Nicorette Adverse Reactions

Effects of smoking cessation: Regardless of the means used, a variety of symptoms are known to be associated with quitting habitual tobacco use. These include emotional or cognitive effects such as dysphoria or depressed mood; insomnia; irritability, frustration or anger; anxiety; difficulty concentrating, and restlessness or impatience. There may also be physical effects such as decreased heart rate; increased appetite or weight gain, dizziness or presyncopal symptoms, cough, constipation, gingival bleeding or aphthous ulceration, or nasopharyngitis. In addition, and of clinical significance, nicotine cravings may result in profound urges to smoke.
Adverse Drug Reactions: Most of the undesirable effects reported by the subjects occur during the early phase of treatment and are mainly dose dependent.
Allergic reactions (including symptoms of anaphylaxis) occur rarely during use of nicotine products.
Irritation in the mouth and throat may be experienced, however most subjects adapt to this with ongoing use.
The chewing gum may stick to, and may in rare cases damage dentures.
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. (See Table 3.)

Click on icon to see table/diagram/image

Post Marketing Data: Adverse drug reactions (ADRs) first identified during post-marketing experience with nicotine are presented. 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, <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data). (See Tables 4 and 5.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image