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 3312.57 15.24 1534 49768 66590 50487232
Metastases to bone 2286.93 15.24 810 50492 17185 50536637
Neoplasm progression 2201.12 15.24 897 50405 28260 50525562
Metastases to liver 1747.36 15.24 685 50617 19419 50534403
Neutropenia 1046.56 15.24 996 50306 146969 50406853
White blood cell count decreased 678.53 15.24 707 50595 116015 50437807
Tumour marker increased 596.05 15.24 201 51101 3639 50550183
Metastases to lung 570.07 15.24 260 51042 10760 50543062
Osteonecrosis of jaw 496.57 15.24 344 50958 32182 50521640
Disease progression 456.15 15.24 523 50779 95343 50458479
Breast cancer metastatic 391.29 15.24 197 51105 10167 50543655
Drug ineffective 332.89 15.24 212 51090 819121 49734701
Neutrophil count decreased 316.81 15.24 306 50996 45720 50508102
Metastases to lymph nodes 308.38 15.24 148 51154 6876 50546946
Carbohydrate antigen 15-3 increased 295.11 15.24 88 51214 1044 50552778
PIK3CA-activated mutation 273.52 15.24 77 51225 733 50553089
Fatigue 243.28 15.24 1378 49924 706223 49847599
Metastases to pleura 233.19 15.24 76 51226 1230 50552592
Metastasis 231.79 15.24 105 51197 4270 50549552
Leukopenia 206.35 15.24 296 51006 67232 50486590
Metastases to skin 205.19 15.24 70 51232 1313 50552509
Breast cancer recurrent 200.50 15.24 91 51211 3717 50550105
Bone pain 199.98 15.24 243 51059 46986 50506836
Metastases to spine 179.22 15.24 77 51225 2754 50551068
Breast cancer 178.85 15.24 219 51083 42671 50511151
Thrombocytopenia 175.84 15.24 395 50907 127278 50426544
Bone lesion 171.21 15.24 90 51212 5080 50548742
Pseudocirrhosis 168.68 15.24 50 51252 580 50553242
Metastases to central nervous system 159.66 15.24 114 51188 11168 50542654
Rheumatoid arthritis 159.63 15.24 12 51290 202538 50351284
Palmar-plantar erythrodysaesthesia syndrome 154.22 15.24 142 51160 19956 50533866
Joint swelling 151.51 15.24 32 51270 245254 50308568
Pleural effusion 151.03 15.24 285 51017 81169 50472653
Maternal exposure during pregnancy 147.26 15.24 3 51299 159775 50394047
Infusion related reaction 142.75 15.24 7 51295 169550 50384272
Ascites 141.30 15.24 178 51124 35683 50518139
Hepatic lesion 124.88 15.24 67 51235 3941 50549881
Therapeutic product effect decreased 123.62 15.24 3 51299 136047 50417775
Hyperglycaemia 120.67 15.24 166 51136 36239 50517583
Systemic lupus erythematosus 117.73 15.24 6 51296 140616 50413206
Osteonecrosis 115.62 15.24 128 51174 22389 50531433
Metastases to peritoneum 113.24 15.24 56 51246 2777 50551045
Asthenia 112.38 15.24 627 50675 318415 50235407
Full blood count abnormal 111.64 15.24 128 51174 23260 50530562
Anaemia 107.40 15.24 523 50779 251933 50301889
Hot flush 105.76 15.24 173 51129 43996 50509826
Decreased appetite 103.89 15.24 441 50861 200482 50353340
Red blood cell count decreased 102.81 15.24 148 51154 33687 50520135
Death 100.04 15.24 617 50685 324762 50229060
Platelet count decreased 99.85 15.24 275 51027 100451 50453371
Arthropathy 98.67 15.24 20 51282 157886 50395936
Drug hypersensitivity 94.45 15.24 70 51232 250940 50302882
Hypotension 89.45 15.24 65 51237 235404 50318418
Second primary malignancy 86.81 15.24 65 51237 6849 50546973
Infusion site coldness 84.49 15.24 23 51279 191 50553631
Mucosal inflammation 81.32 15.24 146 51156 39996 50513826
Bone marrow failure 81.25 15.24 119 51183 27505 50526317
Carcinoembryonic antigen increased 80.05 15.24 36 51266 1438 50552384
Hepatic failure 79.38 15.24 128 51174 32155 50521667
Glossodynia 77.93 15.24 12 51290 115557 50438265
Treatment failure 77.03 15.24 22 51280 137615 50416207
Gamma-glutamyltransferase decreased 75.99 15.24 23 51279 288 50553534
Lymphangiosis carcinomatosa 70.70 15.24 31 51271 1165 50552657
Metastases to chest wall 70.15 15.24 24 51278 454 50553368
Abdominal lymphadenopathy 69.04 15.24 26 51276 655 50553167
Stomatitis 68.26 15.24 242 51060 101102 50452720
