Drugs
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Varenicline (marketed as Chantix) Information
Varenacline (marketed as Chantix) is a medication used as an aid to smoking cessation treatment.
To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this page.
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Related Information
FDA Drug Safety Communication: Safety review update of Chantix (varenicline) and risk of neuropsychiatric adverse events
10/24/2011FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) drug label now contains updated efficacy and safety information
8/2/2011FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information
7/22/2011FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease
6/16/2011FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease FDA Drug Safety Podcast: Chantix may increase cardiovascular risk in certain patients Chantix: Quarterwatch Article
5/19/2011Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
7/1/09Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
7/1/2009- Podcast: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
7/7/2009 Information for Healthcare Professionals: Varenicline (marketed as Chantix)
issued 2/1/2008; updated 5/16/2008Public Health Advisory: Important Information on Chantix (varenicline)
issued 2/1/2008; updated 5/16/2008FDA Issues Public Health Advisory on Chantix
FDA press release (2/1/2008)Early Communication About an Ongoing Safety Review of Varenicline (marketed as Chantix)
11/20/2007
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Labeling Information and Regulatory History from Drugs@FDA
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Contact FDA
1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
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