Promethazine

ATC code D04AA10

Also known as: Promethazin, Prometazin · Brand names: Atosil, Closin, Promethazin Forte Neuraxpharm, Promethazin Neuraxpharm, Proneurin, Prothazin, Phenergan, Promethegan

Key facts
Active substance: Promethazine
ATC code: D04AA10
Authorisation: authorised nationally; no central EU authorisation
Information as of: 2026-10-29

Key facts

Promethazine is a phenothiazine antihistamine. Per the US prescribing information, it is used for allergies, motion sickness, nausea and vomiting, and for sedation.

What it is used for

Allergic and vasomotor rhinitis, allergic conjunctivitis, mild allergic skin manifestations (urticaria, angioedema), dermographism
Adjunct to epinephrine in anaphylaxis after acute manifestations are controlled; allergic reactions to blood or plasma
Prevention and control of nausea and vomiting with anesthesia and surgery; motion sickness
Preoperative, postoperative or obstetric sedation; adjunct to analgesics for postoperative pain

Dosing

Allergy: average 25 mg before retiring, or 6.25 to 12.5 mg three times daily
Motion sickness (adults): 25 mg twice daily, first dose one-half to one hour before travel; children 12.5 to 25 mg twice daily
Nausea and vomiting: 25 mg, then 12.5 to 25 mg every 4 to 6 hours as needed
Sedation: children 12.5 to 25 mg at bedtime, adults 25 to 50 mg
Contraindicated under 2 years of age; further pediatric doses: see the full text

Contraindications

Pediatric patients less than two years of age
Comatose states; hypersensitivity or idiosyncratic reaction to promethazine or other phenothiazines
Treatment of lower respiratory tract symptoms including asthma

Important warnings

Boxed warning: not for children under 2 years because of potentially fatal respiratory depression; lowest effective dose in children 2 years and older
CNS depression, amplified by alcohol, sedatives, narcotics and other CNS depressants; impaired ability to drive
Respiratory depression; avoid in compromised respiratory function (e.g. COPD, sleep apnea)
Lowered seizure threshold; bone-marrow depression (leukopenia, agranulocytosis)
Neuroleptic malignant syndrome

Side effects

Drowsiness is most prominent; also sedation, blurred vision, dizziness, confusion, extrapyramidal symptoms
Blood pressure changes, tachycardia, bradycardia; photosensitivity, urticaria
Dry mouth, nausea, vomiting, jaundice; blood dyscrasias
Paradoxical reactions with hyperexcitability and abnormal movements

Interactions

CNS depressants (alcohol, sedatives, narcotics, anesthetics, tricyclic antidepressants): increased depression, reduce doses
Do not use epinephrine to treat promethazine-associated hypotension
MAOIs: more extrapyramidal effects; anticholinergics: see the full text
May distort pregnancy tests and increase blood glucose

Pregnancy and breastfeeding

No adequate studies in pregnant women; may be used during labor
Not known whether excreted in human milk; discontinue nursing or the drug

Summary of the official product information, written with AI on 2026-10-29. 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.

Germany

AtosilDesitin Arzneimittel Gmbh · 2 register entries
ClosinHolsten Pharma Gmbh · 1 register entry
Promethazin Forte NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
Promethazin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 2 register entries
ProneurinHexal Ag · 1 register entry
ProthazinTeofarma S.R.L. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

USA

PhenerganHikma Pharmaceuticals USA Inc. · 2 register entries
PrometheganCosette Pharmaceuticals, Inc. · 3 register entries

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 18 more European countries

Bulgaria: Aнтиалeрзин
Cyprus: Promethazine Remedica
Czechia: Prothazin
Denmark: Phenergan, Prometazin Actavis, Prometazin Orifarm
France: Phenergan
Greece: Fenimezyl, Prugal-Derm, Titanox
Hungary: Pipolphen
Iceland: Phenergan, Prometazin Actavis
Ireland: Phenergan
Italy: Alontan Antistaminico, Fadezin, Farganesse, Fenazil, Lenil Antiprurito, Mistick Antistaminico, Novaphergan, Prometazina Day Zero, Reactifargan
Malta: Fenazil, Promethazine Remedica
Netherlands: Promethazine Ace, Promethazine Cf, Promethazine Teva
Norway: Phenergan
Poland: Diphergan, Polfergan
Portugal: Prometazina Basi, Prometazina Medlink
Slovakia: Prothazin
Spain: Fenergan
Sweden: Farghess, Lergigan, Prometazin Actavis

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

U.S. Food and Drug Administration. Promethazine Hydrochloride (BluePoint Laboratories) – Prescribing Information, 2025-09-12. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=44cd6d46-fbb9-4836-9426-d8ce2cb6d66d
EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.