Whenever possible, frequency information about the side effects was extracted from the labels. Aggregated frequency information for the drug and, if available, placebo is shown. To the right, you can click on shaded boxes to be taken to mentions of the side effect on the label. (In some cases, the side effect cannot be highlighted due to conversion problems.)
Information about indications was extracted from the indications and usage sections of the labels.
|
MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
(show all 60)
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
|
Headache def
|
Headache def
|
frequent, 24%
|
17%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea def
|
Nausea def
|
0% - 21%
|
0% - 14%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth def
|
Dry mouth def
|
1% - 20%
|
1% - 14%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence def
|
Somnolence def
|
1% - 18%
|
1% - 10%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ejaculation disorder def
|
Ejaculation disorder def
|
1% - 14%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal ejaculation
|
6.1%
|
1%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Hyperhidrosis def
|
Sweating def
|
rare, 4% - 11%
|
1% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sweating increased
|
4% - 11%
|
1% - 9%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea def
|
Diarrhoea def
|
5% - 8%
|
5% - 6%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tremor def
|
Tremor def
|
postmarketing — 6% - 8%
|
6%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tremulousness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Libido decreased def
|
Libido decreased def
|
1% - 7%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido decreased def
|
1% - 7%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anorgasmia def
|
Anorgasmia def
|
2% - 6%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain def
|
Abdominal cramps def
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Abdominal pain def
|
2% - 3%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amenorrhoea def
|
Amenorrhoea def
|
infrequent, frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amnesia def
|
Amnesia def
|
postmarketing — frequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia def
|
Arthralgia def
|
infrequent — 1% - 2%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia def
|
infrequent — 1% - 2%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia def
|
infrequent — 1% - 2%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back distress
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis def
|
Bronchitis def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain def
|
Chest pain def
|
postmarketing — frequent
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state def
|
Confusional state def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Feeling abnormal
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Constipation def
|
Constipation def
|
3% - 5%
|
1% - 4%
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough def
|
Cough def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness def
|
Dizziness def
|
frequent, 1% - 5%
|
1% - 3%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia def
|
Dysgeusia def
|
infrequent, frequent
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
Taste metallic
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea def
|
Dysmenorrhoea def
|
frequent, 2% - 3%
|
2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Dyspepsia def
|
Dyspepsia def
|
infrequent, 3% - 5%
|
1% - 4%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Heartburn def
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ear pain def
|
Ear pain def
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis def
|
Rash def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash def
|
Rash def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased def
|
Body temperature increased def
|
frequent, 1% - 2%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence def
|
Flatulence def
|
frequent, 2%
|
1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gas def
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal bloating def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Flushing def
|
Flushing def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis def
|
Gastroenteritis def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease def
|
Gastrooesophageal reflux disease def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity def
|
Hypersensitivity def
|
postmarketing — frequent
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension def
|
Hypertension def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension worsened
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypertensive
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypotension def
|
Hypotension def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orthostatic hypotension def
|
Orthostatic hypotension def
|
postmarketing, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection def
|
Infection def
|
rare — 4% - 5%
|
4%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza def
|
Influenza def
|
infrequent — 5%
|
4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lethargy def
|
Lethargy def
|
frequent, 3%
|
1%
|
|
|
x
|
|
|
|
|
|
|
|
|
Menstrual disorder def
|
Menstrual disorder def
|
infrequent — 2%
|
1%
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Muscle spasms def
|
Cramp muscle def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramps of lower extremities
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasal congestion def
|
Nasal congestion def
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Orgasm abnormal def
|
Orgasm abnormal def
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain def
|
Pain def
|
rare — 2% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ache def
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity def
|
Pain in extremity def
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Leg pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Palpitations def
|
Palpitations def
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia def
|
Paraesthesia def
|
frequent, 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyuria def
|
Polyuria def
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urine output increased
|
Polyuria def
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus def
|
Pruritus def
|
rare — frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection def
|
Respiratory tract infection def
|
4% - 5%
|
4%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Rhinitis def
|
Rhinitis def
|
3% - 5%
|
3% - 4%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal pain def
|
Shoulder pain def
|
frequent, 3%
|
1%
|
|
|
x
|
|
|
|
|
|
|
|
|
Salivary hypersecretion def
|
Salivary hypersecretion def
|
infrequent, frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinus headache
|
Sinus headache
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Tachycardia def
|
Tachycardia def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinnitus def
|
Tinnitus def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toothache def
|
Toothache def
|
infrequent — 2%
|
0%
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Upper respiratory tract infection def
|
Upper respiratory tract infection def
|
4% - 5%
|
4%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Pollakiuria def
|
Pollakiuria def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition urgency def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract infection def
|
Urinary tract infection def
|
infrequent, frequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Vertigo def
|
Vertigo def
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting def
|
Vomiting def
|
frequent, 0% - 4%
|
0% - 3%
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Weight increased def
