Prescription medicine
Lorazepam Brand names: Ativan, Loreev
Lorazepam (Ativan) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.0344 per lorazepam 0.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the lorazepam FDA label on DailyMed (effective July 9, 2025, Bausch Health US LLC); the NDA 17794 record on Drugs@FDA; every lorazepam label on DailyMed.
Highlights of the record
FDA label of July 9, 2025; 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 ).
The use of benzodiazepines, including Ativan, 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 Ativan and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ).
The continued use of benzodiazepines, including Ativan, 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 Ativan after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageAtivan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Forms and strengths
- 0.5 mg
- 1 mg
- 1.5 mg
- 2 mg
- 3 mg
- 2 mg/ml
- 4 mg/ml
Tablet; injection; extended-release capsule; liquid; concentrate.
On the market
- Earliest approval on file
- September 30, 1977 Ativan, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 53 first December 10, 1985; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 39 of which 36 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- January 8, 2034 Loreev XR capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0344 per tablet Lorazepam 0.5 mg tablet
- Shortage (FDA)
- 10 of 11 presentations limited or unavailable updated October 5, 2026
- Recalls by its makers (FDA)
- 8 since 2012 1 Class I among all firms' recalls; latest January 21, 2025; 11 more by firms not listed as its makers
- FAERS reports
- 178,731 through July 30, 2026
What is lorazepam used for?
From the label: indications and usageAtivan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of Ativan (lorazepam) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Conditions named in the indications of lorazepam's FDA labels, with every medicine labeled for each:
From other lorazepam labelsAnxiety: INDICATIONS AND USAGE Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Ativan), Bausch Health US LLC, effective July 9, 2025 (SPL set 89057c93-8155-4040-acec-64e877bd2b4c), via openFDA; the full label on DailyMed
What does the patient leaflet for lorazepam 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 ATIVAN?ATIVAN is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system 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 ATIVAN with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including ATIVAN 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 ATIVAN. 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 ATIVAN exactly as prescribed by your healthcare provider. o Take ATIVAN exactly as your healthcare provider prescribed. o Do not share your ATIVAN with other people. o Keep ATIVAN in a safe place and away from children. • Physical dependence and withdrawal reactions. ATIVAN can cause physical dependence and withdrawal reactions. o Do not suddenly stop taking ATIVAN. […]
From the patient leaflet: How should I store ATIVAN?Store ATIVAN in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C). • Keep ATIVAN and all medicines out of the reach of children.
Source: FDA drug label (Ativan), Bausch Health US LLC, effective July 9, 2025 (SPL set 89057c93-8155-4040-acec-64e877bd2b4c), via openFDA; the full label on DailyMed
Is there a generic for lorazepam (Ativan)?
The FDA approved the first generic lorazepam on December 10, 1985. 53 generic applications are approved; 18 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 lorazepam from 36 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Ativan injection; a patent listed only for Loreev XR capsules runs to January 8, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1977 earliest approval on file
- 1985 first generic approved
- 2034 last listed patent
- 2018 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lorazepam (Ativan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0344 per Lorazepam 0.5 mg tablet, down 18% from $0.0422 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.
- Lorazepam 0.5 mg tablet (generic)
- Loreev XR 2 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lorazepam 0.5 mg tablet | Generic | $0.0344 per tablet | $1.03 | -18% |
| Lorazepam 1 mg tablet | Generic | $0.0367 per tablet | $1.10 | -24% |
| Lorazepam 2 mg tablet | Generic | $0.0731 per tablet | $2.19 | -4% |
| Lorazepam 2 mg/mL oral concent | Generic | $0.686 per mL | n/a | +6% |
| Lorazepam 2 mg/mL vial | Generic | $2.17 per mL | n/a | +99% |
| Lorazepam intensol 2 mg/mL | Generic | $0.686 per mL | n/a | +6% |
| Loreev XR 1 mg capsule | Brand | $14.21 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $426.29 | -0.3% |
| Loreev XR 1.5 mg capsule | Brand | $14.25 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $427.46 | -0.3% |
| Loreev XR 2 mg capsule | Brand | $14.19 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $425.72 | -0.4% |
| Loreev XR 3 mg capsule | Brand | $14.23 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $426.80 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is lorazepam in shortage?
