palbociclib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| cyclin dependant kinase inhibitors | 4941 | 571190-30-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation. In vitro, palbociclib reduced cellular proliferation of estrogen receptor (ER)-positive breast cancer cell lines by blocking progression of the cell from G1 into S phase of the cell cycle. Treatment of breast cancer cell lines with the combination of palbociclib and antiestrogens leads to decreased retinoblastoma (Rb) protein phosphorylation resulting in reduced E2F expression and signaling, and increased growth arrest compared to treatment with each drug alone. In vitro treatment of ER-positive breast cancer cell lines with the combination of palbociclib and antiestrogens led to increased cell senescence compared to each drug alone, which was sustained for up to 6 days following palbociclib removal and was greater if antiestrogen treatment was continued. In vivo studies using a patient-derived ER-positive breast cancer xenograft model demonstrated that the combination of palbociclib and letrozole increased the inhibition of Rb phosphorylation, downstream signaling, and tumor growth compared to each drug alone.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 94 | mg | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 9, 2016 | EMA | Pfizer Limited | |
| Feb. 3, 2015 | FDA | PFIZER INC | |
| Sept. 27, 2017 | PMDA | Pfizer Japan Inc |
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 |
|---|---|---|---|---|---|---|
| Neoplasm progression | 14159.20 | 17.16 | 4594 | 135097 | 31834 | 63317497 |
| White blood cell count decreased | 9988.68 | 17.16 | 5223 | 134468 | 133881 | 63215450 |
| Fatigue | 4972.08 | 17.16 | 7726 | 131965 | 880302 | 62469029 |
| Neutropenia | 4725.58 | 17.16 | 3536 | 136155 | 171469 | 63177862 |
| Full blood count abnormal | 1971.14 | 17.16 | 1087 | 138604 | 30630 | 63318701 |
| Alopecia | 1960.80 | 17.16 | 3008 | 136683 | 334528 | 63014803 |
| Neutrophil count decreased | 1535.99 | 17.16 | 1149 | 138542 | 55257 | 63294074 |
| Full blood count decreased | 1305.81 | 17.16 | 776 | 138915 | 25248 | 63324083 |
| Nausea | 1288.32 | 17.16 | 4450 | 135241 | 850021 | 62499310 |
| Hot flush | 1227.90 | 17.16 | 967 | 138724 | 50192 | 63299139 |
| Stomatitis | 1106.91 | 17.16 | 1442 | 138249 | 137283 | 63212048 |
| Drug ineffective | 1038.51 | 17.16 | 506 | 139185 | 1044259 | 62305072 |
| Disease progression | 1002.47 | 17.16 | 1291 | 138400 | 121467 | 63227864 |
| Red blood cell count decreased | 906.26 | 17.16 | 736 | 138955 | 39909 | 63309422 |
| Tumour marker increased | 860.84 | 17.16 | 345 | 139346 | 4570 | 63344761 |
| Decreased appetite | 823.23 | 17.16 | 1748 | 137943 | 249304 | 63100027 |
| Death | 767.13 | 17.16 | 2175 | 137516 | 372206 | 62977125 |
| Product dose omission issue | 746.72 | 17.16 | 1613 | 138078 | 232700 | 63116631 |
| Malignant neoplasm progression | 714.76 | 17.16 | 892 | 138799 | 81229 | 63268102 |
| Platelet count decreased | 589.45 | 17.16 | 976 | 138715 | 115146 | 63234185 |
| Constipation | 583.20 | 17.16 | 1428 | 138263 | 223515 | 63125816 |
| Metastases to bone | 575.59 | 17.16 | 430 | 139261 | 20589 | 63328742 |
| Dry skin | 575.21 | 17.16 | 667 | 139024 | 56220 | 63293111 |
| Leukopenia | 561.22 | 17.16 | 768 | 138923 | 76522 | 63272809 |
| Bone marrow failure | 530.88 | 17.16 | 471 | 139220 | 28819 | 63320512 |
| Infusion related reaction | 512.82 | 17.16 | 5 | 139686 | 245516 | 63103815 |
| Bone pain | 500.16 | 17.16 | 609 | 139082 | 54032 | 63295299 |
| Rheumatoid arthritis | 490.27 | 17.16 | 15 | 139676 | 253804 | 63095527 |
| Oral pain | 479.92 | 17.16 | 439 | 139252 | 27955 | 63321376 |
| Diarrhoea | 478.95 | 17.16 | 2942 | 136749 | 712424 | 62636907 |
| Epistaxis | 473.57 | 17.16 | 686 | 139005 | 72039 | 63277292 |
| Maternal exposure during pregnancy | 452.67 | 17.16 | 6 | 139685 | 220056 | 63129275 |
| Contraindicated product administered | 451.87 | 17.16 | 5 | 139686 | 217643 | 63131688 |
| Systemic lupus erythematosus | 416.00 | 17.16 | 9 | 139682 | 208909 | 63140422 |
| Second primary malignancy | 403.50 | 17.16 | 239 | 139452 | 7714 | 63341617 |
| Therapy cessation | 366.05 | 17.16 | 391 | 139300 | 30066 | 63319265 |
| Therapeutic product effect decreased | 353.93 | 17.16 | 17 | 139674 | 193170 | 63156161 |
| Asthenia | 342.69 | 17.16 | 1708 | 137983 | 381896 | 62967435 |
| Drug hypersensitivity | 342.25 | 17.16 | 128 | 139563 | 310559 | 63038772 |
| Toxicity to various agents | 335.42 | 17.16 | 68 | 139623 | 247182 | 63102149 |
| Hand deformity | 333.99 | 17.16 | 3 | 139688 | 159454 | 63189877 |
| Metastases to liver | 333.86 | 17.16 | 331 | 139360 | 23308 | 63326023 |
| Arthropathy | 326.02 | 17.16 | 61 | 139630 | 234731 | 63114600 |
| Product dose omission in error | 322.84 | 17.16 | 204 | 139487 | 7408 | 63341923 |
| Joint swelling | 316.71 | 17.16 | 163 | 139528 | 327503 | 63021828 |
| Treatment failure | 312.57 | 17.16 | 36 | 139655 | 199007 | 63150324 |
| Completed suicide | 303.86 | 17.16 | 3 | 139688 | 145670 | 63203661 |
| Swelling | 289.21 | 17.16 | 122 | 139569 | 275256 | 63074075 |
| Thrombocytopenia | 269.92 | 17.16 | 838 | 138853 | 150319 | 63199012 |
| Pericarditis | 264.50 | 17.16 | 5 | 139686 | 131574 | 63217757 |
| Drug intolerance | 263.68 | 17.16 | 178 | 139513 | 308483 | 63040848 |
| Neuropathy peripheral | 247.93 | 17.16 | 677 | 139014 | 112990 | 63236341 |
| Hypersensitivity | 235.30 | 17.16 | 180 | 139511 | 292505 | 63056826 |
| Wound | 233.99 | 17.16 | 39 | 139652 | 163224 | 63186107 |
| Breast cancer metastatic | 231.22 | 17.16 | 200 | 139491 | 11818 | 63337513 |
| Taste disorder | 211.09 | 17.16 | 201 | 139490 | 13461 | 63335870 |
| Hypotension | 206.20 | 17.16 | 178 | 139513 | 272426 | 63076905 |
| White blood cell count abnormal | 201.17 | 17.16 | 141 | 139550 | 6101 | 63343230 |
| Lower respiratory tract infection | 190.92 | 17.16 | 31 | 139660 | 132276 | 63217055 |
| Intentional product use issue | 189.01 | 17.16 | 28 | 139663 | 127864 | 63221467 |
| Dysgeusia | 188.06 | 17.16 | 355 | 139336 | 46355 | 63302976 |
| Psoriatic arthropathy | 185.89 | 17.16 | 3 | 139688 | 91517 | 63257814 |
| Acute kidney injury | 185.02 | 17.16 | 184 | 139507 | 263231 | 63086100 |
| Cytopenia | 179.84 | 17.16 | 171 | 139520 | 11430 | 63337901 |
| Blood test abnormal | 179.60 | 17.16 | 196 | 139495 | 15433 | 63333898 |
| Onychoclasis | 178.61 | 17.16 | 131 | 139560 | 6091 | 63343240 |
| Carbohydrate antigen 15-3 increased | 177.85 | 17.16 | 79 | 139612 | 1369 | 63347962 |
| Discomfort | 175.82 | 17.16 | 74 | 139617 | 167300 | 63182031 |
| Therapy change | 165.52 | 17.16 | 124 | 139567 | 5957 | 63343374 |
| Lacrimation increased | 161.78 | 17.16 | 213 | 139478 | 20418 | 63328913 |
| Injection site pain | 161.39 | 17.16 | 43 | 139648 | 129757 | 63219574 |
| Asthma | 157.20 | 17.16 | 43 | 139648 | 127518 | 63221813 |
| Laboratory test abnormal | 156.61 | 17.16 | 241 | 139450 | 26671 | 63322660 |
| Therapeutic product effect incomplete | 148.86 | 17.16 | 45 | 139646 | 125011 | 63224320 |
| COVID-19 | 145.85 | 17.16 | 563 | 139128 | 112540 | 63236791 |
| Injection site erythema | 144.04 | 17.16 | 10 | 139681 | 83164 | 63266167 |
| Overdose | 141.41 | 17.16 | 39 | 139652 | 115039 | 63234292 |
| Anaemia | 136.28 | 17.16 | 1107 | 138584 | 292323 | 63057008 |
| Tachycardia | 136.21 | 17.16 | 45 | 139646 | 118111 | 63231220 |
| Glossodynia | 136.13 | 17.16 | 116 | 139575 | 178760 | 63170571 |
| Haemoglobin decreased | 134.48 | 17.16 | 655 | 139036 | 144830 | 63204501 |
| Musculoskeletal stiffness | 134.17 | 17.16 | 125 | 139566 | 184493 | 63164838 |
| Irritable bowel syndrome | 134.17 | 17.16 | 13 | 139678 | 82399 | 63266932 |
| PIK3CA-activated mutation | 134.01 | 17.16 | 59 | 139632 | 1000 | 63348331 |
| Ill-defined disorder | 132.83 | 17.16 | 13 | 139678 | 81742 | 63267589 |
| Hypertension | 128.77 | 17.16 | 263 | 139428 | 279040 | 63070291 |
| Osteonecrosis of jaw | 126.82 | 17.16 | 255 | 139436 | 34868 | 63314463 |
| Mobility decreased | 121.81 | 17.16 | 57 | 139634 | 121102 | 63228229 |
| Fibromyalgia | 120.21 | 17.16 | 17 | 139674 | 80403 | 63268928 |
| Cancer pain | 118.95 | 17.16 | 79 | 139612 | 3126 | 63346205 |
| Madarosis | 116.91 | 17.16 | 77 | 139614 | 3004 | 63346327 |
| Suicide attempt | 116.05 | 17.16 | 4 | 139687 | 60914 | 63288417 |
| Cough | 111.78 | 17.16 | 1058 | 138633 | 291685 | 63057646 |
| Ageusia | 111.15 | 17.16 | 144 | 139547 | 13584 | 63335747 |
| Hepatic enzyme increased | 109.87 | 17.16 | 172 | 139519 | 202156 | 63147175 |
| Psoriasis | 109.61 | 17.16 | 28 | 139663 | 86929 | 63262402 |
| White blood cell disorder | 107.67 | 17.16 | 68 | 139623 | 2466 | 63346865 |
| Sinusitis | 106.50 | 17.16 | 211 | 139480 | 226442 | 63122889 |
| Injury | 106.00 | 17.16 | 17 | 139674 | 73230 | 63276101 |
| Blood cholesterol increased | 101.26 | 17.16 | 40 | 139651 | 93992 | 63255339 |
| Condition aggravated | 100.03 | 17.16 | 500 | 139191 | 401717 | 62947614 |
