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Mirtazapine

Mirtabene, Mirtazapin !@ctavis, Mirtazapin +pharma, Mirtazapin Actavis · ATC code N06AX11

Also known as: Mirtazapin · Brand names: Mirtabene, Mirtazapin !@ctavis, Mirtazapin +pharma, Mirtazapin Actavis, Mirtazapin Bluefish, Mirtazapin G.L., Mirtazapin Genericon, Mirtazapin Grindeks, Mirtazapin Hcs, Mirtazapin Hexal, Mirtazapin Stada, Mirtel, Mirta, Mirtalich, Mirtazapine Abz …

Key facts
Active substance
Mirtazapine
Drug class
Antidepressant
ATC code
N06AX11
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].

Key facts

Mirtazapine is an antidepressant used to treat major depressive disorder (MDD) in adults.

What it is used for

  • Major depressive disorder in adults
  • Not approved for pediatric patients

Dosing

  • Starting dose 15 mg once daily, preferably in the evening before sleep
  • If response is inadequate, up to a maximum of 45 mg per day; dose changes not at intervals of less than 1 to 2 weeks
  • Strong CYP3A inducers: dose increase may be needed; strong CYP3A4 inhibitors or cimetidine: dose decrease may be needed
  • At least 14 days between MAOIs and mirtazapine in either direction
  • Gradual dose reduction rather than abrupt stopping

Contraindications

  • Taking MAOIs (including linezolid and intravenous methylene blue) or within 14 days of stopping them
  • Known hypersensitivity to mirtazapine or any excipient

Important warnings

  • Boxed warning: antidepressants increased suicidal thoughts and behaviors in pediatric and young adult patients; close monitoring
  • Agranulocytosis
  • Serotonin syndrome, especially with other serotonergic drugs
  • Severe skin reactions (DRESS, SJS, TEN), QT prolongation, angle-closure glaucoma
  • Screening for bipolar disorder before starting (risk of mania/hypomania)
  • Somnolence, increased appetite and weight gain, hyponatremia, elevated lipids

Side effects

  • Most common: somnolence, increased appetite, weight gain and dizziness
  • Serious: agranulocytosis, serotonin syndrome, seizures, transaminase elevations
  • Discontinuation symptoms on dose reduction or stopping

Interactions

  • MAOIs contraindicated; other serotonergic drugs increase serotonin syndrome risk
  • CYP3A inducers (e.g. carbamazepine, phenytoin, rifampin) and inhibitors (e.g. ketoconazole, clarithromycin) alter levels

Pregnancy and breastfeeding

  • Prolonged experience has not reliably identified a risk of major birth defects or miscarriage; untreated depression carries its own risks

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

Patient information (US)

Patient information (US) →

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.

Austria

  • MirtabeneTeva B.V · 2 register entries
  • Mirtazapin !@ctavisActavis Group Ptc Ehf. · 1 register entry
  • Mirtazapin +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Mirtazapin ActavisActavis Group Ptc Ehf. · 2 register entries
  • Mirtazapin BluefishBluefish Pharmaceuticals Ab · 1 register entry
  • Mirtazapin G.L.G.L. Pharma Gmbh · 1 register entry
  • Mirtazapin GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Mirtazapin GrindeksGrindeks · 1 register entry
  • Mirtazapin HcsHcs Bvba · 1 register entry
  • Mirtazapin HexalHexal Pharma Gmbh · 1 register entry
  • Mirtazapin StadaStada Arzneimittel Gmbh · 1 register entry
  • MirtelG.L. Pharma Gmbh · 1 register entry

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

Germany

  • MirtaAbz-Pharma Gmbh, Tad Pharma Gmbh · 2 register entries
  • MirtalichWinthrop Arzneimittel Gmbh · 1 register entry
  • Mirtazapin1 A Pharma Gmbh, 123 Acurae Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Hormosan Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Amarox Pharma Gmbh, Ametas Medical Gmbh, Abz-Pharma Gmbh, Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Viatris Germany Gmbh, Biomo Pharma Gmbh, Aliud Pharma Gmbh · 21 register entries
  • Mirtazapine AbzAbz-Pharma Gmbh · 1 register entry
  • Remergil SoltabOrganonhealthcare Gmbh · 1 register entry

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

Turkey

  • MiresNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 6 register entries
  • MitazenSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • MolremCELTİS İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • RedepraGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 6 register entries
  • RemeronORGANON TURKEY İLAÇLARI LİMİTED ŞİRKETİ · 2 register entries
  • UlkapinULKAR İLAÇ PAZARLAMA LTD. ŞTİ. · 6 register entries
  • VelorinACTAVİS İLAÇLARI A.Ş., TEVA İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
  • ZestatABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 4 register entries

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

USA

  • RemeronOrganon LLC · 1 register entry
  • RemeronsoltabOrganon LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 27 more European countries
Belgium
Mirtazapine Ab, Mirtazapine Eg, Mirtazapine Grindeks, Mirtazapine Instant Eg, Mirtazapine Sandoz, Mirtazapine Viatris, Remergon Soltab
Bulgaria
Мирзатен, Миртазапин Гриндекс, Ремирта
Croatia
Calixta, Mirtazapin Genericon, Mirtazapin Grindeks, Mirzaten, Mizantir
Cyprus
Mirtazapin Aurobindo, Remeron
Czechia
Miranox, Mirtazapin +pharma, Mirtazapin Sandoz, Mirtazapin Sanexcel, Mirtazapin Viatris, Mirtazapine Grindeks, Mirtor, Mirzaten
Denmark
Combar, Mirtazapin "hexal", Mirtazapin "sandoz", Mirtazapin Actavis, Mirtazapin Alternova, Mirtazapin Bluefish, Mirtazapin Grindeks, Mirtazapin Krka, Mirtazapin Orion, Mirtazapin Stada, Mirtazapin Teva, Mirtazapin Viatris, Mirtazapine Grindeks, Mirtin
Estonia
Mirtastad, Mirtazapin Actavis, Mirtazapin Orion, Mirtazapine Grindeks, Mirzaten
Finland
Mirtazapin Actavis, Mirtazapin Grindeks, Mirtazapin Hexal, Mirtazapin Krka, Mirtazapin Orion, Mirtazapin Ratiopharm, Mirtazapin Sandoz, Mirtazapine Grindeks
France
Mirtazapine Almus, Mirtazapine Arrow, Mirtazapine Biogaran, Mirtazapine Bluefish, Mirtazapine Cristers, Mirtazapine Eg, Mirtazapine Ethypharm, Mirtazapine Grindeks, Mirtazapine Sandoz, Mirtazapine Teva, Mirtazapine Viatris, Mirtazapine Zentiva, Mirtazapine Zydus, Norset
Greece
Anchopriv, Azapin, Depreram, Merdaten, Mirtamor, Mirtapil, Mirtazapin Grindeks, Mirtazapina Grindeks, Mirtazapine Mylan, Motofen, Remeron, Saxib
Hungary
Mirtadepi, Mirtastad, Mirtazapin Orion, Mirtazapin Sandoz, Mirtazapin Sanexcel, Mirtazapine Grindeks, Mirzaten, Mizapin, Yarocen
Iceland
Miron Smelt, Mirtazapin Bluefish, Mirtazapin Krka, Mirtazapin Sandoz, Míron
Ireland
Mirap, Mirtazapine Accord Healthcare Ireland, Mirtazapine Bluefish, Mirtazapine Grindeks, Zismirt, Zispin
Italy
Mirtazapin Grindeks, Mirtazapina Almus, Mirtazapina Alter, Mirtazapina Aurobindo, Mirtazapina Doc, Mirtazapina Eg, Mirtazapina Grindeks, Mirtazapina Krka, Mirtazapina Mylan Generics, Mirtazapina Sandoz Bv, Mirtazapina Sandoz Gmbh, Mirtazapina Teva Italia, Mirtazapina Zentiva, Punglydep, Remeron, Zapin
Latvia
Mirtastad, Mirtazapine Grindeks, Mirzaten
Lithuania
Mirtazapin Actavis, Mirtazapin Grindeks, Mirtazapine Grindeks, Mirtazapine Orion, Mirzaten
Luxembourg
Mirtazapin Ratiopharm, Mirtazapine Eg, Remergon Soltab
Malta
Mirap, Mirtazapine Aurobindo, Mirtazapine Flas Normogen
Netherlands
Mirtazapine Amarox, Mirtazapine Aurobindo, Mirtazapine Cf, Mirtazapine Dispergeerbaar Ratiopharm, Mirtazapine Ratiopharm, Mirtazapine Sandoz, Mirtazapine Smelttab Viatris, Mirtazapine Teva, Mirtazapine Viatris, Mirzasna, Mitabor Disper, Remeron, Tabletten
Norway
Mirtazapin Actavis, Mirtazapin Bluefish, Mirtazapin Hexal, Mirtazapin Orion, Mirtazapin Sandoz, Mirtazapine Grindeks, Mirtin, Remeron
Poland
Auromirta Oro, Mirtagen, Mirtazapine Bluefish, Mirtor, Mirzaten, Remirta Oro
Portugal
Mirtazapin Grindeks, Mirtazapina Almus, Mirtazapina Alter, Mirtazapina Aurobindo, Mirtazapina Aurovitas, Mirtazapina Azevedos, Mirtazapina Bluefish, Mirtazapina Bluepharma, Mirtazapina Ciclum, Mirtazapina Farmoz, Mirtazapina Generis, Mirtazapina Grindeks, Mirtazapina Jaba, Mirtazapina Krka, Mirtazapina Mylan, Mirtazapina Psidep, Mirtazapina Ratiopharm, Mirtazapina Refta, Mirtazapina Sandoz, Mirtazapina Teva, Mirtazapina Tolife, Mirtazapina Viatris, Mirtazapina Zentiva, Remeron Soltab
Romania
Mirtazapin Arena, Mirtazapină Aurobindo, Mirzaten, Pharmataz, Remeron Soltab
Slovakia
Mirzaten
Slovenia
Mirtazapin Grindeks, Mirtazapine Grindeks, Mirzaten
Spain
Afloyan, Mirtazapina Almus, Mirtazapina Alter, Mirtazapina Aristo, Mirtazapina Aurobindo, Mirtazapina Aurovitas Spain, Mirtazapina Cinfa, Mirtazapina Combino Pharm, Mirtazapina Combix, Mirtazapina Flas, Mirtazapina Mabo, Mirtazapina Normon, Mirtazapina Qualigen, Mirtazapina Sandoz, Mirtazapina Stada, Mirtazapina Tarbis, Mirtazapina Tecnigen, Mirtazapina Teva-Ratio, Mirtazapina Tevagen, Mirtazapina Viatris Pharmaceuticals, Mirtazapine Grindeks, Rexer
Sweden
Mirtazapin Actavis, Mirtazapin Alternova, Mirtazapin Bluefish, Mirtazapin Hexal, Mirtazapin Krka, Mirtazapin Newbury, Mirtazapin Orion, Mirtazapin Sandoz, Mirtazapine Bluefish, Mirtazapine Grindeks, Mirtin

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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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. Mirtazapine (AvKARE) – Prescribing Information, 2025-09-23. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e5478a6a-a29a-9f61-e053-2995a90a11d0
  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. 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. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC N06AX.

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

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.