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 20)
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
|
Oedema def
|
Oedema def
|
postmarketing — 2% - 86.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fluid retention
|
Fluid retention
|
2% - 76%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Generalised oedema
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia def
|
Asthenia def
|
0.2% - 74.9%
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue def
|
1% - 74.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weakness def
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Fatigue def
|
Fatigue def
|
1% - 74.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea def
|
Nausea def
|
3% - 73%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle spasms def
|
Cramp muscle def
|
postmarketing, 0.4% - 62%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea def
|
Diarrhoea def
|
3% - 58.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting def
|
Vomiting def
|
2% - 58%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain def
|
Abdominal pain def
|
1% - 57.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain def
|
Abdominal pain def
|
1% - 57.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain def
|
Pain def
|
0.4% - 57.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage def
|
Haemorrhage def
|
rare — 0.4% - 53%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin def
|
Haemorrhage def
|
rare — 0.4% - 53%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis def
|
Rash def
|
rare — 3% - 49.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis def
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash def
|
Rash def
|
rare — 3% - 49.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eruption
|
infrequent
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Musculoskeletal pain def
|
Musculoskeletal pain def
|
2% - 49%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenia def
|
Neutropenia def
|
0% - 48%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia def
|
Anaemia def
|
rare, 0% - 42%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased def
|
Body temperature increased def
|
postmarketing, 2% - 41%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia def
|
Arthralgia def
|
1% - 40%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia def
|
1% - 40%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
0% - 32.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache def
|
Headache def
|
0.6% - 36%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia def
|
0% - 35.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia def
|
Thrombocytopenia def
|
0% - 33%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
Myalgia def
|
0% - 32.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight increased def
|
Weight increased def
|
postmarketing, 0.6% - 32%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough def
|
Cough def
|
0% - 27%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia def
|
Dyspepsia def
|
0% - 27%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasopharyngitis def
|
Nasopharyngitis def
|
0% - 22%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea def
|
Dyspnoea def
|
postmarketing, 0.9% - 21%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia def
|
Leukopenia def
|
0.7% - 19.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
Infection def
|
Infection def
|
rare, 0% - 19%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection def
|
Respiratory tract infection def
|
0% - 19%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection def
|
Upper respiratory tract infection def
|
0% - 19%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus def
|
Pruritus def
|
0.8% - 18.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Night sweats def
|
Night sweats def
|
0.2% - 17%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis def
|
Sweating def
|
0.2% - 17%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation def
|
Constipation def
|
0.4% - 16%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness def
|
Dizziness def
|
0% - 16%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pharyngitis def
|
Pharyngitis def
|
0% - 15%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Alopecia def
|
Alopecia def
|
infrequent, 3.2% - 14.8%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Insomnia def
|
Insomnia def
|
0% - 14%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia def
|
Hypokalaemia def
|
0.8% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia def
|
Pneumonia def
|
rare, 1% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety def
|
Anxiety def
|
infrequent, 0% - 12%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Anguish def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills def
|
Rigors
|
0% - 12%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain def
|
Chest pain def
|
0.4% - 11%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Influenza def
|
Influenza def
|
0% - 11%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis def
|
Sinusitis def
|
0.4% - 11%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Flatulence def
|
Flatulence def
|
0.1% - 10.1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphopenia def
|
Lymphopenia def
|
0.7% - 10.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage def
|
Gastrointestinal haemorrhage def
|
0.4% - 8%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
Creatinine increased def
|
0% - 8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased def
|
Aspartate aminotransferase increased def
|
0% - 7.1%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased def
|
Alanine aminotransferase increased def
|
0% - 7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood alkaline phosphatase increased def
|
Phosphatase alkaline increased
|
0% - 5.5%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood bilirubin increased def
|
Blood bilirubin increased def
|
0% - 3.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal distension def
|
Abdominal distension def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Distention def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dehydration def
|
Dehydration def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dermatitis exfoliative def
|
Dermatitis exfoliative def
|
infrequent
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Flushing def
|
Flushing def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Gastritis def
|
Gastritis def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Gastroenteritis def
|
Gastroenteritis def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease def
|
Gastrooesophageal reflux disease def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Gout def
|
Gout def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Cardiac failure def
|
Cardiac failure def
|
postmarketing, infrequent
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Haematuria def
|
Haematuria def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hepatitis def
|
Hepatitis def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Herpes virus infection def
|
Herpes NOS def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Herpes simplex def
|
Herpes simplex def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Herpes zoster def
|
Herpes zoster def
|
infrequent
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Hypertension def
|
Hypertension def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypertrophy def
|
Hypertrophy def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypotension def
|
Hypotension def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Menorrhagia def
|
Menorrhagia def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nail disorder def
|
Nail disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pancytopenia def
|
Pancytopenia def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Cytopenia def
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia def
|
Paraesthesia def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Neuropathy peripheral def
|
Neuropathy peripheral def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Neuropathy def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pigmentation disorder def
|
Pigmentation def