| Adverse event | 99.31 | 17.16 | 15 | 139676 | 67544 | 63281787 |
| Type 2 diabetes mellitus | 99.06 | 17.16 | 12 | 139679 | 63856 | 63285475 |
| Confusional state | 98.70 | 17.16 | 235 | 139456 | 236145 | 63113186 |
| Fall | 98.55 | 17.16 | 486 | 139205 | 391848 | 62957483 |
| Breast pain | 97.04 | 17.16 | 108 | 139583 | 8690 | 63340641 |
| Cardiac arrest | 97.01 | 17.16 | 41 | 139650 | 92504 | 63256827 |
| Myelosuppression | 96.44 | 17.16 | 181 | 139510 | 23522 | 63325809 |
| Bradycardia | 95.38 | 17.16 | 22 | 139669 | 73205 | 63276126 |
| Lymphoedema | 93.66 | 17.16 | 122 | 139569 | 11570 | 63337761 |
| Cardio-respiratory arrest | 93.65 | 17.16 | 11 | 139680 | 59948 | 63289383 |
| Decreased immune responsiveness | 93.13 | 17.16 | 81 | 139610 | 4820 | 63344511 |
| Coma | 90.78 | 17.16 | 16 | 139675 | 64348 | 63284983 |
| Injection site reaction | 90.76 | 17.16 | 11 | 139680 | 58513 | 63290818 |
| Illness | 90.22 | 17.16 | 275 | 139416 | 48784 | 63300547 |
| Osteoarthritis | 89.61 | 17.16 | 49 | 139642 | 95294 | 63254037 |
| Adverse drug reaction | 89.02 | 17.16 | 32 | 139659 | 79682 | 63269649 |
| Drug interaction | 88.51 | 17.16 | 237 | 139454 | 228894 | 63120437 |
| Metastases to lung | 88.37 | 17.16 | 124 | 139567 | 12626 | 63336705 |
| Urticaria | 88.06 | 17.16 | 143 | 139548 | 165659 | 63183672 |
| Back pain | 87.89 | 17.16 | 928 | 138763 | 263217 | 63086114 |
| Anaphylactic reaction | 87.82 | 17.16 | 19 | 139672 | 66081 | 63283250 |
| Oral mucosal blistering | 86.01 | 17.16 | 83 | 139608 | 5650 | 63343681 |
| Seizure | 85.94 | 17.16 | 99 | 139592 | 132535 | 63216796 |
| Neoplasm recurrence | 83.63 | 17.16 | 59 | 139632 | 2579 | 63346752 |
| Medication error | 83.15 | 17.16 | 9 | 139682 | 52275 | 63297056 |
| Wheezing | 83.00 | 17.16 | 54 | 139637 | 95541 | 63253790 |
| Metabolic acidosis | 82.35 | 17.16 | 4 | 139687 | 45065 | 63304266 |
| C-reactive protein increased | 81.54 | 17.16 | 54 | 139637 | 94653 | 63254678 |
| Hepatic lesion | 80.32 | 17.16 | 74 | 139617 | 4751 | 63344580 |
| Knee arthroplasty | 79.75 | 17.16 | 12 | 139679 | 54194 | 63295137 |
| Immune system disorder | 79.37 | 17.16 | 103 | 139588 | 9731 | 63339600 |
| Injection site pruritus | 79.36 | 17.16 | 5 | 139686 | 45111 | 63304220 |
| Nail disorder | 79.18 | 17.16 | 119 | 139572 | 12896 | 63336435 |
| Suicidal ideation | 76.95 | 17.16 | 21 | 139670 | 62400 | 63286931 |
| Off label use | 76.41 | 17.16 | 1036 | 138655 | 673426 | 62675905 |
| Depressed level of consciousness | 76.31 | 17.16 | 21 | 139670 | 62057 | 63287274 |
| Flatulence | 75.87 | 17.16 | 207 | 139484 | 34495 | 63314836 |
| Syncope | 75.63 | 17.16 | 88 | 139603 | 117297 | 63232034 |
| Oxygen saturation decreased | 71.67 | 17.16 | 54 | 139637 | 88531 | 63260800 |
| Respiratory failure | 71.58 | 17.16 | 71 | 139620 | 101787 | 63247544 |
| Hyponatraemia | 70.90 | 17.16 | 85 | 139606 | 111815 | 63237516 |
| Nasal dryness | 70.00 | 17.16 | 67 | 139624 | 4514 | 63344817 |
| Gingival pain | 69.83 | 17.16 | 88 | 139603 | 8074 | 63341257 |
| Body surface area increased | 69.49 | 17.16 | 17 | 139674 | 31 | 63349300 |
| Incorrect dose administered | 67.08 | 17.16 | 24 | 139667 | 59944 | 63289387 |
| Sedation | 66.22 | 17.16 | 5 | 139686 | 38804 | 63310527 |
| Pleural effusion | 65.87 | 17.16 | 390 | 139301 | 92820 | 63256511 |
| Blood pressure increased | 65.33 | 17.16 | 164 | 139527 | 161898 | 63187433 |
| Memory impairment | 64.76 | 17.16 | 422 | 139269 | 103836 | 63245495 |
| Hip arthroplasty | 64.73 | 17.16 | 13 | 139678 | 47633 | 63301698 |
| Hypoglycaemia | 63.92 | 17.16 | 26 | 139665 | 60039 | 63289292 |
| Tumour marker abnormal | 63.74 | 17.16 | 26 | 139665 | 361 | 63348970 |
| Gastrointestinal haemorrhage | 63.74 | 17.16 | 51 | 139640 | 81125 | 63268206 |
| Therapeutic response decreased | 63.29 | 17.16 | 28 | 139663 | 61497 | 63287834 |
| Plasma cell myeloma | 63.09 | 17.16 | 4 | 139687 | 35901 | 63313430 |
| Flushing | 63.05 | 17.16 | 44 | 139647 | 75043 | 63274288 |
| Gastrointestinal disorder | 62.61 | 17.16 | 121 | 139570 | 131118 | 63218213 |
| Bursitis | 62.56 | 17.16 | 5 | 139686 | 37036 | 63312295 |
| Cardiac failure congestive | 62.05 | 17.16 | 67 | 139624 | 92366 | 63256965 |
| Oedema peripheral | 61.72 | 17.16 | 212 | 139479 | 189299 | 63160032 |
| Multiple organ dysfunction syndrome | 61.32 | 17.16 | 24 | 139667 | 56728 | 63292603 |
| Blood pressure systolic increased | 60.23 | 17.16 | 15 | 139676 | 47382 | 63301949 |
| Product quality issue | 60.14 | 17.16 | 5 | 139686 | 35860 | 63313471 |
| Carbohydrate antigen 27.29 increased | 59.62 | 17.16 | 16 | 139675 | 49 | 63349282 |
| Angioedema | 59.38 | 17.16 | 16 | 139675 | 47949 | 63301382 |
| Respiratory arrest | 59.32 | 17.16 | 3 | 139688 | 32642 | 63316689 |
| Injection site swelling | 58.65 | 17.16 | 16 | 139675 | 47556 | 63301775 |
| Pneumonia | 58.57 | 17.16 | 683 | 139008 | 456084 | 62893247 |
| Pancytopenia | 58.17 | 17.16 | 389 | 139302 | 96544 | 63252787 |
| Oedema | 57.85 | 17.16 | 78 | 139613 | 97544 | 63251787 |
| Septic shock | 57.34 | 17.16 | 38 | 139653 | 66591 | 63282740 |
| Liver injury | 57.01 | 17.16 | 31 | 139660 | 60489 | 63288842 |
| Encephalopathy | 55.79 | 17.16 | 9 | 139682 | 38611 | 63310720 |
| Musculoskeletal chest pain | 55.63 | 17.16 | 135 | 139556 | 20948 | 63328383 |
| Hypokalaemia | 55.59 | 17.16 | 89 | 139602 | 103715 | 63245616 |
| Hair texture abnormal | 55.47 | 17.16 | 57 | 139634 | 4186 | 63345145 |
| Pulmonary hypertension | 55.11 | 17.16 | 8 | 139683 | 37115 | 63312216 |
| Erythema | 54.30 | 17.16 | 201 | 139490 | 175550 | 63173781 |
| Hypoacusis | 53.73 | 17.16 | 145 | 139546 | 24006 | 63325325 |
| Inflammation | 52.64 | 17.16 | 62 | 139629 | 82211 | 63267120 |
| Skin exfoliation | 52.63 | 17.16 | 211 | 139480 | 42891 | 63306440 |
| Inappropriate schedule of product administration | 52.11 | 17.16 | 93 | 139598 | 103872 | 63245459 |
| Metastases to pleura | 51.53 | 17.16 | 36 | 139655 | 1549 | 63347782 |
| Body surface area decreased | 51.33 | 17.16 | 12 | 139679 | 16 | 63349315 |
| Palpitations | 51.20 | 17.16 | 107 | 139584 | 112663 | 63236668 |
| Lactic acidosis | 50.87 | 17.16 | 11 | 139680 | 38276 | 63311055 |
| Obesity | 50.71 | 17.16 | 4 | 139687 | 29948 | 63319383 |
| Coronary artery disease | 50.41 | 17.16 | 6 | 139685 | 32371 | 63316960 |
| Loss of consciousness | 50.39 | 17.16 | 116 | 139575 | 118005 | 63231326 |
| Unevaluable event | 50.36 | 17.16 | 25 | 139666 | 51361 | 63297970 |
| Impaired healing | 50.26 | 17.16 | 93 | 139598 | 102449 | 63246882 |
| Prescribed underdose | 50.16 | 17.16 | 4 | 139687 | 29685 | 63319646 |
| Injection site bruising | 49.99 | 17.16 | 15 | 139676 | 41895 | 63307436 |
| Dizziness | 49.86 | 17.16 | 1268 | 138423 | 428657 | 62920674 |
| International normalised ratio increased | 49.56 | 17.16 | 20 | 139671 | 46405 | 63302926 |
| Blister | 49.54 | 17.16 | 135 | 139556 | 129679 | 63219652 |
| Prescribed overdose | 49.24 | 17.16 | 8 | 139683 | 34145 | 63315186 |
| Haematotoxicity | 49.07 | 17.16 | 80 | 139611 | 9296 | 63340035 |
| Delirium | 48.92 | 17.16 | 25 | 139666 | 50516 | 63298815 |
| Rhinorrhoea | 48.67 | 17.16 | 278 | 139413 | 65299 | 63284032 |
| Unresponsive to stimuli | 48.58 | 17.16 | 8 | 139683 | 33808 | 63315523 |
| Dyspepsia | 47.54 | 17.16 | 386 | 139305 | 101810 | 63247521 |
| Malignant pleural effusion | 47.37 | 17.16 | 42 | 139649 | 2564 | 63346767 |
| Metastases to lymph nodes | 47.37 | 17.16 | 73 | 139618 | 8085 | 63341246 |
| Orthostatic hypotension | 46.81 | 17.16 | 11 | 139680 | 36149 | 63313182 |
| Metastases to spine | 46.79 | 17.16 | 46 | 139645 | 3203 | 63346128 |
| Foot deformity | 46.38 | 17.16 | 4 | 139687 | 27849 | 63321482 |
| Sleep apnoea syndrome | 46.36 | 17.16 | 5 | 139686 | 29128 | 63320203 |
| Dysarthria | 46.25 | 17.16 | 18 | 139673 | 42693 | 63306638 |
| Abdominal pain | 46.11 | 17.16 | 418 | 139273 | 293038 | 63056293 |
| Pneumonia aspiration | 45.73 | 17.16 | 10 | 139681 | 34530 | 63314801 |
| Dry mouth | 45.23 | 17.16 | 310 | 139381 | 77553 | 63271778 |
| Pulmonary thrombosis | 45.20 | 17.16 | 74 | 139617 | 8628 | 63340703 |
| Hyperkalaemia | 45.19 | 17.16 | 32 | 139659 | 54171 | 63295160 |
| Agitation | 45.11 | 17.16 | 39 | 139652 | 59718 | 63289613 |
| Drug withdrawal syndrome | 45.02 | 17.16 | 4 | 139687 | 27190 | 63322141 |
| Psychotic disorder | 44.77 | 17.16 | 3 | 139688 | 25709 | 63323622 |
| Metastases to kidney | 44.06 | 17.16 | 17 | 139674 | 202 | 63349129 |
| Feeling cold | 43.99 | 17.16 | 134 | 139557 | 23754 | 63325577 |
| Heart rate increased | 43.98 | 17.16 | 88 | 139603 | 94150 | 63255181 |
| Ascites | 43.96 | 17.16 | 192 | 139499 | 40536 | 63308795 |
| Altered state of consciousness | 43.77 | 17.16 | 3 | 139688 | 25227 | 63324104 |
| Neutrophil count abnormal | 43.63 | 17.16 | 42 | 139649 | 2850 | 63346481 |
| Hallucination | 43.59 | 17.16 | 34 | 139657 | 54783 | 63294548 |
| Nail growth abnormal | 43.21 | 17.16 | 22 | 139669 | 523 | 63348808 |
| Oropharyngeal pain | 42.93 | 17.16 | 355 | 139336 | 94132 | 63255199 |
| Atrial fibrillation | 42.50 | 17.16 | 124 | 139567 | 116512 | 63232819 |
| Leukocytosis | 42.44 | 17.16 | 4 | 139687 | 25931 | 63323400 |
| Weight increased | 42.05 | 17.16 | 369 | 139322 | 260423 | 63088908 |
| Heart rate decreased | 41.96 | 17.16 | 24 | 139667 | 45536 | 63303795 |
| Injection site haemorrhage | 41.86 | 17.16 | 3 | 139688 | 24311 | 63325020 |
| Haematuria | 41.66 | 17.16 | 7 | 139684 | 29150 | 63320181 |
| Carcinoembryonic antigen increased | 41.50 | 17.16 | 33 | 139658 | 1732 | 63347599 |
| Angina pectoris | 41.29 | 17.16 | 8 | 139683 | 30070 | 63319261 |
| Spinal pain | 41.13 | 17.16 | 90 | 139601 | 13049 | 63336282 |
| Pneumonitis | 41.07 | 17.16 | 170 | 139521 | 35052 | 63314279 |
| Product dispensing error | 41.05 | 17.16 | 78 | 139613 | 10227 | 63339104 |
| Hair growth abnormal | 40.71 | 17.16 | 41 | 139650 | 2940 | 63346391 |
| Therapy non-responder | 40.70 | 17.16 | 65 | 139626 | 75836 | 63273495 |
| Blood pressure fluctuation | 40.41 | 17.16 | 26 | 139665 | 46291 | 63303040 |
| Appetite disorder | 40.41 | 17.16 | 64 | 139627 | 7257 | 63342074 |
| Emotional distress | 40.02 | 17.16 | 11 | 139680 | 32538 | 63316793 |
| Blood creatine phosphokinase increased | 39.90 | 17.16 | 9 | 139682 | 30421 | 63318910 |
| Product packaging difficult to open | 39.87 | 17.16 | 13 | 139678 | 90 | 63349241 |
| Pancreatitis | 39.55 | 17.16 | 30 | 139661 | 49025 | 63300306 |
| Drug dependence | 39.48 | 17.16 | 4 | 139687 | 24479 | 63324852 |
| Drug ineffective for unapproved indication | 39.19 | 17.16 | 13 | 139678 | 34050 | 63315281 |
| Eating disorder | 38.19 | 17.16 | 110 | 139581 | 18906 | 63330425 |
| Pseudocirrhosis | 37.84 | 17.16 | 22 | 139669 | 685 | 63348646 |
| Metastases to retroperitoneum | 37.58 | 17.16 | 14 | 139677 | 150 | 63349181 |
| Vomiting | 37.53 | 17.16 | 1546 | 138145 | 558071 | 62791260 |
| Aggression | 37.47 | 17.16 | 4 | 139687 | 23494 | 63325837 |
| Breast cancer recurrent | 37.45 | 17.16 | 47 | 139644 | 4294 | 63345037 |
| Acute myocardial infarction | 37.41 | 17.16 | 12 | 139679 | 32112 | 63317219 |
| Respiratory distress | 37.27 | 17.16 | 14 | 139677 | 33937 | 63315394 |
| Myocardial infarction | 37.27 | 17.16 | 105 | 139586 | 99788 | 63249543 |
| Dysphagia | 36.65 | 17.16 | 326 | 139365 | 88259 | 63261072 |
| Body temperature increased | 36.59 | 17.16 | 18 | 139673 | 37174 | 63312157 |
| Joint range of motion decreased | 36.23 | 17.16 | 13 | 139678 | 32415 | 63316916 |
| Hypoxia | 36.21 | 17.16 | 47 | 139644 | 59745 | 63289586 |
| Tremor | 35.94 | 17.16 | 159 | 139532 | 132080 | 63217251 |
| Blood pressure diastolic decreased | 35.87 | 17.16 | 4 | 139687 | 22702 | 63326629 |
| Stevens-Johnson syndrome | 35.62 | 17.16 | 6 | 139685 | 24944 | 63324387 |
| Mucosal inflammation | 35.51 | 17.16 | 200 | 139491 | 46728 | 63302603 |
| Basal cell carcinoma | 35.29 | 17.16 | 9 | 139682 | 27982 | 63321349 |
| Rash maculo-papular | 35.27 | 17.16 | 13 | 139678 | 31883 | 63317448 |
| Grip strength decreased | 35.02 | 17.16 | 4 | 139687 | 22283 | 63327048 |
| Cytomegalovirus infection | 34.91 | 17.16 | 3 | 139688 | 20949 | 63328382 |
| Chest pain | 34.60 | 17.16 | 306 | 139385 | 215653 | 63133678 |
| Infection | 34.44 | 17.16 | 330 | 139361 | 228843 | 63120488 |
| Dry eye | 34.42 | 17.16 | 179 | 139512 | 40582 | 63308749 |
| Bone cancer | 33.99 | 17.16 | 27 | 139664 | 1415 | 63347916 |
| Dyskinesia | 33.81 | 17.16 | 14 | 139677 | 31988 | 63317343 |
| Faeces soft | 33.14 | 17.16 | 51 | 139640 | 5641 | 63343690 |
| Granulocyte count decreased | 33.11 | 17.16 | 25 | 139666 | 1215 | 63348116 |
| Anaphylactic shock | 33.05 | 17.16 | 6 | 139685 | 23627 | 63325704 |
| Wrong technique in product usage process | 32.85 | 17.16 | 54 | 139637 | 62286 | 63287045 |
| Nasal discomfort | 32.55 | 17.16 | 46 | 139645 | 4714 | 63344617 |
| Mental status changes | 32.20 | 17.16 | 24 | 139667 | 39575 | 63309756 |
| Sinus tachycardia | 32.18 | 17.16 | 7 | 139684 | 24261 | 63325070 |
| Mitral valve incompetence | 32.12 | 17.16 | 3 | 139688 | 19591 | 63329740 |
| Thrombosis | 31.97 | 17.16 | 248 | 139443 | 64507 | 63284824 |
| Weight decreased | 31.91 | 17.16 | 816 | 138875 | 275982 | 63073349 |
| Hypomagnesaemia | 31.30 | 17.16 | 12 | 139679 | 28725 | 63320606 |
| Proteinuria | 31.20 | 17.16 | 3 | 139688 | 19142 | 63330189 |
| Adnexa uteri mass | 31.12 | 17.16 | 18 | 139673 | 555 | 63348776 |
| Metastases to skin | 30.62 | 17.16 | 27 | 139664 | 1636 | 63347695 |
| Joint dislocation | 30.50 | 17.16 | 3 | 139688 | 18797 | 63330534 |
| Ventricular tachycardia | 30.38 | 17.16 | 4 | 139687 | 19975 | 63329356 |
| Hemiparesis | 30.30 | 17.16 | 7 | 139684 | 23275 | 63326056 |
| Hair disorder | 30.30 | 17.16 | 23 | 139668 | 1127 | 63348204 |
| Metastases to bladder | 30.15 | 17.16 | 13 | 139678 | 209 | 63349122 |
| Pallor | 29.76 | 17.16 | 15 | 139676 | 30553 | 63318778 |
| Diabetic ketoacidosis | 29.12 | 17.16 | 5 | 139686 | 20500 | 63328831 |
| Incorrect route of product administration | 29.02 | 17.16 | 12 | 139679 | 27440 | 63321891 |
| Cardiac failure | 28.80 | 17.16 | 100 | 139591 | 89042 | 63260289 |
| Staphylococcal infection | 28.70 | 17.16 | 29 | 139662 | 41227 | 63308104 |
| Adrenal insufficiency | 28.70 | 17.16 | 3 | 139688 | 17912 | 63331419 |
| Hypercholesterolaemia | 28.60 | 17.16 | 6 | 139685 | 21328 | 63328003 |
| Multiple sclerosis | 28.57 | 17.16 | 9 | 139682 | 24363 | 63324968 |
| Haematoma | 28.44 | 17.16 | 21 | 139670 | 34799 | 63314532 |
| Loss of personal independence in daily activities | 28.27 | 17.16 | 114 | 139577 | 97176 | 63252155 |
| General physical health deterioration | 28.18 | 17.16 | 295 | 139396 | 201107 | 63148224 |
| Trichorrhexis | 27.98 | 17.16 | 23 | 139668 | 1266 | 63348065 |
| Tachypnoea | 27.45 | 17.16 | 3 | 139688 | 17299 | 63332032 |
| Obstructive airways disorder | 27.39 | 17.16 | 6 | 139685 | 20693 | 63328638 |
| Drug level increased | 27.37 | 17.16 | 8 | 139683 | 22728 | 63326603 |
| Insomnia | 27.32 | 17.16 | 643 | 139048 | 214609 | 63134722 |
| Chronic kidney disease | 27.16 | 17.16 | 36 | 139655 | 45362 | 63303969 |
| Vasculitis | 26.85 | 17.16 | 4 | 139687 | 18205 | 63331126 |
| Red blood cell count abnormal | 26.73 | 17.16 | 21 | 139670 | 1083 | 63348248 |
| Melaena | 26.55 | 17.16 | 17 | 139674 | 30348 | 63318983 |
| Arrhythmia | 26.31 | 17.16 | 27 | 139664 | 38113 | 63311218 |
| Urine odour abnormal | 26.25 | 17.16 | 49 | 139642 | 6340 | 63342991 |
| Device malfunction | 26.16 | 17.16 | 4 | 139687 | 17853 | 63331478 |
| Hypervolaemia | 26.11 | 17.16 | 15 | 139676 | 28398 | 63320933 |
| Parosmia | 26.00 | 17.16 | 48 | 139643 | 6158 | 63343173 |
| Toothache | 25.89 | 17.16 | 97 | 139594 | 19102 | 63330229 |
| Injection site rash | 25.82 | 17.16 | 5 | 139686 | 18804 | 63330527 |
| Increased appetite | 25.76 | 17.16 | 62 | 139629 | 9568 | 63339763 |
| Swelling face | 25.74 | 17.16 | 64 | 139627 | 63411 | 63285920 |
| Aphthous ulcer | 25.49 | 17.16 | 78 | 139613 | 13860 | 63335471 |
| Radiation injury | 25.43 | 17.16 | 15 | 139676 | 480 | 63348851 |
| Poor quality product administered | 25.38 | 17.16 | 33 | 139658 | 3123 | 63346208 |
| Drug eruption | 25.18 | 17.16 | 16 | 139675 | 28678 | 63320653 |
| Arthritis | 24.94 | 17.16 | 151 | 139540 | 115770 | 63233561 |
| Prehypertension | 24.65 | 17.16 | 7 | 139684 | 28 | 63349303 |
| Joint effusion | 24.58 | 17.16 | 4 | 139687 | 17056 | 63332275 |
| Cardiogenic shock | 24.13 | 17.16 | 5 | 139686 | 17927 | 63331404 |
| Metastasis | 24.08 | 17.16 | 42 | 139649 | 5155 | 63344176 |
| Skin ulcer | 23.90 | 17.16 | 36 | 139655 | 43009 | 63306322 |
| Eructation | 23.76 | 17.16 | 55 | 139636 | 8278 | 63341053 |
| Night sweats | 23.57 | 17.16 | 186 | 139505 | 48628 | 63300703 |
| Muscle twitching | 23.53 | 17.16 | 7 | 139684 | 19661 | 63329670 |
| Abnormal behaviour | 23.24 | 17.16 | 9 | 139682 | 21417 | 63327914 |
| Osteoporosis | 23.10 | 17.16 | 58 | 139633 | 57280 | 63292051 |
| Treatment noncompliance | 22.95 | 17.16 | 29 | 139662 | 37296 | 63312035 |
| No adverse event | 22.63 | 17.16 | 35 | 139656 | 41370 | 63307961 |
| Chronic obstructive pulmonary disease | 22.57 | 17.16 | 67 | 139624 | 62619 | 63286712 |
| Transient ischaemic attack | 22.52 | 17.16 | 30 | 139661 | 37723 | 63311608 |
| Ovarian cyst | 22.40 | 17.16 | 4 | 139687 | 15941 | 63333390 |
| Ovarian disorder | 22.39 | 17.16 | 16 | 139675 | 714 | 63348617 |
| Foreign body in throat | 22.39 | 17.16 | 12 | 139679 | 318 | 63349013 |
| Macular degeneration | 22.22 | 17.16 | 13 | 139678 | 24363 | 63324968 |
| Shock | 22.12 | 17.16 | 12 | 139679 | 23451 | 63325880 |
| Pulmonary arterial hypertension | 22.10 | 17.16 | 11 | 139680 | 22566 | 63326765 |
| Upper gastrointestinal haemorrhage | 22.03 | 17.16 | 7 | 139684 | 18845 | 63330486 |
| Intervertebral disc degeneration | 21.99 | 17.16 | 4 | 139687 | 15728 | 63333603 |
| Myalgia | 21.85 | 17.16 | 448 | 139243 | 146081 | 63203250 |
| Metastases to adrenals | 21.71 | 17.16 | 16 | 139675 | 749 | 63348582 |
| Metastases to peritoneum | 21.69 | 17.16 | 32 | 139659 | 3410 | 63345921 |
| Coagulopathy | 21.68 | 17.16 | 9 | 139682 | 20535 | 63328796 |
| Tendonitis | 21.68 | 17.16 | 8 | 139683 | 19607 | 63329724 |
| Ear infection | 21.18 | 17.16 | 32 | 139659 | 38181 | 63311150 |
| Lip pain | 21.15 | 17.16 | 23 | 139668 | 1803 | 63347528 |
| Lupus-like syndrome | 21.14 | 17.16 | 4 | 139687 | 15291 | 63334040 |
| Pleural neoplasm | 21.07 | 17.16 | 12 | 139679 | 359 | 63348972 |
| Arthralgia | 21.06 | 17.16 | 1489 | 138202 | 568221 | 62781110 |
| Circulatory collapse | 21.01 | 17.16 | 11 | 139680 | 21927 | 63327404 |
| Road traffic accident | 20.96 | 17.16 | 30 | 139661 | 36602 | 63312729 |
| Infusion site coldness | 20.94 | 17.16 | 10 | 139681 | 206 | 63349125 |
| Hypersomnia | 20.93 | 17.16 | 87 | 139604 | 17968 | 63331363 |
| Mean cell volume increased | 20.93 | 17.16 | 32 | 139659 | 3519 | 63345812 |
| Acute respiratory distress syndrome | 20.82 | 17.16 | 13 | 139678 | 23521 | 63325810 |
| Autoimmune disorder | 20.76 | 17.16 | 6 | 139685 | 17171 | 63332160 |
| Artificial menopause | 20.74 | 17.16 | 6 | 139685 | 26 | 63349305 |
| Hypothyroidism | 20.59 | 17.16 | 39 | 139652 | 42593 | 63306738 |
| Eastern Cooperative Oncology Group performance status worsened | 20.42 | 17.16 | 19 | 139672 | 1235 | 63348096 |
| Respiratory depression | 20.25 | 17.16 | 3 | 139688 | 13712 | 63335619 |
| Exostosis | 20.23 | 17.16 | 7 | 139684 | 17855 | 63331476 |
| Feeding disorder | 20.13 | 17.16 | 70 | 139621 | 13292 | 63336039 |
| Tongue blistering | 20.08 | 17.16 | 21 | 139670 | 1574 | 63347757 |
| Tumour pain | 20.06 | 17.16 | 20 | 139671 | 1417 | 63347914 |
| Neuroendocrine breast tumour | 20.04 | 17.16 | 6 | 139685 | 30 | 63349301 |
| Noninfective gingivitis | 20.01 | 17.16 | 20 | 139671 | 1421 | 63347910 |
| Liver function test abnormal | 19.99 | 17.16 | 48 | 139643 | 48133 | 63301198 |
| Tongue discomfort | 19.97 | 17.16 | 25 | 139666 | 2278 | 63347053 |
| Sepsis | 19.92 | 17.16 | 228 | 139463 | 152895 | 63196436 |
| Gingival bleeding | 19.89 | 17.16 | 67 | 139624 | 12520 | 63336811 |
| Pain | 19.89 | 17.16 | 1383 | 138308 | 739245 | 62610086 |
| Joint neoplasm | 19.87 | 17.16 | 7 | 139684 | 63 | 63349268 |
| Hepatitis | 19.56 | 17.16 | 36 | 139655 | 39752 | 63309579 |
| Peripheral venous disease | 19.46 | 17.16 | 5 | 139686 | 15472 | 63333859 |
| Hypogeusia | 19.46 | 17.16 | 19 | 139672 | 1312 | 63348019 |
| Underdose | 19.44 | 17.16 | 19 | 139672 | 27437 | 63321894 |
| Hypoaesthesia | 19.25 | 17.16 | 496 | 139195 | 167897 | 63181434 |
| Bronchospasm | 19.18 | 17.16 | 7 | 139684 | 17273 | 63332058 |
| Hypertensive crisis | 19.11 | 17.16 | 5 | 139686 | 15281 | 63334050 |
| Soft tissue neoplasm | 19.04 | 17.16 | 7 | 139684 | 72 | 63349259 |
| Feeling abnormal | 19.03 | 17.16 | 444 | 139247 | 147948 | 63201383 |
| Pyrexia | 18.98 | 17.16 | 844 | 138847 | 469634 | 62879697 |
| Product substitution issue | 18.58 | 17.16 | 6 | 139685 | 15990 | 63333341 |
| Myocardial ischaemia | 18.56 | 17.16 | 3 | 139688 | 12856 | 63336475 |
| Cyanosis | 18.56 | 17.16 | 7 | 139684 | 16928 | 63332403 |
| Product use complaint | 18.56 | 17.16 | 25 | 139666 | 2449 | 63346882 |
| Migraine | 18.56 | 17.16 | 142 | 139549 | 103204 | 63246127 |
| Osteonecrosis | 18.52 | 17.16 | 16 | 139675 | 24514 | 63324817 |
| Blood pressure decreased | 18.38 | 17.16 | 77 | 139614 | 64945 | 63284386 |
| Tongue disorder | 18.23 | 17.16 | 58 | 139633 | 10522 | 63338809 |
| Urinary retention | 18.16 | 17.16 | 24 | 139667 | 30277 | 63319054 |
| Face oedema | 18.11 | 17.16 | 11 | 139680 | 20201 | 63329130 |
| Dental discomfort | 18.11 | 17.16 | 12 | 139679 | 473 | 63348858 |
| Acute respiratory failure | 18.05 | 17.16 | 30 | 139661 | 34455 | 63314876 |
| Metastases to the mediastinum | 18.04 | 17.16 | 12 | 139679 | 476 | 63348855 |
| Hallucination, visual | 18.00 | 17.16 | 10 | 139681 | 19288 | 63330043 |
| Uveitis | 17.96 | 17.16 | 3 | 139688 | 12550 | 63336781 |
| Nail discolouration | 17.96 | 17.16 | 26 | 139665 | 2724 | 63346607 |
| Mastectomy | 17.93 | 17.16 | 20 | 139671 | 1613 | 63347718 |
| Acute cutaneous lupus erythematosus | 17.84 | 17.16 | 10 | 139681 | 290 | 63349041 |
| Femur fracture | 17.80 | 17.16 | 41 | 139650 | 41715 | 63307616 |
| Breast cancer female | 17.80 | 17.16 | 4 | 139687 | 13555 | 63335776 |
| Mania | 17.60 | 17.16 | 3 | 139688 | 12364 | 63336967 |
| Haemorrhage intracranial | 17.53 | 17.16 | 4 | 139687 | 13415 | 63335916 |
| Skin sensitisation | 17.51 | 17.16 | 15 | 139676 | 874 | 63348457 |
| Clostridium difficile colitis | 17.33 | 17.16 | 12 | 139679 | 20557 | 63328774 |
| Cholelithiasis | 17.26 | 17.16 | 45 | 139646 | 43880 | 63305451 |
| Gamma-glutamyltransferase decreased | 17.24 | 17.16 | 10 | 139681 | 310 | 63349021 |
| Product packaging issue | 17.23 | 17.16 | 17 | 139674 | 1189 | 63348142 |
| Spinal osteoarthritis | 17.23 | 17.16 | 7 | 139684 | 16179 | 63333152 |
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 |
|---|---|---|---|---|---|---|
| Product use issue | 537.45 | 32.45 | 199 | 2687 | 63017 | 34891028 |
| Neoplasm progression | 487.30 | 32.45 | 145 | 2741 | 23155 | 34930890 |
| Fatigue | 145.10 | 32.45 | 164 | 2722 | 370489 | 34583556 |
| Product use in unapproved indication | 139.72 | 32.45 | 98 | 2788 | 117401 | 34836644 |
| Off label use | 127.04 | 32.45 | 163 | 2723 | 419361 | 34534684 |
| White blood cell count decreased | 111.87 | 32.45 | 79 | 2807 | 95366 | 34858679 |
| Hydrocephalus | 57.20 | 32.45 | 20 | 2866 | 5212 | 34948833 |
| Neutropenia | 53.32 | 32.45 | 65 | 2821 | 156713 | 34797332 |
| Hot flush | 52.80 | 32.45 | 27 | 2859 | 18039 | 34936006 |
| Death | 50.75 | 32.45 | 105 | 2781 | 397944 | 34556101 |
| Xerosis | 43.08 | 32.45 | 10 | 2876 | 594 | 34953451 |
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 | 13134.13 | 17.99 | 4408 | 127345 | 47274 | 79565361 |
| White blood cell count decreased | 9566.54 | 17.99 | 5101 | 126652 | 183187 | 79429448 |
| Fatigue | 6116.32 | 17.99 | 7530 | 124223 | 922197 | 78690438 |
| Alopecia | 3346.35 | 17.99 | 2882 | 128871 | 228473 | 79384162 |
| Neutropenia | 3064.02 | 17.99 | 3020 | 128733 | 284690 | 79327945 |
| Full blood count abnormal | 1931.37 | 17.99 | 1057 | 130696 | 39417 | 79573218 |
| Nausea | 1592.83 | 17.99 | 4282 | 127471 | 952914 | 78659721 |
| Full blood count decreased | 1398.04 | 17.99 | 743 | 131010 | 26076 | 79586559 |
| Hot flush | 1391.80 | 17.99 | 957 | 130796 | 53920 | 79558715 |
| Stomatitis | 1265.42 | 17.99 | 1379 | 130374 | 145378 | 79467257 |
| Neutrophil count decreased | 1202.74 | 17.99 | 1095 | 130658 | 92864 | 79519771 |
| Product dose omission issue | 1007.96 | 17.99 | 1608 | 130145 | 245929 | 79366706 |
| Tumour marker increased | 888.91 | 17.99 | 315 | 131438 | 3957 | 79608678 |
| Red blood cell count decreased | 838.67 | 17.99 | 722 | 131031 | 56791 | 79555844 |
| Drug ineffective | 811.49 | 17.99 | 389 | 131364 | 1080524 | 78532111 |
| Decreased appetite | 760.02 | 17.99 | 1717 | 130036 | 340701 | 79271934 |
| Dry skin | 616.83 | 17.99 | 657 | 131096 | 67338 | 79545297 |
| Constipation | 607.18 | 17.99 | 1401 | 130352 | 281649 | 79330986 |
| Disease progression | 598.96 | 17.99 | 1084 | 130669 | 183278 | 79429357 |
| Bone pain | 549.22 | 17.99 | 563 | 131190 | 55179 | 79557456 |
| Oral pain | 541.85 | 17.99 | 437 | 131316 | 31361 | 79581274 |
| Diarrhoea | 515.93 | 17.99 | 2831 | 128922 | 877658 | 78734977 |
| Toxicity to various agents | 483.61 | 17.99 | 63 | 131690 | 421477 | 79191158 |
| Death | 416.01 | 17.99 | 1943 | 129810 | 564571 | 79048064 |
| Acute kidney injury | 413.11 | 17.99 | 171 | 131582 | 519233 | 79093402 |
| Platelet count decreased | 409.70 | 17.99 | 957 | 130796 | 193707 | 79418928 |
| Epistaxis | 385.31 | 17.99 | 674 | 131079 | 110841 | 79501794 |
| Product dose omission in error | 383.85 | 17.99 | 208 | 131545 | 7580 | 79605055 |
| Infusion related reaction | 354.27 | 17.99 | 5 | 131748 | 230232 | 79382403 |
| Leukopenia | 346.54 | 17.99 | 660 | 131093 | 115853 | 79496782 |
| Bone marrow failure | 345.09 | 17.99 | 424 | 131329 | 50683 | 79561952 |
| Metastases to bone | 326.46 | 17.99 | 292 | 131461 | 24135 | 79588500 |
| Asthenia | 319.01 | 17.99 | 1676 | 130077 | 510013 | 79102622 |
| Second primary malignancy | 302.92 | 17.99 | 224 | 131529 | 14126 | 79598509 |
| Hypotension | 294.44 | 17.99 | 182 | 131571 | 440135 | 79172500 |
| Rheumatoid arthritis | 289.25 | 17.99 | 13 | 131740 | 208457 | 79404178 |
| Therapy cessation | 287.11 | 17.99 | 332 | 131421 | 37230 | 79575405 |
| Drug hypersensitivity | 236.35 | 17.99 | 99 | 131654 | 298817 | 79313818 |
| Contraindicated product administered | 235.77 | 17.99 | 5 | 131748 | 157533 | 79455102 |
| White blood cell count abnormal | 235.62 | 17.99 | 136 | 131617 | 5609 | 79607026 |
| Neuropathy peripheral | 230.46 | 17.99 | 631 | 131122 | 140674 | 79471961 |
| Taste disorder | 229.15 | 17.99 | 198 | 131555 | 15625 | 79597010 |
| Therapeutic product effect decreased | 218.52 | 17.99 | 13 | 131740 | 163850 | 79448785 |
| Drug interaction | 216.61 | 17.99 | 220 | 131533 | 414963 | 79197672 |
| Onychoclasis | 215.42 | 17.99 | 127 | 131626 | 5451 | 79607184 |
| Maternal exposure during pregnancy | 209.82 | 17.99 | 3 | 131750 | 136535 | 79476100 |
| Dysgeusia | 209.70 | 17.99 | 355 | 131398 | 56822 | 79555813 |
| Laboratory test abnormal | 206.15 | 17.99 | 243 | 131510 | 27805 | 79584830 |
| Blood test abnormal | 200.45 | 17.99 | 193 | 131560 | 17517 | 79595118 |
| Lacrimation increased | 199.81 | 17.99 | 215 | 131538 | 22262 | 79590373 |
| Overdose | 198.31 | 17.99 | 33 | 131720 | 184173 | 79428462 |
| Carbohydrate antigen 15-3 increased | 186.28 | 17.99 | 71 | 131682 | 1108 | 79611527 |
| Treatment failure | 178.15 | 17.99 | 33 | 131720 | 170453 | 79442182 |
| Tachycardia | 174.20 | 17.99 | 40 | 131713 | 177728 | 79434907 |
| Cardiac arrest | 174.17 | 17.99 | 36 | 131717 | 172060 | 79440575 |
| Intentional product use issue | 173.52 | 17.99 | 23 | 131730 | 152089 | 79460546 |
| Systemic lupus erythematosus | 173.26 | 17.99 | 6 | 131747 | 121143 | 79491492 |
| Metastases to liver | 169.04 | 17.99 | 221 | 131532 | 28093 | 79584542 |
| Breast cancer metastatic | 165.40 | 17.99 | 127 | 131626 | 8475 | 79604160 |
| Hand deformity | 156.66 | 17.99 | 3 | 131750 | 103916 | 79508719 |
| Malignant neoplasm progression | 152.47 | 17.99 | 533 | 131220 | 135457 | 79477178 |
| Pericarditis | 149.63 | 17.99 | 5 | 131748 | 104231 | 79508404 |
| Drug intolerance | 148.10 | 17.99 | 131 | 131622 | 263988 | 79348647 |
| Illness | 147.54 | 17.99 | 271 | 131482 | 46240 | 79566395 |
| Joint swelling | 144.74 | 17.99 | 158 | 131595 | 288488 | 79324147 |
| Bradycardia | 144.30 | 17.99 | 25 | 131728 | 135532 | 79477103 |
| Therapy change | 139.56 | 17.99 | 108 | 131645 | 7291 | 79605344 |
| Cardio-respiratory arrest | 137.69 | 17.99 | 11 | 131742 | 108499 | 79504136 |
| Arthropathy | 134.62 | 17.99 | 62 | 131691 | 177049 | 79435586 |
| Respiratory failure | 133.42 | 17.99 | 66 | 131687 | 180845 | 79431790 |
| Gastrointestinal haemorrhage | 131.88 | 17.99 | 40 | 131713 | 147679 | 79464956 |
| Madarosis | 127.49 | 17.99 | 71 | 131682 | 2731 | 79609904 |
| Multiple organ dysfunction syndrome | 126.20 | 17.99 | 23 | 131730 | 120223 | 79492412 |
| COVID-19 | 124.09 | 17.99 | 553 | 131200 | 157121 | 79455514 |
| Therapeutic product effect incomplete | 123.51 | 17.99 | 40 | 131713 | 141605 | 79471030 |
| Back pain | 123.50 | 17.99 | 893 | 130860 | 303287 | 79309348 |
| Cough | 122.50 | 17.99 | 1029 | 130724 | 365760 | 79246875 |
| Metabolic acidosis | 121.97 | 17.99 | 3 | 131750 | 82526 | 79530109 |
| Pneumonia | 116.91 | 17.99 | 628 | 131125 | 659618 | 78953017 |
| Breast pain | 116.79 | 17.99 | 102 | 131651 | 8163 | 79604472 |
| Suicide attempt | 115.53 | 17.99 | 5 | 131748 | 82927 | 79529708 |
| Psoriatic arthropathy | 114.65 | 17.99 | 3 | 131750 | 77996 | 79534639 |
| Lymphoedema | 114.32 | 17.99 | 121 | 131632 | 12292 | 79600343 |
| Asthma | 112.85 | 17.99 | 41 | 131712 | 135054 | 79477581 |
| Hypersensitivity | 112.18 | 17.99 | 162 | 131591 | 262077 | 79350558 |
| Lower respiratory tract infection | 111.77 | 17.99 | 37 | 131716 | 129183 | 79483452 |
| Injection site pain | 110.87 | 17.99 | 38 | 131715 | 129800 | 79482835 |
| Product use issue | 110.71 | 17.99 | 658 | 131095 | 209164 | 79403471 |
| Ageusia | 110.62 | 17.99 | 137 | 131616 | 16495 | 79596140 |
| Coma | 110.61 | 17.99 | 17 | 131736 | 100632 | 79512003 |
| Arthralgia | 109.67 | 17.99 | 1433 | 130320 | 570370 | 79042265 |
| Hyperkalaemia | 109.57 | 17.99 | 27 | 131726 | 114371 | 79498264 |
| Memory impairment | 108.43 | 17.99 | 418 | 131335 | 111316 | 79501319 |
| Decreased immune responsiveness | 107.83 | 17.99 | 82 | 131671 | 5393 | 79607242 |
| Hyponatraemia | 107.35 | 17.99 | 82 | 131671 | 177766 | 79434869 |
| Depressed level of consciousness | 106.96 | 17.99 | 16 | 131737 | 96636 | 79515999 |
| Seizure | 106.61 | 17.99 | 93 | 131660 | 188741 | 79423894 |
| Septic shock | 106.49 | 17.99 | 35 | 131718 | 122766 | 79489869 |
| Hypertension | 106.30 | 17.99 | 244 | 131509 | 330748 | 79281887 |
| Confusional state | 105.73 | 17.99 | 230 | 131523 | 317767 | 79294868 |
| Syncope | 105.46 | 17.99 | 85 | 131668 | 179364 | 79433271 |
| Swelling | 103.84 | 17.99 | 123 | 131630 | 216588 | 79396047 |
| White blood cell disorder | 103.54 | 17.99 | 65 | 131688 | 3127 | 79609508 |
| Nail disorder | 101.19 | 17.99 | 111 | 131642 | 11741 | 79600894 |
| Oral mucosal blistering | 96.18 | 17.99 | 81 | 131672 | 6170 | 79606465 |
| Hypoglycaemia | 95.33 | 17.99 | 25 | 131728 | 101569 | 79511066 |
| Atrial fibrillation | 94.07 | 17.99 | 113 | 131640 | 197773 | 79414862 |
| C-reactive protein increased | 93.72 | 17.99 | 48 | 131705 | 128979 | 79483656 |
| Injection site erythema | 93.66 | 17.99 | 10 | 131743 | 78187 | 79534448 |
| Cytopenia | 93.20 | 17.99 | 140 | 131613 | 20243 | 79592392 |
| Wound | 92.49 | 17.99 | 38 | 131715 | 116141 | 79496494 |
| Cardiac failure congestive | 92.05 | 17.99 | 61 | 131692 | 142341 | 79470294 |
| Cancer pain | 91.25 | 17.99 | 73 | 131680 | 5172 | 79607463 |
| Fall | 91.16 | 17.99 | 455 | 131298 | 487174 | 79125461 |
| Oxygen saturation decreased | 87.94 | 17.99 | 52 | 131701 | 128995 | 79483640 |
| Condition aggravated | 87.28 | 17.99 | 479 | 131274 | 500645 | 79111990 |
| Blood pressure systolic increased | 87.23 | 17.99 | 6 | 131747 | 66980 | 79545655 |
| Acute myocardial infarction | 86.99 | 17.99 | 12 | 131741 | 77024 | 79535611 |
| Myocardial infarction | 86.61 | 17.99 | 106 | 131647 | 184023 | 79428612 |
| Haemoglobin decreased | 86.02 | 17.99 | 645 | 131108 | 221474 | 79391161 |
| Dyspepsia | 85.32 | 17.99 | 381 | 131372 | 108306 | 79504329 |
| International normalised ratio increased | 85.11 | 17.99 | 18 | 131735 | 84703 | 79527932 |
| Flatulence | 84.22 | 17.99 | 205 | 131548 | 42519 | 79570116 |
| Anaphylactic reaction | 83.70 | 17.99 | 18 | 131735 | 83725 | 79528910 |
| Angioedema | 83.18 | 17.99 | 13 | 131740 | 76022 | 79536613 |
| Delirium | 82.95 | 17.99 | 19 | 131734 | 84608 | 79528027 |
| Thrombocytopenia | 82.08 | 17.99 | 732 | 131021 | 264527 | 79348108 |
| Coronary artery disease | 82.05 | 17.99 | 7 | 131746 | 65467 | 79547168 |
| Lactic acidosis | 81.76 | 17.99 | 10 | 131743 | 70349 | 79542286 |
| Respiratory arrest | 81.75 | 17.99 | 3 | 131750 | 57547 | 79555088 |
| Medication error | 81.65 | 17.99 | 9 | 131744 | 68633 | 79544002 |
| Nasal dryness | 80.43 | 17.99 | 64 | 131689 | 4499 | 79608136 |
| Sepsis | 79.87 | 17.99 | 207 | 131546 | 269221 | 79343414 |
| Gingival pain | 79.84 | 17.99 | 86 | 131667 | 8912 | 79603723 |
| Haematuria | 79.46 | 17.99 | 10 | 131743 | 68826 | 79543809 |
| Injury | 78.81 | 17.99 | 16 | 131737 | 77480 | 79535155 |
| Cardiac failure | 78.39 | 17.99 | 84 | 131669 | 154758 | 79457877 |
| Osteonecrosis of jaw | 77.44 | 17.99 | 200 | 131553 | 43026 | 79569609 |
| Encephalopathy | 77.29 | 17.99 | 10 | 131743 | 67387 | 79545248 |
| Psoriasis | 76.85 | 17.99 | 26 | 131727 | 89561 | 79523074 |
| Pneumonia aspiration | 76.64 | 17.99 | 10 | 131743 | 66957 | 79545678 |
| Oedema peripheral | 75.41 | 17.99 | 193 | 131560 | 252095 | 79360540 |
| Hair texture abnormal | 74.20 | 17.99 | 55 | 131698 | 3479 | 79609156 |
| Mobility decreased | 74.13 | 17.99 | 56 | 131697 | 122119 | 79490516 |
| Immune system disorder | 73.59 | 17.99 | 91 | 131662 | 10938 | 79601697 |
| Ill-defined disorder | 72.66 | 17.99 | 11 | 131742 | 65864 | 79546771 |
| Blood pressure increased | 70.92 | 17.99 | 152 | 131601 | 211208 | 79401427 |
| Blood creatine phosphokinase increased | 70.73 | 17.99 | 12 | 131741 | 66078 | 79546557 |
| Wheezing | 70.11 | 17.99 | 54 | 131699 | 116610 | 79496025 |
| Tumour marker abnormal | 70.09 | 17.99 | 24 | 131729 | 270 | 79612365 |
| Agitation | 69.62 | 17.99 | 39 | 131714 | 99676 | 79512959 |
| Dry mouth | 69.42 | 17.99 | 309 | 131444 | 87710 | 79524925 |
| Plasma cell myeloma | 68.68 | 17.99 | 5 | 131748 | 53254 | 79559381 |
| Neoplasm recurrence | 67.72 | 17.99 | 56 | 131697 | 4158 | 79608477 |
| Suicidal ideation | 67.52 | 17.99 | 21 | 131732 | 76319 | 79536316 |
| Anaemia | 66.77 | 17.99 | 1069 | 130684 | 443946 | 79168689 |
| Loss of consciousness | 65.80 | 17.99 | 110 | 131643 | 167833 | 79444802 |
| Musculoskeletal stiffness | 65.50 | 17.99 | 118 | 131635 | 174890 | 79437745 |
| Hallucination | 65.15 | 17.99 | 30 | 131723 | 85715 | 79526920 |
| Irritable bowel syndrome | 65.09 | 17.99 | 12 | 131741 | 62229 | 79550406 |
| Oropharyngeal pain | 64.89 | 17.99 | 354 | 131399 | 108999 | 79503636 |
| Incorrect dose administered | 64.42 | 17.99 | 23 | 131730 | 76607 | 79536028 |
| Sedation | 63.81 | 17.99 | 6 | 131747 | 51889 | 79560746 |
| Discomfort | 63.74 | 17.99 | 68 | 131685 | 125549 | 79487086 |
| Myelosuppression | 63.67 | 17.99 | 178 | 131575 | 40118 | 79572517 |
