Table 2 Summary of serious adverse events in the included trials

Bose et al., 2008

Escitalopram

1 bowel obstruction, 1 nausea, 1 arrythmia, 1 respiratory arrest, 1 retinal detachment, 1 chest pain

5 out of 96

1 syncope

1 out of 109

Ball et al., 2014

Paroxetine

No serious adverse event

0 out of 74

1 unspecified serious adverse event

1 out of 78

Andreoli et al., 2002

Fluoxetine

No serious adverse event

0 out of 97

1 suicide

1 out of 76

Kasper et al., 2011

Escitalopram

No serious adverse event

0 out of 128

1 hospitalisation due to appendicitis

1 out of 50

Kasper et al. (A), 2005

Escitalopram

1 death (suicide)

1 out of 173

1 death (probably drowned)

1 out of 160

Ravindran et al., 1995

Sertraline

9 unspecified serious adverse events

4 out of 25

3 unspecified serious adverse events

2 out of 13

March et al., 1990

Fluvoxamine

1 hospitalisation due to worsening of depression

1 out of 13

1 suicide attempt

1 out of 12

Rapaport et al., 2009

Paroxetine

2 chestpain, 1 osteoarthritis, 1 ankle fracture, 1 atrial fibrillation, 1 femur fracture,1 coronary artery occlusion, 1 pneumonia, 1 confusional state, 1 depression

10 out of 267

1 neprholithiasis, 1 aortic aneurism

2 out of 127

Higuchi et al., 2011

Paroxetine

1 suicide and 8 unspecified serious adverse events

9 out of 213

1 unspecified serious adverse event

1 out of 139

Schneider et al., 2003

Sertraline

17 unspecified serious adverse events

17 out of 284

11 unspecified serious adverse events

11 out of 311

Sheehan et al., 2009

Fluoxetine

1 suicidal ideation/suicidality, 1 worsening of depression, 2 suicide attempts, 1 anxiety/agitation/racing thoughts, 1 syncope, 1 ankle fracture, 1 viral gastro enteritis

8 out of 76

2 suicidal ideation/suicidality, 2 worsening of depression, 1 nose bleed, 1 allergic reaction

6 out of 67

Nemroff et al., 2005

Fluxetine

1 unspecified serious adverese event

1 out of 86

1 unspecified serious adverse event

1 out of 78

Fabre et al., 1996

Fluvoxamine

1 hospitalisation (non-cardiac chest pain)

1 out of 22

1 hospitalisation, 1 ruptured ectopic pregnancy, 1 hernia repair

2 out of 19

Feighner et al., 1999

Citalopram

3 suicide attempts, 1 miscarriage, 1 intestinal flu symptoms, 1 chest pain, 1 severe thinking abnormality, 1 allergic reaction

8 out of 349

No serious adverse event

0 out of 86

SCT-MD 01 (B), 2002

Escitalopram

1 anaphylaxis, 1 suicide attempt

2 out of 94

1 gallbladder stones

1 out of 46

SCT-MD 01 (C), 2002

Citalopram

1 coma, 1 intestinal fistula

2 out of 93

1 non-accidental overdose

1 out of 45

SCT-MD 02 (A), 2002

Escitalopram

1 suicidal tendency, suicide attempt; 1 non-accidental overdose, suidal attempt, tachycardia

