What the label lists and what reports show
Oxazepam side effects
Oxazepam's FDA label lists its adverse reactions in its own words. FAERS holds 21,381 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is toxicity to various agents (2,858 reports).
- 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 FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of oxazepam?Oxazepam may cause serious side effects, including: See “What is the most important information I should know about oxazepam?” Low blood pressure. Oxazepam can cause low blood pressure especially in elderly people. Oxazepam can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how oxazepam affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking oxazepam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, oxazepam may make your sleepiness or dizziness much worse. The most common side effects of oxazepam include: • drowsiness • dizziness • vertigo (sensation of loss of balance) • headache These are not all the possible side effects of oxazepam. […]
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
What does the label list?
From the label: adverse reactionsThe 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. …
Source: FDA drug label, 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?
21,381 reports list oxazepam among the medicines taken, 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. Of the 19 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Oxazepam: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions