Potential side effects of empagliflozin

Empagliflozin has already been tested in over many thousands of people with and without chronic kidney disease and is generally well-tolerated. It now has a licence from health regulators for use in certain types of people who have type 2 diabetes, and people with heart failure or chronic kidney disease (with or without diabetes). Nevertheless you may experience some symptoms when taking empagliflozin due to the way the drug works in the body.

For example, empagliflozin causes increased salt and water loss into the urine and some people report noticing a need to pass urine more often initially. Some have reported symptoms suggestive of dehydration, such as increased levels of thirst or feeling faint. Constipation can also happen as a result of dehydration. It may be necessary to change some of your other pills to compensate if these symptoms occur.

Empagliflozin also works by increasing sugar in the urine. This can occasionally cause pain on passing urine and/or increase the chance of fungal genital tract infections, like thrush. Such infections are usually easily treated with a cheap topical cream (occasionally it may require a course of antifungal pills). Urine infections have been reported and may require a course of antibiotics. If such treatment is ever needed, your GP or local research team will help diagnose and treat you. In uncommon circumstances, the urine infection may be severe and require treatment in hospital with antibiotics through a drip. In exceedingly very rare circumstances, such infections can become serious and spread to the area around the anus and genitals. Please contact your doctor immediately if you develop any symptoms of pain, tenderness, redness or swelling of the genital area.

Low blood sugar may also occur, almost exclusively in people with diabetes who are already taking insulin or certain diabetes pills (like gliclazide). Common low blood sugar symptoms include: sweating, shakiness, hunger, restlessness, slurred speech, and confusion. A sugary drink normally reverses the problem.

For people with diabetes, there is a risk of a condition called ketoacidosis. If you have had ketoacidosis in the last five years you cannot join the trial. Ketoacidosis is caused by a build up of ketones that occurs if there is too little insulin in the body. This can happen if the blood sugar is high but also even when your blood sugar is normal. The symptoms of ketoacidosis are non-specific, including feeling or being sick, tummy ache, and shortness of breath. Others may notice the smell of pear drops or nail varnish remover on your breath. Ketoacidosis is treated with insulin and fluid intake. Ketoacidosis can sometimes be life-threatening (if not appropriately treated) and may need hospital treatment with a drip and insulin. Ketoacidosis can rarely occur in people without diabetes, and is triggered by restricted food intake or severe dehydration. You are therefore instructed to stop your study pills if you are ever unable to eat (such as waiting for an operation in hospital) or generally unwell because of an acute illness. If you intermittently fast (such as for Ramadan) then please discuss this with your study team and follow local guidance.

If new information is learnt about empagliflozin during the trial, we will share it with you in a new leaflet.