MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
Alopecia
|
Alopecia
|
1-83% - 83%
|
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
58%
|
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
58% - 56-81%
|
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
46% - 6-92%
|
|
x
|
x
|
x
|
x
|
x
|
Frank hematuria
|
12%
|
|
x
|
x
|
|
|
|
Microscopic hematuria
|
|
|
x
|
x
|
|
x
|
|
Neurotoxicity
|
CNS toxicity
|
12%
|
|
x
|
x
|
|
|
x
|
Neurotoxicity
|
|
|
|
|
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
10%
|
|
x
|
x
|
x
|
x
|
x
|
Nephropathy toxic
|
Nephrotoxicity
|
6%
|
|
|
|
x
|
x
|
|
Nephropathy toxic
|
|
|
x
|
x
|
|
|
|
Renal failure
|
Renal impairment
|
6%
|
|
x
|
x
|
x
|
|
|
Renal failure
|
1%
|
|
|
|
|
x
|
|
Renal impairment
|
Renal impairment
|
6%
|
|
x
|
x
|
x
|
|
|
Cystitis haemorrhagic
|
Cystitis haemorrhagic
|
1-10%
|
|
|
|
x
|
x
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
3%
|
|
x
|
x
|
|
|
|
Phlebitis
|
Phlebitis
|
2%
|
|
x
|
x
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, 1% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
Fever of unknown origin
|
1%
|
|
x
|
x
|
|
x
|
|
Thrombophlebitis
|
Thrombophlebitis
|
1%
|
|
|
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
1%
|
|
x
|
x
|
x
|
|
x
|
Coagulopathy
|
Coagulopathy
|
1%
|
|
x
|
x
|
|
|
|
Dermatitis
|
Dermatitis
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
Rash
|
postmarketing
|
|
|
|
|
|
x
|
Diarrhoea
|
Diarrhoea
|
1%
|
|
x
|
x
|
x
|
|
x
|
Encephalitis
|
Encephalitis
|
1%
|
|
|
|
x
|
x
|
|
Asthenia
|
Fatigue
|
1%
|
|
x
|
x
|
|
|
x
|
Asthenia
|
|
|
|
|
x
|
x
|
|
Fatigue
|
Fatigue
|
1%
|
|
x
|
x
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, 1%
|
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
1%
|
|
|
|
|
x
|
x
|
Salivary hypersecretion
|
Salivation
|
1%
|
|
x
|
x
|
|
|
|
Salivary hypersecretion
|
postmarketing
|
|
|
|
|
|
x
|
Stomatitis
|
Stomatitis
|
1%
|
|
x
|
x
|
x
|
|
x
|
Polyneuropathy
|
Polyneuropathy
|
postmarketing, 1%
|
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
1%
|
|
x
|
x
|
|
|
x
|
Discomfort
|
Malaise
|
1%
|
|
x
|
x
|
|
|
x
|
Feeling abnormal
|
Malaise
|
1%
|
|
x
|
x
|
|
|
x
|
Confusional state
|
|
|
x
|
x
|
x
|
x
|
|
Ill-defined disorder
|
Malaise
|
1%
|
|
x
|
x
|
|
|
x
|
Convulsion
|
Convulsions generalised
|
1%
|
|
|
|
x
|
x
|
|
Convulsion
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing, 1%
|
|
x
|
x
|
x
|
|
x
|
Hypertension
|
Hypertension
|
postmarketing, 1%
|
|
x
|
x
|
x
|
|
x
|
Hypotension
|
Hypotension
|
postmarketing, 1%
|
|
x
|
x
|
x
|
|
x
|
Cardiotoxicity
|
Cardiotoxicity
|
postmarketing, 1%
|
|
x
|
x
|
x
|
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
|
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
|
|
x
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
|
|
|
|
x
|
Alveolitis allergic
|
Alveolitis allergic
|
postmarketing
|
|
|
|
|
|
x
|
Amenorrhoea
|
Amenorrhoea
|
postmarketing
|
|
|
|
|
x
|
x
|
Amnesia
|
Amnesia
|
postmarketing
|
|
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing
|
|
|
|
|
|
x
|
Anaemia neonatal
|
Anaemia neonatal
|
postmarketing
|
|
|
|
|
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
|
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
x
|
Myalgia
|
postmarketing
|
|
|
|
|
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
|
|
x
|
Atrial flutter
|
Atrial flutter
|
postmarketing
|
|
|
|
|
|
x
|
Azoospermia
|
Azoospermia
|
postmarketing
|
|
|
|
|
x
|
x
|
Oligospermia
|
postmarketing
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
x
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
|
|
|
x
