Topotecan
Side effects
Options:
Hide MedDRA Preferred Terms
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display all 27 labels
MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
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3
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4
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5
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6
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7
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8
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9
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10
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11
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12
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13
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14
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15
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16
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17
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18
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19
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20
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Leukopenia
|
Leukopenia
|
very common, 91% - 97%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
very common, 0% - 54%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
very common, 1.9% - 98%
|
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
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x
|
x
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x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
very common, 1% - 97%
|
|
x
|
x
|
x
|
x
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x
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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
|
Body temperature increased
|
Body temperature increased
|
very common, 0% - 43%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
Colitis
|
Colitis
|
very common
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
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Infection
|
Infection
|
very common, 0% - 43%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing — 0.5% - 81%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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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
|
x
|
Thrombocytopenia aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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x
|
x
|
Mucosal inflammation
|
Mucosal inflammation
|
very common, 14%
|
|
|
|
|
x
|
x
|
x
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x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
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Febrile neutropenia
|
Febrile neutropenia
|
very common, 0% - 28%
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|
|
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x
|
x
|
x
|
x
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x
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x
|
|
x
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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
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
5% - 14%
|
|
|
|
|
x
|
x
|
x
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x
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x
|
|
|
x
|
x
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x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very common, 0% - 64%
|
|
|
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
|
x
|
x
|
Asthenia
|
Fatigue
|
very common, 0% - 29%
|
|
|
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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x
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x
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x
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x
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x
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x
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x
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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%
|
|
|
x
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|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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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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Fatigue
|
Fatigue
|
very common, 0% - 29%
|
|
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
2% - 8%
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
common, 1% - 22%
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
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x
|
x
|
x
|
x
|
Pain
|
Pain
|
1% - 50%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
common
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
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Myelosuppression
|
|
|
|
|
|
|
|
|
|
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|
|
x
|
|
|
x
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x
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x
|
x
|
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
Sepsis
|
Sepsis
|
common, 0% - 43%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
2% - 43%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
0.8% - 5%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
Vomiting
|
Vomiting
|
very common, 0% - 45%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
very common, 0% - 32%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
common, 0.3% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Discomfort
|
Malaise
|
common, 0.3% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
common, 0.3% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
common, 0.3% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 1% - 22%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 1% - 22%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
very common, 0% - 19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
very common, 0% - 29%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
1% - 19%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
0% - 4%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
0% - 4%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Arthralgia
|
0.2% - 3%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
0% - 15%
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
common, 0% - 16%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
common, 0% - 16%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 0% - 18%
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
common, 0.8% - 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
1% - 18%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0.2% - 3%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Chest pain
|
Chest pain
|
0.3% - 2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
common, 0% - 6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
uncommon, 0% - 30%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Neuropathy peripheral
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Hypoaesthesia
|
Hypoaesthesia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Paresis
|
Paresis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing — 1% - 14%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing — 1% - 14%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
very common, 0% - 18%
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extravasation
|
Extravasation
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing — 4% - 6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
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postmarketing
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Lung disorder
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Lung disorder
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postmarketing
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x
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x
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x
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x
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x
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x
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x
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Pruritus
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Pruritus
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postmarketing, 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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Urticaria
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Urticaria
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rare
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Skin disorder
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Unspecified disorder of skin and subcutaneous tissue
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postmarketing
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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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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postmarketing, rare
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Anaphylactoid reaction
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Anaphylactoid reaction
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postmarketing
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Neutropenic colitis
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Neutropenic colitis
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postmarketing, 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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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Back pain
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Back pain
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x
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x
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x
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x
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x
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Pleuritic pain
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Pleuritic pain
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x
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x
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Dysmenorrhoea
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Dysmenorrhoea
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x
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x
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Ear pain
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Ear pain
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x
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x
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Epistaxis
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Epistaxis
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x
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x
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Cardiac arrest
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Cardiac arrest
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x
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x
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Dyspepsia
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Heartburn
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x
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x
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Lethargy
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Lethargy
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x
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x
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Muscle spasms
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Cramp muscle
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x
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x
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Neoplasm
|
Neoplasm
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x
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x
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x
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x
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x
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Neuralgia
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Neuralgia
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x
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x
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Pelvic pain
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Pelvic pain
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x
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x
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Pharyngitis
|
Pharyngitis
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0% - 1%
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Pleural effusion
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Pleural effusion
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x
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x
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Pulmonary embolism
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Pulmonary embolism
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x
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x
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Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
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x
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x
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Rhinitis
|
Rhinitis
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x
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x
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Hyperhidrosis
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Sweating
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x
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x
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Angiopathy
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Angiopathy
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x
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x
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x
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x
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x
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x
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x
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Weight increased
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Weight increased
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x
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x
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Chills
|
Chills
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x
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x
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Rigors
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x
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x
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Acute leukaemia
|
Acute leukaemia
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x
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Bone pain
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Bone pain
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x
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x
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x
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x
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x
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x
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Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
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x
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x
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Rash erythematous
|
Rash erythematous
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x
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x
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x
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x
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Dermatitis bullous
|
Bullous eruption
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x
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x
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x
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x
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Lung neoplasm malignant
|
Lung neoplasm malignant
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x
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Hepatobiliary disease
|
Hepatobiliary disease
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Blood bilirubin increased
|
Blood bilirubin increased
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x
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x
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x
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x
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x
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x
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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 maculo-papular
|
Rash maculo-papular
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x
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x
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x
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x
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Hepatic pain
|
Hepatic pain
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x
|
x
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Tumour pain
|
Tumour pain
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x
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x
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Respiratory failure
|
Respiratory failure
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x
|
x
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Metastatic neoplasm
|
Metastatic carcinoma
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x
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Dyspareunia
|
Dyspareunia
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x
|
x
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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: | 41 |
Source: | EMA |
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Side effects: | 43 |
Source: | FDA |
---|
Side effects: | 45 |
Source: | Medsafe |
---|
Side effects: | 47 |
Source: | FDA Structured Product Label |
---|
Side effects: | 47 |
Source: | medicines.org.au |
---|
Side effects: | 49 |
Source: | Health Canada |
---|
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: | 80 |
Source: | FDA Structured Product Label |
---|
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
|