Xanax XRalprazolam
According to the FDA label: Alprazolam tablets are indicated for the: acute treatment of generalized anxiety disorder (GAD) in adults. treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam is a benzodiazepine indicated for the: Acute treatment of generalized anxiety disorder in adults. ( 1 ) Treatment of panic disorder with or without agoraphobia in adults. ( 1 )
202,801 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Xanax XR in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 13,505 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Nausea 12,980 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 12,053 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Abuse 11,053 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Anxiety 10,246 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Headache 10,008 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pain 9,892 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Toxicity to Various Agents 8,976 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Diarrhoea 8,897 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Dyspnoea 8,340 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Dizziness 7,937 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Completed Suicide 7,631 reports
A report that a person died by suicide. This is recorded in adverse event data when it occurs during medication use, and its presence does not establish that the drug was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Depression 7,271 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Insomnia 7,223 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Vomiting 7,213 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 129,301 |
| Male | 61,730 |
| Unknown | 666 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 2,712 |
| 18-34 | 19,975 |
| 35-49 | 30,392 |
| 50-64 | 43,066 |
| 65-74 | 23,950 |
| 75+ | 19,073 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Xanax XR. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 82,041 |
| Hospitalization | 64,964 |
| Non-Serious | 59,366 |
| Death | 33,233 |
| Life-Threatening | 8,123 |
| Disability | 4,988 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Xanax XR. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 4 |
| 2004 | 3,044 |
| 2005 | 3,604 |
| 2006 | 3,461 |
| 2007 | 3,263 |
| 2008 | 4,049 |
| 2009 | 4,919 |
| 2010 | 7,820 |
| 2011 | 7,880 |
| 2012 | 9,790 |
| 2013 | 9,602 |
| 2014 | 10,364 |
| 2015 | 14,127 |
| 2016 | 14,595 |
| 2017 | 13,476 |
| 2018 | 14,881 |
| 2019 | 15,447 |
| 2020 | 14,600 |
| 2021 | 10,509 |
| 2022 | 9,666 |
| 2023 | 8,853 |
| 2024 | 8,537 |
| 2025 | 8,346 |
| 2026 (partial) | 1,961 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Xanax XR
In FDA adverse event reports that mention Xanax XR, these medications appeared most often in the same report.
- Gabapentin (21,056 reports)
- Omeprazole (20,901 reports)
- Aspirin (18,780 reports)
- Ergocalciferol (18,676 reports)
- Furosemide (18,127 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026