What the label lists and what reports show
Quazepam side effects
Quazepam's FDA label: “Most common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Atland Pharmaceuticals at 1-844-416-4284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.” FAERS holds 300 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 suicide attempt (27 reports).
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the quazepam FDA label on DailyMed (effective October 23, 2025, Atland Pharmaceuticals, 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 Quazepam Tablets?Quazepam Tablets may cause serious side effects, including: See “What is the most important information I should know about Quazepam Tablets?” Other conditions. Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem. Severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing. Other symptoms may include nausea and vomiting. Get emergency medical help right away if you have these symptoms after taking Quazepam Tablets. Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts. Quazepam Tablets can make you sleepy or dizzy and can slow your thinking and motor skills. […]
Source: FDA drug label, NDA018708 (Galt Pharms), as published by Atland Pharmaceuticals, LLC, effective October 23, 2025 (SPL set f7d63f3f-5303-48ab-bce2-35fd62c45799), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Atland Pharmaceuticals at 1-844-416-4284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the label: Risks from Concomitant Use with Opioids [see Warnings and Precautions ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.4 )] Abnormal thinking and behavior changes, and complex behaviors [see Warnings and Precautions ( 5.7 )] Worsening of depression [see Warnings and Precautions ( 5.8 )] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>1%): drowsiness, headache, fatigue, dizziness, dry mouth, dyspepsia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Atland Pharmaceuticals at 1-844-416-4284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The table shows adverse reactions occurring at an incidence of 1% or greater in relatively short-duration, placebo-controlled clinical trials of Quazepam Tablets.
Source: FDA drug label, NDA018708 (Galt Pharms), as published by Atland Pharmaceuticals, LLC, effective October 23, 2025 (SPL set f7d63f3f-5303-48ab-bce2-35fd62c45799), via openFDA; the full label on DailyMed
What do FAERS reports show?
300 reports list quazepam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 136 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 21 reactions below, 3 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.
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?
- Quazepam: 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