Champix Adverse Reactions

Smoking cessation with or without treatment is associated with various symptoms. For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking. Smoking cessation, with or without pharmacotherapy, has also been associated with the exacerbation of underlying psychiatric illness. No attempt has been made in either the design or the analysis of the varenicline studies to distinguish between adverse events associated with study drug treatment or those possibly associated with nicotine withdrawal.
Pre-marketing development clinical trials included approximately 4,000 patients treated with varenicline for up to 1 year (average exposure 84 days). In general, when adverse reactions occurred, onset was in the first week of therapy; severity was generally mild to moderate and there were no differences by age, race or gender with regard to the incidence of adverse reactions.
In patients treated with the recommended dose of 1 mg BID following an initial titration period the adverse event most commonly reported was nausea (28.6%). In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
The treatment discontinuation rate due to adverse events was 11.4% for varenicline compared with 9.7% for placebo. In this group, the discontinuation rates for the most common adverse events in varenicline treated patients were as follows: nausea (2.7% vs. 0.6% for placebo), headache (0.6% vs. 1.0% for placebo), insomnia (1.3% vs. 1.2% for placebo), and abnormal dreams (0.2% vs. 0.2% for placebo).
All adverse drug reactions (ADRs) listed in the table as follows are presented by the Medical Dictionary for Regulatory Activities (MedDRA, Version 16) System Organ Class (SOC), based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline. Within each category, the ADRs are presented in order of frequency, and then by decreasing order of clinical importance. (See Table 20.)

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ADRs frequencies are based on treatment emergent all causality adverse events from 18 placebo controlled smoking cessation studies (A3051002, A3051007, A3051016, A3051028, A3051036, A3051037, A3051045, A3051046_48, A3051049, A3051054, A3051055, A3051072, A3051080, A3051095, A3051104, A3051115, A3051122 and A3051139).
* CIOMS III categories: Very Common ≥1/10 (≥10%); Common ≥1/100 to <1/10 (≥1% and <10%); Uncommon ≥1/1,000 to <1/100 (≥0.1% and <1%); Rare ≥1/10,000 to <1/1,000 (≥0.01% and <0.1%); Very Rare <1/10,000 (<0.01%).
Post-marketing Experience: The following adverse events have been reported during post-approval use of varenicline. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
There have been reports of depressed mood, agitation, changes in behavior or thinking, anxiety, psychosis, mood swings, aggressive behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking varenicline (see Precautions).
There have also been reports of hypersensitivity reactions, such as angioedema and of rare but severe cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients taking varenicline (see Precautions).