82/100 · Critical
Manufactured by Hikma Pharmaceuticals USA Inc.
Lorazepam Adverse Events: High Seriousness and Diverse Reactions
415,572 FDA adverse event reports analyzed
Last updated: 2026-05-12
LORAZEPAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hikma Pharmaceuticals USA Inc.. Based on analysis of 415,572 FDA adverse event reports, LORAZEPAM has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for LORAZEPAM include FATIGUE, NAUSEA, DRUG INEFFECTIVE, DIARRHOEA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LORAZEPAM.
Lorazepam has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 415,572 adverse event reports for this medication, which is primarily manufactured by Hikma Pharmaceuticals Usa Inc..
The most commonly reported adverse events include Fatigue, Nausea, Drug Ineffective. Of classified reports, 76.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Lorazepam reports show a high percentage of serious adverse events (76.9%).
The most common reactions include fatigue, nausea, and drug ineffectiveness. A wide range of reactions are reported, indicating diverse safety concerns.
Patients taking Lorazepam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Lorazepam can interact with other drugs, leading to increased risk of adverse effects. Overdose is a significant concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Lorazepam received a safety concern score of 82/100 (high concern). This is based on a 76.9% serious event ratio across 174,434 classified reports. The score accounts for 415,572 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 104,735, Male: 58,051, Unknown: 287. The most frequently reported age groups are age 61 (2,895 reports), age 59 (2,800 reports), age 64 (2,710 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 174,434 classified reports for LORAZEPAM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Lorazepam can interact with other drugs, leading to increased risk of adverse effects. Overdose is a significant concern.
If you are taking Lorazepam, here are important things to know. The most commonly reported side effects include fatigue, nausea, drug ineffective, diarrhoea, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or stopping lorazepam to avoid potential interactions. Monitor for signs of serious adverse events, especially in elderly patients. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulators have issued warnings about the serious nature of adverse events, particularly in elderly patients.
The FDA has received approximately 415,572 adverse event reports associated with Lorazepam. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Lorazepam include Fatigue, Nausea, Drug Ineffective, Diarrhoea, Off Label Use. By volume, the top reported reactions are: Fatigue (13,459 reports), Nausea (13,332 reports), Drug Ineffective (12,123 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Lorazepam.
Out of 174,434 classified reports, 134,128 (76.9%) were classified as serious and 40,306 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Lorazepam break down by patient sex as follows: Female: 104,735, Male: 58,051, Unknown: 287. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Lorazepam adverse events are: age 61: 2,895 reports, age 59: 2,800 reports, age 64: 2,710 reports, age 65: 2,671 reports, age 60: 2,620 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Lorazepam adverse event reports is Hikma Pharmaceuticals Usa Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Lorazepam include: Dyspnoea, Anxiety, Headache, Pain, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Lorazepam to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Lorazepam has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Lorazepam reports show a high percentage of serious adverse events (76.9%).
Key safety signals identified in Lorazepam's adverse event data include: Death and pneumonia are among the most serious reported outcomes.. Drug interactions and overdose are significant safety signals.. Severe reactions like delirium and acute kidney injury are also reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Lorazepam can interact with other drugs, leading to increased risk of adverse effects. Overdose is a significant concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Lorazepam.
Consult healthcare providers before starting or stopping lorazepam to avoid potential interactions. Monitor for signs of serious adverse events, especially in elderly patients.
Lorazepam has 415,572 adverse event reports on file with the FDA. The most common reactions include fatigue, nausea, and drug ineffectiveness. The volume of reports for Lorazepam reflects both the drug's usage level and the vigilance of the reporting community.
Regulators have issued warnings about the serious nature of adverse events, particularly in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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