sitagliptin
Januvia, Ristaben, Tesavel, Xelevia · ATC code A10BH01
Brand names: Januvia, Ristaben, Tesavel, Xelevia, Jansitin, Jazeta, Frekidir, Meliglix, Mifoglame, Sitagavia, Arliptin, Asugar, Glipass, Glipdia, Gluvia …
- Key facts
- Active substance
- sitagliptin
- Drug class
- Dipeptidyl peptidase-4 inhibitors
- ATC code
- A10BH01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Januvia 25 mg film-coated tablets / Januvia 50 mg film-coated tablets / Januvia 100 mg film-coated tablets · Ristaben 25 mg film-coated tablets / Ristaben 50 mg film-coated tablets / Ristaben 100 mg film-coated tablets · Tesavel 25 mg film-coated tablets / Tesavel 50 mg film-coated tablets / Tesavel 100 mg film-coated tablets · Xelevia 25 mg film-coated tablets / Xelevia 50 mg film-coated tablets / Xelevia 100 mg film-coated tablets
- Marketing authorisation holder
- Merck Sharp and Dohme B.V, Merck Sharp & Dohme B.V.
- Information as of
- 2026-10-27
Key facts
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is used in adults with type 2 diabetes to improve glycaemic control, alone or in combination.
What it is used for
- Monotherapy when metformin is inappropriate due to contraindications or intolerance
- Dual therapy with metformin, a sulphonylurea or a PPARγ agonist (thiazolidinedione)
- Triple therapy with a sulphonylurea and metformin or with a PPARγ agonist and metformin
- Add-on to insulin (with or without metformin)
Dosing
- 100 mg once daily, with or without food
- With a sulphonylurea or insulin, a lower dose of these may be considered to reduce hypoglycaemia
- GFR 30 to < 45 mL/min: 50 mg once daily
- GFR < 30 mL/min including dialysis: 25 mg once daily
- Assess renal function before starting and periodically; no adjustment in mild to moderate hepatic impairment or by age
- Not for children and adolescents 10 to 17 years (insufficient efficacy)
Contraindications
- Hypersensitivity to the active substance or any excipient
Important warnings
- Not for type 1 diabetes or diabetic ketoacidosis
- Acute pancreatitis, very rarely necrotising or fatal; stop if suspected and do not restart if confirmed
- Hypoglycaemia in combination with insulin or a sulphonylurea
- Hypersensitivity reactions including anaphylaxis, angioedema and exfoliative skin conditions
- Dose adjustment in renal impairment
Side effects
- Common: hypoglycaemia (mainly with a sulphonylurea or insulin), headache
- Uncommon: dizziness, constipation
- Serious: pancreatitis, hypersensitivity reactions, interstitial lung disease
Interactions
- Low risk of clinically meaningful interactions
- Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin) could alter kinetics in severe renal impairment
Pregnancy and breastfeeding
- Should not be used during pregnancy (lack of human data)
- Should not be used during breast-feeding
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- JanuviaMerck Sharp and Dohme B.V · EMEA/H/C/000722
- RistabenMerck Sharp & Dohme B.V. · EMEA/H/C/001234
- Sitagliptin Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/005598
- TesavelMerck Sharp & Dohme B.V. · EMEA/H/C/000910
- XeleviaMerck Sharp & Dohme B.V. · EMEA/H/C/000762
Source: European Medicines Agency (EMA), product information
Austria
- JansitinG.L. Pharma Gmbh · 1 register entry
- JazetaZentiva, K.S. · 1 register entry
- Sitagliptin1a Pharma Gmbh, Sandoz Gmbh, Genericon Pharma Gesellschaft M.B.H., Grindeks, +pharma Arzneimittel Gmbh, Viatris Limited, Zentiva, K.S., Stada Arzneimittel Gmbh, Hcs Bvba · 10 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- FrekidirPharmathen, Pharmathen S.A. · 2 register entries
- JansitinG.L. Pharma Gmbh · 1 register entry
- MeliglixPharmazac Sa · 1 register entry
- MifoglameBausch Health Ireland Limited · 1 register entry
- SitagaviaTad Pharma Gmbh · 1 register entry
