Recommended Topic Related To:

Nicotrol

"Several actions have been taken to reduce tobacco use. Learn how you can help eliminate smoking as the leading preventable cause of disease and death in the world and save lives.

What Is World No Tobacco Day?

World No Tobacco Day (W"...

Nicotrol

Nicotrol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Nicotrol (nicotine inhalation system) is used to aid in smoking cessation. Using a controlled amount of nicotine helps reduce nicotine withdrawal symptoms when you quit smoking. Nicotine is the primary ingredient in tobacco products. Common side effects include headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others.

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. 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. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nicotrol in Detail - Patient Information: Side Effects

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • blisters inside your mouth;
  • fast or pounding heartbeats, fluttering in your chest;
  • extreme weakness or dizziness;
  • severe nausea and vomiting; or
  • bronchospasm (wheezing, tightness in your chest, trouble breathing).

Less serious side effects may include:

  • mild dizziness;
  • dry mouth, upset stomach, burping, or hiccups;
  • muscle or joint pain;
  • 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Nicotrol Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, nausea, mouth/tooth/throat pain, cough, runny/stuffy nose, change in taste, heartburn, hiccups, sweating, or diarrhea may occur. Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Serious side effects are more likely if you continue to smoke while using this product. Do not smoke while you are using this medication.

Stop using this medication and tell your doctor right away if you have any serious side effects, including: severe dizziness, mental/mood changes (e.g., irritability, trouble sleeping, vivid dreams), numbness/tingling in hands/feet, swelling hands/ankles/feet.

Stop using this medication and get medical help right away if you have any very serious side effects, including: chest pain, confusion, severe headache, fast/irregular/pounding heartbeat, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Nicotrol (Nicotine Inhalation System)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Nicotrol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

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.

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) »

A A A

Nicotrol - User Reviews

Nicotrol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Nicotrol sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Smoking Cessation

Get tips, treatments, & motivation.