delamanid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4819 | 681492-22-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an antitubercular agent
|
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 22, 2013 | EMA | ||
| July 4, 2014 | PMDA |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 178.85 | 51.97 | 65 | 1579 | 54523 | 56235900 |
| Anaemia | 73.05 | 51.97 | 61 | 1583 | 267450 | 56022973 |
| Tuberculosis | 67.18 | 51.97 | 21 | 1623 | 11008 | 56279415 |
| Vomiting | 62.00 | 51.97 | 74 | 1570 | 498154 | 55792269 |
| Off label use | 61.82 | 51.97 | 78 | 1566 | 556102 | 55734321 |
| Intentional product use issue | 55.25 | 51.97 | 35 | 1609 | 99698 | 56190725 |
| Neuropathy peripheral | 54.25 | 51.97 | 35 | 1609 | 102858 | 56187565 |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 240.47 | 39.22 | 89 | 1834 | 37898 | 31657523 |
| Tuberculosis | 153.48 | 39.22 | 44 | 1879 | 8297 | 31687124 |
| Neuropathy peripheral | 97.04 | 39.22 | 59 | 1864 | 75590 | 31619831 |
| Incorrect product administration duration | 94.07 | 39.22 | 26 | 1897 | 4276 | 31691145 |
| Intentional product use issue | 88.71 | 39.22 | 48 | 1875 | 49299 | 31646122 |
| Off label use | 72.16 | 39.22 | 96 | 1827 | 347178 | 31348243 |
| Anaemia | 63.64 | 39.22 | 71 | 1852 | 213451 | 31481970 |
| Vomiting | 59.18 | 39.22 | 70 | 1853 | 223903 | 31471518 |
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 |
|---|---|---|---|---|---|---|
| Electrocardiogram QT prolonged | 386.70 | 34.66 | 149 | 3497 | 83368 | 70841430 |
| Tuberculosis | 168.64 | 34.66 | 52 | 3594 | 14796 | 70910002 |
| Neuropathy peripheral | 164.37 | 34.66 | 94 | 3552 | 126802 | 70797996 |
| Incorrect product administration duration | 140.40 | 34.66 | 42 | 3604 | 10782 | 70914016 |
| Intentional product use issue | 131.84 | 34.66 | 80 | 3566 | 120062 | 70804736 |
| Off label use | 125.99 | 34.66 | 171 | 3475 | 742889 | 70181909 |
| Anaemia | 123.63 | 34.66 | 126 | 3520 | 403297 | 70521501 |
| Vomiting | 104.02 | 34.66 | 139 | 3507 | 592972 | 70331826 |
| Psychotic disorder | 59.79 | 34.66 | 32 | 3614 | 37669 | 70887129 |
| Drug-induced liver injury | 57.91 | 34.66 | 36 | 3610 | 56077 | 70868721 |
| Drug resistance | 53.87 | 34.66 | 30 | 3616 | 38160 | 70886638 |
| Hypokalaemia | 51.22 | 34.66 | 47 | 3599 | 131141 | 70793657 |
| Product use in unapproved indication | 49.50 | 34.66 | 57 | 3589 | 207421 | 70717377 |
| Aspartate aminotransferase increased | 46.68 | 34.66 | 44 | 3602 | 126934 | 70797864 |
| Meningitis tuberculous | 46.13 | 34.66 | 11 | 3635 | 1186 | 70923612 |
| HIV infection | 44.28 | 34.66 | 11 | 3635 | 1406 | 70923392 |
| Optic neuritis | 41.36 | 34.66 | 16 | 3630 | 8884 | 70915914 |
| Blood sodium decreased | 37.40 | 34.66 | 22 | 3624 | 30976 | 70893822 |
| Bicytopenia | 36.94 | 34.66 | 12 | 3634 | 4016 | 70920782 |
| Respiratory failure | 36.30 | 34.66 | 44 | 3602 | 168691 | 70756107 |
| Pneumothorax | 35.61 | 34.66 | 20 | 3626 | 25826 | 70898972 |
| Haemoglobin decreased | 35.48 | 34.66 | 48 | 3598 | 205111 | 70719687 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J04AK06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Other drugs for treatment of tuberculosis |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Drug resistant tuberculosis | indication | 423709000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.92 | Basic |
| pKa2 | 4.66 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| D09785 | KEGG_DRUG |
| CHEBI:134742 | CHEBI |
| CHEMBL218650 | ChEMBL_ID |
| C516022 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9401 | INN_ID |
| DB11637 | DRUGBANK_ID |
| 8OOT6M1PC7 | UNII |
| 015849 | NDDF |
| 714097004 | SNOMEDCT_US |
| 714098009 | SNOMEDCT_US |
| C3489682 | UMLSCUI |
| 6480466 | PUBCHEM_CID |
Pharmaceutical products:
None