Is Nicotine Patch Contraindicated with Chantix (Varenicline)?
No, nicotine patch is not contraindicated with varenicline (Chantix), though this combination is not currently recommended as standard first-line therapy and may increase side effects. 1
FDA Labeling and Safety Profile
The FDA drug label explicitly states that co-administration of varenicline (1 mg twice daily) with transdermal nicotine (21 mg/day) for up to 12 days did not affect nicotine pharmacokinetics, but the incidence of adverse reactions was greater for the combination than for nicotine replacement therapy (NRT) alone. 1 Specifically, using varenicline with a nicotine patch may cause nausea, vomiting, headache, dizziness, upset stomach, and tiredness to happen more often than with nicotine patch alone. 1
There is no absolute contraindication listed in the FDA labeling—only a warning about increased side effects. 1
Current Guideline Recommendations
The National Comprehensive Cancer Network (NCCN) 2016 guidelines list varenicline monotherapy OR combination NRT (patch plus short-acting NRT) as preferred primary therapy options, but do not recommend combining varenicline with NRT as standard first-line treatment. 2
The guidelines note that blood nicotine levels from NRT, including combination NRT, are significantly less than from smoking cigarettes, and NRT is well tolerated with nicotine toxicity being rare and transient, even when used with smoking. 2
Evidence on Combination Therapy
The NCCN guidelines classify varenicline plus NRT under "Other Regimens" that are not currently recommended based on existing data: 2
One study (n=435) found that adding nicotine patch to varenicline significantly increased cessation rates at 12 weeks, 24 weeks, and 6-month follow-up, with the only significant side effect difference being increased skin reactions (14.4% vs 7.8%; P=.03). 2
However, two other RCTs (n=341 and n=117) did not find enhanced cessation rates when combining varenicline with nicotine patch, and found no significant changes in adverse effect profiles. 2
A systematic review found that combination therapy with varenicline standard plus NRT standard had the highest odds ratio for sustained abstinence (OR 5.75,95% CI 2.27-14.90), though with high uncertainty. 3
Clinical Decision Algorithm
For standard smoking cessation:
- Start with varenicline monotherapy (1 mg twice daily after titration) OR combination NRT (patch plus short-acting form) as first-line. 2, 4
- Reserve varenicline plus NRT combination for patients who fail monotherapy with either agent. 2
If considering combination therapy:
- Counsel patients about increased risk of nausea, vomiting, headache, dizziness, upset stomach, and tiredness. 1
- Monitor closely for these side effects, particularly in cancer patients undergoing chemotherapy where nausea management is critical. 2, 5
- Ensure follow-up within 2-3 weeks of starting therapy to assess tolerability. 2, 4
Important Caveats
The combination is not licensed for use in the UK despite evidence suggesting it may be among the most clinically effective options. 3 In the US, while not explicitly contraindicated, it is not FDA-approved as a combination regimen and should be used with awareness of increased side effects. 1
The NCCN emphasizes that in most circumstances, side effects related to smoking cessation medications are minimal and considered an acceptable risk compared to continued smoking, with serious side effects being extremely rare. 2, 5