Whenever possible, frequency information about the side effects was extracted from the labels. Aggregated frequency information for the drug and, if available, placebo is shown. To the right, you can click on shaded boxes to be taken to mentions of the side effect on the label. (In some cases, the side effect cannot be highlighted due to conversion problems.)
Information about indications was extracted from the indications and usage sections of the labels.
|
MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
(show all 14)
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
|
Asthenia def
|
Asthenia def
|
13% - 31%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Fatigue def
|
postmarketing, 13% - 31%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weakness def
|
postmarketing, 13% - 31%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue def
|
Fatigue def
|
postmarketing, 13% - 31%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased def
|
Body temperature increased def
|
postmarketing, 11% - 26%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fever chills
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough def
|
Cough def
|
postmarketing, 0% - 21%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough increased
|
0% - 6%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia def
|
postmarketing, 0% - 19%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain def
|
Pain def
|
postmarketing, 0% - 19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection def
|
Infection def
|
postmarketing, 4% - 17%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection def
|
Respiratory tract infection def
|
postmarketing, 9% - 14%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis def
|
Sweating def
|
0% - 14%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Sweating increased
|
postmarketing, 0% - 14%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection def
|
Upper respiratory tract infection def
|
postmarketing, 9% - 14%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis def
|
Rhinitis def
|
3% - 11%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Abdominal pain def
|
Abdominal pain def
|
8% - 10%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Gastrointestinal pain def
|
Abdominal pain def
|
8% - 10%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Back pain def
|
Back pain def
|
4% - 9%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Bronchitis def
|
Bronchitis def
|
postmarketing, 6% - 9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache def
|
Headache def
|
postmarketing, 9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes virus infection def
|
Herpes NOS def
|
postmarketing, 7% - 8%
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
Herpes simplex def
|
Herpes simplex def
|
7% - 8%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Influenza def
|
Influenza def
|
5% - 8%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pneumonia def
|
Pneumonia def
|
postmarketing, 3% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema def
|
Oedema def
|
postmarketing, 0% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral def
|
Oedema peripheral def
|
0% - 7%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Diarrhoea def
|
Diarrhoea def
|
postmarketing, 5% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin disorder def
|
Skin disorder def
|
postmarketing, 0% - 6%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Weight decreased def
|
Weight decreased def
|
1% - 6%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
0% - 6%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Chest pain def
|
Chest pain def
|
0% - 5%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Dyspnoea def
|
Dyspnoea def
|
postmarketing, 1% - 5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis def
|
Rash def
|
postmarketing, 4% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash def
|
Rash def
|
postmarketing, 4% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea def
|
Nausea def
|
postmarketing, 1% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis def
|
Sinusitis def
|
postmarketing, 1% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection def
|
Urinary tract infection def
|
postmarketing, 4% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acidosis def
|
Acidosis def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia def
|
Alopecia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Alveolitis allergic def
|
Alveolitis allergic def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock def
|
Anaphylactic shock def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia def
|
Anaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemolytic anaemia def
|
Haemolytic anaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia haemolytic autoimmune def
|
Anaemia haemolytic autoimmune def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Aneurysm def
|
Aneurysm def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris def
|
Angina pectoris def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia def
|
Arrhythmia def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia def
|
Arthralgia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Autoimmune disorder def
|
Autoimmune disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Neoplasm malignant def
|
Neoplasm malignant def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Skin cancer def
|
Skin cancer def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cerebellar syndrome def
|
Cerebellar syndrome def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Nervous system disorder def
|
Cerebellar syndrome def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Nervous system disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Transient ischaemic attack def
|
Transient ischaemic attack def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cholelithiasis def
|
Cholelithiasis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Coma def
|
Coma def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state def
|
Confusional state def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation def
|
Constipation def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis def
|
Cystitis def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder pain def
|
Cystitis def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis noninfective def
|
Cystitis def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cyst def
|
Cyst def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Pancytopenia def
|
Cytopenia def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancytopenia def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone marrow depression def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myelosuppression def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphagia def
|
Dysphagia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Dehydration def
|
Dehydration def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysuria def
|
Dysuria def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Effusion def
|
Effusion def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toxic epidermal necrolysis def
|
Toxic epidermal necrolysis def
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Necrolysis epidermal
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Epistaxis def
|
Epistaxis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Erythema multiforme def
|
Erythema multiforme def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oesophagitis def
|
Oesophagitis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Eye disorder def
|
Eye disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Fibrosis def
|
Fibrosis def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flank pain def
|
Flank pain def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder def
|
Gastrointestinal disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage def
|
Gastrointestinal haemorrhage def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder def
|
Cardiac disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cardiac failure def
|
Cardiac failure def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure congestive def
|
Cardiac failure congestive def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Haematuria def
|
Haematuria def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Factor VIII deficiency def
|
Factor VIII deficiency def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Haemoptysis def
|
Haemoptysis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage def
|
Haemorrhage def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin def
|
Haemorrhage def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes zoster def
|
Herpes zoster def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Hyperglycaemia def
|
Hyperglycaemia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia def
|
Hyperkalaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity def
|
Hypersensitivity def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypocalcaemia def
|
Hypocalcaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Immune system disorder def
|
Immune system disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Infarction def
|
Infarction def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Acute myeloid leukaemia def
|
Acute myeloid leukaemia def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Acute leukaemia def
|
Acute myeloid leukaemia def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Myeloid leukaemia def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Myeloid leukaemia def
|
Myeloid leukaemia def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Progressive multifocal leukoencephalopathy def
|
Progressive multifocal leukoencephalopathy def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
Lymphoproliferative disorder def
|
Lymphoproliferative disorder def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
X-linked lymphoproliferative syndrome def
|
Lymphoproliferative disorder def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Mediastinal disorder def
|
Mediastinal disorder def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Myelodysplastic syndrome def
|
Myelodysplastic syndrome def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Myocardial infarction def
|
Myocardial infarction def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Acute coronary syndrome def
|
Myocardial infarction def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm def
|
Neoplasm def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Solid tumour def
|
postmarketing
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Neuritis def
|
Neuritis def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Neuropathy peripheral def
|
Neuritis def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Neuropathy peripheral def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenia def
|
Neutropenia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Opportunistic infection def
|
Opportunistic infection def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic nerve disorder def
|
Optic nerve disorder def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Optic neuritis def
|
Optic neuritis def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Osteoporosis def
|
Osteoporosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia def
|
Paraesthesia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Pemphigus def
|
Pemphigus def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Pericardial effusion def
|
Pericardial effusion def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngitis def
|
Pharyngitis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Phlebitis def
|
Phlebitis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Polyp def
|
Polyp def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Proteinuria def
|
Proteinuria def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Protein urine present
|
Proteinuria def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus def
|
Pruritus def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary fibrosis def
|
Pulmonary fibrosis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Purpura def
|
Purpura def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Vascular purpura
|
Purpura def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Renal failure def
|
Renal failure def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute respiratory distress syndrome def
|
Acute respiratory distress syndrome def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Seborrhoeic dermatitis def
|
Seborrhoeic dermatitis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion def
|
Seizures def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Stomatitis def
|
Stomatitis def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebrovascular accident def
|
Cerebrovascular accident def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia def
|
Tachycardia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Supraventricular tachycardia def
|
Supraventricular tachycardia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia def
|
Thrombocytopenia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombosis def
|
Thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Tumour lysis syndrome def
|
Tumour lysis syndrome def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erythema def
|
Erythema def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Venous thrombosis def
|
Venous thrombosis def
|
postmarketing
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Viral infection def
|
Viral infection def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vomiting def
|
Vomiting def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills def
|
Chills def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic failure def
|
Hepatic failure def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Agitation def
|
Agitation def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperphosphataemia def
|
Hyperphosphataemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis haemorrhagic
|
Cystitis haemorrhagic
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Deep vein thrombosis def
|
Deep vein thrombosis def
|
postmarketing
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Crystalluria
|
Crystalluria
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urate crystalluria
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Crystal urine
|
Crystalluria
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary haemorrhage def
|
Pulmonary haemorrhage def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal impairment def
|
Kidney function abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Urinary hesitation
|
Urinary hesitation
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Metabolic acidosis def
|
Metabolic acidosis def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise def
|
Malaise def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Discomfort def
|
Malaise def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ill-defined disorder
|
Malaise def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
Myalgia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Lung infiltration
|
Lung infiltration
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal function test abnormal
|
Renal function test abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypoxia def
|
Hypoxia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Autoimmune thrombocytopenia
|
Autoimmune thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Aplasia
|
Aplasia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatobiliary disease def
|
Hepatobiliary disease def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Leukoencephalopathy def
|
Leukoencephalopathy def
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
Mucosal inflammation def
|
Mucosal inflammation def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Blindness def
|
Blindness def
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Respiratory distress def
|
Respiratory distress def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Visual impairment def
|
Visual disturbance
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aortic dissection def
|
Dissecting aortic aneurysm, thoracic
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Blood uric acid
|
Urate
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood uric acid increased
|
Hyperuricaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperuricaemia def
|
Hyperuricaemia def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder def
|
Sleep disorder def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenic purpura def
|
Thrombocytopenic purpura def
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Pulmonary toxicity
|
Pulmonary toxicity
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acquired haemophilia
|
Acquired haemophilia
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Respiratory failure def
|
Respiratory failure def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin toxicity
|
Skin toxicity
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Death
|
Death
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deafness def
|
Hearing impaired def
|
postmarketing
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hearing impaired def
|
Hearing impaired def
|
postmarketing
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cell death def
|
Cytolysis def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia def
|
Leukopenia def
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Myelofibrosis def
|
Myelofibrosis def
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Myeloid metaplasia
|
Myelofibrosis def
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia def
|
Numbness def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Sensory loss
|
Numbness def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Haemoglobin decreased def
|
Haemoglobin decreased def
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Radial nerve palsy
|
Wrist drop
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Evans syndrome def
|
Evans syndrome def
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Neutrophil count decreased def
|
Neutrophil count decreased def
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Absolute neutrophil count decreased
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Lung infection def
|
Lung infection def
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Cerebral haemorrhage def
|
Cerebral haemorrhage def
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Indication
|
Labels
|
|
Chronic lymphocytic leukaemia def
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Chronic lymphocytic leukaemia refractory def
|
|
|
|
|
|
|
|
x
|
|
|
|
Leukaemia def
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphocytic leukaemia def
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Lymphoma def
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Renal impairment def
|
x
|
x
|
|
|
|
|
|
x
|
|
|