Neuropathy peripheral 67.72 15.24 234 51068 96523 50457299
Bone disorder 65.90 15.24 88 51214 18664 50535158
Fall 64.92 15.24 153 51149 334779 50219043
Polyneuropathy 64.06 15.24 70 51232 12061 50541761
Pleural neoplasm 63.97 15.24 19 51283 222 50553600
Lymphoedema 63.35 15.24 61 51241 9061 50544761
Musculoskeletal stiffness 62.46 15.24 26 51276 128455 50425367
Haematotoxicity 60.97 15.24 56 51246 7839 50545983
Bone sequestrum 60.36 15.24 29 51273 1349 50552473
Nausea 60.07 15.24 1025 50277 704373 49849449
Malignant pleural effusion 59.04 15.24 34 51268 2296 50551526
Overdose 57.55 15.24 15 51287 99712 50454110
Drug interaction 57.17 15.24 71 51231 199550 50354272
Off label use 56.68 15.24 268 51034 474158 50079664
Intentional product use issue 56.64 15.24 6 51296 76912 50476910
Metastases to thorax 56.60 15.24 17 51285 207 50553615
Metastases to pelvis 56.21 15.24 19 51283 346 50553476
Osteolysis 56.11 15.24 34 51268 2523 50551299
Pneumonia 55.67 15.24 197 51105 378204 50175618
Wound 55.44 15.24 19 51283 105775 50448047
Swelling 54.89 15.24 74 51228 200798 50353024
Condition aggravated 54.17 15.24 140 51162 296918 50256904
Full blood count decreased 54.11 15.24 88 51214 22258 50531564
Spinal pain 53.03 15.24 60 51242 10743 50543079
Skin toxicity 51.84 15.24 38 51264 3875 50549947
Metastases to the mediastinum 51.51 15.24 19 51283 451 50553371
Discomfort 50.98 15.24 23 51279 108357 50445465
General physical health deterioration 50.00 15.24 280 51022 142154 50411668
Hypertransaminasaemia 49.96 15.24 36 51266 3575 50550247
Infusion site induration 49.58 15.24 22 51280 851 50552971
Hypersensitivity 49.51 15.24 89 51213 215072 50338750
Metastases to retroperitoneum 48.49 15.24 14 51288 147 50553675
Intentional overdose 48.35 15.24 4 51298 62500 50491322
Toxicity to various agents 47.91 15.24 89 51213 212410 50341412
Headache 47.46 15.24 310 50992 506225 50047597
Sinusitis 46.42 15.24 63 51239 170495 50383327
Metastases to adrenals 44.33 15.24 19 51283 675 50553147
Hormone receptor positive breast cancer 43.69 15.24 17 51285 469 50553353
Electrocardiogram PR shortened 43.45 15.24 14 51288 218 50553604
Portal hypertension 42.83 15.24 32 51270 3360 50550462
Eastern Cooperative Oncology Group performance status worsened 42.52 15.24 18 51284 620 50553202
Mobility decreased 42.51 15.24 14 51288 79934 50473888
Injection site necrosis 42.35 15.24 22 51280 1211 50552611
Tooth extraction 42.17 15.24 49 51253 9026 50544796
Asthma 41.95 15.24 19 51283 89318 50464504
Oestradiol increased 41.81 15.24 11 51291 79 50553743
Invasive lobular breast carcinoma 41.54 15.24 18 51284 657 50553165
Recurrent cancer 40.20 15.24 24 51278 1733 50552089
Isosthenuria 39.72 15.24 11 51291 98 50553724
Superinfection 39.20 15.24 25 51277 2031 50551791
Acute kidney injury 38.89 15.24 111 51191 227947 50325875
Cough 38.66 15.24 394 50908 240870 50312952
Cancer pain 38.58 15.24 27 51275 2560 50551262
Diarrhoea 38.56 15.24 822 50480 587654 49966168
Bradycardia 38.51 15.24 9 51293 64417 50489405
Ejection fraction decreased 37.03 15.24 67 51235 18453 50535369
Bone cancer metastatic 37.00 15.24 11 51291 129 50553693
Adnexa uteri mass 36.85 15.24 15 51287 467 50553355
Breast cancer stage IV 36.60 15.24 16 51286 597 50553225
Myelosuppression 36.55 15.24 56 51246 13461 50540361
Oral pain 36.12 15.24 79 51223 24954 50528868
Bladder hypertrophy 36.10 15.24 12 51290 207 50553615
Post-traumatic neck syndrome 35.86 15.24 23 51279 1887 50551935
Metastatic neoplasm 35.75 15.24 30 51272 3724 50550098
Therapeutic product effect incomplete 35.04 15.24 25 51277 91490 50462332
Alopecia 34.97 15.24 391 50911 244656 50309166
Tachycardia 34.73 15.24 30 51272 99733 50454089
Blood bilirubin increased 34.24 15.24 90 51212 31948 50521874
Pyelitis 34.15 15.24 11 51291 171 50553651
Interstitial lung disease 34.09 15.24 125 51177 53051 50500771
Metastases to kidney 33.46 15.24 11 51291 183 50553639
Psoriasis 33.46 15.24 14 51288 68986 50484836
Suicide attempt 33.46 15.24 6 51296 51726 50502096
Cardio-respiratory arrest 33.27 15.24 7 51295 53885 50499937
Confusional state 32.80 15.24 89 51213 185839 50367983
Pneumonitis 32.67 15.24 84 51218 29426 50524396
Suicidal ideation 32.58 15.24 8 51294 55377 50498445
Hepatic function abnormal 32.11 15.24 89 51213 32592 50521230
Pustule 32.03 15.24 18 51284 1160 50552662
Carbohydrate antigen 27.29 increased 31.79 15.24 8 51294 47 50553775
BRAF gene mutation 31.79 15.24 8 51294 47 50553775
Tumour marker abnormal 31.67 15.24 11 51291 218 50553604
Constipation 31.53 15.24 307 50995 185401 50368421
Metastases to soft tissue 31.38 15.24 10 51292 150 50553672
Prehypertension 31.34 15.24 7 51295 22 50553800
Epistaxis 31.13 15.24 138 51164 63816 50490006
Loss of consciousness 31.03 15.24 36 51266 104317 50449505
Lymphadenopathy 30.74 15.24 89 51213 33410 50520412
Taste disorder 30.69 15.24 40 51262 8284 50545538
Tumour marker decreased 30.58 15.24 8 51294 56 50553766
Cardiac arrest 30.54 15.24 24 51278 83627 50470195
Jaw disorder 30.51 15.24 31 51271 4912 50548910
Abdominal discomfort 30.50 15.24 126 51176 231515 50322307
Back pain 30.44 15.24 349 50953 219681 50334141
Drug intolerance 30.23 15.24 117 51185 218987 50334835
Vasodilatation 29.89 15.24 22 51280 2257 50551565
Drug resistance 29.78 15.24 62 51240 18927 50534895
Dysgeusia 29.75 15.24 97 51205 38819 50515003
Fibromyalgia 29.56 15.24 5 51297 44973 50508849
Arthritis 29.08 15.24 27 51275 86694 50467128
Adverse drug reaction 28.78 15.24 10 51292 55212 50498610
Nephroangiosclerosis 28.62 15.24 9 51293 129 50553693
Nasopharyngitis 28.59 15.24 100 51202 192827 50360995
Mean cell haemoglobin decreased 28.48 15.24 25 51277 3298 50550524
Lacrimation increased 28.45 15.24 57 51245 16935 50536887
Dyspnoea exertional 28.39 15.24 115 51187 51118 50502704
Weight increased 28.37 15.24 107 51195 201784 50352038
Lower respiratory tract infection 28.14 15.24 33 51269 95168 50458654
Hospitalisation 28.12 15.24 17 51285 67920 50485902
Creatinine renal clearance increased 27.88 15.24 13 51289 565 50553257
Retinal detachment 27.78 15.24 30 51272 5099 50548723
Hypermetabolism 27.25 15.24 9 51293 152 50553670
Dry skin 27.24 15.24 101 51201 43090 50510732
Pulmonary tumour thrombotic microangiopathy 27.14 15.24 7 51295 46 50553776
Mouth swelling 26.84 15.24 26 51276 3890 50549932
Oxygen saturation decreased 26.76 15.24 21 51281 73227 50480595
Fluid retention 26.69 15.24 9 51293 50640 50503182
Vein disorder 26.50 15.24 27 51275 4292 50549530
Adverse event 26.38 15.24 6 51296 43757 50510065
Malignant peritoneal neoplasm 26.22 15.24 13 51289 648 50553174
Seizure 25.98 15.24 50 51252 117824 50435998
Invasive ductal breast carcinoma 25.91 15.24 31 51271 5890 50547932
Exposed bone in jaw 25.89 15.24 22 51280 2778 50551044
International normalised ratio increased 25.84 15.24 6 51296 43146 50510676
Ovarian disorder 25.84 15.24 13 51289 669 50553153
Agitation 25.61 15.24 11 51291 53373 50500449
Carcinoid tumour pulmonary 25.12 15.24 11 51291 412 50553410
Tremor 25.10 15.24 49 51253 114854 50438968
Heart rate increased 24.80 15.24 25 51277 77225 50476597
Somnolence 24.56 15.24 78 51224 154907 50398915
Infusion site haemorrhage 24.55 15.24 22 51280 2982 50550840
Peritoneal disorder 24.51 15.24 11 51291 437 50553385
Hypoglycaemia 24.22 15.24 12 51290 53569 50500253
Elliptocytosis 24.17 15.24 6 51296 33 50553789
Cardiac failure congestive 24.14 15.24 30 51272 84352 50469470
Blood pressure increased 24.02 15.24 63 51239 133069 50420753
RET gene mutation 23.99 15.24 5 51297 10 50553812
Pathological fracture 23.90 15.24 34 51268 7648 50546174
Bone debridement 23.74 15.24 9 51293 231 50553591
Osteosclerosis 23.73 15.24 23 51279 3444 50550378
