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 Rotigotine is an agonist at all 5 dopamine receptor subtypes (D1-D5) but binds to the D3 receptor with the highest affinity. It is also an antagonist at α-2-adrenergic receptors and an agonist at the 5HT1A receptors. Rotigotine also inhibits dopamine uptake and prolactin secretion. There is no indication of a QT/QTc prolonging effect of Neupro in doses up to 24 mg/24 hours. The effects of Neupro at doses up to 24 mg/24 hours (supratherapeutic doses) on the QT/QTc interval was evaluated in a double-blind, randomized, placebo- and positive-controlled (moxifloxacin 400 mg IV, single dose) parallel-group trial with an overall treatment period of 52 days in male and female patients with advanced-stage Parkinson's disease. Assay sensitivity was confirmed by significant QTc prolongation by moxifloxacin.
Marketing Status Prescription
ATC Code N04BC09
DrugBank ID DB05271
KEGG ID D05768
MeSH ID C047508
PubChem ID 180335
TTD Drug ID D0E4JL
NDC Product Code 17337-0078
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Application site reaction12.07.01.006; 08.02.01.006--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Binge eating19.09.01.001--Not Available
Compulsions19.06.05.003--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Cough22.02.03.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Disorientation19.13.01.002; 17.02.05.015--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dizziness postural24.06.02.008; 17.02.05.004; 02.01.02.005--Not Available
Dry mouth07.06.01.002--
Dysaesthesia17.02.06.003--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Ear disorder04.03.01.001--Not Available
Eating disorder19.09.01.008; 14.03.01.008--Not Available
Eczema23.03.04.006--
Erythema23.03.06.001--Not Available
Fall12.01.08.002--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
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