Gefitinib
Side effects
Options:
Hide MedDRA Preferred Terms
MedDRA Preferred Term
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Side effect
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Data for drug
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Placebo
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Labels
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1
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2
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3
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4
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5
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Diarrhoea
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Diarrhoea
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very common, 0% - 66.7%
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x
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x
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x
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x
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x
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Gastrointestinal disorder
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Gastrointestinal disorder
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very common, 32.7%
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x
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x
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x
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Mediastinal disorder
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Mediastinal disorder
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common, 28.2%
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x
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x
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x
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Dermatitis
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Rash
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very common, 0% - 68.9%
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x
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x
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x
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x
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x
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Dermatitis
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x
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Rash
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Rash
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very common, 0% - 68.9%
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x
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x
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x
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x
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x
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Eruption
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x
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Malnutrition
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Malnutrition
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very common
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x
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x
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x
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Hepatobiliary disease
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Hepatobiliary disease
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very common
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x
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x
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Dry skin
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Dry skin
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very common, 0% - 29.2%
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x
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x
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x
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x
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x
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Nausea
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Nausea
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rare — 0% - 23.6%
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x
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x
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x
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x
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x
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Skin disorder
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Unspecified disorder of skin and subcutaneous tissue
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very common, 4.6%
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x
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x
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x
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Acne
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Acne
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0% - 32.5%
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x
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x
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Urethral disorder
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Urinary tract disorder
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common, 12.8%
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x
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x
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x
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Urinary tract disorder
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Urinary tract disorder
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common, 12.8%
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x
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x
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x
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Vomiting
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Vomiting
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rare — 0% - 19.8%
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x
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x
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x
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x
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x
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Alanine aminotransferase increased
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Alanine aminotransferase increased
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0.98% - 23.6%
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x
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x
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Stomatitis
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Stomatitis
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0% - 8%
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x
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x
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x
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x
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Mouth ulceration
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1%
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x
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x
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Malaise
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Feeling sick
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rare, very common
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x
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Decreased appetite
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Anorexia
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0% - 18.9%
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x
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x
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x
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x
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x
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Appetite absent
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common
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x
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Aspartate aminotransferase increased
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Aspartate aminotransferase increased
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0.98% - 22.6%
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x
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x
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Pruritus
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Pruritus
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common — 0% - 35.8%
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x
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x
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x
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x
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x
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Alopecia
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Alopecia
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common, 1-10%
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x
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x
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x
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x
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Dehydration
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Dehydration
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common
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x
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x
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x
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x
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Eye disorder
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Eye disorder
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common
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x
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x
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Body temperature increased
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Body temperature increased
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common
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x
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x
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x
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x
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Haemoptysis
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Haemoptysis
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common
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x
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Haemorrhage
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Haemorrhage
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common
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x
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Haemoglobin
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Haemorrhage
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common
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x
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Gastric ulcer
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Gastric ulcer
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common
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x
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Dry mouth
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Dry mouth
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common
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x
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x
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x
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Tenderness
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Tenderness
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common
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x
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Ocular hyperaemia
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Eye redness
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common
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x
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Dry eye
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Dry eye
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common
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x
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x
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x
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Oral pain
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Sore mouth
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common
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x
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Angiopathy
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Angiopathy
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common, 4.8%
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x
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x
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x
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Nervous system disorder
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Nervous system disorder
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4.5%
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x
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Pain
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Pain
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rare, 0.877% - 16%
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x
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x
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Haematuria
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Haematuria
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0% - 6%
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x
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x
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x
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x
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x
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Blepharitis
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Blepharitis
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0.877% - 5.66%
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x
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x
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x
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x
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Abdominal pain
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Abdominal pain
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2.91% - 7.55%
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x
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x
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Gastrointestinal pain
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Abdominal pain
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2.91% - 7.55%
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x
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x
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Asthenia
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Asthenia
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common, 0% - 10.4%
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x
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x
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x
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x
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x
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Fatigue
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x
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Weight decreased
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Weight decreased
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1.94% - 5.66%
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x
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x
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x
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Nail disorder
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Nail disorder
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0% - 8.49%
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x
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x
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x
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x
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Conjunctivitis
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Conjunctivitis
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0.98% - 9.43%
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x
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x
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x
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x
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x
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Amblyopia
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Amblyopia
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2%
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x
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Oedema peripheral
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Oedema peripheral
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2%
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x
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x
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x
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Epistaxis
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Epistaxis
