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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NITROFURANTOIN\NITROFURANTOIN: 1,469 Adverse Event Reports & Safety Profile

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1,469
Total FAERS Reports
29 (2.0%)
Deaths Reported
296
Hospitalizations
1,469
As Primary/Secondary Suspect
56
Life-Threatening
122
Disabilities

Active Ingredient: NITROFURANTOIN\NITROFURANTOIN MONOHYDRATE ·

First Report: 1985 · Latest Report: 20250825

What Are the Most Common NITROFURANTOIN\NITROFURANTOIN Side Effects?

#1 Most Reported
Drug hypersensitivity
440 reports (30.0%)
#2 Most Reported
Nausea
230 reports (15.7%)
#3 Most Reported
Headache
177 reports (12.0%)

All NITROFURANTOIN\NITROFURANTOIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 440 30.0% 17 37
Nausea 230 15.7% 16 95
Headache 177 12.1% 1 33
Dyspnoea 170 11.6% 14 75
Vomiting 168 11.4% 15 72
Fatigue 164 11.2% 0 48
Urinary tract infection 160 10.9% 15 65
Pyrexia 150 10.2% 0 64
Rash 140 9.5% 0 31
Dizziness 136 9.3% 0 35
Drug ineffective 125 8.5% 0 46
Pain 119 8.1% 14 41
Arthralgia 115 7.8% 13 24
Diarrhoea 100 6.8% 1 24
Pruritus 99 6.7% 0 21
Chills 98 6.7% 0 20
Malaise 96 6.5% 0 31
Abdominal pain upper 90 6.1% 2 20
Asthenia 87 5.9% 1 31
Feeling abnormal 87 5.9% 0 19

Who Reports NITROFURANTOIN\NITROFURANTOIN Side Effects? Age & Gender Data

Gender: 92.8% female, 7.2% male. Average age: 60.8 years. Most reports from: US. View detailed demographics →

Is NITROFURANTOIN\NITROFURANTOIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 2
2002 1 0 0
2005 1 0 0
2006 3 0 0
2007 2 0 1
2008 2 0 0
2009 1 0 0
2010 1 0 1
2011 8 1 2
2012 5 1 1
2013 28 1 16
2014 49 1 18
2015 57 1 16
2016 62 1 17
2017 96 0 19
2018 78 1 18
2019 54 0 11
2020 62 1 23
2021 41 0 7
2022 53 0 10
2023 34 0 5
2024 40 0 10
2025 19 0 4

View full timeline →

What Is NITROFURANTOIN\NITROFURANTOIN Used For?

IndicationReports
Urinary tract infection 550
Product used for unknown indication 368
Cystitis 120
Prophylaxis urinary tract infection 16
Infection 11
Nephrolithiasis 10
Prophylaxis 8
Kidney infection 7

NITROFURANTOIN\NITROFURANTOIN vs Alternatives: Which Is Safer?

NITROFURANTOIN\NITROFURANTOIN vs NITROFURAZONE NITROFURANTOIN\NITROFURANTOIN vs NITROGLYCERIN NITROFURANTOIN\NITROFURANTOIN vs NITROUS NITROFURANTOIN\NITROFURANTOIN vs NITROUS\OXYGEN NITROFURANTOIN\NITROFURANTOIN vs NIVOLUMAB NITROFURANTOIN\NITROFURANTOIN vs NIVOLUMAB\RELATLIMAB-RMBW NITROFURANTOIN\NITROFURANTOIN vs NIZATIDINE NITROFURANTOIN\NITROFURANTOIN vs NOMEGESTROL NITROFURANTOIN\NITROFURANTOIN vs NORDAZEPAM NITROFURANTOIN\NITROFURANTOIN vs NOREPINEPHRINE

Official FDA Label for NITROFURANTOIN\NITROFURANTOIN

Official prescribing information from the FDA-approved drug label.