What the label lists and what reports show
Sufentanil side effects
Sufentanil's FDA label: “Most common adverse reactions were apnea, rigidity, and bradycardia.” FAERS holds 1,247 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 anaphylactic shock (229 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the sufentanil FDA label on DailyMed (effective June 1, 2026, Hospira, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions were apnea, rigidity, and bradycardia.
From the label: adverse reactions, continuedThe following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Skeletal Muscle Rigidity and Skeletal Muscle Movement [see Warnings and Precautions (5.5) ] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Severe Cardiovascular Depression [see Warnings and Precautions (5.6) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.7) ] • Serotonin Syndrome [see Warnings and Precautions (5.8) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.11) ] • Seizures [see Warnings and Precautions (5.12) ] Most common adverse reactions were apnea, rigidity, and bradycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 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 reaction 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. …
Source: FDA drug label, Hospira, Inc., effective June 1, 2026 (SPL set 20293943-46ff-4345-1aa4-929b4e017a25), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,247 reports list sufentanil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 179 are coded as a death and 499 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 24 reactions below, 2 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?
- Sufentanil: 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