Selected adverse drug reactions are listed in the table as follows by System Organ Class (SOC). The adverse reactions listed may also be associated with the underlying disease and/or concomitant medications. (See Table 2.)
![](https://mpfshstrg.blob.core.windows.net/mpf-uat-common-resources/Images/monograph/table.gif)
The following adverse drug reactions were reported during Post-Marketing Surveillance: Immune system disorders: Uncommon: Hypersensitivity; Rare: Angioedema, allergic reaction.
Nervous system disorders: Very Common: Headache; Uncommon: Loss of consciousness, mental impairment.
Eye disorders: Rare: Keratitis.
Cardiac disorders: Rare: Congestive heart failure.
Respiratory, thoracic and mediastinal disorders: Rare: Pulmonary oedema.
Gastrointestinal disorders: Common: Nausea, diarrhoea; Rare: Swollen tongue.
Skin and subcutaneous tissue disorders: Uncommon: Face swelling, pruritus.
Renal and urinary disorders: Rare: Urinary retention.
Reproductive system and breast disorders: Rare: Gynaecomastia.
General disorders and administration site conditions: Uncommon: Malaise.
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