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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
Molfile Inchi Smiles Synonyms: tetrahydrocannabinol THC dronabinol marinol	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. Molecular weight: 314.47 Formula: C21H30O2 CLOGP: 7.24 LIPINSKI: 1 HAC: 2 HDO: 1 TPSA: 29.46 ALOGS: -5.08 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tetrahydrocannabinol
THC
dronabinol
marinol

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.

Molecular weight: 314.47
Formula: C21H30O2
CLOGP: 7.24
LIPINSKI: 1
HAC: 2
HDO: 1
TPSA: 29.46
ALOGS: -5.08
ROTB: 4

Status: OFP

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	74.20	16.22	116	7229	250936	63230741
Dehydration	52.38	16.22	81	7264	173273	63308404
Failure to thrive	50.89	16.22	22	7323	7176	63474501
Nausea	49.49	16.22	212	7133	854259	62627418
Death	39.98	16.22	114	7231	374267	63107410
Vomiting	38.75	16.22	147	7198	559470	62922207
Disease progression	32.43	16.22	54	7291	122704	63358973
Intracranial pressure increased	27.50	16.22	13	7332	5214	63476463
Diarrhoea	27.32	16.22	158	7187	715208	62766469
Drug ineffective	26.20	16.22	51	7294	1044714	62436963
Hypophagia	25.07	16.22	24	7321	31235	63450442
Plasma cell myeloma	24.06	16.22	25	7320	35880	63445797
Vascular device infection	23.38	16.22	13	7332	7299	63474378
Flatulence	21.19	16.22	23	7322	34679	63446998
Malnutrition	21.01	16.22	16	7329	15282	63466395
Sepsis	20.72	16.22	51	7294	153072	63328605
Hyperlipasaemia	19.81	16.22	6	7339	707	63480970
Constipation	19.72	16.22	64	7281	224879	63256798
Rheumatoid arthritis	19.57	16.22	3	7342	253816	63227861
Defaecation disorder	19.27	16.22	6	7339	775	63480902
Joint swelling	19.15	16.22	7	7338	327659	63154018
Hypokalaemia	19.00	16.22	39	7306	103765	63377912
White blood cell count decreased	18.47	16.22	46	7299	139058	63342619
Urinary tract infection	17.78	16.22	69	7276	264615	63217062
Weight decreased	17.66	16.22	71	7274	276727	63204950
Immune-mediated enterocolitis	16.74	16.22	7	7338	2104	63479573
Malignant neoplasm progression	16.40	16.22	32	7313	82089	63399588

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
Drug abuse	157.14	16.11	151	7964	98945	34849871
Toxicity to various agents	128.04	16.11	192	7923	200170	34748646
Hangover	68.40	16.11	20	8095	1031	34947785
Brain oedema	51.91	16.11	35	8080	13786	34935030
Respiratory depression	51.33	16.11	37	8078	16208	34932608
Nausea	48.83	16.11	181	7934	339727	34609089
Decreased appetite	48.36	16.11	114	8001	166278	34782538
Aggression	42.93	16.11	49	8066	38915	34909901
Failure to thrive	40.21	16.11	25	8090	8576	34940240
Poisoning	38.97	16.11	28	8087	12198	34936618
Dehydration	38.76	16.11	90	8025	129879	34818937
Asphyxia	34.85	16.11	21	8094	6814	34942002
Muscle mass	31.04	16.11	8	8107	256	34948560
Vomiting	30.66	16.11	126	7989	247495	34701321
Pulmonary oedema	27.96	16.11	44	8071	47485	34901331
Seizure	26.32	16.11	68	8047	104789	34844027
Weight decreased	26.11	16.11	95	8020	176206	34772610
Dysarthria	25.94	16.11	36	8079	34746	34914070
Testicular atrophy	24.65	16.11	8	8107	584	34948232
Drug dependence	24.23	16.11	29	8086	24188	34924628
Death	23.40	16.11	165	7950	397884	34550932
Substance abuse	23.21	16.11	17	8098	7624	34941192
Myocardial fibrosis	22.58	16.11	9	8106	1188	34947628
Sleep disorder	22.44	16.11	32	8083	31656	34917160
Fatigue	21.98	16.11	154	7961	370499	34578317
Adrenergic syndrome	21.79	16.11	5	8110	97	34948719
Cardiac death	19.94	16.11	8	8107	1075	34947741
Confusional state	19.91	16.11	76	8039	144084	34804732
Plasma cell myeloma	19.50	16.11	35	8080	42002	34906814
Rebound effect	19.16	16.11	11	8104	3263	34945553
Drug screen negative	18.97	16.11	5	8110	175	34948641
Paradoxical drug reaction	18.92	16.11	11	8104	3340	34945476
Neonatal infection	18.86	16.11	6	8109	411	34948405
Withdrawal syndrome	17.82	16.11	18	8097	12437	34936379
Mucosal infection	17.73	16.11	5	8110	226	34948590
Drug screen positive	17.27	16.11	11	8104	3932	34944884
Drug withdrawal syndrome	17.03	16.11	22	8093	19812	34929004
Neuromuscular blockade	17.00	16.11	5	8110	263	34948553
Paranoia	16.47	16.11	17	8098	12051	34936765

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
Drug abuse	159.55	14.73	163	12900	162528	79568797
Toxicity to various agents	141.97	14.73	250	12813	421290	79310035
Dehydration	85.63	14.73	149	12914	248038	79483287
Decreased appetite	77.34	14.73	172	12891	342246	79389079
Failure to thrive	77.03	14.73	38	13025	11806	79719519
Hangover	61.50	14.73	20	13043	2092	79729233
Nausea	59.71	14.73	311	12752	956885	78774440
Aggression	51.54	14.73	52	13011	50906	79680419
Respiratory depression	47.42	14.73	38	13025	27592	79703733
Brain oedema	46.05	14.73	36	13027	25227	79706098
Vomiting	43.20	14.73	219	12844	665609	79065716
Death	43	14.73	195	12868	566319	79165006
Poisoning	39.68	14.73	33	13030	25239	79706086
Asphyxia	36.05	14.73	23	13040	11697	79719628
Disease progression	35.38	14.73	87	12976	184275	79547050
Hypophagia	34.80	14.73	40	13023	45327	79685998
Plasma cell myeloma	34.36	14.73	43	13020	53216	79678109
Pulmonary oedema	33.01	14.73	55	13008	88199	79643126
Testicular atrophy	31.10	14.73	8	13055	363	79730962
Muscle mass	29.33	14.73	8	13055	456	79730869
Dysarthria	29.20	14.73	45	13018	67577	79663748
Substance abuse	28.33	14.73	19	13044	10507	79720818
Weight decreased	26.67	14.73	122	12941	355076	79376249
Behaviour disorder	26.16	14.73	15	13048	6298	79725027
Fatigue	25.58	14.73	248	12815	929479	78801846
Infective pulmonary exacerbation of cystic fibrosis	24.92	14.73	19	13044	12832	79718493
Rheumatoid arthritis	23.89	14.73	3	13060	208467	79522858
Drug ineffective	23.81	14.73	94	12969	1080819	78650506
Drug hypersensitivity	23.14	14.73	10	13053	298906	79432419
Myocardial fibrosis	22.47	14.73	9	13054	1709	79729616
Seizure	21.55	14.73	74	12989	188760	79542565
Adrenergic syndrome	21.44	14.73	5	13058	150	79731175
Malnutrition	21.00	14.73	22	13041	22480	79708845
Joint swelling	20.29	14.73	11	13052	288635	79442690
Drug dependence	20.28	14.73	29	13034	40740	79690585
Cardiac death	19.74	14.73	8	13055	1566	79729759
Mucosal infection	19.63	14.73	6	13057	513	79730812
Mental status changes	18.98	14.73	37	13026	66922	79664403
Defaecation disorder	17.85	14.73	6	13057	695	79730630
Confusional state	17.40	14.73	100	12963	317897	79413428
Diarrhoea	17.34	14.73	220	12843	880269	78851056
Febrile neutropenia	17.06	14.73	79	12984	230920	79500405
Hypersensitivity	17.01	14.73	11	13052	262228	79469097
Malignant neoplasm progression	16.13	14.73	54	13009	135936	79595389
Hypokalaemia	16.04	14.73	56	13007	143984	79587341
Accidental poisoning	16.02	14.73	7	13056	1650	79729675
Agitation	15.96	14.73	44	13019	99671	79631654
White blood cell count decreased	15.87	14.73	67	12996	188221	79543104
Intracranial pressure increased	15.47	14.73	12	13051	8310	79723015
Vascular device infection	15.26	14.73	13	13050	10263	79721062
Accidental overdose	15.24	14.73	25	13038	39556	79691769
Arthralgia	15.04	14.73	46	13017	571757	79159568
Neuromuscular blockade	14.91	14.73	5	13058	575	79730750
Paradoxical drug reaction	14.77	14.73	11	13052	7174	79724151

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])	Bioact source	MoA source
Cannabinoid receptor 1	GPCR	P21554	CNR1_HUMAN	AGONIST	Ki	8.54	CHEMBL	CHEMBL
Fatty-acid amide hydrolase 1	Enzyme	O00519	FAAH1_HUMAN		IC50	4.36	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		EC50	7.99	CHEMBL
Glycine receptor subunit alpha-1	Ion channel	P23415	GLRA1_HUMAN		EC50	5.89	CHEMBL
Glycine receptor subunit alpha-2	Ion channel	P23416	GLRA2_HUMAN	ALLOSTERIC MODULATOR	EC50	6	IUPHAR
Cannabinoid receptor 2	GPCR	P34972	CNR2_HUMAN		Ki	8.48	CHEMBL
Glycine receptor subunit alpha-3	Ion channel	O75311	GLRA3_HUMAN	ALLOSTERIC MODULATOR	EC50	5.30	IUPHAR
N-arachidonyl glycine receptor	GPCR	Q14330	GPR18_HUMAN		EC50	6.02	CHEMBL
Transient receptor potential cation channel subfamily A member 1	Ion channel	O75762	TRPA1_HUMAN	ACTIVATOR	EC50	4.90	IUPHAR
Monoacylglycerol lipase ABHD12	Enzyme	Q8N2K0	ABD12_HUMAN		IC50	4.94	CHEMBL
G-protein coupled receptor 55	GPCR	Q9Y2T6	GPR55_HUMAN		IC50	4.85	CHEMBL
Cannabinoid receptor	GPCR	P21554 P34972	CNR1_HUMAN CNR2_HUMAN		Ki	7.39	CHEMBL
L-lactate dehydrogenase A chain	Enzyme	P00338	LDHA_HUMAN		Ki	4.85	CHEMBL
Monoacylglycerol lipase ABHD6	Enzyme	Q9BV23	ABHD6_HUMAN		IC50	4.32	CHEMBL
Cannabinoid receptor 1	GPCR		CNR1_RAT		Ki	7.43	CHEMBL
Cannabinoid receptor 2	GPCR		CNR2_MOUSE		Ki	8.04	CHEMBL
Cannabinoid receptor 1	GPCR		CNR1_MOUSE		Ki	7.40	CHEMBL
Cannabinoid receptor	GPCR		CNR1_RAT CNR2_RAT		Ki	7.34	CHEMBL
Transient receptor potential cation channel subfamily V member 2	Ion channel		TRPV2_RAT	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
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
C0039663	UMLSCUI
D013759	MESH_DESCRIPTOR_UI
16078	PUBCHEM_CID

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	0904-6745	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	0904-6746	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	0904-7144	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	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	17478-761	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	17478-762	CAPSULE	5 mg	ORAL	ANDA	32 sections
Dronabinol	HUMAN PRESCRIPTION DRUG LABEL	1	17478-763	CAPSULE	10 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	42858-867	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	42858-868	CAPSULE	5 mg	ORAL	ANDA	31 sections
DRONABINOL	HUMAN PRESCRIPTION DRUG LABEL	1	42858-869	CAPSULE	10 mg	ORAL	ANDA	31 sections