Gastrointestinal disorder 23.61 15.24 37 51265 94419 50459403
Hyperchromic anaemia 23.59 15.24 6 51296 37 50553785
Metastases to spinal cord 23.59 15.24 6 51296 37 50553785
Haemoglobin decreased 23.41 15.24 214 51088 127002 50426820
Mediastinal disorder 23.39 15.24 10 51292 353 50553469
Transaminases 23.32 15.24 7 51295 85 50553737
Cytopenia 23.23 15.24 36 51266 8739 50545083
Osteomyelitis 23.08 15.24 62 51240 22291 50531531
Injection site hypoaesthesia 22.90 15.24 10 51292 372 50553450
Bile duct stenosis 22.82 15.24 14 51288 1062 50552760
Neoplasm 22.66 15.24 29 51273 5899 50547923
Hydronephrosis 22.55 15.24 35 51267 8506 50545316
Syncope 22.43 15.24 44 51258 102958 50450864
Metastases to breast 22.30 15.24 9 51293 274 50553548
Musculoskeletal chest pain 21.90 15.24 54 51248 18432 50535390
Nail disorder 21.85 15.24 37 51265 9671 50544151
Plasma cell myeloma 21.68 15.24 3 51299 31319 50522503
Influenza 21.51 15.24 36 51266 89502 50464320
Blood pressure fluctuation 21.41 15.24 5 51297 35818 50518004
Loss of personal independence in daily activities 21 15.24 24 51278 70026 50483796
Gingivitis 20.86 15.24 31 51271 7253 50546569
Blister 20.84 15.24 34 51268 85384 50468438
Metastases to eye 20.84 15.24 7 51295 125 50553697
Ill-defined disorder 20.82 15.24 15 51287 54639 50499183
Granulocytopenia 20.64 15.24 26 51276 5205 50548617
Spinal cord compression 20.63 15.24 22 51280 3687 50550135
Blood creatinine increased 20.57 15.24 140 51162 76020 50477802
Hepatic cancer metastatic 20.53 15.24 9 51293 338 50553484
Metastases to ovary 20.46 15.24 9 51293 341 50553481
Malignant ascites 20.43 15.24 12 51290 841 50552981
Jaundice 20.31 15.24 66 51236 26363 50527459
Pain in jaw 20.29 15.24 85 51217 38343 50515479
Sepsis 20.29 15.24 68 51234 132857 50420965
Metabolic acidosis 20.28 15.24 7 51295 38818 50515004
Hallucination 20.27 15.24 11 51291 46646 50507176
Pulmonary embolism 20.21 15.24 174 51128 101530 50452292
Hyponatraemia 20.14 15.24 42 51260 96097 50457725
Feeling cold 19.99 15.24 54 51248 19477 50534345
Aspartate aminotransferase increased 19.66 15.24 141 51161 77857 50475965
Vulvovaginal dryness 19.65 15.24 17 51285 2200 50551622
Pulmonary mass 19.43 15.24 52 51250 18653 50535169
Cytogenetic analysis abnormal 19.21 15.24 11 51291 735 50553087
Metastases to meninges 19.07 15.24 16 51286 1986 50551836
Product quality issue 19.06 15.24 4 51298 30854 50522968
Skin sensitisation 18.98 15.24 11 51291 752 50553070
Blood creatinine abnormal 18.88 15.24 18 51284 2640 50551182
Hip arthroplasty 18.68 15.24 4 51298 30425 50523397
Cachexia 18.64 15.24 23 51279 4510 50549312
Pancreatitis 18.58 15.24 10 51292 42604 50511218
Hepatic enzyme increased 18.52 15.24 74 51228 137306 50416516
Gingival swelling 18.49 15.24 21 51281 3774 50550048
Hepatotoxicity 18.29 15.24 65 51237 27161 50526661
Tooth disorder 18.16 15.24 60 51242 24168 50529654
Hormone refractory breast cancer 18.05 15.24 4 51298 12 50553810
Adenocarcinoma 18.00 15.24 17 51285 2464 50551358
Breast cancer female 17.95 15.24 28 51274 6834 50546988
Onychoclasis 17.67 15.24 24 51278 5172 50548650
Intestinal metastasis 17.56 15.24 6 51296 113 50553709
Bronchitis 17.51 15.24 51 51251 104108 50449714
Hepatic cirrhosis 17.39 15.24 48 51254 17529 50536293
Body surface area decreased 17.36 15.24 4 51298 15 50553807
Gastrointestinal haemorrhage 17.13 15.24 30 51272 73291 50480531
Blood creatinine decreased 16.94 15.24 23 51279 4953 50548869
Debridement 16.88 15.24 12 51290 1167 50552655
Bone cancer 16.80 15.24 12 51290 1175 50552647
Septic shock 16.70 15.24 20 51282 57155 50496667
Treatment noncompliance 16.52 15.24 5 51297 30145 50523677
Metastases to muscle 16.48 15.24 6 51296 137 50553685
Oral disorder 16.48 15.24 29 51273 7815 50546007
Excessive granulation tissue 16.47 15.24 10 51292 745 50553077
Nail avulsion 16.44 15.24 6 51296 138 50553684
