85/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Nitrofurantoin Adverse Events: High Serious Reaction Rate
39,526 FDA adverse event reports analyzed
Last updated: 2026-05-12
NITROFURANTOIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 39,526 FDA adverse event reports, NITROFURANTOIN has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for NITROFURANTOIN include URINARY TRACT INFECTION, FATIGUE, NAUSEA, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NITROFURANTOIN.
Nitrofurantoin has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 39,526 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Urinary Tract Infection, Fatigue, Nausea. Of classified reports, 80.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nitrofurantoin reports include a high percentage of serious adverse events, particularly urinary tract infections and gastrointestinal issues.
The most common reactions are fatigue, nausea, and pain, but serious conditions like kidney injury and pneumonia are also reported. Reported reactions are diverse, with over 100 distinct reactions recorded, indicating a wide range of potential side effects. The majority of reports are from females, with a significant number of adverse events reported in older adults.
Patients taking Nitrofurantoin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nitrofurantoin can cause serious adverse events such as kidney injury and pneumonia. It is important to monitor patients, especially the elderly, for signs of these conditions and to avoid drug interactions, particularly with other antibiotics and an This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nitrofurantoin received a safety concern score of 85/100 (high concern). This is based on a 80.4% serious event ratio across 15,763 classified reports. The score accounts for 39,526 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 12,216, Male: 2,275, Unknown: 26. The most frequently reported age groups are age 53 (335 reports), age 69 (285 reports), age 61 (272 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 15,763 classified reports for NITROFURANTOIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Nitrofurantoin can cause serious adverse events such as kidney injury and pneumonia. It is important to monitor patients, especially the elderly, for signs of these conditions and to avoid drug interactions, particularly with other antibiotics and an
If you are taking Nitrofurantoin, here are important things to know. The most commonly reported side effects include urinary tract infection, fatigue, nausea, headache, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of kidney injury and pneumonia, especially in elderly patients. Be aware of potential drug interactions, particularly with other antibiotics and anticoagulants. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Nitrofurantoin for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 39,526 adverse event reports associated with Nitrofurantoin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Nitrofurantoin include Urinary Tract Infection, Fatigue, Nausea, Headache, Pain. By volume, the top reported reactions are: Urinary Tract Infection (1,301 reports), Fatigue (1,240 reports), Nausea (1,186 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nitrofurantoin.
Out of 15,763 classified reports, 12,680 (80.4%) were classified as serious and 3,083 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Nitrofurantoin break down by patient sex as follows: Female: 12,216, Male: 2,275, Unknown: 26. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Nitrofurantoin adverse events are: age 53: 335 reports, age 69: 285 reports, age 61: 272 reports, age 73: 270 reports, age 75: 270 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Nitrofurantoin adverse event reports is Ani Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Nitrofurantoin include: Dyspnoea, Diarrhoea, Rash, Malaise, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Nitrofurantoin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Nitrofurantoin has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Nitrofurantoin reports include a high percentage of serious adverse events, particularly urinary tract infections and gastrointestinal issues.
Key safety signals identified in Nitrofurantoin's adverse event data include: High percentage of serious adverse events (80.4%). Multiple reports of kidney injury and pneumonia. Diverse range of reactions including neurological and cardiovascular issues. Significant number of reports involving falls and confusion in elderly patients. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nitrofurantoin can cause serious adverse events such as kidney injury and pneumonia. It is important to monitor patients, especially the elderly, for signs of these conditions and to avoid drug interactions, particularly with other antibiotics and an Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nitrofurantoin.
Monitor for signs of kidney injury and pneumonia, especially in elderly patients. Be aware of potential drug interactions, particularly with other antibiotics and anticoagulants.
Nitrofurantoin has 39,526 adverse event reports on file with the FDA. The most common reactions are fatigue, nausea, and pain, but serious conditions like kidney injury and pneumonia are also reported. The volume of reports for Nitrofurantoin reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Nitrofurantoin for safety. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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