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 | 3312.57 | 15.24 | 1534 | 49768 | 66590 | 50487232 |
| Metastases to bone | 2286.93 | 15.24 | 810 | 50492 | 17185 | 50536637 |
| Neoplasm progression | 2201.12 | 15.24 | 897 | 50405 | 28260 | 50525562 |
| Metastases to liver | 1747.36 | 15.24 | 685 | 50617 | 19419 | 50534403 |
| Neutropenia | 1046.56 | 15.24 | 996 | 50306 | 146969 | 50406853 |
| White blood cell count decreased | 678.53 | 15.24 | 707 | 50595 | 116015 | 50437807 |
| Tumour marker increased | 596.05 | 15.24 | 201 | 51101 | 3639 | 50550183 |
| Metastases to lung | 570.07 | 15.24 | 260 | 51042 | 10760 | 50543062 |
| Osteonecrosis of jaw | 496.57 | 15.24 | 344 | 50958 | 32182 | 50521640 |
| Disease progression | 456.15 | 15.24 | 523 | 50779 | 95343 | 50458479 |
| Breast cancer metastatic | 391.29 | 15.24 | 197 | 51105 | 10167 | 50543655 |
| Drug ineffective | 332.89 | 15.24 | 212 | 51090 | 819121 | 49734701 |
| Neutrophil count decreased | 316.81 | 15.24 | 306 | 50996 | 45720 | 50508102 |
| Metastases to lymph nodes | 308.38 | 15.24 | 148 | 51154 | 6876 | 50546946 |
| Carbohydrate antigen 15-3 increased | 295.11 | 15.24 | 88 | 51214 | 1044 | 50552778 |
| PIK3CA-activated mutation | 273.52 | 15.24 | 77 | 51225 | 733 | 50553089 |
| Fatigue | 243.28 | 15.24 | 1378 | 49924 | 706223 | 49847599 |
| Metastases to pleura | 233.19 | 15.24 | 76 | 51226 | 1230 | 50552592 |
| Metastasis | 231.79 | 15.24 | 105 | 51197 | 4270 | 50549552 |
| Leukopenia | 206.35 | 15.24 | 296 | 51006 | 67232 | 50486590 |
| Metastases to skin | 205.19 | 15.24 | 70 | 51232 | 1313 | 50552509 |
| Breast cancer recurrent | 200.50 | 15.24 | 91 | 51211 | 3717 | 50550105 |
| Bone pain | 199.98 | 15.24 | 243 | 51059 | 46986 | 50506836 |
| Metastases to spine | 179.22 | 15.24 | 77 | 51225 | 2754 | 50551068 |
| Breast cancer | 178.85 | 15.24 | 219 | 51083 | 42671 | 50511151 |
| Thrombocytopenia | 175.84 | 15.24 | 395 | 50907 | 127278 | 50426544 |
| Bone lesion | 171.21 | 15.24 | 90 | 51212 | 5080 | 50548742 |
| Pseudocirrhosis | 168.68 | 15.24 | 50 | 51252 | 580 | 50553242 |
| Metastases to central nervous system | 159.66 | 15.24 | 114 | 51188 | 11168 | 50542654 |
| Rheumatoid arthritis | 159.63 | 15.24 | 12 | 51290 | 202538 | 50351284 |
| Palmar-plantar erythrodysaesthesia syndrome | 154.22 | 15.24 | 142 | 51160 | 19956 | 50533866 |
| Joint swelling | 151.51 | 15.24 | 32 | 51270 | 245254 | 50308568 |
| Pleural effusion | 151.03 | 15.24 | 285 | 51017 | 81169 | 50472653 |
| Maternal exposure during pregnancy | 147.26 | 15.24 | 3 | 51299 | 159775 | 50394047 |
| Infusion related reaction | 142.75 | 15.24 | 7 | 51295 | 169550 | 50384272 |
| Ascites | 141.30 | 15.24 | 178 | 51124 | 35683 | 50518139 |
| Hepatic lesion | 124.88 | 15.24 | 67 | 51235 | 3941 | 50549881 |
| Therapeutic product effect decreased | 123.62 | 15.24 | 3 | 51299 | 136047 | 50417775 |
| Hyperglycaemia | 120.67 | 15.24 | 166 | 51136 | 36239 | 50517583 |
| Systemic lupus erythematosus | 117.73 | 15.24 | 6 | 51296 | 140616 | 50413206 |
| Osteonecrosis | 115.62 | 15.24 | 128 | 51174 | 22389 | 50531433 |
| Metastases to peritoneum | 113.24 | 15.24 | 56 | 51246 | 2777 | 50551045 |
| Asthenia | 112.38 | 15.24 | 627 | 50675 | 318415 | 50235407 |
| Full blood count abnormal | 111.64 | 15.24 | 128 | 51174 | 23260 | 50530562 |
| Anaemia | 107.40 | 15.24 | 523 | 50779 | 251933 | 50301889 |
| Hot flush | 105.76 | 15.24 | 173 | 51129 | 43996 | 50509826 |
| Decreased appetite | 103.89 | 15.24 | 441 | 50861 | 200482 | 50353340 |
| Red blood cell count decreased | 102.81 | 15.24 | 148 | 51154 | 33687 | 50520135 |
| Death | 100.04 | 15.24 | 617 | 50685 | 324762 | 50229060 |
| Platelet count decreased | 99.85 | 15.24 | 275 | 51027 | 100451 | 50453371 |
| Arthropathy | 98.67 | 15.24 | 20 | 51282 | 157886 | 50395936 |
| Drug hypersensitivity | 94.45 | 15.24 | 70 | 51232 | 250940 | 50302882 |
| Hypotension | 89.45 | 15.24 | 65 | 51237 | 235404 | 50318418 |
| Second primary malignancy | 86.81 | 15.24 | 65 | 51237 | 6849 | 50546973 |
| Infusion site coldness | 84.49 | 15.24 | 23 | 51279 | 191 | 50553631 |
| Mucosal inflammation | 81.32 | 15.24 | 146 | 51156 | 39996 | 50513826 |
| Bone marrow failure | 81.25 | 15.24 | 119 | 51183 | 27505 | 50526317 |
| Carcinoembryonic antigen increased | 80.05 | 15.24 | 36 | 51266 | 1438 | 50552384 |
| Hepatic failure | 79.38 | 15.24 | 128 | 51174 | 32155 | 50521667 |
| Glossodynia | 77.93 | 15.24 | 12 | 51290 | 115557 | 50438265 |
| Treatment failure | 77.03 | 15.24 | 22 | 51280 | 137615 | 50416207 |
| Gamma-glutamyltransferase decreased | 75.99 | 15.24 | 23 | 51279 | 288 | 50553534 |
| Lymphangiosis carcinomatosa | 70.70 | 15.24 | 31 | 51271 | 1165 | 50552657 |
| Metastases to chest wall | 70.15 | 15.24 | 24 | 51278 | 454 | 50553368 |
| Abdominal lymphadenopathy | 69.04 | 15.24 | 26 | 51276 | 655 | 50553167 |
| Stomatitis | 68.26 | 15.24 | 242 | 51060 | 101102 | 50452720 |
| Neuropathy peripheral | 67.72 | 15.24 | 234 | 51068 | 96523 | 50457299 |
| Bone disorder | 65.90 | 15.24 | 88 | 51214 | 18664 | 50535158 |
| Fall | 64.92 | 15.24 | 153 | 51149 | 334779 | 50219043 |
| Polyneuropathy | 64.06 | 15.24 | 70 | 51232 | 12061 | 50541761 |
