Topotecan
Side effects
Options:
Show MedDRA Preferred Terms,
display only 20 labels
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Side effect
|
Data for drug
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Placebo
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Labels
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1
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2
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3
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4
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5
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20
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21
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22
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23
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24
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25
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26
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27
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Leukopenia
|
very common, 91% - 97%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Alopecia
|
very common, 0% - 54%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Anaemia
|
very common, 1.9% - 98%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Neutropenia
|
very common, 1% - 97%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Body temperature increased
|
very common, 0% - 43%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Colitis
|
very common
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x
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x
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x
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x
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Infection
|
very common, 0% - 43%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Thrombocytopenia
|
postmarketing — 0.5% - 81%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Mucosal inflammation
|
very common, 14%
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x
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x
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x
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x
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x
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x
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Febrile neutropenia
|
very common, 0% - 28%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Mediastinal disorder
|
5% - 14%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Nausea
|
very common, 0% - 64%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Fatigue
|
very common, 0% - 29%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Pneumonia
|
2% - 8%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Asthenia
|
very common, 0% - 25%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Dizziness
|
common
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x
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x
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Dyspnoea
|
common, 1% - 22%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Pain
|
1% - 50%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Pancytopenia
|
common
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Paraesthesia
|
common
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Alanine aminotransferase increased
|
common
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x
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x
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x
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x
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Sepsis
|
common, 0% - 43%
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|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Infestation NOS
|
2% - 43%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Intestinal obstruction
|
0.8% - 5%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Vomiting
|
very common, 0% - 45%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Diarrhoea
|
very common, 0% - 32%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Malaise
|
common, 0.3% - 5%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Abdominal pain
|
postmarketing — 1% - 22%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Anorexia
|
very common, 0% - 19%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Constipation
|
very common, 0% - 29%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Malnutrition
|
1% - 19%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Myalgia
|
0% - 4%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Cough
|
0% - 15%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Rash
|
common, 0% - 16%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Headache
|
common, 0% - 18%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Hyperbilirubinaemia
|
common, 0.8% - 1%
|
|
|
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|
x
|
x
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x
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x
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x
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x
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x
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x
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x
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Nervous system disorder
|
1% - 18%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Arthralgia
|
0.2% - 3%
|
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|
x
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x
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x
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x
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x
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x
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x
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x
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x
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Chest pain
|
0.3% - 2%
|
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|
x
|
x
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x
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x
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x
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x
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x
|
x
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|
Hypersensitivity
|
common, 0% - 6%
|
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x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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|
Neuropathy
|
uncommon, 0% - 30%
|
|
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|
x
|
|
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x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Hypoaesthesia
|
uncommon
|
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|
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x
|
x
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Paresis
|
uncommon
|
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x
|
x
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Neuropathy peripheral
|
uncommon
|
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x
|
x
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Haemorrhage
|
postmarketing — 1% - 14%
|
|
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|
x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Stomatitis
|
very common, 0% - 18%
|
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Anaphylactic shock
|
rare
|
|
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x
|
x
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x
|
x
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x
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x
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Angioedema
|
postmarketing, rare
|
|
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x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
|
|
Dermatitis
|
postmarketing
|
|
|
|
|
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|
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x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
|
x
|
x
|
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Extravasation
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
|
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
postmarketing — 4% - 6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lung disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
postmarketing, common
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urticaria
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Interstitial lung disease
|
postmarketing, rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenic colitis
|
postmarketing, very common
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood and lymphatic system disorders
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Pleuritic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac arrest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Heartburn
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Lethargy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pelvic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngitis
|
0% - 1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute respiratory distress syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute leukaemia
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone pain
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Bullous eruption
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Lung neoplasm malignant
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood bilirubin increased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tumour pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myelosuppression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Metastatic carcinoma
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspareunia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
| Side effects: | 8 |
|---|
| Source: | FDA |
|---|
| Side effects: | 13 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 29 |
|---|
| Source: | BC Cancer |
|---|
| Side effects: | 40 |
|---|
| Source: | EMA |
|---|
| Side effects: | 40 |
|---|
| Source: | EMA |
|---|
| Side effects: | 40 |
|---|
| Source: | EMA |
|---|
| Side effects: | 40 |
|---|
| Source: | EMA |
|---|
| Side effects: | 40 |
|---|
| Source: | EMA |
|---|
| Side effects: | 41 |
|---|
| Source: | EMA |
|---|
| Side effects: | 45 |
|---|
| Source: | Medsafe |
|---|
| Side effects: | 47 |
|---|
| Source: | medicines.org.au |
|---|
| Side effects: | 43 |
|---|
| Source: | FDA |
|---|
| Side effects: | 49 |
|---|
| Source: | Health Canada |
|---|
| Side effects: | 47 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 49 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 49 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 49 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 49 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 49 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 50 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 50 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 75 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 76 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 80 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 81 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 81 |
|---|
| Source: | FDA Structured Product Label |
|---|
| Side effects: | 81 |
|---|
| 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
|
