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Serax Side Effects

Generic name: oxazepam

Medically reviewed by Drugs.com. Last updated on Nov 9, 2020.

Note: This document contains side effect information about oxazepam. Some of the dosage forms listed on this page may not apply to the brand name Serax.

For the Consumer

Applies to oxazepam: oral capsules

Warning

Special Alerts:

[Posted 09/23/2020]

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: The FDA is requiring the Boxed Warning, FDA's most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

RECOMMENDATION:

Health Care Professionals

  • Consider the patient's condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction, available at: [Web].

  • Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.

  • Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.

  • Take precautions when benzodiazepines are used in combination with opioid addiction medications, available at: [Web].

Patients, Parents, and Caregivers

  • Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.

  • Take benzodiazepines and all medicines exactly as prescribed by your health care professional

  • Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.

  • Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.

  • Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

For more information visit the FDA website at: [Web] and [Web].

Side effects include:

Drowsiness, dizziness, vertigo, headache.

For Healthcare Professionals

Applies to oxazepam: oral capsule, oral tablet

Nervous system

Rare (less than 0.1%): Slurred speech, tremor, ataxia

Frequency not reported: Drowsiness, amnesia, anterograde amnesia, reduced alertness, dizziness, light-headedness, vertigo, headache, syncope, dysarthria, changes in EEG pattern, stupor, memory impairment[Ref]

Other

Rare (less than 0.1%): Edema

Frequency not reported: Fever, fatigue[Ref]

Genitourinary

Rare (less than 0.1%): Altered libido

Frequency not reported: Incontinence, urinary retention, menstrual irregularities[Ref]

Hepatic

Rare (less than 0.1%): Jaundice, hepatic impairment

Frequency not reported: Increased liver enzymes[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia

Frequency not reported: Blood dyscrasias (including agranulocytosis)[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity[Ref]

Cardiovascular

Frequency not reported: Hypotension[Ref]

Dermatologic

Rare (less than 0.1%): Minor diffuse skin rashes (morbilliform, urticarial and maculopapular)[Ref]

Gastrointestinal

Rare (less than 0.1%):Nausea

Frequency not reported: Salivation changes, gastrointestinal disorders[Ref]

General

The most commonly reported side effects were drowsiness, headache, and fatigue.[Ref]

Musculoskeletal

Frequency not reported: Muscle weakness[Ref]

Ocular

Frequency not reported: Blurred vision, diplopia[Ref]

Psychiatric

Rare (less than 0.1%): Lethargy

Frequency not reported: Disorientation, nightmares, mild excitatory effects with stimulation of affect, numbed emotions, restlessness, agitation, irritability, delusions, rages, psychoses, inappropriate behavior, behavioral adverse effects (including paradoxical aggressive outbursts), excitement, hallucinations, uncovering of depression with suicidal tendencies, withdrawal symptoms (including persistent tinnitus, involuntary movements, paresthesia, perceptual changes, confusion, convulsions, muscle cramps, abdominal cramps, vomiting), aggression, euphoria[Ref]

References

1. "Product Information. Serax (oxazepam)." Wyeth-Ayerst Laboratories (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.