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 | 191.42 | 44.26 | 68 | 1600 | 59462 | 63427892 |
| Anaemia | 75.86 | 44.26 | 62 | 1606 | 293368 | 63193986 |
| Vomiting | 69.80 | 44.26 | 79 | 1589 | 559538 | 62927816 |
| Off label use | 62.62 | 44.26 | 82 | 1586 | 674380 | 62812974 |
| Neuropathy peripheral | 56.94 | 44.26 | 36 | 1632 | 113631 | 63373723 |
| Intentional product use issue | 53.06 | 44.26 | 36 | 1632 | 127856 | 63359498 |
| Incorrect product administration duration | 51.83 | 44.26 | 17 | 1651 | 11529 | 63475825 |
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 | 276.07 | 37.32 | 100 | 1983 | 40852 | 34913996 |
| Neuropathy peripheral | 100.33 | 37.32 | 62 | 2021 | 83201 | 34871647 |
| Incorrect product administration duration | 91.64 | 37.32 | 26 | 2057 | 4785 | 34950063 |
| Intentional product use issue | 80.85 | 37.32 | 48 | 2035 | 59768 | 34895080 |
| Tuberculosis | 80.79 | 37.32 | 27 | 2056 | 8550 | 34946298 |
| Off label use | 66.45 | 37.32 | 101 | 1982 | 419423 | 34535425 |
| Anaemia | 62.81 | 37.32 | 73 | 2010 | 233262 | 34721586 |
| Vomiting | 59.30 | 37.32 | 73 | 2010 | 247548 | 34707300 |
| HIV infection | 38.41 | 37.32 | 10 | 2073 | 1329 | 34953519 |
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 | 433.72 | 34.00 | 163 | 3713 | 90223 | 79650289 |
| Neuropathy peripheral | 170.44 | 34.00 | 98 | 3778 | 141207 | 79599305 |
| Incorrect product administration duration | 142.65 | 34.00 | 43 | 3833 | 11979 | 79728533 |
| Anaemia | 124.50 | 34.00 | 129 | 3747 | 444886 | 79295626 |
| Intentional product use issue | 121 | 34.00 | 81 | 3795 | 152031 | 79588481 |
| Off label use | 119.72 | 34.00 | 180 | 3696 | 907035 | 78833477 |
| Vomiting | 109.56 | 34.00 | 147 | 3729 | 665681 | 79074831 |
| Tuberculosis | 78.28 | 34.00 | 29 | 3847 | 15169 | 79725343 |
| Drug-induced liver injury | 59.24 | 34.00 | 38 | 3838 | 66079 | 79674433 |
| Psychotic disorder | 58.65 | 34.00 | 32 | 3844 | 41370 | 79699142 |
| Drug resistance | 52.63 | 34.00 | 30 | 3846 | 42183 | 79698329 |
| Hypokalaemia | 51.63 | 34.00 | 48 | 3828 | 143992 | 79596520 |
| Aspartate aminotransferase increased | 51.24 | 34.00 | 47 | 3829 | 138594 | 79601918 |
| HIV infection | 47.40 | 34.00 | 11 | 3865 | 1116 | 79739396 |
| Meningitis tuberculous | 46.66 | 34.00 | 11 | 3865 | 1194 | 79739318 |
| Product use in unapproved indication | 45.01 | 34.00 | 58 | 3818 | 250301 | 79490211 |
| Optic neuritis | 41.19 | 34.00 | 16 | 3860 | 9504 | 79731008 |
| Respiratory failure | 39.09 | 34.00 | 46 | 3830 | 180865 | 79559647 |
| Drug ineffective | 38.54 | 34.00 | 4 | 3872 | 1080909 | 78659603 |
| Blood sodium decreased | 37.11 | 34.00 | 22 | 3854 | 33233 | 79707279 |
| Bicytopenia | 35.86 | 34.00 | 12 | 3864 | 4658 | 79735854 |
| Benign soft tissue neoplasm | 35.06 | 34.00 | 6 | 3870 | 126 | 79740386 |
| Pneumothorax | 34.94 | 34.00 | 20 | 3856 | 28303 | 79712209 |
| Haemoglobin decreased | 34.59 | 34.00 | 48 | 3828 | 222071 | 79518441 |
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 |
| DB11637 | DRUGBANK_ID |
| 015849 | NDDF |
| 714097004 | SNOMEDCT_US |
| 714098009 | SNOMEDCT_US |
| C3489682 | UMLSCUI |
| 9401 | INN_ID |
| 6480466 | PUBCHEM_CID |
| 8OOT6M1PC7 | UNII |
Pharmaceutical products:
None