The FDA Drug Shortage Database lists 10 of 11 lorazepam presentations as limited or unavailable (updated October 5, 2026); the first entry was posted on May 3, 2018. 1 more presentation is on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Ativan, Injection, 2 mg/1 mL (NDC 0641-6000-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ativan, Injection, 2 mg/1 mL (NDC 0641-6001-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ativan, Injection, 4 mg/1 mL (NDC 0641-6002-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Ativan, Injection, 4 mg/1 mL (NDC 0641-6003-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6044-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Lorazepam, Injection, 2 mg/1 mL (NDC 0641-6046-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Lorazepam, Injection, 2 mg/1 mL (NDC 65219-368-02) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Lorazepam, Injection, 2 mg/1 mL (NDC 76329-8261-1) | Amphastar Pharmaceuticals, Inc. | Current | October 5, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has lorazepam been recalled?
The FDA's Enforcement Report lists 19 recalls naming lorazepam since 2012: 1 Class I (the most serious), 17 Class II, 1 Class III; 6 still ongoing. 11 of them are by firms that FDA's NDC Directory does not list as a maker of lorazepam and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 22, 2025 | Class II | Hikma Pharmaceuticals USA Inc. not a listed maker | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds |
| February 17, 2025 | Class II | Safecor Health, LLC not a listed maker | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. |
| January 21, 2025 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and … |
| May 11, 2023 | Class II | Hikma Pharmaceuticals USA Inc. not a listed maker | Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated … |
| May 1, 2023 | Class II | RemedyRepack Inc. | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity … |
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| July 11, 2022 | Class II | Hikma Pharmaceuticals USA Inc. not a listed maker | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples. |
| August 6, 2020 | Class II | Family Pharmacy of Statesville not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lorazepam label say about other medicines?
The lorazepam label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name lorazepam. 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 |
|---|---|---|
| Aminophylline | drug interactions | Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam. |
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity [see Contraindications ( 4 )]. |
| Cimetidine | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. |
| Clozapine | drug interactions | Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest. |
| Disulfiram | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. |
| Ethyl alcohol | drug interactions | Lorazepam Injection, like other injectable benzodiazepines, produces additive depression of the central nervous system when administered with other CNS depressants such as ethyl alcohol, phenothiazines, barbiturates, MAO inhibitors, and other antidepressants. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of Ativan 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: |
| Haloperidol | drug interactions | Apnea, coma, bradycardia, arrhythmia, heart arrest, and death have been reported with the concomitant use of haloperidol and lorazepam. |
| Loxapine | drug interactions | There have been rare reports of significant respiratory depression, stupor and/or hypotension with the concomitant use of loxapine and lorazepam. |
| Metoprolol | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. |
| Metronidazole | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. |
| Norethindrone | drug interactions | LORAZEPAM-ORAL CONTRACEPTIVE STEROIDS INTERACTION Coadministration of lorazepam (2 mg intravenously) with oral contraceptive steroids (norethindrone acetate, 1 mg, and ethinyl estradiol, 50 μg, for at least 6 months) to healthy females (n=7) was associated with a 55% decrease in half-life, a 50% increase in the volume … |
| Probenecid | drug interactions | Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. |
| Propranolol | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole, and propoxyphene. |
Every other medicine the lorazepam label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ranitidine | drug interactions | Concurrent administration of any of the following drugs with lorazepam had no effect on the pharmacokinetics of lorazepam: metoprolol, cimetidine, ranitidine, disulfiram, propranolol, metronidazole … |
| Scopolamine | drug interactions | When scopolamine is used concomitantly with injectable lorazepam, an increased incidence of sedation, hallucinations and irrational behavior has been observed. |
| Theophylline | drug interactions | Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam. |
Other labels that name lorazepam
Source: FDA drug label (Ativan), Bausch Health US LLC, effective July 9, 2025 (SPL set 89057c93-8155-4040-acec-64e877bd2b4c), via openFDA; the full label on DailyMed
What do FAERS reports show for lorazepam?
The FDA Adverse Event Reporting System holds 178,731 reports that list lorazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25,768 are coded as a death and 74,535 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 lorazepam?
11 other medicines are given the same way (oral) and in the same FDA class as lorazepam 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 |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lorazepam compare with medicines for the same use?
13 side-by-side pages set lorazepam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lorazepam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Lorazepam side effects
- the label's list beside FAERS reports
- Lorazepam shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other