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 |