tamoxifen ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2561 10540-29-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tamoxifen
  • tamoxifen citrate
  • tamoxifene
  • tamoxifene citrate
One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.
  • Molecular weight: 371.52
  • Formula: C26H29NO
  • CLOGP: 6.82
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -5.56
  • ROTB: 8

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.18 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1977 FDA

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
Metastases to bone 1811.70 11.70 627 39240 20392 63428763
Malignant neoplasm progression 1639.79 11.70 867 39000 81254 63367901
Metastases to liver 1061.57 11.70 438 39429 23201 63425954
Metastases to lung 595.02 11.70 243 39624 12507 63436648
Metastases to lymph nodes 509.33 11.70 192 39675 7966 63441189
Breast cancer recurrent 490.55 11.70 159 39708 4182 63444973
Breast cancer metastatic 434.13 11.70 191 39676 11827 63437328
Disease progression 417.48 11.70 447 39420 122311 63326844
Neoplasm progression 397.99 11.70 261 39606 36167 63412988
Osteonecrosis of jaw 241.57 11.70 190 39677 34933 63414222
Breast cancer 238.49 11.70 216 39651 48167 63400988
Metastasis 232.00 11.70 96 39771 5101 63444054
Metastases to central nervous system 204.62 11.70 118 39749 12987 63436168
Metastases to spine 190.26 11.70 73 39794 3176 63445979
Tumour marker increased 157.92 11.70 72 39795 4843 63444312
Uterine polyp 156.60 11.70 56 39811 1994 63447161
Endometrial hyperplasia 153.57 11.70 45 39822 835 63448320
Hot flush 147.29 11.70 171 39696 50988 63398167
Metastases to pleura 146.86 11.70 50 39817 1535 63447620
Bone lesion 145.61 11.70 72 39795 5809 63443346
Bone disorder 137.27 11.70 111 39756 21215 63427940
PIK3CA-activated mutation 136.96 11.70 43 39824 1016 63448139
Osteonecrosis 135.76 11.70 117 39750 24413 63424742
Second primary malignancy 127.86 11.70 73 39794 7880 63441275
Neuropathy peripheral 125.22 11.70 242 39625 113425 63335730
Contraindicated product administered 112.13 11.70 6 39861 217642 63231513
Metastases to skin 110.55 11.70 41 39826 1622 63447533
Acute myeloid leukaemia 109.82 11.70 89 39778 17058 63432097
Drug ineffective 109.21 11.70 318 39549 1044447 62404708
Hormone receptor positive breast cancer 109.11 11.70 31 39836 513 63448642
Hepatic lesion 104.61 11.70 54 39813 4771 63444384
Systemic lupus erythematosus 103.87 11.70 7 39860 208911 63240244
Metastases to peritoneum 103.01 11.70 48 39819 3394 63445761
Sarcoma uterus 101.29 11.70 18 39849 20 63449135
Pseudocirrhosis 101.08 11.70 31 39836 676 63448479
Glossodynia 98.60 11.70 3 39864 178873 63270282
Rheumatoid arthritis 96.06 11.70 21 39846 253798 63195357
Endometrial hypertrophy 96.03 11.70 25 39842 292 63448863
Therapeutic product effect decreased 91.72 11.70 8 39859 193179 63255976
Hysteroscopy 90.38 11.70 17 39850 32 63449123
Neutropenia 90.27 11.70 278 39589 174727 63274428
Carbohydrate antigen 15-3 increased 90.05 11.70 34 39833 1414 63447741
Device related thrombosis 90.04 11.70 36 39831 1749 63447406
Joint swelling 89.67 11.70 47 39820 327619 63121536
Synovitis 88.04 11.70 8 39859 186910 63262245
Bone pain 87.12 11.70 137 39730 54504 63394651
Osteolysis 85.76 11.70 40 39827 2834 63446321
Metastases to the mediastinum 85.36 11.70 25 39842 463 63448692
Palmar-plantar erythrodysaesthesia syndrome 83.69 11.70 87 39780 22928 63426227
Death 81.82 11.70 456 39411 373925 63075230
Endometrial cancer 78.40 11.70 39 39828 3186 63445969
Ascites 76.14 11.70 110 39757 40618 63408537
Uterine cancer 72.23 11.70 42 39825 4691 63444464
Wound 71.73 11.70 9 39858 163254 63285901
Tonsillar disorder 71.44 11.70 27 39840 1126 63448029
Pulmonary mass 70.88 11.70 79 39788 22517 63426638
Lymphadenopathy 70.63 11.70 103 39764 38355 63410800
Recurrent cancer 66.66 11.70 30 39837 1957 63447198
Hepatic enzyme increased 66.61 11.70 22 39845 202306 63246849
Endometrial atrophy 65.59 11.70 14 39853 62 63449093
Lymphoedema 65.15 11.70 56 39811 11636 63437519
Nasal disorder 64.83 11.70 33 39834 2831 63446324
Metastases to pelvis 64.58 11.70 20 39847 451 63448704
Abdominal discomfort 64.33 11.70 64 39803 320821 63128334
Nail disorder 63.86 11.70 58 39809 12957 63436198
Pleural effusion 63.64 11.70 164 39703 93046 63356109
Excessive eye blinking 61.74 11.70 25 39842 1255 63447900
Blood uric acid decreased 61.63 11.70 22 39845 779 63448376
Ejection fraction decreased 61.50 11.70 73 39794 22259 63426896
Maternal exposure during pregnancy 61.00 11.70 31 39836 220031 63229124
Maculopathy 59.91 11.70 29 39838 2233 63446922
Invasive ductal breast carcinoma 59.71 11.70 43 39824 6915 63442240
Acute promyelocytic leukaemia 58.50 11.70 22 39845 905 63448250
Swelling 57.43 11.70 53 39814 275325 63173830
Endocervical curettage 57.36 11.70 9 39858 0 63449155
Eosinophil percentage increased 56.26 11.70 22 39845 1007 63448148
Malignant pleural effusion 56.02 11.70 29 39838 2577 63446578
Metastatic neoplasm 54.87 11.70 34 39833 4261 63444894
Retinopathy 53.84 11.70 30 39837 3089 63446066
Infusion related reaction 52.69 11.70 46 39821 245475 63203680
Breast mass 52.59 11.70 42 39825 7880 63441275
Metastases to chest wall 52.19 11.70 18 39849 575 63448580
Hypertriglyceridaemia 52.16 11.70 38 39829 6221 63442934
Eastern Cooperative Oncology Group performance status worsened 52.05 11.70 22 39845 1232 63447923
Invasive lobular breast carcinoma 52.01 11.70 20 39847 875 63448280
Ovarian hyperstimulation syndrome 51.85 11.70 32 39835 3982 63445173
Pericarditis 51.57 11.70 10 39857 131569 63317586
Disease recurrence 51.36 11.70 75 39792 27955 63421200
Left ventricular dilatation 51.14 11.70 17 39850 484 63448671
Metastases to thorax 49.25 11.70 14 39853 232 63448923
Arthropathy 49.16 11.70 45 39822 234747 63214408
Dural arteriovenous fistula 47.83 11.70 9 39858 17 63449138
Endometrial thickening 47.67 11.70 15 39852 357 63448798
