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 Parkinson's disease and for the treatment of primary moderate-severe restless legs syndrome [FDA label].
Marketing Status approved; investigational
ATC Code N04BC04
DrugBank ID DB00268
KEGG ID D08489
MeSH ID C046649
PubChem ID 5095
TTD Drug ID D0R9EQ
NDC Product Code 16729-232; 43547-555; 46708-263; 0228-3640; 55111-661; 69452-356; 69452-357; 69452-359; 70518-2439; 70518-3478; 0781-5784; 55111-728; 61919-780; 71335-0064; 72189-364; 16729-233; 16729-236; 46708-266; 50090-4684; 0228-3659; 68462-259; 71335-1167; 62332-109; 62332-111; 0781-5782; 43353-258; 43353-267; 43547-556; 46708-262; 50090-4804; 62332-107; 69452-358; 69452-360; 69452-361; 43353-266; 0228-3661; 68462-257; 68462-258; 70518-3482; 70518-3618; 71335-1982; 0781-5786; 10135-676; 10135-679; 55111-659; 55111-662; 70518-2750; 71335-1231; 10135-677; 16729-234; 16729-238; 43353-265; 71335-1188; 71335-9653; 72189-222; 0781-5788; 10135-675; 16729-237; 46708-265; 50090-4803; 62332-110; 68462-253; 68462-254; 68462-256; 71335-9656; 0781-5780; 10135-673; 58032-1011; 16729-235; 43547-557; 46708-264; 0228-3658; 0228-3660; 55111-727; 62332-108; 68462-255; 69452-362; 72189-416; 72189-494; 10135-674; 10135-678; 43547-554; 43547-558
UNII 030PYR8953
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
*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)
Seborrhoeic keratosis23.10.01.008; 16.26.01.008--Not Available
Sedation17.02.04.005--Not Available
Seizure17.12.03.001--
Sensory disturbance17.02.07.006--Not Available
Sepsis11.01.11.003--
Shock24.06.02.002--Not Available
Sinus congestion22.04.06.001--Not Available
Sinus headache22.12.03.022; 17.14.01.002--
Sinusitis22.07.03.007; 11.01.13.005--
Skin cancer23.08.02.002; 16.03.02.002--Not Available
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin hypertrophy23.01.04.002--Not Available
Skin lesion23.03.03.010--Not Available
Skin odour abnormal23.03.03.012--
Skin papilloma23.10.01.002; 16.26.01.002; 11.05.07.001--
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.001--
Sleep disorder19.02.04.001--Not Available
Sneezing22.12.03.024--
Somnambulism19.02.03.006; 17.15.02.004--Not Available
Somnolence19.02.05.003; 17.02.04.0060.000212%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Squamous cell carcinoma16.16.01.002--Not Available
Stomatitis07.05.06.005--
Stress19.06.02.004--Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.011--Not Available
Suicidal ideation19.12.01.0030.000289%
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