Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Pulmonary Reactions [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Neuropathy [see Warnings and Precautions (5.4)] Hemolytic anemia [see Warnings and Precautions (5.5)] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.6)] Persistence or Reappearance of Bacteriuria [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of nitrofurantoin formulations, including nitrofurantoin oral suspension, were identified in clinical studies or post-marketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory : chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred.
Chronic pulmonary reactions have occurred generally in patients who have received continuous treatment for six months or longer.
Malaise, dyspnea on exertion, cough, and altered pulmonary function are common manifestations which can occur insidiously.
Radiologic and histologic findings of diffuse interstitial pneumonitis or fibrosis, or both, are also common manifestations of the chronic pulmonary reaction.
Fever is prominent.
The severity of chronic pulmonary reactions and their degrees of resolution appear to be related to the duration of therapy after the first clinical signs appear.
Pulmonary function may be impaired permanently, even after cessation of therapy.
The risk is greater when chronic pulmonary reactions are not recognized early.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin.
If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin.
(5.1) Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures.
(5.2) Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur.
Monitor liver function tests.
Like all medications, Nitrofurantoin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: