Glypressin Adverse Reactions

The reporting of safety data rely on published literature and post marketing surveillance.
Clinical Trials: Three studies assessed safety as primary outcome in totally 1341 patients.
Caletti 1991, a prospective, uncontrolled observational study, enrolled 1258 patients. 21% of the patients experienced a side-effect. The side-effects reported were consistent with the known pharmacological actions of terlipressin.
Bruha 2009, a randomised, double-blind study enrolled 25 patients that were randomised to either 5-day or 10-day treatment. Serum sodium and serum creatinine decreased in both arms during treatment, but rose again after discontinuation of treatment.
Solà 2010, a retrospective cohort study, included 58 patients. Over a 5 day treatment period 67% of the patients developed acute reduction in serum sodium. The hyponatraemia was found to develop rapidly after start of therapy, but was usually reversible with a median recovery time of 4 days after discontinuation of terlipressin.
The most commonly reported undesirable effects in clinical trials (frequency 1-10%) are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea and headache.
The antidiuretic effect of GLYPRESSIN may cause hyponatraemia unless the fluid balance is controlled. (See table.)

Click on icon to see table/diagram/image

Post-Marketing Experience: The following additional adverse reactions have been reported in post-marketing use: Venticular fibrillation (frequency not known).