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 2638.34 12.75 1100 103430 17420 50483174
Disease progression 1434.14 12.75 1344 103186 94522 50406072
Metastases to central nervous system 1273.83 12.75 569 103961 10713 50489881
Myelosuppression 1076.91 12.75 536 103994 12981 50487613
Palmar-plantar erythrodysaesthesia syndrome 1072.39 12.75 610 103920 19488 50481106
Diarrhoea 1048.47 12.75 3114 101416 585362 49915232
Cardiotoxicity 998.54 12.75 417 104113 6610 50493984
Neuropathy peripheral 788.92 12.75 985 103545 95772 50404822
Febrile neutropenia 732.67 12.75 954 103576 96713 50403881
Drug ineffective 659.16 12.75 446 104084 818887 49681707
Neutropenia 575.40 12.75 1067 103463 146898 50353696
Bone marrow failure 535.05 12.75 449 104081 27175 50473419
Metastases to bone 465.76 12.75 347 104183 17648 50482946
Mucosal inflammation 446.53 12.75 480 104050 39662 50460932
Metastases to liver 425.29 12.75 344 104186 19760 50480834
Cardiac dysfunction 383.19 12.75 141 104389 1560 50499034
Chills 382.63 12.75 703 103827 95984 50404610
Metastases to lung 381.72 12.75 254 104276 10766 50489828
Polyneuropathy 368.92 12.75 258 104272 11873 50488721
Left ventricular dysfunction 341.98 12.75 233 104297 10273 50490321
Rheumatoid arthritis 338.34 12.75 20 104510 202530 50298064
Drug hypersensitivity 305.30 12.75 72 104458 250938 50249656
Interstitial lung disease 299.24 12.75 453 104077 52723 50447871
Breast cancer recurrent 297.23 12.75 149 104381 3659 50496935
Malignant neoplasm progression 288.08 12.75 510 104020 67614 50432980
Metastases to lymph nodes 287.92 12.75 180 104350 6844 50493750
Cardiac failure 284.61 12.75 540 103990 75500 50425094
Joint swelling 274.38 12.75 83 104447 245203 50255391
Completed suicide 256.25 12.75 3 104527 131886 50368708
Cardiomyopathy 254.63 12.75 230 104300 15356 50485238
Fall 253.64 12.75 193 104337 334739 50165855
Condition aggravated 242.23 12.75 158 104372 296900 50203694
Synovitis 235.53 12.75 4 104526 123861 50376733
Peripheral sensory neuropathy 233.29 12.75 154 104376 6437 50494157
Systemic lupus erythematosus 228.45 12.75 16 104514 140606 50359988
Therapeutic product effect decreased 225.38 12.75 14 104516 136036 50364558
Skin toxicity 203.82 12.75 117 104413 3796 50496798
Death 199.32 12.75 1250 103280 324129 50176465
Arthropathy 196.43 12.75 43 104487 157863 50342731
Metastasis 194.28 12.75 118 104412 4257 50496337
Breast cancer metastatic 191.43 12.75 164 104366 10200 50490394
Pleural effusion 190.86 12.75 479 104051 80975 50419619
Drug interaction 182.83 12.75 92 104438 199529 50301065
Sinusitis 179.54 12.75 64 104466 170494 50330100
Abdominal discomfort 178.36 12.75 131 104399 231510 50269084
Metastases to skin 172.97 12.75 75 104455 1308 50499286
Pneumonitis 172.51 12.75 256 104274 29254 50471340
Lymphoedema 171.85 12.75 146 104384 8976 50491618
Epistaxis 170.08 12.75 395 104135 63559 50437035
Nail disorder 169.96 12.75 149 104381 9559 50491035
Neutropenic sepsis 167.55 12.75 175 104355 13972 50486622
Neoplasm progression 163.39 12.75 248 104282 28909 50471685
Neurotoxicity 159.84 12.75 174 104356 14566 50486028
Onycholysis 153.07 12.75 68 104462 1260 50499334
Product dose omission issue 146.68 12.75 100 104430 183738 50316856
Treatment failure 140.86 12.75 54 104476 137583 50363011
Pyrexia 140.80 12.75 1298 103232 378905 50121689
Stomatitis 139.87 12.75 494 104036 100850 50399744
Weight increased 130.15 12.75 135 104395 201756 50298838
Osteonecrosis of jaw 127.83 12.75 236 104294 32290 50468304
Onychoclasis 125.11 12.75 96 104434 5100 50495494
Decreased appetite 120.91 12.75 769 103761 200154 50300440
Gastrointestinal toxicity 120.55 12.75 90 104440 4587 50496007
Glossodynia 120.49 12.75 44 104486 115525 50385069
Computerised tomogram thorax abnormal 119.50 12.75 58 104472 1325 50499269
Drug intolerance 118.48 12.75 168 104362 218936 50281658
Haematotoxicity 118.24 12.75 111 104419 7784 50492810
Bone pain 117.19 12.75 284 104246 46945 50453649
Nail discolouration 116.26 12.75 68 104462 2286 50498308
Toxicity to various agents 115.83 12.75 162 104368 212337 50288257
Swelling 115.73 12.75 147 104383 200725 50299869
Therapeutic product effect incomplete 115.63 12.75 24 104506 91491 50409103
Nail toxicity 114.37 12.75 38 104492 302 50500292
Hypokalaemia 111.31 12.75 417 104113 87575 50413019
Injection site pain 111.21 12.75 45 104485 110979 50389615
Maternal exposure during pregnancy 110.89 12.75 100 104430 159678 50340916
Drug abuse 109.53 12.75 3 104527 59843 50440751
Confusional state 109.26 12.75 134 104396 185794 50314800
Somnolence 108.76 12.75 96 104434 154889 50345705
Ventricular hypokinesia 108.00 12.75 79 104451 3901 50496693
Pain 107.07 12.75 729 103801 578174 49922420
Nausea 104.89 12.75 2039 102491 703359 49797235
Psoriasis 103.43 12.75 11 104519 68989 50431605
Acute myeloid leukaemia 101.65 12.75 140 104390 14934 50485660
Overdose 100.57 12.75 40 104490 99687 50400907
Lacrimation increased 100.14 12.75 148 104382 16844 50483750
Alveolitis 98.99 12.75 63 104467 2471 50498123
Metastatic neoplasm 98.46 12.75 73 104457 3681 50496913
Vomiting 98.16 12.75 1413 103117 459345 50041249
Mitral valve incompetence 97.01 12.75 148 104382 17323 50483271
Hospitalisation 96.48 12.75 13 104517 67924 50432670
Loss of personal independence in daily activities 95.78 12.75 15 104515 70035 50430559
Product use issue 93.99 12.75 102 104428 149373 50351221
Pericardial effusion 93.50 12.75 180 104350 25409 50475185
Neutropenic infection 92.16 12.75 45 104485 1042 50499552
Onychomadesis 91.04 12.75 68 104462 3468 50497126
Biopsy lung abnormal 89.15 12.75 26 104504 126 50500468
Dyspnoea 87.40 12.75 1601 102929 546007 49954587
Exposure during pregnancy 87.27 12.75 73 104457 120942 50379652
Disease recurrence 86.94 12.75 152 104378 19929 50480665
Wound 86.41 12.75 56 104474 105738 50394856
Lymphangiosis carcinomatosa 85.19 12.75 44 104486 1152 50499442
Dry skin 84.85 12.75 238 104292 42953 50457641
Injection site erythema 84.29 12.75 25 104505 74911 50425683
Cellulitis 83.35 12.75 328 104202 70470 50430124
Metastases to spine 83.24 12.75 59 104471 2772 50497822
Hypertransaminasaemia 83.20 12.75 65 104465 3546 50497048
Radiation necrosis 83.09 12.75 30 104500 313 50500281
Musculoskeletal stiffness 82.64 12.75 86 104444 128395 50372199
Dysgeusia 81.97 12.75 220 104310 38696 50461898
Breast pain 81.69 12.75 89 104441 7455 50493139
Leukopenia 80.42 12.75 314 104216 67214 50433380
Colitis 79.34 12.75 216 104314 38313 50462281
Asthenia 78.70 12.75 1005 103525 318037 50182557
Paronychia 77.79 12.75 69 104461 4495 50496099
Inappropriate schedule of product administration 77.16 12.75 26 104504 71805 50428789
Thrombocytopenia 76.91 12.75 489 104041 127184 50373410
Recall phenomenon 75.63 12.75 32 104498 524 50500070
Neutrophil count decreased 75.57 12.75 238 104292 45788 50454806
Radiation skin injury 73.98 12.75 36 104494 827 50499767
Lung infiltration 73.72 12.75 113 104417 13280 50487314
Fibromyalgia 73.33 12.75 5 104525 44973 50455621
Suicide attempt 73.21 12.75 10 104520 51722 50448872
Organising pneumonia 73.18 12.75 68 104462 4706 50495888
Hyperpyrexia 70.50 12.75 55 104475 2994 50497600
Vascular device infection 70.22 12.75 64 104466 4320 50496274
Contusion 70.01 12.75 77 104453 112106 50388488
Osteonecrosis 68.72 12.75 147 104383 22370 50478224
Fatigue 68.61 12.75 1928 102602 705673 49794921
Dermatitis acneiform 66.50 12.75 60 104470 3997 50496597
Hepatic enzyme increased 65.95 12.75 114 104416 137266 50363328
Hot flush 65.84 12.75 221 104309 43948 50456646
Arthritis 65.41 12.75 50 104480 86671 50413923
Aortitis 64.77 12.75 33 104497 839 50499755
Onychalgia 64.68 12.75 32 104498 763 50499831
Injection site swelling 64.32 12.75 6 104524 41767 50458827
Nail dystrophy 64.07 12.75 32 104498 779 50499815
Injection site bruising 63.28 12.75 3 104527 36765 50463829
Recurrent cancer 62.04 12.75 41 104489 1716 50498878
Asthma 61.84 12.75 56 104474 89281 50411313
Injection site pruritus 61.71 12.75 6 104524 40405 50460189
Multifocal micronodular pneumocyte hyperplasia 60.72 12.75 17 104513 69 50500525
Bronchial polyp 60.72 12.75 17 104513 69 50500525
Constipation 60.58 12.75 618 103912 185090 50315504
Mobility decreased 60.41 12.75 46 104484 79902 50420692
Erysipelas 59.74 12.75 71 104459 6537 50494057
Duodenal ulcer perforation 59.62 12.75 11 104519 45600 50454994
Anaemia 59.55 12.75 789 103741 251667 50248927
Acute interstitial pneumonitis 59.53 12.75 28 104502 595 50499999
Osteoarthritis 59.24 12.75 34 104496 68572 50432022
Systolic dysfunction 58.50 12.75 37 104493 1435 50499159
Cough 57.30 12.75 755 103775 240509 50260085
Ejection fraction abnormal 57.01 12.75 30 104500 817 50499777
Alanine aminotransferase increased 56.67 12.75 344 104186 88015 50412579
Madarosis 56.65 12.75 45 104485 2515 50498079
Dehydration 54.92 12.75 518 104012 151931 50348663
Migraine 54.76 12.75 45 104485 75235 50425359
Myalgia 54.44 12.75 441 104089 123878 50376716
Blood cholesterol increased 54.27 12.75 23 104507 55192 50445402
Injection site reaction 53.92 12.75 18 104512 50014 50450580
Discomfort 53.79 12.75 88 104442 108292 50392302
Hepatic function abnormal 52.73 12.75 168 104362 32513 50468081
Erythema 52.49 12.75 497 104033 145917 50354677
Oligohydramnios 52.35 12.75 62 104468 5688 50494906
Breast neoplasm 52.18 12.75 33 104497 1280 50499314
Radiation pneumonitis 51.67 12.75 33 104497 1302 50499292
Product use in unapproved indication 51.23 12.75 101 104429 115718 50384876
Congestive cardiomyopathy 51.06 12.75 60 104470 5458 50495136
Second primary malignancy 50.86 12.75 67 104463 6847 50493747
Feeling abnormal 50.85 12.75 115 104415 125377 50375217
Injury 50.34 12.75 19 104511 48906 50451688
Irritable bowel syndrome 49.65 12.75 22 104508 51419 50449175
Incorrect dose administered 49.48 12.75 19 104511 48395 50452199
Paraesthesia 49.15 12.75 420 104110 119823 50380771
Hyperkalaemia 48.94 12.75 19 104511 48070 50452524
Axillary pain 48.87 12.75 34 104496 1550 50499044
Mastectomy 48.79 12.75 33 104497 1436 50499158
Device related infection 48.57 12.75 122 104408 20613 50479981
Blood uric acid decreased 48.32 12.75 25 104505 657 50499937
Sedation 48.20 12.75 4 104526 30606 50469988
Tumour marker increased 48.17 12.75 49 104481 3791 50496803
Drug reaction with eosinophilia and systemic symptoms 46.81 12.75 3 104527 28421 50472173
Nail infection 46.38 12.75 36 104494 1945 50498649
Chest discomfort 46.19 12.75 339 104191 92383 50408211
Lactic acidosis 45.91 12.75 7 104523 33348 50467246
Atelectasis 45.44 12.75 110 104420 18160 50482434
Pulmonary embolism 45.18 12.75 362 104168 101342 50399252
Mastitis 45.10 12.75 38 104492 2309 50498285
Hallucination 44.95 12.75 20 104510 46637 50453957
Blood bilirubin increased 44.85 12.75 157 104373 31881 50468713
Invasive ductal breast carcinoma 44.52 12.75 58 104472 5863 50494731
Plasma cell myeloma 44.45 12.75 6 104524 31316 50469278
Rhabdomyolysis 43.92 12.75 13 104517 39014 50461580
Metastases to meninges 43.89 12.75 35 104495 1967 50498627
Alopecia areata 43.70 12.75 30 104500 1338 50499256
Blood lactate dehydrogenase increased 43.64 12.75 113 104417 19449 50481145
Suicidal ideation 42.96 12.75 31 104499 55354 50445240
Hypoglycaemia 42.87 12.75 29 104501 53552 50447042
Urticaria 42.42 12.75 132 104398 129429 50371165
Ejection fraction 42.37 12.75 28 104502 1172 50499422
Therapy cessation 42.09 12.75 3 104527 26008 50474586
Intentional product misuse 42.03 12.75 22 104508 46712 50453882
White blood cell count decreased 41.71 12.75 396 104134 116326 50384268
Granulocyte count decreased 41.71 12.75 24 104506 782 50499812
Dermatitis 41.16 12.75 91 104439 14160 50486434
Skin fissures 40.66 12.75 68 104462 8600 50491994
Influenza 40.53 12.75 77 104453 89461 50411133
Nasal congestion 40.46 12.75 28 104502 51092 50449502
Adverse event 40.25 12.75 20 104510 43743 50456851
Peripheral motor neuropathy 40.18 12.75 29 104501 1402 50499192
Chronic kidney disease 40.00 12.75 16 104514 39755 50460839
Hyperbilirubinaemia 39.56 12.75 71 104459 9499 50491095
Bronchitis 39.37 12.75 99 104431 104060 50396534
Gait disturbance 39.11 12.75 168 104362 149837 50350757
Tonsillar disorder 38.64 12.75 25 104505 1009 50499585
Depression 37.99 12.75 194 104336 165229 50335365
International normalised ratio increased 37.80 12.75 21 104509 43131 50457463
Transaminases increased 37.79 12.75 135 104395 27689 50472905
Ascites 37.33 12.75 160 104370 35701 50464893
Hepatotoxicity 36.89 12.75 132 104398 27094 50473500
Irritability 36.84 12.75 7 104523 28419 50472175
Neoplasm recurrence 36.81 12.75 34 104496 2335 50498259
Skin exfoliation 36.57 12.75 152 104378 33460 50467134
Dyspnoea exertional 36.42 12.75 205 104325 51028 50449566
Acute respiratory distress syndrome 36.38 12.75 111 104419 20988 50479606
Blood glucose increased 36.24 12.75 57 104473 71267 50429327
Peripheral swelling 36.05 12.75 263 104267 205673 50294921
Pseudocirrhosis 35.95 12.75 20 104510 610 50499984
Wrong technique in product usage process 35.84 12.75 37 104493 55473 50445121
Arthralgia 35.68 12.75 665 103865 438037 50062557
Hyperfibrinogenaemia 35.58 12.75 9 104521 22 50500572
Dermatomyositis 35.50 12.75 32 104498 2129 50498465
Electrocardiogram QT prolonged 35.33 12.75 33 104497 51853 50448741
Pericarditis 35.33 12.75 68 104462 78621 50421973
Pulmonary toxicity 35.03 12.75 50 104480 5512 50495082
Blister 34.82 12.75 78 104452 85340 50415254
Tumour pain 34.70 12.75 25 104505 1205 50499389
Jaw operation 34.53 12.75 21 104509 759 50499835
Ear infection 34.51 12.75 6 104524 25964 50474630
Anxiety 34.47 12.75 220 104310 177386 50323208
Coma 34.42 12.75 40 104490 56839 50443755
Aspartate aminotransferase increased 34.29 12.75 277 104253 77721 50422873
Neoplasm 34.02 12.75 51 104479 5877 50494717
Ventricular dysfunction 33.89 12.75 34 104496 2587 50498007
Dyskinesia 33.78 12.75 8 104522 27853 50472741
Cystitis noninfective 33.71 12.75 21 104509 793 50499801
Osteoporosis 33.67 12.75 26 104504 44853 50455741
Platelet count decreased 33.66 12.75 337 104193 100389 50400205
Breast mass 33.52 12.75 53 104477 6396 50494198
Cataract 33.50 12.75 29 104501 47271 50453323
Toxic cardiomyopathy 33.34 12.75 12 104518 124 50500470
Cardiac disorder 33.26 12.75 176 104354 42803 50457791
Unresponsive to stimuli 33.00 12.75 11 104519 30598 50469996
Eosinophil percentage increased 32.97 12.75 22 104508 936 50499658
Sleep apnoea syndrome 32.87 12.75 5 104525 23863 50476731
Carcinoembryonic antigen increased 32.81 12.75 26 104504 1448 50499146
Enterocolitis 32.80 12.75 53 104477 6514 50494080
Hair colour changes 32.79 12.75 34 104496 2690 50497904
Aggression 32.60 12.75 3 104527 21113 50479481
Impaired healing 32.48 12.75 59 104471 69727 50430867
Product prescribing error 32.30 12.75 3 104527 20958 50479636
Wheezing 32.08 12.75 49 104481 61998 50438596
Blood creatinine decreased 31.73 12.75 45 104485 4931 50495663
Performance status decreased 31.68 12.75 36 104494 3159 50497435
Tachycardia 31.53 12.75 330 104200 99433 50401161
Acute pulmonary oedema 31.44 12.75 55 104475 7212 50493382
Breast disorder 31.38 12.75 29 104501 1993 50498601
Breast inflammation 30.88 12.75 11 104519 110 50500484
Chronic obstructive pulmonary disease 30.83 12.75 39 104491 53396 50447198
Troponin I increased 30.62 12.75 28 104502 1898 50498696
Perforation 30.46 12.75 21 104509 943 50499651
Breast oedema 30.44 12.75 8 104522 24 50500570
Cardio-respiratory arrest 30.40 12.75 40 104490 53852 50446742
Device issue 30.40 12.75 3 104527 19969 50480625
Diabetes mellitus 30.19 12.75 34 104496 48999 50451595
Delirium 30.11 12.75 21 104509 38171 50462423
Keratitis 29.88 12.75 31 104499 2454 50498140
HER2 positive breast cancer 29.79 12.75 14 104516 297 50500297
Basal cell carcinoma 29.75 12.75 6 104524 23350 50477244
Gait inability 29.67 12.75 20 104510 37007 50463587
Accidental overdose 29.56 12.75 3 104527 19530 50481064
Vocal cord paralysis 29.55 12.75 26 104504 1675 50498919
Metastases to chest wall 29.55 12.75 16 104514 462 50500132
Eye pain 29.34 12.75 11 104519 28438 50472156
Agranulocytosis 29.14 12.75 104 104426 21317 50479277
Foot deformity 28.94 12.75 3 104527 19207 50481387
Enterocolitis infectious 28.54 12.75 24 104506 1454 50499140
Mental status changes 28.52 12.75 20 104510 36252 50464342
Excessive eye blinking 28.47 12.75 20 104510 926 50499668
Nodular regenerative hyperplasia 28.40 12.75 13 104517 259 50500335
Left ventricular dilatation 28.35 12.75 15 104515 413 50500181
Bladder irritation 28.28 12.75 12 104518 198 50500396
Pulmonary mass 28.23 12.75 94 104436 18611 50481983
Hepatic lesion 28.19 12.75 38 104492 3970 50496624
Myocarditis 27.92 12.75 55 104475 7892 50492702
Metastases to breast 27.91 12.75 13 104517 270 50500324
Malignant pleural effusion 27.90 12.75 29 104501 2301 50498293
Lymphadenopathy 27.88 12.75 140 104390 33359 50467235
Depressed level of consciousness 27.86 12.75 40 104490 51913 50448681
Seroma 27.79 12.75 26 104504 1815 50498779
Foetal exposure during pregnancy 27.52 12.75 11 104519 27348 50473246
Therapy partial responder 27.37 12.75 49 104481 6542 50494052
Adverse drug reaction 27.23 12.75 45 104485 55177 50445417
Respiratory arrest 27.17 12.75 14 104516 29995 50470599
Mouth ulceration 26.86 12.75 122 104408 27902 50472692
Cytomegalovirus infection 26.56 12.75 3 104527 17959 50482635
Meibomian gland dysfunction 26.37 12.75 10 104520 121 50500473
Mean platelet volume decreased 26.36 12.75 24 104506 1618 50498976
Red cell distribution width increased 26.25 12.75 56 104474 8503 50492091
Sense of oppression 26.19 12.75 19 104511 926 50499668
Nephrolithiasis 26.15 12.75 20 104510 34673 50465921
Gastrointestinal haemorrhage 25.94 12.75 72 104458 73249 50427345
Treatment noncompliance 25.94 12.75 15 104515 30135 50470459
Hydrothorax 25.67 12.75 17 104513 714 50499880
Axillary vein thrombosis 25.64 12.75 13 104517 327 50500267
Product quality issue 25.64 12.75 16 104514 30842 50469752
Eosinophilia 25.47 12.75 4 104526 18648 50481946
Rash pustular 25.42 12.75 47 104483 6434 50494160
Diastolic dysfunction 25.41 12.75 42 104488 5260 50495334
Blood alkaline phosphatase increased 25.26 12.75 148 104382 37378 50463216
Cardiac failure congestive 25.21 12.75 276 104254 84106 50416488
Sensory disturbance 25.03 12.75 67 104463 11762 50488832
Hip arthroplasty 24.97 12.75 16 104514 30413 50470181
Vessel puncture site bruise 24.91 12.75 13 104517 348 50500246
Hypoaesthesia 24.86 12.75 385 104145 126872 50373722
Bone lesion 24.84 12.75 41 104489 5129 50495465
Metastases to pleura 24.79 12.75 21 104509 1285 50499309
Computerised tomogram thorax 24.74 12.75 10 104520 145 50500449
Hair texture abnormal 24.71 12.75 34 104496 3622 50496972
Calcium ionised increased 24.66 12.75 9 104521 97 50500497
Nasal disorder 24.59 12.75 27 104503 2281 50498313
Hypervolaemia 24.45 12.75 11 104519 25488 50475106
Nail bed bleeding 24.37 12.75 12 104518 283 50500311
Injection site haemorrhage 24.22 12.75 7 104523 21339 50479255
Asthenopia 24.17 12.75 25 104505 1972 50498622
Dysaesthesia 24.15 12.75 34 104496 3701 50496893
Nail ridging 24.11 12.75 12 104518 290 50500304
Therapy interrupted 24.01 12.75 6 104524 20146 50480448
Bile duct stenosis 23.99 12.75 19 104511 1057 50499537
Intercepted product preparation error 23.93 12.75 13 104517 378 50500216
Blood creatine increased 23.81 12.75 39 104491 4848 50495746
Vulvovaginal dryness 23.73 12.75 26 104504 2191 50498403
Rhinorrhoea 23.65 12.75 185 104345 51398 50449196
Brachial plexopathy 23.65 12.75 9 104521 110 50500484
Gastric disorder 23.62 12.75 16 104514 29532 50471062
Emotional distress 23.62 12.75 15 104515 28648 50471946
Vulvovaginal inflammation 23.60 12.75 15 104515 587 50500007
Orthostatic hypotension 23.52 12.75 16 104514 29465 50471129
Central nervous system lesion 23.45 12.75 57 104473 9432 50491162
Biliary sepsis 23.35 12.75 17 104513 833 50499761
Joint injury 23.20 12.75 8 104522 21781 50478813
Abnormal behaviour 23.14 12.75 6 104524 19652 50480942
Bradycardia 22.99 12.75 63 104467 64363 50436231
Blood pressure fluctuation 22.99 12.75 24 104506 35799 50464795
Eastern Cooperative Oncology Group performance status worsened 22.80 12.75 15 104515 623 50499971
Vascular fragility 22.74 12.75 9 104521 123 50500471
Odynophagia 22.70 12.75 45 104485 6487 50494107
Coronary artery disease 22.58 12.75 17 104513 29709 50470885
Disorientation 22.51 12.75 24 104506 35460 50465134
Pustule 22.48 12.75 19 104511 1159 50499435
Retinal detachment 22.42 12.75 39 104491 5090 50495504
Osteolysis 22.34 12.75 27 104503 2530 50498064
Dysuria 22.24 12.75 117 104413 28387 50472207
Swollen tongue 22.23 12.75 16 104514 28614 50471980
Hypoxia 22.16 12.75 181 104349 50942 50449652
Xerophthalmia 22.12 12.75 12 104518 348 50500246
Embolism 21.85 12.75 46 104484 6922 50493672
Acute leukaemia 21.82 12.75 18 104512 1062 50499532
Acoustic stimulation tests abnormal 21.78 12.75 8 104522 88 50500506
Sopor 21.68 12.75 7 104523 19872 50480722
Lymphangitis 21.63 12.75 16 104514 804 50499790
Infusion related reaction 21.60 12.75 480 104050 169077 50331517
Osteosclerosis 21.59 12.75 31 104499 3436 50497158
Hiccups 21.47 12.75 22 104508 1717 50498877
Plantar erythema 21.24 12.75 10 104520 213 50500381
Sarcoid-like reaction 21.16 12.75 5 104525 8 50500586
Secondary cerebellar degeneration 21.14 12.75 7 104523 55 50500539
Tumour lysis syndrome 20.99 12.75 47 104483 7374 50493220
Superior vena cava syndrome 20.97 12.75 14 104516 596 50499998
Left ventricular enlargement 20.92 12.75 7 104523 57 50500537
Breast cancer 20.88 12.75 156 104374 42734 50457860
Dyschezia 20.79 12.75 22 104508 1782 50498812
Atrial thrombosis 20.66 12.75 20 104510 1457 50499137
Acute kidney injury 20.29 12.75 340 104190 227718 50272876
Osteitis condensans 20.26 12.75 6 104524 31 50500563
Renal impairment 20.16 12.75 84 104446 75577 50425017
Tricuspid valve incompetence 20.01 12.75 65 104465 12705 50487889
Gallbladder disorder 19.92 12.75 5 104525 16737 50483857
Bone sequestrum 19.92 12.75 19 104511 1359 50499235
Headache 19.87 12.75 850 103680 505685 49994909
Tooth extraction 19.81 12.75 52 104478 9023 50491571