|
Weight increased def
|
frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased def
|
Weight decreased def
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Yawning def
|
Yawning def
|
frequent, 1% - 2%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Apathy def
|
Apathy def
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flat affect
|
Apathy def
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Migraine def
|
Migraine def
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Migraine aggravated
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sinus congestion
|
Sinus congestion
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Accommodation disorder
|
Accommodation disorder
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Myalgia def
|
Myalgia def
|
infrequent — 1% - 2%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
Increased appetite
|
frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Decreased appetite
|
frequent, 3%
|
1%
|
|
|
x
|
|
|
|
|
|
|
|
|
Anorexia def
|
2% - 4%
|
2%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
frequent, 3%
|
2%
|
x
|
|
x
|
|
|
|
|
|
|
x
|
|
Depression def
|
Depression aggravated
|
postmarketing — frequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vision blurred def
|
Vision blurred def
|
frequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Sexual dysfunction
|
Sexual dysfunction
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menopausal symptoms def
|
Hot flush def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hot flush def
|
Hot flush def
|
infrequent, frequent
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Sleep disorder def
|
Sleep disorder def
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Female sexual dysfunction
|
Female sexual dysfunction
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety def
|
Anxiety def
|
postmarketing — 3% - 4%
|
3%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety attack
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal pain def
|
Abdominal pain def
|
2% - 3%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis def
|
Sinusitis def
|
1% - 3%
|
1% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erectile dysfunction def
|
Erectile dysfunction def
|
postmarketing, 1% - 3%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abscess def
|
Abscess def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Aggression def
|
Aggression def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aggressive reaction
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia def
|
Alopecia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock def
|
Anaphylactic shock def
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Anaemia def
|
Anaemia def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris def
|
Angina pectoris def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia def
|
Arrhythmia def
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthritis def
|
Arthritis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rheumatoid arthritis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Asthenia def
|
Asthenia def
|
postmarketing — 1%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weakness def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthma def
|
Asthma def
|
rare — infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ataxia def
|
Ataxia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast feeding def
|
Breast feeding def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bruxism def
|
Bruxism def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Carpal tunnel syndrome def
|
Carpal tunnel syndrome def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebrovascular disorder def
|
Cerebrovascular disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cholecystitis def
|
Cholecystitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cholelithiasis def
|
Cholelithiasis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Colitis def
|
Colitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Conjunctivitis def
|
Conjunctivitis def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion def
|
Convulsion def
|
postmarketing — infrequent
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Seizures def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cystitis def
|
Cystitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bladder pain def
|
Cystitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cystitis noninfective def
|
Cystitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysphagia def
|
Dysphagia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delusion def
|
Delusion def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depersonalisation def
|
Depersonalisation def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug abuse def
|
Drug abuse def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dyspnoea def
|
Dyspnoea def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysuria def
|
Dysuria def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eczema def
|
Eczema def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema def
|
Oedema def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis def
|
Epistaxis def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eructation def
|
Eructation def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oesophagitis def
|
Oesophagitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Extrapyramidal disorder def
|
Extrapyramidal disorder def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye infection def
|
Eye infection def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Folliculitis def
|
Folliculitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Furuncle def
|
Furunculosis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Retching def
|
Gagging def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis def
|
Gastritis def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder def
|
Gastrointestinal disorder def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingivitis def
|
Gingivitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gout def
|
Gout def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Hallucination def
|
Hallucination def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure def
|
Cardiac failure def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematoma def
|
Haematoma def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haematuria def
|
Haematuria def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood urine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhage def
|
Haemorrhage def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin def
|
Haemorrhage def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhoids def
|
Haemorrhoids def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes virus infection def
|
Herpes NOS def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Herpes simplex def
|
Herpes simplex def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypercholesterolaemia def
|
Hypercholesterolaemia def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hyperglycaemia def
|
Hyperglycaemia def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypertrophy def
|
Hypertrophy def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia def
|
Hypoaesthesia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Incontinence def
|
Incontinence def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased def
|
Libido increased def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infarction def
|
Infarction def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Inflammation def
|
Inflammation def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Ischaemia def
|
Ischaemia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthropathy def
|
Arthropathy def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Osteoarthritis def
|