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
|
|
|
|
x
|
Renal cell carcinoma
|
Renal cell carcinoma
|
postmarketing
|
|
|
|
|
|
x
|
Congestive cardiomyopathy
|
Congestive cardiomyopathy
|
postmarketing
|
|
|
|
|
|
x
|
Catatonia
|
Catatonia
|
postmarketing
|
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
|
|
x
|
Cholestasis
|
Cholestasis
|
postmarketing
|
|
|
|
|
|
x
|
Colitis
|
Colitis
|
postmarketing
|
|
|
|
|
|
x
|
Infection
|
Infection
|
postmarketing, 8%
|
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing
|
|
|
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
x
|
Cough
|
Cough
|
postmarketing
|
|
|
|
|
|
x
|
Cyst
|
Cyst
|
postmarketing
|
|
|
|
|
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
|
|
x
|
Hearing impaired
|
postmarketing
|
|
|
|
|
|
x
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
|
|
x
|
Delusion
|
Delusion
|
postmarketing
|
|
|
|
|
|
x
|
Disseminated intravascular coagulation
|
Disseminated intravascular coagulation
|
postmarketing
|
|
|
|
|
|
x
|
Dysarthria
|
Dysarthria
|
postmarketing
|
|
|
|
|
|
x
|
Osteoarthritis
|
Dysarthria
|
postmarketing
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
|
|
|
|
x
|
Echolalia
|
Echolalia
|
postmarketing
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
x
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
|
|
|
x
|
Enterocolitis
|
Enterocolitis
|
postmarketing
|
|
|
|
|
|
x
|
Enuresis
|
Enuresis
|
postmarketing
|
|
|
|
|
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
|
|
x
|
Rash
|
Rash
|
postmarketing
|
|
|
|
|
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
postmarketing
|
|
|
|
|
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
x
|
Fanconi syndrome
|
Fanconi syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Renal tubular disorder
|
Fanconi syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
Faecal incontinence
|
Faecal incontinence
|
postmarketing
|
|
|
|
|
|
x
|
Microsomia
|
Microsomia
|
postmarketing
|
|
|
|
|
|
x
|
Flushing
|
Flushing
|
postmarketing
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
|
|
|
|
x
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
|
|
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Venoocclusive liver disease
|
Venoocclusive liver disease
|
postmarketing
|
|
|
|
|
|
x
|
Herpes zoster
|
Herpes zoster
|
postmarketing
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
postmarketing
|
|
|
|
|
|
x
|
Pulmonary hypertension
|
Pulmonary hypertension
|
postmarketing
|
|
|
|
|
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing
|
|
|
|
|
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
x
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
postmarketing
|
|
|
|
x
|
|
x
|
Infertility
|
Infertility
|
postmarketing
|
|
|
|
|
|
x
|
Inflammation
|
Inflammation
|
postmarketing
|
|
|
|
|
x
|
x
|
Renal failure chronic
|
Renal failure chronic
|
postmarketing
|
|
x
|
x
|
|
|
x
|
Bundle branch block left
|
Bundle branch block left
|
postmarketing
|
|
|
|
|
|
x
|
Left ventricular failure
|
Left ventricular failure
|
postmarketing
|
|
|
|
|
|
x
|
Pulmonary oedema
|
Left ventricular failure
|
postmarketing
|
|
|
|
|
|
x
|
Pulmonary oedema
|
postmarketing, 1%
|
|
|
|
x
|
x
|
x
|
Acute lymphocytic leukaemia
|
Acute lymphocytic leukaemia
|
postmarketing
|
|
|
|
|
|
x
|
Acute myeloid leukaemia
|
Acute myeloid leukaemia
|
postmarketing
|
|
|
|
|
|
x
|
Acute leukaemia
|
Acute myeloid leukaemia
|
postmarketing
|
|
|
|
|
|
x
|
Acute leukaemia
|
postmarketing
|
|
|
|
|
|
x
|
Acute promyelocytic leukaemia
|
Acute promyelocytic leukaemia
|
postmarketing
|
|
|
|
|
|
x
|
Progressive multifocal leukoencephalopathy
|
Progressive multifocal leukoencephalopathy
|
postmarketing
|
|
|
|
|
|
x
|
Lymphoma
|
Lymphoma
|
postmarketing
|
|
|
|
|
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
postmarketing
|
|
|
|
|
|
x
|
Non-Hodgkin's lymphoma
|
postmarketing
|
|
|
|
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
x
|
Premature menopause
|
Premature menopause
|
postmarketing
|
|
|
|
|
|
x
|
Methaemoglobinaemia
|
Methaemoglobinaemia
|
postmarketing
|
|
|
|
|
|
x
|
Dyskinesia
|
Movement disorder
|
postmarketing
|
|
|
|
|
|
x
|
Movement disorder
|
Movement disorder
|
postmarketing
|
|
|
|
|
|
x
|
Multi-organ failure
|
Multi-organ failure
|
postmarketing
|
|
|
|
|
|
x
|
Mutism
|
Mutism
|
postmarketing
|
|
|
|
|
x
|
x
|
Fungal infection
|
Fungal infection
|
postmarketing
|
|
|
|
|
|
x
|
Myelodysplastic syndrome
|
Myelodysplastic syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
x
|
Myocarditis
|
Myocarditis
|
postmarketing
|
|
|
|
|
|
x
|
Nail disorder
|
Nail disorder
|
postmarketing
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
x
|
Neuralgia
|
Neuralgia
|
postmarketing
|
|
|
|
|
|
x
|
Osteomalacia
|
Osteomalacia
|
postmarketing
|
|
|
|
|
|
x
|
Ovarian disorder
|
Ovarian disorder
|
postmarketing
|
|
|
|
|
|
x
|
Pain
|
Pain
|
postmarketing
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
postmarketing
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
postmarketing, 1%
|
|
|
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
|
|
x
|
Myelosuppression
|
postmarketing
|
|
x
|
x
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
|
|
x
|
Pericardial effusion
|
Pericardial effusion
|
postmarketing
|
|
|
|
|
|
x
|
Pericarditis
|
Pericarditis
|
postmarketing
|
|
|
|
|
|
x
|
Petechiae
|
Petechiae
|
postmarketing
|
|
|
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
postmarketing
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
postmarketing
|
|
|
|
|
|
x
|
Polyp
|
Polyp
|
postmarketing
|
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
postmarketing
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
postmarketing
|
|
|
|
|
|
x
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
x
|
Pruritus
|
Pruritus
|
postmarketing
|
|
|
|
|
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
|
|
x
|
Pulmonary fibrosis
|
Pulmonary fibrosis
|
postmarketing
|
|
|
|
|
|
x
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
|
|
x
|
Rickets
|
Rickets
|
postmarketing
|
|
|
|
|
|
x
|
Cardiogenic shock
|
Cardiogenic shock
|
postmarketing
|
|
|
|
|
|
x
|
Septic shock
|
Septic shock
|
postmarketing
|
|
|
|
|
|
x
|
Status epilepticus
|
Status epilepticus
|
postmarketing
|
|
|
|
|
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
|
|
|
|
x
|
Tubulointerstitial nephritis
|
Tubulointerstitial nephritis
|
postmarketing
|
|
|
|
|
|
x
|
Tumour lysis syndrome
|
Tumour lysis syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Erythema
|
Erythema
|
postmarketing
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
|
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
postmarketing
|
|
|
|
|
|
x
|
Ventricular fibrillation
|
Ventricular fibrillation
|
postmarketing
|
|
|
|
|
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
postmarketing
|
|
|
|
|
|
x
|
Vertigo
|
Vertigo
|
postmarketing
|
|
|
|
|
|
x
|
Hepatitis viral
|
Hepatitis viral
|
postmarketing
|
|
|
|
|
|
x
|
Chills
|
Chills
|
postmarketing
|
|
|
|
|
|
x
|
Polydipsia
|
Polydipsia
|
postmarketing
|
|
|
|
|
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
|
|
x
|
Bundle branch block right
|
Bundle branch block right
|
postmarketing
|
|
|
|
|
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