Completed suicide 47.65 11.70 16 39851 145657 63303498
Recall phenomenon 46.81 11.70 17 39850 633 63448522
Treatment failure 45.54 11.70 35 39832 199008 63250147
Product use issue 45.30 11.70 43 39824 220477 63228678
Uterine leiomyoma 45.15 11.70 41 39826 9157 63439998
Tooth extraction 45.07 11.70 43 39824 10221 63438934
Vitreous detachment 44.85 11.70 23 39844 2004 63447151
Ovarian cancer 44.70 11.70 34 39833 5942 63443213
Hypersensitivity 44.47 11.70 72 39795 292613 63156542
Exposure during pregnancy 44.47 11.70 21 39846 155526 63293629
Endometriosis 43.66 11.70 32 39835 5288 63443867
Acquired gene mutation 43.33 11.70 18 39849 965 63448190
Peritoneal disorder 43.26 11.70 15 39852 487 63448668
Pleural disorder 43.18 11.70 16 39851 631 63448524
Metastases to spinal cord 42.77 11.70 11 39856 122 63449033
Lymphangiosis carcinomatosa 42.77 11.70 20 39847 1425 63447730
Rash 42.22 11.70 195 39672 560676 62888479
Bronchomalacia 41.08 11.70 12 39855 220 63448935
Metastases to ovary 40.68 11.70 14 39853 444 63448711
Oestradiol abnormal 40.32 11.70 9 39858 51 63449104
Vulvovaginal dryness 39.71 11.70 24 39843 2877 63446278
Cerebral venous thrombosis 38.70 11.70 21 39846 2053 63447102
Breast cancer female 38.45 11.70 45 39822 13514 63435641
Nasopharyngitis 38.19 11.70 63 39804 254194 63194961
Lymphadenopathy mediastinal 37.84 11.70 23 39844 2785 63446370
Pulmonary embolism 37.55 11.70 159 39708 116525 63332630
Onycholysis 37.46 11.70 19 39848 1617 63447538
Polyneuropathy 37.41 11.70 46 39821 14543 63434612
Pneumonia 37.27 11.70 154 39713 456613 62992542
Exposed bone in jaw 36.98 11.70 23 39844 2902 63446253
Haematotoxicity 36.91 11.70 37 39830 9339 63439816
Metastases to muscle 36.88 11.70 10 39857 138 63449017
Spinal cord compression 36.43 11.70 26 39841 4122 63445033
Reversible cerebral vasoconstriction syndrome 36.41 11.70 22 39845 2636 63446519
Condition aggravated 35.75 11.70 131 39736 402086 63047069
Drug hypersensitivity 35.60 11.70 90 39777 310597 63138558
Sinusitis 35.13 11.70 55 39812 226598 63222557
BRAF gene mutation 34.90 11.70 8 39859 52 63449103
Radiation necrosis 34.53 11.70 12 39855 392 63448763
Endometrial disorder 34.16 11.70 14 39853 725 63448430
Radiation skin injury 34.08 11.70 15 39852 928 63448227
Portal hypertension 33.69 11.70 24 39843 3795 63445360
Hypertransaminasaemia 33.50 11.70 30 39837 6579 63442576
Metastases to nervous system 33.24 11.70 8 39859 66 63449089
Discomfort 32.79 11.70 34 39833 167340 63281815
Menopause 32.68 11.70 21 39846 2804 63446351
Psoriatic arthropathy 31.81 11.70 9 39858 91511 63357644
Blood creatinine decreased 31.79 11.70 27 39840 5518 63443637
Oestrogen receptor assay positive 31.76 11.70 12 39855 500 63448655
Neoplasm recurrence 31.48 11.70 20 39847 2618 63446537
Metastases to uterus 31.17 11.70 8 39859 88 63449067
Bone cancer metastatic 31.07 11.70 9 39858 160 63448995
Osteosclerosis 31.03 11.70 23 39844 3865 63445290
Vaginal haemorrhage 30.80 11.70 59 39808 27428 63421727
Blood phosphorus increased 30.62 11.70 21 39846 3124 63446031
Muscle injury 30.20 11.70 3 39864 65342 63383813
Endometrial adenocarcinoma 30.20 11.70 15 39852 1221 63447934
Menopausal disorder 30.09 11.70 7 39860 49 63449106
Blister 29.46 11.70 23 39844 129791 63319364
Left ventricular dysfunction 29.46 11.70 37 39830 11951 63437204
Jaundice 29.41 11.70 60 39807 29191 63419964
Mucosal inflammation 29.40 11.70 80 39787 46848 63402307
Malignant neoplasm of pleura 29.27 11.70 7 39860 56 63449099
Infection 28.13 11.70 64 39803 229109 63220046
Cardiac cirrhosis 28.06 11.70 8 39859 134 63449021
Cervical polyp 27.96 11.70 9 39858 231 63448924
Hydrothorax 27.91 11.70 13 39854 918 63448237
Atrophic vulvovaginitis 27.80 11.70 16 39851 1752 63447403
Bone sequestrum 27.71 11.70 15 39852 1459 63447696
Uterine dilation and curettage 27.57 11.70 13 39854 944 63448211
Tumour invasion 27.53 11.70 8 39859 144 63449011
Drug abuse 27.40 11.70 6 39861 72512 63376643
Intentional product use issue 27.36 11.70 24 39843 127868 63321287
Meningeal disorder 27.35 11.70 9 39858 248 63448907
Osteitis condensans 27.35 11.70 6 39861 31 63449124
Pain in jaw 27.10 11.70 74 39793 43422 63405733
Adenocarcinoma 27.09 11.70 19 39848 2931 63446224
Adnexa uteri mass 26.98 11.70 11 39856 562 63448593
Metastases to eye 26.93 11.70 8 39859 156 63448999
Radiation pneumonitis 26.71 11.70 15 39852 1568 63447587
Contusion 26.65 11.70 33 39834 150011 63299144
Gingival bleeding 26.50 11.70 36 39831 12551 63436604
Central nervous system lesion 26.41 11.70 33 39834 10602 63438553
RET gene mutation 26.38 11.70 5 39862 10 63449145
Pruritus 26.36 11.70 127 39740 361326 63087829
BRCA2 gene mutation 26.20 11.70 7 39860 91 63449064
Folliculitis 26.20 11.70 6 39861 70311 63378844
Leiomyoma 26.14 11.70 10 39857 431 63448724
Porphyria non-acute 26.08 11.70 9 39858 288 63448867
Peripheral swelling 26.06 11.70 83 39784 265859 63183296
Jaw operation 25.86 11.70 12 39855 840 63448315
Tympanic membrane disorder 25.40 11.70 8 39859 191 63448964
Cardiomyopathy 25.17 11.70 42 39825 17542 63431613
Loss of personal independence in daily activities 25.05 11.70 15 39852 97275 63351880
Amenorrhoea 25.00 11.70 31 39836 9883 63439272
Therapeutic product effect incomplete 24.95 11.70 25 39842 125031 63324124
Alopecia 24.37 11.70 119 39748 337417 63111738
Pain 24.21 11.70 324 39543 740304 62708851
Metastases to stomach 24.19 11.70 8 39859 224 63448931
HER2 positive breast cancer 24.00 11.70 9 39858 367 63448788
Mucosal toxicity 23.93 11.70 9 39858 370 63448785
Actinomycosis 23.48 11.70 12 39855 1038 63448117
Alopecia areata 23.22 11.70 14 39853 1671 63447484
Tumour marker decreased 23.13 11.70 6 39861 69 63449086
Sequestrectomy 23.12 11.70 11 39856 815 63448340
Endometrial cancer stage I 23.09 11.70 8 39859 259 63448896
Cerebral haemorrhage 22.98 11.70 56 39811 30673 63418482
Hepatic cirrhosis 22.84 11.70 49 39818 24685 63424470
