MedeliX
Start asking

Quetiapine

Quetialan, Quetiapin, Quexima, Seroquel · ATC code N05AH04

Also known as: Quetiapin, ketiapin, Quetiapine Fumarate · Brand names: Quetialan, Quexima, Seroquel, Aquetia, Desiquet, Quetiapine Ratiopharm, Ankep, As-Kalmeks, Cedrina, Etipin, Gyrex, Keday XR, Ketap, Ketidose, Ketilept …

Key facts
Active substance
Quetiapine
Drug class
Antipsychotics
ATC code
N05AH04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1)]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].
Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.2)].
In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.2)].
Quetiapine is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4)].

Key facts

Quetiapine is an atypical antipsychotic. Per the US label it is used for schizophrenia and for manic and depressive episodes of bipolar disorder, as well as maintenance treatment.

What it is used for

  • Schizophrenia in adults and adolescents (13 to 17 years)
  • Acute manic episodes of bipolar I disorder, alone or with lithium or divalproex (adults; children 10 to 17 years as monotherapy)
  • Acute depressive episodes of bipolar disorder (monotherapy)
  • Maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex

Dosing

  • Schizophrenia, adults: day 1 25 mg twice daily, then titrate; recommended 150 to 750 mg/day, maximum 750 mg/day
  • Bipolar mania, adults: titrate over 4 days to 400 mg; recommended 400 to 800 mg/day, maximum 800 mg/day
  • Bipolar depression, adults: once daily at bedtime, titrated to 300 mg/day
  • Hepatic impairment: start at 25 mg/day, increase in steps of 25 mg/day to 50 mg/day
  • Paediatric dosing and adjustments with CYP3A4 inhibitors/inducers in the full text

Contraindications

  • Hypersensitivity to quetiapine or any excipient

Important warnings

  • Boxed warning: increased mortality in elderly patients with dementia-related psychosis; not approved for this use
  • Boxed warning: increased risk of suicidal thoughts and behaviours in children, adolescents and young adults
  • Neuroleptic malignant syndrome, tardive dyskinesia
  • Metabolic changes (hyperglycaemia, dyslipidaemia, weight gain)
  • Hypotension, falls, leukopenia/neutropenia, QT prolongation

Side effects

  • Common: somnolence, dizziness, dry mouth, constipation, weight gain, dyspepsia, increased ALT
  • Postural hypotension, asthenia
  • Increased blood pressure in children and adolescents

Interactions

  • Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase and inducers (e.g. phenytoin, carbamazepine, rifampin, St. John's wort) decrease quetiapine exposure; dose adjustment needed
  • Potentiates cognitive and motor effects of alcohol; caution with other centrally acting drugs

Pregnancy and breastfeeding

  • Neonates exposed in the third trimester risk extrapyramidal and withdrawal symptoms; no established risk of major birth defects
  • Present at low levels in breast milk; weigh breastfeeding benefits against the mother's need

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 →

Common questions – ask Medelix

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

  • QuetialanG.L. Pharma Gmbh · 3 register entries
  • Quetiapin1a Pharma Gmbh, G.L. Pharma Gmbh, Fairmed Healthcare Gmbh, Neuraxpharm Arzneimittel Gmbh, Teva B.V, Genericon Pharma Gesellschaft M.B.H., +pharma Arzneimittel Gmbh, Accord Healthcare B.V., Aristo Pharma Gmbh (Art 57), Sandoz Gmbh, Stada Arzneimittel Gmbh, Krka, D.D., Novo Mesto, Hcs Bvba · 15 register entries
  • QueximaExeltis Germany Gmbh · 1 register entry
  • SeroquelCheplapharm Arzneimittel Gmbh · 2 register entries

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

Germany

  • AquetiaItf Pharma Gmbh · 1 register entry
  • DesiquetRosemont Pharmaceuticals Limited · 1 register entry
  • Quetiapin1 A Pharma Gmbh, Fairmed Healthcare Gmbh, Hec Pharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Glenmark Arzneimittel Gmbh, Hormosan Pharma Gmbh, Devatis Gmbh, Accord Healthcare B.V., Aristo Pharma Gmbh (Art 57), Hexal Ag, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Ipca Productos Farmaceuticos Unipessoal Lda, Abz-Pharma Gmbh, Tad Pharma Gmbh, Aliud Pharma Gmbh · 25 register entries
  • Quetiapine RatiopharmRatiopharm Gmbh · 1 register entry
  • SeroquelCheplapharm Arzneimittel Gmbh · 2 register entries

