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

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 3260.34 11.59 2653 115510 172352 63198507
Malignant neoplasm progression 3186.80 11.59 1952 116211 80169 63290690
Metastases to bone 2474.29 11.59 1058 117105 19961 63350898
Neoplasm progression 2422.91 11.59 1235 116928 35193 63335666
Metastases to liver 1663.44 11.59 833 117330 22806 63348053
White blood cell count decreased 1358.43 11.59 1476 116687 137628 63233231
Disease progression 778.14 11.59 1047 117116 121711 63249148
Hot flush 737.80 11.59 672 117491 50487 63320372
Leukopenia 732.17 11.59 808 117355 76482 63294377
Drug ineffective 718.51 11.59 542 117621 1044223 62326636
Breast cancer metastatic 677.05 11.59 365 117798 11653 63359206
Metastases to lung 673.30 11.59 371 117792 12379 63358480
Bone pain 609.08 11.59 623 117540 54018 63316841
Osteonecrosis of jaw 608.05 11.59 512 117651 34611 63336248
Tumour marker increased 579.77 11.59 248 117915 4667 63366192
Metastases to lymph nodes 491.12 11.59 259 117904 7899 63362960
Fatigue 469.94 11.59 3034 115129 884994 62485865
Carbohydrate antigen 15-3 increased 419.77 11.59 141 118022 1307 63369552
Neutrophil count decreased 379.82 11.59 496 117667 55910 63314949
Breast cancer 374.32 11.59 456 117707 47927 63322932
PIK3CA-activated mutation 354.66 11.59 115 118048 944 63369915
Systemic lupus erythematosus 339.22 11.59 11 118152 208907 63161952
Rheumatoid arthritis 329.54 11.59 42 118121 253777 63117082
Therapeutic product effect decreased 325.51 11.59 7 118156 193180 63177679
Breast cancer recurrent 322.93 11.59 159 118004 4182 63366677
Contraindicated product administered 322.55 11.59 21 118142 217627 63153232
Infusion related reaction 317.84 11.59 41 118122 245480 63125379
Second primary malignancy 314.98 11.59 192 117971 7761 63363098
Maternal exposure during pregnancy 284.20 11.59 37 118126 220025 63150834
Drug hypersensitivity 276.80 11.59 116 118047 310571 63060288
Bone lesion 269.52 11.59 156 118007 5725 63365134
Hand deformity 267.73 11.59 6 118157 159451 63211408
Thrombocytopenia 261.79 11.59 744 117419 150413 63220446
Joint swelling 256.03 11.59 146 118017 327520 63043339
Synovitis 254.89 11.59 26 118137 186892 63183967
Metastasis 251.93 11.59 143 118020 5054 63365805
Pleural effusion 250.65 11.59 543 117620 92667 63278192
Arthropathy 239.36 11.59 70 118093 234722 63136137
Metastases to spine 238.69 11.59 118 118045 3131 63367728
Polyneuropathy 234.68 11.59 204 117959 14385 63356474
Alopecia 233.68 11.59 1241 116922 336295 63034564
Treatment failure 226.86 11.59 47 118116 198996 63171863
Completed suicide 225.16 11.59 11 118152 145662 63225197
Hypersensitivity 222.12 11.59 135 118028 292550 63078309
Metastases to pleura 220.60 11.59 90 118073 1495 63369364
Metastases to skin 216.43 11.59 90 118073 1573 63369286
Anaemia 210.67 11.59 1090 117073 292340 63078519
Off label use 209.77 11.59 606 117557 673856 62697003
Osteonecrosis 207.44 11.59 242 117921 24288 63346571
Nausea 198.78 11.59 2442 115721 852029 62518830
Glossodynia 196.22 11.59 46 118117 178830 63192029
Decreased appetite 193.08 11.59 951 117212 250101 63120758
Full blood count abnormal 190.65 11.59 264 117899 31453 63339406
Pericarditis 188.22 11.59 15 118148 131564 63239295
Neuropathy peripheral 187.53 11.59 550 117613 113117 63257742
Metastases to central nervous system 184.55 11.59 170 117993 12935 63357924
Lymphoedema 177.07 11.59 158 118005 11534 63359325
Swelling 172.70 11.59 155 118008 275223 63095636
Wound 171.30 11.59 46 118117 163217 63207642
Toxicity to various agents 170.14 11.59 127 118036 247123 63123736
Ascites 168.43 11.59 285 117878 40443 63330416
Skin hypopigmentation 167.66 11.59 61 118102 730 63370129
Ovarian hyperstimulation syndrome 166.93 11.59 100 118063 3914 63366945
Carcinoembryonic antigen increased 159.80 11.59 74 118089 1691 63369168
Intentional product use issue 156.88 11.59 25 118138 127867 63242992
Psoriatic arthropathy 155.33 11.59 3 118160 91517 63279342
Helicobacter infection 153.75 11.59 4 118159 92781 63278078
Gamma-glutamyltransferase increased 152.63 11.59 247 117916 33784 63337075
Condition aggravated 145.77 11.59 334 117829 401883 62968976
Aspartate aminotransferase increased 141.44 11.59 429 117734 89848 63281011
Sinusitis 139.18 11.59 130 118033 226523 63144336
Haematotoxicity 138.62 11.59 125 118038 9251 63361608
Hepatotoxicity 133.47 11.59 244 117919 36797 63334062
Duodenal ulcer perforation 133.41 11.59 7 118156 87202 63283657
Metastases to peritoneum 128.41 11.59 80 118083 3362 63367497
Dry skin 125.87 11.59 307 117856 56580 63314279
Red blood cell count decreased 125.82 11.59 251 117912 40394 63330465
Electrocardiogram QT prolonged 125.11 11.59 315 117848 59215 63311644
Injection site pain 122.81 11.59 44 118119 129756 63241103
Product use issue 122.33 11.59 138 118025 220382 63150477
Hepatic lesion 121.85 11.59 88 118075 4737 63366122
Discomfort 120.29 11.59 82 118081 167292 63203567
Hypotension 117.89 11.59 204 117959 272400 63098459
Injection site erythema 117.49 11.59 10 118153 83164 63287695
Epistaxis 117.12 11.59 349 117814 72376 63298483
Palmar-plantar erythrodysaesthesia syndrome 117.04 11.59 177 117986 22838 63348021
Irritable bowel syndrome 116.17 11.59 10 118153 82402 63288457
Full blood count decreased 114.13 11.59 187 117976 25837 63345022
Alanine aminotransferase increased 114.04 11.59 438 117725 103332 63267527
Exposure during pregnancy 113.39 11.59 75 118088 155472 63215387
Bone disorder 112.72 11.59 167 117996 21159 63349700
Drug intolerance 111.98 11.59 256 117907 308405 63062454
Diarrhoea 111.73 11.59 1909 116254 713457 62657402
Abdominal discomfort 110.17 11.59 274 117889 320611 63050248
Intentional overdose 107.30 11.59 8 118155 74144 63296715
Overdose 102.26 11.59 43 118120 115035 63255824
Spinal pain 100.19 11.59 123 118040 13016 63357843
Malignant pleural effusion 98.31 11.59 61 118102 2545 63368314
Muscle injury 97.62 11.59 6 118157 65339 63305520
Metastases to chest wall 97.59 11.59 38 118125 555 63370304
Pseudocirrhosis 94.50 11.59 39 118124 668 63370191
Blister 94.06 11.59 63 118100 129751 63241108
Constipation 93.83 11.59 728 117435 224215 63146644
Nail disorder 91.52 11.59 117 118046 12898 63357961
Mucosal dryness 88.05 11.59 58 118105 2686 63368173
Folliculitis 87.91 11.59 13 118150 70304 63300555
Pleural neoplasm 87.63 11.59 31 118132 340 63370519
Fibromyalgia 87.50 11.59 21 118142 80399 63290460
Musculoskeletal stiffness 87.44 11.59 130 118033 184488 63186371
Hepatic enzyme increased 86.88 11.59 152 118011 202176 63168683
Erysipelas 85.93 11.59 89 118074 7816 63363043
Injection site reaction 85.57 11.59 6 118157 58518 63312341
Mucosal inflammation 85.03 11.59 235 117928 46693 63324166
Stomatitis 84.95 11.59 494 117669 138231 63232628
Blood alkaline phosphatase increased 84.73 11.59 222 117941 42745 63328114
Tooth extraction 84.66 11.59 100 118063 10164 63360695
Ejection fraction decreased 82.85 11.59 149 118014 22183 63348676
Drug abuse 82.81 11.59 17 118146 72501 63298358
Onychoclasis 82.38 11.59 78 118085 6144 63364715
Pulmonary embolism 80.42 11.59 429 117734 116255 63254604
Transaminases increased 80.00 11.59 179 117984 31188 63339671
Lymphangiosis carcinomatosa 78.89 11.59 43 118120 1402 63369457
Ill-defined disorder 78.54 11.59 27 118136 81728 63289131
Taste disorder 78.04 11.59 111 118052 13551 63357308
Adverse event 76.80 11.59 16 118147 67543 63303316
Urticaria 75.39 11.59 120 118043 165682 63205177
Cancer pain 75.38 11.59 56 118107 3149 63367710
Lymphadenopathy 75.11 11.59 198 117965 38260 63332599
Pneumonitis 74.64 11.59 187 117976 35035 63335824
Skin toxicity 73.96 11.59 65 118098 4649 63366210
Metastases to pelvis 73.35 11.59 29 118134 442 63370417
Asthenia 72.99 11.59 1059 117104 382545 62988314
Blood creatinine increased 72.57 11.59 340 117823 87504 63283355
Bone marrow failure 72.30 11.59 165 117998 29125 63341734
Psoriasis 71.80 11.59 36 118127 86921 63283938
Multiple sclerosis relapse 70.79 11.59 5 118158 48473 63322386
Cardio-respiratory arrest 70.69 11.59 13 118150 59946 63310913
Knee arthroplasty 70.17 11.59 9 118154 54197 63316662
Suicide attempt 70.14 11.59 14 118149 60904 63309955
Lower respiratory tract infection 69.88 11.59 86 118077 132221 63238638
Injection site swelling 69.20 11.59 5 118158 47567 63323292
Myalgia 68.29 11.59 487 117676 146042 63224817
Breast pain 68.11 11.59 83 118080 8715 63362144
Mobility decreased 68.03 11.59 75 118088 121084 63249775
Invasive ductal breast carcinoma 67.95 11.59 74 118089 6884 63363975
