MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
Otitis media
|
Otitis media
|
8.7% - 45%
|
11.2% - 58%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
3.1% - 16%
|
2.5% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
0.8% - 49%
|
9.8% - 70%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
postmarketing, 3.3% - 17%
|
4.3% - 22%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 1.8% - 13%
|
2% - 14%
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
1.9% - 10%
|
3.3% - 17%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear disorder
|
Ear disorder
|
1.7% - 9%
|
1.2% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing, 2.2% - 24%
|
2.2% - 20%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing, 2.2% - 24%
|
2.2% - 20%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing, 4.5% - 68%
|
2.9% - 21%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
postmarketing, 3.5% - 18%
|
3.7% - 19%
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
Asthma aggravated
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
1% - 5%
|
0.4% - 2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tympanic membrane disorder
|
Tympanic membrane disorder
|
1% - 5%
|
1.2% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
1% - 5%
|
1.5% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bronchitis
|
Bronchitis
|
postmarketing, 1.6% - 17%
|
2.1% - 15%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
postmarketing, 1.7% - 9%
|
2.5% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 2.1% - 15%
|
3.5% - 25%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Dermatitis
|
postmarketing, 1% - 5%
|
1.9% - 10%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
Confusional state
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dyspepsia
|
Dyspepsia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Asthenia
|
Fatigue
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Body temperature decreased
|
Body temperature decreased
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Hypothermia
|
Body temperature decreased
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza
|
Influenza
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rhinorrhoea
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nightmare
|
Nightmare
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ache
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Pain in extremity
|
Pain in extremity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immunodeficiency
|
Immunocompromised
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Agitation
|
Agitation
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Enterocolitis haemorrhagic
|
Hemorrhagic colitis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Abnormal behaviour
|
Abnormal behaviour
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Oropharyngeal pain
|
Throat sore
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatitis fulminant
|
Hepatitis fulminant
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Visual impairment
|
Visual disturbance
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Angina pectoris
|
Angina unstable
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Angina unstable
|
Angina unstable
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis diaper
|
Dermatitis diaper
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Encephalitis
|
Encephalitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Humerus fracture
|
Humerus fracture
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Liver disorder
|
Liver disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatocellular injury
|
Liver disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Foetor hepaticus
|
Liver disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Acute tonsillitis
|
Peritonsillar abscess
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Peritonsillar abscess
|
Peritonsillar abscess
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Encephalopathy
|
Encephalopathy
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ocular hyperaemia
|
Eye redness
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eye discharge
|
Eye discharge
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dermatitis atopic
|
Eczema allergic atopic
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pseudomembranous colitis
|
Pseudomembranous colitis
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|