Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pioglitazone
Drug ID BADD_D01777
Description Pioglitazone is an antihyperglycemic used as an adjunct to diet, exercise, and other antidiabetic medications to manage type 2 diabetes mellitus.[L11416,L11419,L11422,L11425] It is administered as a racemic mixture, though there is no pharmacologic difference between the enantiomers and they appear to interconvert _in vivo_ with little consequence.[L11416] The thiazolidinedione class of medications, which also includes [rosiglitazone] and [troglitazone], exerts its pharmacological effect primarily by promoting insulin sensitivity and the improved uptake of blood glucose[L11416] via agonism at the peroxisome proliferator-activated receptor-gamma (PPARγ).[A19757] PPARs are ligand-activated transcription factors that are involved in the expression of more than 100 genes and affect numerous metabolic processes, most notably lipid and glucose homeostasis.[A19759] Thiazolidinediones, including pioglitazone, have fallen out of favor in recent years due to the presence of multiple adverse effects and warnings regarding their use (e.g. congestive heart failure, bladder cancer) and the availability of safer and more effective alternatives for patients with type 2 diabetes mellitus.[L11461]
Indications and Usage Pioglitazone is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.[L11416] It is also available in combination with [metformin],[L11419] [glimepiride],[L11422] or [alogliptin][L11425] for the same indication.
Marketing Status approved; investigational
ATC Code A10BG03
DrugBank ID DB01132
KEGG ID D08378
MeSH ID D000077205
PubChem ID 4829
TTD Drug ID D03OFF
NDC Product Code 0093-7271; 50090-4586; 53002-2757; 61919-781; 64764-151; 68071-5210; 68382-308; 71335-1333; 71335-1385; 43547-428; 71610-495; 72189-105; 0781-5421; 0781-5422; 0904-7090; 50090-4556; 50090-6412; 53002-2755; 68071-5245; 68788-7514; 70518-2129; 71335-1759; 71335-1298; 16714-647; 33342-054; 57237-220; 57237-221; 68382-306; 68788-7989; 70518-2609; 70771-1021; 71335-1659; 0781-5420; 11532-0012; 16714-645; 0093-7272; 64764-301; 64764-451; 70771-1023; 71335-1343; 33342-055; 43547-427; 57237-219; 68071-2886; 68071-4964; 0904-7096; 16729-020; 50090-4605; 70518-2431; 70771-1022; 72189-293; 16714-646; 60687-391; 68788-7511; 71335-1137; 16729-021; 0093-7273; 43547-426; 68071-2264; 68382-307; 11532-0011; 11532-0013; 16729-022; 33342-056; 53002-2756
UNII X4OV71U42S
Synonyms Pioglitazone | 5-(4-(2-(5-Ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione | U 72107A | U72,107A | U-72107A | U72107A | AD 4833 | AD-4833 | AD4833 | Pioglitazone Hydrochloride | Actos
Chemical Information
Molecular Formula C19H20N2O3S
CAS Registry Number 111025-46-8
SMILES CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3
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 pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic shock10.01.07.002; 24.06.02.004--Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000215%
Angina unstable24.04.04.004; 02.02.02.0040.000172%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Atrial flutter02.03.03.0030.000086%
Back pain15.03.04.005--
Benign prostatic hyperplasia21.04.02.0010.000129%Not Available
Bladder cancer20.03.04.001; 16.08.01.0010.162798%Not Available
Bladder neoplasm20.03.04.002; 16.08.03.0020.000429%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Breast feeding26.05.01.001--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.0020.003434%Not Available
Cardiac tamponade02.06.01.0010.000086%
Cardiovascular disorder02.11.01.010; 24.03.02.0090.000172%Not Available
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Congenital anomaly03.02.01.001--Not Available
Coronary artery disease02.02.01.001; 24.04.04.0060.000215%Not Available
Cough22.02.03.001--
Cyst16.02.02.002; 08.03.05.001--Not Available
Death08.04.01.001--
Developmental delay19.07.05.003; 08.01.03.037--Not Available
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