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Dexmedetomidine

Dexmedetomidine is a sedative medication used intravenously in intensive care and procedural settings, and — as Igalmi sublingual film — for acute agitation in adults with schizophrenia or bipolar disorder.

Brand names DexdomitorPrecedexSileoDexmedesedSedexodine +7 more
Drug classes Adrenergic Alpha2-agonists
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 47 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

Dexmedetomidine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Dexmedetomidine is a hospital sedative that quiets nerve activity in the brain, widely used for ICU patients on a breathing machine and people having procedures, and as the Igalmi under-the-tongue film it quickly settles agitation in adults with schizophrenia or bipolar disorder; it has been around since about 1998 and is available generically. Patients usually stay calm but easy to rouse, with breathing generally preserved, and dry mouth is what people themselves tend to notice. The one thing to look for is a dangerously slow heart rate or low blood pressure, likelier in older adults and people with heart disease or diabetes, so trained staff watch it continuously.

Clinical pearls

  • After more than a day of use, racing heart, spiking blood pressure, nausea or agitation after stopping can signal withdrawal.
  • Give the care team a full list of opioids, sleep aids and blood pressure or heart-slowing medicines, since the effects add up.
  • Mention any liver disease beforehand, because the body clears dexmedetomidine more slowly and a lower dose may be needed.
  • It passes into breast milk, so if you nurse after a procedure, watch your baby for irritability.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Sublingual film
Earliest FDA record1998
Companies listing it with the FDA27
FDA label last updatedJun 2, 2026
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Dexmedetomidine, written from its FDA label.

What Dexmedetomidine Is Used For

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Dexmedetomidine is approved for several distinct uses depending on the specific product and setting:

  • ICU sedation (adults): Intravenous dexmedetomidine products sedate adults who are on a mechanical ventilator in an intensive care unit. The infusion must not run longer than 24 hours.
  • Procedural sedation (adults): Intravenous products are used to sedate non-intubated adults before or during surgery and other medical procedures.
  • Procedural sedation (children): Several intravenous products — including Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride and Precedex — are approved to sedate children aged 1 month to less than 18 years before and during non-invasive procedures (such as MRI scans). This approval does not extend to all intravenous products.
  • Acute agitation (Igalmi only): Igalmi sublingual film is approved specifically for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This is a completely separate use from the intravenous forms and applies only within 24 hours of the first dose.

How Dexmedetomidine Works

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Dexmedetomidine is an alpha-2 adrenergic receptor agonist — it selectively activates alpha-2 receptors in the brain and nervous system. Turning on these receptors calms nerve signaling, producing sedation and reducing the body's fight-or-flight stress response. This lowers heart rate and blood pressure while — at recommended doses — generally keeping breathing intact.

At higher doses or with rapid intravenous administration, the drug can also activate alpha-1 receptors, which may cause a brief rise in blood pressure. This is why the infusion rate is carefully controlled by medical staff.

Dexmedetomidine Dosage

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Intravenous dexmedetomidine is given only in a hospital or procedural setting by healthcare professionals using a controlled infusion pump — it is never taken at home. The dose is individualized and carefully adjusted to achieve the desired level of sedation, and infusions must not exceed 24 hours. Igalmi sublingual film is placed under the tongue and allowed to dissolve under the supervision of a healthcare provider; it is not swallowed.

  • Intravenous forms: given as a continuous infusion, titrated to effect; some formulations require dilution before use, others come ready to use
  • Igalmi (sublingual film): dissolved under the tongue; do not use beyond 24 hours from the first dose
  • Older adults and people with liver disease may need a lower dose — your care team will determine this

Dosing details from the FDA-approved label

From the Dexmedetomidine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Initiation of Intensive Care Unit Sedation (adult patients)
    • A loading infusion of one mcg/kg over 10 minutes
    • For adult patients being converted from alternate sedative therapy: a loading dose may not be required. Patients over 65 years of age and adult patients with impaired hepatic function: consider a dose reduction
  • Maintenance of Intensive Care Unit Sedation (adult patients)
    • A maintenance infusion of 0.2 to 0.7 mcg/kg/hour
    • The rate should be adjusted to achieve the desired level of sedation
    • Patients over 65 years of age and adult patients with impaired hepatic function: consider a dose reduction
  • Initiation of Procedural Sedation (adult patients)
    • A loading infusion of one mcg/kg over 10 minutes
    • For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable
    • Adult patients with impaired hepatic function: consider a dose reduction
  • Initiation of Procedural Sedation: awake fiberoptic intubation in adult patients
    • A loading infusion of one mcg/kg over 10 minutes
  • Initiation of Procedural Sedation: patients over 65 years of age
    • A loading infusion of 0.5 mcg/kg over 10 minutes
  • Maintenance of Procedural Sedation (adult patients)
    • Generally initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hour
    • Adjust the rate to achieve the targeted level of sedation
    • Patients over 65 years of age and adult patients with impaired hepatic function: consider a dose reduction
  • Maintenance of Procedural Sedation: awake fiberoptic intubation in adult patients
    • A maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. ( 2.1 ) Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. ( 2.1 ) The 200 mcg/50 mL single-dose vials and 400 mcg/100 mL single-dose vials do not require further dilution prior to administration. ( 2.4 ) For Adult Intensive Care Unit Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion of 0.2 mcg/kg/ hour to 0.7 mcg/kg/ hour . ( 2.2 ) For Adult Procedural Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 mcg/kg/ hour to 1 mcg/kg/ hour . ( 2.2 ) For Sedation of Pediatric Patients During Non-invasive Procedures : Patients 1 month to less than 2 years old initiate at 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hour to 1.5 mcg/kg/ hour ; patients 2 to less than 18 years old initiate at 2 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/ hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hour to 1.5 mcg/kg/ hour . ( 2.2 ) Alternative Doses : Recommended for patients over 65 years of age and awake fiberoptic intubation patients. ( 2.2 ) 2.1 Administration Instructions Dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered using a controlled infusion device. 2.2 Recommended Dosage Table 1: Recommended Dosage in Adult Patients INDICATION DOSAGE AND ADMINISTRATION Initiation of Intensive Care Unit Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes. For adult patients being converted from alternate sedative therapy: a loading dose may not be required. For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations ( 8.5 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Dexmedetomidine Side Effects

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The most common side effects reported in adults are low blood pressure (hypotension), slow heart rate (bradycardia), and dry mouth. In children, slow breathing (bradypnea), slow heart rate, high blood pressure, and low blood pressure are the most frequently reported effects.

Common side effects

  • Low blood pressure (hypotension)
  • Slow heart rate (bradycardia)
  • Dry mouth
  • Slow breathing (bradypnea) — more common in children
  • High blood pressure (hypertension) — especially early in infusion or in children
  • Nausea
  • Agitation after stopping the medicine

When to get medical help

  • Call for immediate help if heart rate drops very low or you feel faint — serious slow heart rate and even cardiac arrest have been reported
  • Seek urgent care if blood pressure drops significantly (dizziness, weakness, feeling faint)
  • Tell your care team right away if you notice your heart racing or blood pressure spiking after the medicine is stopped — this may be a withdrawal effect
  • Alert your team if breathing becomes very slow or labored (especially in children)
  • Report signs of severe agitation, nausea, or vomiting after the infusion ends

Serious reactions requiring immediate attention include severely slow heart rate or cardiac arrest, a dangerous drop in blood pressure, and — with infusions longer than 24 hours — signs of withdrawal (racing heart, high blood pressure, agitation) after the medicine stops. ARDS (a serious lung condition) and respiratory failure have also been reported with infusions longer than 24 hours.

