Entecavir
  
Side effects 
	
		
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| MedDRA Preferred Term | Side effect | Data for drug | Placebo | Labels | 
|  | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 
| Oedema peripheral | Oedema peripheral | 16% |  |  |  |  |  |  | x | x | 
| Ascites | Ascites | 15% |  |  |  |  |  |  | x | x | 
| Body temperature increased | Body temperature increased | 14% |  |  |  |  |  |  | x | x | 
| Hepatic encephalopathy | Hepatic encephalopathy | 10% |  |  |  |  |  |  | x | x | 
| Upper respiratory tract infection | Upper respiratory tract infection | 10% |  |  |  |  |  |  | x | x | 
| Haematuria | Haematuria | 6% - 10% |  | x |  |  |  |  | x | x | 
| Glycosuria | Glycosuria | 3% - 6% |  | x |  | x |  |  | x | x | 
| Asthenia | Fatigue | common, 1% - 6% |  | x | x | x | x | x | x | x | 
| Fatigue | Fatigue | common, 1% - 6% |  | x | x | x | x | x | x | x | 
| Abdominal pain upper | Abdominal pain upper | postmarketing, 2% - 5% |  | x |  |  |  |  |  |  | 
| Headache | Headache | common, 1% - 9% |  | x | x | x | x | x | x | x | 
| Nausea | Nausea | uncommon — 1% - 3% |  | x | x | x | x | x | x | x | 
| Blood bicarbonate decreased | Blood bicarbonate decreased | 2% |  |  |  |  |  | x | x | x | 
| Dizziness | Dizziness | uncommon — 1% - 4% |  | x | x | x | x | x | x | x | 
| Hyperglycaemia | Hyperglycaemia | 1% - 2% |  | x |  | x |  |  | x | x | 
| Diarrhoea | Diarrhoea | uncommon — 0% - 1% |  | x | x | x | x | x | x | x | 
| Dyspepsia | Dyspepsia | uncommon — 0% - 2% |  | x | x | x | x | x | x | x | 
| Renal failure | Renal failure | 1% |  |  |  |  |  | x | x | x | 
| Vomiting | Vomiting | uncommon — 0% - 1% |  | x | x | x | x | x | x | x | 
| Insomnia | Insomnia | uncommon — 0% - 2% |  | x | x | x | x | x | x | x | 
| Somnolence | Somnolence | uncommon — 0% - 1% |  | x | x | x | x | x | x | x | 
| Lactic acidosis | Lactic acidosis | postmarketing, common |  |  |  | x | x | x | x | x | 
| Alopecia | Alopecia | postmarketing, uncommon |  |  |  |  | x | x | x | x | 
| Dermatitis | Rash | postmarketing, uncommon |  | x | x | x | x | x | x | x | 
| Rash | Rash | postmarketing, uncommon |  | x | x | x | x | x | x | x | 
| Gastrointestinal disorder | Gastrointestinal disorder | postmarketing, common |  | x |  |  | x | x |  |  | 
| Immune system disorder | Immune system disorder | postmarketing |  |  |  | x | x | x | x | x | 
| Lactose intolerance | Lactose intolerance | postmarketing |  | x |  |  |  |  |  |  | 
| Lactase deficiency | Lactose intolerance | postmarketing |  | x |  |  |  |  |  |  | 
| Leukopenia | Leukopenia | postmarketing |  | x |  |  |  |  |  |  | 
| Neutropenia | Neutropenia | postmarketing |  | x |  |  |  |  |  |  | 
| Pancreatitis | Pancreatitis | postmarketing |  | x |  |  |  |  |  |  | 
| Malnutrition | Malnutrition | postmarketing |  | x |  |  |  | x | x | x | 
| Skin disorder | Unspecified disorder of skin and subcutaneous tissue | postmarketing |  | x | x | x | x | x | x | x | 
| Hepatobiliary disease | Hepatobiliary disease | postmarketing, common |  |  |  |  | x | x | x | x | 
| Anaphylactic shock | Anaphylactoid reaction | postmarketing, rare |  |  |  | x | x | x | x | x | 
| Anaphylactoid reaction | Anaphylactoid reaction | postmarketing, rare |  |  |  | x | x | x | x | x | 
| Platelet count decreased | Platelet count decreased | postmarketing |  | x |  |  |  |  |  |  | 
| Transaminases increased | Transaminases increased | postmarketing, common |  |  |  |  | x | x | x | x | 
| Hepatic cirrhosis | Decompensated cirrhosis | postmarketing |  |  |  |  |  | x |  |  | 
| Abdominal pain | Abdominal pain |  |  |  |  |  |  |  |  | x | 
| Gastrointestinal pain | Abdominal pain |  |  |  |  |  |  |  |  | x | 
| Mental disorder | Mental disorder |  |  |  |  |  | x | x |  |  | 
| Hepatitis | Hepatitis |  |  | x | x | x | x | x | x | x | 
| Hepatitis B | Hepatitis B |  |  |  |  |  |  | x |  |  | 
| Hepatomegaly | Hepatomegaly |  |  |  |  | x |  |  | x | x | 
| Hepatorenal syndrome | Hepatorenal syndrome |  |  |  |  |  |  |  | x | x | 
| Immunodeficiency | Immunodeficiency |  |  |  |  |  |  | x |  |  | 
| Nervous system disorder | Nervous system disorder |  |  |  |  |  | x | x |  |  | 
| Upper gastrointestinal haemorrhage | Upper gastrointestinal haemorrhage |  |  |  |  |  |  |  | x | x | 
| Viraemia | Viraemia |  |  | x | x | x |  | x |  |  | 
| Hepatic failure | Hepatic failure |  |  |  |  |  |  |  | x | x | 
| Infection | Infection mixed |  |  |  | x |  |  | x |  |  | 
| Hepatitis B e antigen positive | Hepatitis B e antigen positive |  |  |  |  | x |  | x |  | x | 
| Laboratory test abnormal | Laboratory test abnormal |  |  | x | x | x |  |  | x | x | 
| Blood creatinine increased | Serum creatinine increased |  |  |  |  |  |  |  | x | x | 
| Hepatic cancer | Hepatocellular carcinoma |  |  |  |  |  | x | x | x | x | 
| Hepatocellular carcinoma | Hepatocellular carcinoma |  |  |  |  |  | x | x | x | x | 
| Product taste abnormal | Product taste abnormal |  |  |  |  |  |  |  |  | x | 
	 
 
  Indications
	Information about indications was extracted from the indications and usage sections of the labels.
	
 
	  
	  
		| Side effects: | 26 | 
|---|
		| Source: | Health Canada | 
|---|
		 
	  
	  
		| Side effects: | 15 | 
|---|
		| Source: | FDA | 
|---|
		 
	  
	  
		| Side effects: | 21 | 
|---|
		| Source: | FDA | 
|---|
		 
	  
	  
		| Side effects: | 22 | 
|---|
		| Source: | EMA | 
|---|
		 
	  
	  
		| Side effects: | 31 | 
|---|
		| Source: | Medsafe | 
|---|
		 
	  
	  
		| Side effects: | 36 | 
|---|
		| Source: | FDA Structured Product Label | 
|---|
		 
	  
	  
		| Side effects: | 39 | 
|---|
		| Source: | FDA Structured Product Label | 
|---|
		 
	  
  
 
  
	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 |