Dabrafenib
Side effects
Options:
Hide MedDRA Preferred Terms
MedDRA Preferred Term
|
Side effect
|
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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Lymphopenia
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Lymphopenia
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6% - 59%
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|
|
x
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Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
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2% - 56%
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|
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x
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Decreased appetite
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Decreased appetite
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very common, 0% - 30%
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x
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x
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x
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Hypophosphataemia
|
Hypophosphataemia
|
common, 0% - 47%
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|
x
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x
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x
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Hypoalbuminaemia
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Hypoalbuminaemia
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0% - 53%
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|
|
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x
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Hypokalaemia
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Hypokalaemia
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2% - 29%
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|
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x
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Blood alkaline phosphatase increased
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Phosphatase alkaline increased
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0% - 67%
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|
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x
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x
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Aspartate aminotransferase increased
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Aspartate aminotransferase increased
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0% - 60%
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x
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Hyperkalaemia
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Hyperkalaemia
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0% - 22%
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|
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x
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Chills
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Chills
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very common, 0% - 58%
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x
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x
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x
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Rigors
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|
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x
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|
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Body temperature increased
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Body temperature increased
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very common, 0% - 71%
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x
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x
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x
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Reaction febrile
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|
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x
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Oedema peripheral
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Oedema peripheral
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0% - 31%
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|
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x
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Alanine aminotransferase increased
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Alanine aminotransferase increased
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0% - 42%
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|
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x
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Blood creatinine increased
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Creatinine increased
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0% - 24%
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x
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Neutropenia
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Neutropenia
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0% - 55%
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|
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x
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x
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Hyperglycaemia
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Hyperglycaemia
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common, 0% - 67%
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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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very common, 0% - 50.8%
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x
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x
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x
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Thrombocytopenia
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Thrombocytopenia
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0% - 31%
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x
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Hyponatraemia
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Hyponatraemia
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0% - 55%
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|
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x
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x
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Pruritus
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Pruritus
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0% - 13%
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|
x
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x
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Bowen's disease
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Bowen's disease
|
common
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|
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x
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Basal cell carcinoma
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Basal cell carcinoma
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common
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x
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x
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Asthenia
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Fatigue
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very common, 0% - 57%
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x
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x
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x
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Asthenia
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very common, 0% - 17.6%
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x
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x
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x
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Fatigue
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Fatigue
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very common, 0% - 57%
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x
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x
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x
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Keratoacanthoma
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Keratoacanthoma
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common
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x
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x
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x
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Actinic keratosis
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Actinic keratosis
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common, 0% - 15%
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x
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x
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x
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Seborrhoeic keratosis
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Actinic keratosis
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common, 0% - 15%
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x
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x
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x
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Seborrhoeic keratosis
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common
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x
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x
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Skin lesion
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Skin lesion
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common
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x
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x
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Acrochordon
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Acrochordon
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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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common, 0% - 18%
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x
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x
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x
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Influenza like illness
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Influenza like illness
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common
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x
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x
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Squamous cell carcinoma of skin
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Squamous cell carcinoma of skin
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common
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x
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x
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x
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Insomnia
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Insomnia
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0% - 18%
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x
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Dizziness
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Dizziness
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0% - 16%
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x
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Hypocalcaemia
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Hypocalcaemia
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0% - 20%
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x
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Back pain
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Back pain
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0% - 18%
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x
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x
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Urinary tract infection
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Urinary tract infection
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0% - 13%
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x
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Vomiting
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Vomiting
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very common, 0% - 43%
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x
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x
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x
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Anaemia
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Anaemia
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0% - 55%
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x
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x
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Leukopenia
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Leukopenia
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0% - 62%
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x
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x
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Haemorrhage
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Haemorrhage
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0% - 16%
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x
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Haemoglobin
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Haemorrhage
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0% - 16%
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x
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Hypercalcaemia
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Hypercalcaemia
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0% - 19%
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x
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Night sweats
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Night sweats
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0% - 24%
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x
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Dry mouth
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Dry mouth
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0% - 11%
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x
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Abdominal pain
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Abdominal pain
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0% - 33%
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x
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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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0% - 33%
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x
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x
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x
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Constipation
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Constipation
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common, 0% - 22%
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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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0% - 11%
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x
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x
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Diarrhoea
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Diarrhoea
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very common, 0% - 36%
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x
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x
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x
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Headache
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Headache
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very common, 0% - 37%
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x
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x
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x
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Hyperbilirubinaemia
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Hyperbilirubinaemia
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0% - 15%
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|
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x
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Pain in extremity
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Pain in extremity
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very common, 0% - 19%
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x
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x
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x
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Erythema
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Erythema
