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Chantix and Lower Abdominal Pain

Chantix is the brand name of the drug varenicline, a prescription medication that was approved by the U.S. Food and Drug Administration in 2006 to help patients stop smoking. Abdominal pain, both upper and lower, was observed among the 4500 patients taking Chantix during the clinical trials before the drug was approved.

  1. Clinical Trials Experience

    • During the clinical trials, abdominal pain occurred in 5 percent of patients receiving the 0.5mg dose and 7 percent of patients receiving the 1-mg dosage compared with 5 percent of patients receiving placebo (sugar pill). The most common side effects of therapy with Chantix were nausea, sleep problems (trouble sleeping or vivid, unusual or strange dreams), constipation, gas and vomiting.

    Clinical Practice

    • The rate of side effects observed when a drug is used in clinical practice may vary from that observed during the clinical trials.

    Post-marketing Issues

    • The U.S. Food and Drug Administration did issue a Public Health Advisory after Chantix was approved for marketing to report changes in behavior, agitation, depressed mood, thoughts of suicide and actual suicidal behavior among some patients taking Chantix, including those with no pre-existing psychiatric illness. As a result, Pfizer has made important changes to the prescribing information for Chantix to warn health care providers of these reports. However, there were no reports of any serious side effects related to lower abdominal pain after the drug was marketed.

    See Your Physician

    • All medicines can cause side effects in some people. If you continue to experience lower abdominal pain while taking Chantix, or if it becomes bothersome, talk with your doctor. Product labeling for Chantix suggests that lowering the dosage may help control side effects, so your doctor may wish to adjust the dosage of Chantix that you are receiving.

    Risks vs. Benefits

    • Smoking is a significant health problem, and Chantrix has demonstrated good efficacy in patients who are motivated to stop smoking. However, as with all medications, your physician needs to evaluate the benefits of Chantix compared with the risks of therapy. You should also be aware that smoking cessation, with or without drug therapy, is associated with nicotine withdrawal symptoms.

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