Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rosiglitazone
Drug ID BADD_D02419
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 Not Available
ATC Code A10BG02
DrugBank ID DB00412
KEGG ID D08491
MeSH ID D000077154
PubChem ID 77999
TTD Drug ID Not Available
NDC Product Code Not Available
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 C18H19N3O3S
CAS Registry Number 122320-73-4
SMILES CN(CCOC1=CC=C(C=C1)CC2C(=O)NC(=O)S2)C3=CC=CC=N3
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)
Endocarditis02.09.01.001; 11.01.16.0010.000209%
Epistaxis24.07.01.005; 22.04.03.001--
Essential hypertension24.08.02.0080.000601%Not Available
Extrasystoles02.03.02.0030.000601%Not Available
Eye disorder06.08.03.0010.002303%Not Available
Eye haemorrhage24.07.05.002; 06.07.02.001--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Eyelid ptosis06.05.01.002; 17.17.02.004--Not Available
Facial bones fracture15.08.04.001; 12.04.05.0020.000300%Not Available
Facial paralysis17.04.03.0080.001502%Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.008--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Fluid overload02.05.04.004; 14.05.06.001--Not Available
Fluid retention20.01.02.003; 14.05.06.0020.005707%Not Available
Foot fracture15.08.03.012; 12.04.01.012--Not Available
Fracture15.08.02.001; 12.04.02.0010.003504%
Gait disturbance17.02.05.016; 08.01.02.002--
Gallbladder disorder09.03.02.001--Not Available
Gangrene24.04.05.003; 23.06.06.001; 11.02.01.003--Not Available
Gastric haemorrhage07.12.01.001; 24.07.02.007--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Generalised oedema14.05.06.007; 08.01.07.004--
Generalised tonic-clonic seizure17.12.01.002--Not Available
Glaucoma06.03.01.002--
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
Haemorrhagic stroke17.08.01.011; 24.07.04.0140.000757%Not Available
Hallucination19.10.02.002--
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