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An event is serious (based on the ICH definition) when the patient outcome is:

  • * death

  • * life-threatening

  • * hospitalisation

  • * disability

  • * congenital anomaly

  • * other medically important event

A 43-year-old man developed end stage renal disease secondary to acute renal failure during treatment with omeprazole for epigastric pain, haematochezia and heartburn.

The man presented to hospital with haematochezia, heartburn and epigastric pain for which he had been receiving omeprazole [route and dosage not stated]. Examination revealed decreased breath sounds and wheezes. He was admitted. His creatinine level was 11.2 mg/dL and urea level was 200 mg/dL.

The man started receiving haemodialysis. His medical history included hypertension, non-adherence to unspecified anti-hypertensive medicines, alcohol abuse, chronic smoking and past hospitalisation (4 months prior to presentation) due to haemoptysis, high BP, microhaematuria, hypokalaemia, proteinuria and creatinine elevation. Fundus examination showed high grade retinopathy with cotton wool spots and flame haemorrhages. Laboratory findings revealed supine renin level of 41.37 microunits/mL and aldosterone level of 30 ng/dL. His renal function showed no improvement. Kidney biopsy revealed advanced benign nephrosclerosis with FSGS, marked interstitial inflammation with eosinophils and a single crescent. Acute interstitial nephritis (acute renal failure) triggered by omeprazole on the background of advanced ischaemic nephropathy, which eventually led to permanent renal failure was considered [duration of treatment to reaction onset not stated].