| Hypokalaemia | 63.52 | 17.99 | 87 | 131666 | 143953 | 79468682 |
| Orthostatic hypotension | 62.82 | 17.99 | 9 | 131744 | 56155 | 79556480 |
| Aggression | 62.37 | 17.99 | 6 | 131747 | 50952 | 79561683 |
| Dry eye | 62.20 | 17.99 | 167 | 131586 | 36764 | 79575871 |
| Adverse event | 62.13 | 17.99 | 12 | 131741 | 60202 | 79552433 |
| Dizziness | 62.04 | 17.99 | 1217 | 130536 | 525224 | 79087411 |
| Type 2 diabetes mellitus | 61.96 | 17.99 | 10 | 131743 | 57112 | 79555523 |
| Rhinorrhoea | 61.45 | 17.99 | 269 | 131484 | 75805 | 79536830 |
| Abdominal discomfort | 61.42 | 17.99 | 659 | 131094 | 250068 | 79362567 |
| Carbohydrate antigen 27.29 increased | 60.39 | 17.99 | 15 | 131738 | 45 | 79612590 |
| Insomnia | 60.34 | 17.99 | 645 | 131108 | 244525 | 79368110 |
| Unresponsive to stimuli | 59.99 | 17.99 | 10 | 131743 | 55778 | 79556857 |
| Urticaria | 59.82 | 17.99 | 136 | 131617 | 185065 | 79427570 |
| PIK3CA-activated mutation | 59.81 | 17.99 | 26 | 131727 | 577 | 79612058 |
| Hypoxia | 59.27 | 17.99 | 50 | 131703 | 103193 | 79509442 |
| Dysarthria | 59.10 | 17.99 | 19 | 131734 | 67603 | 79545032 |
| Hypoacusis | 58.71 | 17.99 | 144 | 131609 | 30006 | 79582629 |
| Angina pectoris | 58.54 | 17.99 | 8 | 131745 | 51724 | 79560911 |
| Injection site reaction | 58.51 | 17.99 | 10 | 131743 | 54775 | 79557860 |
| Cytomegalovirus infection | 58.00 | 17.99 | 3 | 131750 | 42641 | 79569994 |
| Febrile neutropenia | 57.88 | 17.99 | 192 | 131561 | 230807 | 79381828 |
| Injection site pruritus | 57.43 | 17.99 | 3 | 131750 | 42280 | 79570355 |
| Vomiting | 57.02 | 17.99 | 1471 | 130282 | 664357 | 78948278 |
| Altered state of consciousness | 56.84 | 17.99 | 4 | 131749 | 43818 | 79568817 |
| Fibromyalgia | 56.37 | 17.99 | 18 | 131735 | 64322 | 79548313 |
| Renal failure | 56.07 | 17.99 | 159 | 131594 | 200809 | 79411826 |
| Psychotic disorder | 56.04 | 17.99 | 3 | 131750 | 41399 | 79571236 |
| Musculoskeletal chest pain | 55.54 | 17.99 | 125 | 131628 | 24639 | 79587996 |
| Pulmonary hypertension | 55.45 | 17.99 | 7 | 131746 | 48073 | 79564562 |
| Respiratory distress | 55.40 | 17.99 | 14 | 131739 | 58325 | 79554310 |
| Metastases to lung | 55.29 | 17.99 | 104 | 131649 | 18059 | 79594576 |
| Body surface area increased | 55.02 | 17.99 | 17 | 131736 | 134 | 79612501 |
| Heart rate decreased | 54.36 | 17.99 | 24 | 131729 | 70292 | 79542343 |
| General physical health deterioration | 54.14 | 17.99 | 252 | 131501 | 274986 | 79337649 |
| Ventricular tachycardia | 53.89 | 17.99 | 4 | 131749 | 41931 | 79570704 |
| Cardiogenic shock | 53.86 | 17.99 | 4 | 131749 | 41910 | 79570725 |
| Melaena | 53.40 | 17.99 | 17 | 131736 | 60873 | 79551762 |
| Oedema | 52.95 | 17.99 | 72 | 131681 | 119508 | 79493127 |
| Product packaging difficult to open | 52.85 | 17.99 | 13 | 131740 | 37 | 79612598 |
| Inappropriate schedule of product administration | 52.83 | 17.99 | 87 | 131666 | 133541 | 79479094 |
| Blood cholesterol increased | 52.57 | 17.99 | 37 | 131716 | 83683 | 79528952 |
| Stevens-Johnson syndrome | 52.51 | 17.99 | 3 | 131750 | 39163 | 79573472 |
| Off label use | 52.49 | 17.99 | 1122 | 130631 | 906093 | 78706542 |
| Rash maculo-papular | 52.22 | 17.99 | 14 | 131739 | 56064 | 79556571 |
| Drug dependence | 52.08 | 17.99 | 4 | 131749 | 40765 | 79571870 |
| Appetite disorder | 51.87 | 17.99 | 64 | 131689 | 7675 | 79604960 |
| Abdominal pain | 51.71 | 17.99 | 404 | 131349 | 389165 | 79223470 |
| Pyrexia | 51.61 | 17.99 | 800 | 130953 | 677909 | 78934726 |
| Flushing | 51.60 | 17.99 | 42 | 131711 | 88226 | 79524409 |
| Therapeutic response decreased | 51.39 | 17.99 | 23 | 131730 | 66830 | 79545805 |
| Drug ineffective for unapproved indication | 51.23 | 17.99 | 11 | 131742 | 51227 | 79561408 |
| Hair growth abnormal | 51.12 | 17.99 | 40 | 131713 | 2744 | 79609891 |
| Leukocytosis | 50.92 | 17.99 | 6 | 131747 | 43449 | 79569186 |
| Pancreatitis | 50.55 | 17.99 | 25 | 131728 | 68550 | 79544085 |
| Hypoaesthesia | 49.92 | 17.99 | 484 | 131269 | 178868 | 79433767 |
| Erythema | 49.71 | 17.99 | 195 | 131558 | 223095 | 79389540 |
| Skin exfoliation | 49.28 | 17.99 | 201 | 131552 | 54899 | 79557736 |
| Therapy non-responder | 49.06 | 17.99 | 48 | 131705 | 92257 | 79520378 |
| Hepatic lesion | 49.00 | 17.99 | 59 | 131694 | 6900 | 79605735 |
| Blood pressure fluctuation | 48.71 | 17.99 | 25 | 131728 | 67120 | 79545515 |
| Mental status changes | 48.47 | 17.99 | 25 | 131728 | 66934 | 79545701 |
| Feeling cold | 48.47 | 17.99 | 130 | 131623 | 28599 | 79584036 |
| Adverse drug reaction | 47.75 | 17.99 | 25 | 131728 | 66367 | 79546268 |
| Hepatic enzyme increased | 47.68 | 17.99 | 149 | 131604 | 182461 | 79430174 |
| Body surface area decreased | 47.59 | 17.99 | 12 | 131741 | 39 | 79612596 |
| Eating disorder | 47.01 | 17.99 | 105 | 131648 | 20592 | 79592043 |
| Product dispensing error | 46.82 | 17.99 | 81 | 131672 | 13182 | 79599453 |
| Unevaluable event | 46.18 | 17.99 | 17 | 131736 | 55568 | 79557067 |
| Rhabdomyolysis | 45.76 | 17.99 | 62 | 131691 | 103069 | 79509566 |
| Spinal pain | 45.45 | 17.99 | 87 | 131666 | 15305 | 79597330 |
| Sleep apnoea syndrome | 45.43 | 17.99 | 4 | 131749 | 36474 | 79576161 |
| Circulatory collapse | 44.64 | 17.99 | 5 | 131748 | 37663 | 79574972 |
| Bursitis | 44.45 | 17.99 | 4 | 131749 | 35840 | 79576795 |
| Nail growth abnormal | 44.41 | 17.99 | 20 | 131733 | 484 | 79612151 |
| Feeling abnormal | 43.51 | 17.99 | 428 | 131325 | 158771 | 79453864 |
| Osteoarthritis | 43.47 | 17.99 | 48 | 131705 | 87261 | 79525374 |
| Trichorrhexis | 43.41 | 17.99 | 23 | 131730 | 800 | 79611835 |
| Carcinoembryonic antigen increased | 43.32 | 17.99 | 33 | 131720 | 2176 | 79610459 |
| Upper gastrointestinal haemorrhage | 43.22 | 17.99 | 8 | 131745 | 41372 | 79571263 |
| Hypomagnesaemia | 43.14 | 17.99 | 12 | 131741 | 46899 | 79565736 |
| Drug level increased | 42.87 | 17.99 | 7 | 131746 | 39644 | 79572991 |
| Drug eruption | 42.78 | 17.99 | 10 | 131743 | 43925 | 79568710 |
| Drug withdrawal syndrome | 42.72 | 17.99 | 4 | 131749 | 34714 | 79577921 |
| Arrhythmia | 42.71 | 17.99 | 24 | 131729 | 61248 | 79551387 |
| Adnexa uteri mass | 42.41 | 17.99 | 18 | 131735 | 376 | 79612259 |
| Shock | 42.23 | 17.99 | 10 | 131743 | 43538 | 79569097 |
| Pallor | 42.12 | 17.99 | 15 | 131738 | 50047 | 79562588 |
| Proteinuria | 42.06 | 17.99 | 3 | 131750 | 32499 | 79580136 |
| Product quality issue | 41.52 | 17.99 | 4 | 131749 | 33936 | 79578699 |
| Tachypnoea | 41.37 | 17.99 | 3 | 131750 | 32060 | 79580575 |
| Heart rate increased | 41.16 | 17.99 | 86 | 131667 | 120638 | 79491997 |
| Cerebral haemorrhage | 41.06 | 17.99 | 22 | 131731 | 57651 | 79554984 |
| Obesity | 40.79 | 17.99 | 5 | 131748 | 35120 | 79577515 |
| Accidental exposure to product | 40.22 | 17.99 | 3 | 131750 | 31319 | 79581316 |
| Haematoma | 40.05 | 17.99 | 18 | 131735 | 52177 | 79560458 |
| Injection site swelling | 39.86 | 17.99 | 14 | 131739 | 47118 | 79565517 |
| Anaphylactic shock | 39.72 | 17.99 | 6 | 131747 | 35990 | 79576645 |
| Night sweats | 39.65 | 17.99 | 181 | 131572 | 51914 | 79560721 |
| Diabetic ketoacidosis | 39.27 | 17.99 | 5 | 131748 | 34117 | 79578518 |
| Acute respiratory failure | 39.15 | 17.99 | 25 | 131728 | 59516 | 79553119 |
| Emotional distress | 39.11 | 17.99 | 9 | 131744 | 39960 | 79572675 |
| Neutrophil count abnormal | 39.09 | 17.99 | 38 | 131715 | 3488 | 79609147 |
| Sinus tachycardia | 38.84 | 17.99 | 7 | 131746 | 36901 | 79575734 |
| Tremor | 38.18 | 17.99 | 148 | 131605 | 169935 | 79442700 |
| Prescribed overdose | 38.14 | 17.99 | 8 | 131745 | 37875 | 79574760 |
| Incorrect route of product administration | 38.14 | 17.99 | 6 | 131747 | 34923 | 79577712 |
| Abnormal behaviour | 38.13 | 17.99 | 7 | 131746 | 36414 | 79576221 |
| Knee arthroplasty | 38.06 | 17.99 | 12 | 131741 | 43236 | 79569399 |
| Nasal discomfort | 37.81 | 17.99 | 46 | 131707 | 5437 | 79607198 |
| Pulmonary thrombosis | 37.43 | 17.99 | 70 | 131683 | 12101 | 79600534 |
| Acute respiratory distress syndrome | 37.42 | 17.99 | 13 | 131740 | 44054 | 79568581 |
| Prescribed underdose | 37.41 | 17.99 | 3 | 131750 | 29511 | 79583124 |
| Pruritus | 37.29 | 17.99 | 884 | 130869 | 393764 | 79218871 |
| Dyskinesia | 36.68 | 17.99 | 14 | 131739 | 44759 | 79567876 |
| Urine odour abnormal | 35.95 | 17.99 | 48 | 131705 | 6225 | 79606410 |
| Chest pain | 35.93 | 17.99 | 296 | 131457 | 282008 | 79330627 |
| Pseudocirrhosis | 35.86 | 17.99 | 19 | 131734 | 661 | 79611974 |
| Blood pressure diastolic decreased | 35.83 | 17.99 | 4 | 131749 | 30212 | 79582423 |
| Electrocardiogram QT prolonged | 35.58 | 17.99 | 59 | 131694 | 90327 | 79522308 |
| Hypervolaemia | 35.56 | 17.99 | 13 | 131740 | 42677 | 79569958 |
| Coagulopathy | 35.45 | 17.99 | 8 | 131745 | 35998 | 79576637 |
| Basal cell carcinoma | 35.43 | 17.99 | 9 | 131744 | 37366 | 79575269 |
| Inflammation | 35.25 | 17.99 | 63 | 131690 | 93690 | 79518945 |
| Injection site haemorrhage | 34.86 | 17.99 | 3 | 131750 | 27867 | 79584768 |
| Malignant pleural effusion | 34.83 | 17.99 | 35 | 131718 | 3345 | 79609290 |
| Blood pressure decreased | 34.63 | 17.99 | 70 | 131683 | 99396 | 79513239 |
| Respiratory depression | 34.49 | 17.99 | 3 | 131750 | 27627 | 79585008 |
| Hemiparesis | 34.22 | 17.99 | 7 | 131746 | 33726 | 79578909 |
| Hair disorder | 34.10 | 17.99 | 22 | 131731 | 1110 | 79611525 |
| Staphylococcal infection | 33.74 | 17.99 | 28 | 131725 | 58267 | 79554368 |
| Ventricular fibrillation | 33.71 | 17.99 | 6 | 131747 | 31920 | 79580715 |
| Injection site bruising | 33.29 | 17.99 | 13 | 131740 | 40989 | 79571646 |
| Withdrawal syndrome | 33.29 | 17.99 | 3 | 131750 | 26851 | 79585784 |
| Obstructive airways disorder | 33.03 | 17.99 | 6 | 131747 | 31453 | 79581182 |
| Liver injury | 33.01 | 17.99 | 27 | 131726 | 56587 | 79556048 |
| Body temperature increased | 31.54 | 17.99 | 17 | 131736 | 44403 | 79568232 |
| Toothache | 31.33 | 17.99 | 88 | 131665 | 19882 | 79592753 |
| Thrombosis | 31.26 | 17.99 | 242 | 131511 | 83858 | 79528777 |
| Tubulointerstitial nephritis | 31.25 | 17.99 | 12 | 131741 | 38223 | 79574412 |
| Myocardial ischaemia | 31.24 | 17.99 | 3 | 131750 | 25516 | 79587119 |
| Wrong technique in product usage process | 31.19 | 17.99 | 46 | 131707 | 73829 | 79538806 |
| Palpitations | 31.17 | 17.99 | 106 | 131647 | 126504 | 79486131 |
| Pancreatitis acute | 31.04 | 17.99 | 22 | 131731 | 49582 | 79563053 |
| Disorientation | 30.71 | 17.99 | 35 | 131718 | 62741 | 79549894 |
| Urinary retention | 30.61 | 17.99 | 29 | 131724 | 56601 | 79556034 |
| Pleural neoplasm | 30.52 | 17.99 | 14 | 131739 | 354 | 79612281 |
| Metastases to bladder | 30.52 | 17.99 | 13 | 131740 | 274 | 79612361 |
| Chronic kidney disease | 30.13 | 17.99 | 39 | 131714 | 66115 | 79546520 |
| Alanine aminotransferase increased | 30.11 | 17.99 | 152 | 131601 | 162418 | 79450217 |
| Weight decreased | 30.07 | 17.99 | 784 | 130969 | 354414 | 79258221 |
| Increased appetite | 29.75 | 17.99 | 63 | 131690 | 11915 | 79600720 |
| Faeces soft | 29.60 | 17.99 | 51 | 131702 | 8272 | 79604363 |
| Ovarian disorder | 29.57 | 17.99 | 15 | 131738 | 476 | 79612159 |
| Prehypertension | 29.55 | 17.99 | 7 | 131746 | 16 | 79612619 |
| Hyperglycaemia | 29.50 | 17.99 | 44 | 131709 | 70291 | 79542344 |
| Breast cancer recurrent | 29.17 | 17.99 | 30 | 131723 | 2947 | 79609688 |
| Treatment noncompliance | 29.16 | 17.99 | 26 | 131727 | 52242 | 79560393 |
| Granulocyte count decreased | 29.00 | 17.99 | 24 | 131729 | 1784 | 79610851 |
| Body height decreased | 28.48 | 17.99 | 51 | 131702 | 8529 | 79604106 |
| Renal tubular necrosis | 28.03 | 17.99 | 4 | 131749 | 25035 | 79587600 |
| Haemorrhage intracranial | 27.49 | 17.99 | 5 | 131748 | 26188 | 79586447 |
| Poor quality product administered | 27.47 | 17.99 | 32 | 131721 | 3613 | 79609022 |
| Hallucination, visual | 27.20 | 17.99 | 10 | 131743 | 32719 | 79579916 |
| Drug-induced liver injury | 27.11 | 17.99 | 42 | 131711 | 66075 | 79546560 |
| Haematotoxicity | 26.96 | 17.99 | 71 | 131682 | 15448 | 79597187 |
| Neurotoxicity | 26.92 | 17.99 | 10 | 131743 | 32508 | 79580127 |
| Bone cancer | 26.77 | 17.99 | 24 | 131729 | 1988 | 79610647 |
| Deep vein thrombosis | 26.63 | 17.99 | 106 | 131647 | 120813 | 79491822 |
| Vulvovaginal dryness | 26.61 | 17.99 | 25 | 131728 | 2199 | 79610436 |
| Foot deformity | 26.59 | 17.99 | 4 | 131749 | 24070 | 79588565 |
| Chronic obstructive pulmonary disease | 26.54 | 17.99 | 64 | 131689 | 85355 | 79527280 |
| Hip arthroplasty | 26.40 | 17.99 | 13 | 131740 | 35743 | 79576892 |
| Liver function test abnormal | 26.39 | 17.99 | 41 | 131712 | 64434 | 79548201 |
| Face oedema | 26.24 | 17.99 | 7 | 131746 | 28129 | 79584506 |
| Transient ischaemic attack | 26.20 | 17.99 | 29 | 131724 | 52666 | 79559969 |
| Haematochezia | 26.19 | 17.99 | 67 | 131686 | 87578 | 79525057 |
| Aphthous ulcer | 26.08 | 17.99 | 74 | 131679 | 16815 | 79595820 |
| Myelodysplastic syndrome | 25.63 | 17.99 | 9 | 131744 | 30292 | 79582343 |
| Skin ulcer | 25.62 | 17.99 | 31 | 131722 | 54119 | 79558516 |
| Labelled drug-drug interaction medication error | 25.56 | 17.99 | 7 | 131746 | 27643 | 79584992 |
| Bronchospasm | 25.55 | 17.99 | 5 | 131748 | 24854 | 79587781 |
| Headache | 25.48 | 17.99 | 1322 | 130431 | 652450 | 78960185 |
| Subdural haematoma | 25.47 | 17.99 | 10 | 131743 | 31424 | 79581211 |
| Rectal haemorrhage | 25.46 | 17.99 | 55 | 131698 | 76245 | 79536390 |
| Pleural effusion | 25.22 | 17.99 | 358 | 131395 | 144904 | 79467731 |
| Emotional disorder | 25.18 | 17.99 | 66 | 131687 | 14321 | 79598314 |
| Device malfunction | 25.03 | 17.99 | 3 | 131750 | 21445 | 79591190 |
| Osteonecrosis | 25.02 | 17.99 | 10 | 131743 | 31085 | 79581550 |
| Clostridium difficile colitis | 24.98 | 17.99 | 11 | 131742 | 32272 | 79580363 |
| Parosmia | 24.97 | 17.99 | 43 | 131710 | 6971 | 79605664 |
| Restlessness | 24.90 | 17.99 | 24 | 131729 | 46468 | 79566167 |
| Therapeutic response unexpected | 24.81 | 17.99 | 81 | 131672 | 19865 | 79592770 |
| Red blood cell count abnormal | 24.80 | 17.99 | 20 | 131733 | 1433 | 79611202 |
| Diabetes mellitus inadequate control | 24.69 | 17.99 | 5 | 131748 | 24259 | 79588376 |
| Hypersomnia | 24.56 | 17.99 | 89 | 131664 | 22997 | 79589638 |
| Hepatic encephalopathy | 24.54 | 17.99 | 5 | 131748 | 24161 | 79588474 |
| Blood triglycerides increased | 24.42 | 17.99 | 3 | 131750 | 21037 | 79591598 |
| Nasopharyngitis | 24.35 | 17.99 | 570 | 131183 | 253311 | 79359324 |
| Mastectomy | 24.35 | 17.99 | 18 | 131735 | 1134 | 79611501 |
| Product use complaint | 24.29 | 17.99 | 25 | 131728 | 2458 | 79610177 |
| Accidental overdose | 24.18 | 17.99 | 18 | 131735 | 39563 | 79573072 |
| Diabetes mellitus | 24.15 | 17.99 | 59 | 131694 | 78331 | 79534304 |
| Abdominal pain upper | 24.14 | 17.99 | 511 | 131242 | 223308 | 79389327 |
| Toxic skin eruption | 23.96 | 17.99 | 4 | 131749 | 22289 | 79590346 |
| Sinusitis | 23.95 | 17.99 | 207 | 131546 | 195294 | 79417341 |
| Gastrointestinal disorder | 23.94 | 17.99 | 112 | 131641 | 122093 | 79490542 |
| Lip pain | 23.73 | 17.99 | 23 | 131730 | 2104 | 79610531 |
| Tongue blistering | 23.57 | 17.99 | 20 | 131733 | 1539 | 79611096 |
| Haemoptysis | 23.51 | 17.99 | 35 | 131718 | 55964 | 79556671 |
| Nephropathy toxic | 23.48 | 17.99 | 3 | 131750 | 20416 | 79592219 |
| Muscle twitching | 23.40 | 17.99 | 6 | 131747 | 24758 | 79587877 |
| Metastases to retroperitoneum | 23.34 | 17.99 | 12 | 131741 | 392 | 79612243 |
| Grip strength decreased | 23.33 | 17.99 | 4 | 131749 | 21865 | 79590770 |
| Joint range of motion decreased | 23.25 | 17.99 | 13 | 131740 | 33269 | 79579366 |
| Hepatitis | 23.23 | 17.99 | 35 | 131718 | 55692 | 79556943 |
| Paraesthesia | 23.23 | 17.99 | 415 | 131338 | 175908 | 79436727 |
| Epilepsy | 23.19 | 17.99 | 20 | 131733 | 40840 | 79571795 |
| Muscle spasms | 22.93 | 17.99 | 411 | 131342 | 174319 | 79438316 |
| Cerebral infarction | 22.86 | 17.99 | 25 | 131728 | 45651 | 79566984 |
| Metastases to lymph nodes | 22.78 | 17.99 | 52 | 131701 | 10345 | 79602290 |
| Tongue discomfort | 22.74 | 17.99 | 24 | 131729 | 2429 | 79610206 |
| Noninfective gingivitis | 22.73 | 17.99 | 20 | 131733 | 1616 | 79611019 |
| Infusion site coldness | 22.71 | 17.99 | 10 | 131743 | 229 | 79612406 |
| Peritonitis | 22.58 | 17.99 | 9 | 131744 | 28027 | 79584608 |
| Eructation | 22.19 | 17.99 | 53 | 131700 | 10856 | 79601779 |
| Agranulocytosis | 22.14 | 17.99 | 25 | 131728 | 45005 | 79567630 |
| Cyanosis | 22.13 | 17.99 | 7 | 131746 | 25175 | 79587460 |
| Dental discomfort | 22.12 | 17.99 | 12 | 131741 | 438 | 79612197 |
| Radiation injury | 22.05 | 17.99 | 15 | 131738 | 828 | 79611807 |
| Cholelithiasis | 22.03 | 17.99 | 33 | 131720 | 52631 | 79560004 |
| Ataxia | 21.94 | 17.99 | 7 | 131746 | 25032 | 79587603 |
| Aphasia | 21.85 | 17.99 | 27 | 131726 | 46705 | 79565930 |
| Joint neoplasm | 21.84 | 17.99 | 7 | 131746 | 63 | 79612572 |
| Nail discolouration | 21.83 | 17.99 | 26 | 131727 | 3005 | 79609630 |
| Neuroendocrine breast tumour | 21.74 | 17.99 | 6 | 131747 | 30 | 79612605 |
| Splenomegaly | 21.70 | 17.99 | 4 | 131749 | 20750 | 79591885 |
| Metastases to eye | 21.65 | 17.99 | 10 | 131743 | 257 | 79612378 |
| Hallucination, auditory | 21.61 | 17.99 | 4 | 131749 | 20689 | 79591946 |
| Product packaging issue | 21.11 | 17.99 | 17 | 131736 | 1216 | 79611419 |
| Gingival bleeding | 21.06 | 17.99 | 67 | 131686 | 16209 | 79596426 |
| Atrial flutter | 20.90 | 17.99 | 5 | 131748 | 21620 | 79591015 |
| Hypothyroidism | 20.80 | 17.99 | 34 | 131719 | 52358 | 79560277 |
| Nail avulsion | 20.75 | 17.99 | 8 | 131745 | 129 | 79612506 |
| Hyperaesthesia teeth | 20.66 | 17.99 | 20 | 131733 | 1826 | 79610809 |
| Oral herpes | 20.60 | 17.99 | 95 | 131658 | 27359 | 79585276 |
| Tooth disorder | 20.60 | 17.99 | 92 | 131661 | 26141 | 79586494 |
| Dialysis | 20.55 | 17.99 | 3 | 131750 | 18459 | 79594176 |
| Cardiomegaly | 20.36 | 17.99 | 9 | 131744 | 26343 | 79586292 |
| Inappropriate antidiuretic hormone secretion | 20.30 | 17.99 | 9 | 131744 | 26304 | 79586331 |
