Prescription medication · Benzodiazepine
alprazolam
Also sold as Xanax. Alprazolam is used to treat generalized anxiety disorder (GAD) and panic disorder (PD) in adults.
Data updated 2026-05-15
- 200,719
- FDA reportsHeavily reported
- 27
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 3
- Recall records
What the data shows
alprazolam (Xanax) is a prescription Benzodiazepine, in the top 5% of tracked drugs by FAERS report volume (200,719 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
alprazolam (Xanax) is a prescription Benzodiazepine. Alprazolam is used to treat generalized anxiety disorder (GAD) and panic disorder (PD) in adults.
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders. It belongs to a class of drugs called benzodiazepines, which work by slowing down activity in the brain.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$5.23/unit
Generic Price
$0.02/unit
Generic Savings
99%
Generic Available
Yes (12 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Alprazolam is used to treat generalized anxiety disorder (GAD) and panic disorder (PD) in adults.
Common side effects
Drowsiness, Light-headedness, Dry mouth
Key warnings
Alprazolam can be habit-forming, leading to abuse, misuse, and addiction, which can result in overdose or death.
The sections below are summarized in plain English from alprazolam's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Alprazolam works by affecting certain chemicals in your brain called neurotransmitters. It enhances the effects of a neurotransmitter called GABA, which helps to calm your nerves. This can reduce feelings of anxiety and panic.
How to Take It
For anxiety, the usual starting dose is 0.25 mg to 0.5 mg three times a day. Your doctor may increase the dose every 3 to 4 days, up to a maximum of 4 mg per day. For panic disorder, the starting dose is 0.5 mg three times a day, and your doctor may increase it every 3 to 4 days by no more than 1 mg per day. Always use the lowest dose that works for you, and talk to your doctor about how long you need to take it.
This is a plain-language summary of alprazolam's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Taking alprazolam late in pregnancy can cause sedation or withdrawal symptoms in the newborn. Breastfeeding is not recommended while taking alprazolam because it can cause sedation and feeding problems in the baby.
This is a plain-language summary of alprazolam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of alprazolam's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store alprazolam at room temperature, away from moisture and heat.
Side Effects (from patient reports)
Based on 200,719 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for alprazolam, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
12,854 reports
- Feeling tired
Feeling tired
11,935 reports
- Misusing the drug
Misusing the drug
10,943 reports
- Feeling worried or nervous
Feeling worried or nervous
10,169 reports
- Pain in your head
Pain in your head
9,923 reports
- Discomfort
Discomfort
9,815 reports
- Harmful effect from a substance
Harmful effect from a substance
8,865 reports
- Loose stools
Loose stools
8,786 reports
- Difficulty breathing
Difficulty breathing
8,253 reports
- Feeling unsteady
Feeling unsteady
7,864 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for alprazolam each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where alprazolam sits
alprazolam has more FDA adverse-event reports than 95% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is alprazolam; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 200,719 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
200,719
Reports Mentioning Death
32,899
16.4% of reports — not proof of cause
Hospitalization Reports
64,280
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | NAUSEA | 12,856 |
| 3 | FATIGUE | 11,933 |
| 4 | DRUG ABUSE | 10,943 |
| 5 | ANXIETY | 10,174 |
| 6 | HEADACHE | 9,926 |
| 7 | PAIN | 9,818 |
| 8 | TOXICITY TO VARIOUS AGENTS | 8,863 |
| 9 | DIARRHOEA | 8,787 |
| 10 | DYSPNOEA | 8,255 |
| 11 | DIZZINESS | 7,861 |
| 12 | COMPLETED SUICIDE | 7,524 |
| 13 | DEPRESSION | 7,225 |
| 14 | INSOMNIA | 7,179 |
| 15 | VOMITING | 7,134 |
| 17 | FALL | 6,923 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Alprazolam can be habit-forming, leading to abuse, misuse, and addiction, which can result in overdose or death. Taking alprazolam with opioid pain medicines can cause severe sleepiness, breathing problems, coma, and death. Suddenly stopping alprazolam can cause life-threatening withdrawal symptoms. Talk to your doctor about how to safely stop taking it.