Hepatic cytolysis 67.94 11.59 111 118052 15296 63355563
Infection 67.93 11.59 210 117953 228963 63141896
Trigger finger 67.60 11.59 60 118103 4348 63366511
Seizure 67.16 11.59 89 118074 132545 63238314
Peripheral swelling 66.52 11.59 262 117901 265680 63105179
Progesterone increased 65.82 11.59 16 118147 36 63370823
Adverse drug reaction 65.81 11.59 33 118130 79681 63291178
Pathological fracture 64.63 11.59 81 118082 8753 63362106
Arthralgia 63.86 11.59 1447 116716 568263 62802596
C-reactive protein abnormal 63.86 11.59 6 118157 46090 63324769
Therapeutic product effect incomplete 63.24 11.59 84 118079 124972 63245887
Oxygen saturation decreased 62.81 11.59 44 118119 88541 63282318
Neoplasm malignant 60.63 11.59 156 118007 29705 63341154
Asthma 60.21 11.59 90 118073 127471 63243388
Bone marrow infiltration 59.82 11.59 28 118135 656 63370203
Interstitial lung disease 59.73 11.59 251 117912 61657 63309202
Jaundice 59.58 11.59 153 118010 29098 63341761
Blood bilirubin increased 59.54 11.59 178 117985 36962 63333897
Drug interaction 59.05 11.59 223 117940 228908 63141951
Blood cholesterol increased 58.76 11.59 53 118110 93979 63276880
Wheezing 58.41 11.59 55 118108 95540 63275319
Loss of personal independence in daily activities 57.11 11.59 58 118105 97232 63273627
Hydronephrosis 57.07 11.59 84 118079 10578 63360281
Eastern Cooperative Oncology Group performance status worsened 56.75 11.59 33 118130 1221 63369638
Platelet count decreased 56.47 11.59 390 117773 115732 63255127
Lacrimation increased 56.31 11.59 121 118042 20510 63350349
Metastases to abdominal wall 55.79 11.59 17 118146 111 63370748
Musculoskeletal chest pain 55.66 11.59 122 118041 20961 63349898
Device related thrombosis 55.51 11.59 37 118126 1748 63369111
Injury 55.15 11.59 34 118129 73213 63297646
Type 2 diabetes mellitus 54.93 11.59 25 118138 63843 63307016
Back pain 54.92 11.59 741 117422 263404 63107455
Pyelitis 54.15 11.59 19 118144 203 63370656
Injection site bruising 54.15 11.59 7 118156 41903 63328956
Metastases to adrenals 53.88 11.59 27 118136 738 63370121
General physical health deterioration 53.59 11.59 592 117571 200810 63170049
Unevaluable event 52.88 11.59 15 118148 51371 63319488
Metastases to thorax 52.25 11.59 19 118144 227 63370632
Pain 52.12 11.59 1019 117144 739609 62631250
Osteolysis 51.98 11.59 43 118120 2831 63368028
Dysgeusia 51.96 11.59 198 117965 46512 63324347
Body surface area increased 51.83 11.59 13 118150 35 63370824
Madarosis 51.40 11.59 44 118119 3037 63367822
Cardiac arrest 51.17 11.59 58 118105 92487 63278372
Hip arthroplasty 50.74 11.59 13 118150 47633 63323226
Pregnancy 50.48 11.59 5 118158 36831 63334028
Coma 49.69 11.59 29 118134 64335 63306524
Anaphylactic reaction 49.33 11.59 31 118132 66069 63304790
Concomitant disease aggravated 49.08 11.59 72 118091 9040 63361819
Rash 48.64 11.59 743 117420 560128 62810731
Prescribed overdose 48.52 11.59 4 118159 34149 63336710
Weight increased 48.27 11.59 286 117877 260506 63110353
Hormone receptor positive HER2 negative breast cancer 47.85 11.59 16 118147 146 63370713
Hepatorenal failure 47.43 11.59 24 118139 670 63370189
Medication error 47.30 11.59 19 118144 52265 63318594
Exposed bone in jaw 47.23 11.59 41 118122 2884 63367975
Hormone receptor positive breast cancer 46.75 11.59 22 118141 522 63370337
Confusional state 46.56 11.59 254 117909 236126 63134733
Hydrothorax 46.15 11.59 26 118137 905 63369954
Metastases to stomach 45.88 11.59 17 118146 215 63370644
Metastases to the mediastinum 45.87 11.59 21 118142 467 63370392
Wrong technique in product usage process 45.48 11.59 30 118133 62310 63308549
Neoplasm 45.42 11.59 62 118101 7283 63363576
Metastases to meninges 45.13 11.59 38 118125 2564 63368295
Blood lactate dehydrogenase increased 45.12 11.59 119 118044 22997 63347862
Gastrointestinal disorder 45.00 11.59 112 118051 131127 63239732
Oral pain 44.49 11.59 135 118028 28259 63342600
Invasive lobular breast carcinoma 44.38 11.59 25 118138 870 63369989
Tumour marker abnormal 43.90 11.59 19 118144 368 63370491
Sequestrectomy 43.49 11.59 24 118139 802 63370057
Decreased immune responsiveness 42.51 11.59 49 118114 4852 63366007
Generalised tonic-clonic seizure 42.34 11.59 3 118160 29013 63341846
Bone sequestrum 42.13 11.59 29 118134 1445 63369414
Heart rate increased 42.07 11.59 69 118094 94169 63276690
Thoracic vertebral fracture 41.67 11.59 47 118116 4545 63366314
Bone debridement 41.38 11.59 16 118147 229 63370630
Anisocytosis 40.96 11.59 22 118141 696 63370163
Therapy non-responder 40.42 11.59 49 118114 75852 63295007
Humerus fracture 40.35 11.59 65 118098 8851 63362008
Loss of consciousness 40.35 11.59 101 118062 118020 63252839
Pneumonia 39.58 11.59 605 117558 456162 62914697
Osteomyelitis 39.17 11.59 122 118041 25898 63344961
Vitiligo 38.93 11.59 27 118136 1362 63369497
Depressed level of consciousness 38.77 11.59 35 118128 62043 63308816
Hepatic failure 38.72 11.59 150 118013 35506 63335353
Superior vena cava syndrome 38.71 11.59 21 118142 678 63370181
Encephalopathy 38.41 11.59 12 118151 38608 63332251
Orthostatic hypotension 38.25 11.59 10 118153 36150 63334709
Therapy partial responder 38.12 11.59 70 118093 10588 63360271
Congestive cardiomyopathy 37.95 11.59 52 118111 6130 63364729
Radiation skin injury 37.94 11.59 23 118140 920 63369939
White blood cell count abnormal 37.56 11.59 52 118111 6190 63364669
Myelosuppression 37.42 11.59 113 118050 23590 63347269
Body surface area decreased 37.42 11.59 9 118154 19 63370840
Osteosclerosis 37.36 11.59 41 118122 3847 63367012
Hospitalisation 37.32 11.59 63 118100 85018 63285841
Hypocalcaemia 36.57 11.59 136 118027 31577 63339282
Hypertensive crisis 36.50 11.59 85 118078 15201 63355658
Isosthenuria 36.03 11.59 12 118151 108 63370751
Bursitis 35.97 11.59 12 118151 37029 63333830
Delirium 35.96 11.59 25 118138 50516 63320343
No adverse event 35.93 11.59 16 118147 41389 63329470
Nail dystrophy 35.80 11.59 23 118140 1020 63369839
Electrocardiogram PR shortened 35.77 11.59 15 118148 268 63370591
Blood pressure fluctuation 35.57 11.59 21 118142 46296 63324563
Septic shock 35.49 11.59 43 118120 66586 63304273
Nasopharyngitis 35.25 11.59 303 117860 253954 63116905
Respiratory failure 34.86 11.59 87 118076 101771 63269088
Cardiotoxicity 34.80 11.59 59 118104 8379 63362480
Gastrointestinal haemorrhage 34.79 11.59 61 118102 81115 63289744
Premature delivery 34.77 11.59 7 118156 30274 63340585
Bladder hypertrophy 34.68 11.59 14 118149 226 63370633
Inappropriate schedule of product administration 34.65 11.59 90 118073 103875 63266984
Pleural disorder 34.62 11.59 19 118144 628 63370231
Respiratory arrest 34.58 11.59 9 118154 32636 63338223
Recall phenomenon 34.54 11.59 19 118144 631 63370228
Blood pressure increased 34.22 11.59 170 117993 161892 63208967
Onychomadesis 34.17 11.59 48 118115 5792 63365067
Drug withdrawal syndrome 34.05 11.59 5 118158 27189 63343670
Prescribed underdose 33.80 11.59 7 118156 29682 63341177
Hepatic steatosis 33.70 11.59 124 118039 28645 63342214
Contusion 33.67 11.59 154 118009 149890 63220969
Flushing 33.49 11.59 55 118108 75032 63295827
Elliptocytosis 33.12 11.59 10 118153 63 63370796
Lymphadenopathy mediastinal 33.04 11.59 33 118130 2775 63368084
Breast cancer female 33.04 11.59 76 118087 13483 63357376
Hypermetabolism 33.01 11.59 13 118150 196 63370663
Carbohydrate antigen 125 increased 32.96 11.59 33 118130 2783 63368076
Jaw disorder 32.85 11.59 45 118118 5304 63365555
Intentional product misuse 32.78 11.59 39 118124 60878 63309981
Gene mutation 32.41 11.59 26 118137 1639 63369220
Glomerular filtration rate decreased 32.38 11.59 75 118088 13366 63357493
Arthritis 32.38 11.59 109 118054 115812 63255047
Metastases to bladder 32.25 11.59 13 118150 209 63370650
Vulvovaginal dryness 32.14 11.59 33 118130 2868 63367991
Urinary tract inflammation 32.06 11.59 9 118154 42 63370817
Drug dependence 31.84 11.59 4 118159 24479 63346380
Metastases to ovary 31.77 11.59 16 118147 442 63370417
Toothache 31.71 11.59 93 118070 19106 63351753
Injection site haemorrhage 31.56 11.59 4 118159 24310 63346549
Pulmonary mass 31.33 11.59 103 118060 22493 63348366
Gastroenteritis radiation 31.31 11.59 16 118147 456 63370403
Ear infection 31.27 11.59 16 118147 38197 63332662
Liver injury 31.25 11.59 40 118123 60480 63310379
Poikilocytosis 31.21 11.59 12 118151 169 63370690
Purulent discharge 31.05 11.59 41 118122 4665 63366194
Product quality issue 30.90 11.59 14 118149 35851 63335008
Calcification metastatic 30.83 11.59 12 118151 175 63370684
Foot deformity 30.83 11.59 7 118156 27846 63343013
Hallucination 30.68 11.59 34 118129 54783 63316076
Osteitis 30.55 11.59 34 118129 3240 63367619
Lymphopenia 30.48 11.59 89 118074 18238 63352621
Somnolence 30.43 11.59 201 117962 178484 63192375
Debridement 30.27 11.59 22 118141 1196 63369663
Malignant neoplasm of pleura 30.18 11.59 9 118154 54 63370805
Hepatic echinococciasis 30.04 11.59 9 118154 55 63370804
Carbohydrate antigen 27.29 increased 29.91 11.59 9 118154 56 63370803
Metabolic acidosis 29.86 11.59 24 118139 45045 63325814
Metastases to muscle 29.84 11.59 11 118152 137 63370722
Muscle spasticity 29.76 11.59 3 118160 21791 63349068
Red blood cell sedimentation rate increased 29.67 11.59 23 118140 43959 63326900
Abdominal lymphadenopathy 29.53 11.59 18 118145 727 63370132
Unresponsive to stimuli 29.44 11.59 13 118150 33803 63337056
Dental fistula 29.38 11.59 17 118146 623 63370236
Cardiac failure congestive 29.31 11.59 82 118081 92351 63278508
Osteoma cutis 29.30 11.59 6 118157 3 63370856
Heart rate decreased 29.28 11.59 25 118138 45535 63325324
Sedation 29.23 11.59 18 118145 38791 63332068
Tumour pain 29.17 11.59 23 118140 1414 63369445
Headache 29.02 11.59 928 117235 632313 62738546
Intestinal metastasis 28.93 11.59 11 118152 150 63370709
Metastases to eye 28.74 11.59 11 118152 153 63370706
Ischaemic stroke 28.72 11.59 86 118077 17871 63352988
Tumour marker decreased 28.64 11.59 9 118154 66 63370793
Gingivitis 28.44 11.59 54 118109 8375 63362484
Breast mass 28.29 11.59 52 118111 7870 63362989
Plasma cell myeloma 27.96 11.59 16 118147 35889 63334970
Abortion spontaneous 27.84 11.59 28 118135 47167 63323692
Cachexia 27.65 11.59 43 118120 5683 63365176
Bile duct stenosis 27.44 11.59 21 118142 1235 63369624
Neoplasm recurrence 27.42 11.59 29 118134 2609 63368250
Calcium deficiency 27.41 11.59 20 118143 1094 63369765
Joint range of motion decreased 27.41 11.59 13 118150 32415 63338444
Staphylococcal infection 27.30 11.59 22 118141 41234 63329625
Blood bilirubin abnormal 26.88 11.59 19 118144 988 63369871
Skin weeping 26.83 11.59 17 118146 736 63370123
Concomitant disease progression 26.83 11.59 26 118137 2108 63368751
Hypoglycaemia 26.78 11.59 44 118119 60021 63310838
Bone trimming 26.65 11.59 7 118156 24 63370835
Recurrent cancer 26.48 11.59 25 118138 1962 63368897
Bradycardia 26.27 11.59 61 118102 73166 63297693
Malaise 25.98 11.59 583 117580 415371 62955488
Superinfection 25.93 11.59 28 118135 2579 63368280
Grip strength decreased 25.91 11.59 5 118158 22282 63348577
Incorrect dose administered 25.75 11.59 45 118118 59923 63310936
Sleep apnoea syndrome 25.68 11.59 11 118152 29122 63341737
Gingival swelling 25.39 11.59 36 118127 4382 63366477
Drug reaction with eosinophilia and systemic symptoms 25.06 11.59 16 118147 33820 63337039
Ovarian enlargement 25.04 11.59 14 118149 480 63370379
Peritoneal disorder 24.83 11.59 14 118149 488 63370371
Skin exfoliation 24.75 11.59 151 118012 42951 63327908
Injection site rash 24.64 11.59 3 118160 18806 63352053
Mastectomy 24.59 11.59 22 118141 1611 63369248
Ovarian rupture 24.38 11.59 7 118156 36 63370823
Suicidal ideation 24.04 11.59 50 118113 62371 63308488
Nephrosclerosis 23.86 11.59 18 118145 1036 63369823
Myeloproliferative neoplasm 23.86 11.59 14 118149 527 63370332
Tachyarrhythmia 23.73 11.59 35 118128 4415 63366444
Neutrophil count abnormal 23.56 11.59 28 118135 2864 63367995
Blood pressure decreased 23.46 11.59 54 118109 64968 63305891
Radiation oesophagitis 23.45 11.59 12 118151 343 63370516
Premature baby 23.38 11.59 5 118158 20730 63350129
CYP3A4 polymorphism 23.27 11.59 8 118155 80 63370779
Migraine 23.22 11.59 106 118057 103240 63267619
Metastases to bone marrow 23.17 11.59 13 118150 449 63370410
Hypoxia 22.94 11.59 48 118115 59744 63311115
Cytopenia 22.92 11.59 60 118103 11541 63359318
Resorption bone increased 22.91 11.59 19 118144 1255 63369604
Tremor 22.89 11.59 148 118015 132091 63238768
Mental status changes 22.78 11.59 24 118139 39575 63331284
Drug level increased 22.73 11.59 7 118156 22729 63348130
Malignant peritoneal neoplasm 22.63 11.59 15 118148 702 63370157
Skin lesion 22.55 11.59 115 118048 30606 63340253
Dyskinesia 22.54 11.59 16 118147 31986 63338873
Aphthous ulcer 22.52 11.59 67 118096 13871 63356988
Age-related macular degeneration 22.51 11.59 15 118148 708 63370151
Dermatitis 22.36 11.59 76 118087 16882 63353977
Therapy cessation 22.35 11.59 114 118049 30343 63340516
Periodontitis 22.14 11.59 29 118134 3274 63367585
Gingival erythema 22.12 11.59 15 118148 729 63370130
Breast oedema 22.08 11.59 7 118156 53 63370806
Paraneoplastic syndrome 22.04 11.59 14 118149 609 63370250
Mean cell volume increased 21.99 11.59 30 118133 3521 63367338
Dyschezia 21.71 11.59 24 118139 2270 63368589
Cutaneous lupus erythematosus 21.67 11.59 26 118137 2686 63368173
Multiple pregnancy 21.63 11.59 7 118156 57 63370802
Infusion site pain 21.36 11.59 3 118160 16866 63353993
Granulocyte count decreased 21.28 11.59 18 118145 1222 63369637
Dysarthria 21.26 11.59 29 118134 42682 63328177
Neuroendocrine breast tumour 21.04 11.59 6 118157 30 63370829
Joint neoplasm 21.02 11.59 7 118156 63 63370796
Breast neoplasm 20.99 11.59 19 118144 1413 63369446
RET gene mutation 20.97 11.59 5 118158 10 63370849
Basophil count increased 20.91 11.59 16 118147 941 63369918
Adrenal insufficiency 20.86 11.59 4 118159 17911 63352948
Nail toxicity 20.77 11.59 11 118152 338 63370521
Vitreous detachment 20.57 11.59 22 118141 2005 63368854
Bone erosion 20.54 11.59 4 118159 17713 63353146
Aggression 20.51 11.59 9 118154 23489 63347370
Pericardial effusion 20.33 11.59 110 118053 29948 63340911
Drug ineffective for unapproved indication 20.33 11.59 20 118143 34043 63336816
Vaccination site reaction 20.29 11.59 8 118155 121 63370738
Haemoglobin decreased 20.29 11.59 382 117781 145103 63225756
Withdrawal syndrome 20.27 11.59 6 118157 19991 63350868
Multiple sclerosis 20.25 11.59 10 118153 24362 63346497
Dyspnoea exertional 20.22 11.59 186 117977 60116 63310743
Platelet count abnormal 20.20 11.59 28 118135 3336 63367523
Metastases to neck 20.19 11.59 7 118156 72 63370787
Soft tissue neoplasm 20.19 11.59 7 118156 72 63370787
Liver function test increased 20.15 11.59 117 118046 32694 63338165
Sopor 20.13 11.59 8 118155 22156 63348703
Depressed mood 20.12 11.59 136 118027 40055 63330804
Visual impairment 20.09 11.59 243 117920 84203 63286656
Dental discomfort 19.95 11.59 12 118151 473 63370386
Plastic surgery 19.93 11.59 7 118156 75 63370784
Antisynthetase syndrome 19.93 11.59 7 118156 75 63370784
Tongue discomfort 19.93 11.59 23 118140 2280 63368579
Fall 19.88 11.59 567 117596 391767 62979092
Breast disorder 19.80 11.59 24 118139 2506 63368353
Radiation injury 19.73 11.59 12 118151 483 63370376
Impaired healing 19.72 11.59 111 118052 102431 63268428
Agitation 19.70 11.59 52 118111 59705 63311154
Angioedema 19.69 11.59 37 118126 47928 63322931
Haemoconcentration 19.66 11.59 8 118155 132 63370727
Peripheral sensory neuropathy 19.53 11.59 43 118120 7408 63363451
Radiation pneumonitis 19.36 11.59 19 118144 1564 63369295
Mouth swelling 19.36 11.59 33 118130 4707 63366152
Adjusted calcium increased 19.30 11.59 5 118158 16 63370843
Cytogenetic analysis abnormal 19.27 11.59 15 118148 905 63369954
Renal impairment 19.20 11.59 250 117913 88105 63282754
Transaminases 19.15 11.59 7 118156 85 63370774
Road traffic accident 19.13 11.59 24 118139 36608 63334251
Cough 19.11 11.59 695 117468 292048 63078811
Keloid scar 19.07 11.59 9 118154 215 63370644
Ovarian fibrosis 18.92 11.59 4 118159 3 63370856
BRCA1 gene mutation 18.85 11.59 5 118158 18 63370841
Dilatation ventricular 18.82 11.59 23 118140 2422 63368437
Aortic arteriosclerosis 18.79 11.59 38 118125 6171 63364688
Invasive breast carcinoma 18.74 11.59 13 118150 656 63370203
SAPHO syndrome 18.65 11.59 7 118156 92 63370767
Status epilepticus 18.62 11.59 3 118160 15230 63355629
Clostridium difficile infection 18.52 11.59 17 118146 29905 63340954
Lung opacity 18.48 11.59 26 118137 3142 63367717
Tooth loss 18.47 11.59 40 118123 6816 63364043
Macular hole 18.31 11.59 14 118149 822 63370037
Obstructive airways disorder 17.95 11.59 8 118155 20691 63350168
Meningeal disorder 17.89 11.59 9 118154 248 63370611
Febrile infection 17.77 11.59 18 118145 1539 63369320
Mucinous breast carcinoma 17.70 11.59 5 118158 24 63370835
Metastatic neoplasm 17.67 11.59 30 118133 4265 63366594
Pneumonia aspiration 17.65 11.59 23 118140 34517 63336342
Oral discomfort 17.58 11.59 47 118116 9154 63361705
Carcinoid tumour pulmonary 17.55 11.59 11 118152 467 63370392
Abscess jaw 17.47 11.59 17 118146 1385 63369474
Pancreatic neoplasm 17.47 11.59 13 118150 733 63370126
Selenium deficiency 17.37 11.59 5 118158 26 63370833
Haematochezia 17.34 11.59 47 118116 53497 63317362
Malignant ascites 17.32 11.59 14 118149 892 63369967
Adjusted calcium decreased 17.31 11.59 8 118155 182 63370677
Hypersensitivity vasculitis 17.29 11.59 29 118134 4083 63366776
Rouleaux formation 17.21 11.59 5 118158 27 63370832
Gait deviation 17.19 11.59 6 118157 63 63370796
Ovarian cancer stage IV 17.13 11.59 9 118154 272 63370587
Pain in jaw 17.11 11.59 139 118024 43357 63327502
Spinal cord compression 17.10 11.59 29 118134 4119 63366740
Left ventricular dilatation 17.08 11.59 11 118152 490 63370369
Acute promyelocytic leukaemia 17.04 11.59 14 118149 913 63369946
Onycholysis 17.03 11.59 18 118145 1618 63369241
Nail avulsion 17.03 11.59 8 118155 189 63370670
Swollen tongue 16.95 11.59 24 118139 34776 63336083
Bone fistula 16.94 11.59 6 118157 66 63370793
Congestive hepatopathy 16.94 11.59 24 118139 2918 63367941
Hepatic calcification 16.91 11.59 5 118158 29 63370830
Oestrogen receptor assay positive 16.86 11.59 11 118152 501 63370358
Vertigo 16.80 11.59 178 117985 59709 63311150
Cytomegalovirus infection 16.80 11.59 9 118154 20943 63349916
Skin fissures 16.78 11.59 53 118110 11335 63359524
Dysaesthesia 16.76 11.59 30 118133 4448 63366411
Ophthalmic migraine 16.75 11.59 7 118156 124 63370735
Joint dislocation 16.73 11.59 7 118156 18793 63352066
Mucosal hypertrophy 16.63 11.59 5 118158 31 63370828
Hair texture abnormal 16.62 11.59 29 118134 4214 63366645
Mixed anxiety and depressive disorder 16.52 11.59 9 118154 293 63370566
Biopsy bone abnormal 16.36 11.59 5 118158 33 63370826
Peri-implantitis 16.25 11.59 6 118157 75 63370784
Nail growth abnormal 16.24 11.59 11 118152 534 63370325
Metastases to kidney 16.22 11.59 8 118155 211 63370648
Portal hypertension 16.15 11.59 27 118136 3792 63367067
Vulvovaginal inflammation 16.11 11.59 13 118150 826 63370033
Jaw operation 15.94 11.59 13 118150 839 63370020
Ovarian cancer recurrent 15.91 11.59 14 118149 1003 63369856
Ostectomy 15.89 11.59 4 118159 11 63370848
Vaginal cuff dehiscence 15.89 11.59 4 118159 11 63370848
Hydroxyproline increased 15.87 11.59 3 118160 0 63370859
Triple negative breast cancer 15.83 11.59 7 118156 143 63370716
Poor venous access 15.81 11.59 4 118159 14781 63356078
Feeling hot 15.71 11.59 45 118118 50309 63320550
Myocardial infarction 15.70 11.59 115 118048 99778 63271081
Product dose omission in error 15.69 11.59 40 118123 7572 63363287
Cornea verticillata 15.66 11.59 7 118156 147 63370712
Hormone refractory breast cancer 15.63 11.59 4 118159 12 63370847
Pelvic fluid collection 15.62 11.59 13 118150 863 63369996
Cholestasis 15.58 11.59 101 118062 29333 63341526
Hilar lymphadenopathy 15.57 11.59 15 118148 1207 63369652
Cyanosis 15.57 11.59 6 118157 16929 63353930
Menopausal symptoms 15.56 11.59 21 118142 2440 63368419
Androgenetic alopecia 15.53 11.59 7 118156 150 63370709
Bronchitis 15.51 11.59 153 118010 124782 63246077
Groin pain 15.50 11.59 48 118115 10155 63360704
Psychotic disorder 15.46 11.59 15 118148 25697 63345162
Blood pressure diastolic abnormal 15.42 11.59 4 118159 14538 63356321
Underdose 15.40 11.59 17 118146 27439 63343420
Neutropenic sepsis 15.34 11.59 66 118097 16372 63354487
Device malfunction 15.33 11.59 7 118156 17850 63353009
Gait inability 15.33 11.59 49 118114 52910 63317949
Metastases to uterus 15.26 11.59 6 118157 90 63370769
Vestibular neuronitis 15.26 11.59 11 118152 590 63370269
Bone cancer 15.25 11.59 16 118147 1426 63369433
Obesity 15.25 11.59 20 118143 29932 63340927
Central nervous system lesion 15.21 11.59 49 118114 10586 63360273
Oestradiol increased 15.20 11.59 6 118157 91 63370768
Blood calcium increased 15.16 11.59 45 118118 9305 63361554
Blood pressure diastolic decreased 15.16 11.59 12 118151 22694 63348165
Orthopnoea 15.15 11.59 35 118128 6226 63364633
Neutrophil Pelger-Huet anomaly present 15.14 11.59 6 118157 92 63370767
BRCA2 gene mutation 15.14 11.59 6 118157 92 63370767
Pneumonia herpes viral 15.11 11.59 5 118158 44 63370815
Coronary artery disease 15.11 11.59 23 118140 32354 63338505
Dental care 15.08 11.59 14 118149 1075 63369784
Bone cancer metastatic 15.03 11.59 7 118156 162 63370697
Dysphagia 15.01 11.59 240 117923 88345 63282514
Kidney fibrosis 14.97 11.59 18 118145 1863 63368996
Aortic thrombosis 14.97 11.59 14 118149 1085 63369774
Polyglandular autoimmune syndrome type II 14.92 11.59 5 118158 46 63370813
COVID-19 14.75 11.59 294 117869 112809 63258050
Blood oestrogen decreased 14.70 11.59 8 118155 260 63370599
Soft tissue infection 14.69 11.59 19 118144 2118 63368741
Creatinine renal clearance increased 14.66 11.59 11 118152 628 63370231
Postmenopausal haemorrhage 14.66 11.59 19 118144 2123 63368736
Transfusion 14.65 11.59 5 118158 15212 63355647
Posterior reversible encephalopathy syndrome 14.58 11.59 7 118156 17338 63353521
Monocyte count decreased 14.58 11.59 19 118144 2134 63368725
Metastases to heart 14.58 11.59 6 118157 102 63370757
Disability 14.54 11.59 8 118155 18339 63352520
Eating disorder 14.53 11.59 72 118091 18944 63351915
Jugular vein thrombosis 14.48 11.59 23 118140 3095 63367764
Hypervolaemia 14.44 11.59 19 118144 28394 63342465
Osteoarthritis 14.39 11.59 111 118052 95232 63275627
Psychomotor disadaptation syndrome 14.37 11.59 4 118159 18 63370841
Right ventricular failure 14.36 11.59 7 118156 17181 63353678
Metastases to soft tissue 14.29 11.59 7 118156 182 63370677
Libido decreased 14.23 11.59 21 118142 2651 63368208
Ocular vasculitis 14.20 11.59 5 118158 54 63370805
B-cell lymphoma stage III 14.19 11.59 4 118159 19 63370840
Respiratory distress 14.11 11.59 26 118137 33925 63336934
Poisoning 14.09 11.59 4 118159 13696 63357163
Cor pulmonale acute 14.07 11.59 9 118154 396 63370463
Gastroenteritis viral 14.05 11.59 14 118149 23686 63347173
Adenocarcinoma 14.03 11.59 22 118141 2928 63367931
Lymphatic obstruction 14.02 11.59 4 118159 20 63370839
Paralysis recurrent laryngeal nerve 13.96 11.59 5 118158 57 63370802
Papillary thyroid cancer 13.88 11.59 19 118144 2237 63368622
Pleural fluid analysis abnormal 13.79 11.59 3 118160 3 63370856
Primary pulmonary melanoma 13.79 11.59 3 118160 3 63370856
Altered state of consciousness 13.74 11.59 16 118147 25214 63345645
Uterine mass 13.69 11.59 8 118155 299 63370560
Metastases to breast 13.66 11.59 8 118155 300 63370559
Feeling jittery 13.63 11.59 4 118159 13399 63357460
Blood pressure systolic increased 13.62 11.59 44 118119 47353 63323506
Actinomycosis 13.59 11.59 13 118150 1037 63369822
Cerebral venous thrombosis 13.58 11.59 18 118145 2056 63368803
Breast ulceration 13.44 11.59 5 118158 64 63370795
Metastases to spinal cord 13.38 11.59 6 118157 127 63370732
Ovarian disorder 13.37 11.59 11 118152 719 63370140
Tachycardia 13.32 11.59 148 118015 118008 63252851
Superior vena cava occlusion 13.30 11.59 5 118158 66 63370793
Cytokine release syndrome 13.28 11.59 5 118158 14309 63356550
Cardiac valve sclerosis 13.28 11.59 4 118159 25 63370834
Toxic nodular goitre 13.28 11.59 4 118159 25 63370834
Lymphangitis 13.22 11.59 12 118151 895 63369964
Blood phosphorus decreased 13.18 11.59 27 118136 4426 63366433
Denture wearer 13.16 11.59 7 118156 217 63370642
Spondylitic myelopathy 13.14 11.59 4 118159 26 63370833
Lupus-like syndrome 13.13 11.59 6 118157 15289 63355570
Metastases to nervous system 13.10 11.59 5 118158 69 63370790
Fungal infection 13.00 11.59 31 118132 36843 63334016
Nightmare 12.99 11.59 10 118153 19184 63351675
Hepatomegaly 12.89 11.59 50 118113 11839 63359020
Autoimmune disorder 12.89 11.59 8 118155 17169 63353690
Joint injury 12.87 11.59 22 118141 29550 63341309
Oral disorder 12.85 11.59 41 118122 8813 63362046
Anaphylactic shock 12.85 11.59 15 118148 23618 63347241
Sensory disturbance 12.84 11.59 55 118108 13617 63357242
Thirst 12.82 11.59 56 118107 13985 63356874
Death 12.78 11.59 834 117329 373547 62997312
General physical condition abnormal 12.75 11.59 26 118137 4248 63366611
Post procedural complication 12.75 11.59 8 118155 17066 63353793
Coeliac disease 12.68 11.59 4 118159 12793 63358066
Chest wall mass 12.66 11.59 5 118158 76 63370783
Progesterone abnormal 12.58 11.59 3 118160 6 63370853
Nitrituria 12.58 11.59 3 118160 6 63370853
CD4/CD8 ratio increased 12.58 11.59 3 118160 6 63370853
Rectosigmoid cancer recurrent 12.58 11.59 3 118160 6 63370853
Device breakage 12.58 11.59 3 118160 11539 63359320
Body temperature increased 12.54 11.59 32 118131 37160 63333699
Herpes simplex encephalitis 12.53 11.59 8 118155 351 63370508