| Electrolyte imbalance | 20.25 | 17.99 | 13 | 131740 | 30868 | 79581767 |
| Mania | 20.25 | 17.99 | 3 | 131750 | 18257 | 79594378 |
| Feeding disorder | 20.21 | 17.99 | 66 | 131687 | 16188 | 79596447 |
| Acute coronary syndrome | 20.20 | 17.99 | 5 | 131748 | 21128 | 79591507 |
| Metastases to spine | 20.19 | 17.99 | 30 | 131723 | 4294 | 79608341 |
| Ileus | 20.17 | 17.99 | 9 | 131744 | 26202 | 79586433 |
| Metastases to kidney | 20.00 | 17.99 | 12 | 131741 | 532 | 79612103 |
| Soft tissue neoplasm | 19.96 | 17.99 | 7 | 131746 | 85 | 79612550 |
| Bacteraemia | 19.96 | 17.99 | 15 | 131738 | 32809 | 79579826 |
| Pulmonary arterial hypertension | 19.93 | 17.99 | 11 | 131742 | 28355 | 79584280 |
| Joint effusion | 19.88 | 17.99 | 3 | 131750 | 18011 | 79594624 |
| Skin sensitisation | 19.81 | 17.99 | 15 | 131738 | 980 | 79611655 |
| Neutropenic sepsis | 19.74 | 17.99 | 10 | 131743 | 27054 | 79585581 |
| Hypertensive crisis | 19.69 | 17.99 | 5 | 131748 | 20765 | 79591870 |
| Bone lesion | 19.41 | 17.99 | 35 | 131718 | 5884 | 79606751 |
| Hypovolaemia | 19.40 | 17.99 | 3 | 131750 | 17688 | 79594947 |
| Hypogeusia | 19.27 | 17.99 | 19 | 131734 | 1775 | 79610860 |
| Metastases to spinal cord | 19.13 | 17.99 | 6 | 131747 | 50 | 79612585 |
| Breast cancer | 19.12 | 17.99 | 108 | 131645 | 33673 | 79578962 |
| Acute myeloid leukaemia | 18.93 | 17.99 | 14 | 131739 | 30871 | 79581764 |
| Haematemesis | 18.86 | 17.99 | 36 | 131717 | 52228 | 79560407 |
| Aspiration | 18.83 | 17.99 | 5 | 131748 | 20153 | 79592482 |
| Foreign body in throat | 18.74 | 17.99 | 11 | 131742 | 468 | 79612167 |
| Metastases to the mediastinum | 18.73 | 17.99 | 12 | 131741 | 598 | 79612037 |
| Tumour pain | 18.71 | 17.99 | 21 | 131732 | 2278 | 79610357 |
| Post procedural complication | 18.63 | 17.99 | 8 | 131745 | 23821 | 79588814 |
| Tumour marker decreased | 18.62 | 17.99 | 6 | 131747 | 55 | 79612580 |
| Supraventricular tachycardia | 18.54 | 17.99 | 6 | 131747 | 21264 | 79591371 |
| Tongue disorder | 18.52 | 17.99 | 58 | 131695 | 13917 | 79598718 |
| Joint dislocation | 18.29 | 17.99 | 3 | 131750 | 16936 | 79595699 |
| Gamma-glutamyltransferase decreased | 18.21 | 17.99 | 10 | 131743 | 374 | 79612261 |
| Psychomotor hyperactivity | 18.16 | 17.99 | 3 | 131750 | 16846 | 79595789 |
| Uveitis | 18.13 | 17.99 | 3 | 131750 | 16827 | 79595808 |
| Acute cutaneous lupus erythematosus | 18.02 | 17.99 | 10 | 131743 | 382 | 79612253 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EF01 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Cyclin-dependent kinase (CDK) inhibitors |
| FDA MoA | N0000175082 | Kinase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000190114 | Cytochrome P450 3A Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agents |
| CHEBI has role | CHEBI:82665 | EC 2.7.11.22 (cyclin-dependent kinase) inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hormone receptor positive malignant neoplasm of breast | indication | 417181009 | |
| Human epidermal growth factor 2 negative carcinoma of breast | indication | 431396003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.03 | Basic |
| pKa2 | 7.08 | Basic |
| pKa3 | 5.81 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 100MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 100MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 125MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 125MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 125MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 75MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 75MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 75MG | IBRANCE | PFIZER | N207103 | Feb. 3, 2015 | RX | CAPSULE | ORAL | 7456168 | Jan. 16, 2023 | TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 100MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 100MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 125MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 125MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 75MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
| 75MG | IBRANCE | PFIZER | N212436 | Nov. 1, 2019 | RX | TABLET | ORAL | 7456168 | Jan. 16, 2023 | PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY |
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 |
|---|---|---|---|---|---|---|---|---|---|
| Cyclin-dependent kinase 6 | Kinase | INHIBITOR | IC50 | 7.82 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Cyclin-dependent kinase 4 | Kinase | INHIBITOR | IC50 | 7.96 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| AP2-associated protein kinase 1 | Kinase | Kd | 5.38 | CHEMBL | |||||
| Serine/threonine-protein kinase 16 | Kinase | Kd | 5 | CHEMBL | |||||
| BMP-2-inducible protein kinase | Kinase | Kd | 4.58 | CHEMBL | |||||
| Dual specificity protein kinase CLK1 | Kinase | Kd | 6.56 | CHEMBL | |||||
| Cyclin-dependent kinase 16 | Kinase | Kd | 5.56 | CHEMBL | |||||
| Mitogen-activated protein kinase 9 | Kinase | Kd | 5.54 | CHEMBL | |||||
| Cyclin-dependent kinase 9 | Kinase | IC50 | 6.10 | CHEMBL | |||||
| Cyclin-dependent kinase 17 | Kinase | Kd | 5.90 | CHEMBL | |||||
| Casein kinase II subunit alpha' | Kinase | Kd | 6.31 | CHEMBL | |||||
| Dual specificity mitogen-activated protein kinase kinase 4 | Kinase | Kd | 5.90 | CHEMBL | |||||
| Serine/threonine-protein kinase D2 | Kinase | Kd | 5.25 | CHEMBL | |||||
| Tyrosine-protein kinase JAK3 | Kinase | IC50 | 7.20 | CHEMBL | |||||
| Serine/threonine-protein kinase TAO3 | Kinase | Kd | 4.80 | CHEMBL | |||||
| Serine/threonine-protein kinase TAO2 | Kinase | Kd | 4.55 | CHEMBL | |||||
| Phosphatidylinositol 5-phosphate 4-kinase type-2 gamma | Kinase | Kd | 5.76 | CHEMBL | |||||
| Cyclin-dependent kinase 4/cyclin D1 | Kinase | IC50 | 8.70 | CHEMBL | |||||
| CDK2/Cyclin A | Kinase | IC50 | 6.64 | CHEMBL | |||||
| CDK6/cyclin D1 | Kinase | IC50 | 8.42 | CHEMBL | |||||
| Phosphatidylinositol 5-phosphate 4-kinase type-2 alpha | Kinase | Kd | 6.68 | CHEMBL | |||||
| Uncharacterized protein FLJ45252 | Unclassified | Kd | 4.56 | CHEMBL | |||||
| Ribosomal protein S6 kinase alpha-1 | Kinase | INHIBITOR | IC50 | 5.10 | SCIENTIFIC LITERATURE | ||||
| Dual specificity tyrosine-phosphorylation-regulated kinase 1A | Kinase | INHIBITOR | IC50 | 5.70 | SCIENTIFIC LITERATURE | ||||
| Serine/threonine-protein kinase D3 | Kinase | Kd | 4.79 | CHEMBL | |||||
| Receptor-type tyrosine-protein kinase FLT3 | Kinase | IC50 | 5.46 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| G9ZF61LE7G | UNII |
| D10372 | KEGG_DRUG |
| 4034136 | VUID |
| N0000191426 | NUI |
| 827022-33-3 | SECONDARY_CAS_RN |
| 4034136 | VANDF |
| C3853822 | UMLSCUI |
| CHEBI:85993 | CHEBI |
| LQQ | PDB_CHEM_ID |
| CHEMBL189963 | ChEMBL_ID |
| 5330286 | PUBCHEM_CID |
| DB09073 | DRUGBANK_ID |
| CHEMBL2364621 | ChEMBL_ID |
| 9802 | INN_ID |
| C500026 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7380 | IUPHAR_LIGAND_ID |
| 1601374 | RXNORM |
| 232484 | MMSL |
| 30872 | MMSL |
| d08342 | MMSL |
| 015881 | NDDF |
| 715958001 | SNOMEDCT_US |
| 763549001 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0187 | CAPSULE | 75 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0187 | CAPSULE | 75 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0188 | CAPSULE | 100 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0188 | CAPSULE | 100 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0189 | CAPSULE | 125 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0189 | CAPSULE | 125 mg | ORAL | NDA | 29 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0284 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0284 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0486 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0486 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0688 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0688 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-187 | CAPSULE | 75 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-187 | CAPSULE | 75 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-188 | CAPSULE | 100 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-188 | CAPSULE | 100 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-189 | CAPSULE | 125 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-189 | CAPSULE | 125 mg | ORAL | NDA | 33 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-284 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 32 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-284 | TABLET, FILM COATED | 75 mg | ORAL | NDA | 32 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-486 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-486 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 32 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-688 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 32 sections |
| Ibrance | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-688 | TABLET, FILM COATED | 125 mg | ORAL | NDA | 32 sections |