MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
Diarrhoea
|
Diarrhoea
|
very common, 3.6% - 13.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loose stools
|
common
|
|
|
|
|
|
|
|
|
x
|
x
|
Nausea
|
Nausea
|
very common, 4.5% - 6.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amylase increased
|
Amylase increased
|
4.5% - 6%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
White blood cell count decreased
|
White blood cell count decreased
|
5.7%
|
|
x
|
|
|
|
|
|
|
|
|
White blood cell count low
|
3.6% - 5.7%
|
|
|
|
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
5.5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
uncommon, 5.4% - 6.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
common, 5.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
common, 5.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
4% - 6.1%
|
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
uncommon — 3.8% - 5.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
uncommon — 3.8% - 5.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 4.1% - 5.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 4.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common, 3.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common, 3.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
3.7%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
common, 2%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
common, 2%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Blood triglycerides increased
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
common, 0.8%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Decreased appetite
|
Anorexia
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
2.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Insomnia
|
Insomnia
|
uncommon, 3.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
uncommon, 2.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
uncommon, 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
uncommon, 1.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
uncommon, 1.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
uncommon, 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
uncommon, 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
rare, 1.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
uncommon, 0% - 2.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
uncommon
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis toxic
|
Hepatitis toxic
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
uncommon
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
uncommon
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
|
Renal failure
|
Renal failure
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperamylasaemia
|
Hyperamylasaemia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Varicella zoster
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Herpes zoster
|
|
|
x
|
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lipodystrophy acquired
|
Lipodystrophy acquired
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Cytolytic hepatitis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Hepatitis
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lipohypertrophy
|
Lipohypertrophy
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Buffalo hump
|
|
|
x
|
|
|
|
|
|
|
|
|
Lipoatrophy
|
Lipoatrophy
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
Renal impairment
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0% - 9.6%
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
0.4%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Haemorrhage intracranial
|
Haemorrhage intracranial
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Lipase increased
|
Lipase increased
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic steatosis
|
Hepatic steatosis
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
uncommon, 0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Facial wasting
|
Facial wasting
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Autoimmune disorder
|
Autoimmune disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
|
|
|
|
|
|
|
|
|
|
x
|
Cyst
|
Cyst
|
|
|
|
|
|
|
|
|
|
|
x
|
Depression
|
Depression
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Drug eruption
|
Drug eruption
|
|
|
x
|
|
|
|
|
|
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
|
|
x
|
|
|
|
|
|
|
|
|
Gastroenteritis
|
Gastroenteritis
|
0%
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Basedow's disease
|
Basedow's disease
|
|
|
x
|
|
|
|
|
|
|
|
|
Haemarthrosis
|
Haemarthrosis
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Hepatitis B
|
Hepatitis B
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast enlargement
|
Hypertrophy of breast
|
|
|
x
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inflammation
|
Inflammation
|
|
|
x
|
|
|
|
|
|
|
|
|
Insulin resistance
|
Insulin resistance
|
|
|
x
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure acute
|
Renal failure acute
|
|
|
|
|
|
|
|
|
|
|
x
|
Progressive multifocal leukoencephalopathy
|
Progressive multifocal leukoencephalopathy
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
x
|
Myositis
|
Myositis
|
|
|
x
|
|
|
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Opportunistic infection
|
Opportunistic infection
|
|
|
x
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
x
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
x
|
Pregnancy
|
Pregnancy
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Prurigo
|
Prurigo
|
|
|
x
|
|
|
|
|
|
|
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
|
|
x
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
|
|
x
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
|
|
x
|
|
|
|
|
|
|
|
|
Erythema
|
Erythema
|
|
|
x
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
|
|
x
|
|
|
|
|
|
|
|
|
Muscle haemorrhage
|
Muscle haemorrhage
|
|
|
|
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash macular
|
Rash macular
|
|
|
x
|
|
|
|
|
|
|
|
|
Retching
|
Retching
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Oesophageal candidiasis
|
Oesophageal candidiasis
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumonia streptococcal
|
Pneumonia due to Streptococcus, group b
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
x
|
|
|
|
|
|
|
|
|
Chills
|
Rigors
|
0%
|
|
|
|
|
|
|
|
|
|
x
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Cytomegalovirus chorioretinitis
|
Cytomegalovirus chorioretinitis
|
|
|
|
|
|
|
|
|
|
|
x
|
Liver disorder
|
Hepatic impairment
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Mitochondrial toxicity
|
Mitochondrial toxicity
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Rash papular
|
Rash papular
|
|
|
x
|
|
|
|
|
|
|
|
|
Pneumocystis jirovecii pneumonia
|
Pneumocystis jirovecii pneumonia
|
|
|
|
|
|
|
|
|
|
|
x
|