MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
16
|
17
|
18
|
19
|
20
|
Punctate keratitis
|
Superficial punctate keratopathy
|
very common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
11.1% - 11.5%
|
11.1%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
Discomfort
|
Malaise
|
11.1% - 11.5%
|
11.1%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
Feeling abnormal
|
Malaise
|
11.1% - 11.5%
|
11.1%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
Confusional state
|
very rare — common
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
11.1% - 11.5%
|
11.1%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
Abdominal pain
|
Abdominal pain
|
common
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
common
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
Fatigue
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Asthenia
|
1.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Fatigue
|
Fatigue
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
very rare, common
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Vomiting
|
Vomiting
|
common, 2.5% - 8%
|
2.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Stinging
|
common
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
very rare, common
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Nausea
|
Nausea
|
common, 2.4% - 8%
|
11.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
common, 4%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 1.5% - 5%
|
0.3% - 2.2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 0.9% - 5.9%
|
11.1%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Herpes simplex
|
Herpes simplex
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nasopharyngitis
|
Rhinorrhoea
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nasopharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Rhinorrhoea
|
Rhinorrhoea
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Paraesthesia
|
Paraesthesia
|
0.8% - 1.2%
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Aggression
|
Aggression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Accelerated hair loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Angioedema
|
Angioedema
|
very rare — rare
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coma
|
Coma
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
very rare — common
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis contact
|
Dermatitis contact
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Dysarthria
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, rare
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Dermatitis
|
Rash
|
postmarketing — 1.3% - 1.7%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 1.3% - 1.7%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
postmarketing, common
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Convulsion
|
Convulsion
|
very rare — common
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Encephalopathy
|
Encephalopathy
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
x
|
Mania
|
Mania
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing, common
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Altered state of consciousness
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
Depressed level of consciousness
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
Stupor
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Renal pain
|
Renal pain
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Hallucinations, mixed
|
Auditory and visual hallucinations
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
very rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Type I hypersensitivity
|
Type I hypersensitivity
|
very rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
very rare
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Renal failure acute
|
Renal failure acute
|
very rare
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
very rare
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Renal impairment
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Anuria
|
Anuria
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Cardiac tamponade
|
Cardiac tamponade
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Constipation
|
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Delirium
|
Delirium
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
Disseminated intravascular coagulation
|
Disseminated intravascular coagulation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Digestion impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Herpes virus infection
|
Herpes NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypotension
|
Hypotension
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Inflammation
|
Inflammation
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Irritability
|
Irritability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ischaemia
|
Ischaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity
|
Leg pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Lethargy
|
Lethargy
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Muscle spasms
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Necrosis
|
Necrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Neutropenia
|
Neutropenia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Uveitis
|
Pars planitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Phlebitis
|
Phlebitis
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Aphthous stomatitis
|
Aphthous stomatitis
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
Erythema
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stupor
|
Stupor
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Purpura fulminans
|
Purpura fulminans
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site reaction
|
Application site reaction
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Creatinine increased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Blood creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Dyspepsia
|
Digestion impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neurological symptom
|
Neurologic reaction
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobinaemia
|
Haemoglobinaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin exfoliation
|
Skin exfoliation
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingival pain
|
Gingival pain
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin burning sensation
|
Skin burning sensation
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Oropharyngeal pain
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Chapped lips
|
Chapped lips
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
Rigors
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine analysis abnormal
|
Urine analysis abnormal
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Application site irritation
|
Application site irritation
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site pain
|
Application site pain
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instillation site pain
|
Application site pain
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site phlebitis
|
Injection site phlebitis
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Abdominal discomfort
|
Distress gastrointestinal
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Lip dry
|
Lip dry
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis
|
Sweating increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytosis
|
Thrombocytosis
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Raised liver function tests
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
Insomnia
|
Insomnia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
Sensitisation
|
Sensitisation
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombophlebitis superficial
|
Thrombophlebitis superficial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neutrophilia
|
Neutrophilia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|