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common, 0% - 15%
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x
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x
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x
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Hypomagnesaemia
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Hypomagnesaemia
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0% - 18%
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x
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Dermatitis acneiform
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Dermatitis acneiform
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0% - 16%
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x
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Alopecia
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Alopecia
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very common, 0% - 22%
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x
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x
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x
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Arthralgia
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Arthralgia
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very common, 0% - 44%
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x
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x
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x
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Musculoskeletal discomfort
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Arthralgia
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very common, 0% - 44%
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x
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x
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x
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Myalgia
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very common, 0% - 24%
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x
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x
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x
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Papilloma
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Papilloma
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0% - 27%
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x
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x
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x
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Muscle spasms
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Muscle spasms
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0% - 16%
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x
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Hypersensitivity
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Hypersensitivity
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uncommon
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x
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x
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x
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Renal failure acute
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Renal failure acute
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uncommon
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x
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x
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x
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Acute renal insufficiency
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x
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Malignant melanoma
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Malignant melanoma
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uncommon
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|
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x
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Nephritis
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Nephritis
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uncommon
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x
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x
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Pancreatitis
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Pancreatitis
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uncommon
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x
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x
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x
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Panniculitis
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Panniculitis
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uncommon
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x
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x
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Renal failure
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Renal failure
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uncommon, 0% - 7%
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x
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x
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x
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Uveitis
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Uveitis
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uncommon
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x
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x
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Hyperkeratosis
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Hyperkeratosis
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very common, 0% - 37%
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x
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x
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x
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Arrhythmia
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Arrhythmia
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|
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x
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Mental disorder
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Mental disorder
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x
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Bone disorder
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Bone disorder
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|
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x
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Neoplasm malignant
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Neoplasm malignant
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x
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x
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Squamous cell carcinoma
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Squamous cell carcinoma
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x
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x
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Cellulitis
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Cellulitis
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x
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Infection
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Infection
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|
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x
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Connective tissue disorder
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Connective tissue disorder
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|
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x
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x
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x
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Cough
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Cough
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very common, 0% - 29%
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x
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x
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x
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Cyst
|
Cyst
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|
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x
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x
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x
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Oedema
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Oedema
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x
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Epistaxis
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Epistaxis
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x
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Dermatitis
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Rash
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very common, 0% - 53%
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x
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x
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x
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Rash
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Rash
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very common, 0% - 53%
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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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|
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x
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x
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x
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Eye haemorrhage
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Eye haemorrhage
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|
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x
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Folliculitis
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Folliculitis
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|
|
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x
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Gastrointestinal disorder
|
Gastrointestinal disorder
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|
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x
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x
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x
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Gingival bleeding
|
Gingival bleeding
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|
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x
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Cardiac failure congestive
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Cardiac failure congestive
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x
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Haematuria
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Haematuria
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|
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x
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Hyperhidrosis
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Hyperhidrosis
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|
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x
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Hypertension
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Hypertension
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|
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x
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Refractory hypertension
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|
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|
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x
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Hypotension
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Hypotension
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|
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x
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|
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Immune system disorder
|
Immune system disorder
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|
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x
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x
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x
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Nephropathy
|
Nephropathy
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|
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x
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Lymphoedema
|
Lymphoedema
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|
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|
x
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Mediastinal disorder
|
Mediastinal disorder
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|
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x
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x
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x
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Nasopharyngitis
|
Nasopharyngitis
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0% - 10.2%
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|
|
x
|
x
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Neoplasm
|
Neoplasm
|
|
|
x
|
x
|
x
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Tubulointerstitial nephritis
|
Nephritis interstitial
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|
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|
|
x
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Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
x
|
x
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Paronychia
|
Paronychia
|
|
|
|
|
x
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Polyp
|
Polyp
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|
|
x
|
x
|
x
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Prurigo
|
Prurigo
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|
|
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|
x
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Stomatitis
|
Stomatitis
|
|
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|
|
x
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Urethral disorder
|
Urinary tract disorder
|
|
|
x
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|
x
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Urinary tract disorder
|
Urinary tract disorder
|
|
|
x
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|
x
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Angiopathy
|
Angiopathy
|
|
|
|
|
x
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Vitreous haemorrhage
|
Vitreous haemorrhage
|
|
|
|
|
x
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Rash pustular
|
Rash pustular
|
|
|
|
|
x
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Haemorrhage intracranial
|
Haemorrhage intracranial
|
|
|
|
|
x
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Blindness transient
|
Blindness transient
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
Rash macular
|
Rash macular
|
|
|
|
|
x
|
Rash vesicular
|
Rash vesicular
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
very common, 0% - 24%
|
|
x
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
|
|
|
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
x
|
Abdominal pain lower
|
Abdominal pain lower
|
|
|
|
|
x
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
x
|
Gastric haemorrhage
|
Gastric haemorrhage
|
|
|
|
|
x
|
Dermatitis bullous
|
Rash bullous
|
|
|
|
|
x
|
Azotaemia
|
Azotaemia
|
|
|
x
|
|
|
Disease progression
|
Disease progression
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
|
x
|
Skin papilloma
|
Skin papilloma
|
0% - 24.1%
|
|
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
x
|
Rash generalised
|
Rash generalised
|
|
|
|
|
x
|
Brain stem haemorrhage
|
Brain stem haemorrhage
|
|
|
|
|
x
|
Ejection fraction decreased
|
Ejection fraction decreased
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
x
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT corrected interval prolonged
|
|
|
x
|
|
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Cardiomyopathy
|
Cardiomyopathy
|
|
|
|
|
x
|
Skin toxicity
|
Skin toxicity
|
|
|
|
|
x
|
Ocular toxicity
|
Ocular toxicity
|
|
|
|
|
x
|
Rash papular
|
Rash papular
|
|
|
|
|
x
|
Embolism venous
|
Venous thromboembolism
|
|
|
|
|
x
|
Oropharyngeal pain
|
Oropharyngeal pain
|
0% - 13%
|
|
|
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
|
|
|
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
|
|
|
|
x
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 59 |
Source: | EMA |
---|
Side effects: | 60 |
Source: | medicines.org.au |
---|
Side effects: | 125 |
Source: | FDA Structured Product Label |
---|
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%)
|
|
|
infrequent (0.1% to 1%)
|
|
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rare (<0.1%)
|
|
|
postmarketing
|
|
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0%
|
|
|
no frequency information
|
|
|
not found on label
|