Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pioglitazone hydrochloride
Drug ID BADD_D01778
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 D00945
MeSH ID D000077205
PubChem ID 60560
TTD Drug ID D03OFF
NDC Product Code 50379-0008; 59361-003; 65096-0104; 65862-513; 68554-0030; 50090-6384; 50090-6386; 72606-570; 72606-572; 11532-5001; 62147-0071; 65862-512; 71335-2027; 71335-2082; 72189-292; 53104-7566; 65727-006; 65862-508; 15894-0017; 62147-0020; 50090-5582; 63629-3299; 68788-6419; 71335-9664; 55111-052; 65862-514; 66332-0013; 63629-3330; 68071-2882; 70518-1638; 71610-522; 43353-326; 50090-6393; 63629-3292; 72606-571; 62147-0070; 65015-708; 66332-0011; 62147-0005; 66332-0012
UNII JQT35NPK6C
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 C19H21ClN2O3S
CAS Registry Number 112529-15-4
SMILES CCC1=CN=C(C=C1)CCOC2=CC=C(C=C2)CC3C(=O)NC(=O)S3.Cl
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)
Abnormal weight gain14.03.02.010---
Alanine aminotransferase increased13.03.04.005--
Back pain15.03.04.005--
Bladder neoplasm20.03.04.002; 16.08.03.002---
Blood creatine phosphokinase increased13.04.01.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002---
Cardiovascular disorder02.11.01.010; 24.03.02.009---
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011---
Coronary artery bypass25.03.03.003---
Death08.04.01.001--
Diabetic retinal oedema14.07.01.001; 06.04.06.001; 05.07.01.001---
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Flatulence07.01.04.002--
Fracture15.08.02.001; 12.04.02.001--
Haematocrit decreased13.01.05.001---
Haemoglobin decreased13.01.05.003---
Headache17.14.01.001--
Hepatic failure09.01.03.002--
Hypertension24.08.02.001--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Leg amputation25.14.01.001---
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Oedema14.05.06.010; 08.01.07.006---
Pain in extremity15.03.04.010--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Sinusitis22.07.03.007; 11.01.13.005--
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