| Pleural neoplasm | 63.97 | 15.24 | 19 | 51283 | 222 | 50553600 |
| Lymphoedema | 63.35 | 15.24 | 61 | 51241 | 9061 | 50544761 |
| Musculoskeletal stiffness | 62.46 | 15.24 | 26 | 51276 | 128455 | 50425367 |
| Haematotoxicity | 60.97 | 15.24 | 56 | 51246 | 7839 | 50545983 |
| Bone sequestrum | 60.36 | 15.24 | 29 | 51273 | 1349 | 50552473 |
| Nausea | 60.07 | 15.24 | 1025 | 50277 | 704373 | 49849449 |
| Malignant pleural effusion | 59.04 | 15.24 | 34 | 51268 | 2296 | 50551526 |
| Overdose | 57.55 | 15.24 | 15 | 51287 | 99712 | 50454110 |
| Drug interaction | 57.17 | 15.24 | 71 | 51231 | 199550 | 50354272 |
| Off label use | 56.68 | 15.24 | 268 | 51034 | 474158 | 50079664 |
| Intentional product use issue | 56.64 | 15.24 | 6 | 51296 | 76912 | 50476910 |
| Metastases to thorax | 56.60 | 15.24 | 17 | 51285 | 207 | 50553615 |
| Metastases to pelvis | 56.21 | 15.24 | 19 | 51283 | 346 | 50553476 |
| Osteolysis | 56.11 | 15.24 | 34 | 51268 | 2523 | 50551299 |
| Pneumonia | 55.67 | 15.24 | 197 | 51105 | 378204 | 50175618 |
| Wound | 55.44 | 15.24 | 19 | 51283 | 105775 | 50448047 |
| Swelling | 54.89 | 15.24 | 74 | 51228 | 200798 | 50353024 |
| Condition aggravated | 54.17 | 15.24 | 140 | 51162 | 296918 | 50256904 |
| Full blood count decreased | 54.11 | 15.24 | 88 | 51214 | 22258 | 50531564 |
| Spinal pain | 53.03 | 15.24 | 60 | 51242 | 10743 | 50543079 |
| Skin toxicity | 51.84 | 15.24 | 38 | 51264 | 3875 | 50549947 |
| Metastases to the mediastinum | 51.51 | 15.24 | 19 | 51283 | 451 | 50553371 |
| Discomfort | 50.98 | 15.24 | 23 | 51279 | 108357 | 50445465 |
| General physical health deterioration | 50.00 | 15.24 | 280 | 51022 | 142154 | 50411668 |
| Hypertransaminasaemia | 49.96 | 15.24 | 36 | 51266 | 3575 | 50550247 |
| Infusion site induration | 49.58 | 15.24 | 22 | 51280 | 851 | 50552971 |
| Hypersensitivity | 49.51 | 15.24 | 89 | 51213 | 215072 | 50338750 |
| Metastases to retroperitoneum | 48.49 | 15.24 | 14 | 51288 | 147 | 50553675 |
| Intentional overdose | 48.35 | 15.24 | 4 | 51298 | 62500 | 50491322 |
| Toxicity to various agents | 47.91 | 15.24 | 89 | 51213 | 212410 | 50341412 |
| Headache | 47.46 | 15.24 | 310 | 50992 | 506225 | 50047597 |
| Sinusitis | 46.42 | 15.24 | 63 | 51239 | 170495 | 50383327 |
| Metastases to adrenals | 44.33 | 15.24 | 19 | 51283 | 675 | 50553147 |
| Hormone receptor positive breast cancer | 43.69 | 15.24 | 17 | 51285 | 469 | 50553353 |
| Electrocardiogram PR shortened | 43.45 | 15.24 | 14 | 51288 | 218 | 50553604 |
| Portal hypertension | 42.83 | 15.24 | 32 | 51270 | 3360 | 50550462 |
| Eastern Cooperative Oncology Group performance status worsened | 42.52 | 15.24 | 18 | 51284 | 620 | 50553202 |
| Mobility decreased | 42.51 | 15.24 | 14 | 51288 | 79934 | 50473888 |
| Injection site necrosis | 42.35 | 15.24 | 22 | 51280 | 1211 | 50552611 |
| Tooth extraction | 42.17 | 15.24 | 49 | 51253 | 9026 | 50544796 |
| Asthma | 41.95 | 15.24 | 19 | 51283 | 89318 | 50464504 |
| Oestradiol increased | 41.81 | 15.24 | 11 | 51291 | 79 | 50553743 |
| Invasive lobular breast carcinoma | 41.54 | 15.24 | 18 | 51284 | 657 | 50553165 |
| Recurrent cancer | 40.20 | 15.24 | 24 | 51278 | 1733 | 50552089 |
| Isosthenuria | 39.72 | 15.24 | 11 | 51291 | 98 | 50553724 |
| Superinfection | 39.20 | 15.24 | 25 | 51277 | 2031 | 50551791 |
| Acute kidney injury | 38.89 | 15.24 | 111 | 51191 | 227947 | 50325875 |
| Cough | 38.66 | 15.24 | 394 | 50908 | 240870 | 50312952 |
| Cancer pain | 38.58 | 15.24 | 27 | 51275 | 2560 | 50551262 |
| Diarrhoea | 38.56 | 15.24 | 822 | 50480 | 587654 | 49966168 |
| Bradycardia | 38.51 | 15.24 | 9 | 51293 | 64417 | 50489405 |
| Ejection fraction decreased | 37.03 | 15.24 | 67 | 51235 | 18453 | 50535369 |
| Bone cancer metastatic | 37.00 | 15.24 | 11 | 51291 | 129 | 50553693 |
| Adnexa uteri mass | 36.85 | 15.24 | 15 | 51287 | 467 | 50553355 |
| Breast cancer stage IV | 36.60 | 15.24 | 16 | 51286 | 597 | 50553225 |
| Myelosuppression | 36.55 | 15.24 | 56 | 51246 | 13461 | 50540361 |
| Oral pain | 36.12 | 15.24 | 79 | 51223 | 24954 | 50528868 |
| Bladder hypertrophy | 36.10 | 15.24 | 12 | 51290 | 207 | 50553615 |
| Post-traumatic neck syndrome | 35.86 | 15.24 | 23 | 51279 | 1887 | 50551935 |
| Metastatic neoplasm | 35.75 | 15.24 | 30 | 51272 | 3724 | 50550098 |
| Therapeutic product effect incomplete | 35.04 | 15.24 | 25 | 51277 | 91490 | 50462332 |
| Alopecia | 34.97 | 15.24 | 391 | 50911 | 244656 | 50309166 |
| Tachycardia | 34.73 | 15.24 | 30 | 51272 | 99733 | 50454089 |
| Blood bilirubin increased | 34.24 | 15.24 | 90 | 51212 | 31948 | 50521874 |
| Pyelitis | 34.15 | 15.24 | 11 | 51291 | 171 | 50553651 |
| Interstitial lung disease | 34.09 | 15.24 | 125 | 51177 | 53051 | 50500771 |
| Metastases to kidney | 33.46 | 15.24 | 11 | 51291 | 183 | 50553639 |
| Psoriasis | 33.46 | 15.24 | 14 | 51288 | 68986 | 50484836 |
| Suicide attempt | 33.46 | 15.24 | 6 | 51296 | 51726 | 50502096 |
| Cardio-respiratory arrest | 33.27 | 15.24 | 7 | 51295 | 53885 | 50499937 |
| Confusional state | 32.80 | 15.24 | 89 | 51213 | 185839 | 50367983 |
| Pneumonitis | 32.67 | 15.24 | 84 | 51218 | 29426 | 50524396 |
| Suicidal ideation | 32.58 | 15.24 | 8 | 51294 | 55377 | 50498445 |
| Hepatic function abnormal | 32.11 | 15.24 | 89 | 51213 | 32592 | 50521230 |
| Pustule | 32.03 | 15.24 | 18 | 51284 | 1160 | 50552662 |
| Carbohydrate antigen 27.29 increased | 31.79 | 15.24 | 8 | 51294 | 47 | 50553775 |
| BRAF gene mutation | 31.79 | 15.24 | 8 | 51294 | 47 | 50553775 |
| Tumour marker abnormal | 31.67 | 15.24 | 11 | 51291 | 218 | 50553604 |
| Constipation | 31.53 | 15.24 | 307 | 50995 | 185401 | 50368421 |
| Metastases to soft tissue | 31.38 | 15.24 | 10 | 51292 | 150 | 50553672 |
| Prehypertension | 31.34 | 15.24 | 7 | 51295 | 22 | 50553800 |
| Epistaxis | 31.13 | 15.24 | 138 | 51164 | 63816 | 50490006 |
| Loss of consciousness | 31.03 | 15.24 | 36 | 51266 | 104317 | 50449505 |
| Lymphadenopathy | 30.74 | 15.24 | 89 | 51213 | 33410 | 50520412 |
| Taste disorder | 30.69 | 15.24 | 40 | 51262 | 8284 | 50545538 |
| Tumour marker decreased | 30.58 | 15.24 | 8 | 51294 | 56 | 50553766 |
| Cardiac arrest | 30.54 | 15.24 | 24 | 51278 | 83627 | 50470195 |
| Jaw disorder | 30.51 | 15.24 | 31 | 51271 | 4912 | 50548910 |
| Abdominal discomfort | 30.50 | 15.24 | 126 | 51176 | 231515 | 50322307 |
| Back pain | 30.44 | 15.24 | 349 | 50953 | 219681 | 50334141 |
| Drug intolerance | 30.23 | 15.24 | 117 | 51185 | 218987 | 50334835 |
| Vasodilatation | 29.89 | 15.24 | 22 | 51280 | 2257 | 50551565 |
| Drug resistance | 29.78 | 15.24 | 62 | 51240 | 18927 | 50534895 |
| Dysgeusia | 29.75 | 15.24 | 97 | 51205 | 38819 | 50515003 |
| Fibromyalgia | 29.56 | 15.24 | 5 | 51297 | 44973 | 50508849 |
| Arthritis | 29.08 | 15.24 | 27 | 51275 | 86694 | 50467128 |
| Adverse drug reaction | 28.78 | 15.24 | 10 | 51292 | 55212 | 50498610 |
| Nephroangiosclerosis | 28.62 | 15.24 | 9 | 51293 | 129 | 50553693 |
| Nasopharyngitis | 28.59 | 15.24 | 100 | 51202 | 192827 | 50360995 |
| Mean cell haemoglobin decreased | 28.48 | 15.24 | 25 | 51277 | 3298 | 50550524 |
| Lacrimation increased | 28.45 | 15.24 | 57 | 51245 | 16935 | 50536887 |
| Dyspnoea exertional | 28.39 | 15.24 | 115 | 51187 | 51118 | 50502704 |
| Weight increased | 28.37 | 15.24 | 107 | 51195 | 201784 | 50352038 |
| Lower respiratory tract infection | 28.14 | 15.24 | 33 | 51269 | 95168 | 50458654 |
| Hospitalisation | 28.12 | 15.24 | 17 | 51285 | 67920 | 50485902 |
| Creatinine renal clearance increased | 27.88 | 15.24 | 13 | 51289 | 565 | 50553257 |
| Retinal detachment | 27.78 | 15.24 | 30 | 51272 | 5099 | 50548723 |
| Hypermetabolism | 27.25 | 15.24 | 9 | 51293 | 152 | 50553670 |
| Dry skin | 27.24 | 15.24 | 101 | 51201 | 43090 | 50510732 |
| Pulmonary tumour thrombotic microangiopathy | 27.14 | 15.24 | 7 | 51295 | 46 | 50553776 |
| Mouth swelling | 26.84 | 15.24 | 26 | 51276 | 3890 | 50549932 |
| Oxygen saturation decreased | 26.76 | 15.24 | 21 | 51281 | 73227 | 50480595 |
| Fluid retention | 26.69 | 15.24 | 9 | 51293 | 50640 | 50503182 |
| Vein disorder | 26.50 | 15.24 | 27 | 51275 | 4292 | 50549530 |
| Adverse event | 26.38 | 15.24 | 6 | 51296 | 43757 | 50510065 |
| Malignant peritoneal neoplasm | 26.22 | 15.24 | 13 | 51289 | 648 | 50553174 |
| Seizure | 25.98 | 15.24 | 50 | 51252 | 117824 | 50435998 |
| Invasive ductal breast carcinoma | 25.91 | 15.24 | 31 | 51271 | 5890 | 50547932 |
| Exposed bone in jaw | 25.89 | 15.24 | 22 | 51280 | 2778 | 50551044 |
| International normalised ratio increased | 25.84 | 15.24 | 6 | 51296 | 43146 | 50510676 |
| Ovarian disorder | 25.84 | 15.24 | 13 | 51289 | 669 | 50553153 |
| Agitation | 25.61 | 15.24 | 11 | 51291 | 53373 | 50500449 |
| Carcinoid tumour pulmonary | 25.12 | 15.24 | 11 | 51291 | 412 | 50553410 |
| Tremor | 25.10 | 15.24 | 49 | 51253 | 114854 | 50438968 |
| Heart rate increased | 24.80 | 15.24 | 25 | 51277 | 77225 | 50476597 |
| Somnolence | 24.56 | 15.24 | 78 | 51224 | 154907 | 50398915 |
| Infusion site haemorrhage | 24.55 | 15.24 | 22 | 51280 | 2982 | 50550840 |
| Peritoneal disorder | 24.51 | 15.24 | 11 | 51291 | 437 | 50553385 |
| Hypoglycaemia | 24.22 | 15.24 | 12 | 51290 | 53569 | 50500253 |
| Elliptocytosis | 24.17 | 15.24 | 6 | 51296 | 33 | 50553789 |
| Cardiac failure congestive | 24.14 | 15.24 | 30 | 51272 | 84352 | 50469470 |
| Blood pressure increased | 24.02 | 15.24 | 63 | 51239 | 133069 | 50420753 |
| RET gene mutation | 23.99 | 15.24 | 5 | 51297 | 10 | 50553812 |
| Pathological fracture | 23.90 | 15.24 | 34 | 51268 | 7648 | 50546174 |
| Bone debridement | 23.74 | 15.24 | 9 | 51293 | 231 | 50553591 |
| Osteosclerosis | 23.73 | 15.24 | 23 | 51279 | 3444 | 50550378 |
| Gastrointestinal disorder | 23.61 | 15.24 | 37 | 51265 | 94419 | 50459403 |
| Hyperchromic anaemia | 23.59 | 15.24 | 6 | 51296 | 37 | 50553785 |
| Metastases to spinal cord | 23.59 | 15.24 | 6 | 51296 | 37 | 50553785 |
| Haemoglobin decreased | 23.41 | 15.24 | 214 | 51088 | 127002 | 50426820 |
| Mediastinal disorder | 23.39 | 15.24 | 10 | 51292 | 353 | 50553469 |
| Transaminases | 23.32 | 15.24 | 7 | 51295 | 85 | 50553737 |
| Cytopenia | 23.23 | 15.24 | 36 | 51266 | 8739 | 50545083 |
| Osteomyelitis | 23.08 | 15.24 | 62 | 51240 | 22291 | 50531531 |
| Injection site hypoaesthesia | 22.90 | 15.24 | 10 | 51292 | 372 | 50553450 |
| Bile duct stenosis | 22.82 | 15.24 | 14 | 51288 | 1062 | 50552760 |
| Neoplasm | 22.66 | 15.24 | 29 | 51273 | 5899 | 50547923 |
