letrozole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
aromatase inhibitors, imidazole-triazole derivatives 1556 112809-51-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • CGS-20267
  • CGS 20267
  • letrozole
  • lerozole
  • letrazole
  • femara
Letrozole is a nonsteroidal competitive inhibitor of the aromatase enzyme system; it inhibits the conversion of androgens to estrogens. Used in treatment of hormonally responsive breast cancer (i.e., estrogen and/or progesterone receptor positive or receptor unknown)
  • Molecular weight: 285.31
  • Formula: C17H11N5
  • CLOGP: 1.70
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 0
  • TPSA: 78.29
  • ALOGS: -3.55
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.04 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3.90 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.90 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.57 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.41 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 45 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.670 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.857 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 56.754 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.661 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 43.590 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 74.910 % High 1
herg hERG pIC50 4.661 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.854 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.148 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 41.060 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,STK33,TEK,TTK 21
kinase-selectivity-class MAP2K6 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.312 High 1
mh-clint Mouse hepatocyte intrinsic clearance 2.449 High 1
mppb Mouse plasma protein binding (% unbound) 41.790 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 8.913 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 60.550 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.153 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 84.660 % High 1
rppb Rat plasma protein binding (% unbound) 40.280 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 469.894 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 25, 1997 FDA NOVARTIS PHARMS
Jan. 23, 2006 PMDA Novartis

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
Neutropenia 5614.12 10.78 3893 148022 221011 90255521
Malignant neoplasm progression 4854.92 10.78 2711 149204 104159 90372373
Metastases to bone 3414.65 10.78 1366 150549 24139 90452393
Neoplasm progression 3095.57 10.78 1504 150411 42982 90433550
Metastases to liver 2331.06 10.78 1081 150834 27726 90448806
White blood cell count decreased 1898.40 10.78 1833 150082 165276 90311256
Leukopenia 1265.26 10.78 1169 150746 99541 90376991
Disease progression 1190.11 10.78 1388 150527 155227 90321305
Hot flush 1026.08 10.78 828 151087 58660 90417872
Metastases to lung 999.35 10.78 503 151412 15488 90461044
Osteonecrosis of jaw 905.62 10.78 649 151266 38454 90438078
Breast cancer metastatic 901.91 10.78 461 151454 14671 90461861
Bone pain 827.88 10.78 745 151170 61238 90415294
Fatigue 698.11 10.78 3780 148135 1150243 89326289
Metastases to lymph nodes 687.58 10.78 353 151562 11336 90465196
Carbohydrate antigen 15-3 increased 682.36 10.78 215 151700 1792 90474740
Tumour marker increased 670.54 10.78 280 151635 5527 90471005
Drug ineffective 638.31 10.78 836 151079 1383462 89093070
Neutrophil count decreased 610.60 10.78 674 151241 70858 90405674
Pemphigus 530.26 10.78 3 151912 326861 90149671
Infusion related reaction 518.16 10.78 50 151865 416730 90059802
Systemic lupus erythematosus 506.23 10.78 24 151891 361872 90114660
Breast cancer 476.89 10.78 517 151398 53244 90423288
Hand deformity 465.07 10.78 6 151909 296356 90180176
Second primary malignancy 463.45 10.78 261 151654 10117 90466415
Anaemia 456.97 10.78 1464 150451 351338 90125194
PIK3CA-activated mutation 447.14 10.78 138 151777 1066 90475466
Synovitis 445.14 10.78 27 151888 329725 90146807
Breast cancer recurrent 443.19 10.78 206 151709 5297 90471235
Rheumatoid arthritis 439.01 10.78 48 151867 362566 90113966
Contraindicated product administered 426.80 10.78 28 151887 320111 90156421
Therapeutic product effect decreased 425.46 10.78 8 151907 277563 90198969
Joint swelling 417.52 10.78 161 151754 503139 89973393
Thrombocytopenia 398.30 10.78 997 150918 207728 90268804
Pleural effusion 396.74 10.78 690 151225 111301 90365231
Hepatotoxicity 391.18 10.78 432 151483 45410 90431122
Drug hypersensitivity 390.01 10.78 145 151770 463464 90013068
Electrocardiogram QT prolonged 384.75 10.78 538 151377 71918 90404614
Glossodynia 373.64 10.78 49 151866 321730 90154802
Maternal exposure during pregnancy 373.07 10.78 75 151840 359988 90116544
Arthropathy 369.79 10.78 81 151834 366161 90110371
Pericarditis 367.96 10.78 21 151894 270130 90206402
Bone lesion 363.03 10.78 189 151726 6248 90470284
Nausea 355.73 10.78 3115 148800 1107201 89369331
Psoriatic arthropathy 348.20 10.78 7 151908 228328 90248204
Wound 338.05 10.78 52 151863 302928 90173604
Duodenal ulcer perforation 336.58 10.78 7 151908 221281 90255251
Helicobacter infection 334.32 10.78 10 151905 226840 90249692
Aspartate aminotransferase increased 328.43 10.78 606 151309 102331 90374201
Hypersensitivity 317.75 10.78 184 151731 454493 90022039
Polyneuropathy 307.65 10.78 257 151658 19084 90457448
Metastases to spine 307.29 10.78 142 151773 3601 90472931
Haematotoxicity 303.81 10.78 214 151701 12321 90464211
Metastases to pleura 299.56 10.78 117 151798 1927 90474605
Metastasis 297.71 10.78 163 151752 5974 90470558
Irritable bowel syndrome 295.71 10.78 12 151903 207436 90269096
Lymphoedema 292.71 10.78 217 151698 13536 90462996
Alanine aminotransferase increased 291.25 10.78 625 151290 117713 90358819
Swelling 287.95 10.78 173 151742 418885 90057647
Treatment failure 287.58 10.78 77 151838 303851 90172681
Folliculitis 284.14 10.78 14 151901 204339 90272193
Gamma-glutamyltransferase increased 280.40 10.78 332 151583 37620 90438912
Neuropathy peripheral 275.64 10.78 668 151247 136302 90340230
Metastases to peritoneum 272.21 10.78 135 151780 4020 90472512
Muscle injury 267.00 10.78 6 151909 176648 90299884
Ascites 260.14 10.78 359 151556 47381 90429151
Osteonecrosis 258.65 10.78 267 151648 25974 90450558
Fibromyalgia 258.07 10.78 24 151891 206245 90270287
Ovarian hyperstimulation syndrome 249.81 10.78 143 151772 5719 90470813
Intentional product use issue 244.67 10.78 36 151879 216856 90259676
Metastases to central nervous system 236.31 10.78 212 151703 17330 90459202
Type 2 diabetes mellitus 233.31 10.78 32 151883 203212 90273320
Sinusitis 229.55 10.78 146 151769 342942 90133590
Blister 229.40 10.78 71 151844 254927 90221605
Carcinoembryonic antigen increased 224.16 10.78 99 151816 2251 90474281
Metastases to skin 223.17 10.78 96 151819 2044 90474488
Full blood count abnormal 220.44 10.78 289 151626 36308 90440224
Red blood cell count decreased 219.42 10.78 326 151589 46025 90430507
Alopecia 216.32 10.78 1495 150420 493576 89982956
Transaminases increased 215.24 10.78 288 151627 36904 90439628
Wheezing 212.88 10.78 67 151848 238013 90238519
Injury 208.70 10.78 39 151876 197310 90279222
Discomfort 204.67 10.78 102 151813 274233 90202299
Mobility decreased 203.03 10.78 83 151832 250651 90225881
Ill-defined disorder 198.84 10.78 35 151880 184856 90291676
Diarrhoea 195.00 10.78 2415 149500 936775 89539757
Completed suicide 192.25 10.78 13 151902 145045 90331487
Sleep disorder due to general medical condition, insomnia type 192.05 10.78 5 151910 128689 90347843
Urticaria 190.78 10.78 147 151768 312587 90163945
Lower respiratory tract infection 190.31 10.78 91 151824 250568 90225964
Condition aggravated 189.12 10.78 452 151463 595093 89881439
Exposure during pregnancy 188.09 10.78 82 151833 238328 90238204
Spinal pain 188.01 10.78 178 151737 15589 90460943
Full blood count decreased 187.48 10.78 240 151675 29449 90447083
Blood creatinine increased 184.50 10.78 476 151439 100910 90375622
Abdominal discomfort 183.97 10.78 324 151591 477004 89999528
Hepatic lesion 183.70 10.78 116 151799 5557 90470975
C-reactive protein abnormal 182.82 10.78 7 151908 127422 90349110
Hepatic cytolysis 181.35 10.78 241 151674 30675 90445857
Decreased appetite 179.30 10.78 1162 150753 375378 90101154
Blood alkaline phosphatase increased 175.07 10.78 300 151615 47779 90428753
Blood cholesterol increased 174.76 10.78 65 151850 207947 90268585
Joint range of motion decreased 174.50 10.78 14 151901 135629 90340903
Bursitis 173.89 10.78 12 151903 131642 90344890
Product use issue 173.70 10.78 178 151737 329741 90146791
Dry skin 163.87 10.78 417 151498 87656 90388876
Palmar-plantar erythrodysaesthesia syndrome 163.68 10.78 218 151697 27805 90448727
Pulmonary embolism 163.57 10.78 537 151378 130283 90346249
Pneumonitis 154.80 10.78 271 151644 43899 90432633
Interstitial lung disease 151.86 10.78 371 151544 76034 90400498
Hepatic enzyme increased 151.85 10.78 231 151684 360505 90116027
Skin hypopigmentation 150.20 10.78 61 151854 1118 90475414
Asthma 149.99 10.78 112 151803 242048 90234484
Bone disorder 146.14 10.78 187 151728 22933 90453599
Facet joint syndrome 146.13 10.78 4 151911 98385 90378147
Musculoskeletal stiffness 146.10 10.78 169 151746 296363 90180169
Epistaxis 144.02 10.78 389 151526 84736 90391796
Peripheral swelling 143.72 10.78 298 151617 412808 90063724
Prescribed overdose 141.29 10.78 5 151910 97620 90378912
Onychoclasis 140.34 10.78 109 151806 7290 90469242
Confusional state 139.11 10.78 273 151642 385932 90090600
Injection site pain 138.16 10.78 59 151856 173640 90302892
Constipation 138.09 10.78 873 151042 279522 90197010
Impaired healing 135.41 10.78 116 151799 234083 90242449
Platelet count decreased 134.98 10.78 520 151395 136449 90340083
Psoriasis 134.88 10.78 40 151875 147714 90328818
Mucosal inflammation 134.45 10.78 298 151617 57327 90419205
Overdose 132.92 10.78 49 151866 157660 90318872
Grip strength decreased 126.56 10.78 7 151908 92569 90383963
Off label use 125.96 10.78 1212 150703 1101040 89375492
Asthenia 125.10 10.78 1406 150509 532345 89944187
Blood bilirubin increased 125.06 10.78 245 151670 43225 90433307
Ischaemic stroke 124.21 10.78 169 151746 21997 90454535
Breast cancer stage III 123.35 10.78 4 151911 84443 90392089
Ovarian cancer recurrent 123.32 10.78 58 151857 1532 90475000
Lymphadenopathy 123.31 10.78 251 151664 45524 90431008
Erysipelas 123.11 10.78 110 151805 8942 90467590
Metastases to pelvis 121.21 10.78 43 151872 533 90475999
Infection 120.25 10.78 268 151647 361826 90114706
Skin toxicity 120.25 10.78 96 151819 6683 90469849
Injection site reaction 119.84 10.78 9 151906 92071 90384461
Weight increased 118.11 10.78 336 151579 417591 90058941
Gait inability 116.06 10.78 50 151865 146406 90330126
Tooth extraction 114.99 10.78 118 151797 11395 90465137
Arthralgia 113.17 10.78 1882 150033 776640 89699892
Toxicity to various agents 112.93 10.78 193 151722 287653 90188879
Cancer pain 112.39 10.78 75 151840 3950 90472582
Adverse event 112.38 10.78 29 151886 117389 90359143
Malignant pleural effusion 112.29 10.78 67 151848 2897 90473635
Drug intolerance 111.54 10.78 381 151534 447210 90029322
Gastrointestinal disorder 111.24 10.78 161 151754 256526 90220006
Metastases to chest wall 111.18 10.78 42 151873 629 90475903
Mucosal dryness 110.73 10.78 68 151847 3099 90473433
Invasive ductal breast carcinoma 110.30 10.78 97 151818 7721 90468811
Injection site erythema 109.54 10.78 17 151898 98485 90378047
Lip dry 108.75 10.78 19 151896 100936 90375596
Glomerular filtration rate decreased 108.67 10.78 138 151777 16794 90459738
Lymphangiosis carcinomatosa 108.57 10.78 54 151861 1618 90474914
Intentional overdose 107.11 10.78 15 151900 93819 90382713
Ejection fraction decreased 106.52 10.78 172 151743 26081 90450451
Wound infection 106.30 10.78 24 151891 106378 90370154
Hormone receptor positive breast cancer 104.98 10.78 42 151873 739 90475793
Metastases to the mediastinum 104.80 10.78 40 151875 617 90475915
Therapy partial responder 104.25 10.78 155 151760 21888 90454644
Pseudocirrhosis 103.90 10.78 44 151871 900 90475632
Myalgia 103.38 10.78 572 151343 174553 90301979
Road traffic accident 102.20 10.78 27 151888 107599 90368933
Therapeutic product effect incomplete 100.41 10.78 106 151809 193790 90282742
Eastern Cooperative Oncology Group performance status worsened 98.21 10.78 53 151862 1886 90474646
Hypotension 96.84 10.78 255 151660 325142 90151390
Liver injury 96.73 10.78 86 151829 170481 90306051
Prescribed underdose 95.76 10.78 8 151907 75011 90401521
Jaundice 95.64 10.78 185 151730 32332 90444200
Back pain 95.51 10.78 880 151035 316295 90160237
Pleural neoplasm 93.84 10.78 33 151882 398 90476134
Contusion 92.63 10.78 175 151740 251041 90225491
Vitiligo 91.32 10.78 52 151863 2058 90474474
Pathological fracture 91.07 10.78 96 151819 9564 90466968
Hydronephrosis 90.77 10.78 108 151807 12294 90464238
Metastases to adrenals 89.43 10.78 40 151875 938 90475594
Lower limb fracture 89.41 10.78 17 151898 84996 90391536
Knee arthroplasty 88.84 10.78 16 151899 83166 90393366
Obesity 88.52 10.78 33 151882 105474 90371058
Organising pneumonia 87.22 10.78 84 151831 7513 90469019
Osteolysis 86.93 10.78 61 151854 3489 90473043
Loss of personal independence in daily activities 86.77 10.78 61 151854 136044 90340488
Therapy non-responder 86.19 10.78 62 151853 136642 90339890
Congestive cardiomyopathy 85.73 10.78 82 151833 7272 90469260
Metastases to abdominal wall 85.32 10.78 25 151890 158 90476374
Delirium 85.30 10.78 34 151881 104325 90372207
Osteosclerosis 84.90 10.78 65 151850 4255 90472277
Pregnancy 83.86 10.78 5 151910 62042 90414490
Autoimmune disorder 83.63 10.78 14 151901 76730 90399802
Musculoskeletal chest pain 83.57 10.78 146 151769 23604 90452928
Drug abuse 83.41 10.78 18 151897 82329 90394203
Product quality issue 83.13 10.78 16 151899 79309 90397223
Metastases to meninges 81.87 10.78 60 151855 3675 90472857
Suicide attempt 81.62 10.78 14 151901 75385 90401147
Neoplasm malignant 81.05 10.78 177 151738 33703 90442829
Lacrimation increased 80.86 10.78 155 151760 26907 90449625
Trigger finger 80.76 10.78 68 151847 5102 90471430
Hepatic failure 80.08 10.78 194 151721 39534 90436998
Breast pain 80.03 10.78 93 151822 10325 90466207
Adjustment disorder with depressed mood 78.48 10.78 4 151911 56749 90419783
Mean cell volume increased 78.35 10.78 66 151849 4955 90471577
Invasive breast carcinoma 78.25 10.78 36 151879 903 90475629
Adverse drug reaction 77.48 10.78 50 151865 116651 90359881
Injection site swelling 77.44 10.78 6 151909 59833 90416699
Injection site pruritus 77.05 10.78 3 151912 53831 90422701
Madarosis 76.63 10.78 57 151858 3572 90472960
Hip arthroplasty 76.50 10.78 17 151898 76191 90400341
Blepharospasm 76.38 10.78 4 151911 55441 90421091
Foot deformity 74.40 10.78 7 151908 59644 90416888
Blood lactate dehydrogenase increased 74.39 10.78 146 151769 25786 90450746
Rash 72.87 10.78 920 150995 795180 89681352
Peripheral venous disease 72.53 10.78 25 151890 83896 90392636
Bone erosion 72.50 10.78 4 151911 53017 90423515
Pain 71.19 10.78 1209 150706 995132 89481400
Migraine 70.72 10.78 132 151783 190260 90286272
Red blood cell sedimentation rate increased 70.70 10.78 25 151890 82570 90393962
Hypercholesterolaemia 70.08 10.78 41 151874 100851 90375681
Bone marrow failure 69.99 10.78 162 151753 32059 90444473
Haemoglobin decreased 69.23 10.78 487 151428 161469 90315063
Nasopharyngitis 69.01 10.78 400 151515 406704 90069828
Hormone receptor positive HER2 negative breast cancer 68.97 10.78 24 151891 280 90476252
Hospitalisation 68.61 10.78 68 151847 128032 90348500
Concomitant disease aggravated 67.86 10.78 90 151825 11428 90465104
Breast mass 67.06 10.78 81 151834 9366 90467166
Hydrothorax 66.00 10.78 33 151882 1000 90475532
Multiple sclerosis relapse 65.61 10.78 6 151909 52299 90424233
Progesterone increased 65.48 10.78 16 151899 43 90476489
Medication error 63.78 10.78 31 151884 84621 90391911
Cardio-respiratory arrest 63.55 10.78 14 151901 63126 90413406
Bone marrow infiltration 63.11 10.78 30 151885 812 90475720
Death 62.94 10.78 1095 150820 455456 90021076
Pulmonary mass 61.77 10.78 144 151771 28628 90447904
Body surface area increased 61.20 10.78 15 151900 41 90476491
Device related thrombosis 60.86 10.78 40 151875 2053 90474479
Dysgeusia 60.56 10.78 210 151705 52350 90424182
X-ray abnormal 60.37 10.78 4 151911 45420 90431112
Lupus-like syndrome 60.22 10.78 6 151909 48840 90427692
Ear infection 59.93 10.78 21 151894 69754 90406778
Coeliac disease 59.08 10.78 4 151911 44606 90431926
Radiation skin injury 58.33 10.78 31 151884 1069 90475463
Injection site bruising 58.21 10.78 9 151906 52298 90424234
Oral pain 57.93 10.78 152 151763 32531 90444001
Sciatica 57.60 10.78 51 151864 101331 90375201
Back injury 56.77 10.78 6 151909 46616 90429916
Pyelitis 56.74 10.78 20 151895 243 90476289
Metastases to bone marrow 55.59 10.78 25 151890 594 90475938
Accidental exposure to product 55.52 10.78 4 151911 42362 90434170
Metastases to thorax 55.38 10.78 20 151895 262 90476270
Arthritis 55.34 10.78 124 151791 167191 90309341
Invasive lobular breast carcinoma 54.57 10.78 29 151886 1000 90475532
Basophil count increased 54.25 10.78 30 151885 1121 90475411
Carbohydrate antigen 27.29 increased 53.83 10.78 16 151899 107 90476425
Hepatic steatosis 53.83 10.78 160 151755 36785 90439747
Metastases to stomach 53.82 10.78 19 151896 232 90476300
Hypertensive crisis 53.30 10.78 102 151813 17682 90458850
Oxygen saturation decreased 53.15 10.78 61 151854 107422 90369110
Exposed bone in jaw 53.10 10.78 42 151873 2884 90473648
Breast cancer female 53.01 10.78 92 151823 14794 90461738
Oedema 52.91 10.78 166 151749 200129 90276403
Metastases to ovary 52.85 10.78 23 151892 504 90476028
Thoracic vertebral fracture 52.68 10.78 55 151860 5419 90471113
Intentional product misuse 52.21 10.78 44 151871 89560 90386972
Cytopenia 52.20 10.78 100 151815 17349 90459183
Cough 51.92 10.78 888 151027 368074 90108458
Neoplasm 51.58 10.78 69 151846 8834 90467698
Dyspnoea exertional 51.57 10.78 249 151666 72039 90404493
Seizure 51.39 10.78 112 151803 152517 90324015
Hypocalcaemia 51.20 10.78 172 151743 42196 90434336
Exostosis 51.07 10.78 13 151902 53121 90423411
Anaphylactic reaction 50.97 10.78 43 151872 87481 90389051
Recall phenomenon 50.96 10.78 26 151889 823 90475709
Hepatorenal failure 49.71 10.78 24 151891 673 90475859
No adverse event 49.56 10.78 26 151889 67956 90408576
White blood cell count abnormal 49.49 10.78 62 151853 7442 90469090
Humerus fracture 49.45 10.78 71 151844 9714 90466818
Malaise 48.50 10.78 691 151224 585295 89891237
Serotonin syndrome 48.46 10.78 4 151911 37883 90438649
Mean cell haemoglobin increased 48.30 10.78 45 151870 3860 90472672
Neutrophil count abnormal 48.06 10.78 46 151869 4082 90472450
Lung disorder 48.01 10.78 113 151802 149770 90326762
Osteoarthritis 47.73 10.78 168 151747 195562 90280970
Hypertension 47.45 10.78 514 151401 457018 90019514
Breast cancer stage II 47.29 10.78 3 151912 35331 90441201
Cholestasis 47.12 10.78 151 151764 36148 90440384
Menopausal symptoms 47.09 10.78 40 151875 3038 90473494
Carbohydrate antigen 125 increased 47.03 10.78 41 151874 3225 90473307
Sequestrectomy 46.89 10.78 24 151891 765 90475767
Osteomyelitis 46.82 10.78 127 151788 27719 90448813
Inappropriate schedule of product administration 46.48 10.78 115 151800 149818 90326714
Ovarian cancer 46.37 10.78 57 151858 6710 90469822
Cardiac arrest 46.23 10.78 65 151850 104870 90371662
Myelosuppression 46.01 10.78 195 151720 53396 90423136
Haematocrit decreased 45.49 10.78 164 151751 41668 90434864
Bone sequestrum 45.27 10.78 29 151886 1424 90475108
Pneumonia 45.18 10.78 775 151140 637284 89839248
Joint dislocation 44.63 10.78 10 151905 44572 90431960
Unevaluable event 44.60 10.78 18 151897 54830 90421702
Metastases to muscle 44.57 10.78 15 151900 157 90476375
Body surface area decreased 44.38 10.78 11 151904 32 90476500
Toothache 44.21 10.78 108 151807 22122 90454410
Cardiotoxicity 44.01 10.78 73 151842 11316 90465216
Bone debridement 43.93 10.78 16 151899 215 90476317
Anisocytosis 43.68 10.78 23 151892 778 90475754
Renal impairment 43.29 10.78 314 151601 105107 90371425
Pleural disorder 43.19 10.78 22 151893 694 90475838
Inflammation 42.41 10.78 155 151760 178437 90298095
Lymphadenopathy mediastinal 42.11 10.78 38 151877 3129 90473403
Oestradiol decreased 41.94 10.78 13 151902 102 90476430
Wrong technique in product usage process 41.88 10.78 35 151880 71536 90404996
Gastroenteritis radiation 41.55 10.78 20 151895 557 90475975
Purulent discharge 41.10 10.78 48 151867 5357 90471175
Disability 41.07 10.78 9 151906 40736 90435796
Drug interaction 40.95 10.78 283 151632 276170 90200362
Ovarian enlargement 40.81 10.78 20 151895 580 90475952
Coma 40.70 10.78 37 151878 72595 90403937
Finger deformity 40.66 10.78 4 151911 32893 90443639
Isosthenuria 40.47 10.78 13 151902 116 90476416
Lymphopenia 40.13 10.78 106 151809 22775 90453757
Femoral neck fracture 40.10 10.78 66 151849 10167 90466365
Chest wall tumour 39.87 10.78 11 151904 54 90476478
Encephalopathy 39.84 10.78 14 151901 46430 90430102
Hypoaesthesia 39.78 10.78 336 151579 313874 90162658
Depressed level of consciousness 39.70 10.78 38 151877 72746 90403786
Blood bilirubin abnormal 39.58 10.78 30 151885 1934 90474598
Vulvovaginal dryness 39.51 10.78 38 151877 3393 90473139
Muscle spasticity 39.48 10.78 6 151909 35316 90441216
Tumour marker abnormal 39.30 10.78 17 151898 367 90476165
Cardiac failure 39.28 10.78 316 151599 109180 90367352
Neoplasm recurrence 39.25 10.78 37 151878 3222 90473310
Dermatitis 39.03 10.78 103 151812 22117 90454415
Myeloproliferative neoplasm 38.94 10.78 20 151895 642 90475890
Pericardial effusion 38.87 10.78 143 151772 36690 90439842
Atrial fibrillation 38.78 10.78 368 151547 133243 90343289
Cutaneous lupus erythematosus 38.70 10.78 36 151879 3082 90473450
Vertigo 38.50 10.78 224 151691 69587 90406945
Osteitis 38.27 10.78 39 151876 3734 90472798
Monocyte count decreased 38.27 10.78 33 151882 2558 90473974
Headache 38.23 10.78 1128 150787 861618 89614914
Pancytopenia 37.82 10.78 337 151578 119926 90356606
Intentional self-injury 37.79 10.78 3 151912 29331 90447201
Elliptocytosis 37.61 10.78 11 151904 69 90476463
Periodontitis 37.59 10.78 39 151876 3814 90472718
Walking aid user 37.54 10.78 7 151908 35499 90441033
Motor neurone disease 37.22 10.78 14 151901 207 90476325
Drug withdrawal syndrome 36.83 10.78 3 151912 28720 90447812
Foetal exposure during pregnancy 36.79 10.78 13 151902 42962 90433570
Osteopenia 36.78 10.78 103 151812 22899 90453633
Jaw disorder 36.77 10.78 46 151869 5513 90471019
Hypermetabolism 36.39 10.78 15 151900 286 90476246
Pulmonary fibrosis 36.09 10.78 79 151836 107424 90369108
Tumour invasion 36.05 10.78 15 151900 293 90476239
Gastrooesophageal reflux disease 35.89 10.78 150 151765 166187 90310345
Sleep disorder due to a general medical condition 35.86 10.78 15 151900 44723 90431809
Calcification metastatic 35.74 10.78 13 151902 174 90476358
Progressive bulbar palsy 35.61 10.78 10 151905 53 90476479
Muscular weakness 35.53 10.78 202 151713 206464 90270068
Triple negative breast cancer 35.28 10.78 16 151899 388 90476144
Congenital genital malformation female 35.15 10.78 10 151905 56 90476476
Decreased immune responsiveness 35.06 10.78 57 151858 8691 90467841
Resorption bone increased 34.73 10.78 23 151892 1196 90475336
Sedation 34.27 10.78 19 151896 48152 90428380
Superior vena cava syndrome 34.26 10.78 19 151896 714 90475818
Ageusia 34.01 10.78 80 151835 15996 90460536
Febrile infection 33.95 10.78 28 151887 2041 90474491
Bile duct stenosis 33.77 10.78 26 151889 1716 90474816
Oestrogen receptor assay positive 33.71 10.78 17 151898 525 90476007
Skin lesion 33.67 10.78 138 151777 37227 90439305
Mastectomy 33.60 10.78 28 151887 2071 90474461
Injection site haemorrhage 33.58 10.78 4 151911 28314 90448218
Intestinal metastasis 33.51 10.78 13 151902 210 90476322
Gingivitis 33.49 10.78 58 151857 9311 90467221
Gene mutation 33.24 10.78 28 151887 2102 90474430
Frequent bowel movements 33.12 10.78 28 151887 56907 90419625
Nail dystrophy 33.10 10.78 23 151892 1295 90475237
Neuromuscular toxicity 33.03 10.78 14 151901 287 90476245
Depressed mood 32.98 10.78 169 151746 50053 90426479
Metastases to soft tissue 32.94 10.78 14 151901 289 90476243
Portal hypertension 32.87 10.78 40 151875 4661 90471871
Calcium deficiency 32.86 10.78 23 151892 1310 90475222
Urinary tract inflammation 32.77 10.78 10 151905 74 90476458
Drug dependence 32.74 10.78 5 151910 29322 90447210
Bone cancer 32.65 10.78 25 151890 1637 90474895