- Sitagliptin089pharm Gmbh, 1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Generinobel Gmbh, Zentiva Pharma Gmbh, Aaa-Pharma Gmbh, Micro Labs Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Jubilant Pharmaceuticals Nv, Macleods Pharma España, S.L.U, Ashcure Pharma B.V., Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Laboratorios Liconsa S.A., Viatris Germany Gmbh, Adamed Pharma S.A., Amarox Pharma Gmbh, Ascend Gmbh, Aspire Pharma (Malta) Limited, Hennig Arzneimittel Gmbh & Co. Kg, Cipla Europe Nv, Hexal Ag, Olpha As, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh, Hec Pharm Gmbh, Aliud Pharma Gmbh · 42 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- ArliptinALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
- AsugarİLKO İLAÇ SAN.VE TİC. A.Ş. · 3 register entries
- GlipassSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- GlipdiaBERKO İLAÇ VE KİMYA SAN. A.Ş. · 1 register entry
- GluviaAPİANA ÖZEL SAĞLIK MEDİKAL GIDA TEKSTİL ELEKTRİK DEKORASYON KOZMETİK İTH. İHR. SAN. VE TİC. LTD. ŞTİ. · 3 register entries
- JanuviaMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 2 register entries
- JasitaNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- MaralitSANTA FARMA İLAÇ SAN. A.Ş. · 6 register entries
- SanositaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- SiabetWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- TofaglipSABA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Sitagliptin Eg, Sitagliptin Grindeks, Sitagliptin Sandoz, Sitagliptine Eg, Sitagliptine Krka
- Bulgaria
- Sitagliptin Grindeks, Майсиглу, Мифоглам, Сиглетик, Ситабел, Ядинум, Ямандин
- Croatia
- Adimuplan, Condias, Jaglix, Jimandin, Maysiglu, Sigazix, Sitagliptin Grindeks, Zaxivia
- Cyprus
- Jidinum, Jimandin, Meliglix, Remevia, Sinvia, Sitagliptin Iasis, Sitagliptin Msn, Tybeta
- Czechia
- Anau, Ansifora, Jansitin, Jazeta, Jidinum, Jimandin, Juzina, Lonamo, Maysiglu, Sitagliptin +pharma, Sitagliptin Ashcure, Sitagliptin Auxilto, Sitagliptin Auxpharma, Sitagliptin Glenmark, Sitagliptin Grindeks, Sitagliptin Medreg, Sitagliptin Mylan, Sitagliptin Olpha, Sitagliptin Polpharma, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Teva, Sitagliptin Viatris, Sitagliptin Zentiva, Snasilta, Zaxivia
- Denmark
- Frekidir, Meliglix, Mifoglame, Sitagliptin Ashcure, Sitagliptin Devatis, Sitagliptin Glenmark, Sitagliptin Krka, Sitagliptin Medical Valley, Sitagliptin Orion, Sitagliptin Reddy, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Teva, Sitagliptin Viatris, Sitagliptin Vivanta, Sitagliptin Zentiva
- Estonia
- Adimuplan, Maysiglu, Meliglix, Sitagliptin Generinobel, Sitagliptin Grindeks, Sitagliptin Olpha, Sitagliptin Sandoz, Sitagliptin Teva, Sitagliptin Zentiva
- Finland
- Sitagliptin Apc Instytut, Sitagliptin Ashcure, Sitagliptin Aspire, Sitagliptin Devatis, Sitagliptin Glenmark, Sitagliptin Grindeks, Sitagliptin Krka, Sitagliptin Ratiopharm, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Viatris, Sitagliptin Zentiva
- France
- Sitagliptine Adamed, Sitagliptine Almus, Sitagliptine Arrow, Sitagliptine Bgr, Sitagliptine Cristers, Sitagliptine Eg, Sitagliptine Evolugen, Sitagliptine Gnr Sandoz, Sitagliptine Grindeks, Sitagliptine Hcs, Sitagliptine Liconsa, Sitagliptine Micro Labs, Sitagliptine Olpha, Sitagliptine Pharmathen, Sitagliptine Sandoz, Sitagliptine Teva, Sitagliptine Viatris, Sitagliptine Zentiva K.S, Sitagliptine Zydus
- Greece
- Adimuplan, Axavel, Diabitype, Exanar, Fineria, Frekidir, Glucositin, Janeo, Jidinum, Jimandin, Jytaglen, Meliglix, Siltaben, Sinvia, Sitagavia, Sitagliptin Grindeks, Sitagliptin Rafarm, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Uni-Pharma, Sitagliptin Viofar, Σιταγλιπτίνη
- Hungary
- Ansifora, Jaglix, Jansitin, Jazeta, Juzina, Lonamo, Maysiglu, Sitagliptin Ccav, Sitagliptin Grindeks, Sitagliptin Sandoz, Sitagliptin Teva
- Iceland
- Januvia, Ristaben, Sitagliptin Accord, Sitagliptin Krka, Sitagliptin Medical Valley, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Sun, Sitagliptin Teva, Sitagliptin Viatris, Sitagliptin Zentiva Aps, Tesavel, Xelevia
- Ireland
- Sitagliptin Grindeks, Sitagliptin Krka, Sitagliptin Pinewood Pinewood Laboratories, Sitagliptin Rowa, Sitagliptin Rowex, Sitagliptin Teva, Sitagliptin Viatris
- Italy
- Adaglip, Andamane, Glipterin, Meliglix, Sitagliptin Abdi, Sitagliptin Aurobindo, Sitagliptin Doc, Sitagliptin Eg, Sitagliptin Grindeks, Sitagliptin Hcs, Sitagliptin Liconsa, Sitagliptin Mylan, Sitagliptin Olpha, Sitagliptin Pensa, Sitagliptin Pharmacare, Sitagliptin Sandoz, Sitagliptin Tecnigen, Sitagliptin Teva, Sitagliptin Zentiva Italia, Yamuna
- Latvia
- Adimuplan, Jimandin, Maysiglu, Meliglix, Sitagliptin Grindeks, Sitagliptin Olpha, Sitagliptin Sandoz, Sitagliptin Zentiva
- Liechtenstein
- Januvia, Ristaben, Sitagliptin Accord, Tesavel, Xelevia
- Lithuania
- Adimuplan, Jimandin, Maysiglu, Meliglix, Sitagliptin Grindeks, Sitagliptin Olpha, Sitagliptin Sandoz, Sitagliptin Zentiva
- Luxembourg
- Sitagliptin Eg
- Malta
- Anau, Jidinum, Jimandin, Lonamo, Remevia, Siltaben, Sitagliptin Adair, Sitagliptin Alenicum, Sitagliptin Biofarmoz, Sitagliptin Diagonalis, Sitagliptin Doc, Sitagliptin Galgenicum, Sitagliptin Grindeks, Sitagliptin Hennig, Sitagliptin Olpha, Sitagliptin Pharos, Sitagliptin Rafarm, Zaxivia
- Netherlands
- Adimuplan, Anau, Frekidir, Janeo, Simlerid, Sitaglaza, Sitagliptin Aspire, Sitagliptin Aurobindo, Sitagliptine Amarox, Sitagliptine Ashcure, Sitagliptine Aspire, Sitagliptine Auro, Sitagliptine Aurobindo, Sitagliptine Cf, Sitagliptine Devatis, Sitagliptine Hcs, Sitagliptine Heumann, Sitagliptine Macleods, Sitagliptine Sandoz, Sitagliptine Stada, Sitagliptine Viatris, Sitagliptine Xiromed
- Norway
- Frekidir, Januvia, Ristaben, Sitagliptin, Tesavel, Xelevia
- Poland
- Ansifora, Jansitin, Jazeta, Juzina, Lonamo, Maysiglu, Mifoglame, Phingroum, Sigletic, Simlerid, Sitagliptin Adamed, Sitagliptin Ashcure, Sitagliptin Aurovitas, Sitagliptin Bioton, Sitagliptin Medical Valley, Sitagliptin Medreg, Sitagliptin Olpha, Sitagliptin Polpharma, Sitagliptin Stada, Sitagliptin Tzf, Snasilta, Symgliptin, Sytena
- Portugal
- Itam, Jidinum, Meliglix, Sitagliptin Teva, Sitagliptina, Sitival
- Romania
- Adimuplan, Jansitin, Jazeta, Jidinum, Jimandin, Juzina, Maysiglu, Meliglix, Sitagliptin, Sitagliptina Atb, Snasilta
- Slovakia
- Anau, Ansifora, Jansitin, Jazeta, Jidinum, Jimandin, Juzina, Lonamo, Mapoli, Maysiglu, Sitagavia, Sitagliptin Glenmark, Sitagliptin Hcs, Sitagliptin Iasis, Sitagliptin Krka, Sitagliptin Medreg, Sitagliptin Olpha, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Tad, Sitagliptin Viatris
- Slovenia
- Adimuplan, Maysiglu, Meliglix, Sitagliptin Stada
- Spain
- Altuxerin, Disit, Frekidir, Jidinum, Meliglix, Sitagliptin Aspire, Sitagliptin Vivanta, Sitagliptina Adamed, Sitagliptina Alenicum, Sitagliptina Almus, Sitagliptina Alter, Sitagliptina Ashcure, Sitagliptina Aspire, Sitagliptina Aurovitas, Sitagliptina Cinfa, Sitagliptina Cinfalab, Sitagliptina Cinfamed, Sitagliptina Combix, Sitagliptina Dr. Reddys, Sitagliptina Exeltis, Sitagliptina Gln, Sitagliptina Grindeks, Sitagliptina Kern Pharma, Sitagliptina Krka, Sitagliptina Macleods, Sitagliptina Normon, Sitagliptina Olpha, Sitagliptina Pensa, Sitagliptina Sandoz, Sitagliptina Stada, Sitagliptina Tecnigen, Sitagliptina Tecnimede, Sitagliptina Teva, Sitagliptina Viatris, Sitagliptina Viso Farmacéutica, Sitagliptina Vivanta
- Sweden
- Axavel, Frekidir, Jidinum, Jimandin, Sitagliptin Ashcure, Sitagliptin Aspire, Sitagliptin Devatis, Sitagliptin Glenmark, Sitagliptin Grindeks, Sitagliptin Jubilant, Sitagliptin Krka, Sitagliptin Medical Valley, Sitagliptin Micro Labs, Sitagliptin Mylan, Sitagliptin Reddy, Sitagliptin Sandoz, Sitagliptin Stada, Sitagliptin Viatris Pharma, Sitagliptin Vivanta, Sitagliptin Zentiva K.S., Snasilta
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Januvia – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/januvia-epar-product-information_en.pdf
- European Medicines Agency. Ristaben – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ristaben-epar-product-information_en.pdf
- European Medicines Agency. Tesavel – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/tesavel-epar-product-information_en.pdf
- European Medicines Agency. Xelevia – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/xelevia-epar-product-information_en.pdf
- 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
- 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
- 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 2026-10-27 · 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.