NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

N/A

Manufactured by Aurobindo Pharma Limited

40,073 FDA adverse event reports analyzed

Last updated: 2026-04-14

About NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. The most commonly reported adverse reactions for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 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 (MONOHYDRATE/MACROCRYSTALS).

Top Adverse Reactions

URINARY TRACT INFECTION1,308 reports
FATIGUE1,254 reports
NAUSEA1,210 reports
HEADACHE1,120 reports
PAIN977 reports
DYSPNOEA976 reports
DIARRHOEA893 reports
RASH865 reports
MALAISE861 reports
VOMITING824 reports
PYREXIA819 reports
DIZZINESS799 reports
DRUG INEFFECTIVE755 reports
OFF LABEL USE692 reports
CHRONIC KIDNEY DISEASE588 reports

Report Outcomes

Out of 15,935 classified reports for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS):

Serious 80.3%Non-Serious 19.7%

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 Breakdown

Reports by Sex

Female12,357 (84.2%)
Male2,288 (15.6%)
Unknown26 (0.2%)

Reports by Age

Age 53340 reports
Age 69290 reports
Age 61275 reports
Age 73274 reports
Age 75273 reports
Age 63259 reports
Age 72259 reports
Age 71256 reports
Age 68253 reports
Age 74246 reports
Age 77241 reports
Age 64237 reports
Age 70236 reports
Age 79236 reports
Age 76229 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.