Metastases to bladder 32.58 10.78 13 151902 227 90476305
General physical condition abnormal 31.76 10.78 41 151874 5070 90471462
Deep vein thrombosis 31.56 10.78 262 151653 91358 90385174
Septic shock 31.54 10.78 58 151857 84102 90392430
Adrenal insufficiency 31.42 10.78 6 151909 29915 90446617
Loss of consciousness 31.17 10.78 125 151790 140113 90336419
Poikilocytosis 31.10 10.78 12 151903 191 90476341
Cytogenetic analysis abnormal 31.08 10.78 20 151895 990 90475542
Bladder hypertrophy 31.00 10.78 16 151899 519 90476013
Heart rate increased 30.92 10.78 92 151823 112810 90363722
Generalised tonic-clonic seizure 30.85 10.78 10 151905 34893 90441639
Electrocardiogram PR shortened 30.83 10.78 16 151899 525 90476007
Cytokine release syndrome 30.70 10.78 5 151910 27968 90448564
Cachexia 30.58 10.78 47 151868 6831 90469701
Respiratory arrest 30.42 10.78 9 151906 33302 90443230
Malignant neoplasm of pleura 30.18 10.78 9 151906 61 90476471
Dental fistula 30.15 10.78 17 151898 660 90475872
Hepatic echinococciasis 30.05 10.78 9 151906 62 90476470
Tumour marker decreased 30.05 10.78 9 151906 62 90476470
Osteoma cutis 29.93 10.78 6 151909 3 90476529
Tumour pain 29.85 10.78 25 151890 1862 90474670
Radiation injury 29.83 10.78 17 151898 674 90475858
Recurrent cancer 29.77 10.78 28 151887 2431 90474101
Neck pain 29.70 10.78 95 151820 113868 90362664
Blood pressure increased 29.63 10.78 201 151714 197016 90279516
Debridement 29.51 10.78 21 151894 1228 90475304
Incorrect route of product administration 29.32 10.78 25 151890 50601 90425931
Aphthous ulcer 29.22 10.78 79 151836 17208 90459324
Staphylococcal infection 29.20 10.78 23 151892 48416 90428116
Oophorectomy bilateral 29.10 10.78 10 151905 112 90476420
Orthostatic hypotension 29.03 10.78 17 151898 41810 90434722
Metastases to abdominal cavity 29.03 10.78 16 151899 594 90475938
Metastatic neoplasm 28.95 10.78 38 151877 4777 90471755
Hallucination 28.91 10.78 41 151874 65918 90410614
Retinal vein occlusion 28.85 10.78 28 151887 2528 90474004
Breast disorder 28.80 10.78 29 151886 2738 90473794
Underdose 28.54 10.78 29 151886 53988 90422544
Abscess jaw 28.48 10.78 22 151893 1459 90475073
Non-compaction cardiomyopathy 28.21 10.78 6 151909 6 90476526
Peritoneal disorder 28.20 10.78 16 151899 629 90475903
Alanine aminotransferase decreased 28.19 10.78 18 151897 879 90475653
Concomitant disease progression 28.15 10.78 26 151889 2206 90474326
Bone trimming 28.08 10.78 7 151908 21 90476511
Immunodeficiency 28.04 10.78 19 151896 43215 90433317
Heart rate decreased 27.96 10.78 29 151886 53476 90423056
Respiratory disorder 27.71 10.78 41 151874 64775 90411757
COVID-19 27.70 10.78 417 151498 168426 90308106
Injection site rash 27.26 10.78 4 151911 24169 90452363
Red cell distribution width increased 27.20 10.78 62 151853 12145 90464387
Adverse reaction 27.18 10.78 8 151907 29704 90446828
Unresponsive to stimuli 27.17 10.78 15 151900 38106 90438426
Mouth swelling 27.04 10.78 40 151875 5622 90470910
Malignant ascites 26.87 10.78 18 151897 954 90475578
Dysphagia 26.74 10.78 297 151618 111981 90364551
Blood pressure fluctuation 26.72 10.78 29 151886 52384 90424148
Radiation oesophagitis 26.66 10.78 14 151901 471 90476061
Lymphangitis 26.59 10.78 18 151897 971 90475561
Peripheral sensory neuropathy 26.43 10.78 52 151863 9198 90467334
Macrocytosis 26.39 10.78 28 151887 2810 90473722
Aortic thrombosis 26.35 10.78 20 151895 1292 90475240
Postmenopausal haemorrhage 26.27 10.78 26 151889 2404 90474128
Gingival swelling 26.25 10.78 37 151878 4976 90471556
Abdominal lymphadenopathy 26.16 10.78 18 151897 997 90475535
Drug reaction with eosinophilia and systemic symptoms 26.15 10.78 20 151895 42738 90433794
Hepatocellular injury 26.13 10.78 107 151808 28851 90447681
Breast oedema 25.90 10.78 8 151907 62 90476470
Abdominal pain upper 25.83 10.78 397 151518 332277 90144255
Nail toxicity 25.67 10.78 13 151902 405 90476127
Subclavian vein thrombosis 25.44 10.78 24 151891 2092 90474440
Spinal cord compression 25.35 10.78 36 151879 4875 90471657
Gingival recession 25.34 10.78 22 151893 1721 90474811
Orthopnoea 25.33 10.78 43 151872 6792 90469740
Libido decreased 25.25 10.78 28 151887 2954 90473578
Acute cutaneous lupus erythematosus 25.24 10.78 12 151903 325 90476207
Breast neoplasm 25.13 10.78 21 151894 1559 90474973
Flushing 25.04 10.78 71 151844 88420 90388112
Metabolic acidosis 25.01 10.78 34 151881 55642 90420890
Coronavirus infection 24.96 10.78 38 151877 5477 90471055
Angioedema 24.95 10.78 44 151871 64832 90411700
Incorrect dose administered 24.88 10.78 60 151855 78870 90397662
Feeling hot 24.82 10.78 59 151856 77949 90398583
Onychomycosis 24.82 10.78 16 151899 37360 90439172
Tooth loss 24.73 10.78 45 151870 7509 90469023
Hepatomegaly 24.67 10.78 63 151852 13263 90463269
Cyclic neutropenia 24.62 10.78 5 151910 3 90476529
Hypertransaminasaemia 24.46 10.78 70 151845 15755 90460777
Superinfection 24.27 10.78 28 151887 3084 90473448
Ulcer haemorrhage 24.24 10.78 7 151908 26314 90450218
Acute myeloid leukaemia 24.24 10.78 83 151832 20557 90455975
Ear pain 24.18 10.78 37 151878 57665 90418867
Radiation pneumonitis 24.13 10.78 22 151893 1836 90474696
CYP3A4 polymorphism 24.09 10.78 8 151907 80 90476452
Colitis ulcerative 23.98 10.78 40 151875 60226 90416306
Swollen tongue 23.91 10.78 25 151890 45931 90430601
Nephrosclerosis 23.88 10.78 18 151897 1151 90475381
Metastases to eye 23.87 10.78 10 151905 199 90476333
Age-related macular degeneration 23.84 10.78 15 151900 714 90475818
Night sweats 23.70 10.78 123 151792 128643 90347889
Cystoid macular oedema 23.69 10.78 23 151892 2077 90474455
Hair texture abnormal 23.67 10.78 34 151881 4653 90471879
Hypoxia 23.65 10.78 54 151861 72345 90404187
Therapy cessation 23.63 10.78 122 151793 36239 90440293
Scar pain 23.62 10.78 11 151904 284 90476248
Tongue discomfort 23.47 10.78 26 151889 2739 90473793
Musculoskeletal discomfort 23.42 10.78 83 151832 20908 90455624
Chest pain 23.30 10.78 386 151529 319259 90157273
Ovarian disorder 23.18 10.78 16 151899 891 90475641
Ovarian rupture 23.15 10.78 7 151908 50 90476482
Faeces pale 23.09 10.78 22 151893 1941 90474591
Vitreous detachment 23.07 10.78 24 151891 2354 90474178
Food allergy 23.05 10.78 7 151908 25471 90451061
Gastrointestinal haemorrhage 22.98 10.78 76 151839 90172 90386360
Malignant peritoneal neoplasm 22.94 10.78 15 151900 763 90475769
Cytomegalovirus infection 22.85 10.78 8 151907 26594 90449938
Product dose omission in error 22.82 10.78 81 151834 20422 90456110
Radiation fibrosis - lung 22.80 10.78 7 151908 53 90476479
Vulvovaginal inflammation 22.64 10.78 17 151898 1081 90475451
Lumbar vertebral fracture 22.63 10.78 43 151872 7415 90469117
Premature delivery 22.62 10.78 19 151896 38743 90437789
Suicidal ideation 22.60 10.78 57 151858 73798 90402734
Onycholysis 22.53 10.78 23 151892 2207 90474325
Mental status changes 22.47 10.78 25 151890 44654 90431878
Complication associated with device 22.45 10.78 3 151912 19446 90457086
Selenium deficiency 22.36 10.78 7 151908 57 90476475
Dental care 22.33 10.78 18 151897 1270 90475262
Plastic surgery 22.21 10.78 8 151907 104 90476428
Hyperglycaemia 22.18 10.78 154 151761 50816 90425716
Multiple pregnancy 22.04 10.78 7 151908 60 90476472
Oral discomfort 21.99 10.78 52 151863 10431 90466101
Sleep apnoea syndrome 21.90 10.78 13 151902 31734 90444798
Vaccination site reaction 21.88 10.78 10 151905 247 90476285
Obstructive airways disorder 21.85 10.78 8 151907 25861 90450671
Peritoneal fluid analysis abnormal 21.82 10.78 6 151909 29 90476503
Joint neoplasm 21.74 10.78 7 151908 63 90476469
Metastases to gastrointestinal tract 21.73 10.78 8 151907 111 90476421
Pleural thickening 21.68 10.78 27 151888 3221 90473311
Metastases to uterus 21.67 10.78 8 151907 112 90476420
Product substitution issue 21.66 10.78 73 151842 17935 90458597
Status epilepticus 21.57 10.78 3 151912 18871 90457661
Post thrombotic syndrome 21.48 10.78 13 151902 577 90475955
Tachyarrhythmia 21.36 10.78 35 151880 5371 90471161
Dilatation ventricular 21.32 10.78 23 151892 2353 90474179
Meningeal disorder 21.30 10.78 10 151905 263 90476269
Dyskinesia 21.21 10.78 18 151897 36516 90440016
Adjusted calcium increased 21.18 10.78 6 151909 33 90476499
Menopausal disorder 21.08 10.78 7 151908 70 90476462
Dyschezia 21.05 10.78 25 151890 2840 90473692
Degenerative bone disease 20.79 10.78 10 151905 278 90476254
Dilatation intrahepatic duct acquired 20.70 10.78 14 151901 754 90475778
Adenocarcinoma 20.43 10.78 26 151889 3170 90473362
SAPHO syndrome 20.41 10.78 8 151907 133 90476399
Plasma cell myeloma 20.36 10.78 23 151892 40805 90435727
Dental discomfort 20.36 10.78 12 151903 507 90476025
Pain in jaw 20.31 10.78 144 151771 47841 90428691
Oral disorder 20.29 10.78 50 151865 10295 90466237
Ocular icterus 20.29 10.78 29 151886 3951 90472581
Blood calcium increased 20.27 10.78 55 151860 12003 90464529
Transaminases 20.24 10.78 7 151908 80 90476452
Sopor 20.18 10.78 8 151907 24636 90451896
Skin exfoliation 20.17 10.78 188 151727 67725 90408807
Cellulitis 20.12 10.78 238 151677 91099 90385433
Cardiomyopathy 20.11 10.78 77 151838 20129 90456403
Hyperbilirubinaemia 19.96 10.78 60 151855 13876 90462656
Metastases to neck 19.86 10.78 7 151908 85 90476447
Urinary tract infection 19.82 10.78 661 151254 304971 90171561
RET gene mutation 19.82 10.78 5 151910 16 90476516
Drug tolerance decreased 19.69 10.78 15 151900 32115 90444417
Drug level increased 19.67 10.78 11 151904 27751 90448781
Metastases to nervous system 19.64 10.78 7 151908 88 90476444
Subacute cutaneous lupus erythematosus 19.60 10.78 27 151888 3555 90472977
Oral mucosal erythema 19.51 10.78 19 151896 1723 90474809
Central nervous system lesion 19.46 10.78 53 151862 11593 90464939
Ovarian fibrosis 19.34 10.78 4 151911 3 90476529
Haemoconcentration 19.34 10.78 8 151907 154 90476378
Blood creatinine abnormal 19.32 10.78 29 151886 4128 90472404
Aspartate aminotransferase abnormal 19.27 10.78 23 151892 2626 90473906
Bone cancer metastatic 19.23 10.78 9 151906 235 90476297
Amnesia 19.21 10.78 105 151810 108400 90368132
Respiratory failure 19.15 10.78 118 151797 118300 90358232
Jaw operation 19.11 10.78 14 151901 857 90475675
Glossopharyngeal nerve paralysis 19.04 10.78 6 151909 50 90476482
Granulocyte count decreased 19.02 10.78 22 151893 2430 90474102
Sensory disturbance 19.00 10.78 63 151852 15350 90461182
Withdrawal syndrome 18.96 10.78 7 151908 22517 90454015
Biopsy bone abnormal 18.95 10.78 5 151910 20 90476512
Virilism 18.94 10.78 6 151909 51 90476481
BRCA2 gene mutation 18.89 10.78 7 151908 99 90476433
Blood pressure diastolic abnormal 18.84 10.78 5 151910 19876 90456656
Pelvic mass 18.79 10.78 17 151898 1404 90475128
HER2 positive breast cancer 18.79 10.78 11 151904 459 90476073
Breast cancer stage IV 18.76 10.78 20 151895 2018 90474514
Cornea verticillata 18.75 10.78 9 151906 249 90476283
C-reactive protein increased 18.67 10.78 204 151711 181185 90295347
Soft tissue neoplasm 18.64 10.78 7 151908 103 90476429
Mastitis 18.58 10.78 24 151891 2969 90473563
Blood pressure decreased 18.43 10.78 64 151851 74831 90401701
Platelet count abnormal 18.41 10.78 29 151886 4306 90472226
Fall 18.37 10.78 642 151273 481168 89995364
Congestive hepatopathy 18.33 10.78 24 151891 3009 90473523
Dysarthria 18.31 10.78 40 151875 54442 90422090
Vertebral lesion 18.29 10.78 13 151902 759 90475773
Lung opacity 18.29 10.78 35 151880 6067 90470465
Aggression 18.28 10.78 11 151904 26657 90449875
Aortic arteriosclerosis 18.21 10.78 40 151875 7644 90468888
Chromaturia 18.19 10.78 72 151843 19115 90457417
Somnolence 18.16 10.78 244 151671 208840 90267692
Agitation 18.14 10.78 55 151860 67043 90409489
Keloid scar 18.08 10.78 9 151906 270 90476262
Gingival erythema 18.07 10.78 15 151900 1103 90475429
Neutropenic sepsis 17.97 10.78 69 151846 18061 90458471
Drug tolerance 17.97 10.78 4 151911 17912 90458620
Abortion spontaneous 17.91 10.78 40 151875 54016 90422516
Mucinous breast carcinoma 17.89 10.78 5 151910 26 90476506
Musculoskeletal pain 17.87 10.78 192 151723 171059 90305473
Anaphylactic shock 17.84 10.78 16 151899 31601 90444931
Gait deviation 17.81 10.78 6 151909 63 90476469
Ovarian cancer stage IV 17.78 10.78 9 151906 280 90476252
Carcinoid tumour pulmonary 17.76 10.78 11 151904 509 90476023
Maternal exposure before pregnancy 17.72 10.78 50 151865 11163 90465369
Metastases to breast 17.72 10.78 10 151905 389 90476143
