65/100 · Elevated
Manufactured by Almatica Pharma LLC
Moderate Safety Concerns with Nitrofurantoin Macrocrystals
7,153 FDA adverse event reports analyzed
Last updated: 2026-05-12
NITROFURANTOIN MACROCRYSTALS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Almatica Pharma LLC. Based on analysis of 7,153 FDA adverse event reports, NITROFURANTOIN MACROCRYSTALS has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for NITROFURANTOIN MACROCRYSTALS include URINARY TRACT INFECTION, DRUG HYPERSENSITIVITY, FATIGUE, NAUSEA, FALL. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NITROFURANTOIN MACROCRYSTALS.
Nitrofurantoin Macrocrystals has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 7,153 adverse event reports for this medication, which is primarily manufactured by Almatica Pharma Llc.
The most commonly reported adverse events include Urinary Tract Infection, Drug Hypersensitivity, Fatigue. Of classified reports, 64.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions including falls, pneumonia, and death.
Multiple gastrointestinal and neurological side effects are frequently reported. A significant number of reports involve drug hypersensitivity and allergic reactions.
Patients taking Nitrofurantoin Macrocrystals should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nitrofurantoin Macrocrystals can interact with other drugs, potentially affecting their efficacy. Warnings include monitoring for drug hypersensitivity and allergic reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nitrofurantoin Macrocrystals received a safety concern score of 65/100 (elevated concern). This is based on a 64.6% serious event ratio across 2,976 classified reports. The score accounts for 7,153 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 2,482, Male: 337, Unknown: 6. The most frequently reported age groups are age 58 (53 reports), age 60 (53 reports), age 73 (53 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,976 classified reports for NITROFURANTOIN MACROCRYSTALS:
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 Macrocrystals can interact with other drugs, potentially affecting their efficacy. Warnings include monitoring for drug hypersensitivity and allergic reactions.
If you are taking Nitrofurantoin Macrocrystals, here are important things to know. The most commonly reported side effects include urinary tract infection, drug hypersensitivity, fatigue, nausea, fall. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug dose omission issues. 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 the safety of Nitrofurantoin Macrocrystals, and healthcare providers should be vigilant about serious adverse events and drug interactions.
The FDA has received approximately 7,153 adverse event reports associated with Nitrofurantoin Macrocrystals. 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 Macrocrystals include Urinary Tract Infection, Drug Hypersensitivity, Fatigue, Nausea, Fall. By volume, the top reported reactions are: Urinary Tract Infection (356 reports), Drug Hypersensitivity (266 reports), Fatigue (229 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 Macrocrystals.
Out of 2,976 classified reports, 1,923 (64.6%) were classified as serious and 1,053 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 Macrocrystals break down by patient sex as follows: Female: 2,482, Male: 337, Unknown: 6. 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 Macrocrystals adverse events are: age 58: 53 reports, age 60: 53 reports, age 73: 53 reports, age 68: 52 reports, age 71: 51 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 Macrocrystals adverse event reports is Almatica Pharma Llc. 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 Macrocrystals include: Asthenia, Pain, Diarrhoea, Headache, Dyspnoea. 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 Macrocrystals 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 Macrocrystals has a safety concern score of 65 out of 100 (elevated 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. High incidence of serious reactions including falls, pneumonia, and death.
Key safety signals identified in Nitrofurantoin Macrocrystals's adverse event data include: Falls and pneumonia are notable serious adverse events.. Drug hypersensitivity and allergic reactions are common.. Death reports are a significant concern.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nitrofurantoin Macrocrystals can interact with other drugs, potentially affecting their efficacy. Warnings include monitoring for drug hypersensitivity and allergic reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nitrofurantoin Macrocrystals.
Patients should report any unusual symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug dose omission issues.
Nitrofurantoin Macrocrystals has 7,153 adverse event reports on file with the FDA. Multiple gastrointestinal and neurological side effects are frequently reported. The volume of reports for Nitrofurantoin Macrocrystals reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Nitrofurantoin Macrocrystals, and healthcare providers should be vigilant about serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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