Kidney infection 19.75 12.75 7 104523 18739 50481855
General physical health deterioration 19.68 12.75 408 104122 142026 50358568
Cystoid macular oedema 19.67 12.75 19 104511 1380 50499214
Cardiac failure chronic 19.52 12.75 30 104500 3533 50497061
Sequestrectomy 19.48 12.75 15 104515 801 50499793
Hypothalamo-pituitary disorder 19.47 12.75 14 104516 673 50499921
Pneumonitis chemical 19.45 12.75 9 104521 184 50500410
Viral infection 19.34 12.75 20 104510 29966 50470628
Crying 19.28 12.75 9 104521 20407 50480187
Myeloproliferative neoplasm 19.24 12.75 12 104518 454 50500140
Metastases to the mediastinum 19.15 12.75 12 104518 458 50500136
Bursitis 19.06 12.75 11 104519 22124 50478470
Corneal disorder 19.04 12.75 20 104510 1606 50498988
Gait apraxia 19.02 12.75 5 104525 15 50500579
Post-traumatic pain 18.93 12.75 11 104519 365 50500229
Injection site rash 18.92 12.75 5 104525 16172 50484422
Dysarthria 18.89 12.75 30 104500 37373 50463221
Chromosomal mutation 18.78 12.75 5 104525 16 50500578
Surgery 18.53 12.75 21 104509 30184 50470410
Brain oedema 18.52 12.75 62 104468 12308 50488286
Nasal ulcer 18.47 12.75 20 104510 1663 50498931
Fluid retention 18.47 12.75 49 104481 50600 50449994
Transaminases 18.44 12.75 7 104523 85 50500509
Skin disorder 18.31 12.75 98 104432 23932 50476662
Skin laceration 18.27 12.75 8 104522 18834 50481760
Full blood count abnormal 18.25 12.75 13 104517 23375 50477219
Leukaemia cutis 18.22 12.75 7 104523 88 50500506
Flushing 18.12 12.75 215 104315 66800 50433794
Tumour marker abnormal 17.99 12.75 9 104521 220 50500374
Cerebrovascular accident 17.98 12.75 118 104412 94562 50406032
Multiple sclerosis 17.91 12.75 10 104520 20483 50480111
Palmar erythema 17.91 12.75 19 104511 1544 50499050
Spinal pain 17.85 12.75 56 104474 10747 50489847
Hepatic failure 17.79 12.75 121 104409 32162 50468432
Breast cellulitis 17.77 12.75 12 104518 521 50500073
Congenital syphilitic osteochondritis 17.72 12.75 5 104525 21 50500573
Folliculitis 17.51 12.75 34 104496 39191 50461403
Paralysis recurrent laryngeal nerve 17.50 12.75 6 104524 53 50500541
Pneumonia aspiration 17.50 12.75 23 104507 30981 50469613
Pleural disorder 17.46 12.75 12 104518 536 50500058
Pericardial effusion malignant 17.41 12.75 7 104523 100 50500494
Nasal crusting 17.31 12.75 9 104521 239 50500355
Gingival bleeding 17.08 12.75 57 104473 11296 50489298
Device malfunction 17.08 12.75 5 104525 15116 50485478
Metabolic acidosis 17.03 12.75 34 104496 38791 50461803
Breast induration 17.02 12.75 5 104525 25 50500569
Sinus congestion 16.96 12.75 4 104526 13967 50486627
Spider naevus 16.86 12.75 7 104523 109 50500485
Botryomycosis 16.85 12.75 5 104525 26 50500568
Toxic optic neuropathy 16.84 12.75 8 104522 174 50500420
Device dislocation 16.78 12.75 12 104518 21534 50479060
Breast ulceration 16.76 12.75 6 104524 61 50500533
Retracted nipple 16.71 12.75 4 104526 7 50500587
Full blood count decreased 16.69 12.75 13 104517 22333 50478261
Therapeutic response unexpected 16.67 12.75 6 104524 15909 50484685
Autonomic neuropathy 16.64 12.75 15 104515 998 50499596
Barotrauma 16.63 12.75 8 104522 179 50500415
Capillary leak syndrome 16.58 12.75 20 104510 1870 50498724
Herpangina 16.55 12.75 5 104525 28 50500566
Hyperchlorhydria 16.50 12.75 18 104512 1510 50499084
Merycism 16.47 12.75 8 104522 183 50500411
Alopecia 16.40 12.75 640 103890 244407 50256187
Medication error 16.37 12.75 31 104499 36073 50464521
Cholangiectasis acquired 16.36 12.75 4 104526 8 50500586
Agitation 16.34 12.75 56 104474 53328 50447266
Dilatation ventricular 16.29 12.75 22 104508 2303 50498291
Hepatic neoplasm 16.22 12.75 19 104511 1723 50498871
Toxic neuropathy 16.18 12.75 10 104520 372 50500222
Hallucination, visual 16.14 12.75 7 104523 16575 50484019
Transient ischaemic attack 16.11 12.75 26 104504 32184 50468410
Amnesia 16.09 12.75 40 104490 42220 50458374
Fear 16.09 12.75 5 104525 14544 50486050
Arachnoid cyst 16.01 12.75 8 104522 195 50500399
Status epilepticus 15.96 12.75 4 104526 13402 50487192
Vaginal prolapse 15.95 12.75 10 104520 382 50500212
Borrelia infection 15.94 12.75 7 104523 126 50500468
Telangiectasia 15.86 12.75 13 104517 760 50499834
Metastases to nervous system 15.85 12.75 5 104525 33 50500561
Gingival pain 15.84 12.75 37 104493 5969 50494625
Blood bilirubin decreased 15.81 12.75 12 104518 627 50499967
Dizziness 15.78 12.75 571 103959 345798 50154796
Subclavian vein thrombosis 15.72 12.75 19 104511 1780 50498814
Gamma-glutamyltransferase increased 15.72 12.75 110 104420 29513 50471081
Pneumocystis jirovecii pneumonia 15.70 12.75 66 104464 14597 50485997
Pruritus 15.65 12.75 456 104074 283112 50217482
Mucosal dryness 15.62 12.75 22 104508 2395 50498199
Bone cancer metastatic 15.60 12.75 7 104523 133 50500461
Blood pressure systolic increased 15.59 12.75 31 104499 35418 50465176
Gastrointestinal ulcer perforation 15.55 12.75 3 104527 0 50500594
Inflammatory carcinoma of breast stage IV 15.55 12.75 3 104527 0 50500594
Multiple gated acquisition scan abnormal 15.55 12.75 3 104527 0 50500594
Lymph node fibrosis 15.55 12.75 3 104527 0 50500594
Globulinuria 15.55 12.75 3 104527 0 50500594
Respiratory tract congestion 15.49 12.75 5 104525 14194 50486400
Respiratory depression 15.47 12.75 3 104527 12007 50488587
Product administration error 15.31 12.75 11 104519 19688 50480906
Upper respiratory tract infection 15.27 12.75 77 104453 65821 50434773
Oropharyngeal candidiasis 15.25 12.75 14 104516 954 50499640
Apical granuloma 15.24 12.75 5 104525 38 50500556
Superinfection 15.24 12.75 20 104510 2036 50498558
Creatinine renal clearance decreased 15.24 12.75 3 104527 11878 50488716
Nervousness 15.11 12.75 21 104509 27630 50472964
Prescribed underdose 15.11 12.75 7 104523 15942 50484652
Scintillating scotoma 15.09 12.75 7 104523 144 50500450
Essential thrombocythaemia 15.05 12.75 7 104523 145 50500449
Hyperaesthesia 15.04 12.75 44 104486 8129 50492465
SAPHO syndrome 15.03 12.75 6 104524 84 50500510
Cardiac arrest 15.02 12.75 106 104424 83545 50417049
Premature delivery 15.02 12.75 16 104514 23647 50476947
Frequent bowel movements 15.01 12.75 5 104525 13913 50486681
Acral peeling skin syndrome 14.98 12.75 4 104526 13 50500581
Ocular vasculitis 14.91 12.75 5 104525 41 50500553
Gram stain positive 14.91 12.75 5 104525 41 50500553
Abdominal rigidity 14.90 12.75 18 104512 1686 50498908
Bone erosion 14.89 12.75 3 104527 11684 50488910
Aortic valve incompetence 14.73 12.75 34 104496 5442 50495152
Pleural neoplasm 14.71 12.75 8 104522 233 50500361
Rash follicular 14.70 12.75 5 104525 43 50500551
Thyroid disorder 14.67 12.75 4 104526 12673 50487921
Renal failure 14.67 12.75 145 104385 106488 50394106
Rotator cuff syndrome 14.63 12.75 3 104527 11541 50489053
Pituitary tumour 14.59 12.75 13 104517 852 50499742
Hiatus hernia 14.57 12.75 10 104520 18334 50482260
Dandy-Walker syndrome 14.54 12.75 6 104524 92 50500502
Impaired work ability 14.53 12.75 5 104525 13635 50486959
Cardiac tamponade 14.52 12.75 29 104501 4203 50496391
Folate deficiency 14.46 12.75 19 104511 1936 50498658
Carbohydrate antigen 19-9 increased 14.42 12.75 7 104523 160 50500434
Catheter site pain 14.40 12.75 27 104503 3735 50496859
Laboratory test abnormal 14.39 12.75 16 104514 23192 50477402
Breast haemorrhage 14.38 12.75 7 104523 161 50500433
Generalised tonic-clonic seizure 14.36 12.75 20 104510 26290 50474304
Hydrocephalus 14.31 12.75 31 104499 4757 50495837
Neutropenic colitis 14.16 12.75 21 104509 2396 50498198
Extravasation 14.11 12.75 19 104511 1983 50498611
Infusion site pain 14.09 12.75 4 104526 12342 50488252
Vena cava thrombosis 13.97 12.75 19 104511 2002 50498592
Myositis 13.96 12.75 42 104488 7878 50492716
Corneal bleeding 13.96 12.75 4 104526 18 50500576
Jaundice 13.94 12.75 98 104432 26331 50474263
Feeling jittery 13.94 12.75 3 104527 11157 50489437
Vagus nerve disorder 13.92 12.75 6 104524 103 50500491
Hypocalcaemia 13.89 12.75 99 104431 26717 50473877
Gastritis 13.87 12.75 116 104414 32867 50467727
Diabetic ketoacidosis 13.86 12.75 10 104520 17862 50482732
Cardiac failure acute 13.84 12.75 43 104487 8207 50492387
Intervertebral disc protrusion 13.84 12.75 13 104517 20380 50480214
Sinus bradycardia 13.76 12.75 5 104525 13178 50487416
Bronchospasm 13.74 12.75 64 104466 14790 50485804
Adenocarcinoma gastric 13.74 12.75 10 104520 490 50500104
Inflammatory carcinoma of the breast 13.69 12.75 5 104525 54 50500540
Flatulence 13.62 12.75 25 104505 29433 50471161
Anal erythema 13.60 12.75 7 104523 182 50500412
Eye swelling 13.49 12.75 13 104517 20131 50480463
Loss of consciousness 13.49 12.75 144 104386 104209 50396385
Joint effusion 13.49 12.75 5 104525 13016 50487578
Breast sarcoma 13.48 12.75 3 104527 3 50500591
Metastases to pituitary gland 13.48 12.75 3 104527 3 50500591
Vision blurred 13.47 12.75 101 104429 78546 50422048
Dacryostenosis acquired 13.45 12.75 10 104520 506 50500088
Immunoglobulin G4 related disease 13.45 12.75 5 104525 57 50500537
Urogenital prolapse 13.45 12.75 4 104526 21 50500573
Infection 13.44 12.75 264 104266 172690 50327904
Foot fracture 13.41 12.75 13 104517 20078 50480516
Papilloedema 13.39 12.75 25 104505 3448 50497146
Therapy non-responder 13.37 12.75 57 104473 50965 50449629
Dystonia 13.37 12.75 4 104526 11922 50488672
Bone disorder 13.30 12.75 75 104455 18677 50481917
Bacterial rhinitis 13.30 12.75 4 104526 22 50500572
Ulcerative keratitis 13.28 12.75 20 104510 2313 50498281
Intracranial pressure increased 13.25 12.75 28 104502 4224 50496370
Glaucoma 13.21 12.75 8 104522 15678 50484916
Appendiceal abscess 13.13 12.75 7 104523 196 50500398
Disability 13.07 12.75 5 104525 12770 50487824
Mydriasis 12.98 12.75 3 104527 10624 50489970
Sepsis 12.96 12.75 363 104167 132562 50368032
Opsoclonus myoclonus 12.95 12.75 6 104524 123 50500471
Skin infection 12.91 12.75 55 104475 12236 50488358
Oral candidiasis 12.90 12.75 69 104461 16846 50483748
Colitis ischaemic 12.86 12.75 46 104484 9437 50491157
Skin mass 12.86 12.75 31 104499 5104 50495490
Biliary dilatation 12.84 12.75 18 104512 1951 50498643
Hyperthermia 12.81 12.75 40 104490 7656 50492938

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 142.55 25.93 113 4716 81803 29487895
Palmar-plantar erythrodysaesthesia syndrome 119.72 25.93 55 4774 14704 29554994
Off label use 107.37 25.93 182 4647 300618 29269080
Death 99.12 25.93 189 4640 341895 29227803
Myelosuppression 73.15 25.93 37 4792 12190 29557508
Intentional product use issue 72.36 25.93 58 4771 42440 29527258
Bone marrow failure 68.12 25.93 47 4782 27402 29542296
Anastomotic complication 57.66 25.93 13 4816 336 29569362
Ejection fraction decreased 50.92 25.93 32 4797 15946 29553752
Carbohydrate antigen 15-3 increased 50.07 25.93 9 4820 69 29569629
Tidal volume decreased 48.90 25.93 8 4821 32 29569666
Oligohydramnios 48.15 25.93 11 4818 302 29569396
Metastases to central nervous system 46.83 25.93 23 4806 7108 29562590
Gastric perforation 41.45 25.93 15 4814 2171 29567527
Diarrhoea 40.15 25.93 132 4697 332566 29237132
Pulmonary hypoplasia 39.76 25.93 10 4819 416 29569282
Paranasal sinus discomfort 34.73 25.93 10 4819 698 29569000
Obstruction gastric 32.69 25.93 10 4819 860 29568838
Rectal polyp 32.12 25.93 9 4820 569 29569129
Anastomotic leak 31.85 25.93 9 4820 587 29569111
Metastases to liver 28.67 25.93 20 4809 11836 29557862
Lymphoedema 28.50 25.93 13 4816 3404 29566294
Metastases to lung 28.24 25.93 17 4812 7838 29561860
Foetal growth restriction 27.30 25.93 13 4816 3753 29565945
Metastases to bone 27.03 25.93 18 4811 9880 29559818

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 1695.96 13.70 793 80389 27914 64389636
Myelosuppression 969.30 13.70 511 80671 23319 64394231
Diarrhoea 839.16 13.70 2387 78795 720317 63697233
Palmar-plantar erythrodysaesthesia syndrome 761.16 13.70 466 80716 28353 64389197
Metastases to central nervous system 728.51 13.70 354 80828 13558 64403992
Disease progression 679.00 13.70 863 80319 140817 64276733
Neuropathy peripheral 567.80 13.70 719 80463 116806 64300744
Cardiotoxicity 545.62 13.70 264 80918 10010 64407540
Bone marrow failure 503.30 13.70 444 80738 47508 64370042
Drug ineffective 415.98 13.70 275 80907 839972 63577578
Febrile neutropenia 394.66 13.70 784 80398 186873 64230677
Metastases to bone 351.42 13.70 253 80929 20182 64397368
Metastases to liver 324.31 13.70 257 80925 23684 64393866
Cardiac dysfunction 315.59 13.70 126 81056 2980 64414570
Polyneuropathy 312.03 13.70 233 80949 19661 64397889
Chills 296.22 13.70 580 80602 136684 64280866
Metastases to lung 283.29 13.70 198 80984 15066 64402484
Neutropenia 277.67 13.70 794 80388 238830 64178720
Mucosal inflammation 277.03 13.70 367 80815 62217 64355333
Breast cancer recurrent 235.69 13.70 97 81085 2486 64415064
Left ventricular dysfunction 233.91 13.70 184 80998 16770 64400780
Metastases to lymph nodes 222.48 13.70 138 81044 8579 64408971
Drug interaction 222.21 13.70 89 81093 361994 64055556
Fall 196.66 13.70 143 81039 416683 64000867
Stomatitis 186.04 13.70 420 80762 109185 64308365
Breast cancer metastatic 184.24 13.70 114 81068 7055 64410495
Cardiomyopathy 182.81 13.70 191 80991 25165 64392385
Rheumatoid arthritis 176.34 13.70 7 81175 164287 64253263
Interstitial lung disease 175.42 13.70 383 80799 97349 64320201
Lymphoedema 168.82 13.70 122 81060 9783 64407767
Neutropenic sepsis 161.89 13.70 172 81010 23100 64394450
Toxicity to various agents 160.87 13.70 133 81049 363380 64054170
Malignant neoplasm progression 160.72 13.70 404 80778 112467 64305083
Peripheral sensory neuropathy 160.22 13.70 125 81057 11253 64406297
Nausea 156.63 13.70 1591 79591 784209 63633341
Drug abuse 151.73 13.70 3 81179 132371 64285179
Condition aggravated 150.77 13.70 148 81034 372278 64045272
Drug hypersensitivity 146.50 13.70 58 81124 237757 64179793
Onycholysis 134.70 13.70 57 81125 1569 64415981
Osteonecrosis of jaw 128.41 13.70 201 80981 39624 64377926
Computerised tomogram thorax abnormal 127.36 13.70 58 81124 1911 64415639
Neoplasm progression 125.54 13.70 202 80980 40762 64376788
Cardiac failure 125.28 13.70 409 80773 131964 64285586
Epistaxis 125.05 13.70 337 80845 97794 64319756
Metastases to skin 120.61 13.70 51 81131 1401 64416149
Joint swelling 119.38 13.70 61 81121 215321 64202229
Skin toxicity 118.67 13.70 84 81098 6518 64411032
Nail disorder 117.66 13.70 93 81089 8531 64409019
Contraindicated product administered 114.32 13.70 5 81177 107824 64309726
Product dose omission issue 114.29 13.70 51 81131 194696 64222854
Nail toxicity 113.65 13.70 34 81148 322 64417228
Gastrointestinal toxicity 112.90 13.70 75 81107 5247 64412303
Confusional state 111.22 13.70 99 81083 261045 64156505
Synovitis 110.63 13.70 3 81179 99087 64318463
Pleural effusion 103.93 13.70 373 80809 126186 64291364
Therapeutic product effect decreased 103.38 13.70 12 81170 115339 64302211
Overdose 103.12 13.70 36 81146 159530 64258020
Pneumonitis 102.67 13.70 208 80974 50157 64367393
Bone pain 101.20 13.70 200 80982 47372 64370178
Biopsy lung abnormal 100.91 13.70 26 81156 132 64417418
Alopecia 100.40 13.70 444 80738 165246 64252304
Hypokalaemia 99.86 13.70 359 80823 121544 64296006
Metastasis 99.00 13.70 71 81111 5624 64411926
Vomiting 98.63 13.70 1093 80089 550024 63867526
Nail discolouration 97.02 13.70 52 81130 2448 64415102
Alveolitis 95.60 13.70 59 81123 3633 64413917
Decreased appetite 94.05 13.70 641 80541 280648 64136902
Dysgeusia 86.20 13.70 186 80996 46861 64370689
Fatigue 85.35 13.70 1368 79814 747362 63670188
Neurotoxicity 85.14 13.70 136 81046 27268 64390282
Dyspnoea 83.75 13.70 1318 79864 717356 63700194
Rhabdomyolysis 83.56 13.70 9 81173 91717 64325833
Lacrimation increased 83.29 13.70 109 81073 18237 64399313
Hyperpyrexia 78.55 13.70 59 81123 5018 64412532
Infusion related reaction 76.77 13.70 409 80773 164058 64253492
Hypertransaminasaemia 76.19 13.70 67 81115 7124 64410426
Cellulitis 75.98 13.70 275 80907 93382 64324168
Pyrexia 75.33 13.70 1051 80131 557593 63859957
Arthropathy 75.26 13.70 29 81153 120938 64296612
Somnolence 74.42 13.70 88 81094 203557 64213993
Madarosis 72.74 13.70 42 81140 2288 64415262
Sinusitis 72.73 13.70 47 81135 145881 64271669
Nail dystrophy 72.37 13.70 30 81152 783 64416767
Lymphangiosis carcinomatosa 71.01 13.70 38 81144 1783 64415767
Hyperkalaemia 70.34 13.70 20 81162 101109 64316441
Disease recurrence 70.08 13.70 135 81047 31375 64386175
Aortitis 69.86 13.70 32 81150 1069 64416481
Multifocal micronodular pneumocyte hyperplasia 69.07 13.70 17 81165 69 64417481
Injection site pain 68.82 13.70 27 81155 111381 64306169
Bronchial polyp 68.68 13.70 17 81165 71 64417479
Oligohydramnios 68.63 13.70 45 81137 3079 64414471
Psoriasis 68.03 13.70 6 81176 71697 64345853
Invasive ductal breast carcinoma 67.98 13.70 54 81128 4988 64412562
Ventricular hypokinesia 67.92 13.70 65 81117 7704 64409846
Metastases to meninges 67.89 13.70 43 81139 2772 64414778
Metastatic neoplasm 67.35 13.70 51 81131 4391 64413159
Systemic lupus erythematosus 67.28 13.70 9 81173 77603 64339947
Paraesthesia 67.24 13.70 341 80841 134181 64283369
Hospitalisation 66.94 13.70 8 81174 75199 64342351
Mitral valve incompetence 66.35 13.70 117 81065 25421 64392129
Acute myeloid leukaemia 65.21 13.70 121 81061 27342 64390208
Metastases to spine 64.66 13.70 46 81136 3597 64413953
Hot flush 64.18 13.70 164 81018 46071 64371479
Pericardial effusion 63.84 13.70 148 81034 39106 64378444
Recall phenomenon 63.08 13.70 29 81153 977 64416573
Vascular device infection 62.34 13.70 56 81126 6124 64411426
Abdominal discomfort 61.19 13.70 84 81098 182238 64235312
Therapeutic product effect incomplete 60.83 13.70 27 81155 103455 64314095
Weight increased 60.51 13.70 110 81072 213238 64204312
Neutropenic infection 60.22 13.70 35 81147 1930 64415620
Paronychia 59.97 13.70 56 81126 6436 64411114
Suicide attempt 59.75 13.70 9 81173 70998 64346552
Inappropriate schedule of product administration 59.29 13.70 21 81161 92265 64325285
Acute interstitial pneumonitis 58.90 13.70 28 81154 1019 64416531
Colitis 57.90 13.70 184 80998 58490 64359060
Breast pain 57.83 13.70 57 81125 7004 64410546
Tumour marker increased 57.66 13.70 42 81140 3408 64414142
Haematotoxicity 57.58 13.70 76 81106 12820 64404730
Loss of personal independence in daily activities 56.97 13.70 11 81171 72443 64345107
Onychalgia 56.40 13.70 25 81157 772 64416778
Treatment failure 56.35 13.70 39 81143 116777 64300773
Myocardial infarction 56.04 13.70 76 81106 165745 64251805
Cough 56.03 13.70 604 80578 301544 64116006
Drug reaction with eosinophilia and systemic symptoms 55.89 13.70 3 81179 54214 64363336
Radiation skin injury 55.39 13.70 29 81153 1301 64416249
Alopecia areata 54.34 13.70 30 81152 1498 64416052
Acute kidney injury 53.84 13.70 338 80844 448902 63968648
Lactic acidosis 53.51 13.70 7 81175 61403 64356147
Erysipelas 52.60 13.70 61 81121 9020 64408530
Mastitis 52.57 13.70 32 81150 1922 64415628
Hypoglycaemia 51.98 13.70 24 81158 89868 64327682
Organising pneumonia 51.07 13.70 60 81122 8995 64408555
Tonsillar disorder 50.96 13.70 25 81157 976 64416574
Mastectomy 50.56 13.70 25 81157 993 64416557
Cardio-respiratory arrest 49.96 13.70 31 81151 98362 64319188
International normalised ratio increased 49.20 13.70 19 81163 79148 64338402
Gastrointestinal haemorrhage 48.50 13.70 57 81125 132255 64285295
Axillary pain 48.24 13.70 29 81153 1703 64415847
Ejection fraction 47.81 13.70 26 81156 1260 64416290
Injection site erythema 47.42 13.70 15 81167 70785 64346765
Product use issue 46.89 13.70 74 81108 151641 64265909
Product use in unapproved indication 46.64 13.70 95 81087 176523 64241027
Osteonecrosis 46.52 13.70 107 81075 28122 64389428
Blood uric acid decreased 45.73 13.70 24 81158 1082 64416468
Bradycardia 45.43 13.70 49 81133 118170 64299380
Granulocyte count decreased 45.24 13.70 25 81157 1251 64416299
Onychoclasis 45.12 13.70 41 81141 4551 64412999
Hair texture abnormal 44.46 13.70 34 81148 2970 64414580
Breast mass 43.74 13.70 43 81139 5267 64412283
Atelectasis 43.45 13.70 102 81080 27164 64390386
Erythema 43.42 13.70 392 80790 186678 64230872
Plasma cell myeloma 43.32 13.70 4 81178 46071 64371479
Chest discomfort 43.22 13.70 272 80910 115834 64301716
Device related infection 42.88 13.70 109 81073 30517 64387033
Hallucination 42.76 13.70 19 81163 72769 64344781
Carbohydrate antigen 15-3 increased 42.48 13.70 22 81160 965 64416585
Constipation 42.26 13.70 458 80724 228879 64188671
Therapy partial responder 42.10 13.70 58 81124 10190 64407360
Pseudocirrhosis 41.72 13.70 19 81163 626 64416924
Dry skin 41.28 13.70 150 81032 51011 64366539
White blood cell count decreased 40.94 13.70 339 80843 157498 64260052
Delirium 40.74 13.70 18 81164 69176 64348374
Intentional product misuse 40.73 13.70 20 81162 72275 64345275
Second primary malignancy 39.38 13.70 62 81120 12275 64405275
Myalgia 39.20 13.70 337 80845 158280 64259270
Injection site reaction 39.06 13.70 6 81176 46658 64370892
Electrocardiogram QT prolonged 39.01 13.70 26 81156 79422 64338128
Unresponsive to stimuli 38.88 13.70 8 81174 50385 64367165
Coronary artery disease 38.39 13.70 14 81168 60419 64357131
Neutrophil count decreased 38.06 13.70 195 80987 77001 64340549
Hair colour changes 38.04 13.70 34 81148 3693 64413857
Sedation 37.93 13.70 4 81178 41458 64376092
Pain 37.78 13.70 481 80701 553030 63864520
Vulvovaginal dryness 37.38 13.70 24 81158 1584 64415966
Metastases to chest wall 36.75 13.70 15 81167 376 64417174
Bladder irritation 36.70 13.70 13 81169 218 64417332
Dermatitis acneiform 36.53 13.70 49 81133 8394 64409156
Dermatitis 36.18 13.70 74 81108 17955 64399595
Cytomegalovirus infection 35.59 13.70 3 81179 37196 64380354
Dyskinesia 35.52 13.70 4 81178 39384 64378166
Blood creatinine decreased 35.33 13.70 44 81138 7006 64410544
Irritability 35.06 13.70 3 81179 36743 64380807
Orthostatic hypotension 34.88 13.70 8 81174 46730 64370820
Mobility decreased 34.77 13.70 34 81148 85806 64331744
Drug intolerance 34.55 13.70 121 81061 187871 64229679
Congestive cardiomyopathy 34.43 13.70 53 81129 10291 64407259
Acoustic stimulation tests abnormal 34.37 13.70 8 81174 24 64417526
Nail infection 34.35 13.70 24 81158 1823 64415727
Mental status changes 34.33 13.70 17 81165 61145 64356405
Chronic kidney disease 34.21 13.70 15 81167 57904 64359646
Arthritis 34.18 13.70 33 81149 83781 64333769
Respiratory arrest 34.13 13.70 12 81170 52973 64364577
Blood glucose increased 34.09 13.70 44 81138 98029 64319521
Eosinophilia 34.00 13.70 4 81178 38072 64379478
Perforation 34 13.70 20 81162 1128 64416422
Fibromyalgia 33.86 13.70 3 81179 35728 64381822
Injection site pruritus 33.72 13.70 4 81178 37822 64379728
Hypoaesthesia 33.55 13.70 294 80888 138814 64278736
Mean platelet volume decreased 33.39 13.70 23 81159 1708 64415842
Dehydration 33.29 13.70 418 80764 216345 64201205
Recurrent cancer 33.25 13.70 26 81156 2347 64415203
Contusion 32.97 13.70 58 81124 113907 64303643
Asthenia 32.92 13.70 737 80445 427307 63990243
Coma 32.90 13.70 37 81145 87578 64329972
Jaw operation 32.90 13.70 17 81165 742 64416808
Musculoskeletal stiffness 32.74 13.70 66 81116 123140 64294410
Eosinophil percentage increased 32.48 13.70 21 81161 1403 64416147
Enterocolitis 32.44 13.70 56 81126 11962 64405588
Injury 32.29 13.70 15 81167 55977 64361573
Leukopenia 32.14 13.70 228 80954 101014 64316536
Asthenopia 32.14 13.70 24 81158 2023 64415527
Radiation necrosis 32.11 13.70 13 81169 319 64417231
Feeling abnormal 31.85 13.70 76 81106 133526 64284024
Renal failure 31.38 13.70 120 81062 181568 64235982
Anaemia 31.34 13.70 659 80523 378021 64039529
Accidental overdose 31.31 13.70 3 81179 33554 64383996
Vascular fragility 31.29 13.70 10 81172 120 64417430
Hyperfibrinogenaemia 31.21 13.70 9 81173 74 64417476
Cardiac arrest 31.19 13.70 95 81087 153969 64263581
Tumour pain 31.10 13.70 23 81159 1910 64415640
Breast neoplasm 30.98 13.70 17 81165 839 64416711
Asthma 30.81 13.70 45 81137 95180 64322370
Meibomian gland dysfunction 30.71 13.70 10 81172 128 64417422
Systolic dysfunction 30.31 13.70 28 81154 3174 64414376
Hepatic lesion 30.24 13.70 37 81145 5787 64411763
Red cell distribution width increased 30.19 13.70 55 81127 12254 64405296
Hepatic enzyme increased 30.13 13.70 75 81107 129868 64287682
Keratitis 30.05 13.70 28 81154 3209 64414341
Anastomotic complication 29.74 13.70 13 81169 388 64417162
Computerised tomogram thorax 29.50 13.70 10 81172 146 64417404
Cystitis noninfective 29.47 13.70 18 81164 1088 64416462
Pulmonary embolism 29.15 13.70 297 80885 146059 64271491
Central nervous system lesion 29.13 13.70 53 81129 11796 64405754
Nail bed bleeding 29.06 13.70 12 81170 310 64417240
Vessel puncture site bruise 29.04 13.70 13 81169 411 64417139
Chronic obstructive pulmonary disease 28.94 13.70 28 81154 71020 64346530
Lung infiltration 28.88 13.70 74 81108 20815 64396735
Onychomadesis 28.82 13.70 26 81156 2858 64414692
Nasal disorder 28.82 13.70 26 81156 2858 64414692
Odynophagia 28.78 13.70 47 81135 9594 64407956
Nasal congestion 28.65 13.70 20 81162 59638 64357912
Drug ineffective for unapproved indication 28.49 13.70 3 81179 31130 64386420
Blood lactate dehydrogenase increased 28.41 13.70 99 81083 32979 64384571
Swelling 28.19 13.70 105 81077 160113 64257437
Pulmonary mass 28.10 13.70 80 81102 23936 64393614
Depression 27.96 13.70 127 81055 183164 64234386
Depressed level of consciousness 27.83 13.70 37 81145 81399 64336151
HER2 positive breast cancer 27.71 13.70 11 81171 256 64417294
Therapy cessation 27.60 13.70 4 81178 32485 64385065
Suicidal ideation 27.36 13.70 26 81156 66516 64351034
Hydrothorax 27.35 13.70 18 81164 1239 64416311
Diabetes mellitus 27.30 13.70 26 81156 66448 64351102
Flushing 27.26 13.70 181 81001 78467 64339083
Wheezing 27.14 13.70 37 81145 80542 64337008
Dysarthria 27.12 13.70 21 81161 59385 64358165
Adverse event 27.10 13.70 8 81174 39481 64378069
Papilloedema 27.02 13.70 34 81148 5471 64412079
Abnormal behaviour 26.65 13.70 5 81177 33617 64383933
Neoplasm recurrence 26.64 13.70 28 81154 3711 64413839
Lower respiratory tract infection 26.58 13.70 207 80975 94407 64323143
Skin fissures 26.49 13.70 47 81135 10259 64407291
Osteosclerosis 26.45 13.70 27 81155 3459 64414091
Disorientation 26.44 13.70 19 81163 55809 64361741
Blood creatine phosphokinase increased 26.36 13.70 21 81161 58537 64359013
Cerebrovascular accident 26.33 13.70 87 81095 137496 64280054
Troponin I increased 26.14 13.70 28 81154 3793 64413757
Pustule 26.01 13.70 18 81164 1347 64416203
Breast cellulitis 25.88 13.70 11 81171 306 64417244
Osteolysis 25.55 13.70 24 81158 2779 64414771
Blood pressure fluctuation 25.43 13.70 17 81165 51854 64365696
Carcinoembryonic antigen increased 25.12 13.70 20 81162 1853 64415697
Sense of oppression 25.06 13.70 18 81164 1429 64416121
Medication error 25.00 13.70 16 81166 49950 64367600
Anxiety 24.97 13.70 151 81031 202498 64215052
Excessive eye blinking 24.91 13.70 17 81165 1243 64416307
Wrong technique in product usage process 24.88 13.70 27 81155 64947 64352603
Incorrect dose administered 24.68 13.70 24 81158 60741 64356809
Calcium ionised increased 24.66 13.70 9 81173 165 64417385
Xerophthalmia 24.57 13.70 12 81170 464 64417086
Acute myocardial infarction 24.52 13.70 31 81151 69687 64347863
Metabolic acidosis 24.49 13.70 32 81150 70926 64346624
Peripheral motor neuropathy 24.37 13.70 24 81158 2946 64414604
Breast inflammation 24.24 13.70 8 81174 107 64417443
Bone lesion 24.06 13.70 31 81151 5106 64412444
Cystoid macular oedema 23.92 13.70 19 81163 1755 64415795
Acute pulmonary oedema 23.86 13.70 51 81131 12758 64404792
Influenza 23.53 13.70 63 81119 106468 64311082
Gait disturbance 23.53 13.70 124 81058 172031 64245519
Emotional distress 23.49 13.70 8 81174 36030 64381520
Post-traumatic pain 23.33 13.70 11 81171 393 64417157
Osteitis condensans 23.20 13.70 6 81176 31 64417519
Tachycardia 23.18 13.70 289 80893 149290 64268260
Dysaesthesia 23.17 13.70 30 81152 4965 64412585
Treatment noncompliance 23.05 13.70 13 81169 43469 64374081
Performance status decreased 23.01 13.70 31 81151 5333 64412217
Biliary sepsis 23.00 13.70 17 81165 1411 64416139
Sensory disturbance 22.80 13.70 51 81131 13157 64404393
Breast disorder 22.63 13.70 18 81164 1666 64415884
Subdural haematoma 22.61 13.70 4 81178 28050 64389500
Metastases to pleura 22.52 13.70 16 81166 1248 64416302
Osteoarthritis 22.44 13.70 28 81154 63308 64354242
Sopor 22.29 13.70 5 81177 29656 64387894
Pneumonia aspiration 22.29 13.70 25 81157 59246 64358304
Enterocolitis infectious 22.27 13.70 21 81161 2443 64415107
Renal impairment 22.14 13.70 91 81091 134926 64282624
Wound 22.04 13.70 39 81143 76438 64341112
Lymphangitis 22.00 13.70 16 81166 1295 64416255
Hepatotoxicity 21.86 13.70 104 81078 39858 64377692
Nephrolithiasis 21.84 13.70 14 81168 43669 64373881
Corneal disorder 21.70 13.70 19 81163 2008 64415542
Basal cell carcinoma 21.62 13.70 6 81176 30832 64386718
Rash pustular 21.55 13.70 42 81140 9843 64407707
Death 21.38 13.70 775 80407 481930 63935620
Hyperbilirubinaemia 21.37 13.70 67 81115 21138 64396412
Vaginal prolapse 21.29 13.70 9 81173 247 64417303
Migraine 20.88 13.70 29 81153 62648 64354902
Gait apraxia 20.79 13.70 5 81177 18 64417532
Eye pain 20.65 13.70 7 81175 31618 64385932
Gait inability 20.61 13.70 14 81168 42354 64375196
Hypothalamo-pituitary disorder 20.44 13.70 14 81168 1030 64416520
Pulmonary hypoplasia 20.43 13.70 6 81176 53 64417497
Duodenal ulcer perforation 20.39 13.70 9 81173 34616 64382934
Radiation pneumonitis 20.36 13.70 23 81159 3305 64414245