Cutaneous symptom 17.70 10.78 11 151904 512 90476020
Portal vein thrombosis 17.69 10.78 24 151891 3114 90473418
Hypercalcaemia 17.68 10.78 108 151807 34132 90442400
Electrocardiogram QT interval 17.68 10.78 8 151907 193 90476339
Paraneoplastic syndrome 17.65 10.78 12 151903 652 90475880
Left ventricular dilatation 17.63 10.78 12 151903 653 90475879
Soft tissue infection 17.63 10.78 23 151892 2874 90473658
Macular hole 17.58 10.78 14 151901 971 90475561
Retracted nipple 17.58 10.78 5 151910 28 90476504
Bone fistula 17.56 10.78 6 151909 66 90476466
Gingival bleeding 17.56 10.78 60 151855 14843 90461689
Antisynthetase syndrome 17.56 10.78 7 151908 122 90476410
Psychotic disorder 17.39 10.78 16 151899 31214 90445318
General physical health deterioration 17.28 10.78 744 151171 354371 90122161
Biliary dilatation 17.24 10.78 22 151893 2689 90473843
Herpes simplex encephalitis 17.17 10.78 10 151905 413 90476119
Hepatic calcification 17.15 10.78 5 151910 31 90476501
Blood oestrogen decreased 17.13 10.78 10 151905 415 90476117
Tremor 17.10 10.78 169 151746 153004 90323528
Multiple sclerosis 17.06 10.78 13 151902 27827 90448705
Granulocytopenia 16.96 10.78 35 151880 6406 90470126
Pulpitis dental 16.96 10.78 14 151901 1022 90475510
Mixed anxiety and depressive disorder 16.96 10.78 10 151905 423 90476109
Post procedural inflammation 16.96 10.78 7 151908 134 90476398
Paralysis recurrent laryngeal nerve 16.94 10.78 6 151909 74 90476458
Rouleaux formation 16.88 10.78 5 151910 33 90476499
Dysaesthesia 16.82 10.78 31 151884 5224 90471308
Adjusted calcium decreased 16.71 10.78 8 151907 220 90476312
Impaired quality of life 16.65 10.78 9 151906 23135 90453397
Neuroendocrine breast tumour 16.63 10.78 5 151910 35 90476497
Breast injury 16.58 10.78 6 151909 79 90476453
Poor venous access 16.56 10.78 6 151909 19521 90457011
Hypersensitivity vasculitis 16.53 10.78 27 151888 4132 90472400
Peri-implantitis 16.52 10.78 6 151909 80 90476452
Blood phosphorus decreased 16.49 10.78 30 151885 5004 90471528
Hepatic cyst 16.49 10.78 35 151880 6533 90469999
Cyanosis 16.46 10.78 6 151909 19449 90457083
Hepatitis E 16.37 10.78 18 151897 1881 90474651
Hypoglycaemia 16.32 10.78 61 151854 69787 90406745
Ostectomy 16.30 10.78 4 151911 11 90476521
Retinal phototoxicity 16.30 10.78 4 151911 11 90476521
Ovarian cancer metastatic 16.21 10.78 14 151901 1087 90475445
Endometrial metaplasia 16.18 10.78 3 151912 0 90476532
Hydroxyproline increased 16.18 10.78 3 151912 0 90476532
Mucosal hypertrophy 16.16 10.78 5 151910 39 90476493
Alanine aminotransferase abnormal 16.11 10.78 31 151884 5395 90471137
Myoclonus 16.06 10.78 6 151909 19162 90457370
Virilism foetal 16.05 10.78 4 151911 12 90476520
Hormone refractory breast cancer 16.05 10.78 4 151911 12 90476520
Hyperproteinaemia 16.02 10.78 7 151908 155 90476377
Hepatic mass 16.00 10.78 19 151896 2158 90474374
Multiple allergies 15.98 10.78 3 151912 15143 90461389
Tachycardia 15.96 10.78 178 151737 157495 90319037
Hyperuricaemia 15.95 10.78 35 151880 6684 90469848
Metastases to kidney 15.92 10.78 8 151907 245 90476287
Acute promyelocytic leukaemia 15.91 10.78 14 151901 1115 90475417
Anaemia of malignant disease 15.77 10.78 11 151904 623 90475909
Drug ineffective for unapproved indication 15.70 10.78 58 151857 66586 90409946
Hilar lymphadenopathy 15.65 10.78 15 151900 1333 90475199
Posterior reversible encephalopathy syndrome 15.62 10.78 9 151906 22330 90454202
Upper respiratory tract infection 15.43 10.78 139 151776 128179 90348353
Vaginal cuff dehiscence 15.36 10.78 4 151911 15 90476517
Pneumonia herpes viral 15.33 10.78 5 151910 47 90476485
Device malfunction 15.32 10.78 8 151907 20969 90455563
Injection site mass 15.30 10.78 9 151906 22081 90454451
Oestradiol increased 15.30 10.78 6 151909 100 90476432
Liver function test increased 15.26 10.78 213 151702 84642 90391890
Haematochezia 15.25 10.78 64 151851 70849 90405683
Pancreatic neoplasm 15.24 10.78 13 151902 993 90475539
Periprosthetic metallosis 15.16 10.78 4 151911 16 90476516
B-cell lymphoma stage III 15.16 10.78 4 151911 16 90476516
Groin pain 15.12 10.78 50 151865 12163 90464369
Uterine polyp 15.08 10.78 20 151895 2540 90473992
Feeling cold 15.06 10.78 88 151827 27377 90449155
Premature baby 15.00 10.78 12 151903 25065 90451467
Neutrophil Pelger-Huet anomaly present 14.92 10.78 6 151909 107 90476425
Therapeutic response shortened 14.91 10.78 10 151905 22869 90453663
Ruptured ectopic pregnancy 14.88 10.78 10 151905 533 90475999
Gamma-glutamyltransferase abnormal 14.81 10.78 10 151905 537 90475995
QRS axis abnormal 14.80 10.78 14 151901 1224 90475308
Toxic skin eruption 14.80 10.78 59 151856 15715 90460817
Polyglandular autoimmune syndrome type II 14.80 10.78 5 151910 53 90476479
Psychomotor disadaptation syndrome 14.78 10.78 4 151911 18 90476514
Chronic myelomonocytic leukaemia 14.72 10.78 9 151906 407 90476125
Pelvic fluid collection 14.66 10.78 13 151902 1046 90475486
Pneumonia aspiration 14.65 10.78 29 151886 40911 90435621
Androgenetic alopecia 14.64 10.78 7 151908 192 90476340
Spondylitis 14.56 10.78 3 151912 14175 90462357
Arrhythmia 14.54 10.78 121 151794 42211 90434321
Venous thrombosis 14.48 10.78 30 151885 5507 90471025
Lymphatic obstruction 14.44 10.78 4 151911 20 90476512
Dental caries 14.42 10.78 47 151868 11350 90465182
Dermatitis bullous 14.39 10.78 44 151871 10272 90466260
Eosinophil count decreased 14.35 10.78 22 151893 3190 90473342
Upper respiratory fungal infection 14.25 10.78 7 151908 204 90476328
White blood cell disorder 14.24 10.78 21 151894 2943 90473589
Metastases to heart 14.19 10.78 7 151908 206 90476326
Sinus congestion 14.17 10.78 15 151900 27409 90449123
BRCA1 gene mutation 14.17 10.78 5 151910 61 90476471
Respiratory tract congestion 14.16 10.78 15 151900 27395 90449137
Cor pulmonale acute 14.12 10.78 9 151906 438 90476094
Pseudoradicular syndrome 14.10 10.78 3 151912 3 90476529
Pleural fluid analysis abnormal 14.10 10.78 3 151912 3 90476529
Menopause delayed 14.10 10.78 3 151912 3 90476529
Primary pulmonary melanoma 14.10 10.78 3 151912 3 90476529
Poisoning 14.10 10.78 4 151911 15213 90461319
Biochemical pregnancy 14.09 10.78 5 151910 62 90476470
Body temperature increased 14.08 10.78 34 151881 44676 90431856
Kidney fibrosis 14.01 10.78 18 151897 2216 90474316
Marrow hyperplasia 14.00 10.78 11 151904 748 90475784
Osteoporotic fracture 13.99 10.78 27 151888 4709 90471823
Nail growth abnormal 13.95 10.78 10 151905 592 90475940
Jugular vein thrombosis 13.90 10.78 23 151892 3558 90472974
Denture wearer 13.88 10.78 7 151908 216 90476316
Actinomycosis 13.88 10.78 13 151902 1123 90475409
Mechanical ileus 13.87 10.78 11 151904 758 90475774
Left ventricular dysfunction 13.87 10.78 55 151860 14614 90461918
Bradycardia 13.84 10.78 83 151832 83764 90392768
Pancreatic toxicity 13.81 10.78 5 151910 66 90476466
Mean cell haemoglobin concentration increased 13.75 10.78 10 151905 605 90475927
Gallbladder empyema 13.74 10.78 5 151910 67 90476465
Hypervolaemia 13.73 10.78 21 151894 32736 90443796
Spinal fracture 13.70 10.78 73 151842 21943 90454589
Cardiac valve sclerosis 13.69 10.78 4 151911 25 90476507
Erythroblastosis 13.64 10.78 3 151912 4 90476528
Joint injury 13.63 10.78 21 151894 32643 90443889
Cauda equina syndrome 13.63 10.78 14 151901 1353 90475179
Fluid retention 13.61 10.78 89 151826 88002 90388530
Forearm fracture 13.61 10.78 10 151905 615 90475917
Foetal death 13.58 10.78 9 151906 20714 90455818
Hepatic necrosis 13.58 10.78 32 151883 6406 90470126
Vestibular neuronitis 13.50 10.78 11 151904 788 90475744
Chronic sinusitis 13.48 10.78 12 151903 23790 90452742
Pseudocellulitis 13.48 10.78 6 151909 139 90476393
Memory impairment 13.45 10.78 241 151674 197003 90279529
Nail avulsion 13.45 10.78 8 151907 344 90476188
Abortion early 13.43 10.78 4 151911 27 90476505
Respiratory rate increased 13.42 10.78 5 151910 15996 90460536
Cerebral venous thrombosis 13.42 10.78 18 151897 2310 90474222
Bilirubin conjugated increased 13.37 10.78 21 151894 3109 90473423
Myosclerosis 13.37 10.78 7 151908 234 90476298
Back disorder 13.27 10.78 14 151901 25617 90450915
Breast tenderness 13.27 10.78 19 151896 2593 90473939
Joint destruction 13.26 10.78 3 151912 13284 90463248
Drug resistance 13.25 10.78 92 151823 30357 90446175
Polychromasia 13.24 10.78 7 151908 239 90476293
Temperature regulation disorder 13.20 10.78 4 151911 14575 90461957
Papillary thyroid cancer 13.18 10.78 19 151896 2608 90473924
Maternal exposure timing unspecified 13.14 10.78 11 151904 22472 90454060
Superior vena cava occlusion 13.11 10.78 5 151910 77 90476455
Radicular pain 13.11 10.78 9 151906 497 90476035
Tumour ulceration 13.10 10.78 7 151908 244 90476288
Panniculitis 13.03 10.78 4 151911 14454 90462078
Lymphocyte count decreased 13.03 10.78 102 151813 34948 90441584
Stomatitis 13.01 10.78 574 151341 274124 90202408
Thirst 12.99 10.78 58 151857 16237 90460295
Chronic myeloid leukaemia 12.98 10.78 19 151896 2645 90473887
Paraparesis 12.96 10.78 20 151895 2918 90473614
Spondylitic myelopathy 12.95 10.78 4 151911 31 90476501
Rectosigmoid cancer recurrent 12.89 10.78 3 151912 6 90476526
Genital atrophy 12.89 10.78 3 151912 6 90476526
Progesterone abnormal 12.89 10.78 3 151912 6 90476526
Gastrointestinal toxicity 12.85 10.78 40 151875 9427 90467105
Fractured sacrum 12.84 10.78 18 151897 2409 90474123
Laryngitis 12.74 10.78 43 151872 50710 90425822
Left ventricular failure 12.74 10.78 32 151883 6668 90469864
Fanconi syndrome 12.73 10.78 16 151899 1927 90474605
Pancreatitis 12.68 10.78 67 151848 69759 90406773
Lung infiltration 12.65 10.78 55 151860 15227 90461305
Peripheral artery thrombosis 12.61 10.78 17 151898 2193 90474339
Paraesthesia oral 12.60 10.78 21 151894 31638 90444894
Malignant neoplasm of choroid 12.58 10.78 3 151912 7 90476525
Idiopathic orbital inflammation 12.58 10.78 7 151908 265 90476267
Cholangitis sclerosing 12.54 10.78 17 151898 2204 90474328
Congenital haematological disorder 12.52 10.78 4 151911 35 90476497
Supraventricular tachyarrhythmia 12.50 10.78 5 151910 88 90476444
Globulins decreased 12.32 10.78 8 151907 402 90476130
Oophorectomy 12.27 10.78 10 151905 717 90475815
Skin weeping 12.26 10.78 19 151896 2781 90473751
Mitral valve incompetence 12.24 10.78 72 151843 22452 90454080
Uterine mass 12.24 10.78 8 151907 407 90476125
Mesenteric neoplasm 12.23 10.78 4 151911 38 90476494
Gastroenteritis viral 12.21 10.78 20 151895 30335 90446197
Treatment noncompliance 12.20 10.78 45 151870 51682 90424850
Metastases to spinal cord 12.13 10.78 7 151908 284 90476248
Blood test abnormal 12.05 10.78 68 151847 20884 90455648
Polychromic red blood cells present 12.04 10.78 3 151912 9 90476523
Red blood cell poikilocytes present 12.04 10.78 3 151912 9 90476523
Bronchitis 12.02 10.78 182 151733 152745 90323787
Abscess oral 12.02 10.78 14 151901 1558 90474974
Amyotrophic lateral sclerosis 12.01 10.78 13 151902 1335 90475197
Corneal infection 12.00 10.78 5 151910 98 90476434
Fingerprint loss 11.96 10.78 4 151911 41 90476491
Schizophrenia 11.95 10.78 5 151910 14909 90461623
Dermatitis atopic 11.95 10.78 13 151902 23459 90453073
Infusion site erythema 11.93 10.78 4 151911 13666 90462866
Hormone level abnormal 11.90 10.78 19 151896 2854 90473678
Radius fracture 11.88 10.78 23 151892 4021 90472511
Loose tooth 11.88 10.78 22 151893 3721 90472811
Electrocardiogram repolarisation abnormality 11.79 10.78 13 151902 1363 90475169
Waist circumference increased 11.78 10.78 11 151904 946 90475586
Ventricular hypokinesia 11.76 10.78 27 151888 5314 90471218
Blood parathyroid hormone decreased 11.72 10.78 3 151912 12213 90464319
Tooth development disorder 11.71 10.78 4 151911 44 90476488
Drug exposure before pregnancy 11.70 10.78 11 151904 955 90475577
Thrombocytopenic purpura 11.68 10.78 15 151900 1846 90474686
Breast inflammation 11.67 10.78 6 151909 193 90476339
Rotavirus infection 11.60 10.78 8 151907 445 90476087
Radioisotope scan 11.58 10.78 3 151912 11 90476521
Reflux gastritis 11.57 10.78 13 151902 1391 90475141
Breast conserving surgery 11.57 10.78 12 151903 1173 90475359
Atrophic vulvovaginitis 11.51 10.78 15 151900 1872 90474660
Fungal infection 11.51 10.78 35 151880 42626 90433906
Breast necrosis 11.48 10.78 6 151909 200 90476332
Gastrointestinal angiodysplasia 11.47 10.78 9 151906 611 90475921
Fibrous histiocytoma 11.47 10.78 9 151906 611 90475921
