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)
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypoglycaemic coma17.02.09.005; 14.06.03.004; 05.06.03.0040.000129%Not Available
Immune system disorder10.02.01.001--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Liver disorder09.01.08.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Lung infiltration22.01.02.0040.000086%Not Available
Macular oedema06.04.06.0050.000086%Not Available
Malaise08.01.01.003--
Malignant neoplasm of renal pelvis20.08.01.009; 16.08.05.0010.000086%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.000129%Not Available
Micturition urgency20.02.02.0060.000215%
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.0070.002318%
Myocardial ischaemia24.04.04.010; 02.02.02.008--Not Available
Neoplasm16.16.02.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Nocturia20.02.03.0010.000086%Not Available
Oedema08.01.07.006; 14.05.06.0100.001579%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
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