Sofosbuvir
Side effects
Options:
Show MedDRA Preferred Terms
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
|
1
|
2
|
|
Fatigue
|
very common, 24% - 59%
|
|
x
|
x
|
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Headache
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very common, 20% - 44%
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|
x
|
x
|
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Nausea
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very common, 13% - 34%
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|
x
|
x
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Dizziness
|
very common
|
|
|
x
|
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Pain
|
very common
|
|
|
x
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Pruritus
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common — 8% - 27%
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|
x
|
x
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Vomiting
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very common
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|
|
x
|
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Haemoglobin decreased
|
very common
|
|
|
x
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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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very common
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|
|
x
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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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very common, 4% - 29%
|
|
x
|
x
|
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Irritability
|
very common, 1% - 16%
|
|
x
|
x
|
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Decreased appetite
|
very common, 6% - 18%
|
|
x
|
x
|
|
Rash
|
very common, 8% - 18%
|
|
x
|
x
|
|
Diarrhoea
|
very common, 6% - 17%
|
|
x
|
x
|
|
Influenza like illness
|
very common, 3% - 18%
|
|
x
|
x
|
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Anaemia
|
common — 0% - 21%
|
|
x
|
x
|
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Arthralgia
|
common, very common
|
|
|
x
|
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Cough
|
common, very common
|
|
|
x
|
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Dyspnoea
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common, very common
|
|
|
x
|
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Myalgia
|
common — 0% - 16%
|
|
x
|
x
|
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Chills
|
very common, 1% - 18%
|
|
x
|
x
|
|
Neutropenia
|
very common, 0% - 17%
|
|
x
|
x
|
|
Alopecia
|
common
|
|
|
x
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Anxiety
|
common
|
|
|
x
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Asthenia
|
common, 3% - 21%
|
|
x
|
x
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Back pain
|
common
|
|
|
x
|
|
Chest pain
|
common
|
|
|
x
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Constipation
|
common
|
|
|
x
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Dyspepsia
|
common
|
|
|
x
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Body temperature increased
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common — 0% - 18%
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|
x
|
x
|
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Gastrooesophageal reflux disease
|
common
|
|
|
x
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Nasopharyngitis
|
common
|
|
|
x
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Muscle spasms
|
common
|
|
|
x
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Weight decreased
|
common
|
|
|
x
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Dry mouth
|
common
|
|
|
x
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Agitation
|
common
|
|
|
x
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Migraine
|
common
|
|
|
x
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Dry skin
|
common
|
|
|
x
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Dyspnoea exertional
|
common
|
|
|
x
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Abdominal discomfort
|
common
|
|
|
x
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Disturbance in attention
|
common
|
|
|
x
|
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Memory impairment
|
common
|
|
|
x
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Vision blurred
|
common
|
|
|
x
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Infection
|
|
|
|
x
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Connective tissue disorder
|
|
|
|
x
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Eye disorder
|
|
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x
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Gastrointestinal disorder
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|
|
|
x
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Mediastinal disorder
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|
|
|
x
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Nervous system disorder
|
|
|
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x
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Pancytopenia
|
|
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x
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Suicide
|
|
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x
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Malnutrition
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|
|
|
x
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Unspecified disorder of skin and subcutaneous tissue
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|
|
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x
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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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|
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x
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Infestation NOS
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|
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x
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Blood and lymphatic system disorders
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|
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x
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HCV coinfection
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|
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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 |
|---|
| Side effects: | 57 |
| Source: | EMA |
|---|
Color scheme:
standard – alternative
|
|
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100%
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|
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75%
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|
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50%
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|
|
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10%
|
|
|
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frequent (1% to 100%)
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|
|
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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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