Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Gastrointestinal disorders
Very common (> 1/10): diarrhea, abdominal pain.
Common (> 1/100 and < 1/10): frequent bowel movements, flatulence.
As a rule, these effects abate with continuing treatment. In some cases, diarrhea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
Pigmentation of the colorectal mucosa (melanosis coli) was rarely observed.
Hepatobiliary disorders
Uncommon (≥ 1/1000 and < 1/100): Cases of elevated hepatic enzymes in serum.
Skin and subcutaneous tissue disorders:
Common (> 1/100 and < 1/10): pruritus, rash, eczema.
Other:
Dark urine related to the structure of the molecule and without pathological value can be observed.

Post-marketing surveillance
Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein. Most of them occurred during the first months of treatment. Patients should be monitored for signs and symptoms of hepatic injury.

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=AdversEffectMedic @moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL)