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Table 3 Incidence and relative risk of different types of adverse drug reactions (all imputations) in older vs. younger patients

From: Psychotropic drug-induced adverse drug reactions in 462,661 psychiatric inpatients in relation to age: results from a German drug surveillance program from 1993–2016

Adverse drug reaction

Patients ≥ 65 years of age (N = 99,099)

Patients < 65 years of age (N = 363,562)

≥ 65 vs. < 65

N cases

% of patients

N cases

% of patients

RR (95% CI)

All ADRs

1212

1.223

4517

1.242

0.98 (0.92–1.05)

Delirium, confusion*

118

0.119

184

0.051

2.35 (1.87–2.96)

Delirium*

109

0.110

170

0.047

2.35 (1.85–2.99)

Psychiatric symptoms, excl. delirium

87

0.088

270

0.074

1.18 (0.93–1.51)

Disturbance of consciousness*

20

0.020

34

0.009

2.16 (1.24–3.75)

Psychosis/(pseudo-) hallucinations

9

0.009

39

0.011

0.85 (0.41–1.75)

Restlessness/agitation

24

0.024

66

0.018

1.33 (0.84–2.13)

Sedation

15

0.015

37

0.010

1.49 (0.82–2.71)

Suicidality*

1

0.001

34

0.009

0.11 (0.01–0.79)

Neurological symptoms, excl. EPS

132

0.133

533

0.147

0.91 (0.75–1.10)

Seizures*

24

0.024

162

0.045

0.54 (0.35–0.83)

Myoclonus

6

0.006

35

0.010

0.63 (0.26–1.50)

Ataxia*

20

0.020

24

0.007

3.06 (1.69–5.53)

Tremor

20

0.020

62

0.017

1.18 (0.71–1.96)

Vision disorders, glaucoma

5

0.005

30

0.008

0.61 (0.24–1.58)

Serotonin-syndrome, serotonergic ADRs*

19

0.019

35

0.010

1.99 (1.14–3.48)

Restless legs/arms*

6

0.006

63

0.017

0.35 (0.15–0.81)

EPS

212

0.214

712

0.196

1.09 (0.94–1.27)

Neuroleptic malignant syndrome

13

0.011

42

0.012

1.14 (0.61–2.12)

Tardive dyskinesia

8

0.008

45

0.012

0.65 (0.31–1.38)

Pisa/metronome-syndrome*

58

0.059

59

0.016

3.61 (2.51–5.18)

Atypical dyskinesia

15

0.015

55

0.015

1.00 (0.57–1.77)

Acute dystonia*

10

0.010

185

0.051

0.20 (0.10–0.37)

Parkinsonism*

80

0.081

155

0.043

1.89 (1.45–2.48)

Akathisia*

19

0.019

147

0.040

0.47 (0.29–0.76)

Gastrointestinal disorders

54

0.054

162

0.045

1.22 (0.90–1.66)

(Sub)ileus/severe constipation

11

0.011

38

0.010

1.06 (0.54–2.08)

Nausea/vomiting

13

0.013

36

0.010

1.32 (0.70–2.50)

Liver dysfunction*

61

0.062

358

0.098

0.63 (0.48–0.82)

Elevated transaminases*

61

0.062

356

0.098

0.63 (0.48–0.82)

Cutaneous reactions

137

0.138

541

0.149

0.93 (0.77–1.12)

Edema

49

0.049

182

0.050

0.99 (0.72–1.35)

Allergic cutaneous reactions

80

0.081

313

0.086

0.94 (0.73–1.20)

Cardiovascular disorders*

135

0.136

270

0.074

1.83 (1.49–2.26)

(Orthostatic) syncope*

62

0.063

96

0.026

2.37 (1.72–3.26)

Symptomatic hypotension with vertigo*

23

0.023

26

0.007

3.25 (1.85–5.69)

Arrhythmia

24

0.024

77

0.021

1.14 (0.72–1.81)

Prolonged QT-interval

10

0.010

32

0.009

1.15 (0.56–2.33)

Urological dysfunction

35

0.035

140

0.039

0.92 (0.63–1.33)

Urinary retention

27

0.027

97

0.027

1.02 (0.67–1.56)

Genital dysfunction*

1

0.001

106

0.029

0.03 (0.00–0.25)

Erectile dysfunction

0

0.000

65

0.018

–

Hematologic disorders

56

0.057

209

0.057

0.98 (0.73–1.32)

Agranulocytosis

12

0.012

43

0.012

1.02 (0.54–1.94)

Neutropenia

18

0.018

89

0.024

0.74 (0.45–1.23)

Thrombocytopenia

9

0.009

30

0.008

1.10 (0.52–2.32)

Metabolic disorders, electrolyte imbalances

115

0.116

364

0.100

1.16 (0.94–1.43)

Hyponatremia*

106

0.107

104

0.029

3.74 (2.85–4.90)

Increased prolactin/galactorrhea*

3

0.003

206

0.057

0.05 (0.02–0.17)

Changes in body weight*

11

0.011

494

0.136

0.08 (0.04–0.15)

Weight gain*

10

0.010

493

0.136

0.07 (0.04–0.14)

Others

58

0.059

174

0.048

1.22 (0.91–1.65)

Falls*

24

0.024

15

0.004

5.87 (3.08–11.19)

  1. N number (of); RR relative risk; CI confidence interval; ADR adverse drug reaction; EPS extrapyramidal symptoms
  2. *Indicates a significant result
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Annals of General Psychiatry

ISSN: 1744-859X