KETALAR SIDE EFFECTS

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hemodynamic Instability
• Emergence Reactions
• Respiratory Depression
• Pediatric Neurotoxicity
• Drug-Induced Liver Injury

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.

Administration site disorders: Local pain and exanthema at the injection site.

Immune system disorders: Anaphylaxis.

Neurologic disorders: Emergence reactions (post-operative delirium). 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 history of chronic ketamine use or abuse, lower urinary tract and bladder symptoms including dysuria, increased urinary frequency, urgency, urge incontinence, and hematuria have been reported. In addition, diagnostic studies performed to assess the cause of these symptoms have reported cystitis (including cystitis non-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) as well as hydronephrosis and reduced bladder capacity.

Respiratory disorders: Respiratory depression and apnea following rapid intravenous administration of high doses of KETALAR; laryngospasm, and airway obstruction.

Skin and subcutaneous tissue disorders: Transient erythema and/or morbilliform rash