Dystonia 11.44 10.78 7 151908 16812 90459720
Aspartate aminotransferase decreased 11.44 10.78 11 151904 982 90475550
Chills 11.43 10.78 296 151619 131685 90344847
Ocular vasculitis 11.43 10.78 5 151910 111 90476421
Macular scar 11.39 10.78 5 151910 112 90476420
Breast ulceration 11.37 10.78 6 151909 204 90476328
Vascular device infection 11.34 10.78 3 151912 11949 90464583
Hypokalaemia 11.34 10.78 294 151621 130822 90345710
Tooth disorder 11.29 10.78 90 151825 31000 90445532
Dry mouth 11.29 10.78 229 151686 183830 90292702
Acetonaemia 11.28 10.78 7 151908 325 90476207
Tooth resorption 11.25 10.78 4 151911 50 90476482
Tachycardia paroxysmal 11.24 10.78 7 151908 327 90476205
Vulvovaginal candidiasis 11.24 10.78 22 151893 3878 90472654
Gravitational oedema 11.21 10.78 12 151903 1217 90475315
Ventricular tachycardia 11.18 10.78 15 151900 24693 90451839
Staphylococcal impetigo 11.18 10.78 3 151912 13 90476519
Oral cavity fistula 11.17 10.78 9 151906 635 90475897
Liver disorder 11.08 10.78 140 151775 121129 90355403
Lymph node palpable 11.07 10.78 5 151910 120 90476412
Dry eye 11.07 10.78 147 151768 57784 90418748
Cell death 11.03 10.78 19 151896 3036 90473496
Nail cuticle fissure 11.03 10.78 4 151911 53 90476479
Feeling jittery 11.02 10.78 6 151909 15365 90461167
Acute respiratory failure 11.02 10.78 36 151879 42882 90433650
Infusion site swelling 11.01 10.78 3 151912 11717 90464815
Fracture 11.00 10.78 69 151846 22007 90454525
Caesarean section 10.97 10.78 9 151906 18568 90457964
Nasal dryness 10.97 10.78 27 151888 5556 90470976
Subchondral insufficiency fracture 10.97 10.78 4 151911 54 90476478
Mediastinal disorder 10.93 10.78 8 151907 489 90476043
Visual impairment 10.93 10.78 295 151620 132070 90344462
Monoplegia 10.92 10.78 21 151894 3653 90472879
Hair growth abnormal 10.91 10.78 21 151894 3655 90472877
Proctitis 10.88 10.78 6 151909 15253 90461279
Gangrene 10.84 10.78 4 151911 12872 90463660
Toxic epidermal necrolysis 10.83 10.78 24 151891 32504 90444028
Nitrituria 10.83 10.78 3 151912 15 90476517
CD4/CD8 ratio increased 10.83 10.78 3 151912 15 90476517

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
Product use issue 120.45 27.13 60 1703 76691 42542881
Neutropenia 78.35 27.13 65 1698 199366 42420206
Metastases to lung 59.27 27.13 21 1742 11403 42608169
Hot flush 58.52 27.13 25 1738 22326 42597246
Metastases to bone 50.44 27.13 20 1743 14789 42604783
Epiphysiolysis 50.28 27.13 8 1755 125 42619447
Neoplasm progression 43.32 27.13 22 1741 28978 42590594
Malignant neoplasm progression 41.67 27.13 35 1728 108365 42511207
Hyporesponsive to stimuli 35.61 27.13 9 1754 1537 42618035
PIK3CA-activated mutation 29.19 27.13 5 1758 125 42619447
Wrong patient received product 28.13 27.13 9 1754 3574 42615998
Multiple congenital abnormalities 27.38 27.13 6 1757 554 42619018

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
Neutropenia 3445.68 12.08 2983 114801 371637 110099878
Neoplasm progression 2658.01 12.08 1321 116463 63274 110408241
Metastases to bone 2453.25 12.08 1005 116779 30367 110441148
Malignant neoplasm progression 2195.80 12.08 1672 116112 172895 110298620
White blood cell count decreased 1785.21 12.08 1666 116118 227724 110243791
Metastases to liver 1467.29 12.08 728 117056 34658 110436857
Fatigue 884.91 12.08 3066 114718 1212892 109258623
Hot flush 862.74 12.08 648 117136 65388 110406127
Breast cancer metastatic 822.02 12.08 343 117441 10838 110460677
Metastases to lung 732.88 12.08 397 117387 22666 110448849
Carbohydrate antigen 15-3 increased 629.53 12.08 173 117611 1414 110470101
Osteonecrosis of jaw 593.52 12.08 456 117328 47561 110423954
Bone pain 587.64 12.08 515 117269 64618 110406897
Tumour marker increased 568.40 12.08 211 117573 4849 110466666
Metastases to lymph nodes 560.57 12.08 288 117496 14744 110456771
Disease progression 543.26 12.08 950 116834 243084 110228431
Alopecia 483.57 12.08 1145 116639 363608 110107907
Neutrophil count decreased 445.22 12.08 595 117189 120346 110351169
Leukopenia 400.30 12.08 631 117153 148160 110323355
Drug ineffective 393.18 12.08 636 117148 1519904 108951611
Breast cancer recurrent 390.67 12.08 149 117635 3697 110467818
Nausea 385.95 12.08 2437 115347 1233253 109238262
Bone lesion 318.05 12.08 154 117630 6933 110464582
Second primary malignancy 311.29 12.08 210 117574 17858 110453657
Breast cancer 310.49 12.08 286 117498 38256 110433259
Infusion related reaction 276.17 12.08 39 117745 381123 110090392
Lymphoedema 258.34 12.08 174 117610 14755 110456760
Full blood count decreased 237.08 12.08 227 117557 31872 110439643
Neuropathy peripheral 235.15 12.08 561 117223 178716 110292799
Therapeutic product effect decreased 228.17 12.08 7 117777 244309 110227206
Haematotoxicity 225.61 12.08 184 117600 20898 110450617
Ovarian hyperstimulation syndrome 224.15 12.08 111 117673 5249 110466266
Carcinoembryonic antigen increased 222.32 12.08 91 117693 2733 110468782
Hand deformity 216.89 12.08 3 117781 218503 110253012
Diarrhoea 212.82 12.08 1995 115789 1137510 109334005
Completed suicide 212.70 12.08 11 117773 242370 110229145
Hepatotoxicity 212.16 12.08 298 117486 63102 110408413
Synovitis 210.79 12.08 23 117761 274069 110197446
Red blood cell count decreased 207.57 12.08 301 117483 65622 110405893
Full blood count abnormal 204.95 12.08 275 117509 55777 110415738
Rheumatoid arthritis 204.89 12.08 36 117748 299577 110171938
Electrocardiogram QT prolonged 203.98 12.08 394 117390 108566 110362949
Drug hypersensitivity 201.16 12.08 117 117667 453973 110017542
Systemic lupus erythematosus 199.03 12.08 20 117764 254318 110217197
Joint swelling 196.31 12.08 114 117670 442731 110028784
Contraindicated product administered 195.65 12.08 19 117765 248248 110223267
Anaemia 195.12 12.08 1119 116665 545967 109925548
Psoriatic arthropathy 194.00 12.08 3 117781 196758 110274757
Osteonecrosis 193.27 12.08 208 117576 33533 110437982
PIK3CA-activated mutation 193.16 12.08 57 117727 616 110470899
Metastases to central nervous system 175.43 12.08 165 117619 22652 110448863
Arthralgia 174.30 12.08 1421 116363 778211 109693304
Metastases to spine 172.55 12.08 93 117691 5250 110466265
Pleural effusion 172.48 12.08 497 117287 177212 110294303
Off label use 170.25 12.08 923 116861 1499262 108972253
Duodenal ulcer perforation 166.24 12.08 5 117779 177695 110293820
Skin hypopigmentation 164.77 12.08 61 117723 1390 110470125
Pericarditis 161.99 12.08 21 117763 219093 110252422
Thrombocytopenia 160.38 12.08 766 117018 348119 110123396
Intentional product use issue 156.52 12.08 36 117748 247870 110223645
Arthropathy 155.35 12.08 56 117728 287466 110184049
Toxicity to various agents 154.95 12.08 170 117614 480385 109991130
Metastases to pleura 154.00 12.08 64 117720 1999 110469516
Metastases to peritoneum 152.02 12.08 87 117697 5523 110465992
Maternal exposure during pregnancy 151.31 12.08 42 117742 254841 110216674
Decreased appetite 150.79 12.08 944 116840 474902 109996613
Metastases to skin 144.07 12.08 63 117721 2236 110469279
Wound 142.24 12.08 37 117747 234400 110237115
Treatment failure 141.50 12.08 59 117725 277175 110194340
Irritable bowel syndrome 139.31 12.08 9 117775 164206 110307309
Spinal pain 138.73 12.08 132 117652 18383 110453132
Hepatic lesion 137.48 12.08 95 117689 8398 110463117
Hypersensitivity 136.86 12.08 137 117647 403861 110067654
Folliculitis 134.28 12.08 12 117772 167641 110303874
Hypotension 133.68 12.08 220 117564 523629 109947886
Dry skin 131.60 12.08 328 117456 107325 110364190
Muscle injury 131.56 12.08 4 117780 140803 110330712
Hepatic cytolysis 129.65 12.08 220 117564 54833 110416682
Wheezing 127.56 12.08 56 117728 255174 110216341
Injury 126.29 12.08 19 117765 177246 110294269
Pseudocirrhosis 124.25 12.08 44 117740 879 110470636
Asthenia 123.44 12.08 1197 116587 687802 109783713
Overdose 122.16 12.08 48 117736 233746 110237769
Glossodynia 122.03 12.08 42 117742 221962 110249553
Drug abuse 121.94 12.08 21 117763 177390 110294125
Metastasis 121.11 12.08 87 117697 8180 110463335
Fibromyalgia 120.21 12.08 19 117765 170890 110300625
Breast mass 117.73 12.08 85 117699 8056 110463459
Invasive ductal breast carcinoma 116.27 12.08 78 117706 6568 110464947
Type 2 diabetes mellitus 113.34 12.08 25 117759 177207 110294308
Tooth extraction 111.66 12.08 100 117684 12891 110458624
C-reactive protein abnormal 110.33 12.08 7 117777 129688 110341827
Aspartate aminotransferase increased 110.32 12.08 398 117386 159538 110311977
Constipation 108.40 12.08 702 117082 357084 110114431
Metastases to the mediastinum 107.50 12.08 38 117746 755 110470760
Condition aggravated 106.87 12.08 412 117372 734424 109737091
Ischaemic stroke 106.71 12.08 172 117612 41091 110430424
Bone disorder 106.47 12.08 122 117662 21070 110450445
Bursitis 104.85 12.08 9 117775 129909 110341606
Blister 104.32 12.08 56 117728 227320 110244195
Pathological fracture 104.17 12.08 93 117691 11939 110459576
Urticaria 102.48 12.08 113 117671 318744 110152771
Swelling 100.59 12.08 136 117648 350905 110120610
Invasive breast carcinoma 99.85 12.08 36 117748 759 110470756
Epistaxis 97.30 12.08 333 117451 130039 110341476
Exposure during pregnancy 96.74 12.08 29 117755 167395 110304120
Sleep disorder due to general medical condition, insomnia type 95.22 12.08 4 117780 105639 110365876
Blood alkaline phosphatase increased 92.93 12.08 222 117562 70713 110400802
Intentional overdose 92.57 12.08 15 117769 132486 110339029
Lymphangiosis carcinomatosa 90.92 12.08 47 117737 2435 110469080
Mobility decreased 90.56 12.08 72 117712 237350 110234165
Pleural neoplasm 88.67 12.08 28 117756 386 110471129
Pulmonary embolism 88.56 12.08 457 117327 214017 110257498
Ascites 88.48 12.08 258 117526 92550 110378965
Ill-defined disorder 87.36 12.08 29 117755 156824 110314691
Oral pain 87.32 12.08 149 117635 37295 110434220
Lymphadenopathy 87.12 12.08 203 117581 63632 110407883
Joint range of motion decreased 86.91 12.08 13 117771 121819 110349696
Interstitial lung disease 86.31 12.08 335 117449 138999 110332516
Alanine aminotransferase increased 85.41 12.08 405 117379 183368 110288147
Ejection fraction decreased 85.40 12.08 155 117629 40725 110430790
Palmar-plantar erythrodysaesthesia syndrome 85.01 12.08 155 117629 40870 110430645
Sinusitis 83.91 12.08 116 117668 296572 110174943
Cardiac arrest 83.80 12.08 53 117731 196700 110274815
Malignant pleural effusion 83.76 12.08 53 117731 4040 110467475
Confusional state 82.97 12.08 241 117543 468439 110003076
Delirium 82.47 12.08 21 117763 135004 110336511
Vitiligo 82.32 12.08 47 117737 2970 110468545
Osteosclerosis 81.42 12.08 54 117730 4461 110467054
Injection site pain 81.34 12.08 44 117740 177878 110293637
Blood cholesterol increased 81.17 12.08 48 117736 184737 110286778
Back pain 80.85 12.08 673 117111 370323 110101192
Mucosal dryness 79.34 12.08 52 117732 4211 110467304
Asthma 78.98 12.08 90 117694 250201 110221314
Breast pain 78.18 12.08 73 117711 9927 110461588
Gamma-glutamyltransferase increased 77.23 12.08 189 117595 61120 110410395
Drug interaction 76.83 12.08 274 117510 499909 109971606
Therapy partial responder 76.76 12.08 140 117644 36921 110434594
Prescribed overdose 76.72 12.08 4 117780 87577 110383938
Madarosis 76.31 12.08 47 117737 3416 110468099
Pneumonitis 76.09 12.08 216 117568 76315 110395200
Psoriasis 74.34 12.08 28 117756 139965 110331550
Lower respiratory tract infection 73.94 12.08 90 117694 243016 110228499
Progesterone increased 73.53 12.08 16 117768 40 110471475
Metastases to pelvis 72.38 12.08 29 117755 823 110470692
Cancer pain 72.23 12.08 59 117725 6713 110464802
Transaminases increased 72.11 12.08 188 117596 63202 110408313
Hormone receptor positive breast cancer 71.99 12.08 26 117758 551 110470964
Suicide attempt 71.56 12.08 12 117772 103382 110368133
Organising pneumonia 71.56 12.08 82 117702 14161 110457354
Osteolysis 69.40 12.08 53 117731 5470 110466045
Discomfort 69.06 12.08 76 117708 214631 110256884
Therapy non-responder 68.90 12.08 41 117743 157266 110314249
Trigger finger 68.73 12.08 51 117733 5041 110466474
Breast cancer stage III 68.10 12.08 4 117780 79113 110392402
Carbohydrate antigen 125 increased 67.68 12.08 39 117745 2508 110469007
Mean cell volume increased 65.49 12.08 61 117723 8269 110463246
Stomatitis 64.70 12.08 501 117283 269741 110201774
Injection site reaction 64.70 12.08 9 117775 89061 110382454
Metastases to chest wall 64.41 12.08 25 117759 651 110470864