Acute respiratory distress syndrome 20.35 13.70 100 81082 38835 64378715
Ovarian failure 20.21 13.70 11 81171 534 64417016
Arthralgia 20.20 13.70 414 80768 441846 63975704
Barotrauma 20.00 13.70 8 81174 190 64417360
Spinal pain 19.87 13.70 47 81135 12574 64404976
Agranulocytosis 19.84 13.70 98 81084 38131 64379419
Hypotension 19.74 13.70 349 80833 380625 64036925
Respiratory depression 19.65 13.70 3 81179 23440 64394110
Mouth ulceration 19.65 13.70 87 81095 32357 64385193
Ear infection 19.61 13.70 3 81179 23401 64394149
Subclavian vein thrombosis 19.55 13.70 19 81163 2295 64415255
Hyperchlorhydria 19.54 13.70 17 81165 1782 64415768
Hypervolaemia 19.51 13.70 12 81170 38273 64379277
Gastrointestinal disorder 19.29 13.70 185 80997 89524 64328026
Dizziness 19.26 13.70 404 80778 429759 63987791
Swollen tongue 19.19 13.70 10 81172 34944 64382606
Merycism 19.19 13.70 8 81174 212 64417338
Haemorrhoids 19.04 13.70 70 81112 23931 64393619
Lymphadenopathy 19.02 13.70 112 81070 46574 64370976
Tidal volume decreased 19.01 13.70 6 81176 69 64417481
Dyspepsia 18.97 13.70 169 81013 80143 64337407
Blood cholesterol increased 18.95 13.70 21 81161 50045 64367505
Herpangina 18.85 13.70 5 81177 29 64417521
Vocal cord paralysis 18.84 13.70 18 81164 2128 64415422
Sarcoid-like reaction 18.68 13.70 4 81178 7 64417543
Exposure during pregnancy 18.66 13.70 44 81138 77631 64339919
Blister 18.55 13.70 47 81135 80920 64336630
Pleural neoplasm 18.55 13.70 8 81174 231 64417319
Leukaemia cutis 18.53 13.70 7 81175 142 64417408
Dysuria 18.51 13.70 103 81079 41954 64375596
Skin infection 18.49 13.70 51 81131 14986 64402564
Hallucination, visual 18.45 13.70 6 81176 27828 64389722
Transaminases 18.41 13.70 6 81176 77 64417473
Palmar erythema 18.25 13.70 16 81166 1694 64415856
Agitation 18.23 13.70 54 81128 88313 64329237
Dermatomyositis 18.21 13.70 20 81162 2786 64414764
Blood creatine increased 18.09 13.70 35 81147 8157 64409393
Osteoporosis 17.82 13.70 16 81166 42064 64375486
Cataract 17.81 13.70 23 81159 51239 64366311
Nasal ulcer 17.75 13.70 15 81167 1511 64416039
Metastases to the mediastinum 17.67 13.70 10 81172 524 64417026
Tooth extraction 17.62 13.70 38 81144 9563 64407987
Breast cancer 17.53 13.70 78 81104 29070 64388480
Off label use 17.45 13.70 968 80214 631838 63785712
Pituitary tumour 17.44 13.70 13 81169 1093 64416457
Platelet count decreased 17.30 13.70 302 80880 167409 64250141
Malignant pleural effusion 17.30 13.70 20 81162 2947 64414603
Pleural disorder 17.20 13.70 11 81171 721 64416829
Diabetic ketoacidosis 17.20 13.70 8 81174 29837 64387713
Left ventricular dilatation 17.08 13.70 12 81170 920 64416630
Generalised tonic-clonic seizure 17.07 13.70 15 81167 39842 64377708
Globulinuria 17.04 13.70 3 81179 0 64417550
Lymph node fibrosis 17.04 13.70 3 81179 0 64417550
Discomfort 16.99 13.70 49 81133 80829 64336721
Encephalopathy 16.95 13.70 30 81152 58789 64358761
Back pain 16.81 13.70 423 80759 249748 64167802
Aphasia 16.80 13.70 16 81166 40890 64376660
Tongue coated 16.79 13.70 13 81169 1157 64416393
Rhinorrhoea 16.72 13.70 131 81051 59838 64357712
Temperature intolerance 16.70 13.70 34 81148 8221 64409329
Device issue 16.66 13.70 4 81178 22644 64394906
Dandy-Walker syndrome 16.65 13.70 5 81177 48 64417502
Gastritis 16.57 13.70 101 81081 42517 64375033
Urticaria 16.49 13.70 113 81069 147204 64270346
Catheter site pain 16.48 13.70 24 81158 4438 64413112
Metastases to nervous system 16.47 13.70 5 81177 50 64417500
Axillary vein thrombosis 16.36 13.70 10 81172 605 64416945
Toxic neuropathy 16.36 13.70 11 81171 785 64416765
Gingival pain 16.31 13.70 29 81153 6338 64411212
Breast oedema 16.30 13.70 4 81178 16 64417534
Breast ulceration 16.29 13.70 5 81177 52 64417498
Blood alkaline phosphatase increased 16.28 13.70 124 81058 56155 64361395
Urinary tract disorder 16.25 13.70 20 81162 3146 64414404
Transient ischaemic attack 16.21 13.70 19 81163 44163 64373387
Urinary retention 16.16 13.70 23 81159 49178 64368372
Glossodynia 16.06 13.70 36 81146 64660 64352890
Hepatic function abnormal 16.05 13.70 137 81045 64176 64353374
Eastern Cooperative Oncology Group performance status worsened 16.05 13.70 13 81169 1235 64416315
Spider naevus 16.00 13.70 6 81176 119 64417431
Nail bed tenderness 15.99 13.70 8 81174 326 64417224
Vulvovaginal inflammation 15.92 13.70 9 81173 471 64417079
Paralysis recurrent laryngeal nerve 15.87 13.70 6 81176 122 64417428
Pulmonary toxicity 15.85 13.70 34 81148 8527 64409023
Therapy interrupted 15.84 13.70 3 81179 20033 64397517
Pancreatitis 15.77 13.70 32 81150 59575 64357975
Inflammatory carcinoma of the breast 15.74 13.70 4 81178 19 64417531
Botryomycosis 15.72 13.70 5 81177 59 64417491
Limb injury 15.70 13.70 5 81177 23500 64394050
Product quality issue 15.67 13.70 9 81173 29790 64387760
Status epilepticus 15.59 13.70 4 81178 21659 64395891
Pneumonitis chemical 15.49 13.70 8 81174 349 64417201
Nodular regenerative hyperplasia 15.47 13.70 11 81171 859 64416691
Dental fistula 15.47 13.70 9 81173 497 64417053
Urogenital prolapse 15.41 13.70 4 81178 21 64417529
Borrelia infection 15.34 13.70 6 81176 134 64417416
Clostridial infection 15.34 13.70 25 81157 5094 64412456
Gout 15.32 13.70 4 81178 21409 64396141
Atrial thrombosis 15.27 13.70 19 81163 3023 64414527
Myeloproliferative neoplasm 15.26 13.70 11 81171 878 64416672
Road traffic accident 15.17 13.70 10 81172 30735 64386815
Metastases to breast 15.17 13.70 7 81175 238 64417312
Retinal detachment 15.14 13.70 32 81150 7944 64409606
Folate deficiency 15.07 13.70 18 81164 2745 64414805
Carbohydrate antigen 19-9 increased 15.03 13.70 8 81174 371 64417179
Viral infection 15.00 13.70 14 81168 36126 64381424
Postural orthostatic tachycardia syndrome 14.99 13.70 9 81173 527 64417023
Breast sarcoma 14.96 13.70 3 81179 3 64417547
Psychotic disorder 14.82 13.70 13 81169 34565 64382985
Injection site haemorrhage 14.79 13.70 6 81176 24272 64393278
SAPHO syndrome 14.79 13.70 6 81176 148 64417402
Toothache 14.77 13.70 52 81130 17407 64400143
Tumour haemorrhage 14.70 13.70 20 81162 3473 64414077
Flatulence 14.59 13.70 14 81168 35652 64381898
Ventricular tachycardia 14.54 13.70 13 81169 34252 64383298
Amenorrhoea 14.52 13.70 28 81154 6511 64411039
Infection 14.35 13.70 156 81026 184724 64232826
Corneal bleeding 14.31 13.70 4 81178 29 64417521
Appendiceal abscess 14.23 13.70 7 81175 275 64417275
Chromosomal mutation 14.19 13.70 4 81178 30 64417520
Movement disorder 14.14 13.70 5 81177 21995 64395555
Angioedema 14.08 13.70 36 81146 61785 64355765
Myoclonus 14.07 13.70 7 81175 25111 64392439
Mouth swelling 14.05 13.70 24 81158 5083 64412467
Fear 14.00 13.70 4 81178 20167 64397383
Catheter site bruise 13.95 13.70 7 81175 287 64417263
Plantar erythema 13.93 13.70 7 81175 288 64417262
Frequent bowel movements 13.93 13.70 3 81179 18302 64399248
Blood bilirubin decreased 13.75 13.70 10 81172 809 64416741
Thrombocytopenia 13.75 13.70 374 80808 223427 64194123

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 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
327397006 SNOMEDCT_US
387003001 SNOMEDCT_US
007663 NDDF
017423 NDDF

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 50242-260 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 55513-141 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
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