2 out of 96

No serious adverse event

0 out of 53

SCT-MD 02 (B), 2002

Citalopram

1 cholestasis intrahepatic, dehydration

1 out of 99

No serious adverse event

0 out of 52

Pettinati et al., 2010

Sertraline

15 unspecified serious adverse events

15 out of 40

11 unspecified serious adverse events

11 out of 39

Dube et al., 2010

Escitalopram

1 suicide attempt, 1 gastro enteritis/malaria

2 out of 54

1 near drowning, 1 gastro enteritis

2 out of 122

Learned et al., 2012

Paroxetine

1 intentional over dose, 1 depression, 1 unspecified event

3 out of 166

2 unspecified serious adverese events

2 out of 156

Ratti et al., 2011

Paroxetine

1 hemorrhoidal hemorrhage

1 out of 109

1 rash

1 out of 123

Wang et al., 2014

Escitalopram

3 unspecified serious adverese event

3 out of 114

1 unspecified serious adverese event

1 out of 115

Detke et al., 2004

Paroxetine

1 unspecified serious adverese event

1 out of 85

No serious adverse event

0 out of 93

Mancino et al., 2014

Sertraline

1 hospitalization

1 out of 23

No serious adverse event

0 out of 27

DeRubeis et al., 2005

Paroxetine

1 suicide

1 out of 120

No serious adverse event

0 out of 60

29060-785 (A), 2005

Paroxetine CR 25 mg

3 abnormal laboratory vaue, 1 emotional lability

4 out of 98

1 abnormal laboratory value, 1 gastrointestinal disorder

2 out of 26

29060-785 (B), 2005

Paroxetine CR 12.5 mg

1 abnormal laboratory value

1 out of 94

1 abnormal laboratory value, 1 myocardial infarction

2 out of 26

29060-785 (C), 2005

Citalopram 20 mg

5 abnormal laboratory value, 1 syncope

6 out of 105

1 abnormal laboratory value, 1 suicide

2 out of 25

29060-785 (D), 2005

Citalopram 40 mg

1 abnormal laboratory vaue, 1 emotional lability

2 out of 97

1 abnormal laboratory value

1 out of 25

SCT-MD 27 (A), 2005

Escitalopram

1 depression, 1 abnormal mental status, 1 malignant neoplasm

3 out of 131

1 labyrinthitis

1 out of 66

SCT-MD 27 (B), 2005

Sertraline

1 appendicitis

1 out of 135

No serious adverse event

0 out of 66

SCT-MD 35, 2007

Escitalopram

1 abnormal hepatic function

1 out of 131

1 breast cancer, 1 depression, 1 suicidal ideation, 1 suicide

4 out of 130

SCT-MD 26, 2005

Escitalopram

1 inflicted injury

1 out of 143

No serious adverse event

0 out of 151

MY-1043/BRL-029060/115 (A), 2005

Paroxetine

1 hypertension, 1 diabetes and hypothyroidism, 1 Fibrocystic disease, 1 Ovarian cysts, 1 peptic ulcer hemorrhage, 1 spinal surgery, 1 hypomanic episode with suicidal tendency, 2 Suicidal ideation, 1 alcoholism, 1 neoplasm

11 out of 272

1 suicidal ideation, 1 back pain, 1 trauma

3 out of 57

MY-1043/BRL-029060/115 (B)

Fluoxetine

1 suicidal ideation, 1 neoplasm, 2 acute pyelonephritis, 1 thrombophlebitis, 1 ectopic pregnancy, 1 polycystic granuloma, 2 basal cell carcinomas, 1 myxoid mitral valve

9 out of 278 (10 SAE in 9 participants)

1 viral meningitis, 1 infection, 1 myocardial infarction, 1 mole removal

3 out of 56 (4 SAE in 3 participants)

MY-1045/BRL-029060/1, (A), 2005

Paroxetine

2 depression (worsening), 2 emotional lability, 1 neoplasm, 1 insomnia, 1 nervousness, 1 carcinoma, 1 epistaxis, 1 gastro intestinal disorder, 1 prostate disorder

9 out of 357 (11 SAE in 9 participants)

1 depression (worsening), 1 rectal disorder

2 out of 70

MY-1045/BRL-029060/1, 2005

Fluoxetine

1 depression (worsening), 2 emotional lability, 1 neo plasm, 1 coronary artery disease, 1 thrombo phlebitis, 1 hypoglycemia

7 out of 351

2 depression (worsening), 1 flu syndrome disorder

2 out of 70

29060/448 (A), 2005

Paroxetine IR

1 myocardial infarction, 1 emotional lability

2 out of 104

1 uterine fibroids enlarged, 1 gall bladder disorder

2 out of 50

29060/448 (B), 2005

Paroxetine CR

3 emotional lability, 1 hepatocellular jaundice, 1 manic reaction

6 out of 102

1 dehydration, 1 accidental overdose

2 out of 51

29060/449 (A), 2005

Paroxetine IR

1 emotional lability, 1 abortion, 2 unintended pregnancy

3 out of 112 (4 SAE in 3 participants)

No serious adverse event

0 out of 55

29060/449 (B), 2005

Paroxetine CR

1 abdominal pain, 1 pancreatitis, 1 accidental over dose, 1 unintended pregnancy

2 out of 108 (4 SAE in 2 participants)

No serious adverse event

0 out of 55

PAR 29060.07.001, 2008

Paroxetine

1 acure depression, 1 acute alcohol intoxication and suicide ideation

2 out of 13

No serious adverse event

0 out of 12

Nyth et al., 1992

Citalopram

1 cerebral hemorrhage and death

1 out of 98

1 death

1 out of 51

Perahia et al., 2006

Paroxetine

1 back pain, 1 breast neoplasm

2 out of 97

No serious adverse events

0 out of 99

Mendels et al., 1999

Citalopram

1 prostatic hyper trophy, 1 bronchitis

2 out of 89

1 suicide

1 out of 91

NCT00668525 (A), 2010

Escitalopram

1 chest pain, 1 pharyngitis 1 multiple sclerosis

3 out of 319

1 asthma, 1 haemothorax

2 out of 108

NCT00668525 (B), 2010

Escitalopram

1 chest pain, 1 appendicitis, 2 anxiety, 1 suicidal ideation, 1 suicide attempt, 1 peripheral vasuclar disorder

7 out of 318

1 injury, 1 suicidal ideation

2 out of 107

Nierenberg et al., 2007

Escitalopram

1 death and 3 unspecified serious adverse events

4 out of 274

2 unspecified serious adverse events

2 out of 137

WELL AK130926, 2007

Escitalopram

1 agitation

1 out of 144

No serious adverse event

0 out of 132

WELL AK130927, 2007

Escitalopram

2 suicidal ideation, 1 hepatic function abnormal

3 out of 138

1 suicidal ideation, 1 sudden caridac death

2 out of 141

NCT01473381, 2014

Escitalopram

1 haemorrhagic anaemia, 1 diverticulitis, 1 ilium fracture, 1 road traffic accident, 1 traumatic renal injury, 1 wrist fracture, 1 abortion missed, 1 suicidal ideation, 1 hospitalisaation

6 out of 280 (9 SAE in 6 participants)

1 angina pectoris, 1 gastric disorder, 1 pneumonia, 1 neck abscess, 1 oral abscess, 1 abnormal electrocardiogram ST segment, 1 back pain, 1 suicidal ideation, 1 obstructive airways disorder

3 out of 281 (9 SAE in 3 participants)

Adamson et al., 2015

Citalopram

1 suicidal ideation, severe abdominal cramps

2 out of 73

No serious adverse event

0 out of 65

CIT-MD-03, 2005

Citalopram

2 congestive heart failure, 1 cerebro vascular accident, 1 hyponatremia

4 out of 84

1 cerebro vascular accident, 1 cellulitis

2 out of 90

29060/810 (A), 2005

Paroxetine CR 12.5 mg

2 abnormal laboratory value, 1 carcinoma of lung

3 out of 153

1 cerebro vascular disorder, 1 depression

1 out of 73 (2 SAE in 1 participants)

29060/810 (B), 2005

Paroxetine CR 25 mg

1 abnormal laboratory value, 1 gall bladder disorder, 1 anxiety, 1 emotional lability,

4 out of 148

1 pleura disorder, 1 sinusitis, 1 bronchitis

2 out of 73 (3 SAE in 2 participants)