MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
Dysgeusia
|
Dysgeusia
|
postmarketing — 4.4% - 6%
|
0.9%
|
|
|
x
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing, 1.3% - 5.4%
|
1.7%
|
x
|
x
|
x
|
x
|
Discomfort
|
Discomfort
|
1.5% - 11.1%
|
2.6%
|
|
|
x
|
|
Malaise
|
|
|
|
|
|
x
|
Pruritus
|
Pruritus
|
0.9% - 1.2%
|
1.7%
|
x
|
x
|
x
|
|
Hyperaemia
|
Hyperaemia
|
0.5% - 1.9%
|
0.9%
|
x
|
x
|
x
|
|
Sensation of foreign body
|
Sensation of foreign body
|
0.6% - 1.8%
|
|
x
|
x
|
x
|
|
Asthma
|
Asthma
|
rare, 0.8% - 1%
|
|
|
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 0.5% - 1.3%
|
0.9%
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
0.4% - 1.2%
|
0.9%
|
|
|
x
|
x
|
Lacrimation increased
|
Lacrimation
|
0.2% - 1.3%
|
|
x
|
x
|
x
|
|
Lacrimation increased
|
postmarketing
|
|
|
|
x
|
x
|
Keratitis
|
Keratitis
|
postmarketing, 0.7% - 1.2%
|
|
x
|
x
|
x
|
x
|
Keratoconjunctivitis
|
|
|
x
|
x
|
x
|
|
Rhinitis
|
Rhinitis
|
0.2% - 1%
|
|
x
|
x
|
x
|
x
|
Dry eye
|
Dry eye
|
postmarketing, 0.4% - 1.1%
|
0.9%
|
x
|
x
|
x
|
|
Keratoconjunctivitis sicca
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 0.2% - 2%
|
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
|
|
x
|
x
|
Myalgia
|
|
|
|
|
|
x
|
Asthenia
|
Asthenia
|
postmarketing
|
|
|
|
x
|
x
|
Fatigue
|
postmarketing
|
|
|
|
x
|
x
|
Asthenopia
|
Asthenopia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
x
|
x
|
Blepharitis
|
Blepharitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
|
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
x
|
x
|
Corneal oedema
|
Corneal oedema
|
postmarketing
|
|
|
|
x
|
x
|
Cough
|
Cough
|
postmarketing, rare
|
|
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing
|
|
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Digestion impaired
|
|
|
|
|
x
|
|
Epistaxis
|
Epistaxis
|
postmarketing
|
|
|
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing
|
|
|
|
x
|
x
|
Dermatitis
|
|
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing
|
|
|
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing
|
|
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
x
|
x
|
Digestion impaired
|
|
|
|
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing
|
|
|
|
x
|
x
|
Irritability
|
Irritability
|
postmarketing
|
|
|
|
x
|
x
|
Eye pruritus
|
Eye pruritus
|
postmarketing
|
|
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
postmarketing, rare
|
|
|
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
x
|
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Bronchial hyperreactivity
|
Bronchial hyperreactivity
|
postmarketing, rare
|
|
|
|
x
|
x
|
Photopsia
|
Photopsia
|
postmarketing
|
|
|
|
x
|
x
|
Photophobia
|
Photophobia
|
postmarketing
|
|
|
|
x
|
|
Periorbital oedema
|
Periorbital oedema
|
postmarketing
|
|
|
|
x
|
x
|
Eye pain
|
Eye pain
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Sinus congestion
|
Sinus congestion
|
postmarketing, rare
|
|
|
|
x
|
x
|
Endophthalmitis
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
x
|
x
|
Ocular hyperaemia
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
x
|
x
|
Nasal dryness
|
Nasal dryness
|
rare
|
|
|
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing
|
|
|
|
x
|
x
|
Upset stomach
|
|
|
|
|
|
x
|
Memory impairment
|
Memory impairment
|
postmarketing
|
|
|
|
x
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
postmarketing
|
|
|
|
x
|
x
|
Punctate keratitis
|
Punctate keratitis
|
postmarketing
|
|
|
|
x
|
x
|
Corneal erosion
|
Corneal erosion
|
postmarketing
|
|
|
|
x
|
x
|
Eye discharge
|
Eye discharge
|
postmarketing
|
|
|
|
x
|
x
|
Pruritus generalised
|
Pruritus generalised
|
postmarketing
|
|
|
|
x
|
x
|
Nervousness
|
Feeling jittery
|
postmarketing
|
|
|
|
x
|
x
|
Nervousness
|
|
|
|
|
x
|
x
|
Feeling jittery
|
Feeling jittery
|
postmarketing
|
|
|
|
x
|
x
|
Throat irritation
|
Throat irritation
|
postmarketing
|
|
|
|
x
|
x
|
Hypoaesthesia eye
|
Hypoaesthesia eye
|
postmarketing
|
|
|
|
x
|
x
|
Eyelid margin crusting
|
Eyelid margin crusting
|
postmarketing
|
|
|
|
x
|
x
|
Ocular discomfort
|
Ocular discomfort
|
postmarketing
|
|
x
|
x
|
x
|
x
|
Upper respiratory tract congestion
|
Upper respiratory tract congestion
|
postmarketing, rare
|
|
|
|
x
|
x
|
Medication residue present
|
Medication residue
|
postmarketing
|
|
|
|
x
|
|
Nasopharyngitis
|
Rhinorrhoea
|
postmarketing
|
|
|
|
x
|
x
|
Nasopharyngitis
|
|
|
|
|
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing
|
|
