Kytril Adverse Reactions

Clinical Trials: Summary of the safety profile: The most frequently reported adverse reactions for Kytril are headache and constipation which may be transient. ECG changes including QT prolongation have been reported with Kytril (see Precautions and Interactions).
The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with Kytril.
Frequency categories are as follows: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare (<1/10,000). (See table.)

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Kytril has been well tolerated in human studies. In common with other drugs of this class, headache and constipation have been reported. Cases of hypersensitivity reactions, including rashes and anaphylaxis have been reported. Elevations in hepatic transaminases have been observed and at similar frequency in patients receiving comparator therapy.
As for other 5-HT₃ antagonists, cases of ECG modifications including QT prolongation have been reported with KYTRIL. These ECG changes with KYTRIL were minor and generally not of clinical significance, specifically with no evidence of proarrhythmia.
As with other 5-HT₃ antagonists, cases of serotonin syndrome (including altered mental status, autonomic dysfunction and neuromuscular abnormalities) have been reported following the concomitant use of Kytril and other serotonergic drugs (see Precautions and Interactions).
Post Marketing: The post-marketing safety experience in over 4 million patients is consistent with the clinical trial safety information.
For ECG modifications, see Clinical Trials previously mentioned.
For serotonin syndrome, see Clinical Trials previously mentioned.