Dexmedetomidine Warnings and Precautions

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  • Heart rate and blood pressure drops: Clinically significant slow heart rate (bradycardia) and low blood pressure (hypotension) can occur, and some cases have been fatal. Patients must be continuously monitored. The risk is higher in older adults, people with heart block or severe heart dysfunction, low blood volume, diabetes, or chronic high blood pressure.
  • Cardiac arrest: Has been reported with incorrect administration (e.g., an undiluted bolus dose); always administered by trained staff only.
  • Transient blood pressure spike: A brief rise in blood pressure can happen at the start of the infusion due to initial blood vessel narrowing; the infusion rate may be slowed if this occurs.
  • Tolerance and withdrawal: Using dexmedetomidine for more than 24 hours may lead to tolerance (reduced effect) and withdrawal symptoms — including nausea, vomiting, agitation, rapid heart rate, and high blood pressure — after stopping.
  • Arousability: Some patients can be roused and become alert when stimulated even while receiving the medicine; this alone does not mean the medicine isn't working.
  • Igalmi time limit: Safety and effectiveness of Igalmi have not been established beyond 24 hours from the first dose.

Dexmedetomidine Interactions

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Dexmedetomidine can have important interactions with other medicines that affect the brain or heart:

  • Anesthetics, sedatives, sleep aids (hypnotics), and opioid pain medicines: Combining these with dexmedetomidine significantly increases sedative effects — the dose of one or both medicines may need to be reduced. Specific agents confirmed to interact include sevoflurane, isoflurane, propofol, alfentanil, and midazolam.
  • Blood pressure-lowering medicines and medicines that slow the heart (vasodilators, negative chronotropic agents): Using these together can make low blood pressure and slow heart rate worse; extra caution and monitoring are needed.

Interactions listed in the FDA-approved label

From the Dexmedetomidine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Anesthetics, sedatives, hypnotics, opioids: Co-administration is likely to lead to an enhancement of effects; specific studies confirmed this with sevoflurane, isoflurane, propofol, alfentanil, and midazolam, and no pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated. A reduction in dosage of dexmedetomidine or the concomitant anesthetic, sedative, hypnotic or opioid may be required.
  • Neuromuscular blockers (rocuronium): In one study of 10 healthy adult volunteers, dexmedetomidine 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.
Read the label’s full interactions text

7 DRUG INTERACTIONS Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant medication may be required. ( 7.1 ) 7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine, a reduction in dosage of dexmedetomidine hydrochloride in 0.9% sodium chloride injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required. 7.2 Neuromuscular Blockers In one study of 10 healthy adult volunteers, administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection 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.

7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Dexmedetomidine against a supplement or herb →

Before Taking Dexmedetomidine

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  • Older adults (over 65): Higher risk of low blood pressure and slow heart rate; a lower dose is often considered.
  • Liver disease (hepatic impairment): The body clears dexmedetomidine more slowly; a dose reduction may be needed.
  • Heart conditions: Use with extra caution if you have advanced heart block or severe heart dysfunction — close monitoring is essential.
  • Low blood volume, diabetes, or chronic high blood pressure: These conditions increase the risk of significant blood pressure and heart rate drops.
  • Pregnancy: Dexmedetomidine crosses the placenta. Available human data from later pregnancy have not identified major birth defects, but animal studies showed fetal harm at certain doses. Discuss risks and benefits with your doctor.
  • Breastfeeding: The medicine passes into breast milk. Monitor a breastfed infant for irritability. Discuss the risks and benefits of breastfeeding with your doctor.
  • Children under 1 month: Safety and effectiveness have not been established.
  • Children — ICU sedation: Safety and effectiveness for ICU sedation in children have not been established; this use is not approved for pediatric patients.

Dexmedetomidine Overdose

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Too much dexmedetomidine can cause heart rhythm problems, including first-degree and second-degree heart block (disruptions in the heart's electrical signals), as well as severely slow heart rate and very low blood pressure. One reported case of a very large accidental dose resulted in cardiac arrest, though the patient was successfully resuscitated.

If an overdose is suspected, medical staff will manage it by adjusting or stopping the infusion and providing supportive care — this medicine is only used in monitored hospital settings where help is immediately available.

What Dexmedetomidine Does in the Body

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At recommended intravenous doses, dexmedetomidine produces sedation while keeping breathing rate and blood oxygen levels within normal limits — unlike many other sedatives, it does not significantly suppress breathing at therapeutic doses. It works by reducing activity in the sympathetic nervous system (the body's stress-response system), which lowers heart rate and blood pressure as part of its effect.

How Your Body Processes Dexmedetomidine

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After intravenous administration, dexmedetomidine spreads through the body quickly — within about 6 minutes — and is then eliminated with a half-life (the time it takes for half the drug to leave the body) of roughly 2 hours. It is about 94% bound to proteins in the blood, and it is almost completely broken down (metabolized) by the liver, primarily through enzymes including CYP2A6, with breakdown products excreted mainly in the urine. Because the liver handles most of the drug's clearance, people with liver disease clear it more slowly and may need a lower dose; kidney disease does not significantly affect how the body handles dexmedetomidine.

How to Store Dexmedetomidine

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Dexmedetomidine: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Dexmedetomidine — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting dexmedetomidine — what is it actually used for?

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Dexmedetomidine is a sedative used in hospital settings. If you're receiving the IV form, it's being used to keep you calm and comfortable — either while you're on a breathing machine in the ICU, or before and during a procedure or surgery. If you've been given Igalmi (the under-the-tongue film), it's being used to quickly calm sudden agitation related to schizophrenia or bipolar disorder. It's a medicine your care team gives and monitors — you won't be taking it at home.

Will I be completely unconscious, or will I be able to wake up?

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Dexmedetomidine causes sedation, but it's different from general anesthesia. Some patients can actually be roused — meaning if someone calls your name or stimulates you, you may open your eyes or respond briefly. This is normal and doesn't mean the medicine isn't working. Your care team expects this and monitors your level of sedation throughout.

What side effects should my family watch for while I'm receiving this?

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The most common effects are low blood pressure and a slow heart rate — your care team will be monitoring these continuously. You may also experience dry mouth. After the medicine is stopped, some people feel nauseated, vomit, or feel agitated, especially if they received it for an extended period. If your heart is racing or your blood pressure spikes after treatment ends, let your nurse or doctor know right away.

Are there medicines I'm already taking that could be a problem with this?

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Yes — dexmedetomidine can strengthen the effects of other sedatives, sleep medicines, anesthetics, and opioid pain relievers, so the doses of those medicines may need to be adjusted. Medicines that lower blood pressure or slow the heart can also have a stronger combined effect. Make sure your care team has a complete list of everything you take, including supplements.

I'm older — should I be worried about anything extra?

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If you're over 65, you're more likely to experience low blood pressure and a slow heart rate with this medicine. Your care team is aware of this and will often start at a lower dose and monitor you especially closely. It's not a reason to avoid the medicine if you need it — just something your team actively manages.

I'm pregnant or breastfeeding — is this safe for my baby?

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This is an important question to raise with your doctor. Dexmedetomidine does cross the placenta, and while human data from late pregnancy haven't shown major birth defects, animal studies did show some fetal risks at higher doses. The medicine also passes into breast milk in small amounts. If you're breastfeeding, watch your baby for irritability. Your doctor will weigh the benefits of treatment for you against any potential risk to your baby.

Is Dexmedetomidine available over the counter?

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No. Dexmedetomidine is a prescription medicine: every Dexmedetomidine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Dexmedetomidine first available?

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The earliest FDA record we hold for Dexmedetomidine is from 1998: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Dexmedetomidine was first used.

Who makes Dexmedetomidine?

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27 companies currently list Dexmedetomidine products in the FDA's NDC Directory, including Hospira, Inc., Baxter Healthcare Company, Medical Purchasing Solutions, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Dexmedetomidine on HelloPharmacist

🌿Drug & Supplement CheckerDexmedetomidine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Dexmedetomidine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed Data & References for Dexmedetomidine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Dexmedetomidine Forms and Strengths (How It Comes)

Dexmedetomidine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Dexmedetomidine inactive ingredients by manufacturer.

