| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5121 | 8047-67-4 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
an oral phosphate binder for treatment of hyperphosphatemia
|
| Dose | Unit | Route |
|---|---|---|
| 0.11 | g | O |
| 1.50 | g | O |
None
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 27, 2013 | FDA | VIFOR FRESENIUS |
| 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 |
|---|---|---|---|---|---|---|
| Death | 418.07 | 52.26 | 159 | 655 | 374222 | 63113986 |
| Shunt stenosis | 123.75 | 52.26 | 18 | 796 | 522 | 63487686 |
| Shunt occlusion | 82.40 | 52.26 | 13 | 801 | 652 | 63487556 |
| Product taste abnormal | 73.92 | 52.26 | 14 | 800 | 2053 | 63486155 |
| Diarrhoea | 71.42 | 52.26 | 64 | 750 | 715302 | 62772906 |
| 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 |
|---|---|---|---|---|---|---|
| Death | 618.40 | 37.90 | 310 | 1276 | 397739 | 34557606 |
| Shunt stenosis | 172.52 | 37.90 | 30 | 1556 | 752 | 34954593 |
| Haemoglobin increased | 133.77 | 37.90 | 31 | 1555 | 3378 | 34951967 |
| Faeces discoloured | 116.28 | 37.90 | 38 | 1548 | 14840 | 34940505 |
| Shunt occlusion | 86.24 | 37.90 | 17 | 1569 | 853 | 34954492 |
| Diarrhoea | 82.58 | 37.90 | 94 | 1492 | 389818 | 34565527 |
| Product taste abnormal | 69.73 | 37.90 | 15 | 1571 | 1159 | 34954186 |
| Transferrin saturation increased | 44.00 | 37.90 | 7 | 1579 | 99 | 34955246 |
| Haematocrit increased | 41.30 | 37.90 | 11 | 1575 | 2102 | 34953243 |
| Serum ferritin increased | 41.17 | 37.90 | 14 | 1572 | 6132 | 34949213 |
| Tooth discolouration | 40.21 | 37.90 | 8 | 1578 | 420 | 34954925 |
| 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 |
|---|---|---|---|---|---|---|
| Shunt stenosis | 312.22 | 33.19 | 48 | 1492 | 1343 | 79741505 |
| Shunt occlusion | 178.53 | 33.19 | 30 | 1510 | 1474 | 79741374 |
| Haemoglobin increased | 153.26 | 33.19 | 33 | 1507 | 6099 | 79736749 |
| Serum ferritin increased | 78.12 | 33.19 | 21 | 1519 | 9826 | 79733022 |
| Transferrin saturation increased | 72.26 | 33.19 | 10 | 1530 | 129 | 79742719 |
| Diarrhoea | 68.68 | 33.19 | 84 | 1456 | 880405 | 78862443 |
| Product taste abnormal | 61.09 | 33.19 | 13 | 1527 | 2258 | 79740590 |
| Peripheral arterial occlusive disease | 57.98 | 33.19 | 16 | 1524 | 8242 | 79734606 |
| Haematocrit increased | 53.66 | 33.19 | 13 | 1527 | 4021 | 79738827 |
| Hyperparathyroidism secondary | 53.54 | 33.19 | 12 | 1528 | 2648 | 79740200 |
| Faeces discoloured | 52.11 | 33.19 | 20 | 1520 | 29107 | 79713741 |
None
| Source | Code | Description |
|---|---|---|
| ATC | B03AB02 | BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS IRON PREPARATIONS Iron trivalent, oral preparations |
| ATC | V03AE05 | VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia |
| FDA MoA | N0000020074 | Phosphate Chelating Activity |
| FDA EPC | N0000175597 | Phosphate Binder |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hyperphosphatemia | indication | 20165001 | DOID:0050459 |
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 500MG IRON | VELPHORO | VIFOR FRESENIUS | N205109 | Nov. 27, 2013 | RX | TABLET, CHEWABLE | ORAL | 9561251 | Jan. 23, 2030 | CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS |
None
None
| ID | Source |
|---|---|
| 20344-49-4 | SECONDARY_CAS_RN |
| D04616 | KEGG_DRUG |
| 4021278 | VANDF |
| 4033084 | VANDF |
| C3696416 | UMLSCUI |
| CHEBI:192761 | CHEBI |
| CHEMBL3039566 | ChEMBL_ID |
| DB09146 | DRUGBANK_ID |
| CHEMBL4802224 | ChEMBL_ID |
| CHEMBL1200823 | ChEMBL_ID |
| C000599459 | MESH_SUPPLEMENTAL_RECORD_UI |
| C092844 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14695 | DRUGBANK_ID |
| 1484283 | RXNORM |
| 15814 | MMSL |
| 221324 | MMSL |
| 30331 | MMSL |
| 30334 | MMSL |
| d04725 | MMSL |
| d08266 | MMSL |
| 007471 | NDDF |
| 008975 | NDDF |
| 015366 | NDDF |
| 1285045009 | SNOMEDCT_US |
| 129497004 | SNOMEDCT_US |
| 387206004 | SNOMEDCT_US |
| 421953007 | SNOMEDCT_US |
| 737661000168109 | SNOMEDCT_US |
| 9793696 | PUBCHEM_CID |
| 87PZU03K0K | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Velphoro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49230-645 | TABLET, CHEWABLE | 500 mg | ORAL | NDA | 26 sections |
| Velphoro | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49230-645 | TABLET, CHEWABLE | 500 mg | ORAL | NDA | 26 sections |