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)
Premature baby18.04.02.0010.001095%Not Available
Productive cough22.02.03.0050.000498%
Pyrexia08.05.02.003--
Rash23.03.13.0010.034890%Not Available
Rash erythematous23.03.13.0290.001692%Not Available
Seizure17.12.03.0010.001991%
Skin discolouration23.03.03.0050.001095%Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.0030.001344%Not Available
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.001095%
Somnolence19.02.05.003; 17.02.04.0060.016723%
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.003733%
Stomatitis07.05.06.0050.006172%
Suicidal ideation19.12.01.0030.000747%
Swelling08.01.03.0150.001941%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.003434%Not Available
Tachycardia02.03.02.0070.003882%Not Available
Tardive dyskinesia17.01.02.0120.001095%Not Available
Tension19.06.02.005--Not Available
Therapeutic response unexpected08.06.01.0010.003384%Not Available
Thirst14.03.02.007; 08.01.09.0210.001692%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.000498%Not Available
Tic17.02.05.024; 19.11.04.0010.001692%Not Available
Tongue blistering07.14.02.0140.001692%Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.0070.001095%Not Available
Tremor17.01.06.0020.003882%
Unresponsive to stimuli17.02.05.0310.000498%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.0010.004479%
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