Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ropinirole hydrochloride
Drug ID BADD_D01967
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 D00784
MeSH ID C046649
PubChem ID 68727
TTD Drug ID D0R9EQ
NDC Product Code 43547-269; 43547-270; 43547-599; 65841-716; 70518-2476; 54752-0005; 43547-597; 43547-598; 46708-033; 50090-4348; 62332-036; 63629-4641; 0615-8188; 0904-6373; 43547-596; 46708-031; 46708-032; 50268-743; 55154-7633; 55154-7888; 61919-564; 65841-714; 71335-1626; 0615-8190; 65841-718; 65096-0102; 43547-271; 62332-033; 62332-034; 65841-715; 71335-1434; 0615-8189; 62147-0015; 43547-595; 46708-030; 46708-035; 62332-035; 61187-008; 62147-0008; 64220-121; 43547-273; 50090-1330; 60687-588; 62332-030; 63629-4798; 71335-0727; 0904-6374; 43547-272; 46708-036; 62332-032; 71335-0587; 71335-0829; 0615-8191; 43547-274; 43547-600; 50268-742; 50268-744; 62332-031; 55111-091; 46708-034; 60687-577; 65841-712; 65841-713; 65841-717; 58032-0133; 66039-853; 43547-268; 43547-601; 50268-741
UNII D7ZD41RZI9
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 C16H25ClN2O
CAS Registry Number 91374-20-8
SMILES CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1.Cl
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)
Abdominal discomfort07.01.06.001---
Abdominal pain07.01.05.002--
Anxiety19.06.02.002--
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blood pressure increased13.14.03.005---
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dyskinesia17.01.02.006--
Dyspepsia07.01.02.001--
Fall12.01.08.002--
Fatigue08.01.01.002--
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart rate abnormal13.14.04.006---
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Nausea07.01.07.001--
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Orthostatic hypotension24.06.03.004; 17.05.01.020---
Retinal disorder06.08.03.005---
Somnolence19.02.05.003; 17.02.04.006--
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Vertigo17.02.12.002; 04.04.01.003--
Viral infection11.05.04.001---
Adverse event08.06.01.010---
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