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.
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
|
Asthenia def
|
11.8% - 60.7%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea def
|
0% - 57.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea def
|
0% - 57.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation def
|
0% - 42.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy peripheral def
|
7.25% - 36.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy def
|
postmarketing, 7.25% - 36.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental disorder def
|
postmarketing, 2.72% - 35.3%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting def
|
0% - 35.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased def
|
0% - 35%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia def
|
3.63% - 34.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anorexia def
|
0% - 33.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
0% - 33.8%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia def
|
0% - 27.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysaesthesia def
|
0% - 27.5%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Anaemia def
|
9.37% - 26.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache def
|
0% - 25.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough def
|
0% - 21.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea def
|
postmarketing, 4.83% - 19.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenia def
|
2.42% - 18.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash def
|
postmarketing, 0% - 18.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia def
|
0% - 18.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain def
|
0% - 16%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain def
|
postmarketing, 0% - 16%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone pain def
|
0% - 15.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain in extremity def
|
0% - 15.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Infection def
|
postmarketing, 3.63% - 14.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain def
|
0% - 13.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia def
|
0% - 13.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness def
|
0% - 13.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasopharyngitis def
|
0% - 13.6%
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo def
|
postmarketing, 0% - 13.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes NOS def
|
postmarketing, 0% - 12.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes zoster def
|
0% - 12.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramp muscle def
|
0% - 12.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
0% - 11.8%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rigors
|
0% - 11.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema def
|
postmarketing, 0% - 10.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Edema of lower extremities
|
0% - 10.6%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Acidosis def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal tubular acidosis def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Pancreatitis acute def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amyloidosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Angioedema def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ascites def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aspergillosis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Ataxia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atelectasis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial flutter def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrioventricular block def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Bacteraemia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm malignant def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Candidiasis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Oral candidiasis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac tamponade def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Transient ischaemic attack def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cholestasis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Colitis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Coma def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Deafness def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Dysphagia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diplopia def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Disseminated intravascular coagulation def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug hypersensitivity def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Duodenitis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysarthria def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysautonomia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Effusion def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Embolism def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toxic epidermal necrolysis def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Grand mal convulsion def
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye disorder def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Faecalith def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac flutter
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastritis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Gastrointestinal disorder def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hearing loss bilateral def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac arrest def
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Block heart def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac disorder def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematemesis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematoma def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Subdural haematoma def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematuria def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoptysis def
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatitis def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Keratitis herpetic def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Herpes virus infection def
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hydronephrosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperbilirubinaemia def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia def
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Hypernatraemia def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary hypertension def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypocalcaemia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyponatraemia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Immune system disorder def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Inappropriate antidiuretic hormone secretion def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Incontinence def
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infarction def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Intestinal obstruction def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Intestinal perforation def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ischaemia def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Calculus of kidney def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute def
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Laryngeal oedema def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Leukopenia def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Listeriosis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Lung disorder def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Chronic obstructive pulmonary disease def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphopenia def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Mediastinal disorder def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Melaena def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Meningoencephalitis def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Myocardial infarction def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephritis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephrotic syndrome def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervous system disorder def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Neuralgia def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Obstruction def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic nerve disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
Pancreatitis def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ileus paralytic def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraplegia def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Pericardial effusion def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pericarditis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Peritonitis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Petechiae def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Phlebitis def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Pleural disorder def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia aspiration def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Post herpetic neuralgia def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Psychotic disorder def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary oedema def
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Pulmonary embolism def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute respiratory distress syndrome def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Retinitis pigmentosa def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Seizures def
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Shock def
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiogenic shock def
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Septic shock def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Skin disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
Muscle spasms def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Spinal cord compression def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Stomatitis def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebrovascular accident def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Subarachnoid haemorrhage def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Tachycardia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tooth impacted def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Torsade de pointes def
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Toxoplasmosis def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Tumour lysis syndrome def
|
postmarketing
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
|
Erythema def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Urinary incontinence def
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Urticaria def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vasculitis def
|
postmarketing
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
Venous thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ventricular tachycardia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Viral infection def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Urinary retention def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute febrile neutrophilic dermatosis def
|
postmarketing
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Encephalopathy def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic failure def
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
Agitation def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis haemorrhagic
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Deep vein thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
Atrioventricular block complete def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Necrolysis epidermal
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Myocardial ischaemia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal tubular disorder def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Hepatocellular injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Injection site pain
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Portal vein thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Acute pulmonary oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Colitis ischaemic def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Sinus arrest def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea exertional
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac fibrillation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Motor dysfunction
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Small intestinal obstruction def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lung infiltration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic haemorrhage def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypoxia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sepsis def
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Umbilical cord compression def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hepatobiliary disease def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Cardiac amyloidosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukoencephalopathy def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Solid tumour def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Acute psychosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Duodenitis haemorrhagic
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vision blurred def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematological malignancy def
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Suicidal ideation def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia def
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Bladder spasm def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bradycardia def
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Transaminases increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Blindness def
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
Large intestinal obstruction
|
postmarketing
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
Respiratory distress def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bilateral hydronephrosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paralysis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Face oedema def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhagic stroke
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deafness bilateral def
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Cardio-respiratory arrest def
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Aspiration
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dissecting aortic aneurysm, thoracic
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
COPD exacerbation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperuricaemia def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infestation NOS
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental status changes
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Catheter related infection def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Ischaemic stroke
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Neutrophilic dermatosis
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
Respiratory failure def
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ileus def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hearing impaired def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Reversible posterior leukoencephalopathy syndrome def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Cytolysis def
|
postmarketing
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Gastritis haemorrhagic
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Cerebral haemorrhage def
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytoclastic vasculitis def
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Aggression def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Anxiety def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Bronchitis def
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Chest wall pain def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Connective tissue disorder def
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cytopenia def
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Sudden death def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Dehydration def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enteritis def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Extravasation def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Failure to thrive def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Fatigue def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flushing def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Gastrointestinal haemorrhage def
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
Cardiac failure congestive def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes simplex def
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Herpes zoster ophthalmic def
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hypercalcaemia def
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
|
|
Hyperglycaemia def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia def
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Hypoproteinaemia def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypotension def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orthostatic hypotension def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infertility def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Lethargy def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Leukaemia def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Meningitis def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Musculoskeletal pain def
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Numbness def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pancreatic disorder def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Prurigo def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pruritus def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Respiratory insufficiency def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Respiratory tract infection def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Swelling def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Syncope def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Upper respiratory tract infection def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ureteric obstruction def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Uric acid level increased
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Weight decreased def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Meningitis bacterial def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Burning sensation def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Oedema peripheral def
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Hypochloraemia def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypophosphataemia def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Peripheral sensory neuropathy def
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypomagnesaemia def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemoglobin decreased def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Joint stiffness def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Polyarthritis def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Acute hepatic failure def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Lightheadedness
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Muscle stiffness
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash macular
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash papular
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Disability def
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Malaise def
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal discomfort
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Stools watery def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Discomfort def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Peripheral motor neuropathy def
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Productive cough def
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Frequent bowel movements
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Albright's disease
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Autonomic neuropathy def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cutaneous vasculitis
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Holt-Oram syndrome def
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Platelet count decreased
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stiffness
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Red blood cell count decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Left ventricular ejection fraction
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pruritus generalised
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash generalised
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Anaemia NOS aggravated
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sterility def
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cancer in remission
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Glomerulonephropathy
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Febrile neutropenia def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Pain worsened
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypotensive
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pulmonary toxicity
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Urine output
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Death
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Weakness def
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Indication
|
Labels
|
|
Adverse reaction def
|
|
|
|
|
|
|
|
|
x
|
|
Disease progression def
|
|
|
x
|
x
|
|
|
|
|
|
|
Lymphoma def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Mantle cell lymphoma def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Multiple myeloma def
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|