Nitrofurantoin Monohydrate/macrocrystal Side Effects

In clinical trials of Nitrofurantoin Capsules, USP (monohydrate/macrocrystals), the most frequent clinical adverse events that were reported as possibly or probably drug-related were nausea (8%), headache (6%), and flatulence (1.5%).

Additional clinical adverse events reported as possibly or probably drug-related occurred in less than 1% of patients studied and are listed below within each body system in order of decreasing frequency: Gastrointestinal: Diarrhea, dyspepsia, abdominal pain, constipation, emesis Neurologic: Dizziness, drowsiness, amblyopia Respiratory: Acute pulmonary hypersensitivity reaction (see WARNINGS) Allergic: Pruritus, urticaria Dermatologic: Alopecia Miscellaneous: Fever, chills, malaise The following additional clinical adverse events have been reported with the use of nitrofurantoin: Gastrointestinal: Sialadenitis, pancreatitis.

There have been sporadic reports of pseudomembranous colitis with the use of nitrofurantoin.

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment (see WARNINGS).

Neurologic: Peripheral neuropathy, which may become severe or irreversible, has occurred.

Fatalities have been reported.

Conditions such as renal impairment (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine), anemia, diabetes mellitus, electrolyte imbalance, vitamin B deficiency, and debilitating diseases may increase the possibility of peripheral neuropathy (see WARNINGS).

Asthenia, vertigo, and nystagmus also have been reported with the use of nitrofurantoin.

Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported rarely.

Bulging fontanels, as a sign of benign intracranial hypertension in infants, have been reported rarely.