Table 5.

Adverse events reported in depression treatment trials in patients with ESKD

SeveritySystemAdverse EventBlumenfield et al. (30)Friedli et al. (33)aHaghighat et al. (36)Mehrotra et al. (44)Taraz et al. (46)b
FLU (N=6)PBO (N=7)SERT (N=15)PBO (N=15)Probiotic (N=25)PBO (N=25)CBT (N=60)SERT (N=60)SERT (N=21)PBO (N=22)
NonseriousAutonomicDry mouth01
CardiovascularCardiac unspecified39
Hypotension41
Palpitations10a
GastrointestinalAbdominal pain12
Constipation01
Diarrhea11
Dyspepsia1064
Gastroenteritis02
Gastrointestinal unspecified1122
Nausea5210a73
Vomiting33
MusculoskeletalMyalgia11
NeurologicDizziness1010a53
Headache3010a1142
Insomnia2110a
Nervous system unspecified08
Sensation disturbance10
Tremors10
PsychiatricAbnormal thought10
Anorexia24
Anxiety01
Nervousness11
RespiratoryBronchitis10
Cough02
Dyspnea101
Pharyngitis10
Rhinitis10
Upper respiratory tract infection10
SkinFurunculosis10
Pruritus10
Skin ulcer01
Sweating10a
OtherDehydration01
Edema01
Fatigue1
Flu syndrome10
Hair loss11
Other unspecified317
Sexual dysfunction21
Tooth infection10
SevereGastrointestinalGastrointestinal unspecified11
CardiovascularCardiac unspecified44
OtherDeath1020
Major bleeding12
Other unspecified29
  • FLU, fluoxetine; PBO, placebo; SERT, sertraline; CBT, cognitive behavioral therapy.

  • a The events reported in this table are only those that resulted in study dropout. There were other adverse events reported narratively, but it was not clear from the text in which category or study arm they occurred, so they are not recorded in this table.

  • b It is unclear whether the events of study dropouts were included in these totals. There was one death in each group and some attrition due to adverse events, but the dropouts were not analyzed in this per-protocol study.