The following clinically significant adverse reactions are described elsewhere in the labeling:
The following adverse reactions associated with the use of Ketamine Hydrochloride Injection 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.
Immune system disorders: Anaphylaxis.
Neurologic disorders: Emergence reactions (post-operative delirium), [see Warnings and Precautions (5.2)]. During administration, enhanced muscle tone and spasms (resembling a partial motor or generalized motor seizure).
Psychiatric disorders: Adverse psychiatric events have occurred and/or persisted days to weeks after ketamine exposure.
Renal and urinary disorders: In individuals with a history of long-term ketamine use or abuse, urinary tract complications related to cystitis, reduced bladder capacity, ureteral stenosis (strictures), ureteral obstruction, and hydronephrosis have been reported [see Warnings and Precautions (5.7)]. Cystitis (including cystitis non-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) and reduced bladder capacity may present with genitourinary pain, dysuria, increased urinary frequency, urgency, urge incontinence, and hematuria. Ureteral stenosis (strictures), ureteral obstruction, and hydronephrosis may present with flank and/or pelvic pain, recurrent urinary tract infections, hematuria, nausea and vomiting, and acute kidney injury.
Respiratory disorders: Respiratory depression and apnea following rapid intravenous administration of high doses of ketamine hydrochloride injection; laryngospasm, and airway obstruction.
Skin and subcutaneous tissue disorders: Transient erythema and/or morbilliform rash.
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