Pioglitazone

Contraindications

• Hypersensitivity to pioglitazone
• Heart failure (any NYHA class)
• Active or prior bladder cancer
• Uninvestigated macrohaematuria
• Hepatic impairment with ALT >2.5× ULN
• Type 1 diabetes and diabetic ketoacidosis
• Pregnancy and lactation

Serious adverse effects

• Heart failure decompensation and pulmonary oedema
• Bladder cancer (cumulative risk with use beyond 2 years)
• Distal-bone fractures (especially in postmenopausal women)
• Macular oedema with visual acuity reduction
• Hepatotoxicity (rare)

Common adverse effects

• Weight gain (3-4 kg in the first year)
• Peripheral oedema
• Upper respiratory tract infections
• Headache
• Hypoaesthesia
• Reduced haematocrit (haemodilution)

PregnancyFDA C

FDA Category C. No human pregnancy data. Animal studies show intrauterine growth retardation at high doses. SEGO and redGDPS switch pregnant women with type 2 diabetes to insulin; pioglitazone is stopped. Before planned pregnancy – discontinue in advance and revise the regimen.

Not preferred. Hale L4. Excreted in animal milk; human data are scarce. AEMPS contraindicates use during lactation. When antidiabetic therapy is needed in a breastfeeding mother, metformin (L1) and insulin (L1) are preferred.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.