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 Prescription
ATC Code A10BG02
DrugBank ID DB00412
KEGG ID D00596
MeSH ID D000077154
PubChem ID 5281055
TTD Drug ID D0K5ER
NDC Product Code 67835-0012; 61187-003; 55111-063
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Alanine aminotransferase increased13.03.01.003--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anion gap increased13.02.01.014--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood cholesterol increased13.12.01.002--
Blood triglycerides increased13.12.03.001--Not Available
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002--Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Constipation07.02.02.001--
Death08.04.01.001--
Dermatitis23.03.04.002--Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic retinal oedema14.07.01.001; 06.04.06.001; 05.07.01.001--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.001--Not Available
Fatigue08.01.01.002--
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Fracture15.08.02.001; 12.04.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Haematocrit decreased13.01.05.001--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
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