Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Armodafinil
Drug ID BADD_D00167
Description Armodafinil is the enantiopure of the wakefulness-promoting agent modafinil (Provigil), and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Research has shown that armodafinil significantly improves driving simulator performance in patients with SWD. Armodafinil consists of the (−)-R-enantiomer of the racemic modafinil. Armodafinil is produced by the pharmaceutical company Cephalon Inc. (a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.) and was approved by the U.S. Food and Drug Administration (FDA) in June 2007.
Indications and Usage Investigated for use/treatment in sleep disorders, obstructive sleep apnea, schizophrenia and schizoaffective disorders, depression, and bipolar disorders.
Marketing Status approved; investigational
ATC Code N06BA13
DrugBank ID DB06413
KEGG ID D03215
MeSH ID D000077408
PubChem ID 9690109
TTD Drug ID D0J5RN
NDC Product Code 63285-827; 65129-1185; 0093-3092; 68180-571; 68788-7593; 69339-178; 69339-179; 71335-1193; 63459-215; 65862-807; 68180-572; 68180-573; 63285-030; 63459-225; 63459-205; 69339-180; 72189-133; 72789-126; 0781-8045; 11722-072; 48087-0066; 0093-3094; 68788-7880; 72189-464; 63459-220; 65862-806; 72189-261; 0093-3093; 65862-805; 68788-7826; 71335-1308; 0781-8053; 11722-055; 63285-032; 65015-784; 0378-3431; 0378-3432; 0378-3433; 65085-0058; 65862-998; 69339-177; 71335-1842; 71335-1857; 63285-033; 68180-569; 72189-353; 0781-8029; 0781-8037; 0093-3090; 55700-510
UNII V63XWA605I
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 112111-43-0
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)
Diabetes mellitus14.06.01.001; 05.06.01.0010.000498%Not Available
Diarrhoea07.02.01.001--
Disorientation19.13.01.002; 17.02.05.0150.002439%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.001344%
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.0060.007914%
Drug abuse19.07.06.0100.001842%Not Available
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.001095%Not Available
Drug ineffective08.06.01.0060.037876%Not Available
Drug interaction08.06.03.0010.001941%Not Available
Dry mouth07.06.01.0020.003036%
Dysgeusia17.02.07.003; 07.14.03.0010.000498%
Dyskinesia17.01.02.0060.001941%
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.002190%
Dyspnoea02.11.05.003; 22.02.01.004--
Encephalopathy17.13.02.0010.000498%
Erythema multiforme23.03.01.003; 10.01.03.015--
Extrasystoles02.03.02.0030.001095%Not Available
Fatigue08.01.01.0020.011049%
Feeling abnormal08.01.09.0140.006918%Not Available
Feeling jittery08.01.09.0160.003285%Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.000747%
Gamma-glutamyltransferase increased13.03.04.024--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.0010.016873%
Heart rate increased13.14.04.002--Not Available
Hemiparesis17.01.04.0010.000498%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypersomnia19.02.05.001; 17.15.01.0010.001692%
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