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)
Breech presentation18.03.04.0010.000367%Not Available
Cardiac failure02.05.01.0010.001284%
Cardiac failure congestive02.05.01.0020.000550%Not Available
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000550%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.000367%Not Available
Chest discomfort22.12.02.002; 08.01.08.019; 02.02.02.0090.000550%Not Available
Choking22.12.03.0030.001834%Not Available
Condition aggravated08.01.03.0040.003962%Not Available
Confusional state19.13.01.001; 17.02.03.0050.002201%
Constipation07.02.02.0010.001834%
Coordination abnormal17.02.02.0040.000367%Not Available
Cough22.02.03.001--
Decreased interest19.15.02.0040.000550%Not Available
Decubitus ulcer23.03.11.0060.000367%Not Available
Dehydration14.05.05.0010.001101%
Delirium19.13.02.0010.000917%
Delusion19.10.01.0010.001541%
Dementia19.20.02.001; 17.03.01.0010.002091%Not Available
Depressed level of consciousness17.02.04.0020.000734%
Depressed mood19.15.02.0010.001834%Not Available
Depression19.15.01.001--
Dermatitis allergic23.03.04.003; 10.01.03.0140.001724%Not Available
Dermatitis bullous23.03.01.0020.000367%
Dermatitis contact12.03.01.040; 10.01.01.003; 23.03.04.0040.006017%Not Available
Diabetes mellitus14.06.01.001; 05.06.01.0010.000367%Not Available
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.0020.000367%Not Available
Discomfort08.01.08.0030.000734%Not Available
Disorientation17.02.05.015; 19.13.01.0020.001284%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.001468%
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