fulvestrant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 1255 | 129453-61-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An estradiol derivative and estrogen receptor antagonist that is used for the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 8.30 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 10, 2004 | EMA | ||
| April 25, 2002 | FDA | ASTRAZENECA |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 3525.50 | 15.14 | 1642 | 55610 | 71945 | 56162870 |
| Metastases to bone | 2415.12 | 15.14 | 862 | 56390 | 18646 | 56216169 |
| Neoplasm progression | 2331.96 | 15.14 | 961 | 56291 | 31055 | 56203760 |
| Metastases to liver | 1921.40 | 15.14 | 749 | 56503 | 20837 | 56213978 |
| Breast cancer metastatic | 1825.46 | 15.14 | 660 | 56592 | 14809 | 56220006 |
| Neutropenia | 1179.51 | 15.14 | 1098 | 56154 | 157069 | 56077746 |
| White blood cell count decreased | 773.45 | 15.14 | 787 | 56465 | 125203 | 56109612 |
| Tumour marker increased | 682.61 | 15.14 | 229 | 57023 | 4064 | 56230751 |
| Metastases to lung | 597.53 | 15.14 | 274 | 56978 | 11444 | 56223371 |
| Breast cancer | 557.75 | 15.14 | 434 | 56818 | 48399 | 56186416 |
| Osteonecrosis of jaw | 513.34 | 15.14 | 355 | 56897 | 33003 | 56201812 |
| Disease progression | 512.83 | 15.14 | 582 | 56670 | 104591 | 56130224 |
| Neutrophil count decreased | 368.20 | 15.14 | 345 | 56907 | 49477 | 56185338 |
| Drug ineffective | 356.47 | 15.14 | 252 | 57000 | 918737 | 55316078 |
| PIK3CA-activated mutation | 345.73 | 15.14 | 96 | 57156 | 862 | 56233953 |
| Rheumatoid arthritis | 336.63 | 15.14 | 12 | 57240 | 382592 | 55852223 |
| Metastases to lymph nodes | 324.17 | 15.14 | 156 | 57096 | 7267 | 56227548 |
| Carbohydrate antigen 15-3 increased | 301.75 | 15.14 | 92 | 57160 | 1179 | 56233636 |
| Fatigue | 278.95 | 15.14 | 1551 | 55701 | 787001 | 55447814 |
| Metastasis | 272.83 | 15.14 | 121 | 57131 | 4663 | 56230152 |
| Metastases to pleura | 256.97 | 15.14 | 83 | 57169 | 1299 | 56233516 |
| Leukopenia | 235.35 | 15.14 | 324 | 56928 | 70616 | 56164199 |
| Bone pain | 216.35 | 15.14 | 261 | 56991 | 49924 | 56184891 |
| Breast cancer recurrent | 213.05 | 15.14 | 97 | 57155 | 3978 | 56230837 |
| Thrombocytopenia | 212.45 | 15.14 | 444 | 56808 | 135780 | 56099035 |
| Metastases to skin | 205.20 | 15.14 | 71 | 57181 | 1387 | 56233428 |
| Metastases to spine | 197.89 | 15.14 | 84 | 57168 | 2905 | 56231910 |
| Bone lesion | 189.46 | 15.14 | 98 | 57154 | 5332 | 56229483 |
| Joint swelling | 185.76 | 15.14 | 35 | 57217 | 289765 | 55945050 |
| Infusion related reaction | 181.97 | 15.14 | 7 | 57245 | 208924 | 56025891 |
| Maternal exposure during pregnancy | 177.61 | 15.14 | 3 | 57249 | 189550 | 56045265 |
| Pseudocirrhosis | 167.67 | 15.14 | 50 | 57202 | 591 | 56234224 |
| Metastases to central nervous system | 165.37 | 15.14 | 120 | 57132 | 12016 | 56222799 |
| Pleural effusion | 163.91 | 15.14 | 304 | 56948 | 85176 | 56149639 |
| Palmar-plantar erythrodysaesthesia syndrome | 161.54 | 15.14 | 149 | 57103 | 20916 | 56213899 |
| Ascites | 158.11 | 15.14 | 193 | 57059 | 37351 | 56197464 |
| Therapeutic product effect decreased | 157.44 | 15.14 | 3 | 57249 | 169449 | 56065366 |
| Systemic lupus erythematosus | 156.91 | 15.14 | 6 | 57246 | 180072 | 56054743 |
| Hepatic lesion | 143.31 | 15.14 | 75 | 57177 | 4180 | 56230635 |
| Death | 137.66 | 15.14 | 698 | 56554 | 340728 | 55894087 |
| Asthenia | 131.90 | 15.14 | 692 | 56560 | 342281 | 55892534 |
| Arthropathy | 130.81 | 15.14 | 23 | 57229 | 200252 | 56034563 |
| Hyperglycaemia | 128.62 | 15.14 | 176 | 57076 | 38105 | 56196710 |
| Metastases to peritoneum | 127.72 | 15.14 | 62 | 57190 | 2942 | 56231873 |
| Decreased appetite | 126.62 | 15.14 | 499 | 56753 | 218732 | 56016083 |
| Anaemia | 122.92 | 15.14 | 568 | 56684 | 266943 | 55967872 |
| Hot flush | 122.40 | 15.14 | 191 | 57061 | 46535 | 56188280 |
| Full blood count abnormal | 121.21 | 15.14 | 142 | 57110 | 26320 | 56208495 |
| Osteonecrosis | 117.18 | 15.14 | 131 | 57121 | 23084 | 56211731 |
| Platelet count decreased | 114.47 | 15.14 | 300 | 56952 | 106083 | 56128732 |
| Red blood cell count decreased | 113.55 | 15.14 | 162 | 57090 | 36455 | 56198360 |
| Drug hypersensitivity | 110.52 | 15.14 | 72 | 57180 | 275133 | 55959682 |
| Glossodynia | 102.89 | 15.14 | 16 | 57236 | 152442 | 56082373 |
| Hypotension | 98.60 | 15.14 | 67 | 57185 | 250441 | 55984374 |
| Pericarditis | 97.06 | 15.14 | 3 | 57249 | 108920 | 56125895 |
| Treatment failure | 96.29 | 15.14 | 27 | 57225 | 170365 | 56064450 |
| Second primary malignancy | 93.65 | 15.14 | 70 | 57182 | 7332 | 56227483 |
| Carcinoembryonic antigen increased | 89.43 | 15.14 | 40 | 57212 | 1572 | 56233243 |
| Infusion site coldness | 84.41 | 15.14 | 23 | 57229 | 191 | 56234624 |
| Mucosal inflammation | 84.19 | 15.14 | 154 | 57098 | 42656 | 56192159 |
| Hepatic failure | 82.33 | 15.14 | 133 | 57119 | 33353 | 56201462 |
| Neuropathy peripheral | 81.48 | 15.14 | 260 | 56992 | 102633 | 56132182 |
| Musculoskeletal stiffness | 80.53 | 15.14 | 29 | 57223 | 155978 | 56078837 |
| Bone marrow failure | 78.80 | 15.14 | 119 | 57133 | 28167 | 56206648 |
| Intentional product use issue | 75.80 | 15.14 | 7 | 57245 | 99726 | 56135089 |
| Nausea | 75.47 | 15.14 | 1141 | 56111 | 763037 | 55471778 |
| Gamma-glutamyltransferase decreased | 75.26 | 15.14 | 23 | 57229 | 297 | 56234518 |
| Wound | 74.77 | 15.14 | 24 | 57228 | 138780 | 56096035 |
| Off label use | 72.25 | 15.14 | 306 | 56946 | 555874 | 55678941 |
| Bone disorder | 71.98 | 15.14 | 94 | 57158 | 19449 | 56215366 |
| Fall | 70.99 | 15.14 | 162 | 57090 | 357348 | 55877467 |
| Lymphangiosis carcinomatosa | 69.32 | 15.14 | 31 | 57221 | 1218 | 56233597 |
