|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
|
Gastrointestinal disorder
|
postmarketing — 50% - 58.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
postmarketing, 48.3% - 54.2%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infestation NOS
|
postmarketing, 48.3% - 54.2%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mediastinal disorder
|
postmarketing, 31.7% - 37.1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing — 30% - 34.5%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Connective tissue disorder
|
postmarketing, 29.2% - 36.2%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervous system disorder
|
postmarketing — 26.7% - 27.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental disorder
|
postmarketing — 24.1% - 29.2%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malnutrition
|
uncommon, 21.7% - 32.8%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood and lymphatic system disorders
|
postmarketing — 20.7% - 24.2%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
postmarketing — 17.2% - 17.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder
|
postmarketing — 15% - 22.4%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
9.17% - 12.9%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
6.67% - 13.8%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
postmarketing — 1.7% - 19.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
6.67% - 8.62%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
postmarketing — 6.2% - 12.1%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia
|
5% - 8.62%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Injection site reaction
|
5.8% - 7.7%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Eye disorder
|
4.2% - 8.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion
|
5.8% - 6.9%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder
|
postmarketing — 11.7% - 15.5%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
0% - 6.7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteomyelitis
|
5.8% - 6.03%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
3.3% - 7.8%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Oedema
|
4.3% - 6.7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
postmarketing — 5.4% - 10.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
postmarketing — 4.5% - 9.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
postmarketing — 1.7% - 18.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngolaryngeal pain
|
1.7% - 8.33%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety
|
postmarketing — 5% - 5.2%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
postmarketing — 5% - 5.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erythema
|
postmarketing, 5% - 5.2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infusion site reaction
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
Rash
|
postmarketing — 2.5% - 8.62%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Injection site erythema
|
2.5% - 6.03%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
postmarketing — 3.4% - 5.83%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loose stools
|
1.7% - 5.2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
postmarketing — 2.8% - 5.83%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
postmarketing — 1% - 12.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sepsis
|
2.59% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal haemorrhage
|
1.67% - 5.2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
postmarketing, 3.3% - 6.03%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute
|
0% - 6.03%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Fungal infection
|
postmarketing — 2.6% - 3.2%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Breast disorder
|
postmarketing — 5% - 6.9%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Renal failure
|
postmarketing — 1.7% - 9.5%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence
|
postmarketing, common
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal bloating
|
postmarketing, common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Bacteraemia
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
postmarketing — 1% - 6.9%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased
|
postmarketing — 0% - 8.62%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Sweating increased
|
0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypotension
|
postmarketing — 0% - 7.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
postmarketing — 0.5% - 9.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
postmarketing — 2.1% - 15.5%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Creatine phosphokinase increased
|
1.8% - 2.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
postmarketing — 1.1% - 5.83%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
postmarketing — 0% - 11.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness
|
postmarketing — 2% - 6.03%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea
|
postmarketing, 1.6% - 5.2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain in extremity
|
postmarketing — 1.5% - 9.5%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatine phosphokinase increased
|
1% - 6.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal moniliasis
|
0% - 1.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eosinophilia
|
postmarketing — 0% - 1.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Liver function test abnormal
|
postmarketing — 1% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood alkaline phosphatase increased
|
0% - 1.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
International normalised ratio increased
|
0% - 1.7%
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
Blood phosphorus increased
|
1% - 2.5%
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysgeusia
|
0% - 2.6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Candida infection
|
postmarketing — 0% - 1.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Limb paresis
|
0% - 1.7%
|
|
|
|
|
|
|
|
|
|
x
|
|
Bone disorder
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
|
|
Chills
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
uncommon, 0% - 2.6%
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Electrolyte imbalance
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
|
|
Arrhythmia supraventricular
|
uncommon
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial flutter
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oral candidiasis
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyskinesia
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac arrest
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia
|
postmarketing — 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Proteinuria
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fungaemia
|
postmarketing — 1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Prothrombin level increased
|
postmarketing, 1%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
postmarketing — 1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Miliaria rubra
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Rash vesicular
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
postmarketing — 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingival pain
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vision blurred
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus generalised
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphadenopathy
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia oral
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytosis
|
postmarketing — 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection fungal
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epigastric discomfort
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal impairment
|
postmarketing — 1% - 1.7%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Taste disorders
|
postmarketing, uncommon
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Tremor
|
postmarketing, uncommon
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Vaginal inflammation
|
postmarketing, uncommon
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Muscular weakness
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatobiliary disease
|
postmarketing, uncommon
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Ear and labyrinth disorders
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock
|
postmarketing
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angioedema
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Dysphagia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug eruption
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Flushing
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glossitis
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Immune system disorder
|
postmarketing
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Jaundice
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myopathy
|
postmarketing
|
|
|
x
|
|
x
|
|
|
|
|
x
|
|
Musculoskeletal disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myositis
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Pain
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Pulmonary eosinophilia
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
Rhabdomyolysis
|
postmarketing
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
Syncope
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Tachycardia
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Supraventricular tachycardia
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Urticaria
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Wheezing
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Vesiculobullous rash
|
postmarketing
|
|
x
|
|
|
x
|
|
|
|
|
|
|
Taste metallic
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Extrasystoles
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Rigors
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Transaminases increased
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Drug interaction
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
Serum creatinine increased
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Oropharyngeal swelling
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Eosinophilic pneumonia
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Infusion site reactions
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
Abdominal distension
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cellulitis
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cholangitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Coma
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Confusional state
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Crohn's disease
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Eczema
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hallucination
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphatic disorder
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Mediastinitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Cramp muscle
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stomatitis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urosepsis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypomagnesaemia
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lactic dehydrogenase activity increased
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Phosphatase alkaline increased
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Function kidney decreased
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Discomfort
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Eye irritation
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Intestinal infarction
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Throat sore
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Methicillin-resistant Staphylococcus aureus infection
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alcoholic pancreatitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Feeling jittery
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Serum bicarbonate increased
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Staphylococcus aureus bacteremia
|
|
|
|
|
|
|
|
|
|
|
x
|
