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Hydroxyzine

Atarax · ATC code N05BB01

Also known as: Hydroxyzin, Hidroksizin, Hydroxyzine Pamoate

Key facts
Active substance
Hydroxyzine
Drug class
Anxiolytic
ATC code
N05BB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Hydroxyzine is an antihistamine with sedative effects. Per the US prescribing information, it is used for anxiety and tension, allergic pruritus, and as a sedative around general anesthesia.

What it is used for

  • Symptomatic relief of anxiety and tension, also as an adjunct in organic disease
  • Pruritus due to allergic conditions such as chronic urticaria, atopic and contact dermatoses
  • Sedation as premedication and following general anesthesia

Dosing

  • Anxiety, adults: 50 to 100 mg four times a day.
  • Pruritus, adults: 25 mg three or four times a day.
  • Children under 6 years: 50 mg daily in divided doses; over 6 years: 50 to 100 mg daily in divided doses.
  • Sedation: 50 to 100 mg in adults, 0.6 mg/kg in children.
  • Adjust dose to response; reassess usefulness periodically with long-term use.

Contraindications

  • Early pregnancy
  • Prolonged QT interval
  • Hypersensitivity to hydroxyzine, cetirizine, levocetirizine or any component

Important warnings

  • May potentiate meperidine and barbiturates; modify their use in pre-anesthetic therapy individually
  • QT prolongation and Torsade de Pointes
  • Should not be given to nursing mothers
  • Effectiveness for anxiety beyond 4 months not systematically assessed

Side effects

  • Usually mild and transitory
  • Dry mouth and drowsiness
  • Rare tremor and convulsions, usually at considerably higher doses
  • AGEP, fixed drug eruptions, headache, hallucination, pruritus, rash, urticaria

Interactions

  • Meperidine and barbiturates: effects may be potentiated

Pregnancy and breastfeeding

  • Contraindicated in early pregnancy.
  • Should not be given to nursing mothers.

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)

This product has no separate US patient information.

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

  • AtaraxUcb Pharma Gmbh · 1 register entry

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

Germany

  • AtaraxUcb Pharma Gmbh · 1 register entry
  • Hydroxyzine IpcaIpca Productos Farmaceuticos Unipessoal Lda · 1 register entry

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

Turkey

  • AtaraxUCB PHARMA A.Ş., AVİXA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • ValidolHAKAY İLAÇ PAZARLAMA SAN. VE TİC. LTD. ŞTİ. · 2 register entries

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

Brand names in 20 more European countries
Belgium
Atarax
Bulgaria
Атаракс
Cyprus
Atarax
Czechia
Atarax
Denmark
Hydroxyzine Bluefish, Hydroxyzine Medical Valley, Hydroxyzine Orifarm, Hydroxyzinhydrochlorid Eql Pharma
Finland
Atarax, Hydroxyzine Orifarm
France
Atarax, Hydroxyzine Arrow, Hydroxyzine Biogaran, Hydroxyzine Bluefish, Hydroxyzine Cristers, Hydroxyzine Eg, Hydroxyzine Renaudin, Hydroxyzine Teva, Hydroxyzine Viatris, Hydroxyzine Zentiva
Greece
Atarax, Iremofar
Hungary
Atarax
Iceland
Atarax, Hydroxyzine Bluefish, Hydroxyzine Medical Valley
Ireland
Hydroxyzine Hydrochloride Brillpharma (Ireland)
Italy
Atarax
Luxembourg
Atarax
Netherlands
Hydroxyzine-2hcl
Norway
Atarax, Hydroxyzine Bluefish, Hydroxyzine Medical Valley, Hydroxyzine Orifarm
Poland
Atarax, Comfortin, Hydroxyzine Orion, Hydroxyzinum Adamed, Hydroxyzinum Aflofarm, Hydroxyzinum Amara, Hydroxyzinum Bluefish, Hydroxyzinum Espefa, Hydroxyzinum Hasco, Hydroxyzinum Polfarmex, Hydroxyzinum Pph, Hydroxyzinum Teva, Hydroxyzinum Vp
Portugal
Atarax, Fenartix, Hidroxizina Bluefish, Hidroxizina Farmoz, Hidroxizina Generis, Hidroxizina Ipca, Hidroxizina Pentafarma, Histexil
Slovakia
Atarax
Spain
Atarax, Hidroxizina Bluefish, Hidroxizina Qualigen, Hidroxizina Tarbis
Sweden
Atarax, Hydroxizin Omet Pharma, Hydroxyzine Bluefish, Hydroxyzine Eql Pharma, Hydroxyzine Medical Valley, Hydroxyzine Orifarm, Hydroxyzine Orion

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.

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. Hydroxyzine Pamoate (Teva Pharmaceuticals USA, Inc.) – Prescribing Information, 2022-10-01. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=06068fff-2e79-4721-bcc7-b0938aa20e7a
  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. Wikidata (CC0): ATC N05BB.

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.