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)
Nervous system disorder17.02.10.001---
Oedema08.01.07.006; 14.05.06.010---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003---
Parotid gland enlargement07.06.03.001---
Pericardial effusion02.06.01.002--
Pericarditis02.06.02.001--
Platelet disorder01.08.03.001---
Pleural effusion22.05.02.002--
Pneumonitis22.01.01.006--
Pruritus23.03.12.001--
Pulmonary fibrosis22.01.02.006--
Pulmonary hypertension22.06.01.001; 24.08.03.002--
Pulmonary oedema02.05.02.003; 22.01.03.003--
Purpura01.01.04.003; 23.06.01.004; 24.07.06.005--
Rash23.03.13.001---
Renal failure20.01.03.005---
Respiratory failure14.01.04.003; 22.02.06.002--
Retinal haemorrhage06.10.01.001; 24.07.05.003---
Retinopathy06.10.02.001; 24.03.07.003--
Sinus tachycardia02.03.03.010--
Sinusitis11.01.13.005; 22.07.03.007--
Skin discolouration23.03.03.005---
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Swelling08.01.03.015---
Thrombocytopenia01.08.01.002---
Transient ischaemic attack17.08.04.001; 24.04.06.005--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urticaria10.01.06.001; 23.04.02.001--
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