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 2737.29 13.24 1134 108980 18707 56163246
Disease progression 1559.05 13.24 1432 108682 103741 56078212
Myelosuppression 1471.73 13.24 707 109407 16748 56165205
Metastases to central nervous system 1353.43 13.24 597 109517 11539 56170414
Diarrhoea 1145.08 13.24 3270 106844 635237 55546716
Palmar-plantar erythrodysaesthesia syndrome 1130.88 13.24 630 109484 20435 56161518
Cardiotoxicity 1043.20 13.24 434 109680 7216 56174737
Neuropathy peripheral 852.77 13.24 1028 109086 101865 56080088
Febrile neutropenia 747.68 13.24 975 109139 104570 56077383
Drug ineffective 685.18 13.24 485 109629 918504 55263449
Rheumatoid arthritis 654.79 13.24 21 110093 382583 55799370
Neutropenia 634.53 13.24 1121 108993 157046 56024907
Bone marrow failure 547.10 13.24 449 109665 27837 56154116
Metastases to bone 509.20 13.24 370 109744 19138 56162815
Mucosal inflammation 465.48 13.24 493 109621 42317 56139636
Metastases to liver 464.96 13.24 365 109749 21221 56160732
Chills 430.21 13.24 742 109372 101862 56080091
Breast cancer metastatic 425.69 13.24 303 109811 15166 56166787
Cardiac dysfunction 414.22 13.24 153 109961 1817 56180136
Metastases to lung 406.81 13.24 265 109849 11453 56170500
Polyneuropathy 395.00 13.24 271 109843 12779 56169174
Left ventricular dysfunction 365.36 13.24 243 109871 10880 56171073
Breast cancer recurrent 337.00 13.24 163 109951 3912 56178041
Interstitial lung disease 325.12 13.24 475 109639 56588 56125365
Joint swelling 323.56 13.24 84 110030 289716 55892237
Malignant neoplasm progression 318.61 13.24 540 109574 73047 56108906
Metastases to lymph nodes 313.24 13.24 190 109924 7233 56174720
Drug hypersensitivity 312.56 13.24 77 110037 275128 55906825
Cardiac failure 303.33 13.24 562 109552 81531 56100422
Synovitis 294.50 13.24 4 110110 161301 56020652
Systemic lupus erythematosus 287.30 13.24 16 110098 180062 56001891
Condition aggravated 261.96 13.24 177 109937 344721 55837232
Cardiomyopathy 261.01 13.24 232 109882 16026 56165927
Therapeutic product effect decreased 258.59 13.24 19 110095 169433 56012520
Arthropathy 249.93 13.24 45 110069 200230 55981723
Completed suicide 245.69 13.24 3 110111 133830 56048123
Peripheral sensory neuropathy 243.12 13.24 158 109956 6798 56175155
Fall 241.44 13.24 207 109907 357303 55824650
Death 231.52 13.24 1294 108820 340132 55841821
Abdominal discomfort 223.20 13.24 133 109981 277141 55904812
Metastasis 218.86 13.24 129 109985 4655 56177298
Pleural effusion 213.20 13.24 498 109616 84982 56096971
Skin toxicity 205.93 13.24 118 109996 4035 56177918
Sinusitis 195.64 13.24 71 110043 197510 55984443
Lymphoedema 190.74 13.24 161 109953 10369 56171584
Neoplasm progression 182.98 13.24 267 109847 31749 56150204
Metastases to skin 182.96 13.24 78 110036 1380 56180573
Pneumonitis 181.51 13.24 264 109850 31300 56150653
Treatment failure 181.38 13.24 54 110060 170338 56011615
Neutropenic sepsis 181.37 13.24 184 109930 15001 56166952
Neurotoxicity 178.89 13.24 186 109928 15609 56166344
Epistaxis 178.74 13.24 401 109713 66622 56115331
Breast cancer 177.37 13.24 332 109782 48501 56133452
Nail disorder 167.31 13.24 155 109959 11296 56170657
Drug interaction 165.37 13.24 103 110011 209652 55972301
Glossodynia 164.67 13.24 47 110067 152411 56029542
Onycholysis 160.41 13.24 70 110044 1314 56180639
Product dose omission issue 159.41 13.24 102 110012 204651 55977302
Pyrexia 150.99 13.24 1362 108752 417411 55764542
Swelling 141.74 13.24 156 109958 239615 55942338
Weight increased 140.75 13.24 145 109969 229558 55952395
Psoriasis 139.62 13.24 11 110103 92681 56089272
Pain 139.35 13.24 747 109367 662437 55519516
Osteonecrosis of jaw 139.27 13.24 241 109873 33117 56148836
Drug intolerance 137.94 13.24 190 109924 264628 55917325
Computerised tomogram thorax abnormal 137.26 13.24 64 110050 1411 56180542
Product use issue 129.96 13.24 104 110010 185937 55996016
Onychoclasis 127.96 13.24 98 110016 5487 56176466
Bone pain 127.93 13.24 295 109819 49890 56132063
Hypokalaemia 127.77 13.24 441 109673 93996 56087957
Decreased appetite 127.66 13.24 799 109315 218432 55963521
Wound 125.75 13.24 57 110057 138747 56043206
Maternal exposure during pregnancy 125.01 13.24 112 110002 189441 55992512
Nausea 124.94 13.24 2141 107973 762037 55419916
Ventricular hypokinesia 124.18 13.24 86 110028 4115 56177838
Confusional state 122.38 13.24 136 109978 208019 55973934
Stomatitis 119.74 13.24 511 109603 120299 56061654
Haematotoxicity 119.63 13.24 112 110002 8271 56173682
Drug abuse 117.97 13.24 3 110111 67607 56114346
Vomiting 117.48 13.24 1488 108626 496740 55685213
Nail discolouration 116.00 13.24 68 110046 2428 56179525
Nail toxicity 115.75 13.24 38 110076 308 56181645
Pericardial effusion 113.00 13.24 196 109918 26979 56154974
Therapeutic product effect incomplete 112.06 13.24 34 110080 105997 56075956
Loss of personal independence in daily activities 106.50 13.24 16 110098 81353 56100600
Lacrimation increased 106.25 13.24 154 109960 18194 56163759
Somnolence 106.02 13.24 98 110016 163315 56018638
Toxicity to various agents 105.39 13.24 173 109941 224391 55957562
Gastrointestinal toxicity 105.12 13.24 91 110023 6065 56175888
Acute myeloid leukaemia 104.98 13.24 147 109967 16825 56165128
Mitral valve incompetence 104.59 13.24 152 109962 18001 56163952
Alveolitis 104.06 13.24 65 110049 2608 56179345
Metastatic neoplasm 103.84 13.24 75 110039 3838 56178115
Hospitalisation 102.29 13.24 13 110101 74987 56106966
Musculoskeletal stiffness 101.87 13.24 93 110021 155914 56026039
Injection site pain 101.62 13.24 51 110063 117067 56064886
Overdose 101.39 13.24 40 110074 105790 56076163
Neutrophil count decreased 98.67 13.24 266 109848 49556 56132397
Biopsy lung abnormal 97.80 13.24 28 110086 134 56181819
Thrombocytopenia 97.80 13.24 525 109589 135699 56046254
Dyspnoea 97.19 13.24 1662 108452 590915 55591038
Fibromyalgia 95.90 13.24 5 110109 59598 56122355
Exposure during pregnancy 95.46 13.24 76 110038 136266 56045687
Duodenal ulcer perforation 95.28 13.24 11 110103 68331 56113622
Neutropenic infection 93.40 13.24 45 110069 1070 56180883
Cellulitis 92.78 13.24 340 109774 74609 56107344
Hepatic enzyme increased 92.17 13.24 120 109994 171264 56010689
Hyperpyrexia 92.16 13.24 65 110049 3203 56178750
Asthenia 90.08 13.24 1046 109068 341927 55840026
Dysgeusia 89.78 13.24 227 109887 40688 56141265
Colitis 89.70 13.24 230 109884 41581 56140372
Leukopenia 89.66 13.24 324 109790 70616 56111337
Onychomadesis 89.25 13.24 74 110040 4647 56177306
Radiation necrosis 88.41 13.24 32 110082 357 56181596
Dry skin 87.81 13.24 246 109868 46863 56135090
Discomfort 87.32 13.24 89 110025 141672 56040281
Erysipelas 87.22 13.24 88 110026 7125 56174828
Inappropriate schedule of product administration 85.86 13.24 28 110086 83359 56098594
Lymphangiosis carcinomatosa 85.65 13.24 44 110070 1205 56180748
Paronychia 84.58 13.24 73 110041 4845 56177108
HER2 positive breast cancer 83.62 13.24 31 110083 372 56181581
Metastases to spine 83.25 13.24 59 110055 2930 56179023
Breast pain 83.18 13.24 90 110024 7904 56174049
Recall phenomenon 82.74 13.24 34 110080 546 56181407
Vascular device infection 82.30 13.24 76 110038 5514 56176439
Contusion 82.13 13.24 78 110036 128352 56053601
Anaemia 81.77 13.24 841 109273 266670 55915283
Mobility decreased 81.62 13.24 46 110068 98945 56083008
Nail dystrophy 81.50 13.24 39 110075 913 56181040
Disease recurrence 81.40 13.24 158 109956 23702 56158251
Dermatitis acneiform 79.86 13.24 67 110047 4277 56177676
Organising pneumonia 79.45 13.24 73 110041 5262 56176691
Hypertransaminasaemia 79.20 13.24 69 110045 4638 56177315
Suicide attempt 78.92 13.24 10 110104 57826 56124127
Invasive ductal breast carcinoma 78.40 13.24 81 110033 6745 56175208
Injection site erythema 78 13.24 27 110087 77421 56104532
Asthma 77.51 13.24 64 110050 112706 56069247
Arthritis 77.29 13.24 50 110064 99802 56082151
Blood cholesterol increased 77.17 13.24 23 110091 72556 56109397
Lung infiltration 76.20 13.24 113 110001 13625 56168328
Osteonecrosis 75.89 13.24 151 109963 23064 56158889
Radiation skin injury 75.22 13.24 36 110078 843 56181110
Irritable bowel syndrome 72.23 13.24 22 110092 68436 56113517
Hot flush 70.98 13.24 227 109887 46499 56135454
Hepatic function abnormal 70.94 13.24 187 109927 34371 56147582
Aortitis 69.94 13.24 36 110078 990 56180963
Constipation 68.54 13.24 649 109465 201294 55980659
Osteoarthritis 68.10 13.24 36 110078 80260 56101693
Product use in unapproved indication 67.41 13.24 107 110007 140715 56041238
Plasma cell myeloma 66.30 13.24 7 110107 46639 56135314
Multifocal micronodular pneumocyte hyperplasia 65.27 13.24 18 110096 73 56181880
Bronchial polyp 65.27 13.24 18 110096 73 56181880
Pericarditis 65.24 13.24 70 110044 108853 56073100
Onychalgia 64.34 13.24 32 110082 817 56181136
Injury 63.57 13.24 19 110095 59832 56122121
Granulocyte count decreased 63.57 13.24 33 110081 924 56181029
Dehydration 63.44 13.24 529 109585 158296 56023657
Injection site swelling 63.35 13.24 6 110108 43572 56138381
Myalgia 62.83 13.24 458 109656 131567 56050386
Injection site bruising 62.71 13.24 3 110111 38518 56143435
Recurrent cancer 62.60 13.24 41 110073 1787 56180166
Cough 62.54 13.24 780 109334 259181 55922772
Alanine aminotransferase increased 62.51 13.24 354 109760 93308 56088645
Fatigue 62.42 13.24 1998 108116 786554 55395399
Madarosis 62.40 13.24 48 110066 2705 56179248
Migraine 61.21 13.24 48 110066 86749 56095204
Injection site pruritus 60.36 13.24 6 110108 41925 56140028
Breast neoplasm 60.06 13.24 36 110078 1340 56180613
Oligohydramnios 59.78 13.24 66 110048 5928 56176025
Acute interstitial pneumonitis 59.24 13.24 28 110086 637 56181316
Systolic dysfunction 59.04 13.24 37 110077 1493 56180460
Blood lactate dehydrogenase increased 58.80 13.24 127 109987 20548 56161405
Device related infection 57.26 13.24 130 109984 21750 56160203
Chest discomfort 56.61 13.24 359 109755 98498 56083455
Ejection fraction abnormal 56.54 13.24 32 110082 1068 56180885
White blood cell count decreased 55.95 13.24 430 109684 125560 56056393
Erythema 55.31 13.24 506 109608 155433 56026520
Mastitis 54.95 13.24 43 110071 2485 56179468
Mastectomy 54.07 13.24 35 110079 1495 56180458
Second primary malignancy 53.23 13.24 69 110045 7333 56174620
Adverse event 52.90 13.24 21 110093 55355 56126598
Injection site reaction 52.86 13.24 19 110095 53228 56128725
Radiation pneumonitis 52.47 13.24 34 110080 1455 56180498
Atelectasis 51.96 13.24 116 109998 19192 56162761
Blister 51.85 13.24 83 110031 108804 56073149
Arthralgia 51.21 13.24 683 109431 500986 55680967
Congestive cardiomyopathy 51.13 13.24 60 110054 5759 56176194
Pulmonary embolism 50.60 13.24 371 109743 106753 56075200
Alopecia areata 50.47 13.24 33 110081 1434 56180519
Feeling abnormal 50.41 13.24 117 109997 133485 56048468
Axillary pain 50.25 13.24 35 110079 1690 56180263
Metastases to meninges 50.19 13.24 39 110075 2231 56179722
Paraesthesia 50.14 13.24 431 109683 130083 56051870
Sedation 50.13 13.24 5 110109 34849 56147104
Blood bilirubin increased 49.71 13.24 161 109953 33193 56148760
Hyperkalaemia 49.07 13.24 19 110095 50846 56131107
Nail infection 48.95 13.24 39 110075 2314 56179639
Urticaria 48.92 13.24 134 109980 144542 56037411
Platelet count decreased 48.86 13.24 366 109748 106017 56075936
Incorrect dose administered 48.47 13.24 21 110093 52526 56129427
Tumour marker increased 47.61 13.24 50 110064 4243 56177710
Blood uric acid decreased 47.36 13.24 25 110089 725 56181228
Drug reaction with eosinophilia and systemic symptoms 47.34 13.24 3 110111 30301 56151652
Impaired healing 46.45 13.24 61 110053 86780 56095173
Lactic acidosis 46.13 13.24 7 110107 35339 56146614
Peripheral swelling 45.96 13.24 270 109844 234456 55947497
Dermatitis 45.29 13.24 95 110019 15062 56166891
Aspartate aminotransferase increased 44.85 13.24 296 109818 82306 56099647
Hyperbilirubinaemia 44.09 13.24 75 110039 10160 56171793
Transaminases increased 43.90 13.24 140 109974 28630 56153323
Agranulocytosis 43.87 13.24 120 109994 22539 56159414
Wheezing 42.96 13.24 50 110064 74976 56106977
Nasal congestion 42.56 13.24 29 110085 56341 56125612
Suicidal ideation 41.90 13.24 31 110083 57711 56124242
Hallucination 41.72 13.24 22 110092 49127 56132826
Dyspnoea exertional 41.41 13.24 214 109900 54475 56127478
Ear infection 41.30 13.24 6 110108 31289 56150664
Intentional product misuse 40.93 13.24 25 110089 51479 56130474
Ascites 40.43 13.24 163 109951 37381 56144572
Osteoporosis 40.35 13.24 26 110088 52026 56129927
Depression 40.33 13.24 198 109916 179919 56002034
Gait disturbance 39.85 13.24 174 109940 163147 56018806
Peripheral motor neuropathy 39.55 13.24 29 110085 1519 56180434
Bronchitis 39.50 13.24 102 110012 112209 56069744
Acute respiratory distress syndrome 39.38 13.24 113 110001 21813 56160140
Therapy cessation 38.98 13.24 4 110110 27260 56154693
Tachycardia 38.76 13.24 346 109768 105530 56076423
Tonsillar disorder 38.68 13.24 25 110089 1065 56180888
Chronic kidney disease 38.48 13.24 17 110097 42039 56139914
Skin fissures 38.43 13.24 68 110046 9505 56172448
Hepatotoxicity 38.25 13.24 141 109973 31012 56150941
Hair colour changes 38.12 13.24 37 110077 2858 56179095
Computerised tomogram thorax 37.80 13.24 15 110099 219 56181734
Metastases to chest wall 37.74 13.24 19 110095 498 56181455
Neoplasm 37.45 13.24 54 110060 6347 56175606
Neoplasm recurrence 37.25 13.24 34 110080 2430 56179523
Meibomian gland dysfunction 37.01 13.24 13 110101 132 56181821
Ejection fraction 36.91 13.24 29 110085 1686 56180267
Pseudocirrhosis 36.65 13.24 20 110094 621 56181332
Enterocolitis infectious 36.60 13.24 28 110086 1565 56180388
Ventricular dysfunction 36.49 13.24 35 110079 2664 56179289
Anxiety 36.32 13.24 225 109889 192947 55989006
Influenza 36.27 13.24 83 110031 95178 56086775
Dermatomyositis 36.23 13.24 35 110079 2687 56179266
Cystitis noninfective 36.20 13.24 23 110091 951 56181002
Hyperfibrinogenaemia 36.06 13.24 9 110105 22 56181931
Troponin I increased 36.01 13.24 31 110083 2050 56179903
Skin exfoliation 35.67 13.24 155 109959 36745 56145208
Performance status decreased 35.60 13.24 38 110076 3285 56178668
International normalised ratio increased 35.53 13.24 21 110093 44020 56137933
Foot deformity 35.38 13.24 3 110111 23822 56158131
Wrong technique in product usage process 35.25 13.24 37 110077 58131 56123822
Breast mass 35.06 13.24 55 110059 6964 56174989
Tumour pain 34.84 13.24 25 110089 1266 56180687
Enterocolitis 34.57 13.24 55 110059 7049 56174904
Sleep apnoea syndrome 34.38 13.24 5 110109 26056 56155897
Pulmonary mass 34.38 13.24 103 110011 20367 56161586
Carcinoembryonic antigen increased 34.14 13.24 27 110087 1585 56180368
Cataract 34.08 13.24 30 110084 51217 56130736
Jaw operation 34.04 13.24 21 110093 824 56181129
Toxic cardiomyopathy 33.98 13.24 12 110102 124 56181829
Coma 33.89 13.24 40 110074 59615 56122338
Breast inflammation 33.89 13.24 12 110102 125 56181828
Blood creatinine decreased 33.83 13.24 46 110068 5120 56176833
Foetal exposure during pregnancy 33.69 13.24 12 110102 33811 56148142
Adverse drug reaction 33.57 13.24 47 110067 65085 56116868
Cardiac failure congestive 33.31 13.24 289 109825 87431 56094522
Folliculitis 33.28 13.24 35 110079 54944 56127009
Dyskinesia 33.25 13.24 8 110106 29100 56152853
Left ventricular dilatation 33.14 13.24 17 110097 464 56181489
Eosinophil percentage increased 33.12 13.24 22 110092 982 56180971
Electrocardiogram QT prolonged 32.76 13.24 35 110079 54553 56127400
Blood alkaline phosphatase increased 32.74 13.24 157 109957 38788 56143165
Lymphadenopathy 32.60 13.24 146 109968 35062 56146891
Blood glucose increased 32.38 13.24 61 110053 75090 56106863
Cardiac disorder 32.30 13.24 176 109938 45711 56136242
Gait inability 32.26 13.24 21 110093 41797 56140156
Excessive eye blinking 32.24 13.24 22 110092 1027 56180926
Chronic obstructive pulmonary disease 32.08 13.24 39 110075 57376 56124577
Aggression 32.06 13.24 3 110111 22003 56159950
Unresponsive to stimuli 32.04 13.24 11 110103 31714 56150239
Acute pulmonary oedema 31.84 13.24 55 110059 7542 56174411
Product prescribing error 31.65 13.24 4 110110 23182 56158771
Therapy interrupted 31.40 13.24 6 110108 25619 56156334
Sense of oppression 31.25 13.24 21 110093 956 56180997
Metastases to breast 31.00 13.24 14 110100 286 56181667
Therapy partial responder 30.87 13.24 55 110059 7730 56174223
Basal cell carcinoma 30.70 13.24 6 110108 25215 56156738
Delirium 30.62 13.24 23 110091 42494 56139459
Central nervous system lesion 30.52 13.24 63 110051 9875 56172078
Device issue 30.43 13.24 3 110111 21103 56160850
Hypoxia 30.38 13.24 195 109919 53702 56128251
Perforation 29.95 13.24 21 110093 1025 56180928
Myocarditis 29.41 13.24 58 110056 8800 56173153
Diabetes mellitus 29.28 13.24 36 110078 52699 56129254
Rhabdomyolysis 29.27 13.24 22 110092 40636 56141317
Accidental overdose 29.26 13.24 3 110111 20458 56161495
Hair texture abnormal 29.12 13.24 37 110077 3855 56178098
Pulmonary toxicity 29.11 13.24 54 110060 7829 56174124
Hypoglycaemia 29.04 13.24 40 110074 55775 56126178
Metastases to pleura 28.95 13.24 23 110091 1359 56180594
Breast disorder 28.92 13.24 29 110085 2330 56179623
Depressed level of consciousness 28.80 13.24 41 110073 56392 56125561
Irritability 28.62 13.24 11 110103 29577 56152376
Bladder irritation 28.47 13.24 12 110102 206 56181747
Tumour marker abnormal 28.38 13.24 14 110100 351 56181602
Malignant pleural effusion 28.34 13.24 29 110085 2387 56179566
Vulvovaginal inflammation 28.31 13.24 18 110096 745 56181208
Mouth ulceration 28.26 13.24 124 109990 29516 56152437
Seroma 28.17 13.24 26 110088 1885 56180068
Biliary sepsis 28.08 13.24 19 110095 875 56181078
Hepatic lesion 28.03 13.24 38 110076 4217 56177736
Vocal cord paralysis 27.87 13.24 26 110088 1911 56180042
Hip arthroplasty 27.68 13.24 21 110093 38602 56143351
Joint injury 27.50 13.24 8 110106 25646 56156307
Multiple sclerosis 27.46 13.24 10 110104 27792 56154161
Eye pain 27.40 13.24 13 110101 30834 56151119
Red cell distribution width increased 27.28 13.24 58 110056 9282 56172671
Nephrolithiasis 27.14 13.24 20 110094 37315 56144638
Treatment noncompliance 27.11 13.24 15 110099 32608 56149345
Keratitis 26.75 13.24 31 110083 2936 56179017
Gastric disorder 26.55 13.24 16 110098 33194 56148759
Orthostatic hypotension 26.54 13.24 16 110098 33183 56148770
Diastolic dysfunction 26.50 13.24 43 110071 5602 56176351
Cardio-respiratory arrest 26.48 13.24 42 110072 55279 56126674
Blood pressure fluctuation 26.39 13.24 24 110090 40336 56141617
Bone lesion 26.37 13.24 42 110072 5388 56176565
Rash pustular 26.32 13.24 47 110067 6616 56175337
Axillary vein thrombosis 26.31 13.24 13 110101 327 56181626
Retinal detachment 26.30 13.24 42 110072 5399 56176554
Breast oedema 26.30 13.24 8 110106 49 56181904
Eosinophilia 26.14 13.24 4 110110 20073 56161880
Sensory disturbance 25.86 13.24 68 110046 12475 56169478
Bile duct stenosis 25.59 13.24 20 110094 1154 56180799
Bursitis 25.47 13.24 11 110103 27571 56154382
Hiccups 25.41 13.24 25 110089 1963 56179990
Nodular regenerative hyperplasia 25.27 13.24 14 110100 448 56181505
Dysuria 25.20 13.24 123 109991 30606 56151347
Blood creatine increased 25.10 13.24 40 110074 5133 56176820
Calcium ionised increased 24.98 13.24 9 110105 99 56181854
Type 2 diabetes mellitus 24.97 13.24 33 110081 46829 56135124
Nail bed bleeding 24.88 13.24 12 110102 286 56181667
Hydrothorax 24.81 13.24 17 110097 799 56181154
Hepatitis B reactivation 24.71 13.24 27 110087 2397 56179556
Gastrointestinal haemorrhage 24.44 13.24 72 110042 75879 56106074
Respiratory arrest 24.14 13.24 15 110099 30610 56151343
Brachial plexopathy 24.13 13.24 9 110105 110 56181843
Asthenopia 24.09 13.24 25 110089 2092 56179861
Tumour lysis syndrome 24.07 13.24 50 110064 7873 56174080
Hypervolaemia 23.73 13.24 11 110103 26447 56155506
Mental status changes 23.69 13.24 23 110091 37478 56144475
Injection site haemorrhage 23.66 13.24 7 110107 22194 56159759
Vessel puncture site bruise 23.55 13.24 13 110101 413 56181540
Eastern Cooperative Oncology Group performance status worsened 23.43 13.24 17 110097 876 56181077
Hypoaesthesia 23.42 13.24 398 109716 141093 56040860
Mean platelet volume decreased 23.35 13.24 25 110089 2169 56179784
Nasal disorder 23.31 13.24 27 110087 2555 56179398
Product quality issue 23.07 13.24 17 110097 31719 56150234
Odynophagia 23.07 13.24 45 110069 6773 56175180
Osteolysis 23.05 13.24 27 110087 2586 56179367
Dysaesthesia 23.03 13.24 34 110080 4082 56177871
Nail ridging 22.73 13.24 12 110102 348 56181605
Distichiasis 22.67 13.24 6 110108 20 56181933
Vulvovaginal dryness 22.63 13.24 26 110088 2439 56179514
Flushing 22.60 13.24 223 109891 69877 56112076
Breast cellulitis 22.40 13.24 14 110100 562 56181391
Vascular fragility 22.40 13.24 9 110105 136 56181817
Swollen tongue 22.36 13.24 16 110098 30308 56151645
Acute leukaemia 22.36 13.24 18 110096 1084 56180869
Abnormal behaviour 22.33 13.24 6 110108 20266 56161687
Multicentric reticulohistiocytosis 22.26 13.24 5 110109 6 56181947
Acoustic stimulation tests abnormal 22.20 13.24 8 110106 88 56181865
Lymphangitis 22.16 13.24 16 110098 818 56181135
Illness 22.00 13.24 21 110093 34490 56147463
Embolism 21.82 13.24 46 110068 7318 56174635
Palmar erythema 21.81 13.24 21 110093 1606 56180347
Plantar erythema 21.76 13.24 10 110104 213 56181740
Coronary artery disease 21.74 13.24 17 110097 30779 56151174
Rhinorrhoea 21.69 13.24 188 109926 56849 56125104
Tricuspid valve incompetence 21.61 13.24 66 110048 13187 56168766
Osteosclerosis 21.58 13.24 31 110083 3632 56178321
Sopor 21.57 13.24 7 110107 20915 56161038
Sarcoid-like reaction 21.43 13.24 5 110109 8 56181945
Disorientation 21.39 13.24 24 110090 36589 56145364
Intercepted product preparation error 21.35 13.24 13 110101 498 56181455
Secondary cerebellar degeneration 21.29 13.24 7 110107 57 56181896
Kidney infection 21.25 13.24 7 110107 20718 56161235
Cardiac tamponade 21.17 13.24 34 110080 4392 56177561
Prescribed underdose 21.08 13.24 7 110107 20610 56161343
Dyschezia 21.07 13.24 23 110091 2040 56179913
Pustule 20.91 13.24 19 110095 1350 56180603
Full blood count abnormal 20.81 13.24 13 110101 26449 56155504
Cytomegalovirus infection 20.72 13.24 6 110108 19290 56162663
Atrial thrombosis 20.71 13.24 20 110094 1535 56180418
Left ventricular enlargement 20.58 13.24 7 110107 64 56181889
Osteitis condensans 20.58 13.24 6 110108 31 56181922
Bone sequestrum 20.58 13.24 19 110095 1378 56180575
Superior vena cava syndrome 20.55 13.24 14 110100 652 56181301
Gamma-glutamyltransferase increased 20.54 13.24 117 109997 30888 56151065
Medication error 20.40 13.24 32 110082 42303 56139650
Emotional distress 20.30 13.24 17 110097 29746 56152207
Headache 20.23 13.24 891 109223 558153 55623800
Infection 20.18 13.24 273 109841 199933 55982020
Sequestrectomy 20.15 13.24 15 110099 804 56181149
Tooth extraction 20.12 13.24 52 110062 9441 56172512
Toxic optic neuropathy 19.92 13.24 9 110105 184 56181769
Hypothalamo-pituitary disorder 19.92 13.24 14 110100 686 56181267
Pneumonitis chemical 19.88 13.24 9 110105 185 56181768
Viral infection 19.71 13.24 20 110094 31926 56150027
