FAQ

What are the safety classes and the recommended action(s) per class?

Safety class Description Action
Safe The drug has been evaluated in patients with liver cirrhosis, and no increase in harm was found compared to persons without liver cirrhosis. The safety of the drug is supported by pharmacokinetic studies and/or safety studies over a long period. It might be necessary to use an adjusted dose. This drug can be used in patients with liver cirrhosis.
No additional risks known Limited data suggests that this drug does not increase harm in patients with liver cirrhosis in comparison with persons without liver cirrhosis. It might be necessary to use an adjusted dose.

The drug can be used in patients with liver cirrhosis.

Adverse drug reactions need to be monitored.
Additional risks known Limited data suggests an increase in patient harm in patients with liver cirrhosis compared to persons without liver cirrhosis. However, the number of studies is limited and/or the studies show contradicting results about the safety in patients with liver cirrhosis.

This drug should preferably not be used in patients with liver cirrhosis if there is a safer alternative available.

Adverse drug reactions need to be monitored.
Unsafe Data indicate this drug is not safe in patients with liver cirrhosis. This drug should be avoided in patients with liver cirrhosis.
Unknown For this drug, insufficient data are available to evaluate the safety in patients with liver cirrhosis.

This drug should preferably not be used in patients with liver cirrhosis if there is a safer alternative available.

Individual judgement of therapeutic need vs. additional risks in patients with liver cirrhosis.

Adverse drug reactions need to be monitored.