Nicorette Adverse Reactions

Nicorette Invisi Transdermal Patch & Nicorette Icy Mint Medicated Chewing Gum: Like all medicines, Nicorette Invisi Transdermal Patch/Nicorette Icy Mint Gum can cause side effects. As many of the effects are due to nicotine, they can also occur when nicotine is obtained by smoking.
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.
As would be expected, the types of adverse reactions seen for nicotine in clinical trials are similar to those associated with nicotine administered by other means.
Nicorette Invisi Transdermal Patch: About 20% of users experienced mild local skin reactions during the first weeks of treatment.
Nicorette Icy Mint Medicated Chewing Gum: 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.
Adverse Drug Reactions (ADRs) with patch/oromucosal formulations identified from clinical trials are presented as follows.
Nicorette Invisi Transdermal Patch: (See Table 5.)

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Nicorette Icy Mint Medicated Chewing Gum: (See Table 6.)

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Post Marketing Data: Adverse drug reactions (ADRs) first identified during post-marketing experience with nicotine are presented as follows. Frequencies are given 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).
Frequency categories are estimated from clinical trials.
Nicorette Invisi Transdermal Patch: Frequency category: Common Undesirable Effects: Rash**, Urticaria** (hives).
Frequency category: Uncommon Undesirable Effects: Palpitations**, Tachycardia**, Application site reactions, Asthenia** (abnormal body weakness), Chest discomfort and pain**, Malaise**, Myalgia* (muscle pain), Abnormal dream**,***, Dyspnoea** (shortness of breath), Hyperhidrosis** (increased sweating), Flushing**, Hypertension** (high blood pressure).
Frequency category: Not known Undesirable Effects: Gastrointestinal discomfort*, Anaphylactic reaction**, Pain in extremity, Angioedema**, Erythema**, Seizure**.
Notes: * In vicinity/region of patch.
** systemic effects.
*** systemic effect, identified only for formulations administered during night.
Nicorette Icy Mint Medicated Chewing Gum: Frequency category: Common Undesirable Effects: Diarrhoea^#.
Frequency category: Uncommon Undesirable Effects: Palpitations**, Tachycardia**, Eructation (belching), Glossitis (inflammation of the tongue), Oral mucosal blistering and exfoliation, Paraesthesia oral^# (prickling/tingling sensation in the mouth), Asthenia**(abnormal body weakness), Chest discomfort and pain**, Malaise**, Pain in Jaw*, Abnormal dream**,***, Bronchospasm, Dysphonia, Dyspnoea** (shortness of breath), Nasal congestion, Oropharyngeal pain, Sneezing, Throat tightness, Hyperhidrosis**, Pruritus**, Rash**, Urticaria**, Flushing**, Hypertension**.
Frequency category: Rare Undesirable Effects: Dysphagia (difficulty in swallowing), Hypoaesthesia oral^# (numbness in the mouth area), Retching.
Frequency category: Not known Undesirable Effects: Blurred vision, Lacrimation increased, Dry throat, Gastrointestinal discomfort**, Lip pain, Anaphylactic reaction**, Muscle tightness*, Angioedema**, Erythema**, Seizure**.
Notes: * Tightness of jaw and pain in jaw with nicotine gum formulation.
** systemic effects.
*** systemic effect, identified only for formulations administered during night.
^# reported the same or less frequently than placebo.