Sofosbuvir
Side effects
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Show MedDRA Preferred Terms
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
Fatigue
|
very common, 24% - 59%
|
|
x
|
x
|
Headache
|
very common, 20% - 44%
|
|
x
|
x
|
Nausea
|
very common, 13% - 34%
|
|
x
|
x
|
Dizziness
|
very common
|
|
|
x
|
Pain
|
very common
|
|
|
x
|
Pruritus
|
common — 8% - 27%
|
|
x
|
x
|
Vomiting
|
very common
|
|
|
x
|
Haemoglobin decreased
|
very common
|
|
|
x
|
Blood bilirubin increased
|
very common
|
|
|
x
|
Platelet count decreased
|
very common
|
|
|
x
|
Lymphocyte count decreased
|
very common
|
|
|
x
|
Insomnia
|
very common, 4% - 29%
|
|
x
|
x
|
Irritability
|
very common, 1% - 16%
|
|
x
|
x
|
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
|
Anaemia
|
common — 0% - 21%
|
|
x
|
x
|
Arthralgia
|
common, very common
|
|
|
x
|
Cough
|
common, very common
|
|
|
x
|
Dyspnoea
|
common, very common
|
|
|
x
|
Myalgia
|
common — 0% - 16%
|
|
x
|
x
|
Chills
|
very common, 1% - 18%
|
|
x
|
x
|
Neutropenia
|
very common, 0% - 17%
|
|
x
|
x
|
Alopecia
|
common
|
|
|
x
|
Anxiety
|
common
|
|
|
x
|
Asthenia
|
common, 3% - 21%
|
|
x
|
x
|
Back pain
|
common
|
|
|
x
|
Chest pain
|
common
|
|
|
x
|
Constipation
|
common
|
|
|
x
|
Dyspepsia
|
common
|
|
|
x
|
Body temperature increased
|
common — 0% - 18%
|
|
x
|
x
|
Gastrooesophageal reflux disease
|
common
|
|
|
x
|
Nasopharyngitis
|
common
|
|
|
x
|
Muscle spasms
|
common
|
|
|
x
|
Weight decreased
|
common
|
|
|
x
|
Dry mouth
|
common
|
|
|
x
|
Agitation
|
common
|
|
|
x
|
Migraine
|
common
|
|
|
x
|
Dry skin
|
common
|
|
|
x
|
Dyspnoea exertional
|
common
|
|
|
x
|
Abdominal discomfort
|
common
|
|
|
x
|
Disturbance in attention
|
common
|
|
|
x
|
Memory impairment
|
common
|
|
|
x
|
Vision blurred
|
common
|
|
|
x
|
Infection
|
|
|
|
x
|
Connective tissue disorder
|
|
|
|
x
|
Eye disorder
|
|
|
|
x
|
Gastrointestinal disorder
|
|
|
|
x
|
Mediastinal disorder
|
|
|
|
x
|
Nervous system disorder
|
|
|
|
x
|
Pancytopenia
|
|
|
x
|
|
Suicide
|
|
|
x
|
|
Malnutrition
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
x
|
Hepatobiliary disease
|
|
|
|
x
|
Suicidal ideation
|
|
|
x
|
|
Infestation NOS
|
|
|
|
x
|
Blood and lymphatic system disorders
|
|
|
|
x
|
HCV coinfection
|
|
|
|
x
|
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
|
|
100%
|
|
|
75%
|
|
|
50%
|
|
|
10%
|
|
|
frequent (1% to 100%)
|
|
|
infrequent (0.1% to 1%)
|
|
|
rare (<0.1%)
|
|
|
postmarketing
|
|
|
0%
|
|
|
no frequency information
|
|
|
not found on label
|