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common, 0% - 11.3%
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x
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x
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x
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x
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x
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Dermatitis exfoliative
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Dermatitis exfoliative
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0% - 8.49%
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x
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x
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Interstitial lung disease
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Interstitial lung disease
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0.3 -2% - 1.3%
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x
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x
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x
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x
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x
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Interstitial pneumonia
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0% - 3%
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x
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x
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Mouth ulceration
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Mouth ulceration
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1%
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x
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x
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Rash pustular
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Vesiculobullous rash
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1%
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x
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Rash pustular
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x
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x
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x
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Dermatitis bullous
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Vesiculobullous rash
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1%
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x
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Dyspnoea
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Dyspnoea
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0% - 3%
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x
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x
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x
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Corneal erosion
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Corneal erosion
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1%
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x
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x
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x
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x
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x
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Keratitis
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Keratitis
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0.12%
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x
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x
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Erythema multiforme
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Erythema multiforme
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0.1%
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x
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x
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x
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x
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x
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Stevens-Johnson syndrome
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x
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x
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x
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Pancreatitis
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Pancreatitis
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rare, 0.1%
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x
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x
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x
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x
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x
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Toxic epidermal necrolysis
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Necrolysis epidermal
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0.1%
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x
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Toxic epidermal necrolysis
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x
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x
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x
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x
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Angioedema
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Angioedema
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0.01%
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x
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x
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x
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x
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x
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Hypersensitivity
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Hypersensitivity
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very rare
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x
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x
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x
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x
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Urticaria
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Urticaria
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very rare, 0.01%
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x
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x
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x
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x
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x
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Nettle rash
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very rare
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x
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Lip swelling
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Lip swelling
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very rare
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x
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Anaemia
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Anaemia
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x
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Arrhythmia
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Arrhythmia
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x
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Atrial fibrillation
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Atrial fibrillation
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x
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x
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Bundle branch block
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Bundle branch block
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x
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x
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Infection
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Infection
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x
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Constipation
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Constipation
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x
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x
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Cough
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Cough
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x
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x
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Cystitis
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Cystitis
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x
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Bladder pain
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Cystitis
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x
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Cystitis noninfective
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Cystitis
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x
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Fatigue
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Fatigue
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x
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Cardiac disorder
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Cardiac disorder
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x
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Hepatitis
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Hepatitis
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x
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x
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x
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Hypokalaemia
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Hypokalaemia
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x
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x
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Hypoproteinaemia
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Hypoproteinaemia
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0% - 3%
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x
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Hypotension
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Hypotension
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x
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Ischaemia
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Ischaemia
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x
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Melaena
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Melaena
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x
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Paronychia
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Paronychia
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x
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Pleural effusion
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Pleural effusion
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x
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Pneumonia
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Pneumonia
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0% - 3%
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x
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x
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Proteinuria
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Proteinuria
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x
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x
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Protein urine present
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Proteinuria
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x
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x
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Anorectal disorder
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Rectal disorder
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x
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x
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Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
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0% - 5.83%
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x
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x
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Shock
|
Shock
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0% - 4%
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x
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Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
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x
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x
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x
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Thrombocytopenia
|
Thrombocytopenia
|
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x
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x
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Thrombophlebitis
|
Thrombophlebitis
|
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x
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Ulcer
|
Ulcer
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x
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Hepatic failure
|
Hepatic failure
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x
|
x
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Cystitis haemorrhagic
|
Cystitis haemorrhagic
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|
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x
|
x
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|
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Scrotal oedema
|
Scrotal oedema
|
0% - 3%
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|
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x
|
x
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Gastrointestinal perforation
|
Gastrointestinal perforation
|
|
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x
|
x
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|
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Pulmonary haemorrhage
|
Pulmonary haemorrhage
|
0% - 4%
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x
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Hypomagnesaemia
|
Hypomagnesaemia
|
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x
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Eye pain
|
Eye pain
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x
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|
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Electrocardiogram QT prolonged
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Electrocardiogram QT prolonged
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x
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Electrocardiogram QT corrected interval prolonged
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x
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Skin fissures
|
Skin fissures
|
|
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x
|
x
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|
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Hypoxia
|
Hypoxia
|
0% - 3%
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|
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|
|
x
|
Cutaneous vasculitis
|
Cutaneous vasculitis
|
|
|
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x
|
x
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|
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Sinus arrhythmia
|
Sinoatrial node dysfunction
|
|
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|
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x
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Alveolitis
|
Alveolitis
|
|
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x
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|
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Cancer pain
|
Cancer pain
|
|
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x
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Drug interaction
|
Drug interaction
|
|
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x
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|
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Febrile neutropenia
|
Febrile neutropenia
|
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x
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Infestation
|
Infestation NOS
|
|
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x
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Pulmonary toxicity
|
Pulmonary toxicity
|
|
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x
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Respiratory failure
|
Respiratory failure
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x
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 36 |
Source: | FDA Structured Product Label |
---|
Side effects: | 47 |
Source: | medicines.org.au |
---|
Side effects: | 48 |
Source: | EMA |
---|
Side effects: | 44 |
Source: | BC Cancer |
---|
Side effects: | 89 |
Source: | Health Canada |
---|
Color scheme:
standard – alternative
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100%
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75%
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50%
|
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10%
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frequent (1% to 100%)
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infrequent (0.1% to 1%)
|
|
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rare (<0.1%)
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postmarketing
|
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0%
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|
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no frequency information
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|
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not found on label
|