 13.91 5 95665 32 79648686
Retinal detachment 18.67 13.91 37 95633 9210 79639508
Acute respiratory distress syndrome 18.58 13.91 103 95567 43964 79604754
Ventricular dysfunction 18.53 13.91 29 95641 5994 79642724
Ovarian failure 18.49 13.91 11 95659 665 79648053
Gastric disorder 18.44 13.91 11 95659 37422 79611296
Full blood count abnormal 18.43 13.91 13 95657 40461 79608257
Movement disorder 18.32 13.91 5 95665 27254 79621464
Spinal pain 18.28 13.91 50 95620 15342 79633376
Lymph node fibrosis 18.20 13.91 4 95666 9 79648709
Hand dermatitis 18.19 13.91 9 95661 376 79648342
Device issue 18.16 13.91 5 95665 27103 79621615
Gingival pain 18.16 13.91 36 95634 8962 79639756
Merycism 18.15 13.91 8 95662 256 79648462
Haemorrhoids 18.00 13.91 76 95594 29052 79619666
Therapy non-responder 17.97 13.91 54 95616 92251 79556467
Overflow diarrhoea 17.88 13.91 7 95663 165 79648553
Autoimmune hypothyroidism 17.73 13.91 8 95662 271 79648447
Gout 17.68 13.91 4 95666 24745 79623973
Aphasia 17.62 13.91 18 95652 46714 79602004
Malignant pleural effusion 17.59 13.91 21 95649 3359 79645359
Nail bed tenderness 17.57 13.91 9 95661 405 79648313
Toxic cardiomyopathy 17.53 13.91 9 95661 407 79648311
Gastritis 17.52 13.91 108 95562 47885 79600833
Type 2 diabetes mellitus 17.34 13.91 26 95644 57096 79591622
Cataract 17.24 13.91 30 95640 62090 79586628
Left atrial volume increased 17.18 13.91 3 95667 0 79648718
Metastases to the respiratory system 17.18 13.91 3 95667 0 79648718
Simple mastectomy 17.18 13.91 3 95667 0 79648718
Globulinuria 17.18 13.91 3 95667 0 79648718
Cytokine release syndrome 17.15 13.91 11 95659 35987 79612731
Toxic neuropathy 17.05 13.91 12 95658 968 79647750
Blood creatine increased 16.92 13.91 36 95634 9419 79639299
Dandy-Walker syndrome 16.89 13.91 5 95665 48 79648670
Pituitary tumour 16.84 13.91 13 95657 1209 79647509
Hypertensive crisis 16.78 13.91 59 95611 20711 79628007
Inflammation 16.75 13.91 57 95613 93696 79555022
Vocal cord paralysis 16.75 13.91 18 95652 2569 79646149
Leukaemia cutis 16.72 13.91 7 95663 197 79648521
Protein total decreased 16.72 13.91 35 95635 9057 79639661
Corneal toxicity 16.69 13.91 4 95666 15 79648703
Product quality issue 16.68 13.91 10 95660 33930 79614788
Flatulence 16.64 13.91 16 95654 42708 79606010
Fluid retention 16.54 13.91 37 95633 69772 79578946
Axillary vein thrombosis 16.51 13.91 10 95660 625 79648093
Tooth extraction 16.47 13.91 39 95631 10956 79637762
Toothache 16.37 13.91 57 95613 19913 79628805
Blood phosphorus decreased 16.35 13.91 29 95641 6639 79642079
Agitation 16.25 13.91 63 95607 99652 79549066
Stress cardiomyopathy 16.08 13.91 39 95631 11127 79637591
Secondary cerebellar degeneration 16.04 13.91 5 95665 58 79648660
Naevus haemorrhage 16.01 13.91 6 95664 125 79648593
Botryomycosis 15.96 13.91 5 95665 59 79648659
Loss of consciousness 15.90 13.91 127 95543 167816 79480902
Dysuria 15.77 13.91 110 95560 50841 79597877
Skin infection 15.76 13.91 53 95617 18192 79630526
Paralysis recurrent laryngeal nerve 15.75 13.91 6 95664 131 79648587
Pleural neoplasm 15.62 13.91 8 95662 360 79648358
Urogenital prolapse 15.60 13.91 4 95666 21 79648697
Clostridial infection 15.52 13.91 26 95644 5688 79643030
Metastases to nervous system 15.52 13.91 5 95665 65 79648653
Prescribed underdose 15.51 13.91 8 95662 29506 79619212
Injection site haemorrhage 15.49 13.91 7 95663 27863 79620855
Dental fistula 15.46 13.91 9 95661 523 79648195
Breast ulceration 15.45 13.91 5 95665 66 79648652
Peripheral swelling 15.42 13.91 229 95441 269388 79379330
Tongue coated 15.37 13.91 13 95657 1376 79647342
Rhinorrhoea 15.32 13.91 149 95521 75925 79572793
Gingival swelling 15.32 13.91 23 95647 4586 79644132
Myoclonus 15.29 13.91 7 95663 27653 79621065
Catheter site pain 15.25 13.91 25 95645 5371 79643347
Delusion 15.20 13.91 3 95667 20420 79628298
Entropion 15.11 13.91 5 95665 71 79648647
Human epidermal growth factor receptor increased 15.11 13.91 3 95667 3 79648715
Acute myocardial infarction 15.05 13.91 45 95625 76991 79571727
Bone marrow infiltration 15.03 13.91 10 95660 736 79647982
Spider naevus 14.92 13.91 6 95664 152 79648566
Pleural disorder 14.84 13.91 11 95659 962 79647756
Fear 14.84 13.91 4 95666 21982 79626736
Product administration error 14.81 13.91 10 95660 31836 79616882
Myeloproliferative neoplasm 14.68 13.91 11 95659 978 79647740
Gastric perforation 14.65 13.91 21 95649 4016 79644702
Amenorrhoea 14.60 13.91 30 95640 7662 79641056
Head injury 14.54 13.91 14 95656 37355 79611363
Peripheral sensorimotor neuropathy 14.53 13.91 18 95652 2992 79645726
Gamma-glutamyltransferase abnormal 14.37 13.91 9 95661 597 79648121
Urinary tract disorder 14.37 13.91 20 95650 3722 79644996
Bone disorder 14.34 13.91 53 95617 19060 79629658
Generalised tonic-clonic seizure 14.31 13.91 19 95651 43891 79604827
Irritability 14.25 13.91 17 95653 41127 79607591
Tumour haemorrhage 14.23 13.91 21 95649 4123 79644595
Diabetic ketoacidosis 14.22 13.91 12 95658 34110 79614608
Eye swelling 14.17 13.91 7 95663 26461 79622257
Corneal bleeding 14.16 13.91 4 95666 32 79648686
Hypercholesterolaemia 14.15 13.91 5 95665 23090 79625628
Hyperhidrosis 14.14 13.91 115 95555 151377 79497341
Transient ischaemic attack 14.13 13.91 26 95644 52669 79596049
COVID-19 14.12 13.91 121 95549 157553 79491165
Ejection fraction abnormal 14.10 13.91 16 95654 2424 79646294
Cardiac failure chronic 14.06 13.91 37 95633 11098 79637620
Nasal ulcer 14.05 13.91 15 95655 2125 79646593
Aspartate aminotransferase increased 13.99 13.91 239 95431 138402 79510316
Hyponatraemia 13.98 13.91 141 95529 177707 79471011
Chromosomal mutation 13.94 13.91 4 95666 34 79648684
Haemorrhage intracranial 13.92 13.91 7 95663 26186 79622532

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FD01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
ATC L01XY02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Combinations of antineoplastic agents
FDA MoA N0000020008 HER2/Neu/cerbB2 Antagonists
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological
FDA EPC N0000175661 HER2/neu Receptor Antagonist

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Secondary malignant neoplasm of female breast indication 94297009
Secondary malignant neoplasm of stomach indication 94606003
Human epidermal growth factor 2 positive gastric cancer indication 102453009
HER2-positive salivary gland tumors indication 255072001
HER2-positive rectal cancer indication 363351006 DOID:1993
HER2-positive colon cancer indication 363406005 DOID:219
