Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rotigotine
Drug ID BADD_D01973
Description Rotigotine (Neupro) is a non-ergoline dopamine agonist indicated for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States. It is formulated as a once-daily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Like other dopamine agonists, rotigotine has been shown to possess antidepressant effects and may be useful in the treatment of depression as well. Rotigotine was developed by Aderis Pharmaceuticals. In 1998 Aderis licensed worldwide development and commercialization rights to Schwarz Pharma of Germany. It was approved by the European Medicines Agency in 2006 and by the FDA in 2007. However, all Neupro patches in the United States and some of Europe were recalled in 2008 due to delivery mechanism issues. Rotigotine has been authorized as a treatment for RLS since August 2008.
Indications and Usage For use/treatment in neurologic disorders and parkinson's disease as well as moderate-to-severe primary Restless Legs Syndrome.
Marketing Status approved
ATC Code N04BC09
DrugBank ID DB05271
KEGG ID D05768
MeSH ID C047508
PubChem ID 59227
TTD Drug ID D81KMY
NDC Product Code 50474-808; 58175-0545; 64552-4020; 43263-0100; 50474-801; 50474-805; 12651-117; 11722-056; 17337-0234; 24196-180; 17337-0033; 65015-815; 50474-802; 64552-4097; 82245-0112; 50474-803; 50474-804; 50474-806; 58032-1022
UNII 87T4T8BO2E
Synonyms rotigotine | 2-(N-n-propyl-N-2-thienylethylamino)-5-hydroxytetralin | N 0437, hydrochloride, (S)-isomer | N 0923 | N-0923 | N 0924 | N-0924 | rotigotine, (+)- | (+)-5,6,7,8-tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-1-naphthol | Neupro | N 0437 | N-0437 | N 0437, (+-)-isomer | N 0437, (-)-isomer | N 0437, hydrochloride, (R)-isomer | rotigotine, (+--)- | racemic N-0437 | rotigotine (+-)-form | 1-naphthalenol, 5,6,7,8-tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)- | (+--)-5,6,7,8-tetrahydro-6-(propyl(2-(2-thienyl)ethyl)amino)-1-naphthol | N 0437, (R)-isomer | Rotigotine CDS
Chemical Information
Molecular Formula C19H25NOS
CAS Registry Number 99755-59-6
SMILES CCCN(CCC1=CC=CS1)C2CCC3=C(C2)C=CC=C3O
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)
Application site urticaria23.04.02.002; 10.01.06.002; 12.07.01.028; 08.02.01.0280.001247%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000550%Not Available
Electrocardiogram T wave abnormal13.14.05.009--
Contusion12.01.06.001; 15.03.05.007; 24.07.06.001; 23.03.11.002--
Musculoskeletal stiffness15.03.05.0270.003816%Not Available
Musculoskeletal discomfort15.03.04.0010.000367%Not Available
Application site swelling12.07.01.027; 08.02.01.0270.002055%Not Available
Secretion discharge08.01.03.0190.000367%Not Available
Pre-existing disease08.01.03.0590.000367%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.001541%
Restless legs syndrome15.05.03.012; 17.02.07.0080.005650%Not Available
Application site discolouration23.03.03.023; 12.07.01.030; 08.02.01.0300.001247%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.027--
Freezing phenomenon17.01.05.0060.002568%Not Available
Cardiac disorder02.11.01.0030.000734%Not Available
Gastrointestinal motility disorder07.02.03.0010.001284%Not Available
Impulse-control disorder19.18.01.0020.002348%Not Available
Inflammation10.02.01.089; 08.01.05.0070.000917%Not Available
Limb discomfort15.03.04.0140.000917%Not Available
Malnutrition14.03.02.0040.000367%Not Available
Mental disorder19.07.01.0020.001357%Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000734%Not Available
Abnormal behaviour19.01.01.0010.000550%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.0490.001357%Not Available
Parkinson's disease17.01.05.0100.008585%Not Available
Psychotic disorder19.03.01.0020.000734%
Unevaluable event08.01.03.0510.001101%Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.002825%Not Available
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