Adverse reactions : תופעות לוואי

4.8 Undesirable effects
In placebo-controlled clinical trials for ADHF (REVIVE programme), 53% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, hypotension, and headache.

In a dobutamine-controlled clinical trial for ADHF (SURVIVE), 18% of patients experienced adverse reactions, the most frequent of which were ventricular tachycardia, atrial fibrillation, hypotension, ventricular extrasystoles, tachycardia, and headache.

The following table describes the adverse reactions observed in 1% or greater of patients during REVIVE I, REVIVE II, SURVIVE, LIDO, RUSSLAN, 300105, and 3001024 clinical trials. If the incidence of any particular event in an individual trial was greater than that seen across the other trials, then the higher incidence is reported in the table.

The events considered at least possibly related to levosimendan are displayed by system organ class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 < 1/10).
Table 3
Summary of Adverse Reactions
SURVIVE Clinical Study, REVIVE Programme, and
LIDO/RUSSLAN/300105/3001024 Clinical Studies combined
Body System                  Frequency         Preferred Term
Metabolism and nutrition     Common            Hypokalaemia disorders
Psychiatric disorders        Common            Insomnia
Nervous system disorders     Very Common       Headache
Common            Dizziness
Cardiac disorders            Very Common       Ventricular Tachycardia Common            Atrial Fibrillation
Tachycardia
Ventricular Extrasystoles
Cardiac Failure
Myocardial Ischaemia
Extrasystoles
Vascular disorders           Very Common       Hypotension
Gastrointestinal disorders   Common            Nausea
Constipation
Diarrhoea
Vomiting
Investigations               Common            Haemoglobin Decreased

Post-marketing adverse reactions:
In post-marketing experience, ventricular fibrillation has been reported in patients being administered levosimendan.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il