Dexmedetomidine: uses, dosing, side effects & brands
Dexmedetomidine is a central alpha-2 adrenergic agonist sold in the U.S. under 3 brand and generic names, for pain and psychomotor agitation. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Central Alpha-2 Adrenergic Agonist
- Treats (across its forms)
- Pain and Psychomotor Agitation
- Available as
- Injectable · Solution · Film
- Sold as
- 3 products — Dexmedetomidine Hydrochloride, Precedex and Igalmi
- Prescription?
- Prescription only
- Generic available?
- Yes
How Dexmedetomidine Hydrochloride is dosed
From the FDA label for Dexmedetomidine Hydrochloride (application ANDA202585). Other dexmedetomidine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2 DOSAGE & 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/50mL and 400 mcg/100 mL single-dose bottles, 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 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 to 1 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…
Everything below is the FDA label for Dexmedetomidine Hydrochloride (injectable, solution). Dexmedetomidine is also sold as film, and those are different medicines to take — follow the label for the one you were prescribed.
Dexmedetomidine Hydrochloride side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [ see Warnings and Precautions (5.2) ] • Transient hypertension [ see Warnings and Precautions (5.3) ] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. (6.1) • Adverse reactions in adults associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of adult patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for sedation in the Intensive Care Unit setting in which 1,007 adult patients received…
Who shouldn’t take Dexmedetomidine Hydrochloride
None None. (4)
Dexmedetomidine Hydrochloride 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 hydrochloride in 0.9% sodium chloride injection and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 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.
Every dexmedetomidine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | No data | — | View → | |
| 2 | 60/100 | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Film | No data | — | View → |
Dexmedetomidine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long dexmedetomidine keeps
No dexmedetomidine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does dexmedetomidine expire? The in-use limits and storage rules from its labelsDexmedetomidine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dexmedetomidine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited data indicate that very small amounts of dexmedetomidine are excreted into breastmilk for 4 to 6 hours after the end of an intravenous infusion. The drug is absent from breastmilk by 24 hours after the end of an infusion. The amounts in milk after sublingual use are expected to be less than after intravenous infusion. Because of the low dose in milk and its poor oral bioavailability, dexmedetomidine would not be expected to cause adverse effects in breastfed infants or neonates. Monitor the breastfed infant for irritability during sublingual use.
National Institute of Child Health and Human Development, record revised February 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dexmedetomidine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,831 reports naming dexmedetomidine, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- bradycardia188 reports
- hypotension94 reports
- product administered to patient of inappropriate age71 reports
- pyrexia69 reports
- oxygen saturation decreased57 reports
- diabetes insipidus55 reports
- arteriospasm coronary50 reports
- agitation48 reports
Read these as a signal, not a rate. A report does not mean dexmedetomidine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Dexmedetomidine Hydrochloride?
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine.
What kind of drug is dexmedetomidine?
The FDA classifies dexmedetomidine as a central alpha-2 adrenergic agonist. These drugs activate alpha-2 receptors in the brainstem, which tells the nervous system to send out less norepinephrine and reduce sympathetic (fight-or-flight) signaling to the body. With less of this stimulation, blood vessels relax and heart rate slows, lowering blood pressure. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dexmedetomidine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dexmedetomidine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is dexmedetomidine sold under?
We track 3 dexmedetomidine-containing products in the U.S.: Dexmedetomidine Hydrochloride, Precedex and Igalmi. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does dexmedetomidine come in?
Across the brands we track, dexmedetomidine is currently marketed as injectable, solution and film, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dexmedetomidine?
Yes. Our catalog lists 1 generic dexmedetomidine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has dexmedetomidine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions dexmedetomidine. The most recent: dexmedeTOMIDine HCl PF (Mar 31, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dexmedetomidine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dexmedetomidine
- MLA
- “Dexmedetomidine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dexmedetomidine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dexmedetomidine on DailyMed (NIH) ↗.