| Swelling | 68.45 | 15.14 | 86 | 57166 | 239685 | 55995130 |
| Metastases to chest wall | 68.23 | 15.14 | 24 | 57228 | 493 | 56234322 |
| Abdominal lymphadenopathy | 67.90 | 15.14 | 26 | 57226 | 684 | 56234131 |
| Condition aggravated | 67.90 | 15.14 | 157 | 57095 | 344741 | 55890074 |
| Malignant pleural effusion | 65.81 | 15.14 | 37 | 57215 | 2379 | 56232436 |
| Invasive ductal breast carcinoma | 65.80 | 15.14 | 55 | 57197 | 6771 | 56228044 |
| Haematotoxicity | 65.62 | 15.14 | 60 | 57192 | 8323 | 56226492 |
| Polyneuropathy | 64.75 | 15.14 | 73 | 57179 | 12977 | 56221838 |
| Lymphoedema | 62.95 | 15.14 | 65 | 57187 | 10465 | 56224350 |
| Bone sequestrum | 62.93 | 15.14 | 30 | 57222 | 1367 | 56233448 |
| Metastases to pelvis | 62.44 | 15.14 | 21 | 57231 | 375 | 56234440 |
| Helicobacter infection | 61.93 | 15.14 | 3 | 57249 | 73265 | 56161550 |
| Overdose | 61.21 | 15.14 | 16 | 57236 | 105814 | 56129001 |
| Tumour marker abnormal | 60.11 | 15.14 | 20 | 57232 | 345 | 56234470 |
| Asthma | 59.84 | 15.14 | 20 | 57232 | 112750 | 56122065 |
| Pleural neoplasm | 59.74 | 15.14 | 20 | 57232 | 352 | 56234463 |
| Discomfort | 59.73 | 15.14 | 35 | 57217 | 141726 | 56093089 |
| Spinal pain | 58.15 | 15.14 | 66 | 57186 | 11818 | 56222997 |
| Hypersensitivity | 57.78 | 15.14 | 108 | 57144 | 256300 | 55978515 |
| Full blood count decreased | 57.75 | 15.14 | 93 | 57159 | 23256 | 56211559 |
| Stomatitis | 57.17 | 15.14 | 259 | 56993 | 120551 | 56114264 |
| Pneumonia | 56.54 | 15.14 | 218 | 57034 | 406880 | 55827935 |
| Metastases to thorax | 56.24 | 15.14 | 17 | 57235 | 211 | 56234604 |
| Osteolysis | 55.33 | 15.14 | 34 | 57218 | 2579 | 56232236 |
| Sinusitis | 55.20 | 15.14 | 72 | 57180 | 197509 | 56037306 |
| Diarrhoea | 54.83 | 15.14 | 932 | 56320 | 637575 | 55597240 |
| Intentional overdose | 53.91 | 15.14 | 4 | 57248 | 68113 | 56166702 |
| Cancer pain | 53.60 | 15.14 | 35 | 57217 | 2951 | 56231864 |
| Toxicity to various agents | 52.90 | 15.14 | 92 | 57160 | 224472 | 56010343 |
| Myelosuppression | 52.30 | 15.14 | 76 | 57176 | 17379 | 56217436 |
| Drug interaction | 52.13 | 15.14 | 83 | 57169 | 209672 | 56025143 |
| Skin toxicity | 51.92 | 15.14 | 39 | 57213 | 4114 | 56230701 |
| Metastases to the mediastinum | 51.18 | 15.14 | 19 | 57233 | 458 | 56234357 |
| Invasive lobular breast carcinoma | 50.60 | 15.14 | 22 | 57230 | 807 | 56234008 |
| Psoriasis | 49.95 | 15.14 | 16 | 57236 | 92676 | 56142139 |
| Eastern Cooperative Oncology Group performance status worsened | 49.03 | 15.14 | 22 | 57230 | 871 | 56233944 |
| Infusion site induration | 48.50 | 15.14 | 22 | 57230 | 894 | 56233921 |
| Mobility decreased | 48.41 | 15.14 | 20 | 57232 | 98971 | 56135844 |
| Metastases to retroperitoneum | 48.19 | 15.14 | 14 | 57238 | 150 | 56234665 |
| Drug intolerance | 47.80 | 15.14 | 126 | 57126 | 264692 | 55970123 |
| Injection site necrosis | 47.41 | 15.14 | 24 | 57228 | 1247 | 56233568 |
| Cough | 46.74 | 15.14 | 436 | 56816 | 259525 | 55975290 |
| Hormone receptor positive breast cancer | 46.30 | 15.14 | 18 | 57234 | 494 | 56234321 |
| Oestradiol increased | 46.09 | 15.14 | 12 | 57240 | 82 | 56234733 |
| Headache | 43.97 | 15.14 | 361 | 56891 | 558683 | 55676132 |
| Portal hypertension | 43.71 | 15.14 | 33 | 57219 | 3508 | 56231307 |
| Oral pain | 43.59 | 15.14 | 88 | 57164 | 26205 | 56208610 |
| Metastases to adrenals | 43.50 | 15.14 | 19 | 57233 | 705 | 56234110 |
| Hypertransaminasaemia | 43.46 | 15.14 | 37 | 57215 | 4670 | 56230145 |
| Fibromyalgia | 43.17 | 15.14 | 5 | 57247 | 59598 | 56175217 |
| Adnexa uteri mass | 42.72 | 15.14 | 17 | 57235 | 497 | 56234318 |
| Confusional state | 42.33 | 15.14 | 93 | 57159 | 208062 | 56026753 |
| Electrocardiogram PR shortened | 42.21 | 15.14 | 14 | 57238 | 239 | 56234576 |
| Abdominal discomfort | 42.07 | 15.14 | 143 | 57109 | 277131 | 55957684 |
| Recurrent cancer | 41.83 | 15.14 | 25 | 57227 | 1803 | 56233012 |
| Bradycardia | 41.40 | 15.14 | 9 | 57243 | 67495 | 56167320 |
| Taste disorder | 40.97 | 15.14 | 50 | 57202 | 9665 | 56225150 |
| Lower respiratory tract infection | 40.87 | 15.14 | 34 | 57218 | 114760 | 56120055 |
| Bone cancer metastatic | 40.38 | 15.14 | 12 | 57240 | 140 | 56234675 |
| Tooth extraction | 40.26 | 15.14 | 49 | 57203 | 9444 | 56225371 |
| Epistaxis | 39.74 | 15.14 | 154 | 57098 | 66869 | 56167946 |
| Isosthenuria | 39.68 | 15.14 | 11 | 57241 | 98 | 56234717 |
| Suicide attempt | 39.15 | 15.14 | 6 | 57246 | 57830 | 56176985 |
| Back pain | 38.79 | 15.14 | 390 | 56862 | 236780 | 55998035 |
| Interstitial lung disease | 38.76 | 15.14 | 137 | 57115 | 56926 | 56177889 |
| Bone marrow infiltration | 38.50 | 15.14 | 16 | 57236 | 524 | 56234291 |
| General physical health deterioration | 38.36 | 15.14 | 300 | 56952 | 169710 | 56065105 |
| Acute kidney injury | 38.00 | 15.14 | 122 | 57130 | 240641 | 55994174 |
| Blood bilirubin increased | 37.82 | 15.14 | 96 | 57156 | 33258 | 56201557 |
| Superinfection | 37.70 | 15.14 | 25 | 57227 | 2163 | 56232652 |
| Adverse event | 36.91 | 15.14 | 6 | 57246 | 55370 | 56179445 |
| Metastatic neoplasm | 36.62 | 15.14 | 31 | 57221 | 3882 | 56230933 |
| Lymphadenopathy | 36.51 | 15.14 | 98 | 57154 | 35110 | 56199705 |
| Ejection fraction decreased | 36.03 | 15.14 | 69 | 57183 | 19772 | 56215043 |
| Bladder hypertrophy | 35.59 | 15.14 | 12 | 57240 | 216 | 56234599 |
| Constipation | 35.42 | 15.14 | 337 | 56915 | 201606 | 56033209 |
| Post-traumatic neck syndrome | 35.06 | 15.14 | 23 | 57229 | 1955 | 56232860 |
| Nasopharyngitis | 34.84 | 15.14 | 112 | 57140 | 220847 | 56013968 |
| Suicidal ideation | 34.80 | 15.14 | 8 | 57244 | 57734 | 56177081 |
| Cardio-respiratory arrest | 34.70 | 15.14 | 7 | 57245 | 55314 | 56179501 |
| Drug resistance | 34.35 | 15.14 | 69 | 57183 | 20473 | 56214342 |
| Pyelitis | 33.94 | 15.14 | 11 | 57241 | 174 | 56234641 |
| Arthritis | 33.81 | 15.14 | 31 | 57221 | 99821 | 56134994 |
| Neoplasm | 33.81 | 15.14 | 37 | 57215 | 6364 | 56228451 |
| Adverse drug reaction | 33.77 | 15.14 | 12 | 57240 | 65120 | 56169695 |
| Dry skin | 33.64 | 15.14 | 115 | 57137 | 46994 | 56187821 |
| Plasma cell myeloma | 33.57 | 15.14 | 4 | 57248 | 46642 | 56188173 |
| Therapeutic product effect incomplete | 33.50 | 15.14 | 35 | 57217 | 105996 | 56128819 |
| Jaw disorder | 33.35 | 15.14 | 33 | 57219 | 5050 | 56229765 |
| Metastases to kidney | 33.05 | 15.14 | 11 | 57241 | 190 | 56234625 |
| Hepatic function abnormal | 32.67 | 15.14 | 93 | 57159 | 34465 | 56200350 |
| Alopecia | 32.61 | 15.14 | 448 | 56804 | 293010 | 55941805 |
| Nephroangiosclerosis | 32.25 | 15.14 | 10 | 57242 | 136 | 56234679 |
| Dysgeusia | 32.00 | 15.14 | 103 | 57149 | 40812 | 56194003 |
| Pneumonitis | 31.87 | 15.14 | 87 | 57165 | 31477 | 56203338 |
| BRAF gene mutation | 31.76 | 15.14 | 8 | 57244 | 47 | 56234768 |
| Carbohydrate antigen 27.29 increased | 31.62 | 15.14 | 8 | 57244 | 48 | 56234767 |
| Haemoglobin decreased | 31.52 | 15.14 | 239 | 57013 | 133898 | 56100917 |
| Metastases to soft tissue | 31.35 | 15.14 | 10 | 57242 | 150 | 56234665 |
| Prehypertension | 31.32 | 15.14 | 7 | 57245 | 22 | 56234793 |
| Blister | 31.09 | 15.14 | 39 | 57213 | 108848 | 56125967 |
| Hospitalisation | 30.90 | 15.14 | 19 | 57233 | 74981 | 56159834 |
| Hepatic enzyme increased | 30.55 | 15.14 | 82 | 57170 | 171302 | 56063513 |
| Loss of consciousness | 30.36 | 15.14 | 40 | 57212 | 109309 | 56125506 |
| Hepatic echinococciasis | 30.19 | 15.14 | 8 | 57244 | 59 | 56234756 |
| Tumour marker decreased | 29.96 | 15.14 | 8 | 57244 | 61 | 56234754 |
| Vasodilatation | 29.47 | 15.14 | 22 | 57230 | 2299 | 56232516 |
| Pustule | 29.46 | 15.14 | 18 | 57234 | 1351 | 56233464 |
| Ill-defined disorder | 28.75 | 15.14 | 17 | 57235 | 68526 | 56166289 |
| Oxygen saturation decreased | 28.66 | 15.14 | 23 | 57229 | 79044 | 56155771 |
| Tachycardia | 28.11 | 15.14 | 40 | 57212 | 105836 | 56128979 |
| Weight increased | 28.11 | 15.14 | 129 | 57123 | 229574 | 56005241 |
| Cardiac arrest | 27.82 | 15.14 | 28 | 57224 | 86286 | 56148529 |
| Mouth swelling | 27.63 | 15.14 | 27 | 57225 | 4070 | 56230745 |
| Lacrimation increased | 27.59 | 15.14 | 59 | 57193 | 18289 | 56216526 |
| Exposed bone in jaw | 27.56 | 15.14 | 23 | 57229 | 2825 | 56231990 |
| Osteomyelitis | 27.52 | 15.14 | 70 | 57182 | 24276 | 56210539 |
| Hydronephrosis | 27.34 | 15.14 | 40 | 57212 | 9202 | 56225613 |
| Creatinine renal clearance increased | 27.21 | 15.14 | 13 | 57239 | 595 | 56234220 |
| Dyspnoea exertional | 27.16 | 15.14 | 119 | 57133 | 54570 | 56180245 |
| Hypermetabolism | 26.85 | 15.14 | 9 | 57243 | 159 | 56234656 |
| International normalised ratio increased | 26.74 | 15.14 | 6 | 57246 | 44035 | 56190780 |
| Pulmonary tumour thrombotic microangiopathy | 26.74 | 15.14 | 7 | 57245 | 49 | 56234766 |
| Breast cancer stage IV | 26.71 | 15.14 | 19 | 57233 | 1843 | 56232972 |
| Cardiac failure congestive | 26.55 | 15.14 | 30 | 57222 | 87690 | 56147125 |
| Retinal detachment | 26.25 | 15.14 | 30 | 57222 | 5411 | 56229404 |
| Seizure | 26.16 | 15.14 | 55 | 57197 | 125064 | 56109751 |
| Hip arthroplasty | 26.16 | 15.14 | 4 | 57248 | 38619 | 56196196 |
| Hypoglycaemia | 26.14 | 15.14 | 12 | 57240 | 55803 | 56179012 |
| Blood creatinine increased | 26.13 | 15.14 | 155 | 57097 | 80036 | 56154779 |
| Decreased immune responsiveness | 25.99 | 15.14 | 27 | 57225 | 4376 | 56230439 |
| Aspartate aminotransferase increased | 25.86 | 15.14 | 158 | 57094 | 82444 | 56152371 |
| Gastrointestinal disorder | 25.76 | 15.14 | 47 | 57205 | 112655 | 56122160 |
| Ovarian disorder | 25.60 | 15.14 | 13 | 57239 | 680 | 56234135 |
| Loss of personal independence in daily activities | 25.54 | 15.14 | 27 | 57225 | 81342 | 56153473 |
| Tremor | 25.51 | 15.14 | 53 | 57199 | 121036 | 56113779 |
| Blood pressure increased | 25.46 | 15.14 | 70 | 57182 | 145106 | 56089709 |
| Joint neoplasm | 25.19 | 15.14 | 7 | 57245 | 63 | 56234752 |
| Carcinoid tumour pulmonary | 24.89 | 15.14 | 11 | 57241 | 420 | 56234395 |
| Malignant peritoneal neoplasm | 24.86 | 15.14 | 13 | 57239 | 723 | 56234092 |
| Vein disorder | 24.83 | 15.14 | 27 | 57225 | 4610 | 56230205 |
| Heart rate increased | 24.64 | 15.14 | 29 | 57223 | 83244 | 56151571 |
| Pain in jaw | 24.55 | 15.14 | 93 | 57159 | 39943 | 56194872 |
| Soft tissue neoplasm | 24.35 | 15.14 | 7 | 57245 | 72 | 56234743 |
| Bile duct stenosis | 24.16 | 15.14 | 15 | 57237 | 1159 | 56233656 |
| Peritoneal disorder | 24.16 | 15.14 | 11 | 57241 | 451 | 56234364 |
| Hepatic cyst | 24.10 | 15.14 | 27 | 57225 | 4766 | 56230049 |
| Metastases to eye | 24.10 | 15.14 | 8 | 57244 | 137 | 56234678 |
| Vulvovaginal dryness | 24.04 | 15.14 | 20 | 57232 | 2445 | 56232370 |
| RET gene mutation | 23.98 | 15.14 | 5 | 57247 | 10 | 56234805 |
| Oestrogen receptor assay positive | 23.89 | 15.14 | 11 | 57241 | 463 | 56234352 |
| Bone debridement | 23.71 | 15.14 | 9 | 57243 | 231 | 56234584 |
| Metastases to spinal cord | 23.57 | 15.14 | 6 | 57246 | 37 | 56234778 |
| Agitation | 23.35 | 15.14 | 14 | 57238 | 56022 | 56178793 |
| Transaminases | 23.30 | 15.14 | 7 | 57245 | 85 | 56234730 |
| Fluid retention | 23.27 | 15.14 | 13 | 57239 | 54065 | 56180750 |
| Mediastinal disorder | 23.23 | 15.14 | 10 | 57242 | 358 | 56234457 |
| Hormone receptor positive HER2 negative breast cancer | 23.23 | 15.14 | 8 | 57244 | 154 | 56234661 |
| Hepatic cancer metastatic | 23.13 | 15.14 | 10 | 57242 | 362 | 56234453 |
| Hyperchromic anaemia | 23.04 | 15.14 | 6 | 57246 | 41 | 56234774 |
| Cytopenia | 22.96 | 15.14 | 38 | 57214 | 9717 | 56225098 |
| Somnolence | 22.94 | 15.14 | 87 | 57165 | 163326 | 56071489 |
| Musculoskeletal chest pain | 22.75 | 15.14 | 57 | 57195 | 19584 | 56215231 |
| Mean cell haemoglobin decreased | 22.62 | 15.14 | 25 | 57227 | 4347 | 56230468 |
| Osteosclerosis | 22.60 | 15.14 | 23 | 57229 | 3640 | 56231175 |
| Pathological fracture | 22.48 | 15.14 | 34 | 57218 | 8055 | 56226760 |
| Gingivitis | 22.27 | 15.14 | 33 | 57219 | 7676 | 56227139 |
| Oral disorder | 22.21 | 15.14 | 34 | 57218 | 8141 | 56226674 |
| Injury | 22.20 | 15.14 | 17 | 57235 | 59834 | 56174981 |
| Aphthous ulcer | 22.07 | 15.14 | 42 | 57210 | 11977 | 56222838 |
| Injection site hypoaesthesia | 22.01 | 15.14 | 10 | 57242 | 408 | 56234407 |
| Metastases to bladder | 21.94 | 15.14 | 8 | 57244 | 183 | 56234632 |
| Metastases to breast | 21.76 | 15.14 | 9 | 57243 | 291 | 56234524 |
| Inappropriate schedule of product administration | 21.64 | 15.14 | 32 | 57220 | 83355 | 56151460 |
| Jaundice | 21.60 | 15.14 | 69 | 57183 | 27225 | 56207590 |
| Bronchitis | 21.34 | 15.14 | 52 | 57200 | 112259 | 56122556 |
| Product use issue | 21.28 | 15.14 | 107 | 57145 | 185934 | 56048881 |
| Metastases to meninges | 21.28 | 15.14 | 18 | 57234 | 2252 | 56232563 |
| Pulmonary embolism | 20.90 | 15.14 | 183 | 57069 | 106941 | 56127874 |
| Hallucination | 20.88 | 15.14 | 12 | 57240 | 49137 | 56185678 |
| Drug reaction with eosinophilia and systemic symptoms | 20.84 | 15.14 | 3 | 57249 | 30301 | 56204514 |
| Onychoclasis | 20.77 | 15.14 | 27 | 57225 | 5558 | 56229257 |
| Elliptocytosis | 20.76 | 15.14 | 6 | 57246 | 63 | 56234752 |
| Infusion site haemorrhage | 20.64 | 15.14 | 22 | 57230 | 3673 | 56231142 |
| Pancreatitis | 20.63 | 15.14 | 10 | 57242 | 45070 | 56189745 |
| Type 2 diabetes mellitus | 20.54 | 15.14 | 11 | 57241 | 46851 | 56187964 |
| Peripheral swelling | 20.52 | 15.14 | 147 | 57105 | 234579 | 56000236 |
| Invasive breast carcinoma | 20.47 | 15.14 | 11 | 57241 | 647 | 56234168 |
| Hyponatraemia | 20.44 | 15.14 | 46 | 57206 | 102093 | 56132722 |
| Pulmonary mass | 20.24 | 15.14 | 56 | 57196 | 20414 | 56214401 |
| Pain | 20.23 | 15.14 | 517 | 56735 | 662667 | 55572148 |
| Spinal cord compression | 20.21 | 15.14 | 22 | 57230 | 3762 | 56231053 |
| Granulocytopenia | 20.13 | 15.14 | 26 | 57226 | 5318 | 56229497 |
| Metabolic acidosis | 20.05 | 15.14 | 8 | 57244 | 40446 | 56194369 |
| Bone cancer | 20.02 | 15.14 | 14 | 57238 | 1322 | 56233493 |
| Neoplasm recurrence | 20.00 | 15.14 | 18 | 57234 | 2446 | 56232369 |
| Malignant ascites | 20.00 | 15.14 | 12 | 57240 | 872 | 56233943 |
| Product quality issue | 19.93 | 15.14 | 4 | 57248 | 31732 | 56203083 |
| Syncope | 19.85 | 15.14 | 51 | 57201 | 108148 | 56126667 |
| Gamma-glutamyltransferase increased | 19.83 | 15.14 | 73 | 57179 | 30932 | 56203883 |
| Influenza | 19.81 | 15.14 | 42 | 57210 | 95219 | 56139596 |
| Dyskinesia | 19.74 | 15.14 | 3 | 57249 | 29105 | 56205710 |
| Metastases to ovary | 19.47 | 15.14 | 9 | 57243 | 382 | 56234433 |
| Wheezing | 19.27 | 15.14 | 29 | 57223 | 74997 | 56159818 |
| Orthostatic hypotension | 19.22 | 15.14 | 5 | 57247 | 33194 | 56201621 |
| Gingival swelling | 19.18 | 15.14 | 22 | 57230 | 3984 | 56230831 |
| Feeling cold | 19.04 | 15.14 | 56 | 57196 | 21131 | 56213684 |
| Gastrointestinal haemorrhage | 18.89 | 15.14 | 30 | 57222 | 75921 | 56158894 |
| Osteoarthritis | 18.78 | 15.14 | 33 | 57219 | 80263 | 56154552 |
| Treatment noncompliance | 18.72 | 15.14 | 5 | 57247 | 32618 | 56202197 |
| Transaminases abnormal | 18.69 | 15.14 | 10 | 57242 | 583 | 56234232 |
| Uterine mass | 18.67 | 15.14 | 8 | 57244 | 283 | 56234532 |
| Sepsis | 18.64 | 15.14 | 76 | 57176 | 139764 | 56095051 |
| Transaminases increased | 18.62 | 15.14 | 68 | 57184 | 28702 | 56206113 |
| Nail disorder | 18.59 | 15.14 | 38 | 57214 | 11413 | 56223402 |
| Skin sensitisation | 18.54 | 15.14 | 11 | 57241 | 783 | 56234032 |
| Cytogenetic analysis abnormal | 18.52 | 15.14 | 11 | 57241 | 784 | 56234031 |
| Urticaria | 18.43 | 15.14 | 80 | 57172 | 144596 | 56090219 |
| Blood pressure fluctuation | 18.40 | 15.14 | 9 | 57243 | 40351 | 56194464 |
| No adverse event | 18.35 | 15.14 | 7 | 57245 | 36367 | 56198448 |
| COVID-19 | 18.33 | 15.14 | 135 | 57117 | 74923 | 56159892 |
| Septic shock | 18.20 | 15.14 | 21 | 57231 | 60814 | 56174001 |
| Hormone refractory breast cancer | 18.04 | 15.14 | 4 | 57248 | 12 | 56234803 |
| Blood creatinine abnormal | 18.01 | 15.14 | 18 | 57234 | 2788 | 56232027 |
| Hepatotoxicity | 17.99 | 15.14 | 71 | 57181 | 31082 | 56203733 |
| Gingival pain | 17.96 | 15.14 | 27 | 57225 | 6361 | 56228454 |
| Herpes zoster | 17.92 | 15.14 | 31 | 57221 | 75858 | 56158957 |
| Overflow diarrhoea | 17.85 | 15.14 | 6 | 57246 | 107 | 56234708 |
| Myocardial infarction | 17.64 | 15.14 | 43 | 57209 | 92827 | 56141988 |
| Gingival erythema | 17.63 | 15.14 | 10 | 57242 | 654 | 56234161 |
| Encephalopathy | 17.49 | 15.14 | 7 | 57245 | 35318 | 56199497 |
| Coma | 17.41 | 15.14 | 21 | 57231 | 59634 | 56175181 |
| Intestinal metastasis | 17.07 | 15.14 | 6 | 57246 | 123 | 56234692 |
| Cachexia | 17.01 | 15.14 | 23 | 57229 | 4919 | 56229896 |
| Red blood cell sedimentation rate increased | 16.95 | 15.14 | 8 | 57244 | 36615 | 56198200 |
| Debridement | 16.77 | 15.14 | 12 | 57240 | 1175 | 56233640 |
| Pneumonia aspiration | 16.75 | 15.14 | 6 | 57246 | 32405 | 56202410 |
| Injection site mass | 16.66 | 15.14 | 46 | 57206 | 16747 | 56218068 |
| Drug ineffective for unapproved indication | 16.64 | 15.14 | 3 | 57249 | 25690 | 56209125 |
| Metastases to muscle | 16.46 | 15.14 | 6 | 57246 | 137 | 56234678 |
| Angioedema | 16.39 | 15.14 | 11 | 57241 | 41442 | 56193373 |
