MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
Diarrhoea
|
Diarrhoea
|
very common, 10.8% - 12.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Local reaction
|
Local reaction
|
9% - 9.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
very common, 1% - 19.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
7.1% - 9.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very common, 1% - 29.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytosis
|
Thrombocytosis
|
6.1% - 6.2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 5.9% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common, 4% - 6.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common, 4% - 6.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
common, 5% - 8.3%
|
|
x
|
x
|
|
|
|
x
|
x
|
|
Hypertension
|
Hypertension
|
4.9% - 5.6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
common
|
|
x
|
|
|
|
|
|
|
|
Prothrombin level increased
|
Prothrombin level increased
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
common, 4.7% - 5.6%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Activated partial thromboplastin time prolonged
|
Activated partial thromboplastin time prolonged
|
common
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pseudomembranous colitis
|
Pseudomembranous colitis
|
common
|
|
x
|
|
|
|
|
|
|
x
|
Anaemia
|
Anaemia
|
4.2% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoproteinaemia
|
Hypoproteinaemia
|
common, 3% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
common, 4% - 5%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
common, 2.6% - 4.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
common, 2.4% - 4.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash
|
Rash
|
common, 2.4% - 4.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phlebitis
|
Phlebitis
|
common, 1.8% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
3.5% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough increased
|
3.7% - 3.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
2.8% - 4.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
2.9% - 3.7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
3.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
common, 2.7% - 3.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
Abscess
|
Abscess
|
common, 2% - 3.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
2.5% - 3.7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Amylase increased
|
Amylase increased
|
common, 1.4% - 3.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
2.6% - 3.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
2.7% - 2.9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
2.3% - 3.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Impaired healing
|
Impaired healing
|
postmarketing — 2% - 3.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
2.1% - 2.9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
common, 1.6% - 2.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
1.8% - 2.9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
1.7% - 3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
common, 0.9% - 2.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
common, 0.2% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Serum urea increased
|
common, 0.2% - 2.1%
|
|
|
|
|
|
|
x
|
x
|
|
Hypotension
|
Hypotension
|
1.7% - 2.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
postmarketing — 2%
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Nosocomial pneumonia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ventilator associated pneumonia
|
|
|
|
|
|
|
|
x
|
x
|
|
Hyperhidrosis
|
Sweating
|
1.6% - 2.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
1.2% - 2.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
1% - 2%
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Septic shock
|
Septic shock
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site swelling
|
Injection site swelling
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site inflammation
|
Injection site inflammation
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site reaction
|
Injection site reaction
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver injury
|
Liver injury
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
Hepatocellular injury
|
|
|
|
|
|
|
|
|
|
x
|
Traumatic liver injury
|
Liver injury
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
Sepsis
|
Sepsis
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site phlebitis
|
Injection site phlebitis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Pancreatitis acute
|
Pancreatitis acute
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Anaphylactoid reaction
|
postmarketing
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Cholestasis
|
Cholestasis
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
|
Jaundice
|
Jaundice
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
|
|
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
|
|
|
x
|
x
|
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
postmarketing
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
x
|
Acidosis
|
Acidosis
|
|
|
x
|
|
|
|
|
|
|
|
Atrial fibrillation
|
Atrial fibrillation
|
|
|
|
|
|
|
|
|
|
x
|
Coagulopathy
|
Coagulopathy
|
|
|
|
|
|
|
|
|
|
x
|
Candida infection
|
Candida infection
|
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
|
|
x
|
x
|
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
Confusional state
|
|
|
|
|
|
|
|
|
|
x
|
Feeling abnormal
|
Confusional state
|
|
|
|
|
|
|
|
|
|
x
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
Fungal skin infection
|
Fungal skin infection
|
|
|
|
|
|
|
|
|
|
x
|
Dysgeusia
|
Dysgeusia
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
|
|
|
|
|
x
|
Eosinophilia
|
Eosinophilia
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Faecal incontinence
|
Faecal incontinence
|
|
|
|
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
|
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
x
|
Glossitis
|
Glossitis
|
|
|
|
|
|
|
|
|
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
x
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
|
|
|
|
x
|
Hiccups
|
Hiccups
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Leukopenia
|
Leukopenia
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal discharge
|
Leukorrhea
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
|
|
|
|
x
|
x
|
|
Nervousness
|
Nervousness
|
|
|
|
|
|
|
|
|
|
x
|
Tension
|
Nervousness
|
|
|
|
|
|
|
|
|
|
x
|
Neutropenia
|
Neutropenia
|
|
|
|
|
|
|
|
|
|
x
|
Osteomyelitis
|
Osteomyelitis
|
|
|
|
|
|
|
|
x
|
x
|
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
|
|
x
|
|
|
|
|
|
|
x
|
Peritonitis
|
Peritonitis
|
|
|
|
|
|
|
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
x
|
Prurigo
|
Prurigo
|
|
|
|
|
|
|
|
|
|
x
|
Benign intracranial hypertension
|
Benign intracranial hypertension
|
|
|
x
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
|
|
|
|
|
|
|
|
|
x
|
Tooth discolouration
|
Tooth discolouration
|
|
|
x
|
|
|
|
|
|
|
|
Tremor
|
Tremor
|
|
|
|
|
|
|
|
|
|
x
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Vaginal infection
|
Vaginal inflammation
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Vertigo
|
Vertigo
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginitis
|
Vulvovaginitis
|
|
|
|
|
|
|
|
|
|
x
|
Wound infection
|
Wound infection
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Chills
|
Chills
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Hepatic failure
|
Hepatic failure
|
|
|
x
|
|
|
|
|
|
|
x
|
Sinus bradycardia
|
Sinus bradycardia
|
|
|
|
|
|
|
|
|
|
x
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
|
|
|
|
|
x
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
|
|
|
|
|
|
|
x
|
Hyperphosphataemia
|
Hyperphosphataemia
|
|
|
x
|
|
|
|
|
|
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
|
|
|
|
|
|
|
|
|
x
|
Creatinine renal clearance decreased
|
Creatinine renal clearance decreased
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine increased
|
Creatinine increased
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Scrotal oedema
|
Scrotal oedema
|
|
|
|
|
|
|
|
|
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
|
|
|
|
|
|
|
|
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Kidney function abnormal
|
|
|
|
|
|
|
|
|
|
x
|
Hepatocellular injury
|
Hepatocellular injury
|
|
|
|
|
|
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
|
x
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
|
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginal disorder
|
Vulvovaginal disorder
|
|
|
|
|
|
|
|
|
|
x
|
Abnormal faeces
|
Abnormal faeces
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
|
|
|
|
|
|
|
|
|
x
|
Muscle twitching
|
Muscle twitching
|
|
|
|
|
|
|
|
|
|
x
|
Sputum increased
|
Sputum increased
|
|
|
|
|
|
|
|
|
|
x
|
Increased bronchial secretion
|
Sputum increased
|
|
|
|
|
|
|
|
|
|
x
|
Azotaemia
|
Azotaemia
|
|
|
x
|
|
|
|
|
|
|
|
Mucosal inflammation
|
Mucosal inflammation
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
|
|
x
|
|
|
|
|
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
x
|
Bradycardia
|
Bradycardia
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
x
|
Prothrombin level decreased
|
Prothrombin level decreased
|
|
|
|
|
|
|
|
|
|
x
|
Prothrombin time shortened
|
Prothrombin time shortened
|
|
|
|
|
|
|
|
|
|
x
|
Diabetic foot infection
|
Diabetic foot infection
|
|
|
|
|
|
|
|
x
|
x
|
|
Infestation
|
Infestation NOS
|
|
|
x
|
|
|
|
|
x
|
x
|
|
International normalised ratio increased
|
International normalised ratio increased
|
|
|
|
|
|
|
|
|
|
x
|
Device malfunction
|
Device malfunction
|
|
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Visual impairment
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
x
|