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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: nicotine (NICK o teen)
GENERIC: available FAMILY: Nicotine Products
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Because smoking is extremely dangerous to the developing fetus, the safest thing you can do is not smoke while pregnant (or afterward). Educational and behavioral methods to quit smoking are the best choice. If you cannot stop smoking on your own, use this medicine, if advised to do so by your doctor.

Breast-feeding Warning

No information is available from either human or animal studies. However, since nicotine is excreted into breast milk and could harm your infant, you should consult with your doctor if you are planning to nurse.

Safety Warnings For This Drug [top]


Nicotine has only been shown to be effective when used as an aid to a comprehensive smoking cessation program. Since the above products contain nicotine, do not continue to smoke while using them.

Facts About This Drug [top]

Nicotine, whether in a patch, gum, inhaler, or nasal spray, is used to assist in quitting smoking. This is the same nicotine found in tobacco, pesticides, and some foods. In these products, nicotine serves as a temporary aid to giving up smoking by reducing physical withdrawal symptoms. However, unless the nicotine product is accompanied by a smoking cessation program, the drug works no better than a placebo,[1] because it is treating only the physical, not the psychological addiction.


Nicotine, whether in a patch, gum, inhaler, or nasal spray, is used to assist in quitting smoking. This is the same nicotine found in tobacco, pesticides, and some foods. In these products, nicotine serves as a temporary aid to giving up smoking by reducing physical withdrawal symptoms. However, unless the nicotine product is accompanied by a smoking cessation program, the drug works no better than a placebo,[1] because it is treating only the physical, not the psychological addiction.

Withdrawal signs from smoking include fatigue, headache, slowed heart rate, hunger, difficulty concentrating, irritability, and dreams about smoking. These symptoms start about two hours after the last cigarette, increase for 24 hours, then decrease over several days or weeks.[2] Signs of withdrawal do not require medical attention. Even people who have severe withdrawal are able to quit successfully.[3],[4]

Aids are simple to use and can lull you into unrealistic expectations. To be effective, the use of nicotine products must be accompanied by changes in behavior. Set a quit date, learn ways to cope with urges to smoke (particularly in the morning, with company, and in response to advertising), and plan ways to cope with relapses.[5] Learn how to deal with anger, anxiety, depression, stress, and tension without smoking. People who smoke are more apt to have a history of being depressed.[6] In addition, those who are anxious or depressed tend to have severe withdrawal.[7],[3] Without learning these coping skills, the patch does not work any better than a nonmedicated Band-Aid. While these aids eliminate smoke, they still contain nicotine. If you continue to smoke while using nicotine replacements, you risk serious heart disease.[1] Success rates of stopping smoking by using nicotine replacements are low, especially after six months or a year.[8],[9],[10],[11],[12],[13] However, smokers who try slow withdrawal are apt to smoke less if they do resume smoking.[8],[2]

Nicotine gum continues to satisfy and reinforce oral habits and may lessen weight gain.[14] The gum is harder and thicker than regular chewing gums and can loosen dental work. Not everyone masters the chewing technique. Patches are easier to use. The 16-hour patch mimics patterns of smoking, but the 24-hour patches may get you through the strong urge to smoke in the morning. Both types can irritate your skin. Overall, the various patches do not differ in the rate of people who quit smoking.[15],[16],[17]

You must also gradually stop using nicotine-containing products to prevent addiction to these nicotine products. Quitting smoking reduces your chances of bronchitis, cancers (especially of the lung, mouth, throat, and voice box), emphysema, heart disease, duodenal ulcers, and dulled sense of smell and taste. People who smoke and take psychotropic drugs often require higher doses of the nicotine and are more apt to have serious adverse effects from the psychotropic drugs, such as akathisia (involuntary restlessness, such as rocking from foot to foot).[18],[19] Typically, the amount of weight gain after stopping smoking is a minimal health risk compared to the risks of smoking.[14]

Although most people quit smoking without the aid of organized programs, we recommend such a program, especially if you are using these products. Nicotine replacement is not appropriate for light smokers. A number of nonprescription aids to smoking cessation are also available, including plain chewing gum. According to one study, these work just as well as nicotine replacements for light smokers, in the absence of a comprehensive smoking cessation program.[20] These also are only temporary aids and must be augmented by changes in behavior to be successful.

Before You Use This Drug [top]

Do not use if you have or have had:

  • allergy or hypersensitivity to nicotine
  • allergy or hypersensitivity to menthol (nicotine inhaler)
  • severe or worsening angina
  • life-threatening heart rhythm problems
  • recent heart attack
  • recent stroke
  • pregnancy (nicotine inhaler)
  • chronic nasal disorders (nicotine nasal spray)
    • allergy
    • nasal polyps
    • stuffy nose
    • sinus problems

Tell your doctor if you have or have had:

  • pregnancy or are breast-feeding
  • allergies to drugs
  • angina
  • heart problems
  • Buerger’s disease
  • Prinzmetal’s angina
  • Raynaud’s disease
  • asthma
  • chronic obstructive pulmonary disease (nicotine inhaler)
  • diabetes
  • hyperthyroidism
  • pheochromocytoma
  • liver problems
  • high blood pressure
  • peptic ulcer
  • common cold (nicotine nasal spray)
  • stuffy nose (nicotine nasal spray)
  • dental problems (nicotine gum)
  • temporomandibular (TMJ) disorder (nicotine gum)
  • esophagitis (nicotine gum)
  • throat or mouth inflammation (nicotine gum)
  • skin disease (nicotine patch)

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

For all forms of nicotine replacement therapy:

  • Do not smoke.
  • Do not use during pregnancy.
  • Participate in a smoking cessation program.
  • Read patient directions carefully before using.

For nicotine inhaler:

  • Gradually reduce use of the nicotine inhaler by keeping a record and showing that daily usage is being reduced.
  • Do not use for more than six months.

For nicotine nasal spray:

  • Continue use of spray for at least one week to adapt to the irritant effects of the spray.
  • Taper off use of spray by using only half a dose at a time.
  • Skip doses by not medicating every hour.
  • Gradually reduce use of the nicotine spray by keeping a record and showing that daily usage is being reduced.
  • Set a date for stopping use of spray.
  • Do not use for more than three months.
  • Avoid contact with skin, mouth, eyes, and ears.

For nicotine gum:

  • Do not chew more than 24 pieces a day.
  • Do not use for more than six months.
  • Reduce number of pieces of nicotine gum chewed each day over a two- to three-month period.
  • Do not use if you experience excessive sticking of gum to dental work.
  • Carry nicotine gum at all times during therapy.
  • Use hard sugarless candy between doses of nicotine gum to help alleviate urge to smoke.

For nicotine patch:

  • Do not use for more than 12 weeks. Consult with your doctor if you need the patch for a longer time.
  • If you get abnormal dreams, remove the patch at bedtime and put a new one on when you awake the next day.
  • Call your doctor if you have an allergic reaction; do not apply a new patch. If you do have an allergic reaction to the patch, you could also have a similar reaction to cigarettes or other products containing nicotine.

How to Use This Drug [top]

  • Do not take double doses.
  • Do not share your medication with others.

For nicotine nasal spray:

  • Avoid contact of spray with skin, mouth, eyes, and ears.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

For nicotine gum:

  • Use gum only when there is an urge to smoke.
  • Chew gum slowly and intermittently for 30 minutes.
  • Chew gum several times, then “park” it between cheek and gums; chew again after tingling sensation subsides.
  • Do not chew too fast.
  • Do not chew more than one piece of gum at a time.
  • Do not chew more than one piece within an hour.
  • Do not drink acidic beverages (citrus juices, coffee, soft drinks, or tea) within 15 minutes before or while chewing gum.

For nicotine patch:

  • Keep patch in sealed pouch until ready to apply to skin.
  • Do not trim or cut patch.
  • Apply to clean, dry, healthy skin on upper arm or torso that is free of oil, hair, scars, cuts, burns, or irritation.
  • Press patch firmly in place with palm of hand for about 10 seconds, making sure there is good contact around the edges.
  • Keep patch on during showering, bathing, or swimming.
  • Replace patch if it falls off.
  • Wash hands with plain water after handling patches; do not use soap.
  • Alternate application sites.
  • Do not keep patch on for more than 24 hours.
  • After patch removal, fold used patch in half with adhesive sides together and replace in protective pouch.
  • Remove patch during strenuous exercise to prevent increased nicotine absorption.

Interactions with Other Drugs [top]

Evaluations of Drug Interactions 2003 lists no drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods as causing “highly clinically significant” or “clinically significant” interactions when used together with the drugs in this section. We also found no interactions in the drugs’ FDA-approved professional package inserts. However, as the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • injury or irritation to mouth, teeth, or dental work (nicotine gum)
  • feelings of physical dependence
  • joint pain
  • muscle pain
  • swelling of gums, mouth, or tongue
  • tingling in arms, legs, hands, or feet
  • confusion
  • nasal blister or ulcer (nasal spray)
  • numbness of nose or mouth (nasal spray)
  • difficulty swallowing
  • throat dryness or pain
  • burning, tingling, or prickly sensations in nose, mouth, or head
  • amnesia
  • bronchitis
  • bronchospasm
  • difficulty speaking
  • swelling of feet or lower legs
  • blood-containing blisters on skin
  • fever
  • chills
  • headache or migraine headache
  • nausea or vomiting
  • runny nose
  • shortness of breath
  • chest tightness
  • difficulty breathing
  • wheezing
  • skin rash or redness
  • itching
  • hives
  • tearing of eyes
  • fast heartbeat
  • irregular heartbeat
  • high blood pressure

Call your doctor if these symptoms continue:

  • difficulty sleeping
  • abnormal dreams
  • vomiting
  • dizziness or lightheadedness
  • increased appetite
  • cough
  • indigestion
  • headache
  • earache
  • mouth and throat irritation
  • stuffy nose
  • runny nose
  • nosebleed
  • sneezing
  • sinus problems
  • back pain
  • change in sense of taste
  • diarrhea
  • constipation
  • watery eyes
  • burning or irritation in eyes
  • abdominal pain
  • acne
  • change in sense of smell
  • menstrual problems
  • facial flushing
  • gum problems
  • hoarseness
  • itching
  • vision changes
  • dry mouth
  • increased sputum production
  • fever
  • flatulence
  • flulike symptoms
  • hiccups
  • nausea
  • general pain
  • pain in jaw and back
  • sensation of burning, numbness, tightness, tingling, warmth, or heat
  • tooth disorder
  • drowsiness
  • loss of appetite
  • muscle or joint pain
  • sweating
  • irritability or nervousness

For nicotine nasal spray:

  • Contact physician if nasal irritant effects of spray do not go away after one week.

For nicotine gum:

  • belching
  • increased mouth watering
  • jaw muscle ache

For nicotine patch:

  • redness, itching, or burning at application site

Call your doctor if these symptoms continue after you stop taking this drug:

  • anxiety
  • dizziness
  • feelings of drug dependence
  • mental depression
  • muscle pain
  • difficulty sleeping
  • unusual tiredness or weakness

Signs of overdose:

  • abdominal pain
  • slow, fast, or irregular heartbeat
  • cold sweat
  • confusion
  • difficulty breathing
  • respiratory failure
  • heart failure
  • diarrhea
  • disturbed hearing or vision
  • dizziness
  • extreme exhaustion
  • headache
  • low blood pressure
  • nausea or vomiting
  • pale skin
  • excessive salivation
  • seizures
  • tremors
  • weakness
  • fainting

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

last reviewed February 29, 2024