What the label lists and what reports show
Lorazepam side effects
Lorazepam's FDA label lists its adverse reactions in its own words. FAERS holds 178,731 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 fatigue (13,819 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the lorazepam FDA label on DailyMed (effective July 9, 2025, Bausch Health US 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 ATIVAN?ATIVAN may cause serious side effects, including: • See “What is the most important information I should know about ATIVAN?” • ATIVAN can make you sleepy or dizzy and can slow your thinking and motor skills. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how ATIVAN affects you. o Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking ATIVAN without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, ATIVAN may make your sleepiness or dizziness much worse. • Depression. Pre-existing depression may emerge or worsen during use of benzodiazepines including ATIVAN. The most common side effects of ATIVAN include: • sedation • dizziness • weakness • unsteadiness These are not all the possible side effects of ATIVAN. […]
Source: FDA drug label, Bausch Health US LLC, effective July 9, 2025 (SPL set 89057c93-8155-4040-acec-64e877bd2b4c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses. In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to Ativan (lorazepam) was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age. Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye function/visual disturbance (including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreased orgasm; …
TABLE 1. NUMBER (%) OF STUDY EVENTS IN A DOSE COMPARISON CLINICAL TRIAL
This table is printed in the Lorazepam label published by Hikma Pharmaceuticals USA Inc. of April 10, 2024; the label quoted above does not print one.
| Body System Event | Lorazepam Injection (n=130) One hundred and thirty (130) patients received Lorazepam… |
|---|---|
| Any Study Event (1 or more) Totals are not necessarily the sum of the individual study… | 16 (12.3%) |
| Infection | 1 ( <1%) |
| Hypotension | 2 (1.5%) |
| Liver function tests abnormal | 1 ( <1%) |
| Nausea | 1 ( <1%) |
| Vomiting | 1 ( <1%) |
| Acidosis | 1 ( <1%) |
| Brain edema | 1 ( <1%) |
| Coma | 1 ( <1%) |
| Convulsion | 1 ( <1%) |
| Somnolence | 2 (1.5%) |
| Thinking abnormal | 1 ( <1%) |
| Hyperventilation | 1 ( <1%) |
| Hypoventilation | 1 ( <1%) |
| Respiratory failure | 2 (1.5%) |
| Injection site reaction | 1 ( <1%) |
| Cystitis | 1 ( <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, Bausch Health US LLC, effective July 9, 2025 (SPL set 89057c93-8155-4040-acec-64e877bd2b4c), via openFDA; the full label on DailyMed
What do FAERS reports show?
178,731 reports list lorazepam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 25,768 are coded as a death and 74,535 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, 8 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?
- Lorazepam: 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