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

Stem definitionDrug idCAS RN
1255 129453-61-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ZD9238
  • fulvestrant
  • faslodex
  • ICI 182,780
An estradiol derivative and estrogen receptor antagonist that is used for the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer.
  • Molecular weight: 606.78
  • Formula: C32H47F5O3S
  • CLOGP: 7.54
  • LIPINSKI: 2
  • HAC: 3
  • HDO: 2
  • TPSA: 57.53
  • ALOGS: -4.96
  • ROTB: 15

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
8.30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.00 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 4.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 11.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 10, 2004 EMA
April 25, 2002 FDA ASTRAZENECA

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 3525.50 15.14 1642 55610 71945 56162870
Metastases to bone 2415.12 15.14 862 56390 18646 56216169
Neoplasm progression 2331.96 15.14 961 56291 31055 56203760
Metastases to liver 1921.40 15.14 749 56503 20837 56213978
Breast cancer metastatic 1825.46 15.14 660 56592 14809 56220006
Neutropenia 1179.51 15.14 1098 56154 157069 56077746
White blood cell count decreased 773.45 15.14 787 56465 125203 56109612
Tumour marker increased 682.61 15.14 229 57023 4064 56230751
Metastases to lung 597.53 15.14 274 56978 11444 56223371
Breast cancer 557.75 15.14 434 56818 48399 56186416
Osteonecrosis of jaw 513.34 15.14 355 56897 33003 56201812
Disease progression 512.83 15.14 582 56670 104591 56130224
Neutrophil count decreased 368.20 15.14 345 56907 49477 56185338
Drug ineffective 356.47 15.14 252 57000 918737 55316078
PIK3CA-activated mutation 345.73 15.14 96 57156 862 56233953
Rheumatoid arthritis 336.63 15.14 12 57240 382592 55852223
Metastases to lymph nodes 324.17 15.14 156 57096 7267 56227548
Carbohydrate antigen 15-3 increased 301.75 15.14 92 57160 1179 56233636
Fatigue 278.95 15.14 1551 55701 787001 55447814
Metastasis 272.83 15.14 121 57131 4663 56230152
Metastases to pleura 256.97 15.14 83 57169 1299 56233516
Leukopenia 235.35 15.14 324 56928 70616 56164199
Bone pain 216.35 15.14 261 56991 49924 56184891
Breast cancer recurrent 213.05 15.14 97 57155 3978 56230837
Thrombocytopenia 212.45 15.14 444 56808 135780 56099035
Metastases to skin 205.20 15.14 71 57181 1387 56233428
Metastases to spine 197.89 15.14 84 57168 2905 56231910
Bone lesion 189.46 15.14 98 57154 5332 56229483
Joint swelling 185.76 15.14 35 57217 289765 55945050
Infusion related reaction 181.97 15.14 7 57245 208924 56025891
Maternal exposure during pregnancy 177.61 15.14 3 57249 189550 56045265
Pseudocirrhosis 167.67 15.14 50 57202 591 56234224
Metastases to central nervous system 165.37 15.14 120 57132 12016 56222799
Pleural effusion 163.91 15.14 304 56948 85176 56149639
Palmar-plantar erythrodysaesthesia syndrome 161.54 15.14 149 57103 20916 56213899
Ascites 158.11 15.14 193 57059 37351 56197464
Therapeutic product effect decreased 157.44 15.14 3 57249 169449 56065366
Systemic lupus erythematosus 156.91 15.14 6 57246 180072 56054743
Hepatic lesion 143.31 15.14 75 57177 4180 56230635
Death 137.66 15.14 698 56554 340728 55894087
Asthenia 131.90 15.14 692 56560 342281 55892534
Arthropathy 130.81 15.14 23 57229 200252 56034563
Hyperglycaemia 128.62 15.14 176 57076 38105 56196710
Metastases to peritoneum 127.72 15.14 62 57190 2942 56231873
Decreased appetite 126.62 15.14 499 56753 218732 56016083
Anaemia 122.92 15.14 568 56684 266943 55967872
Hot flush 122.40 15.14 191 57061 46535 56188280
Full blood count abnormal 121.21 15.14 142 57110 26320 56208495
Osteonecrosis 117.18 15.14 131 57121 23084 56211731
Platelet count decreased 114.47 15.14 300 56952 106083 56128732
Red blood cell count decreased 113.55 15.14 162 57090 36455 56198360
Drug hypersensitivity 110.52 15.14 72 57180 275133 55959682
Glossodynia 102.89 15.14 16 57236 152442 56082373
Hypotension 98.60 15.14 67 57185 250441 55984374
Pericarditis 97.06 15.14 3 57249 108920 56125895
Treatment failure 96.29 15.14 27 57225 170365 56064450
Second primary malignancy 93.65 15.14 70 57182 7332 56227483
Carcinoembryonic antigen increased 89.43 15.14 40 57212 1572 56233243
Infusion site coldness 84.41 15.14 23 57229 191 56234624
Mucosal inflammation 84.19 15.14 154 57098 42656 56192159
Hepatic failure 82.33 15.14 133 57119 33353 56201462
Neuropathy peripheral 81.48 15.14 260 56992 102633 56132182
Musculoskeletal stiffness 80.53 15.14 29 57223 155978 56078837
Bone marrow failure 78.80 15.14 119 57133 28167 56206648
Intentional product use issue 75.80 15.14 7 57245 99726 56135089
Nausea 75.47 15.14 1141 56111 763037 55471778
Gamma-glutamyltransferase decreased 75.26 15.14 23 57229 297 56234518
Wound 74.77 15.14 24 57228 138780 56096035
Off label use 72.25 15.14 306 56946 555874 55678941
Bone disorder 71.98 15.14 94 57158 19449 56215366
Fall 70.99 15.14 162 57090 357348 55877467
Lymphangiosis carcinomatosa 69.32 15.14 31 57221 1218 56233597
Swelling 68.45 15.14 86 57166 239685 55995130
Metastases to chest wall 68.23 15.14 24 57228 493 56234322
Abdominal lymphadenopathy 67.90 15.14 26 57226 684 56234131
Condition aggravated 67.90 15.14 157 57095 344741 55890074
Malignant pleural effusion 65.81 15.14 37 57215 2379 56232436
Invasive ductal breast carcinoma 65.80 15.14 55 57197 6771 56228044
Haematotoxicity 65.62 15.14 60 57192 8323 56226492
Polyneuropathy 64.75 15.14 73 57179 12977 56221838
Lymphoedema 62.95 15.14 65 57187 10465 56224350
Bone sequestrum 62.93 15.14 30 57222 1367 56233448
Metastases to pelvis 62.44 15.14 21 57231 375 56234440
Helicobacter infection 61.93 15.14 3 57249 73265 56161550
Overdose 61.21 15.14 16 57236 105814 56129001
Tumour marker abnormal 60.11 15.14 20 57232 345 56234470
Asthma 59.84 15.14 20 57232 112750 56122065
Pleural neoplasm 59.74 15.14 20 57232 352 56234463
Discomfort 59.73 15.14 35 57217 141726 56093089
Spinal pain 58.15 15.14 66 57186 11818 56222997
Hypersensitivity 57.78 15.14 108 57144 256300 55978515
Full blood count decreased 57.75 15.14 93 57159 23256 56211559
Stomatitis 57.17 15.14 259 56993 120551 56114264
Pneumonia 56.54 15.14 218 57034 406880 55827935
Metastases to thorax 56.24 15.14 17 57235 211 56234604
Osteolysis 55.33 15.14 34 57218 2579 56232236
Sinusitis 55.20 15.14 72 57180 197509 56037306
Diarrhoea 54.83 15.14 932 56320 637575 55597240
Intentional overdose 53.91 15.14 4 57248 68113 56166702
Cancer pain 53.60 15.14 35 57217 2951 56231864
Toxicity to various agents 52.90 15.14 92 57160 224472 56010343
Myelosuppression 52.30 15.14 76 57176 17379 56217436
Drug interaction 52.13 15.14 83 57169 209672 56025143
Skin toxicity 51.92 15.14 39 57213 4114 56230701
Metastases to the mediastinum 51.18 15.14 19 57233 458 56234357
Invasive lobular breast carcinoma 50.60 15.14 22 57230 807 56234008
Psoriasis 49.95 15.14 16 57236 92676 56142139
Eastern Cooperative Oncology Group performance status worsened 49.03 15.14 22 57230 871 56233944
Infusion site induration 48.50 15.14 22 57230 894 56233921
Mobility decreased 48.41 15.14 20 57232 98971 56135844
Metastases to retroperitoneum 48.19 15.14 14 57238 150 56234665
Drug intolerance 47.80 15.14 126 57126 264692 55970123
Injection site necrosis 47.41 15.14 24 57228 1247 56233568
Cough 46.74 15.14 436 56816 259525 55975290
Hormone receptor positive breast cancer 46.30 15.14 18 57234 494 56234321
Oestradiol increased 46.09 15.14 12 57240 82 56234733
Headache 43.97 15.14 361 56891 558683 55676132
Portal hypertension 43.71 15.14 33 57219 3508 56231307
Oral pain 43.59 15.14 88 57164 26205 56208610
Metastases to adrenals 43.50 15.14 19 57233 705 56234110
Hypertransaminasaemia 43.46 15.14 37 57215 4670 56230145
Fibromyalgia 43.17 15.14 5 57247 59598 56175217
Adnexa uteri mass 42.72 15.14 17 57235 497 56234318
Confusional state 42.33 15.14 93 57159 208062 56026753
Electrocardiogram PR shortened 42.21 15.14 14 57238 239 56234576
Abdominal discomfort 42.07 15.14 143 57109 277131 55957684
Recurrent cancer 41.83 15.14 25 57227 1803 56233012
Bradycardia 41.40 15.14 9 57243 67495 56167320
Taste disorder 40.97 15.14 50 57202 9665 56225150
Lower respiratory tract infection 40.87 15.14 34 57218 114760 56120055
Bone cancer metastatic 40.38 15.14 12 57240 140 56234675
Tooth extraction 40.26 15.14 49 57203 9444 56225371
Epistaxis 39.74 15.14 154 57098 66869 56167946
Isosthenuria 39.68 15.14 11 57241 98 56234717
Suicide attempt 39.15 15.14 6 57246 57830 56176985
Back pain 38.79 15.14 390 56862 236780 55998035
Interstitial lung disease 38.76 15.14 137 57115 56926 56177889
Bone marrow infiltration 38.50 15.14 16 57236 524 56234291
General physical health deterioration 38.36 15.14 300 56952 169710 56065105
Acute kidney injury 38.00 15.14 122 57130 240641 55994174
Blood bilirubin increased 37.82 15.14 96 57156 33258 56201557
Superinfection 37.70 15.14 25 57227 2163 56232652
Adverse event 36.91 15.14 6 57246 55370 56179445
Metastatic neoplasm 36.62 15.14 31 57221 3882 56230933
Lymphadenopathy 36.51 15.14 98 57154 35110 56199705
Ejection fraction decreased 36.03 15.14 69 57183 19772 56215043
Bladder hypertrophy 35.59 15.14 12 57240 216 56234599
Constipation 35.42 15.14 337 56915 201606 56033209
Post-traumatic neck syndrome 35.06 15.14 23 57229 1955 56232860
Nasopharyngitis 34.84 15.14 112 57140 220847 56013968
Suicidal ideation 34.80 15.14 8 57244 57734 56177081
Cardio-respiratory arrest 34.70 15.14 7 57245 55314 56179501
Drug resistance 34.35 15.14 69 57183 20473 56214342
Pyelitis 33.94 15.14 11 57241 174 56234641
Arthritis 33.81 15.14 31 57221 99821 56134994
Neoplasm 33.81 15.14 37 57215 6364 56228451
Adverse drug reaction 33.77 15.14 12 57240 65120 56169695
Dry skin 33.64 15.14 115 57137 46994 56187821
Plasma cell myeloma 33.57 15.14 4 57248 46642 56188173
Therapeutic product effect incomplete 33.50 15.14 35 57217 105996 56128819
Jaw disorder 33.35 15.14 33 57219 5050 56229765
Metastases to kidney 33.05 15.14 11 57241 190 56234625
Hepatic function abnormal 32.67 15.14 93 57159 34465 56200350
Alopecia 32.61 15.14 448 56804 293010 55941805
Nephroangiosclerosis 32.25 15.14 10 57242 136 56234679
Dysgeusia 32.00 15.14 103 57149 40812 56194003
Pneumonitis 31.87 15.14 87 57165 31477 56203338
BRAF gene mutation 31.76 15.14 8 57244 47 56234768
Carbohydrate antigen 27.29 increased 31.62 15.14 8 57244 48 56234767
Haemoglobin decreased 31.52 15.14 239 57013 133898 56100917
Metastases to soft tissue 31.35 15.14 10 57242 150 56234665
Prehypertension 31.32 15.14 7 57245 22 56234793
Blister 31.09 15.14 39 57213 108848 56125967
Hospitalisation 30.90 15.14 19 57233 74981 56159834
Hepatic enzyme increased 30.55 15.14 82 57170 171302 56063513
Loss of consciousness 30.36 15.14 40 57212 109309 56125506
Hepatic echinococciasis 30.19 15.14 8 57244 59 56234756
Tumour marker decreased 29.96 15.14 8 57244 61 56234754
Vasodilatation 29.47 15.14 22 57230 2299 56232516
Pustule 29.46 15.14 18 57234 1351 56233464
Ill-defined disorder 28.75 15.14 17 57235 68526 56166289
Oxygen saturation decreased 28.66 15.14 23 57229 79044 56155771
Tachycardia 28.11 15.14 40 57212 105836 56128979
Weight increased 28.11 15.14 129 57123 229574 56005241
Cardiac arrest 27.82 15.14 28 57224 86286 56148529
Mouth swelling 27.63 15.14 27 57225 4070 56230745
Lacrimation increased 27.59 15.14 59 57193 18289 56216526
Exposed bone in jaw 27.56 15.14 23 57229 2825 56231990
Osteomyelitis 27.52 15.14 70 57182 24276 56210539
Hydronephrosis 27.34 15.14 40 57212 9202 56225613
Creatinine renal clearance increased 27.21 15.14 13 57239 595 56234220
Dyspnoea exertional 27.16 15.14 119 57133 54570 56180245
Hypermetabolism 26.85 15.14 9 57243 159 56234656
International normalised ratio increased 26.74 15.14 6 57246 44035 56190780
Pulmonary tumour thrombotic microangiopathy 26.74 15.14 7 57245 49 56234766
Breast cancer stage IV 26.71 15.14 19 57233 1843 56232972
Cardiac failure congestive 26.55 15.14 30 57222 87690 56147125
Retinal detachment 26.25 15.14 30 57222 5411 56229404
Seizure 26.16 15.14 55 57197 125064 56109751
Hip arthroplasty 26.16 15.14 4 57248 38619 56196196
Hypoglycaemia 26.14 15.14 12 57240 55803 56179012
Blood creatinine increased 26.13 15.14 155 57097 80036 56154779
Decreased immune responsiveness 25.99 15.14 27 57225 4376 56230439
Aspartate aminotransferase increased 25.86 15.14 158 57094 82444 56152371
Gastrointestinal disorder 25.76 15.14 47 57205 112655 56122160
Ovarian disorder 25.60 15.14 13 57239 680 56234135
Loss of personal independence in daily activities 25.54 15.14 27 57225 81342 56153473
Tremor 25.51 15.14 53 57199 121036 56113779
Blood pressure increased 25.46 15.14 70 57182 145106 56089709
Joint neoplasm 25.19 15.14 7 57245 63 56234752
Carcinoid tumour pulmonary 24.89 15.14 11 57241 420 56234395
Malignant peritoneal neoplasm 24.86 15.14 13 57239 723 56234092
Vein disorder 24.83 15.14 27 57225 4610 56230205
Heart rate increased 24.64 15.14 29 57223 83244 56151571
Pain in jaw 24.55 15.14 93 57159 39943 56194872
Soft tissue neoplasm 24.35 15.14 7 57245 72 56234743
Bile duct stenosis 24.16 15.14 15 57237 1159 56233656
Peritoneal disorder 24.16 15.14 11 57241 451 56234364
Hepatic cyst 24.10 15.14 27 57225 4766 56230049
Metastases to eye 24.10 15.14 8 57244 137 56234678
Vulvovaginal dryness 24.04 15.14 20 57232 2445 56232370
RET gene mutation 23.98 15.14 5 57247 10 56234805
Oestrogen receptor assay positive 23.89 15.14 11 57241 463 56234352
Bone debridement 23.71 15.14 9 57243 231 56234584
Metastases to spinal cord 23.57 15.14 6 57246 37 56234778
Agitation 23.35 15.14 14 57238 56022 56178793
Transaminases 23.30 15.14 7 57245 85 56234730
Fluid retention 23.27 15.14 13 57239 54065 56180750
Mediastinal disorder 23.23 15.14 10 57242 358 56234457
Hormone receptor positive HER2 negative breast cancer 23.23 15.14 8 57244 154 56234661
Hepatic cancer metastatic 23.13 15.14 10 57242 362 56234453
Hyperchromic anaemia 23.04 15.14 6 57246 41 56234774
Cytopenia 22.96 15.14 38 57214 9717 56225098
Somnolence 22.94 15.14 87 57165 163326 56071489
Musculoskeletal chest pain 22.75 15.14 57 57195 19584 56215231
Mean cell haemoglobin decreased 22.62 15.14 25 57227 4347 56230468
Osteosclerosis 22.60 15.14 23 57229 3640 56231175
Pathological fracture 22.48 15.14 34 57218 8055 56226760
Gingivitis 22.27 15.14 33 57219 7676 56227139
Oral disorder 22.21 15.14 34 57218 8141 56226674
Injury 22.20 15.14 17 57235 59834 56174981
Aphthous ulcer 22.07 15.14 42 57210 11977 56222838
Injection site hypoaesthesia 22.01 15.14 10 57242 408 56234407
Metastases to bladder 21.94 15.14 8 57244 183 56234632
Metastases to breast 21.76 15.14 9 57243 291 56234524
Inappropriate schedule of product administration 21.64 15.14 32 57220 83355 56151460
Jaundice 21.60 15.14 69 57183 27225 56207590
