Trial | Experimental intervention | SSRI participants assessed for serious adverse events | Placebo participants assessed for serious adverse events | ||
---|---|---|---|---|---|
Numbers and types of serious adverse events | Proportion of participants with a serious adverse event | Numbers and types of serious adverse events | Proportion of participants with a serious adverse event | ||
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 25Â 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 12.5Â 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 20Â 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 40Â 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 12.5Â 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 25Â 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) |