Afatinib
Side effects
Options:
Hide MedDRA Preferred Terms
MedDRA Preferred Term
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Side effect
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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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Dermatitis acneiform
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Dermatitis acneiform
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very common, 0% - 90%
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x
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x
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Diarrhoea
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Diarrhoea
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very common, 0% - 96%
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x
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x
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Dermatitis
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Rash
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very common, 0% - 90%
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x
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x
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Rash
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Rash
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very common, 0% - 90%
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x
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x
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Paronychia
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Paronychia
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very common, 0% - 58%
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x
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x
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Stomatitis
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Stomatitis
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very common, 0% - 71%
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x
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x
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Mouth ulceration
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x
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Decreased appetite
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Decreased appetite
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very common, 0% - 29%
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x
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x
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Epistaxis
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Epistaxis
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very common, 0% - 17%
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x
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x
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Pruritus
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Pruritus
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very common, 0% - 21%
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x
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x
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Dry skin
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Dry skin
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very common, 0% - 31%
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x
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x
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Dehydration
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Dehydration
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common
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x
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Dysgeusia
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Dysgeusia
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common
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x
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Dyspepsia
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Dyspepsia
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common
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x
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Renal failure
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Renal failure
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common
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x
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Renal impairment
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common
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x
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Muscle spasms
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Muscle spasms
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common
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x
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Aspartate aminotransferase increased
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Aspartate aminotransferase increased
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common, 2% - 8%
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x
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x
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Dry eye
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Dry eye
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common
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x
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Renal impairment
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Renal impairment
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common
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x
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Hypokalaemia
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Hypokalaemia
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common, 2% - 11%
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x
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x
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Vomiting
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Vomiting
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0% - 23%
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x
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x
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Alanine aminotransferase increased
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Alanine aminotransferase increased
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common, 0% - 11%
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x
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x
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Cystitis
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Cystitis
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common, 0% - 13%
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x
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x
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Bladder pain
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Cystitis
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common, 0% - 13%
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x
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x
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Cystitis noninfective
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Cystitis
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common, 0% - 13%
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x
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x
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Weight decreased
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Weight decreased
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common, 0% - 17%
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x
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x
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Cheilitis
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Cheilitis
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common, 0% - 12%
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x
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x
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Conjunctivitis
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Conjunctivitis
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common, 0% - 11%
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x
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x
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Body temperature increased
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Body temperature increased
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common, 0% - 12%
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x
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x
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Nasopharyngitis
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Rhinorrhoea
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common, 0% - 11%
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x
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x
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Nasopharyngitis
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0% - 14%
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x
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Rhinorrhoea
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Rhinorrhoea
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common, 0% - 11%
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x
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x
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Asthenia
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Fatigue
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0% - 19%
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x
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x
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Fatigue
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Fatigue
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0% - 19%
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x
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x
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Nausea
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Nausea
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0% - 25%
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x
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Keratitis
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Keratitis
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uncommon
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x
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x
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Interstitial lung disease
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Interstitial lung disease
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uncommon
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x
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x
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Pneumonia
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Pneumonia
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0.43%
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x
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Sepsis
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Sepsis
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0.43%
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x
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Alopecia
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Alopecia
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0% - 13%
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x
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Back pain
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Back pain
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0% - 14%
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x
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Mental disorder
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Mental disorder
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x
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Infection
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Infection
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x
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x
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Connective tissue disorder
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Connective tissue disorder
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x
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Constipation
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Constipation
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0% - 13%
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x
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Cough
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Cough
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0% - 15%
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x
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Dizziness
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Dizziness
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0% - 11%
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x
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Dyspnoea
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Dyspnoea
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x
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Eye disorder
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Eye disorder
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x
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x
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Gastrointestinal disorder
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Gastrointestinal disorder
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x
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x
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Headache
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Headache
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0% - 14%
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x
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Mediastinal disorder
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Mediastinal disorder
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x
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x
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Nervous system disorder
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Nervous system disorder
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x
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Skin disorder
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Skin disorder
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x
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Unspecified disorder of skin and subcutaneous tissue
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x
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x
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Aphthous stomatitis
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Aphthous stomatitis
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x
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Upper respiratory tract infection
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Upper respiratory tract infection
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0% - 11%
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x
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Urinary tract infection
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Urinary tract infection
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x
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Urethral disorder
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Urinary tract disorder
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x
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Urinary tract disorder
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Urinary tract disorder
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x
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Mouth ulceration
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Mouth ulceration
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x
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Malnutrition
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Malnutrition
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x
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x
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Mucosal ulceration
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Mucosal ulceration
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x
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Mucosal inflammation
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Mucosal ulceration
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x
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Mucosal inflammation
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x
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Conjunctival irritation
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Conjunctival irritation
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x
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Disease progression
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Disease progression
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x
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Left ventricular dysfunction
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Left ventricular dysfunction
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x
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Ventricular dysfunction
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Ventricular dysfunction
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x
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Acne pustular
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Acne pustular
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x
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Hepatobiliary disease
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Hepatobiliary disease
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x
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Nail infection
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Nail infection
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x
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Oral mucosa erosion
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Oral mucosa erosion
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x
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Pruritus generalised
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Pruritus generalised
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x
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Diastolic dysfunction
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Diastolic dysfunction
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x
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Nail bed infection
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Nail bed infection
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x
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Mucosal erosion
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Mucosal erosion
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x
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Skin fissures
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Chapped skin
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x
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Infestation
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Infestation NOS
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x
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x
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Blood potassium decreased
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Blood potassium decreased
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x
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Insomnia
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Insomnia
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0% - 15%
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x
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Pulmonary toxicity
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Pulmonary toxicity
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x
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Conjunctival hyperaemia
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Conjunctival hyperaemia
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x
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Nasal inflammation
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Nasal inflammation
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x
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Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 38 |
Source: | FDA Structured Product Label |
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Side effects: | 67 |
Source: | medicines.org.au |
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Color scheme:
standard – alternative
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100%
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75%
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50%
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10%
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frequent (1% to 100%)
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infrequent (0.1% to 1%)
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rare (<0.1%)
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postmarketing
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0%
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no frequency information
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not found on label
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