What the label lists and what reports show
Flurazepam side effects
Flurazepam's FDA label lists its adverse reactions in its own words. FAERS holds 395 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 drug abuse (65 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the flurazepam FDA label on DailyMed (effective October 28, 2024, Chartwell RX, 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 flurazepam hydrochloride capsules?Flurazepam hydrochloride capsules may cause serious side effects, including: See “What is the most important information I should know about flurazepam hydrochloride capsules?” 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 flurazepam hydrochloride capsules. Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts. […]
Source: FDA drug label, Chartwell RX, LLC, effective October 28, 2024 (SPL set 8f476891-1346-4e8c-ac1b-f8cbdc64f5a1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe 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 )] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions ( 5.6 )] 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 )] Adverse reactions: dizziness, drowsiness, light-headedness, staggering, ataxia, falling. …
Source: FDA drug label, Chartwell RX, LLC, effective October 28, 2024 (SPL set 8f476891-1346-4e8c-ac1b-f8cbdc64f5a1), via openFDA; the full label on DailyMed
What do FAERS reports show?
395 reports list flurazepam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 43 are coded as a death and 205 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 20 reactions below, 5 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?
- Flurazepam: 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