Known Drug Interactions
Examples Ketoconazole, itraconazole, clarithromycin Moderate or Weak Inhibitors of CYP3A Clinical implication Concomitant use of alprazolam with CYP3A inhibitors may increase the concentrations of alprazolam, resulting in increased risk of adverse reactions of alprazolam [see Clinical Pharmacology (12.3) ].
Mechanism: Ketoconazole stops the body from breaking down alprazolam normally, which can increase the risk of side effects.
What to do: Your doctor may need to adjust your dose or monitor you more closely for signs of extra sleepiness.
Examples Ketoconazole, itraconazole, clarithromycin Moderate or Weak Inhibitors of CYP3A Clinical implication Concomitant use of alprazolam with CYP3A inhibitors may increase the concentrations of alprazolam, resulting in increased risk of adverse reactions of alprazolam [see Clinical Pharmacology (12.3) ].
Mechanism: Clarithromycin interferes with the liver's ability to clear alprazolam, which may make the alprazolam stay in your system longer.
What to do: Watch for increased side effects and check with your doctor to see if your alprazolam dose needs to be changed.
Examples Ketoconazole, itraconazole, clarithromycin Moderate or Weak Inhibitors of CYP3A Clinical implication Concomitant use of alprazolam with CYP3A inhibitors may increase the concentrations of alprazolam, resulting in increased risk of adverse reactions of alprazolam [see Clinical Pharmacology (12.3) ].
Mechanism: Itraconazole slows the breakdown of alprazolam in the body, which can increase the amount of medicine in your blood.
What to do: Use these medications together with caution and notify your doctor if you feel overly tired or dizzy.
( 7.1 ) Use with Digoxin: Increase the risk of digoxin toxicity. Digoxin Clinical implication Increased digoxin concentrations have been reported when alprazolam was given, especially in geriatric patients (>65 years of age). Prevention or management In patients on digoxin therapy, measure serum digoxin concentrations before initiating alprazolam.
Mechanism: Alprazolam can cause digoxin levels to build up in the body, which can lead to dangerous side effects. This happens more often in patients over the age of 65.
What to do: Your doctor should check your digoxin blood levels before you start taking alprazolam.
Benzodiazepines Clinical Impact Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )]. Benzodiazepines Clinical Impact Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )].
Mechanism: Aprepitant slows down how fast your body processes alprazolam, which causes the drug to build up in your blood. This can make you feel much more sleepy or dizzy than usual.
What to do: Your doctor may need to lower your dose of alprazolam. Watch closely for increased side effects like extreme drowsiness.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drink alcohol while taking alprazolam?
Can I drive while taking alprazolam?
What should I do if I feel like alprazolam is not working anymore?
Can I take alprazolam with other medications?
How long does alprazolam stay in my system?
Is it safe to stop alprazolam suddenly?
What are the symptoms of alprazolam withdrawal?
Can alprazolam cause depression?
Is alprazolam addictive?
What should I do if I overdose on alprazolam?
What are the common side effects of alprazolam?
Does alprazolam interact with other medications?
What drug class is alprazolam?
Is there a generic version of alprazolam?
Is alprazolam safe during pregnancy?
Has alprazolam been recalled?
Active Recalls
Failed Dissolution Specifications
Viatris, Inc.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Direct Rx
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Direct Rx
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for alprazolam
The FDA label for alprazolam (sold under brand names such as Xanax) classifies it as a prescription-only medication in the Benzodiazepine class. Alprazolam is used to treat generalized anxiety disorder (GAD) and panic disorder (PD) in adults. Official labeling lists 3 commonly reported side effects, including Drowsiness, Light-headedness, Dry mouth.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 200,719 voluntary reports. The database also lists 27 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.02 versus $5.23 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 3, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages