What the label lists and what reports show
Estazolam side effects
Estazolam's FDA label lists its adverse reactions in its own words. FAERS holds 1,940 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 pneumonia (87 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the estazolam FDA label on DailyMed (effective November 11, 2022, Novitium 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 estazolam?Estazolam may cause serious side effects, including: See "What is the most important information I should know about estazolam?” 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. Get emergency medical help right away if you have these symptoms after taking estazolam. Abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts. Estazolam 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 estazolam affects you. […]
Source: FDA drug label, Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsCommonly Observed The most commonly observed adverse events associated with the use of estazolam, not seen at an equivalent incidence among placebo-treated patients were somnolence, hypokinesia, dizziness, and abnormal coordination. Associated with Discontinuation of Treatment Approximately 3% of 1277 patients who received estazolam in U.S. premarketing clinical trials discontinued treatment because of an adverse clinical event. The only event commonly associated with discontinuation, accounting for 1.3% of the total, was somnolence. Incidence in Controlled Clinical Trials The table below enumerates adverse events that occurred at an incidence of 1% or greater among patients with insomnia who received estazolam in 7-night, placebo-controlled trials. Events reported by investigators were classified into standard dictionary (COSTART) terms to establish event frequencies. …
INCIDENCE OF ADVERSE EXPERIENCES IN PLACEBO-CONTROLLED CLINICAL TRIALS (Percentage of Patients Reporting)
This table is printed in the Estazolam label published by Dr. Reddy's Labratories Inc. of February 5, 2024; the label quoted above does not print one.
| Reaction | Estazolam (N = 685) | Placebo (N = 433) |
|---|---|---|
| Headache | 16 | 27 |
| Asthenia | 11 | 8 |
| Malaise | 5 | 5 |
| Lower extremity pain | 3 | 2 |
| Back pain | 2 | 2 |
| Body pain | 2 | 2 |
| Abdominal pain | 1 | 2 |
| Chest pain | 1 | 1 |
| Nausea | 4 | 5 |
| Dyspepsia | 2 | 2 |
| Stiffness | 1 | - |
| Somnolence | 42 | 27 |
| Hypokinesia | 8 | 4 |
| Nervousness | 8 | 11 |
| Dizziness | 7 | 3 |
| Coordination abnormal | 4 | 1 |
| Hangover | 3 | 2 |
| Confusion | 2 | - |
| Depression | 2 | 3 |
| Dream abnormal | 2 | 2 |
| Thinking abnormal | 2 | 1 |
| Cold symptoms | 3 | 5 |
| Pharyngitis | 1 | 2 |
| Pruritus | 1 | - |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Novitium Pharma LLC, effective November 11, 2022 (SPL set e1c77eb1-9cba-4e89-a03f-9fb797add4f0), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,940 reports list estazolam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 305 are coded as a death and 1,042 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 18 reactions below, 9 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?
- Estazolam: 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