MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
65%
|
|
|
x
|
x
|
|
|
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
65%
|
|
|
x
|
x
|
|
|
|
Blood uric acid increased
|
Uric acid level increased
|
17%
|
|
|
x
|
|
|
|
|
Dry eye
|
Dry eye
|
30%
|
|
|
x
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
9%
|
|
|
x
|
|
|
|
|
White blood cell count decreased
|
White blood cell count decreased
|
7%
|
|
|
x
|
x
|
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
1-10%
|
|
|
x
|
x
|
|
|
|
Blood creatinine increased
|
Creatinine increased
|
5%
|
|
|
x
|
x
|
|
|
|
Glycosuria
|
Glycosuria
|
postmarketing, 4%
|
|
|
|
x
|
x
|
x
|
x
|
Ketonuria
|
Ketonuria
|
postmarketing, 3%
|
|
|
|
x
|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
postmarketing, 2%
|
|
|
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
postmarketing, 2%
|
|
|
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing, 7-75%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Anorectal disorder
|
Anus disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Candida infection
|
Candida infection
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Chalazion
|
Chalazion
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Cheilitis
|
Cheilitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Ulcerative keratitis
|
Ulcerative keratitis
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
Cough
|
Cough
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Cyanosis
|
Cyanosis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Cyst
|
Cyst
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Depression
|
Depression
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Dermatitis
|
Dermatitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Scleroderma
|
Scleroderma
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Ectropion
|
Ectropion
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Congenital eye disorder
|
Congenital eye disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Eye disorder
|
Congenital eye disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Eye disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Fasting
|
Fasting
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Furuncle
|
Furunculosis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Gingival bleeding
|
Gingival bleeding
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Gingival hyperplasia
|
Gingival hyperplasia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing
|
|
|
|
|
|
x
|
x
|
Haematuria
|
Haematuria
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
Haemorrhoids
|
Haemorrhoids
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Exostosis
|
Hyperostosis
|
postmarketing, 1-10%
|
|
|
x
|
|
x
|
x
|
x
|
Senile ankylosing vertebral hyperostosis
|
Senile ankylosing vertebral hyperostosis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hypertrichosis
|
Hypertrichosis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Intermittent claudication
|
Intermittent claudication
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Eye pruritus
|
Eye pruritus
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Laryngitis
|
Laryngitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Melaena
|
Melaena
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Hypertonia
|
Hypertonia
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Nail disorder
|
Nail disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing, 1-10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
Neuritis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuritis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Neuropathy peripheral
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
Night blindness
|
Night blindness
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Decreased night vision
|
postmarketing, 1%
|
|
|
x
|
x
|
x
|
x
|
x
|
Otitis externa
|
Otitis externa
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Optic neuritis
|
Papilloedema
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Papilloedema
|
Papilloedema
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Paronychia
|
Paronychia
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Penis disorder
|
Penis disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, 10-50%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Benign intracranial hypertension
|
Benign intracranial hypertension
|
postmarketing, 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
Psoriasis flare-up
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Purpura
|
Purpura
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin mass
|
Skin nodule
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Ulcerative stomatitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Sunburn
|
Sunburn
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Photosensitivity reaction
|
Sunburn
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Photosensitivity reaction
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Photosensitivity
|
|
|
|
x
|
|
|
|
|
Sweat gland disorder
|
Sweat gland disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Tendonitis
|
Tendonitis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Thirst
|
Thirst
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Embolism
|
Thromboembolism
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Embolism venous
|
Thromboembolism
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Tongue disorder
|
Tongue disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Vulvovaginitis
|
Vulvovaginitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Skin papilloma
|
Common wart
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Xerophthalmia
|
Xerophthalmia
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Self injurious behaviour
|
Self injurious behaviour
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Intentional self-injury
|
Self injurious behaviour
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Pyogenic granuloma
|
Pyogenic granuloma
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Migraine
