All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
	1826	68693-11-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: modafinil (+/-)-Modafinil modaphonil modiodal	A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS. 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
0.30	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)	20.90 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	80 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
Dec. 24, 1998	FDA	CEPHALON
Feb. 21, 2020	PMDA	Alfresa Pharma Corporation

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
Multiple sclerosis relapse	410.60	11.29	272	31506	48206	63409038
Multiple sclerosis	303.72	11.29	175	31603	24197	63433047
Depression	231.87	11.29	379	31399	196113	63261131
Pre-existing condition improved	223.05	11.29	100	31678	8144	63449100
Cataplexy	218.76	11.29	61	31717	1195	63456049
Sleep apnoea syndrome	178.03	11.29	134	31644	28999	63428245
Suicidal ideation	159.82	11.29	176	31602	62245	63394999
Anxiety	140.02	11.29	325	31453	217216	63240028
Contraindicated product administered	95.34	11.29	3	31775	217645	63239599
Joint swelling	92.29	11.29	25	31753	327641	63129603
Somnambulism	88.80	11.29	47	31731	5496	63451748
Synovitis	80.37	11.29	3	31775	186915	63270329
Somnolence	76.05	11.29	229	31549	178456	63278788
Product administration interrupted	71.85	11.29	39	31739	4797	63452447
Balance disorder	71.32	11.29	141	31637	84281	63372963
Snoring	71.22	11.29	37	31741	4165	63453079
Influenza like illness	69.45	11.29	122	31656	66702	63390542
Hand deformity	67.06	11.29	3	31775	159454	63297790
Enuresis	65.75	11.29	30	31748	2543	63454701
Treatment failure	64.51	11.29	11	31767	199032	63258212
Off label use	64.05	11.29	153	31625	674309	62782935
Glossodynia	62.32	11.29	8	31770	178868	63278376
Infusion related reaction	61.50	11.29	23	31755	245498	63211746
Memory impairment	60.71	11.29	150	31628	104108	63353136
Migraine	59.46	11.29	148	31630	103198	63354046
Fall	58.08	11.29	365	31413	391969	63065275
Rheumatoid arthritis	56.85	11.29	28	31750	253791	63203453
Major depression	53.72	11.29	39	31739	7979	63449265
Gait disturbance	53.47	11.29	207	31571	182971	63274273
Therapeutic response unexpected	51.65	11.29	55	31723	18704	63438540
Lower respiratory tract infection	48.36	11.29	5	31773	132302	63324942
Seizure	48.16	11.29	161	31617	132473	63324771
Pericarditis	48.03	11.29	5	31773	131574	63325670
Feeling abnormal	47.70	11.29	173	31605	148219	63309025
Systemic lupus erythematosus	46.84	11.29	23	31755	208895	63248349
Arthropathy	46.68	11.29	30	31748	234762	63222482
Muscle spasticity	46.55	11.29	56	31722	21738	63435506
Blood pressure measurement	45.10	11.29	13	31765	288	63456956
Wound	43.09	11.29	14	31764	163249	63293995
General physical health deterioration	42.46	11.29	24	31754	201378	63255866
Feeling drunk	41.84	11.29	26	31752	4116	63453128
Narcolepsy	41.41	11.29	18	31760	1360	63455884
Product use issue	41.40	11.29	30	31748	220490	63236754
Disturbance in attention	41.33	11.29	71	31707	38118	63419126
Surgery	40.49	11.29	68	31710	35844	63421400
Restless legs syndrome	40.20	11.29	48	31730	18483	63438761
Tremor	39.84	11.29	151	31627	132088	63325156
Acute kidney injury	39.68	11.29	44	31734	263371	63193873
Urinary incontinence	39.31	11.29	63	31715	31951	63425293
Psychotic disorder	39.25	11.29	56	31722	25656	63431588
Sleep paralysis	38.79	11.29	14	31764	646	63456598
Death	38.63	11.29	81	31697	374300	63082944
Magnetic resonance imaging abnormal	38.00	11.29	22	31756	3063	63454181
Muscular weakness	37.93	11.29	141	31637	122212	63335032
Hypoaesthesia	37.27	11.29	175	31603	168218	63289026
Rash	36.99	11.29	150	31628	560721	62896523
Drug intolerance	36.95	11.29	61	31717	308600	63148644
Pregnancy on oral contraceptive	35.98	11.29	15	31763	1022	63456222
Stress	35.30	11.29	93	31685	67074	63390170
Dysstasia	35.14	11.29	48	31730	21118	63436126
Heart rate	34.62	11.29	8	31770	70	63457174
Neutropenia	33.90	11.29	23	31755	174982	63282262
Hypersomnia	33.13	11.29	43	31735	18012	63439232
Blood pressure increased	32.68	11.29	164	31614	161898	63295346
Drug ineffective	32.47	11.29	351	31427	1044414	62412830
Thrombocytopenia	31.87	11.29	18	31760	151139	63306105
Hypnagogic hallucination	31.64	11.29	9	31769	190	63457054
Muscle spasms	31.47	11.29	158	31620	155992	63301252
Insomnia	30.98	11.29	199	31579	215053	63242191
Substance use	30.30	11.29	11	31767	516	63456728
Mania	30.12	11.29	34	31744	12333	63444911
Parasomnia	29.96	11.29	11	31767	533	63456711
Hypersensitivity vasculitis	29.84	11.29	21	31757	4091	63453153
Febrile neutropenia	29.79	11.29	11	31767	118438	63338806
Postural orthostatic tachycardia syndrome	29.73	11.29	14	31764	1275	63455969
Post-traumatic stress disorder	29.53	11.29	23	31755	5228	63452016
Abnormal dreams	29.24	11.29	31	31747	10485	63446759
Bipolar disorder	28.66	11.29	27	31751	7933	63449311
Abdominal discomfort	28.62	11.29	75	31703	320810	63136434
Alopecia	28.52	11.29	81	31697	337455	63119789
Secondary progressive multiple sclerosis	28.38	11.29	14	31764	1413	63455831
Irritability	28.03	11.29	54	31724	31640	63425604
Diarrhoea	27.88	11.29	227	31551	715139	62742105
Malignant neoplasm progression	27.81	11.29	4	31774	82117	63375127
Weight decreased	27.34	11.29	234	31544	276564	63180680
Central nervous system lesion	27.21	11.29	30	31748	10605	63446639
Loss of consciousness	27.03	11.29	124	31654	117997	63339247
Intervertebral disc protrusion	26.87	11.29	45	31733	23664	63433580
Histoplasmosis	26.81	11.29	15	31763	1956	63455288
Paranoia	26.57	11.29	31	31747	11648	63445596
Panic attack	26.13	11.29	43	31735	22288	63434956
Pancytopenia	26.12	11.29	8	31770	96925	63360319
Lymphocyte count decreased	26.09	11.29	51	31727	30206	63427038
Vision blurred	26.07	11.29	103	31675	91821	63365423
Optic neuritis	25.49	11.29	26	31752	8409	63448835
Periodic limb movement disorder	25.26	11.29	8	31770	246	63456998
Blister	25.22	11.29	17	31761	129797	63327447
Hallucination, auditory	24.25	11.29	31	31747	12793	63444451
Polycystic ovaries	23.88	11.29	19	31759	4452	63452792
Asthma exercise induced	23.50	11.29	8	31770	310	63456934
Amnesia	23.37	11.29	71	31707	55514	63401730
Enterococcal sepsis	22.65	11.29	12	31766	1406	63455838
Disease progression	22.63	11.29	17	31761	122741	63334503
Peroneal nerve palsy	22.58	11.29	19	31759	4816	63452428
Muscle injury	22.55	11.29	3	31775	65342	63391902
Hypertension	22.47	11.29	226	31552	279077	63178167
Headache	22.19	11.29	442	31336	632799	62824445
Crying	22.17	11.29	41	31737	23302	63433942
Sleep-related eating disorder	21.99	11.29	10	31768	841	63456403
White blood cells urine positive	21.51	11.29	19	31759	5139	63452105
Urinary tract infection	21.21	11.29	214	31564	264470	63192774
Trigeminal neuralgia	21.07	11.29	16	31762	3503	63453741
Bruxism	21.04	11.29	16	31762	3509	63453735
Discomfort	21.02	11.29	32	31746	167342	63289902
Nephrolithiasis	20.91	11.29	57	31721	41927	63415317
Peripheral swelling	20.88	11.29	66	31712	265876	63191368
Paraesthesia	20.68	11.29	142	31636	156824	63300420
Liver injury	20.37	11.29	3	31775	60517	63396727
Neuralgia	20.32	11.29	42	31736	25884	63431360
Cervical spinal stenosis	20.15	11.29	13	31765	2195	63455049
Withdrawal syndrome	20.10	11.29	36	31742	19961	63437283
Drug withdrawal syndrome	20.09	11.29	43	31735	27151	63430093
Urine analysis abnormal	19.97	11.29	18	31760	4998	63452246
Hypnopompic hallucination	19.91	11.29	5	31773	64	63457180
Swelling	19.81	11.29	71	31707	275307	63181937
Cardiac failure	19.68	11.29	10	31768	89132	63368112
Dyskinesia	19.63	11.29	47	31731	31955	63425289
Helicobacter infection	19.62	11.29	11	31767	92774	63364470
Hysterectomy	19.62	11.29	24	31754	9475	63447769
Anaemia	19.58	11.29	78	31700	293352	63163892
Abnormal sleep-related event	19.49	11.29	9	31769	784	63456460
Endometriosis	19.06	11.29	18	31760	5302	63451942
Arthralgia	18.99	11.29	188	31590	569522	62887722
Abdominal pain	18.96	11.29	79	31699	293377	63163867
C-reactive protein increased	18.94	11.29	12	31766	94695	63362549
Hunger	18.90	11.29	18	31760	5361	63451883
Spinal operation	18.89	11.29	22	31756	8249	63448995
Attention deficit hyperactivity disorder	18.45	11.29	14	31764	3062	63454182
