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)
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urine abnormality20.02.01.013--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Uterine disorder21.07.01.006--Not Available
Uterine haemorrhage24.07.03.004; 21.07.01.005--
Uterine leiomyoma21.07.02.004; 16.04.02.001--Not Available
Uterine neoplasm16.12.06.002; 21.07.02.008--Not Available
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Varicose vein24.10.04.001--Not Available
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Vein disorder24.03.02.015--Not Available
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.003--
Vestibular disorder17.02.02.008; 04.04.02.001--
Viral infection11.05.04.001--Not Available
Viral upper respiratory tract infection22.07.02.004; 11.05.04.007--Not Available
Vision blurred17.17.01.010; 06.02.06.0070.000096%
Visual acuity reduced06.02.10.012; 17.17.01.011--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.10.013--Not Available
Vitamin B12 deficiency14.12.02.004--Not Available
Vitreous detachment12.01.04.005; 06.09.01.002--Not Available
Vocal cord paralysis22.04.01.002; 17.04.06.002--
Vomiting07.01.07.0030.000733%
Vulvovaginal candidiasis11.03.03.005; 21.14.02.003--Not Available
Weight decreased13.15.01.005--
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