U.S. flag An official website of the United States government
  1. Home
  2. For Consumers
  3. Consumer Updates
  4. Want to Quit Smoking? FDA-Approved Products Can Help
  1. Consumer Updates

Want to Quit Smoking? FDA-Approved Products Can Help

Smoking Cessation (600x397)


Quitting smoking can be hard, but it is possible. In fact, every time you put out a cigarette is a new chance to try quitting again, according to the U.S. Food and Drug Administration’s newest tobacco education campaign, “Every Try Counts.”

 If you want to quit—almost 70 percent of adult smokers say they do—you may want to use a “smoking cessation” product proven to help. Data has shown that using FDA-approved cessation medicine can double your chance of quitting successfully.

Some products contain nicotine as an active ingredient and others do not. These products include over-the-counter (OTC) options like skin patches, lozenges, and gum, as well as prescription medicines.

Smoking cessation products are intended to help you quit smoking. They are regulated through the FDA’s Center for Drug Evaluation and Research, which ensures that the products are safe and effective and that their benefits outweigh any known associated risks.

The Benefits of Quitting Smoking

No matter how much you smoke—or for how long—quitting will benefit you.

Not only will you lower your risk of getting various cancers, including lung cancer, you’ll also reduce your chances of having heart disease, a stroke, emphysema, and other serious diseases. Quitting also will lower the risk of heart disease and lung cancer in nonsmokers who otherwise would be exposed to your secondhand smoke.

Although there are benefits to quitting at any age, it is important to quit as soon as possible so your body can begin to heal from the damage caused by smoking. For instance, 12 hours after you quit smoking the carbon monoxide level in your blood drops to normal. Carbon monoxide is harmful because it displaces oxygen in the blood and deprives your heart, brain, and other vital organs of oxygen.

What To Know About Smoking Cessation Products

Understanding how smoking cessation products work—and what side effects they may cause—can help you determine which product may be best for you.

If you’re considering one of these products, reading labels and talking to your pharmacist and other health care providers are good first steps to take.

You also can check the FDA’s website for more information on each product at Drugs@FDA, where you can search for each product by name.

And remember to weigh each product’s benefits and risks, among other considerations.

About Nicotine Replacement Therapy (NRT)

Nicotine is the substance primarily responsible for causing addiction to tobacco products. Tobacco users who are addicted to nicotine are used to having nicotine in their bodies.

As you try to quit smoking, you may have symptoms of nicotine withdrawal. When you quit, this withdrawal may cause symptoms like cravings, or urges, to smoke; depression; trouble sleeping; irritability; anxiety; and increased appetite.

Nicotine withdrawal can discourage some smokers from continuing with a quit attempt. But the FDA has approved several smoking cessation products designed to help users gradually withdraw from smoking (that is, “wean” themselves from smoking) by using specific amounts of nicotine that decrease over time. This type of product is called a “nicotine replacement therapy” or NRT. It supplies nicotine in controlled amounts while sparing you from other chemicals found in tobacco products.

NRTs are available over the counter and by prescription. You should generally use them only for a short time to help you manage nicotine cravings and withdrawal. However, the FDA recognizes that some people may need to use these products longer to stay smoke-free. Talk to your health care provider to determine the best course of treatment for you.

Over-the-counter NRTs are approved for sale to people age 18 and older. They are available under various brand names and sometimes as generic products. They include:

  • Skin patches (also called “transdermal nicotine patches”). These patches are placed on the skin, similar to how you would apply an adhesive bandage.
  • Chewing gum (also called “nicotine gum”). This gum must be chewed according to the labeled instructions to be effective.
  • Lozenges (also called “nicotine lozenges”). You use these products by dissolving them in your mouth.

For over-the-counter products, it’s important to follow the instructions on the Drug Facts Label (DFL) and to read the enclosed User’s Guide for complete directions and other important information. Ask your health care provider if you have questions.

Currently, prescription nicotine replacement therapy is available only under the brand name Nicotrol, and is available both as a nasal spray and an oral inhaler. The products are FDA-approved only for use by adults.

If you are under age 18 and want to quit smoking, talk to a health care professional about whether you should use nicotine replacement therapies.

Important Advice for People Considering Nicotine Replacement Therapy

Women who are pregnant or breastfeeding should talk to their health care providers and use nicotine replacement products only if the health care providers approve.

Also talk to your health care provider before using these products if you have:

  • diabetes, heart disease, asthma, or stomach ulcers;
  • had a recent heart attack;
  • high blood pressure that is not controlled with medicine;
  • a history of irregular heartbeat;
  • or been prescribed medication to help you quit smoking.

If you take prescription medication for depression or asthma, tell your health care provider if you are quitting smoking because he or she may need to change your prescription dose.

Stop using a nicotine replacement product and call your health care professional if you have any of the following symptoms:

  • nausea;
  • dizziness;
  • weakness;
  • vomiting;
  • fast or irregular heartbeat;
  • mouth problems with the lozenge or gum;
  • or redness or swelling of the skin around the patch that does not go away.

About Prescription Cessation Medicines Without Nicotine

The FDA has approved two smoking cessation products that do not contain nicotine. They are Chantix (varenicline tartrate) and Zyban (buproprion hydrochloride). Both are available in tablet form and by prescription only.

Chantix acts at sites in the brain affected by nicotine by reducing the rewarding effects of nicotine. The precise way that Zyban helps with smoking cessation is unknown.

As with other prescription products, the FDA has evaluated these medicines and found that the benefits outweigh the risks. For users taking these products, risks include changes in behavior, depressed mood, hostility, aggression, and suicidal thoughts or actions.

The most common side effects of Chantix include nausea; constipation; gas; vomiting; and trouble sleeping or vivid, unusual, or strange dreams. Chantix also may change how you react to alcohol, so talk to your health care provider about your drinking habits (if you drink alcohol) and whether these habits need to change. Chantix is not recommended for people under the age of 18.

The most commonly observed side effects consistently associated with the use of Zyban are dry mouth and insomnia.

Because Zyban contains the same active ingredient as the antidepressant Wellbutrin (bupropion), the FDA encourages people who use Zyban—and those who are considering it—to talk to their health care providers about the risks of treatment with antidepressant medicines. Zyban has not been studied in children under the age of 18 and is not approved for use in children and teenagers.

Note: If your health care provider prescribes Chantix or Zyban, please read the product’s patient medication guide in its entirety. These guides offer important information on side effects, risks, warnings, product ingredients, and what you should talk about with your health care provider before taking the products.

Finally, if you ever have any side effects related to any smoking cessation products, or have any other problems related to your treatment, the FDA would like to hear from you. Please consider making a voluntary and confidential report to the FDA’s MedWatch program.

back to top


Get regular FDA email updates delivered on this topic to your inbox.

Back to Top