Prescription medicine
Alprazolam Brand names: Xanax
Alprazolam (Xanax) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $0.0236 per alprazolam 0.25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the alprazolam FDA label on DailyMed (effective January 18, 2023, PHARMACIA & UPJOHN COMPANY LLC); the NDA 18276 record on Drugs@FDA; every alprazolam label on DailyMed.
Highlights of the record
FDA label of January 18, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 XANAX, 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 XANAX 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 XANAX, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. […]
Used for
From the label: indications and usageXANAX is indicated for the:
acute treatment of generalized anxiety disorder (GAD) in adults.
Forms and strengths
- 0.25 mg
- 0.5 mg
- 1 mg
- 2 mg
- 3 mg
- 1 mg/ml
Tablet; extended-release tablet; orally disintegrating tablet; solution (concentrate).
On the market
- Earliest approval on file
- October 16, 1981 Xanax, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 36 first October 19, 1993; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 33 of which 30 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0236 per tablet Alprazolam 0.25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 23 since 2013 0 Class I among all firms' recalls; latest March 17, 2026
- FAERS reports
- 204,916 through July 30, 2026
What is alprazolam used for?
From the label: indications and usageXANAX is indicated for the:
acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults. XANAX 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.
Conditions named in the indications of alprazolam's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Xanax), PHARMACIA & UPJOHN COMPANY LLC, effective January 18, 2023 (SPL set 388e249d-b9b6-44c3-9f8f-880eced0239f), via openFDA; the full label on DailyMed
What does the patient leaflet for alprazolam say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XANAX?XANAX is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking XANAX with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including XANAX, which can lead to overdose and serious side effects including coma and death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including XANAX. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. o You can develop an addiction even if you take XANAX as prescribed by your healthcare provider. o Take XANAX exactly as your healthcare provider prescribed. o Do not share your XANAX with other people. o Keep XANAX in a safe place and away from children. • Physical dependence and withdrawal reactions. XANAX can cause physical dependence and withdrawal reactions. o Do not suddenly stop taking XANAX. […]
From the patient leaflet: How should I store XANAX?Store XANAX at room temperature between 68°F to 77°F (20°C to 25°C) • Keep XANAX and all medicines out of the reach of children.
Source: FDA drug label (Xanax), PHARMACIA & UPJOHN COMPANY LLC, effective January 18, 2023 (SPL set 388e249d-b9b6-44c3-9f8f-880eced0239f), via openFDA; the full label on DailyMed
Is there a generic for alprazolam (Xanax)?
The FDA approved the first generic alprazolam on October 19, 1993. 36 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists alprazolam from 30 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1981 earliest approval on file
- 1993 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for alprazolam (Xanax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0236 per Alprazolam 0.25 mg tablet, down 1% from $0.0239 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Alprazolam 0.5 mg tablet (generic)
- Xanax 0.25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Alprazolam 0.25 mg tablet | Generic | $0.0236 per tablet | $0.707 | -1% |
| Alprazolam 0.5 mg tablet | Generic | $0.0225 per tablet | $0.673 | -5% |
| Alprazolam 1 mg tablet | Generic | $0.0243 per tablet | $0.730 | -9% |
| Alprazolam 2 mg tablet | Generic | $0.0488 per tablet | $1.46 | -0.3% |
| Alprazolam ER 0.5 mg tablet | Generic | $0.153 per tablet | $4.60 | -9% |
| Alprazolam ER 1 mg tablet | Generic | $0.156 per tablet | $4.68 | -15% |
| Alprazolam ER 2 mg tablet | Generic | $0.206 per tablet | $6.18 | -6% |
| Alprazolam ER 3 mg tablet | Generic | $0.262 per tablet | $7.85 | -13% |
| Alprazolam intensol 1 mg/mL | Generic | $2.87 per mL | n/a | no change |
| Alprazolam ODT 0.25 mg tablet | Generic | $0.970 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $29.09 | -7% |
| Alprazolam ODT 0.5 mg tablet | Generic | $1.23 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $36.93 | -7% |
| Alprazolam ODT 1 mg tablet | Generic | $1.77 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $53.10 | +0.5% |
| Alprazolam XR 0.5 mg tablet | Generic | $0.153 per tablet | $4.60 | -9% |
| Alprazolam XR 1 mg tablet | Generic | $0.156 per tablet | $4.68 | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has alprazolam been recalled?
