MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
Systolic hypertension
|
Systolic hypertension
|
28% - 42%
|
|
|
|
|
x
|
x
|
Respiratory depression
|
Respiratory depression
|
37%
|
32%
|
|
|
x
|
x
|
x
|
Pulmonary function test decreased
|
Respiratory depression
|
37%
|
32%
|
|
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing — 13% - 56%
|
12% - 30%
|
x
|
x
|
x
|
x
|
x
|
Diastolic hypertension
|
Diastolic hypertension
|
12% - 15%
|
|
|
|
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing — 4% - 30%
|
18% - 24%
|
x
|
x
|
x
|
x
|
x
|
Hypertension worsened
|
|
|
|
x
|
|
|
|
Hypokalaemia
|
Hypokalaemia
|
9% - 13.1%
|
|
|
|
|
x
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
1% - 7%
|
|
|
|
|
x
|
x
|
Constipation
|
Constipation
|
6% - 6.1%
|
|
|
|
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
2% - 6%
|
|
|
|
|
x
|
x
|
Fluid retention
|
Generalised oedema
|
2% - 6%
|
|
|
|
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing — 5% - 6%
|
|
x
|
|
x
|
x
|
x
|
Infarction
|
Infarction
|
common
|
|
x
|
|
|
|
|
Withdrawal syndrome
|
Withdrawal syndrome
|
common
|
|
x
|
|
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing — 1% - 44.3%
|
4% - 17%
|
x
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
common
|
|
x
|
|
|
|
|
Bradycardia
|
Bradycardia
|
postmarketing — 0% - 42%
|
3% - 4%
|
x
|
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, 4% - 7%
|
3%
|
|
x
|
x
|
x
|
x
|
Respiratory failure
|
Respiratory failure
|
3% - 5%
|
|
|
|
|
x
|
x
|
Hypoventilation
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Atelectasis
|
Atelectasis
|
3% - 6%
|
3%
|
|
|
|
x
|
|
Pneumothorax
|
Atelectasis
|
3% - 6%
|
3%
|
|
|
|
x
|
|
Nausea
|
Nausea
|
postmarketing — 3% - 11%
|
2% - 9%
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing — 3% - 4%
|
5% - 6%
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
common, 1% - 4%
|
1%
|
x
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 0% - 7%
|
3% - 4%
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing, 2% - 3%
|
2%
|
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
common, 1.64% - 7%
|
2%
|
x
|
|
|
x
|
x
|
Pleural effusion
|
Pleural effusion
|
2% - 6%
|
1%
|
|
x
|
|
x
|
x
|
Chills
|
Chills
|
2%
|
3%
|
|
|
|
x
|
|
Rigors
|
postmarketing, 2%
|
3%
|
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing — 1% - 7%
|
3%
|
x
|
x
|
x
|
x
|
x
|
Respiratory rate decreased
|
Respiratory rate decreased
|
2%
|
4%
|
|
|
x
|
x
|
|
Hypoxia
|
Hypoxia
|
2% - 4%
|
2% - 4%
|
|
x
|
x
|
x
|
x
|
Hypoventilation
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Post procedural haemorrhage
|
Post procedural haemorrhage
|
2% - 4%
|
3%
|
|
|
|
x
|
|
Hypovolaemia
|
Hypovolaemia
|
postmarketing, 3% - 5%
|
2%
|
|
x
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
1% - 2%
|
|
|
|
|
x
|
x
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
1% - 2%
|
|
|
|
|
x
|
x
|
Acidosis
|
Acidosis
|
postmarketing, 1% - 2%
|
1% - 2%
|
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
1% - 2%
|
0%
|
|
|
|
x
|
|
Oliguria
|
Oliguria
|
postmarketing, 1% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
1% - 3%
|
1%
|
|
x
|
|
x
|
|
Sinus tachycardia
|
Sinus tachycardia
|
1% - 2%
|
1%
|
|
|
|
x
|
|
Wheezing
|
Wheezing
|
1% - 2%
|
0%
|
|
|
|
x
|
|
Abdominal distension
|
Abdominal distension
|
uncommon
|
|
x
|
|
|
|
x
|
Cardiac output decreased
|
Cardiac output decreased
|
uncommon
|
|
x
|
|
|
|
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
uncommon
|
|
x
|
|
|
|
|
Metabolic acidosis
|
Metabolic acidosis
|
uncommon
|
|
x
|
|
|
|
|
Hypoalbuminaemia
|
Hypoalbuminaemia
|
uncommon
|
|
x
|
|
|
|
|
Drug ineffective
|
Drug ineffective
|
uncommon
|
|
x
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
0% - 2%
|
1%
|
|
|
|
x
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
postmarketing, 1% - 5%
|
1%
|
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Respiratory acidosis
|
Respiratory acidosis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Apnoea
|
Apnoea
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Atrioventricular block
|
Atrioventricular block
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Block heart
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing, 3%
|
4%
|
|
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing, 3%
|
4%
|
|
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Hypercapnia
|
Hypercapnia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Carbon dioxide increased
|
Hypercapnia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Illusion
|
Illusion
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Nephropathy
|
Nephropathy
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Neuritis
|
Neuritis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuritis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
postmarketing
|
|
|
x
|
x
|
x
|
|
Pain
|
Pain
|
postmarketing, 2%
|
2%
|
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Speech disorder
|
Speech disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
postmarketing — 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
Visual impairment
|
Disorder sight
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Abnormal vision
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Photopsia
|
Photopsia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
Blood urea increased
|
Blood urea increased
|
postmarketing
|
|
|
|
x
|
x
|
|
Urea increased
|
|
|
|
|
|
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Pulmonary congestion
|
Pulmonary congestion
|
postmarketing
|
|
|
x
|
x
|
x
|
|
Respiratory tract congestion
|
Pulmonary congestion
|
postmarketing
|
|
|
x
|
x
|
x
|
|
Extrasystoles
|
Extrasystoles
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Hyperpyrexia
|
Hyperpyrexia
|
postmarketing, 2%
|
3%
|
|
x
|
x
|
x
|
x
|
Light anaesthesia
|
Light anaesthesia
|
postmarketing
|
|
|
x
|
x
|
x
|
|
Electrocardiogram T wave inversion
|
Electrocardiogram T wave inversion
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Blood pressure fluctuation
|
Blood pressure fluctuation
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Hypoventilation
|
Hypoventilation
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
|
|
|
|
|
x
|
x
|
Infection
|
Infection
|
|
|
|
x
|
|
|
|
Decubitus ulcer
|
Decubitus ulcer
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
|
|
|
|
|
|
x
|
Rash
|
Rash
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
|
|
|
x
|
Hypernatraemia
|
Hypernatraemia
|
|
|
|
|
|
|
x
|
Body temperature decreased
|
Body temperature decreased
|
|
|
x
|
|
|
|
|
Hypothermia
|
Body temperature decreased
|
|
|
x
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
x
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
x
|
Pregnancy
|
Pregnancy
|
|
|
x
|
|
|
|
|
Septic shock
|
Septic shock
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
|
|
|
|
x
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
|
|
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
x
|
|
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
x
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
x
|
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
|
|
x
|
Sepsis
|
Sepsis
|
|
|
|
|
|
|
x
|
Electrolyte imbalance
|
Electrolyte imbalance
|
|
|
|
|
|
|
x
|
Sinus arrest
|
Sinus arrest
|
|
|
x
|
|
x
|
x
|
|
Fluid overload
|
Fluid overload
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
|
|
|
x
|
|
|
|