fulvestrant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
estrogen antagonists, including estrogen receptor down-regulators 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
16.70 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 µM/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
BA (Bioavailability) 0 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.846 Moderate 0.78
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.491 Moderate 0.78
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 15.382 10^-6 cm/s Moderate 0.78
dh-clint Dog hepatocyte intrinsic clearance 28.249 uL/min/10^6 cells Moderate 0.78
dppb Dog plasma protein binding (% unbound) 0.220 % Moderate 0.78
fcs-ppb Fetal calf serum protein binding (% unbound) 0.770 % Moderate 0.78
herg hERG pIC50 5.159 pIC50 Moderate 0.78
hh-clint Human hepatocyte intrinsic clearance 97.724 uL/min/10^6 cells Moderate 0.78
hlm-clint Human liver microsomal intrinsic clearance 145.211 uL/min/mg protein Moderate 0.78
hppb Human plasma protein binding (% unbound) 0.260 % Moderate 0.78
kinase-safety-class ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MET,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 43
kinase-selectivity-class AXL,EIF2AK3,GRK2 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 7.889 Moderate 0.78
mh-clint Mouse hepatocyte intrinsic clearance 125.026 Moderate 0.78
mppb Mouse plasma protein binding (% unbound) 0.250 Moderate 0.78
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 18.880 Moderate 0.78
pfas-class PFAS structural alert (1 = True, 0 = False) 1
pppb Pig plasma protein binding (% unbound) 0.650 % Moderate 0.78
rh-clint Rat hepatocyte intrinsic clearance 151.356 uL/min/10^6 cells Moderate 0.78
rh-fuinc Rat hepatocyte fraction unbound in incubation 1.230 % Moderate 0.78
rppb Rat plasma protein binding (% unbound) 0.310 % Moderate 0.78
solubility-dd Solubility at pH 7.4 in DMSO 2.512 uM Moderate 0.78

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 6071.75 15.29 2640 84441 104230 90437136
Metastases to bone 3797.02 15.29 1275 85806 24230 90517136
Metastases to liver 3040.45 15.29 1115 85966 27692 90513674
Neoplasm progression 2939.61 15.29 1226 85855 43260 90498106
Neutropenia 2414.75 15.29 1878 85203 223026 90318340
White blood cell count decreased 1197.96 15.29 1108 85973 166001 90375365
Metastases to lung 1042.39 15.29 437 86644 15554 90525812
Tumour marker increased 1030.74 15.29 332 86749 5475 90535891
Breast cancer metastatic 1004.74 15.29 419 86662 14713 90526653
Osteonecrosis of jaw 825.20 15.29 497 86584 38606 90502760
Disease progression 781.94 15.29 854 86227 155761 90385605
Hyperglycaemia 690.92 15.29 491 86590 50479 90490887
Metastases to lymph nodes 635.37 15.29 281 86800 11408 90529958
Neutrophil count decreased 624.62 15.29 531 86550 71001 90470365
Carbohydrate antigen 15-3 increased 598.02 15.29 171 86910 1836 90539530
Leukopenia 526.44 15.29 563 86518 100147 90441219
Fatigue 484.82 15.29 2286 84795 1151737 89389629
Death 458.77 15.29 1209 85872 455342 90086024
PIK3CA-activated mutation 428.98 15.29 118 86963 1086 90540280
Metastases to pleura 421.29 15.29 131 86950 1913 90539453
Metastasis 361.00 15.29 156 86925 5981 90535385
Infusion related reaction 354.44 15.29 10 87071 416770 90124596
Breast cancer recurrent 343.87 15.29 146 86935 5357 90536009
Thrombocytopenia 342.40 15.29 672 86409 208053 90333313
Metastases to skin 337.86 15.29 112 86969 2028 90539338
Metastases to central nervous system 334.26 15.29 209 86872 17333 90524033
Pleural effusion 329.78 15.29 469 86612 111522 90429844
Maternal exposure during pregnancy 329.40 15.29 3 87078 360060 90181306
Joint swelling 318.96 15.29 51 87030 503249 90038117
Systemic lupus erythematosus 314.06 15.29 7 87074 361889 90179477
Bone pain 312.29 15.29 340 86741 61643 90479723
Breast cancer 308.37 15.29 316 86765 53445 90487921
Rheumatoid arthritis 283.76 15.29 16 87065 362598 90178768
Metastases to spine 283.68 15.29 114 86967 3629 90537737
Ascites 281.80 15.29 285 86796 47455 90493911
Anaemia 280.25 15.29 859 86222 351943 90189423
Contraindicated product administered 278.51 15.29 6 87075 320133 90221233
Bone lesion 257.04 15.29 125 86956 6312 90535054
Drug ineffective 251.56 15.29 605 86476 1383693 89157673
Carcinoembryonic antigen increased 251.38 15.29 92 86989 2258 90539108
Arthropathy 251.12 15.29 29 87052 366213 90175153
Pericarditis 239.26 15.29 4 87077 270147 90271219
Therapeutic product effect decreased 238.33 15.29 6 87075 277565 90263801
Glossodynia 234.90 15.29 20 87061 321759 90219607
Metastases to peritoneum 229.35 15.29 101 86980 4054 90537312
Pseudocirrhosis 226.49 15.29 68 87013 876 90540490
Platelet count decreased 225.64 15.29 442 86639 136527 90404839
Hot flush 216.01 15.29 276 86805 59212 90482154
Second primary malignancy 203.65 15.29 126 86955 10252 90531114
Hepatic lesion 196.44 15.29 100 86981 5573 90535793
Red blood cell count decreased 193.99 15.29 231 86850 46120 90495246
Wound 193.34 15.29 30 87051 302950 90238416
Palmar-plantar erythrodysaesthesia syndrome 192.85 15.29 182 86899 27841 90513525
Drug hypersensitivity 192.31 15.29 103 86978 463506 90077860
Nausea 190.71 15.29 1760 85321 1108556 89432810
Helicobacter infection 180.54 15.29 9 87072 226841 90314525
Polyneuropathy 179.85 15.29 149 86932 19192 90522174
Hepatic failure 179.60 15.29 206 86875 39522 90501844
Decreased appetite 174.34 15.29 770 86311 375770 90165596
Fibromyalgia 171.42 15.29 6 87075 206263 90335103
Musculoskeletal stiffness 170.72 15.29 38 87043 296494 90244872
Swelling 154.36 15.29 107 86974 418951 90122415
Myelosuppression 151.14 15.29 220 86861 53371 90487995
Asthenia 150.85 15.29 952 86129 532799 90008567
Intentional product use issue 144.10 15.29 19 87062 216873 90324493
Full blood count decreased 142.80 15.29 159 86922 29530 90511836
Full blood count abnormal 142.72 15.29 176 86905 36421 90504945
Diarrhoea 137.03 15.29 1440 85641 937750 89603616
Mucosal inflammation 134.91 15.29 217 86864 57408 90483958
Injury 131.79 15.29 17 87064 197332 90344034
Lower respiratory tract infection 131.08 15.29 39 87042 250620 90290746
Condition aggravated 130.55 15.29 233 86848 595312 89946054
Mobility decreased 129.33 15.29 40 87041 250694 90290672
Cancer pain 127.98 15.29 67 87014 3958 90537408
Asthma 127.87 15.29 37 87044 242123 90299243
Discomfort 127.45 15.29 52 87029 274283 90267083
Neuropathy peripheral 127.17 15.29 353 86728 136617 90404749
Wheezing 124.57 15.29 37 87044 238043 90303323
Confusional state 124.11 15.29 113 86968 386092 90155274
Osteonecrosis 123.57 15.29 139 86942 26102 90515264
Sinusitis 123.15 15.29 90 86991 342998 90198368
Haematotoxicity 121.63 15.29 99 86982 12436 90528930
Malignant pleural effusion 119.67 15.29 58 87023 2906 90538460
Ill-defined disorder 114.12 15.29 20 87061 184871 90356495
Eastern Cooperative Oncology Group performance status worsened 113.09 15.29 49 87032 1890 90539476
Type 2 diabetes mellitus 113.07 15.29 28 87053 203216 90338150
Pneumonitis 109.83 15.29 171 86910 43999 90497367
Hormone receptor positive HER2 negative breast cancer 109.25 15.29 30 87051 274 90541092
Joint range of motion decreased 109.12 15.29 5 87076 135638 90405728
Blister 106.57 15.29 56 87025 254942 90286424
Haemoglobin decreased 106.34 15.29 370 86711 161586 90379780
Skin toxicity 105.14 15.29 71 87010 6708 90534658
Injection site necrosis 101.05 15.29 42 87039 1459 90539907
Hypersensitivity 100.35 15.29 177 86904 454500 90086866
Interstitial lung disease 99.42 15.29 224 86857 76181 90465185
Blood cholesterol increased 98.94 15.29 38 87043 207974 90333392
Hepatic enzyme increased 95.44 15.29 124 86957 360612 90180754
Transaminases increased 95.29 15.29 146 86935 37046 90504320
Aspartate aminotransferase increased 95.24 15.29 265 86816 102672 90438694
Bone disorder 93.07 15.29 113 86968 23007 90518359
Gastrointestinal disorder 92.51 15.29 67 87014 256620 90284746
Blood creatinine increased 91.82 15.29 259 86822 101127 90440239
Bursitis 91.20 15.29 10 87071 131644 90409722
Psoriasis 91.13 15.29 16 87065 147738 90393628
Abdominal discomfort 90.56 15.29 203 86878 477125 90064241
Hepatotoxicity 90.51 15.29 160 86921 45682 90495684
Back pain 89.55 15.29 566 86515 316609 90224757
Overdose 89.13 15.29 21 87060 157688 90383678
Weight increased 88.36 15.29 167 86914 417760 90123606
Lymphoedema 86.46 15.29 85 86996 13668 90527698
Spinal pain 83.77 15.29 89 86992 15678 90525688
Infusion site coldness 83.57 15.29 23 87058 212 90541154
Hypotension 82.86 15.29 115 86966 325282 90216084
Metastases to chest wall 82.03 15.29 29 87052 642 90540724
Facet joint syndrome 81.24 15.29 3 87078 98386 90442980
Adverse event 81.13 15.29 9 87072 117409 90423957
Neoplasm 79.48 15.29 67 87014 8836 90532530
Wound infection 79.28 15.29 6 87075 106396 90434970
Urticaria 79.16 15.29 111 86970 312623 90228743
Lymphadenopathy 76.85 15.29 149 86932 45626 90495740
Invasive ductal breast carcinoma 76.39 15.29 62 87019 7756 90533610
Gait inability 76.14 15.29 23 87058 146433 90394933
Cough 75.94 15.29 610 86471 368352 90173014
Grip strength decreased 75.83 15.29 3 87078 92573 90448793
Glomerular filtration rate decreased 75.17 15.29 87 86994 16845 90524521
Metastases to thorax 75.00 15.29 22 87059 260 90541106
Nasopharyngitis 74.87 15.29 176 86905 406928 90134438
Metastases to pelvis 74.65 15.29 26 87055 550 90540816
Osteolysis 74.51 15.29 45 87036 3505 90537861
Hypercholesterolaemia 74.30 15.29 6 87075 100886 90440480
Gamma-glutamyltransferase decreased 73.82 15.29 23 87058 338 90541028
Headache 73.79 15.29 506 86575 862240 89679126
Intentional overdose 73.74 15.29 4 87077 93830 90447536
Bone marrow failure 73.58 15.29 120 86961 32101 90509265
Bone sequestrum 72.77 15.29 33 87048 1420 90539946
Lymphangiosis carcinomatosa 71.39 15.29 34 87047 1638 90539728
Metastases to the mediastinum 71.31 15.29 26 87055 631 90540735
Metastatic neoplasm 71.28 15.29 49 87032 4766 90536600
Metastases to spinal cord 69.98 15.29 21 87060 270 90541096
Bone marrow infiltration 68.52 15.29 27 87054 815 90540551
Breast cancer stage III 68.28 15.29 3 87078 84444 90456922
Product use in unapproved indication 67.04 15.29 139 86942 336097 90205269
Fall 66.89 15.29 238 86843 481572 90059794
Onychoclasis 66.70 15.29 56 87025 7343 90534023
Pleural neoplasm 65.81 15.29 22 87059 409 90540957
Therapeutic product effect incomplete 65.53 15.29 54 87027 193842 90347524
Cytopenia 64.95 15.29 82 86999 17367 90523999
Erythema multiforme 64.84 15.29 69 87012 12177 90529189
Metastases to adrenals 64.61 15.29 27 87054 951 90540415
Gamma-glutamyltransferase increased 64.27 15.29 124 86957 37828 90503538
Blood bilirubin abnormal 63.32 15.29 33 87048 1931 90539435
Portal hypertension 62.97 15.29 45 87036 4656 90536710
Blood bilirubin increased 62.86 15.29 133 86948 43337 90498029
Blood glucose increased 62.83 15.29 218 86863 95028 90446338
Lower limb fracture 62.75 15.29 5 87076 85008 90456358
Jaundice 62.27 15.29 112 86969 32405 90508961
Peripheral swelling 62.15 15.29 197 86884 412909 90128457
Lip dry 62.10 15.29 11 87070 100944 90440422
Obesity 61.72 15.29 13 87068 105494 90435872
Knee arthroplasty 61.10 15.29 5 87076 83177 90458189
Osteoarthritis 60.77 15.29 59 87022 195671 90345695
Abdominal lymphadenopathy 60.34 15.29 26 87055 989 90540377
Tumour marker abnormal 60.23 15.29 20 87061 364 90541002
Metastases to meninges 60.04 15.29 40 87041 3695 90537671
White blood cell count abnormal 59.95 15.29 53 87028 7451 90533915
Adverse drug reaction 59.45 15.29 19 87062 116682 90424684
Metastases to eye 58.66 15.29 17 87064 192 90541174
Hospitalisation 58.29 15.29 25 87056 128075 90413291
Pneumonia 57.60 15.29 368 86713 637691 89903675
Pulmonary mass 57.54 15.29 101 86980 28671 90512695
Oral pain 56.84 15.29 108 86973 32575 90508791
Prescribed underdose 56.54 15.29 4 87077 75015 90466351
Nasal mucosal disorder 56.45 15.29 30 87051 1827 90539539
Metastases to retroperitoneum 56.44 15.29 16 87065 166 90541200
Alanine aminotransferase increased 56.11 15.29 244 86837 118094 90423272
Product use issue 55.68 15.29 149 86932 329770 90211596
Dyspnoea exertional 55.31 15.29 174 86907 72114 90469252
Oestradiol increased 55.03 15.29 14 87067 92 90541274
Hip arthroplasty 54.83 15.29 5 87076 76203 90465163
Constipation 54.11 15.29 457 86624 279938 90261428
Pulmonary fibrosis 53.89 15.29 18 87063 107485 90433881
Loss of personal independence in daily activities 53.79 15.29 32 87049 136073 90405293
Off label use 53.66 15.29 742 86339 1101510 89439856
Carbohydrate antigen 27.29 increased 52.96 15.29 14 87067 109 90541257
Product quality issue 52.53 15.29 7 87074 79318 90462048
Arthritis 52.44 15.29 50 87031 167265 90374101
Liver injury 52.27 15.29 52 87029 170515 90370851
Hepatic function abnormal 51.82 15.29 128 86953 46160 90495206
Dry skin 51.64 15.29 194 86887 87879 90453487
Suicide attempt 51.53 15.29 6 87075 75393 90465973
Bone cancer 50.95 15.29 27 87054 1635 90539731
Impaired healing 49.95 15.29 93 86988 234106 90307260
Migraine 49.73 15.29 66 87015 190326 90351040
Bradycardia 49.73 15.29 10 87071 83837 90457529
Hormone receptor positive breast cancer 49.72 15.29 21 87060 760 90540606
Streptococcal sepsis 49.61 15.29 35 87046 3549 90537817
Pulmonary embolism 49.07 15.29 252 86829 130568 90410798
Portal vein thrombosis 48.98 15.29 33 87048 3105 90538261
Nail bed inflammation 48.92 15.29 27 87054 1774 90539592
Osteosclerosis 48.10 15.29 37 87044 4283 90537083
Bone cancer metastatic 47.61 15.29 15 87066 229 90541137
Isosthenuria 47.61 15.29 13 87068 116 90541250
Renal impairment 47.43 15.29 214 86867 105207 90436159
Metastases to bone marrow 47.41 15.29 19 87062 600 90540766
Drug intolerance 47.41 15.29 245 86836 447346 90094020
Mean cell volume increased 47.34 15.29 39 87042 4982 90536384
Invasive lobular breast carcinoma 47.24 15.29 22 87059 1007 90540359
Epistaxis 47.03 15.29 184 86897 84941 90456425
Adnexa uteri mass 46.63 15.29 19 87062 627 90540739
Recurrent cancer 46.08 15.29 29 87052 2430 90538936
Tooth extraction 45.90 15.29 56 87025 11457 90529909
Blood alkaline phosphatase increased 45.66 15.29 125 86956 47954 90493412
Acquired gene mutation 45.61 15.29 23 87058 1256 90540110
Neoplasm recurrence 45.51 15.29 32 87049 3227 90538139
Foot deformity 45.48 15.29 3 87078 59648 90481718
Diabetic ketoacidosis 45.38 15.29 83 86998 24324 90517042
Lacrimation increased 45.31 15.29 88 86993 26974 90514392
Infection 44.97 15.29 187 86894 361907 90179459
Musculoskeletal toxicity 44.93 15.29 18 87063 568 90540798
Pleural disorder 44.74 15.29 19 87062 697 90540669
Spinal cord haematoma 44.24 15.29 14 87067 217 90541149
Chest wall mass 44.06 15.29 18 87063 598 90540768
Peripheral venous disease 43.94 15.29 13 87068 83908 90457458
Therapy partial responder 43.59 15.29 77 87004 21966 90519400
Suicidal ideation 43.40 15.29 9 87072 73846 90467520
Toothache 43.11 15.29 77 87004 22153 90519213
Pain in jaw 42.85 15.29 122 86959 47863 90493503
Adjustment disorder with depressed mood 42.85 15.29 3 87078 56750 90484616
Blood creatinine abnormal 42.81 15.29 34 87047 4123 90537243
Ageusia 42.44 15.29 64 87017 16012 90525354
Jaw disorder 41.91 15.29 38 87043 5521 90535845
Neoplasm malignant 41.48 15.29 97 86984 33783 90507583
COVID-19 41.36 15.29 291 86790 168552 90372814
Unevaluable event 41.12 15.29 3 87078 54845 90486521
Ejection fraction decreased 41.10 15.29 83 86998 26170 90515196
Red blood cell sedimentation rate increased 41.10 15.29 14 87067 82581 90458785
Medication error 41.01 15.29 15 87066 84637 90456729
Feeling cold 40.83 15.29 85 86996 27380 90513986
Dysgeusia 40.65 15.29 127 86954 52433 90488933
Mean cell haemoglobin increased 40.35 15.29 32 87049 3873 90537493
Scan abnormal 40.12 15.29 17 87064 620 90540746
Ear infection 39.99 15.29 9 87072 69766 90471600
Electrocardiogram PR shortened 39.35 15.29 16 87065 525 90540841
Erysipelas 39.32 15.29 46 87035 9006 90532360
Basophil count increased 39.01 15.29 20 87061 1131 90540235
Granulocytopenia 38.99 15.29 39 87042 6402 90534964
Infusion site induration 38.61 15.29 22 87059 1537 90539829
Night sweats 38.60 15.29 40 87041 128726 90412640
Pyelitis 38.48 15.29 13 87068 250 90541116
Pseudomonal sepsis 37.63 15.29 32 87049 4270 90537096
Musculoskeletal chest pain 37.07 15.29 75 87006 23675 90517691
Amnesia 36.92 15.29 30 87051 108475 90432891
Contusion 36.90 15.29 121 86960 251095 90290271
Hypermetabolism 36.76 15.29 13 87068 288 90541078
Metastases to breast 36.75 15.29 14 87067 385 90540981
Drug interaction 36.70 15.29 139 86942 276314 90265052
Metastases to soft tissue 36.68 15.29 13 87068 290 90541076
White blood cell disorder 36.58 15.29 27 87054 2937 90538429
Hydronephrosis 36.54 15.29 52 87029 12350 90529016
Intestinal metastasis 36.52 15.29 12 87069 211 90541155
Cardio-respiratory arrest 36.48 15.29 8 87073 63132 90478234
Malignant ascites 36.19 15.29 18 87063 954 90540412
Ovarian cancer 35.60 15.29 38 87043 6729 90534637
Paronychia 35.31 15.29 41 87040 7965 90533401
Metastases to kidney 35.03 15.29 12 87069 241 90541125
Lymphadenopathy mediastinal 34.99 15.29 27 87054 3140 90538226
Oedema 34.88 15.29 89 86992 200206 90341160
Hepatic cyst 34.76 15.29 37 87044 6531 90534835
Neutrophil count abnormal 34.67 15.29 30 87051 4098 90537268
Tumour flare 34.56 15.29 15 87066 581 90540785
Ovarian disorder 34.38 15.29 17 87064 890 90540476
Blood glucose abnormal 34.37 15.29 44 87037 9448 90531918
Inappropriate schedule of product administration 34.26 15.29 57 87024 149876 90391490
Pancytopenia 34.10 15.29 215 86866 120048 90421318
Electrocardiogram QT prolonged 34.03 15.29 149 86932 72307 90469059
Inflammation 33.76 15.29 76 87005 178516 90362850
Toxicity to various agents 33.68 15.29 152 86929 287694 90253672
Therapy non-responder 33.10 15.29 50 87031 136654 90404712
Bladder hypertrophy 32.78 15.29 14 87067 521 90540845
Pancreatitis 32.78 15.29 13 87068 69813 90471553
Vasodilatation 32.77 15.29 25 87056 2859 90538507
X-ray abnormal 32.62 15.29 3 87078 45421 90495945
Oestrogen receptor assay positive 32.60 15.29 14 87067 528 90540838
Nephroangiosclerosis 32.44 15.29 11 87070 214 90541152
Haemoglobin abnormal 32.39 15.29 37 87044 7063 90534303
Decreased immune responsiveness 32.38 15.29 41 87040 8707 90532659
Pathological fracture 32.21 15.29 43 87038 9617 90531749
Body surface area increased 32.07 15.29 8 87073 48 90541318
General physical health deterioration 32.03 15.29 499 86582 354616 90186750
Metastases to bladder 31.75 15.29 11 87070 229 90541137
Bone marrow disorder 31.66 15.29 25 87056 3007 90538359
Loss of consciousness 31.41 15.29 54 87027 140184 90401182
Bile duct stenosis 31.29 15.29 20 87061 1722 90539644
BRAF gene mutation 31.26 15.29 8 87073 54 90541312
Post-traumatic neck syndrome 31.25 15.29 23 87058 2491 90538875
Back injury 31.14 15.29 4 87077 46618 90494748
Superinfection 31.08 15.29 25 87056 3087 90538279
Brain oedema 30.91 15.29 58 87023 17327 90524039
Breast cancer stage IV 30.78 15.29 21 87060 2017 90539349
Road traffic accident 30.52 15.29 35 87046 107591 90433775
Haematocrit decreased 30.45 15.29 99 86982 41733 90499633
Hyperglycaemic hyperosmolar nonketotic syndrome 30.41 15.29 18 87063 1351 90540015
Hypertension 30.37 15.29 287 86794 457245 90084121
Drug ineffective for unapproved indication 30.32 15.29 13 87068 66631 90474735
Exposed bone in jaw 30.28 15.29 24 87057 2902 90538464
Tumour marker decreased 30.18 15.29 8 87073 63 90541303
Tachycardia 29.88 15.29 67 87014 157606 90383760
Drug resistance 29.74 15.29 80 87001 30369 90510997
Fractured sacrum 29.71 15.29 22 87059 2405 90538961
Metastases to ovary 29.70 15.29 13 87068 514 90540852
Hypertransaminasaemia 29.65 15.29 54 87027 15771 90525595
Prehypertension 29.65 15.29 7 87074 32 90541334
Corticobasal degeneration 29.45 15.29 6 87075 11 90541355
Sensory disturbance 29.39 15.29 53 87028 15360 90526006
Vulvovaginal dryness 28.95 15.29 25 87056 3406 90537960
Activated PI3 kinase delta syndrome 28.48 15.29 8 87073 80 90541286
Cachexia 28.30 15.29 34 87047 6844 90534522
Hepatic cancer metastatic 28.29 15.29 12 87069 439 90540927
Exostosis 28.24 15.29 8 87073 53126 90488240
Bone erosion 28.15 15.29 8 87073 53013 90488353
Osteomyelitis 28.05 15.29 74 87007 27772 90513594
Blood albumin abnormal 27.88 15.29 16 87065 1133 90540233
Metastases to nervous system 27.88 15.29 8 87073 87 90541279
Metastases to abdominal cavity 27.88 15.29 13 87068 597 90540769
Intentional product misuse 27.81 15.29 27 87054 89577 90451789
Malignant peritoneal neoplasm 27.77 15.29 14 87067 764 90540602
Parosmia 27.56 15.29 34 87047 7035 90534331
Joint dislocation 27.11 15.29 5 87076 44577 90496789
Oral disorder 27.04 15.29 41 87040 10304 90531062
Acanthosis 27.03 15.29 10 87071 253 90541113
Alopecia 26.94 15.29 644 86437 494427 90046939
Fluid retention 26.81 15.29 27 87054 88064 90453302
Hallucination 26.78 15.29 15 87066 65944 90475422
Blood calcium abnormal 26.65 15.29 19 87062 1958 90539408
Radiation fibrosis - lung 26.65 15.29 7 87074 53 90541313
Onychomadesis 26.22 15.29 6 87075 45992 90495374
Metastases to uterus 26.03 15.29 8 87073 112 90541254
Chills 25.89 15.29 216 86865 131765 90409601
Insomnia 25.77 15.29 201 86880 333273 90208093
Oestradiol abnormal 25.68 15.29 7 87074 62 90541304
Seizure 25.67 15.29 69 87012 152560 90388806
Memory impairment 25.64 15.29 100 86981 197144 90344222
Joint neoplasm 25.58 15.29 7 87074 63 90541303
Tumour invasion 25.50 15.29 10 87071 298 90541068
Hepatic echinococciasis 25.49 15.29 7 87074 64 90541302
Transaminases abnormal 25.44 15.29 13 87068 730 90540636
Blood alkaline phosphatase abnormal 25.30 15.29 16 87065 1352 90540014
Retinal detachment 25.30 15.29 32 87049 6790 90534576
Invasive breast carcinoma 25.29 15.29 14 87067 925 90540441
Peritoneal fluid analysis abnormal 25.14 15.29 6 87075 29 90541337
Tumour pain 25.13 15.29 18 87063 1869 90539497
Elliptocytosis 24.66 15.29 7 87074 73 90541293
Angioedema 24.59 15.29 16 87065 64860 90476506
Bone debridement 24.55 15.29 9 87072 222 90541144
Transaminases 24.08 15.29 7 87074 80 90541286
Pain 24.04 15.29 752 86329 995589 89545777
Stomatitis 23.99 15.29 384 86697 274314 90267052
Cardiac arrest 23.87 15.29 40 87041 104895 90436471
Disability 23.87 15.29 5 87076 40740 90500626
Tumour ulceration 23.82 15.29 9 87072 242 90541124
Hyperchromic anaemia 23.77 15.29 7 87074 84 90541282
International normalised ratio increased 23.57 15.29 8 87073 47308 90494058
Carcinoid tumour pulmonary 23.51 15.29 11 87070 509 90540857
Pulmonary tumour thrombotic microangiopathy 23.40 15.29 7 87074 89 90541277
Mouth swelling 23.32 15.29 28 87053 5634 90535732
Spinal cord compression 23.09 15.29 26 87055 4885 90536481
Injection site reaction 22.95 15.29 33 87048 92047 90449319
Weight decreased 22.76 15.29 501 86580 379409 90161957
BRCA2 gene mutation 22.71 15.29 7 87074 99 90541267
Hepatic neoplasm 22.68 15.29 18 87063 2180 90539186
Oxygen saturation decreased 22.62 15.29 43 87038 107440 90433926
RET gene mutation 22.58 15.29 5 87076 16 90541350
Soft tissue neoplasm 22.46 15.29 7 87074 103 90541263
Thyroid calcification 22.45 15.29 6 87075 49 90541317
Adenocarcinoma 22.45 15.29 21 87060 3175 90538191
Dyskinesia 22.42 15.29 4 87077 36530 90504836
Vein disorder 22.18 15.29 27 87054 5509 90535857
Pleural thickening 22.16 15.29 21 87060 3227 90538139
Treatment noncompliance 22.12 15.29 11 87070 51716 90489650
Depression 21.93 15.29 184 86897 300417 90240949
Metastases to gastrointestinal tract 21.92 15.29 7 87074 112 90541254
Respiratory arrest 21.91 15.29 3 87078 33308 90508058
KL-6 increased 21.75 15.29 7 87074 115 90541251
Anisocytosis 21.73 15.29 12 87069 789 90540577
QRS axis abnormal 21.71 15.29 14 87067 1224 90540142
Tremor 21.65 15.29 75 87006 153098 90388268
Depressed level of consciousness 21.37 15.29 23 87058 72761 90468605
Peritoneal disorder 21.26 15.29 11 87070 634 90540732
Agitation 21.07 15.29 20 87061 67078 90474288
Injection site ulcer 20.98 15.29 11 87070 652 90540714
Epilepsy 20.95 15.29 29 87052 82177 90459189
Injection site hypoaesthesia 20.94 15.29 11 87070 654 90540712
Mediastinal disorder 20.90 15.29 10 87071 487 90540879
Delirium 20.89 15.29 43 87038 104316 90437050
Chronic cutaneous lupus erythematosus 20.86 15.29 12 87069 854 90540512
Treatment failure 20.86 15.29 189 86892 303739 90237627
Varicose vein 20.53 15.29 30 87051 7297 90534069
Platelet count abnormal 20.47 15.29 23 87058 4312 90537054
Pustule 20.36 15.29 19 87062 2864 90538502
Tooth disorder 20.35 15.29 71 87010 31019 90510347
Coma 20.18 15.29 24 87057 72608 90468758
Lung disorder 20.11 15.29 75 87006 149808 90391558
Breast pain 20.09 15.29 36 87045 10382 90530984
Gastrointestinal haemorrhage 19.98 15.29 35 87046 90213 90451153
Injection site abscess 19.66 15.29 14 87067 1440 90539926
Red cell distribution width increased 19.59 15.29 39 87042 12168 90529198
Cardiac failure congestive 19.47 15.29 41 87040 98653 90442713
Uterine mass 19.45 15.29 9 87072 406 90540960
Glomerular filtration rate increased 19.42 15.29 16 87065 2044 90539322
Metastases to neck 19.40 15.29 6 87075 86 90541280
Gingival swelling 19.36 15.29 24 87057 4989 90536377
Rectal haemorrhage 19.32 15.29 31 87050 82713 90458653
Cytogenetic analysis abnormal 19.15 15.29 12 87069 998 90540368
Osteoporosis 19.13 15.29 40 87041 96491 90444875
Skin sensitisation 19.10 15.29 12 87069 1003 90540363
Vitiligo 19.08 15.29 16 87065 2094 90539272
Body surface area decreased 19.02 15.29 5 87076 38 90541328
Adrenal insufficiency 18.97 15.29 3 87078 29918 90511448
Gene mutation 18.95 15.29 16 87065 2114 90539252
Gingivitis 18.87 15.29 33 87048 9336 90532030
Adverse reaction 18.79 15.29 3 87078 29709 90511657
Tooth fracture 18.73 15.29 39 87042 12561 90528805
Oesophageal adenocarcinoma 18.64 15.29 7 87074 185 90541181
Laryngitis 18.59 15.29 13 87068 50740 90490626
Surgery 18.52 15.29 10 87071 44877 90496489
Mean cell haemoglobin decreased 18.46 15.29 25 87056 5670 90535696
Drug reaction with eosinophilia and systemic symptoms 18.43 15.29 9 87072 42749 90498617
Sleep apnoea syndrome 18.38 15.29 4 87077 31743 90509623
Bronchitis 18.33 15.29 80 87001 152847 90388519
Hormone refractory breast cancer 18.26 15.29 4 87077 12 90541354
Mediastinal fibrosis 18.18 15.29 5 87076 46 90541320
Cognitive disorder 18.17 15.29 24 87057 69383 90471983
Gaze palsy 18.15 15.29 14 87067 1627 90539739
Monocyte count decreased 18.15 15.29 17 87064 2574 90538792
Sedation 18.09 15.29 12 87069 48159 90493207
Unresponsive to stimuli 18.05 15.29 7 87074 38114 90503252
Gingival erythema 18.03 15.29 12 87069 1106 90540260
Macular degeneration 17.93 15.29 7 87074 37963 90503403
Rectal cancer 17.88 15.29 16 87065 2285 90539081
Alanine aminotransferase abnormal 17.86 15.29 24 87057 5402 90535964
Pulmonary valve incompetence 17.85 15.29 14 87067 1667 90539699
Orthostatic hypotension 17.73 15.29 9 87072 41818 90499548
Walking aid user 17.69 15.29 6 87075 35500 90505866
Concomitant disease aggravated 17.53 15.29 36 87045 11482 90529884
