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pioglitazone

Actos · ATC code A10BG03

Also known as: Pioglitazon · Brand names: Actos, Pioglitazon Aurobindo, Dialic, Dropia, Dyndion, Glifix, Pioforce, Piofox, Piondia

Key facts
Active substance
pioglitazone
Drug class
2,4-thiazolidinedione
ATC code
A10BG03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Actos 15 mg tablets / Actos 30 mg tablets / Actos 45 mg tablets
Marketing authorisation holder
CHEPLAPHARM Arzneimittel GmbH
Information as of
2026-10-27

Key facts

Pioglitazone is an antidiabetic of the thiazolidinedione class. It is used as second- or third-line treatment of type 2 diabetes in adults.

What it is used for

  • Monotherapy when metformin is inappropriate due to contraindications or intolerance
  • Dual therapy with metformin or (if metformin is not tolerated) with a sulphonylurea
  • Triple therapy with metformin and a sulphonylurea
  • Combination with insulin when metformin is inappropriate

Dosing

  • Start at 15 mg or 30 mg once daily; may be increased in increments up to 45 mg once daily
  • Once daily with or without food
  • With insulin: continue the current insulin dose and decrease it if hypoglycaemia occurs
  • Elderly: start at the lowest dose and increase gradually
  • No dose adjustment in renal impairment; not for dialysis patients or in hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Cardiac failure or history of cardiac failure (NYHA I to IV)
  • Hepatic impairment
  • Diabetic ketoacidosis
  • Current or past bladder cancer; uninvestigated macroscopic haematuria

Important warnings

  • Fluid retention and heart failure, especially with insulin or NSAIDs; discontinue if cardiac status worsens
  • Bladder cancer reported more often in trials
  • Increased risk of bone fractures in women
  • Check liver enzymes before starting and periodically thereafter
  • Strong CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin): monitor glycaemic control closely

Side effects

  • Common: upper respiratory tract infection, weight increased
  • Oedema; bone fractures more frequent in women than with comparators
  • Uncommon: bladder cancer, sinusitis
  • With sulphonylureas or insulin: hypoglycaemia may occur

Interactions

  • Gemfibrozil may increase and rifampicin decrease pioglitazone exposure; consider dose adjustment
  • No relevant effect on digoxin, warfarin, phenprocoumon and metformin

Pregnancy and breastfeeding

  • Should not be used in pregnancy
  • Should not be given to breast-feeding women

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Germany

  • Pioglitazon AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • ActosACİNO TURKEY İLAÇ A.Ş. · 2 register entries
  • DialicVİTALİS İLAÇ SAN. TİC. A.Ş., CELTİS İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
  • DropiaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
  • DyndionGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 9 register entries
  • GlifixBİLİM İLAÇ SAN. VE TİC. A.Ş. · 12 register entries
  • PioforceBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
  • PiofoxNEUTEC İLAÇ SAN. TİC. A.Ş · 9 register entries
  • PiondiaSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 6 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 16 more European countries
Bulgaria
Pioglitazone Sanovel, Пизона, Риодин
Croatia
Novapio, Pioglitazon Pliva
Cyprus
Glitact, Glitact®, Zipion
Czechia
Novapio, Pioglitazon Viatris
Greece
Glitact, Raglitan, Zatrip, Zipion
Iceland
Actos, Pioglitazone Accord, Pioglitazone Actavis
Italy
Pioglitazone Aurobindo, Pioglitazone Doc Generici, Pioglitazone Mylan, Pioglitazone Tecnigen, Pioglitazone Zentiva
Latvia
Zipion
Liechtenstein
Actos, Pioglitazone Accord, Pioglitazone Actavis
Malta
Novapio
Netherlands
Pioglitazone Hydrochloride Aurobindo, Pioglitazone Sanovel
Norway
Actos, Pioglitazone Accord, Pioglitazone Actavis
Poland
Pioglitazone Bioton
Portugal
Pioglitazona Atrolex, Pioglitazona Aurovitas, Pioglitazona Bluepharma, Pioglitazona Farmoz, Pioglitazona Generis, Pioglitazona Mylan, Pioglitazona Sandoz, Pioglitazona Sarb, Pioglitazona Tetrafarma, Pioglitazona Viatris, Pioglitazona Zentiva
Spain
Pioglitazona Aurovitas, Pioglitazona Cinfa, Pioglitazona Normon
Sweden
Pioglitazone Holsten

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Actos – EPAR, Product Information (OF THE TEXT 08/2023 Detailed information on this medicinal p). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/actos-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC A10BG.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.