Injection

Into a vein
Brands Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Dexmedetomidine Hydrochloride in Sodium Chloride Dexmedetomidine in Dextrose Precedex
How this form is used
What it may be used for
  • Sedation of adults on a mechanical ventilator in an intensive care unit (ICU) — infusion duration must not exceed 24 hours
  • Sedation of non-intubated adults before or during surgery and other procedures
  • Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride and several other intravenous products: sedation of children aged 1 month to less than 18 years before and during non-invasive procedures
Important instructions
  • Given only by healthcare professionals using a controlled infusion pump in an ICU or operating room setting
  • Dexmedetomidine in Dextrose premixed bags (200 mcg/50 mL and 400 mcg/100 mL): do not require dilution before use
  • Concentrate vial formulations (100 mcg/mL): must be diluted before administration — follow your institution's preparation instructions
  • Continuously monitor blood pressure, heart rate, and oxygen levels throughout the infusion and as needed after it ends
Available strengths 5 strengths
4 mcg/mL 100 mcg/mL 200 mcg/2 mL 200 mcg/50 mL 400 mcg/100 mL
209 FDA-listed product records ⓘ

Sublingual film

Under the tongue
Brands Igalmi
How this form is used
What it may be used for
  • Igalmi is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults
  • Igalmi's safety and effectiveness have only been established within 24 hours of the first dose
Important instructions
  • Igalmi is placed under the tongue and allowed to dissolve — it is not swallowed
  • Igalmi is administered and supervised by a healthcare provider; patients are monitored after dosing
  • Do not use Igalmi beyond 24 hours from the first dose, as safety beyond that window has not been established
Available strengths 2 strengths
120 mcg 180 mcg
6 FDA-listed product records ⓘ

Dexmedetomidine on the U.S. Market: Products, Makers and Brands

How Dexmedetomidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

27 companies list 82 Dexmedetomidine product records with the FDA, mostly as injection, sublingual film; the earliest marketing or approval year on record is 1998. Brand names on the directory include Dexdomitor, Precedex, Sileo and 9 more; the rest are generics.

2
Dose forms ⓘ
27
Labelers (makers, repackagers, distributors)
8
Brand names
82
FDA-listed product records ⓘ
1998
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Hospira, Inc.16%
Baxter Healthcare Company7%
Medical Purchasing Solutions, LLC6%
Amneal Pharmaceuticals LLC5%
Gland Pharma Limited5%
Hikma Pharmaceuticals USA Inc.5%
Other makers56%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How Widely Dexmedetomidine Is Used (Medicaid Data)

A general measure of how commonly Dexmedetomidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Dexmedetomidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

27,524
Medicaid prescriptions filled (Q1–Q4 2025)
$1.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dexmedetomidine prescribed? Of the 1,603 medications we measure, Dexmedetomidine ranks #753 by Medicaid prescriptions — more than 53% of them.

Where Dexmedetomidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #753 of 1,603
#748 Magnesium Sulfate / Po... 28,515 Rx #749 Milnacipran 28,086 Rx #750 Magnesium Sulfate / Po... 27,756 Rx #751 Alirocumab Injection 27,746 Rx #752 Resmetirom 27,539 Rx #753 Dexmedetomidine 27,524 Rx #754 Golimumab Injection 27,172 Rx #755 Metronidazole Injectio... 27,056 Rx #756 Emicizumab 27,047 Rx #757 Zolmitriptan 27,026 Rx #758 Abemaciclib 27,007 Rx

Utilization by Dexmedetomidine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2 mL / 0.1 mg/mL injection is the most-dispensed Dexmedetomidine product — about 65% of these Medicaid prescriptions.

2 ML dexmedetomidine 0.1 MG/ML Injection Most dispensed

17,814 Medicaid prescriptions (Q1–Q4 2025) 65% of Dexmedetomidine prescriptions shown $689,305 gross reimbursement (before rebates) ≈ $39 per prescription (gross)

Summed across the 11 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309710

20 ML dexmedetomidine 0.004 MG/ML Injection

5,510 Medicaid prescriptions (Q1–Q4 2025) 20% of Dexmedetomidine prescriptions shown $847,660 gross reimbursement (before rebates) ≈ $154 per prescription (gross)

Summed across the 4 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1718900

50 ML dexmedetomidine 0.004 MG/ML Injection

2,165 Medicaid prescriptions (Q1–Q4 2025) 8% of Dexmedetomidine prescriptions shown $149,065 gross reimbursement (before rebates) ≈ $69 per prescription (gross)

