Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Istradefylline
Drug ID BADD_D02484
Description Istradefylline, or KW6002, was developed by Kyowa Hakko Kirin in Japan for the treatment of Parkinson's disease as an adjunct to standard therapy.[A184067] Unlike standard dopaminergic therapies for Parkinson's, Istradefylline targets adenosine A2A receptors in the basal ganglia.[A184067] This region of the brain is highly involved in motor control.[A184067] Istradefylline is indicated as an adjunct treatment to [levodopa] and [carbidopa] for Parkinson's disease.[L8237] This drug was first approved in Japan on 25 March 2013.[A184067] Istradefylline was granted FDA approval on 27 August 2019.[L8213]
Indications and Usage Istradefylline is indicated in adjunct to levodopa and carbidopa in the treatment of Parkinson's disease.[L8237]
Marketing Status approved; investigational
ATC Code N04CX01
DrugBank ID DB11757
KEGG ID D04641
MeSH ID C111599
PubChem ID 5311037
TTD Drug ID D0F4ZY
NDC Product Code 46016-1550; 12079-2003; 42747-604; 42747-602; 46016-1551
UNII 2GZ0LIK7T4
Synonyms istradefylline | 8-(2-(3,4-dimethoxyphenyl)ethenyl)-1,3-diethyl-3,7-dihydro-7-methyl-1H-purine-2,6-dione | KW 6002 | KW-6002
Chemical Information
Molecular Formula C20H24N4O4
CAS Registry Number 155270-99-8
SMILES CCN1C2=C(C(=O)N(C1=O)CC)N(C(=N2)C=CC3=CC(=C(C=C3)OC)OC)C
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)
Obsessive-compulsive disorder19.06.05.0020.001247%Not Available
On and off phenomenon17.01.05.0040.010456%Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.0200.001431%Not Available
Paralysis17.01.04.0040.000367%Not Available
Paranoia19.05.01.0050.001908%Not Available
Pollakiuria20.02.02.0070.000807%
Psychomotor hyperactivity19.11.02.003; 17.01.02.0110.000807%Not Available
Rash erythematous23.03.13.0290.000807%Not Available
Rash macular23.03.13.0030.000807%Not Available
Retching07.01.07.0020.001247%Not Available
Sleep disorder19.02.04.0010.004660%Not Available
Sleep talking19.02.03.005; 17.15.02.0030.001798%Not Available
Sluggishness08.01.01.0040.000807%Not Available
Somnambulism19.02.03.006; 17.15.02.0040.001431%Not Available
Somnolence19.02.05.003; 17.02.04.0060.012951%
Speech disorder17.02.08.003; 22.12.03.027; 19.19.02.0020.003229%Not Available
Stress19.06.02.0040.001871%Not Available
Swollen tongue10.01.05.015; 07.14.02.003; 23.04.01.0140.000367%Not Available
Therapeutic response unexpected08.06.01.0010.003302%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.001431%Not Available
Thirst14.03.02.007; 08.01.09.0210.001247%Not Available
Tremor17.01.06.0020.031589%
Urinary incontinence20.02.02.010; 17.05.01.0080.000807%
Vitreous floaters06.09.01.0050.000807%
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.001798%Not Available
Energy increased08.01.03.0170.006237%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.006164%Not Available
Muscle tightness15.05.03.0070.001431%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.017317%Not Available
Musculoskeletal stiffness15.03.05.0270.004916%Not Available
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