Musculoskeletal chest pain 63.62 12.08 112 117672 28735 110442780
Grip strength decreased 63.48 12.08 6 117778 80168 110391347
Myalgia 63.44 12.08 430 117354 221951 110249564
Gait inability 63.40 12.08 33 117751 136343 110335172
Dysgeusia 63.32 12.08 191 117593 69794 110401721
Lip dry 62.22 12.08 15 117769 100068 110371447
Skin toxicity 61.17 12.08 69 117715 11714 110459801
Multiple organ dysfunction syndrome 60.40 12.08 44 117740 151666 110319849
Mucosal inflammation 60.22 12.08 232 117552 95909 110375606
Metastases to meninges 59.63 12.08 47 117737 5081 110466434
Hepatic enzyme increased 58.97 12.08 162 117622 320730 110150785
Congestive cardiomyopathy 58.56 12.08 74 117710 14145 110457370
Pneumonia 58.25 12.08 625 117159 876089 109595426
Metastases to ovary 57.41 12.08 20 117764 380 110471135
Injection site erythema 56.83 12.08 15 117769 94161 110377354
Cytokine release syndrome 56.37 12.08 5 117779 70301 110401214
Road traffic accident 56.15 12.08 22 117762 107376 110364139
Gastrointestinal haemorrhage 56.13 12.08 56 117728 165462 110306053
Therapeutic product effect incomplete 56.06 12.08 95 117689 223710 110247805
Menopausal symptoms 55.25 12.08 34 117750 2467 110469048
Septic shock 54.92 12.08 52 117732 157476 110314039
Medication error 54.41 12.08 22 117762 105344 110366171
Device related thrombosis 54.34 12.08 38 117746 3424 110468091
Glomerular filtration rate decreased 53.28 12.08 104 117680 28852 110442663
Onychoclasis 53.09 12.08 51 117733 7186 110464329
Invasive lobular breast carcinoma 52.73 12.08 23 117761 811 110470704
Oestradiol decreased 52.45 12.08 13 117771 67 110471448
Pulmonary mass 52.41 12.08 120 117664 37181 110434334
Platelet count decreased 52.28 12.08 422 117362 230021 110241494
Wound infection 51.70 12.08 19 117765 96446 110375069
Gastrointestinal disorder 51.63 12.08 113 117671 241839 110229676
Adverse event 51.07 12.08 26 117758 108783 110362732
Cough 50.83 12.08 731 117053 460910 110010605
Hormone receptor positive HER2 negative breast cancer 50.06 12.08 16 117768 230 110471285
Hospitalisation 49.72 12.08 47 117737 142446 110329069
White blood cell count abnormal 49.38 12.08 48 117736 6861 110464654
Product quality issue 49.21 12.08 11 117773 77288 110394227
Respiratory failure 48.95 12.08 97 117687 215235 110256280
Impaired healing 48.81 12.08 84 117700 196633 110274882
Infection 48.80 12.08 209 117575 361991 110109524
Musculoskeletal stiffness 48.66 12.08 145 117639 279677 110191838
Hydrothorax 48.40 12.08 27 117757 1631 110469884
Seizure 48.27 12.08 102 117682 221083 110250432
Serotonin syndrome 47.99 12.08 4 117780 59149 110412366
Body surface area increased 47.81 12.08 14 117770 147 110471368
Peripheral venous disease 47.81 12.08 15 117769 84102 110387413
Carbohydrate antigen 27.29 increased 47.65 12.08 13 117771 103 110471412
Intentional product misuse 47.36 12.08 43 117741 132861 110338654
Blood bilirubin increased 47.30 12.08 183 117601 75789 110395726
Product use in unapproved indication 47.26 12.08 281 117503 447096 110024419
Cutaneous lupus erythematosus 47.22 12.08 35 117749 3453 110468062
Peripheral swelling 46.90 12.08 246 117538 403788 110067727
Encephalopathy 46.88 12.08 14 117770 81041 110390474
Obesity 46.27 12.08 32 117752 113319 110358196
Isosthenuria 45.99 12.08 13 117771 119 110471396
Erysipelas 45.72 12.08 63 117721 13095 110458420
Injection site swelling 45.46 12.08 6 117778 61784 110409731
Breast cancer female 45.29 12.08 61 117723 12407 110459108
Lacrimation increased 45.08 12.08 101 117683 30849 110440666
Hepatorenal failure 44.83 12.08 24 117760 1336 110470179
Oxygen saturation decreased 44.74 12.08 61 117723 156921 110314594
Recall phenomenon 44.24 12.08 24 117760 1372 110470143
Body surface area decreased 44.17 12.08 11 117773 58 110471457
Prescribed underdose 44.15 12.08 8 117776 65166 110406349
Loss of personal independence in daily activities 44.07 12.08 57 117727 149963 110321552
Gastroenteritis radiation 43.78 12.08 20 117764 788 110470727
Lower limb fracture 43.61 12.08 13 117771 75335 110396180
Pneumonia aspiration 43.54 12.08 16 117768 81217 110390298
Cytomegalovirus infection 43.30 12.08 4 117780 54440 110417075
Injection site pruritus 42.90 12.08 3 117781 51255 110420260
Electrocardiogram PR shortened 42.84 12.08 16 117768 374 110471141
Metastases to stomach 42.39 12.08 15 117769 299 110471216
Metabolic acidosis 42.28 12.08 27 117757 99717 110371798
Anisocytosis 41.95 12.08 22 117762 1174 110470341
Drug dependence 41.65 12.08 3 117781 50017 110421498
Depressed level of consciousness 41.61 12.08 35 117749 112243 110359272
Blood creatinine increased 41.52 12.08 335 117449 182554 110288961
Loss of consciousness 40.80 12.08 93 117691 196213 110275302
Bone marrow failure 40.74 12.08 145 117639 57703 110413812
Cardio-respiratory arrest 40.65 12.08 38 117746 115798 110355717
Exposed bone in jaw 40.22 12.08 33 117751 3778 110467737
Foot deformity 40.11 12.08 3 117781 48477 110423038
Chest wall tumour 39.95 12.08 10 117774 54 110471461
Thoracic vertebral fracture 39.82 12.08 42 117742 6613 110464902
Decreased immune responsiveness 39.57 12.08 50 117734 9556 110461959
Inappropriate schedule of product administration 39.52 12.08 100 117684 203537 110267978
Elliptocytosis 39.48 12.08 11 117773 95 110471420
Drug reaction with eosinophilia and systemic symptoms 39.45 12.08 19 117765 82076 110389439
Hypoxia 39.31 12.08 48 117736 129467 110342048
Multiple sclerosis relapse 39.15 12.08 4 117780 50236 110421279
Orthostatic hypotension 39.13 12.08 11 117773 66238 110405277
Osteitis 38.77 12.08 34 117750 4262 110467253
Pleural disorder 38.64 12.08 20 117764 1039 110470476
Postmenopausal haemorrhage 38.02 12.08 24 117760 1822 110469693
Wrong technique in product usage process 37.91 12.08 23 117761 87325 110384190
Pyelitis 37.86 12.08 15 117769 413 110471102
Respiratory arrest 37.71 12.08 8 117776 58291 110413224
Pregnancy 37.47 12.08 5 117779 51062 110420453
Mastectomy 37.15 12.08 22 117762 1489 110470026
Myelosuppression 36.83 12.08 198 117586 94142 110377373
Gingivitis 36.70 12.08 50 117734 10281 110461234
Adverse drug reaction 36.61 12.08 35 117749 105524 110365991
Metastases to bone marrow 36.56 12.08 19 117765 995 110470520
Blood pressure fluctuation 36.44 12.08 17 117767 74807 110396708
Ovarian disorder 36.42 12.08 16 117768 574 110470941
Mean cell haemoglobin increased 36.40 12.08 37 117747 5580 110465935
Oophorectomy bilateral 36.35 12.08 10 117774 82 110471433
Anaphylactic reaction 36.14 12.08 41 117743 114259 110357256
Nail dystrophy 35.86 12.08 20 117764 1208 110470307
Depressed mood 35.85 12.08 144 117640 60665 110410850
Progressive bulbar palsy 35.73 12.08 10 117774 88 110471427
Urinary tract infection 35.61 12.08 516 117268 325766 110145749
Radiation skin injury 35.58 12.08 22 117762 1610 110469905
Injection site bruising 35.36 12.08 6 117778 51257 110420258
Abdominal discomfort 35.22 12.08 260 117524 393598 110077917
Unresponsive to stimuli 35.15 12.08 12 117772 63778 110407737
Hair texture abnormal 35.10 12.08 31 117753 3923 110467592
Osteoma cutis 35.08 12.08 6 117778 0 110471515
Haemoglobin decreased 34.96 12.08 412 117372 248315 110223200
Autoimmune disorder 34.92 12.08 13 117771 65470 110406045
Red blood cell sedimentation rate increased 34.86 12.08 20 117764 78282 110393233
Weight increased 34.73 12.08 283 117501 419361 110052154
Unevaluable event 34.67 12.08 10 117774 59217 110412298
Coma 34.40 12.08 45 117739 117824 110353691
No adverse event 34.12 12.08 18 117766 73821 110397694
Gingival recession 34.11 12.08 21 117763 1525 110469990
Sequestrectomy 34.03 12.08 17 117767 819 110470696
Metastases to eye 33.99 12.08 13 117771 325 110471190
Back injury 33.93 12.08 5 117779 47394 110424121
Cytopenia 33.92 12.08 89 117695 30027 110441488
Metastases to bladder 33.80 12.08 13 117771 330 110471185
Lung disorder 33.73 12.08 90 117694 179957 110291558
Basophil count increased 33.49 12.08 22 117762 1788 110469727
Product dose omission in error 33.43 12.08 76 117708 23436 110448079
Hepatic echinococciasis 33.37 12.08 9 117775 68 110471447
Breast disorder 33.09 12.08 24 117760 2290 110469225
Bone sequestrum 33.08 12.08 19 117765 1214 110470301
Cardiogenic shock 32.99 12.08 10 117774 57328 110414187
Adjustment disorder with depressed mood 32.91 12.08 4 117780 43879 110427636
Aggression 32.87 12.08 11 117773 59199 110412316
Knee arthroplasty 32.82 12.08 14 117770 64934 110406581
BRCA1 gene mutation 32.81 12.08 9 117775 73 110471442
Hallucination 32.49 12.08 36 117748 101396 110370119
Lupus-like syndrome 32.43 12.08 3 117781 40789 110430726
Oedema 32.20 12.08 115 117669 209861 110261654
Sedation 32.18 12.08 17 117767 69666 110401849
Monocyte count decreased 31.83 12.08 29 117755 3822 110467693
Resorption bone increased 31.73 12.08 20 117764 1514 110470001
Mental status changes 31.72 12.08 21 117763 76101 110395414
Hepatic steatosis 31.53 12.08 119 117665 48712 110422803
Ovarian enlargement 31.49 12.08 13 117771 399 110471116
Drug intolerance 31.46 12.08 279 117505 406233 110065282
Neuromuscular toxicity 31.22 12.08 13 117771 408 110471107
Calcification metastatic 31.20 12.08 10 117774 145 110471370
Bone debridement 31.19 12.08 13 117771 409 110471106
Hyperkalaemia 31.00 12.08 61 117723 135735 110335780
Coronary artery disease 30.94 12.08 19 117765 71671 110399844
Subclavian vein thrombosis 30.89 12.08 25 117759 2807 110468708
Hypertransaminasaemia 30.78 12.08 75 117709 24180 110447335
Bone trimming 30.76 12.08 7 117777 23 110471492
Tumour marker decreased 30.70 12.08 8 117776 52 110471463
Generalised tonic-clonic seizure 30.63 12.08 10 117774 54670 110416845
Obstructive airways disorder 30.54 12.08 6 117778 46143 110425372
Polyneuropathy 30.50 12.08 89 117695 31923 110439592
Myocardial infarction 30.26 12.08 104 117680 191979 110279536
Breast oedema 30.07 12.08 8 117776 57 110471458
Dental care 29.81 12.08 17 117767 1072 110470443
Migraine 29.79 12.08 89 117695 171563 110299952
Hydronephrosis 29.60 12.08 67 117717 20598 110450917
Macrocytosis 29.50 12.08 26 117758 3281 110468234
Hypertension 29.39 12.08 375 117409 509709 109961806
Hypermetabolism 29.35 12.08 14 117770 609 110470906
Drug ineffective for unapproved indication 29.26 12.08 40 117744 102798 110368717
Heart rate decreased 29.21 12.08 27 117757 82729 110388786
Intentional self-injury 29.11 12.08 3 117781 37426 110434089
Liver injury 29.08 12.08 74 117710 150339 110321176
Product use issue 28.71 12.08 204 117580 311491 110160024
Aphthous ulcer 28.60 12.08 67 117717 21069 110450446
Ovarian cancer recurrent 28.45 12.08 14 117770 653 110470862
Angioedema 28.34 12.08 38 117746 98462 110373053
Agitation 28.28 12.08 48 117736 113003 110358512
Myeloproliferative neoplasm 28.27 12.08 18 117766 1387 110470128
Tumour marker abnormal 28.21 12.08 11 117773 290 110471225
Radiation injury 28.01 12.08 16 117768 1012 110470503
Femoral neck fracture 27.98 12.08 49 117735 12518 110458997
Skin lesion 27.87 12.08 119 117665 51512 110420003
Eastern Cooperative Oncology Group performance status worsened 27.81 12.08 24 117760 2945 110468570
Neoplasm malignant 27.80 12.08 95 117689 37048 110434467
Cholestasis 27.66 12.08 139 117645 64379 110407136
Acute cutaneous lupus erythematosus 27.65 12.08 12 117772 418 110471097
Red cell distribution width increased 27.40 12.08 59 117725 17543 110453972
Vulvovaginal dryness 27.35 12.08 23 117761 2724 110468791
Ovarian rupture 27.34 12.08 7 117777 42 110471473
X-ray abnormal 27.33 12.08 4 117780 38113 110433402
Sciatica 27.24 12.08 35 117749 92364 110379151
Vertigo 27.20 12.08 172 117612 86698 110384817
Contusion 27.10 12.08 142 117642 233219 110238296
Dental fistula 26.93 12.08 13 117771 581 110470934
Vulvovaginal inflammation 26.91 12.08 14 117770 735 110470780
Concomitant disease aggravated 26.80 12.08 56 117728 16308 110455207
Plasma cell myeloma 26.72 12.08 17 117767 62919 110408596
Hip arthroplasty 26.69 12.08 13 117771 55800 110415715
Bladder hypertrophy 26.68 12.08 16 117768 1108 110470407
Vaccination site reaction 26.64 12.08 10 117774 237 110471278
Humerus fracture 26.61 12.08 44 117740 10732 110460783
Portal hypertension 26.54 12.08 39 117745 8598 110462917
Incorrect route of product administration 26.26 12.08 18 117766 64043 110407472
Neoplasm recurrence 26.08 12.08 30 117754 5202 110466313
Amaurosis fugax 25.86 12.08 21 117763 2369 110469146
