MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
Hypoalbuminaemia
|
Hypoalbuminaemia
|
0% - 58%
|
0% - 47%
|
|
|
x
|
x
|
Decreased appetite
|
Decreased appetite
|
very common
|
|
|
|
|
x
|
Anorexia
|
postmarketing, 0% - 29%
|
0% - 18%
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing, very common
|
|
|
x
|
x
|
x
|
Amylase increased
|
Amylase increased
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Tumour pain
|
Tumour pain
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Lymphopenia
|
Lymphopenia
|
postmarketing — 6% - 47%
|
6% - 42%
|
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 0% - 55%
|
0% - 25%
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing, 1% - 46%
|
1% - 45%
|
x
|
x
|
x
|
x
|
Asthenia
|
postmarketing — 0% - 6%
|
1% - 2%
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 1% - 46%
|
1% - 45%
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
1% - 14%
|
1% - 12%
|
|
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Folliculitis
|
Folliculitis
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Glossodynia
|
Glossodynia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Infarction
|
Infarction
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Muscle spasms
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Nasopharyngitis
|
Rhinorrhoea
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing — 0% - 15%
|
1% - 8%
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing — 0% - 15%
|
1% - 8%
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing — 0% - 31%
|
0% - 26%
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
1% - 11%
|
1% - 8%
|
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
0% - 7%
|
1% - 3%
|
x
|
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
0% - 7%
|
1% - 3%
|
x
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing — 1% - 11%
|
1% - 14%
|
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing, 0% - 16%
|
0% - 12%
|
x
|
x
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
postmarketing, 0% - 40%
|
0% - 16%
|
x
|
x
|
x
|
x
|
Cholangitis
|
Cholangitis
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
Cholecystitis
|
Cholecystitis
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
uncommon
|
|
x
|
|
|
x
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
|
x
|
Erythema multiforme minor
|
|
|
|
|
x
|
|
Interstitial lung disease
|
Interstitial pneumonia
|
uncommon
|
|
x
|
|
|
x
|
Interstitial lung disease
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
uncommon
|
|
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 0% - 40%
|
0% - 16%
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 0% - 40%
|
0% - 16%
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing, 1% - 17%
|
0% - 2%
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing, 0% - 24%
|
0% - 20%
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing — 0% - 11%
|
0% - 5%
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
|
|
|
|
|
x
|
Weight decreased
|
Weight decreased
|
postmarketing, 0% - 30%
|
0% - 10%
|
x
|
x
|
x
|
x
|
Mucosal inflammation
|
Mucosal inflammation
|
postmarketing — 0% - 11%
|
0% - 5%
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
0% - 13%
|
0% - 6%
|
|
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
Dehydration
|
Dehydration
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Hypertensive crisis
|
Hypertensive crisis
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Hyperthyroidism
|
Hyperthyroidism
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
Jaundice
|
Jaundice
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Radiation pneumonitis
|
Radiation pneumonitis
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
Leukoencephalopathy
|
Leukoencephalopathy
|
postmarketing, uncommon
|
|
|
x
|
x
|
x
|
Respiratory distress
|
Respiratory distress
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
International normalised ratio abnormal
|
International normalised ratio abnormal
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 0% - 10%
|
0% - 6%
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, 0% - 19%
|
0% - 11%
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
|
Bone disorder
|
Bone disorder
|
postmarketing
|
|
x
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
x
|
x
|
x
|
|
Skin cancer
|
Skin cancer
|
postmarketing
|
|
x
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
x
|
x
|
x
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
x
|
x
|
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing
|
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Gastrointestinal symptom NOS
|
|
|
|
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
x
|
x
|
x
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, common
|
|
x
|
x
|
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
x
|
x
|
x
|
|
Keratoacanthoma
|
Keratoacanthoma
|