Multiple allergies 12.51 11.59 5 118158 13797 63357062
Adrenal mass 12.39 11.59 12 118151 972 63369887
Gastrooesophageal reflux disease 12.35 11.59 116 118047 95523 63275336
Mediastinal disorder 12.29 11.59 8 118155 363 63370496
Injection site mass 12.28 11.59 10 118153 18646 63352213
Malignant neoplasm of choroid 12.27 11.59 3 118160 7 63370852
Fanconi syndrome 12.21 11.59 14 118149 1378 63369481
Breast injury 12.20 11.59 5 118158 84 63370775
HER2 positive breast cancer 12.19 11.59 8 118155 368 63370491
Acute respiratory failure 12.15 11.59 29 118134 34456 63336403
Nasal congestion 12.13 11.59 72 118091 65588 63305271
Chronic cutaneous lupus erythematosus 12.11 11.59 8 118155 372 63370487
Tooth development disorder 12.11 11.59 4 118159 35 63370824
Congenital haematological disorder 12.11 11.59 4 118159 35 63370824
Supraventricular tachyarrhythmia 12.10 11.59 5 118158 86 63370773
Pseudomonas infection 12.05 11.59 3 118160 11210 63359649
Forearm fracture 12.01 11.59 9 118154 513 63370346
Femoral neck fracture 11.95 11.59 39 118124 8484 63362375
Bone marrow oedema syndrome 11.91 11.59 4 118159 37 63370822
Toxic epidermal necrolysis 11.82 11.59 18 118145 25316 63345543
Hepatitis E 11.79 11.59 14 118149 1430 63369429
Acute myeloid leukaemia 11.76 11.59 63 118100 17084 63353775
Subclavian vein thrombosis 11.76 11.59 16 118147 1874 63368985
Breast conserving surgery 11.74 11.59 12 118151 1037 63369822
Red blood cell poikilocytes present 11.72 11.59 3 118160 9 63370850
Polychromic red blood cells present 11.72 11.59 3 118160 9 63370850
Inferior vena caval occlusion 11.72 11.59 3 118160 9 63370850
Facet joint syndrome 11.67 11.59 4 118159 12134 63358725
Alopecia areata 11.61 11.59 15 118148 1670 63369189
Shock 11.61 11.59 16 118147 23447 63347412

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 113.67 29.11 52 1214 63164 34892501
Metastases to lung 66.25 29.11 21 1245 9299 34946366
Epiphysiolysis 53.09 29.11 8 1258 99 34955566
Hot flush 45.79 29.11 19 1247 18047 34937618
Metastases to bone 42.27 29.11 16 1250 11954 34943711
Hyporesponsive to stimuli 39.79 29.11 9 1257 1099 34954566
Neoplasm progression 35.00 29.11 17 1249 23283 34932382
Drug exposure before pregnancy 34.67 29.11 4 1262 3 34955662
Wrong patient received product 31.98 29.11 9 1257 2645 34953020
PIK3CA-activated mutation 31.07 29.11 5 1261 97 34955568
Neutropenia 31.05 29.11 33 1233 156745 34798920
Breast cancer recurrent 29.74 29.11 4 1262 20 34955645

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
Neoplasm progression 2055.56 12.24 1053 89122 50629 79603584
Neutropenia 1923.74 12.24 1973 88202 285737 79368476
Metastases to bone 1786.46 12.24 759 89416 23668 79630545
White blood cell count decreased 1333.87 12.24 1334 88841 186954 79467259
Malignant neoplasm progression 1304.95 12.24 1141 89034 134849 79519364
Metastases to liver 1030.45 12.24 544 89631 27770 79626443
Fatigue 705.94 12.24 2474 87701 927253 78726960
Hot flush 667.90 12.24 529 89646 54348 79599865
Breast cancer metastatic 604.37 12.24 260 89915 8342 79645871
Alopecia 543.26 12.24 953 89222 230402 79423811
Tumour marker increased 505.37 12.24 188 89987 4084 79650129
Metastases to lung 504.05 12.24 292 89883 17871 79636342
Bone pain 440.31 12.24 420 89755 55322 79598891
Osteonecrosis of jaw 426.36 12.24 369 89806 42857 79611356
Drug ineffective 411.82 12.24 372 89803 1080541 78573672
Metastases to lymph nodes 401.57 12.24 208 89967 10189 79644024
Carbohydrate antigen 15-3 increased 390.10 12.24 113 90062 1066 79653147
Disease progression 388.56 12.24 725 89450 183637 79470576
Breast cancer recurrent 298.05 12.24 116 90059 2861 79651352
Neutrophil count decreased 283.60 12.24 434 89741 93525 79560688
Nausea 260.99 12.24 1910 88265 955286 78698927
Breast cancer 250.62 12.24 246 89929 33535 79620678
Bone lesion 250.61 12.24 126 90049 5793 79648420
Completed suicide 238.45 12.24 9 90166 245758 79408455
Full blood count abnormal 218.77 12.24 249 89926 40225 79613988
Second primary malignancy 206.63 12.24 153 90022 14197 79640016
Toxicity to various agents 201.76 12.24 113 90062 421427 79232786
Skin hypopigmentation 183.72 12.24 61 90114 934 79653279
Neuropathy peripheral 182.46 12.24 456 89719 140849 79513364
Leukopenia 179.72 12.24 403 89772 116110 79538103
PIK3CA-activated mutation 174.07 12.24 52 90123 551 79653662
Off label use 166.63 12.24 502 89673 906713 78747500
Full blood count decreased 160.42 12.24 174 90001 26645 79627568
Carcinoembryonic antigen increased 159.20 12.24 68 90107 2141 79652072
Therapeutic product effect decreased 158.89 12.24 6 90169 163857 79490356
Infusion related reaction 157.42 12.24 34 90141 230203 79424010
Osteonecrosis 152.50 12.24 182 89993 30913 79623300
Metastases to skin 150.50 12.24 61 90114 1678 79652535
Rheumatoid arthritis 142.08 12.24 31 90144 208439 79445774
Lymphoedema 140.97 12.24 115 90060 12298 79641915
Hypotension 139.46 12.24 176 89999 440141 79214072
Diarrhoea 139.32 12.24 1563 88612 878926 78775287
Stomatitis 139.11 12.24 423 89752 146334 79507879
Decreased appetite 137.12 12.24 755 89420 341663 79312550
Metastases to pleura 132.74 12.24 54 90121 1500 79652713
Metastases to central nervous system 132.28 12.24 125 90050 16250 79637963
Metastases to spine 131.97 12.24 74 90101 4250 79649963
Arthralgia 131.15 12.24 1098 89077 570705 79083508
Ovarian hyperstimulation syndrome 130.91 12.24 69 90106 3502 79650711
Drug hypersensitivity 129.26 12.24 90 90085 298826 79355387
Contraindicated product administered 128.68 12.24 14 90161 157524 79496689
Red blood cell count decreased 126.98 12.24 231 89944 57282 79596931
Drug abuse 126.64 12.24 17 90158 162674 79491539
Dry skin 119.48 12.24 248 89927 67747 79586466
Pseudocirrhosis 114.90 12.24 39 90136 641 79653572
Joint swelling 111.99 12.24 97 90078 288549 79365664
Metastasis 109.61 12.24 78 90097 6802 79647411
Systemic lupus erythematosus 109.27 12.24 7 90168 121142 79533071
Hand deformity 103.58 12.24 3 90172 103916 79550297
Synovitis 103.53 12.24 22 90153 150712 79503501
Intentional product use issue 102.85 12.24 23 90152 152089 79502124
Drug interaction 100.09 12.24 199 89976 414984 79239229
Overdose 99.20 12.24 42 90133 184164 79470049
Treatment failure 96.51 12.24 36 90139 170450 79483763
Maternal exposure during pregnancy 95.69 12.24 19 90156 136519 79517694
Haematotoxicity 95.11 12.24 102 90073 15417 79638796
Nail disorder 94.83 12.24 90 90085 11762 79642451
Hypersensitivity 94.77 12.24 94 90081 262145 79392068
Pleural effusion 92.52 12.24 367 89808 144895 79509318
Constipation 91.92 12.24 591 89584 282459 79371754
Intentional overdose 90.24 12.24 8 90167 105952 79548261
Hepatic lesion 88.70 12.24 69 90106 6890 79647323
Tooth extraction 87.03 12.24 83 90092 10912 79643301
Thrombocytopenia 85.60 12.24 553 89622 264706 79389507
Arthropathy 85.28 12.24 47 90128 177064 79477149
Pathological fracture 84.28 12.24 80 90095 10457 79643756
Cardiac arrest 82.38 12.24 46 90129 172050 79482163
Pleural neoplasm 81.93 12.24 26 90149 342 79653871
Epistaxis 80.28 12.24 293 89882 111222 79542991
Bone disorder 79.48 12.24 103 90072 19010 79635203
Anaemia 78.83 12.24 809 89366 444206 79210007
Condition aggravated 78.20 12.24 297 89878 500827 79153386
Oral pain 75.67 12.24 132 90043 31666 79622547
Metastases to peritoneum 75.32 12.24 52 90123 4320 79649893
Spinal pain 75.31 12.24 90 90085 15302 79638911
Malignant pleural effusion 74.77 12.24 47 90128 3333 79650880
Progesterone increased 74.07 12.24 16 90159 35 79654178
Asthenia 72.38 12.24 890 89285 510799 79143414
Dysgeusia 72.13 12.24 183 89992 56994 79597219
Invasive ductal breast carcinoma 72.03 12.24 57 90118 5835 79648378
Pericarditis 72.01 12.24 15 90160 104221 79549992
Lymphangiosis carcinomatosa 71.60 12.24 39 90136 2115 79652098
Breast pain 70.43 12.24 65 90110 8200 79646013
Ejection fraction decreased 70.20 12.24 134 90041 34443 79619770
Hepatotoxicity 66.49 12.24 166 90009 51186 79603027
Cardio-respiratory arrest 66.48 12.24 20 90155 108490 79545723
Madarosis 64.60 12.24 40 90135 2762 79651451
Gastrointestinal haemorrhage 64.43 12.24 44 90131 147675 79506538
Breast mass 63.22 12.24 56 90119 6698 79647515
Mucosal dryness 62.89 12.24 43 90132 3516 79650697
Pulmonary embolism 62.32 12.24 369 89806 171285 79482928
Metastases to the mediastinum 61.88 12.24 24 90151 586 79653627
Back pain 61.65 12.24 569 89606 303611 79350602
Injection site erythema 61.24 12.24 8 90167 78189 79576024
Taste disorder 60.75 12.24 82 90093 15741 79638472
Suicide attempt 59.24 12.24 11 90164 82921 79571292
Seizure 59.13 12.24 76 90099 188758 79465455
Lymphadenopathy 58.61 12.24 162 90013 53085 79601128
Pneumonia 58.59 12.24 472 89703 659774 78994439
Palmar-plantar erythrodysaesthesia syndrome 58.36 12.24 121 90054 33013 79621200
Cancer pain 58.31 12.24 48 90127 5197 79649016
Respiratory failure 57.49 12.24 72 90103 180839 79473374
Metastases to chest wall 57.27 12.24 22 90153 523 79653690
Electrocardiogram QT prolonged 56.43 12.24 227 89948 90159 79564054
Duodenal ulcer perforation 56.37 12.24 5 90170 66206 79588007
Injection site pain 56.19 12.24 39 90136 129799 79524414
Trigger finger 56.09 12.24 43 90132 4202 79650011
Coma 55.70 12.24 22 90153 100627 79553586
Wound 54.24 12.24 32 90143 116147 79538066
Device related thrombosis 53.63 12.24 35 90140 2648 79651565
Multiple organ dysfunction syndrome 53.53 12.24 35 90140 120211 79534002
Ascites 52.24 12.24 196 89979 75366 79578847
Exposure during pregnancy 51.39 12.24 25 90150 101107 79553106
Hepatic cytolysis 50.00 12.24 101 90074 27050 79627163
Carbohydrate antigen 125 increased 49.90 12.24 31 90144 2153 79652060
Oxygen saturation decreased 49.23 12.24 44 90131 129003 79525210
Septic shock 49.13 12.24 40 90135 122761 79531452
Decreased immune responsiveness 48.49 12.24 44 90131 5431 79648782
Coronary artery disease 48.26 12.24 8 90167 65466 79588747
Bone marrow failure 48.07 12.24 147 90028 50960 79603253
Musculoskeletal chest pain 47.86 12.24 94 90081 24670 79629543
Delirium 47.66 12.24 18 90157 84609 79569604
Irritable bowel syndrome 47.25 12.24 7 90168 62234 79591979
Skin toxicity 46.35 12.24 52 90123 8262 79645951
Orthostatic hypotension 45.82 12.24 5 90170 56159 79598054
Pneumonia aspiration 45.51 12.24 10 90165 66957 79587256
Invasive lobular breast carcinoma 45.08 12.24 20 90155 691 79653522
Hepatorenal failure 44.76 12.24 24 90151 1261 79652952
Aspartate aminotransferase increased 44.63 12.24 289 89886 138352 79515861
Injury 44.45 12.24 16 90159 77480 79576733
Osteolysis 43.51 12.24 38 90137 4460 79649753
Body surface area increased 43.49 12.24 13 90162 138 79654075
Sinusitis 42.62 12.24 99 90076 195402 79458811
Blood alkaline phosphatase increased 42.24 12.24 163 90012 63501 79590712
Metastases to meninges 42.23 12.24 34 90141 3567 79650646
Onychoclasis 42.06 12.24 41 90134 5537 79648676
Encephalopathy 42.05 12.24 12 90163 67385 79586828
Injection site reaction 41.96 12.24 6 90169 54779 79599434
Lacrimation increased 41.85 12.24 84 90091 22393 79631820
Injection site swelling 41.68 12.24 3 90172 47129 79607084
Isosthenuria 41.63 12.24 12 90163 111 79654102
Electrocardiogram PR shortened 41.46 12.24 15 90160 300 79653913
Psoriasis 41.36 12.24 25 90150 89562 79564651
Myocardial infarction 41.15 12.24 92 90083 184037 79470176
Swelling 40.91 12.24 118 90057 216593 79437620
Anisocytosis 40.73 12.24 21 90154 1018 79653195
Muscle injury 40.45 12.24 4 90171 48557 79605656
Respiratory arrest 40.33 12.24 8 90167 57542 79596671
Urticaria 40.20 12.24 94 90081 185107 79469106
Metastases to eye 40.02 12.24 14 90161 253 79653960
Wheezing 39.65 12.24 44 90131 116620 79537593
Metastases to ovary 39.63 12.24 15 90160 342 79653871
Gamma-glutamyltransferase increased 39.61 12.24 144 90031 54536 79599677
Metabolic acidosis 39.56 12.24 22 90153 82507 79571706
BRCA1 gene mutation 39.38 12.24 9 90166 28 79654185
White blood cell count abnormal 39.21 12.24 40 90135 5705 79648508
Loss of consciousness 39.11 12.24 82 90093 167861 79486352
Myalgia 38.95 12.24 350 89825 185291 79468922
Thoracic vertebral fracture 38.47 12.24 38 90137 5215 79648998
Unevaluable event 38.38 12.24 8 90167 55577 79598636
Nail dystrophy 38.35 12.24 20 90155 993 79653220
Multiple sclerosis relapse 38.33 12.24 4 90171 46529 79607684
Generalised tonic-clonic seizure 38.25 12.24 3 90172 43907 79610306
Depressed level of consciousness 38.02 12.24 32 90143 96620 79557593
Blister 37.47 12.24 48 90127 119428 79534785
Mucosal inflammation 37.37 12.24 177 89998 75403 79578810
Exposed bone in jaw 37.14 12.24 32 90143 3688 79650525
Therapy non-responder 37.00 12.24 30 90145 92275 79561938
Blood pressure fluctuation 36.62 12.24 15 90160 67130 79587083
Pyelitis 36.60 12.24 14 90161 329 79653884
Body surface area decreased 36.51 12.24 9 90166 42 79654171
Medication error 36.37 12.24 16 90159 68626 79585587
Vitiligo 36.13 12.24 25 90150 2084 79652129
Bradycardia 36.13 12.24 61 90114 135496 79518717
Aggression 35.88 12.24 7 90168 50951 79603262
C-reactive protein abnormal 35.45 12.24 6 90169 48361 79605852
Metastases to bladder 35.30 12.24 13 90162 274 79653939
Adverse event 35.28 12.24 12 90163 60202 79594011
Glossodynia 35.09 12.24 39 90136 103298 79550915
Metastases to stomach 35.08 12.24 13 90162 279 79653934
Elliptocytosis 35.04 12.24 10 90165 89 79654124
Tumour marker abnormal 34.99 12.24 13 90162 281 79653932
Drug dependence 34.92 12.24 3 90172 40766 79613447
Discomfort 34.90 12.24 55 90120 125562 79528651
Hepatic enzyme increased 34.78 12.24 99 90076 182511 79471702
Hepatic echinococciasis 34.77 12.24 9 90166 53 79654160
Osteoma cutis 34.72 12.24 6 90169 0 79654213
Unresponsive to stimuli 34.68 12.24 10 90165 55778 79598435
Pneumonitis 34.18 12.24 148 90027 60712 79593501
Plasma cell myeloma 34.13 12.24 9 90166 53250 79600963
Metastases to pelvis 33.74 12.24 16 90159 646 79653567
Cardiac failure congestive 33.60 12.24 69 90106 142333 79511880
Wrong technique in product usage process 33.56 12.24 21 90154 73854 79580359
Gingivitis 33.49 12.24 46 90129 8975 79645238
Alanine aminotransferase increased 33.33 12.24 305 89870 162265 79491948
Hallucination 32.98 12.24 29 90146 85716 79568497
Sequestrectomy 32.58 12.24 17 90158 845 79653368
Fibromyalgia 32.54 12.24 16 90159 64324 79589889
Folliculitis 32.51 12.24 11 90164 55369 79598844
Drug reaction with eosinophilia and systemic symptoms 32.46 12.24 16 90159 64228 79589985
Gastroenteritis radiation 32.26 12.24 16 90159 714 79653499
Bone sequestrum 32.08 12.24 19 90156 1210 79653003
Cytomegalovirus infection 31.90 12.24 5 90170 42639 79611574
Prescribed overdose 31.87 12.24 3 90172 37880 79616333
Hyperkalaemia 31.87 12.24 50 90125 114348 79539865
Hormone receptor positive HER2 negative breast cancer 31.69 12.24 10 90165 129 79654084
Osteosclerosis 31.47 12.24 30 90145 3941 79650272
Hydrothorax 31.44 12.24 20 90155 1448 79652765
Therapy partial responder 31.18 12.24 64 90111 17333 79636880
Polyneuropathy 31.18 12.24 78 90097 24073 79630140
Acute kidney injury 30.87 12.24 408 89767 518996 79135217
Myelosuppression 30.79 12.24 108 90067 40188 79614025
Pleural disorder 30.64 12.24 17 90158 956 79653257
Sleep apnoea syndrome 30.39 12.24 3 90172 36475 79617738
Bone trimming 30.34 12.24 7 90168 23 79654190
Cutaneous lupus erythematosus 30.32 12.24 26 90149 2977 79651236
Injection site bruising 30.24 12.24 5 90170 40997 79613216
Tumour marker decreased 30.10 12.24 8 90167 53 79654160
Therapeutic product effect incomplete 29.85 12.24 73 90102 141572 79512641
Hypoxia 29.84 12.24 44 90131 103199 79551014
Osteitis 29.76 12.24 29 90146 3914 79650299
Hypoglycaemia 29.66 12.24 43 90132 101551 79552662
Bone debridement 29.50 12.24 13 90162 442 79653771
Skin weeping 29.48 12.24 17 90158 1030 79653183
Cough 29.40 12.24 580 89595 366209 79288004
Ovarian rupture 29.27 12.24 7 90168 28 79654185
Mental status changes 29.11 12.24 20 90155 66939 79587274
Intentional product misuse 29.06 12.24 39 90136 95126 79559087
Cardiogenic shock 29.01 12.24 6 90169 41908 79612305
Ovarian enlargement 28.76 12.24 12 90163 356 79653857
Confusional state 28.73 12.24 226 89949 317771 79336442
Pulmonary mass 28.70 12.24 85 90090 28949 79625264
Adverse drug reaction 28.64 12.24 20 90155 66372 79587841
Hypermetabolism 28.45 12.24 12 90163 366 79653847
Knee arthroplasty 28.31 12.24 7 90168 43241 79610972
Recall phenomenon 28.18 12.24 17 90158 1120 79653093
Blood pressure increased 28.11 12.24 133 90042 211227 79442986
Heart rate decreased 28.00 12.24 23 90152 70293 79583920
Anaphylactic reaction 28 12.24 32 90143 83711 79570502
Bladder hypertrophy 27.81 12.24 14 90161 645 79653568
Dental fistula 27.55 12.24 13 90162 519 79653694
Breast oedema 27.52 12.24 7 90168 38 79654175
Calcification metastatic 27.46 12.24 9 90166 132 79654081
Invasive breast carcinoma 27.37 12.24 13 90162 527 79653686
Tachycardia 27.23 12.24 106 90069 177662 79476551
Infection 27.19 12.24 161 90014 241551 79412662
Hair texture abnormal 26.69 12.24 26 90149 3508 79650705
Asthma 26.64 12.24 72 90103 135023 79519190
Interstitial lung disease 26.60 12.24 218 89957 112382 79541831
Insomnia 26.59 12.24 407 89768 244763 79409450
Blood pressure systolic increased 26.56 12.24 22 90153 66964 79587249
Mobility decreased 26.51 12.24 62 90113 122113 79532100
Resorption bone increased 26.49 12.24 18 90157 1457 79652756
Agitation 26.45 12.24 45 90130 99670 79554543
Product dose omission in error 26.37 12.24 38 90137 7750 79646463
Drug withdrawal syndrome 26.13 12.24 4 90171 34714 79619499
Ill-defined disorder 25.68 12.24 22 90153 65853 79588360
Postmenopausal haemorrhage 25.66 12.24 18 90157 1534 79652679
Poikilocytosis 25.55 12.24 11 90164 353 79653860
Mastectomy 25.43 12.24 16 90159 1136 79653077
Humerus fracture 25.27 12.24 41 90134 9272 79644941
Breast cancer female 25.24 12.24 46 90129 11415 79642798
Cytokine release syndrome 25.23 12.24 5 90170 35993 79618220
Gingival erythema 25.14 12.24 13 90162 634 79653579
Osteomyelitis 25.03 12.24 88 90087 32777 79621436
Neoplasm malignant 24.95 12.24 86 90089 31724 79622489
Macular hole 24.92 12.24 14 90161 807 79653406
Drug level increased 24.85 12.24 7 90168 39644 79614569
Heart rate increased 24.83 12.24 63 90112 120661 79533552
Haematochezia 24.70 12.24 38 90137 87607 79566606
Mucinous breast carcinoma 24.70 12.24 6 90169 26 79654187
Ischaemic stroke 24.63 12.24 88 90087 33043 79621170
Musculoskeletal stiffness 24.54 12.24 108 90067 174900 79479313
Keloid scar 24.51 12.24 9 90166 188 79654025
Erysipelas 24.47 12.24 44 90131 10806 79643407
Joint neoplasm 24.46 12.24 7 90168 63 79654150
Hydronephrosis 24.27 12.24 58 90117 17396 79636817
Vaccination site reaction 24.18 12.24 8 90167 121 79654092
Neuroendocrine breast tumour 24.00 12.24 6 90169 30 79654183
Vulvovaginal dryness 23.99 12.24 20 90155 2204 79652009
Blood cholesterol increased 23.88 12.24 36 90139 83684 79570529
CYP3A4 polymorphism 23.80 12.24 7 90168 70 79654143
Nail avulsion 23.71 12.24 8 90167 129 79654084
Skin exfoliation 23.67 12.24 124 90051 54976 79599237
Hospitalisation 23.66 12.24 44 90131 94192 79560021
Depressed mood 23.57 12.24 113 90062 48367 79605846
Aphthous ulcer 23.35 12.24 56 90119 16833 79637380
Sedation 23.23 12.24 15 90160 51880 79602333
Blood calcium increased 23.23 12.24 42 90133 10358 79643855
Ovarian fibrosis 23.14 12.24 4 90171 0 79654213
Breast disorder 23.04 12.24 19 90156 2062 79652151
Nephrosclerosis 23.01 12.24 18 90157 1812 79652401
Drug intolerance 22.79 12.24 190 89985 263929 79390284
Blood pressure decreased 22.78 12.24 49 90126 99417 79554796
Age-related macular degeneration 22.70 12.24 14 90161 960 79653253
Mouth swelling 22.68 12.24 31 90144 6020 79648193
Drug ineffective for unapproved indication 22.68 12.24 15 90160 51223 79602990
Transaminases increased 22.61 12.24 117 90058 51626 79602587
Soft tissue neoplasm 22.57 12.24 7 90168 85 79654128
Multiple pregnancy 22.54 12.24 6 90169 40 79654173
Jaw disorder 22.43 12.24 28 90147 4978 79649235
Ovarian disorder 22.41 12.24 11 90164 480 79653733
Therapy cessation 22.37 12.24 93 90082 37469 79616744
Angioedema 22.37 12.24 32 90143 76003 79578210
Type 2 diabetes mellitus 22.36 12.24 19 90156 57103 79597110
Dyspepsia 22.31 12.24 204 89971 108483 79545730
Haematuria 22.27 12.24 27 90148 68809 79585404
Hormone receptor positive breast cancer 22.24 12.24 10 90165 357 79653856
Nail growth abnormal 22.13 12.24 11 90164 493 79653720
Urinary tract inflammation 22.09 12.24 9 90166 251 79653962
Congestive cardiomyopathy 21.90 12.24 44 90131 11736 79642477
Menopausal symptoms 21.90 12.24 18 90157 1945 79652268
Vulvovaginal candidiasis 21.86 12.24 20 90155 2494 79651719
Superior vena cava syndrome 21.86 12.24 15 90160 1234 79652979
Vitreous detachment 21.68 12.24 19 90156 2240 79651973
Biopsy bone abnormal 21.54 12.24 5 90170 17 79654196
Loss of personal independence in daily activities 21.51 12.24 53 90122 102527 79551686
Metastases to spinal cord 21.37 12.24 6 90169 50 79654163
Superinfection 21.29 12.24 27 90148 4875 79649338
Malignant peritoneal neoplasm 21.19 12.24 12 90163 702 79653511
Platelet count decreased 21.04 12.24 323 89852 194341 79459872
Haemoconcentration 21.03 12.24 8 90167 185 79654028
Carbohydrate antigen 27.29 increased 20.96 12.24 6 90169 54 79654159
Staphylococcal infection 20.91 12.24 21 90154 58274 79595939
Inappropriate schedule of product administration 20.90 12.24 79 90096 133549 79520664
Dental care 20.90 12.24 13 90162 905 79653308
Acute respiratory failure 20.73 12.24 22 90153 59519 79594694
Epiphysiolysis 20.63 12.24 7 90168 115 79654098
Hepatic steatosis 20.60 12.24 91 90084 37647 79616566
Lymphadenopathy mediastinal 20.36 12.24 25 90150 4371 79649842
Dysarthria 20.35 12.24 28 90147 67594 79586619
Tongue discomfort 20.34 12.24 19 90156 2434 79651779
Dental discomfort 20.29 12.24 10 90165 440 79653773
Toothache 20.25 12.24 59 90116 19911 79634302
Gait deviation 20.22 12.24 6 90169 62 79654151
Paraesthesia 20.00 12.24 295 89880 176028 79478185
Radiation skin injury 19.99 12.24 15 90160 1419 79652794
Skin lesion 19.96 12.24 97 90078 41747 79612466
Adrenal insufficiency 19.87 12.24 4 90171 28483 79625730
Adjusted calcium decreased 19.84 12.24 8 90167 217 79653996
Respiratory distress 19.82 12.24 22 90153 58317 79595896
Fall 19.73 12.24 411 89764 487218 79166995
Rouleaux formation 19.68 12.24 5 90170 27 79654186
Bursitis 19.56 12.24 8 90167 35836 79618377
Neoplasm 19.33 12.24 36 90139 9080 79645133
Acute myocardial infarction 19.31 12.24 36 90139 77000 79577213
Paraneoplastic syndrome 19.30 12.24 13 90162 1037 79653176
Injection site haemorrhage 19.26 12.24 4 90171 27866 79626347
Nail toxicity 19.20 12.24 9 90166 354 79653859
Child-Pugh-Turcotte score abnormal 19.11 12.24 4 90171 7 79654206
Transaminases 19.04 12.24 6 90169 77 79654136
Flushing 18.98 12.24 45 90130 88223 79565990
Granulocyte count decreased 18.97 12.24 16 90159 1792 79652421
Ventricular tachycardia 18.94 12.24 12 90163 41923 79612290
Obstructive airways disorder 18.90 12.24 6 90169 31453 79622760
RET gene mutation 18.76 12.24 4 90171 8 79654205
Selenium deficiency 18.70 12.24 5 90170 34 79654179
Vulvovaginal inflammation 18.47 12.24 10 90165 536 79653677
Visual impairment 18.44 12.24 172 90003 91959 79562254
Syncope 18.38 12.24 123 90052 179326 79474887
Antisynthetase syndrome 18.28 12.24 7 90168 165 79654048
Pregnancy 18.26 12.24 4 90171 26847 79627366
Rhabdomyolysis 18.13 12.24 58 90117 103073 79551140
Mixed anxiety and depressive disorder 18.10 12.24 9 90166 404 79653809
Bone marrow infiltration 18.09 12.24 11 90164 735 79653478
Hip arthroplasty 17.92 12.24 9 90166 35747 79618466
Vaginal cuff dehiscence 17.87 12.24 4 90171 11 79654202
Altered state of consciousness 17.87 12.24 14 90161 43808 79610405
BRCA2 gene mutation 17.83 12.24 6 90169 96 79654117
Aortic thrombosis 17.78 12.24 15 90160 1680 79652533
Urinary tract infection 17.77 12.24 421 89754 274091 79380122
Shock 17.64 12.24 14 90161 43534 79610679
Pancreatitis acute 17.64 12.24 18 90157 49586 79604627
B-cell lymphoma stage III 17.61 12.24 4 90171 12 79654201
Foot deformity 17.61 12.24 3 90172 24071 79630142
Myeloproliferative neoplasm 17.60 12.24 12 90163 977 79653236
Meningeal disorder 17.50 12.24 9 90166 434 79653779
Ophthalmic migraine 17.46 12.24 7 90168 187 79654026
Dyskinesia 17.39 12.24 15 90160 44758 79609455
Hydroxyproline increased 17.36 12.24 3 90172 0 79654213
Acute promyelocytic leukaemia 17.32 12.24 14 90161 1477 79652736
Toxic epidermal necrolysis 17.24 12.24 15 90160 44566 79609647
Hyponatraemia 17.18 12.24 124 90051 177724 79476489
Psychotic disorder 17.17 12.24 13 90162 41389 79612824
Lung opacity 17.16 12.24 25 90150 5149 79649064
Upper gastrointestinal haemorrhage 17.15 12.24 13 90162 41367 79612846
Metastases to bone marrow 17.11 12.24 11 90164 811 79653402
Trichorrhexis 17.10 12.24 11 90164 812 79653401
Angina pectoris 17.04 12.24 20 90155 51712 79602501
Right ventricular failure 17.03 12.24 3 90172 23494 79630719
Metastases to thorax 17.02 12.24 7 90168 200 79654013
Peripheral swelling 17.02 12.24 209 89966 269408 79384805
Sopor 17.01 12.24 8 90167 33002 79621211
Disorientation 16.95 12.24 28 90147 62748 79591465
Pallor 16.88 12.24 19 90156 50043 79604170
Radiation injury 16.86 12.24 11 90164 832 79653381
Triple negative breast cancer 16.77 12.24 6 90169 116 79654097
Hypersensitivity vasculitis 16.75 12.24 29 90146 6914 79647299
Poisoning 16.72 12.24 4 90171 25268 79628945
Pneumocystis jirovecii pneumonia 16.57 12.24 8 90167 32500 79621713
Abdominal lymphadenopathy 16.51 12.24 13 90162 1321 79652892
Vertigo 16.44 12.24 134 90041 68948 79585265
Neoplasm recurrence 16.42 12.24 22 90153 4192 79650021
Withdrawal syndrome 16.35 12.24 5 90170 26849 79627364
Tooth loss 16.35 12.24 29 90146 7046 79647167
Somnolence 16.34 12.24 182 89993 238799 79415414
No adverse event 16.31 12.24 11 90164 37181 79617032
Mean cell volume increased 16.25 12.24 27 90148 6226 79647987
Dysaesthesia 16.21 12.24 26 90149 5822 79648391
Lymphopenia 16.16 12.24 73 90102 30484 79623729
Creatinine renal clearance increased 16.06 12.24 11 90164 902 79653311
Blood bilirubin increased 16.05 12.24 129 90046 66103 79588110
Ventricular fibrillation 16.05 12.24 8 90167 31918 79622295
Breast discharge 16.04 12.24 10 90165 699 79653514
Dorsal ramus syndrome 16 12.24 4 90171 20 79654193
Adjusted calcium increased 15.88 12.24 5 90170 64 79654149
Lactic acidosis 15.83 12.24 35 90140 70324 79583889
Bronchopulmonary aspergillosis 15.83 12.24 3 90172 22291 79631922
Metastases to nervous system 15.81 12.24 5 90170 65 79654148
Breast ulceration 15.74 12.24 5 90170 66 79654147
Plastic surgery 15.60 12.24 5 90170 68 79654145
Blood creatine phosphokinase increased 15.60 12.24 32 90143 66058 79588155
Purulent discharge 15.59 12.24 26 90149 6013 79648200
Product use issue 15.47 12.24 157 90018 209665 79444548
Prescribed underdose 15.45 12.24 7 90168 29507 79624706
Debridement 15.41 12.24 14 90161 1731 79652482
Hypocalcaemia 15.40 12.24 103 90072 49821 79604392
Stevens-Johnson syndrome 15.36 12.24 13 90162 39153 79615060
Pancreatic neoplasm 15.36 12.24 13 90162 1463 79652750
Mucosal hypertrophy 15.34 12.24 5 90170 72 79654141
Gene mutation 15.32 12.24 17 90158 2669 79651544
Anaphylactic shock 15.32 12.24 11 90164 35985 79618228
Human epidermal growth factor receptor increased 15.28 12.24 3 90172 3 79654210
Primary pulmonary melanoma 15.28 12.24 3 90172 3 79654210
Metastases to uterus 15.28 12.24 5 90170 73 79654140
Myocarditis 15.27 12.24 3 90172 21730 79632483
Cardiotoxicity 15.25 12.24 39 90136 12200 79642013
Leukocytosis 15.19 12.24 16 90159 43439 79610774
Dilatation ventricular 15.19 12.24 21 90154 4123 79650090
Congestive hepatopathy 15.12 12.24 22 90153 4525 79649688
Lower respiratory tract infection 15.09 12.24 85 90090 129135 79525078
Breast conserving surgery 15.05 12.24 10 90165 780 79653433
Muscle spasticity 15.01 12.24 3 90172 21472 79632741
Incorrect dose administered 14.98 12.24 41 90134 76589 79577624
Cerebral venous thrombosis 14.97 12.24 17 90158 2736 79651477
Product quality issue 14.93 12.24 10 90165 33930 79620283
Androgenetic alopecia 14.91 12.24 6 90169 162 79654051
Cornea verticillata 14.80 12.24 6 90169 165 79654048
Subclavian vein thrombosis 14.79 12.24 16 90159 2441 79651772
Breast injury 14.74 12.24 5 90170 82 79654131
Axillary pain 14.73 12.24 15 90160 2134 79652079
Neutrophil count abnormal 14.65 12.24 19 90156 3507 79650706
Jaw operation 14.61 12.24 10 90165 819 79653394
Oophorectomy 14.55 12.24 7 90168 292 79653921
Mastitis 14.49 12.24 15 90160 2176 79652037
Gastrointestinal disorder 14.48 12.24 80 90095 122125 79532088
Macrocytosis 14.40 12.24 17 90158 2853 79651360
Tremor 14.37 12.24 123 90052 169960 79484253
Subdural haematoma 14.19 12.24 9 90166 31425 79622788
Tooth resorption 14.18 12.24 4 90171 34 79654179
Chronic cutaneous lupus erythematosus 14.16 12.24 8 90167 466 79653747
Fractured sacrum 14.15 12.24 13 90162 1630 79652583
Onychomadesis 14.11 12.24 23 90152 5219 79648994
Pain in jaw 14.11 12.24 95 90080 46056 79608157
Suicidal ideation 14.08 12.24 42 90133 76298 79577915
Congenital haematological disorder 14.07 12.24 4 90171 35 79654178
Progesterone abnormal 14.07 12.24 3 90172 6 79654207
Chronic kidney disease 14.01 12.24 34 90141 66120 79588093
Breast cancer stage IV 14.00 12.24 14 90161 1950 79652263
Oophorectomy bilateral 13.97 12.24 4 90171 36 79654177
Red blood cell sedimentation rate increased 13.85 12.24 19 90156 45923 79608290
Respiratory depression 13.78 12.24 7 90168 27623 79626590
Renal failure 13.75 12.24 153 90022 200815 79453398
HER2 positive breast cancer 13.74 12.24 7 90168 331 79653882
Jugular vein thrombosis 13.72 12.24 21 90154 4517 79649696
Cor pulmonale acute 13.72 12.24 9 90166 687 79653526
Papilloedema 13.70 12.24 25 90150 6208 79648005
Emotional distress 13.66 12.24 15 90160 39954 79614259
Vomiting 13.63 12.24 900 89275 664928 78989285
Clostridium difficile infection 13.53 12.24 17 90158 42668 79611545
Cytogenetic analysis abnormal 13.46 12.24 11 90164 1179 79653034
Fibrous histiocytoma 13.45 12.24 9 90166 710 79653503
Grip strength decreased 13.45 12.24 4 90171 21865 79632348
Peri-implantitis 13.43 12.24 6 90169 211 79654002
Pulmonary hypertension 13.40 12.24 21 90154 48059 79606154
Onychalgia 13.37 12.24 10 90165 942 79653271
Cytopenia 13.36 12.24 52 90123 20331 79633882
Bone marrow oedema syndrome 13.34 12.24 4 90171 43 79654170
Spinal cord compression 13.29 12.24 25 90150 6352 79647861
Change of bowel habit 13.29 12.24 16 90159 2741 79651472
Adenocarcinoma 13.21 12.24 19 90156 3867 79650346
Premature delivery 13.19 12.24 5 90170 23462 79630751
Dry eye 13.13 12.24 79 90096 36852 79617361
Kidney fibrosis 13.08 12.24 18 90157 3517 79650696
Joint stiffness 13.06 12.24 85 90090 40745 79613468
Chronic obstructive pulmonary disease 13.03 12.24 51 90124 85368 79568845
Circulatory collapse 13.02 12.24 14 90161 37654 79616559
Toxic nodular goitre 12.94 12.24 4 90171 48 79654165
Monocyte count decreased 12.92 12.24 17 90158 3184 79651029
Carcinoid tumour pulmonary 12.90 12.24 7 90168 377 79653836
Alopecia areata 12.88 12.24 13 90162 1830 79652383
Coagulopathy 12.88 12.24 13 90162 35993 79618220
Intestinal metastasis 12.86 12.24 7 90168 379 79653834
Dermatitis 12.86 12.24 53 90122 21268 79632945
Adrenal mass 12.81 12.24 11 90164 1262 79652951
Acute cutaneous lupus erythematosus 12.76 12.24 7 90168 385 79653828
Vision blurred 12.72 12.24 179 89996 105719 79548494
Anuria 12.59 12.24 4 90171 20959 79633254
Bone cancer metastatic 12.57 12.24 6 90169 246 79653967
Portal hypertension 12.56 12.24 26 90149 7082 79647131
Red blood cell poikilocytes present 12.54 12.24 3 90172 12 79654201
Polychromic red blood cells present 12.54 12.24 3 90172 12 79654201
Paralysis recurrent laryngeal nerve 12.53 12.24 5 90170 132 79654081
Hypervolaemia 12.52 12.24 18 90157 42672 79611541
Blood phosphorus decreased 12.51 12.24 25 90150 6643 79647570
Mucosal toxicity 12.42 12.24 8 90167 592 79653621
Oral mucosal blistering 12.41 12.24 24 90151 6227 79647986
Oral disorder 12.40 12.24 32 90143 10063 79644150
Tumour ulceration 12.37 12.24 6 90169 255 79653958
Hallucination, auditory 12.34 12.24 4 90171 20689 79633524
SAPHO syndrome 12.29 12.24 7 90168 414 79653799
Blood test abnormal 12.28 12.24 46 90129 17664 79636549

FDA Adverse Event Reporting System (Pediatric)

None

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 D047072 Aromatase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D004965 Estrogen Antagonists
MeSH PA D006727 Hormone Antagonists
MeSH PA D065088 Steroid Synthesis Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50790 aromatase inhibitors

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 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 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 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

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 Dec. 10, 2024 NEW PATIENT POPULATION

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

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Femara HUMAN PRESCRIPTION DRUG LABEL 1 0078-0249 TABLET, FILM COATED 2.50 mg ORAL NDA 27 sections
Femara HUMAN PRESCRIPTION DRUG LABEL 1 0078-0249 TABLET, FILM COATED 2.50 mg ORAL NDA 27 sections
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 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 25 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 24724-030 TABLET 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 50090-3474 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 50268-476 TABLET 2.50 mg ORAL ANDA 28 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 51991-759 TABLET 2.50 mg ORAL ANDA 30 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 51991-759 TABLET 2.50 mg ORAL ANDA 30 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 57884-2021 TABLET 2.50 mg ORAL ANDA 26 sections
Letrozole Human Prescription Drug Label 1 59651-180 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 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 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 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 68071-5264 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