Summed across the 7 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1718906

100 ML dexmedetomidine 0.004 MG/ML Injection

1,876 Medicaid prescriptions (Q1–Q4 2025) 7% of Dexmedetomidine prescriptions shown $218,618 gross reimbursement (before rebates) ≈ $117 per prescription (gross)

Summed across the 10 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1718909

dexmedetomidine 0.1 MG/ML Injectable Solution

159 Medicaid prescriptions (Q1–Q4 2025) <1% of Dexmedetomidine prescriptions shown $1,622 gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1788947

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dexmedetomidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 34 of 158 listed Dexmedetomidine NDCs with Medicaid activity.

Compare Dexmedetomidine Products

A representative set of FDA-listed product records for Dexmedetomidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 82 of 82 products — FDA National Drug Code Directory. See every product, package size and price: browse all 82 Dexmedetomidine NDCs →

Dexmedetomidine Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Dexmedetomidine recalls since July 2021.

✅No Dexmedetomidine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Dexmedetomidine RxCUI 48937 4 dose forms · 11 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 377219 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 0.1 MG/ML RxCUI 1535224 hydrochloride 0.5 MG/ML RxCUI 1535228 0.1 MG/ML RxCUI 1788947
  3. Dose form (SCDF) Oral Gel RxCUI 1732667 No current FDA listing
    Clinical drug / strength (SCD) 0.00009 MG/MG RxCUI 1732668
  4. Dose form (SCDF) Sublingual Film RxCUI 2601118 In current FDA listings
    Clinical drug / strength (SCD) 0.12 MG RxCUI 2601119 0.18 MG RxCUI 2601129

Look up RxCUI 48937 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Dexmedetomidine Brand Names

Dexmedetomidine is sold under 12 brand names in the FDA directory — Dexdomitor, Precedex, Sileo, Dexmedesed and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Dexdomitor Precedex Sileo Dexmedesed Sedexodine Dexased Igalmi Dexmedvet Dexvetra Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Dexmedetomidine Hydrochloride in Sodium Chloride Dexmedetomidine in Dextrose

Who Makes Dexmedetomidine: Manufacturers and Labelers

27 companies list Dexmedetomidine products with the FDA. By number of product records, the largest are Hospira, Inc., Baxter Healthcare Company, Medical Purchasing Solutions, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hospira, Inc. 13 Baxter Healthcare Company 6 Medical Purchasing Solutions, LLC 5 Amneal Pharmaceuticals LLC 4 Gland Pharma Limited 4 Hikma Pharmaceuticals USA Inc. 4 Piramal Critical Care Inc 4 WG Critical Care, LLC 4 Eugia US LLC 3 Mylan Institutional LLC 3 Par Health USA, LLC 3 Precision Dose, Inc. 3 ProPharma Distribution 3 Sandoz Inc. 3 BioXcel Therapeutics, Inc. 2 Civica, Inc. 2 Dr.Reddy's Laboratories Inc 2 Fresenius Kabi USA, LLC 2 Sagent Pharmaceuticals 2 Somerset Therapeutics, LLC 2 Wilshire Pharmaceuticals, Inc. 2 Accord Healthcare Inc. 1 Avenacy Inc. 1 Baxter Healthcare Corporation 1

…and 3 more on the FDA NDC directory.

Dexmedetomidine Drug Class (RxNorm)

Dexmedetomidine belongs to the Central alpha-2 Adrenergic Agonist class.

Pharmacologic class Central alpha-2 Adrenergic Agonist
Drug family (ATC) Other hypnotics and sedatives
How it works Adrenergic alpha2-Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Dexmedetomidine Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 2, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dexmedetomidine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dexmedetomidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
47
Finished products in the current FDA directory
82
Companies listing them (makers, repackagers, distributors)
27
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
WG Critical Care, LLC
Linked label effective
Jun 2, 2026
Composite sections available
24
Linked SPL Set ID
0d2710f2-ee47-4114-ab5c-8dca74cdcb8d
Linked SPL Document ID
42a0bb50-be84-4c46-abfd-fd44c6f10087
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. WG Critical Care, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →