Entecavir
Side effects
Options:
Show MedDRA Preferred Terms
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
|
Oedema peripheral
|
16%
|
|
|
|
|
|
|
x
|
x
|
|
Ascites
|
15%
|
|
|
|
|
|
|
x
|
x
|
|
Body temperature increased
|
14%
|
|
|
|
|
|
|
x
|
x
|
|
Hepatic encephalopathy
|
10%
|
|
|
|
|
|
|
x
|
x
|
|
Upper respiratory tract infection
|
10%
|
|
|
|
|
|
|
x
|
x
|
|
Haematuria
|
6% - 10%
|
|
x
|
|
|
|
|
x
|
x
|
|
Glycosuria
|
3% - 6%
|
|
x
|
|
x
|
|
|
x
|
x
|
|
Fatigue
|
common, 1% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain upper
|
postmarketing, 2% - 5%
|
|
x
|
|
|
|
|
|
|
|
Headache
|
common, 1% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
uncommon — 1% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood bicarbonate decreased
|
2%
|
|
|
|
|
|
x
|
x
|
x
|
|
Dizziness
|
uncommon — 1% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
1% - 2%
|
|
x
|
|
x
|
|
|
x
|
x
|
|
Diarrhoea
|
uncommon — 0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
uncommon — 0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
|
Vomiting
|
uncommon — 0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
uncommon — 0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence
|
uncommon — 0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lactic acidosis
|
postmarketing, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia
|
postmarketing, uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Rash
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
postmarketing, common
|
|
x
|
|
|
x
|
x
|
|
|
|
Immune system disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Lactose intolerance
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Leukopenia
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Neutropenia
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Pancreatitis
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Malnutrition
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatobiliary disease
|
postmarketing, common
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Anaphylactoid reaction
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Platelet count decreased
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Transaminases increased
|
postmarketing, common
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Blood and lymphatic system disorders
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
Decompensated cirrhosis
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
Abdominal pain
|
|
|
|
|
|
|
|
|
x
|
|
Mental disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
Hepatitis
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatitis B
|
|
|
|
|
|
|
x
|
|
|
|
Hepatomegaly
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Hepatorenal syndrome
|
|
|
|
|
|
|
|
x
|
x
|
|
Immunodeficiency
|
|
|
|
|
|
|
x
|
|
|
|
Nervous system disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
Upper gastrointestinal haemorrhage
|
|
|
|
|
|
|
|
x
|
x
|
|
Viraemia
|
|
|
x
|
x
|
x
|
|
x
|
|
|
|
Hepatic failure
|
|
|
|
|
|
|
|
x
|
x
|
|
Infection mixed
|
|
|
|
x
|
|
|
x
|
|
|
|
Hepatitis B e antigen positive
|
|
|
|
|
x
|
|
x
|
|
x
|
|
Laboratory test abnormal
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Serum creatinine increased
|
|
|
|
|
|
|
|
x
|
x
|
|
Hepatocellular carcinoma
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
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
|
