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NICOTROL® NS Adverse Reactions (nicotine)

ADVERSE REACTIONS

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 (See DRUG ABUSE AND DEPENDENCE).

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 EventActivePlacebo
HEADACHE18%15%
BACK PAIN6%4%
DYSPNEA5%6%
NAUSEA5%5%
ARTHRALGIA5%1%
MENSTRUAL DISORDER4%4%
PALPITATION4%4%
FLATULENCE4%3%
TOOTH DISORDER4%1%
GUM PROBLEMS4%1%
MYALGIA3%4%
ABDOMINAL PAIN3%3%
CONFUSION3%3%
ACNE3%1%
DYSMENORRHEA3%0%
PRURITUS2%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

Adverse reactions not listed above that have been identified during post-marketing experience with the nicotine nasal spray formulation are listed below:

General disorders and administration site conditions: chest pain
Immune system disorders: anaphylactic reaction
Gastrointestinal disorders: dysphagia

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