Arthropathy def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysarthria def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Nephrolithiasis def
|
Calculus of kidney def
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laryngitis def
|
Laryngitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis def
|
Leukocytosis def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia def
|
Leukopenia def
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lipoma def
|
Lipoma def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain def
|
Breast pain def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menorrhagia def
|
Menorrhagia def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Prolonged menses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Metrorrhagia def
|
Metrorrhagia def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertonia def
|
Hypertonia def
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fungal infection def
|
Fungal infection def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Mydriasis def
|
Mydriasis def
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial infarction def
|
Myocardial infarction def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute coronary syndrome def
|
Myocardial infarction def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm def
|
Neoplasm def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervousness def
|
Nervousness def
|
postmarketing, infrequent
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling jittery
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Tension def
|
Nervousness def
|
postmarketing, infrequent
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuralgia def
|
Neuralgia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neurosis def
|
Neurosis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nightmare def
|
Nightmare def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nodule def
|
Nodule def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear infection def
|
Otitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Otitis media def
|
Otitis media def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Panic reaction def
|
Panic reaction def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Penis disorder def
|
Penis disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pneumonia def
|
Pneumonia def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Premenstrual syndrome def
|
Premenstrual syndrome def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Prostatic disorder def
|
Prostatic disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Psoriasis def
|
Psoriasis def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psychotic disorder def
|
Psychotic disorder def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paranoia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Purpura def
|
Purpura def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Idiopathic thrombocytopenic purpura def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Restless legs syndrome def
|
Restless legs syndrome def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Salpingitis def
|
Salpingitis def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin mass
|
Skin nodule def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Speech disorder def
|
Speech disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Stomatitis def
|
Stomatitis def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebrovascular accident def
|
Cerebrovascular accident def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Shock def
|
Syncope def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock def
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Syncope def
|
Syncope def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness def
|
Syncope def
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Testicular disorder def
|
Testicular disorder def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Thirst def
|
Thirst def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tic def
|
Tic def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Tracheitis
|
Tracheitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Unintended pregnancy def
|
Unintended pregnancy def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary incontinence def
|
Urinary incontinence def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urticaria def
|
Urticaria def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal inflammation def
|
Vaginal inflammation def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vaginal infection def
|
Vaginal inflammation def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Varicose vein def
|
Varicose vein def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Viral infection def
|
Viral infection def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Visual impairment def
|
Visual impairment def
|
infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Visual disturbance
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Visual acuity reduced
|
Visual impairment def
|
infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blindness def
|
Visual impairment def
|
infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Xerophthalmia def
|
Xerophthalmia def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary retention def
|
Urinary retention def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills def
|
Chills def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Rigors
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition urgency def
|
Micturition urgency def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Affect lability
|
Mood swings
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral def
|
Oedema peripheral def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Leg edema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypokinesia def
|
Hypokinesia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alcohol intolerance def
|
Alcohol intolerance def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial ischaemia def
|
Myocardial ischaemia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mania def
|
Manic psychosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Mania def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscular weakness def
|
Muscular weakness def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Bone pain def
|
Bone pain def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Eye pain def
|
Eye pain def
|
infrequent
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Paranoia def
|
Paranoid reaction
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paranoia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased def
|
Phosphatase alkaline increased
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperreflexia
|
Hyperreflexia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased def
|
Alanine aminotransferase increased def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin discolouration def
|
Skin discolouration def
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry skin def
|
Dry skin def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Joint stiffness def
|
Joint stiffness def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaw stiffness
|
infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Photosensitivity reaction def
|
Photosensitivity reaction def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Photosensitivity def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal stiffness
|
Muscle stiffness
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Stiffness
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Blood urine
|
Blood urine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urine present
|
Blood urine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise def
|
Malaise def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Discomfort def
|
Malaise def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Discomfort def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Ill-defined disorder
|
Malaise def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Muscle twitching def
|
Muscle twitching def
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest discomfort
|
Chest tightness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Abdominal discomfort
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thinking abnormal
|
Thinking abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Mental disability
|
Thinking abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Derealisation def
|
Derealisation def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hallucination, auditory
|
Hallucination, auditory
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Euphoric mood def
|
Euphoric mood def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation def
|
Excitability
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkinesia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Suicidal ideation def
|
Suicidal tendency
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Eye irritation
|
Eye irritation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Glucose tolerance impaired def
|
Glucose tolerance abnormal
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Gravitational oedema
|
Gravitational oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Peripheral ischaemia def
|
Peripheral ischaemia def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lymphadenopathy def
|
Lymphadenopathy cervical def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urine abnormality
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urine analysis abnormal
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Galactorrhoea
|
Galactorrhoea
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain def
|
Back distress
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain def
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Crying def
|
Crying abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pain in jaw
|
Pain in jaw
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastric polyps def
|
Gastric polyps def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Frequent bowel movements
|
Frequent bowel movements
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal dryness
|
Vaginal dryness def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pelvic inflammatory disease def
|
Pelvic inflammatory disease def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Major depression def
|
Depressive type psychosis
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Melancholia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Balance disorder
|
Dysequilibrium
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood bilirubin increased def
|
Blood bilirubin increased def
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Extrasystoles def
|
Extrasystoles def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dystonia def
|
Dystonia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia def
|
Hyperkinesia def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bradycardia def
|
Bradycardia def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tooth abscess
|
Tooth abscess
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Coordination abnormal
|
Coordination abnormal
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Food craving def
|
Carbohydrate craving
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Memory impairment def
|
Forgetfulness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling jittery
|
Feeling jittery
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Lip dry
|
Lip dry
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait disturbance def
|
Gait disturbance def
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood glucose abnormal
|
Blood glucose abnormal
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Acne def
|
Acne def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sluggishness
|
Sluggishness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension def
|
Abdominal bloating def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast neoplasm def
|
Breast neoplasm def
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Drug dependence def
|
Drug dependence def
|
infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphonia def
|
Dysphonia def
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Breast enlargement
|
Breast enlargement
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal haemorrhage def
|
Vaginal haemorrhage def
|
rare, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abortion spontaneous def
|
Abortion spontaneous def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ageusia def
|
Ageusia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Agranulocytosis def
|
Agranulocytosis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Aplastic anaemia def
|
Aplastic anaemia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Haemolytic anaemia def
|
Haemolytic anaemia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Hypochromic anaemia def
|
Hypochromic anaemia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Anger def
|
Anger def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Angioedema def
|
Angioedema def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Appendicitis def
|
Appendicitis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rheumatoid arthritis def
|
Rheumatoid arthritis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Atrial fibrillation def
|
Atrial fibrillation def
|
postmarketing, rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Bacterial infection def
|
Bacterial infection def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Mental disorder def
|
Mental disorder def
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coagulopathy def
|
Coagulopathy def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone disorder def
|
Bone disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Breast disorder def
|
Breast disorder def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Bronchospasm def
|
Bronchospasm def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bundle branch block def
|
Bundle branch block def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bursitis def
|
Bursitis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm malignant def
|
Neoplasm malignant def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Candidiasis def
|
Candidiasis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Catatonia def
|
Catatonia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cellulitis def
|
Cellulitis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Transient ischaemic attack def
|
Transient ischaemic attack def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Connective tissue disorder def
|
Connective tissue disorder def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Sudden death def
|
Sudden death def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dehydration def
|
Dehydration def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delirium def
|
Delirium def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Diabetes mellitus def
|
Diabetes mellitus def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Diplopia def
|
Diplopia def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Diverticulitis def
|
Diverticulitis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Duodenal ulcer def
|
Duodenal ulcer def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Dysarthria def
|
Dysarthria def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Dyskinesia def
|
Dyskinesia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Ecchymosis def
|
Ecchymosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Embolism def
|
Embolism def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Endocrine disorder def
