dronabinol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| cannabinoid receptors agonists | 4109 | 1972-08-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.91 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 8.90 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 3.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.05 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 33 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 31, 1985 | FDA | ABBVIE |
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 |
|---|---|---|---|---|---|---|
| Decreased appetite | 69.91 | 16.58 | 106 | 6406 | 200817 | 50397795 |
| Dehydration | 50.94 | 16.58 | 79 | 6433 | 152370 | 50446242 |
| Nausea | 44.95 | 16.58 | 194 | 6318 | 705204 | 49893408 |
| Failure to thrive | 41.60 | 16.58 | 19 | 6493 | 6339 | 50592273 |
| Vomiting | 40.08 | 16.58 | 140 | 6372 | 460618 | 50137994 |
| Disease progression | 35.27 | 16.58 | 52 | 6460 | 95814 | 50502798 |
| Death | 34.65 | 16.58 | 106 | 6406 | 325273 | 50273339 |
| Plasma cell myeloma | 24.69 | 16.58 | 25 | 6487 | 31297 | 50567315 |
| Diarrhoea | 24.64 | 16.58 | 144 | 6368 | 588332 | 50010280 |
| Sepsis | 20.82 | 16.58 | 50 | 6462 | 132875 | 50465737 |
| Defaecation disorder | 20.77 | 16.58 | 6 | 6506 | 539 | 50598073 |
| Drug ineffective | 20.73 | 16.58 | 47 | 6465 | 819286 | 49779326 |
| Immune-mediated enterocolitis | 20.71 | 16.58 | 7 | 6505 | 1053 | 50597559 |
| Hypophagia | 19.81 | 16.58 | 21 | 6491 | 27707 | 50570905 |
| Malnutrition | 19.40 | 16.58 | 15 | 6497 | 13174 | 50585438 |
| Constipation | 18.32 | 16.58 | 59 | 6453 | 185649 | 50412963 |
| Malignant neoplasm progression | 18.24 | 16.58 | 32 | 6480 | 68092 | 50530520 |
| White blood cell count decreased | 17.31 | 16.58 | 43 | 6469 | 116679 | 50481933 |
| Weight decreased | 17.23 | 16.58 | 65 | 6447 | 221180 | 50377432 |
| Flatulence | 17.07 | 16.58 | 20 | 6492 | 29438 | 50569174 |
| Hypokalaemia | 17.01 | 16.58 | 36 | 6476 | 87956 | 50510656 |
| Rheumatoid arthritis | 16.62 | 16.58 | 3 | 6509 | 202547 | 50396065 |
| Hyperlipasaemia | 16.62 | 16.58 | 5 | 6507 | 517 | 50598095 |
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 91.89 | 17.18 | 157 | 7061 | 173504 | 29393805 |
| Hangover | 68.85 | 17.18 | 20 | 7198 | 957 | 29566352 |
| Drug abuse | 67.51 | 17.18 | 90 | 7128 | 79793 | 29487516 |
| Brain oedema | 54.25 | 17.18 | 35 | 7183 | 12185 | 29555124 |
| Nausea | 45.44 | 17.18 | 164 | 7054 | 289091 | 29278218 |
| Decreased appetite | 42.59 | 17.18 | 103 | 7115 | 145239 | 29422070 |
| Dehydration | 42.17 | 17.18 | 89 | 7129 | 114659 | 29452650 |
| Respiratory depression | 41.79 | 17.18 | 31 | 7187 | 13492 | 29553817 |
| Failure to thrive | 39.09 | 17.18 | 24 | 7194 | 7660 | 29559649 |
| Aggression | 36.21 | 17.18 | 44 | 7174 | 35497 | 29531812 |
| Vomiting | 30.42 | 17.18 | 117 | 7101 | 212143 | 29355166 |
| Pulmonary oedema | 27.01 | 17.18 | 42 | 7176 | 42693 | 29524616 |
| Muscle mass | 26.72 | 17.18 | 7 | 7211 | 227 | 29567082 |
| Weight decreased | 24.79 | 17.18 | 87 | 7131 | 150818 | 29416491 |
| Rebound effect | 23.60 | 17.18 | 11 | 7207 | 2020 | 29565289 |
| Testicular atrophy | 21.24 | 17.18 | 7 | 7211 | 510 | 29566799 |
| Fatigue | 20.71 | 17.18 | 140 | 7078 | 316681 | 29250628 |
| Paradoxical drug reaction | 20.48 | 17.18 | 11 | 7207 | 2730 | 29564579 |
| Dysarthria | 20.39 | 17.18 | 31 | 7187 | 30880 | 29536429 |
| Seizure | 20.10 | 17.18 | 59 | 7159 | 93064 | 29474245 |