|
Migraine
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Alcohol intolerance
|
Alcohol intolerance
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin atrophy
|
Skin atrophy
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin thinness
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
Bleeding time prolonged
|
Bleeding time prolonged
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Hair colour changes
|
Hair discoloration
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Impaired healing
|
Impaired healing
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin hypertrophy
|
Skin hypertrophy
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Intracranial pressure increased
|
Intracranial pressure increased
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin irritation
|
Skin irritation
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Acute myocardial infarction
|
Acute myocardial infarction
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Skin fissures
|
Skin fissures
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Atrophic vulvovaginitis
|
Vaginitis atrophic
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Proctalgia
|
Rectal tenesmus
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Rectal tenesmus
|
Rectal tenesmus
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Anorectal discomfort
|
Rectal tenesmus
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Skin odour abnormal
|
Skin odour abnormal
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Tongue ulceration
|
Tongue ulceration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Urine abnormality
|
Urine abnormality
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Urine analysis abnormal
|
Urine abnormality
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Saliva altered
|
Saliva altered
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Hair texture abnormal
|
Hair texture abnormal
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Bullous eruption
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Dermatitis psoriasiform
|
Dermatitis psoriasiform
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Bursitis
|
Olecranon bursitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Madarosis
|
Madarosis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Eyebrow loss of
|
|
|
|
x
|
|
|
|
|
Cerumen impaction
|
Ceruminosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Adenocarcinoma pancreas
|
Adenocarcinoma pancreas
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Capillary leak syndrome
|
Capillary leak syndrome
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing, 1- 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cold sweat
|
Sticky skin
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sticky skin
|
Sticky skin
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Suicidal ideation
|
Suicidal ideation
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Chills
|
Rigors
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Laboratory test abnormal
|
Laboratory test abnormal
|
postmarketing
|
|
|
|
|
x
|
x
|
|
Skin fragility
|
Skin fragility
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Monocyte count decreased
|
Monocyte count decreased
|
postmarketing
|
|
|
|
|
|
|
x
|
Gait disturbance
|
Gait disturbance
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Blood sodium increased
|
Sodium high
|
postmarketing
|
|
|
|
|
|
|
x
|
Menopausal symptoms
|
Hot flush
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Lung neoplasm malignant
|
Carcinoma of lung
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Acne
|
Acne
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
White blood cell count increased
|
White blood cell count increased
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 1-10%
|
|
|
x
|
x
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Ageusia
|
Ageusia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Congenital anomaly
|
Congenital anomaly
|
|
|
|
|
x
|
|
|
|
Developmental delay
|
Congenital anomaly
|
|
|
|
|
x
|
|
|
|
Alcoholism
|
Alcoholism
|
|
|
x
|
|
|
|
|
|
Alcohol abuse
|
Alcoholism
|
|
|
x
|
|
|
|
|
|
Balanoposthitis
|
Balanoposthitis
|
|
|
|
|
x
|
|
|
|
Pancytopenia
|
Cytopenia
|
|
|
|
x
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
x
|
|
|
|
|
|
Diabetic
|
|
|
|
x
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
|
|
|
|
|
Hordeolum
|
Hordeolum
|
|
|
|
x
|
x
|
|
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
|
|
|
x
|
|
|
|
|
Hypervitaminosis A
|
Hypervitaminosis A
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Iritis
|
Iritis
|
|
|
|
x
|
|
|
|
|
Muscle spasms
|
Cramps of lower extremities
|
|
|
|
|
x
|
|
|
|
Obesity
|
Obesity
|
|
|
x
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
|
|
|
x
|
x
|
|
|
|
Retinal haemorrhage
|
Retinal haemorrhage
|
|
|
|
x
|
|
|
|
|
Scotoma
|
Scotoma
|
|
|
|
x
|
|
|
|
|
Erythema
|
Erythema
|
|
|
x
|
x
|
x
|
|
|
|
Redness
|
|
|
|
x
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
x
|
|
|
|
|
Vasculitis
|
Vasculitis
|
|
|
|
|
x
|
|
|
|
Vomiting
|
Vomiting
|
|
|
x
|
|
|
|
|
|
Weight decreased
|
Weight decreased
|
|
|
|
x
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
|
|
x
|
|
|
|
|
|
Cataract
|
Cataract
|
|
|
|
|
x
|
|
|
|
High density lipoprotein decreased
|
High density lipoprotein decreased
|
|
|
|
|
x
|
|
|
|
Bone pain
|
Bone pain
|
|
|
x
|
|
x
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
x
|
|
|
|
Drug tolerance decreased
|
Decreased tolerance
|
|
|
|
x
|
|
|
|
|
Scab
|
Scab
|
|
|
|
x
|
|
|
|
|
Visual acuity reduced
|
Visual acuity reduced
|
|
|
|
x
|
|
|
|
|
Eye irritation
|
Eye irritation
|
|
|
|
x
|
|
|
|
|
Visual impairment
|
Visual disturbance
|
|
|
x
|
|
|
|
|
|
Lip dry
|
Lip dry
|
|
|
|
x
|
x
|
|
|
|
Febrile neutropenia
|
Febrile neutropenia
|
|
|
|
x
|
|
|
|
|
Hepatitis F
|
Hepatitis F
|
|
|
|
|
x
|
|
|
|
Cataract subcapsular
|
Posterior subcapsular cataract
|
|
|
|
x
|
|
|
|
|
Liver function test abnormal
|
Raised liver function tests
|
|
|
|
x
|
|
|
|
|