Nicotrol Side Effects

Generic Name: nicotine

Please note - some side effects for Nicotrol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nicotrol - for the Consumer

Nicotrol Inhaler

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nicotrol Inhaler:

Anxiety; coughing; diarrhea; flu-like symptoms; headache; hiccups; indigestion; mouth or throat irritation; muscle aches; nausea; pain in the jaw and neck; runny nose; taste changes.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; chest pain; depression; fever; irregular or fast heartbeat; pounding in the chest; severe dizziness or headache; shortness of breath.

Nicotrol NS Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nicotrol NS Spray:

Acne; back pain; burning or irritation of the mouth, nose, or eyes; changes in taste and smell; constipation; cough; earache; flushing of the face; gas; headache; hoarseness; indigestion; irritability; joint pain; mouth sores; nasal ulcers or blisters; nausea; nose bleed; numbness of the mouth; painful menstruation; runny nose; sinus irritation; sneezing; sore throat; stuffy nose; tingling; tooth disorder; watery eyes.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; lightheadedness; memory loss; severe dizziness or headache; shortness of breath; tightness in the chest; tremor.

Nicotrol Side Effects - for the Professional

Nicotrol Inhaler

Assessment of adverse events in the 1,439 patients (730 on active drug) who participated in controlled clinical trials (including three dose finding studies) is complicated by the occurrence of signs and symptoms of nicotine withdrawal in some patients and nicotine excess in others. The incidence of adverse events is confounded by: (1) the many minor complaints that smokers commonly have, (2) continued smoking by many patients and (3) the local irritation from both the active drug and the placebo.

Local Irritation

Nicotrol Inhaler and the placebo were both associated with local irritant side effects. Local irritation in mouth and throat was reported by 40% of patients on active drug as compared to 18% of patients on placebo. Irritant effects were higher in the two pivotal trials with higher doses being 66% on active drug and 42% on placebo. Coughing (32% active versus 12% placebo) and rhinitis (23% active versus 16% placebo) were also higher on active drug. The majority of patients rated these symptoms as mild. The frequency of cough, and mouth and throat irritation declined with continued use of Nicotrol Inhaler. Other adverse events that occurred in over 3% of patients on active drug in placebo controlled pivotal trials considered possibly related to the local irritant effects of the Nicotrol Inhaler are taste comments, pain in jaw and neck, tooth disorders and sinusitis.

Symptoms of withdrawal were common in both active and placebo groups. Common withdrawal symptoms seen in over 3% of patients on active drug included: dizziness, anxiety, sleep disorder, depression, withdrawal syndrome, drug dependence, fatigue and myalgia.

The most common nicotine-related adverse event was dyspepsia. This was present in 18% of patients in the active group compared to 9% of patients in the placebo group. Other nicotine related events present in greater than 3% of patients on active drug include nausea, diarrhea, and hiccup.

Smoking related adverse events present in greater than 3% of patients on active drug include chest discomfort, bronchitis, and hypertension.

Adverse events of unknown relationship to nicotine occurring in greater than 3% of patients on active drug include headache (26% of patients on active and 15% of patients on placebo), influenza-like symptoms, pain, back-pain, allergy, paresthesias, flatulence and fever.

Side Effects by Body System

Cardiovascular

Cardiovascular effects have included increases in heart rate and blood pressure. New ventricular and supraventricular tachycardia, increase in PVC frequency, less supraventricular arrhythmia, less arrhythmia and lower heart rate, new ST segment depression, and an improvement in ST- or T-wave changes have been reported in patients with coronary artery disease given transdermal nicotine for smoking cessation. The average heart rate and incidence of arrhythmias or angina has not been shown to be significantly different from baseline while smoking and during transdermal nicotine therapy in patients with coronary artery disease. In patients with coronary artery disease, nicotine may cause coronary artery vasoconstriction. Myocardial infarction has been rarely associated with the use of nicotine patches. Some of these patients were also smoking (receiving a greater than recommended dose of nicotine) and some may have had underlying coronary artery disease. At least one case of intracerebral hematoma has also been reported.

