saxagliptin
Onglyza · ATC code A10BH03
Also known as: Saksagliptin
- Key facts
- Active substance
- saxagliptin
- Drug class
- Dipeptidyl peptidase-4 inhibitors
- ATC code
- A10BH03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Onglyza 2.5 mg film-coated tablets / Onglyza 5 mg film-coated tablets
- Marketing authorisation holder
- AstraZeneca AB
- Information as of
- 2026-10-28
Key facts
Saxagliptin (Onglyza) is a DPP-4 inhibitor that improves glycaemic control in adults with type 2 diabetes.
What it is used for
- Type 2 diabetes in adults as an adjunct to diet and exercise: as monotherapy when metformin is inappropriate, or in combination with other diabetes medicines including insulin when these are inadequate.
Dosing
- 5 mg once daily, with or without a meal at any time of day; tablets must not be split.
- Moderate renal impairment with GFR < 45 mL/min and severe renal impairment: 2.5 mg once daily; not recommended with haemodialysis. Renal function should be checked before starting and periodically.
- With insulin or a sulphonylurea, a lower dose of these may be needed to reduce hypoglycaemia.
- No adjustment in mild or moderate hepatic impairment (caution in moderate); not recommended in severe.
- A missed dose should be taken when remembered, but not a double dose on the same day; not recommended in children and adolescents.
Contraindications
- Hypersensitivity to the active substance or any excipient, or history of a serious hypersensitivity reaction (anaphylaxis, angioedema) to any DPP4 inhibitor.
Important warnings
- Not for type 1 diabetes or diabetic ketoacidosis; not a substitute for insulin.
- Acute pancreatitis: discontinue with persistent severe abdominal pain and do not restart if confirmed.
- Bullous pemphigoid and skin disorders can occur; discontinue if blisters develop.
- Heart failure: consider risk factors; symptoms should be reported immediately.
- Joint pain, sometimes severe, has been reported with DPP4 inhibitors.
Side effects
- Most common: upper respiratory tract infection (7.7%), urinary tract infection (6.8%) and headache (6.5%).
- Others: rash, hypoglycaemia in combination with insulin or sulphonylureas; uncommon: hypersensitivity reactions and pancreatitis; rare: anaphylactic reactions including anaphylactic shock.
Interactions
- Potent CYP3A4/5 inhibitors increase saxagliptin exposure (ketoconazole: AUC 2.5-fold).
- CYP3A4/5 inducers (e.g. carbamazepine, phenobarbital, phenytoin) may lower levels; glycaemic control should be assessed carefully.
Pregnancy and breastfeeding
- Should not be used during pregnancy unless clearly necessary.
- During breast-feeding, a decision between stopping breast-feeding and stopping therapy is required.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
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)
- OnglyzaAstraZeneca AB · EMEA/H/C/001039
Source: European Medicines Agency (EMA), product information
Turkey
- OnglyzaASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 8 more European countries
- France
- Saxagliptine Arrow, Saxagliptine Biogaran
- Hungary
- Saxagliptin Pharos
- Iceland
- Onglyza
- Liechtenstein
- Onglyza
- Malta
- Saxagliptin Pharos
- Netherlands
- Saxagliptine Sandoz
- Norway
- Onglyza
- Portugal
- Saxagliptina Generis
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Onglyza – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/onglyza-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC A10BH.
Editorial: Medelix editorial team · last updated 2026-10-28 · 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.