Lymphopenia	18.43	11.29	33	31745	18294	63438950
Hangover	18.40	11.29	11	31767	1625	63455619
Product use in unapproved indication	18.22	11.29	39	31739	179041	63278203
Vitamin D deficiency	17.96	11.29	28	31750	13864	63443380
Therapeutic product effect incomplete	17.62	11.29	22	31756	125034	63332210
Incoherent	17.53	11.29	16	31762	4514	63452730
Injection site scar	17.35	11.29	9	31769	1009	63456235
Cognitive disorder	17.01	11.29	64	31714	55751	63401493
Stomatitis	16.96	11.29	27	31751	138698	63318546
Folliculitis	16.90	11.29	7	31771	70310	63386934
Movement disorder	16.87	11.29	35	31743	21626	63435618
Pneumonia	16.81	11.29	147	31631	456620	63000624
Tardive dyskinesia	16.78	11.29	21	31757	8481	63448763
Oedema mouth	16.76	11.29	12	31766	2401	63454843
Progressive multifocal leukoencephalopathy	16.57	11.29	26	31752	12945	63444299
Unevaluable event	16.56	11.29	60	31718	51326	63405918
Dizziness	16.35	11.29	304	31474	429621	63027623
Apnoea	16.13	11.29	20	31758	8002	63449242
Emotional disorder	15.97	11.29	26	31752	13353	63443891
Clumsiness	15.85	11.29	11	31767	2096	63455148
Loss of bladder sensation	15.66	11.29	4	31774	55	63457189
Uterine leiomyoma	15.48	11.29	21	31757	9177	63448067
Coordination abnormal	15.41	11.29	26	31752	13747	63443497
Poor quality sleep	15.28	11.29	32	31746	19903	63437341
Seasonal affective disorder	15.23	11.29	6	31772	353	63456891
Psoriatic arthropathy	15.23	11.29	14	31764	91506	63365738
Obsessive-compulsive disorder	15.05	11.29	14	31764	4046	63453198
Maternal exposure during pregnancy	14.99	11.29	58	31720	220004	63237240
Urine abnormality	14.93	11.29	18	31760	7001	63450243
Depersonalisation/derealisation disorder	14.85	11.29	9	31769	1363	63455881
Abnormal behaviour	14.82	11.29	33	31745	21393	63435851
Platelet count decreased	14.77	11.29	22	31756	116100	63341144
Infection	14.61	11.29	62	31716	229111	63228133
Haemoglobin decreased	14.53	11.29	32	31746	145453	63311791
CD4 lymphocytes decreased	14.52	11.29	9	31769	1418	63455826
Paralysis	14.29	11.29	21	31757	9879	63447365
Nausea	14.28	11.29	542	31236	853929	62603315
Renal impairment	14.14	11.29	14	31764	88341	63368903
International normalised ratio increased	14.10	11.29	3	31775	46422	63410822
Perinatal depression	14.03	11.29	7	31771	724	63456520
Hepatic enzyme increased	13.99	11.29	53	31725	202275	63254969
Brachial plexus injury	13.97	11.29	3	31775	18	63457226
Suicide attempt	13.96	11.29	64	31714	60854	63396390
Road traffic accident	13.75	11.29	45	31733	36587	63420657
Neurogenic bladder	13.50	11.29	12	31766	3273	63453971
Invasive ductal breast carcinoma	13.44	11.29	17	31761	6941	63450303
Wheezing	13.27	11.29	17	31761	95578	63361666
Haemoglobin urine present	13.24	11.29	7	31771	816	63456428
Urinary sediment present	13.15	11.29	10	31768	2193	63455051
Meniscus injury	13.14	11.29	17	31761	7097	63450147
Therapeutic product effect decreased	13.10	11.29	51	31727	193136	63264108
Flushing	13.07	11.29	73	31705	75014	63382230
Ankle fracture	12.92	11.29	28	31750	17827	63439417
Urine leukocyte esterase positive	12.62	11.29	12	31766	3567	63453677
Septic shock	12.57	11.29	9	31769	66620	63390624
Hypoaesthesia oral	12.51	11.29	23	31755	13010	63444234
Impaired healing	12.49	11.29	20	31758	102522	63354722
Spinal osteoarthritis	12.42	11.29	26	31752	16160	63441084
Treatment noncompliance	12.38	11.29	44	31734	37281	63419963
Relapsing-remitting multiple sclerosis	12.37	11.29	6	31772	584	63456660
Injection site reaction	12.33	11.29	60	31718	58464	63398780
Pyrexia	12.24	11.29	164	31614	470314	62986930
Loss of control of legs	12.20	11.29	8	31770	1388	63455856
Fatigue	12.03	11.29	551	31227	887477	62569767
Micturition urgency	11.91	11.29	19	31759	9592	63447652
Tic	11.58	11.29	8	31770	1512	63455732
Bladder disorder	11.52	11.29	18	31760	8928	63448316
Generalised anxiety disorder	11.48	11.29	9	31769	2065	63455179
Product substitution issue	11.48	11.29	25	31753	15971	63441273
B-lymphocyte count decreased	11.39	11.29	7	31771	1087	63456157
Nocturia	11.36	11.29	17	31761	8124	63449120
Papilloma viral infection	11.35	11.29	8	31770	1562	63455682

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
Cataplexy	183.36	14.73	38	12045	288	34944560
Sleep apnoea syndrome	157.17	14.73	94	11989	20227	34924621
Pre-existing condition improved	136.15	14.73	46	12037	2546	34942302
Multiple sclerosis relapse	104.76	14.73	62	12021	13071	34931777
Multiple sclerosis	100.29	14.73	48	12035	6597	34938251
Suicidal ideation	93.80	14.73	91	11992	40297	34904551
Depression	86.89	14.73	135	11948	96963	34847885
Anxiety	83.12	14.73	134	11949	99294	34845554
Product administration interrupted	79.02	14.73	28	12055	1787	34943061
Therapeutic response unexpected	72.46	14.73	44	12039	9713	34935135
Tic	50.82	14.73	21	12062	2037	34942811
Obsessive-compulsive disorder	48.94	14.73	28	12055	5536	34939312
Bipolar disorder	47.86	14.73	24	12059	3645	34941203
Somnambulism	45.76	14.73	22	12061	3050	34941798
Sleep paralysis	45.75	14.73	11	12072	173	34944675
Somnolence	44.37	14.73	110	11973	111006	34833842
Memory impairment	42.59	14.73	63	12020	43255	34901593
Acute kidney injury	40.55	14.73	28	12055	304960	34639888
Cognitive disorder	39.26	14.73	49	12034	28644	34916204
Psychotic disorder	38.76	14.73	45	12038	24407	34920441
Narcolepsy	38.40	14.73	12	12071	517	34944331
Migraine	36.14	14.73	37	12046	17441	34927407
Delusion	36.13	14.73	32	12051	12603	34932245
Feeling abnormal	35.80	14.73	72	12011	63163	34881685
Concussion	34.96	14.73	17	12066	2416	34942432
Foetal malnutrition	32.31	14.73	7	12076	67	34944781
Tourette's disorder	31.94	14.73	7	12076	71	34944777
Anaemia	31.54	14.73	21	12062	233314	34711534
Mania	31.08	14.73	26	12057	9485	34935363
Road traffic accident	30.86	14.73	34	12049	17416	34927432
Insomnia	29.64	14.73	91	11992	103816	34841032
Neutropenia	29.12	14.73	9	12074	156769	34788079
Wrong dose	28.99	14.73	10	12073	589	34944259
Headache	27.91	14.73	140	11943	200495	34744353
Irritability	27.32	14.73	38	12045	24652	34920196
Post-traumatic stress disorder	26.60	14.73	13	12070	1868	34942980
Fall	26.42	14.73	139	11944	202746	34742102
Hypertension	26.34	14.73	105	11978	136338	34808510
Thrombocytopenia	25.58	14.73	11	12072	156236	34788612
Nephrolithiasis	25.43	14.73	41	12042	30292	34914556
Foetal hypokinesia	24.93	14.73	8	12075	376	34944472
Gait disturbance	24.68	14.73	75	12008	85065	34859783
Paranoia	23.96	14.73	25	12058	12043	34932805
Condition aggravated	23.20	14.73	129	11954	192067	34752781
Abnormal sleep-related event	23.06	14.73	8	12075	479	34944369
Post concussion syndrome	22.93	14.73	6	12077	135	34944713
Aggression	22.80	14.73	45	12038	38919	34905929
Blood pressure increased	22.24	14.73	74	12009	88028	34856820
Death	21.87	14.73	68	12015	397981	34546867
Renal failure	21.67	14.73	9	12074	130548	34814300
Abnormal dreams	21.28	14.73	19	12064	7559	34937289
Trismus	20.46	14.73	12	12071	2483	34942365
Snoring	19.62	14.73	13	12070	3333	34941515
Hypotension	19.54	14.73	29	12054	221620	34723228
Urinary tract infection	18.93	14.73	68	12015	84013	34860835
Psychotic symptom	18.70	14.73	10	12073	1733	34943115
Disease progression	18.67	14.73	7	12076	108070	34836778
Periodic limb movement disorder	18.35	14.73	5	12078	132	34944716
Complex regional pain syndrome	18.23	14.73	7	12076	560	34944288
Restless legs syndrome	17.84	14.73	18	12065	8336	34936512
Schizotypal personality disorder	17.62	14.73	3	12080	6	34944842
Magical thinking	17.62	14.73	3	12080	6	34944842
Influenza like illness	17.49	14.73	33	12050	27601	34917247
Hallucination	17.45	14.73	48	12035	51450	34893398
Hypnagogic hallucination	17.20	14.73	4	12079	54	34944794
Secondary progressive multiple sclerosis	16.87	14.73	6	12077	387	34944461
General physical health deterioration	16.70	14.73	12	12071	128257	34816591
Seizure	16.58	14.73	76	12007	104781	34840067
Renal impairment	16.53	14.73	6	12077	94507	34850341
Fatigue	16.52	14.73	198	11885	370455	34574393
Disturbance in attention	16.44	14.73	31	12052	25914	34918934
Rib hypoplasia	16.09	14.73	3	12080	12	34944836
Trigeminal neuralgia	15.91	14.73	8	12075	1221	34943627
Platelet count decreased	15.85	14.73	11	12072	119706	34825142
Hallucination, auditory	15.73	14.73	20	12063	11897	34932951
Antiphospholipid antibodies	15.54	14.73	3	12080	15	34944833
Pulmonary hypoplasia	15.49	14.73	6	12077	491	34944357
Muscle spasms	15.49	14.73	59	12024	74942	34869906
Muscle spasticity	15.04	14.73	14	12069	5874	34938974
Balance disorder	14.89	14.73	39	12044	40615	34904233
Nervousness	14.85	14.73	20	12063	12586	34932262

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
Multiple sclerosis relapse	407.83	11.75	241	29957	46292	79667898
Multiple sclerosis	334.43	11.75	165	30033	22117	79692073
Cataplexy	279.54	11.75	66	30132	868	79713322
Depression	171.66	11.75	300	29898	216490	79497700
Pre-existing condition improved	116.87	11.75	52	30146	5511	79708679
Sleep apnoea syndrome	102.10	11.75	95	30103	36383	79677807
Anxiety	99.81	11.75	261	29937	248251	79465939
Suicidal ideation	91.52	11.75	128	30070	76212	79637978
Memory impairment	84.89	11.75	152	30046	111582	79602608
Fall	80.26	11.75	381	29817	487248	79226942
Acute kidney injury	70.67	11.75	56	30142	519348	79194842
Gait disturbance	66.61	11.75	201	29997	207305	79506885
Somnolence	63.55	11.75	217	29981	238764	79475426
Narcolepsy	58.54	11.75	21	30177	1265	79712925
Muscle spasticity	56.40	11.75	54	30144	21421	79692769
Influenza like illness	56.31	11.75	99	30099	71608	79642582
Urinary tract infection	56.07	11.75	229	29969	274283	79439907
Febrile neutropenia	55.89	11.75	10	30188	230989	79483201
Sleep paralysis	55.56	11.75	17	30181	621	79713569
Balance disorder	53.87	11.75	117	30081	98740	79615450
Feeling abnormal	52.76	11.75	156	30042	159043	79555147
Off label use	50.98	11.75	175	30023	907040	78807150
Joint swelling	50.58	11.75	23	30175	288623	79425567
Migraine	50.49	11.75	106	30092	87387	79626803
Tic	50.46	11.75	24	30174	2962	79711228
Psychotic disorder	50.46	11.75	70	30128	41332	79672858
Therapeutic response unexpected	50.20	11.75	49	30149	19897	79694293
Obsessive-compulsive disorder	50.04	11.75	30	30168	5897	79708293
Somnambulism	48.41	11.75	29	30169	5692	79708498
General physical health deterioration	48.12	11.75	22	30176	275216	79438974
Feeling drunk	48.11	11.75	27	30171	4692	79709498
Blood pressure measurement	47.80	11.75	14	30184	439	79713751
Product administration interrupted	47.22	11.75	25	30173	3874	79710316
Headache	46.90	11.75	414	29784	653358	79060832
Hypoaesthesia	46.89	11.75	162	30036	179190	79535000
Thrombocytopenia	46.69	11.75	21	30177	265238	79448952
Insomnia	46.52	11.75	200	29998	244970	79469220
Mania	46.22	11.75	45	30153	18215	79695975
Seizure	45.46	11.75	166	30032	188668	79525522
Contraindicated product administered	44.90	11.75	4	30194	157534	79556656
Abnormal dreams	44.66	11.75	36	30162	11376	79702814
Neutropenia	44.40	11.75	27	30171	287683	79426507
Enuresis	43.15	11.75	22	30176	3154	79711036
Rheumatoid arthritis	40.80	11.75	14	30184	208456	79505734
Secondary progressive multiple sclerosis	39.08	11.75	16	30182	1381	79712809
Magnetic resonance imaging abnormal	38.58	11.75	21	30177	3438	79710752
Cognitive disorder	38.36	11.75	83	30115	69843	79644347
Anaemia	38.07	11.75	69	30129	444946	79269244
Death	37.66	11.75	101	30097	566413	79147777
Bipolar disorder	36.00	11.75	27	30171	7680	79706510
Malignant neoplasm progression	34.87	11.75	5	30193	135985	79578205
Hypnagogic hallucination	34.35	11.75	9	30189	185	79714005
Muscle spasms	34.25	11.75	144	30054	174586	79539604
Treatment failure	34.14	11.75	11	30187	170475	79543715
Heart rate	33.82	11.75	8	30190	106	79714084
Delusion	33.48	11.75	40	30158	20383	79693807
Disease progression	33.37	11.75	14	30184	184348	79529842
Hyperkalaemia	32.34	11.75	3	30195	114395	79599795
Pregnancy on oral contraceptive	31.82	11.75	12	30186	833	79713357
Optic neuritis	30.98	11.75	27	30171	9493	79704697
Tourette's disorder	30.63	11.75	7	30191	79	79714111
Wrong dose	29.81	11.75	14	30184	1680	79712510
Hypersomnia	29.59	11.75	40	30158	23046	79691144
Snoring	29.39	11.75	21	30177	5545	79708645
Pancytopenia	29.34	11.75	13	30185	165732	79548458
Restless legs syndrome	29.14	11.75	37	30161	20055	79694135
Concussion	29.02	11.75	26	30172	9477	79704713
Urinary incontinence	28.95	11.75	54	30144	40855	79673335
Attention deficit hyperactivity disorder	28.59	11.75	17	30181	3292	79710898
Renal impairment	28.53	11.75	12	30186	157771	79556419
Hallucination, auditory	28.28	11.75	37	30161	20656	79693534
Dysstasia	28.12	11.75	43	30155	27703	79686487
Cardiac failure	27.64	11.75	12	30186	154830	79559360
Lower respiratory tract infection	26.47	11.75	8	30190	129212	79584978
Vision blurred	26.23	11.75	94	30104	105804	79608386
Fatigue	26.07	11.75	495	29703	929232	78784958
Peroneal nerve palsy	25.65	11.75	20	30178	6022	79708168
Histoplasmosis	25.39	11.75	14	30184	2351	79711839
Progressive multifocal leukoencephalopathy	25.35	11.75	35	30163	20565	79693625
Road traffic accident	25.29	11.75	53	30145	43611	79670579
Disturbance in attention	25.27	11.75	58	30140	50743	79663447
Hypersensitivity vasculitis	25.27	11.75	21	30177	6922	79707268
Infusion related reaction	25.24	11.75	30	30168	230207	79483983
Panic attack	25.21	11.75	38	30160	24178	79690012
Muscular weakness	25.17	11.75	124	30074	160605	79553585
Tremor	25.08	11.75	129	30069	169954	79544236
Irritability	25.08	11.75	51	30147	41093	79673097
Amnesia	25.01	11.75	66	30132	62991	79651199
Loss of consciousness	24.50	11.75	127	30071	167816	79546374
Abnormal behaviour	24.44	11.75	47	30151	36374	79677816
Pericarditis	24.16	11.75	5	30193	104231	79609959
Glossodynia	23.86	11.75	5	30193	103332	79610858
White blood cells urine positive	23.42	11.75	19	30179	6056	79708134
Renal failure	23.32	11.75	25	30173	200943	79513247
Dyskinesia	23.25	11.75	52	30146	44721	79669469
Hunger	23.12	11.75	18	30180	5410	79708780
Blood pressure increased	23.09	11.75	148	30050	211212	79502978
Stress	22.63	11.75	74	30124	79538	79634652
Suicide attempt	22.60	11.75	76	30122	82856	79631334
Post-traumatic stress disorder	22.57	11.75	17	30181	4864	79709326
Trigeminal neuralgia	22.31	11.75	15	30183	3594	79710596
Urine analysis abnormal	22.25	11.75	19	30179	6501	79707689
Lymphocyte count decreased	21.36	11.75	52	30146	47237	79666953
Hangover	21.30	11.75	12	30186	2100	79712090
Nervousness	21.06	11.75	42	30156	33373	79680817
Product use in unapproved indication	20.34	11.75	40	30158	250319	79463871
Hypotension	20.13	11.75	92	30106	440225	79273965
Diarrhoea	19.73	11.75	226	29972	880263	78833927
Septic shock	19.67	11.75	11	30187	122790	79591400
Platelet count decreased	19.63	11.75	27	30171	194637	79519553
Oedema mouth	19.63	11.75	13	30185	3038	79711152
Paranoia	19.53	11.75	30	30168	19402	79694788
Tardive dyskinesia	19.50	11.75	22	30176	10549	79703641
Drug withdrawal syndrome	18.79	11.75	41	30157	34677	79679513
Psychotic symptom	18.59	11.75	12	30186	2685	79711505
Laboratory test abnormal	18.58	11.75	36	30162	28012	79686178
Enterococcal sepsis	18.47	11.75	12	30186	2714	79711476
Product use issue	18.39	11.75	32	30166	209790	79504400
International normalised ratio increased	17.80	11.75	5	30193	84716	79629474
Cervical spinal stenosis	17.51	11.75	11	30187	2348	79711842
Endometriosis	17.46	11.75	13	30185	3655	79710535
Poor quality sleep	17.35	11.75	31	30167	22691	79691499
Magical thinking	17.34	11.75	3	30195	6	79714184
Substance use	17.31	11.75	8	30190	926	79713264
Withdrawal syndrome	17.22	11.75	34	30164	26820	79687370
Movement disorder	16.86	11.75	34	30164	27225	79686965
Head injury	16.78	11.75	41	30157	37328	79676862
Interstitial lung disease	16.75	11.75	11	30187	112589	79601601
Urine abnormality	16.71	11.75	18	30180	8201	79705989
Paraesthesia	16.58	11.75	119	30079	176204	79537986
Schizotypal personality disorder	16.48	11.75	3	30195	9	79714181
Sleep attacks	16.41	11.75	5	30193	180	79714010
Nausea	16.38	11.75	476	29722	956720	78757470
Breast cancer	16.18	11.75	38	30160	33743	79680447
Pneumonia	16.15	11.75	166	30032	660080	79054110
Drug intolerance	16.10	11.75	49	30149	264070	79450120
Haemoglobin decreased	15.96	11.75	38	30160	222081	79492109
Incoherent	15.91	11.75	17	30181	7675	79706515
Hypoaesthesia oral	15.90	11.75	23	30175	14101	79700089
Surgery	15.84	11.75	37	30161	32729	79681461
Invasive ductal breast carcinoma	15.82	11.75	15	30183	5877	79708313
Spinal operation	15.50	11.75	17	30181	7900	79706290
Major depression	15.40	11.75	18	30180	8962	79705228
Central nervous system lesion	15.39	11.75	22	30176	13346	79700844
Haematochezia	15.31	11.75	7	30191	87638	79626552
Flushing	15.19	11.75	70	30128	88198	79625992
Abdominal pain	15.18	11.75	86	30112	389483	79324707
Bladder disorder	15.10	11.75	18	30180	9147	79705043
C-reactive protein increased	15.02	11.75	16	30182	129011	79585179
Injection site scar	15.01	11.75	7	30191	826	79713364
Dizziness	14.92	11.75	281	29917	526160	79188030
Rash	14.73	11.75	144	30054	578214	79135976
Arthropathy	14.64	11.75	28	30170	177083	79537107
Depersonalisation/derealisation disorder	14.63	11.75	9	30189	1853	79712337
Hypnopompic hallucination	14.52	11.75	4	30194	100	79714090
Nightmare	14.52	11.75	31	30167	25830	79688360
Urinary sediment present	14.40	11.75	10	30188	2525	79711665
Neuralgia	14.33	11.75	36	30162	33348	79680842
Substance use disorder	14.22	11.75	7	30191	931	79713259
Blood creatinine increased	14.18	11.75	23	30175	155034	79559156
B-lymphocyte count decreased	14.17	11.75	8	30190	1406	79712784
Emotional disorder	14.16	11.75	22	30176	14365	79699825
Hepatic function abnormal	14.14	11.75	5	30193	73102	79641088
Euphoric mood	14.11	11.75	16	30182	7710	79706480
Haemoglobin urine present	14.10	11.75	7	30191	948	79713242
Intervertebral disc protrusion	14.06	11.75	29	30169	23592	79690598
Speech disorder	14.05	11.75	49	30149	54396	79659794
Blood pressure systolic increased	13.99	11.75	4	30194	66982	79647208
Oxygen saturation decreased	13.93	11.75	17	30181	129030	79585160
Neurogenic bladder	13.81	11.75	12	30186	4200	79709990
Delayed sleep phase	13.55	11.75	3	30195	29	79714161
Dyspnoea	13.49	11.75	236	29962	856789	78857401
Product substitution issue	13.41	11.75	26	30172	20230	79693960
Hallucination	13.31	11.75	66	30132	85679	79628511
Electrocardiogram QT prolonged	13.22	11.75	9	30189	90377	79623813
Hysterectomy	13.21	11.75	14	30184	6258	79707932
Erythema	13.20	11.75	42	30156	223248	79490942
Lymphopenia	13.16	11.75	33	30165	30524	79683666
Muscle tightness	13.06	11.75	20	30178	12894	79701296
Extra dose administered	13.01	11.75	16	30182	8399	79705791
Trismus	12.96	11.75	13	30185	5454	79708736
Nephrolithiasis	12.93	11.75	47	30151	53244	79660946
Sleep-related eating disorder	12.87	11.75	6	30192	708	79713482
Somatic delusion	12.84	11.75	6	30192	712	79713478
Haematuria	12.82	11.75	5	30193	68831	79645359
Hypertension	12.82	11.75	186	30012	330806	79383384
Multiple organ dysfunction syndrome	12.82	11.75	16	30182	120230	79593960
Ankle fracture	12.76	11.75	23	30175	16946	79697244
Papilloma viral infection	12.66	11.75	8	30190	1726	79712464
Pyrexia	12.65	11.75	181	30017	678528	79035662
Blister	12.63	11.75	16	30182	119460	79594730
Dihydrotestosterone increased	12.53	11.75	3	30195	42	79714148
Product dose omission issue	12.48	11.75	146	30052	247391	79466799
Asthenia	12.45	11.75	267	29931	511422	79202768
Rash maculo-papular	12.37	11.75	3	30195	56075	79658115
Periodic limb movement disorder	12.36	11.75	4	30194	176	79714014
Stomatitis	12.30	11.75	23	30175	146734	79567456
Bruxism	12.26	11.75	11	30187	4015	79710175
Drug ineffective	12.23	11.75	314	29884	1080599	78633591
Urine leukocyte esterase positive	12.11	11.75	11	30187	4080	79710110
Systemic lupus erythematosus	12.01	11.75	17	30181	121132	79593058
Drug abuser	11.93	11.75	13	30185	6000	79708190
Treatment noncompliance	11.76	11.75	45	30153	52223	79661967

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N06BA07	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
FDA PE	N0000175651	Increased Sympathetic Activity
FDA PE	N0000175729	Central Nervous System Stimulation
FDA EPC	N0000175769	Sympathomimetic-like Agent
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
Hypersomnia	indication	77692006
Sleepiness Due To Obstructive Sleep Apnea	indication
Sleepiness Due To Shift Work Sleep Disorder	indication
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Myocardial infarction	contraindication	22298006	DOID:5844
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Left ventricular hypertrophy	contraindication	55827005
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Aggressive behavior	contraindication	61372001
Psychotic disorder	contraindication	69322001
Mania	contraindication	231494001
Acute coronary syndrome	contraindication	394659003
Mitral valve prolapse	contraindication	409712001
Myocardial ischemia	contraindication	414795007	DOID:3393

🐶 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])	Mechanism action	Bioact source	MoA source
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	Ki	5.84		DRUG MATRIX	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	4.41		CHEMBL
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN					WOMBAT-PK
Cytochrome P450 1A2	Enzyme	P05177	CP1A2_HUMAN		Ki	4.40		WOMBAT-PK
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN					WOMBAT-PK
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		EC50	6.62		WOMBAT-PK
Sodium-dependent serotonin transporter	Transporter		SC6A4_RAT		Ki	4.50		CHEMBL
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	5.60		CHEMBL
Transporter	Transporter		Q63380_RAT		IC50	4.19		CHEMBL

External reference:

ID	Source
4021149	VUID
N0000148602	NUI
D01832	KEGG_DRUG
4021149	VANDF
C0066677	UMLSCUI
CHEBI:31859	CHEBI
CHEMBL1373	ChEMBL_ID
DB00745	DRUGBANK_ID
D000077408	MESH_DESCRIPTOR_UI
4236	PUBCHEM_CID
7555	IUPHAR_LIGAND_ID
6055	INN_ID
R3UK8X3U3D	UNII
30125	RXNORM
52652	MMSL
7873	MMSL
d04378	MMSL
005305	NDDF
116082007	SNOMEDCT_US
387004007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6423	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6424	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6791	TABLET	100 mg	ORAL	ANDA	19 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6791	TABLET	100 mg	ORAL	ANDA	19 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6792	TABLET	200 mg	ORAL	ANDA	19 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6792	TABLET	200 mg	ORAL	ANDA	19 sections
PROVIGIL	HUMAN PRESCRIPTION DRUG LABEL	1	21695-234	TABLET	100 mg	ORAL	NDA	25 sections
PROVIGIL	HUMAN PRESCRIPTION DRUG LABEL	1	21695-235	TABLET	200 mg	ORAL	NDA	25 sections
Modafinil	Human Prescription Drug Label	1	23155-604	TABLET	100 mg	ORAL	ANDA	24 sections
Modafinil	Human Prescription Drug Label	1	23155-605	TABLET	200 mg	ORAL	ANDA	24 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	42043-160	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	42043-161	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	42291-599	TABLET	100 mg	ORAL	ANDA	30 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	42291-600	TABLET	200 mg	ORAL	ANDA	30 sections
MODAFINIL	HUMAN PRESCRIPTION DRUG LABEL	1	42549-678	TABLET	200 mg	ORAL	NDA authorized generic	25 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	43353-831	TABLET	200 mg	ORAL	ANDA	28 sections
modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	43353-925	TABLET	200 mg	ORAL	NDA authorized generic	25 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	43353-956	TABLET	200 mg	ORAL	NDA authorized generic	28 sections
Modafinil	Human Prescription Drug Label	1	46708-385	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	Human Prescription Drug Label	1	46708-385	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	Human Prescription Drug Label	1	46708-386	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	Human Prescription Drug Label	1	46708-386	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	Human Prescription Drug Label	1	50090-2472	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	Human Prescription Drug Label	1	50090-2473	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3865	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4144	TABLET	200 mg	ORAL	ANDA	19 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50268-570	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50268-570	TABLET	100 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50268-571	TABLET	200 mg	ORAL	ANDA	29 sections
Modafinil	HUMAN PRESCRIPTION DRUG LABEL	1	50268-571	TABLET	200 mg	ORAL	ANDA	29 sections