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dapagliflozin

Edistride, Forxiga · ATC code A10BK01

Brand names: Edistride, Forxiga, Dapagliflozin +pharma, Dapagliflozin Accord, Dapagliflozin Devatis, Dapagliflozin Genericon, Dapagliflozin Reddy, Dapagliflozin Sandoz, Dapagliflozin Stada, Dapagliflozin Tad, Odelniqva, Daglin, Figozap, Zinodap, Calira …

Key facts
Active substance
dapagliflozin
Drug class
Gliflozins
ATC code
A10BK01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Edistride 5 mg film-coated tablets / Edistride 10 mg film-coated tablets · Forxiga 5 mg film-coated tablets / Forxiga 10 mg film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. It is used in type 2 diabetes mellitus, symptomatic chronic heart failure and chronic kidney disease (Forxiga, Edistride).

What it is used for

  • Insufficiently controlled type 2 diabetes in adults and children aged 10 years and above, as an adjunct to diet and exercise: monotherapy when metformin is not tolerated, or added to other diabetes medicines
  • Symptomatic chronic heart failure in adults
  • Chronic kidney disease in adults

Dosing

  • All three indications: 10 mg once daily
  • With insulin or an insulin secretagogue (e.g. a sulphonylurea): consider a lower dose of these (hypoglycaemia risk)
  • No dose adjustment based on renal function; initiation not recommended at GFR < 25 mL/min
  • Type 2 diabetes: glucose-lowering efficacy reduced at GFR < 45 mL/min; consider additional treatment if needed
  • Severe hepatic impairment: starting dose 5 mg, increase to 10 mg if well tolerated
  • Missed dose: take within 12 hours, otherwise skip

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Should not be used in type 1 diabetes
  • Diabetic ketoacidosis, rare but potentially fatal, possibly with only moderately raised glucose; assess immediately if non-specific symptoms occur
  • Necrotising fasciitis of the perineum (Fournier's gangrene), rare but life-threatening
  • Volume depletion and hypotension, especially in the elderly and with diuretics
  • Urinary tract infections; consider temporary interruption for pyelonephritis or urosepsis
  • Increase in lower limb amputations (primarily toe) seen with SGLT2 inhibitors; counsel on preventive foot care

Side effects

  • Most frequent: genital infections (vulvovaginitis, balanitis)
  • Common: urinary tract infection, dizziness, back pain, polyuria, rash
  • Hypoglycaemia when used with a sulphonylurea or insulin
  • Rare: diabetic ketoacidosis; Fournier's gangrene and angioedema have been reported

Interactions

  • Thiazide and loop diuretics: added diuresis, risk of dehydration and hypotension
  • Insulin and insulin secretagogues: hypoglycaemia risk; lower dose may be required
  • Urine glucose tests will be positive during treatment

Pregnancy and breastfeeding

  • Not recommended in the second and third trimesters; discontinue when pregnancy is detected
  • Should not be used while 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.

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

Austria

  • Dapagliflozin +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Dapagliflozin AccordAccord Healthcare B.V. · 1 register entry
  • Dapagliflozin DevatisDevatis Gmbh · 1 register entry
  • Dapagliflozin GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Dapagliflozin ReddyReddy Holding Gmbh · 1 register entry
  • Dapagliflozin SandozSandoz Gmbh · 1 register entry
  • Dapagliflozin StadaStada Arzneimittel Gmbh · 1 register entry
  • Dapagliflozin TadTad Pharma Gmbh · 1 register entry
  • OdelniqvaPharmapath Sa · 1 register entry

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

Germany

  • DaglinZaklady Farmaceutyczne Polpharma S.A. · 1 register entry
  • Dapagliflozin123 Acurae Pharma Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Macleods Pharma España, S.L.U, Devatis Gmbh, Vivanta Generics S.R.O, Ascend Gmbh, Elpen Pharmaceutical Co. Inc., Betapharm Arzneimittel Gmbh, Denk Pharma Gmbh & Co. Kg, Tad Pharma Gmbh · 12 register entries
  • FigozapBasics Gmbh · 1 register entry
  • ZinodapFarmitalia S.R.L. · 1 register entry

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

Turkey

  • CaliraSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • DaniptaİLKO İLAÇ SAN.VE TİC. A.Ş. · 4 register entries
  • DapadapSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DapgeonGENVEON İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • DapitusEİP ECZACIBAŞI İLAÇ PAZARLAMA A.Ş · 2 register entries
  • DapligSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DaprenzaBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • ForzigaASTRAZENECA İLAÇ SAN. VE TİC. LTD. ŞTİ. · 4 register entries
  • GlazoneSANTA FARMA İLAÇ SAN. A.Ş. · 2 register entries
  • GlyxarALİ RAİF İLAÇ SAN. A.Ş. · 2 register entries
  • JaglifNOBEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TrenicatGÜREL İLAÇ TİC. A.Ş. · 2 register entries

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

Brand names in 28 more European countries
Belgium
Dapagliflozin Ab, Dapagliflozin Eg, Dapagliflozin Sandoz, Dapagliflozine Hcs
Bulgaria
Dapagliflozin Sandoz, Dapagliflozin Tchaikapharma, Дагетия, Даграфорс, Далзиор, Дапаглифлозин Полфарма, Дапалиф, Дапастада, Фивота
Croatia
Daforbis, Dagrafors, Dalzior, Dapagliflozin Frontier, Dapagliflozin Stada, Daplemsen, Rizegmef, Zemryda
Cyprus
Daforbis, Dapagliflozin Farmoz, Dapagliflozin Sandoz, Dapagliflozin Stada, Dapagliflozin Tad, Dofliga, Fordapa
Czechia
Dagetia, Dagrafors, Dapagliflozin Fmk, Dapagliflozin Polpharma, Dapagliflozin Reddy, Dapagliflozin Sandoz, Dapagliflozin Stada, Daplemsen, Fivotta, Odelniqva
Denmark
Dapagliflozin, Dofliga, Figozap
Estonia
Dagrafors, Dapagliflozin Alembic, Dapagliflozin Olpha, Dapagliflozin Stada, Daplemsen, Fivotta, Rizegmef
Finland
Dapagliflozin Devatis, Dapagliflozin Krka, Dapagliflozin Orion, Dapagliflozin Ratiopharm, Dapagliflozin Sandoz, Dapagliflozin Stada, Figozap
France
Dapagliflozine Accord, Dapagliflozine Arrow, Dapagliflozine Biogaran, Dapagliflozine Eg, Dapagliflozine Krka, Dapagliflozine Olpha, Dapagliflozine Pharmaki, Dapagliflozine Sun, Dolpeaqio
Greece
Brolertix, Daforbis, Dagrafors, Dapagliflozin Sandoz, Dapagliflozin Stada, Dapagliflozin Win Medica, Dapaglut, Darxipa, Dofliga
Hungary
Dagrafors, Dapagliflozin Sandoz, Daperin, Dolpeaqio, Fivotta, Odelniqva, Pilagan, Zedilarf
Iceland
Dapagliflozin Krka, Dapagliflozin Sandoz, Dapagliflozin Viatris, Edistride, Forxiga
Ireland
Dapagliflozin Clonmel, Dapagliflozin Krka, Dapagliflozin Msn, Dapagliflozin Rowex
Italy
Dapagliflozin Aurobindo, Dapagliflozin Doc, Dapagliflozin Dr. Reddy’s, Dapagliflozin Krka, Dapagliflozin Teva, Dapaglifozin Tecnigen, Figozap, Valkozin, Zinodap
Latvia
Daglin, Dagrafors, Dapagliflozin Olpha, Dapagliflozin Polpharma, Dapagliflozin Stada, Daplemsen, Fivotta, Rizegmef
Liechtenstein
Dapagliflozin Viatris, Edistride, Forxiga
Lithuania
Dagrafors, Dapagliflozin Accord, Dapagliflozin Olpha, Dapagliflozin Polpharma, Dapagliflozin Stada, Daplemsen, Fivotta, Rizegmef
Luxembourg
Dapagliflozin Eg
Malta
Dapagliflozin Ascend, Dapagliflozin Aurobindo, Dapagliflozin Clonmel, Dapagliflozin Denk, Dapagliflozin Sandoz, Dapagliflozin Torrent, Pilagan
Netherlands
Dapagliflozin Alembic, Dapagliflozin Amarox, Dapagliflozin Aurobindo, Dapagliflozin Sandoz, Dapagliflozine Accord, Dapagliflozine Amarox, Dapagliflozine Cf, Dapagliflozine Devatis, Dapagliflozine Hcs, Dapagliflozine Macleods, Dapagliflozine Reddy, Dapagliflozine Steden Pharma, Dapagliflozine Vivanta, Daplemsen, Daplozy, Figozap, Rizegmef, Rizegmeg
Norway
Dapagliflozin Accord, Dapagliflozin Alembic, Dapagliflozin Devatis, Dapagliflozin Krka, Dapagliflozin Orion, Dapagliflozin Sandoz, Dapagliflozin Stada, Dapagliflozin Viatris, Dapagliflozin Vivanta, Edistride, Figozap, Forxiga
Poland
Daforbis, Dagrafors, Dalzior, Dapagliflozin Aurovitas, Dapagliflozin Stada, Dapazyna, Dapheria, Daplemsen, Diaflix, Figozap, Fivotta, Nerila, Odelniqva, Rizegmef, Zedilarf
Portugal
Dalzior, Dapagliflozin Ipca, Dapagliflozina Anova, Dapagliflozina Bluepharma, Dapagliflozina Farmak, Dapagliflozina Generis, Dapagliflozina Ipca, Dapagliflozina Krka, Dapagliflozina Pentafarma, Dapagliflozina Sandoz, Dapagliflozina Stada, Dapagliflozina Tad, Dapagliflozina Tecnigen, Dapaglifozina Aurovitas, Daperin
Romania
Daforbis, Dagetia, Dagrafors, Dapagliflozin Dr. Reddy’s, Dapagliflozin Stada, Daplemsen, Figozap, Fivotta, Rizegmef
Slovakia
Dagetia, Dagrafors, Dapagliflozin Olpha, Dapagliflozin Stada, Rizegmef
Slovenia
Dagrafors, Dapagliflozin Hcs, Dapagliflozin Krka, Dapagliflozin Stada, Daplemsen
Spain
Daforbis, Dapagliflozina Aurovitas, Dapagliflozina Combix, Dapagliflozina Dr. Reddys, Dapagliflozina Juta, Dapagliflozina Krka, Dapagliflozina Mabo, Dapagliflozina Normon, Dapagliflozina Olpha, Dapagliflozina Sandoz, Dapagliflozina Stada, Dapagliflozina Tarbis, Dapagliflozina Tecnigen, Dapagliflozina Teva, Dapagliflozina Vivanta, Daperin, Figozap, Glapira, Zedilarf
Sweden
Daforbis, Dapagliflozin Adalvo, Dapagliflozin Alembic, Dapagliflozin Devatis, Dapagliflozin Krka, Dapagliflozin Orion, Dapagliflozin Reddy, Dapagliflozin Sandoz, Dapagliflozin Stada, Dapagliflozin Vivanta, Figozap

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

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Sources

  1. European Medicines Agency. Edistride – 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/edistride-epar-product-information_en.pdf
  2. European Medicines Agency. Forxiga – 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/forxiga-epar-product-information_en.pdf
  3. 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
  4. 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
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC A10BK.

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.