Intraocular pressure test abnormal 17.47 15.29 7 87074 221 90541145
Periodontitis 17.44 15.29 20 87061 3833 90537533
Respiratory disorder 17.40 15.29 22 87059 64794 90476572
Hepatobiliary disease 17.29 15.29 9 87072 525 90540841
Incorrect dose administered 17.12 15.29 31 87050 78899 90462467
Mucosal dryness 17.04 15.29 18 87063 3149 90538217
Overflow diarrhoea 17.01 15.29 6 87075 132 90541234
Plasma cell myeloma 16.99 15.29 9 87072 40819 90500547
Gingival pain 16.91 15.29 32 87049 9620 90531746
Debridement 16.83 15.29 12 87069 1237 90540129
Heart rate increased 16.83 15.29 54 87027 112848 90428518
Stress 16.75 15.29 33 87048 81362 90460004
Madarosis 16.70 15.29 19 87062 3610 90537756
Pelvic bone injury 16.61 15.29 5 87076 65 90541301
Blood pressure increased 16.60 15.29 116 86965 197101 90344265
Triple negative breast cancer 16.59 15.29 8 87073 396 90540970
Sequestrectomy 16.55 15.29 10 87071 779 90540587
Device issue 16.55 15.29 4 87077 29533 90511833
Pancreatic toxicity 16.54 15.29 5 87076 66 90541300
Hydrothorax 16.45 15.29 11 87070 1022 90540344
Product dose omission in error 16.28 15.29 50 87031 20453 90520913
Nail dystrophy 16.25 15.29 12 87069 1306 90540060
Sciatica 16.17 15.29 47 87034 101335 90440031
Gastrointestinal toxicity 16.11 15.29 31 87050 9436 90531930
Embolism 16.08 15.29 31 87050 9450 90531916
Influenza 16.00 15.29 74 87007 139190 90402176
Underdose 15.94 15.29 17 87064 54000 90487366
Ulcer haemorrhage 15.90 15.29 3 87078 26318 90515048
Glycosylated haemoglobin 15.89 15.29 5 87076 76 90541290
Staphylococcal infection 15.73 15.29 14 87067 48425 90492941
Eosinophilia 15.72 15.29 4 87077 28529 90512837
Metastases to muscle 15.72 15.29 6 87075 166 90541200
Breast injury 15.65 15.29 5 87076 80 90541286
Mucinous breast carcinoma 15.63 15.29 4 87077 27 90541339
Colitis ulcerative 15.61 15.29 21 87060 60245 90481121
Hypervolaemia 15.53 15.29 6 87075 32751 90508615
Periodontal disease 15.52 15.29 13 87068 1699 90539667
Pruritus 15.48 15.29 399 86682 541126 90000240
Aphthous ulcer 15.48 15.29 44 87037 17243 90524123
Excessive granulation tissue 15.47 15.29 10 87071 878 90540488
Laryngitis viral 15.43 15.29 5 87076 84 90541282
Diabetes mellitus 15.40 15.29 111 86970 64764 90476602
Febrile infection 15.32 15.29 14 87067 2055 90539311

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 63.51 42.21 19 711 14790 42605815
Xerosis 48.24 42.21 9 721 907 42619698
Metastases to lymph nodes 45.33 42.21 12 718 5986 42614619

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
Malignant neoplasm progression 2846.36 15.98 1592 65446 172975 110349286
Neoplasm progression 2486.65 15.98 1061 65977 63534 110458727
Metastases to bone 2472.91 15.98 868 66170 30504 110491757
Metastases to liver 1944.73 15.98 751 66287 34635 110487626
Neutropenia 1523.64 15.98 1475 65563 373145 110149116
White blood cell count decreased 1187.63 15.98 1035 66003 228355 110293906
Breast cancer metastatic 743.27 15.98 273 66765 10908 110511353
Metastases to lung 737.51 15.98 333 66705 22730 110499531
Tumour marker increased 689.38 15.98 212 66826 4848 110517413
Fatigue 660.97 15.98 1915 65123 1214043 109308218
Osteonecrosis of jaw 580.41 15.98 362 66676 47655 110474606
Metastases to lymph nodes 489.93 15.98 220 66818 14812 110507449
Neutrophil count decreased 474.02 15.98 468 66570 120473 110401788
Hyperglycaemia 409.40 15.98 369 66669 84721 110437540
Disease progression 395.22 15.98 604 66434 243430 110278831
Carbohydrate antigen 15-3 increased 379.41 15.98 103 66935 1484 110520777
Breast cancer recurrent 301.01 15.98 106 66932 3740 110518521
Bone pain 281.30 15.98 266 66772 64867 110457394
Metastases to central nervous system 268.01 15.98 169 66869 22648 110499613
Metastases to skin 265.86 15.98 85 66953 2214 110520047
Breast cancer 261.66 15.98 204 66834 38338 110483923
Pseudocirrhosis 249.43 15.98 66 66972 857 110521404
PIK3CA-activated mutation 239.89 15.98 60 66978 613 110521648
Leukopenia 237.40 15.98 366 66672 148425 110373836
Nausea 235.51 15.98 1412 65626 1234278 109287983
Hot flush 231.97 15.98 241 66797 65795 110456466
Metastases to pleura 217.06 15.98 71 66967 1992 110520269
Bone lesion 215.97 15.98 99 66939 6988 110515273
Death 211.16 15.98 910 66128 697959 109824302
Infusion related reaction 190.02 15.98 10 67028 381152 110141109
Thrombocytopenia 189.93 15.98 552 66486 348333 110173928
Full blood count decreased 177.99 15.98 151 66887 31948 110490313
Pleural effusion 174.15 15.98 353 66685 177356 110344905
Red blood cell count decreased 173.64 15.98 207 66831 65716 110456545
Decreased appetite 165.07 15.98 647 66391 475199 110047062
Metastases to spine 163.95 15.98 75 66963 5268 110516993
Asthenia 159.64 15.98 831 66207 688168 109834093
Second primary malignancy 159.42 15.98 112 66926 17956 110504305
Metastasis 155.05 15.98 83 66955 8184 110514077
Alopecia 154.28 15.98 529 66509 364224 110158037
Carcinoembryonic antigen increased 148.06 15.98 58 66980 2766 110519495
Diarrhoea 144.98 15.98 1181 65857 1138324 109383937
Joint swelling 141.67 15.98 46 66992 442799 110079462
Platelet count decreased 138.40 15.98 378 66660 230065 110292196
Systemic lupus erythematosus 135.74 15.98 4 67034 254334 110267927
Anaemia 134.37 15.98 671 66367 546415 109975846
Rheumatoid arthritis 129.42 15.98 15 67023 299598 110222663
Myelosuppression 127.10 15.98 215 66823 94125 110428136
Drug ineffective 126.75 15.98 485 66553 1520055 109002206
Therapeutic product effect decreased 123.02 15.98 6 67032 244310 110277951
Metastases to peritoneum 121.42 15.98 62 66976 5548 110516713
Full blood count abnormal 120.46 15.98 159 66879 55893 110466368
Hepatic lesion 117.87 15.98 70 66968 8423 110513838
Pericarditis 114.94 15.98 4 67034 219110 110303151
Arthropathy 109.03 15.98 21 67017 287501 110234760
Off label use 106.80 15.98 508 66530 1499677 109022584
Palmar-plantar erythrodysaesthesia syndrome 105.03 15.98 127 66911 40898 110481363
Hypotension 104.70 15.98 98 66940 523751 109998510
Hormone receptor positive HER2 negative breast cancer 103.20 15.98 25 67013 221 110522040
Neuropathy peripheral 100.62 15.98 287 66751 178990 110343271
Ascites 98.86 15.98 191 66847 92617 110429644
Cancer pain 97.08 15.98 57 66981 6715 110515546
Back pain 96.65 15.98 463 66575 370533 110151728
Skin toxicity 94.66 15.98 69 66969 11714 110510547
Intentional product use issue 92.11 15.98 19 67019 247887 110274374
Injection site necrosis 91.63 15.98 36 67002 1730 110520531
Mobility decreased 90.73 15.98 17 67021 237405 110284856
Infusion site coldness 90.16 15.98 23 67015 256 110522005
Confusional state 89.78 15.98 91 66947 468589 110053672
Drug hypersensitivity 89.48 15.98 86 66952 454004 110068257
Hepatic failure 87.77 15.98 153 66885 68586 110453675
Osteonecrosis 87.27 15.98 105 66933 33636 110488625
Irritable bowel syndrome 86.11 15.98 3 67035 164212 110358049
Overdose 84.66 15.98 19 67019 233775 110288486
Fibromyalgia 83.52 15.98 5 67033 170904 110351357
Oral pain 83.22 15.98 108 66930 37336 110484925
Treatment failure 83.12 15.98 32 67006 277202 110245059
Gamma-glutamyltransferase decreased 81.89 15.98 23 67015 378 110521883
Haemoglobin decreased 81.88 15.98 333 66705 248394 110273867
Bone disorder 81.03 15.98 81 66957 21111 110501150
Asthma 79.98 15.98 26 67012 250265 110271996
Stomatitis 79.79 15.98 350 66688 269892 110252369
Haematotoxicity 79.55 15.98 80 66958 21002 110501259
Wound 79.18 15.98 22 67016 234415 110287846
Hepatotoxicity 78.20 15.98 139 66899 63261 110459000
Musculoskeletal stiffness 77.96 15.98 36 67002 279786 110242475
Condition aggravated 77.20 15.98 211 66827 734625 109787636
Metastases to eye 76.43 15.98 21 67017 317 110521944
Pneumonia 76.43 15.98 274 66764 876440 109645821
Cough 76.33 15.98 510 66528 461131 110061130
Mucosal inflammation 75.80 15.98 175 66863 95966 110426295
Toxicity to various agents 75.41 15.98 109 66929 480446 110041815
Spinal pain 74.94 15.98 73 66965 18442 110503819
Wheezing 72.40 15.98 32 67006 255198 110267063
Injury 71.45 15.98 11 67027 177254 110345007
Glossodynia 69.29 15.98 24 67014 221980 110300281
Lymphangiosis carcinomatosa 67.34 15.98 32 67006 2450 110519811
Bradycardia 66.59 15.98 8 67030 155509 110366752
Lymphoedema 66.38 15.98 62 66976 14867 110507394
Intentional overdose 64.37 15.98 4 67034 132497 110389764
Pneumonitis 63.32 15.98 142 66896 76389 110445872
Fall 62.80 15.98 174 66864 603308 109918953
Nasal mucosal disorder 62.74 15.98 28 67010 1855 110520406
Drug interaction 62.49 15.98 131 66907 500052 110022209
Eastern Cooperative Oncology Group performance status worsened 61.91 15.98 32 67006 2937 110519324
Nail bed inflammation 60.73 15.98 28 67010 2002 110520259
Lower respiratory tract infection 60.72 15.98 36 67002 243070 110279191
Adnexa uteri mass 60.54 15.98 19 67019 465 110521796
Streptococcal sepsis 58.13 15.98 37 67001 5035 110517226
Interstitial lung disease 57.83 15.98 201 66837 139133 110383128
Swelling 57.66 15.98 77 66961 350964 110171297
Bursitis 57.35 15.98 6 67032 129912 110392349
Metastases to pelvis 57.33 15.98 21 67017 831 110521430
Product use in unapproved indication 56.86 15.98 116 66922 447261 110075000
Metastases to breast 56.58 15.98 17 67021 358 110521903
Joint range of motion decreased 55.43 15.98 5 67033 121827 110400434
Acute kidney injury 54.36 15.98 200 66838 635230 109887031
Type 2 diabetes mellitus 53.87 15.98 20 67018 177212 110345049
Isosthenuria 53.26 15.98 13 67025 119 110522142
Blood glucose increased 53.14 15.98 189 66849 132307 110389954
Osteolysis 52.86 15.98 36 67002 5487 110516774
Electrocardiogram PR shortened 51.67 15.98 16 67022 374 110521887
Infusion site induration 50.83 15.98 22 67016 1354 110520907
Constipation 50.75 15.98 381 66657 357405 110164856
Portal hypertension 50.70 15.98 42 66996 8595 110513666
Metastases to chest wall 50.50 15.98 18 67020 658 110521603
Metastases to retroperitoneum 50.21 15.98 16 67022 412 110521849
Carbohydrate antigen 27.29 increased 49.75 15.98 12 67026 104 110522157
Lymphadenopathy 49.00 15.98 115 66923 63720 110458541
Tooth extraction 48.47 15.98 49 66989 12942 110509319
Pain in jaw 48.10 15.98 100 66938 51077 110471184
Psoriasis 47.51 15.98 13 67025 139980 110382281
Bone marrow failure 47.47 15.98 107 66931 57741 110464520
Neoplasm 47.30 15.98 45 66993 11042 110511219
Blister 47.19 15.98 41 66997 227335 110294926
Tumour marker abnormal 46.95 15.98 14 67024 287 110521974
Pleural neoplasm 46.61 15.98 15 67023 399 110521862
Wound infection 46.59 15.98 3 67035 96462 110425799
Metastases to meninges 45.73 15.98 32 67006 5096 110517165
Ovarian disorder 45.17 15.98 16 67022 574 110521687
Cytopenia 45.07 15.98 72 66966 30044 110492217
Cardio-respiratory arrest 44.87 15.98 8 67030 115828 110406433
Malignant pleural effusion 44.79 15.98 29 67009 4064 110518197
Osteosclerosis 44.57 15.98 30 67008 4485 110517776
Ill-defined disorder 43.94 15.98 20 67018 156833 110365428
Feeling cold 43.83 15.98 76 66962 33911 110488350
Adverse event 43.28 15.98 7 67031 108802 110413459
Metastases to thorax 43.12 15.98 13 67025 277 110521984
Gastrointestinal disorder 42.93 15.98 50 66988 241902 110280359
Dry skin 42.69 15.98 153 66885 107500 110414761
Cardiac arrest 42.65 15.98 34 67004 196719 110325542
Suicide attempt 42.62 15.98 6 67032 103388 110418873
Erythema multiforme 42.49 15.98 58 66980 21039 110501222
Gait inability 42.10 15.98 15 67023 136361 110385900
Abdominal lymphadenopathy 41.89 15.98 21 67017 1807 110520454
Discomfort 41.85 15.98 41 66997 214666 110307595
Bone cancer 41.33 15.98 23 67015 2447 110519814
Sinusitis 41.11 15.98 73 66965 296615 110225646
Lacrimation increased 40.95 15.98 70 66968 30880 110491381
Metastases to the mediastinum 40.56 15.98 16 67022 777 110521484
Post-traumatic neck syndrome 40.27 15.98 23 67015 2572 110519689
Hospitalisation 40.18 15.98 18 67020 142475 110379786
Drug ineffective for unapproved indication 40.06 15.98 7 67031 102831 110419430
Paronychia 39.89 15.98 41 66997 11040 110511221
Aspartate aminotransferase increased 39.70 15.98 197 66841 159739 110362522
Pleural disorder 39.34 15.98 17 67021 1042 110521219
Blood cholesterol increased 38.73 15.98 33 67005 184752 110337509
Pyelitis 38.15 15.98 13 67025 415 110521846
Hormone receptor positive breast cancer 38.01 15.98 14 67024 563 110521698
Therapy partial responder 37.90 15.98 75 66963 36986 110485275
Urticaria 37.73 15.98 86 66952 318771 110203490
Vasodilatation 37.26 15.98 25 67013 3719 110518542
Breast cancer stage III 36.66 15.98 3 67035 79114 110443147
White blood cell disorder 36.57 15.98 25 67013 3834 110518427
Ejection fraction decreased 36.24 15.98 78 66960 40802 110481459
Metastases to spinal cord 36.07 15.98 11 67027 244 110522017
Hepatic enzyme increased 36.02 15.98 89 66949 320803 110201458
International normalised ratio increased 35.85 15.98 5 67033 86767 110435494
Obesity 35.80 15.98 12 67026 113339 110408922
Prehypertension 35.69 15.98 7 67031 19 110522242
Product quality issue 35.63 15.98 3 67035 77296 110444965
Tumour marker decreased 35.18 15.98 8 67030 52 110522209
Therapeutic product effect incomplete 34.82 15.98 51 66987 223754 110298507
Febrile neutropenia 34.66 15.98 89 66949 316678 110205583
Lower limb fracture 34.52 15.98 3 67035 75345 110446916
Lip dry 34.52 15.98 9 67029 100074 110422187
Peripheral venous disease 34.40 15.98 5 67033 84112 110438149
Invasive ductal breast carcinoma 34.27 15.98 30 67008 6616 110515645
Neoplasm recurrence 34.00 15.98 27 67011 5205 110517056
Ovarian cancer 33.64 15.98 25 67013 4371 110517890