|
Endocrine disorder def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hormone level abnormal
|
Endocrine disorder def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eosinophilia def
|
Eosinophilia def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Toxic epidermal necrolysis def
|
Toxic epidermal necrolysis def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Necrolysis epidermal
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Grand mal convulsion def
|
Grand mal convulsion def
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Tonic-clonic seizures def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Erythema multiforme def
|
Erythema multiforme def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Stevens-Johnson syndrome def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Congenital eye disorder def
|
Congenital eye disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Eye disorder def
|
Congenital eye disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Eye disorder def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Intra-uterine death def
|
Intra-uterine death def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Gastrointestinal haemorrhage def
|
Gastrointestinal haemorrhage def
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
Gingival bleeding def
|
Gingival bleeding def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glaucoma def
|
Glaucoma def
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
Glossitis def
|
Glossitis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Goitre def
|
Goitre def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gynaecomastia def
|
Gynaecomastia def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Seasonal allergy def
|
Seasonal allergy def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Rhinitis seasonal
|
Seasonal allergy def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Cardiac arrest def
|
Cardiac arrest def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder def
|
Cardiac disorder def
|
postmarketing, rare
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Hepatitis def
|
Hepatitis def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hiccups def
|
Hiccups def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hyperbilirubinaemia def
|
Hyperbilirubinaemia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperaesthesia def
|
Hyperaesthesia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperprolactinaemia def
|
Hyperprolactinaemia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Pulmonary hypertension def
|
Pulmonary hypertension def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypertensive crisis
|
Hypertensive crisis
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypertrichosis def
|
Hypertrichosis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia def
|
Hypoglycaemia def
|
postmarketing, rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia def
|
Hypokalaemia def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyponatraemia def
|
Hyponatraemia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Hypothyroidism def
|
Hypothyroidism def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Conversion disorder def
|
Hysteria def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Immune system disorder def
|
Immune system disorder def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Inappropriate antidiuretic hormone secretion def
|
Inappropriate antidiuretic hormone secretion def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Jaundice def
|
Jaundice def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Keratitis def
|
Keratitis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute def
|
Renal failure acute def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Lymphocytosis def
|
Lymphocytosis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphopenia def
|
Lymphopenia def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Mediastinal disorder def
|
Mediastinal disorder def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Melanosis def
|
Melanosis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myoclonus def
|
Myoclonus def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Necrosis def
|
Necrosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Nervous system disorder def
|
Nervous system disorder def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuroleptic malignant syndrome def
|
Neuroleptic malignant syndrome def
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Malignant syndrome NOS
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Nystagmus def
|
Nystagmus def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Obesity def
|
Obesity def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oliguria def
|
Oliguria def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteoporosis def
|
Osteoporosis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis def
|
Pancreatitis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancytopenia def
|
Pancytopenia def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Personality disorder def
|
Personality disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Phlebitis def
|
Phlebitis def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Supraventricular extrasystoles def
|
Supraventricular extrasystoles def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Priapism def
|
Priapism def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Eyelid ptosis def
|
Ptosis def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Uterovaginal prolapse
|
Ptosis def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anal pruritus def
|
Anal pruritus def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus genital
|
Anal pruritus def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anorectal discomfort
|
Anal pruritus def
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary embolism def
|
Pulmonary embolism def
|
postmarketing, rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pyelonephritis def
|
Pyelonephritis def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal failure def
|
Renal failure def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Respiratory disorder def
|
Respiratory disorder def
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhabdomyolysis def
|
Rhabdomyolysis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Stevens-Johnson syndrome def
|
Stevens-Johnson syndrome def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Gastric ulcer def
|
Gastric ulcer def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration def
|
Ulcerative stomatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Withdrawal syndrome def
|
Withdrawal syndrome def
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia def
|
Thrombocytopenia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombosis def
|
Thrombosis def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Tooth disorder def
|
Tooth disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Torsade de pointes def
|
Torsade de pointes def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ulcer def
|
Ulcer def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erythema def
|
Erythema def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urethral disorder def
|
Urinary tract disorder def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder def
|
Urinary tract disorder def
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Angiopathy def
|
Angiopathy def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Vasodilation procedure
|
Vasodilation def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Venous thrombosis def
|
Venous thrombosis def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ventricular tachycardia def
|
Ventricular tachycardia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Idiopathic thrombocytopenic purpura def
|
Idiopathic thrombocytopenic purpura def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Idiopathic thrombocytopenia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Choreoathetosis
|
Choreoathetosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic failure def
|
Hepatic failure def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ventricular arrhythmia def
|
Ventricular arrhythmia def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stupor def
|
Stupor def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressed level of consciousness def
|
Stupor def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Photophobia def
|
Photophobia def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cataract def
|
Cataract def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Deep vein thrombosis def
|
Deep vein thrombosis def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Drug level decreased
|
Drug level decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Drug level increased
|
Drug level increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hepatic necrosis def
|
Hepatic necrosis def
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Prothrombin level increased
|
Prothrombin level increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Electrocardiogram QT prolonged def
|
Electrocardiogram QT prolonged def
|
postmarketing
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Aspartate aminotransferase increased def
|
Aspartate aminotransferase increased def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tendon disorder
|
Tendon disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sensory disturbance def
|
Sensory disturbance def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
postmarketing, rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Menometrorrhagia
|
Menometrorrhagia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Hallucination, visual
|
Hallucination, visual
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Sputum increased
|
Sputum increased
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Increased bronchial secretion
|
Sputum increased
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Breast cancer female
|
Breast cancer female
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Crocodile tears syndrome
|
Crocodile tears syndrome
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypomania def
|
Hypomania def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
Sepsis def
|
Sepsis def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rectal haemorrhage def
|
Rectal haemorrhage def
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hepatobiliary disease def
|
Hepatobiliary disease def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Acute psychosis
|
Acute psychosis
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatitis fulminant
|
Hepatitis fulminant
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Akathisia def
|
Akathisia def
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Lacrimation increased def
|
Lacrimation def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Neuropathy peripheral def
|
Neuropathy def
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Neuropathy peripheral def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Face oedema def
|
Face oedema def
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypohidrosis def
|
Sweating decreased
|
rare
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Prothrombin level decreased
|
Prothrombin level decreased
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Renal pain
|
Renal pain
|
rare
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Prothrombin time shortened
|
Prothrombin time shortened
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tardive dyskinesia def
|
Tardive dyskinesia def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Aortic dissection def
|
Dissecting aortic aneurysm, thoracic
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Completed suicide
|
Completed suicide
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Arterial disorder def
|
Arterial disorder def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
International normalised ratio increased def
|
International normalised ratio increased def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thrombocytopenic purpura def
|
Thrombocytopenic purpura def
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Death
|
Death
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Coronary artery disease def
|
Coronary artery disease def
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiovascular disorder def
|
Cardiovascular disorder def
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Collagen disorder def
|
Collagen disorder def
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Coma def
|
Coma def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Riley-Day syndrome def
|
Riley-Day syndrome def
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Muscle rigidity def
|
Muscle rigidity def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal disorder def
|
Musculoskeletal disorder def
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Parity def
|
Parity def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngitis def
|
Pharyngitis def
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition disorder def
|
Micturition disorder def
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vestibular disorder def
|
Vestibular disorder def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blunted affect
|
Blunted affect
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Autonomic nervous system imbalance
|
Autonomic nervous system imbalance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Osteoarthropathy def
|
Osteoarthropathy def
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ejaculation failure
|
Ejaculation failure
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Drug interaction def
|
Drug interaction def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autonomic neuropathy def
|
Unspecified disorder of autonomic nervous system def
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
Hyperthermia def
|
Hyperthermia def
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indication
|
Labels
|
|
Agitation def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Anxiety def
|
|
|
x
|
|
|
|
|
|
|
|
|
Anxiety disorder def
|
|
|
x
|
|
|
|
|
|
|
|
|
Bradypsychic response
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Cerebration impaired def
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
|
Decreased interest
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Depressed mood def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Depressive disorder def
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressive episode
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Dysphoria
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Fatigue def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Feeling guilty def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Generalised anxiety disorder def
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypersomnia def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Insomnia def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Irritability def
|
|
|
x
|
|
|
|
|
|
|
|
|
Major depression def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Major depressive disorder, single episode
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Muscle tension
|
|
|
x
|
|
|
|
|
|
|
|
|
Sickness
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Sleep disturbance
|
|
|
x
|
|
|
|
|
|
|
|
|
Suicidal ideation def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Suicide def
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Suicide attempt def
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Tension def
|
|
|
x
|
|
|
|
|
|
|
|
|
Worry def
|
|
|
x
|
|
|
|
|
|
|
|