MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
Cough
|
Cough
|
46% - 57%
|
46%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cough increased
|
6% - 10%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
8% - 62%
|
9% - 62%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Stomatitis
|
Mouth ulceration
|
23%
|
23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
23%
|
23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
21%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oedema
|
Oedema
|
4% - 54%
|
5% - 54%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
15% - 21%
|
15%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Infection
|
Infection
|
2% - 16%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing — 2% - 62%
|
3% - 62%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing, 11% - 38%
|
8% - 38%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
0.5% - 57%
|
2.5% - 46%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
0.5% - 57%
|
2.5% - 46%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Arthralgia
|
0% - 6%
|
0% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
1.4% - 11%
|
11%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 1% - 23%
|
2% - 23%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchitis
|
Bronchitis
|
3% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anorectal disorder
|
Rectal disorder
|
4% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hallucination
|
Hallucination
|
postmarketing — 8%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 1% - 23%
|
0% - 23%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
3% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
1% - 8%
|
1% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
0.9% - 23%
|
23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
1% - 12%
|
0% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
1% - 12%
|
0% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
0.5% - 3%
|
2%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
0% - 43%
|
1% - 15%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Fatigue
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Dehydration
|
Dehydration
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
postmarketing — 1% - 31%
|
0% - 31%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
1% - 13%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
1.3% - 14%
|
1.5% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vomiting
|
Vomiting
|
postmarketing — 1% - 8%
|
0% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
0% - 21%
|
0% - 15%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Nasopharyngitis
|
Rhinorrhoea
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Rhinorrhoea
|
Rhinorrhoea
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
1% - 43%
|
1% - 31%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Constipation
|
Constipation
|
1% - 21%
|
0% - 15%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Chills
|
Chills
|
1% - 1.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Back pain
|
Back pain
|
0.5% - 29%
|
2% - 15%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depression
|
Depression
|
0% - 21%
|
0% - 15%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
0% - 4%
|
0% - 2%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
0% - 1.8%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
0% - 12%
|
0% - 12%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
very rare — 0.6% - 8%
|
0.2% - 8%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing — 7% - 38%
|
5% - 38%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — 1% - 14%
|
0% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 1% - 14%
|
0% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 6%
|
0% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Eczema
|
Eczema
|
0% - 1%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Influenza
|
Influenza
|
0% - 7%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
Nervousness
|
Nervousness
|
0% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tension
|
Nervousness
|
0% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
0% - 1%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing — 0% - 5%
|
0% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
0% - 3%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Migraine
|
Migraine
|
1%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
Acne
|
Acne
|
1%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
Aggression
|
Aggression
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Alopecia
|
Alopecia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare — rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Angioedema
|
Angioedema
|
very rare, postmarketing
|
|
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
|
x
|
Coma
|
Coma
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing — 7%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing — 7%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysarthria
|
Dysarthria
|
very rare, postmarketing
|
|
|
x
|
x
|
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
|
x
|
x
|
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
very rare — rare
|
|
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
|
x
|
|
|
x
|
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
postmarketing
|
|
|
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
|
x
|
x
|
x
|
x
|
Renal impairment
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion
|
Convulsion
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare — 0.1% - 5%
|
0.7% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
very rare — 4%
|
6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immunodeficiency
|
Immunocompromised
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Encephalopathy
|
Encephalopathy
|
very rare, postmarketing
|
|
x
|
x
|
x
|
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
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Microangiopathic haemolytic anaemia
|
Microangiopathic haemolytic anaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neurological symptom
|
Neurologic reaction
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Blood creatinine increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Creatinine increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Mania
|
Mania
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menorrhagia
|
Prolonged menses
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Altered state of consciousness
|
Depressed level of consciousness
|
postmarketing, rare
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
Depressed level of consciousness
|
postmarketing, rare
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucinations, mixed
|
Auditory and visual hallucinations
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Renal impairment
|
Renal impairment
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Liver function test abnormal
|
Raised liver function tests
|
very rare — rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Thrombotic microangiopathy
|
Thrombotic microangiopathy
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cytomegalovirus infection
|
Cytomegalovirus infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Fatigue
|
Fatigue
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|