Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The evaluation of undesirable effects is based on the following frequency data: 
Very common (1/10)
Common (1/100 to <1/10)
Uncommon (1/1,000 to <1/100)
Rare (1/10,000 to <1/1,000)
Very rare / Not known (<1/10,000 / cannot be estimated from available data) 
Gastrointestinal disorders:
In clinical trials, reports of soft stools or diarrhoea during UDCA therapy were common.
Very rarely, severe right upper abdominal pain has occurred during the treatment of PBC.

Hepatobiliary disorders:
During treatment with UDCA, calcification of gallstones can occur in very rare cases.
During therapy of the advanced stages of PBC, in very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.

Skin and subcutaneous tissue disorders:
Very rarely, urticaria can occur.

Reporting of suspected adverse reactions
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. Healthcare professionals are asked to report any suspected adverse reactions.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffect Medic@moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).