Table 2.
Adverse Events Associated With Pharmacotherapy, by Treatment Group (n = 228)
| Side effects | NRT patch & gum | Varenicline | ||
| ART (n = 82) | No ART (n = 28) | ART (n = 83) | No ART (n = 35) | |
| At least one AE | 48 (58.5) | 19 (67.9) | 65 (78.3) | 29 (82.9) |
| Stopped/switched drug due to AE | 2 (2.4) | 0 | 9 (10.8) | 8 (22.9) |
| Varenicline & NRT AEs | ||||
| Nausea | 9 (11.0) | 4 (14.3) | 27 (32.5) | 11 (31.4) |
| Vomiting | 1 (1.2) | 2 (7.1) | 2 (2.4) | 2 (5.7) |
| Insomnia | 7 (8.5) | 2 (7.1) | 5 (6.0) | 3 (8.6) |
| Abnormal/vivid dreams | 9 (11.0) | 2 (7.1) | 21 (25.3) | 6 (17.1) |
| Dizziness | 1 (1.2) | 0 | 0 | 2 (5.7) |
| Fatigue/weakness | 1 (1.2) | 2 (7.1) | 6 (7.2) | 2 (5.7) |
| Varenicline-specific AEs | ||||
| Constipation | 8 (9.6) | 3 (8.6) | ||
| Flatulence | 9 (10.8) | 2 (5.7) | ||
| Dry mouth | 3 (3.6) | 0 | ||
| Dyspepsia | 3 (3.6) | 1 (2.9) | ||
| Difficulty sleeping | 15 (18.1) | 6 (17.1) | ||
| Anxiety | 5 (6.0) | 1 (2.9) | ||
| Headache | 6 (7.2) | 3 (8.6) | ||
| Suicide ideation | 0 | 1 (2.9) | ||
| Depressed mood | 4 (4.8) | 4 (11.4) | ||
| Agitation | 9 (10.8) | 3 (8.6) | ||
| Changes in behavior | 4 (4.8) | 2 (5.7) | ||
| NRT-specific AEs | ||||
| Skin rash | 9 (11.0) | 8 (28.6)* | ||
| Skin redness around patch site | 3 (3.7) | 3 (10.7) | ||
| Rapid heart rate or palpitations | 1 (1.2) | 0 | ||
| Gum, tooth, or jaw soreness | 1 (1.2) | 1 (3.6) | ||
| Hiccups | 0 | 2 (7.1) | ||
Note. All results are given as n (%). AE = adverse event; ART = antiretroviral therapy; NRT = nicotine replacement therapy.
*p < .05 by Fisher’s exact test.