Table 5.
Observed adverse effects in all studies
| Side effect: | Balance difficulty, falls or injury | Dizziness, nausea | Urinary symptoms | URTI, flu-like symptoms, fatigue | Gastrointestinal symptoms (excluding nausea) | Confusion, mood or behavioral symptoms | Headache | Other | Death | Institutionalization | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tariot et al. [13] (blinded RCT) Monotherapy (n = 201) | 20 | 16 | 16 | 26 | 27 | 28 | 5 | 8 | NR | NR | |
| Combination (n = 202) | 25 | 14 | 23 | 25 | 13 | 35 | 13 | 10 | NR | NR | |
| Porsteinsson et al. [20] (blinded RCT) Monotherapy (n = 216) | 40 | 16 | 0 | 22 | 14 | 41 | 0 | 6 | NR | NR | |
| Combination (n = 217) | 36 | 16 | 0 | 38 | 12 | 43 | 0 | 11 | NR | NR | |
| Howard et al. [21] (blinded RCT) Monotherapy (ChEI) (n = 73) | 9 | 2 | 5 | 6 | 5 | 7 | NR | 10 | 14 | NR | |
| Combination (n = 73) | 3 | 0 | 5 | 5 | 7 | 8 | NR | 12 | 7 | NR | |
| Monotherapy (memantine) (n = 76) | 8 | 0 | 8 | 7 | 3 | 7 | NR | 7 | 10 | NR | |
| Atri et al. [12] (cohort) Monotherapy (n = 122) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | |
| Combination (n = 116) | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | |
| Hartmann and Mobius [29] (cohort) No comparator | |||||||||||
| Combination (n = 158) | NR | 1 | 1 | 1 | NR | 4 | NR | NR | NR | NR | |
| Lopez et al. [28] (cohort) Monotherapy (n = 387) | NR | NR | NR | NR | NR | NR | NR | NR | 126 | 83 | |
| Combination (n = 140) | NR | NR | NR | NR | NR | NR | NR | NR | 20 | 7 | |
| Schneider et al. [27] (cohort) Monotherapy (n = 86) | NR | NR | NR | NR | NR | NR | NR | NR | 1 | NR | |
| Combination (n = 73) | NR | NR | NR | NR | NR | NR | NR | NR | 2 | NR | |
| Dantoine et al. [14] (open label) No comparator | |||||||||||
| Combination (n = 86) | NR | 1 | NR | 1 | 0 | 0 | NR | 0 | 0 | NR | |
| Shua-Haim et al. [26] (open label) No comparator | |||||||||||
| Combination group (n = 16) | 3 | 3 | 2 | 1 | 3 | 9 | 2 | 4 | 0 | NR | |
| Olin et al. [25] (open label) No comparator | |||||||||||
| Combination (n = 117) | 17 | 44 | 8 | 6 | 32 | 34 | NR | 29 | 1 | NR | |
| Riepe et al. [24] (open label) No comparator | |||||||||||
| Combination (n = 95) | 2 | 2 | NR | 2 | 8 | 6 | NR | 18 | NR | NR | |
| Farlow et al. [22] (open-label RCT) Monotherapy (n = 135) | 6 | 1 | 7 | NR | 2 | 32 | NR | 33 | 0 | NR | |
| Combination (n = 126) | 7 | 8 | 4 | NR | 1 | 28 | NR | 23 | 1 | NR | |
| Choi et al. [23] (open-label RCT) Monotherapy (n = 83) | 0 | 4 | 2 | 2 | 0 | 2 | NR | 38 | NR | NR | |
| Combination (n = 88) | 2 | 3 | 0 | 3 | 3 | 0 | NR | 34 | NR | NR | |
NR = None reported; URTI = upper respiratory tract infection.