Prescription medicine
Oxazepam First approved as Serax
Oxazepam (Serax) is a prescription medicine with an FDA approval on record since 1965. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.725 per oxazepam 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the oxazepam FDA label on DailyMed (effective July 11, 2025, Leading Pharma, LLC); the NDA 15539 record on Drugs@FDA; every oxazepam label on DailyMed.
Highlights of the record
FDA label of July 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. […]
Used for
From the label: indications and usageOxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Forms and strengths
- 10 mg
- 15 mg
- 30 mg
Capsule; gelatin-coated capsule.
On the market
- Earliest approval on file
- June 4, 1965 Serax, Alpharma Us Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first January 16, 1987; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.725 per capsule Oxazepam 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 21,381 through July 30, 2026
What is oxazepam used for?
From the label: indications and usageOxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Anxiety associated with depression is also responsive to oxazepam therapy. This product has been found particularly useful in the management of anxiety, tension, agitation and irritability in older patients. Alcoholics with acute tremulousness, inebriation, or with anxiety associated with alcohol withdrawal are responsive to therapy. […]
Conditions named in the indications of oxazepam's FDA labels, with every medicine labeled for each:
From other oxazepam labelsAnxiety: INDICATIONS Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (OXAZEPAM), Leading Pharma, LLC, effective July 11, 2025 (SPL set 67f821fa-5663-4d69-82c9-5ee13a09f324), via openFDA; the full label on DailyMed
What does the patient leaflet for oxazepam say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about oxazepam?Oxazepam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation). Do not drive or operate heavy machinery until you know how taking oxazepam with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including oxazepam, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including oxazepam. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take oxazepam exactly as prescribed by your healthcare provider. Take oxazepam exactly as your healthcare provider prescribed. Do not share your oxazepam with other people. Keep oxazepam in a safe place and away from children. Physical dependence and withdrawal reactions. Oxazepam can cause physical dependence and withdrawal reactions, especially if you continue to take oxazepam for several days to several weeks. Do not suddenly stop taking oxazepam. […]
From the patient leaflet: How should I store oxazepam capsules?Store oxazepam capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep oxazepam capsules in a tightly closed container and out of the light. Keep oxazepam capsules and all medicines out of the reach of children.
Source: FDA drug label (Oxazepam), Actavis Pharma, Inc., effective August 1, 2023 (SPL set a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43), via openFDA; the full label on DailyMed
Is there a generic for oxazepam (Serax)?
The FDA approved the first generic oxazepam on January 16, 1987. 12 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists oxazepam from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1965 earliest approval on file
- 1987 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for oxazepam (Serax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.725 per Oxazepam 10 mg capsule, down 14% from $0.843 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Oxazepam 10 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Oxazepam 10 mg capsule | Generic | $0.725 per capsule | $21.74 | -14% |
| Oxazepam 15 mg capsule | Generic | $0.884 per capsule | $26.51 | -19% |
| Oxazepam 30 mg capsule | Generic | $1.35 per capsule | $40.48 | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the oxazepam label say about other medicines?
The oxazepam label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name oxazepam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of oxazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see DRUG ABUSE AND DEPENDENCE: |
Other labels that name oxazepam
Source: FDA drug label (OXAZEPAM), Leading Pharma, LLC, effective July 11, 2025 (SPL set 67f821fa-5663-4d69-82c9-5ee13a09f324), via openFDA; the full label on DailyMed
What do FAERS reports show for oxazepam?
The FDA Adverse Event Reporting System holds 21,381 reports that list oxazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,840 are coded as a death and 10,509 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as oxazepam?
11 other medicines are given the same way (oral) and in the same FDA class as oxazepam or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clonazepam | Anxiety | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Amitriptyline and chlordiazepoxide | Anxiety | 1 labeler | $1.20 per unit 5-12.5 | No current entry |
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxazepam compare with medicines for the same use?
5 side-by-side pages set oxazepam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxazepam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Oxazepam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other