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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.

NORFLOXACIN: 799 Adverse Event Reports & Safety Profile

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799
Total FAERS Reports
313 (39.2%)
Deaths Reported
207
Hospitalizations
799
As Primary/Secondary Suspect
40
Life-Threatening
112
Disabilities
Jun 17, 1991
FDA Approved
Discontinued
Status

FDA Application: 019384 ·

First Report: 19900101 · Latest Report: 20250330

What Are the Most Common NORFLOXACIN Side Effects?

#1 Most Reported
Fatigue
307 reports (38.4%)
#2 Most Reported
Dizziness
283 reports (35.4%)
#3 Most Reported
Nausea
271 reports (33.9%)

All NORFLOXACIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 307 38.4% 182 64
Dizziness 283 35.4% 204 62
Nausea 271 33.9% 159 54
Vomiting 264 33.0% 154 50
Arthralgia 237 29.7% 201 14
Malaise 231 28.9% 169 44
Cardio-respiratory arrest 226 28.3% 226 12
Haemorrhagic stroke 226 28.3% 226 0
Tachycardia 226 28.3% 220 1
Coma 220 27.5% 205 11
Dyspnoea 220 27.5% 202 14
Fall 220 27.5% 213 5
Pruritus 219 27.4% 205 5
Sepsis 218 27.3% 216 2
Chills 217 27.2% 207 2
Altered state of consciousness 216 27.0% 213 1
Diarrhoea 216 27.0% 209 3
Myalgia 215 26.9% 179 9
Ocular discomfort 215 26.9% 210 0
Amaurosis fugax 213 26.7% 211 0

Who Reports NORFLOXACIN Side Effects? Age & Gender Data

Gender: 78.4% female, 21.6% male. Average age: 56.5 years. Most reports from: PT. View detailed demographics →

Is NORFLOXACIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2001 1 0 0
2002 1 0 0
2003 1 0 0
2005 1 0 0
2008 10 0 5
2010 12 9 11
2011 9 0 5
2012 8 0 7
2013 5 0 4
2014 37 5 22
2015 26 2 16
2016 11 3 9
2017 13 1 3
2018 16 2 9
2019 23 0 12
2020 15 0 3
2021 1 0 0
2022 3 0 2
2023 10 0 3
2024 7 1 1
2025 5 0 0

View full timeline →

What Is NORFLOXACIN Used For?

IndicationReports
Product used for unknown indication 540
Urinary tract infection 45
Cystitis 33
Prophylaxis 10
Antibiotic prophylaxis 8
Prostatitis 8
Toxicity to various agents 8
Diarrhoea 6
Suicide attempt 6
Cystitis noninfective 5

NORFLOXACIN vs Alternatives: Which Is Safer?

NORFLOXACIN vs NORGESTREL NORFLOXACIN vs NORTRIPTYLINE NORFLOXACIN vs NORVASC NORFLOXACIN vs NORVIR NORFLOXACIN vs NOSCAPINE NORFLOXACIN vs NOVOLOG NORFLOXACIN vs NPLATE NORFLOXACIN vs NUSINERSEN NORFLOXACIN vs NUTROPIN AQ NORFLOXACIN vs NUVARING

Official FDA Label for NORFLOXACIN

Official prescribing information from the FDA-approved drug label.