Diabetic ketoacidosis 33.62 15.98 77 66961 41981 110480280
Decreased immune responsiveness 33.60 15.98 35 67003 9571 110512690
Dysgeusia 33.52 15.98 106 66932 69879 110452382
Metastases to bladder 32.86 15.98 11 67027 332 110521929
Hypertransaminasaemia 32.28 15.98 55 66983 24200 110498061
Loss of consciousness 32.27 15.98 43 66995 196263 110325998
Mean cell volume increased 32.14 15.98 32 67006 8298 110513963
Tachycardia 32.09 15.98 55 66983 226590 110295671
Hepatic cyst 32.08 15.98 31 67007 7752 110514509
Inappropriate schedule of product administration 32.08 15.98 46 66992 203591 110318670
Onychoclasis 32.07 15.98 30 67008 7207 110515054
Medication error 31.83 15.98 12 67026 105354 110416907
Gastrointestinal haemorrhage 31.80 15.98 32 67006 165486 110356775
Dyspnoea exertional 31.60 15.98 136 66902 103924 110418337
Suicidal ideation 31.36 15.98 9 67029 93928 110428333
Hyperkalaemia 31.32 15.98 22 67016 135774 110386487
Glomerular filtration rate decreased 31.31 15.98 60 66978 28896 110493365
Metastases to ovary 31.21 15.98 11 67027 389 110521872
Varicose vein 31.20 15.98 29 67009 6911 110515350
Hypersensitivity 30.80 15.98 133 66905 403865 110118396
Toothache 30.77 15.98 53 66985 23522 110498739
Transaminases increased 30.35 15.98 96 66942 63294 110458967
Metastases to kidney 30.26 15.98 12 67026 591 110521670
Nephroangiosclerosis 30.26 15.98 11 67027 426 110521835
Pulmonary fibrosis 30.20 15.98 12 67026 102030 110420231
Sleep disorder 30.19 15.98 46 66992 198598 110323663
Oestradiol increased 30.01 15.98 8 67030 107 110522154
BRCA2 gene mutation 29.94 15.98 8 67030 108 110522153
Pseudomonal sepsis 29.94 15.98 32 67006 9014 110513247
Hallucination 29.90 15.98 12 67026 101420 110420841
Hypermetabolism 29.88 15.98 12 67026 611 110521650
Invasive lobular breast carcinoma 29.72 15.98 13 67025 821 110521440
Recurrent cancer 29.68 15.98 21 67017 3402 110518859
Osteoarthritis 29.02 15.98 41 66997 182582 110339679
Bladder hypertrophy 29.00 15.98 14 67024 1110 110521151
Portal vein thrombosis 28.88 15.98 28 67010 7030 110515231
Acquired gene mutation 28.88 15.98 19 67019 2735 110519526
Joint neoplasm 28.78 15.98 7 67031 63 110522198
Adverse drug reaction 28.73 15.98 14 67024 105545 110416716
Angioedema 28.47 15.98 12 67026 98488 110423773
Product dose omission in error 28.28 15.98 51 66987 23461 110498800
Mean cell haemoglobin increased 28.25 15.98 25 67013 5592 110516669
Metastases to soft tissue 28.22 15.98 12 67026 707 110521554
Hepatic echinococciasis 28.12 15.98 7 67031 70 110522191
Musculoskeletal chest pain 27.85 15.98 57 66981 28790 110493471
Epistaxis 27.81 15.98 154 66884 130218 110392043
Vein disorder 27.80 15.98 26 67012 6244 110516017
Loss of personal independence in daily activities 27.70 15.98 30 67008 149990 110372271
Superinfection 27.70 15.98 25 67013 5738 110516523
Malignant peritoneal neoplasm 27.69 15.98 12 67026 741 110521520
Pancreatitis 27.68 15.98 11 67027 93522 110428739
Exposed bone in jaw 27.66 15.98 21 67017 3790 110518471
Weight increased 27.41 15.98 146 66892 419498 110102763
Therapy non-responder 27.37 15.98 33 67005 157274 110364987
Breast pain 27.31 15.98 32 67006 9968 110512293
Breast mass 27.30 15.98 29 67009 8112 110514149
Metastases to uterus 27.27 15.98 7 67031 80 110522181
Oral disorder 27.26 15.98 35 67003 11968 110510293
Radiation fibrosis - lung 26.88 15.98 7 67031 85 110522176
Blood bilirubin increased 26.80 15.98 104 66934 75868 110446393
Lymphadenopathy mediastinal 26.77 15.98 24 67014 5460 110516801
Blood glucose abnormal 26.76 15.98 36 67002 12880 110509381
Dysarthria 26.40 15.98 9 67029 84112 110438149
Hypercholesterolaemia 26.36 15.98 11 67027 90826 110431435
Prescribed underdose 26.36 15.98 4 67034 65170 110457091
Infusion site haemorrhage 26.24 15.98 22 67016 4576 110517685
Delirium 26.06 15.98 26 67012 134999 110387262
Sepsis 26.03 15.98 106 66932 327240 110195021
Elliptocytosis 25.90 15.98 7 67031 99 110522162
Seizure 25.88 15.98 60 66978 221125 110301136
Soft tissue neoplasm 25.64 15.98 7 67031 103 110522158
Inflammation 25.47 15.98 49 66989 193189 110329072
Drug reaction with eosinophilia and systemic symptoms 25.39 15.98 9 67029 82086 110440175
Blood pressure fluctuation 25.29 15.98 7 67031 74817 110447444
Intentional product misuse 25.18 15.98 26 67012 132878 110389383
Agitation 25.18 15.98 19 67019 113032 110409229
Madarosis 24.96 15.98 19 67019 3444 110518817
Orthostatic hypotension 24.75 15.98 5 67033 66244 110456017
Eosinophilia 24.75 15.98 3 67035 57933 110464328
Tooth disorder 24.67 15.98 55 66983 29454 110492807
Rectal haemorrhage 24.38 15.98 22 67016 119811 110402450
Thyroid calcification 24.38 15.98 6 67032 57 110522204
Mouth swelling 24.31 15.98 26 67012 7328 110514933
Knee arthroplasty 24.06 15.98 5 67033 64943 110457318
Hydronephrosis 23.81 15.98 44 66994 20621 110501640
Syncope 23.64 15.98 55 66983 202481 110319780
Hepatic function abnormal 23.59 15.98 112 66926 89183 110433078
Depressed level of consciousness 23.59 15.98 20 67018 112258 110410003
Hip arthroplasty 23.57 15.98 3 67035 55810 110466451
Coma 23.55 15.98 22 67016 117847 110404414
Peritoneal disorder 23.49 15.98 11 67027 815 110521446
Unresponsive to stimuli 23.45 15.98 5 67033 63785 110458476
Nasopharyngitis 23.16 15.98 142 66896 394219 110128042
Skin sensitisation 23.16 15.98 12 67026 1107 110521154
Mean cell haemoglobin decreased 23.08 15.98 25 67013 7149 110515112
Body surface area increased 23.01 15.98 7 67031 154 110522107
Pulmonary tumour thrombotic microangiopathy 22.97 15.98 7 67031 155 110522106
Peritoneal fluid analysis abnormal 22.96 15.98 6 67032 74 110522187
Hyperglycaemic hyperosmolar nonketotic syndrome 22.77 15.98 17 67021 2992 110519269
Polyneuropathy 22.76 15.98 56 66982 31956 110490305
Blood creatinine increased 22.73 15.98 189 66849 182700 110339561
Nail avulsion 22.71 15.98 7 67031 161 110522100
Transaminases 22.67 15.98 6 67032 78 110522183
Pathological fracture 22.62 15.98 32 67006 12000 110510261
Blood creatine phosphokinase increased 22.62 15.98 8 67030 73069 110449192
Oxygen saturation decreased 22.30 15.98 38 67000 156944 110365317
Multiple organ dysfunction syndrome 22.22 15.98 36 67002 151674 110370587
Cardiogenic shock 22.12 15.98 4 67034 57334 110464927
Epilepsy 22.11 15.98 17 67021 100192 110422069
Metastases to gastrointestinal tract 22.09 15.98 7 67031 177 110522084
Bone sequestrum 22.06 15.98 12 67026 1221 110521040
Vulvovaginal dryness 21.87 15.98 16 67022 2731 110519530
Parosmia 21.80 15.98 33 67005 13147 110509114
Metastatic neoplasm 21.63 15.98 22 67016 5851 110516410
Transaminases abnormal 21.62 15.98 11 67027 977 110521284
Sleep disorder due to a general medical condition 21.53 15.98 3 67035 52109 110470152
Chronic cutaneous lupus erythematosus 21.30 15.98 11 67027 1008 110521253
Fractured sacrum 21.24 15.98 14 67024 2022 110520239
Dyskinesia 21.17 15.98 3 67035 51443 110470818
Chronic obstructive pulmonary disease 21.08 15.98 21 67017 109137 110413124
Cardiac failure congestive 21.04 15.98 37 67001 150963 110371298
Invasive breast carcinoma 20.81 15.98 10 67028 785 110521476
Arthritis 20.80 15.98 44 66994 167542 110354719
Tumour pain 20.77 15.98 16 67022 2951 110519310
Septic shock 20.71 15.98 40 66998 157488 110364773
Brain oedema 20.65 15.98 53 66985 31045 110491216
Pustule 20.48 15.98 17 67021 3487 110518774
Mediastinal fibrosis 20.46 15.98 5 67033 46 110522215
Infection 20.45 15.98 132 66906 362068 110160193
Pneumonia aspiration 20.31 15.98 12 67026 81221 110441040
Coronary artery disease 20.30 15.98 9 67029 71681 110450580
Encephalopathy 20.23 15.98 12 67026 81043 110441218
Pulmonary mass 20.21 15.98 59 66979 37242 110485019
Haemoptysis 20.13 15.98 9 67029 71345 110450916
Drug intolerance 20.09 15.98 154 66884 406358 110115903
Osteomyelitis 19.93 15.98 58 66980 36542 110485719
Metastases to abdominal cavity 19.87 15.98 10 67028 868 110521393
Pulmonary embolism 19.80 15.98 208 66830 214266 110307995
Bone debridement 19.80 15.98 8 67030 414 110521847
Anisocytosis 19.64 15.98 11 67027 1185 110521076
RET gene mutation 19.63 15.98 4 67034 14 110522247
Metabolic acidosis 19.48 15.98 19 67019 99725 110422536
Adenocarcinoma 19.46 15.98 18 67020 4262 110517999
Staphylococcal infection 19.46 15.98 9 67029 69935 110452326
Tongue blistering 19.43 15.98 13 67025 1924 110520337
Treatment noncompliance 19.38 15.98 10 67028 72980 110449281
Sedation 19.33 15.98 9 67029 69674 110452587
Blood pressure increased 19.10 15.98 86 66952 258287 110263974
Aphasia 19.06 15.98 6 67032 58991 110463270
Melaena 18.89 15.98 9 67029 68748 110453513
Nasal dryness 18.56 15.98 20 67018 5686 110516575
Night sweats 18.52 15.98 33 67005 133950 110388311
Gamma-glutamyltransferase increased 18.51 15.98 80 66958 61229 110461032
Dorsal ramus syndrome 18.48 15.98 4 67034 20 110522241
KL-6 increased 18.36 15.98 7 67031 310 110521951
Tumour ulceration 18.34 15.98 7 67031 311 110521950
Laryngitis viral 18.29 15.98 5 67033 74 110522187
Bone cancer metastatic 18.25 15.98 7 67031 315 110521946
Accidental exposure to product 18.22 15.98 4 67034 50004 110472257
Breast injury 18.05 15.98 5 67033 78 110522183
Myocardial infarction 18.04 15.98 58 66980 192025 110330236
Vomiting 17.95 15.98 698 66340 909977 109612284
Toxic epidermal necrolysis 17.92 15.98 6 67032 56721 110465540
Excessive granulation tissue 17.80 15.98 10 67028 1084 110521177
Intestinal metastasis 17.77 15.98 8 67030 541 110521720
Red blood cell sedimentation rate increased 17.64 15.98 13 67025 78289 110443972
Unevaluable event 17.47 15.98 7 67031 59220 110463041
Loose tooth 17.41 15.98 15 67023 3238 110519023
Sequestrectomy 17.40 15.98 9 67029 827 110521434
Gingivitis 17.28 15.98 26 67012 10305 110511956
Retinal detachment 17.25 15.98 27 67011 11073 110511188
Aphthous ulcer 17.23 15.98 39 66999 21097 110501164
Lung disorder 17.17 15.98 54 66984 179993 110342268
Mucinous breast carcinoma 17.09 15.98 4 67034 30 110522231
Adjustment disorder with depressed mood 17.06 15.98 3 67035 43880 110478381
White blood cell count abnormal 17.05 15.98 21 67017 6888 110515373
Tremor 17.02 15.98 64 66974 202168 110320093
Drug level increased 17.02 15.98 4 67034 47715 110474546
Injection site ulcer 16.97 15.98 9 67029 871 110521390
Laboratory test abnormal 16.92 15.98 62 66976 44017 110478244
Back injury 16.85 15.98 4 67034 47395 110474866
Pancreatic toxicity 16.79 15.98 5 67033 102 110522159
Overflow diarrhoea 16.79 15.98 6 67032 221 110522040
Blood creatinine decreased 16.73 15.98 24 67014 9113 110513148
Incorrect dose administered 16.73 15.98 23 67015 103618 110418643
Breast cancer stage IV 16.71 15.98 12 67026 1991 110520270
Mental status changes 16.68 15.98 13 67025 76109 110446152
QRS axis abnormal 16.60 15.98 13 67025 2455 110519806
Periodontal disease 16.60 15.98 12 67026 2010 110520251
Skin fissures 16.57 15.98 42 66996 24416 110497845
Congenital haematological disorder 16.55 15.98 4 67034 35 110522226
Leukocytosis 16.47 15.98 6 67032 53822 110468439
Carcinoid tumour pulmonary 16.39 15.98 7 67031 417 110521844
Vascular device infection 16.38 15.98 33 67005 16479 110505782
Haematochezia 16.38 15.98 28 67010 115496 110406765
Hyponatraemia 16.36 15.98 72 66966 217581 110304680
Ear infection 16.06 15.98 9 67029 62723 110459538
Oedema 16.06 15.98 69 66969 209907 110312354
Creatinine renal clearance increased 16.01 15.98 15 67023 3610 110518651

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 D004965 Estrogen Antagonists
MeSH PA D006727 Hormone Antagonists
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D065171 Estrogen Receptor Antagonists
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50792 estrogen receptor antagonist
CHEBI has role CHEBI:50837 estrogen antagonist

Related Drugs by ATC class:

L02BA Anti-estrogens 3 drugs
elacestranttamoxifentoremifene

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




🐶 Veterinary Drug Use

None

🐶 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
399950 MMSL
43430 MMSL
d04799 MMSL
009642 NDDF
385519002 SNOMEDCT_US
404845006 SNOMEDCT_US
22X328QOC4 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0781-3532 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 0781-9055 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 16714-070 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 18 sections
FULVESTRANT HUMAN PRESCRIPTION DRUG LABEL 1 16729-436 INJECTION 250 mg INTRAMUSCULAR ANDA 25 sections
fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 25021-471 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 30 sections
fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 25021-471 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 30 sections
Fulvestrant HUMAN PRESCRIPTION DRUG LABEL 1 43598-262 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
Fulvestrant Human Prescription Drug Label 1 55150-394 INJECTION 50 mg INTRAVENOUS ANDA 27 sections
Fulvestrant Human Prescription Drug Label 1 62332-650 INJECTION 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 68001-484 INJECTION, SOLUTION 250 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 68001-626 INJECTION 50 mg INTRAMUSCULAR ANDA 27 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 70121-1463 INJECTION, SOLUTION 250 mg INTRAMUSCULAR ANDA 27 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 83634-203 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 27 sections
CLIGAVYX HUMAN PRESCRIPTION DRUG LABEL 1 83831-159 INJECTION 250 mg INTRAMUSCULAR NDA 23 sections