MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
Influenza like illness
|
Influenza-like symptoms
|
common, 3% - 3.59%
|
3.24%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
1.35% - 2.14%
|
1.93%
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
common, 0% - 3.08%
|
0% - 3.57%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Lightheadedness
|
|
|
|
|
|
|
|
|
|
x
|
Headache
|
Headache
|
postmarketing — 0% - 7.53%
|
0% - 8.65%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
common, 1.52% - 2.65%
|
1.8%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
common, 0.404% - 5.05%
|
1.8% - 4.29%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute bronchitis
|
0.431% - 2.02%
|
|
|
|
|
|
|
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
uncommon, 2.05% - 2.12%
|
1.08%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
uncommon, 2.05% - 2.12%
|
1.08%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
common, 0.947% - 2.56%
|
2.52%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
0% - 3.59%
|
0% - 4.68%
|
|
|
|
|
|
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
0% - 2.46%
|
0% - 7.14%
|
|
|
|
|
|
|
x
|
x
|
Rhinorrhoea
|
0% - 2.15%
|
0%
|
|
|
|
|
|
|
x
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
0.676% - 2.84%
|
1.72% - 1.98%
|
|
|
|
|
|
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
common, 0% - 2.15%
|
0% - 1.08%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
common, 0.901% - 1.45%
|
2.16% - 3.22%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
common, 0% - 1.75%
|
0.644% - 0.721%
|
|
|
|
|
|
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing — 0% - 1.41%
|
0.901% - 1.07%
|
|
|
|
|
|
|
x
|
x
|
Asthenia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing — 0% - 1.41%
|
0.901% - 1.07%
|
|
|
|
|
|
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
0.47% - 1.16%
|
1.5%
|
|
|
|
|
|
|
|
x
|
Pain
|
Pain
|
common, 0.568% - 1.54%
|
0.541%
|
|
|
|
|
|
|
x
|
x
|
Back pain
|
Back pain
|
common, 0.216% - 4.04%
|
1.44% - 1.72%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
postmarketing — 0.225% - 4.3%
|
0% - 3.57%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
common, 0% - 3.45%
|
0% - 1.85%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
uncommon, 1.05% - 1.28%
|
0.858%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
common, 0% - 1.86%
|
0% - 3.57%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 1.97%
|
0.721% - 1.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 1.97%
|
0.721% - 1.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
common, 0.513% - 1.06%
|
0.541%
|
|
|
|
|
|
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0.676% - 1.7%
|
0.858% - 1.62%
|
|
|
|
|
|
|
x
|
x
|
Chest pain
|
Chest pain
|
common, 0.379% - 1.05%
|
0.541% - 0.858%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Blood uric acid increased
|
0.386% - 1.32%
|
1.29%
|
|
|
|
|
|
|
|
x
|
Hyperuricaemia
|
uncommon, 0% - 1.77%
|
0.901%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood glucose increased
|
Blood glucose increased
|
0.632% - 1.13%
|
2.58%
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
common, 0.189% - 1.26%
|
1.08% - 1.29%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tracheobronchitis
|
Acute bronchitis
|
0.431% - 2.02%
|
|
|
|
|
|
|
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
common, 0% - 1.59%
|
0% - 0.644%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
0% - 3.77%
|
0% - 3.57%
|
|
|
|
|
|
|
x
|
x
|
Arthritis
|
Arthritis
|
common, 0% - 1.03%
|
0.18%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
uncommon, 0% - 1.77%
|
0.901%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Inflicted injury
|
0.513% - 1.33%
|
0.541%
|
|
|
|
|
|
|
x
|
|
Insomnia
|
Insomnia
|
0.189% - 1.59%
|
1.44% - 1.93%
|
|
|
|
|
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 1.7%
|
0.858% - 1.08%
|
|
|
|
|
|
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
uncommon
|
|
|
|
|
|
|
|
x
|
x
|
Eczema
|
Eczema
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
uncommon
|
|
x
|
x
|
|
|
|
|
x
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Shock
|
Syncope
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Syncope
|
Syncope
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood potassium increased
|
Blood potassium increased
|
uncommon
|
|
|
|
|
|
|
|
|
x
|
Toothache
|
Toothache
|
0.189% - 1.54%
|
0.36%
|
|
|
|
|
|
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
common, 0.379% - 1.19%
|
0.721% - 1.29%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