| Adenocarcinoma | 16.30 | 15.14 | 17 | 57235 | 2768 | 56232047 |
| Radiation fibrosis - lung | 16.26 | 15.14 | 4 | 57248 | 21 | 56234794 |
| Body surface area decreased | 16.26 | 15.14 | 4 | 57248 | 21 | 56234794 |
| Blood creatinine decreased | 16.22 | 15.14 | 23 | 57229 | 5143 | 56229672 |
| Tooth disorder | 16.20 | 15.14 | 60 | 57192 | 25493 | 56209322 |
| Nail avulsion | 16.19 | 15.14 | 6 | 57246 | 144 | 56234671 |
| Unresponsive to stimuli | 16.18 | 15.14 | 6 | 57246 | 31719 | 56203096 |
| Gastrointestinal submucosal tumour | 15.95 | 15.14 | 4 | 57248 | 23 | 56234792 |
| Neoplasm malignant | 15.89 | 15.14 | 62 | 57190 | 26993 | 56207822 |
| Incorrect dose administered | 15.87 | 15.14 | 18 | 57234 | 52529 | 56182286 |
| Hyperkalaemia | 15.82 | 15.14 | 17 | 57235 | 50848 | 56183967 |
| Excessive granulation tissue | 15.79 | 15.14 | 10 | 57242 | 800 | 56234015 |
| Sequestrectomy | 15.69 | 15.14 | 10 | 57242 | 809 | 56234006 |
| Depressed level of consciousness | 15.29 | 15.14 | 21 | 57231 | 56412 | 56178403 |
| Lymphadenopathy mediastinal | 15.28 | 15.14 | 16 | 57236 | 2617 | 56232198 |
| Weight decreased | 15.27 | 15.14 | 336 | 56916 | 240378 | 55994437 |
| Glycosylated haemoglobin | 15.26 | 15.14 | 5 | 57247 | 82 | 56234733 |
| Breast injury | 15.20 | 15.14 | 5 | 57247 | 83 | 56234732 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Xerosis | 55.01 | 46.99 | 9 | 442 | 512 | 31696381 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Neoplasm progression | 1922.71 | 16.17 | 808 | 44293 | 44420 | 70838923 |
| Metastases to bone | 1573.45 | 16.17 | 576 | 44525 | 21800 | 70861543 |
| Malignant neoplasm progression | 1512.85 | 16.17 | 948 | 44153 | 120791 | 70762552 |
| Metastases to liver | 1130.96 | 16.17 | 472 | 44629 | 25406 | 70857937 |
| Breast cancer metastatic | 1003.76 | 16.17 | 337 | 44764 | 9809 | 70873534 |
| White blood cell count decreased | 818.85 | 16.17 | 752 | 44349 | 169389 | 70713954 |
| Neutropenia | 789.06 | 16.17 | 891 | 44210 | 256265 | 70627078 |
| Tumour marker increased | 539.11 | 16.17 | 166 | 44935 | 3628 | 70879715 |
| Fatigue | 459.05 | 16.17 | 1350 | 43751 | 822969 | 70060374 |
| Metastases to lung | 436.41 | 16.17 | 212 | 44889 | 16272 | 70867071 |
| Osteonecrosis of jaw | 413.87 | 16.17 | 281 | 44820 | 40721 | 70842622 |
| Breast cancer | 409.58 | 16.17 | 259 | 44842 | 33290 | 70850053 |
| Neutrophil count decreased | 285.36 | 16.17 | 307 | 44794 | 83249 | 70800094 |
| Carbohydrate antigen 15-3 increased | 265.19 | 16.17 | 72 | 45029 | 986 | 70882357 |
| Disease progression | 251.09 | 16.17 | 396 | 44705 | 156276 | 70727067 |
| Metastases to lymph nodes | 218.29 | 16.17 | 110 | 44991 | 9128 | 70874215 |
| Bone pain | 206.37 | 16.17 | 205 | 44896 | 50617 | 70832726 |
| Breast cancer recurrent | 203.83 | 16.17 | 74 | 45027 | 2719 | 70880624 |
| Drug ineffective | 199.93 | 16.17 | 183 | 44918 | 939569 | 69943774 |
| PIK3CA-activated mutation | 196.39 | 16.17 | 50 | 45051 | 524 | 70882819 |
| Pseudocirrhosis | 185.36 | 16.17 | 49 | 45052 | 602 | 70882741 |
| Alopecia | 170.22 | 16.17 | 384 | 44717 | 198106 | 70685237 |
| Bone lesion | 168.68 | 16.17 | 78 | 45023 | 5352 | 70877991 |
| Metastases to pleura | 163.52 | 16.17 | 52 | 45049 | 1266 | 70882077 |
| Metastases to skin | 150.60 | 16.17 | 51 | 45050 | 1520 | 70881823 |
| Rheumatoid arthritis | 143.81 | 16.17 | 11 | 45090 | 291794 | 70591549 |
| Asthenia | 141.93 | 16.17 | 621 | 44480 | 457045 | 70426298 |
| Hot flush | 139.81 | 16.17 | 165 | 44936 | 49419 | 70833924 |
| Metastasis | 130.53 | 16.17 | 68 | 45033 | 6046 | 70877297 |
| Nausea | 130.02 | 16.17 | 955 | 44146 | 851133 | 70032210 |
| Full blood count abnormal | 128.97 | 16.17 | 132 | 44969 | 33746 | 70849597 |
| Leukopenia | 114.27 | 16.17 | 226 | 44875 | 106334 | 70777009 |
| Thrombocytopenia | 110.74 | 16.17 | 369 | 44732 | 238741 | 70644602 |
| Hypotension | 110.25 | 16.17 | 60 | 45041 | 404321 | 70479022 |
| Metastases to spine | 109.66 | 16.17 | 52 | 45049 | 3777 | 70879566 |
| Decreased appetite | 107.92 | 16.17 | 431 | 44670 | 304349 | 70578994 |
| Red blood cell count decreased | 102.21 | 16.17 | 145 | 44956 | 52016 | 70831327 |
| Metastases to central nervous system | 101.71 | 16.17 | 81 | 45020 | 14953 | 70868390 |
| Infusion related reaction | 98.55 | 16.17 | 7 | 45094 | 197527 | 70685816 |
| Platelet count decreased | 96.16 | 16.17 | 290 | 44811 | 177932 | 70705411 |
| Infusion site coldness | 93.79 | 16.17 | 23 | 45078 | 204 | 70883139 |
| Stomatitis | 91.01 | 16.17 | 231 | 44870 | 128280 | 70755063 |
| Acute kidney injury | 86.37 | 16.17 | 105 | 44996 | 474519 | 70408824 |
| Gamma-glutamyltransferase decreased | 82.58 | 16.17 | 23 | 45078 | 348 | 70882995 |
| Joint swelling | 82.49 | 16.17 | 29 | 45072 | 253182 | 70630161 |
| Osteonecrosis | 82.11 | 16.17 | 97 | 45004 | 29063 | 70854280 |
| Hepatic lesion | 81.60 | 16.17 | 50 | 45051 | 6067 | 70877276 |
| Palmar-plantar erythrodysaesthesia syndrome | 80.88 | 16.17 | 98 | 45003 | 30149 | 70853194 |
| Carcinoembryonic antigen increased | 78.52 | 16.17 | 34 | 45067 | 1996 | 70881347 |
| Toxicity to various agents | 77.82 | 16.17 | 77 | 45024 | 382095 | 70501248 |
| Therapeutic product effect decreased | 77.79 | 16.17 | 3 | 45098 | 143015 | 70740328 |
| Drug interaction | 77.50 | 16.17 | 77 | 45024 | 381364 | 70501979 |
| Full blood count decreased | 76.53 | 16.17 | 85 | 45016 | 23833 | 70859510 |
| Pleural effusion | 71.44 | 16.17 | 216 | 44885 | 132648 | 70750695 |
| Neuropathy peripheral | 70.78 | 16.17 | 209 | 44892 | 126687 | 70756656 |
| Pneumonia | 70.08 | 16.17 | 174 | 44927 | 596058 | 70287285 |
| Second primary malignancy | 69.01 | 16.17 | 61 | 45040 | 12990 | 70870353 |
| Spinal pain | 68.15 | 16.17 | 62 | 45039 | 13708 | 70869635 |
| Oral pain | 67.86 | 16.17 | 88 | 45013 | 28978 | 70854365 |
| Lymphangiosis carcinomatosa | 67.57 | 16.17 | 30 | 45071 | 1871 | 70881472 |
| Off label use | 67.16 | 16.17 | 245 | 44856 | 742815 | 70140528 |
| Anaemia | 66.81 | 16.17 | 462 | 44639 | 402961 | 70480382 |
| Invasive ductal breast carcinoma | 66.26 | 16.17 | 43 | 45058 | 5766 | 70877577 |
| Ascites | 66.12 | 16.17 | 138 | 44963 | 67409 | 70815934 |
| Overdose | 63.43 | 16.17 | 15 | 45086 | 169730 | 70713613 |
| Diarrhoea | 62.14 | 16.17 | 765 | 44336 | 782576 | 70100767 |
| Infusion site induration | 59.22 | 16.17 | 22 | 45079 | 863 | 70882480 |
| Bone disorder | 59.15 | 16.17 | 64 | 45037 | 17426 | 70865917 |
| Hyperglycaemia | 58.55 | 16.17 | 128 | 44973 | 64544 | 70818799 |
| Adnexa uteri mass | 58.28 | 16.17 | 17 | 45084 | 306 | 70883037 |
| Metastases to peritoneum | 58.17 | 16.17 | 34 | 45067 | 3785 | 70879558 |
| Skin toxicity | 57.92 | 16.17 | 43 | 45058 | 7155 | 70876188 |
| Fall | 55.79 | 16.17 | 125 | 44976 | 443971 | 70439372 |
| Bradycardia | 55.31 | 16.17 | 7 | 45094 | 124608 | 70758735 |
| Intentional product use issue | 55.18 | 16.17 | 6 | 45095 | 120136 | 70763207 |
| Bone marrow failure | 54.99 | 16.17 | 106 | 44995 | 48904 | 70834439 |
| Lymphoedema | 54.71 | 16.17 | 50 | 45051 | 11119 | 70872224 |
| Cough | 54.04 | 16.17 | 373 | 44728 | 325004 | 70558339 |
| Death | 53.13 | 16.17 | 526 | 44575 | 509535 | 70373808 |
| Systemic lupus erythematosus | 52.62 | 16.17 | 3 | 45098 | 101899 | 70781444 |
| Injection site necrosis | 50.08 | 16.17 | 22 | 45079 | 1337 | 70882006 |
| Drug hypersensitivity | 48.79 | 16.17 | 57 | 45044 | 262402 | 70620941 |
| Metastases to pelvis | 48.61 | 16.17 | 17 | 45084 | 559 | 70882784 |
| Abdominal lymphadenopathy | 48.49 | 16.17 | 21 | 45080 | 1233 | 70882110 |
| Intentional overdose | 47.63 | 16.17 | 4 | 45097 | 98431 | 70784912 |
| Arthropathy | 47.46 | 16.17 | 18 | 45083 | 150039 | 70733304 |
| Tumour marker abnormal | 47.24 | 16.17 | 14 | 45087 | 267 | 70883076 |
| Mucosal inflammation | 46.99 | 16.17 | 121 | 44980 | 67729 | 70815614 |
| Electrocardiogram PR shortened | 46.95 | 16.17 | 14 | 45087 | 273 | 70883070 |
| Sepsis | 46.66 | 16.17 | 52 | 45049 | 244493 | 70638850 |
| Myelosuppression | 46.52 | 16.17 | 75 | 45026 | 30070 | 70853273 |
| Back pain | 46.28 | 16.17 | 313 | 44788 | 270839 | 70612504 |
| Cardiac arrest | 46.04 | 16.17 | 22 | 45079 | 159812 | 70723531 |
| Cancer pain | 45.82 | 16.17 | 32 | 45069 | 4842 | 70878501 |
| Post-traumatic neck syndrome | 45.16 | 16.17 | 23 | 45078 | 1950 | 70881393 |
| Metastases to chest wall | 44.94 | 16.17 | 15 | 45086 | 427 | 70882916 |
| Isosthenuria | 44.51 | 16.17 | 11 | 45090 | 101 | 70883242 |
| Tooth extraction | 43.28 | 16.17 | 42 | 45059 | 10065 | 70873278 |
| Metastases to retroperitoneum | 43.11 | 16.17 | 14 | 45087 | 365 | 70882978 |
| Pericarditis | 42.23 | 16.17 | 3 | 45098 | 84702 | 70798641 |
| Condition aggravated | 41.90 | 16.17 | 136 | 44965 | 427499 | 70455844 |
| Cardio-respiratory arrest | 41.56 | 16.17 | 7 | 45094 | 100670 | 70782673 |
| Lacrimation increased | 41.47 | 16.17 | 57 | 45044 | 19842 | 70863501 |
| Osteolysis | 40.01 | 16.17 | 26 | 45075 | 3493 | 70879850 |
| Hypertransaminasaemia | 39.88 | 16.17 | 38 | 45063 | 8905 | 70874438 |
| Pleural neoplasm | 39.43 | 16.17 | 13 | 45088 | 356 | 70882987 |
| Metastases to breast | 38.71 | 16.17 | 12 | 45089 | 268 | 70883075 |
| Treatment failure | 38.32 | 16.17 | 22 | 45079 | 144120 | 70739223 |
| Confusional state | 38.22 | 16.17 | 77 | 45024 | 284321 | 70599022 |
| Constipation | 38.16 | 16.17 | 283 | 44818 | 252155 | 70631188 |
| Dry skin | 37.96 | 16.17 | 99 | 45002 | 55832 | 70827511 |
| Asthma | 37.35 | 16.17 | 15 | 45086 | 120778 | 70762565 |
| International normalised ratio increased | 37.15 | 16.17 | 4 | 45097 | 80722 | 70802621 |
| Hepatic failure | 37.08 | 16.17 | 100 | 45001 | 57525 | 70825818 |
| Metastases to eye | 36.26 | 16.17 | 11 | 45090 | 228 | 70883115 |
| Prehypertension | 36.21 | 16.17 | 7 | 45094 | 16 | 70883327 |
| Portal hypertension | 35.64 | 16.17 | 31 | 45070 | 6461 | 70876882 |
| Malignant pleural effusion | 35.22 | 16.17 | 23 | 45078 | 3116 | 70880227 |
| Tumour marker decreased | 35.07 | 16.17 | 8 | 45093 | 50 | 70883293 |
| Hyperkalaemia | 35.04 | 16.17 | 12 | 45089 | 106579 | 70776764 |
| Infusion site haemorrhage | 34.99 | 16.17 | 22 | 45079 | 2793 | 70880550 |
| Mobility decreased | 34.90 | 16.17 | 11 | 45090 | 102988 | 70780355 |
| Metastases to thorax | 34.76 | 16.17 | 10 | 45091 | 171 | 70883172 |
| Pain in jaw | 34.76 | 16.17 | 81 | 45020 | 42588 | 70840755 |
| Hepatic echinococciasis | 34.67 | 16.17 | 8 | 45093 | 53 | 70883290 |
| Vein disorder | 34.57 | 16.17 | 26 | 45075 | 4412 | 70878931 |
| Metastases to the mediastinum | 34.49 | 16.17 | 13 | 45088 | 531 | 70882812 |
| Pyelitis | 34.05 | 16.17 | 11 | 45090 | 282 | 70883061 |
| Superinfection | 33.56 | 16.17 | 25 | 45076 | 4181 | 70879162 |
| Musculoskeletal stiffness | 33.34 | 16.17 | 27 | 45074 | 147733 | 70735610 |
| Loss of consciousness | 33.25 | 16.17 | 30 | 45071 | 155686 | 70727657 |
| Vasodilatation | 33.13 | 16.17 | 22 | 45079 | 3066 | 70880277 |
| Dysgeusia | 32.96 | 16.17 | 87 | 45014 | 49415 | 70833928 |
| Plasma cell myeloma | 32.75 | 16.17 | 4 | 45097 | 73197 | 70810146 |
| Hormone receptor positive breast cancer | 32.67 | 16.17 | 11 | 45090 | 322 | 70883021 |
| Ejection fraction decreased | 32.64 | 16.17 | 65 | 45036 | 30697 | 70852646 |
| Ovarian disorder | 32.56 | 16.17 | 12 | 45089 | 460 | 70882883 |
| Syncope | 31.85 | 16.17 | 35 | 45066 | 165674 | 70717669 |
| Suicide attempt | 31.79 | 16.17 | 6 | 45095 | 79504 | 70803839 |
| Haematotoxicity | 31.29 | 16.17 | 41 | 45060 | 13633 | 70869710 |
| Tachycardia | 31.01 | 16.17 | 33 | 45068 | 158513 | 70724830 |
| Carbohydrate antigen 27.29 increased | 30.66 | 16.17 | 7 | 45094 | 44 | 70883299 |
| Taste disorder | 30.61 | 16.17 | 37 | 45064 | 11348 | 70871995 |
| Bladder hypertrophy | 29.86 | 16.17 | 12 | 45089 | 583 | 70882760 |
| Onychoclasis | 29.81 | 16.17 | 25 | 45076 | 4959 | 70878384 |
| Lymphadenopathy | 29.73 | 16.17 | 83 | 45018 | 48708 | 70834635 |
| Psoriasis | 29.19 | 16.17 | 13 | 45088 | 98420 | 70784923 |
| Pustule | 29.12 | 16.17 | 16 | 45085 | 1583 | 70881760 |
| Myocardial infarction | 29.05 | 16.17 | 40 | 45061 | 171605 | 70711738 |
| Nephroangiosclerosis | 29.03 | 16.17 | 10 | 45091 | 314 | 70883029 |
| Cardiac failure congestive | 29.03 | 16.17 | 26 | 45075 | 135431 | 70747912 |
| Hypoglycaemia | 28.72 | 16.17 | 12 | 45089 | 94352 | 70788991 |
| Gastrointestinal haemorrhage | 28.71 | 16.17 | 27 | 45074 | 137381 | 70745962 |
| Mean cell haemoglobin decreased | 28.61 | 16.17 | 25 | 45076 | 5243 | 70878100 |
| Creatinine renal clearance increased | 28.60 | 16.17 | 13 | 45088 | 857 | 70882486 |
| Joint neoplasm | 28.45 | 16.17 | 7 | 45094 | 63 | 70883280 |
| Metastases to kidney | 28.43 | 16.17 | 11 | 45090 | 483 | 70882860 |
| Mouth swelling | 28.28 | 16.17 | 25 | 45076 | 5324 | 70878019 |
| Decreased immune responsiveness | 28.03 | 16.17 | 24 | 45077 | 4897 | 70878446 |
| Oxygen saturation decreased | 27.89 | 16.17 | 20 | 45081 | 116409 | 70766934 |
| Malignant peritoneal neoplasm | 27.73 | 16.17 | 12 | 45089 | 703 | 70882640 |
| Haemoglobin decreased | 27.65 | 16.17 | 224 | 44877 | 204935 | 70678408 |
| Septic shock | 27.26 | 16.17 | 19 | 45082 | 112239 | 70771104 |
| Drug intolerance | 27.10 | 16.17 | 65 | 45036 | 225622 | 70657721 |
| Metabolic acidosis | 26.92 | 16.17 | 7 | 45094 | 74339 | 70809004 |
| Metastases to soft tissue | 26.85 | 16.17 | 10 | 45091 | 395 | 70882948 |
| Seizure | 26.72 | 16.17 | 45 | 45056 | 177917 | 70705426 |
| Agitation | 26.65 | 16.17 | 13 | 45088 | 93362 | 70789981 |
| Soft tissue neoplasm | 26.55 | 16.17 | 7 | 45094 | 85 | 70883258 |
| Pulmonary tumour thrombotic microangiopathy | 26.18 | 16.17 | 7 | 45094 | 90 | 70883253 |
| Oestradiol increased | 25.90 | 16.17 | 7 | 45094 | 94 | 70883249 |
| Exposed bone in jaw | 25.90 | 16.17 | 20 | 45081 | 3529 | 70879814 |
| Atrial fibrillation | 25.53 | 16.17 | 49 | 45052 | 184299 | 70699044 |
| Recurrent cancer | 25.25 | 16.17 | 17 | 45084 | 2424 | 70880919 |
| Peritoneal disorder | 25.10 | 16.17 | 11 | 45090 | 665 | 70882678 |
| Vulvovaginal dryness | 24.70 | 16.17 | 15 | 45086 | 1791 | 70881552 |
| Hyponatraemia | 24.47 | 16.17 | 40 | 45061 | 160047 | 70723296 |
| Osteomyelitis | 24.09 | 16.17 | 57 | 45044 | 30261 | 70853082 |
| Blood creatine phosphokinase increased | 23.70 | 16.17 | 5 | 45096 | 61258 | 70822085 |
| Neoplasm | 23.65 | 16.17 | 27 | 45074 | 7797 | 70875546 |
| Feeling cold | 23.57 | 16.17 | 51 | 45050 | 25519 | 70857824 |
| Metastases to bladder | 23.48 | 16.17 | 8 | 45093 | 243 | 70883100 |
| Aphthous ulcer | 23.35 | 16.17 | 37 | 45064 | 14619 | 70868724 |
| Toothache | 23.34 | 16.17 | 42 | 45059 | 18388 | 70864955 |
| Metastatic neoplasm | 23.14 | 16.17 | 21 | 45080 | 4627 | 70878716 |
| Skin sensitisation | 22.77 | 16.17 | 11 | 45090 | 832 | 70882511 |
| Hallucination | 22.72 | 16.17 | 10 | 45091 | 76250 | 70807093 |
| Suicidal ideation | 22.58 | 16.17 | 8 | 45093 | 69588 | 70813755 |
| Transaminases | 22.45 | 16.17 | 6 | 45095 | 77 | 70883266 |
| Tooth disorder | 22.36 | 16.17 | 48 | 45053 | 23890 | 70859453 |
| Pneumonia aspiration | 22.30 | 16.17 | 6 | 45095 | 62283 | 70821060 |
| Irritable bowel syndrome | 22.21 | 16.17 | 3 | 45098 | 50847 | 70832496 |
| Epistaxis | 22.20 | 16.17 | 126 | 44975 | 102501 | 70780842 |
| Metastases to ovary | 22.16 | 16.17 | 8 | 45093 | 289 | 70883054 |
| Blood pressure increased | 22.07 | 16.17 | 55 | 45046 | 188462 | 70694881 |
| Bone sequestrum | 21.96 | 16.17 | 12 | 45089 | 1174 | 70882169 |
| Drug reaction with eosinophilia and systemic symptoms | 21.91 | 16.17 | 5 | 45096 | 58008 | 70825335 |
| Elliptocytosis | 21.78 | 16.17 | 6 | 45095 | 87 | 70883256 |
| Oral disorder | 21.63 | 16.17 | 28 | 45073 | 9201 | 70874142 |
| Gingival pain | 21.59 | 16.17 | 24 | 45077 | 6733 | 70876610 |
| Hospitalisation | 21.37 | 16.17 | 13 | 45088 | 82555 | 70800788 |
| Hypermetabolism | 21.36 | 16.17 | 8 | 45093 | 321 | 70883022 |
| Eastern Cooperative Oncology Group performance status worsened | 21.08 | 16.17 | 13 | 45088 | 1595 | 70881748 |
| RET gene mutation | 21.06 | 16.17 | 4 | 45097 | 8 | 70883335 |
| Angioedema | 21.04 | 16.17 | 8 | 45093 | 66602 | 70816741 |
| Tremor | 21.00 | 16.17 | 42 | 45059 | 155582 | 70727761 |
| Osteosclerosis | 20.96 | 16.17 | 18 | 45083 | 3687 | 70879656 |
| Mental status changes | 20.91 | 16.17 | 7 | 45094 | 63094 | 70820249 |
| Gingivitis | 20.82 | 16.17 | 26 | 45075 | 8244 | 70875099 |
| Coronary artery disease | 20.72 | 16.17 | 7 | 45094 | 62729 | 70820614 |
| Nail avulsion | 20.67 | 16.17 | 6 | 45095 | 106 | 70883237 |
| Unresponsive to stimuli | 20.59 | 16.17 | 4 | 45097 | 51927 | 70831416 |
| Overflow diarrhoea | 20.57 | 16.17 | 6 | 45095 | 108 | 70883235 |
| Blood pressure fluctuation | 20.54 | 16.17 | 6 | 45095 | 59006 | 70824337 |
| Nail disorder | 20.44 | 16.17 | 29 | 45072 | 10395 | 70872948 |
| Transaminases abnormal | 20.39 | 16.17 | 10 | 45091 | 782 | 70882561 |
| Metastases to spinal cord | 20.32 | 16.17 | 5 | 45096 | 45 | 70883298 |
| Parosmia | 20.20 | 16.17 | 20 | 45081 | 4911 | 70878432 |
| Encephalopathy | 20.16 | 16.17 | 7 | 45094 | 61654 | 70821689 |
| Madarosis | 20.14 | 16.17 | 15 | 45086 | 2508 | 70880835 |
