Sofosbuvir
Side effects
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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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Asthenia
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Fatigue
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very common, 24% - 59%
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x
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x
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Asthenia
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common, 3% - 21%
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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, 24% - 59%
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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, 20% - 44%
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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, 13% - 34%
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x
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x
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Dizziness
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Dizziness
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very common
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|
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x
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Pain
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Pain
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very common
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x
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Pruritus
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Pruritus
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common — 8% - 27%
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x
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x
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Vomiting
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Vomiting
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very common
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x
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Haemoglobin decreased
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Haemoglobin decreased
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very common
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x
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Blood bilirubin increased
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Blood bilirubin increased
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very common
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x
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Platelet count decreased
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Platelet count decreased
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very common
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|
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x
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Lymphocyte count decreased
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Lymphocyte count decreased
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very common
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|
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x
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Insomnia
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Insomnia
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very common, 4% - 29%
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x
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x
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Irritability
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Irritability
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very common, 1% - 16%
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x
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x
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Decreased appetite
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Decreased appetite
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very common, 6% - 18%
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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, 8% - 18%
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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, 8% - 18%
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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, 6% - 17%
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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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very common, 3% - 18%
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x
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x
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Anaemia
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Anaemia
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common — 0% - 21%
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x
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x
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Arthralgia
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Arthralgia
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common, very common
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x
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Musculoskeletal discomfort
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Arthralgia
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common, very common
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x
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Myalgia
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common — 0% - 16%
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x
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x
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Cough
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Cough
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common, very common
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x
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Dyspnoea
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Dyspnoea
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common, very common
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|
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x
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Myalgia
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Myalgia
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common — 0% - 16%
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x
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x
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Chills
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Chills
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very common, 1% - 18%
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x
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x
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Neutropenia
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Neutropenia
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very common, 0% - 17%
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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
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x
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Anxiety
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Anxiety
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common
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x
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Back pain
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Back pain
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common
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x
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Chest pain
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Chest pain
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common
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x
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Constipation
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Constipation
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common
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x
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Dyspepsia
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Dyspepsia
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common
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|
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x
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Body temperature increased
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Body temperature increased
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common — 0% - 18%
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x
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x
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Gastrooesophageal reflux disease
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Gastrooesophageal reflux disease
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common
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x
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Nasopharyngitis
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Nasopharyngitis
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common
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x
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Muscle spasms
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Muscle spasms
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common
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|
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x
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Weight decreased
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Weight decreased
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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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Agitation
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Agitation
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common
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x
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Migraine
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Migraine
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common
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x
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Dry skin
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Dry skin
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common
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x
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Dyspnoea exertional
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Dyspnoea exertional
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common
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x
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Abdominal discomfort
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Abdominal discomfort
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common
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x
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Disturbance in attention
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Disturbance in attention
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common
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x
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Memory impairment
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Memory impairment
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common
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x
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Vision blurred
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Vision blurred
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common
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x
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Infection
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Infection
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x
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Connective tissue disorder
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Connective tissue disorder
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x
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Eye disorder
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Eye disorder
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x
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Gastrointestinal disorder
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Gastrointestinal disorder
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x
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Mediastinal disorder
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Mediastinal disorder
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x
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Nervous system disorder
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Nervous system disorder
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x
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Pancytopenia
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Pancytopenia
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x
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Completed suicide
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Suicide
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x
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Malnutrition
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Malnutrition
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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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x
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Hepatobiliary disease
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Hepatobiliary disease
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|
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x
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Suicidal ideation
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Suicidal ideation
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x
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Infestation
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Infestation NOS
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x
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Hepatitis C
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HCV coinfection
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x
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Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 19 |
Source: | FDA Structured Product Label |
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Side effects: | 57 |
Source: | EMA |
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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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no frequency information
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not found on label
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