In patients with coronary artery disease, nicotine may cause coronary artery vasoconstriction. This can be important to patients with ischemic heart disease.

In patients with coronary artery disease given transdermal nicotine for smoking cessation, the following have been reported: new ventricular and supraventricular tachycardia, increase in PVC frequency, less supraventricular arrhythmia, less arrhythmia and lower heart rate, new ST segment depression, and an improvement in ST- or T-wave changes. The average heart rate and incidence of arrhythmias or angina has not been shown to be significantly different from baseline while smoking and during transdermal nicotine therapy in patients with coronary artery disease.

Myocardial infarction has been rarely associated with the use of nicotine patches. Some of these patients were also smoking (receiving a greater than recommended dose of nicotine) and some may have had underlying coronary artery disease.

Respiratory

Respiratory side effects have included bronchospasm in patients with preexisting asthma. It has been associated with the use of nicotine nasal spray and inhaler. Sore throat reported in at least two patients has been associated with the use of the nicotine gums.

Dermatologic

Dermatologic side effects have included itching and local erythema at the patch site in up to half of patients treated. Skin irritation rarely required drug discontinuation. Contact dermatitis due to nicotine or the contents of the nicotine transdermal patch has been reported. Nicotine gum has been associated with increased sweating.

Gastrointestinal

Gastrointestinal side effects have included nausea, dry mouth, dyspepsia, and diarrhea with the patch and gum formulations in approximately 6% of patients. Use of nicotine gum may also cause hiccups, flatulence, increased salivation, stomatitis, tooth disorder, glossitis, and unpleasant taste. The use of nicotine has been shown to decrease lower esophageal sphincter pressure. Heartburn has been associated with nicotine lozenges in 5% to 5.8% of patients.

Nervous system

Nervous system side effects have been reported in 3% to 12% of patients. These have included lightheadedness, headache, sleep disturbances, abnormal dreams, irritability, dizziness, and tremor. Stroke due to severe cerebral artery vasospasm has been reported in a patient with a recent history of subarachnoid hemorrhage shortly after applying a 10 mg nicotine patch.

Musculoskeletal

Musculoskeletal side effects have rarely included arthralgias and myalgias. Jaw pain has been associated with the use of nicotine gum.

Hematologic

Hematologic side effects have included increases in platelet aggregation and enhanced thrombus formation.

Local

Local side effects have been reported most frequently with the use of nicotine nasal spray. Nicotine inhaler also produced local irritant effects including coughing and rhinitis in 40% of patients.

Endocrine

Endocrine side effects have included hyperinsulinemia and insulin resistance during the long-term use of nicotine gum.

Metabolic

Metabolic side effects including at least one case of hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) have been reported.

A 39-year-old male in good health experienced hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) after being administered a nicotine patch. The patient presented complaining of a worsening cough that had progressed over the past month. A chest radiograph showed pneumonia with bilateral lower lobe infiltrates. He was administered a nicotine patch (21 mg/d), ticarcillin/clavulanate, tobramycin, nebulized albuterol, and ipratropium. His urine sodium and osmolarity were 156 mmol/L and 550 mOsm/kg, respectively, confirming the diagnosis of SIADH. On day 12, his serum sodium was 130 mmol/L. The serum sodium continued to decrease despite fluid restriction to 128 mmol/L and 126 mmol/L on Day 14 and 15, respectively. The nicotine patch was reduced to 14 mg/d on Day 16. The patient continued the same fluid restriction and regular diet while the serum sodium remained low at 129 mmol/L. The nicotine patch was further reduced to 7 mg/d on Day 17. The patient was discharged after 18 days of hospitalization with a sodium level of 131 mmol/L.

Ocular

Ocular side effects including vision problems reported in at least two patients have been associated with the use of the nicotine gums.

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