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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug overdose
* Drug interaction
In a retrospective analysis of 86 patients who reported adverse drug reactions (ADRs) between January 2012 and December 2016, 12 patients [6 men and 6 women] aged 31−85 years1 were described [not all ages stated], who developed nausea, vomiting, xanthopsia, atrioventricular block, gynaecomastia, haematuria, frequent urination, dysuria, cardiorespiratory arrest, anaphylactic shock, epileptic seizures, facial redness and swelling, lip and pharyngeal cavity ulcers, partial erosion of the scrotum, abdominal distension, loss of finger nails, numbness in limbs, sensory dullness, hard-knotted blisters on hands, abnormal liver function or gastrointestinal bleeding during treatment with digoxin, spironolactone, clopidogrel, warfarin,...