Prescription medicine
Midazolam Brand names: Nayzilam; first approved as Versed
Midazolam (Versed) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.233 per mL (Midazolam HCl 2 mg/2 mL vial) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $327.05 per unit (Nayzilam 5 mg nasal spray).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC); the NDA 18654 record on Drugs@FDA; every midazolam label on DailyMed.
Highlights of the record
FDA label of January 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Personnel and Equipment for Monitoring and Resuscitation Adults and Pediatrics: Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam should be used only in hospital or ambulatory care settings, including physicians' and dental offices, that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured (see WARNINGS ). For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure. Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation (see WARNINGS , PRECAUTIONS, Drug Interactions ). Individualization of Dosage Midazolam must never be used without individualization of dosage. […]
Used for
From the label: indications and usageMidazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;
Forms and strengths
- 1 mg/ml
- 2 mg/ml
- 2 mg/2ml
- 5 mg/ml
- 5 mg/.1ml
- 5 mg/5ml
- 10 mg/.7ml
- 10 mg/2ml
Injection (solution); injection; syrup; spray.
On the market
- Earliest approval on file
- December 20, 1985 Versed, Hlr; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 38 first June 20, 2000; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 25 of which 22 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- June 20, 2038 Midazolam In 0.9% Sodium Chloride injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.233 per mL Midazolam HCl 2 mg/2 mL vial
- Shortage (FDA)
- 12 of 27 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 19 since 2012 4 Class I among all firms' recalls; latest November 9, 2023; 10 more by firms not listed as its makers
- FAERS reports
- 29,268 through July 30, 2026
What is midazolam used for?
From the label: indications and usageMidazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. […]
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), via openFDA; the full label on DailyMed
What does the patient leaflet for midazolam 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 NAYZILAM?NAYZILAM 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 medical help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking NAYZILAM with opioids may affect you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including NAYZILAM, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including midazolam (the active ingredient in NAYZILAM). 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 have any of these serious side effects. You can develop an addiction even if you use NAYZILAM as prescribed by your healthcare provider. Use NAYZILAM exactly as your healthcare provider prescribed. Do not share your NAYZILAM with other people. Keep NAYZILAM in a safe place and away from children. Physical dependence and withdrawal reactions. Benzodiazepines, including NAYZILAM, can cause physical dependence and withdrawal reactions, especially if you use NAYZILAM daily. NAYZILAM is not intended for daily use. Do not suddenly stop using NAYZILAM without talking to your healthcare provider. […]
From the patient leaflet: What should I avoid while using NAYZILAM?See " What is the most important information I should know about NAYZILAM? " What are the possible side effects of NAYZILAM? NAYZILAM may cause serious side effects, including: See " What is the most important information I should know about NAYZILAM? " Increase in eye pressure in people with acute narrow-angle glaucoma. See " Do not use NAYZILAM if you: " The most common side effects of NAYZILAM include: sleepiness headache runny nose nasal discomfort throat irritation These are not all the possible side effects of NAYZILAM. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
From the patient leaflet: How should I store NAYZILAM?Store NAYZILAM at room temperature between 68°F to 77°F (20°C to 25°C). Keep NAYZILAM in the blister package until ready to use. Keep NAYZILAM and all medicines out of the reach of children.
Source: FDA drug label (Nayzilam), UCB, Inc., effective January 19, 2023 (SPL set 2b29422e-54d5-4a49-8522-e9cf752368c3), via openFDA; the full label on DailyMed
Is there a generic for midazolam (Versed)?
The FDA approved the first generic midazolam on June 20, 2000. 38 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists midazolam from 22 labelers under a generic (ANDA) application and from 3 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 Versed injection; a patent listed only for Midazolam In 0.9% Sodium Chloride injection runs to June 20, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 2000 first generic approved
- 2038 last listed patent
- 2020 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 midazolam (Versed)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.233 per mL (Midazolam HCl 2 mg/2 mL vial), up 3% from $0.227 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.
- Midazolam HCl 2 mg/2 mL vial (generic)
- Nayzilam 5 mg nasal spray (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Midazolam HCl 10 mg/2 mL vial | Generic | $0.565 per mL | $1.13 per vial | -6% |
| Midazolam HCl 2 mg/2 mL vial | Generic | $0.233 per mL | $0.467 per vial | +3% |
| Midazolam HCl 2 mg/mL syrup | Generic | $0.618 per mL | n/a | -9% |
| Midazolam HCl 5 mg/mL vial | Generic | $1.23 per mL | n/a | +23% |
| Midazolam HCl 50 mg/10 mL vial | Generic | $0.382 per mL | $3.82 per vial | -15% |
| Nayzilam 5 mg nasal spray | Brand | $327.05 per unit | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is midazolam in shortage?
The FDA Drug Shortage Database lists 12 of 27 midazolam presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on April 2, 2020. 15 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Midazolam Hydrochloride Preservative Free, Injection, 10 mg/2 mL (5 mg/mL) (NDC 0409-2308-02) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2 mL (NDC 76045-211-20) | Fresenius Kabi USA, LLC | Current | September 15, 2026 |
| Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-0001-25) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Midazolam Hydrochloride Preservative Free, Injection, 2 mg/2mL (1 mg/mL) (NDC 0409-2305-17) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Midazolam Hydrochloride Preservative Free, Injection, 5 mg/5 mL (1 mg/mL) (NDC 0409-2305-05) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Midazolam Hydrochloride Preservative Free, Injection, 5 mg/mL (5 mg/mL) (NDC 0409-2308-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6056-10) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Midazolam Hydrochloride, Injection, 1 mg/1 mL (NDC 0641-6057-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has midazolam been recalled?
The FDA's Enforcement Report lists 29 recalls naming midazolam since 2012: 4 Class I (the most serious), 25 Class II, 0 Class III; 2 still ongoing. 10 of them are by firms that FDA's NDC Directory does not list as a maker of midazolam 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 |
|---|---|---|---|
| November 9, 2023 | Class II | SCA Pharmaceuticals, LLC | Lack of Assurance of Sterility |
| 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. |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| June 12, 2018 | Class II | Avella of Deer Valley, Inc. Store 38 | Lack of Assurance of Sterility: Potential leakage of bags. |
| October 27, 2017 | Class I | Fresenius Kabi USA, LLC | Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL |
| October 10, 2017 | Class II | Banner Pharmacy Services, LLC not a listed maker | Lack of Assurance of Sterility. |
| December 16, 2016 | Class II | Fresenius Kabi USA, LLC | Failed Impurities/Degradation Specifications |
| November 18, 2016 | Class II | Cantrell Drug Company | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the midazolam label say about other medicines?
The midazolam label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 45 other medicines name midazolam. 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 |
|---|---|---|
| Atropine | drug interactions | No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine … |
| Cimetidine | drug interactions | Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Clarithromycin | drug interactions | 7.1 CYP3A4 Inhibitors Clinical Impact: Concomitant use of CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. … diltiazem, verapamil Strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin |
| Codeine | drug interactions | 7.2 Opioids Clinical Impact: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. … the minimum required [see ]. Examples: Morphine, hydrocodone, oxymorphone, codeine, fentanyl |
| Diazepam | drug interactions | No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine … |
| Diltiazem | drug interactions | Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Droperidol | drug interactions | Other CNS Depressants The sedative effect of intravenous midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly opioids (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. |
| Dyclonine | drug interactions | … succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and Cetacaine) have been observed in adults or pediatric patients. |
| Erythromycin | drug interactions | Other Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Fentanyl | boxed warning | Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl (see DOSAGE AND ADMINISTRATION for complete information). |
| Flumazenil | warnings | The immediate availability of specific reversal agents (flumazenil) is highly recommended. |
| Glycopyrrolate | drug interactions | No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine … |
| Hydrocodone | drug interactions | 7.2 Opioids Clinical Impact: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. … dosages and durations to the minimum required [see ]. Examples: Morphine, hydrocodone, oxymorphone, codeine, fentanyl |
| Hydroxyzine | drug interactions | No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine, d-tubocurarine, succinylcholine and other nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine … |
Every other medicine the midazolam label names
| Medicine named | Section | What the label says |
|---|---|---|
| Itraconazole | drug interactions | … ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Ketoconazole | drug interactions | … as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Lidocaine | drug interactions | … nondepolarizing muscle relaxants) or topical local anesthetics (including lidocaine, dyclonine HCl and Cetacaine) have been observed in adults or pediatric patients. |
| Meperidine | drug interactions | … the central nervous system, particularly opioids (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. |
| Morphine | drug interactions | … depresses the central nervous system, particularly opioids (e.g., morphine, meperidine and fentanyl) and also secobarbital and droperidol. |
| Nifedipine | drug interactions | No interaction was observed in healthy subjects between midazolam and nifedipine. |
| Oxymorphone | drug interactions | 7.2 Opioids Clinical Impact: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. … durations to the minimum required [see ]. Examples: Morphine, hydrocodone, oxymorphone, codeine, fentanyl |
| Ranitidine | drug interactions | … known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
| Scopolamine | drug interactions | No significant adverse interactions with commonly used premedications or drugs used during anesthesia and surgery (including atropine, scopolamine, glycopyrrolate, diazepam, hydroxyzine … |
| Succinylcholine | drug interactions | Midazolam does not protect against the characteristic circulatory changes noted after administration of succinylcholine or pancuronium and does not protect against the increased intracranial pressure … |
| Verapamil | drug interactions | … system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole. |
Other labels that name midazolam
- Aprepitant
- Armodafinil
- Atazanavir
- Atomoxetine
- Belumosudil
- Bicalutamide
- Carbamazepine
- Ceritinib
- Cobicistat
- Dabrafenib
- Darunavir
- Deferasirox
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Elagolix
- Enzalutamide
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Fosaprepitant
- Glycerol phenylbutyrate
- Isavuconazonium
- Ivacaftor
- Lapatinib ditosylate
- Lenacapavir
- Letermovir
- Lonafarnib
- Modafinil
- Nelfinavir
- Paclitaxel
- Palbociclib
- Posaconazole
- Ritonavir
- Spironolactone
- Stiripentol
- Tacrolimus
- Tecovirimat
- Telotristat
- Toremifene
- Voriconazole
- Voxelotor
Source: FDA drug label (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), via openFDA; the full label on DailyMed
What do FAERS reports show for midazolam?
The FDA Adverse Event Reporting System holds 29,268 reports that list midazolam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,581 are coded as a death and 13,549 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 next?
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Midazolam side effects
- the label's list beside FAERS reports
- Midazolam shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other