Radiation fibrosis - lung 16.27 15.24 4 51298 21 50553801
Cardiotoxicity 16.10 15.24 27 51275 7000 50546822
Encephalopathy 16.08 15.24 7 51295 33704 50520118
Volvulus 16.03 15.24 13 51289 1538 50552284
No adverse event 15.98 15.24 7 51295 33571 50520251
Gastrointestinal submucosal tumour 15.97 15.24 4 51298 23 50553799
Orthostatic hypotension 15.95 15.24 5 51297 29476 50524346
Sequestrectomy 15.75 15.24 10 51292 806 50553016
Glycosylated haemoglobin 15.69 15.24 5 51297 75 50553747
Metastases to bone marrow 15.63 15.24 7 51295 277 50553545
Uterine mass 15.56 15.24 7 51295 280 50553542
Gingival erythema 15.52 15.24 9 51293 616 50553206
Pneumonia aspiration 15.50 15.24 6 51296 30998 50522824
Urticaria 15.50 15.24 73 51229 129488 50424334
Oestrogen receptor assay positive 15.49 15.24 8 51294 435 50553387
Coma 15.46 15.24 21 51281 56858 50496964
Bone marrow disorder 15.40 15.24 14 51288 1934 50551888
Myocardial infarction 15.39 15.24 43 51259 88984 50464838
Inappropriate schedule of product administration 15.36 15.24 31 51271 71800 50482022

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 55.27 49.67 9 426 481 29573611

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 1803.98 15.31 748 39809 40216 64417959
Metastases to bone 1502.46 15.31 542 40015 19893 64438282
Malignant neoplasm progression 1386.77 15.31 869 39688 112002 64346173
Metastases to liver 1028.60 15.31 430 40127 23511 64434664
White blood cell count decreased 730.14 15.31 679 39878 157158 64301017
Neutropenia 716.93 15.31 815 39742 238809 64219366
Tumour marker increased 487.87 15.31 150 40407 3300 64454875
Metastases to lung 399.24 15.31 194 40363 15070 64443105
Osteonecrosis of jaw 397.81 15.31 270 40287 39555 64418620
Fatigue 380.40 15.31 1179 39378 747551 63710624
Breast cancer metastatic 271.92 15.31 118 40439 7051 64451124
Carbohydrate antigen 15-3 increased 270.95 15.31 72 40485 915 64457260
Neutrophil count decreased 245.92 15.31 272 40285 76924 64381251
Disease progression 232.73 15.31 360 40197 141320 64316855
Metastases to lymph nodes 216.56 15.31 107 40450 8610 64449565
Bone pain 191.49 15.31 190 40367 47382 64410793
Breast cancer recurrent 191.37 15.31 69 40488 2514 64455661
Pseudocirrhosis 186.35 15.31 49 40508 596 64457579
Drug ineffective 181.33 15.31 158 40399 840089 63618086
Alopecia 162.28 15.31 336 40221 165354 64292821
PIK3CA-activated mutation 161.88 15.31 42 40515 483 64457692
Bone lesion 157.90 15.31 73 40484 5064 64453111
Metastases to pleura 153.78 15.31 49 40508 1215 64456960
Metastases to skin 151.09 15.31 50 40507 1402 64456773
Breast cancer 145.13 15.31 131 40426 29017 64429158
Asthenia 126.47 15.31 568 39989 427476 64030699
Hot flush 125.38 15.31 150 40407 46085 64412090
Full blood count abnormal 119.99 15.31 119 40438 29638 64428537
Metastasis 115.57 15.31 61 40496 5634 64452541
Nausea 109.02 15.31 854 39703 784946 63673229
Metastases to spine 106.48 15.31 50 40507 3593 64454582
Leukopenia 103.37 15.31 209 40348 101033 64357142
Hypotension 99.70 15.31 58 40499 380916 64077259
Metastases to central nervous system 99.28 15.31 77 40480 13835 64444340
Stomatitis 97.65 15.31 214 40343 109391 64348784
Infusion site coldness 94.04 15.31 23 40534 204 64457971
Thrombocytopenia 93.28 15.31 331 40226 223470 64234705
Red blood cell count decreased 92.27 15.31 132 40425 48254 64409921
Decreased appetite 90.30 15.31 383 40174 280906 64177269
Platelet count decreased 85.88 15.31 266 40291 167445 64290730
Acute kidney injury 84.39 15.31 95 40462 449145 64009030
Gamma-glutamyltransferase decreased 83.52 15.31 23 40534 337 64457838
Osteonecrosis 82.18 15.31 95 40462 28134 64430041
Drug interaction 81.53 15.31 65 40492 362018 64096157
Palmar-plantar erythrodysaesthesia syndrome 80.59 15.31 95 40462 28724 64429451
Hepatic lesion 79.20 15.31 48 40509 5776 64452399
Infusion related reaction 77.68 15.31 7 40550 164460 64293715
