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Table 2 Most frequently reported SOCs and PTs for each antibiotic with proven efficacy against CRE in different spontaneous reporting systems

From: Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study

 FaersItalyUK
SOCPTSOCPTSOCPT
ColistinGeneral 12.8%Acute kidney injury 4.8%Respiratory 16.4%Acute kidney injury 10.7%Investigation 17.0%Acute kidney injury 8.5%
Renal 8.9%Drug ineffective 3.0%Skin 15.6%Oral paraesthesia 5.3%Renal 14.1%Blood creatinine increased 3.2%
Infections 8.9%Drug resistance 2.4%Renal 15.1%Pruritus 4.9%General 13.4%Drug interaction 3.2%
Respiratory 4.9%Pathogen resistance 1.8%Nervous 11.6%Erythema 4.4%Nervous 9.4%Blood urea increased 2.8%
Nervous 4.7%Multiple organ dysfunction syndrome 1.7%General 11.1%Cough 4.0%Gastrointestinal 9.4%Off-label use 2.1%
MeropenemGeneral 9.9%Drug ineffective 2.3%Skin 48.2%Erythema 11.4%Skin 14.3%Neutropenia 3.1%
Infections 8.0%Pyrexia 1.9%Blood 10.8%Rash 8.4%General 12.9%Rash 2.3%
Investigation 5.9%Drug interaction 1.4%General 7.6%Urticaria 6.3%Investigation 11.7%Nausea 2.3%
Skin 5.7%Sepsis 1.1%Respiratory 4.5%Pruritus 5.0%Blood 9.3%Anaphylactic reaction 2.1%
Blood 5.2%Thrombocytopenia 1.1%Gastrointestinal 4.1%Thrombocytopenia 2.8%Nervous 8.6%Pyrexia – Liver function test abnormal 1.8%
TigecyclineGeneral 13.1%Drug ineffective 4.1%Gastrointestinal 28.3%Nausea 7.8%General 17.2%Liver function test abnormal 4.6%
Infections 9.4%Death 2.2%Skin 21.0%Vomiting 6.8%Gastrointestinal 16.7%Drug ineffective 4.6%
Gastrointestinal 7.9%Nausea 2.2%Investigation 11.9%Erythema 5.9%Investigation 14.3%Nausea 3.7%
Investigation 6.8%Pancreatitis 2.1%Hepatobiliary 8.7%Rash 4.6%Infections 11.8%Acute pancreatitis 3.2%
Blood 5.1%Sepsis 1.7%Blood 6.4%Acute pancreatitis 4.1%Ear 6.4%Thrombocytopenia – Death 2.8%
GentamicinGeneral 9.0%Acute kidney injury 4.4%Skin 40.3%Erythema 10.0%Renal 13.9%Acute kidney injury 8.0%
Renal 7.6%Pyrexia 2.1%Renal 11.8%Urticaria 7.9%Ear 11.9%Hypotension 6.3%
Infections 5.8%Drug ineffective 1.4%General 10.4%Acute kidney injury 6.3%Vascular 8.9%Anaphylactic reaction 5.6%
Skin 5.3%Renal failure 1.3%Eye 6.9%Rash 6.0%Nervous 8.4%Ototoxicity 2.2%
Investigations 4.6%Dizziness 1.1%Nervous 3.9%Pruritus 4.6%Immune 8.1%Deafness 2.1%
Ceftazidime/AvibactamGeneral 22.0%Death 6.7%General 28.2%Thrombocytopenia 7.7%Investigations 25.0%Product use issue 18.8%
Infections 10.4%Drug ineffective 5.9%Infections 20.5%Direct Coombs test positive 7.7%Infections 18.8%Hypernatraemia 15.6%
Injury 8.0%Off-label use 4.1%Skin 12.8%Septic shock 7.7%Injury 18.8%Platelet count decreased 6.3%
Investigations 6.3%Pathogen resistance 3.7%Investigations 10.3%Multiple organ dysfunction syndrome 7.7%Metabolism 15.6%ALT increased 6.3%
Renal 4.9%Drug resistance 3.5%Blood 7.7%Condition aggravated 7.7%General 12.5%Pathogen resistance 6.3%