{"id":"pioglitazone","brandName":"Actos","genericName":"pioglitazone","companyId":"takeda","companyName":"Takeda","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"CDGSH iron-sulfur domain-containing protein 2, Bile salt export pump, CDGSH iron-sulfur domain-containing protein 1","_target_confidence":0.5},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: CONGESTIVE HEART FAILURE Thiazolidinediones, including pioglitazone , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . After initiation of pioglitazone , and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. Pioglitazone is not recommended in patients with symptomatic heart failure. Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. Thiazolidinediones, including pioglitazone, cause or exacerbate congestive heart failure in some patients. (5.1) After initiation of pioglitazone, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. (5.1) Pioglitazone is not recommended in patients with symptomatic heart failure. (5.1) Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. (4 , 5.1)"],"safetySignals":[{"date":"","signal":"BLADDER CANCER","source":"FDA FAERS","actionTaken":"8850 reports"},{"date":"","signal":"BLOOD GLUCOSE INCREASED","source":"FDA FAERS","actionTaken":"3553 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"3094 reports"},{"date":"","signal":"WEIGHT DECREASED","source":"FDA FAERS","actionTaken":"2193 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1779 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1592 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1583 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"1581 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1539 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"1528 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Upper respiratory tract infection","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Sinusitis","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Myalgia","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Pharyngitis","drugRate":"5%","severity":"common","organSystem":""}],"contraindications":["Acute vomiting","Adrenal cortical hypofunction","Alcohol intoxication","Alcoholism","Asthenia","Autonomic dysreflexia","Body fluid retention","Breastfeeding (mother)","Cardiogenic shock","Chronic heart failure","Cobalamin deficiency","Decompensated cardiac failure","Dehydration","Disease of liver","Edema","Fever","Fever greater than 100.4 Fahrenheit","Fracture of bone","Glucose-6-phosphate dehydrogenase deficiency anemia","Hemolytic anemia","Hepatic porphyria","Hypoglycemic disorder","Hypopituitarism","Infectious disease","Ketoacidosis","Kidney disease","Lactic acidosis","Liver function tests abnormal","Macular retinal edema","Malignant tumor of urinary bladder","Metabolic acidosis","Myocardial infarction","Primary adrenocortical insufficiency","Radiography with IV Iodinated Contrast Agent","Sepsis syndrome","Severe Hypoxemia","Severe diarrhea","Shock","Surgical procedure","Traumatic injury"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Congestive heart failure","drugRate":"1.3%","severity":"serious"}]},"trials":["NCT00352287","NCT01911728","NCT06243536","NCT05411965","NCT00927355","NCT04370093","NCT00762736","NCT00481663","NCT01322308","NCT04883125","NCT02172235","NCT03060772","NCT00242177","NCT06446531","NCT00482183","NCT01339143","NCT00634036","NCT05919147","NCT03646292","NCT06649162","NCT00665353","NCT04416269","NCT01289119","NCT01253928","NCT03452267","NCT01614301","NCT00867126","NCT01612858","NCT00290940","NCT02365233","NCT03030300","NCT00494312","NCT00362440","NCT04473274","NCT00232583","NCT00269061","NCT01931566","NCT00736996","NCT00531882","NCT01695707","NCT01068444","NCT01947790","NCT01346254","NCT01432405","NCT01206400","NCT00419484","NCT02535832","NCT01655719","NCT01134835","NCT01010243"],"indications":{"approved":[{"name":"Diabetes mellitus type 2","diseaseId":"diabetes-mellitus-type-2","approvalDate":"","lineOfTherapy":"","approvalCountry":"United 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