postmarketing
|
|
x
|
x
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Nephrotic syndrome
|
Nephrotic syndrome
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
x
|
x
|
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
|
x
|
Erythema
|
Erythema
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
x
|
x
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
rare
|
|
|
|
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
postmarketing — 11% - 35%
|
3% - 11%
|
x
|
x
|
x
|
x
|
Peripheral sensory neuropathy
|
Peripheral sensory neuropathy
|
postmarketing
|
|
x
|
x
|
x
|
|
Leukocytoclastic vasculitis
|
Allergic cutaneous angiitis
|
postmarketing
|
|
|
x
|
|
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
x
|
|
|
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Lipase increased
|
Lipase increased
|
postmarketing, very common
|
|
x
|
x
|
x
|
x
|
Squamous cell carcinoma of skin
|
Squamous cell carcinoma of skin
|
postmarketing
|
|
|
x
|
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
x
|
x
|
x
|
|
Prothrombin level abnormal
|
Prothrombin level abnormal
|
postmarketing
|
|
x
|
x
|
x
|
|
Blood potassium decreased
|
Potassium low
|
postmarketing
|
|
|
x
|
|
|
Drug-induced liver injury
|
Drug-induced hepatitis
|
postmarketing, rare
|
|
x
|
x
|
|
x
|
Dysphonia
|
Dysphonia
|
postmarketing
|
|
x
|
x
|
|
x
|
Hoarseness
|
0% - 5%
|
0% - 1%
|
x
|
|
x
|
|
Recall phenomenon
|
Radiation recall reaction (dermatologic)
|
postmarketing
|
|
x
|
x
|
|
|
Hepatic cancer
|
Hepatocellular carcinoma
|
postmarketing
|
|
|
x
|
|
|
Hepatocellular carcinoma
|
Hepatocellular carcinoma
|
postmarketing
|
|
|
x
|
|
|
Osteonecrosis of jaw
|
Osteonecrosis of jaw
|
postmarketing
|
|
|
|
|
x
|
Constipation
|
Constipation
|
postmarketing, 0% - 15%
|
0% - 11%
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing, 0% - 27%
|
0% - 3%
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
x
|
x
|
Ascites
|
Ascites
|
|
|
|
|
x
|
|
Burning mouth syndrome
|
Burning mouth syndrome
|
|
|
|
|
|
x
|
Neoplasm malignant
|
Carcinoma
|
|
|
|
|
x
|
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
|
|
x
|
|
|
|
Transient ischaemic attack
|
Transient ischaemic attack
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
|
|
|
|
x
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
x
|
x
|
Varices oesophageal
|
Varices oesophageal
|
|
|
|
|
x
|
x
|
Glossitis
|
Glossitis
|
|
|
|
|
|
x
|
Cardiac failure
|
Cardiac failure
|
|
|
|
|
x
|
|
Haematoma
|
Haematoma
|
|
|
|
|
x
|
|
Ischaemia
|
Ischaemia
|
|
|
|
x
|
|
|
Renal failure acute
|
Renal failure acute
|
|
|
|
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
|
|
|
x
|
|
|
Acute coronary syndrome
|
Myocardial infarction
|
|
|
|
x
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
|
|
x
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
x
|
|
Aphthous stomatitis
|
Aphthous stomatitis
|
|
|
|
|
|
x
|
Completed suicide
|
Suicide
|
|
|
|
|
x
|
|
Dizziness
|
Syncope
|
|
|
|
|
x
|
|
Shock
|
Syncope
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
|
|
|
|
x
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
x
|
|
Embolism
|
Thromboembolism
|
|
|
|
|
x
|
x
|
Embolism venous
|
Thromboembolism
|
|
|
|
|
x
|
x
|
Vascular headache
|
Vascular headache
|
|
|
x
|
|
|
|
Urogenital disorder
|
Urogenital disorder
|
|
|
x
|
|
|
|
Mouth ulceration
|
Mouth ulceration
|
|
|
|
|
|
x
|
Tubulointerstitial nephritis
|
Acute interstitial nephritis
|
|
|
|
|
x
|
|
Gastrointestinal perforation
|
Gastrointestinal perforation
|
|
|
|
x
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
x
|
|
|
Dry skin
|
Dry skin
|
postmarketing, 0% - 11%
|
0% - 6%
|
x
|
x
|
x
|
x
|
Abdominal rigidity
|
Abdominal rigidity
|
|
|
|
|
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
x
|
|
Brain cancer metastatic
|
Brain cancer metastatic
|
|
|
|
|
x
|
|
Metastases to central nervous system
|
Brain cancer metastatic
|
|
|
|
|
x
|
|
Oesophageal pain
|
Oesophageal pain
|
|
|
|
|
|
x
|
Oral pain
|
Oral pain
|
|
|
|
|
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
|
|
|
|
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
x
|
Abdominal pain lower
|
Abdominal pain lower
|
|
|
|
|
|
x
|
Abdominal tenderness
|
Abdominal tenderness
|
|
|
|
|
|
x
|
Disease progression
|
Disease progression
|
|
|
|
|
|
x
|
Blood pressure systolic increased
|
Blood pressure systolic increased
|
|
|
|
|
|
x
|
Metastatic renal cell carcinoma
|
Metastatic renal cell carcinoma
|
|
|
|
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
|
|
|
|
|
x
|
Hepatic pain
|
Hepatic pain
|
|
|
|
|
|
x
|
Blood thyroid stimulating hormone increased
|
Thyrotropin high
|
|
|
|
|
|
x
|
Drug interaction
|
Drug interaction
|
|
|
|
|
x
|
|
Oesophageal discomfort
|
Oesophageal discomfort
|
|
|
|
|
|
x
|
Oropharyngeal discomfort
|
Oropharyngeal discomfort
|
|
|
|
|
|
x
|
Mood swings
|
Mood alteration NOS
|
|
|
|
|
x
|
|