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)
Abdominal pain upper07.01.05.003--
Agitation19.06.02.001; 17.02.05.0120.007864%
Alanine aminotransferase increased13.03.04.005--
Amnesia19.20.01.001; 17.03.02.0010.001941%
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000747%Not Available
Anxiety19.06.02.0020.015529%
Apathy19.04.04.0020.001692%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000995%
Arrhythmia02.03.02.0010.000747%Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.001742%
Blister23.03.01.001; 12.01.06.0020.002538%Not Available
Blood uric acid decreased13.02.04.004--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.0020.000498%Not Available
Bruxism19.11.03.001; 07.01.06.0080.002538%Not Available
Cheilitis23.03.03.025; 07.05.01.0010.001095%
Chest discomfort08.01.08.019; 02.02.02.009; 22.12.02.0020.001941%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.005823%Not Available
Chromaturia20.02.01.0020.001941%
Confusional state19.13.01.001; 17.02.03.0050.004280%
Constipation07.02.02.001--
Depressed level of consciousness17.02.04.0020.001095%
Depressed mood19.15.02.001--Not Available
Depression19.15.01.0010.008959%
Dermatitis23.03.04.002--Not Available
Dermatitis contact10.01.01.003; 23.03.04.004; 12.03.01.040--Not Available
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