Nicorette Icy Mint Gum Side Effects

Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent. Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use. Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of Nicorette chewing gum.
As would be expected, the types of adverse reactions seen for the chewing gum in clinical trials are similar to those associated with nicotine administered by other means.
Clinical Trial Data: The safety of nicotine from clinical trial data is based on data on a meta-analysis of randomized clinical trials (RCTs) for the treatment of smoking cessation.
ADRs with oral formulations identified from clinical trials are presented as follows in Table 2. (See Table 2.)

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Post Marketing Data: Adverse drug reactions first identified during post-marketing experience with nicotine are presented in Table 3. Frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and < 1/10; Uncommon ≥1/1,000 and < 1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data). (See Table 3.)

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Undesirable effects that may arise from combination treatment (chewing gum and patch) differ from each treatment alone only with regards to local undesirable effects that may be attributed to pharmaceutical form. The frequency of these undesirable effects is comparable with that given in the summary of product characteristics for the respective product.