Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The list of the following adverse effects relates to those experienced with topical oral salicylates at OTC doses, in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Adverse events which have been associated with salicylates are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and<1/100), rare (≥1/10,000 and <1/1000), very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are 

presented in order of decreasing seriousness.
There have been post-marketing reports of cases of suspected Reyes syndrome and possible salicylate toxicity in children who had a history of use of choline salicylate gels but causality has not been established.

System Organ Class                   Frequency                            Adverse Events Immune system disorders              Not known                            Hypersensitivity Nervous system disorders             Not known                            Paraesthesia (transient numbing and stinging)
Respiratory, thoracic and            Not known                            Bronchospasm and asthma1 mediastinal disorders
Gastrointestinal disorders           Not known                            Stomatitis 

Description of Selected Adverse Reactions
1 Salicylates
may precipitate bronchospasm and induce asthma attacks in susceptible patients. They can cause stomatitis, burns and allergic reactions.

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/