Deprescribing error 22.76 11.70 5 39862 26 63449129
Fibromyalgia 22.75 11.70 11 39856 80409 63368746
Jaw disorder 22.71 11.70 22 39845 5327 63443828
Sensory loss 22.65 11.70 30 39837 10208 63438947
Breast disorder 22.55 11.70 16 39851 2514 63446641
Haemangioma of liver 22.11 11.70 12 39855 1173 63447982
Metastases to breast 21.97 11.70 8 39859 300 63448855
Neoplasm 21.87 11.70 25 39842 7320 63441835
Blood alkaline phosphatase increased 21.86 11.70 68 39799 42899 63406256
Malignant neoplasm of choroid 21.83 11.70 4 39863 6 63449149
Product dose omission issue 21.66 11.70 75 39792 234238 63214917
Ventricular hypokinesia 21.43 11.70 20 39847 4624 63444531
Pathological fracture 21.28 11.70 27 39840 8807 63440348
Hysterectomy 21.27 11.70 28 39839 9471 63439684
Toothache 21.25 11.70 41 39826 19158 63429997
Abdominal lymphadenopathy 21.09 11.70 10 39857 735 63448420
Blood bilirubin abnormal 21.05 11.70 11 39856 996 63448159
Oxygen saturation decreased 20.99 11.70 15 39852 88570 63360585
Central nervous system infection 20.95 11.70 10 39857 746 63448409
Dental operation 20.74 11.70 12 39855 1327 63447828
Protein total decreased 20.66 11.70 22 39845 5955 63443200
Arteriovenous malformation 20.57 11.70 12 39855 1348 63447807
Skin hypopigmentation 20.52 11.70 10 39857 781 63448374
Tumour flare 20.18 11.70 8 39859 380 63448775
Fibrous histiocytoma 20.13 11.70 9 39858 578 63448577
Ovarian cyst 20.09 11.70 36 39831 15909 63433246
Myelodysplastic syndrome 20.06 11.70 37 39830 16717 63432438
Blood bilirubin increased 20.04 11.70 60 39807 37080 63412075
Hepatic steatosis 20.01 11.70 51 39816 28718 63420437
Macular hole 20.00 11.70 10 39857 826 63448329
Intentional overdose 19.71 11.70 11 39856 74141 63375014
Blood cholesterol increased 19.68 11.70 18 39849 94014 63355141
Paraneoplastic syndrome 19.61 11.70 9 39858 614 63448541
Performance status decreased 19.25 11.70 17 39850 3661 63445494
Gastrointestinal toxicity 19.19 11.70 24 39843 7717 63441438
Mobility decreased 19.14 11.70 29 39838 121130 63328025
Uterine polypectomy 19.12 11.70 3 39864 0 63449155
Ovarian cancer stage IV 18.94 11.70 7 39860 274 63448881
Metastases to bone marrow 18.83 11.70 8 39859 454 63448701
Therapy partial responder 18.77 11.70 28 39839 10630 63438525
Somnolence 18.75 11.70 54 39813 178631 63270524
Intestinal metastasis 18.60 11.70 6 39861 155 63449000
Platelet count abnormal 18.51 11.70 16 39851 3348 63445807
Neutrophilia 18.48 11.70 18 39849 4388 63444767
Myalgia 18.42 11.70 156 39711 146373 63302782
Activated PI3 kinase delta syndrome 18.34 11.70 4 39863 20 63449135
Congestive cardiomyopathy 18.34 11.70 21 39846 6161 63442994
Breath odour 18.27 11.70 11 39856 1309 63447846
Injection site extravasation 18.18 11.70 25 39842 8816 63440339
Skin exfoliation 18.16 11.70 64 39803 43038 63406117
Heart rate irregular 17.99 11.70 42 39825 22379 63426776
Osteomyelitis 17.96 11.70 46 39821 25974 63423181
Aeromonas infection 17.93 11.70 5 39862 77 63449078
Carcinoembryonic antigen increased 17.70 11.70 12 39855 1753 63447402
Adenomyosis 17.66 11.70 8 39859 530 63448625
Visual acuity reduced 17.64 11.70 41 39826 21785 63427370
Gastrointestinal haemorrhage 17.64 11.70 15 39852 81161 63367994
Portal vein thrombosis 17.58 11.70 14 39853 2616 63446539
Lymphangioleiomyomatosis 17.57 11.70 6 39861 186 63448969
Cardiotoxicity 17.56 11.70 24 39843 8414 63440741
Respiratory tract oedema 17.56 11.70 8 39859 537 63448618
Septic shock 17.54 11.70 10 39857 66619 63382536
Corneal graft rejection 17.45 11.70 4 39863 26 63449129
Breast neoplasm 17.45 11.70 11 39856 1421 63447734
Sensory disturbance 17.39 11.70 31 39836 13641 63435514
Polypectomy 17.39 11.70 9 39858 799 63448356
Oophorectomy 17.38 11.70 8 39859 550 63448605
Acute kidney injury 17.24 11.70 96 39771 263319 63185836
Corneal degeneration 17.20 11.70 5 39862 90 63449065
Weight increased 17.09 11.70 95 39772 260697 63188458
Diabetic hyperosmolar coma 17.07 11.70 7 39860 363 63448792
Pulmonary radiation injury 17.04 11.70 3 39864 3 63449152
Back pain 16.91 11.70 246 39621 263899 63185256
Deep vein thrombosis 16.86 11.70 100 39767 83700 63365455
Respiratory tract inflammation 16.77 11.70 8 39859 596 63448559
Ovarian cancer metastatic 16.51 11.70 9 39858 888 63448267
Debridement 16.47 11.70 10 39857 1208 63447947
Depressed mood 16.36 11.70 59 39808 40132 63409023
Menopausal symptoms 16.23 11.70 13 39854 2448 63446707
Cortisol increased 16.07 11.70 7 39860 422 63448733
Migraine 16.07 11.70 25 39842 103321 63345834
Urticaria 16.05 11.70 52 39815 165750 63283405
Uterine haemorrhage 16.00 11.70 16 39851 4025 63445130
Invasive breast carcinoma 16.00 11.70 8 39859 661 63448494
Acute lymphocytic leukaemia 15.98 11.70 13 39854 2503 63446652
Knee arthroplasty 15.98 11.70 7 39860 54199 63394956
Hydronephrosis 15.98 11.70 26 39841 10636 63438519
Non-alcoholic steatohepatitis 15.84 11.70 11 39856 1670 63447485
Fungal disease carrier 15.75 11.70 4 39863 42 63449113
Enterocolitis bacterial 15.70 11.70 6 39861 258 63448897
Intermenstrual bleeding 15.68 11.70 22 39845 7904 63441251
Liver scan abnormal 15.67 11.70 4 39863 43 63449112
Diverticulitis 15.50 11.70 3 39864 39554 63409601
Disturbance in attention 15.49 11.70 56 39811 38133 63411022
Product administered at inappropriate site 15.38 11.70 14 39853 3135 63446020
Injection site pain 15.31 11.70 37 39830 129763 63319392
Headache 15.30 11.70 293 39574 632948 62816207
Libido decreased 15.30 11.70 13 39854 2659 63446496
Salpingitis 15.13 11.70 6 39861 285 63448870
Atrial thrombosis 15.06 11.70 11 39856 1807 63447348
Confusional state 15.00 11.70 87 39780 236293 63212862
Encephalopathy 14.99 11.70 3 39864 38617 63410538
Wheezing 14.98 11.70 23 39844 95572 63353583
Oral pustule 14.97 11.70 4 39863 52 63449103
Blood follicle stimulating hormone decreased 14.97 11.70 3 39864 9 63449146
Neurotoxicity 14.94 11.70 33 39834 16957 63432198
Acarodermatitis 14.93 11.70 9 39858 1074 63448081
Periodontitis 14.81 11.70 14 39853 3289 63445866
Deafness 14.81 11.70 34 39833 17923 63431232
Blood copper increased 14.73 11.70 3 39864 10 63449145
Ventricular dysfunction 14.66 11.70 13 39854 2815 63446340
Gingivitis 14.64 11.70 22 39845 8407 63440748
Blood follicle stimulating hormone increased 14.55 11.70 5 39862 158 63448997
Breast cancer in situ 14.52 11.70 10 39857 1498 63447657
Adenoid cystic carcinoma 14.51 11.70 3 39864 11 63449144
Spinal pain 14.47 11.70 28 39839 13111 63436044
Coagulation factor V level decreased 14.44 11.70 6 39861 322 63448833
Neutrophil count increased 14.42 11.70 32 39835 16495 63432660
Salpingo-oophorectomy bilateral 14.40 11.70 5 39862 163 63448992
Nasal dryness 14.34 11.70 16 39851 4565 63444590
Hip arthroplasty 14.29 11.70 6 39861 47640 63401515
Drug resistance 14.26 11.70 39 39828 22894 63426261
Breast cancer stage IV 14.20 11.70 11 39856 1975 63447180
Sepsis 14.15 11.70 49 39818 153074 63296081
Rapidly progressive osteoarthritis 14.11 11.70 3 39864 13 63449142
Red blood cell sedimentation rate increased 14.08 11.70 5 39862 43977 63405178
Hydrocephalus 14.05 11.70 17 39850 5283 63443872
Injection site erythema 14.03 11.70 19 39848 83155 63366000
Purulent discharge 13.98 11.70 16 39851 4690 63444465
Chronic hepatic failure 13.93 11.70 7 39860 584 63448571
Breast pain 13.93 11.70 22 39845 8776 63440379
Atypical femur fracture 13.87 11.70 17 39850 5355 63443800
Oesophageal varices haemorrhage 13.85 11.70 9 39858 1225 63447930
Myocardial infarction 13.85 11.70 26 39841 99867 63349288
Cutaneous sarcoidosis 13.79 11.70 6 39861 361 63448794
Oral mucosal hypertrophy 13.76 11.70 3 39864 15 63449140
Injection site reaction 13.74 11.70 10 39857 58514 63390641
Progesterone receptor assay positive 13.74 11.70 6 39861 364 63448791
Madarosis 13.70 11.70 13 39854 3068 63446087
Retinal artery occlusion 13.69 11.70 10 39857 1643 63447512
Pelvic mass 13.66 11.70 9 39858 1253 63447902
Metastases to neck 13.61 11.70 4 39863 75 63449080
Hair texture abnormal 13.59 11.70 15 39852 4228 63444927
Medication error 13.54 11.70 8 39859 52276 63396879
Hypotension 13.49 11.70 108 39759 272496 63176659
Varices oesophageal 13.46 11.70 13 39854 3135 63446020
Postmenopausal haemorrhage 13.46 11.70 11 39856 2131 63447024
Overdose 13.42 11.70 33 39834 115045 63334110
Vertebral lesion 13.38 11.70 7 39860 635 63448520
Hepatic cancer metastatic 13.38 11.70 6 39861 388 63448767
Musculoskeletal chest pain 13.26 11.70 36 39831 21047 63428108
Anorectal disorder 13.19 11.70 10 39857 1739 63447416
Multiple sclerosis relapse 13.16 11.70 7 39860 48471 63400684
Trigger finger 13.12 11.70 15 39852 4393 63444762
Papillary thyroid cancer 12.96 11.70 11 39856 2245 63446910
Adverse event 12.91 11.70 14 39853 67545 63381610
Tooth disorder 12.90 11.70 43 39824 28114 63421041
Corneal disorder 12.86 11.70 10 39857 1804 63447351
Oestradiol increased 12.80 11.70 4 39863 93 63449062
Pneumonia aspiration 12.76 11.70 3 39864 34537 63414618
Ocular toxicity 12.72 11.70 7 39860 703 63448452
Desmoid tumour 12.72 11.70 4 39863 95 63449060
Chronic myeloid leukaemia 12.70 11.70 11 39856 2307 63446848
Prescribed overdose 12.55 11.70 3 39864 34150 63415005
Type 2 diabetes mellitus 12.47 11.70 13 39854 63855 63385300
Breast reconstruction 12.37 11.70 5 39862 250 63448905
Intraductal proliferative breast lesion 12.29 11.70 12 39855 2933 63446222
Peripheral sensorimotor neuropathy 12.24 11.70 9 39858 1494 63447661
Metastases to adrenals 12.24 11.70 7 39860 758 63448397
Blood oestrogen increased 12.23 11.70 4 39863 108 63449047
Toxicity to various agents 12.21 11.70 98 39769 247152 63202003
Arthritis 12.18 11.70 35 39832 115886 63333269
Internal fixation of fracture 12.17 11.70 7 39860 766 63448389
Blood lactate dehydrogenase increased 12.14 11.70 37 39830 23079 63426076
Gastrointestinal disorder 12.12 11.70 42 39825 131197 63317958
Blood pressure fluctuation 12.12 11.70 7 39860 46310 63402845
Nasal congestion 12.12 11.70 14 39853 65646 63383509
Superior sagittal sinus thrombosis 12.02 11.70 7 39860 784 63448371
Incorrect dose administered 11.94 11.70 12 39855 59956 63389199
Dental caries 11.91 11.70 23 39844 10756 63438399
HER2 gene amplification 11.86 11.70 3 39864 31 63449124
Ovarian granulosa-theca cell tumour 11.86 11.70 3 39864 31 63449124
Cholestasis 11.80 11.70 43 39824 29391 63419764
Alanine aminotransferase increased 11.75 11.70 108 39759 103662 63345493
Pulmonary hypoplasia 11.70 11.70 5 39862 288 63448867

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
Metastases to bone 89.16 26.03 28 1251 11942 34943710
Carbohydrate antigen 15-3 increased 63.54 26.03 9 1270 69 34955583
Metastases to lung 53.86 26.03 18 1261 9302 34946350
Metastases to central nervous system 36.35 26.03 13 1266 8192 34947460
Breast cancer metastatic 32.83 26.03 5 1274 66 34955586
Metastases to the mediastinum 32.03 26.03 6 1273 285 34955367
Malignant neoplasm progression 31.72 26.03 26 1253 88020 34867632
PIK3CA-activated mutation 31.02 26.03 5 1274 97 34955555
Hepatic lesion 28.91 26.03 9 1270 3703 34951949
Encapsulating peritoneal sclerosis 27.81 26.03 6 1273 583 34955069

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
Metastases to bone 1327.15 12.46 459 31004 23968 79688957
Malignant neoplasm progression 827.74 12.46 567 30896 135423 79577502
Metastases to liver 602.21 12.46 270 31193 28044 79684881
Metastases to lung 524.13 12.46 215 31248 17948 79694977
Breast cancer metastatic 380.72 12.46 139 31324 8463 79704462
Breast cancer recurrent 377.13 12.46 107 31356 2870 79710055
Metastases to lymph nodes 376.38 12.46 145 31318 10252 79702673
Neoplasm progression 257.16 12.46 191 31272 51491 79661434
Breast cancer 243.88 12.46 157 31306 33624 79679301
Disease progression 233.76 12.46 324 31139 184038 79528887
Osteonecrosis of jaw 195.65 12.46 151 31312 43075 79669850
Metastases to central nervous system 177.81 12.46 99 31364 16276 79696649
Metastases to spine 158.94 12.46 61 31402 4263 79708662
Bone lesion 127.49 12.46 57 31406 5862 79707063
Hot flush 123.07 12.46 129 31334 54748 79658177
Sarcoma uterus 117.92 12.46 18 31445 6 79712919
Metastases to skin 107.27 12.46 36 31427 1703 79711222
Metastasis 107.25 12.46 53 31410 6827 79706098
Tumour marker increased 104.52 12.46 45 31418 4227 79708698
Osteonecrosis 99.73 12.46 89 31374 31006 79681919
Hepatic lesion 97.88 12.46 50 31413 6909 79706016
Neuropathy peripheral 97.77 12.46 189 31274 141116 79571809
Endometrial hyperplasia 94.92 12.46 26 31437 610 79712315
Second primary malignancy 94.51 12.46 63 31400 14287 79698638
Acute myeloid leukaemia 90.44 12.46 84 31379 30801 79682124
Carbohydrate antigen 15-3 increased 87.21 12.46 28 31435 1151 79711774
PIK3CA-activated mutation 86.98 12.46 24 31439 579 79712346
Metastases to the mediastinum 86.71 12.46 24 31439 586 79712339
Endometrial cancer 85.86 12.46 32 31431 2062 79710863
Device related thrombosis 85.04 12.46 34 31429 2649 79710276
Pseudocirrhosis 84.13 12.46 24 31439 656 79712269
Metastases to pleura 83.46 12.46 29 31434 1525 79711400
Tonsillar disorder 77.27 12.46 26 31437 1240 79711685
Breast mass 76.51 12.46 42 31421 6712 79706213
Bone disorder 76.21 12.46 62 31401 19051 79693874
Lymphadenopathy 75.57 12.46 99 31364 53148 79659777
Uterine polyp 75.32 12.46 27 31436 1557 79711368
Bone pain 72.02 12.46 99 31364 55643 79657282
Endometrial atrophy 70.40 12.46 13 31450 41 79712884
Nail disorder 63.87 12.46 46 31417 11806 79701119
Metastases to peritoneum 63.20 12.46 32 31431 4340 79708585
Lymphoedema 61.96 12.46 46 31417 12367 79700558
Nasal disorder 61.63 12.46 30 31433 3739 79709186
Hormone receptor positive breast cancer 59.43 12.46 16 31447 351 79712574
Metastases to pelvis 58.46 12.46 18 31445 644 79712281
Acute promyelocytic leukaemia 58.27 12.46 22 31441 1469 79711456
Blood uric acid decreased 57.67 12.46 21 31442 1267 79711658
Metastases to chest wall 57.51 12.46 17 31446 528 79712397
Invasive lobular breast carcinoma 57.19 12.46 18 31445 693 79712232
Maculopathy 57.01 12.46 26 31437 2799 79710126
Osteolysis 56.62 12.46 30 31433 4468 79708457
Uterine cancer 56.24 12.46 28 31435 3663 79709262
Completed suicide 55.98 12.46 14 31449 245753 79467172
Pulmonary mass 55.89 12.46 63 31400 28971 79683954
Excessive eye blinking 55.46 12.46 22 31441 1679 79711246
Retinopathy 54.85 12.46 28 31435 3863 79709062
Eosinophil percentage increased 54.31 12.46 21 31442 1497 79711428
Mucosal toxicity 51.66 12.46 16 31447 584 79712341
Eastern Cooperative Oncology Group performance status worsened 51.33 12.46 22 31441 2043 79710882
Ejection fraction decreased 50.16 12.46 65 31398 34512 79678413
Recurrent cancer 48.79 12.46 23 31440 2670 79710255
Endometrial thickening 48.34 12.46 13 31450 284 79712641
Disease recurrence 47.69 12.46 72 31391 44037 79668888
Joint swelling 46.72 12.46 28 31435 288618 79424307
Vitreous detachment 46.25 12.46 21 31442 2238 79710687
Left ventricular dilatation 45.78 12.46 17 31446 1084 79711841
Recall phenomenon 45.25 12.46 17 31446 1120 79711805
Metastases to eye 44.93 12.46 12 31451 255 79712670
Neutropenia 44.73 12.46 228 31235 287482 79425443
Bronchomalacia 44.50 12.46 12 31451 265 79712660
Endometrial hypertrophy 44.30 12.46 11 31452 173 79712752
Lymphangiosis carcinomatosa 44.02 12.46 20 31443 2134 79710791
Reversible cerebral vasoconstriction syndrome 43.09 12.46 22 31441 3035 79709890
Cerebral venous thrombosis 42.29 12.46 21 31442 2732 79710193
Contraindicated product administered 42.18 12.46 6 31457 157532 79555393
Therapeutic product effect decreased 42.14 12.46 7 31456 163856 79549069
Synovitis 42.14 12.46 5 31458 150729 79562196
Hypertriglyceridaemia 41.90 12.46 37 31426 12703 79700222
Breast cancer female 41.16 12.46 35 31428 11426 79701499
Lymphadenopathy mediastinal 40.80 12.46 24 31439 4372 79708553
Peritoneal disorder 40.57 12.46 14 31449 721 79712204
Pleural disorder 40.37 12.46 15 31448 958 79711967
Rheumatoid arthritis 40.13 12.46 16 31447 208454 79504471
BRCA2 gene mutation 39.73 12.46 9 31454 93 79712832
Uterine leiomyoma 39.35 12.46 27 31436 6416 79706509
Pulmonary embolism 38.72 12.46 152 31311 171502 79541423
Acute kidney injury 38.65 12.46 93 31370 519311 79193614
Pneumonia 37.68 12.46 134 31329 660112 79052813
Metastases to ovary 37.08 12.46 11 31452 346 79712579
Invasive ductal breast carcinoma 36.72 12.46 25 31438 5867 79707058
Adnexa uteri mass 36.01 12.46 11 31452 383 79712542
Palmar-plantar erythrodysaesthesia syndrome 35.70 12.46 54 31409 33080 79679845
Endometrial adenocarcinoma 35.38 12.46 14 31449 1061 79711864
Ovarian cancer 35.26 12.46 21 31442 3913 79709012
Menopause 35.18 12.46 17 31446 2085 79710840
Oestradiol abnormal 34.86 12.46 7 31456 38 79712887
Vaginal haemorrhage 34.79 12.46 43 31420 21774 79691151
Radiation necrosis 34.69 12.46 11 31452 434 79712491
Menopausal disorder 34.55 12.46 7 31456 40 79712885
Endometriosis 33.98 12.46 20 31443 3648 79709277
Ascites 33.92 12.46 85 31378 75477 79637448
Systemic lupus erythematosus 33.91 12.46 4 31459 121145 79591780
Pathological fracture 33.46 12.46 30 31433 10507 79702418
Drug ineffective 32.53 12.46 272 31191 1080641 78632284
Haematotoxicity 32.15 12.46 35 31428 15484 79697441
Hepatic enzyme increased 32.02 12.46 16 31447 182594 79530331
Vulvovaginal dryness 31.33 12.46 16 31447 2208 79710717
Left ventricular dysfunction 30.62 12.46 38 31425 19323 79693602
Tooth extraction 30.44 12.46 29 31434 10966 79701959
Blood creatinine decreased 30.38 12.46 25 31438 7800 79705125
Hypertransaminasaemia 30.30 12.46 30 31433 11894 79701031
Radiation pneumonitis 30.15 12.46 19 31444 3914 79709011
Osteitis condensans 30.13 12.46 6 31457 31 79712894
Glossodynia 29.97 12.46 3 31460 103334 79609591
Tympanic membrane disorder 29.40 12.46 8 31455 183 79712742
Metastases to thorax 28.76 12.46 8 31455 199 79712726
Amenorrhoea 28.67 12.46 24 31439 7668 79705257
Exposed bone in jaw 28.59 12.46 18 31445 3702 79709223
Cardiomyopathy 28.35 12.46 45 31418 28729 79684196
Radiation skin injury 28.32 12.46 13 31450 1421 79711504
Pleural effusion 28.31 12.46 123 31340 145139 79567786
Sensory loss 28.14 12.46 30 31433 12961 79699964
Alopecia areata 28.14 12.46 14 31449 1829 79711096
Cardiac cirrhosis 28.03 12.46 8 31455 219 79712706
Malignant pleural effusion 27.61 12.46 17 31446 3363 79709562
Sepsis 27.28 12.46 40 31423 269388 79443537
Tumour marker decreased 27.14 12.46 6 31457 55 79712870
Atrophic vulvovaginitis 26.70 12.46 12 31451 1249 79711676
Portal hypertension 26.13 12.46 22 31441 7086 79705839
Septic shock 26.07 12.46 8 31455 122793 79590132
Gastrointestinal haemorrhage 25.81 12.46 13 31450 147706 79565219
Arteriovenous malformation 25.78 12.46 13 31450 1748 79711177
Wound 25.71 12.46 7 31456 116172 79596753
Metastases to uterus 25.67 12.46 6 31457 72 79712853
Deprescribing error 25.41 12.46 5 31458 24 79712901
Congestive cardiomyopathy 25.16 12.46 27 31436 11753 79701172
Osteosclerosis 25.10 12.46 17 31446 3954 79708971
Skin toxicity 25.08 12.46 23 31440 8291 79704634
Hysteroscopy 24.92 12.46 5 31458 27 79712898
Hypersensitivity 24.58 12.46 41 31422 262198 79450727
Endometrial cancer stage I 24.51 12.46 7 31456 192 79712733
Menopausal symptoms 24.44 12.46 13 31450 1950 79710975
Myocardial infarction 24.41 12.46 22 31441 184107 79528818
Sequestrectomy 24.15 12.46 10 31453 852 79712073
Metastatic neoplasm 23.64 12.46 18 31445 5024 79707901
Drug abuse 23.34 12.46 18 31445 162673 79550252
Breast cancer in situ 23.26 12.46 10 31453 936 79711989
Treatment failure 23.04 12.46 20 31443 170466 79542459
RET gene mutation 22.96 12.46 4 31459 8 79712917
Fibrous histiocytoma 22.40 12.46 9 31454 710 79712215
Porphyria non-acute 22.04 12.46 9 31454 740 79712185
Hepatic steatosis 21.93 12.46 47 31416 37691 79675234
Adenomyosis 21.68 12.46 7 31456 293 79712632
Oxygen saturation decreased 21.60 12.46 12 31451 129035 79583890
Cervical polyp 21.35 12.46 6 31457 155 79712770
Invasive breast carcinoma 21.22 12.46 8 31455 532 79712393
Gingival bleeding 21.15 12.46 29 31434 16247 79696678
Cardiotoxicity 20.94 12.46 25 31438 12214 79700711
Lymphangioleiomyomatosis 20.93 12.46 6 31457 167 79712758
Leiomyoma 20.78 12.46 7 31456 335 79712590
Toothache 20.74 12.46 32 31431 19938 79692987
Injection site extravasation 20.37 12.46 22 31441 9647 79703278
Hypotension 20.29 12.46 97 31366 440220 79272705
Back pain 20.25 12.46 196 31267 303984 79408941
Madarosis 20.15 12.46 13 31450 2789 79710136
Non-alcoholic steatohepatitis 20.03 12.46 12 31451 2260 79710665
Abdominal lymphadenopathy 19.97 12.46 10 31453 1324 79711601
Toxicity to various agents 19.93 12.46 92 31371 421448 79291477
Gastrointestinal toxicity 19.86 12.46 20 31443 8089 79704836
Pain in jaw 19.75 12.46 51 31412 46100 79666825
Hepatic cirrhosis 19.74 12.46 43 31420 34863 79678062
Tumour invasion 19.70 12.46 7 31456 393 79712532
Protein total decreased 19.70 12.46 21 31442 9071 79703854
Central nervous system infection 19.67 12.46 10 31453 1367 79711558
Therapy partial responder 19.66 12.46 29 31434 17368 79695557
Disturbance in attention 19.58 12.46 54 31409 50747 79662178
Paraneoplastic syndrome 19.12 12.46 9 31454 1041 79711884
Superior sagittal sinus thrombosis 19.02 12.46 9 31454 1054 79711871
Meningeal disorder 19.01 12.46 7 31456 436 79712489
Multiple organ dysfunction syndrome 18.97 12.46 12 31451 120234 79592691
Atypical femur fracture 18.95 12.46 16 31447 5173 79707752
Ovarian cyst 18.68 12.46 24 31439 12631 79700294
Nasal dryness 18.60 12.46 15 31448 4548 79708377
Postmenopausal haemorrhage 18.54 12.46 10 31453 1542 79711383
Paraesthesia 18.46 12.46 126 31337 176197 79536728
Breast disorder 18.37 12.46 11 31452 2070 79710855
Onycholysis 18.36 12.46 11 31452 2072 79710853
Product administered at inappropriate site 18.25 12.46 14 31449 3951 79708974
Metabolic acidosis 18.21 12.46 5 31458 82524 79630401
Deafness 18.16 12.46 31 31432 21006 79691919
Spinal cord compression 18.00 12.46 17 31446 6360 79706565
Spinal pain 17.89 12.46 26 31437 15366 79697559
Metastases to stomach 17.83 12.46 6 31457 286 79712639
Bone sequestrum 17.78 12.46 9 31454 1220 79711705
Encapsulating peritoneal sclerosis 17.70 12.46 8 31455 843 79712082
Cortisol increased 17.60 12.46 7 31456 538 79712387
Respiratory tract inflammation 17.55 12.46 8 31455 860 79712065
Corneal degeneration 17.55 12.46 5 31458 136 79712789
Respiratory tract oedema 17.50 12.46 8 31455 866 79712059
Neoplasm recurrence 17.49 12.46 14 31449 4200 79708725
Ovarian hyperstimulation syndrome 17.30 12.46 13 31450 3558 79709367
Intermenstrual bleeding 17.21 12.46 16 31447 5868 79707057
Metastases to meninges 17.20 12.46 13 31450 3588 79709337
Breast neoplasm 17.01 12.46 8 31455 924 79712001
Pericarditis 17.00 12.46 10 31453 104226 79608699
Abdominal discomfort 16.99 12.46 47 31416 250680 79462245
Liver scan abnormal 16.96 12.46 4 31459 50 79712875
Product use issue 16.84 12.46 36 31427 209786 79503139
Vertebral lesion 16.71 12.46 7 31456 614 79712311
Performance status decreased 16.69 12.46 16 31447 6097 79706828
Acarodermatitis 16.68 12.46 9 31454 1389 79711536
Neutrophilia 16.59 12.46 18 31445 7933 79704992
Dyspareunia 16.48 12.46 10 31453 1928 79710997
Cerebral haemorrhage 16.31 12.46 55 31408 57618 79655307
Polyneuropathy 16.30 12.46 32 31431 24119 79688806
Arthropathy 16.30 12.46 28 31435 177083 79535842
Hydrothorax 16.27 12.46 9 31454 1459 79711466
Corneal graft rejection 16.23 12.46 4 31459 61 79712864
Central nervous system lesion 16.15 12.46 23 31440 13345 79699580
Intentional overdose 16.14 12.46 11 31452 105949 79606976
Exposure during pregnancy 16.08 12.46 10 31453 101122 79611803
Breast pain 16.02 12.46 18 31445 8247 79704678
Skin exfoliation 15.99 12.46 53 31410 55047 79657878
Heart rate irregular 15.98 12.46 38 31425 32641 79680284
Lower limb fracture 15.96 12.46 31 31432 23184 79689741
Ventricular hypokinesia 15.95 12.46 19 31444 9260 79703665
Blood phosphorus increased 15.87 12.46 20 31443 10327 79702598
Infusion related reaction 15.72 12.46 43 31420 230194 79482731
Actinomycosis 15.62 12.46 8 31455 1111 79711814
Cardio-respiratory arrest 15.56 12.46 12 31451 108498 79604427
Discomfort 15.49 12.46 16 31447 125601 79587324
Respiratory failure 15.40 12.46 30 31433 180881 79532044
Hair colour changes 15.35 12.46 13 31450 4219 79708706
Trigger finger 15.32 12.46 13 31450 4232 79708693
Depressed mood 15.30 12.46 48 31415 48432 79664493
Hair texture abnormal 15.23 12.46 12 31451 3522 79709403
Swelling 15.15 12.46 40 31423 216671 79496254
Infection 15.15 12.46 47 31416 241665 79471260
Breath odour 15.06 12.46 9 31454 1687 79711238
Diabetic hyperosmolar coma 15.04 12.46 7 31456 790 79712135
Encephalopathy 15.02 12.46 4 31459 67393 79645532
Cutaneous sarcoidosis 15.01 12.46 6 31457 467 79712458
Oral mucosal hypertrophy 14.98 12.46 3 31460 16 79712909
Psoriatic arthropathy 14.98 12.46 6 31457 77993 79634932
Corneal disorder 14.94 12.46 10 31453 2281 79710644
Anorectal disorder 14.93 12.46 10 31453 2283 79710642
Blood oestrogen increased 14.89 12.46 4 31459 87 79712838
Pneumonia aspiration 14.88 12.46 4 31459 66963 79645962
Deep vein thrombosis 14.86 12.46 90 31373 120829 79592096
Haemangioma of liver 14.86 12.46 8 31455 1230 79711695
Blood alkaline phosphatase increased 14.84 12.46 57 31406 63607 79649318
Rapidly progressive osteoarthritis 14.83 12.46 3 31460 17 79712908
Debridement 14.82 12.46 9 31454 1736 79711189
Jaw operation 14.77 12.46 7 31456 822 79712103
Mucosal inflammation 14.72 12.46 64 31399 75516 79637409
Coma 14.60 12.46 11 31452 100638 79612287
Condition aggravated 14.58 12.46 127 31336 500997 79211928
Hepatotoxicity 14.55 12.46 49 31414 51303 79661622
Blood potassium abnormal 14.36 12.46 11 31452 3099 79709826
Breast reconstruction 14.32 12.46 4 31459 101 79712824
Oestradiol increased 14.25 12.46 4 31459 103 79712822
Adenocarcinoma 14.23 12.46 12 31451 3874 79709051
Adenoid cystic carcinoma 14.16 12.46 3 31460 22 79712903
Sensory disturbance 14.06 12.46 23 31440 15054 79697871
Metastases to breast 14.02 12.46 5 31458 284 79712641
Loss of personal independence in daily activities 13.90 12.46 12 31451 102568 79610357
Retinal artery occlusion 13.80 12.46 11 31452 3283 79709642
Cystoid macular oedema 13.78 12.46 9 31454 1971 79710954
Portal vein thrombosis 13.59 12.46 14 31449 5813 79707112
Ovarian granulosa-theca cell tumour 13.52 12.46 3 31460 28 79712897
Nasopharyngitis 13.47 12.46 53 31410 253828 79459097
Chronic hepatic failure 13.40 12.46 7 31456 1012 79711913
Coagulation factor V level decreased 13.34 12.46 6 31457 625 79712300
Pruritus 13.34 12.46 96 31367 394552 79318373
HER2 positive breast cancer 13.26 12.46 5 31458 333 79712592
Blood pressure fluctuation 13.16 12.46 5 31458 67140 79645785
Enterocolitis bacterial 13.09 12.46 6 31457 653 79712272
Unresponsive to stimuli 13.04 12.46 3 31460 55785 79657140
Metastases to muscle 12.95 12.46 5 31458 355 79712570
Folliculitis 12.90 12.46 3 31460 55377 79657548
Carcinoembryonic antigen increased 12.89 12.46 9 31454 2200 79710725
Uterine haemorrhage 12.82 12.46 10 31453 2893 79710032
Atrial thrombosis 12.79 12.46 11 31452 3645 79709280
Aeromonas infection 12.74 12.46 5 31458 371 79712554
Atypical fracture 12.70 12.46 6 31457 700 79712225
Rhabdomyosarcoma 12.56 12.46 4 31459 160 79712765
Gastric infection 12.54 12.46 11 31452 3742 79709183
Dental operation 12.54 12.46 7 31456 1155 79711770

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L02BA01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONE ANTAGONISTS AND RELATED AGENTS
Anti-estrogens
FDA MoA N0000000168 Selective Estrogen Receptor Modulators
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D050071 Bone Density Conservation Agents
MeSH PA D004965 Estrogen Antagonists
MeSH PA D020847 Estrogen Receptor Modulators
MeSH PA D006727 Hormone Antagonists
MeSH PA D020845 Selective Estrogen Receptor Modulators
FDA EPC N0000175826 Estrogen Agonist/Antagonist
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:37700 protein kinase C inhibitors
CHEBI has role CHEBI:48422 angiogenesis antagonist
CHEBI has role CHEBI:50646 antiosteoporotic
CHEBI has role CHEBI:50792 estrogen receptor antagonists
CHEBI has role CHEBI:50837 oestrogen antagonist
CHEBI has role CHEBI:62872 quinoline oxidase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Infiltrating duct carcinoma of breast indication 408643008 DOID:3008
Carcinoma of female breast indication 447782002
Prevention of Breast Carcinoma indication
Pain of breast off-label use 53430007
Endometrial carcinoma off-label use 254878006 DOID:2871
Malignant tumor of ovary off-label use 363443007 DOID:2394
Hypercalcemia contraindication 66931009 DOID:12678
Leukopenia contraindication 84828003 DOID:615
Bilateral cataracts contraindication 95722004
Deep venous thrombosis contraindication 128053003
Cerebrovascular accident contraindication 230690007
Pulmonary thromboembolism contraindication 233935004
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Visual impairment contraindication 397540003
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 8.61 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Estrogen receptor Nuclear hormone receptor MODULATOR Ki 7.51 CHEMBL CHEMBL
Beta-1 adrenergic receptor GPCR Ki 5.00 DRUG MATRIX
Prostaglandin G/H synthase 2 Enzyme IC50 4.46 WOMBAT-PK
Prostaglandin G/H synthase 1 Enzyme IC50 5.36 DRUG MATRIX
Mu-type opioid receptor GPCR Ki 5.15 DRUG MATRIX
D(1A) dopamine receptor GPCR Ki 5.37 DRUG MATRIX
D(2) dopamine receptor GPCR Ki 5.34 DRUG MATRIX
Adenosine receptor A2a GPCR Ki 5.40 DRUG MATRIX
Alpha-2A adrenergic receptor GPCR Ki 6.14 DRUG MATRIX
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.50 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.80 CHEMBL
3-beta-hydroxysteroid-Delta(8),Delta(7)-isomerase Enzyme Ki 8.30 WOMBAT-PK
Multidrug resistance protein 1 Transporter Ki 7 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 5.91 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.84 DRUG MATRIX
5-hydroxytryptamine receptor 1A GPCR Ki 5.16 DRUG MATRIX
5-hydroxytryptamine receptor 2A GPCR Ki 5.86 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.88 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.62 DRUG MATRIX
5-hydroxytryptamine receptor 6 GPCR Ki 5.98 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.79 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 6.44 DRUG MATRIX
Histamine H2 receptor GPCR Ki 5.03 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 6.17 DRUG MATRIX
Muscarinic acetylcholine receptor M2 GPCR Ki 5.56 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 6.20 DRUG MATRIX
Muscarinic acetylcholine receptor M4 GPCR Ki 6.17 DRUG MATRIX
Muscarinic acetylcholine receptor M5 GPCR Ki 5.73 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5.66 WOMBAT-PK
Beta-3 adrenergic receptor GPCR Ki 5.24 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.84 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.68 DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor Ki 7.46 WOMBAT-PK
D(4) dopamine receptor GPCR Ki 5.41 DRUG MATRIX
Alpha-1D adrenergic receptor GPCR Ki 5.61 DRUG MATRIX
Kappa-type opioid receptor GPCR Ki 5.20 DRUG MATRIX
Progesterone receptor Nuclear hormone receptor IC50 6.89 CHEMBL
Delta-type opioid receptor GPCR Ki 5.33 DRUG MATRIX
Estrogen receptor beta Nuclear hormone receptor IC50 5.91 WOMBAT-PK
G-protein coupled estrogen receptor 1 GPCR IC50 7.50 WOMBAT-PK
Estrogen-related receptor gamma Nuclear hormone receptor Ki 7.10 WOMBAT-PK
Epidermal growth factor receptor Kinase IC50 5.45 DRUG MATRIX
Substance-P receptor GPCR Ki 5.07 DRUG MATRIX
Tyrosine-protein kinase Lck Kinase IC50 5.10 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.92 DRUG MATRIX
Receptor tyrosine-protein kinase erbB-2 Kinase IC50 5.53 DRUG MATRIX
Glucosylceramidase Enzyme EC50 5.60 CHEMBL
Thromboxane-A synthase Enzyme IC50 6.04 DRUG MATRIX
Steroid hormone receptor ERR1 Nuclear hormone receptor IC50 6.70 CHEMBL
Substance-K receptor GPCR Ki 5.91 DRUG MATRIX
B2 bradykinin receptor GPCR Ki 4.92 DRUG MATRIX
Melanocortin receptor 4 GPCR Ki 4.53 DRUG MATRIX
Melanocortin receptor 5 GPCR Ki 4.60 DRUG MATRIX
Melanocortin receptor 3 GPCR Ki 4.76 DRUG MATRIX
Serine/threonine-protein phosphatase 2B catalytic subunit alpha isoform Enzyme IC50 4.52 DRUG MATRIX
Solute carrier family 22 member 2 Transporter IC50 4.06 WOMBAT-PK
Emopamil-binding protein-like Enzyme Ki 8.55 CHEMBL
Anti-estrogen binding site (AEBS) Enzyme Kd 9 CHEMBL
Adenosine receptor A1 GPCR Ki 4.86 DRUG MATRIX
Sodium/potassium-transporting ATPase subunit alpha-2 Ion channel IC50 4.81 DRUG MATRIX
Androgen receptor Transcription factor Ki 4.82 DRUG MATRIX
Membrane-associated progesterone receptor component 1 Membrane receptor Ki 6.42 DRUG MATRIX
Progesterone receptor Transcription factor Ki 5.59 DRUG MATRIX
Alpha-1A adrenergic receptor GPCR IC50 4.66 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 4.92 CHEMBL
C-8 sterol isomerase Enzyme Ki 5.82 CHEMBL
Transcriptional activator protein luxR Unclassified IC50 4.40 CHEMBL

External reference:

IDSource
4019939 VUID
N0000148024 NUI
D00966 KEGG_DRUG
54965-24-1 SECONDARY_CAS_RN
4018462 VANDF
4019939 VANDF
C0039286 UMLSCUI
CHEBI:41774 CHEBI
CTX PDB_CHEM_ID
CHEMBL83 ChEMBL_ID
DB00675 DRUGBANK_ID
CHEMBL786 ChEMBL_ID
D013629 MESH_DESCRIPTOR_UI
2733526 PUBCHEM_CID
1016 IUPHAR_LIGAND_ID
3299 INN_ID
094ZI81Y45 UNII
10324 RXNORM
2281 MMSL
4270 MMSL
5540 MMSL
d00381 MMSL
002670 NDDF
004826 NDDF
373345002 SNOMEDCT_US
41395001 SNOMEDCT_US
75959001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0144 TABLET 10 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0144 TABLET 10 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0144 TABLET 10 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0274 TABLET 20 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0274 TABLET 20 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0274 TABLET 20 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0591-2472 TABLET 10 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0591-2472 TABLET 10 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0591-2473 TABLET 20 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 0591-2473 TABLET 20 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0485 TABLET 10 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0485 TABLET 10 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 50090-0942 TABLET 20 mg ORAL ANDA 25 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-439 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-439 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-439 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-440 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-440 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51407-440 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-446 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-446 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-447 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-447 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-642 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-642 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-642 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-643 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-643 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
Tamoxifen Citrate HUMAN PRESCRIPTION DRUG LABEL 1 51862-643 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
SOLTAMOX HUMAN PRESCRIPTION DRUG LABEL 1 51862-682 LIQUID 20 mg ORAL NDA 33 sections