|
infrequent
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Pigmentation skin def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Psoriasis def
|
Psoriasis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Purpura def
|
Purpura def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vascular purpura
|
Purpura def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Renal failure def
|
Renal failure def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sciatica def
|
Sciatica def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Gastric ulcer def
|
Gastric ulcer def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Shock def
|
Syncope def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Shock def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Syncope def
|
Syncope def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Loss of consciousness def
|
Syncope def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tachycardia def
|
Tachycardia def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tinnitus def
|
Tinnitus def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ulcer def
|
Ulcer def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pollakiuria def
|
Pollakiuria def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vertigo def
|
Vertigo def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Weight decreased def
|
Weight decreased def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypophosphataemia def
|
Hypophosphataemia def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Stomatitis def
|
Mouth ulceration def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Mouth ulceration def
|
Mouth ulceration def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Migraine def
|
Migraine def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dry skin def
|
Dry skin def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Photosensitivity reaction def
|
Photosensitivity reaction def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Photosensitivity def
|
infrequent
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Musculoskeletal stiffness
|
Muscle stiffness
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Stiffness
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Rash vesicular
|
Rash vesicular
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Memory impairment def
|
Memory impairment def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Dermatitis bullous def
|
Bullous eruption
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blister def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Sepsis def
|
Sepsis def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Peripheral coldness
|
Peripheral coldness
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Sexual dysfunction
|
Sexual dysfunction
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Feeling cold
|
Coldness
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Acute generalised exanthematous pustulosis def
|
Acute generalised exanthematous pustulosis def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Breast enlargement
|
Breast enlargement
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Somnolence def
|
Somnolence def
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Delirium tremens def
|
Delirium tremens def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Aplastic anaemia def
|
Aplastic anaemia def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Angioedema def
|
Angioedema def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ascites def
|
Ascites def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Brain oedema def
|
Edema cerebral def
|
postmarketing, rare
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Breast feeding def
|
Breast feeding def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm malignant def
|
Neoplasm malignant def
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Carcinogenicity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac tamponade def
|
Cardiac tamponade def
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cytogenetic abnormality def
|
Cytogenetic abnormality def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Colitis def
|
Colitis def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Confusional state def
|
Confusional state def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Feeling abnormal
|
Confusional state def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Conjunctivitis def
|
Conjunctivitis def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Convulsion def
|
Convulsion def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Diverticulitis def
|
Diverticulitis def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ehlers-Danlos syndrome def
|
Ehlers-Danlos syndrome def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Embolism def
|
Embolism def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eosinophilia def
|
Eosinophilia def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Toxic epidermal necrolysis def
|
Toxic epidermal necrolysis def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme def
|
Erythema multiforme def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Assisted fertilisation
|
Fertilization def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Fibrosis def
|
Fibrosis def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Glaucoma def
|
Glaucoma def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cardiac disorder def
|
Cardiac disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkalaemia def
|
Hyperkalaemia def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypersensitivity def
|
Hypersensitivity def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyponatraemia def
|
Hyponatraemia def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Intestinal obstruction def
|
Intestinal obstruction def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Jaundice def
|
Jaundice def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Mastocytic leukaemia def
|
Mastocytic leukaemia def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphoma def
|
Lymphoma def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Mastocytoma def
|
Mastocytoma def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Necrosis def
|
Necrosis def
|
rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
Obstruction def
|
Obstruction def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Osteonecrosis def
|
Osteonecrosis def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Necrosis ischaemic def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ovarian disorder def
|
Ovarian disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancreatitis def
|
Pancreatitis def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Optic neuritis def
|
Papilloedema def
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Papilloedema def
|
Papilloedema def
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Parity def
|
Parity def
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pericarditis def
|
Pericarditis def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pulmonary fibrosis def
|
Pulmonary fibrosis def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Retinal haemorrhage def
|
Retinal haemorrhage def
|
rare
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Skin disorder def
|
Skin disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Swelling def
|
Swelling def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Testicular disorder def
|
Testicular disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombosis def
|
Thrombosis def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Erythema def
|
Erythema def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy def
|
Angiopathy def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vitreous haemorrhage def
|
Vitreous haemorrhage def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Acute febrile neutrophilic dermatosis def
|
Acute febrile neutrophilic dermatosis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Neutrophilic dermatosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hepatic failure def
|
Hepatic failure def
|
rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal perforation
|
Gastrointestinal perforation
