letrozole ๐Ÿถ 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
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 ยตM/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

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
Malignant neoplasm progression 2462.50 11.51 1573 96816 66551 50440184
Neutropenia 2395.06 11.51 2108 96281 145857 50360878
Neoplasm progression 2041.57 11.51 1038 97351 28119 50478616
Metastases to bone 1957.87 11.51 868 97521 17127 50489608
Metastases to liver 1255.01 11.51 663 97726 19441 50487294
White blood cell count decreased 1031.94 11.51 1201 97188 115521 50391214
Disease progression 717.20 11.51 907 97482 94959 50411776
Drug ineffective 632.36 11.51 411 97978 818922 49687813
Hot flush 611.17 11.51 578 97811 43591 50463144
Leukopenia 577.82 11.51 684 97705 66844 50439891
Breast cancer metastatic 568.89 11.51 314 98075 10050 50496685
Osteonecrosis of jaw 565.16 11.51 484 97905 32042 50474693
Metastases to lung 532.15 11.51 307 98082 10713 50496022
Bone pain 488.38 11.51 528 97861 46701 50460034
Tumour marker increased 419.69 11.51 186 98203 3654 50503081
Metastases to lymph nodes 405.35 11.51 220 98169 6804 50499931
Fatigue 387.16 11.51 2519 95870 705082 49801653
Breast cancer 322.14 11.51 407 97982 42483 50464252
Carbohydrate antigen 15-3 increased 310.84 11.51 107 98282 1025 50505710
Breast cancer recurrent 296.82 11.51 146 98243 3662 50503073
Rheumatoid arthritis 258.43 11.51 42 98347 202508 50304227
Second primary malignancy 257.29 11.51 163 98226 6751 50499984
Neutrophil count decreased 249.35 11.51 373 98016 45653 50461082
Therapeutic product effect decreased 244.09 11.51 4 98385 136046 50370689
Alopecia 243.67 11.51 1032 97357 244015 50262720
Contraindicated product administered 239.80 11.51 12 98377 148946 50357789
Drug hypersensitivity 235.09 11.51 97 98292 250913 50255822
Systemic lupus erythematosus 227.41 11.51 11 98378 140611 50366124
Maternal exposure during pregnancy 223.07 11.51 25 98364 159753 50346982
Infusion related reaction 216.61 11.51 35 98354 169522 50337213
PIK3CA-activated mutation 212.50 11.51 74 98315 736 50505999
Completed suicide 211.09 11.51 11 98378 131878 50374857
Polyneuropathy 209.53 11.51 180 98209 11951 50494784
Thrombocytopenia 209.49 11.51 634 97755 127039 50379696
Bone lesion 207.79 11.51 128 98261 5042 50501693
Osteonecrosis 198.84 11.51 232 98157 22285 50484450
Metastases to spine 195.52 11.51 100 98289 2731 50504004
Metastasis 193.04 11.51 115 98274 4260 50502475
Pleural effusion 190.40 11.51 461 97928 80993 50425742
Metastases to pleura 184.88 11.51 76 98313 1230 50505505
Joint swelling 182.49 11.51 127 98262 245159 50261576
Skin hypopigmentation 178.54 11.51 61 98328 570 50506165
Metastases to skin 177.34 11.51 75 98314 1308 50505427
Hand deformity 171.68 11.51 5 98384 100194 50406541
Decreased appetite 171.49 11.51 809 97580 200114 50306621
Full blood count abnormal 170.89 11.51 219 98170 23169 50483566
Toxicity to various agents 170.37 11.51 101 98288 212398 50294337
Hypersensitivity 161.88 11.51 110 98279 215051 50291684
Synovitis 157.18 11.51 26 98363 123839 50382896
Arthropathy 156.04 11.51 56 98333 157850 50348885
Treatment failure 151.84 11.51 40 98349 137597 50369138
Off label use 149.84 11.51 451 97938 473975 50032760
Nausea 148.27 11.51 2051 96338 703347 49803388
Lymphoedema 144.77 11.51 129 98260 8993 50497742
Metastases to central nervous system 143.36 11.51 141 98248 11141 50495594
Neuropathy peripheral 142.51 11.51 463 97926 96294 50410441
Gamma-glutamyltransferase increased 127.24 11.51 216 98173 29407 50477328
Anaemia 122.44 11.51 875 97514 251581 50255154
Glossodynia 121.13 11.51 37 98352 115532 50391203
Injection site pain 115.54 11.51 36 98353 110988 50395747
Injection site erythema 114.57 11.51 8 98381 74928 50431807
Sinusitis 113.21 11.51 99 98290 170459 50336276
Pericarditis 113.14 11.51 11 98378 78678 50428057
Bone disorder 110.23 11.51 158 98231 18594 50488141
Wound 108.85 11.51 35 98354 105759 50400976
Haematotoxicity 108.46 11.51 103 98286 7792 50498943
Ascites 108.45 11.51 225 98164 35636 50471099
Swelling 108.27 11.51 139 98250 200733 50306002
Condition aggravated 106.60 11.51 265 98124 296793 50209942
Carcinoembryonic antigen increased 104.50 11.51 53 98336 1421 50505314
Dry skin 103.59 11.51 247 98142 42944 50463791
Hepatotoxicity 102.03 11.51 187 98202 27039 50479696
Hypotension 101.97 11.51 189 98200 235280 50271455
Palmar-plantar erythrodysaesthesia syndrome 101.89 11.51 158 98231 19940 50486795
Stomatitis 98.23 11.51 424 97965 100920 50405815
Ejection fraction decreased 94.45 11.51 146 98243 18374 50488361
Red blood cell count decreased 93.89 11.51 205 98184 33630 50473105
Aspartate aminotransferase increased 92.91 11.51 348 98041 77650 50429085
Mucosal dryness 92.47 11.51 58 98331 2359 50504376
Malignant pleural effusion 91.89 11.51 57 98332 2273 50504462
Intentional overdose 91.82 11.51 8 98381 62496 50444239
Overdose 90.88 11.51 40 98349 99687 50407048
Nail disorder 90.69 11.51 103 98286 9605 50497130
Intentional product use issue 85.47 11.51 22 98367 76896 50429839
Tooth extraction 84.29 11.51 96 98293 8979 50497756
Metastases to peritoneum 84.07 11.51 58 98331 2775 50503960
Ovarian hyperstimulation syndrome 83.74 11.51 61 98328 3183 50503552
Electrocardiogram QT prolonged 83.40 11.51 256 98133 51630 50455105
Helicobacter infection 83.26 11.51 3 98386 49699 50457036
Hepatic lesion 80.69 11.51 65 98324 3943 50502792
Taste disorder 80.63 11.51 90 98299 8234 50498501
Epistaxis 80.07 11.51 290 98099 63664 50443071
Exposure during pregnancy 79.36 11.51 71 98318 120944 50385791
Psoriatic arthropathy 78.23 11.51 3 98386 47029 50459706
Injection site reaction 77.48 11.51 5 98384 50027 50456708
Pseudocirrhosis 76.92 11.51 33 98356 597 50506138
Seizure 76.29 11.51 70 98319 117804 50388931
Diarrhoea 76.08 11.51 1583 96806 586893 49919842
Full blood count decreased 74.46 11.51 146 98243 22200 50484535
Constipation 74.46 11.51 616 97773 185092 50321643
Irritable bowel syndrome 71.85 11.51 8 98381 51433 50455302
Bone marrow failure 71.73 11.51 163 98226 27461 50479274
General physical health deterioration 71.43 11.51 498 97891 141936 50364799
Mucosal inflammation 71.10 11.51 205 98184 39937 50466798
Product use issue 71.04 11.51 113 98276 149362 50357373
Lymphangiosis carcinomatosa 70.49 11.51 38 98351 1158 50505577
Drug intolerance 69.85 11.51 207 98182 218897 50287838
Alanine aminotransferase increased 69.61 11.51 348 98041 88011 50418724
Neoplasm malignant 69.60 11.51 147 98242 23568 50483167
Spinal pain 69.40 11.51 95 98294 10708 50496027
Cardio-respiratory arrest 69.03 11.51 11 98378 53881 50452854
Drug abuse 68.66 11.51 16 98373 59830 50446905
Onychoclasis 67.99 11.51 66 98323 5130 50501605
Abdominal discomfort 67.42 11.51 228 98161 231413 50275322
Discomfort 67.05 11.51 67 98322 108313 50398422
Drug interaction 66.25 11.51 185 98204 199436 50307299
Progesterone increased 65.13 11.51 16 98373 36 50506699
Trigger finger 64.98 11.51 56 98333 3732 50503003
Metastases to chest wall 64.90 11.51 27 98362 451 50506284
Multiple sclerosis relapse 64.49 11.51 5 98384 42959 50463776
Arthralgia 64.26 11.51 1203 97186 437499 50069236
Duodenal ulcer perforation 63.94 11.51 7 98382 45604 50461131
Skin toxicity 63.41 11.51 56 98333 3857 50502878
Pleural neoplasm 63.15 11.51 22 98367 219 50506516
Psoriasis 62.34 11.51 28 98361 68972 50437763
Erysipelas 61.54 11.51 70 98319 6538 50500197
Suicide attempt 61.02 11.51 13 98376 51719 50455016
Pneumonitis 60.50 11.51 159 98230 29351 50477384
Pulmonary embolism 59.72 11.51 370 98019 101334 50405401
Metastases to pelvis 57.72 11.51 23 98366 342 50506393
Oxygen saturation decreased 56.96 11.51 36 98353 73212 50433523
Muscle injury 56.61 11.51 4 98385 37107 50469628
Blood alkaline phosphatase increased 56.47 11.51 181 98208 37345 50469390
Injection site bruising 55.98 11.51 4 98385 36764 50469971
Bone marrow infiltration 55.45 11.51 24 98365 444 50506291
Breast cancer female 54.48 11.51 67 98322 6795 50499940
Breast pain 54.08 11.51 70 98319 7474 50499261
Adverse event 53.70 11.51 10 98379 43753 50462982
Asthenia 53.44 11.51 894 97495 318148 50188587
Therapeutic product effect incomplete 52.78 11.51 60 98329 91455 50415280
Blister 52.61 11.51 53 98336 85365 50421370
Urticaria 52.54 11.51 108 98281 129453 50377282
Knee arthroplasty 51.54 11.51 5 98384 35841 50470894
Cardiac arrest 51.41 11.51 52 98337 83599 50423136
Loss of personal independence in daily activities 51.03 11.51 37 98352 70013 50436722
Lymphadenopathy 50.79 11.51 162 98227 33337 50473398
Anaphylactic reaction 50.32 11.51 21 98368 54034 50452701
Unevaluable event 49.61 11.51 14 98375 46052 50460683
Pyelitis 49.18 11.51 17 98372 165 50506570
Transaminases increased 49.17 11.51 142 98247 27682 50479053
Myalgia 49.04 11.51 411 97978 123908 50382827
Eastern Cooperative Oncology Group performance status worsened 48.35 11.51 24 98365 614 50506121
Peripheral swelling 48.22 11.51 221 98168 205715 50301020
Hormone receptor positive breast cancer 48.20 11.51 22 98367 464 50506271
Ill-defined disorder 48.10 11.51 23 98366 54631 50452104
Wrong technique in product usage process 47.88 11.51 24 98365 55486 50451249
Exposed bone in jaw 47.23 11.51 41 98348 2759 50503976
Lacrimation increased 47.18 11.51 103 98286 16889 50489846
Hepatorenal failure 46.63 11.51 23 98366 580 50506155
Device related thrombosis 46.60 11.51 30 98359 1277 50505458
Osteolysis 46.31 11.51 39 98350 2518 50504217
Hepatic enzyme increased 45.78 11.51 127 98262 137253 50369482
Metastases to the mediastinum 45.74 11.51 21 98368 449 50506286
Metastases to thorax 45.73 11.51 17 98372 207 50506528
Infection 45.16 11.51 178 98211 172776 50333959
Hydronephrosis 44.48 11.51 68 98321 8473 50498262
Madarosis 44.23 11.51 38 98351 2522 50504213
Coma 44.16 11.51 28 98361 56851 50449884
Neoplasm 44.06 11.51 56 98333 5872 50500863
Cancer pain 43.88 11.51 38 98351 2549 50504186
Metastases to adrenals 43.58 11.51 23 98366 671 50506064
Dysgeusia 43.33 11.51 170 98219 38746 50467989
Pregnancy 42.86 11.51 4 98385 29573 50477162
Sequestrectomy 42.79 11.51 24 98365 792 50505943
Bone sequestrum 42.76 11.51 29 98360 1349 50505386
Musculoskeletal stiffness 42.64 11.51 119 98270 128362 50378373
Gastrointestinal disorder 42.45 11.51 74 98315 94382 50412353
C-reactive protein abnormal 42.41 11.51 3 98386 27806 50478929
Folliculitis 42.09 11.51 12 98377 39213 50467522
Metastases to stomach 40.70 11.51 15 98374 178 50506557
Osteomyelitis 40.39 11.51 115 98274 22238 50484497
Musculoskeletal chest pain 40.36 11.51 102 98287 18384 50488351
Concomitant disease aggravated 40.16 11.51 63 98326 8028 50498707
Blood bilirubin increased 39.84 11.51 145 98244 31893 50474842
Generalised tonic-clonic seizure 39.66 11.51 3 98386 26307 50480428
Thoracic vertebral fracture 39.38 11.51 44 98345 4029 50502706
Metastases to meninges 39.31 11.51 32 98357 1970 50504765
Abortion spontaneous 39.25 11.51 16 98373 41756 50464979
Adverse drug reaction 39.15 11.51 30 98359 55192 50451543
Onychomadesis 39.09 11.51 41 98348 3495 50503240
Loss of consciousness 38.99 11.51 91 98298 104262 50402473
Platelet count decreased 38.13 11.51 330 98059 100396 50406339
Lower respiratory tract infection 38.04 11.51 80 98309 95121 50411614
Pneumonia 38.00 11.51 513 97876 377888 50128847
Fibromyalgia 37.97 11.51 20 98369 44958 50461777
Blood lactate dehydrogenase increased 37.67 11.51 103 98286 19459 50487276
Nail dystrophy 37.56 11.51 22 98367 789 50505946
Bone debridement 37.52 11.51 15 98374 225 50506510
Asthma 37.47 11.51 73 98316 89264 50417471
Mobility decreased 36.50 11.51 62 98327 79886 50426849
Blood creatinine increased 36.22 11.51 263 98126 75897 50430838
Drug reaction with eosinophilia and systemic symptoms 35.95 11.51 6 98383 28418 50478317
Somnolence 35.86 11.51 167 98222 154818 50351917
Hypermetabolism 35.76 11.51 13 98376 148 50506587
Respiratory failure 35.29 11.51 78 98311 91103 50415632
Skin weeping 35.27 11.51 17 98372 407 50506328
Gastrointestinal haemorrhage 35.21 11.51 55 98334 73266 50433469
Metastases to ovary 35.20 11.51 16 98373 334 50506401
Heart rate increased 35.18 11.51 60 98329 77190 50429545
Back pain 35.12 11.51 612 97777 219418 50287317
Interstitial lung disease 34.74 11.51 199 98190 52977 50453758
No adverse event 34.71 11.51 11 98378 33567 50473168
Metabolic acidosis 34.68 11.51 16 98373 38809 50467926
Electrocardiogram PR shortened 34.55 11.51 14 98375 218 50506517
Pain 34.49 11.51 860 97529 578043 49928692
Osteosclerosis 34.46 11.51 38 98351 3429 50503306
Respiratory arrest 34.46 11.51 8 98381 30001 50476734
Metastases to bladder 34.42 11.51 13 98376 166 50506569
Recall phenomenon 33.71 11.51 18 98371 538 50506197
Urinary tract inflammation 33.62 11.51 9 98380 32 50506703
Invasive ductal breast carcinoma 33.49 11.51 49 98340 5872 50500863
Septic shock 33.49 11.51 37 98352 57138 50449597
Flushing 33.41 11.51 49 98340 66966 50439769
Therapy non-responder 33.35 11.51 30 98359 50992 50455743
Encephalopathy 33.18 11.51 12 98377 33699 50473036
Invasive lobular breast carcinoma 33.09 11.51 19 98370 656 50506079
Isosthenuria 32.66 11.51 11 98378 98 50506637
Weight increased 32.63 11.51 244 98145 201647 50305088
Oral pain 32.58 11.51 115 98274 24918 50481817
Gingivitis 32.45 11.51 54 98335 7230 50499505
Drug withdrawal syndrome 32.39 11.51 5 98384 25076 50481659
Premature delivery 32.25 11.51 4 98385 23659 50483076
Bladder hypertrophy 31.87 11.51 13 98376 206 50506529
Orthostatic hypotension 31.67 11.51 9 98380 29472 50477263
Gastroenteritis radiation 31.65 11.51 16 98373 426 50506309
Tumour pain 31.46 11.51 23 98366 1207 50505528
Lymphadenopathy mediastinal 31.19 11.51 31 98358 2480 50504255
Intentional product misuse 31.12 11.51 27 98362 46707 50460028
Blood pressure increased 31.06 11.51 143 98246 132989 50373746
Jaw disorder 31.05 11.51 43 98346 4900 50501835
Purulent discharge 30.75 11.51 40 98349 4292 50502443
Superinfection 30.50 11.51 28 98361 2028 50504707
Cardiac failure congestive 30.39 11.51 75 98314 84307 50422428
Abdominal lymphadenopathy 30.30 11.51 18 98371 663 50506072
Debridement 30.05 11.51 22 98367 1157 50505578
Myelosuppression 29.94 11.51 75 98314 13442 50493293
Hallucination 29.82 11.51 28 98361 46629 50460106
Metastases to muscle 29.74 11.51 11 98378 132 50506603
Tumour marker decreased 29.66 11.51 9 98380 55 50506680
Dental fistula 29.48 11.51 17 98372 592 50506143
Bradycardia 29.37 11.51 50 98339 64376 50442359
Osteoma cutis 29.04 11.51 6 98383 3 50506732
Rash 29.04 11.51 639 97750 436832 50069903
Depressed level of consciousness 28.94 11.51 35 98354 51918 50454817
Blood pressure fluctuation 28.69 11.51 17 98372 35806 50470929
Gingival swelling 28.44 11.51 36 98353 3759 50502976
Wheezing 28.43 11.51 48 98341 61999 50444736
Glomerular filtration rate decreased 28.32 11.51 67 98322 11585 50495150
Heart rate decreased 28.28 11.51 18 98371 36479 50470256
Jaundice 28.25 11.51 114 98275 26315 50480420
Recurrent cancer 28.18 11.51 25 98364 1732 50505003
Injection site haemorrhage 28.15 11.51 4 98385 21342 50485393
Hypocalcaemia 28.13 11.51 115 98274 26701 50480034
Delirium 28.03 11.51 20 98369 38172 50468563
Hip arthroplasty 28.03 11.51 12 98377 30417 50476318
Hospitalisation 27.21 11.51 57 98332 67880 50438855
Product quality issue 27.13 11.51 13 98376 30845 50475890
Concomitant disease progression 26.80 11.51 26 98363 2019 50504716
Unresponsive to stimuli 26.75 11.51 13 98376 30596 50476139
Osteitis 26.54 11.51 31 98358 2979 50503756
Cytopenia 26.45 11.51 55 98334 8720 50498015
Medication error 26.38 11.51 19 98370 36085 50470650
Bone trimming 26.34 11.51 7 98382 24 50506711
Confusional state 26.24 11.51 233 98156 185695 50321040
Injury 26.16 11.51 34 98355 48891 50457844
Pleural disorder 25.74 11.51 15 98374 533 50506202
Drug dependence 25.37 11.51 4 98385 19755 50486980
Premature baby 25.23 11.51 3 98386 18334 50488401
Nephrosclerosis 25.21 11.51 18 98371 910 50505825
Hypoglycaemia 24.96 11.51 41 98348 53540 50453195
Plasma cell myeloma 24.89 11.51 15 98374 31307 50475428
Calcium deficiency 24.83 11.51 18 98371 932 50505803
Elliptocytosis 24.75 11.51 7 98382 32 50506703
Nasopharyngitis 24.57 11.51 248 98141 192679 50314056
Incorrect dose administered 24.52 11.51 35 98354 48379 50458356
Dysarthria 24.43 11.51 22 98367 37381 50469354
Staphylococcal infection 24.42 11.51 20 98369 35596 50471139
Ovarian rupture 24.41 11.51 7 98382 34 50506701
Therapy partial responder 24.34 11.51 45 98344 6546 50500189
Lymphopenia 24.09 11.51 76 98313 15545 50491190
Vitiligo 23.84 11.51 19 98370 1135 50505600
Agitation 23.81 11.51 42 98347 53342 50453393
Skin lesion 23.73 11.51 109 98280 26618 50480117
Fall 23.72 11.51 484 97905 334448 50172287
Neoplasm recurrence 23.61 11.51 26 98363 2343 50504392
Pulmonary mass 23.54 11.51 85 98304 18620 50488115
Metastases to eye 23.27 11.51 9 98380 123 50506612
Muscle spasticity 23.18 11.51 3 98386 17181 50489554
Blood pressure decreased 23.16 11.51 46 98343 55863 50450872
Malignant peritoneal neoplasm 23.14 11.51 15 98374 646 50506089
Pathological fracture 22.98 11.51 48 98341 7634 50499101
CYP3A4 polymorphism 22.93 11.51 8 98381 80 50506655
Mental status changes 22.91 11.51 22 98367 36250 50470485
Decreased immune responsiveness 22.85 11.51 33 98356 3908 50502827
Granulocyte count decreased 22.74 11.51 16 98373 790 50505945
Coronary artery disease 22.57 11.51 15 98374 29711 50477024
Carbohydrate antigen 27.29 increased 22.38 11.51 7 98382 48 50506687
Toothache 22.32 11.51 78 98311 16816 50489919
Cytomegalovirus infection 22.26 11.51 4 98385 17958 50488777
Metastases to abdominal wall 22.25 11.51 8 98381 88 50506647
Hypertensive crisis 22.15 11.51 66 98323 13088 50493647
Multiple pregnancy 22.01 11.51 7 98382 51 50506684
Tremor 21.99 11.51 132 98257 114771 50391964
Dyschezia 21.91 11.51 22 98367 1782 50504953
Superior vena cava syndrome 21.75 11.51 14 98375 596 50506139
Plastic surgery 21.66 11.51 7 98382 54 50506681
Tumour marker abnormal 21.56 11.51 10 98379 219 50506516
Type 2 diabetes mellitus 21.53 11.51 21 98368 34354 50472381
Skin exfoliation 21.44 11.51 125 98264 33487 50473248
Injection site rash 21.41 11.51 3 98386 16174 50490561
Antisynthetase syndrome 21.33 11.51 7 98382 57 50506678
Hepatic steatosis 21.32 11.51 99 98290 24285 50482450
Ear infection 21.26 11.51 12 98377 25958 50480777
Dyskinesia 21.23 11.51 14 98375 27847 50478888
Hepatic failure 21.21 11.51 121 98268 32162 50474573
Neutrophil count abnormal 21.14 11.51 25 98364 2434 50504301
Sleep apnoea syndrome 21.06 11.51 10 98379 23858 50482877
Keloid scar 20.92 11.51 9 98380 164 50506571
Suicidal ideation 20.92 11.51 48 98341 55337 50451398
Congestive cardiomyopathy 20.79 11.51 38 98351 5480 50501255
RET gene mutation 20.75 11.51 5 98384 10 50506725
Bile duct stenosis 20.71 11.51 17 98372 1059 50505676
Nail toxicity 20.59 11.51 11 98378 329 50506406
Intestinal metastasis 20.58 11.51 8 98381 111 50506624
BRCA1 gene mutation 20.43 11.51 5 98384 11 50506724
Foot deformity 20.38 11.51 6 98383 19204 50487531
Hypoxia 20.38 11.51 43 98346 51080 50455655
Contusion 20.37 11.51 131 98258 112052 50394683
Vitreous detachment 20.19 11.51 21 98368 1773 50504962
Metastases to neck 20.15 11.51 7 98382 69 50506666
Peri-implantitis 20.15 11.51 6 98383 34 50506701
Therapy cessation 20.15 11.51 102 98287 25909 50480826
Mouth swelling 20.14 11.51 31 98358 3885 50502850
Basophil count increased 20.03 11.51 15 98374 817 50505918
Sedation 20.00 11.51 18 98371 30592 50476143
Blood cholesterol increased 19.94 11.51 49 98340 55166 50451569
Radiation oesophagitis 19.93 11.51 10 98379 262 50506473
Myeloproliferative neoplasm 19.91 11.51 12 98377 454 50506281
Anisocytosis 19.89 11.51 13 98376 568 50506167
Dermatitis 19.88 11.51 67 98322 14184 50492551
Mastectomy 19.86 11.51 19 98370 1450 50505285
Periodontitis 19.73 11.51 27 98362 3042 50503693
Metastases to spinal cord 19.72 11.51 6 98383 37 50506698
Breast neoplasm 19.71 11.51 18 98371 1295 50505440
Adjusted calcium decreased 19.66 11.51 8 98381 126 50506609
Body surface area decreased 19.58 11.51 5 98384 14 50506721
Radiation skin injury 19.54 11.51 15 98374 848 50505887
Tongue discomfort 19.48 11.51 21 98368 1847 50504888
Vulvovaginal inflammation 19.47 11.51 13 98376 589 50506146
Hydrothorax 19.45 11.51 14 98375 717 50506018
Thirst 19.44 11.51 55 98334 10595 50496140
Myocardial infarction 19.37 11.51 98 98291 88929 50417806
Breast cancer stage IV 19.26 11.51 13 98376 600 50506135
Arthritis 19.13 11.51 95 98294 86626 50420109
Chronic cutaneous lupus erythematosus 19.10 11.51 8 98381 136 50506599
Clostridium difficile infection 19.10 11.51 13 98376 25426 50481309
Adjusted calcium increased 19.08 11.51 5 98384 16 50506719
Tachyarrhythmia 19.05 11.51 31 98358 4074 50502661
SAPHO syndrome 19.00 11.51 7 98382 83 50506652
Malaise 18.95 11.51 502 97887 335030 50171705
Dilatation ventricular 18.94 11.51 23 98366 2302 50504433
Transaminases 18.85 11.51 7 98382 85 50506650
Cardiotoxicity 18.83 11.51 42 98347 6985 50499750
Ovarian fibrosis 18.75 11.51 4 98385 3 50506732
Drug level increased 18.73 11.51 7 98382 19261 50487474
Visual impairment 18.64 11.51 209 98180 68066 50438669
Pain in jaw 18.43 11.51 133 98256 38295 50468440
Paraneoplastic syndrome 18.43 11.51 12 98377 521 50506214
Aggression 18.40 11.51 9 98380 21107 50485628
Carcinoid tumour pulmonary 18.35 11.51 11 98378 412 50506323
Headache 18.30 11.51 802 97587 505733 50001002
Oral discomfort 18.30 11.51 45 98344 7972 50498763
Gene mutation 18.26 11.51 17 98372 1254 50505481
Left ventricular dilatation 18.23 11.51 11 98378 417 50506318
Pericardial effusion 18.20 11.51 98 98291 25491 50481244
Cutaneous lupus erythematosus 18.12 11.51 23 98366 2408 50504327
Sopor 18.05 11.51 8 98381 19871 50486864
Inappropriate schedule of product administration 18.05 11.51 75 98314 71756 50434979
Carbohydrate antigen 125 increased 17.85 11.51 23 98366 2444 50504291
Hepatic calcification 17.84 11.51 5 98384 22 50506713
Meningeal disorder 17.82 11.51 9 98380 239 50506496
Withdrawal syndrome 17.76 11.51 6 98383 17584 50489151
Congestive hepatopathy 17.66 11.51 23 98366 2471 50504264
Triple negative breast cancer 17.63 11.51 7 98382 103 50506632
Onycholysis 17.62 11.51 17 98372 1311 50505424
Radiation pneumonitis 17.55 11.51 17 98372 1318 50505417
Pancreatic neoplasm 17.53 11.51 13 98376 697 50506038
Malignant ascites 17.52 11.51 14 98375 839 50505896
Migraine 17.46 11.51 81 98308 75199 50431536
Multiple sclerosis 17.46 11.51 9 98380 20484 50486251
Abscess jaw 17.30 11.51 17 98372 1341 50505394
Nasal congestion 17.21 11.51 47 98342 51073 50455662
Dysaesthesia 17.05 11.51 28 98361 3707 50503028
Nail growth abnormal 17.05 11.51 11 98378 470 50506265
Bursitis 17.04 11.51 11 98378 22124 50484611
Macular hole 17.01 11.51 13 98376 730 50506005
Mucosal hypertrophy 17.00 11.51 5 98384 27 50506708
Metastatic neoplasm 16.95 11.51 28 98361 3726 50503009
Gait deviation 16.94 11.51 6 98383 63 50506672
Hypersensitivity vasculitis 16.87 11.51 29 98360 3986 50502749
Tachycardia 16.86 11.51 119 98270 99644 50407091
Dental discomfort 16.82 11.51 10 98379 369 50506366
Metastases to kidney 16.81 11.51 8 98381 186 50506549
Gingival erythema 16.70 11.51 12 98377 613 50506122
Biopsy bone abnormal 16.70 11.51 5 98384 29 50506706
Bone fistula 16.69 11.51 6 98383 66 50506669
Body surface area increased 16.60 11.51 4 98385 8 50506727
Status epilepticus 16.58 11.51 3 98386 13403 50493332
Vulvovaginal dryness 16.57 11.51 21 98368 2196 50504539
Prescribed overdose 16.55 11.51 4 98385 14596 50492139
Respiratory distress 16.49 11.51 21 98368 30468 50476267
Jaw operation 16.45 11.51 13 98376 767 50505968
Dental care 16.44 11.51 14 98375 918 50505817
Pelvic fluid collection 16.40 11.51 13 98376 770 50505965
Adenocarcinoma 16.21 11.51 22 98367 2459 50504276
Red blood cell sedimentation rate increased 16.19 11.51 20 98369 29396 50477339
Liver function test increased 16.18 11.51 95 98294 25511 50481224
Peripheral sensory neuropathy 16.12 11.51 38 98351 6553 50500182
Soft tissue infection 16.12 11.51 19 98370 1843 50504892
Pneumonia aspiration 16.11 11.51 22 98367 30982 50475753
Metastases to uterus 16.00 11.51 6 98383 75 50506660
Bone marrow oedema syndrome 15.99 11.51 4 98385 10 50506725
Bronchitis 15.82 11.51 128 98261 104031 50402704
Nail avulsion 15.81 11.51 7 98382 137 50506598
Hormone receptor positive HER2 negative breast cancer 15.74 11.51 3 98386 0 50506735
Hydroxyproline increased 15.74 11.51 3 98386 0 50506735
Aortic thrombosis 15.72 11.51 14 98375 975 50505760
Ostectomy 15.71 11.51 4 98385 11 50506724
Multiple organ dysfunction syndrome 15.68 11.51 48 98341 50289 50456446
Breast mass 15.58 11.51 37 98352 6412 50500323
Tooth loss 15.56 11.51 36 98353 6134 50500601
Hormone refractory breast cancer 15.46 11.51 4 98385 12 50506723
Androgenetic alopecia 15.45 11.51 7 98382 145 50506590
Pneumonia herpes viral 15.43 11.51 5 98384 39 50506696
Cor pulmonale acute 15.41 11.51 9 98380 321 50506414
Oestradiol increased 15.38 11.51 6 98383 84 50506651
Oestrogen receptor assay positive 15.38 11.51 10 98379 433 50506302
Peritoneal disorder 15.28 11.51 10 98379 438 50506297
Neutrophil Pelger-Huet anomaly present 15.26 11.51 6 98383 86 50506649
Orthopnoea 15.24 11.51 34 98355 5655 50501080
Blood calcium increased 15.22 11.51 41 98348 7678 50499057
Ocular vasculitis 15.21 11.51 5 98384 41 50506694
Kidney fibrosis 15.08 11.51 17 98372 1572 50505163
Acute promyelocytic leukaemia 15.02 11.51 13 98376 871 50505864
Dyspnoea exertional 14.98 11.51 159 98230 51074 50455661
Radiculopathy 14.93 11.51 31 98358 4910 50501825
Cytogenetic analysis abnormal 14.81 11.51 12 98377 734 50506001
Jugular vein thrombosis 14.80 11.51 22 98367 2674 50504061
Polyglandular autoimmune syndrome type II 14.80 11.51 5 98384 45 50506690
Infusion site pain 14.77 11.51 3 98386 12343 50494392
Toxic nodular goitre 14.57 11.51 4 98385 16 50506719
Humerus fracture 14.55 11.51 40 98349 7578 50499157
Mean cell volume increased 14.55 11.51 23 98366 2949 50503786
Drug ineffective for unapproved indication 14.53 11.51 12 98377 21269 50485466
Malignant neoplasm of pleura 14.51 11.51 5 98384 48 50506687
Pulmonary arterial hypertension 14.45 11.51 11 98378 20308 50486427
Hypervolaemia 14.39 11.51 17 98372 25482 50481253
Aortic arteriosclerosis 14.24 11.51 32 98357 5350 50501385
Swollen tongue 14.20 11.51 21 98368 28609 50478126
Psychomotor disadaptation syndrome 14.20 11.51 4 98385 18 50506717
Soft tissue inflammation 14.15 11.51 8 98381 268 50506467
B-cell lymphoma stage III 14.02 11.51 4 98385 19 50506716
Actinomycosis 14.00 11.51 13 98376 956 50505779
Paralysis recurrent laryngeal nerve 13.99 11.51 5 98384 54 50506681
Paraesthesia 13.97 11.51 319 98070 119924 50386811
Cyanosis 13.96 11.51 6 98383 15178 50491557
Angioedema 13.95 11.51 33 98356 37643 50469092
Libido decreased 13.93 11.51 20 98369 2356 50504379
Uterine mass 13.86 11.51 8 98381 279 50506456
Lymphatic obstruction 13.85 11.51 4 98385 20 50506715
Corneal infection 13.83 11.51 5 98384 56 50506679
Chronic kidney disease 13.81 11.51 36 98353 39735 50467000
Lung opacity 13.66 11.51 18 98371 1955 50504780
Primary pulmonary melanoma 13.66 11.51 3 98386 3 50506732
Bone erosion 13.65 11.51 3 98386 11684 50495051
Ovarian disorder 13.60 11.51 11 98378 671 50506064
Prescribed underdose 13.59 11.51 7 98382 15942 50490793
Superior vena cava occlusion 13.59 11.51 5 98384 59 50506676
Right ventricular failure 13.51 11.51 7 98382 15886 50490849
Groin pain 13.48 11.51 43 98346 8848 50497887
Chest wall mass 13.37 11.51 5 98384 62 50506673
Papillary thyroid cancer 13.37 11.51 18 98371 1997 50504738
Premature labour 13.30 11.51 3 98386 11473 50495262
Cardiac valve sclerosis 13.24 11.51 4 98385 24 50506711
Aphthous ulcer 13.20 11.51 48 98341 10549 50496186
Peritoneal lesion 13.20 11.51 3 98386 4 50506731
Joint range of motion decreased 13.19 11.51 10 98379 18502 50488233
Cachexia 13.18 11.51 28 98361 4505 50502230
Denture wearer 13.18 11.51 7 98382 207 50506528
Hilar lymphadenopathy 13.14 11.51 13 98376 1034 50505701
Ovarian cancer recurrent 13.06 11.51 12 98377 870 50505865
Eating disorder 13.06 11.51 62 98327 15347 50491388
Creatinine renal clearance increased 12.98 11.51 10 98379 568 50506167
Poisoning 12.97 11.51 4 98385 12425 50494310
Spondylitic myelopathy 12.97 11.51 4 98385 26 50506709
Blood phosphorus decreased 12.92 11.51 25 98364 3764 50502971
Bone cancer metastatic 12.83 11.51 6 98383 134 50506601
Fibrous histiocytoma 12.69 11.51 9 98380 450 50506285
Chronic obstructive pulmonary disease 12.69 11.51 57 98332 53378 50453357
Dyspepsia 12.48 11.51 208 98181 73889 50432846
Grip strength decreased 12.47 11.51 4 98385 12117 50494618
Rectosigmoid cancer recurrent 12.45 11.51 3 98386 6 50506729
Progesterone abnormal 12.45 11.51 3 98386 6 50506729
Nitrituria 12.45 11.51 3 98386 6 50506729
Coagulopathy 12.40 11.51 10 98379 17934 50488801
Cellulitis 12.39 11.51 200 98189 70598 50436137
Emotional distress 12.38 11.51 23 98366 28640 50478095
Device malfunction 12.36 11.51 7 98382 15114 50491621
Post procedural complication 12.33 11.51 7 98382 15097 50491638
Gastroenteritis viral 12.33 11.51 11 98378 18775 50487960
Malignant neoplasm of choroid 12.14 11.51 3 98386 7 50506728
Mediastinal disorder 12.13 11.51 8 98381 355 50506380
Posterior reversible encephalopathy syndrome 12.07 11.51 7 98382 14921 50491814
Metastases to soft tissue 12.07 11.51 6 98383 154 50506581
Limb injury 11.97 11.51 13 98376 20237 50486498
Altered state of consciousness 11.95 11.51 15 98374 21895 50484840
Congenital haematological disorder 11.94 11.51 4 98385 35 50506700
Tooth development disorder 11.94 11.51 4 98385 35 50506700
Supraventricular tachyarrhythmia 11.94 11.51 5 98384 85 50506650
Change of bowel habit 11.93 11.51 16 98373 1768 50504967
Pustule 11.86 11.51 13 98376 1165 50505570
White blood cell count abnormal 11.86 11.51 30 98359 5410 50501325
Anaphylactic shock 11.85 11.51 13 98376 20142 50486593
Lymphangitis 11.84 11.51 11 98378 809 50505926
KL-6 increased 11.84 11.51 4 98385 36 50506699
Subclavian vein thrombosis 11.83 11.51 16 98373 1783 50504952
Disability 11.83 11.51 5 98384 12770 50493965
Psychotic disorder 11.82 11.51 15 98374 21797 50484938
Bone cancer 11.78 11.51 13 98376 1174 50505561
Blood oestrogen increased 11.78 11.51 5 98384 88 50506647
Obstructive airways disorder 11.75 11.51 8 98381 15644 50491091
Pneumocystis jirovecii pneumonia 11.68 11.51 7 98382 14656 50492079
Vertigo 11.67 11.51 153 98236 51679 50455056
Acute cutaneous lupus erythematosus 11.66 11.51 7 98382 263 50506472
Hyponatraemia 11.64 11.51 125 98264 96014 50410721
Polychromic red blood cells present 11.59 11.51 3 98386 9 50506726
Actinic elastosis 11.59 11.51 3 98386 9 50506726
Inferior vena caval occlusion 11.59 11.51 3 98386 9 50506726
Red blood cell poikilocytes present 11.59 11.51 3 98386 9 50506726
Monoplegia 11.56 11.51 20 98369 2763 50503972
Fear 11.51 11.51 7 98382 14542 50492193

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 115.33 29.02 48 926 51396 29522157
Metastases to lung 63.08 29.02 19 955 7836 29565717
Epiphysiolysis 46.32 29.02 7 967 98 29573455
Hyporesponsive to stimuli 42.02 29.02 9 965 942 29572611
Hot flush 36.93 29.02 15 959 14855 29558698
Drug exposure before pregnancy 35.05 29.02 4 970 3 29573550
Wrong patient received product 34.19 29.02 9 965 2273 29571280
Neoplasm progression 33.68 29.02 15 959 18597 29554956
PIK3CA-activated mutation 31.64 29.02 5 969 95 29573458
Breast cancer recurrent 30.13 29.02 4 970 20 29573533
Pathological fracture 29.52 29.02 9 965 3846 29569707
Multiple congenital abnormalities 29.14 29.02 6 968 518 29573035

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 1726.68 12.02 873 73368 40091 64384400
Metastases to bone 1418.06 12.02 615 73626 19820 64404671
Neutropenia 1362.29 12.02 1521 72720 238103 64186388
White blood cell count decreased 1028.64 12.02 1078 73163 156759 64267732
Malignant neoplasm progression 968.09 12.02 896 73345 111975 64312516
Metastases to liver 804.96 12.02 439 73802 23502 64400989
Fatigue 576.87 12.02 2026 72215 746704 63677787
Hot flush 562.82 12.02 449 73792 45786 64378705
Breast cancer metastatic 517.44 12.02 222 74019 6947 64417544
Alopecia 513.12 12.02 781 73460 164909 64259582
Osteonecrosis of jaw 403.87 12.02 348 73893 39477 64385014
Tumour marker increased 398.85 12.02 150 74091 3300 64421191
Metastases to lung 394.94 12.02 236 74005 15028 64409463
Disease progression 367.14 12.02 616 73625 141064 64283427
Drug ineffective 342.05 12.02 281 73960 839966 63584525
Bone pain 341.66 12.02 343 73898 47229 64377262
Metastases to lymph nodes 338.38 12.02 176 74065 8541 64415950
Carbohydrate antigen 15-3 increased 300.32 12.02 89 74152 898 64423593
Breast cancer recurrent 283.04 12.02 108 74133 2475 64422016
Completed suicide 219.52 12.02 9 74232 224405 64200086
Nausea 218.68 12.02 1597 72644 784203 63640288
Breast cancer 208.91 12.02 210 74031 28938 64395553
Toxicity to various agents 197.10 12.02 86 74155 363427 64061064
Full blood count abnormal 194.46 12.02 204 74037 29553 64394938
Bone lesion 194.45 12.02 102 74139 5035 64419456
Skin hypopigmentation 190.63 12.02 61 74180 810 64423681
Neutrophil count decreased 176.67 12.02 318 73923 76878 64347613
Second primary malignancy 172.15 12.02 130 74111 12207 64412284
Osteonecrosis 148.93 12.02 173 74068 28056 64396435
Neuropathy peripheral 138.95 12.02 371 73870 117154 64307337
Stomatitis 138.78 12.02 355 73886 109250 64315241
PIK3CA-activated mutation 132.52 12.02 41 74200 484 64424007
Metastases to skin 131.89 12.02 53 74188 1399 64423092
Leukopenia 130.34 12.02 330 73911 100912 64323579
Arthralgia 121.22 12.02 897 73344 441363 63983128
Therapeutic product effect decreased 118.52 12.02 3 74238 115348 64309143
Decreased appetite 117.83 12.02 636 73605 280653 64143838
Hypotension 116.72 12.02 161 74080 380813 64043678
Metastases to spine 114.64 12.02 64 74177 3579 64420912
Metastases to pleura 110.90 12.02 45 74196 1219 64423272
Full blood count decreased 110.20 12.02 133 74108 22449 64402042
Lymphoedema 109.46 12.02 91 74150 9814 64414677
Infusion related reaction 107.97 12.02 28 74213 164439 64260052
Drug interaction 106.95 12.02 157 74084 361926 64062565
Carcinoembryonic antigen increased 106.23 12.02 49 74192 1824 64422667
Drug hypersensitivity 104.52 12.02 73 74168 237742 64186749
Off label use 102.62 12.02 379 73862 632427 63792064
Rheumatoid arthritis 102.22 12.02 31 74210 164263 64260228
Metastases to central nervous system 101.07 12.02 101 74140 13811 64410680
Drug abuse 98.21 12.02 17 74224 132357 64292134
Red blood cell count decreased 97.75 12.02 189 74052 48197 64376294
Diarrhoea 97.53 12.02 1263 72978 721441 63703050
Dry skin 95.11 12.02 193 74048 50968 64373523
Pseudocirrhosis 92.96 12.02 33 74208 612 64423879
Nail disorder 92.75 12.02 78 74163 8546 64415945
Metastasis 90.70 12.02 65 74176 5630 64418861
Tooth extraction 87.47 12.02 79 74162 9522 64414969
Contraindicated product administered 86.55 12.02 11 74230 107818 64316673
Overdose 82.84 12.02 40 74201 159526 64264965
Ejection fraction decreased 82.55 12.02 131 74110 28576 64395915
Constipation 81.18 12.02 496 73745 228841 64195650
Cardiac arrest 77.90 12.02 40 74201 154024 64270467
Bone disorder 75.79 12.02 95 74146 16664 64407827
Joint swelling 75.38 12.02 82 74159 215300 64209191
Intentional overdose 75.11 12.02 8 74233 89936 64334555
Maternal exposure during pregnancy 74.07 12.02 11 74230 95873 64328618
Progesterone increased 73.79 12.02 16 74225 35 64424456
Ovarian hyperstimulation syndrome 73.60 12.02 44 74197 2801 64421690
Pleural effusion 73.02 12.02 314 73927 126245 64298246
Malignant pleural effusion 71.89 12.02 44 74197 2923 64421568
Haematotoxicity 69.63 12.02 80 74161 12816 64411675
Mucosal dryness 68.89 12.02 43 74198 2958 64421533
Oral pain 65.08 12.02 115 74126 27378 64397113
Thrombocytopenia 64.59 12.02 460 73781 223341 64201150
Metastases to the mediastinum 64.57 12.02 24 74217 510 64423981
Systemic lupus erythematosus 64.56 12.02 7 74234 77605 64346886
Hepatic lesion 63.30 12.02 53 74188 5771 64418720
Lymphangiosis carcinomatosa 62.84 12.02 34 74207 1787 64422704
Gastrointestinal haemorrhage 61.63 12.02 38 74203 132274 64292217
Hypersensitivity 61.09 12.02 82 74159 196370 64228121
Taste disorder 60.41 12.02 64 74177 9369 64415122
Cardio-respiratory arrest 60.40 12.02 19 74222 98374 64326117
Trigger finger 60.01 12.02 42 74199 3503 64420988
Spinal pain 59.40 12.02 73 74168 12548 64411943
Dysgeusia 59.09 12.02 152 74089 46895 64377596
Seizure 58.98 12.02 63 74178 166829 64257662
Treatment failure 58.05 12.02 31 74210 116785 64307706
Madarosis 57.60 12.02 35 74206 2295 64422196
Pleural neoplasm 57.54 12.02 18 74223 221 64424270
Intentional product use issue 57.50 12.02 19 74222 95345 64329146
Invasive ductal breast carcinoma 57.12 12.02 47 74194 4995 64419496
Arthropathy 55.98 12.02 35 74206 120932 64303559
Synovitis 55.91 12.02 22 74219 99068 64325423
Pneumonia 55.89 12.02 396 73845 559180 63865311
Injection site erythema 54.96 12.02 8 74233 70792 64353699
Epistaxis 54.70 12.02 241 74000 97890 64326601
Pulmonary embolism 53.93 12.02 320 73921 146036 64278455
Palmar-plantar erythrodysaesthesia syndrome 52.70 12.02 108 74133 28711 64395780
Breast pain 52.65 12.02 52 74189 7009 64417482
Respiratory failure 52.45 12.02 65 74176 161118 64263373
Bone marrow failure 52.25 12.02 147 74094 47805 64376686
Injection site pain 51.88 12.02 32 74209 111376 64313115
Asthenia 51.68 12.02 734 73507 427310 63997181
Condition aggravated 50.88 12.02 238 74003 372188 64052303
Suicide attempt 50.76 12.02 10 74231 70997 64353494
Multiple organ dysfunction syndrome 50.26 12.02 27 74214 101386 64323105
Coronary artery disease 46.51 12.02 7 74234 60426 64364065
Back pain 46.01 12.02 465 73776 249706 64174785
Coma 45.39 12.02 22 74219 87593 64336898
Breast mass 45.07 12.02 42 74199 5268 64419223
Anaemia 44.34 12.02 646 73595 378034 64046457
Septic shock 44.15 12.02 34 74207 105403 64319088
Metastases to ovary 43.91 12.02 15 74226 247 64424244
Hepatorenal failure 43.58 12.02 23 74218 1149 64423342
Device related thrombosis 43.19 12.02 28 74213 2057 64422434
Myocardial infarction 43.15 12.02 78 74163 165743 64258748
Oxygen saturation decreased 43.08 12.02 36 74205 107140 64317351
Metabolic acidosis 43.02 12.02 14 74227 70944 64353547
Drug reaction with eosinophilia and systemic symptoms 42.38 12.02 6 74235 54211 64370280
Metastases to chest wall 41.59 12.02 16 74225 375 64424116
BRCA1 gene mutation 41.41 12.02 9 74232 20 64424471
Lymphadenopathy 41.31 12.02 133 74108 46553 64377938
Pneumonia aspiration 41.02 12.02 9 74232 59262 64365229
Pericarditis 40.32 12.02 11 74230 62505 64361986
Osteolysis 40.13 12.02 30 74211 2773 64421718
Metastases to peritoneum 40.05 12.02 33 74208 3514 64420977
Metastases to meninges 40.01 12.02 30 74211 2785 64421706
Ascites 39.79 12.02 159 74082 61842 64362649
Electrocardiogram PR shortened 39.52 12.02 14 74227 258 64424233
Orthostatic hypotension 39.42 12.02 4 74237 46734 64377757
Nail dystrophy 39.14 12.02 19 74222 794 64423697
Respiratory arrest 38.85 12.02 7 74234 52978 64371513
Gingivitis 38.82 12.02 46 74195 7613 64416878
Exposed bone in jaw 38.45 12.02 32 74209 3455 64421036
Onychoclasis 38.36 12.02 36 74205 4556 64419935
Hepatotoxicity 38.26 12.02 117 74124 39845 64384646
Isosthenuria 38.04 12.02 11 74230 101 64424390
Exposure during pregnancy 38.02 12.02 21 74220 77654 64346837
Delirium 37.99 12.02 16 74225 69178 64355313
Metastases to bladder 37.83 12.02 13 74228 218 64424273
Skin weeping 37.51 12.02 17 74224 607 64423884
Pathological fracture 37.49 12.02 49 74192 8956 64415535
Breast cancer female 36.98 12.02 37 74204 5066 64419425
Polyneuropathy 36.90 12.02 75 74166 19819 64404672
Injection site reaction 36.86 12.02 5 74236 46659 64377832
Encephalopathy 36.74 12.02 11 74230 58808 64365683
Thoracic vertebral fracture 36.71 12.02 35 74206 4518 64419973
Metastases to stomach 36.43 12.02 13 74228 245 64424246
Musculoskeletal chest pain 36.36 12.02 78 74163 21401 64403090
Unevaluable event 36.32 12.02 7 74234 50482 64374009
Loss of consciousness 35.80 12.02 73 74168 148292 64276199
Wrong technique in product usage process 35.71 12.02 15 74226 64959 64359532
Wound 35.55 12.02 22 74219 76455 64348036
Bradycardia 35.07 12.02 51 74190 118168 64306323
Generalised tonic-clonic seizure 34.71 12.02 3 74238 39854 64384637
Osteoma cutis 34.61 12.02 6 74235 0 64424491
Metastases to eye 34.24 12.02 12 74229 214 64424277
Psoriasis 34.21 12.02 20 74221 71683 64352808
Multiple sclerosis relapse 33.48 12.02 4 74237 41131 64383360
Metastases to pelvis 33.43 12.02 15 74226 523 64423968
Gastroenteritis radiation 33.38 12.02 16 74225 650 64423841
Carbohydrate antigen 125 increased 33.00 12.02 23 74218 1905 64422586
Bone sequestrum 32.61 12.02 19 74222 1153 64423338
Cardiac failure congestive 32.58 12.02 63 74178 130517 64293974
Sinusitis 32.56 12.02 75 74166 145853 64278638
Sequestrectomy 32.54 12.02 17 74224 832 64423659
Urinary tract inflammation 32.33 12.02 9 74232 71 64424420
Aggression 32.03 12.02 7 74234 46225 64378266
Cytomegalovirus infection 31.85 12.02 3 74238 37196 64387295
Mucosal inflammation 31.37 12.02 149 74092 62435 64362056
Pyelitis 31.36 12.02 12 74229 277 64424214
Neoplasm malignant 31.24 12.02 80 74161 24608 64399883
Tumour marker decreased 31.22 12.02 8 74233 44 64424447
Hallucination 31.07 12.02 23 74218 72765 64351726
Injection site bruising 30.97 12.02 3 74238 36370 64388121
Unresponsive to stimuli 30.44 12.02 10 74231 50383 64374108
Hypermetabolism 30.43 12.02 12 74229 301 64424190
Bone trimming 30.22 12.02 7 74234 23 64424468
Invasive lobular breast carcinoma 30.10 12.02 14 74227 531 64423960
Electrocardiogram QT prolonged 30.07 12.02 175 74066 79273 64345218
Gamma-glutamyltransferase increased 30.01 12.02 123 74118 48387 64376104
Decreased immune responsiveness 29.95 12.02 31 74210 4417 64420074
Plasma cell myeloma 29.92 12.02 8 74233 46067 64378424
Hyperkalaemia 29.63 12.02 44 74197 101085 64323406
Agitation 29.41 12.02 35 74206 88332 64336159
Tachycardia 29.40 12.02 82 74159 149497 64274994
Ovarian rupture 29.35 12.02 7 74234 27 64424464
Cancer pain 29.26 12.02 30 74211 4227 64420264
Lacrimation increased 29.21 12.02 65 74176 18281 64406210
Skin toxicity 29.17 12.02 37 74204 6565 64417926
Pneumonitis 29.05 12.02 125 74116 50240 64374251
Anaphylactic reaction 28.92 12.02 22 74219 68642 64355849
Keloid scar 28.66 12.02 9 74232 112 64424379
Blood pressure fluctuation 28.47 12.02 12 74229 51859 64372632
Elliptocytosis 28.39 12.02 7 74234 32 64424459
Myalgia 28.25 12.02 293 73948 158324 64266167
Dental fistula 27.96 12.02 13 74228 493 64423998
Therapy non-responder 27.90 12.02 21 74220 65878 64358613
Mental status changes 27.87 12.02 18 74223 61144 64363347
Drug dependence 27.71 12.02 3 74238 33309 64391182
Depressed level of consciousness 27.37 12.02 32 74209 81404 64343087
Adverse event 27.32 12.02 6 74235 39483 64385008
Irritable bowel syndrome 27.26 12.02 5 74236 37364 64387127
Recall phenomenon 27.17 12.02 16 74225 990 64423501
Therapeutic product effect incomplete 26.62 12.02 49 74192 103433 64321058
Urticaria 26.61 12.02 84 74157 147233 64277258
Bladder hypertrophy 26.61 12.02 13 74228 551 64423940
Acute kidney injury 26.54 12.02 361 73880 448879 63975612
Mouth swelling 26.43 12.02 31 74210 5076 64419415
Bone debridement 26.36 12.02 12 74229 433 64424058
Cutaneous lupus erythematosus 26.28 12.02 23 74218 2659 64421832
Pleural disorder 26.19 12.02 14 74227 718 64423773
Injury 26.17 12.02 16 74225 55976 64368515
Superinfection 26.02 12.02 27 74214 3859 64420632
Osteitis 25.76 12.02 26 74215 3596 64420895
Osteomyelitis 25.69 12.02 80 74161 27507 64396984
Hypoglycaemia 25.48 12.02 40 74201 89852 64334639
Heart rate decreased 25.37 12.02 16 74225 55051 64369440
Hypoxia 25.20 12.02 39 74202 88110 64336381
Nephrosclerosis 25.17 12.02 18 74223 1553 64422938
Acute myocardial infarction 24.97 12.02 26 74215 69692 64354799
Osteosclerosis 24.75 12.02 25 74216 3461 64421030
Intentional product misuse 24.74 12.02 28 74213 72267 64352224
Blood calcium increased 24.58 12.02 39 74202 8503 64415988
Cough 24.54 12.02 486 73755 301662 64122829
Duodenal ulcer perforation 24.48 12.02 5 74236 34620 64389871
Postmenopausal haemorrhage 24.29 12.02 17 74224 1418 64423073
Rhabdomyolysis 23.98 12.02 43 74198 91683 64332808
Breast cancer stage IV 23.84 12.02 12 74229 543 64423948
Paraesthesia 23.72 12.02 248 73993 134274 64290217
CYP3A4 polymorphism 23.67 12.02 7 74234 70 64424421
Hormone receptor positive breast cancer 23.44 12.02 10 74231 308 64424183
Peri-implantitis 23.42 12.02 6 74235 33 64424458
Macular hole 23.38 12.02 13 74228 721 64423770
Vitiligo 23.27 12.02 18 74223 1750 64422741
Dental care 23.27 12.02 13 74228 728 64423763
Drug withdrawal syndrome 23.23 12.02 4 74237 31287 64393204
C-reactive protein abnormal 23.21 12.02 3 74238 29044 64395447
Nail growth abnormal 23.09 12.02 11 74230 441 64424050
Ovarian fibrosis 23.07 12.02 4 74237 0 64424491
Multiple pregnancy 22.84 12.02 6 74235 37 64424454
Ovarian disorder 22.79 12.02 11 74230 454 64424037
White blood cell count abnormal 22.72 12.02 28 74213 4826 64419665
Dysarthria 22.60 12.02 21 74220 59385 64365106
Tongue discomfort 22.60 12.02 19 74222 2080 64422411
Skin exfoliation 22.59 12.02 107 74134 44778 64379713
Renal failure 22.53 12.02 120 74121 181568 64242923
Insomnia 22.50 12.02 336 73905 197500 64226991
Malignant peritoneal neoplasm 22.24 12.02 12 74229 627 64423864
Hair texture abnormal 22.17 12.02 22 74219 2982 64421509
Adjusted calcium decreased 22.16 12.02 8 74233 156 64424335
Aspartate aminotransferase increased 22.14 12.02 223 74018 119565 64304926
Blood pressure decreased 22.01 12.02 41 74200 86158 64338333
Metastases to spinal cord 21.94 12.02 6 74235 44 64424447
Syncope 21.91 12.02 100 74141 157535 64266956
Vitreous detachment 21.77 12.02 18 74223 1926 64422565
Wheezing 21.77 12.02 37 74204 80542 64343949
Respiratory distress 21.74 12.02 17 74224 52314 64372177
Nail avulsion 21.47 12.02 7 74234 99 64424392
Biopsy bone abnormal 21.45 12.02 5 74236 17 64424474
Dyspepsia 21.36 12.02 162 74079 80150 64344341
Blood alkaline phosphatase increased 21.32 12.02 124 74117 56155 64368336
Knee arthroplasty 21.07 12.02 3 74238 26996 64397495
Medication error 21.05 12.02 16 74225 49950 64374541
Body surface area decreased 21.02 12.02 5 74236 19 64424472
Pulmonary mass 20.86 12.02 68 74173 23948 64400543
Lymphadenopathy mediastinal 20.85 12.02 24 74217 3852 64420639
Fall 20.80 12.02 346 73895 416480 64008011
Loss of personal independence in daily activities 20.76 12.02 32 74209 72422 64352069
Skin lesion 20.62 12.02 90 74151 36392 64388099
Jaw disorder 20.60 12.02 26 74215 4591 64419900
Therapy cessation 20.58 12.02 83 74158 32406 64392085
Tumour marker abnormal 20.50 12.02 8 74233 195 64424296
Cardiogenic shock 20.36 12.02 6 74235 32421 64392070
Swelling 20.32 12.02 105 74136 160113 64264378
Drug level increased 20.28 12.02 7 74234 34189 64390302
Blood pressure increased 20.28 12.02 116 74125 172436 64252055
Gait deviation 20.12 12.02 6 74235 62 64424429
Neoplasm 20.09 12.02 32 74209 6999 64417492
Haematuria 20.06 12.02 24 74217 60447 64364044
Hepatic enzyme increased 19.54 12.02 80 74161 129863 64294628
Chronic cutaneous lupus erythematosus 19.53 12.02 8 74233 222 64424269
Vulvovaginal inflammation 19.51 12.02 10 74231 470 64424021
Mastectomy 19.46 12.02 13 74228 1005 64423486
Therapy partial responder 19.44 12.02 39 74202 10209 64414282
Myelosuppression 19.39 12.02 66 74175 23764 64400727
Antisynthetase syndrome 19.23 12.02 7 74234 140 64424351
Nail toxicity 19.22 12.02 9 74232 347 64424144
Bone marrow infiltration 19.09 12.02 10 74231 492 64423999
Child-Pugh-Turcotte score abnormal 19.04 12.02 4 74237 7 64424484
Aortic thrombosis 19.03 12.02 15 74226 1499 64422992
Transaminases 18.94 12.02 6 74235 77 64424414
SAPHO syndrome 18.91 12.02 7 74234 147 64424344
Anisocytosis 18.89 12.02 12 74229 851 64423640
Emotional distress 18.74 12.02 9 74232 36029 64388462
Heart rate increased 18.72 12.02 55 74186 98620 64325871
RET gene mutation 18.69 12.02 4 74237 8 64424483
Gingival erythema 18.61 12.02 10 74231 518 64423973
Myeloproliferative neoplasm 18.57 12.02 12 74229 877 64423614
Cytopenia 18.41 12.02 49 74192 15422 64409069
Muscle injury 18.32 12.02 4 74237 26433 64398058
Trichorrhexis 18.27 12.02 11 74230 709 64423782
Abdominal lymphadenopathy 18.27 12.02 13 74228 1113 64423378
Triple negative breast cancer 18.20 12.02 6 74235 88 64424403
Hydronephrosis 18.11 12.02 46 74195 14079 64410412
Staphylococcal infection 18.03 12.02 19 74222 50659 64373832
Meningeal disorder 17.94 12.02 9 74232 404 64424087
Metastases to thorax 17.81 12.02 7 74234 174 64424317
Epiphysiolysis 17.78 12.02 6 74235 95 64424396
Blister 17.74 12.02 42 74199 80925 64343566
B-cell lymphoma stage III 17.54 12.02 4 74237 12 64424479
Somnolence 17.49 12.02 150 74091 203495 64220996
Drug ineffective for unapproved indication 17.41 12.02 7 74234 31126 64393365
Hydroxyproline increased 17.31 12.02 3 74238 0 64424491
Purulent discharge 17.20 12.02 26 74215 5435 64419056
Confusional state 17.19 12.02 205 74036 260939 64163552
Cellulitis 17.14 12.02 174 74067 93483 64331008
Flushing 17.07 12.02 41 74200 78607 64345884
Angioedema 17.06 12.02 28 74213 61793 64362698
Mucosal hypertrophy 17 12.02 5 74236 49 64424442
Hypersensitivity vasculitis 16.93 12.02 29 74212 6732 64417759
Invasive breast carcinoma 16.77 12.02 9 74232 465 64424026
Adjusted calcium increased 16.73 12.02 5 74236 52 64424439
No adverse event 16.67 12.02 6 74235 28555 64395936
Dental discomfort 16.67 12.02 8 74233 326 64424165
Bone marrow oedema syndrome 16.65 12.02 4 74237 16 64424475
Coagulopathy 16.55 12.02 8 74233 31912 64392579
Pancreatitis acute 16.48 12.02 15 74226 42840 64381651
Metastases to uterus 16.32 12.02 5 74236 57 64424434
Gastrointestinal toxicity 16.29 12.02 25 74216 5297 64419194
Visual impairment 16.23 12.02 143 74098 73934 64350557
Hyponatraemia 16.23 12.02 102 74139 148237 64276254
Chronic kidney disease 16.20 12.02 26 74215 57893 64366598
Injection site haemorrhage 16.17 12.02 4 74237 24274 64400217
Dyskinesia 16.11 12.02 13 74228 39375 64385116
Dysaesthesia 16.05 12.02 24 74217 4971 64419520
Thirst 16.05 12.02 44 74197 14093 64410398
Debridement 16.04 12.02 14 74227 1612 64422879
Pustule 16.04 12.02 13 74228 1352 64423139
Dilatation ventricular 16.02 12.02 21 74220 3849 64420642
Blood pressure systolic increased 16.01 12.02 20 74221 49433 64375058
Vomiting 15.92 12.02 781 73460 550336 63874155
Paraneoplastic syndrome 15.88 12.02 11 74230 902 64423589
Acute promyelocytic leukaemia 15.85 12.02 13 74228 1375 64423116
Pneumocystis jirovecii pneumonia 15.81 12.02 6 74235 27628 64396863
Pancreatic neoplasm 15.80 12.02 13 74228 1382 64423109
Plastic surgery 15.79 12.02 5 74236 64 64424427
Fibrous histiocytoma 15.69 12.02 9 74232 530 64423961
Congestive hepatopathy 15.59 12.02 21 74220 3952 64420539
Glossodynia 15.45 12.02 32 74209 64664 64359827
Right ventricular failure 15.39 12.02 3 74238 21468 64403023
Sedation 15.37 12.02 15 74226 41447 64383044
Asthma 15.36 12.02 57 74184 95168 64329323
Subclavian vein thrombosis 15.35 12.02 16 74225 2298 64422193
Acute respiratory failure 15.34 12.02 21 74220 49913 64374578
Jaw operation 15.25 12.02 10 74231 749 64423742
Primary pulmonary melanoma 15.23 12.02 3 74238 3 64424488
Upper gastrointestinal haemorrhage 15.20 12.02 11 74230 35209 64389282
Fractured sacrum 15.16 12.02 13 74228 1462 64423029
Adenocarcinoma 15.15 12.02 19 74222 3332 64421159
Breast discharge 15.12 12.02 9 74232 568 64423923
Vertigo 15.11 12.02 118 74123 58893 64365598
Neoplasm recurrence 15.03 12.02 20 74221 3719 64420772
Pain in jaw 14.92 12.02 89 74152 40666 64383825
Haematochezia 14.88 12.02 34 74207 66339 64358152
Angina pectoris 14.84 12.02 18 74223 45063 64379428
Hydrothorax 14.83 12.02 12 74229 1245 64423246
Androgenetic alopecia 14.80 12.02 6 74235 162 64424329
Tooth resorption 14.79 12.02 4 74237 28 64424463
Toothache 14.78 12.02 49 74192 17410 64407081
Discomfort 14.68 12.02 46 74195 80832 64343659
Granulocyte count decreased 14.68 12.02 12 74229 1264 64423227
Psychomotor disadaptation syndrome 14.67 12.02 4 74237 29 64424462
Change of bowel habit 14.66 12.02 16 74225 2422 64422069
Depressed mood 14.65 12.02 89 74152 40923 64383568
Jugular vein thrombosis 14.65 12.02 20 74221 3811 64420680
Infection 14.64 12.02 139 74102 184741 64239750
Sopor 14.54 12.02 8 74233 29653 64394838
Cor pulmonale acute 14.50 12.02 9 74232 613 64423878
Ventricular tachycardia 14.40 12.02 11 74230 34254 64390237
Gastrointestinal disorder 14.27 12.02 54 74187 89655 64334836
Prescribed overdose 14.24 12.02 3 74238 20328 64404163
Bone cancer metastatic 14.21 12.02 6 74235 180 64424311
Hospitalisation 14.20 12.02 42 74199 75165 64349326
Creatinine renal clearance increased 14.16 12.02 10 74231 846 64423645
Mobility decreased 14.09 12.02 51 74190 85789 64338702
Ill-defined disorder 14.07 12.02 18 74223 44034 64380457
Neutrophil count abnormal 14.03 12.02 17 74224 2879 64421612
Product dose omission in error 14.02 12.02 16 74225 2543 64421948
Progesterone abnormal 14.02 12.02 3 74238 6 64424485
Congenital haematological disorder 14.00 12.02 4 74237 35 64424456
Shock 13.99 12.02 14 74227 38226 64386265
Ventricular fibrillation 13.95 12.02 5 74236 23855 64400636
Disorientation 13.86 12.02 27 74214 55801 64368690
Poisoning 13.83 12.02 4 74237 21875 64402616
Incorrect dose administered 13.73 12.02 31 74210 60734 64363757
Altered state of consciousness 13.72 12.02 14 74227 37888 64386603
Carcinoid tumour pulmonary 13.72 12.02 7 74234 326 64424165
Anaphylactic shock 13.71 12.02 9 74232 30319 64394172
Toxic nodular goitre 13.71 12.02 4 74237 38 64424453
Blood phosphorus decreased 13.67 12.02 24 74217 5681 64418810
Transaminases increased 13.61 12.02 93 74148 44501 64379990
Withdrawal syndrome 13.60 12.02 5 74236 23487 64401004
Joint stiffness 13.53 12.02 70 74171 30334 64394157
Aphthous ulcer 13.50 12.02 39 74202 12867 64411624
Clostridium difficile infection 13.50 12.02 13 74228 36150 64388341
Urinary tract infection 13.32 12.02 355 73886 231241 64193250
Actinomycosis 13.30 12.02 10 74231 932 64423559
Recurrent cancer 13.28 12.02 15 74226 2358 64422133
Tremor 13.26 12.02 108 74133 148122 64276369
Acute cutaneous lupus erythematosus 13.17 12.02 7 74234 355 64424136
Interstitial lung disease 13.13 12.02 171 74070 97561 64326930
Kidney fibrosis 13.11 12.02 17 74224 3084 64421407
Adverse drug reaction 13.10 12.02 20 74221 45444 64379047
Carbohydrate antigen 27.29 increased 13.02 12.02 4 74237 46 64424445
Bronchopulmonary aspergillosis 13.00 12.02 3 74238 19082 64405409
Superior vena cava occlusion 12.92 12.02 5 74236 119 64424372
Anuria 12.88 12.02 3 74238 18961 64405530
Pregnancy 12.85 12.02 4 74237 20861 64403630
Gingival swelling 12.83 12.02 19 74222 3901 64420590
Tooth development disorder 12.79 12.02 4 74237 49 64424442
Lymphopenia 12.79 12.02 61 74180 25596 64398895
Paralysis recurrent laryngeal nerve 12.77 12.02 5 74236 123 64424368
Alanine aminotransferase increased 12.77 12.02 228 74013 138803 64285688
Lung opacity 12.69 12.02 17 74224 3182 64421309
Platelet count decreased 12.68 12.02 267 73974 167444 64257047
Pericardial effusion 12.67 12.02 83 74158 39171 64385320
Metastases to breast 12.63 12.02 6 74235 239 64424252
Red blood cell poikilocytes present 12.49 12.02 3 74238 12 64424479
Polychromic red blood cells present 12.49 12.02 3 74238 12 64424479
Clostridium difficile colitis 12.42 12.02 8 74233 27215 64397276
Pulmonary hypertension 12.41 12.02 19 74222 43120 64381371
Blood creatine phosphokinase increased 12.33 12.02 31 74210 58527 64365964
KL-6 increased 12.31 12.02 4 74237 56 64424435
Mucosal pain 12.30 12.02 3 74238 13 64424478
Psychotic disorder 12.26 12.02 13 74228 34565 64389926
Cholangitis sclerosing 12.25 12.02 13 74228 1906 64422585
Folliculitis 12.21 12.02 10 74231 30067 64394424
HER2 positive breast cancer 12.14 12.02 6 74235 261 64424230
Toxic epidermal necrolysis 12.07 12.02 15 74226 37151 64387340
Lymphangioleiomyomatosis 12.04 12.02 5 74236 144 64424347

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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hormone receptor positive malignant neoplasm of breast indication 417181009
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 March 13, 2022 NEW CHEMICAL ENTITY
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
72965 RXNORM
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
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 25 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 50268-476 TABLET 2.50 mg ORAL ANDA 28 sections
LETROZOLE HUMAN PRESCRIPTION DRUG LABEL 1 51991-759 TABLET 2.50 mg ORAL ANDA 28 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 63629-7819 TABLET, FILM COATED 2.50 mg ORAL ANDA 25 sections
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