What the label lists and what reports show
Propofol side effects
Propofol's FDA label: “The most common adverse reactions >1% were bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and …” FAERS holds 36,431 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 hypotension (2,932 reports).
- Generic listed
Check it at the source: the propofol FDA label on DailyMed (effective September 11, 2025, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions >1% were bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia.
From the label: adverse reactions, continuedThe following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] • Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] • Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. 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. Anesthesia and MAC Sedation in Adults The following estimates of adverse events for DIPRIVAN include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective September 11, 2025 (SPL set e3105799-a4b6-f3f4-e6e2-b2b29bbdb538), via openFDA; the full label on DailyMed
What do FAERS reports show?
36,431 reports list propofol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,941 are coded as a death and 15,592 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 22 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?
- Propofol: 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