0.379% - 1.59%
|
0.721%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Spinal disorder
|
Spinal disorder
|
0.47% - 0.901%
|
1.5%
|
|
|
|
|
|
|
|
x
|
Spondyloarthropathy
|
Spinal disorder
|
0.47% - 0.901%
|
1.5%
|
|
|
|
|
|
|
|
x
|
Nausea
|
Nausea
|
postmarketing, 0.189% - 2.05%
|
0.858% - 0.901%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood potassium decreased
|
Blood potassium decreased
|
uncommon, 0.0702% - 1.13%
|
0%
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
0.171% - 1.03%
|
0.36% - 1.07%
|
|
|
|
|
|
|
x
|
x
|
Gout
|
Gout
|
0.353% - 1.03%
|
0.18%
|
|
|
|
|
|
|
x
|
|
Erectile dysfunction
|
Erectile dysfunction
|
0.353% - 2.05%
|
0%
|
|
|
|
|
|
|
x
|
|
Viral infection
|
Viral infection
|
0.171% - 0.421%
|
1.07%
|
|
|
|
|
|
|
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
0% - 0.883%
|
0.36%
|
|
|
|
|
|
|
x
|
|
Alopecia
|
Alopecia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
rare, uncommon
|
|
|
|
|
|
|
|
x
|
x
|
Gastrointestinal disorder
|
Unspecified disorder of intestine
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing, 0% - 3.23%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malabsorption
|
Sprue
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Blood creatinine increased
|
postmarketing, 0.641% - 0.913%
|
1.07%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
Diabetes mellitus
|
Diabetic
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
Microalbuminuria
|
Microalbuminuria
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia
|
Anaemia
|
|
|
|
|
|
|
|
|
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
|
|
|
|
|
|
|
|
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
|
|
|
|
|
|
|
|
|
x
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
|
|
x
|
Appetite absent
|
|
|
|
|
|
|
|
|
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
x
|
x
|
Infection
|
Infection
|
|
|
|
|
|
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
x
|
x
|
Constipation
|
Constipation
|
|
|
|
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
|
|
|
|
|
|
|
|
|
x
|
Eosinophilia
|
Eosinophilia
|
0%
|
0% - 3.57%
|
|
|
|
|
|
|
x
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
|
|
|
|
|
|
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
0% - 3.23%
|
0%
|
|
|
|
|
|
|
x
|
x
|
Glycosuria
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
0% - 3.45%
|
0%
|
|
|
|
|
|
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
x
|
Hyponatraemia
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
x
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
|
|
|
|
|
|
|
x
|
Leukopenia
|
Leukopenia
|
|
|
|
|
|
|
|
|
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
|
|
|
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure
|
Renal failure
|
|
|
|
|
|
|
|
|
|
x
|
Sialoadenitis
|
Sialoadenitis
|
|
|
|
|
|
|
|
|
|
x
|
Sleep disorder
|
Sleep disturbance
|
|
|
|
|
|
|
|
|
|
x
|
Muscle spasms
|
Muscle spasms
|
|
|
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
|
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
x
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
|
|
x
|
Blood urea increased
|
Blood urea increased
|
uncommon, 0%
|
0% - 2.25%
|
|
|
|
|
|
|
x
|
x
|
Pancytopenia
|
Bone marrow depression
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
|
|
|
|
|
|
|
|
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
x
|
|
Xanthopsia
|
Xanthopsia
|
|
|
|
|
|
|
|
|
|
x
|
Cutaneous vasculitis
|
Cutaneous vasculitis
|
|
|
|
|
|
|
|
|
|
x
|
Viral upper respiratory tract infection
|
Viral upper respiratory tract infection
|
0%
|
0% - 3.57%
|
|
|
|
|
|
|
x
|
|
Electrolyte imbalance
|
Electrolyte imbalance
|
|
|
|
|
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
|
|
|
|
|
|
x
|
Epigastric discomfort
|
Gastric irritation
|
|
|
|
|
|
|
|
|
|
x
|
Systemic lupus erythematosus
|
Lupus erythematosus
|
|
|
|
|
|
|
|
|
|
x
|
Transaminases increased
|
Transaminases increased
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Respiratory distress
|
Respiratory distress
|
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypovolaemia
|
Hypovolaemia
|
|
|
|
|
|
|
|
|
|
x
|
Vasculitis necrotising
|
Angiitis necrotising
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
x
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
0% - 3.23%
|
0% - 1.85%
|
|
|
|
|
|
|
x
|
|
Blood bilirubin increased
|
Bilirubin value increased
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pseudohyperkalaemia
|
Pseudohyperkalaemia
|
0% - 1.08%
|
0% - 7.14%
|
|
|
|
|
|
|
x
|
|
Rhinorrhoea
|
Rhinorrhoea
|
0% - 2.15%
|
0%
|
|
|
|
|
|
|
x
|
|