Nicotrol NS Side Effects

Generic Name: nicotine

Please note - some side effects for Nicotrol NS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nicotrol NS - for the Consumer

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Nicotrol NS Spray:

Severe allergic reactions (rash; hives; itching; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nicotrol NS Side Effects - for the Professional

Nicotrol NS

Assessment of adverse events in the 730 patients who participated in controlled clinical trials 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 the many minor complaints that smokers commonly have, by continued smoking by many patients and the local irritation from both active drug and the pepper placebo. No serious adverse events were reported during the trials.

Common Smoker's Complaints

Common complaints experienced by the smokers in the study (users of both active and placebo spray) include: chest tightness, dyspepsia, paraesthesia (tingling) in limbs, constipation, and stomatitis.

Tobacco Withdrawal Symptoms

Symptoms of tobacco withdrawal were frequent in users of both active and placebo sprays. Common withdrawal symptoms seen in over 5% of patients included: anxiety, irritability, restlessness, cravings, dizziness, impaired concentration, weight increase, emotional lability, somnolence and fatigue, increased sweating, and insomnia. Less frequently seen probable withdrawal symptoms (under 5%) included: confusion, depression, apathy, tremor, increased appetite, incoordination and increased dreaming.

Anxiety, irritability, restlessness and tobacco cravings occurred about equally in both groups, while other symptoms tended to be slightly more common on placebo spray.

Effects of the Spray

Nicotrol NS and the pepper-containing placebo were both associated with irritant side effects on the nasopharyngeal and ocular tissues. During the first 2 days of treatment, nasal irritation was reported by nearly all (94%) of the patients, the majority of whom rated it as either moderate or severe. Both the frequency and severity of nasal irritation declined with continued use of Nicotrol NS but was still experienced by most (81%) of the patients after 3 weeks of treatment, with most patients rating it as moderate or mild.

Other common side-effects for both active and placebo groups were: runny nose, throat irritation, watering eyes, sneezing, and coughing.

The following local events were reported somewhat more commonly for active than for placebo spray: nasal congestion, subjective comments related to the taste or use of the dosage form, sinus irritation, transient epistaxis, eye irritation, transient changes in sense of smell, pharyngitis, paraethesias of the nose, mouth or head, numbness of the nose, or mouth, burning of the nose or eyes, earache, facial flushing, transient changes in sense of taste, hoarseness, nasal ulcer or blister.

Effects of Nicotine

Feelings of dependence on the spray were reported by more patients on active spray than placebo. Drug-like effects such as calming were also more frequent on active spray..

Other Adverse Effects

Adverse events which could not be classified and listed above and which were reported by >1% of patients on active spray are listed in the following table:

Adverse Events Not Attributable to Intercurrent Illness

Adverse Event	Active	Placebo
HEADACHE	18%	15%
BACK PAIN	6%	4%
DYSPNEA	5%	6%
NAUSEA	5%	5%
ARTHRALGIA	5%	1%
MENSTRUAL DISORDER	4%	4%
PALPITATION	4%	4%
FLATULENCE	4%	3%
TOOTH DISORDER	4%	1%
GUM PROBLEMS	4%	1%
MYALGIA	3%	4%
ABDOMINAL PAIN	3%	3%
CONFUSION	3%	3%
ACNE	3%	1%
DYSMENORRHEA	3%	0%
PRURITUS	2%	3%

Adverse events reported with a frequency of <1% among active spray users are listed below:

Body as a Whole: edema peripheral, pain, numbness, allergy
Gastrointestinal: dry mouth, hiccup, diarrhea
Hematologic: purpura
Neurological: aphasia, amnesia, migraine, numbness
Respiratory: bronchitis, bronchospasm, sputum increased
Skin and appendages: rash, purpura
Special Senses: vision abnormal

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Side Effects by Body System - for Healthcare Professionals

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. Gastrointestinal side effects associated with nicotine gum reported postmarketing have included oral blistering.

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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