Oxazepam
Anxiolit Forte, Praxiten · ATC code N05BA04
Also known as: Oksazepam · Brand names: Anxiolit Forte, Praxiten, Adumbran, Durazepam Forte, Oxa-Ct, Oxazepam Ratiopharm
- Key facts
- Active substance
- Oxazepam
- Drug class
- Benzodiazepine drug
- ATC code
- N05BA04
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
- Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
- Limit dosages and durations to the minimum required.
- Follow patients for signs and symptoms of respiratory depression and sedation [see WARNINGS and PRECAUTIONS].
- The use of benzodiazepines, including oxazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing oxazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see WARNINGS].
- The continued use of benzodiazepines, including oxazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of oxazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage [see DOSAGE AND ADMINISTRATION and WARNINGS].
Key facts
Oxazepam is a benzodiazepine. Per the US prescribing information, the capsules are used for anxiety disorders, short-term relief of anxiety symptoms and anxiety associated with alcohol withdrawal.
What it is used for
- Anxiety disorders and short-term relief of anxiety symptoms, including anxiety associated with depression
- Anxiety, tension, agitation and irritability in older patients
- Acute tremulousness, inebriation or anxiety in alcohol withdrawal
- Effectiveness for more than 4 months has not been assessed
Dosing
- Mild to moderate anxiety: 10 to 15 mg, 3 or 4 times daily
- Severe anxiety, agitation or anxiety with depression: 15 to 30 mg, 3 or 4 times daily
- Older patients: initially 10 mg 3 times daily, cautiously increased to 15 mg 3 or 4 times daily if necessary
- Alcohol withdrawal: 15 to 30 mg, 3 or 4 times daily
- Not indicated under 6 years; stop or reduce by gradual taper; lower initial dose in patients already on opioids
Contraindications
- Previous hypersensitivity to oxazepam
- Not indicated in psychoses
Important warnings
- Boxed warning: concomitant use with opioids may cause profound sedation, respiratory depression, coma and death
- Boxed warning: risks of abuse, misuse and addiction, which can lead to overdose or death
- Boxed warning: physical dependence; abrupt discontinuation or rapid dose reduction may cause life-threatening withdrawal reactions
- Neonatal sedation and withdrawal syndrome after use late in pregnancy
- Caution where a drop in blood pressure could cause cardiac complications
Side effects
- Transient mild drowsiness in the first few days
- Dizziness, vertigo, headache, rarely syncope; mild paradoxical reactions
- Rarely: skin rash, nausea, lethargy, edema, slurred speech, tremor, altered libido, ataxia
- Rare: leukopenia and hepatic dysfunction including jaundice; periodic blood counts and liver tests are advisable
Interactions
- Opioids: risk of severe sedation and respiratory depression
- Alcohol and other CNS depressants: additive effects – dose adjustment or avoidance may be required
Pregnancy and breastfeeding
- Use late in pregnancy may cause sedation and withdrawal symptoms in the newborn
- Breastfed infants should be monitored for excessive sedation and poor feeding
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.
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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
- Anxiolit ForteG.L. Pharma Gmbh · 1 register entry
- PraxitenViatris Austria Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- AdumbranTeofarma S.R.L. · 1 register entry
- Durazepam ForteViatris Germany Gmbh · 1 register entry
- Oxa-CtAbz-Pharma Gmbh · 1 register entry
- Oxazepam RatiopharmRatiopharm Gmbh · 1 register entry
- PraxitenTeofarma S.R.L. · 2 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Brand names in 18 more European countries
- Belgium
- Oxazepam Eg
- Croatia
- Oksazepam Belupo, Praxiten
- Czechia
- Oxazepam Léčiva
- Denmark
- Oxabenz, Oxazepam Alternova, Oxazepam Gxmed
- Finland
- Opamox, Oxamin
- France
- Oxazepam Arrow, Oxazepam Biogaran, Oxazepam Substipharm, Oxazepam Viatris, Pibaxalam, Seresta
- Iceland
- Sobril
- Italy
- Serpax
- Latvia
- Nozepam, Tazepam
- Lithuania
- Nozepam, Tazepam
- Luxembourg
- Oxazepam Eg
- Netherlands
- Oxazepam Accord, Oxazepam Auro, Oxazepam Aurobindo, Oxazepam Cf, Oxazepam Ria, Oxazepam Teva
- Norway
- Delipam, Sobril
- Poland
- Oksazepam Tzf, Oxazepam Espefa, Oxazepam Gsk
- Portugal
- Serenal
- Slovakia
- Oxazepam Léčiva
- Slovenia
- Oksazepam Belupo
- Sweden
- Delipam, Oxascand
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.
Other substances in the same group
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. OXAZEPAM (Leading Pharma, LLC) – Prescribing Information, 2025-07-11. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=67f821fa-5663-4d69-82c9-5ee13a09f324
- 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
- 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
- Wikidata (CC0): ATC N05BA.
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.