Safety of nitrofurantoin

Rare but serious side effects are mainly pulmonary and hepatic reactions. These side effects seem to depend on prolonged treatment.

How frequent are side effects?

The French Committee on Drug Monitoring reported severe adverse effects, mainly pulmonary or hepatic, with a frequency of 1 case per about 25000 short-term prescriptions (<1 month). This frequency increased with treatment duration to 1 case per about 8000 long-term prescriptions (>1 month).

A survey led by the CDC estimated nearly identical incidence rates in emergency department visits triggered by nitrofurantoin and quinolone use (9.8 versus 9.2 visits per 10 000 outpatient prescriptions, respectively); the study aggregated data for short- and long-term nitrofurantoin therapy.

Patients with impaired kidney function

Though nitrofurantoin is contraindicated in patients with a creatinine clearance (CrCl) below 60 mL/min according to many product informations data supporting are nonexistent. In a recent study, the authors of an extensive literature search are calling for well-designed clinical trials in patients with various degrees of renal impairment and recommend using this drug in patients with a CrCl of 40 mL/min or higher until new information becomes available. See more details.

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