Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ropinirole
Drug ID BADD_D01966
Description Ropinirole, also known as _ReQuip_, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome [FDA label], [A174547]. It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA [FDA label] for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome [A174547]. In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole [A35711].
Indications and Usage For the treatment of the signs and symptoms of idiopathic Parkinson's disease. Also used for the treatment of restless legs syndrome.
Marketing Status Prescription; Discontinued
ATC Code N04BC04
DrugBank ID DB00268
KEGG ID D08489
MeSH ID C046649
PubChem ID 5095
TTD Drug ID D0R9EQ
NDC Product Code 43353-267; 55111-727; 43353-265; 0228-3660; 46708-262; 60429-822; 10135-677; 0228-3659; 68462-259; 0378-5505; 10135-676; 16729-238; 43353-258; 50090-4684; 55111-662; 50090-5167; 71335-1188; 71335-0064; 60429-818; 50090-4803; 10135-673; 68462-258; 43353-266; 68462-254; 46708-265; 71335-1231; 62332-109; 68462-257; 0228-3640; 0378-5502; 46708-264; 58032-1011; 0781-5786; 60429-821; 0378-5504; 16729-237; 10135-678; 70518-2439; 10135-679; 55111-659; 50090-2068; 71335-1982; 16729-233; 46708-266; 72189-222; 16729-232; 0378-5501; 0378-5503; 68462-253; 60429-817; 60429-823; 68462-255; 16729-235; 62332-108; 55111-661; 70518-2750; 60429-819; 55111-728; 0378-5525; 0781-5784; 0228-3658; 16729-234; 63629-8123; 10135-674; 10135-675; 68462-256; 61919-780; 0378-5550; 62332-110; 60429-820; 71335-1167; 62332-107; 0228-3661; 16729-236; 46708-263; 0781-5780; 0781-5788; 62332-111; 0781-5782
Synonyms ropinirole | 4-(2-(di-n-propylamino)ethyl)-2(3H)-indolone | ropinirol | SK&F 101468 | SKF 101468 | SK&F-101,468 | Requip | ropinirole hydrochloride
Chemical Information
Molecular Formula C16H24N2O
CAS Registry Number 91374-21-9
SMILES CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal adhesions07.07.03.001; 12.02.03.006--Not Available
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.0020.001281%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal rigidity07.01.05.0110.000427%Not Available
Abnormal dreams17.15.02.001; 19.02.03.0010.000640%Not Available
Abnormal faeces07.01.03.0010.000427%Not Available
Abscess11.01.08.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.002--
Acne23.02.01.001--Not Available
Actinic keratosis23.01.06.001--Not Available
Acute psychosis19.03.01.0010.001281%Not Available
Adenocarcinoma16.16.01.004--Not Available
Aggression19.05.01.0010.001494%Not Available
Agitation17.02.05.012; 19.06.02.0010.001067%
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Alcohol abuse19.07.02.0070.000427%Not Available
Alcoholism19.07.02.0010.000111%Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.000640%Not Available
Amenorrhoea05.05.01.002; 21.01.02.001--
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaemia vitamin B12 deficiency01.03.01.001; 14.12.02.001--Not Available
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