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Duloxetine

Cymbalta, Duloxetine Lilly, Yentreve · ATC code N06AX21

Also known as: Duloxetin · Brand names: Cymbalta, Duloxetine Lilly, Yentreve, Dulasolan, Dutilox, Duloxalta, Duloxecat, Dulxetenon, Doletin, Dosetia, Dulaxat, Dulester, Duloxat, Duloxx, Duxalta …

Key facts
Active substance
Duloxetine
Drug class
Antidepressant
ATC code
N06AX21
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Cymbalta 30 mg hard gastro-resistant capsules / Cymbalta 60 mg hard gastro-resistant capsules · Duloxetine Lilly 30 mg hard gastro-resistant capsules / Duloxetine Lilly 60 mg hard gastro-resistant capsules · YENTREVE 20 mg hard gastro-resistant capsules / YENTREVE 40 mg hard gastro-resistant capsules
Marketing authorisation holder
Eli Lilly Nederland B.V.
Information as of
2026-10-27

Key facts

Duloxetine is a serotonin-noradrenaline reuptake inhibitor. It is used in adults for depression, generalised anxiety disorder and diabetic neuropathic pain, and in women for stress urinary incontinence.

What it is used for

  • Cymbalta/Duloxetine Lilly: major depressive disorder in adults
  • Cymbalta/Duloxetine Lilly: generalised anxiety disorder in adults
  • Cymbalta/Duloxetine Lilly: diabetic peripheral neuropathic pain in adults
  • Yentreve: moderate to severe stress urinary incontinence in women

Dosing

  • Depression (Cymbalta/Duloxetine Lilly): 60 mg once daily; doses up to 120 mg per day have been evaluated in trials.
  • Generalised anxiety disorder: start 30 mg once daily, 60 mg if response is insufficient; escalation up to 90 mg or 120 mg may be considered.
  • Diabetic neuropathic pain: 60 mg daily; evaluate response after 2 months.
  • Yentreve (stress incontinence): 40 mg twice daily; some patients may start at 20 mg twice daily for two weeks.
  • Must not be used in liver disease with hepatic impairment or severe renal impairment (CrCl <30 ml/min).
  • Avoid abrupt discontinuation; reduce gradually over at least one to two weeks.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Combination with nonselective, irreversible MAOIs
  • Liver disease resulting in hepatic impairment; severe renal impairment
  • Combination with potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, enoxacin)
  • Initiation in uncontrolled hypertension

Important warnings

  • Blood pressure increase up to hypertensive crisis; monitor blood pressure especially in the first month
  • Serotonin syndrome or neuroleptic malignant syndrome, particularly with other serotonergic agents
  • Caution with a history of mania, bipolar disorder or seizures
  • Mydriasis: caution with raised intraocular pressure or risk of narrow-angle glaucoma
  • Suicidal ideation and behaviour may occur

Side effects

  • Most common: nausea, headache, dry mouth, somnolence, dizziness
  • Yentreve: mainly nausea, dry mouth, fatigue and constipation
  • Others: insomnia, decreased appetite, decreased libido, anxiety
  • Rarer or serious: hyponatraemia, SIADH, mania, hallucinations, suicidal ideation

Interactions

  • MAOIs: do not combine; at least 14 days after an MAOI and at least 5 days after duloxetine before an MAOI
  • Moclobemide not recommended; linezolid should not be given
  • Potent CYP1A2 inhibitors raise duloxetine levels
  • Other serotonergic agents (SSRIs, SNRIs, tricyclics, triptans): risk of serotonin syndrome

Pregnancy and breastfeeding

  • Two large observational studies do not suggest an overall increased risk of major malformations; data on cardiac malformations are inconclusive.
  • Animal studies have shown reproductive toxicity.

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

  • DulasolanG.L. Pharma Gmbh · 1 register entry
  • Duloxetin1a Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Accord Healthcare B.V., Sandoz Gmbh, Stada Arzneimittel Gmbh, G.L. Pharma Gmbh, Krka, D.D., Novo Mesto · 10 register entries
  • DutiloxTowa Pharmaceutical Europe S.L. · 1 register entry

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

Germany

  • DulasolanG.L. Pharma Gmbh · 1 register entry
  • DuloxaltaTad Pharma Gmbh · 1 register entry
  • DuloxecatTowa Pharmaceutical Europe S.L. · 1 register entry
  • DuloxetinTillomed Pharma Gmbh, 1 A Pharma Gmbh, Ratiopharm Gmbh, Generinobel Gmbh, Neuraxpharm Arzneimittel Gmbh, Stadapharm Gmbh, Puren Pharma Gmbh & Co. Kg, Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Abz-Pharma Gmbh, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Hennig Arzneimittel Gmbh & Co. Kg, Towa Pharmaceutical Europe S.L., Biomo Pharma Gmbh, Betapharm Arzneimittel Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 27 register entries
  • DulxetenonNeuraxpharm Arzneimittel Gmbh · 1 register entry
  • DutiloxFarmak International Sp. Z O.O., Towa Pharmaceutical Europe S.L. · 2 register entries

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

Turkey

  • CymbaltaLİLLY İLAÇ TİC. LTD. ŞTİ. · 1 register entry
  • DoletinALİ RAİF İLAÇ SAN. A.Ş. · 2 register entries
  • DosetiaNOBEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DulaxatWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DulesterİLKO İLAÇ SAN.VE TİC. A.Ş. · 2 register entries
  • DuloxatWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • DuloxxSANTA FARMA İLAÇ SAN. A.Ş. · 4 register entries
  • DuxaltaALİ RAİF İLAÇ SAN. A.Ş. · 2 register entries
  • DuxetNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 2 register entries
  • DyloxiaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • KomoxSANTA FARMA İLAÇ SAN. A.Ş. · 2 register entries
  • LoduxNOBEL SAĞLIK ÜRÜNLERİ LTD ŞTİ · 2 register entries
Show all 13 brand names
  • NexetinNOBEL İLAÇ SAN. VE 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
Duloxetin Ab, Duloxetine Aurobindo, Duloxetine Eg, Duloxetine Eurogenerics, Duloxetine Krka, Duloxetine Liconsa, Duloxetine Sandoz, Duloxetine Teva, Duloxétine Ab, Dutilox
Bulgaria
Dulasolan, Duxet, Аритави, Дуксет, Дулодет, Дулсевиа, Нексетин, Онелар
Croatia
Dolyxan, Duloksetin Pliva, Duloksetin Stada, Dulsevia, Onelar
Cyprus
Dulox, Duloxetine Accord, Dulsevia, Onelar
Czechia
Dolyxan, Dulasolan, Duloxetin +pharma, Dulsevia, Onelar
Denmark
Aritavi, Duciltia, Duloxetin Krka, Duloxetin Stada, Duloxetin “hexal”, Duloxetine Medical Valley, Duloxetine Orion, Loxentia
Estonia
Duloxetine Alembic, Dulsevia, Onelar
Finland
Duloxetin Stada, Duloxetine Accord, Duloxetine Accordpharma, Duloxetine Krka, Duloxetine Liconsa, Duloxetine Orion, Loxentia
France
Duloxetine Accord, Duloxetine Almus, Duloxetine Arrow, Duloxetine Biogaran, Duloxetine Eg, Duloxetine Evolugen, Duloxetine Sandoz, Duloxetine Teva, Duloxetine Towa Pharmaceutical Europe, Duloxetine Viatris Sante, Duloxetine Zydus
Greece
Duciltia, Duloxetine Liconsa, Dulsevia, Onelar
Hungary
Duciltia, Dulodet, Duloxetin Sandoz, Duloxetin Stada, Duloxetine Liconsa, Dulsevia
Iceland
Aritavi, Cymbalta, Duloxetin Krka, Duloxetin W&h, Duloxetine Lilly, Duloxetine Medical Valley, Duloxetine Viatris, Duloxetine Zentiva, Yentreve
Ireland
Duloxetine Accord, Duloxetine Clonmel, Duloxetine Krka, Duloxetine Pinewood Laboratories, Loxentia
Italy
Alikres, Dulex, Duloxetina Almus, Duloxetina Alter, Duloxetina Aurobindo, Duloxetina Doc Generici, Duloxetina Eg, Duloxetina Krka, Duloxetina Pensa, Duloxetina Sandoz, Duloxetina Teva, Dulxetenon, Ezequa, Siloxezol
Latvia
Dulsevia
Liechtenstein
Cymbalta, Duloxetine Lilly, Duloxetine Viatris, Duloxetine Zentiva, Yentreve
Lithuania
Dulsevia
Luxembourg
Duloxetin Ab, Duloxetine Liconsa
Malta
Onelar
Netherlands
Dulasolan, Dulodet, Duloxetine Accord, Duloxetine Amarox, Duloxetine Hydrochloride Aurobindo, Duloxetine Krka, Duloxetine Laboratorios Liconsa, Duloxetine Liconsa, Duloxetine Sandoz, Duloxetine Stada, Duloxetine Teva, Duloxetine Towa, Duloxetine Xiromed, Dutilox, Onelar
Norway
Cymbalta, Duloxetin Krka, Duloxetin Pensa, Duloxetine Liconsa, Duloxetine Lilly, Duloxetine Medical Valley, Duloxetine Viatris, Duloxetine Zentiva, Yentreve
Poland
Aurodulox, Depratal, Dulofor, Duloxetine +pharma, Duloxetine Medical Valley, Duloxetine Sandoz, Dulsevia, Dulxetenon, Dutilox
Portugal
Duloxetina Alter, Duloxetina Amperlem, Duloxetina Aurovitas, Duloxetina Bluepharma, Duloxetina Ciclum, Duloxetina Eignapharma, Duloxetina Farmoz, Duloxetina Generis, Duloxetina Krka, Duloxetina Liconsa, Duloxetina Lumec, Duloxetina Odipe, Duloxetina Pentafarma, Duloxetina Pharmakern, Duloxetina Ratiopharm, Duloxetina Tecnigen, Duloxetina Teva, Duloxetina Tolife, Dulxetenon
Romania
Dozzex, Duloxetina Stada, Duloxetine Hydrochloride Pharmaclan, Duloxetină Dr. Reddy's, Duloxetină Sandoz, Duloxetină Terapia, Dulsevia, Onelar, Zatinex
Slovakia
Duloxetin Krka, Duloxetin Sandoz, Duloxetin Stada, Dulsevia, Dulxetenon, Loxentia, Onelar
Slovenia
Duloksetin Sandoz, Dulsevia
Spain
Dedulox, Dulotex, Duloxetina Almus, Duloxetina Alter, Duloxetina Aristo, Duloxetina Aurovitas, Duloxetina Cinfa, Duloxetina Cinfamed, Duloxetina Combix, Duloxetina Durban, Duloxetina Eignapharma, Duloxetina Genesis, Duloxetina Kern Pharma, Duloxetina Krka, Duloxetina La Colina, Duloxetina Liconsa, Duloxetina Mabo - Farma, Duloxetina Normon, Duloxetina Pensa Pharma, Duloxetina Qualigen, Duloxetina Ratio, Duloxetina Sandoz, Duloxetina Stada, Duloxetina Stadagen, Duloxetina Tarbis, Duloxetina Tecnigen, Duloxetina Tevagen, Duloxetina Viatris Pharmaceuticals, Duloxetina Vir, Ludotim, Nixenca, Oxitril, Xeristar
Sweden
Aritavi, Dulmis, Duloxetin Actavis, Duloxetin Amarox, Duloxetin Pensa, Duloxetin Stada, Duloxetin Teva, Duloxetine Accord, Duloxetine Accordpharma, Duloxetine Krka, Duloxetine Medical Valley, Duloxetine Orion, Duloxetine Sandoz, Duloxetine Stada Nordic, Loxentia

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

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Sources

  1. European Medicines Agency. Cymbalta – EPAR, Product Information (OF THE TEXT Detailed information on this medicine is availab). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/cymbalta-epar-product-information_en.pdf
  2. European Medicines Agency. Duloxetine Lilly – EPAR, Product Information (OF THE TEXT Detailed information on this medicine is availab). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/duloxetine-lilly-epar-product-information_en.pdf
  3. European Medicines Agency. Yentreve – EPAR, Product Information (OF THE TEXT Detailed information on this medicine is availab). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/yentreve-epar-product-information_en.pdf
  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. 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
  6. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  7. Wikidata (CC0): ATC N06AX.

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.