| Wound | 19.92 | 16.17 | 20 | 45081 | 98712 | 70784631 |
| Hepatic cyst | 19.92 | 16.17 | 21 | 45080 | 5550 | 70877793 |
| Hypersensitivity | 19.85 | 16.17 | 77 | 45024 | 229735 | 70653608 |
| Hydronephrosis | 19.64 | 16.17 | 35 | 45066 | 15207 | 70868136 |
| Metastases to meninges | 19.32 | 16.17 | 16 | 45085 | 3120 | 70880223 |
| Musculoskeletal chest pain | 19.25 | 16.17 | 44 | 45057 | 22837 | 70860506 |
| Invasive lobular breast carcinoma | 19.22 | 16.17 | 9 | 45092 | 635 | 70882708 |
| Adverse event | 19.21 | 16.17 | 4 | 45097 | 49457 | 70833886 |
| Adenocarcinoma | 19.16 | 16.17 | 17 | 45084 | 3636 | 70879707 |
| Interstitial lung disease | 19.12 | 16.17 | 123 | 44978 | 104562 | 70778781 |
| Pancreatitis | 19.02 | 16.17 | 8 | 45093 | 62660 | 70820683 |
| Excessive granulation tissue | 18.98 | 16.17 | 10 | 45091 | 909 | 70882434 |
| Bone debridement | 18.95 | 16.17 | 8 | 45093 | 441 | 70882902 |
| Retinal detachment | 18.78 | 16.17 | 25 | 45076 | 8442 | 70874901 |
| Febrile neutropenia | 18.59 | 16.17 | 67 | 45034 | 204251 | 70679092 |
| Metastases to uterus | 18.51 | 16.17 | 5 | 45096 | 67 | 70883276 |
| Blood creatinine decreased | 18.33 | 16.17 | 23 | 45078 | 7326 | 70876017 |
| Fibromyalgia | 18.33 | 16.17 | 4 | 45097 | 47870 | 70835473 |
| Dorsal ramus syndrome | 18.29 | 16.17 | 4 | 45097 | 20 | 70883323 |
| Coma | 18.08 | 16.17 | 19 | 45082 | 91825 | 70791518 |
| Respiratory failure | 17.66 | 16.17 | 52 | 45049 | 168683 | 70714660 |
| Breast injury | 17.63 | 16.17 | 5 | 45096 | 81 | 70883262 |
| Breast mass | 17.55 | 16.17 | 20 | 45081 | 5765 | 70877578 |
| Adverse drug reaction | 17.54 | 16.17 | 6 | 45095 | 53338 | 70830005 |
| Pneumonitis | 17.51 | 16.17 | 75 | 45026 | 54522 | 70828821 |
| Discomfort | 17.40 | 16.17 | 25 | 45076 | 105411 | 70777932 |
| Carcinoid tumour pulmonary | 17.34 | 16.17 | 7 | 45094 | 344 | 70882999 |
| Depressed level of consciousness | 17.31 | 16.17 | 18 | 45083 | 87413 | 70795930 |
| Dysarthria | 17.29 | 16.17 | 9 | 45092 | 62304 | 70821039 |
| Sequestrectomy | 16.82 | 16.17 | 9 | 45092 | 844 | 70882499 |
| Fractured sacrum | 16.68 | 16.17 | 11 | 45090 | 1515 | 70881828 |
| Pathological fracture | 16.39 | 16.17 | 25 | 45076 | 9558 | 70873785 |
| Congenital haematological disorder | 16.36 | 16.17 | 4 | 45097 | 35 | 70883308 |
| Inappropriate schedule of product administration | 16.32 | 16.17 | 27 | 45074 | 107528 | 70775815 |
| Blood pressure systolic increased | 16.30 | 16.17 | 8 | 45093 | 57251 | 70826092 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L02BA03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Anti-estrogens |
| FDA MoA | N0000000145 | Estrogen Receptor Antagonists |
| FDA MoA | N0000000168 | Selective Estrogen Receptor Modulators |
| FDA EPC | N0000175582 | Estrogen Receptor Antagonist |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D018931 | Antineoplastic Agents, Hormonal |
| MeSH PA | D004965 | Estrogen Antagonists |
| MeSH PA | D065171 | Estrogen Receptor Antagonists |
| MeSH PA | D006727 | Hormone Antagonists |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:50792 | estrogen receptor antagonists |
| CHEBI has role | CHEBI:50837 | oestrogen antagonist |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.92 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9022 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9022 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 25 sections |
| FASLODEX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA | 25 sections |
| FASLODEX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-0720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-7720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA authorized generic | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-7720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA authorized generic | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5019 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5019 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3079 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3492 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-070 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-118 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-436 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 25 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-462 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-262 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-715 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | NDA | 28 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-311 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 28 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-424 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-484 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant68001-510 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-510 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-522 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 25 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-522 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-317 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-1463 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70534-002 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70700-284 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1688 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1626 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 1 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1626 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 1 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70860-211 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |