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)
Application site hypersensitivity12.07.01.014; 10.01.03.009; 08.02.01.0130.001981%Not Available
Hypophagia14.03.01.006; 07.01.06.010; 19.09.01.0040.000550%Not Available
Instillation site reaction12.07.01.046; 08.02.01.046--Not Available
Application site exfoliation23.03.07.007; 12.07.01.022; 08.02.01.0220.000367%Not Available
Application site burn23.03.11.013; 12.07.01.038; 08.02.01.0380.000367%Not Available
Hypersexuality19.08.03.0050.000734%Not Available
Liver injury12.01.17.012; 09.01.07.0220.000367%Not Available
Terminal insomnia19.02.01.004; 17.15.03.004--Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000367%Not Available
Application site haemorrhage08.02.01.040; 24.07.01.048; 12.07.01.0400.000367%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.000734%
Gambling disorder19.07.06.0150.001174%Not Available
Cardiac failure chronic02.05.01.0090.000367%Not Available
Kleptomania19.18.01.0070.000367%Not Available
Persecutory delusion19.10.01.0070.000550%Not Available
Camptocormia15.03.05.004; 17.02.05.0530.000367%Not Available
Internal haemorrhage24.07.01.0720.000367%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.000807%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000367%Not Available
Illness08.01.03.0910.000367%Not Available
Medical device site dryness23.03.03.091; 12.02.21.006; 08.07.01.0220.000550%Not Available
Medical device site hypertrophy08.07.01.030; 12.02.21.0140.000367%Not Available
Terminal agitation08.01.03.102; 19.06.02.0110.000367%Not Available
Therapeutic product effect decreased08.06.01.0500.002165%Not Available
Therapeutic product effect incomplete08.06.01.0520.001981%Not Available
Therapeutic product effect variable08.06.01.0550.000991%Not Available
Therapeutic product ineffective08.06.01.0570.002678%Not Available
Therapeutic response shortened08.06.01.0620.000367%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.001541%Not Available
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