Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions for granisetron are headache and constipation, which may be transient. ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).
Tabulated list of adverse reactions
The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with granisetron and other 5-HT3 antagonists.
Frequency categories are as follows:
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 (<1/10,000)
Immune system disorders
Uncommon          Hypersensitivity reactions e.g. anaphylaxis, urticaria Psychiatric disorders
Common            Insomnia
Nervous system disorders
Very common Headache
Uncommon          Extrapyramidal Reactions
Uncommon          Serotonin Syndrome (see also sections 4.4 and 4.5)
Cardiac disorders
Uncommon         QT prolongation
Gastrointestinal disorders
Very common Constipation
Common           Diarrhoea
Hepatobiliary disorders
Common           Elevated hepatic transaminases*
Skin and subcutaneous tissue disorders
Uncommon         Rash
*Occurred at a similar frequency in patients receiving comparator therapy 
Description of selected adverse reactions
As for other 5-HT3 antagonists, ECG changes including QT prolongation have been reported with granisetron (see sections 4.4 and 4.5).

As with other 5-HT3 antagonists, cases of serotonin syndrome (including altered mental status, autonomic dysfunction and neuromuscular abnormalities) have been reported following the concomitant use of granisetron and other serotonergic drugs (see sections 4.4 and 4.5).

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. 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
Additionally, you can also report to Padagis via the following address: Padagis.co.il.