Nicotrol Side Effects Center

Last updated on RxList: 6/27/2022
Nicotrol Side Effects Center

What Is Nicotrol?

Nicotrol (nicotine inhalation system) contains nicotine, the primary ingredient in tobacco products, and is used to aid in smoking cessation. Using a controlled amount of nicotine helps reduce nicotine withdrawal symptoms when you quit smoking.

What Are Side Effects of Nicotrol?

Common side effects of Nicotrol include:

Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Nicotrol

The initial dosage of Nicotrol Inhaler is individualized. The recommended dosing is between 6 and 16 cartridges a day for up to 12 weeks, followed by a gradual reduction.

What Drugs, Substances, or Supplements Interact with Nicotrol?

Nicotrol may interact with imipramine, oxazepam, propranolol, labetalol, prazosin, theophylline, pentazocine, or insulin. Tell your doctor all medications you use. Nicotine and smoking may harm a fetus.

Nicotrol During Pregnancy or Breastfeeding

If you are pregnant, try to stop smoking without using a nicotine replacement product if possible. During pregnancy, Nicotrol should be used only when prescribed. Nicotine from smoking and from this medication passes into breast milk and could have undesirable effects on a nursing infant. Smoking near an infant can also harm the infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop using this medication.

Additional Information

Our Nicotrol (nicotine inhalation system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Nicotrol Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest;
  • blisters inside your mouth;
  • problems with your teeth or jaw; or
  • wheezing, tightness in your chest, trouble breathing.

Common side effects may include:

  • dizziness;
  • dry mouth, upset stomach, burping, or hiccups;
  • mouth or throat soreness;
  • changes in taste; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nicotrol (Nicotine Inhalation System)


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Nicotrol Professional Information


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 (nicotine inhalation system) 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 (nicotine inhalation system) 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 (nicotine inhalation system) 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.

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.

Drug Abuse And Dependence

NICOTROL (nicotine inhalation system) Inhaler is likely to have a low abuse potential based on differences between the product and cigarettes in three characteristics commonly considered important in contributing to abuse: slower absorption, smaller fluctuations in blood levels and lower blood levels of nicotine. NICOTROL Inhaler, like many other nicotine-based smoking cessation therapies, does not produce arterial concentrations similar to cigarettes. However, nicotine withdrawal symptoms were noted in clinical trials at the time of NICOTROL (nicotine inhalation system) Inhaler tapering and after NICOTROL (nicotine inhalation system) Inhaler discontinuation.

Dependence might occur from transference of tobacco-related nicotine dependence to the NICOTROL (nicotine inhalation system) Inhaler. The use of the inhaler beyond 6 months has not been evaluated in clinical trials and is not recommended. To minimize the risk of dependence, patients should be encouraged to withdraw gradually from NICOTROL (nicotine inhalation system) Inhaler therapy after 3 months of usage (See DOSAGE AND ADMINISTRATION). If necessary, dose reduction can be achieved by gradual reduction of the dose over a 6 to 12 week period.

Read the entire FDA prescribing information for Nicotrol (Nicotine Inhalation System)

© Nicotrol Patient Information is supplied by Cerner Multum, Inc. and Nicotrol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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