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armodafinil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4501	112111-43-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nuvigil CEP-10953 armodafinil R-modafinil	Molecular weight: 273.35 Formula: C15H15NO2S CLOGP: 0.94 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 60.16 ALOGS: -2.64 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nuvigil
CEP-10953
armodafinil
R-modafinil

Molecular weight: 273.35
Formula: C15H15NO2S
CLOGP: 0.94
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 60.16
ALOGS: -2.64
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.15	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	13.06 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
June 5, 2007	FDA	CEPHALON

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
Pre-existing condition improved	262.71	15.18	91	14631	8153	63466147
Anxiety	224.95	15.18	264	14458	217277	63257023
Sleep apnoea syndrome	223.83	15.18	117	14605	29016	63445284
Depression	187.46	15.18	229	14493	196263	63278037
Suicidal ideation	174.72	15.18	132	14590	62289	63412011
Product administration interrupted	122.33	15.18	45	14677	4791	63469509
Somnambulism	112.81	15.18	44	14678	5499	63468801
Therapeutic response unexpected	112.55	15.18	64	14658	18695	63455605
Feeling abnormal	87.05	15.18	137	14585	148255	63326045
Multiple sclerosis relapse	71.22	15.18	71	14651	48407	63425893
Cataplexy	69.15	15.18	21	14701	1235	63473065
Enuresis	69	15.18	25	14697	2548	63471752
Blood pressure increased	67.97	15.18	129	14593	161933	63312367
Somnolence	67.38	15.18	136	14586	178549	63295751
Surgery	61.05	15.18	57	14665	35855	63438445
Feeling jittery	60.29	15.18	38	14684	13365	63460935
Memory impairment	57.99	15.18	94	14628	104164	63370136
Snoring	57.12	15.18	25	14697	4177	63470123
Headache	52.85	15.18	287	14435	632954	62841346
Panic attack	47.00	15.18	40	14682	22291	63452009
Tremor	46.68	15.18	98	14624	132141	63342159
Migraine	42.95	15.18	82	14640	103264	63371036
Insomnia	42.67	15.18	128	14594	215124	63259176
Initial insomnia	42.37	15.18	23	14699	6134	63468166
Stress	40.69	15.18	63	14659	67104	63407196
Weight decreased	37.58	15.18	145	14577	276653	63197647
Hangover	36.90	15.18	14	14708	1622	63472678
Bipolar disorder	36.88	15.18	23	14699	7937	63466363
Fall	36.87	15.18	184	14538	392150	63082150
Contraindicated product administered	33.98	15.18	5	14717	217643	63256657
General physical health deterioration	32.93	15.18	4	14718	201398	63272902
Bruxism	32.41	15.18	16	14706	3509	63470791
Sleep paralysis	31.95	15.18	10	14712	650	63473650
Impaired driving ability	31.45	15.18	17	14705	4494	63469806
Restless legs syndrome	30.69	15.18	29	14693	18502	63455798
Sensorimotor disorder	30.54	15.18	9	14713	477	63473823
Feeling drunk	29.98	15.18	16	14706	4126	63470174
Multiple sclerosis	29.16	15.18	32	14690	24340	63449960
Hysterectomy	28.57	15.18	21	14701	9478	63464822
Narcolepsy	28.25	15.18	11	14711	1367	63472933
Gaze palsy	27.93	15.18	11	14711	1409	63472891
Acute kidney injury	26.53	15.18	14	14708	263401	63210899
Drug intolerance	26.16	15.18	20	14702	308641	63165659
Death	26.13	15.18	29	14693	374352	63099948
Joint swelling	25.59	15.18	23	14699	327643	63146657
Sleep-related eating disorder	25.58	15.18	9	14713	842	63473458
Unevaluable event	25.43	15.18	44	14678	51342	63422958
Seizure	25.42	15.18	78	14644	132556	63341744
Neutropenia	25.15	15.18	5	14717	175000	63299300
Oropharyngeal blistering	25.00	15.18	9	14713	900	63473400
Head injury	24.51	15.18	31	14691	27365	63446935
Off label use	24.34	15.18	78	14644	674384	62799916
Victim of spousal abuse	23.94	15.18	4	14718	12	63474288
Stevens-Johnson syndrome	23.55	15.18	29	14693	24921	63449379
Illness	22.97	15.18	41	14681	49018	63425282
Irritability	22.45	15.18	32	14690	31662	63442638
Drug tolerance	22.35	15.18	16	14706	6933	63467367
Glossodynia	22.06	15.18	7	14715	178869	63295431
Discomfort	21.65	15.18	6	14716	167368	63306932
Substance use	21.46	15.18	7	14715	520	63473780
Palpitations	21.31	15.18	66	14656	112704	63361596
Toxicity to various agents	20.97	15.18	16	14706	247234	63227066
Abnormal dreams	20.43	15.18	18	14704	10498	63463802
Major depression	20.31	15.18	16	14706	8002	63466298
Nervousness	20.08	15.18	30	14692	30949	63443351
Intervertebral disc protrusion	19.91	15.18	26	14696	23683	63450617
Vitamin D deficiency	19.75	15.18	20	14702	13872	63460428
Pyrexia	19.43	15.18	51	14671	470427	63003873
Nausea	19.29	15.18	291	14431	854180	62620120
Therapeutic product effect increased	19.05	15.18	8	14714	1207	63473093
Gastric bypass	18.98	15.18	9	14713	1808	63472492
Retching	18.87	15.18	20	14702	14625	63459675
Paranoia	18.81	15.18	18	14704	11661	63462639
Hypertension	18.26	15.18	119	14603	279184	63195116
Amnesia	18.21	15.18	40	14682	55545	63418755
Abdominal pain	18.08	15.18	25	14697	293431	63180869
Hypoaesthesia	17.95	15.18	82	14640	168311	63305989
Dizziness	17.47	15.18	164	14558	429761	63044539
Drug diversion	17.45	15.18	7	14715	941	63473359
Parasomnia	17.30	15.18	6	14716	538	63473762
Nasal septum deviation	17.25	15.18	8	14714	1528	63472772
Systemic lupus erythematosus	17.11	15.18	14	14708	208904	63265396
Therapeutic product effect decreased	17.03	15.18	12	14710	193175	63281125
Thrombocytopenia	16.80	15.18	7	14715	151150	63323150
Foot fracture	16.72	15.18	24	14698	23890	63450410
Lower respiratory tract infection	16.63	15.18	5	14717	132302	63341998
Essential tremor	16.52	15.18	7	14715	1081	63473219
Central nervous system lesion	16.39	15.18	16	14706	10619	63463681
Concussion	16.33	15.18	15	14707	9229	63465071
Wrong technique in product usage process	16.22	15.18	41	14681	62299	63412001
Asthma exercise induced	16.16	15.18	5	14717	313	63473987
Mania	16.13	15.18	17	14705	12350	63461950
Intentional dose omission	16.04	15.18	14	14708	8061	63466239
Rapid eye movement sleep behaviour disorder	16.04	15.18	5	14717	321	63473979
Hypotension	16.02	15.18	24	14698	272580	63201720
Wound	15.96	15.18	9	14713	163254	63311046
Product use in unapproved indication	15.95	15.18	11	14711	179069	63295231
Febrile neutropenia	15.78	15.18	4	14718	118445	63355855
Tonsillolith	15.75	15.18	3	14719	22	63474278
Vision blurred	15.72	15.18	52	14670	91872	63382428
Gastrooesophageal reflux disease	15.39	15.18	53	14669	95586	63378714

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
Sleep apnoea syndrome	154.47	23.31	68	4582	20253	34932028
Depression	81.13	23.31	81	4569	97017	34855264
Suicidal ideation	78.57	23.31	55	4595	40333	34911948
Pre-existing condition improved	78.23	23.31	24	4626	2568	34949713
Anxiety	68.79	23.31	75	4575	99353	34852928
Product administration interrupted	59.88	23.31	18	4632	1797	34950484
Somnambulism	50.58	23.31	18	4632	3054	34949227
Insomnia	48.18	23.31	64	4586	103843	34848438
Feeling abnormal	39.02	23.31	45	4605	63190	34889091
Therapeutic response unexpected	38.80	23.31	21	4629	9736	34942545
Somnolence	37.66	23.31	59	4591	111057	34841224
Blood pressure increased	35.89	23.31	51	4599	88051	34864230
Rash	35.61	23.31	86	4564	222666	34729615
Feeling jittery	29.09	23.31	13	4637	3990	34948291
Hypertension	28.88	23.31	59	4591	136384	34815897
Cataplexy	28.64	23.31	7	4643	319	34951962
Migraine	27.58	23.31	21	4629	17457	34934824
Tremor	26.77	23.31	43	4607	82544	34869737
Headache	25.37	23.31	71	4579	200564	34751717
Narcolepsy	25.28	23.31	7	4643	522	34951759
Sleep-related eating disorder	24.26	23.31	6	4644	287	34951994

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
Pre-existing condition improved	115.64	16.44	39	10790	5524	79728035
Sleep apnoea syndrome	115.26	16.44	68	10761	36410	79697149
Anxiety	112.68	16.44	153	10676	248359	79485200
Depression	100.55	16.44	135	10694	216655	79516904
Multiple sclerosis relapse	95.33	16.44	66	10763	46467	79687092
Feeling abnormal	87.69	16.44	108	10721	159091	79574468
Somnambulism	69.61	16.44	27	10802	5694	79727865
Suicidal ideation	63.00	16.44	64	10765	76276	79657283
Somnolence	60.73	16.44	113	10716	238868	79494691
Memory impairment	58.59	16.44	74	10755	111660	79621899
Enuresis	53.37	16.44	19	10810	3157	79730402
Cataplexy	51.99	16.44	14	10815	920	79732639
Headache	50.15	16.44	198	10631	653574	79079985
Product administration interrupted	49.57	16.44	19	10810	3880	79729679
Blood pressure increased	46.42	16.44	94	10735	211266	79522293
Snoring	46.29	16.44	20	10809	5546	79728013
Fall	45.14	16.44	157	10672	487472	79246087
Tremor	41.39	16.44	79	10750	170004	79563555
Feeling jittery	40.70	16.44	24	10805	12817	79720742
Therapeutic response unexpected	40.14	16.44	28	10801	19918	79713641
Migraine	36.72	16.44	52	10777	87441	79646118
Multiple sclerosis	35.15	16.44	27	10802	22255	79711304
Weight decreased	35.13	16.44	117	10712	355081	79378478
Vitamin D deficiency	30.99	16.44	21	10808	14258	79719301
Insomnia	30.97	16.44	88	10741	245082	79488477
Narcolepsy	30.66	16.44	10	10819	1276	79732283
Head injury	30.21	16.44	31	10798	37338	79696221
Sensorimotor disorder	29.88	16.44	9	10820	885	79732674
Seizure	29.12	16.44	73	10756	188761	79544798
Sleep paralysis	28.29	16.44	8	10821	630	79732929
Feeling drunk	26.78	16.44	13	10816	4706	79728853
Restless legs syndrome	26.67	16.44	22	10807	20070	79713489
Surgery	26.16	16.44	27	10802	32739	79700820
Victim of spousal abuse	26.08	16.44	4	10825	12	79733547
Hangover	25.81	16.44	10	10819	2102	79731457
Nervousness	25.71	16.44	27	10802	33388	79700171
Gaze palsy	25.65	16.44	11	10818	2994	79730565
Acute kidney injury	25.45	16.44	20	10809	519384	79214175
Impaired driving ability	25.08	16.44	13	10816	5402	79728157
Initial insomnia	24.73	16.44	14	10815	6924	79726635
Hypoaesthesia	24.23	16.44	66	10763	179286	79554273
Neutropenia	23.84	16.44	5	10824	287705	79445854
Paranoia	23.16	16.44	20	10809	19412	79714147
Panic attack	23.12	16.44	22	10807	24194	79709365
Trigeminal neuralgia	20.65	16.44	10	10819	3599	79729960
Abnormal dreams	20.61	16.44	15	10814	11397	79722162
Toxicity to various agents	19.68	16.44	17	10812	421523	79312036
Bruxism	19.62	16.44	10	10819	4016	79729543
Stress	19.37	16.44	37	10792	79575	79653984
Febrile neutropenia	19.17	16.44	4	10825	230995	79502564
Nausea	19.11	16.44	206	10623	956990	78776569
Unevaluable event	18.97	16.44	30	10799	55555	79678004
Sleep-related eating disorder	18.85	16.44	6	10823	708	79732851
Dry eye	18.61	16.44	24	10805	36907	79696652
Palpitations	18.52	16.44	48	10781	126562	79606997
Hypersomnia	18.38	16.44	19	10810	23067	79710492
Dizziness	18.20	16.44	128	10701	526313	79207246
Hysterectomy	18.00	16.44	11	10818	6261	79727298
Muscle spasms	17.62	16.44	58	10771	174672	79558887
Amnesia	17.47	16.44	31	10798	63026	79670533
Balance disorder	17.13	16.44	40	10789	98817	79634742
Retching	16.92	16.44	16	10813	17451	79716108
Abdominal pain	16.66	16.44	17	10812	389552	79344007

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N06BA13	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D000697	Central Nervous System Stimulants
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D064690	Wakefulness-Promoting Agents
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:77567	wakefulness-promoting agent

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Narcolepsy	indication	60380001	DOID:8986
Sleepiness Due To Obstructive Sleep Apnea	indication
Sleepiness Due To Shift Work Sleep Disorder	indication
Suicidal thoughts	contraindication	6471006
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Left ventricular hypertrophy	contraindication	55827005
Hepatic failure	contraindication	59927004
Psychotic disorder	contraindication	69322001
Mania	contraindication	231494001
Mitral valve prolapse	contraindication	409712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.23	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
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	IC50	5.50	WOMBAT-PK	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	4.41	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		EC50	6.92	WOMBAT-PK
Cytochrome P450 1A2	Enzyme	P05177	CP1A2_HUMAN				WOMBAT-PK
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN				WOMBAT-PK
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN				WOMBAT-PK
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	5.49	CHEMBL

External reference:

ID	Source
D03215	KEGG_DRUG
4026237	VANDF
CHEBI:77590	CHEBI
CHEMBL1201192	ChEMBL_ID
8474	INN_ID
DB06413	DRUGBANK_ID
V63XWA605I	UNII
641465	RXNORM
116668	MMSL
23941	MMSL
241076	MMSL
d06842	MMSL
012231	NDDF
428694009	SNOMEDCT_US
429452005	SNOMEDCT_US
C0066677	UMLSCUI
D000077408	MESH_DESCRIPTOR_UI
9690109	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3094	TABLET	250 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3094	TABLET	250 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3094	TABLET	250 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3431	TABLET	50 mg	ORAL	ANDA	31 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3432	TABLET	150 mg	ORAL	ANDA	31 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3433	TABLET	250 mg	ORAL	ANDA	31 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8029	TABLET	50 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8029	TABLET	50 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8029	TABLET	50 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8029	TABLET	50 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8037	TABLET	150 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8037	TABLET	150 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8037	TABLET	150 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8037	TABLET	150 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8045	TABLET	200 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8045	TABLET	200 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8045	TABLET	200 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8045	TABLET	200 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8053	TABLET	250 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8053	TABLET	250 mg	ORAL	NDA authorized generic	28 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8053	TABLET	250 mg	ORAL	NDA authorized generic	28 sections