What the label lists and what reports show
Dexmedetomidine side effects
Dexmedetomidine's FDA label: “The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth.” FAERS holds 6,295 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is bradycardia (471 reports).
- Generic listed
- In shortage
Check it at the source: the dexmedetomidine FDA label on DailyMed (effective May 20, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth.
Table 3: Adverse Reactions with an Incidence >2%-Adult Intensive Care Unit Sedation Population <24 hours 26 subjects in the all PRECEDEX group and 10 subjects in the randomized PRECEDEX group had exposure for greater…
| Adverse Event | All PRECEDEX (N = 1007) (%) | Randomized PRECEDEX (N = 798) (%) | Placebo (N = 400) (%) | Propofol (N = 188) (%) |
|---|---|---|---|---|
| Hypotension | 25% | 24% | 12% | 13% |
| Hypertension | 12% | 13% | 19% | 4% |
| Nausea | 9% | 9% | 9% | 11% |
| Bradycardia | 5% | 5% | 3% | 0 |
| Atrial Fibrillation | 4% | 5% | 3% | 7% |
| Pyrexia | 4% | 4% | 4% | 4% |
| Dry Mouth | 4% | 3% | 1% | 1% |
| Vomiting | 3% | 3% | 5% | 3% |
| Hypovolemia | 3% | 3% | 2% | 5% |
| Atelectasis | 3% | 3% | 3% | 6% |
| Pleural Effusion | 2% | 2% | 1% | 6% |
| Agitation | 2% | 2% | 3% | 1% |
| Tachycardia | 2% | 2% | 4% | 1% |
| Anemia | 2% | 2% | 2% | 2% |
| Hyperthermia | 2% | 2% | 3% | 0 |
| Chills | 2% | 2% | 3% | 2% |
| Hyperglycemia | 2% | 2% | 2% | 3% |
| Hypoxia | 2% | 2% | 2% | 3% |
| Post-procedural Hemorrhage | 2% | 2% | 3% | 4% |
| Pulmonary Edema | 1% | 1% | 1% | 3% |
| Hypocalcemia | 1% | 1% | 0 | 2% |
| Acidosis | 1% | 1% | 1% | 2% |
| Urine Output Decreased | 1% | 1% | 0 | 2% |
| Sinus Tachycardia | 1% | 1% | 1% | 2% |
| Ventricular Tachycardia | <1% | 1% | 1% | 5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 ) • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. ( 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 Hospira, Inc. at 1-800-441-4100, 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. …
Source: FDA drug label, 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?
6,295 reports list dexmedetomidine among the medicines taken, 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. Of the 18 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dexmedetomidine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions