Table 3.
Adverse drug reactions and dropout rate.
Study | ADRs |
Dropout rate (%) |
||||
---|---|---|---|---|---|---|
Events | Treatment (%) | Control (%) | Total (%) | Treatment (%) | Control (%) | |
RCTs | ||||||
Lenze et al., 2021 | Pneumonia | 3 (3.8) | 6 (8.3) | Fluvoxamine-treated participants, 18 of 80 stopped responding to the surveys prior to day 15 compared with 19 of 72 who were randomized to placebo | 18 (22.5) | 19 (26.4) |
Shortness of breath | 2 (2.5) | 4 (5.6) | ||||
Headache or head pain | 2 (2.5) | 1 (1.4) | ||||
Gastroenteritis, nausea, or vomiting | 1 (1.3) | 5 (6.9) | ||||
Muscle aches | 1 (1.3) | 0 | ||||
Bacterial infection | 1 (1.3) | 0 | ||||
Vasovagal syncope | 1 (1.3) | 0 | ||||
Teeth chattering | 1 (1.3) | 0 | ||||
Dehydration | 1 (1.3) | 0 | ||||
Low oxygen saturation or hypoxia | 0 | 6 (8.3) | ||||
Chest pain or tightness | 0 | 2 (2.8) | ||||
Fever | 0 | 2 (2.8) | ||||
Acute respiratory failure | 0 | 1 (1.4) | ||||
Hypercapnia | 0 | 1 (1.4) | ||||
Flank pain | 0 | 1 (1.4) | ||||
Serious adverse eventsa | 1 (1.3) | 5 (6.9) | ||||
Other adverse eventsb | 11 (13.8) | 6 (8.3) | ||||
Reis et al., 2021 | No significant differences in the fluvoxamine and placebo groups | 330 (22.0) | 193 (26.0) | 137 (18.0) | ||
Prospective cohort study | ||||||
Seftel et al., 2021 | No serious ADRs occurred with fluvoxamine | NR | ||||
Calusic et al., 2021a, Calusic et al., 2021b | NR | NR | NR | NR | ||
Retrospective study | ||||||
Németh et al., 2021 | NR | NR | NR | NA | ||
Hoertel et al., 2021 | NR | NR | NR | NA | ||
Oskotsky et al., 2021 | NR | NR | NR | NA |
Abbreviations: ADRs = adverse drug reactions; NR = not reported; NA = not applicable; RCT = randomized controlled trial.
Serious adverse events = One patient in the placebo group had more than 1 serious adverse event. The total No. of serious adverse events was 1 in the fluvoxamine group and 6 in the placebo group.
Other adverse events = There were patients in the placebo group who had more than 1 other adverse event.