Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rotigotine hydrochloride
Drug ID BADD_D01974
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 180335
TTD Drug ID D0E4JL
NDC Product Code 17337-0078
UNII 6Q1W9573L2
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 C19H26ClNOS
CAS Registry Number 125572-93-2
SMILES CCCN(CCC1=CC=CS1)C2CCC3=C(C2)C=CC=C3O.Cl
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)
Nightmare19.02.03.003--Not Available
Obsessive-compulsive disorder19.06.05.002--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain08.01.08.004--
Papule23.03.03.038--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Road traffic accident12.01.08.006--Not Available
Serum ferritin decreased13.11.01.031--Not Available
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Sleep attacks19.02.02.005--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Stereotypy19.11.03.006; 17.01.02.016--Not Available
Swelling08.01.03.015--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tinnitus17.04.07.004; 04.04.01.002--
Tongue disorder07.14.01.002--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria10.01.06.001; 23.04.02.001--
Vertigo17.02.12.002; 04.04.01.003--
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