Prescription medicine
Dexmedetomidine Brand names: Precedex, Igalmi
Dexmedetomidine (Precedex) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 23 generic labelers.
- Generic listed
- In shortage
Check it at the source: the dexmedetomidine FDA label on DailyMed (effective May 20, 2026, Hospira, Inc.); the NDA 21038 record on Drugs@FDA; every dexmedetomidine label on DailyMed.
Highlights of the record
FDA label of May 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting.
Forms and strengths
- 100ml
- 2ml
- 50ml
Injection (solution); injection; injection (solution) (concentrate); film.
On the market
- Earliest approval on file
- December 17, 1999 Precedex, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 33 first August 18, 2014; 29 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 27 of which 23 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- July 4, 2032 Precedex injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 11 of 59 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest August 6, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 6,295 through July 30, 2026
What is dexmedetomidine used for?
From the label: indications and usagePRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for:
Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. ( 1.1 )
Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. ( 1.2 )
Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. ( 1.2 ) 1.1 Intensive Care Unit Sedation PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. […]
FDA pharmacologic class: Central alpha-2 Adrenergic Agonist.
Source: FDA drug label (Precedex), Hospira, Inc., effective May 20, 2026 (SPL set 548a88c0-afda-427e-75ac-5af0cfa2224c), via openFDA; the full label on DailyMed
Is there a generic for dexmedetomidine (Precedex)?
The FDA approved the first generic dexmedetomidine on August 18, 2014. 33 generic applications are approved; 29 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 dexmedetomidine from 23 labelers under a generic (ANDA) application and from 4 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 7 patents for Precedex injection, the last expiring on July 4, 2032; a patent listed only for Igalmi film runs to January 12, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1999 earliest approval on file
- 2014 first generic approved
- 2032 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)
Is dexmedetomidine in shortage?
The FDA Drug Shortage Database lists 11 of 59 dexmedetomidine presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on April 10, 2020. 45 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 0143-9532-25) | Hikma Pharmaceuticals USA, Inc. | Current | September 18, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | Accord Healthcare Inc. | Current | September 15, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-432-93) | Accord Healthcare Inc. | Current | September 15, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25) | Par Health, USA LLC | Current | August 18, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04) | HQ Specialty Pharma | Current | October 1, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04) | HQ Specialty Pharma | Current | October 1, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02) | Eugia US LLC | Current | October 2, 2026 |
| Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 63323-421-02) | Fresenius Kabi USA, LLC | Current | October 6, 2026 |
Every dexmedetomidine presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has dexmedetomidine been recalled?
The FDA's Enforcement Report lists 3 recalls naming dexmedetomidine since 2019: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of dexmedetomidine 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 |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office not a listed maker | cGMP deviations: Temperature abuse |
| April 12, 2019 | Class II | CMC Enterprise Pharmacy not a listed maker | Lack of sterility assurance. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dexmedetomidine label say about other medicines?
The dexmedetomidine label names 7 other medicines in its interaction, contraindication or warning sections. 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 | warnings and precautions | The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. |
| Glycopyrrolate | warnings and precautions | The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. |
| Isoflurane | drug interactions | Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. |
| Midazolam | drug interactions | Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. |
| Propofol | drug interactions | Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. |
| Rocuronium | drug interactions | In one study of 10 healthy adult volunteers, administration of PRECEDEX for 45 minutes at a plasma concentration of one ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration. |
| Sevoflurane | drug interactions | Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. |
Source: FDA drug label (Precedex), Hospira, Inc., effective May 20, 2026 (SPL set 548a88c0-afda-427e-75ac-5af0cfa2224c), via openFDA; the full label on DailyMed
What do FAERS reports show for dexmedetomidine?
The FDA Adverse Event Reporting System holds 6,295 reports that list dexmedetomidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 838 are coded as a death and 2,791 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 central alpha-2 adrenergic agonists
- the pharmacologic class, with prices and generics
- Dexmedetomidine side effects
- the label's list beside FAERS reports
- Dexmedetomidine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other