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
|
Muscle spasms
|
Cramp muscle
|
66%
|
10%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscle spasms
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Discomfort
|
Discomfort
|
66%
|
10%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
postmarketing, 1% - 28%
|
1% - 8%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
19%
|
9%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal pain
|
Throat sore
|
19%
|
9%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Eructation
|
Eructation
|
postmarketing, 16%
|
15%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 11% - 23%
|
1% - 11%
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal distension
|
Abdominal bloating
|
12%
|
2%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Enlargement abdomen
|
postmarketing, 2% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Abdominal distension
|
postmarketing, 1.3%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
Flatulence
|
Abdominal bloating
|
12%
|
2%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Flatulence
|
postmarketing — 0.7% - 50%
|
2% - 30%
|
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Haemorrhoids
|
Haemorrhoids
|
postmarketing, 11%
|
0%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Pharyngitis
|
Pharyngitis
|
postmarketing, 11% - 22%
|
9% - 15%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Asthenia
|
postmarketing, 1% - 20%
|
4% - 16%
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
postmarketing, 1% - 28%
|
8%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Back pain
|
Back pain
|
postmarketing, 1.2% - 21%
|
1% - 11%
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Back distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervousness
|
Nervousness
|
postmarketing, 6%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing, 6%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
very rare — 1.1% - 17%
|
1% - 9%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
very rare — 1.1% - 17%
|
1% - 9%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
very rare — 3% - 8%
|
1% - 5%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Back distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Constipation
|
Constipation
|
postmarketing, 4% - 13%
|
1% - 13%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 0% - 26%
|
0% - 13%
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug fever
|
very rare, postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
Headache
|
Headache
|
postmarketing — 2% - 53%
|
0.559% - 49%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Hypertonia
|
Hypertonia
|
postmarketing, 4% - 5%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinitis
|
Rhinitis
|
postmarketing, 5% - 43%
|
5% - 36%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Tenderness
|
Tenderness
|
5%
|
3%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysuria
|
Micturition burning
|
5%
|
4%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysuria
|
postmarketing, 1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
1.4% - 15%
|
3%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rhinorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anorectal disorder
|
Rectal disorder
|
1% - 7%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Anorectal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Influenza like illness
|
Influenza like illness
|
postmarketing, 4%
|
4%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Colitis ulcerative
|
Colitis ulcerative
|
uncommon, 0.8% - 12%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Proctocolitis
|
Colitis ulcerative
|
uncommon, 0.8% - 12%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 0% - 40%
|
5% - 49%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Proctalgia
|
Rectal tenesmus
|
postmarketing, 6% - 7%
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Proctalgia
|
postmarketing, 1.8% - 10%
|
0% - 3%
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Rectal tenesmus
|
Rectal tenesmus
|
postmarketing, 6% - 7%
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Anorectal discomfort
|
Rectal tenesmus
|
postmarketing, 6% - 7%
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Anal discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anorectal discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Discomfort rectal
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 1.5% - 66%
|
10% - 44%
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal cramps
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 1.5% - 66%
|
10% - 44%
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Chest pain
|
Chest pain
|
postmarketing — 3% - 8%
|
2% - 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Colitis
|
Colitis
|
1.2% - 10%
|
0% - 8%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pancolitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
postmarketing — 0.7% - 15%
|
2.4% - 8%
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
postmarketing, 1% - 5%
|
2% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza
|
Influenza
|
0% - 14%
|
2% - 20%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 1.3% - 47%
|
3% - 15%
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
postmarketing, 0% - 7%
|
3% - 6%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
postmarketing, 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Hyperhidrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Chills
|
Chills
|
postmarketing, 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
postmarketing, 3% - 5%
|
2% - 11%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
very rare — 3% - 8%
|
1% - 5%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
2% - 3%
|
0%
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
x
|
|
|
Lipase increased
|
Lipase increased
|
0% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
0.565% - 2.3%
|
1.12%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety
|
Anxiety
|
postmarketing, 2% - 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Arthritis
|
Arthritis
|
postmarketing, 1% - 2%
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rheumatoid arthritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bronchitis
|
Bronchitis
|
postmarketing, 2% - 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing, 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 1% - 28%
|
8%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Arthropathy
|
Arthropathy
|
postmarketing, 2% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
postmarketing, 2% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing — 0.565% - 10%
|
0% - 7%
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing, 1% - 28%
|
1% - 8%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
postmarketing, 1% - 28%
|
1% - 8%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Confusional state
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, 1% - 28%
|
1% - 8%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Cough
|
Cough increased
|
0.7% - 12%
|
1% - 16%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cough
|
very rare — 0% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Acne
|
Acne
|
1.2% - 3.5%
|
0% - 1%
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
Insomnia
|
Insomnia
|
postmarketing, 1% - 5%
|
0% - 5%
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
Dyspepsia
|
Dyspepsia
|
rare, 0.8% - 9%
|
1% - 9%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — 1% - 23%
|
0% - 4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 1% - 23%
|
0% - 4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amblyopia
|
Amblyopia
|
1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimal disorder
|
Lacrimal disorder
|
1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimal structural disorder
|
Lacrimal disorder
|
1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prostatic disorder
|
Prostatic disorder
|
1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vomiting
|
Vomiting
|
postmarketing — 0.6% - 6%
|
2% - 7%
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
postmarketing, 1.2% - 5%
|
3%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Asthma
|
Asthma
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exacerbation of asthma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Cystitis
|
Cystitis
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bladder pain
|
Cystitis
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cystitis noninfective
|
Cystitis
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Vaginal inflammation
|
Vaginal inflammation
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal infection
|
Vaginal inflammation
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0.565% - 1.12%
|
0%
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Drug ineffective
|
Drug ineffective
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Crohn's disease
|
Crohns disease aggravated
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Agranulocytosis
|
Agranulocytosis
|
very rare, postmarketing
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
very rare — 0% - 7%
|
0%
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
Alopecia reversible
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alveolitis allergic
|
Alveolitis allergic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia
|
Anaemia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
Decreased appetite
|
Anorexia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast feeding
|
Breast feeding
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Neck pain
|
Neck pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cholecystitis
|
Cholecystitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Coma
|
Coma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Infection
|
Infection
|
postmarketing, 3.2% - 9%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Depression
|
Depression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Ear disorder
|
Ear disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Ear pain
|
Ear pain
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
Eating disorder
|
Eating disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Epididymitis
|
Epididymitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Erythema nodosum
|
Erythema nodosum
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cardiac flutter
|
Cardiac flutter
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gastritis
|
Gastritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing, 2% - 5%
|
1%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
Gastrointestinal symptom NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing, 8% - 10%
|
8%
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Glossodynia
|
Glossodynia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gout
|
Gout
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Guillain-Barre syndrome
|
Guillain-Barre syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
Haematochezia
|
Haematochezia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Haematuria
|
Haematuria
|
postmarketing, 0% - 3%
|
1%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Hepatitis
|
Hepatitis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Hepatitis toxic
|
Hepatitis toxic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hyperaesthesia
|
Hyperaesthesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypotension
|
Hypotension
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Nephropathy
|
Nephropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
Renal failure chronic
|
Renal failure chronic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
Leukopenia
|
Leukopenia
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Liver disorder
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatic impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatocellular injury
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatocellular injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Foetor hepaticus
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Malabsorption
|
Malabsorption
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Menorrhagia
|
Menorrhagia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Myelitis transverse
|
Myelitis transverse
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Myocarditis
|
Myocarditis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chronic interstitial nephritis
|
very rare
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Glomerulonephritis minimal lesion
|
Lipoid nephrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Azoospermia
|
Oligospermia
|
very rare, postmarketing
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing, 0% - 5%
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Peptic ulcer perforation
|
Peptic ulcer perforation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Pericardial effusion
|
Pericardial effusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Pericarditis
|
Pericarditis
|
postmarketing, rare
|
0%
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pericarditis constrictive
|
Pericarditis constrictive
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
Neuropathy
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Pleurisy
|
Pleurisy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Pneumonia aspiration
|
Pneumonia aspiration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anal pruritus
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pruritus genital
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Psoriasis
|
Psoriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Pulmonary eosinophilia
|
Pulmonary eosinophilia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Pyoderma
|
Pyoderma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis infected
|
Pyoderma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal failure
|
Renal failure
|
very rare, postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Reye's syndrome
|
Reye's syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Steatorrhoea
|
Steatorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stomatitis
|
Stomatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Thrombosis
|
Thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Tremor
|
Tremor
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Pollakiuria
|
Pollakiuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Urticaria
|
Urticaria
|
postmarketing — 0% - 2%
|
1%
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vasodilation procedure
|
Vasodilation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Weight decreased
|
Weight decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
Dry mouth
|
Dry mouth
|
postmarketing, 1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Acute febrile neutrophilic dermatosis
|
Acute febrile neutrophilic dermatosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Micturition urgency
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Burning sensation
|
Burning sensation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mood swings
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Affect lability
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Rash pustular
|
Rash pustular
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pyoderma gangrenosum
|
Pyoderma gangrenosum
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
Mouth ulceration
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Migraine
|
Migraine
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Diarrhoea haemorrhagic
|
Diarrhoea haemorrhagic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Tongue discolouration
|
Tongue discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tongue disorder
|
Tongue oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tongue oedema
|
Tongue oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Kidney fibrosis
|
Kidney fibrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Liver injury
|
Hepatocellular injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Hepatic necrosis
|
Hepatic necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Skin necrosis
|
Skin necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Skin exfoliation
|
Skin necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eye pain
|
Eye pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Skin discolouration
|
Skin discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dry skin
|
Dry skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Interstitial lung disease
|
Interstitial pneumonia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
Interstitial lung disease
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Lung fibrosis interstitial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Rectal discharge
|
Rectal discharge
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Increased appetite
|
Increased appetite
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Upset stomach
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Rash erythematous
|
Rash erythematous
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
Faeces discoloured
|
Faeces discoloured
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Condition aggravated
|
Condition aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Dyschezia
|
Dyschezia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Frequent bowel movements
|
Frequent bowel movements
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Mucous stools
|
Mucous stools
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing, 2% - 4%
|
5%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye swelling
|
Eye swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Bilirubin total increased
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Defaecation urgency
|
Defaecation urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
Musculoskeletal stiffness
|
Stiffness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Rash generalised
|
Rash generalised
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Chromaturia
|
Chromaturia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urine color abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Ear congestion
|
Ear congestion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine abnormal
|
Blood creatinine abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Rectal spasm
|
Rectal cramps
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lupus-like syndrome
|
Lupus-like syndrome
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
Medication residue present
|
Medication residue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lichenoid keratosis
|
Lichenoid keratosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Parosmia
|
Parosmia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eosinophilic pneumonia
|
Eosinophilic pneumonia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
postmarketing, 0% - 2%
|
3%
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Feeling hot
|
Feeling hot
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dyspnoea
|
Dyspnoea
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
Blood disorder
|
Blood disorder
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Neutropenia
|
Neutropenia
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
|
x
|
|
|
|
|
x
|
|
|
Lung infiltration
|
Lung infiltration
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
Pancreatitis acute
|
Pancreatitis acute
|
very rare
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
very rare
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
Cholestasis
|
Cholestasis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
very rare
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
Lung disorder
|
Lung disorder
|
very rare, 0% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Nephrotic syndrome
|
Nephrotic syndrome
|
very rare
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Pancytopenia
|
Pancytopenia
|
very rare
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Bone marrow depression
|
very rare
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Systemic lupus erythematosus
|
Lupus erythematosus
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Systemic lupus erythematosus
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Alveolitis
|
Alveolitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Allergic exanthema
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dermatitis atopic
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Adenovirus infection
|
Adenovirus infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Albuminuria
|
Albuminuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Amenorrhoea
|
Amenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Blister
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Obliterative bronchiolitis
|
Obliterative bronchiolitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Candida infection
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholangitis sclerosing
|
Cholangitis sclerosing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cholelithiasis
|
Cholelithiasis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Deafness
|
Deafness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Duodenal ulcer
|
Duodenal ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Faecal incontinence
|
Faecal incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hirsutism
|
Hirsutism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypomenorrhoea
|
Hypomenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infertility
|
Infertility
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Intestinal obstruction
|
Intestinal obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lethargy
|
Lethargy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Lichen planus
|
Lichen planus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Breast pain
|
Breast pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Melaena
|
Melaena
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Metrorrhagia
|
Metrorrhagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Myelitis
|
Myelitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nail disorder
|
Nail disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Nephritis
|
Nephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Proteinuria
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Protein urine present
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prurigo
|
Prurigo
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Rectal polyp
|
Rectal polyp
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Scotoma
|
Scotoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shock
|
Shock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tachycardia
|
Tachycardia
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Micturition disorder
|
Micturition disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute interstitial pneumonitis
|
Hamman-Rich syndrome
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Idiopathic pulmonary fibrosis
|
Hamman-Rich syndrome
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Amylase increased
|
Amylase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
|
Serum amylase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Creatinine renal clearance decreased
|
Creatinine renal clearance decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Oesophageal ulcer
|
Oesophageal ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
|
|
Body mass index decreased
|
Body mass index decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal pain lower
|
Abdominal pain lower
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Blood creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Urine abnormality
|
Urine abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine analysis abnormal
|
Urine abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
Dry eye
|
Dry eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nephropathy toxic
|
Nephrotoxicity
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematocrit decreased
|
Haematocrit decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytosis
|
Thrombocytosis
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Administration site reaction
|
Administration site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sperm concentration decreased
|
Sperm count decreased
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Local reaction
|
Local reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
Blood methaemoglobin present
|
Blood methaemoglobin present
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pleuropericarditis
|
Pleuropericarditis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|