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Intracranial pressure increased def
|
Intracranial pressure increased def
|
postmarketing, rare
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Joint swelling
|
Joint swelling
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Apoptosis def
|
Apoptosis def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Interstitial lung disease def
|
Interstitial pneumonia
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Necrosis ischaemic def
|
Necrosis ischaemic def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal impairment def
|
Function kidney decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Disease progression def
|
Disease progression def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Macular oedema def
|
Macular oedema def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Systemic mastocytosis def
|
Indolent systemic mastocytosis def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Tumour necrosis def
|
Tumour necrosis def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vision blurred def
|
Vision blurred def
|
rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Liver disorder def
|
Hepatic impairment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Ileus def
|
Ileus def
|
rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Death
|
Death
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Metastatic neoplasm def
|
Metastatic disease def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain def
|
Back pain def
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blister def
|
Blister def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Varicella def
|
Varicella def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dysgeusia def
|
Dysgeusia def
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ecchymosis def
|
Ecchymosis def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Effusion def
|
Effusion def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis def
|
Epistaxis def
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Gastrointestinal neoplasm def
|
Gastrointestinal neoplasm def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gynaecomastia def
|
Gynaecomastia def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cardiac failure congestive def
|
Cardiac failure congestive def
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
Blood disorder def
|
Blood disorder def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperplasia def
|
Hyperplasia def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immunosuppression def
|
Immunosuppression def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inflammation def
|
Inflammation def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Nephropathy def
|
Nephropathy def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal disorder def
|
Musculoskeletal disorder def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myelodysplastic syndrome def
|
Myelodysplasia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Myeloproliferative disorder def
|
Myeloproliferative disorder def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephrotic syndrome def
|
Nephrosis def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opportunistic infection def
|
Opportunistic infection def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Papilloma def
|
Papilloma def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pericardial effusion def
|
Pericardial effusion def
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
Petechiae def
|
Petechiae def
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Pleural disorder def
|
Pleural disorder def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion def
|
Pleural effusion def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alveolar proteinosis def
|
Alveolar proteinosis def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Pulmonary oedema def
|
Pulmonary oedema def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis def
|
Rhinitis def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiogenic shock def
|
Cardiogenic shock def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tumour lysis syndrome def
|
Tumour lysis syndrome def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Viral infection def
|
Viral infection def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Oedema peripheral def
|
Oedema peripheral def
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Edema of lower extremities
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Periorbital oedema def
|
Periorbital oedema def
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
Blood urea increased
|
Blood urea increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generalised oedema
|
Generalised oedema
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal tubular disorder def
|
Renal tubular disorder def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic necrosis def
|
Hepatic necrosis def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Bone pain def
|
Bone pain def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation increased def
|
Lacrimation increased def
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lacrimation def
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute hepatic failure def
|
Acute hepatic failure def
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aphagia
|
Aphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal discharge def
|
Vaginal discharge def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea exertional
|
Dyspnoea exertional
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tenderness def
|
Tenderness def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sexually active
|
Sexually active
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal discomfort
|
Throat sore def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Oropharyngeal pain
|
Throat sore def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Pharyngolaryngeal pain def
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Left ventricular dysfunction def
|
Left ventricular dysfunction def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular dysfunction def
|
Ventricular dysfunction def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematological malignancy def
|
Haematological malignancy def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Face oedema def
|
Face oedema def
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephropathy toxic
|
Nephropathy toxic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction def
|
Drug interaction def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye oedema
|
Eye oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Febrile neutropenia def
|
Febrile neutropenia def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cardiomyopathy def
|
Cardiomyopathy def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone marrow necrosis
|
Bone marrow necrosis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Haematochezia def
|
Blood in stool
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac hypertrophy def
|
Cardiac hypertrophy def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calcinosis def
|
Deposit calcium def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cell death def
|
Cytolysis def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Gastrointestinal tract irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal tract irritation
|
Gastrointestinal tract irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebral haemorrhage def
|
Cerebral haemorrhage def
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Indication
|
Labels
|
|
Blast cell crisis def
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chronic myeloid leukaemia def
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chronic phase chronic myeloid leukemia def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
Gastrointestinal stromal tumour def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukaemia def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myeloid leukaemia def
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Philadelphia chromosome positive
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sarcoma def
|
|
|
|
x
|
|
|
|
|
|
|