| Sleep disorder | 19.81 | 17.18 | 27 | 7191 | 24359 | 29542950 |
| Substance abuse | 19.72 | 17.18 | 15 | 7203 | 6772 | 29560537 |
| Drug screen negative | 19.33 | 17.18 | 5 | 7213 | 154 | 29567155 |
| Withdrawal syndrome | 18.96 | 17.18 | 18 | 7200 | 10974 | 29556335 |
| Plasma cell myeloma | 18.76 | 17.18 | 33 | 7185 | 37082 | 29530227 |
| Paranoia | 18.63 | 17.18 | 17 | 7201 | 9860 | 29557449 |
| Neonatal infection | 18.62 | 17.18 | 6 | 7212 | 407 | 29566902 |
| Neuromuscular blockade | 18.17 | 17.18 | 5 | 7213 | 196 | 29567113 |
| Drug withdrawal syndrome | 17.87 | 17.18 | 22 | 7196 | 17962 | 29549347 |
| Confusional state | 17.86 | 17.18 | 70 | 7148 | 127807 | 29439502 |
| Mucosal infection | 17.68 | 17.18 | 5 | 7213 | 217 | 29567092 |
| Cardiac death | 17.48 | 17.18 | 7 | 7211 | 889 | 29566420 |
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 |
|---|---|---|---|---|---|---|
| Toxicity to various agents | 98.95 | 14.91 | 208 | 11396 | 363305 | 64123823 |
| Dehydration | 87.56 | 14.91 | 147 | 11457 | 216616 | 64270512 |
| Drug abuse | 67.55 | 14.91 | 100 | 11504 | 132274 | 64354854 |
| Decreased appetite | 67.33 | 14.91 | 153 | 11451 | 281136 | 64205992 |
| Failure to thrive | 66.50 | 14.91 | 34 | 11570 | 10370 | 64476758 |
| Hangover | 61.73 | 14.91 | 20 | 11584 | 1881 | 64485247 |
| Nausea | 55.67 | 14.91 | 283 | 11321 | 785517 | 63701611 |
| Brain oedema | 45.18 | 14.91 | 35 | 11569 | 22040 | 64465088 |
| Vomiting | 45.03 | 14.91 | 207 | 11397 | 550910 | 63936218 |
| Disease progression | 43.02 | 14.91 | 85 | 11519 | 141595 | 64345533 |
| Aggression | 42.78 | 14.91 | 47 | 11557 | 46185 | 64440943 |
| Respiratory depression | 39.14 | 14.91 | 33 | 11571 | 23410 | 64463718 |
| Plasma cell myeloma | 36.13 | 14.91 | 43 | 11561 | 46032 | 64441096 |
| Death | 34.80 | 14.91 | 175 | 11429 | 482530 | 64004598 |
| Hypophagia | 32.79 | 14.91 | 38 | 11566 | 39549 | 64447579 |
| Pulmonary oedema | 29.88 | 14.91 | 52 | 11552 | 78622 | 64408506 |
| Behaviour disorder | 26.83 | 14.91 | 14 | 11590 | 4448 | 64482680 |
| Testicular atrophy | 26.20 | 14.91 | 7 | 11597 | 335 | 64486793 |
| Weight decreased | 26.00 | 14.91 | 111 | 11493 | 285628 | 64201500 |
| Muscle mass | 24.90 | 14.91 | 7 | 11597 | 406 | 64486722 |
| Infective pulmonary exacerbation of cystic fibrosis | 24.78 | 14.91 | 19 | 11585 | 11777 | 64475351 |
| Substance abuse | 24.11 | 14.91 | 17 | 11587 | 9275 | 64477853 |
| Dysarthria | 23.52 | 14.91 | 40 | 11564 | 59366 | 64427762 |
| Fatigue | 22.45 | 14.91 | 219 | 11385 | 748511 | 63738617 |
| Drug hypersensitivity | 21.42 | 14.91 | 8 | 11596 | 237807 | 64249321 |
| Febrile neutropenia | 21.16 | 14.91 | 78 | 11526 | 187579 | 64299549 |
| Mucosal infection | 19.98 | 14.91 | 6 | 11598 | 439 | 64486689 |
| Defaecation disorder | 19.75 | 14.91 | 6 | 11598 | 457 | 64486671 |
| Rheumatoid arthritis | 19.73 | 14.91 | 3 | 11601 | 164291 | 64322837 |
| Confusional state | 18.27 | 14.91 | 94 | 11510 | 261050 | 64226078 |
| Drug ineffective | 18.01 | 14.91 | 84 | 11520 | 840163 | 63646965 |
| Mental status changes | 17.70 | 14.91 | 36 | 11568 | 61126 | 64426002 |
| Rebound effect | 17.61 | 14.91 | 11 | 11593 | 4906 | 64482222 |
| Cardiac death | 16.88 | 14.91 | 7 | 11597 | 1321 | 64485807 |
| Accidental overdose | 16.58 | 14.91 | 25 | 11579 | 33532 | 64453596 |
| White blood cell count decreased | 16.46 | 14.91 | 64 | 11540 | 157773 | 64329355 |
| Diarrhoea | 16.36 | 14.91 | 200 | 11404 | 722504 | 63764624 |
| Malignant neoplasm progression | 16.31 | 14.91 | 51 | 11553 | 112820 | 64374308 |
| Seizure | 16.06 | 14.91 | 66 | 11538 | 166826 | 64320302 |
| Paranoia | 15.77 | 14.91 | 17 | 11587 | 16335 | 64470793 |
| Hypokalaemia | 15.74 | 14.91 | 53 | 11551 | 121850 | 64365278 |
| Myocardial fibrosis | 15.71 | 14.91 | 7 | 11597 | 1573 | 64485555 |
| Paradoxical drug reaction | 15.42 | 14.91 | 11 | 11593 | 6109 | 64481019 |
| Joint swelling | 15.24 | 14.91 | 10 | 11594 | 215372 | 64271756 |
| Malnutrition | 15.23 | 14.91 | 18 | 11586 | 19107 | 64468021 |
| Abdominal pain | 15.09 | 14.91 | 102 | 11502 | 312273 | 64174855 |
| Neuromuscular blockade | 15.05 | 14.91 | 5 | 11599 | 509 | 64486619 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A04AD10 | ALIMENTARY TRACT AND METABOLISM ANTIEMETICS AND ANTINAUSEANTS ANTIEMETICS AND ANTINAUSEANTS Other antiemetics |
| FDA CS | M0003267 | Cannabinoids |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D063386 | Cannabinoid Receptor Agonists |
| MeSH PA | D063385 | Cannabinoid Receptor Modulators |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D006213 | Hallucinogens |
| MeSH PA | D006728 | Hormones |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D018689 | Sensory System Agents |
| FDA EPC | N0000175782 | Cannabinoid |
| CHEBI has role | CHEBI:25212 | metabolites |
| CHEBI has role | CHEBI:35499 | hallucinogens |
| CHEBI has role | CHEBI:53000 | epitope role |
| CHEBI has role | CHEBI:67072 | cannabinoid receptor agonists |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chemotherapy-induced nausea and vomiting | indication | 236084000 | |
| Anorexia from HIV | indication | ||
| Tachyarrhythmia | contraindication | 6285003 | |
| Alcoholism | contraindication | 7200002 | |
| Bipolar disorder | contraindication | 13746004 | DOID:3312 |
| Lowered convulsive threshold | contraindication | 19260006 | |
| Depressive disorder | contraindication | 35489007 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Low blood pressure | contraindication | 45007003 | |
| Schizophrenia | contraindication | 58214004 | DOID:5419 |
| Substance abuse | contraindication | 66214007 | |
| Epilepsy | contraindication | 84757009 | DOID:1826 |
| Syncope | contraindication | 271594007 | |
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.15 | acidic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Cannabinoid receptor 1 | GPCR | AGONIST | Ki | 8.54 | CHEMBL | CHEMBL | |||
| D(3) dopamine receptor | GPCR | EC50 | 7.99 | CHEMBL | |||||
| Glycine receptor subunit alpha-1 | Ion channel | EC50 | 5.89 | CHEMBL | |||||
| Glycine receptor subunit alpha-2 | Ion channel | ALLOSTERIC MODULATOR | EC50 | 6 | IUPHAR | ||||
| Cannabinoid receptor 2 | GPCR | Ki | 8.48 | CHEMBL | |||||
| Glycine receptor subunit alpha-3 | Ion channel | ALLOSTERIC MODULATOR | EC50 | 5.30 | IUPHAR | ||||
| N-arachidonyl glycine receptor | GPCR | EC50 | 6.02 | CHEMBL | |||||
| Transient receptor potential cation channel subfamily A member 1 | Ion channel | ACTIVATOR | EC50 | 4.90 | IUPHAR | ||||
| G-protein coupled receptor 55 | GPCR | IC50 | 4.85 | CHEMBL | |||||
| Cannabinoid receptor | GPCR | Ki | 7.39 | CHEMBL | |||||
| Cannabinoid receptor 1 | GPCR | Ki | 7.43 | CHEMBL | |||||
| Cannabinoid receptor 2 | GPCR | Ki | 8.04 | CHEMBL | |||||
| Cannabinoid receptor 1 | GPCR | Ki | 7.40 | CHEMBL | |||||
| Cannabinoid receptor | GPCR | Ki | 7.34 | CHEMBL | |||||
| Transient receptor potential cation channel subfamily V member 2 | Ion channel | ACTIVATOR | EC50 | 4.85 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| 4018511 | VUID |
