85/100 · Critical
Manufactured by Viatris Specialty LLC
Alprazolam Adverse Events: High Seriousness and Diverse Reactions
413,410 FDA adverse event reports analyzed
Last updated: 2026-05-12
ALPRAZOLAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. Based on analysis of 413,410 FDA adverse event reports, ALPRAZOLAM has a safety score of 85 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 ALPRAZOLAM include DRUG INEFFECTIVE, NAUSEA, FATIGUE, DRUG ABUSE, ANXIETY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALPRAZOLAM.
Alprazolam has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 413,410 adverse event reports for this medication, which is primarily manufactured by Viatris Specialty Llc.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 70.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Alprazolam reports include a high percentage of serious adverse events, particularly related to respiratory issues and suicidal behavior.
The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. Overdose and drug abuse are significant concerns, with a high number of reports related to these issues.
Patients taking Alprazolam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Alprazolam can cause severe respiratory depression and should be used with caution in patients with respiratory conditions. It also has a high risk of drug abuse and overdose, necessitating strict monitoring and patient education. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Alprazolam received a safety concern score of 85/100 (high concern). This is based on a 70.7% serious event ratio across 200,668 classified reports. The score accounts for 413,410 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: 128,112, Male: 61,107, Unknown: 667. The most frequently reported age groups are age 58 (3,135 reports), age 53 (3,030 reports), age 55 (3,006 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 200,668 classified reports for ALPRAZOLAM:
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.
Alprazolam can cause severe respiratory depression and should be used with caution in patients with respiratory conditions. It also has a high risk of drug abuse and overdose, necessitating strict monitoring and patient education.
If you are taking Alprazolam, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, drug abuse, anxiety. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of respiratory distress, especially in elderly or those with pre-existing respiratory conditions. Strictly adhere to prescribed dosages and avoid self-adjustment of the medication. 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.
The FDA continues to monitor alprazolam for safety, and healthcare providers are advised to follow strict guidelines for prescribing and monitoring patients on this medication.
The FDA has received approximately 413,410 adverse event reports associated with Alprazolam. 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 Alprazolam include Drug Ineffective, Nausea, Fatigue, Drug Abuse, Anxiety. By volume, the top reported reactions are: Drug Ineffective (13,400 reports), Nausea (12,850 reports), Fatigue (11,934 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Alprazolam.
Out of 200,668 classified reports, 141,845 (70.7%) were classified as serious and 58,823 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 Alprazolam break down by patient sex as follows: Female: 128,112, Male: 61,107, Unknown: 667. 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 Alprazolam adverse events are: age 58: 3,135 reports, age 53: 3,030 reports, age 55: 3,006 reports, age 59: 2,999 reports, age 60: 2,950 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 Alprazolam adverse event reports is Viatris Specialty Llc. 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 Alprazolam include: Headache, Pain, Toxicity To Various Agents, Diarrhoea, Dyspnoea. 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 Alprazolam 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.
Alprazolam has a safety concern score of 85 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. Alprazolam reports include a high percentage of serious adverse events, particularly related to respiratory issues and suicidal behavior.
Key safety signals identified in Alprazolam's adverse event data include: High percentage of serious adverse events (70.7%). Multiple reports of respiratory arrest and cardiac arrest. Significant number of suicide-related events (completed suicide, suicide attempt, suicidal ideation). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Alprazolam can cause severe respiratory depression and should be used with caution in patients with respiratory conditions. It also has a high risk of drug abuse and overdose, necessitating strict monitoring and patient education. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Alprazolam.
Patients should be closely monitored for signs of respiratory distress, especially in elderly or those with pre-existing respiratory conditions. Strictly adhere to prescribed dosages and avoid self-adjustment of the medication.
Alprazolam has 413,410 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Alprazolam reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor alprazolam for safety, and healthcare providers are advised to follow strict guidelines for prescribing and monitoring patients on this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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