|
|
x
|
x
|
Oropharyngeal pain
|
Oropharyngeal pain
|
postmarketing
|
|
|
|
x
|
x
|
Somnolence
|
Somnolence
|
postmarketing
|
|
|
|
x
|
x
|
Upper-airway cough syndrome
|
Upper-airway cough syndrome
|
postmarketing
|
|
|
|
x
|
x
|
Amnesia
|
Amnesia
|
|
|
|
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
x
|
Back pain
|
Back pain
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
x
|
Bronchitis
|
Bronchitis
|
|
|
|
|
x
|
|
Infection
|
Infection
|
|
|
|
|
|
x
|
Conjunctivitis allergic
|
Conjunctivitis allergic
|
|
|
|
|
|
x
|
Corneal disorder
|
Corneal disorder
|
|
|
|
|
|
x
|
Corneal epithelium disorder
|
|
|
|
|
|
x
|
Libido decreased
|
Libido decreased
|
|
|
|
|
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
|
|
|
|
|
x
|
Depersonalisation
|
Depersonalisation
|
|
|
|
|
x
|
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
x
|
Foreign body in eye
|
Foreign body in eye
|
|
|
|
|
|
x
|
Eyelid disorder
|
Eyelid disorder
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
|
|
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
|
|
x
|
x
|
|
x
|
Hypertension
|
Hypertension
|
|
|
|
|
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
|
|
x
|
x
|
x
|
|
Tension
|
Nervousness
|
|
|
|
|
x
|
x
|
Nightmare
|
Nightmare
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
|
|
x
|
x
|
x
|
x
|
Pterygium
|
Pterygium
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
|
|
|
|
|
x
|
Sneezing
|
Sneezing
|
|
|
|
|
|
x
|
Muscle spasms
|
Muscle spasms
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
|
|
|
|
x
|
x
|
Tremor
|
Tremor
|
|
|
|
|
|
x
|
Erythema
|
Erythema
|
|
|
|
|
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
Vertigo
|
Vertigo
|
|
|
|
|
|
x
|
Vomiting
|
Vomiting
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
|
|
|
|
x
|
|
Apathy
|
Apathy
|
|
|
|
|
|
x
|
Flat affect
|
Apathy
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
|
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
x
|
Scab
|
Scab
|
|
|
x
|
x
|
x
|
|
Malaise
|
Malaise
|
|
|
|
|
|
x
|
Feeling abnormal
|
Malaise
|
|
|
|
|
|
x
|
Feeling abnormal
|
|
|
|
|
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
x
|
Decreased appetite
|
Decreased appetite
|
|
|
|
|
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
x
|
Motor dysfunction
|
Motor dysfunction
|
|
|
|
|
|
x
|
Intraocular pressure increased
|
Intraocular pressure increased
|
|
|
|
|
|
x
|
Eye irritation
|
Eye irritation
|
|
|
|
|
|
x
|
Keratopathy
|
Keratopathy
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
Chest discomfort
|
|
|
|
|
|
x
|
Heart rate irregular
|
Heart rate irregular
|
|
|
|
|
|
x
|
Erythema of eyelid
|
Erythema of eyelid
|
|
|
|
|
|
x
|
Frequent bowel movements
|
Frequent bowel movements
|
|
|
|
|
|
x
|
Skin tightness
|
Skin tightness
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
Eye swelling
|
Eye swelling
|
|
|
|
|
|
x
|
Madarosis
|
Madarosis
|
|
|
|
|
|
x
|
Depressed mood
|
Depressed mood
|
|
|
|
|
|
x
|
Vital dye staining cornea present
|
Corneal staining
|
|
|
|
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
|
x
|
Red blood cell count decreased
|
Red blood cell count decreased
|
|
|
|
|
|
x
|
Bradycardia
|
Bradycardia
|
|
|
|
|
|
x
|
Abnormal sensation in eye
|
Abnormal sensation in eye
|
|
|
|
|
|
x
|
Blood pressure increased
|
Blood pressure increased
|
|
|
|
|
|
x
|
Subconjunctival cyst
|
Subconjunctival cyst
|
|
|
|
|
|
x
|
Paraesthesia oral
|
Paraesthesia oral
|
|
|
|
|
|
x
|
Hypoaesthesia oral
|
Hypoaesthesia oral
|
|
|
|
|
|
x
|
Deposit eye
|
Deposit eye
|
|
|
|
|
|
x
|
Visual impairment
|
Visual disturbance
|
|
|
|
|
|
x
|
Abnormal vision
|
|
|
|
|
x
|
|
Meibomianitis
|
Meibomianitis
|
|
|
|
|
x
|
x
|
Renal pain
|
Renal pain
|
|
|
x
|
x
|
x
|
x
|
Blood chloride increased
|
Blood chloride increased
|
|
|
|
|
|
x
|
Scleral pigmentation
|
Scleral pigmentation
|
|
|
|
|
|
x
|
Eyelids pruritus
|
Eyelids pruritus
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
x
|
Eye allergy
|
Eye allergy
|
|
|
|
|
|
x
|
Optic nerve cupping
|
Optic nerve cupping
|
|
|
|
|
|
x
|
Corneal epithelium defect
|
Corneal epithelium defect
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
x
|
Cardio-respiratory distress
|
Cardio-respiratory distress
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
|
|
|
|
|
x
|
Foreign body sensation in eyes
|
Foreign body sensation in eyes
|
|
|
|
|
|
x
|
Conjunctival hyperaemia
|
Conjunctival hyperaemia
|
|
|
|
|
|
x
|
Ageusia
|
Ageusia
|
|
|
|
|
|
x
|