HER2-positive carcinoma of breast indication 427685000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Receptor tyrosine-protein kinase erbB-2 Kinase ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
P188ANX8CK UNII
D03257 KEGG_DRUG
4021140 VUID
N0000148593 NUI
4021140 VANDF
4038908 VANDF
C0728747 UMLSCUI
CHEMBL1201585 ChEMBL_ID
DB00072 DRUGBANK_ID
D000068878 MESH_DESCRIPTOR_UI
7637 INN_ID
C000630669 MESH_SUPPLEMENTAL_RECORD_UI
5082 IUPHAR_LIGAND_ID
101306 RXNORM
11893 MMSL
266775 MMSL
33398 MMSL
7554 MMSL
d04357 MMSL
007663 NDDF
017423 NDDF
327397006 SNOMEDCT_US
387003001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ontruzant HUMAN PRESCRIPTION DRUG LABEL 1 0006-5033 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
Trazimera HUMAN PRESCRIPTION DRUG LABEL 1 0069-0308 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
Herceptin Hylecta HUMAN PRESCRIPTION DRUG LABEL 2 50242-077 INJECTION, SOLUTION 600 mg SUBCUTANEOUS BLA 28 sections
Herceptin HUMAN PRESCRIPTION DRUG LABEL 1 50242-132 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 25 sections
Phesgo HUMAN PRESCRIPTION DRUG LABEL 3 50242-245 INJECTION, SOLUTION 600 mg SUBCUTANEOUS BLA 30 sections
Phesgo HUMAN PRESCRIPTION DRUG LABEL 3 50242-245 INJECTION, SOLUTION 600 mg SUBCUTANEOUS BLA 30 sections
Phesgo HUMAN PRESCRIPTION DRUG LABEL 3 50242-260 INJECTION, SOLUTION 600 mg SUBCUTANEOUS BLA 30 sections
Phesgo HUMAN PRESCRIPTION DRUG LABEL 3 50242-260 INJECTION, SOLUTION 600 mg SUBCUTANEOUS BLA 30 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-132 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 420 mg INTRAVENOUS BLA 28 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-132 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 420 mg INTRAVENOUS BLA 28 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-132 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 420 mg INTRAVENOUS BLA 28 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-141 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-141 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
Kanjinti HUMAN PRESCRIPTION DRUG LABEL 1 55513-141 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
HERZUMA HUMAN PRESCRIPTION DRUG LABEL 1 63459-303 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
HERZUMA HUMAN PRESCRIPTION DRUG LABEL 1 63459-303 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
HERZUMA HUMAN PRESCRIPTION DRUG LABEL 1 63459-303 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
OGIVRI HUMAN PRESCRIPTION DRUG LABEL 1 67457-845 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 420 mg INTRAVENOUS BLA 29 sections
OGIVRI HUMAN PRESCRIPTION DRUG LABEL 1 67457-991 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
Ontruzant HUMAN PRESCRIPTION DRUG LABEL 1 78206-147 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
Ontruzant HUMAN PRESCRIPTION DRUG LABEL 1 78206-147 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 28 sections
OGIVRI HUMAN PRESCRIPTION DRUG LABEL 1 83257-001 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 150 mg INTRAVENOUS BLA 29 sections
OGIVRI HUMAN PRESCRIPTION DRUG LABEL 1 83257-003 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 420 mg INTRAVENOUS BLA 29 sections