pharmacopeia
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/api/v1/drug/oxazepam

Boxed 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.

2D structure
7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one
SMILES C1=CC=C(C=C1)C2=NC(C(=O)NC3=C2C=C(C=C3)Cl)O
InChIKey ADIMAYPTOBDMTL-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: GABA A Modulators.

GABA A

Indications

Sourced from openFDA
  • Oxazepam 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.

Contraindications

Sourced from openFDA
  • History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses.contraindicated

Dosage & administration

Sourced from openFDA

Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects. Oxazepam Usual Dose Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily This product is not indicated in pediatric patients under 6 years of age. Absolute dosage for pediatric patients 6 to 12 years of age is not established. Discontinuation or Dosage Reduction of Oxazepam To reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see WARNINGS : Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE : Dependence ] .

Warnings & precautions

Sourced from openFDA

Risks from Concomitant Use with Opioids: Concomitant use of benzodiazepines, including oxazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe oxazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of oxazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking oxazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when oxazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see PRECAUTIONS : Drug Interactions ]. Abuse, Misuse, and Addiction: The use of benzodiazepines, including oxazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.

Adverse reactions

Sourced from openFDA

The necessity for discontinuation of therapy due to undesirable effects has been rare. Transient mild drowsiness is commonly seen in the first few days of therapy. If it persists, the dosage should be reduced. In few instances, dizziness, vertigo, headache and rarely syncope have occurred either alone or together with drowsiness. Mild paradoxical reactions; i.e., excitement, stimulation of affect, have been reported in psychiatric patients; these reactions may be secondary to relief of anxiety and usually appear in the first two weeks of therapy. Other side effects occurring during oxazepam therapy include rare instances of minor diffuse skin rashes - morbilliform, urticarial, and maculopapular, nausea, lethargy, edema, slurred speech, tremor, and altered libido. Such side effects have been infrequent and are generally controlled with reduction of dosage. A case of an extensive fixed drug eruption also has been reported. Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable. Ataxia with oxazepam has been reported in rare instances and does not appear to be specifically related to dose or age.

Overdosage

Sourced from openFDA

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS , Abuse, Misuse, and Addiction ). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management.

Approval history

Sourced from openFDA
  • Aug 10, 1987ANDAANDA071026Tp Anda Holdings
  • Apr 14, 1988ANDAANDA072253Actavis Elizabeth
  • Mar 3, 2025ANDAANDA218261Leading

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
20,832 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Toxicity To Various Agents2,78213%
  2. 2Fall1,4907.2%
  3. 3Drug Abuse1,4737.1%
  4. 4Hypotension1,3766.6%
  5. 5Drug Interaction1,1625.6%
  6. 6Coma1,0645.1%
  7. 7Depressed Level Of Consciousness9404.5%
  8. 8Somnolence9284.5%
  9. 9Pain8934.3%
  10. 10Constipation8614.1%
  11. 11Cognitive Disorder8284.0%
  12. 12Death8183.9%
  13. 13Overdose8183.9%
  14. 14Sedation7713.7%
  15. 15Dyspnoea7573.6%

Literature

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Recent PubMed references pinned to Oxazepam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Oxazepam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Oxazepam. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • UGT2B15CPIC C/D (provisional)ClinPGx 3

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Oxazepam work?
Mechanism-of-action class: GABA A Modulators.
What is Oxazepam used for?
According to FDA labeling, Oxazepam carries indications including: Oxazepam 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Oxazepam?
Oxazepam is classified as Benzodiazepine derivatives, Benzodiazepine, GABA A Modulators, Increased Central Nervous System GABA Activity.
What are the contraindications for Oxazepam?
Oxazepam labeling lists contraindications including: History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses.. Always consult the full prescribing information and a clinician.
Note. Data for oxazepam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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