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)
Immune system disorder10.02.01.001--Not Available
Influenza like illness08.01.03.0100.001095%
Insomnia19.02.01.002; 17.15.03.0020.011248%
Irritability19.04.02.013; 08.01.03.0110.004728%
Lethargy19.04.04.004; 08.01.01.008; 17.02.04.0030.001095%
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.003036%Not Available
Loss of consciousness17.02.04.0040.001244%Not Available
Malabsorption14.02.01.004; 07.17.01.0010.001692%
Mania19.16.02.0020.001095%
Migraine24.03.05.003; 17.14.02.0010.003882%Not Available
Mood altered19.04.02.0070.001095%Not Available
Mood swings19.04.03.0010.001941%Not Available
Mouth ulceration07.05.06.0040.003285%Not Available
Movement disorder17.01.02.0100.001344%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000498%
Myopathy15.05.05.0010.001095%Not Available
Nausea07.01.07.0010.016375%
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.004479%Not Available
Oesophageal stenosis07.13.02.0010.000498%
Oral discomfort07.05.05.0010.001692%Not Available
Oral mucosal blistering07.05.05.0170.001095%Not Available
Pain08.01.08.004--
Palpitations02.11.04.0120.008113%
Pancytopenia01.03.03.003--Not Available
Panic attack19.06.04.0010.001941%Not Available
Paraesthesia23.03.03.094; 17.02.06.0050.003285%
Personality change19.05.01.006; 17.02.05.0190.002538%
Polyuria20.02.03.002--Not Available
Pregnancy18.08.02.0040.002538%Not Available
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