Remitch Adverse Reactions

Improvement of pruritus in hemodialysis patients: Confirmatory study, adverse reactions were reported in 25.0% of patients (28/112) in the 2.5 μg group and 35.1% of patients (40/114) in the 5 μg group. The major adverse reactions in the 2.5 μg group were insomnia in 7.1% of patients (8/112), sleepiness in 4.5% (5/112), constipation and prolactin increased each in 2.7% (3/112); the major adverse reactions in the 5 μg group were insomnia in 14.0% (16/114), constipation in 7.0% (8/114), sleepiness in 3.5% (4/114), itching aggravated, prolactin increased, and thyroid stimulating hormone increased each in 2.6% (3/114). Long-term administration study, adverse reactions were reported in 48.8% of patients (103/211). The major adverse reactions were insomnia in 20.4% of patients (43/211), constipation in 7.1% (15/211), prolactin increased in 3.3% (7/211), and sleepiness in 2.4% (5/211).
Clinically significant adverse reactions: Hepatic function disorder, Jaundice (both incidence unknown): Hepatic function disorder accompanied by markedly increased AST, ALT, Al-P and γ-GTP, and jaundice may occur. (See Table 15.)

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