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)
C-reactive protein increased13.09.01.0070.001657%Not Available
Cardiac failure02.05.01.0010.001513%
Cardiac failure congestive02.05.01.002--Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000432%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Choking22.02.05.0010.009114%Not Available
Confusional state19.13.01.001; 17.02.03.0050.008286%
Conjunctivitis11.01.06.012; 06.04.01.0020.001657%
Constipation07.02.02.0010.006629%
Coordination abnormal17.02.02.0040.001657%Not Available
Cough22.02.03.001--
Death08.04.01.001--
Decreased interest19.15.02.0040.003314%Not Available
Decubitus ulcer23.03.11.0060.000432%Not Available
Dehydration14.05.05.0010.004143%
Delusion19.10.01.0010.002486%
Dementia19.20.02.001; 17.03.01.0010.003314%Not Available
Depressed mood19.15.02.0010.008286%Not Available
Depression19.15.01.0010.004972%
Dermatitis allergic10.01.03.014; 23.03.04.0030.005800%Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.0030.008286%Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.0030.003314%Not Available
Disorientation19.13.01.002; 17.02.05.0150.003314%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.004972%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.018229%
Dizziness postural17.02.05.004; 02.01.02.005; 24.06.02.008--Not Available
Drooling17.02.05.0050.004143%Not Available
Drug hypersensitivity10.01.01.001--Not Available
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