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Nicotrol (Nicotine Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

Withdrawal

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.

Nicotine-Related Adverse Events

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

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

Other Adverse Events

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.



REPORTS OF SUSPECTED NICOTROL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nicotrol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nicotrol side effects / adverse reactions in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 64 year old female weighing 57.4 kg (126.3 pounds)

Reactions: Pruritus, Ageusia, Oedema Peripheral, Feeling Abnormal

Adverse event resulted in: hospitalization

Suspect drug(s):
Nicotrol
    Indication: Smoking Cessation Therapy
    Start date: 2011-09-27
    End date: 2011-09-27

Nicotine
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Corticosteroid; Valium; Klonopin; Synthroid



Possible Nicotrol side effects / adverse reactions in 78 year old female

Reported by a consumer/non-health professional from United States on 2011-11-10

Patient: 78 year old female

Reactions: Dyspnoea, Drug Intolerance, Cough

Suspect drug(s):
Nicotrol



Possible Nicotrol side effects / adverse reactions in 78 year old female

Reported by a consumer/non-health professional from United States on 2011-11-14

Patient: 78 year old female

Reactions: Dyspnoea, Drug Intolerance, Cough

Suspect drug(s):
Nicotrol



See index of all Nicotrol side effect reports >>

Drug label data at the top of this Page last updated: 2013-06-19

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