{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "pioglitazone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "•Initiate pioglitazone tablets at 15 mg or 30 mg once daily.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "Limit initial dose to 15 mg once daily in patients with NYHA Class I or II heart failure.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) •If there is inadequate glycemic control, the dose can be increased in 15 mg increments up to a maximum of 45 mg once daily.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of pioglitazone hydrochloride in pediatric patients have not been established. Pioglitazone hydrochloride is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures, and urinary bladder tumors [see Warnings and Precautions ( 5.1 , 5.4 , 5.5 and 5.6 )].",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for pioglitazone (Pioglitazone), retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Monitoring liver tests while on pioglitazone tablets are not recommended in patients without liver disease.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "Routine periodic monitoring of liver tests during treatment with pioglitazone tablets are not recommended in patients without liver disease.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "Patients with type 2 diabetes may have fatty liver disease or cardiac disease with episodic congestive heart failure, both of which may cause liver test abnormalities, and they may also have other forms of liver disease, many of which can be treated or managed.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5-and 35-times the 45 mg clinical dose, respectively, based on body surface area [see Data].",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone hydrochloride, like other thiazolidinediones, may result in ovulation in some anovulatory women.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "When pregnant rats received pioglitazone during late gestation and lactation, delayed postnatal development, attributed to decreased body weight, occurred in offspring at maternal doses of 10 mg/kg and above or ≥2 times the 45 mg clinical dose, by body surface area. 8.2 Lactation Risk Summary There is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      },
      {
        "text": "Pioglitazone is present in rat milk; however due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk.",
        "source": "US FDA label for pioglitazone (Pioglitazone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/pioglitazone.json",
        "verbatim": true
      }
    ]
  }
}