Bronchitis 21.34 15.14 52 57200 112259 56122556
Product use issue 21.28 15.14 107 57145 185934 56048881
Metastases to meninges 21.28 15.14 18 57234 2252 56232563
Pulmonary embolism 20.90 15.14 183 57069 106941 56127874
Hallucination 20.88 15.14 12 57240 49137 56185678
Drug reaction with eosinophilia and systemic symptoms 20.84 15.14 3 57249 30301 56204514
Onychoclasis 20.77 15.14 27 57225 5558 56229257
Elliptocytosis 20.76 15.14 6 57246 63 56234752
Infusion site haemorrhage 20.64 15.14 22 57230 3673 56231142
Pancreatitis 20.63 15.14 10 57242 45070 56189745
Type 2 diabetes mellitus 20.54 15.14 11 57241 46851 56187964
Peripheral swelling 20.52 15.14 147 57105 234579 56000236
Invasive breast carcinoma 20.47 15.14 11 57241 647 56234168
Hyponatraemia 20.44 15.14 46 57206 102093 56132722
Pulmonary mass 20.24 15.14 56 57196 20414 56214401
Pain 20.23 15.14 517 56735 662667 55572148
Spinal cord compression 20.21 15.14 22 57230 3762 56231053
Granulocytopenia 20.13 15.14 26 57226 5318 56229497
Metabolic acidosis 20.05 15.14 8 57244 40446 56194369
Bone cancer 20.02 15.14 14 57238 1322 56233493
Neoplasm recurrence 20.00 15.14 18 57234 2446 56232369
Malignant ascites 20.00 15.14 12 57240 872 56233943
Product quality issue 19.93 15.14 4 57248 31732 56203083
Syncope 19.85 15.14 51 57201 108148 56126667
Gamma-glutamyltransferase increased 19.83 15.14 73 57179 30932 56203883
Influenza 19.81 15.14 42 57210 95219 56139596
Dyskinesia 19.74 15.14 3 57249 29105 56205710
Metastases to ovary 19.47 15.14 9 57243 382 56234433
Wheezing 19.27 15.14 29 57223 74997 56159818
Orthostatic hypotension 19.22 15.14 5 57247 33194 56201621
Gingival swelling 19.18 15.14 22 57230 3984 56230831
Feeling cold 19.04 15.14 56 57196 21131 56213684
Gastrointestinal haemorrhage 18.89 15.14 30 57222 75921 56158894
Osteoarthritis 18.78 15.14 33 57219 80263 56154552
Treatment noncompliance 18.72 15.14 5 57247 32618 56202197
Transaminases abnormal 18.69 15.14 10 57242 583 56234232
Uterine mass 18.67 15.14 8 57244 283 56234532
Sepsis 18.64 15.14 76 57176 139764 56095051
Transaminases increased 18.62 15.14 68 57184 28702 56206113
Nail disorder 18.59 15.14 38 57214 11413 56223402
Skin sensitisation 18.54 15.14 11 57241 783 56234032
Cytogenetic analysis abnormal 18.52 15.14 11 57241 784 56234031
Urticaria 18.43 15.14 80 57172 144596 56090219
Blood pressure fluctuation 18.40 15.14 9 57243 40351 56194464
No adverse event 18.35 15.14 7 57245 36367 56198448
COVID-19 18.33 15.14 135 57117 74923 56159892
Septic shock 18.20 15.14 21 57231 60814 56174001
Hormone refractory breast cancer 18.04 15.14 4 57248 12 56234803
Blood creatinine abnormal 18.01 15.14 18 57234 2788 56232027
Hepatotoxicity 17.99 15.14 71 57181 31082 56203733
Gingival pain 17.96 15.14 27 57225 6361 56228454
Herpes zoster 17.92 15.14 31 57221 75858 56158957
Overflow diarrhoea 17.85 15.14 6 57246 107 56234708
Myocardial infarction 17.64 15.14 43 57209 92827 56141988
Gingival erythema 17.63 15.14 10 57242 654 56234161
Encephalopathy 17.49 15.14 7 57245 35318 56199497
Coma 17.41 15.14 21 57231 59634 56175181
Intestinal metastasis 17.07 15.14 6 57246 123 56234692
Cachexia 17.01 15.14 23 57229 4919 56229896
Red blood cell sedimentation rate increased 16.95 15.14 8 57244 36615 56198200
Debridement 16.77 15.14 12 57240 1175 56233640
Pneumonia aspiration 16.75 15.14 6 57246 32405 56202410
Injection site mass 16.66 15.14 46 57206 16747 56218068
Drug ineffective for unapproved indication 16.64 15.14 3 57249 25690 56209125
Metastases to muscle 16.46 15.14 6 57246 137 56234678
Angioedema 16.39 15.14 11 57241 41442 56193373
Adenocarcinoma 16.30 15.14 17 57235 2768 56232047
Radiation fibrosis - lung 16.26 15.14 4 57248 21 56234794
Body surface area decreased 16.26 15.14 4 57248 21 56234794
Blood creatinine decreased 16.22 15.14 23 57229 5143 56229672
Tooth disorder 16.20 15.14 60 57192 25493 56209322
Nail avulsion 16.19 15.14 6 57246 144 56234671
Unresponsive to stimuli 16.18 15.14 6 57246 31719 56203096
Gastrointestinal submucosal tumour 15.95 15.14 4 57248 23 56234792
Neoplasm malignant 15.89 15.14 62 57190 26993 56207822
Incorrect dose administered 15.87 15.14 18 57234 52529 56182286
Hyperkalaemia 15.82 15.14 17 57235 50848 56183967
Excessive granulation tissue 15.79 15.14 10 57242 800 56234015
Sequestrectomy 15.69 15.14 10 57242 809 56234006
Depressed level of consciousness 15.29 15.14 21 57231 56412 56178403
Lymphadenopathy mediastinal 15.28 15.14 16 57236 2617 56232198
Weight decreased 15.27 15.14 336 56916 240378 55994437
Glycosylated haemoglobin 15.26 15.14 5 57247 82 56234733
Breast injury 15.20 15.14 5 57247 83 56234732

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
Xerosis 55.01 46.99 9 442 512 31696381

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 1922.71 16.17 808 44293 44420 70838923
Metastases to bone 1573.45 16.17 576 44525 21800 70861543
Malignant neoplasm progression 1512.85 16.17 948 44153 120791 70762552
Metastases to liver 1130.96 16.17 472 44629 25406 70857937
Breast cancer metastatic 1003.76 16.17 337 44764 9809 70873534
White blood cell count decreased 818.85 16.17 752 44349 169389 70713954
Neutropenia 789.06 16.17 891 44210 256265 70627078
Tumour marker increased 539.11 16.17 166 44935 3628 70879715
Fatigue 459.05 16.17 1350 43751 822969 70060374
Metastases to lung 436.41 16.17 212 44889 16272 70867071
Osteonecrosis of jaw 413.87 16.17 281 44820 40721 70842622
Breast cancer 409.58 16.17 259 44842 33290 70850053
Neutrophil count decreased 285.36 16.17 307 44794 83249 70800094
Carbohydrate antigen 15-3 increased 265.19 16.17 72 45029 986 70882357
Disease progression 251.09 16.17 396 44705 156276 70727067
Metastases to lymph nodes 218.29 16.17 110 44991 9128 70874215
Bone pain 206.37 16.17 205 44896 50617 70832726
Breast cancer recurrent 203.83 16.17 74 45027 2719 70880624
Drug ineffective 199.93 16.17 183 44918 939569 69943774
PIK3CA-activated mutation 196.39 16.17 50 45051 524 70882819
Pseudocirrhosis 185.36 16.17 49 45052 602 70882741
Alopecia 170.22 16.17 384 44717 198106 70685237
Bone lesion 168.68 16.17 78 45023 5352 70877991
Metastases to pleura 163.52 16.17 52 45049 1266 70882077
Metastases to skin 150.60 16.17 51 45050 1520 70881823
Rheumatoid arthritis 143.81 16.17 11 45090 291794 70591549
Asthenia 141.93 16.17 621 44480 457045 70426298
Hot flush 139.81 16.17 165 44936 49419 70833924
Metastasis 130.53 16.17 68 45033 6046 70877297
Nausea 130.02 16.17 955 44146 851133 70032210
Full blood count abnormal 128.97 16.17 132 44969 33746 70849597
Leukopenia 114.27 16.17 226 44875 106334 70777009
Thrombocytopenia 110.74 16.17 369 44732 238741 70644602
Hypotension 110.25 16.17 60 45041 404321 70479022
Metastases to spine 109.66 16.17 52 45049 3777 70879566
Decreased appetite 107.92 16.17 431 44670 304349 70578994
Red blood cell count decreased 102.21 16.17 145 44956 52016 70831327
Metastases to central nervous system 101.71 16.17 81 45020 14953 70868390
Infusion related reaction 98.55 16.17 7 45094 197527 70685816
Platelet count decreased 96.16 16.17 290 44811 177932 70705411
Infusion site coldness 93.79 16.17 23 45078 204 70883139
Stomatitis 91.01 16.17 231 44870 128280 70755063
Acute kidney injury 86.37 16.17 105 44996 474519 70408824
Gamma-glutamyltransferase decreased 82.58 16.17 23 45078 348 70882995
Joint swelling 82.49 16.17 29 45072 253182 70630161
Osteonecrosis 82.11 16.17 97 45004 29063 70854280
Hepatic lesion 81.60 16.17 50 45051 6067 70877276
Palmar-plantar erythrodysaesthesia syndrome 80.88 16.17 98 45003 30149 70853194
Carcinoembryonic antigen increased 78.52 16.17 34 45067 1996 70881347
Toxicity to various agents 77.82 16.17 77 45024 382095 70501248
Therapeutic product effect decreased 77.79 16.17 3 45098 143015 70740328
Drug interaction 77.50 16.17 77 45024 381364 70501979
Full blood count decreased 76.53 16.17 85 45016 23833 70859510
Pleural effusion 71.44 16.17 216 44885 132648 70750695
Neuropathy peripheral 70.78 16.17 209 44892 126687 70756656
Pneumonia 70.08 16.17 174 44927 596058 70287285
Second primary malignancy 69.01 16.17 61 45040 12990 70870353
Spinal pain 68.15 16.17 62 45039 13708 70869635
Oral pain 67.86 16.17 88 45013 28978 70854365
Lymphangiosis carcinomatosa 67.57 16.17 30 45071 1871 70881472
Off label use 67.16 16.17 245 44856 742815 70140528
Anaemia 66.81 16.17 462 44639 402961 70480382
Invasive ductal breast carcinoma 66.26 16.17 43 45058 5766 70877577
Ascites 66.12 16.17 138 44963 67409 70815934
Overdose 63.43 16.17 15 45086 169730 70713613
Diarrhoea 62.14 16.17 765 44336 782576 70100767
Infusion site induration 59.22 16.17 22 45079 863 70882480
Bone disorder 59.15 16.17 64 45037 17426 70865917
Hyperglycaemia 58.55 16.17 128 44973 64544 70818799
Adnexa uteri mass 58.28 16.17 17 45084 306 70883037
Metastases to peritoneum 58.17 16.17 34 45067 3785 70879558
Skin toxicity 57.92 16.17 43 45058 7155 70876188
Fall 55.79 16.17 125 44976 443971 70439372
Bradycardia 55.31 16.17 7 45094 124608 70758735
Intentional product use issue 55.18 16.17 6 45095 120136 70763207
Bone marrow failure 54.99 16.17 106 44995 48904 70834439
Lymphoedema 54.71 16.17 50 45051 11119 70872224
Cough 54.04 16.17 373 44728 325004 70558339
Death 53.13 16.17 526 44575 509535 70373808
Systemic lupus erythematosus 52.62 16.17 3 45098 101899 70781444
Injection site necrosis 50.08 16.17 22 45079 1337 70882006
Drug hypersensitivity 48.79 16.17 57 45044 262402 70620941
Metastases to pelvis 48.61 16.17 17 45084 559 70882784
Abdominal lymphadenopathy 48.49 16.17 21 45080 1233 70882110
Intentional overdose 47.63 16.17 4 45097 98431 70784912
Arthropathy 47.46 16.17 18 45083 150039 70733304
Tumour marker abnormal 47.24 16.17 14 45087 267 70883076
Mucosal inflammation 46.99 16.17 121 44980 67729 70815614
Electrocardiogram PR shortened 46.95 16.17 14 45087 273 70883070
Sepsis 46.66 16.17 52 45049 244493 70638850
Myelosuppression 46.52 16.17 75 45026 30070 70853273
Back pain 46.28 16.17 313 44788 270839 70612504
Cardiac arrest 46.04 16.17 22 45079 159812 70723531
Cancer pain 45.82 16.17 32 45069 4842 70878501
Post-traumatic neck syndrome 45.16 16.17 23 45078 1950 70881393
Metastases to chest wall 44.94 16.17 15 45086 427 70882916
Isosthenuria 44.51 16.17 11 45090 101 70883242
Tooth extraction 43.28 16.17 42 45059 10065 70873278
Metastases to retroperitoneum 43.11 16.17 14 45087 365 70882978
Pericarditis 42.23 16.17 3 45098 84702 70798641
Condition aggravated 41.90 16.17 136 44965 427499 70455844
Cardio-respiratory arrest 41.56 16.17 7 45094 100670 70782673
Lacrimation increased 41.47 16.17 57 45044 19842 70863501
Osteolysis 40.01 16.17 26 45075 3493 70879850
Hypertransaminasaemia 39.88 16.17 38 45063 8905 70874438
Pleural neoplasm 39.43 16.17 13 45088 356 70882987
Metastases to breast 38.71 16.17 12 45089 268 70883075
Treatment failure 38.32 16.17 22 45079 144120 70739223
Confusional state 38.22 16.17 77 45024 284321 70599022
Constipation 38.16 16.17 283 44818 252155 70631188
Dry skin 37.96 16.17 99 45002 55832 70827511
Asthma 37.35 16.17 15 45086 120778 70762565
International normalised ratio increased 37.15 16.17 4 45097 80722 70802621
Hepatic failure 37.08 16.17 100 45001 57525 70825818
Metastases to eye 36.26 16.17 11 45090 228 70883115
Prehypertension 36.21 16.17 7 45094 16 70883327
Portal hypertension 35.64 16.17 31 45070 6461 70876882
Malignant pleural effusion 35.22 16.17 23 45078 3116 70880227
Tumour marker decreased 35.07 16.17 8 45093 50 70883293
Hyperkalaemia 35.04 16.17 12 45089 106579 70776764
Infusion site haemorrhage 34.99 16.17 22 45079 2793 70880550
Mobility decreased 34.90 16.17 11 45090 102988 70780355
Metastases to thorax 34.76 16.17 10 45091 171 70883172
Pain in jaw 34.76 16.17 81 45020 42588 70840755
Hepatic echinococciasis 34.67 16.17 8 45093 53 70883290
Vein disorder 34.57 16.17 26 45075 4412 70878931
Metastases to the mediastinum 34.49 16.17 13 45088 531 70882812
Pyelitis 34.05 16.17 11 45090 282 70883061
Superinfection 33.56 16.17 25 45076 4181 70879162
Musculoskeletal stiffness 33.34 16.17 27 45074 147733 70735610
Loss of consciousness 33.25 16.17 30 45071 155686 70727657
Vasodilatation 33.13 16.17 22 45079 3066 70880277
Dysgeusia 32.96 16.17 87 45014 49415 70833928
Plasma cell myeloma 32.75 16.17 4 45097 73197 70810146
Hormone receptor positive breast cancer 32.67 16.17 11 45090 322 70883021
Ejection fraction decreased 32.64 16.17 65 45036 30697 70852646
Ovarian disorder 32.56 16.17 12 45089 460 70882883
Syncope 31.85 16.17 35 45066 165674 70717669
Suicide attempt 31.79 16.17 6 45095 79504 70803839
Haematotoxicity 31.29 16.17 41 45060 13633 70869710
Tachycardia 31.01 16.17 33 45068 158513 70724830
Carbohydrate antigen 27.29 increased 30.66 16.17 7 45094 44 70883299
Taste disorder 30.61 16.17 37 45064 11348 70871995
Bladder hypertrophy 29.86 16.17 12 45089 583 70882760
Onychoclasis 29.81 16.17 25 45076 4959 70878384
Lymphadenopathy 29.73 16.17 83 45018 48708 70834635
Psoriasis 29.19 16.17 13 45088 98420 70784923
Pustule 29.12 16.17 16 45085 1583 70881760
Myocardial infarction 29.05 16.17 40 45061 171605 70711738
Nephroangiosclerosis 29.03 16.17 10 45091 314 70883029
Cardiac failure congestive 29.03 16.17 26 45075 135431 70747912
Hypoglycaemia 28.72 16.17 12 45089 94352 70788991
Gastrointestinal haemorrhage 28.71 16.17 27 45074 137381 70745962
Mean cell haemoglobin decreased 28.61 16.17 25 45076 5243 70878100
Creatinine renal clearance increased 28.60 16.17 13 45088 857 70882486
Joint neoplasm 28.45 16.17 7 45094 63 70883280
Metastases to kidney 28.43 16.17 11 45090 483 70882860
Mouth swelling 28.28 16.17 25 45076 5324 70878019
Decreased immune responsiveness 28.03 16.17 24 45077 4897 70878446
Oxygen saturation decreased 27.89 16.17 20 45081 116409 70766934
Malignant peritoneal neoplasm 27.73 16.17 12 45089 703 70882640
Haemoglobin decreased 27.65 16.17 224 44877 204935 70678408
Septic shock 27.26 16.17 19 45082 112239 70771104
Drug intolerance 27.10 16.17 65 45036 225622 70657721
Metabolic acidosis 26.92 16.17 7 45094 74339 70809004
Metastases to soft tissue 26.85 16.17 10 45091 395 70882948
Seizure 26.72 16.17 45 45056 177917 70705426
Agitation 26.65 16.17 13 45088 93362 70789981
Soft tissue neoplasm 26.55 16.17 7 45094 85 70883258
Pulmonary tumour thrombotic microangiopathy 26.18 16.17 7 45094 90 70883253
Oestradiol increased 25.90 16.17 7 45094 94 70883249
Exposed bone in jaw 25.90 16.17 20 45081 3529 70879814
Atrial fibrillation 25.53 16.17 49 45052 184299 70699044
Recurrent cancer 25.25 16.17 17 45084 2424 70880919
Peritoneal disorder 25.10 16.17 11 45090 665 70882678
Vulvovaginal dryness 24.70 16.17 15 45086 1791 70881552
Hyponatraemia 24.47 16.17 40 45061 160047 70723296
Osteomyelitis 24.09 16.17 57 45044 30261 70853082
Blood creatine phosphokinase increased 23.70 16.17 5 45096 61258 70822085
Neoplasm 23.65 16.17 27 45074 7797 70875546
Feeling cold 23.57 16.17 51 45050 25519 70857824
Metastases to bladder 23.48 16.17 8 45093 243 70883100
Aphthous ulcer 23.35 16.17 37 45064 14619 70868724
Toothache 23.34 16.17 42 45059 18388 70864955
Metastatic neoplasm 23.14 16.17 21 45080 4627 70878716
Skin sensitisation 22.77 16.17 11 45090 832 70882511
Hallucination 22.72 16.17 10 45091 76250 70807093
Suicidal ideation 22.58 16.17 8 45093 69588 70813755
Transaminases 22.45 16.17 6 45095 77 70883266
Tooth disorder 22.36 16.17 48 45053 23890 70859453
Pneumonia aspiration 22.30 16.17 6 45095 62283 70821060
Irritable bowel syndrome 22.21 16.17 3 45098 50847 70832496
Epistaxis 22.20 16.17 126 44975 102501 70780842
Metastases to ovary 22.16 16.17 8 45093 289 70883054
Blood pressure increased 22.07 16.17 55 45046 188462 70694881
Bone sequestrum 21.96 16.17 12 45089 1174 70882169
Drug reaction with eosinophilia and systemic symptoms 21.91 16.17 5 45096 58008 70825335
Elliptocytosis 21.78 16.17 6 45095 87 70883256
Oral disorder 21.63 16.17 28 45073 9201 70874142
Gingival pain 21.59 16.17 24 45077 6733 70876610
Hospitalisation 21.37 16.17 13 45088 82555 70800788
Hypermetabolism 21.36 16.17 8 45093 321 70883022
Eastern Cooperative Oncology Group performance status worsened 21.08 16.17 13 45088 1595 70881748
RET gene mutation 21.06 16.17 4 45097 8 70883335
Angioedema 21.04 16.17 8 45093 66602 70816741
Tremor 21.00 16.17 42 45059 155582 70727761
Osteosclerosis 20.96 16.17 18 45083 3687 70879656
Mental status changes 20.91 16.17 7 45094 63094 70820249
Gingivitis 20.82 16.17 26 45075 8244 70875099
Coronary artery disease 20.72 16.17 7 45094 62729 70820614
Nail avulsion 20.67 16.17 6 45095 106 70883237
Unresponsive to stimuli 20.59 16.17 4 45097 51927 70831416
Overflow diarrhoea 20.57 16.17 6 45095 108 70883235
Blood pressure fluctuation 20.54 16.17 6 45095 59006 70824337
Nail disorder 20.44 16.17 29 45072 10395 70872948
Transaminases abnormal 20.39 16.17 10 45091 782 70882561
Metastases to spinal cord 20.32 16.17 5 45096 45 70883298
Parosmia 20.20 16.17 20 45081 4911 70878432
Encephalopathy 20.16 16.17 7 45094 61654 70821689
Madarosis 20.14 16.17 15 45086 2508 70880835
Wound 19.92 16.17 20 45081 98712 70784631
Hepatic cyst 19.92 16.17 21 45080 5550 70877793
Hypersensitivity 19.85 16.17 77 45024 229735 70653608
Hydronephrosis 19.64 16.17 35 45066 15207 70868136
Metastases to meninges 19.32 16.17 16 45085 3120 70880223
Musculoskeletal chest pain 19.25 16.17 44 45057 22837 70860506
Invasive lobular breast carcinoma 19.22 16.17 9 45092 635 70882708
Adverse event 19.21 16.17 4 45097 49457 70833886
Adenocarcinoma 19.16 16.17 17 45084 3636 70879707
Interstitial lung disease 19.12 16.17 123 44978 104562 70778781
Pancreatitis 19.02 16.17 8 45093 62660 70820683
Excessive granulation tissue 18.98 16.17 10 45091 909 70882434
Bone debridement 18.95 16.17 8 45093 441 70882902
Retinal detachment 18.78 16.17 25 45076 8442 70874901
Febrile neutropenia 18.59 16.17 67 45034 204251 70679092
Metastases to uterus 18.51 16.17 5 45096 67 70883276
Blood creatinine decreased 18.33 16.17 23 45078 7326 70876017
Fibromyalgia 18.33 16.17 4 45097 47870 70835473
Dorsal ramus syndrome 18.29 16.17 4 45097 20 70883323
Coma 18.08 16.17 19 45082 91825 70791518
Respiratory failure 17.66 16.17 52 45049 168683 70714660
Breast injury 17.63 16.17 5 45096 81 70883262
Breast mass 17.55 16.17 20 45081 5765 70877578
Adverse drug reaction 17.54 16.17 6 45095 53338 70830005
Pneumonitis 17.51 16.17 75 45026 54522 70828821
Discomfort 17.40 16.17 25 45076 105411 70777932
Carcinoid tumour pulmonary 17.34 16.17 7 45094 344 70882999
Depressed level of consciousness 17.31 16.17 18 45083 87413 70795930
Dysarthria 17.29 16.17 9 45092 62304 70821039
Sequestrectomy 16.82 16.17 9 45092 844 70882499
Fractured sacrum 16.68 16.17 11 45090 1515 70881828
Pathological fracture 16.39 16.17 25 45076 9558 70873785
Congenital haematological disorder 16.36 16.17 4 45097 35 70883308
Inappropriate schedule of product administration 16.32 16.17 27 45074 107528 70775815
Blood pressure systolic increased 16.30 16.17 8 45093 57251 70826092

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L02BA03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONE ANTAGONISTS AND RELATED AGENTS
Anti-estrogens
FDA MoA N0000000145 Estrogen Receptor Antagonists
FDA MoA N0000000168 Selective Estrogen Receptor Modulators
FDA EPC N0000175582 Estrogen Receptor Antagonist
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D004965 Estrogen Antagonists
MeSH PA D065171 Estrogen Receptor Antagonists
MeSH PA D006727 Hormone Antagonists
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:50792 estrogen receptor antagonists
CHEBI has role CHEBI:50837 oestrogen antagonist

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

DiseaseRelationSNOMED_IDDOID
Metastatic Breast Cancer Progression Post-Antiestrogen Therapy indication
Blood coagulation disorder contraindication 64779008 DOID:1247
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
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 10.92 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
250MG/5ML (50MG/ML) FULVESTRANT FRESENIUS KABI USA N210326 May 20, 2019 RX SOLUTION INTRAMUSCULAR 10188663 Feb. 14, 2034 TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
250MG/5ML (50MG/ML) FULVESTRANT FRESENIUS KABI USA N210326 May 20, 2019 RX SOLUTION INTRAMUSCULAR 9833459 Feb. 14, 2034 TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN
250MG/5ML (50MG/ML) FULVESTRANT FRESENIUS KABI USA N210326 May 20, 2019 RX SOLUTION INTRAMUSCULAR 9271990 May 17, 2034 TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Estrogen receptor Nuclear hormone receptor ANTAGONIST Ki 9.62 WOMBAT-PK CHEMBL
Estrogen receptor beta Nuclear hormone receptor ANTAGONIST Ki 8.74 WOMBAT-PK CHEMBL
Progesterone receptor Nuclear hormone receptor IC50 9.68 CHEMBL
G-protein coupled estrogen receptor 1 GPCR EC50 7 WOMBAT-PK
Bile acid receptor Nuclear hormone receptor IC50 6.10 CHEMBL
Steroid hormone receptor ERR1 Nuclear hormone receptor IC50 8.70 CHEMBL
Bifunctional epoxide hydrolase 2 Enzyme Ki 7.59 CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor EC50 5.71 CHEMBL
NAD-dependent protein deacylase sirtuin-5, mitochondrial Enzyme IC50 5.58 CHEMBL
Estrogen receptor Transcription factor IC50 8.23 CHEMBL
Beta-lactamase TEM Enzyme IC50 4.25 CHEMBL

External reference:

IDSource
4021350 VUID
N0000148770 NUI
D01161 KEGG_DRUG
4021350 VANDF
C0935916 UMLSCUI
CHEBI:31638 CHEBI
FVS PDB_CHEM_ID
CHEMBL1358 ChEMBL_ID
D000077267 MESH_DESCRIPTOR_UI
DB00947 DRUGBANK_ID
1015 IUPHAR_LIGAND_ID
7712 INN_ID
22X328QOC4 UNII
104741 PUBCHEM_CID
203870 RXNORM
16618 MMSL
300687 MMSL
43430 MMSL
d04799 MMSL
009642 NDDF
385519002 SNOMEDCT_US
404845006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0143-9022 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0143-9022 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
FASLODEX HUMAN PRESCRIPTION DRUG LABEL 1 0310-0720 INJECTION 50 mg INTRAMUSCULAR NDA 25 sections
FASLODEX HUMAN PRESCRIPTION DRUG LABEL 1 0310-0720 INJECTION 50 mg INTRAMUSCULAR NDA 25 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0310-7720 INJECTION 50 mg INTRAMUSCULAR NDA authorized generic 25 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0310-7720 INJECTION 50 mg INTRAMUSCULAR NDA authorized generic 25 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0591-5019 INJECTION 250 mg INTRAMUSCULAR NDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0591-5019 INJECTION 250 mg INTRAMUSCULAR NDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0781-3079 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0781-3492 INJECTION 50 mg INTRAMUSCULAR ANDA 26 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 16714-070 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 18 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 16714-118 INJECTION 50 mg INTRAMUSCULAR ANDA 26 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 16729-436 INJECTION 250 mg INTRAMUSCULAR ANDA 25 sections
fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 25021-462 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 43598-262 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 63323-715 INJECTION, SOLUTION 50 mg INTRAMUSCULAR NDA 28 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 67457-311 INJECTION 50 mg INTRAMUSCULAR ANDA 28 sections
fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 68001-424 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 68001-484 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant68001-510 HUMAN PRESCRIPTION DRUG LABEL 1 68001-510 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 68001-522 INJECTION 250 mg INTRAMUSCULAR ANDA 25 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 68001-522 INJECTION 250 mg INTRAMUSCULAR ANDA 25 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 68462-317 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 70121-1463 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 27 sections
fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 70534-002 INJECTION 50 mg INTRAMUSCULAR ANDA 26 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 70700-284 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 18 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 70710-1688 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 18 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 70771-1626 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 1 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 70771-1626 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 1 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 70860-211 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections