Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rosiglitazone maleate
Drug ID BADD_D01970
Description Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It is marketed by the pharmaceutical company GlaxoSmithKline as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Like other thiazolidinediones, the mechanism of action of rosiglitazone is by activation of the intracellular receptor class of the peroxisome proliferator-activated receptors (PPARs), specifically PPARγ. Rosiglitazone is a selective ligand of PPARγ, and has no PPARα-binding action. Apart from its effect on insulin resistance, it appears to have an anti-inflammatory effect: nuclear factor kappa-B (NFκB) levels fall and inhibitor (IκB) levels increase in patients on rosiglitazone. Recent research has suggested that rosiglitazone may also be of benefit to a subset of patients with Alzheimer's disease not expressing the ApoE4 allele. This is the subject of a clinical trial currently underway.
Indications and Usage Rosiglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Marketing Status approved; investigational
ATC Code A10BG02
DrugBank ID DB00412
KEGG ID D00596
MeSH ID D000077154
PubChem ID 5281055
TTD Drug ID D0K5ER
NDC Product Code 67835-0012; 55111-063; 61187-003
UNII KX2339DP44
Synonyms Rosiglitazone | Rosiglitazone Maleate | 5-((4-(2-Methyl-2-(pyridinylamino)ethoxy)phenyl)methyl)-2,4-thiazolidinedione-2-butenedioate | Avandia | BRL 49653 | BRL-49653 | BRL49653
Chemical Information
Molecular Formula C22H23N3O7S
CAS Registry Number 155141-29-0
SMILES CN(CCOC1=CC=C(C=C1)CC2C(=O)NC(=O)S2)C3=CC=CC=N3.C(=CC(=O)O)C(=O)O
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)
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anion gap increased13.02.01.014--Not Available
Aortic valve incompetence02.07.03.001--Not Available
Arteriosclerosis24.04.02.001--Not Available
Arthralgia15.01.02.001--
Ascites09.01.05.003; 07.07.01.001; 02.05.04.002--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.003--
Atrioventricular block02.03.01.002--Not Available
Atrioventricular block complete02.03.01.003--
Back pain15.03.04.005--
Blindness06.02.10.003; 17.17.01.003--Not Available
Blood cholesterol increased13.12.01.002--
Blood triglycerides increased13.12.03.001--Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cardiac hypertrophy02.04.02.017--Not Available
Cardiogenic shock24.06.02.006; 02.05.01.003--Not Available
Cardiomegaly02.04.02.001--Not Available
Cardiomyopathy02.04.01.001--Not Available
Carotid artery stenosis24.04.06.001; 17.08.02.001--Not Available
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