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)
Abnormal dreams19.02.03.001; 17.15.02.0010.001284%Not Available
Abnormal faeces07.01.03.0010.000367%Not Available
Ageusia17.02.07.001; 07.14.03.0030.001284%Not Available
Aggression19.05.01.0010.001468%Not Available
Agitation19.06.02.001; 17.02.05.0120.002568%
Akinesia17.01.02.0030.001101%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.001101%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000917%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.000550%
Anosmia22.04.03.006; 17.04.04.0010.001284%
Anxiety19.06.02.0020.003852%
Aphasia19.21.01.001; 17.02.03.0010.000734%
Application site dermatitis23.03.04.014; 12.07.01.018; 08.02.01.0180.001981%Not Available
Application site erythema23.03.06.005; 12.07.01.001; 08.02.01.0010.017537%Not Available
Application site irritation12.07.01.003; 08.02.01.0030.006604%Not Available
Application site pain12.07.01.004; 08.02.01.0040.004733%Not Available
Application site pruritus23.03.12.004; 12.07.01.005; 08.02.01.0050.014712%Not Available
Application site rash23.03.13.008; 12.07.01.016; 08.02.01.0160.011961%Not Available
Application site reaction12.07.01.006; 08.02.01.0060.011520%Not Available
Arrhythmia02.03.02.0010.000550%Not Available
Arthralgia15.01.02.001--
Aspiration22.02.07.0070.000367%
Asthenia08.01.01.0010.002752%Not Available
Atrial fibrillation02.03.03.0020.001101%
Binge eating19.09.01.0010.000807%Not Available
Blister23.03.01.001; 12.01.06.0020.003706%Not Available
Blood glucose decreased13.02.02.001--Not Available
Blood pressure fluctuation24.06.01.0020.000550%Not Available
Blood urea increased13.13.01.006--Not Available
Bradykinesia17.01.02.0040.000550%Not Available
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