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 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 59227
TTD Drug ID D81KMY
NDC Product Code 50474-802; 17337-0033; 50474-806; 17337-0234; 50474-808; 24196-180; 50474-805; 64552-4020; 12651-117; 82245-0112; 65015-815; 64552-4097; 43263-0100; 11722-056; 50474-804; 50474-801; 50474-803; 58175-0545; 58032-1022
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
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)
Loss of consciousness17.02.04.0040.009943%Not Available
Malaise08.01.01.0030.013257%
Memory impairment19.20.01.003; 17.03.02.0030.011600%
Micturition urgency20.02.02.0060.007457%
Middle insomnia19.02.01.003; 17.15.03.0030.006629%Not Available
Movement disorder17.01.02.0100.004143%Not Available
Muscle rigidity15.05.04.001; 17.05.02.0050.002486%Not Available
Muscle spasms15.05.03.0040.005800%
Muscular weakness17.05.03.005; 15.05.06.0010.003314%
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.0020.002486%Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.000648%Not Available
Neuroleptic malignant syndrome08.05.01.005; 17.05.02.003; 15.05.04.015; 12.03.01.0030.004972%Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nightmare19.02.03.0030.009114%Not Available
Nocturia20.02.03.0010.006629%Not Available
Obsessive-compulsive disorder19.06.05.0020.003314%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.002486%
On and off phenomenon17.01.05.0040.005800%Not Available
Pain08.01.08.0040.008286%
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Pancytopenia01.03.03.0030.002486%Not Available
Panic attack19.06.04.0010.004972%Not Available
Panic disorder19.06.04.0020.003314%Not Available
Paraesthesia17.02.06.005--
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