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 frequently reported undesirable effects in clinical trials are abdominal pain, nausea, diarrhoea, pallor, dyspnoea (for type 1 HRS), respiratory failure (for type 1 HRS), vomiting, and bradycardia.
The antidiuretic effect of terlipressin may cause hyponatraemia unless the fluid balance is controlled. There are adverse reactions that appear twice in the table, as the estimated frequencies differ between indications. (See table.)

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Description of selected adverse reactions: Safety related to method of administration: Based on results from a dedicated randomised controlled multicentre trial, administration of terlipressin as continuous IV infusion may be associated with lower rates of severe adverse events than with administration by IV bolus (see Dosage & Administration and Pharmacology: Pharmacodynamics under Actions).
Post-Marketing Experience: The following additional adverse reactions have been reported in post-marketing use: Ventricular fibrillation (frequency not known).