Is Chantix Safe? 6 Things Pharmacists Want You to Know About Chantix Risks
Key takeaways:
Chantix (varenicline) is a prescription medication that helps you quit smoking. But it has a history of label changes regarding possible side effects.
Many people wonder about whether Chantix can cause depression or suicidal thoughts or actions. While it’s possible, these Chantix risks are rare. However, you should report any mood changes to your prescriber immediately.
Brand-name Chantix was discontinued in 2021 due to a recall. Now, a generic version is widely available. Generic Chantix is safe to use, and the benefits outweigh the risks for many people.
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Table of contents
Chantix (varenicline) is a prescription medication that helps people quit smoking. It’s been FDA approved since 2006 and helped many people successfully quit using cigarettes. But Chantix also has a confusing history of label changes, and many people question how safe it is.
What’s more, Pfizer recalled brand-name Chantix in June 2021 because of the presence of impurities. Since then, brand-name Chantix has been discontinued. But generic versions (varenicline) are available.
If you’re taking generic Chantix, you may be wondering if it’s safe due to its history of label changes and the brand-name version being discontinued. Below, we’ll discuss Chantix safety and whether the benefits outweigh Chantix risks.
Although brand-name Chantix has been discontinued, we’ll refer to varenicline as Chantix throughout this article because it’s the more commonly known name.
1. Is Chantix safe?
Chantix is safe for many people. But whether the benefits of any medication outweigh the risks depends on your individual situation. This includes what other medications you take and whether you have other health conditions that could change how a medication affects your body. We’ll talk more about Chantix risks throughout this article.
Chantix testimonial: One woman describes her experience using Chantix to quit smoking.
Tips for quitting smoking: Medications are just one of several tools to help you quit smoking.
Smoking cessation program benefits: These programs combine several tools to help you quit smoking. They may be the most effective way to help you quit.
2. What are the side effects of Chantix?
Like all medications, Chantix can have side effects. Some are mild and common. Others may be more severe, but are less likely to occur.
The most common side effects of Chantix include:
Nausea and vomiting
Sleep problems, including trouble sleeping or vivid, unusual dreams
Constipation, gas, and/or abdominal pain
These side effects are usually manageable. For example, taking Chantix with a meal and glass of water can help lessen nausea.
More severe side effects include serious skin reactions, mood changes, and a negative reaction with alcohol leading to aggression. There’s also a higher risk of accidental injuries — including from traffic accidents — while taking Chantix.
Though these severe risks are rare, they’re important to be aware of so you can seek medical care if needed. For example, if you develop a rash after starting Chantix, you should seek emergency care to make sure it doesn’t develop into a serious skin reaction.
3. Can Chantix cause depression or suicidal thoughts?
Whether Chantix can affect your mental health is a confusing topic. This is because FDA warnings about Chantix causing mental health issues have changed over time.
It’s true that mental health changes — including depression and suicidal thoughts or actions — can happen to people taking Chantix. Although it’s rare, it’s still possible. This can happen in people with or without a history of mental health issues.
However, Chantix is less likely than originally thought to cause these mental health changes. The FDA added a boxed warning to Chantix for these changes in 2009, but it was removed in 2016. A boxed warning (formerly called a “black box warning”) is the most serious type of warning that the FDA can give a medication. Boxed warnings are typically permanent. But a few medications, including Chantix, have had boxed warnings removed.
Chantix’s boxed warning was removed because large studies showed that it didn’t increase the risk for mental health issues more than other medications used to help people quit smoking. Some research showed it didn’t increase the risk compared to placebo (a pill with no medication in it), either.
History of Chantix’s boxed warning
Here’s the timeline for Chantix’s boxed warning:
2009: Three years after the FDA approved Chantix, it added a boxed warning to the package insert. The warning discussed the risk of serious psychiatric symptoms in people using Chantix, including depression, suicidal thoughts, and hostility. This was discovered through reports of Chantix side effects submitted after FDA approval.
2011: The FDA sponsored two studies comparing Chantix to nicotine replacement therapy (NRT), such as nicotine patches (Nicoderm CQ, Habitrol). Compared to NRT, Chantix didn’t cause more hospitalizations due to mental health issues.
2015: Chantix’s manufacturer (Pfizer) completed a clinical trial evaluating Chantix’s safety. It was called the EAGLES study. It compared the safety of bupropion sustained-release (previously available as Zyban), Chantix, and the nicotine patch. Bupropion SR is another medication that helps people quit smoking, though the brand-name version (Wellbutrin SR) isn’t FDA approved for smoking cessation. The study found that Chantix didn’t cause more psychiatric side effects than the nicotine patch, Wellbutrin SR, or a placebo. In fact, Chantix was better than the other medications at helping people quit smoking.
2016: As a result of these studies, the FDA removed the boxed warning for Chantix.
Despite the removal of Chantix’s boxed warning, it can still cause mood changes. So if you’re taking Chantix and experience any mood changes — including depression, suicidal thoughts, or panic — stop taking it and contact your prescriber immediately.
4. Is brand-name Chantix still available?
Brand-name Chantix isn’t available in the U.S. due to a recall in 2021. However, generic Chantix — called varenicline — is now available at any pharmacy.
Why was Chantix recalled in 2021?
In June 2021, Pfizer voluntarily recalled Chantix. This means that they stopped producing the medication and removed it from pharmacy shelves. They didn’t recall it because they thought Chantix wasn’t effective, or that the medication itself was too risky.
The Chantix recall occurred due to the presence of unacceptable levels of nitrosamines in the medication. When taken in large amounts for a long time, nitrosamines are chemicals that may increase your risk of cancer.
5. Is it safe to take generic Chantix after the recall of brand-name Chantix?
Yes. While it’s possible that generic varenicline products contain nitrosamines, if they do it’s in very small amounts (a level low enough to be deemed safe by the FDA).
Importantly, the health benefits of quitting smoking are greater than the risks posed by the nitrosamines — even those found in brand-name Chantix. In fact, the FDA never recommended stopping production of brand-name Chantix even after it was recalled. In general, nitrosamines are only considered concerning when large amounts are consumed over long periods of time. And most people don’t take Chantix long term.
6. Who shouldn’t take Chantix?
For many people, the benefits of taking Chantix outweigh the risks. Taking Chantix is one of the most (if not the most) effective ways to quit smoking. And if you smoke, quitting is one of the best things you can do for your health.
However, Chantix isn’t the best option for everyone. And there are some situations where you may need to be more cautious if you take it. So make sure your prescriber knows your full health history before starting this medication. This includes whether you drink alcohol, and if you’re pregnant or breastfeeding.
Additionally, if you have a history of the following health conditions, inform your HCP before starting Chantix:
Kidney disease
Mental health conditions involving symptoms like depression, hallucinations, or aggression
Seizures
Heart disease
If your prescriber knows your health history, they can help you decide whether Chantix is a good option for you. In some cases, you may need a lower Chantix dosage. Or you may need to avoid taking it altogether. In this case, NRT or bupropion SR may be a better option to help you quit.
The bottom line
Chantix (varenicline) is an effective medication for quitting smoking. However, it has a confusing history of label changes that can have you questioning whether it's safe to take.
Chantix is considered safe for many people. And it’s one of the most effective ways to quit smoking. The risk of Chantix causing depression or suicidal thoughts is low. However, these risks are possible, so you should report any mental changes to your prescriber immediately.
Brand-name Chantix is no longer available because it was recalled in 2021. However, generic Chantix is available and safe to take.
Before starting Chantix, give your prescriber your full health history, including whether you drink alcohol. They can weigh the Chantix risks versus benefits and help you decide if it’s a good choice for you.
Why trust our experts?
References
Anthenelli, R. M., et al. (2016). Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): A double-blind, randomised, placebo-controlled clinical trial. The Lancet.
U.S. Food and Drug Administration. (2013). Public health advisory: FDA requires new boxed warnings for the smoking cessation drugs Chantix and Zyban.
U.S. Food and Drug Administration. (2013). Public health advisory: Important information on Chantix (varenicline).
U.S. Food and Drug Administration. (2016). FDA drug safety communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events.
U.S. Food and Drug Administration. (2022). FDA Drug Safety Podcast: FDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings.
U.S. Food and Drug Administration. (2022). FDA updates and press announcements on nitrosamine in varenicline (Chantix).
Zydus Pharmaceuticals Inc. (2024). Varenicline- varenicline tablet, film coated [package insert].
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