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

Turkey

  • AnkepANGELİNİ İLAÇ SAN. VE TİC. A.Ş. · 13 register entries
  • As-KalmeksAPOTEX İLAÇ SAN VE TİC. LTD. ŞTİ. · 6 register entries
  • CedrinaSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 24 register entries
  • EtipinMÜNİR ŞAHİN İLAÇ SAN. VE TİC A.Ş. · 15 register entries
  • GyrexSANTA FARMA İLAÇ SAN. A.Ş. · 13 register entries
  • Keday XRNOBEL İLAÇ SAN. VE TİC. A.Ş. · 10 register entries
  • KetapHELBA İLAÇ İÇ VE DIŞ SAN. TİC. A.Ş., HELBA İLAÇ İÇ VE DIŞ SAN. TİC. LTD. ŞTİ. · 17 register entries
  • KetidoseSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • KetileptFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 10 register entries
  • KetinelBİOFARMA İLAÇ SAN. VE TİC. A.Ş. · 10 register entries
  • KetyaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 12 register entries
  • MadrinaASET İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
Show all 18 brand names
  • QueleptİLKO İLAÇ SAN.VE TİC. A.Ş. · 21 register entries
  • QuetDEVA HOLDİNG A.Ş. · 20 register entries
  • QuetaminHUMANİS SAĞLIK A.Ş. · 5 register entries
  • SequaNEUTEC İLAÇ SAN. TİC. A.Ş · 15 register entries
  • SerexGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 7 register entries
  • SeroquelLİVA İLAÇ PAZARLAMA SAN. VE TİC. A.Ş. · 6 register entries

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

USA

  • SeroquelAstraZeneca Pharmaceuticals LP, H2-Pharma, LLC · 2 register entries
  • Seroquel XRAstraZeneca Pharmaceuticals LP · 1 register entry

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

Brand names in 27 more European countries
Belgium
Ketyalix, Quetiapin Retard Sandoz, Quetiapin Sandoz, Quetiapine Ab, Quetiapine Eg, Quetiapine Krka, Quetiapine Retard Eg, Quetiapine Retard Teva, Quetiapine Retard Viatris, Quetiapine Teva, Quetiapine Viatris, Quexima, Seroquel
Bulgaria
Бревенокс, Квентиакс, Кветиапин Aкорд, Кветиапин Акорд, Сетинин, Теваквел, Хедонин
Croatia
Kventiax, Kvetiapin Pharmas, Kvetiapin Xr Pharmas, Loquen, Q-Pin, Seroquel
Cyprus
Aquetia, Ketipine, Quetiapine Accord, Quetiapine Viatris, Seroquel, Tomel
Czechia
Derin, Equilion, Hedonin, Ketilept, Kventiax, Questax, Quetiapin Neuraxpharm, Quetiapin Retard Teva, Quetiapin Teva, Quetiapine Accord, Quetiapine Polpharma, Quetiapine Viatris
Denmark
Antoreq, Biquetan, Quentiax, Quetiapin "hexal", Quetiapin "sandoz", Quetiapin Accord, Quetiapin G.L. Pharma, Quetiapin Krka, Quetiapin Medical Valley, Quetiapin Orion, Quetiapin Pharmathen, Quetiapin Viatris, Quetiapin Zentiva, Quetiapine Teva, Seroquel Prolong, Stadaquel
Estonia
Ketipinor, Kventiax, Quetiapine Accord, Quetiapine Teva, Seroquel
Finland
Biquetan, Ketipinor, Quetiapin Hexal, Quetiapin Krka, Quetiapin Medical Valley, Quetiapin Orion, Quetiapin Ratiopharm, Quetiapine Accord, Quetiapine Teva, Seroquel, Zenaxel
France
Lp, Queliva, Quetiapine Eg Lp, Quetiapine Italfarmaco, Quetiapine Lp Accord, Quetiapine Lp Arrow, Quetiapine Lp Biogaran, Quetiapine Lp Cristers, Quetiapine Lp Eg, Quetiapine Lp Evolugen, Quetiapine Lp Krka, Quetiapine Lp Sandoz, Quetiapine Lp Zentiva, Quetiapine Teva, Quetiapine Viatris Lp, Quetiapine Viatris Sante Lp, Xeroquel Lp
Greece
Anaquetan Xr, Aquetia, Arezil Xr, Etiaben Xr, Etiapin, Ketipine, Matepil, Megazon, Quapianol, Quental, Quepin, Quetiapine Accord, Quetiapine Ariti, Quetiapine Mylan, Quetiapine Rosemont, Quetiapine Tad, Quetiapine Viatris, Secuelia Xr, Seropin, Seroquel, Serotiapin, Tiaquel
Hungary
Ketilept, Kventiax, Quetiapine Accord, Quetiapine Teva, Seroquel Xr
Iceland
Quetiapin Actavis, Quetiapin Krka, Quetiapin Medical Valley, Quetiapin Viatris, Seroquel
Ireland
Notiabolfen Xl, Quentiax Sr, Quetex, Quetiapine Krka, Seropia, Seroquel, Tevaquel
Italy
Akelya, Quentiax, Quetiapina, Seroquel, Xetamed, Yadina
Latvia
Ketipinor, Kventiax, Quetiapine Accord, Quetiapine Polpharma, Quetiapine Teva
Lithuania
Hedonin, Ketipinor, Kventiax, Quetiapine Accord, Quetiapine Actavis, Quetiapine Polpharma, Quetiapine Teva
Luxembourg
Aquetia, Quetiapine Eg, Quetiapine Retard Eg, Quetiapine Retard Viatris, Quexima, Seroquel
Malta
Quetex, Quetiapine Accord Healthcare, Quetiapine Aurobindo, Quetiapine Viatris
Netherlands
Aquetia, Quetiapine, Seroquel
Norway
Quetiapin Krka, Quetiapin Orion, Quetiapin Sandoz, Quetiapine Accord, Quetiapine Medical Valley, Quetiapine Teva, Seroquel, Zenaxel
Poland
Apotiapina, Bonogren, Kefrenex, Ketilept, Ketipinor, Ketrel, Kvelux Sr, Kventiax, Kwetaplex, Kwetina, Kwexyma, Pinexet, Quetiapine Aurovitas, Quetiapine Orion, Setinin
Portugal
Anaquetan Xr, Aquetia, Quetamed, Quetiapina Accord, Quetiapina Alter, Quetiapina Aristo, Quetiapina Aurobindo, Quetiapina Aurovitas, Quetiapina Azevedos, Quetiapina Bluelife, Quetiapina Bluepharma, Quetiapina Bravet, Quetiapina Ciclum, Quetiapina Farmoz, Quetiapina Generis, Quetiapina Ipca, Quetiapina Kventiax, Quetiapina Lp Bluepharma, Quetiapina Mylan, Quetiapina Pentafarma, Quetiapina Pharmathen, Quetiapina Ratiopharm, Quetiapina Ritisca, Quetiapina Rocoz, Quetiapina Sandoz, Quetiapina Sr Alter, Quetiapina Sr Farmoz, Quetiapina Sr Rocoz, Quetiapina Sr Tolife, Quetiapina Sr Zentiva, Quetiapina Teva, Quetiapina Tolife, Quetiapina Zentiva, Quetiapine Ratiopharm, Quetiapine Teva, Seroquel, Zenexel, Zerpi
Romania
Kventiax, Quetiapina Accord, Quetiapine Accord, Quetiapină Accord, Quetiapină Teva, Quetiapină Zentiva, Seroquel Xr, Treksta, Uniquet
Slovakia
Derin, Equilion, Hedonin Xr, Ketilept Prolong, Kventiax, Questax Xr, Quetiapin Sandoz, Quetiapin Sr Zentiva, Quetiapin Viatris, Quetiapine Accord, Seroquel Xr
Slovenia
Kvelux, Kventiax, Kvetiapin Accord, Loquen, Seroquel
Spain
Atrolak Prolong, Ketyalix, Psicotric, Qudix, Quentiax, Quetiapina, Rocoz, Seroquel, Zenaxel
Sweden
Biquetan, Quetiapin Hexal, Quetiapin Krka, Quetiapin Medical Valley, Quetiapin Orion, Quetiapin Sandoz, Quetiapin Stada, Quetiapine Accord, Quetiapine Teva, Quetiapine Viatris, Seroquel, Zenaxel

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.

Other substances in the same group

Related calculators

Another question about this substance?

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

Sources

  1. U.S. Food and Drug Administration. Quetiapine Fumarate (Rising Pharma Holdings, Inc.) – Prescribing Information, 2025-10-28. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=532c8ace-4cf5-4a08-bae7-2af8c41ffa3d
  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 N05AH.

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.