Table 2. Treatment-Emergent AEs*

Varenicline (n=353), n (%)Placebo (n=350), n (%)Difference Between Groups, %95% CI for Difference
Total AEs949656
Participants with ≥1 AE288 (81.6)227 (64.9)16.710.3–23.2
Participants who stopped drug because of AE34 (9.6)15 (4.3)5.31.6–9.1
Participants with ≥1 serious AE23 (6.5)21 (6.0)0.5−3.1–4.1
Deaths (all causes)2 (0.6)5 (1.4)−0.8−2.3–0.6
Most common AEs
    Nausea104 (29.5)30 (8.6)20.915.3–26.5
    Headache45 (12.7)39 (11.1)1.6−3.2–6.4
    Insomnia42 (11.9)23 (6.6)5.31.1–9.6
    Vomiting29 (8.2)4 (1.1)7.14.0–10.1
    Abnormal dreams28 (7.9)6 (1.7)6.23.1–9.4
    Fatigue25 (7.1)14 (4.0)3.1−0.3–6.5
    Nasopharyngitis23 (6.5)30 (8.6)−2.1−6.0–1.8
    Constipation23 (6.5)7 (2.0)4.51.6–7.5
    Diarrhea22 (6.2)18 (5.1)1.1−2.3–4.5
    Dizziness22 (6.2)16 (4.6)1.7−1.7–5.0
    Dyspepsia19 (5.4)12 (3.4)2.0−1.1–5.0
Psychiatric AEs§
    Sleep disorders or disturbances (abnormal dreams, insomnia, nightmare, sleep disorder)78 (22.1)34 (9.7)12.47.1–17.7
    Anxiety disorders or symptoms (anxiety, generalized anxiety disorder, neurosis, phobia, stress)12 (3.4)16 (4.6)−1.2−4.1–1.7
    Depressed mood disorders or disturbances (depression, depressed mood, depressive symptom, dysthymia)11 (3.1)8 (2.3)0.8−1.6–3.2
    Bipolar disorder1 (0.3)0 (0)0.3−0.4–1.0
    Other mood disorders or disturbances (apathy, listlessness, dysphoria, mood alteration, mood swings, emotional disorder)9 (2.5)3 (0.9)1.7−0.2–3.6
(Continued)