| Hydronephrosis | 22.55 | 15.24 | 35 | 51267 | 8506 | 50545316 |
| Syncope | 22.43 | 15.24 | 44 | 51258 | 102958 | 50450864 |
| Metastases to breast | 22.30 | 15.24 | 9 | 51293 | 274 | 50553548 |
| Musculoskeletal chest pain | 21.90 | 15.24 | 54 | 51248 | 18432 | 50535390 |
| Nail disorder | 21.85 | 15.24 | 37 | 51265 | 9671 | 50544151 |
| Plasma cell myeloma | 21.68 | 15.24 | 3 | 51299 | 31319 | 50522503 |
| Influenza | 21.51 | 15.24 | 36 | 51266 | 89502 | 50464320 |
| Blood pressure fluctuation | 21.41 | 15.24 | 5 | 51297 | 35818 | 50518004 |
| Loss of personal independence in daily activities | 21 | 15.24 | 24 | 51278 | 70026 | 50483796 |
| Gingivitis | 20.86 | 15.24 | 31 | 51271 | 7253 | 50546569 |
| Blister | 20.84 | 15.24 | 34 | 51268 | 85384 | 50468438 |
| Metastases to eye | 20.84 | 15.24 | 7 | 51295 | 125 | 50553697 |
| Ill-defined disorder | 20.82 | 15.24 | 15 | 51287 | 54639 | 50499183 |
| Granulocytopenia | 20.64 | 15.24 | 26 | 51276 | 5205 | 50548617 |
| Spinal cord compression | 20.63 | 15.24 | 22 | 51280 | 3687 | 50550135 |
| Blood creatinine increased | 20.57 | 15.24 | 140 | 51162 | 76020 | 50477802 |
| Hepatic cancer metastatic | 20.53 | 15.24 | 9 | 51293 | 338 | 50553484 |
| Metastases to ovary | 20.46 | 15.24 | 9 | 51293 | 341 | 50553481 |
| Malignant ascites | 20.43 | 15.24 | 12 | 51290 | 841 | 50552981 |
| Jaundice | 20.31 | 15.24 | 66 | 51236 | 26363 | 50527459 |
| Pain in jaw | 20.29 | 15.24 | 85 | 51217 | 38343 | 50515479 |
| Sepsis | 20.29 | 15.24 | 68 | 51234 | 132857 | 50420965 |
| Metabolic acidosis | 20.28 | 15.24 | 7 | 51295 | 38818 | 50515004 |
| Hallucination | 20.27 | 15.24 | 11 | 51291 | 46646 | 50507176 |
| Pulmonary embolism | 20.21 | 15.24 | 174 | 51128 | 101530 | 50452292 |
| Hyponatraemia | 20.14 | 15.24 | 42 | 51260 | 96097 | 50457725 |
| Feeling cold | 19.99 | 15.24 | 54 | 51248 | 19477 | 50534345 |
| Aspartate aminotransferase increased | 19.66 | 15.24 | 141 | 51161 | 77857 | 50475965 |
| Vulvovaginal dryness | 19.65 | 15.24 | 17 | 51285 | 2200 | 50551622 |
| Pulmonary mass | 19.43 | 15.24 | 52 | 51250 | 18653 | 50535169 |
| Cytogenetic analysis abnormal | 19.21 | 15.24 | 11 | 51291 | 735 | 50553087 |
| Metastases to meninges | 19.07 | 15.24 | 16 | 51286 | 1986 | 50551836 |
| Product quality issue | 19.06 | 15.24 | 4 | 51298 | 30854 | 50522968 |
| Skin sensitisation | 18.98 | 15.24 | 11 | 51291 | 752 | 50553070 |
| Blood creatinine abnormal | 18.88 | 15.24 | 18 | 51284 | 2640 | 50551182 |
| Hip arthroplasty | 18.68 | 15.24 | 4 | 51298 | 30425 | 50523397 |
| Cachexia | 18.64 | 15.24 | 23 | 51279 | 4510 | 50549312 |
| Pancreatitis | 18.58 | 15.24 | 10 | 51292 | 42604 | 50511218 |
| Hepatic enzyme increased | 18.52 | 15.24 | 74 | 51228 | 137306 | 50416516 |
| Gingival swelling | 18.49 | 15.24 | 21 | 51281 | 3774 | 50550048 |
| Hepatotoxicity | 18.29 | 15.24 | 65 | 51237 | 27161 | 50526661 |
| Tooth disorder | 18.16 | 15.24 | 60 | 51242 | 24168 | 50529654 |
| Hormone refractory breast cancer | 18.05 | 15.24 | 4 | 51298 | 12 | 50553810 |
| Adenocarcinoma | 18.00 | 15.24 | 17 | 51285 | 2464 | 50551358 |
| Breast cancer female | 17.95 | 15.24 | 28 | 51274 | 6834 | 50546988 |
| Onychoclasis | 17.67 | 15.24 | 24 | 51278 | 5172 | 50548650 |
| Intestinal metastasis | 17.56 | 15.24 | 6 | 51296 | 113 | 50553709 |
| Bronchitis | 17.51 | 15.24 | 51 | 51251 | 104108 | 50449714 |
| Hepatic cirrhosis | 17.39 | 15.24 | 48 | 51254 | 17529 | 50536293 |
| Body surface area decreased | 17.36 | 15.24 | 4 | 51298 | 15 | 50553807 |
| Gastrointestinal haemorrhage | 17.13 | 15.24 | 30 | 51272 | 73291 | 50480531 |
| Blood creatinine decreased | 16.94 | 15.24 | 23 | 51279 | 4953 | 50548869 |
| Debridement | 16.88 | 15.24 | 12 | 51290 | 1167 | 50552655 |
| Bone cancer | 16.80 | 15.24 | 12 | 51290 | 1175 | 50552647 |
| Septic shock | 16.70 | 15.24 | 20 | 51282 | 57155 | 50496667 |
| Treatment noncompliance | 16.52 | 15.24 | 5 | 51297 | 30145 | 50523677 |
| Metastases to muscle | 16.48 | 15.24 | 6 | 51296 | 137 | 50553685 |
| Oral disorder | 16.48 | 15.24 | 29 | 51273 | 7815 | 50546007 |
| Excessive granulation tissue | 16.47 | 15.24 | 10 | 51292 | 745 | 50553077 |
| Nail avulsion | 16.44 | 15.24 | 6 | 51296 | 138 | 50553684 |
| Radiation fibrosis - lung | 16.27 | 15.24 | 4 | 51298 | 21 | 50553801 |
| Cardiotoxicity | 16.10 | 15.24 | 27 | 51275 | 7000 | 50546822 |
| Encephalopathy | 16.08 | 15.24 | 7 | 51295 | 33704 | 50520118 |
| Volvulus | 16.03 | 15.24 | 13 | 51289 | 1538 | 50552284 |
| No adverse event | 15.98 | 15.24 | 7 | 51295 | 33571 | 50520251 |
| Gastrointestinal submucosal tumour | 15.97 | 15.24 | 4 | 51298 | 23 | 50553799 |
| Orthostatic hypotension | 15.95 | 15.24 | 5 | 51297 | 29476 | 50524346 |
| Sequestrectomy | 15.75 | 15.24 | 10 | 51292 | 806 | 50553016 |
| Glycosylated haemoglobin | 15.69 | 15.24 | 5 | 51297 | 75 | 50553747 |
| Metastases to bone marrow | 15.63 | 15.24 | 7 | 51295 | 277 | 50553545 |
| Uterine mass | 15.56 | 15.24 | 7 | 51295 | 280 | 50553542 |
| Gingival erythema | 15.52 | 15.24 | 9 | 51293 | 616 | 50553206 |
| Pneumonia aspiration | 15.50 | 15.24 | 6 | 51296 | 30998 | 50522824 |
| Urticaria | 15.50 | 15.24 | 73 | 51229 | 129488 | 50424334 |
| Oestrogen receptor assay positive | 15.49 | 15.24 | 8 | 51294 | 435 | 50553387 |
| Coma | 15.46 | 15.24 | 21 | 51281 | 56858 | 50496964 |
| Bone marrow disorder | 15.40 | 15.24 | 14 | 51288 | 1934 | 50551888 |
| Myocardial infarction | 15.39 | 15.24 | 43 | 51259 | 88984 | 50464838 |
| Inappropriate schedule of product administration | 15.36 | 15.24 | 31 | 51271 | 71800 | 50482022 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event 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 | 55.27 | 49.67 | 9 | 426 | 481 | 29573611 |
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 | 1803.98 | 15.31 | 748 | 39809 | 40216 | 64417959 |
| Metastases to bone | 1502.46 | 15.31 | 542 | 40015 | 19893 | 64438282 |
| Malignant neoplasm progression | 1386.77 | 15.31 | 869 | 39688 | 112002 | 64346173 |
| Metastases to liver | 1028.60 | 15.31 | 430 | 40127 | 23511 | 64434664 |
| White blood cell count decreased | 730.14 | 15.31 | 679 | 39878 | 157158 | 64301017 |
| Neutropenia | 716.93 | 15.31 | 815 | 39742 | 238809 | 64219366 |
| Tumour marker increased | 487.87 | 15.31 | 150 | 40407 | 3300 | 64454875 |
| Metastases to lung | 399.24 | 15.31 | 194 | 40363 | 15070 | 64443105 |
| Osteonecrosis of jaw | 397.81 | 15.31 | 270 | 40287 | 39555 | 64418620 |
| Fatigue | 380.40 | 15.31 | 1179 | 39378 | 747551 | 63710624 |
| Breast cancer metastatic | 271.92 | 15.31 | 118 | 40439 | 7051 | 64451124 |
| Carbohydrate antigen 15-3 increased | 270.95 | 15.31 | 72 | 40485 | 915 | 64457260 |
| Neutrophil count decreased | 245.92 | 15.31 | 272 | 40285 | 76924 | 64381251 |
| Disease progression | 232.73 | 15.31 | 360 | 40197 | 141320 | 64316855 |
| Metastases to lymph nodes | 216.56 | 15.31 | 107 | 40450 | 8610 | 64449565 |
| Bone pain | 191.49 | 15.31 | 190 | 40367 | 47382 | 64410793 |
| Breast cancer recurrent | 191.37 | 15.31 | 69 | 40488 | 2514 | 64455661 |
| Pseudocirrhosis | 186.35 | 15.31 | 49 | 40508 | 596 | 64457579 |
| Drug ineffective | 181.33 | 15.31 | 158 | 40399 | 840089 | 63618086 |
| Alopecia | 162.28 | 15.31 | 336 | 40221 | 165354 | 64292821 |
| PIK3CA-activated mutation | 161.88 | 15.31 | 42 | 40515 | 483 | 64457692 |
| Bone lesion | 157.90 | 15.31 | 73 | 40484 | 5064 | 64453111 |
| Metastases to pleura | 153.78 | 15.31 | 49 | 40508 | 1215 | 64456960 |
| Metastases to skin | 151.09 | 15.31 | 50 | 40507 | 1402 | 64456773 |
| Breast cancer | 145.13 | 15.31 | 131 | 40426 | 29017 | 64429158 |
| Asthenia | 126.47 | 15.31 | 568 | 39989 | 427476 | 64030699 |
| Hot flush | 125.38 | 15.31 | 150 | 40407 | 46085 | 64412090 |
| Full blood count abnormal | 119.99 | 15.31 | 119 | 40438 | 29638 | 64428537 |
| Metastasis | 115.57 | 15.31 | 61 | 40496 | 5634 | 64452541 |
| Nausea | 109.02 | 15.31 | 854 | 39703 | 784946 | 63673229 |
| Metastases to spine | 106.48 | 15.31 | 50 | 40507 | 3593 | 64454582 |
| Leukopenia | 103.37 | 15.31 | 209 | 40348 | 101033 | 64357142 |
| Hypotension | 99.70 | 15.31 | 58 | 40499 | 380916 | 64077259 |
| Metastases to central nervous system | 99.28 | 15.31 | 77 | 40480 | 13835 | 64444340 |
| Stomatitis | 97.65 | 15.31 | 214 | 40343 | 109391 | 64348784 |
| Infusion site coldness | 94.04 | 15.31 | 23 | 40534 | 204 | 64457971 |
| Thrombocytopenia | 93.28 | 15.31 | 331 | 40226 | 223470 | 64234705 |
| Red blood cell count decreased | 92.27 | 15.31 | 132 | 40425 | 48254 | 64409921 |
| Decreased appetite | 90.30 | 15.31 | 383 | 40174 | 280906 | 64177269 |
| Platelet count decreased | 85.88 | 15.31 | 266 | 40291 | 167445 | 64290730 |
| Acute kidney injury | 84.39 | 15.31 | 95 | 40462 | 449145 | 64009030 |
| Gamma-glutamyltransferase decreased | 83.52 | 15.31 | 23 | 40534 | 337 | 64457838 |
| Osteonecrosis | 82.18 | 15.31 | 95 | 40462 | 28134 | 64430041 |
| Drug interaction | 81.53 | 15.31 | 65 | 40492 | 362018 | 64096157 |
| Palmar-plantar erythrodysaesthesia syndrome | 80.59 | 15.31 | 95 | 40462 | 28724 | 64429451 |
| Hepatic lesion | 79.20 | 15.31 | 48 | 40509 | 5776 | 64452399 |
| Infusion related reaction | 77.68 | 15.31 | 7 | 40550 | 164460 | 64293715 |
| Full blood count decreased | 72.56 | 15.31 | 80 | 40477 | 22502 | 64435673 |
| Toxicity to various agents | 71.42 | 15.31 | 74 | 40483 | 363439 | 64094736 |
| Lymphangiosis carcinomatosa | 69.13 | 15.31 | 30 | 40527 | 1791 | 64456384 |
| Pneumonia | 67.83 | 15.31 | 158 | 40399 | 559418 | 63898757 |
| Pleural effusion | 67.81 | 15.31 | 204 | 40353 | 126355 | 64331820 |
| Rheumatoid arthritis | 67.78 | 15.31 | 11 | 40546 | 164283 | 64293892 |
| Joint swelling | 66.67 | 15.31 | 26 | 40531 | 215356 | 64242819 |
| Spinal pain | 65.33 | 15.31 | 58 | 40499 | 12563 | 64445612 |
| Carcinoembryonic antigen increased | 65.09 | 15.31 | 29 | 40528 | 1844 | 64456331 |
| Second primary malignancy | 62.48 | 15.31 | 56 | 40501 | 12281 | 64445894 |
| Ascites | 60.89 | 15.31 | 126 | 40431 | 61875 | 64396300 |
| Infusion site induration | 60.76 | 15.31 | 22 | 40535 | 811 | 64457364 |
| Anaemia | 60.35 | 15.31 | 426 | 40131 | 378254 | 64079921 |
| Therapeutic product effect decreased | 60.04 | 15.31 | 3 | 40554 | 115348 | 64342827 |
| Overdose | 58.86 | 15.31 | 14 | 40543 | 159552 | 64298623 |
| Neuropathy peripheral | 58.82 | 15.31 | 185 | 40372 | 117340 | 64340835 |
| Hyperglycaemia | 57.65 | 15.31 | 122 | 40435 | 60846 | 64397329 |
| Bone marrow failure | 57.48 | 15.31 | 106 | 40451 | 47846 | 64410329 |
| Bone disorder | 56.68 | 15.31 | 61 | 40496 | 16698 | 64441477 |
| Metastases to peritoneum | 55.48 | 15.31 | 32 | 40525 | 3515 | 64454660 |
| Oral pain | 52.39 | 15.31 | 75 | 40482 | 27418 | 64430757 |
| Lymphoedema | 52.23 | 15.31 | 46 | 40511 | 9859 | 64448316 |
| Adnexa uteri mass | 51.03 | 15.31 | 15 | 40542 | 281 | 64457894 |
| Abdominal lymphadenopathy | 50.90 | 15.31 | 21 | 40536 | 1105 | 64457070 |
| Bradycardia | 50.85 | 15.31 | 7 | 40550 | 118212 | 64339963 |
| Off label use | 50.36 | 15.31 | 216 | 40341 | 632590 | 63825585 |
| Mucosal inflammation | 48.82 | 15.31 | 116 | 40441 | 62468 | 64395707 |
| Electrocardiogram PR shortened | 47.84 | 15.31 | 14 | 40543 | 258 | 64457917 |
| Fall | 47.82 | 15.31 | 121 | 40436 | 416705 | 64041470 |
| Metastases to chest wall | 46.91 | 15.31 | 15 | 40542 | 376 | 64457799 |
| Cough | 46.40 | 15.31 | 337 | 40220 | 301811 | 64156364 |
| Post-traumatic neck syndrome | 46.20 | 15.31 | 23 | 40534 | 1879 | 64456296 |
| Osteolysis | 45.75 | 15.31 | 26 | 40531 | 2777 | 64455398 |
| Tooth extraction | 45.52 | 15.31 | 42 | 40515 | 9559 | 64448616 |
| Hypertransaminasaemia | 45.31 | 15.31 | 37 | 40520 | 7154 | 64451021 |
| Pleural neoplasm | 45.14 | 15.31 | 13 | 40544 | 226 | 64457949 |
| Isosthenuria | 44.63 | 15.31 | 11 | 40546 | 101 | 64458074 |
| Injection site necrosis | 44.40 | 15.31 | 20 | 40537 | 1305 | 64456870 |
| Sepsis | 43.94 | 15.31 | 48 | 40509 | 230293 | 64227882 |
| Skin toxicity | 43.78 | 15.31 | 35 | 40522 | 6567 | 64451608 |
| Metastases to retroperitoneum | 43.49 | 15.31 | 14 | 40543 | 359 | 64457816 |
| Diarrhoea | 42.41 | 15.31 | 663 | 39894 | 722041 | 63736134 |
| Cardiac arrest | 42.33 | 15.31 | 22 | 40535 | 154042 | 64304133 |
| Intentional overdose | 42.00 | 15.31 | 4 | 40553 | 89940 | 64368235 |
| Back pain | 40.69 | 15.31 | 283 | 40274 | 249888 | 64208287 |
| Intentional product use issue | 40.19 | 15.31 | 6 | 40551 | 95358 | 64362817 |
| Cardio-respiratory arrest | 39.65 | 15.31 | 7 | 40550 | 98386 | 64359789 |
| Drug hypersensitivity | 39.64 | 15.31 | 55 | 40502 | 237760 | 64220415 |
| Infusion site haemorrhage | 39.20 | 15.31 | 22 | 40535 | 2293 | 64455882 |
| Metastases to pelvis | 38.46 | 15.31 | 14 | 40543 | 524 | 64457651 |
| Systemic lupus erythematosus | 37.46 | 15.31 | 3 | 40554 | 77609 | 64380566 |
| Hepatic failure | 37.23 | 15.31 | 97 | 40460 | 55297 | 64402878 |
| Vein disorder | 36.75 | 15.31 | 26 | 40531 | 4061 | 64454114 |
| Prehypertension | 36.29 | 15.31 | 7 | 40550 | 16 | 64458159 |
| Tumour marker decreased | 36.03 | 15.31 | 8 | 40549 | 44 | 64458131 |
| Tachycardia | 35.99 | 15.31 | 25 | 40532 | 149554 | 64308621 |
| Constipation | 35.87 | 15.31 | 257 | 40300 | 229080 | 64229095 |
| International normalised ratio increased | 35.72 | 15.31 | 4 | 40553 | 79163 | 64379012 |
| Superinfection | 35.59 | 15.31 | 25 | 40532 | 3861 | 64454314 |
| Arthropathy | 35.17 | 15.31 | 16 | 40541 | 120951 | 64337224 |
| Portal hypertension | 35.05 | 15.31 | 30 | 40527 | 6189 | 64451986 |
| Metastases to thorax | 34.87 | 15.31 | 10 | 40547 | 171 | 64458004 |
| Metastases to the mediastinum | 34.87 | 15.31 | 13 | 40544 | 521 | 64457654 |
| Pyelitis | 34.32 | 15.31 | 11 | 40546 | 278 | 64457897 |
| Mean cell haemoglobin decreased | 34.26 | 15.31 | 25 | 40532 | 4097 | 64454078 |
| Ejection fraction decreased | 33.82 | 15.31 | 63 | 40494 | 28644 | 64429531 |
| Vasodilatation | 33.81 | 15.31 | 22 | 40535 | 2996 | 64455179 |
| Hyperkalaemia | 33.32 | 15.31 | 11 | 40546 | 101118 | 64357057 |
| Hormone receptor positive breast cancer | 33.28 | 15.31 | 11 | 40546 | 307 | 64457868 |
| Confusional state | 32.95 | 15.31 | 72 | 40485 | 261072 | 64197103 |
| Loss of consciousness | 32.87 | 15.31 | 27 | 40530 | 148338 | 64309837 |
| Ovarian disorder | 32.87 | 15.31 | 12 | 40545 | 453 | 64457722 |
| Metastases to eye | 32.68 | 15.31 | 10 | 40547 | 216 | 64457959 |
| Death | 32.60 | 15.31 | 454 | 40103 | 482251 | 63975924 |
| Syncope | 32.15 | 15.31 | 31 | 40526 | 157604 | 64300571 |
| Condition aggravated | 32.13 | 15.31 | 123 | 40434 | 372303 | 64085872 |
| Pustule | 31.67 | 15.31 | 16 | 40541 | 1349 | 64456826 |
| Myelosuppression | 31.52 | 15.31 | 55 | 40502 | 23775 | 64434400 |
| Cancer pain | 31.33 | 15.31 | 24 | 40533 | 4233 | 64453942 |
| Dysgeusia | 31.22 | 15.31 | 82 | 40475 | 46965 | 64411210 |
| Carbohydrate antigen 27.29 increased | 30.87 | 15.31 | 7 | 40550 | 43 | 64458132 |
| Mobility decreased | 30.73 | 15.31 | 8 | 40549 | 85832 | 64372343 |
| Bladder hypertrophy | 30.62 | 15.31 | 12 | 40545 | 552 | 64457623 |
| Lacrimation increased | 30.57 | 15.31 | 47 | 40510 | 18299 | 64439876 |
| Pain in jaw | 30.13 | 15.31 | 74 | 40483 | 40681 | 64417494 |
| Malignant pleural effusion | 29.31 | 15.31 | 20 | 40537 | 2947 | 64455228 |
| Metastases to kidney | 29.24 | 15.31 | 11 | 40546 | 452 | 64457723 |
| Malignant peritoneal neoplasm | 29.16 | 15.31 | 12 | 40545 | 627 | 64457548 |
| Creatinine renal clearance increased | 28.94 | 15.31 | 13 | 40544 | 843 | 64457332 |
| Dry skin | 28.83 | 15.31 | 84 | 40473 | 51077 | 64407098 |
| Treatment failure | 28.80 | 15.31 | 19 | 40538 | 116797 | 64341378 |
| Agitation | 28.44 | 15.31 | 10 | 40547 | 88357 | 64369818 |
| Mouth swelling | 27.49 | 15.31 | 24 | 40533 | 5083 | 64453092 |
| Haematotoxicity | 27.28 | 15.31 | 37 | 40520 | 12859 | 64445316 |
| Metastases to soft tissue | 27.28 | 15.31 | 10 | 40547 | 382 | 64457793 |
| Elliptocytosis | 27.02 | 15.31 | 6 | 40551 | 33 | 64458142 |
| Pulmonary tumour thrombotic microangiopathy | 26.78 | 15.31 | 7 | 40550 | 83 | 64458092 |
| Lymphadenopathy | 26.64 | 15.31 | 77 | 40480 | 46609 | 64411566 |
| Suicide attempt | 26.63 | 15.31 | 6 | 40551 | 71001 | 64387174 |
| Metabolic acidosis | 26.60 | 15.31 | 6 | 40551 | 70952 | 64387223 |
| Cardiac failure congestive | 26.25 | 15.31 | 26 | 40531 | 130554 | 64327621 |
| Myocardial infarction | 26.00 | 15.31 | 40 | 40517 | 165781 | 64292394 |
| Hypoglycaemia | 25.95 | 15.31 | 12 | 40545 | 89880 | 64368295 |
| Recurrent cancer | 25.86 | 15.31 | 17 | 40540 | 2356 | 64455819 |
| Gastrointestinal haemorrhage | 25.85 | 15.31 | 27 | 40530 | 132285 | 64325890 |
| Oxygen saturation decreased | 25.66 | 15.31 | 18 | 40539 | 107158 | 64351017 |
| Peritoneal disorder | 25.65 | 15.31 | 11 | 40546 | 638 | 64457537 |
| Onychoclasis | 25.57 | 15.31 | 22 | 40535 | 4570 | 64453605 |
| Asthma | 25.56 | 15.31 | 14 | 40543 | 95211 | 64362964 |
| Nephroangiosclerosis | 25.55 | 15.31 | 9 | 40548 | 306 | 64457869 |
| Musculoskeletal stiffness | 25.38 | 15.31 | 24 | 40533 | 123182 | 64334993 |
| Tumour marker abnormal | 25.23 | 15.31 | 8 | 40549 | 195 | 64457980 |
| Tooth disorder | 24.95 | 15.31 | 48 | 40509 | 22354 | 64435821 |
| Septic shock | 24.86 | 15.31 | 18 | 40539 | 105419 | 64352756 |
| Feeling cold | 24.27 | 15.31 | 49 | 40508 | 23629 | 64434546 |
| Exposed bone in jaw | 24.22 | 15.31 | 19 | 40538 | 3468 | 64454707 |
| Metastatic neoplasm | 24.16 | 15.31 | 21 | 40536 | 4421 | 64453754 |
| Toothache | 24.01 | 15.31 | 41 | 40516 | 17418 | 64440757 |
| Vulvovaginal dryness | 23.81 | 15.31 | 14 | 40543 | 1594 | 64456581 |
| Seizure | 23.63 | 15.31 | 43 | 40514 | 166849 | 64291326 |
| Skin sensitisation | 23.44 | 15.31 | 11 | 40546 | 789 | 64457386 |
| Nail disorder | 23.39 | 15.31 | 28 | 40529 | 8596 | 64449579 |
| Metastases to ovary | 23.23 | 15.31 | 8 | 40549 | 254 | 64457921 |
| Hyponatraemia | 23.04 | 15.31 | 36 | 40521 | 148303 | 64309872 |
| Taste disorder | 22.96 | 15.31 | 29 | 40528 | 9404 | 64448771 |
| Transaminases | 22.52 | 15.31 | 6 | 40551 | 77 | 64458098 |
| Blood pressure fluctuation | 22.47 | 15.31 | 3 | 40554 | 51868 | 64406307 |
| Bone sequestrum | 22.22 | 15.31 | 12 | 40545 | 1160 | 64457015 |
| Osteosclerosis | 22.10 | 15.31 | 18 | 40539 | 3468 | 64454707 |
| Blood creatine phosphokinase increased | 21.85 | 15.31 | 5 | 40552 | 58553 | 64399622 |
| Hypermetabolism | 21.84 | 15.31 | 8 | 40549 | 305 | 64457870 |
| Atrial fibrillation | 21.71 | 15.31 | 47 | 40510 | 171042 | 64287133 |
| Oestradiol increased | 21.53 | 15.31 | 6 | 40551 | 92 | 64458083 |
| Drug reaction with eosinophilia and systemic symptoms | 21.53 | 15.31 | 4 | 40553 | 54213 | 64403962 |
| Blood pressure increased | 21.40 | 15.31 | 48 | 40509 | 172504 | 64285671 |
| Tremor | 21.15 | 15.31 | 38 | 40519 | 148192 | 64309983 |
| RET gene mutation | 21.10 | 15.31 | 4 | 40553 | 8 | 64458167 |
| Nail avulsion | 21.07 | 15.31 | 6 | 40551 | 100 | 64458075 |
| Invasive lobular breast carcinoma | 20.76 | 15.31 | 9 | 40548 | 536 | 64457639 |
| Suicidal ideation | 20.62 | 15.31 | 8 | 40549 | 66534 | 64391641 |
| Adenocarcinoma | 20.60 | 15.31 | 17 | 40540 | 3334 | 64454841 |
| Hallucination | 20.58 | 15.31 | 10 | 40547 | 72778 | 64385397 |
| Haemoglobin decreased | 20.52 | 15.31 | 200 | 40357 | 194863 | 64263312 |
| Metastases to spinal cord | 20.38 | 15.31 | 5 | 40552 | 45 | 64458130 |
| Pneumonia aspiration | 20.32 | 15.31 | 6 | 40551 | 59265 | 64398910 |
| Musculoskeletal chest pain | 20.31 | 15.31 | 43 | 40514 | 21436 | 64436739 |
| Retinal detachment | 20.18 | 15.31 | 25 | 40532 | 7951 | 64450224 |
| Invasive ductal breast carcinoma | 20.01 | 15.31 | 20 | 40537 | 5022 | 64453153 |
| Angioedema | 19.89 | 15.31 | 7 | 40550 | 61814 | 64396361 |
| Excessive granulation tissue | 19.73 | 15.31 | 10 | 40547 | 849 | 64457326 |
| Pneumonitis | 19.65 | 15.31 | 73 | 40484 | 50292 | 64407883 |
| Poor venous access | 19.56 | 15.31 | 31 | 40526 | 12386 | 64445789 |
| Mental status changes | 19.55 | 15.31 | 7 | 40550 | 61155 | 64397020 |
| Oral disorder | 19.49 | 15.31 | 26 | 40531 | 8895 | 64449280 |
| Unresponsive to stimuli | 19.42 | 15.31 | 4 | 40553 | 50389 | 64407786 |
| Gingivitis | 19.37 | 15.31 | 24 | 40533 | 7635 | 64450540 |
| Blood creatinine decreased | 19.31 | 15.31 | 23 | 40534 | 7027 | 64451148 |
| Osteomyelitis | 19.24 | 15.31 | 49 | 40508 | 27538 | 64430637 |
| Hydronephrosis | 19.20 | 15.31 | 33 | 40524 | 14092 | 64444083 |
| Plasma cell myeloma | 19.18 | 15.31 | 3 | 40554 | 46072 | 64412103 |
| Coronary artery disease | 19.17 | 15.31 | 7 | 40550 | 60426 | 64397749 |
| Bone debridement | 19.11 | 15.31 | 8 | 40549 | 437 | 64457738 |
| Madarosis | 19.07 | 15.31 | 14 | 40543 | 2316 | 64455859 |
| Hospitalisation | 18.85 | 15.31 | 12 | 40545 | 75195 | 64382980 |
| Fluid retention | 18.75 | 15.31 | 7 | 40550 | 59599 | 64398576 |
| Anaphylactic reaction | 18.56 | 15.31 | 10 | 40547 | 68654 | 64389521 |
| Encephalopathy | 18.34 | 15.31 | 7 | 40550 | 58812 | 64399363 |
| Therapeutic product effect incomplete | 18.17 | 15.31 | 23 | 40534 | 103459 | 64354716 |
| Pathological fracture | 17.79 | 15.31 | 25 | 40532 | 8980 | 64449195 |
| Carcinoid tumour pulmonary | 17.78 | 15.31 | 7 | 40550 | 326 | 64457849 |
| Parosmia | 17.67 | 15.31 | 18 | 40539 | 4622 | 64453553 |
| Hypersensitivity | 17.49 | 15.31 | 64 | 40493 | 196388 | 64261787 |
| Breast cancer stage IV | 17.41 | 15.31 | 8 | 40549 | 547 | 64457628 |
| Breast mass | 17.38 | 15.31 | 19 | 40538 | 5291 | 64452884 |
| Pancreatitis | 17.14 | 15.31 | 8 | 40549 | 59599 | 64398576 |
| Fractured sacrum | 17.13 | 15.31 | 11 | 40546 | 1464 | 64456711 |
| Epistaxis | 17.11 | 15.31 | 113 | 40444 | 98018 | 64360157 |
| Dysarthria | 17.04 | 15.31 | 8 | 40549 | 59398 | 64398777 |
| Sequestrectomy | 16.96 | 15.31 | 9 | 40548 | 840 | 64457335 |
| Dyspnoea exertional | 16.76 | 15.31 | 91 | 40466 | 73639 | 64384536 |
| Metastases to meninges | 16.72 | 15.31 | 14 | 40543 | 2801 | 64455374 |
| Decreased immune responsiveness | 16.48 | 15.31 | 17 | 40540 | 4431 | 64453744 |
| Metastases to bladder | 16.47 | 15.31 | 6 | 40551 | 225 | 64457950 |
| Heart rate decreased | 16.45 | 15.31 | 7 | 40550 | 55060 | 64403115 |
| Congenital haematological disorder | 16.40 | 15.31 | 4 | 40553 | 35 | 64458140 |
| Aphasia | 16.28 | 15.31 | 3 | 40554 | 40903 | 64417272 |
| Eastern Cooperative Oncology Group performance status worsened | 16.24 | 15.31 | 10 | 40547 | 1238 | 64456937 |
| Loose tooth | 16.22 | 15.31 | 14 | 40543 | 2920 | 64455255 |
| Gingival pain | 16.18 | 15.31 | 20 | 40537 | 6347 | 64451828 |
| Debridement | 16.16 | 15.31 | 11 | 40546 | 1615 | 64456560 |
| Metastases to breast | 16.13 | 15.31 | 6 | 40551 | 239 | 64457936 |
| Immunodeficiency | 16.09 | 15.31 | 33 | 40524 | 16091 | 64442084 |
| Retroperitoneal cancer | 16.01 | 15.31 | 4 | 40553 | 39 | 64458136 |
| Psoriasis | 15.93 | 15.31 | 13 | 40544 | 71690 | 64386485 |
| Coma | 15.88 | 15.31 | 19 | 40538 | 87596 | 64370579 |
| Ascariasis | 15.83 | 15.31 | 3 | 40554 | 6 | 64458169 |
| Xerosis | 15.78 | 15.31 | 9 | 40548 | 968 | 64457207 |
| Blood creatinine abnormal | 15.70 | 15.31 | 16 | 40541 | 4111 | 64454064 |
| Melaena | 15.69 | 15.31 | 7 | 40550 | 53541 | 64404634 |
| Interstitial lung disease | 15.52 | 15.31 | 110 | 40447 | 97622 | 64360553 |
| Respiratory failure | 15.36 | 15.31 | 51 | 40506 | 161132 | 64297043 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| 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 (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 |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-7720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA authorized generic | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0310-7720 | INJECTION | 50 mg | INTRAMUSCULAR | NDA authorized generic | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5019 | INJECTION | 250 mg | INTRAMUSCULAR | NDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3079 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-3492 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-070 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-118 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-436 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 25 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-462 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-262 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63323-715 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | NDA | 28 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-311 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 28 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-424 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-484 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant68001-510 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-510 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-522 | INJECTION | 250 mg | INTRAMUSCULAR | ANDA | 25 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-317 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70121-1463 | INJECTION, SOLUTION | 250 mg | INTRAMUSCULAR | ANDA | 27 sections |
| fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70534-002 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 26 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70700-284 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1688 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 18 sections |
| FULVESTRANT | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1626 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 1 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70860-211 | INJECTION, SOLUTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-555 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71731-6121 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |
| Fulvestrant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72603-105 | INJECTION | 50 mg | INTRAMUSCULAR | ANDA | 27 sections |