Full blood count decreased 72.56 15.31 80 40477 22502 64435673
Toxicity to various agents 71.42 15.31 74 40483 363439 64094736
Lymphangiosis carcinomatosa 69.13 15.31 30 40527 1791 64456384
Pneumonia 67.83 15.31 158 40399 559418 63898757
Pleural effusion 67.81 15.31 204 40353 126355 64331820
Rheumatoid arthritis 67.78 15.31 11 40546 164283 64293892
Joint swelling 66.67 15.31 26 40531 215356 64242819
Spinal pain 65.33 15.31 58 40499 12563 64445612
Carcinoembryonic antigen increased 65.09 15.31 29 40528 1844 64456331
Second primary malignancy 62.48 15.31 56 40501 12281 64445894
Ascites 60.89 15.31 126 40431 61875 64396300
Infusion site induration 60.76 15.31 22 40535 811 64457364
Anaemia 60.35 15.31 426 40131 378254 64079921
Therapeutic product effect decreased 60.04 15.31 3 40554 115348 64342827
Overdose 58.86 15.31 14 40543 159552 64298623
Neuropathy peripheral 58.82 15.31 185 40372 117340 64340835
Hyperglycaemia 57.65 15.31 122 40435 60846 64397329
Bone marrow failure 57.48 15.31 106 40451 47846 64410329
Bone disorder 56.68 15.31 61 40496 16698 64441477
Metastases to peritoneum 55.48 15.31 32 40525 3515 64454660
Oral pain 52.39 15.31 75 40482 27418 64430757
Lymphoedema 52.23 15.31 46 40511 9859 64448316
Adnexa uteri mass 51.03 15.31 15 40542 281 64457894
Abdominal lymphadenopathy 50.90 15.31 21 40536 1105 64457070
Bradycardia 50.85 15.31 7 40550 118212 64339963
Off label use 50.36 15.31 216 40341 632590 63825585
Mucosal inflammation 48.82 15.31 116 40441 62468 64395707
Electrocardiogram PR shortened 47.84 15.31 14 40543 258 64457917
Fall 47.82 15.31 121 40436 416705 64041470
Metastases to chest wall 46.91 15.31 15 40542 376 64457799
Cough 46.40 15.31 337 40220 301811 64156364
Post-traumatic neck syndrome 46.20 15.31 23 40534 1879 64456296
Osteolysis 45.75 15.31 26 40531 2777 64455398
Tooth extraction 45.52 15.31 42 40515 9559 64448616
Hypertransaminasaemia 45.31 15.31 37 40520 7154 64451021
Pleural neoplasm 45.14 15.31 13 40544 226 64457949
Isosthenuria 44.63 15.31 11 40546 101 64458074
Injection site necrosis 44.40 15.31 20 40537 1305 64456870
Sepsis 43.94 15.31 48 40509 230293 64227882
Skin toxicity 43.78 15.31 35 40522 6567 64451608
Metastases to retroperitoneum 43.49 15.31 14 40543 359 64457816
Diarrhoea 42.41 15.31 663 39894 722041 63736134
Cardiac arrest 42.33 15.31 22 40535 154042 64304133
Intentional overdose 42.00 15.31 4 40553 89940 64368235
Back pain 40.69 15.31 283 40274 249888 64208287
Intentional product use issue 40.19 15.31 6 40551 95358 64362817
Cardio-respiratory arrest 39.65 15.31 7 40550 98386 64359789
Drug hypersensitivity 39.64 15.31 55 40502 237760 64220415
Infusion site haemorrhage 39.20 15.31 22 40535 2293 64455882
Metastases to pelvis 38.46 15.31 14 40543 524 64457651
Systemic lupus erythematosus 37.46 15.31 3 40554 77609 64380566
Hepatic failure 37.23 15.31 97 40460 55297 64402878
Vein disorder 36.75 15.31 26 40531 4061 64454114
Prehypertension 36.29 15.31 7 40550 16 64458159
Tumour marker decreased 36.03 15.31 8 40549 44 64458131
Tachycardia 35.99 15.31 25 40532 149554 64308621
Constipation 35.87 15.31 257 40300 229080 64229095
International normalised ratio increased 35.72 15.31 4 40553 79163 64379012
Superinfection 35.59 15.31 25 40532 3861 64454314
Arthropathy 35.17 15.31 16 40541 120951 64337224
Portal hypertension 35.05 15.31 30 40527 6189 64451986
Metastases to thorax 34.87 15.31 10 40547 171 64458004
Metastases to the mediastinum 34.87 15.31 13 40544 521 64457654
Pyelitis 34.32 15.31 11 40546 278 64457897
Mean cell haemoglobin decreased 34.26 15.31 25 40532 4097 64454078
Ejection fraction decreased 33.82 15.31 63 40494 28644 64429531
Vasodilatation 33.81 15.31 22 40535 2996 64455179
Hyperkalaemia 33.32 15.31 11 40546 101118 64357057
Hormone receptor positive breast cancer 33.28 15.31 11 40546 307 64457868