postmarketing
|
|
|
|
|
|
x
|
Panic attack
|
Panic attack
|
postmarketing
|
|
|
|
|
|
x
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
|
|
x
|
Swelling face
|
Swelling face
|
postmarketing
|
|
|
|
|
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
x
|
Growth retardation
|
Growth retardation
|
postmarketing
|
|
|
|
|
|
x
|
Skin necrosis
|
Skin necrosis
|
postmarketing
|
|
|
|
|
|
x
|
Skin exfoliation
|
Skin necrosis
|
postmarketing
|
|
|
|
|
|
x
|
Portal vein thrombosis
|
Portal vein thrombosis
|
postmarketing
|
|
|
|
|
|
x
|
Nephrogenic diabetes insipidus
|
Nephrogenic diabetes insipidus
|
postmarketing
|
|
|
|
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
x
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
postmarketing
|
|
|
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
x
|
Interstitial lung disease
|
Interstitial pneumonia
|
postmarketing, 1%
|
|
|
|
x
|
x
|
x
|
Interstitial lung disease
|
postmarketing
|
|
|
|
|
|
x
|
Lung fibrosis interstitial
|
|
|
|
|
x
|
|
|
Metabolic acidosis
|
Metabolic acidosis
|
postmarketing, 31%
|
|
x
|
x
|
x
|
x
|
x
|
Rash macular
|
Rash macular
|
postmarketing
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
postmarketing
|
|
|
|
|
|
x
|
Muscle twitching
|
Muscle twitching
|
postmarketing
|
|
|
|
|
|
x
|
Asterixis
|
Asterixis
|
postmarketing
|
|
|
|
|
|
x
|
Perseveration
|
Perseveration
|
postmarketing
|
|
|
|
|
|
x
|
Tenderness
|
Tenderness
|
postmarketing
|
|
|
|
|
|
x
|
Eye irritation
|
Eye irritation
|
postmarketing
|
|
|
|
|
|
x
|
Mucosal ulceration
|
Mucosal ulceration
|
postmarketing
|
|
|
|
|
|
x
|
Mucosal inflammation
|
Mucosal ulceration
|
postmarketing
|
|
|
|
|
|
x
|
Mucosal inflammation
|
postmarketing
|
|
|
|
|
|
x
|
Aminoaciduria
|
Aminoaciduria
|
postmarketing
|
|
|
|
|
|
x
|
Hypoxia
|
Hypoxia
|
postmarketing
|
|
|
|
|
|
x
|
Sepsis
|
Sepsis
|
postmarketing
|
|
|
|
|
|
x
|
Caecitis
|
Caecitis
|
postmarketing
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
x
|
Leukoencephalopathy
|
Leukoencephalopathy
|
postmarketing
|
|
|
|
|
|
x
|
Hepatitis fulminant
|
Hepatitis fulminant
|
postmarketing
|
|
|
|
|
|
x
|
Mania
|
Mania
|
postmarketing
|
|
|
|
|
|
x
|
Myocardial depression
|
Myocardial depression
|
postmarketing
|
|
|
|
|
|
x
|
Capillary leak syndrome
|
Capillary leak syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Dysaesthesia
|
Dysaesthesia
|
postmarketing
|
|
|
|
|
|
x
|
Bradycardia
|
Bradycardia
|
postmarketing
|
|
|
|
|
|
x
|
Electrocardiogram QRS complex abnormal
|
Electrocardiogram QRS complex abnormal
|
postmarketing
|
|
|
|
|
|
x
|
Electrocardiogram T wave inversion
|
Electrocardiogram T wave inversion
|
postmarketing
|
|
|
|
|
|
x
|
Bradyphrenia
|
Bradyphrenia
|
postmarketing
|
|
|
|
|
|
x
|
Gait disturbance
|
Gait disturbance
|
postmarketing
|
|
|
|
|
|
x
|
Ejection fraction decreased
|
Ejection fraction decreased
|
postmarketing
|
|
|
|
|
|
x
|
Ovarian failure
|
Ovarian failure
|
postmarketing
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
x
|
Blood oestrogen decreased
|
Blood oestrogen decreased
|
postmarketing
|
|
|
|
|
|
x
|
Blood gonadotrophin increased
|
Blood gonadotrophin increased
|
postmarketing
|
|
|
|
|
|
x
|
Electrocardiogram ST segment abnormal
|
Electrocardiogram ST segment abnormal
|
postmarketing
|
|
|
|
|
|
x
|
Urinary retention
|
Feeling of residual urine
|
postmarketing
|
|
|
|
|
|
x
|
Myocardial haemorrhage
|
Myocardial haemorrhage
|
postmarketing
|
|
|
|
|
|
x
|
Cardiomyopathy
|
Cardiomyopathy
|
postmarketing
|
|
|
|
|
|
x
|
Hepatitis
|
Cytolytic hepatitis
|
postmarketing
|
|
|
|
|
|
x
|
Haematotoxicity
|
Haematotoxicity
|
postmarketing
|
|
|
|
|
|
x
|
Urine phosphorus increased
|
Urine phosphate increased
|
postmarketing
|
|
|
|
x
|
x
|
x
|
Febrile bone marrow aplasia
|
Febrile bone marrow aplasia
|
postmarketing
|
|
|
|
|
|
x
|
Respiratory failure
|
Respiratory failure
|
postmarketing
|
|
|
|
|
|
x
|
Ileus
|
Ileus
|
postmarketing
|
|
|
|
|
|
x
|
Sarcoma
|
Sarcoma
|
postmarketing
|
|
|
|
|
|
x
|
Hearing impaired
|
Hearing impaired
|
postmarketing
|
|
|
|
|
|
x
|
Ovulation disorder
|
Ovulation disorder
|
postmarketing
|
|
|
|
|
|
x
|
Psychotic disorder
|
Paranoia
|
postmarketing
|
|
|
|
|
|
x
|
Paranoia
|
Paranoia
|
postmarketing
|
|
|
|
|
|
x
|
Recall phenomenon
|
Radiation recall reaction (dermatologic)
|
postmarketing
|
|
|
|
|
|
x
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
postmarketing
|
|
|
|
|
|
x
|
Logorrhoea
|
Logorrhoea
|
postmarketing
|
|
|
|
|
|
x
|
Visual impairment
|
Visual impairment
|
postmarketing
|
|
|
|
|
|
x
|
Acidosis
|
Acidosis
|
|
|
x
|
x
|
x
|
|
|
Renal tubular acidosis
|
Renal tubular acidosis
|
|
|
x
|
x
|
x
|
x
|
|
Road traffic accident
|
Renal tubular acidosis
|
|
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
|
|
x
|
x
|
|
x
|
x
|
Coma
|
Coma
|
|
|
x
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
|
|
x
|
x
|
x
|
x
|
|
Dizziness
|
Dizziness
|
|
|
x
|
x
|
x
|
x
|
|
Dysuria
|
Dysuria
|
|
|
x
|
x
|
x
|
x
|
|
Extravasation
|
Extravasation
|
|
|
|
|
|
x
|
|
Hallucination
|
Hallucination
|
|
|
x
|
x
|
x
|
x
|
|
Haematemesis
|
Haematemesis
|
|
|
|
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
x
|
x
|
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
x
|
x
|
|
Incontinence
|
Incontinence
|
|
|
|
|
|
x
|
|
Nephropathy
|
Nephropathy
|
|
|
|
|
x
|
|
|
Renal failure acute
|
Renal failure acute
|
|
|
x
|
x
|
|
|
|
Renal neoplasm
|
Renal neoplasm
|
|
|
|
|
x
|
|
|
Leukopenia
|
Leukopenia
|
|
|
x
|
x
|
|
x
|
x
|
Necrosis
|
Necrosis
|
|
|
|
|
|
x
|
|
Obstruction
|
Obstruction
|
|
|
|
|
x
|
|
|
Pelvic neoplasm
|
Pelvic neoplasm
|
|
|
|
|
x
|
|
|
Proteinuria
|
Proteinuria
|
|
|
x
|
x
|
x
|
x
|
|
Protein urine present
|
Proteinuria
|
|
|
x
|
x
|
x
|
x
|
|
Pollakiuria
|
Pollakiuria
|
|
|
x
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
x
|
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
x
|
x
|
|
Stupor
|
Stupor
|
|
|
|
|
|
x
|
|
Depressed level of consciousness
|
Stupor
|
|
|
|
|
|
x
|
|
Agitation
|
Agitation
|
|
|
|
|
|
x
|
|
Brain cancer metastatic
|
Brain cancer metastatic
|
|
|
|
|
x
|
|
|
Metastases to central nervous system
|
Brain cancer metastatic
|
|
|
|
|
x
|
|
|
Disorientation
|
Disorientation
|
|
|
x
|
x
|
x
|
x
|
|
Hallucination, auditory
|
Hallucination, auditory
|
|
|
|
|
|
x
|
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
|
|
|
|
x
|
Arrhythmia supraventricular
|
Arrhythmia supraventricular
|
|
|
|
|
|
x
|
|
Electrocardiogram ST segment
|
Electrocardiogram ST segment
|
|
|
|
|
x
|
x
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
x
|
|
|
Blood creatinine increased
|
Serum creatinine increased
|
|
|
|
|
x
|
x
|
|
Major depression
|
Psychosis depressive
|
|
|
x
|
x
|
x
|
x
|
|
Febrile neutropenia
|
Febrile neutropenia
|
|
|
|
|
|
x
|
x
|
Cerebral arteriosclerosis
|
Cerebral arteriosclerosis
|
|
|
|
|
x
|
|
|
Pulmonary toxicity
|
Pulmonary toxicity
|
|
|
|
|
x
|
|
|
Rash papular
|
Rash papular
|
|
|
|
|
|
|
x
|
Renal rickets
|
Renal rickets
|
|
|
x
|
x
|
x
|
x
|
|
Renal tubular necrosis
|
Renal tubular necrosis
|
|
|
|
|
x
|
x
|
|
Somnolence
|
Somnolence
|
|
|
x
|
x
|
x
|
x
|
|
Hypertonic bladder
|
Bladder irritation
|
|
|
x
|
x
|
|
|
|
Bladder irritation
|
Bladder irritation
|
|
|
x
|
x
|
|
|
|