Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Modafinil
Drug ID BADD_D01484
Description Modafinil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by modafinil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Modafinil activates glutamatergic circuits while inhibiting GABA.
Indications and Usage To improve wakefulness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy.
Marketing Status approved; investigational
ATC Code N06BA07
DrugBank ID DB00745
KEGG ID D01832
MeSH ID D000077408
PubChem ID 4236
TTD Drug ID D07HQC
NDC Product Code 46438-0655; 63285-000; 63552-066; 70771-1051; 71205-477; 46438-0102; 65862-602; 60505-2526; 65862-601; 68071-2844; 69452-343; 65129-1102; 71205-544; 71335-1096; 63459-201; 68084-721; 70771-1052; 71335-1402; 72578-006; 63459-101; 23155-604; 71335-1793; 71610-685; 71335-1122; 72578-005; 50268-571; 55253-801; 57237-155; 60505-2527; 62332-385; 69452-342; 71335-1173; 0904-6423; 58175-0378; 63552-067; 23155-605; 46708-385; 55253-802; 63285-001; 46708-386; 63629-7315; 68084-621; 68788-7432; 68788-8280; 0904-6424; 0904-6791; 0904-6792; 72761-023; 42043-161; 50268-570; 57237-154; 62332-386; 63629-4998; 68788-8079; 63415-0036; 65862-576; 42043-160; 43353-925
UNII R3UK8X3U3D
Synonyms Modafinil | 2-((Diphenylmethyl)sulfinyl)acetamide | Vigil | Sparlon | Nuvigil | Alertec | Benzhydrylsulfinylacetamide | Armodafinil | 2-((R)-(Diphenylmethyl)sulfinyl)acetamide | R-Modafinil | R Modafinil | Provigil | Modiodal | CRL 40476 | CRL-40476
Chemical Information
Molecular Formula C15H15NO2S
CAS Registry Number 68693-11-8
SMILES C1=CC=C(C=C1)C(C2=CC=CC=C2)S(=O)CC(=O)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dry mouth07.06.01.002--
Dry skin23.03.03.001--
Dysgeusia07.14.03.001; 17.02.07.0030.000906%
Dyskinesia17.01.02.006--
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.0010.001399%
Dysphagia07.01.06.0030.000823%
Dyspnoea02.11.05.003; 22.02.01.004--
Ear disorder04.03.01.001---
Ear pain04.03.01.003--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Eczema23.03.04.006--
Ejaculation disorder21.03.01.002--
Electrocardiogram abnormal13.14.05.001---
Emotional disorder19.04.02.0050.000906%-
Eosinophilia01.02.04.001--
Epistaxis22.04.03.001; 24.07.01.005--
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye pain06.08.03.002--
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.0030.000906%-
Fatigue08.01.01.0020.007532%
Feeling abnormal08.01.09.0140.002922%-
Feeling jittery08.01.09.0160.002511%-
Female orgasmic disorder19.08.01.005; 21.03.02.0180.000412%-
Flatulence07.01.04.002--
Frequent bowel movements07.02.04.0020.000412%-
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.000412%
Galactorrhoea05.03.04.002; 21.05.02.0020.001399%-
Gamma-glutamyltransferase increased13.03.04.024--
Gastrooesophageal reflux disease07.02.02.0030.000412%
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