| N0000146833 | NUI |
| D00306 | KEGG_DRUG |
| 4018511 | VANDF |
| CHEBI:66964 | CHEBI |
| TCI | PDB_CHEM_ID |
| CHEMBL465 | ChEMBL_ID |
| 5547 | INN_ID |
| DB00470 | DRUGBANK_ID |
| 7J8897W37S | UNII |
| 16078 | PUBCHEM_CID |
| 10402 | RXNORM |
| 138250 | MMSL |
| 1589 | MMSL |
| 4645 | MMSL |
| d00866 | MMSL |
| 001685 | NDDF |
| 010757 | NDDF |
| 108415005 | SNOMEDCT_US |
| 386846008 | SNOMEDCT_US |
| 72024007 | SNOMEDCT_US |
| 96225007 | SNOMEDCT_US |
| D013759 | MESH_DESCRIPTOR_UI |
| C0039663 | UMLSCUI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1450 | CAPSULE | 2.50 mg | ORAL | ANDA | 26 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1451 | CAPSULE | 5 mg | ORAL | ANDA | 26 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-1452 | CAPSULE | 10 mg | ORAL | ANDA | 26 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0527-4125 | CAPSULE | 2.50 mg | ORAL | ANDA | 18 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6745 | CAPSULE | 2.50 mg | ORAL | ANDA | 31 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6746 | CAPSULE | 5 mg | ORAL | ANDA | 31 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7144 | CAPSULE | 2.50 mg | ORAL | NDA | 29 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7145 | CAPSULE | 5 mg | ORAL | NDA | 29 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-761 | CAPSULE | 2.50 mg | ORAL | ANDA | 32 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-762 | CAPSULE | 5 mg | ORAL | ANDA | 32 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-763 | CAPSULE | 10 mg | ORAL | ANDA | 32 sections |
| SYNDROS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 20482-335 | SOLUTION | 5 mg | ORAL | NDA | 32 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-960 | CAPSULE | 2.50 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-961 | CAPSULE | 5 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-962 | CAPSULE | 10 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-449 | CAPSULE | 2.50 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-450 | CAPSULE | 5 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-451 | CAPSULE | 10 mg | ORAL | ANDA | 19 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42858-867 | CAPSULE | 2.50 mg | ORAL | ANDA | 31 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42858-868 | CAPSULE | 5 mg | ORAL | ANDA | 31 sections |
| DRONABINOL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42858-869 | CAPSULE | 10 mg | ORAL | ANDA | 31 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-867 | CAPSULE | 2.50 mg | ORAL | ANDA | 23 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-868 | CAPSULE | 5 mg | ORAL | ANDA | 23 sections |
| Dronabinol | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-869 | CAPSULE | 10 mg | ORAL | ANDA | 23 sections |
| Marinol | Human Prescription Drug Label | 1 | 53097-568 | CAPSULE | 2.50 mg | ORAL | NDA | 29 sections |
| Marinol | Human Prescription Drug Label | 1 | 53097-569 | CAPSULE | 5 mg | ORAL | NDA | 29 sections |
| Marinol | Human Prescription Drug Label | 1 | 53097-570 | CAPSULE | 10 mg | ORAL | NDA | 29 sections |
| MARINOL | Human Prescription Drug Label | 1 | 53097-571 | CAPSULE | 2.50 mg | ORAL | NDA | 29 sections |
| MARINOL | Human Prescription Drug Label | 1 | 53097-572 | CAPSULE | 5 mg | ORAL | NDA | 29 sections |
| MARINOL | Human Prescription Drug Label | 1 | 53097-573 | CAPSULE | 10 mg | ORAL | NDA | 29 sections |