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)
Postmenopausal haemorrhage24.07.03.002; 21.02.01.002--Not Available
Rectal tenesmus07.03.03.001; 15.05.03.011--Not Available
Procedural complication12.02.05.005--
Major depression19.15.01.003--Not Available
Infected cyst16.02.02.003; 11.01.08.021--Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Congenital eye disorder03.01.01.002; 06.08.03.011--Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Urine output increased13.13.03.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 08.01.03.027; 21.02.02.001--
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
Bacterial infection11.02.01.005--Not Available
Benign neoplasm16.02.02.007--Not Available
Blood electrolytes abnormal13.11.02.002--Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Embolism24.01.01.009--
Impulse-control disorder19.18.01.0020.000193%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Intervertebral disc degeneration15.10.01.002--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Nasal mucosal disorder22.04.03.009--Not Available
Perineal pain21.10.01.003--
Peripheral embolism24.01.02.005--Not Available
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