Benzodiazepine · Brand: Xanax, Alprazolam Extended Release + 2 more

Alprazolam Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Anxiety

Quick answer

Based on 202,000+ FDA adverse event reports, the most-reported alprazolam reactions include nausea, fatigue, and anxiety. FDA reports 1 active Class II recall of alprazolam, primarily for failed dissolution specifications. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

FDA Boxed Warning

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) , Drug Interactions (7.1) ] . The use of benzodiazepines, including alprazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing alprazolam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ] . The continued use of benzodiazepines, including alprazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. ( 5.1 , 7.1 ) The use of benzodiazepines, including alprazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing alprazolam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. ( 5.2 ) Abrupt discontinuation or rapid dosage reduction of alprazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam or reduce the dosage. ( 2.2 , 5.3 )

Common Side Effects of Alprazolam

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for alprazolam. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Nausea	12,982	6.4%
Fatigue	12,059	5.9%
Anxiety	10,245	5.1%
Headache	10,013	4.9%
Pain	9,894	4.9%
Diarrhoea	8,897	4.4%
Toxicity To Various Agents	8,977	4.4%
Dyspnoea	8,339	4.1%
Dizziness	7,937	3.9%
Completed Suicide	7,631	3.8%

Source: FDA FAERS·Updated May 28, 2026·n=202,863+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—
Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established.	6,952	3.4%

From the FDA-approved label, Section 5.1: Risks from Concomitant Use with Opioids

Concomitant use of benzodiazepines, including alprazolam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
Show full Section 5.1See less
If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of alprazolam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking alprazolam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions (7.1) ] .

From the FDA-approved label, Section 5.4: Effects on Driving and Operating Machinery Because of its

CNS depressant effects, patients receiving alprazolam should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the concomitant use of alcohol and other CNS depressant drugs during treatment with alprazolam [see Drug Interactions (7.1) ] .

Source: DailyMed (alprazolam label)·Updated May 28, 2026

Alprazolam Recalls

FDA enforcement actions matched to alprazolam via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2026-04-15	Failed Dissolution Specifications Viatris, Inc.	Class II	—	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 7 closed recalls (2013 to 2022)

Includes resolved and terminated recalls matched to alprazolam. Most recent first.

Date	Reason	Class	Quantity	Status
2022-05-11	Failed Dissolution Specifications: low out-of-specification dissolution test results observed. Viatris Inc	Class II	6,789 bottles	Terminated
2015-11-04	Subpotent Drug Pfizer Inc.	Class II	21,120 HDPE bottles	Terminated
2014-12-31	Subpotent Drug Neolpharma, Inc.	Class II	12,310 bottles	Terminated
2014-08-06	Presence of Foreign Substance; tablets may contain stainless steel metal particulates Sandoz Incorporated	Class II	1,332 bottles	Terminated
2014-03-19	Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. Actavis Elizabeth LLC	Class II	9447 Bottles	Terminated
2014-03-12	Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Actavis Elizabeth LLC	Class II	5,148 bottles	Terminated
2013-12-04	Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets Actavis Elizabeth LLC	Class II	756 bottles	Terminated

Alprazolam Shortages

FDA-listed shortages of alprazolam products. Strength and dosage-form level detail.

No active or recent shortages of alprazolam are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Alprazolam Safe?

Alprazolam is FDA-approved. The label's Warnings and Precautions section covers risks from concomitant use with opioids (Section 5.1), abuse, misuse, and (Section 5.2), dependence and withdrawal (Section 5.3), effects on driving and operating machinery because of its (Section 5.4), interaction with drugs that inhibit metabolism via cytochrome (Section 5.5), patients with depression (Section 5.6), mania (Section 5.7), neonatal sedation and withdrawal syndrome (Section 5.8), risk in patients with impaired respiratory function (Section 5.9).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (alprazolam label)·Updated May 28, 2026

FDA-Approved Indications

Alprazolam is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Anxiety

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 )

Source: DailyMed (alprazolam label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of alprazolam?

Nausea, fatigue, and anxiety are among the most-reported reactions in FDA FAERS data for alprazolam. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is alprazolam the same as Xanax?

Alprazolam is the generic name; Xanax is a brand name for the same active ingredient. Other brand names include Alprazolam Extended Release, Xanax Xr, and Alprazolam Xr. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has alprazolam been recalled?

Yes. Alprazolam has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by failed dissolution specifications, subpotent or out-of-spec content, and contamination or foreign material. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are alprazolam's current ongoing recalls about?

Active alprazolam recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is failed dissolution specifications. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Does alprazolam have an FDA boxed warning?

Yes. The FDA-approved label for alprazolam carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.