Confusional state 32.95 15.31 72 40485 261072 64197103
Loss of consciousness 32.87 15.31 27 40530 148338 64309837
Ovarian disorder 32.87 15.31 12 40545 453 64457722
Metastases to eye 32.68 15.31 10 40547 216 64457959
Death 32.60 15.31 454 40103 482251 63975924
Syncope 32.15 15.31 31 40526 157604 64300571
Condition aggravated 32.13 15.31 123 40434 372303 64085872
Pustule 31.67 15.31 16 40541 1349 64456826
Myelosuppression 31.52 15.31 55 40502 23775 64434400
Cancer pain 31.33 15.31 24 40533 4233 64453942
Dysgeusia 31.22 15.31 82 40475 46965 64411210
Carbohydrate antigen 27.29 increased 30.87 15.31 7 40550 43 64458132
Mobility decreased 30.73 15.31 8 40549 85832 64372343
Bladder hypertrophy 30.62 15.31 12 40545 552 64457623
Lacrimation increased 30.57 15.31 47 40510 18299 64439876
Pain in jaw 30.13 15.31 74 40483 40681 64417494
Malignant pleural effusion 29.31 15.31 20 40537 2947 64455228
Metastases to kidney 29.24 15.31 11 40546 452 64457723
Malignant peritoneal neoplasm 29.16 15.31 12 40545 627 64457548
Creatinine renal clearance increased 28.94 15.31 13 40544 843 64457332
Dry skin 28.83 15.31 84 40473 51077 64407098
Treatment failure 28.80 15.31 19 40538 116797 64341378
Agitation 28.44 15.31 10 40547 88357 64369818
Mouth swelling 27.49 15.31 24 40533 5083 64453092
Haematotoxicity 27.28 15.31 37 40520 12859 64445316
Metastases to soft tissue 27.28 15.31 10 40547 382 64457793
Elliptocytosis 27.02 15.31 6 40551 33 64458142
Pulmonary tumour thrombotic microangiopathy 26.78 15.31 7 40550 83 64458092
Lymphadenopathy 26.64 15.31 77 40480 46609 64411566
Suicide attempt 26.63 15.31 6 40551 71001 64387174
Metabolic acidosis 26.60 15.31 6 40551 70952 64387223
Cardiac failure congestive 26.25 15.31 26 40531 130554 64327621
Myocardial infarction 26.00 15.31 40 40517 165781 64292394
Hypoglycaemia 25.95 15.31 12 40545 89880 64368295
Recurrent cancer 25.86 15.31 17 40540 2356 64455819
Gastrointestinal haemorrhage 25.85 15.31 27 40530 132285 64325890
Oxygen saturation decreased 25.66 15.31 18 40539 107158 64351017
Peritoneal disorder 25.65 15.31 11 40546 638 64457537
Onychoclasis 25.57 15.31 22 40535 4570 64453605
Asthma 25.56 15.31 14 40543 95211 64362964
Nephroangiosclerosis 25.55 15.31 9 40548 306 64457869
Musculoskeletal stiffness 25.38 15.31 24 40533 123182 64334993
Tumour marker abnormal 25.23 15.31 8 40549 195 64457980
Tooth disorder 24.95 15.31 48 40509 22354 64435821
Septic shock 24.86 15.31 18 40539 105419 64352756
Feeling cold 24.27 15.31 49 40508 23629 64434546
Exposed bone in jaw 24.22 15.31 19 40538 3468 64454707
Metastatic neoplasm 24.16 15.31 21 40536 4421 64453754
Toothache 24.01 15.31 41 40516 17418 64440757
Vulvovaginal dryness 23.81 15.31 14 40543 1594 64456581
Seizure 23.63 15.31 43 40514 166849 64291326
Skin sensitisation 23.44 15.31 11 40546 789 64457386
Nail disorder 23.39 15.31 28 40529 8596 64449579
Metastases to ovary 23.23 15.31 8 40549 254 64457921
Hyponatraemia 23.04 15.31 36 40521 148303 64309872
Taste disorder 22.96 15.31 29 40528 9404 64448771
Transaminases 22.52 15.31 6 40551 77 64458098
Blood pressure fluctuation 22.47 15.31 3 40554 51868 64406307
Bone sequestrum 22.22 15.31 12 40545 1160 64457015
Osteosclerosis 22.10 15.31 18 40539 3468 64454707
Blood creatine phosphokinase increased 21.85 15.31 5 40552 58553 64399622
Hypermetabolism 21.84 15.31 8 40549 305 64457870
Atrial fibrillation 21.71 15.31 47 40510 171042 64287133
Oestradiol increased 21.53 15.31 6 40551 92 64458083
Drug reaction with eosinophilia and systemic symptoms 21.53 15.31 4 40553 54213 64403962
Blood pressure increased 21.40 15.31 48 40509 172504 64285671
Tremor 21.15 15.31 38 40519 148192 64309983
RET gene mutation 21.10 15.31 4 40553 8 64458167
Nail avulsion 21.07 15.31 6 40551 100 64458075
Invasive lobular breast carcinoma 20.76 15.31 9 40548 536 64457639
Suicidal ideation 20.62 15.31 8 40549 66534 64391641
Adenocarcinoma 20.60 15.31 17 40540 3334 64454841
Hallucination 20.58 15.31 10 40547 72778 64385397
Haemoglobin decreased 20.52 15.31 200 40357 194863 64263312
Metastases to spinal cord 20.38 15.31 5 40552 45 64458130
Pneumonia aspiration 20.32 15.31 6 40551 59265 64398910
Musculoskeletal chest pain 20.31 15.31 43 40514 21436 64436739
Retinal detachment 20.18 15.31 25 40532 7951 64450224
Invasive ductal breast carcinoma 20.01 15.31 20 40537 5022 64453153
Angioedema 19.89 15.31 7 40550 61814 64396361
Excessive granulation tissue 19.73 15.31 10 40547 849 64457326
Pneumonitis 19.65 15.31 73 40484 50292 64407883
Poor venous access 19.56 15.31 31 40526 12386 64445789
Mental status changes 19.55 15.31 7 40550 61155 64397020
Oral disorder 19.49 15.31 26 40531 8895 64449280
Unresponsive to stimuli 19.42 15.31 4 40553 50389 64407786
Gingivitis 19.37 15.31 24 40533 7635 64450540
Blood creatinine decreased 19.31 15.31 23 40534 7027 64451148
Osteomyelitis 19.24 15.31 49 40508 27538 64430637
Hydronephrosis 19.20 15.31 33 40524 14092 64444083
Plasma cell myeloma 19.18 15.31 3 40554 46072 64412103
Coronary artery disease 19.17 15.31 7 40550 60426 64397749
Bone debridement 19.11 15.31 8 40549 437 64457738
Madarosis 19.07 15.31 14 40543 2316 64455859
Hospitalisation 18.85 15.31 12 40545 75195 64382980
Fluid retention 18.75 15.31 7 40550 59599 64398576
Anaphylactic reaction 18.56 15.31 10 40547 68654 64389521
Encephalopathy 18.34 15.31 7 40550 58812 64399363
Therapeutic product effect incomplete 18.17 15.31 23 40534 103459 64354716
Pathological fracture 17.79 15.31 25 40532 8980 64449195
Carcinoid tumour pulmonary 17.78 15.31 7 40550 326 64457849
Parosmia 17.67 15.31 18 40539 4622 64453553
Hypersensitivity 17.49 15.31 64 40493 196388 64261787
Breast cancer stage IV 17.41 15.31 8 40549 547 64457628
Breast mass 17.38 15.31 19 40538 5291 64452884
Pancreatitis 17.14 15.31 8 40549 59599 64398576
Fractured sacrum 17.13 15.31 11 40546 1464 64456711
Epistaxis 17.11 15.31 113 40444 98018 64360157
Dysarthria 17.04 15.31 8 40549 59398 64398777
Sequestrectomy 16.96 15.31 9 40548 840 64457335
Dyspnoea exertional 16.76 15.31 91 40466 73639 64384536
Metastases to meninges 16.72 15.31 14 40543 2801 64455374
Decreased immune responsiveness 16.48 15.31 17 40540 4431 64453744
Metastases to bladder 16.47 15.31 6 40551 225 64457950
Heart rate decreased 16.45 15.31 7 40550 55060 64403115
Congenital haematological disorder 16.40 15.31 4 40553 35 64458140
Aphasia 16.28 15.31 3 40554 40903 64417272
Eastern Cooperative Oncology Group performance status worsened 16.24 15.31 10 40547 1238 64456937
Loose tooth 16.22 15.31 14 40543 2920 64455255
Gingival pain 16.18 15.31 20 40537 6347 64451828
Debridement 16.16 15.31 11 40546 1615 64456560
Metastases to breast 16.13 15.31 6 40551 239 64457936
Immunodeficiency 16.09 15.31 33 40524 16091 64442084
Retroperitoneal cancer 16.01 15.31 4 40553 39 64458136
Psoriasis 15.93 15.31 13 40544 71690 64386485
Coma 15.88 15.31 19 40538 87596 64370579
Ascariasis 15.83 15.31 3 40554 6 64458169
Xerosis 15.78 15.31 9 40548 968 64457207
Blood creatinine abnormal 15.70 15.31 16 40541 4111 64454064
Melaena 15.69 15.31 7 40550 53541 64404634
Interstitial lung disease 15.52 15.31 110 40447 97622 64360553
Respiratory failure 15.36 15.31 51 40506 161132 64297043

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 (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
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 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 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 70860-211 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 71288-555 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 71731-6121 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 72603-105 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections