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. 2022 Mar 23;307:108–114. doi: 10.1016/j.jad.2022.03.059

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.

a

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.

b

Other adverse events = There were patients in the placebo group who had more than 1 other adverse event.