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
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
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
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)
Vision blurred17.17.01.010;
Visual impairment06.02.10.0130.001842%-
Withdrawal syndrome19.07.06.023;
Seasonal allergy22.04.04.008;;
Brain oedema17.07.02.003;
Lip blister23.03.01.016;
Balance disorder08.01.03.081;
Deep vein thrombosis24.01.02.0030.000747%-
Drug tolerance08.06.01.0030.001692%-
Gaze palsy17.02.05.044;
Lung neoplasm malignant22.08.01.001;
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002---
Adverse event08.06.01.0100.004231%-
Cardiac disorder02.11.01.0030.000498%-
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Abnormal behaviour19.01.01.0010.001692%-
Decreased appetite14.03.01.005;
Psychiatric symptom19.01.02.001---
Drug intolerance08.06.01.0130.002787%-
Psychotic disorder19.03.01.0020.000747%
Treatment failure08.06.01.0170.001692%-
Oropharyngeal pain22.12.03.016;
Mouth swelling23.04.01.020;;
Pulmonary cavitation22.01.02.0220.000498%-
Vasogenic cerebral oedema17.07.02.0080.000498%-
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