The FDA's Enforcement Report lists 23 recalls naming alprazolam since 2013: 0 Class I (the most serious), 23 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 17, 2026 | Class II | Viatris, Inc. | Failed Dissolution Specifications |
| March 2, 2023 | Class II | Breckenridge Pharmaceutical, Inc | CGMP Deviations: Potential risk of Cross Contamination |
| April 28, 2022 | Class II | Viatris Inc | Failed Dissolution Specifications: low out-of-specification dissolution test results observed. |
| March 2, 2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process. |
| February 22, 2022 | Class II | Preferred Pharmaceuticals, Inc. | CGMP deviations |
| February 15, 2022 | Class II | ANI Pharmaceuticals, Inc. | cGMP Deviations |
| October 23, 2019 | Class II | Mylan Pharmaceuticals Inc. | Presence of Foreign Substance |
| January 18, 2019 | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the alprazolam label say about other medicines?
The alprazolam label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name alprazolam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Butorphanol | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Carbamazepine | drug interactions | Examples; Carbamazepine, phenytoin |
| Cimetidine | drug interactions | Examples; Nefazodone, fluvoxamine, cimetidine, erythromycin |
| Clarithromycin | drug interactions | Examples; Ketoconazole, itraconazole, clarithromycin |
| Codeine | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Digoxin | drug interactions | Use with Digoxin: Increase the risk of digoxin toxicity. |
| Erythromycin | drug interactions | Examples; Nefazodone, fluvoxamine, cimetidine, erythromycin |
| Fentanyl | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Flumazenil | warnings and precautions | Abrupt discontinuation or rapid dosage reduction of XANAX after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3) ]. |
| Fluvoxamine | drug interactions | Examples; Nefazodone, fluvoxamine, cimetidine, erythromycin |
| Hydromorphone | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Itraconazole | contraindications | • taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.6), Warnings and Precautions (5.5), Drug Interactions (7.1) ] Known hypersensitivity to alprazolam or other benzodiazepines. |
| Ketoconazole | contraindications | • taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.6), Warnings and Precautions (5.5), Drug Interactions (7.1) ] Known hypersensitivity to alprazolam or other benzodiazepines. |
Every other medicine the alprazolam label names
| Medicine named | Section | What the label says |
|---|---|---|
| Meperidine | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil … |
| Methadone | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil … |
| Morphine | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil … |
| Nefazodone | drug interactions | Examples; Nefazodone, fluvoxamine, cimetidine, erythromycin |
| Oxycodone | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil … |
| Oxymorphone | drug interactions | Examples; Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil … |
| Phenytoin | drug interactions | Examples; Carbamazepine, phenytoin |
| Remifentanil | drug interactions | … alfentanil, butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Ritonavir | contraindications | • taking strong cytochrome P450 3A (CYP3A) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see Dosage and Administration (2.6), Warnings and Precautions (5.5), Drug Interactions … |
| Sufentanil | drug interactions | … butorphanol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Tapentadol | drug interactions | … dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
| Tramadol | drug interactions | … dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol. |
Other labels that name alprazolam
Source: FDA drug label (Xanax), PHARMACIA & UPJOHN COMPANY LLC, effective January 18, 2023 (SPL set 388e249d-b9b6-44c3-9f8f-880eced0239f), via openFDA; the full label on DailyMed
What do FAERS reports show for alprazolam?
The FDA Adverse Event Reporting System holds 204,916 reports that list alprazolam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 33,446 are coded as a death and 65,648 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as alprazolam?
11 other medicines are given the same way (oral) and in the same FDA class as alprazolam or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clonazepam | Anxiety | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Amitriptyline and chlordiazepoxide | Anxiety | 1 labeler | $1.20 per unit 5-12.5 | No current entry |
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
Every medicine labeled for the same conditions as alprazolam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does alprazolam compare with medicines for the same use?
13 side-by-side pages set alprazolam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to alprazolam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Alprazolam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other