Myeloproliferative neoplasm 19.61 13.24 12 110102 464 56181489
Metastases to the mediastinum 19.58 13.24 12 110102 465 56181488
Xerophthalmia 19.56 13.24 12 110102 466 56181487
Bone erosion 19.46 13.24 3 110111 14971 56166982
Hepatic failure 19.39 13.24 122 109992 33364 56148589
Post-traumatic pain 19.38 13.24 11 110103 369 56181584
Gallbladder disorder 19.34 13.24 5 110109 17329 56164624
Gait apraxia 19.29 13.24 5 110109 15 56181938
Pneumocystis jirovecii pneumonia 19.22 13.24 71 110043 15630 56166323
Cardiac failure chronic 19.12 13.24 31 110083 4036 56177917
Fluid retention 19.09 13.24 49 110065 54029 56127924
Chromosomal mutation 19.05 13.24 5 110109 16 56181937
Cystoid macular oedema 19.00 13.24 19 110095 1522 56180431
Neutropenic colitis 18.84 13.24 25 110089 2718 56179235
Brain oedema 18.82 13.24 63 110051 13208 56168745
Transaminases 18.81 13.24 7 110107 85 56181868
Creatinine renal clearance decreased 18.73 13.24 3 110111 14556 56167397
Injection site rash 18.71 13.24 5 110109 16953 56165000
Rectal haemorrhage 18.65 13.24 142 109972 41325 56140628
Corneal disorder 18.61 13.24 20 110094 1742 56180211
Sinus congestion 18.60 13.24 4 110110 15720 56166233
Nasopharyngitis 18.60 13.24 312 109802 220647 55961306
Leukaemia cutis 18.59 13.24 7 110107 88 56181865
Entropion 18.57 13.24 6 110108 46 56181907
Autonomic neuropathy 18.44 13.24 16 110098 1069 56180884
Therapy non-responder 18.44 13.24 60 110054 61295 56120658
Pruritus 18.40 13.24 475 109639 316148 55865805
Spinal pain 18.28 13.24 58 110056 11826 56170127
Hydrocephalus 18.20 13.24 34 110080 4955 56176998
Breast sarcoma 18.19 13.24 4 110110 4 56181949
Dysarthria 18.02 13.24 31 110083 39519 56142434
Gingival bleeding 18.00 13.24 57 110057 11609 56170344
Congenital syphilitic osteochondritis 17.99 13.24 5 110109 21 56181932
Skin disorder 17.90 13.24 100 110014 26209 56155744
Vasogenic cerebral oedema 17.86 13.24 12 110102 546 56181407
Paralysis recurrent laryngeal nerve 17.82 13.24 6 110108 53 56181900
Inflammation 17.81 13.24 72 110042 68999 56112954
Pleural disorder 17.78 13.24 12 110102 550 56181403
Pericardial effusion malignant 17.78 13.24 7 110107 100 56181853
Telangiectasia 17.65 13.24 14 110100 825 56181128
Bradycardia 17.64 13.24 70 110044 67434 56114519
Status epilepticus 17.61 13.24 4 110110 15137 56166816
Gastritis 17.42 13.24 122 109992 34580 56147373
Overflow diarrhoea 17.41 13.24 7 110107 106 56181847
Chest wall abscess 17.34 13.24 6 110108 58 56181895
Renal impairment 17.32 13.24 90 110024 80623 56101330
Noninfective conjunctivitis 17.30 13.24 4 110110 6 56181947
Surgery 17.18 13.24 23 110091 32463 56149490
Skin laceration 17.14 13.24 9 110105 20147 56161806
Dilatation ventricular 17.13 13.24 22 110092 2316 56179637
Botryomycosis 17.12 13.24 5 110109 26 56181927
Pituitary tumour 17.08 13.24 14 110100 865 56181088
Barotrauma 17.05 13.24 8 110106 179 56181774
Neuromyopathy 17.02 13.24 12 110102 591 56181362
Hypersensitivity 17.01 13.24 377 109737 256031 55925922
Spider naevus 17.00 13.24 7 110107 113 56181840
Breast ulceration 16.99 13.24 6 110108 62 56181891
Inflammatory carcinoma of the breast 16.99 13.24 6 110108 62 56181891
Breast haemorrhage 16.97 13.24 8 110106 181 56181772
Hepatic cancer metastatic 16.93 13.24 10 110104 362 56181591
Retracted nipple 16.92 13.24 4 110110 7 56181946
Hyperaesthesia 16.91 13.24 46 110068 8611 56173342
Nasal ulcer 16.86 13.24 20 110094 1942 56180011
Capillary leak syndrome 16.82 13.24 20 110094 1946 56180007
Breast induration 16.81 13.24 5 110109 28 56181925
Herpangina 16.81 13.24 5 110109 28 56181925
Disability 16.77 13.24 5 110109 15775 56166178
Oral candidiasis 16.76 13.24 77 110037 18686 56163267
Joint dislocation 16.76 13.24 5 110109 15768 56166185
Toxic neuropathy 16.69 13.24 10 110104 372 56181581
Cholangiectasis acquired 16.58 13.24 4 110110 8 56181945
Device dislocation 16.57 13.24 12 110102 22594 56159359
Nasal crusting 16.56 13.24 9 110105 277 56181676
Aortic valve incompetence 16.56 13.24 35 110079 5577 56176376
Hepatic neoplasm 16.54 13.24 19 110095 1782 56180171
Hyperchlorhydria 16.48 13.24 18 110096 1597 56180356
Respiratory tract congestion 16.46 13.24 5 110109 15586 56166367
Arachnoid cyst 16.42 13.24 8 110106 195 56181758
Metabolic acidosis 16.42 13.24 34 110080 40420 56141533
Full blood count decreased 16.34 13.24 13 110101 23336 56158617
Subclavian vein thrombosis 16.28 13.24 19 110095 1813 56180140
Jaundice 16.15 13.24 100 110014 27194 56154759
Upper respiratory tract infection 16.15 13.24 78 110036 71210 56110743
Adenocarcinoma gastric 16.13 13.24 11 110103 513 56181440
Frequent bowel movements 16.06 13.24 6 110108 16418 56165535
Blood pressure systolic increased 16.01 13.24 35 110079 40801 56141152
Mucosal dryness 15.99 13.24 22 110092 2476 56179477
Merycism 15.95 13.24 8 110106 208 56181745
Metastases to nervous system 15.74 13.24 5 110109 36 56181917
Inflammatory carcinoma of breast stage IV 15.72 13.24 3 110111 0 56181953
Left atrial volume increased 15.72 13.24 3 110111 0 56181953
Multiple gated acquisition scan abnormal 15.72 13.24 3 110111 0 56181953
Globulinuria 15.72 13.24 3 110111 0 56181953
Poisoning 15.70 13.24 3 110111 12810 56169143
Gingival pain 15.66 13.24 37 110077 6351 56175602
Transient ischaemic attack 15.59 13.24 26 110088 33551 56148402
Thyroid disorder 15.59 13.24 4 110110 13934 56168019
Blood phosphorus decreased 15.54 13.24 28 110086 3969 56177984
Apical granuloma 15.51 13.24 5 110109 38 56181915
Product administration error 15.49 13.24 11 110103 20918 56161035
Therapeutic response unexpected 15.42 13.24 7 110107 17037 56164916
Extravasation 15.42 13.24 20 110094 2127 56179826
Bone cancer metastatic 15.41 13.24 7 110107 145 56181808
Intracranial pressure increased 15.38 13.24 30 110084 4515 56177438
Agitation 15.35 13.24 57 110057 55979 56125974
Back pain 15.35 13.24 588 109526 236582 55945371
Fear 15.35 13.24 5 110109 14903 56167050
Catheter site pain 15.34 13.24 29 110085 4264 56177689
Sepsis 15.34 13.24 370 109744 139470 56042483
Joint effusion 15.33 13.24 5 110109 14893 56167060
Vaginal prolapse 15.30 13.24 10 110104 434 56181519
Infusion site pain 15.30 13.24 4 110110 13758 56168195
Bronchospasm 15.28 13.24 66 110048 15603 56166350
Scintillating scotoma 15.24 13.24 7 110107 149 56181804
Dyspnoea at rest 15.20 13.24 27 110087 3786 56178167
Acral peeling skin syndrome 15.19 13.24 4 110110 13 56181940
Bone disorder 15.15 13.24 77 110037 19466 56162487
Pneumonia aspiration 15.14 13.24 25 110089 32386 56149567
Superinfection 15.12 13.24 20 110094 2168 56179785
Respiratory depression 15.05 13.24 3 110111 12432 56169521
Abdominal rigidity 15.01 13.24 18 110096 1767 56180186
Hiatus hernia 14.98 13.24 10 110104 19642 56162311
Oropharyngeal candidiasis 14.97 13.24 14 110100 1032 56180921
Rash follicular 14.97 13.24 5 110109 43 56181910
Gram stain positive 14.97 13.24 5 110109 43 56181910
Dizziness 14.94 13.24 593 109521 375547 55806406
Nervousness 14.88 13.24 21 110093 28994 56152959
HER2 negative breast cancer 14.87 13.24 5 110109 44 56181909
Blood bilirubin decreased 14.86 13.24 12 110102 726 56181227
Dandy-Walker syndrome 14.85 13.24 6 110108 92 56181861
Impaired work ability 14.80 13.24 5 110109 14567 56167386
Ocular vasculitis 14.77 13.24 5 110109 45 56181908
Hypoalbuminaemia 14.75 13.24 50 110064 10549 56171404
Laboratory test abnormal 14.63 13.24 16 110098 24679 56157274
Essential thrombocythaemia 14.62 13.24 7 110107 164 56181789
Myositis 14.59 13.24 43 110071 8425 56173528
Central nervous system neoplasm 14.55 13.24 4 110110 16 56181937
Rotator cuff syndrome 14.55 13.24 3 110111 12140 56169813
Underdose 14.51 13.24 15 110099 23742 56158211
SAPHO syndrome 14.45 13.24 6 110108 99 56181854
Vena cava thrombosis 14.43 13.24 19 110095 2050 56179903
Feeling jittery 14.38 13.24 3 110111 12043 56169910
Hypocalcaemia 14.37 13.24 101 110013 28659 56153294
Vulvovaginal candidiasis 14.37 13.24 23 110091 2963 56178990
Glaucoma 14.35 13.24 8 110106 17321 56164632
Cardiac failure acute 14.29 13.24 44 110070 8829 56173124
Foot fracture 14.22 13.24 13 110101 21796 56160157
Nail bed tenderness 14.21 13.24 9 110105 370 56181583
Stress 14.21 13.24 63 110051 58847 56123106
Corneal bleeding 14.17 13.24 4 110110 18 56181935
Intervertebral disc protrusion 14.06 13.24 13 110101 21681 56160272
Device malfunction 14.02 13.24 7 110107 16129 56165824
Peripheral sensorimotor neuropathy 14.02 13.24 15 110099 1300 56180653
Pneumothorax 14.02 13.24 62 110052 14805 56167148
Skin infection 13.97 13.24 57 110057 13138 56168815
Catheter site erythema 13.94 13.24 27 110087 4043 56177910
Dacryostenosis acquired 13.87 13.24 10 110104 510 56181443
Vagus nerve disorder 13.78 13.24 6 110108 112 56181841
Pulmonary arterial hypertension 13.78 13.24 19 110095 26484 56155469
Crying 13.72 13.24 13 110101 21427 56160526
Cerebrovascular accident 13.71 13.24 126 109988 99144 56082809
Anal erythema 13.68 13.24 7 110107 190 56181763
Limb injury 13.68 13.24 14 110100 22256 56159697
Folate deficiency 13.68 13.24 19 110095 2158 56179795
Urogenital prolapse 13.67 13.24 4 110110 21 56181932
Gastrointestinal ulcer perforation 13.64 13.24 3 110111 3 56181950
Metastases to pituitary gland 13.64 13.24 3 110111 3 56181950
Eye swelling 13.63 13.24 13 110101 21363 56160590
Road traffic accident 13.56 13.24 21 110093 27906 56154047
Bone marrow infiltration 13.54 13.24 10 110104 530 56181423
Arrhythmia 13.53 13.24 116 109998 34967 56146986
Bacterial rhinitis 13.51 13.24 4 110110 22 56181931
Soft tissue infection 13.48 13.24 18 110096 1969 56179984
Premature delivery 13.47 13.24 20 110094 27040 56154913
Appendiceal abscess 13.45 13.24 7 110107 197 56181756
Amnesia 13.44 13.24 46 110068 46276 56135677
Joint range of motion decreased 13.37 13.24 18 110096 25347 56156606
Ulcerative keratitis 13.34 13.24 20 110094 2435 56179518
Naevus haemorrhage 13.27 13.24 6 110108 123 56181830

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 199.18 25.30 149 5536 90315 31601344
Off label use 119.57 25.30 218 5467 347056 31344603
Palmar-plantar erythrodysaesthesia syndrome 115.25 25.30 56 5629 15427 31676232
Myelosuppression 108.16 25.30 53 5632 14867 31676792
Death 89.82 25.30 198 5487 360371 31331288
Oligohydramnios 73.29 25.30 16 5669 322 31691337
Bone marrow failure 63.27 25.30 47 5638 27961 31663698
Pulmonary hypoplasia 63.21 25.30 15 5670 443 31691216
Intentional product use issue 60.10 25.30 58 5627 49289 31642370
Anastomotic complication 55.52 25.30 13 5672 362 31691297
Therapy partial responder 52.63 25.30 25 5660 6537 31685122
Carbohydrate antigen 15-3 increased 49.11 25.30 9 5676 70 31691589
Tidal volume decreased 48.15 25.30 8 5677 32 31691627
Ejection fraction decreased 47.97 25.30 33 5652 17401 31674258
Delusion of grandeur 47.15 25.30 13 5672 704 31690955
Metastases to central nervous system 43.29 25.30 23 5662 7613 31684046
Diarrhoea 40.05 25.30 146 5539 352263 31339396
Gastric perforation 38.97 25.30 15 5670 2344 31689315
Breast cancer 35.99 25.30 9 5676 332 31691327
Onycholysis 35.03 25.30 10 5675 615 31691044
Nasal discomfort 33.55 25.30 12 5673 1528 31690131
Paranasal sinus discomfort 33.39 25.30 10 5675 728 31690931
Neuropathy peripheral 31.56 25.30 52 5633 75597 31616062
Obstruction gastric 31.52 25.30 10 5675 882 31690777
Anastomotic leak 30.69 25.30 9 5676 609 31691050
Rectal polyp 30.45 25.30 9 5676 626 31691033
Alopecia 30.34 25.30 27 5658 20668 31670991
Metastases to liver 30.16 25.30 22 5663 12705 31678954
Metastases to lung 28.14 25.30 18 5667 8404 31683255
Drug interaction 26.94 25.30 3 5682 208540 31483119
Lymphoedema 26.90 25.30 13 5672 3527 31688132
Malignant sweat gland neoplasm 26.46 25.30 4 5681 7 31691652
Affective disorder 26.23 25.30 13 5672 3723 31687936
Foetal growth restriction 25.98 25.30 13 5672 3802 31687857

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
Ejection fraction decreased 1754.40 13.67 822 85918 29940 70811764
Myelosuppression 1320.92 13.67 673 86067 29472 70812232
Diarrhoea 900.49 13.67 2531 84209 780810 70060894
Palmar-plantar erythrodysaesthesia syndrome 796.15 13.67 483 86257 29764 70811940
Disease progression 777.24 13.67 957 85783 155715 70685989
Metastases to central nervous system 774.88 13.67 375 86365 14659 70827045
Neuropathy peripheral 630.42 13.67 776 85964 126120 70715584
Cardiotoxicity 576.10 13.67 278 86462 10792 70830912
Bone marrow failure 505.92 13.67 444 86296 48566 70793138
Drug ineffective 434.52 13.67 312 86428 939440 69902264
Breast cancer metastatic 408.04 13.67 214 86526 9932 70831772
Febrile neutropenia 395.52 13.67 811 85929 203507 70638197
Metastases to bone 382.68 13.67 273 86467 22103 70819601
Metastases to liver 353.74 13.67 276 86464 25602 70816102
Polyneuropathy 338.25 13.67 249 86491 21166 70820538
Chills 332.68 13.67 618 86122 144168 70697536
Cardiac dysfunction 330.49 13.67 134 86606 3403 70838301
Rheumatoid arthritis 319.18 13.67 8 86732 291797 70549907
Neutropenia 316.33 13.67 855 85885 256301 70585403
Mucosal inflammation 301.75 13.67 393 86347 67457 70774247
Metastases to lung 290.83 13.67 205 86535 16279 70825425
Breast cancer recurrent 271.95 13.67 109 86631 2684 70839020
Left ventricular dysfunction 250.79 13.67 194 86546 17763 70823941
Metastases to lymph nodes 244.16 13.67 148 86592 9090 70832614
Drug interaction 211.71 13.67 101 86639 381340 70460364
Lymphoedema 190.31 13.67 136 86604 11033 70830671
Fall 187.18 13.67 161 86579 443935 70397769
Cardiomyopathy 186.49 13.67 194 86546 26179 70815525
Breast cancer 185.65 13.67 217 86523 33332 70808372
Interstitial lung disease 183.01 13.67 399 86341 104286 70737418
Malignant neoplasm progression 174.36 13.67 429 86311 121310 70720394
Nausea 174.16 13.67 1695 85045 850393 69991311
Neutropenic sepsis 170.83 13.67 180 86560 24650 70817054
Condition aggravated 168.37 13.67 165 86575 427470 70414234
Peripheral sensory neuropathy 167.28 13.67 130 86610 11980 70829724
Stomatitis 165.47 13.67 435 86305 128076 70713628
Drug abuse 164.98 13.67 3 86737 147253 70694451
Drug hypersensitivity 157.41 13.67 62 86678 262397 70579307
Onycholysis 157.17 13.67 65 86675 1738 70839966
Toxicity to various agents 155.63 13.67 143 86597 382029 70459675
Joint swelling 148.30 13.67 62 86678 253149 70588555
Computerised tomogram thorax abnormal 144.45 13.67 64 86676 2034 70839670
Synovitis 143.28 13.67 3 86737 129225 70712479
Contraindicated product administered 142.30 13.67 5 86735 134607 70707097
Neoplasm progression 139.21 13.67 220 86520 45008 70796696
Cardiac failure 133.87 13.67 433 86307 143108 70698596
Osteonecrosis of jaw 132.54 13.67 204 86536 40798 70800906
Product dose omission issue 127.72 13.67 53 86687 217415 70624289
Epistaxis 127.63 13.67 343 86397 102284 70739420
Metastases to skin 124.76 13.67 53 86687 1518 70840186
Confusional state 123.51 13.67 100 86640 284298 70557406
Therapeutic product effect decreased 118.42 13.67 17 86723 143001 70698703
Pleural effusion 117.79 13.67 394 86346 132470 70709234
Nail disorder 116.72 13.67 99 86641 10325 70831379
Metastasis 114.76 13.67 79 86661 6035 70835669
Skin toxicity 114.32 13.67 84 86656 7114 70834590
Nail toxicity 114.24 13.67 34 86706 326 70841378
Vomiting 111.58 13.67 1161 85579 591950 70249754
Biopsy lung abnormal 109.82 13.67 28 86712 140 70841564
Hypokalaemia 109.25 13.67 381 86359 130807 70710897
Bone pain 106.74 13.67 209 86531 50613 70791091
Overdose 105.23 13.67 38 86702 169707 70671997
Gastrointestinal toxicity 104.56 13.67 76 86664 6329 70835375
Invasive ductal breast carcinoma 101.88 13.67 72 86668 5737 70835967
Pneumonitis 100.99 13.67 213 86527 54384 70787320
Alveolitis 100.56 13.67 61 86679 3750 70837954
Hyperpyrexia 99.83 13.67 69 86671 5305 70836399
Arthropathy 97.52 13.67 31 86709 150026 70691678
Decreased appetite 96.74 13.67 671 86069 304109 70537595
Psoriasis 96.46 13.67 6 86734 98427 70743277
Nail discolouration 94.56 13.67 52 86688 2654 70839050
Nail dystrophy 92.30 13.67 37 86703 911 70840793
Systemic lupus erythematosus 92.04 13.67 9 86731 101893 70739811
Cellulitis 91.80 13.67 298 86442 98630 70743074
Neurotoxicity 90.28 13.67 144 86596 29682 70812022
Alopecia 89.65 13.67 479 86261 198011 70643693
Dysgeusia 89.10 13.67 191 86549 49311 70792393
Dyspnoea 89.02 13.67 1377 85363 768683 70073021
Lacrimation increased 87.98 13.67 115 86625 19784 70821920
Fatigue 84.85 13.67 1446 85294 822873 70018831
Pyrexia 83.43 13.67 1119 85621 605833 70235871
Sinusitis 83.24 13.67 52 86688 169143 70672561
Abdominal discomfort 80.72 13.67 86 86654 214572 70627132
HER2 positive breast cancer 80.41 13.67 26 86714 335 70841369
Ventricular hypokinesia 79.89 13.67 72 86668 8140 70833564
Erysipelas 79.28 13.67 78 86662 9846 70831858
Madarosis 78.69 13.67 45 86695 2478 70839226
Treatment failure 78.55 13.67 39 86701 144103 70697601
Pericardial effusion 77.27 13.67 163 86577 41613 70800091
Somnolence 77.10 13.67 90 86650 215516 70626188
Paronychia 76.78 13.67 66 86674 7008 70834696
Multifocal micronodular pneumocyte hyperplasia 73.66 13.67 18 86722 73 70841631
Bronchial polyp 73.27 13.67 18 86722 75 70841629
Hyperkalaemia 72.93 13.67 20 86720 106571 70735133
Hypertransaminasaemia 72.77 13.67 71 86669 8872 70832832
Metastases to meninges 72.13 13.67 46 86694 3090 70838614
Aortitis 72.08 13.67 35 86705 1376 70840328
Vascular device infection 71.50 13.67 67 86673 7963 70833741
Rhabdomyolysis 71.34 13.67 15 86725 95745 70745959
Lymphangiosis carcinomatosa 70.50 13.67 38 86702 1863 70839841
Plasma cell myeloma 70.14 13.67 5 86735 73196 70768508
Mitral valve incompetence 70.10 13.67 121 86619 26607 70815097
Weight increased 69.87 13.67 118 86622 242213 70599491
Metastatic neoplasm 68.80 13.67 52 86688 4596 70837108
Recall phenomenon 68.74 13.67 31 86709 1028 70840676
Inappropriate schedule of product administration 68.49 13.67 23 86717 107532 70734172
Oligohydramnios 68.32 13.67 45 86695 3195 70838509
Loss of personal independence in daily activities 68.19 13.67 11 86729 84899 70756805
Paraesthesia 66.89 13.67 353 86387 145184 70696520
Suicide attempt 66.86 13.67 9 86731 79501 70762203
Haematotoxicity 66.72 13.67 83 86657 13591 70828113
Acute myeloid leukaemia 64.67 13.67 127 86613 30813 70810891
Colitis 64.47 13.67 198 86542 63616 70778088
Mastitis 64.35 13.67 37 86703 2059 70839645
Hot flush 63.91 13.67 168 86572 49416 70792288
Injection site pain 63.82 13.67 32 86708 117587 70724117
Metastases to spine 63.79 13.67 46 86694 3783 70837921
Hospitalisation 63.46 13.67 12 86728 82556 70759148
Product use issue 63.37 13.67 76 86664 179861 70661843
Therapy partial responder 62.93 13.67 77 86663 12397 70829307
Disease recurrence 61.90 13.67 140 86600 37463 70804241
Alopecia areata 61.51 13.67 33 86707 1603 70840101
Neutropenic infection 60.44 13.67 35 86705 1974 70839730
Granulocyte count decreased 59.74 13.67 31 86709 1406 70840298
Infusion related reaction 59.73 13.67 430 86310 197104 70644600
Breast pain 59.00 13.67 58 86682 7313 70834391
Drug reaction with eosinophilia and systemic symptoms 58.48 13.67 3 86737 58010 70783694
Acute interstitial pneumonitis 58.11 13.67 28 86712 1082 70840622
Product use in unapproved indication 58.00 13.67 103 86637 207375 70634329
Tumour marker increased 57.39 13.67 43 86697 3751 70837953
Cough 57.24 13.67 629 86111 324748 70516956
Therapeutic product effect incomplete 56.03 13.67 39 86701 119843 70721861
Onychalgia 55.95 13.67 25 86715 811 70840893
Organising pneumonia 55.57 13.67 65 86675 9985 70831719
Lactic acidosis 55.54 13.67 7 86733 65017 70776687
Radiation skin injury 55.51 13.67 29 86711 1334 70840370
Pain 55.49 13.67 497 86243 628319 70213385
Myocardial infarction 54.79 13.67 78 86662 171567 70670137
Onychoclasis 53.08 13.67 46 86694 4938 70836766
Neutrophil count decreased 52.52 13.67 222 86518 83334 70758370
White blood cell count decreased 52.37 13.67 372 86368 169769 70671935
Device related infection 50.95 13.67 118 86622 32067 70809637
Chest discomfort 50.65 13.67 292 86448 124089 70717615
Hair texture abnormal 50.25 13.67 37 86703 3143 70838561
Mastectomy 49.93 13.67 25 86715 1051 70840653
Osteonecrosis 49.60 13.67 110 86630 29050 70812654
Tonsillar disorder 49.54 13.67 25 86715 1069 70840635
Gastrointestinal haemorrhage 49.49 13.67 57 86683 137351 70704353
Axillary pain 48.85 13.67 30 86710 1885 70839819
International normalised ratio increased 48.45 13.67 19 86721 80707 70760997
Atelectasis 47.86 13.67 108 86632 28854 70812850
Mobility decreased 47.48 13.67 34 86706 102965 70738739
Acute kidney injury 47.32 13.67 363 86377 474261 70367443
Cardio-respiratory arrest 46.72 13.67 33 86707 100644 70741060
Fibromyalgia 46.65 13.67 3 86737 47871 70793833
Dermatitis acneiform 46.40 13.67 56 86684 8889 70832815
Leukopenia 45.92 13.67 254 86486 106306 70735398
Metastases to chest wall 45.64 13.67 18 86722 424 70841280
Erythema 45.36 13.67 407 86333 199156 70642548
Computerised tomogram thorax 44.61 13.67 15 86725 220 70841484
Drug intolerance 44.57 13.67 135 86605 225552 70616152
Blood uric acid decreased 44.54 13.67 24 86716 1176 70840528
Carbohydrate antigen 15-3 increased 44.49 13.67 23 86717 1035 70840669
Constipation 44.36 13.67 488 86252 251950 70589754
Arthritis 44.31 13.67 33 86707 97947 70743757
Myalgia 44.28 13.67 354 86386 167538 70674166
Injection site erythema 44.03 13.67 17 86723 72907 70768797
Breast mass 43.50 13.67 44 86696 5741 70835963
Hair colour changes 43.39 13.67 37 86703 3886 70837818
Hepatic enzyme increased 42.91 13.67 79 86661 156911 70684793
Intentional product misuse 42.65 13.67 22 86718 79573 70762131
Musculoskeletal stiffness 42.52 13.67 72 86668 147688 70694016
Pseudocirrhosis 42.07 13.67 19 86721 632 70841072
Dry skin 41.89 13.67 157 86583 55774 70785930
Meibomian gland dysfunction 41.83 13.67 13 86727 146 70841558
Asthma 41.48 13.67 52 86688 120741 70720963
Bradycardia 41.40 13.67 55 86685 124560 70717144
Hallucination 40.98 13.67 21 86719 76239 70765465
Delirium 40.92 13.67 20 86720 74594 70767110
Ejection fraction 40.91 13.67 26 86714 1736 70839968
Second primary malignancy 40.86 13.67 64 86676 12987 70828717
Contusion 40.05 13.67 59 86681 127977 70713727
Sedation 39.98 13.67 5 86735 46726 70794978
Injury 39.74 13.67 15 86725 65230 70776474
Anaemia 39.21 13.67 702 86038 402721 70438983
Breast neoplasm 39.06 13.67 20 86720 882 70840822
Unresponsive to stimuli 38.95 13.67 8 86732 51923 70789781
Coronary artery disease 38.93 13.67 14 86726 62722 70778982
Injection site reaction 38.83 13.67 7 86733 49845 70791859
Orthostatic hypotension 38.75 13.67 8 86732 51735 70789969
Hypoglycaemia 38.68 13.67 35 86705 94329 70747375
Blood lactate dehydrogenase increased 38.31 13.67 112 86628 35015 70806689
Nail infection 38.06 13.67 27 86713 2164 70839540
Dermatitis 37.35 13.67 77 86663 19340 70822364
Cytomegalovirus infection 37.28 13.67 3 86737 39755 70801949
Radiation necrosis 36.69 13.67 15 86725 389 70841315
Bladder irritation 36.68 13.67 13 86727 225 70841479
Blood creatinine decreased 36.48 13.67 45 86695 7304 70834400
Product prescribing error 36.35 13.67 3 86737 38949 70802755
Swelling 36.35 13.67 114 86626 188425 70653279
Adverse event 36.32 13.67 8 86732 49453 70792251
Central nervous system lesion 36.15 13.67 59 86681 12394 70829310
Dyskinesia 36.12 13.67 4 86736 41070 70800634
Duodenal ulcer perforation 36.08 13.67 9 86731 51103 70790601
Asthenia 35.91 13.67 771 85969 456895 70384809
Drug ineffective for unapproved indication 35.88 13.67 3 86737 38535 70803169
Wound 35.50 13.67 41 86699 98691 70743013
Vulvovaginal dryness 35.47 13.67 24 86716 1782 70839922
Electrocardiogram QT prolonged 35.41 13.67 30 86710 83487 70758217
Eosinophilia 35.27 13.67 4 86736 40315 70801389
Wheezing 35.06 13.67 38 86702 94132 70747572
Dehydration 34.73 13.67 426 86314 225716 70615988
Acoustic stimulation tests abnormal 34.60 13.67 8 86732 24 70841680
Pulmonary mass 34.35 13.67 89 86651 25944 70815760
Feeling abnormal 34.31 13.67 77 86663 142242 70699462
Coma 34.27 13.67 37 86703 91807 70749897
Enterocolitis 34.06 13.67 59 86681 13007 70828697
Chronic kidney disease 34.04 13.67 16 86724 61041 70780663
Injection site pruritus 34.03 13.67 4 86736 39206 70802498
Congestive cardiomyopathy 33.40 13.67 53 86687 10873 70830831
Recurrent cancer 33.26 13.67 26 86714 2415 70839289
Mental status changes 32.99 13.67 18 86722 63083 70778621
Chronic obstructive pulmonary disease 32.78 13.67 28 86712 77613 70764091
Perforation 32.74 13.67 20 86720 1245 70840459
Eosinophil percentage increased 32.68 13.67 21 86719 1429 70840275
Agranulocytosis 32.61 13.67 116 86624 40182 70801522
Nasal congestion 32.53 13.67 20 86720 65652 70776052
Cystitis noninfective 32.36 13.67 20 86720 1271 70840433
Flushing 32.20 13.67 191 86549 81981 70759723
Jaw operation 32.14 13.67 17 86723 802 70840902
Accidental overdose 31.98 13.67 3 86737 35118 70806586
Respiratory arrest 31.86 13.67 13 86727 53920 70787784
Blood glucose increased 31.67 13.67 48 86692 102934 70738770
Asthenopia 31.25 13.67 24 86716 2172 70839532
Arthralgia 31.15 13.67 431 86309 502959 70338745
Hypoaesthesia 31.14 13.67 306 86434 153433 70688271
Platelet count decreased 31.03 13.67 344 86396 177878 70663826
Vascular fragility 30.99 13.67 10 86730 128 70841576
Discomfort 30.67 13.67 51 86689 105385 70736319
Depression 30.67 13.67 132 86608 198842 70642862
Blood pressure fluctuation 30.61 13.67 17 86723 58995 70782709
Cardiac arrest 30.56 13.67 97 86643 159737 70681967
Mean platelet volume decreased 30.46 13.67 24 86716 2255 70839449
Hyperfibrinogenaemia 30.45 13.67 9 86731 84 70841620
Troponin I increased 30.44 13.67 31 86709 4077 70837627
Blood cholesterol increased 30.20 13.67 21 86719 64583 70777121
Tumour pain 30.01 13.67 23 86717 2075 70839629
Sense of oppression 29.74 13.67 20 86720 1470 70840234
Red cell distribution width increased 29.68 13.67 57 86683 13600 70828104
Depressed level of consciousness 29.64 13.67 38 86702 87393 70754311
Hepatic lesion 29.63 13.67 37 86703 6080 70835624
Systolic dysfunction 29.14 13.67 28 86712 3433 70838271
Diabetes mellitus 29.01 13.67 27 86713 71797 70769907
Tachycardia 28.98 13.67 309 86431 158237 70683467
Enterocolitis infectious 28.96 13.67 25 86715 2669 70839035
Glossodynia 28.90 13.67 38 86702 86449 70755255
Anxiety 28.82 13.67 155 86585 220175 70621529
Renal failure 28.79 13.67 126 86614 188944 70652760
Onychomadesis 28.68 13.67 30 86710 4071 70837633
Medication error 28.65 13.67 17 86723 56895 70784809
Anastomotic complication 28.63 13.67 13 86727 438 70841266
Lung infiltration 28.61 13.67 74 86666 21550 70820154
Pulmonary embolism 28.59 13.67 304 86436 155563 70686141
Hepatic function abnormal 28.56 13.67 161 86579 67835 70773869
Irritability 28.44 13.67 6 86734 38219 70803485
Suicidal ideation 28.30 13.67 26 86714 69570 70772134
Nasal discomfort 28.14 13.67 32 86708 4769 70836935
Odynophagia 27.91 13.67 47 86693 10128 70831576
Breast inflammation 27.90 13.67 9 86731 115 70841589
Excessive eye blinking 27.87 13.67 19 86721 1428 70840276
Vessel puncture site bruise 27.68 13.67 13 86727 474 70841230
Osteoarthritis 27.51 13.67 30 86710 74117 70767587
Tumour marker abnormal 27.47 13.67 11 86729 270 70841434
Biliary sepsis 27.28 13.67 19 86721 1479 70840225
Keratitis 27.20 13.67 28 86712 3729 70837975
Blister 27.09 13.67 51 86689 100475 70741229
Metastases to pleura 27.05 13.67 18 86722 1300 70840404
Dysarthria 26.89 13.67 22 86718 62291 70779413
Disorientation 26.85 13.67 19 86721 57904 70783800
Abnormal behaviour 26.76 13.67 5 86735 34704 70807000
Hydrothorax 26.58 13.67 18 86722 1338 70840366
Wrong technique in product usage process 26.38 13.67 27 86713 68671 70773033
Nasal disorder 26.38 13.67 26 86714 3288 70838416
Carcinoembryonic antigen increased 26.33 13.67 21 86719 2009 70839695
Death 26.12 13.67 812 85928 509249 70332455
Neoplasm recurrence 26.09 13.67 28 86712 3913 70837791
Papilloedema 26.03 13.67 34 86706 5844 70835860
Blood creatine phosphokinase increased 25.98 13.67 22 86718 61241 70780463
Performance status decreased 25.74 13.67 33 86707 5568 70836136
Osteosclerosis 25.73 13.67 27 86713 3678 70838026
Breast cellulitis 25.70 13.67 11 86729 321 70841383
Therapy cessation 25.65 13.67 5 86735 33671 70808033
Vulvovaginal candidiasis 25.53 13.67 22 86718 2344 70839360
Metabolic acidosis 25.52 13.67 32 86708 74314 70767390
Gait disturbance 25.45 13.67 128 86612 184978 70656726
Bone lesion 24.97 13.67 32 86708 5398 70836306
Treatment noncompliance 24.76 13.67 13 86727 46561 70795143
Hepatotoxicity 24.69 13.67 113 86627 43873 70797831
Calcium ionised increased 24.62 13.67 9 86731 171 70841533
Multicentric reticulohistiocytosis 24.60 13.67 5 86735 6 70841698
Vulvovaginal inflammation 24.52 13.67 12 86728 480 70841224
Skin fissures 24.45 13.67 47 86693 11223 70830481
Nail bed bleeding 24.40 13.67 12 86728 485 70841219
Ear infection 24.32 13.67 3 86737 28333 70813371
Nephrolithiasis 24.02 13.67 14 86726 47309 70794395
Pustule 23.91 13.67 18 86722 1581 70840123
Peripheral motor neuropathy 23.88 13.67 24 86716 3108 70838596
Off label use 23.76 13.67 1123 85617 741937 70099767
Basal cell carcinoma 23.66 13.67 6 86734 33692 70808012
Back pain 23.59 13.67 464 86276 270688 70571016
Emotional distress 23.58 13.67 8 86732 37180 70804524
Post-traumatic pain 23.45 13.67 11 86729 400 70841304
Osteitis condensans 23.37 13.67 6 86734 31 70841673
Sensory disturbance 23.32 13.67 52 86688 13780 70827924
Acute pulmonary oedema 23.27 13.67 51 86689 13361 70828343
Exposure during pregnancy 23.20 13.67 45 86695 87672 70754032
Irritable bowel syndrome 23.15 13.67 17 86723 50833 70790871
Renal impairment 23.09 13.67 94 86646 143843 70697861
Sopor 23.07 13.67 5 86735 31262 70810442
Subdural haematoma 23.07 13.67 4 86736 29294 70812410
HER2 positive gastric cancer 22.83 13.67 4 86736 0 70841704
Cerebrovascular accident 22.83 13.67 94 86646 143376 70698328
Cystoid macular oedema 22.80 13.67 19 86721 1933 70839771
Hyperbilirubinaemia 22.76 13.67 70 86670 22498 70819206
Osteoporosis 22.72 13.67 16 86724 48891 70792813
Gait inability 22.50 13.67 15 86725 47160 70794544
Dyspepsia 22.48 13.67 186 86554 88891 70752813
Temperature intolerance 22.23 13.67 39 86701 8684 70833020
Dysaesthesia 22.15 13.67 30 86710 5338 70836366
Xerophthalmia 22.08 13.67 12 86728 598 70841106
Lymphangitis 22.00 13.67 16 86724 1333 70840371
Palmar erythema 22.00 13.67 18 86722 1785 70839919
Migraine 21.89 13.67 34 86706 72204 70769500
Influenza 21.73 13.67 69 86671 113631 70728073
Urticaria 21.70 13.67 114 86626 162935 70678769
Osteolysis 21.55 13.67 24 86716 3495 70838209
Pneumonia aspiration 21.18 13.67 27 86713 62262 70779442
Rash pustular 21.16 13.67 42 86698 10266 70831438
Blood alkaline phosphatase increased 21.01 13.67 133 86607 58388 70783316
Left ventricular dilatation 21.00 13.67 14 86726 1014 70840690
Corneal disorder 20.99 13.67 19 86721 2160 70839544
Gait apraxia 20.93 13.67 5 86735 18 70841686
Distichiasis 20.93 13.67 5 86735 18 70841686
Lymphadenopathy 20.80 13.67 116 86624 48675 70793029
Breast disorder 20.78 13.67 18 86722 1931 70839773
Radiation pneumonitis 20.61 13.67 24 86716 3669 70838035
Pulmonary hypoplasia 20.60 13.67 6 86734 53 70841651
Overflow diarrhoea 20.55 13.67 7 86733 107 70841597
Respiratory depression 20.43 13.67 3 86737 24828 70816876
Acute respiratory distress syndrome 20.27 13.67 102 86638 41152 70800552
Pericarditis 20.27 13.67 46 86694 84659 70757045
Barotrauma 20.22 13.67 8 86732 190 70841514
Swollen tongue 20.20 13.67 10 86730 37036 70804668
Hypothalamo-pituitary disorder 20.20 13.67 14 86726 1081 70840623
Spinal pain 20.18 13.67 49 86691 13721 70827983
Infection 20.12 13.67 163 86577 210622 70631082
Delusion of grandeur 20.11 13.67 13 86727 894 70840810
Dermatomyositis 20.09 13.67 23 86717 3452 70838252
Breast sarcoma 20.06 13.67 4 86736 4 70841700
Vaginal prolapse 20.05 13.67 9 86731 295 70841409
Dizziness 20.05 13.67 424 86316 463717 70377987
Ovarian failure 19.90 13.67 11 86729 567 70841137
Mouth ulceration 19.84 13.67 89 86651 34260 70807444
Hypervolaemia 19.79 13.67 12 86728 39694 70802010
Acute myocardial infarction 19.62 13.67 37 86703 72850 70768854
Dysuria 19.61 13.67 109 86631 45685 70796019
Subclavian vein thrombosis 19.60 13.67 19 86721 2355 70839349
Hyperchlorhydria 19.58 13.67 17 86723 1829 70839875
Haemorrhoids 19.30 13.67 72 86668 25516 70816188
Tidal volume decreased 19.18 13.67 6 86734 69 70841635
Skin infection 19.15 13.67 53 86687 16059 70825645
Hypotension 19.08 13.67 364 86376 404017 70437687
Agitation 19.03 13.67 55 86685 93320 70748384
Gastritis 19.00 13.67 106 86634 44485 70797219
Herpangina 18.99 13.67 5 86735 29 70841675
Inflammatory carcinoma of the breast 18.99 13.67 5 86735 29 70841675
Impaired healing 18.94 13.67 39 86701 74335 70767369
Eye pain 18.91 13.67 9 86731 34093 70807611
Merycism 18.67 13.67 8 86732 234 70841470
Transaminases 18.58 13.67 6 86734 77 70841627
Gastrointestinal disorder 18.57 13.67 204 86536 105223 70736481
Thrombocytopenia 18.43 13.67 402 86338 238708 70602996
Blood creatine increased 18.34 13.67 36 86704 8728 70832976
Therapy interrupted 18.23 13.67 4 86736 24798 70816906
Entropion 18.06 13.67 5 86735 36 70841668
Nail bed tenderness 18.05 13.67 9 86731 375 70841329
Toxic neuropathy 18.04 13.67 12 86728 866 70840838
Cataract 18.03 13.67 25 86715 55620 70786084
Retinal detachment 17.99 13.67 35 86705 8432 70833272
Vocal cord paralysis 17.96 13.67 18 86722 2323 70839381
Sarcoid-like reaction 17.83 13.67 4 86736 10 70841694
Encephalopathy 17.77 13.67 30 86710 61631 70780073
Metastases to the mediastinum 17.77 13.67 10 86730 534 70841170
Urinary retention 17.62 13.67 23 86717 52497 70789207
Metastases to breast 17.55 13.67 8 86732 272 70841432
Maternal exposure during pregnancy 17.47 13.67 77 86663 115268 70726436
Eastern Cooperative Oncology Group performance status worsened 17.45 13.67 15 86725 1593 70840111
Device issue 17.41 13.67 4 86736 24021 70817683
Pituitary tumour 17.31 13.67 13 86727 1138 70840566
Limb injury 17.30 13.67 5 86735 25747 70815957
Colitis ulcerative 17.26 13.67 10 86730 33913 70807791
Lower respiratory tract infection 17.23 13.67 211 86529 111702 70730002
Leukaemia cutis 17.18 13.67 7 86733 180 70841524
Globulinuria 17.12 13.67 3 86737 0 70841704
Left atrial volume increased 17.12 13.67 3 86737 0 70841704
Tooth extraction 17.04 13.67 38 86702 10069 70831635
Malignant pleural effusion 16.85 13.67 20 86720 3119 70838585
Dandy-Walker syndrome 16.79 13.67 5 86735 48 70841656
Illness 16.71 13.67 9 86731 31782 70809922
Aphasia 16.60 13.67 17 86723 43232 70798472
Transient ischaemic attack 16.59 13.67 19 86721 45925 70795779
Road traffic accident 16.57 13.67 11 86729 34671 70807033
Tongue coated 16.56 13.67 13 86727 1215 70840489
Axillary vein thrombosis 16.52 13.67 10 86730 612 70841092
Clostridial infection 16.50 13.67 26 86714 5303 70836401
Adenocarcinoma gastric 16.45 13.67 15 86725 1721 70839983
Catheter site pain 16.44 13.67 25 86715 4943 70836761
Generalised tonic-clonic seizure 16.42 13.67 16 86724 41645 70800059
Pleural disorder 16.39 13.67 11 86729 806 70840898
Metastases to nervous system 16.35 13.67 5 86735 53 70841651
Breast ulceration 16.35 13.67 5 86735 53 70841651
Gout 16.34 13.67 4 86736 23002 70818702
Adverse drug reaction 16.27 13.67 25 86715 53319 70788385
Oral candidiasis 16.22 13.67 67 86673 24885 70816819
Spider naevus 16.17 13.67 6 86734 119 70841585
Alopecia totalis 16.12 13.67 8 86732 330 70841374
Angioedema 16.07 13.67 36 86704 66574 70775130
Viral infection 16.02 13.67 14 86726 38377 70803327
Naevus haemorrhage 15.99 13.67 6 86734 123 70841581
Paralysis recurrent laryngeal nerve 15.99 13.67 6 86734 123 70841581
Nasal ulcer 15.90 13.67 15 86725 1798 70839906
Urinary tract disorder 15.87 13.67 20 86720 3317 70838387
Foot deformity 15.87 13.67 3 86737 20652 70821052
Botryomycosis 15.86 13.67 5 86735 59 70841645
Full blood count abnormal 15.85 13.67 11 86729 33867 70807837
Pancreatitis 15.84 13.67 33 86707 62635 70779069
Hypoxia 15.70 13.67 179 86561 93165 70748539
Gingival pain 15.67 13.67 29 86711 6728 70834976
Movement disorder 15.64 13.67 5 86735 24124 70817580
Pneumonitis chemical 15.56 13.67 8 86732 356 70841348
Dental fistula 15.53 13.67 9 86731 508 70841196
Urogenital prolapse 15.53 13.67 4 86736 21 70841683
Pleural neoplasm 15.45 13.67 8 86732 361 70841343
Gastric disorder 15.35 13.67 11 86729 33311 70808393
Injection site haemorrhage 15.33 13.67 6 86734 25521 70816183
Gastric perforation 15.26 13.67 21 86719 3794 70837910
Amenorrhoea 15.15 13.67 29 86711 6901 70834803
Joint injury 15.10 13.67 7 86733 26925 70814779
Myeloproliferative neoplasm 15.08 13.67 11 86729 921 70840783
Diabetic ketoacidosis 15.05 13.67 10 86730 31502 70810202
Atrial thrombosis 14.82 13.67 19 86721 3206 70838498
Fluid retention 14.70 13.67 35 86705 63350 70778354
Hepatitis 14.69 13.67 24 86716 49956 70791748
Flatulence 14.67 13.67 15 86725 38166 70803538
Product administration error 14.61 13.67 9 86731 29514 70812190
Incorrect dose administered 14.57 13.67 38 86702 66681 70775023
Myoclonus 14.55 13.67 7 86733 26348 70815356
Carbohydrate antigen 19-9 increased 14.53 13.67 8 86732 409 70841295
Postural orthostatic tachycardia syndrome 14.45 13.67 9 86731 580 70841124
Corneal bleeding 14.43 13.67 4 86736 29 70841675
Frequent bowel movements 14.40 13.67 4 86736 21149 70820555
Rhinorrhoea 14.36 13.67 134 86606 66237 70775467
Hypertensive crisis 14.36 13.67 54 86686 19208 70822496
Pulmonary toxicity 14.33 13.67 37 86703 10761 70830943
Chromosomal mutation 14.31 13.67 4 86736 30 70841674
Appendiceal abscess 14.23 13.67 7 86733 283 70841421
Product quality issue 14.19 13.67 10 86730 30551 70811153
Tumour haemorrhage 14.16 13.67 20 86720 3702 70838002
Folate deficiency 14.16 13.67 18 86722 3012 70838692
Fear 14.05 13.67 4 86736 20807 70820897
Toothache 14.02 13.67 52 86688 18378 70823326
Bronchitis 13.96 13.67 85 86655 117158 70724546
Labelled drug-drug interaction medication error 13.95 13.67 6 86734 24121 70817583
Nodular regenerative hyperplasia 13.90 13.67 12 86728 1281 70840423
Lymphocyte count decreased 13.84 13.67 96 86644 43443 70798261
HER2 positive salivary gland cancer 13.84 13.67 3 86737 6 70841698
Catheter site bruise 13.83 13.67 7 86733 301 70841403
Mouth swelling 13.74 13.67 24 86716 5325 70836379
Plantar erythema 13.73 13.67 7 86733 306 70841398

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
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
4021140 VANDF
4038908 VANDF

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 55513-141 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
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