Pioglitazone

DRUG INFORMATION

  ADULT
    - •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
    - 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
    - ( 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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