Nitrofurantoin MHRA drug safety updates

Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions

MHRA Drug Safety Update April 2023

Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation. 

Advice for healthcare professionals:

• Advise patients and caregivers to be vigilant for new or worsening respiratory symptoms while taking nitrofurantoin and promptly investigate any symptoms that may indicate a pulmonary adverse reaction
• Pulmonary reactions may occur with short- or long-term use of nitrofurantoin, and increased vigilance for acute pulmonary reactions is required in the first week of treatment
• Patients receiving long-term therapy, for example for recurrent urinary tract infections, should be closely monitored for new or worsening respiratory symptoms, especially if elderly
• Immediately discontinue nitrofurantoin if new or worsening symptoms of pulmonary damage occur
• Be vigilant for symptoms and signs of liver dysfunction in patients taking nitrofurantoin for any duration, but particularly with long-term use, and monitor patients periodically for signs of hepatitis and for changes in biochemical tests that would indicate hepatitis or liver injury
• Use caution when prescribing nitrofurantoin in patients with pulmonary disease or hepatic dysfunction, which may mask the signs and symptoms of adverse reactions
• Advise patients to read carefully the advice in the Patient Information Leaflet about symptoms of possible pulmonary and hepatic reactions and to seek medical advice if they experience these symptoms
• Report suspected adverse drug reactions (ADRs) to the Yellow Card scheme

Advice for healthcare professionals to give to patients and caregivers:

• Nitrofurantoin is an effective antibiotic used to prevent and treat infections of the bladder, kidney, and other parts of the urinary tract, but it has been linked to side effects affecting the lungs and liver
• If you are taking nitrofurantoin, seek medical advice if you experience trouble breathing, shortness of breath, a lingering cough, coughing up blood or mucus, or pain or discomfort when breathing. These may be symptoms of a side effect affecting the lungs
• Talk to your doctor or another healthcare professional promptly if you develop yellowing of the skin or eyes, upper right abdominal pain, dark urine and pale or grey-coloured stools, itching or joint pain and swelling. These may be symptoms of a side effect affecting the liver.

Nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m2

MHRA Drug Safety Update February 2015

Advice for healthcare professionals:

• Nitrofurantoin is contraindicated in patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m².
• Nitrofurantoin should not be used to treat sepsis syndrome secondary to urinary tract infection or suspected upper urinary tract infections
• Check renal function when choosing to treat with nitrofurantoin, especially in the elderly.
• Closely monitor for signs of pulmonary, hepatic, neurological, haematological, and gastrointestinal side effects during treatment