Staphylococcal infection 25.67 12.08 22 117762 69922 110401593
Oestrogen receptor assay positive 25.54 12.08 11 117773 376 110471139
Haematochezia 25.42 12.08 53 117731 115471 110356044
Aortic thrombosis 25.37 12.08 20 117764 2163 110469352
Bradycardia 25.32 12.08 83 117701 155434 110316081
Hepatic failure 25.30 12.08 142 117642 68597 110402918
Sleep apnoea syndrome 25.26 12.08 6 117778 40441 110431074
Poikilocytosis 25.14 12.08 11 117773 391 110471124
Adrenal insufficiency 25.11 12.08 7 117777 42383 110429132
C-reactive protein increased 25.08 12.08 133 117651 217786 110253729
Lymphadenopathy mediastinal 24.93 12.08 30 117754 5454 110466061
Cytogenetic analysis abnormal 24.89 12.08 16 117768 1253 110470262
Joint neoplasm 24.87 12.08 7 117777 63 110471452
Mucinous breast carcinoma 24.70 12.08 6 117778 28 110471487
Anaphylactic shock 24.66 12.08 12 117772 51534 110419981
Haematocrit decreased 24.61 12.08 137 117647 65980 110405535
Metastases to soft tissue 24.58 12.08 13 117771 706 110470809
Jaw disorder 24.50 12.08 29 117755 5183 110466332
Nail toxicity 24.43 12.08 11 117773 419 110471096
Lymphopenia 24.38 12.08 96 117688 40074 110431441
Osteopenia 24.37 12.08 65 117719 22144 110449371
Hepatic mass 24.30 12.08 22 117762 2876 110468639
CYP3A4 polymorphism 24.21 12.08 7 117777 70 110471445
Lymphangitis 24.08 12.08 17 117767 1555 110469960
Selenium deficiency 24.03 12.08 7 117777 72 110471443
Ear infection 23.93 12.08 19 117765 62713 110408802
Vitreous detachment 23.87 12.08 21 117763 2644 110468871
Hepatocellular injury 23.79 12.08 112 117672 50530 110420985
Metastases to adrenals 23.78 12.08 17 117767 1586 110469929
Pericardial effusion 23.64 12.08 122 117662 57095 110414420
Arthritis 23.61 12.08 95 117689 167491 110304024
Age-related macular degeneration 23.49 12.08 14 117770 959 110470556
Osteomyelitis 23.47 12.08 89 117695 36511 110435004
Ovarian fibrosis 23.38 12.08 4 117780 0 110471515
Hypocalcaemia 23.38 12.08 134 117650 65232 110406283
Keloid scar 23.34 12.08 9 117775 230 110471285
Purulent discharge 23.25 12.08 33 117751 7050 110464465
Muscle spasticity 23.08 12.08 5 117779 35910 110435605
Exostosis 23.07 12.08 10 117774 45946 110425569
Drug level increased 23.00 12.08 11 117773 47708 110423807
Radiation fibrosis - lung 22.98 12.08 7 117777 85 110471430
Product substitution issue 22.83 12.08 65 117719 22996 110448519
Macular hole 22.74 12.08 14 117770 1017 110470498
Muscular weakness 22.69 12.08 163 117621 248305 110223210
Dilatation intrahepatic duct acquired 22.64 12.08 13 117771 830 110470685
Nail avulsion 22.58 12.08 8 117776 160 110471355
Multiple pregnancy 22.52 12.08 6 117778 43 110471472
Injection site haemorrhage 22.48 12.08 4 117780 33024 110438491
Tongue discomfort 22.42 12.08 21 117763 2867 110468648
Nephrosclerosis 22.38 12.08 18 117766 2003 110469512
Metastases to muscle 22.35 12.08 10 117774 375 110471140
Hypercholesterolaemia 22.33 12.08 39 117745 90798 110380717
Bone marrow infiltration 22.29 12.08 13 117771 855 110470660
Cardiotoxicity 22.28 12.08 53 117731 16828 110454687
Sleep disorder due to a general medical condition 22.23 12.08 14 117770 52098 110419417
Oophorectomy 22.15 12.08 10 117774 383 110471132
Nasopharyngitis 21.93 12.08 292 117492 394069 110077446
Cyclic neutropenia 21.84 12.08 5 117779 17 110471498
Biopsy bone abnormal 21.84 12.08 5 117779 17 110471498
Soft tissue neoplasm 21.75 12.08 7 117777 103 110471412
Retinal vein occlusion 21.72 12.08 24 117760 3983 110467532
Acute respiratory failure 21.68 12.08 29 117755 75231 110396284
Therapy cessation 21.65 12.08 100 117684 44757 110426758
Retracted nipple 21.62 12.08 5 117779 18 110471497
BRCA2 gene mutation 21.38 12.08 7 117777 109 110471406
Psychotic disorder 21.29 12.08 14 117770 50923 110420592
Tooth loss 21.27 12.08 34 117750 8062 110463453
Malignant peritoneal neoplasm 21.27 12.08 12 117772 741 110470774
Colitis ulcerative 21.10 12.08 31 117753 77332 110394183
Frequent bowel movements 21.09 12.08 27 117757 71363 110400152
Toothache 21.00 12.08 64 117720 23511 110448004
Vision blurred 20.98 12.08 220 117564 128802 110342713
Mouth swelling 20.87 12.08 32 117752 7322 110464193
Shock 20.73 12.08 16 117768 53572 110417943
Mastitis 20.63 12.08 19 117765 2539 110468976
Subacute cutaneous lupus erythematosus 20.58 12.08 26 117758 4968 110466547
Ventricular tachycardia 20.56 12.08 14 117770 49995 110421520
Blood pressure decreased 20.45 12.08 59 117725 115032 110356483
Meningeal disorder 20.41 12.08 10 117774 462 110471053
Gingival erythema 20.40 12.08 13 117771 1003 110470512
Myoclonus 20.40 12.08 5 117779 32993 110438522
Hypoglycaemia 20.28 12.08 60 117724 116044 110355471
Nightmare 20.25 12.08 8 117776 38855 110432660
Glossopharyngeal nerve paralysis 20.15 12.08 6 117778 67 110471448
Ruptured ectopic pregnancy 20.15 12.08 10 117774 475 110471040
Vulvovaginal candidiasis 20.14 12.08 21 117763 3264 110468251
Dyspnoea exertional 20.13 12.08 184 117600 103876 110367639
Haemoconcentration 20.10 12.08 8 117776 223 110471292
Neutrophil count abnormal 20.02 12.08 26 117758 5106 110466409
Dysarthria 19.88 12.08 37 117747 84084 110387431
Blood pressure increased 19.68 12.08 178 117606 258195 110213320
Peritoneal fluid analysis abnormal 19.61 12.08 6 117778 74 110471441
Oral disorder 19.57 12.08 41 117743 11962 110459553
Metastases to abdominal cavity 19.56 12.08 12 117772 866 110470649
Pleural thickening 19.54 12.08 21 117763 3378 110468137
Neoplasm 19.41 12.08 39 117745 11048 110460467
Breast injury 19.39 12.08 6 117778 77 110471438
Adjusted calcium increased 19.39 12.08 6 117778 77 110471438
Child-Pugh-Turcotte score abnormal 19.34 12.08 4 117780 7 110471508
Transaminases 19.32 12.08 6 117778 78 110471437
Dental discomfort 19.31 12.08 10 117774 520 110470995
Adjusted calcium decreased 19.28 12.08 8 117776 249 110471266
Alanine aminotransferase decreased 19.20 12.08 16 117768 1872 110469643
Ventricular fibrillation 19.19 12.08 10 117774 41303 110430212
Superinfection 19.14 12.08 27 117757 5736 110465779
Rouleaux formation 19.12 12.08 5 117779 33 110471482
Osteoarthritis 19.10 12.08 115 117669 182508 110289007
Nail growth abnormal 19.05 12.08 10 117774 535 110470980
HER2 positive breast cancer 19.03 12.08 9 117775 384 110471131
Motor neurone disease 19.01 12.08 11 117773 713 110470802
Blood calcium increased 18.99 12.08 52 117732 17988 110453527
Urinary tract inflammation 18.92 12.08 9 117775 389 110471126
Neuroendocrine breast tumour 18.87 12.08 5 117779 35 110471480
Spinal cord compression 18.87 12.08 31 117753 7521 110463994
Poisoning 18.81 12.08 4 117780 29101 110442414
Sleep disorder 18.78 12.08 129 117655 198515 110273000
Epiphysiolysis 18.77 12.08 7 117777 163 110471352
Heart rate increased 18.74 12.08 84 117700 143750 110327765
Electrocardiogram QT interval 18.48 12.08 8 117776 277 110471238
Breast cancer stage IV 18.37 12.08 16 117768 1987 110469528
Jaundice 18.36 12.08 117 117667 59119 110412396
Metastases to thorax 18.34 12.08 8 117776 282 110471233
Hypothermia 18.31 12.08 3 117781 26299 110445216
Fall 18.29 12.08 496 117288 602986 109868529
Sopor 18.27 12.08 8 117776 36538 110434977
Rash 18.14 12.08 703 117081 820261 109651254
Plastic surgery 18.06 12.08 6 117778 98 110471417
Dyskinesia 17.90 12.08 17 117767 51429 110420086
Joint dislocation 17.88 12.08 7 117777 34183 110437332
B-cell lymphoma stage III 17.85 12.08 4 117780 12 110471503
Incorrect dose administered 17.79 12.08 54 117730 103587 110367928
Tachycardia 17.76 12.08 155 117629 226490 110245025
Rhabdomyolysis 17.76 12.08 67 117717 120334 110351181
Abscess jaw 17.68 12.08 15 117769 1799 110469716
Swollen tongue 17.66 12.08 23 117761 60339 110411176
Cornea verticillata 17.59 12.08 8 117776 312 110471203
Bone cancer metastatic 17.54 12.08 8 117776 314 110471201
Hydroxyproline increased 17.54 12.08 3 117781 0 110471515
Endometrial metaplasia 17.54 12.08 3 117781 0 110471515
Blood pressure systolic increased 17.49 12.08 39 117745 82952 110388563
Bacterial infection 17.49 12.08 14 117770 46022 110425493
Skin exfoliation 17.47 12.08 156 117628 87495 110384020
Jaw operation 17.45 12.08 11 117773 833 110470682
Vaginal cuff dehiscence 17.38 12.08 4 117780 14 110471501
RET gene mutation 17.38 12.08 4 117780 14 110471501
Mixed anxiety and depressive disorder 17.38 12.08 10 117774 641 110470874
Cellulitis 17.36 12.08 208 117576 125808 110345707
Dermatitis 17.28 12.08 67 117717 27770 110443745
Blood lactate dehydrogenase increased 17.26 12.08 93 117691 44241 110427274
Metastases to abdominal wall 17.26 12.08 7 117777 205 110471310
Toxic epidermal necrolysis 17.23 12.08 21 117763 56706 110414809
Respiratory disorder 17.23 12.08 31 117753 71351 110400164
Post thrombotic syndrome 17.18 12.08 10 117774 655 110470860
Deep vein thrombosis 17.18 12.08 226 117558 139661 110331854
Chronic sinusitis 17.16 12.08 3 117781 25081 110446434
Superior vena cava syndrome 17.14 12.08 13 117771 1328 110470187
Vertebral lesion 17.11 12.08 10 117774 660 110470855
Inflammation 17.05 12.08 128 117656 193110 110278405
Gait deviation 16.98 12.08 6 117778 119 110471396
Gastrointestinal toxicity 16.93 12.08 37 117747 11111 110460404
Granulocyte count decreased 16.87 12.08 21 117763 3953 110467562
Visual impairment 16.85 12.08 218 117566 134210 110337305
Insomnia 16.83 12.08 503 117281 360087 110111428
Suicidal ideation 16.81 12.08 48 117736 93889 110377626
Disorientation 16.78 12.08 31 117753 70640 110400875
Breast conserving surgery 16.72 12.08 11 117773 896 110470619
Chronic obstructive pulmonary disease 16.58 12.08 60 117724 109098 110362417
Non-compaction cardiomyopathy 16.55 12.08 5 117779 59 110471456
Gastrooesophageal reflux disease 16.46 12.08 118 117666 179858 110291657
Triple negative breast cancer 16.46 12.08 9 117775 523 110470992
Dilatation ventricular 16.45 12.08 21 117763 4054 110467461
Retinal phototoxicity 16.41 12.08 4 117780 19 110471496
Post procedural inflammation 16.40 12.08 7 117777 234 110471281
Aspiration 16.38 12.08 6 117778 30527 110440988
Metastases to breast 16.38 12.08 8 117776 367 110471148
Hallucination, auditory 16.32 12.08 4 117780 26393 110445122
Calcium deficiency 16.32 12.08 12 117772 1170 110470345
Trichorrhexis 16.31 12.08 11 117773 934 110470581
Ageusia 16.27 12.08 52 117732 19593 110451922
Dorsal ramus syndrome 16.24 12.08 4 117780 20 110471495
Intestinal metastasis 16.19 12.08 9 117775 540 110470975
General physical condition abnormal 16.13 12.08 29 117755 7561 110463954
Respiratory depression 16.01 12.08 7 117777 31994 110439521
Neck pain 15.98 12.08 72 117712 123058 110348457
Myocarditis 15.97 12.08 6 117778 30049 110441466
Right ventricular failure 15.91 12.08 4 117780 25950 110445565
Underdose 15.88 12.08 27 117757 63527 110407988
Pancreatitis 15.86 12.08 49 117735 93484 110378031
Upper gastrointestinal haemorrhage 15.80 12.08 18 117766 50078 110421437
Bronchopulmonary aspergillosis 15.80 12.08 6 117778 29857 110441658
Androgenetic alopecia 15.66 12.08 7 117777 262 110471253
Dysaesthesia 15.64 12.08 27 117757 6820 110464695
Flushing 15.63 12.08 58 117726 104678 110366837
Aspergillus infection 15.61 12.08 4 117780 25612 110445903
Ovarian cancer metastatic 15.58 12.08 10 117774 781 110470734
Adverse reaction 15.57 12.08 6 117778 29588 110441927
Pulmonary fibrosis 15.56 12.08 56 117728 101986 110369529
Blood test abnormal 15.56 12.08 66 117718 28488 110443027
Withdrawal syndrome 15.48 12.08 7 117777 31373 110440142
Head discomfort 15.47 12.08 50 117734 18950 110452565
Erythroblastosis 15.46 12.08 3 117781 3 110471512
Menopause delayed 15.46 12.08 3 117781 3 110471512
Primary pulmonary melanoma 15.46 12.08 3 117781 3 110471512
Human epidermal growth factor receptor increased 15.46 12.08 3 117781 3 110471512
Hypersensitivity vasculitis 15.38 12.08 27 117757 6910 110464605
Dry eye 15.37 12.08 107 117677 55686 110415829
Periodontitis 15.26 12.08 23 117761 5185 110466330
Ovarian cancer 15.20 12.08 21 117763 4375 110467140
Peritoneal disorder 15.19 12.08 10 117774 816 110470699
Antisynthetase syndrome 15.18 12.08 7 117777 282 110471233
Acute promyelocytic leukaemia 15.13 12.08 14 117770 1882 110469633
Respiratory rate increased 15.12 12.08 4 117780 25079 110446436
Metastases to uterus 15.03 12.08 5 117779 82 110471433
Herpes simplex encephalitis 14.98 12.08 10 117774 835 110470680
Myofascial pain syndrome 14.97 12.08 16 117768 2557 110468958
Metastases to nervous system 14.80 12.08 7 117777 299 110471216
Metastases to gastrointestinal tract 14.73 12.08 6 117778 178 110471337
Skin weeping 14.69 12.08 19 117765 3716 110467799
Blood phosphorus decreased 14.68 12.08 28 117756 7637 110463878
Poor venous access 14.61 12.08 4 117780 24518 110446997
Pain in jaw 14.60 12.08 99 117685 51078 110420437
Tumour ulceration 14.54 12.08 7 117777 311 110471204
Disability 14.51 12.08 7 117777 30216 110441299
Maternal exposure before pregnancy 14.48 12.08 27 117757 7238 110464277
Bile duct stenosis 14.46 12.08 16 117768 2660 110468855
Hepatic cyst 14.37 12.08 28 117756 7755 110463760
Gene mutation 14.36 12.08 18 117766 3411 110468104
Congenital haematological disorder 14.31 12.08 4 117780 35 110471480
Onychomycosis 14.29 12.08 12 117772 38519 110432996
Fractured sacrum 14.28 12.08 14 117770 2022 110469493
Progesterone abnormal 14.25 12.08 3 117781 6 110471509
Antinuclear antibody increased 14.15 12.08 11 117773 1165 110470350
Haemophagocytic lymphohistiocytosis 14.13 12.08 8 117776 31551 110439964
Schizophrenia 14.11 12.08 3 117781 21823 110449692
Blood creatine phosphokinase increased 14.08 12.08 36 117748 73041 110398474
Musculoskeletal discomfort 14.08 12.08 56 117728 23482 110448033
Pseudomonas infection 14.08 12.08 6 117778 27847 110443668
Carbohydrate antigen 15-3 14.07 12.08 5 117779 101 110471414
Macular scar 14.07 12.08 5 117779 101 110471414
Pancreatic toxicity 14.02 12.08 5 117779 102 110471413
Respiratory distress 14.00 12.08 33 117751 68841 110402674
Oral mucosal blistering 14.00 12.08 28 117756 7906 110463609
Blood pressure diastolic abnormal 13.97 12.08 5 117779 25810 110445705
Dystonia 13.97 12.08 5 117779 25800 110445715
Cystoid macular oedema 13.86 12.08 16 117768 2784 110468731
Tremor 13.84 12.08 143 117641 202089 110269426
Peri-implantitis 13.82 12.08 6 117778 209 110471306
Congestive hepatopathy 13.82 12.08 22 117762 5198 110466317
Chest pain 13.67 12.08 301 117483 376074 110095441
Tooth resorption 13.66 12.08 4 117780 42 110471473
Abdominal lymphadenopathy 13.63 12.08 13 117771 1815 110469700
Pancreatic neoplasm 13.62 12.08 13 117771 1816 110469699
Laboratory test abnormal 13.62 12.08 87 117697 43992 110427523
Injection site rash 13.62 12.08 4 117780 23415 110448100
Uterine enlargement 13.60 12.08 10 117774 975 110470540
Change of bowel habit 13.55 12.08 16 117768 2853 110468662
Lumbar vertebral fracture 13.52 12.08 30 117754 9101 110462414
Vasculitis 13.51 12.08 11 117773 35862 110435653
Anaemia of malignant disease 13.50 12.08 10 117774 986 110470529
Cor pulmonale acute 13.49 12.08 9 117775 751 110470764
Cerebral venous thrombosis 13.47 12.08 17 117767 3245 110468270
Chest wall mass 13.46 12.08 6 117778 223 110471292
Osteoporotic fracture 13.46 12.08 22 117762 5315 110466200
Idiopathic orbital inflammation 13.45 12.08 7 117777 368 110471147
Mucosal hypertrophy 13.42 12.08 5 117779 116 110471399
Intraductal proliferative breast lesion 13.39 12.08 16 117768 2889 110468626
Gingival bleeding 13.35 12.08 49 117735 19790 110451725
Paralysis recurrent laryngeal nerve 13.34 12.08 6 117778 228 110471287
Walking aid user 13.33 12.08 5 117779 25070 110446445
Subclavian artery thrombosis 13.33 12.08 4 117780 46 110471469
Hypervolaemia 13.31 12.08 20 117764 49440 110422075
Debridement 13.30 12.08 13 117771 1870 110469645
Procedural pain 13.28 12.08 11 117773 35554 110435961
Posterior reversible encephalopathy syndrome 13.24 12.08 10 117774 33851 110437664
Feeling hot 13.24 12.08 51 117733 91055 110380460
Emotional distress 13.21 12.08 17 117767 44830 110426685
Acute kidney injury 13.18 12.08 548 117236 634882 109836633
Faeces pale 13.08 12.08 17 117767 3340 110468175
Haematuria 13.03 12.08 45 117739 82960 110388555
Circulatory collapse 12.97 12.08 16 117768 42977 110428538
Tooth disorder 12.95 12.08 64 117720 29445 110442070
SAPHO syndrome 12.92 12.08 8 117776 587 110470928
Paraneoplastic syndrome 12.88 12.08 11 117773 1331 110470184
Spinal fracture 12.87 12.08 53 117731 22580 110448935
Hepatomegaly 12.85 12.08 51 117733 21363 110450152
Orthopnoea 12.85 12.08 33 117751 10988 110460527
Metastases to spinal cord 12.84 12.08 6 117778 249 110471266
Lactic acidosis 12.82 12.08 53 117731 92758 110378757
Recurrent cancer 12.82 12.08 17 117767 3406 110468109
Subdural haematoma 12.74 12.08 12 117772 36442 110435073
Uterine disorder 12.72 12.08 14 117770 2312 110469203
Polychromic red blood cells present 12.72 12.08 3 117781 12 110471503
Red blood cell poikilocytes present 12.72 12.08 3 117781 12 110471503
Carcinoma in situ 12.71 12.08 5 117779 135 110471380
Ocular icterus 12.70 12.08 23 117761 6030 110465485
Paranoia 12.69 12.08 4 117780 22370 110449145
Fibrous histiocytoma 12.68 12.08 9 117775 830 110470685
Adenocarcinoma 12.68 12.08 19 117765 4261 110467254
Lung opacity 12.68 12.08 34 117750 11618 110459897
Subchondral insufficiency fracture 12.68 12.08 4 117780 55 110471460
Cataract 12.67 12.08 135 117649 79350 110392165
Carcinoid tumour pulmonary 12.64 12.08 7 117777 417 110471098
Breast ulceration 12.60 12.08 6 117778 260 110471255
Stevens-Johnson syndrome 12.59 12.08 19 117765 46882 110424633
Metastases to heart 12.52 12.08 7 117777 425 110471090
Fracture 12.51 12.08 56 117728 24732 110446783
Leukocytosis 12.44 12.08 24 117760 53804 110417711
Blood oestrogen decreased 12.41 12.08 6 117778 269 110471246
Melaena 12.40 12.08 35 117749 68722 110402793
Vomiting 12.34 12.08 1128 116656 909547 109561968
Onychalgia 12.32 12.08 10 117774 1127 110470388
Empty sella syndrome 12.25 12.08 5 117779 149 110471366
Cholangitis sclerosing 12.22 12.08 17 117767 3565 110467950
Onycholysis 12.22 12.08 15 117769 2784 110468731
Vaginal haemorrhage 12.18 12.08 56 117728 25018 110446497
Cardiomyopathy 12.17 12.08 69 117715 33456 110438059
Skin fragility 12.16 12.08 10 117774 1148 110470367
Pancreatitis acute 12.16 12.08 29 117755 60245 110411270
Hyponatraemia 12.15 12.08 161 117623 217492 110254023
Febrile infection 12.13 12.08 19 117765 4429 110467086
Ophthalmic migraine 12.13 12.08 8 117776 655 110470860
Bone marrow oedema syndrome 12.12 12.08 4 117780 64 110471451
Jugular vein thrombosis 12.11 12.08 21 117763 5324 110466191

FDA Adverse Event Reporting System (Pediatric)

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
Drug exposure before pregnancy 113.85 112.20 14 6 0 113933

Pharmacologic Action:

SourceCodeDescription
ATC L02BG04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONE ANTAGONISTS AND RELATED AGENTS
Aromatase inhibitors
FDA MoA N0000175080 Aromatase Inhibitors
FDA EPC N0000175563 Aromatase Inhibitor
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D004965 Estrogen Antagonists
MeSH PA D006727 Hormone Antagonists
MeSH PA D047072 Aromatase Inhibitors
MeSH PA D065088 Steroid Synthesis Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50646 bone density conservation agent
CHEBI has role CHEBI:50790 EC 1.14.14.14 (aromatase) inhibitor

Related Drugs by ATC class:

L02BG Aromatase inhibitors 5 drugs
aminoglutethimideanastrozoleexemestaneformestanevorozole

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

DiseaseRelationSNOMED_IDDOID
Induction of ovulation in polycystic ovarian syndrome indication 237055002 DOID:11612
Induction of ovulation in unexplained infertility indication 237145004
Hormone receptor positive malignant neoplasm of breast indication 417181009
Controlled ovarian stimulation indication 732970000
Early Breast Cancer Hormone Receptor Positive and Postmenopausal indication
Malignant tumor of ovary off-label use 363443007 DOID:2394
Hypercholesterolemia contraindication 13644009
Hyperbilirubinemia contraindication 14783006 DOID:2741
Cirrhosis of liver contraindication 19943007 DOID:5082
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Osteoporosis contraindication 64859006 DOID:11476
Liver function tests abnormal contraindication 166603001
Pregnancy, function contraindication 289908002
Osteopenia contraindication 312894000
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Dizziness contraindication 404640003
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.04 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9416136 Aug. 20, 2029 ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9416136 Aug. 20, 2029 AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9416136 Aug. 20, 2029 TREATMENT OF PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 8962630 Dec. 9, 2029 ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 8962630 Dec. 9, 2029 AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 8962630 Dec. 9, 2029 TREATMENT OF PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9868739 Nov. 9, 2031 ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9868739 Nov. 9, 2031 AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 9868739 Nov. 9, 2031 TREATMENT OF PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 12544380 Aug. 7, 2034 ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL 12544380 Aug. 7, 2034 AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL Sept. 17, 2027 FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2(HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
2.5MG;EQ 200MG BASE KISQALI FEMARA CO-PACK (COPACKAGED) NOVARTIS N209935 May 4, 2017 RX TABLET ORAL March 17, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Aromatase Enzyme INHIBITOR IC50 8.22 WOMBAT-PK CHEMBL
Cytochrome P450 11B1, mitochondrial Enzyme IC50 5.58 CHEMBL
Cytochrome P450 11B2, mitochondrial Enzyme IC50 5.85 CHEMBL
Aromatase Enzyme IC50 6.54 CHEMBL

External reference:

IDSource
4021049 VUID
N0000148513 NUI
D00964 KEGG_DRUG
4021049 VANDF
C0246421 UMLSCUI
CHEBI:6413 CHEBI
CHEMBL1444 ChEMBL_ID
DB01006 DRUGBANK_ID
D000077289 MESH_DESCRIPTOR_UI
3902 PUBCHEM_CID
5209 IUPHAR_LIGAND_ID
7118 INN_ID
7LKK855W8I UNII
203769 RXNORM
11317 MMSL
173561 MMSL
4963 MMSL
d04156 MMSL
006298 NDDF
108777007 SNOMEDCT_US
386911004 SNOMEDCT_US
7LKK855W8I INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Femara HUMAN PRESCRIPTION DRUG LABEL 1 0078-0249 TABLET, FILM COATED 2.50 mg ORAL NDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7620 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 0093-7620 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 16729-034 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 17856-0032 TABLET, FILM COATED 2.50 mg ORAL ANDA 24 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 23155-875 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 23155-875 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 24535-0801 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 24979-726 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 42254-243 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 42291-374 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 50090-3474 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 50090-8002 TABLET 2.50 mg ORAL ANDA 28 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 50268-476 TABLET 2.50 mg ORAL ANDA 28 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 50268-476 TABLET 2.50 mg ORAL ANDA 28 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 51407-986 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 51991-759 TABLET 2.50 mg ORAL ANDA 29 sections
Femara HUMAN PRESCRIPTION DRUG LABEL 1 54868-4151 TABLET, FILM COATED 2.50 mg ORAL NDA 26 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 54868-6252 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 55111-646 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Letrozole Human Prescription Drug Label 1 59651-180 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 62135-491 TABLET, FILM COATED 2.50 mg ORAL ANDA 24 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 63629-7819 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
Letrozole Human Prescription Drug Label 1 63850-0025 TABLET 2.50 mg ORAL ANDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 68071-2167 TABLET, FILM COATED 2.50 mg ORAL ANDA 24 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 68071-5264 TABLET, FILM COATED 2.50 mg ORAL ANDA 24 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 69117-0004 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 71205-587 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 71335-1526 TABLET 2.50 mg ORAL ANDA 28 sections
Letrozole HUMAN PRESCRIPTION DRUG LABEL 1 71335-2396 TABLET, FILM COATED 2.50 mg ORAL ANDA 26 sections