What the label lists and what reports show
Ketamine side effects
Ketamine's FDA label: “The most common adverse reactions are emergence reactions and elevated blood pressure and pulse ( 6 ).” FAERS holds 4,846 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 infusion site pain (733 reports).
- Generic listed
- A presentation discontinued
- DEA Schedule III
Check it at the source: the ketamine FDA label on DailyMed (effective March 27, 2026, Par Health USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are emergence reactions and elevated blood pressure and pulse ( 6 ).
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hemodynamic Instability [see Warnings and Precautions ( 5.1 )] Emergence Reactions [see Warnings and Precautions ( 5.2 )] Respiratory Depression [see Warnings and Precautions ( 5.3 )] Pediatric Neurotoxicity [see Warnings and Precautions ( 5.5 )] Drug-Induced Liver Injury [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of KETALAR were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: Elevated blood pressure, heart rate, and cardiac index; decreases in blood pressure and heart rate; arrhythmias; cardiac decompensation (in patients with suspected catecholamine depletion). Eye disorders: Diplopia, nystagmus, elevation in intraocular pressure. Gastrointestinal disorders: Anorexia, nausea, vomiting; hepatobiliary dysfunction, biliary duct dilatation, biliary duct stricture and/or stenosis with or without evidence of biliary obstruction; secondary sclerosing cholangitis [see Warnings and Precautions ( 5.6 )]. Administration site disorders: Local pain and exanthema at the injection site. …
Source: FDA drug label, Par Health USA, LLC, effective March 27, 2026 (SPL set 14e8f864-8b8a-4e7e-8439-e510d3107063), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,846 reports list ketamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 539 are coded as a death and 1,529 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. Reports rose sharply in 2025 (1,105, against a median of 143 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 3 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?
- Ketamine: 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