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Precautions and Warnings With Varenicline

Knowing the precautions and warnings with varenicline before starting treatment can help determine whether the drug is suitable for you. If you have kidney disease, your healthcare provider may need to prescribe a lower dosage or monitor you more closely. Precautions and warnings with varenicline also extend to people who are allergic to any active or inactive ingredients used to make the medication.

Varenicline: What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking varenicline tartrate (Chantix™) if you have:
  • Kidney disease, such as kidney failure (renal failure)
  • Any mental illness
  • Heart disease 
  • A history of suicidal behavior
  • Any allergies, including allergies to food, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
Make sure to tell your healthcare provider about all other medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Varenicline

Warnings and precautions to be aware of prior to taking varenicline include the following:
  • There have been reports of suicidal thoughts, suicidal behavior, or strange or aggressive behavior in people taking varenicline. However, it is not clear if varenicline itself or simply the act of quitting smoking caused these cases (since nicotine withdrawal can worsen psychiatric conditions). If you have any mental illness or if you have a history of suicidal behavior or thoughts, discuss this with your healthcare provider before taking varenicline. If you notice any unusual behavior in yourself (or anyone else taking varenicline), please seek medical attention.


  • Like many medications, varenicline can cause life-threatening skin reactions known as Stevens-Johnson syndrome or erythema multiforme. Seek immediate medical attention if you develop an unexplained skin rash, especially if it involves mouth sores or any unusual symptoms.
  • Like many medications, varenicline can cause life-threatening allergic reactions. Seek immediate medical attention if you develop unexplained swelling of the mouth or throat. 


  • There have been reports of severe drowsiness and accidental injuries (such as car accidents) in people taking varenicline. Be sure to see how varenicline affects you before driving or operating heavy machinery.
  • Varenicline is unlikely to interact with most other medications (see Drug Interactions With Varenicline). However, the act of stopping smoking can affect the way your body handles medications. Be sure to ask your healthcare provider about how stopping smoking may affect the other medications you are taking.


  • In studies of varenicline in people with cardiovascular disease, the drug slightly increased the risk of chest pain (angina) and nonfatal heart attacks and strokes. If you have heart disease, you and your healthcare provider must decide if the benefits of stopping smoking outweigh the risks in your case. 


  • The kidneys help to remove varenicline from your body. If you have kidney disease, you may require extra monitoring by your healthcare provider and you may need to take a lower varenicline dosage.
  • Varenicline is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are not known (see Chantix and Pregnancy).
  • It is not known if varenicline passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Chantix and Breastfeeding).
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Varenicline Tartrate Drug Information

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