For acute uncomplicated cystitis in non-pregnant women, norfloxacin is not recommended as first line. 2018 and 2019 restricted fluoroquinolones because of severe and potentially irreversible adverse effects (tendinitis, tendon rupture, peripheral neuropathy, aortic aneurysm). When alternatives are available (nitrofurantoin, fosfomycin, trimethoprim-sulfamethoxazole), fluoroquinolones are not used for simple cystitis. Norfloxacin is reserved for confirmed resistance to first-line agents in patients without risk factors for fluoroquinolone adverse effects.

Not prescribed in patients over 60, after organ transplantation, on systemic glucocorticoids, with connective tissue diseases, or with QT prolongation.

Sources

Acute bronchitis in immunocompetent adults

Not recommended

For acute uncomplicated bronchitis in immunocompetent adults, norfloxacin is not prescribed. An antibiotic does not shorten cough duration in a viral infection, while a fluoroquinolone with severe and irreversible adverse effects (tendinitis, aortic aneurysm) is used only under strict indications. 2018 explicitly restricts fluoroquinolone use in simple infections where alternatives exist or antibiotics are not indicated.

Sources

Practical notes

Timing and administration

Take 1 hour before or 2 hours after a meal, with a full glass of water. Do not co-administer with dairy, antacids, calcium, iron, magnesium, zinc, or sucralfate – divalent cations form non-absorbable complexes and reduce bioavailability 2-3-fold. The interval is at least 2 hours before and 6 hours after norfloxacin.

Dose titration

Standard doses: UTI – 400 mg twice daily for 3-7 days; SBP prophylaxis – 400 mg once daily long-term; travelers' diarrhea – 400 mg twice daily for 1-3 days. At eGFR 10-30 mL/min/1.73 m², the dosing interval is extended to 24 hours. In the elderly, the dose is unchanged, but renal function and tendon status are monitored.

Monitoring

Before starting prolonged therapy (SBP prophylaxis), check ECG, serum potassium and magnesium, creatinine, and eGFR. On long-term therapy, the need for continuation and tolerability are reassessed every 3-6 months. Tendon pain, swelling, or tendinopathy is an immediate indication to stop the drug and limit physical activity. In patients on antidiabetics, glycemia is monitored in the first days of therapy.

Special situations

Concomitant NSAIDs raise seizure risk; warfarin – INR prolongation; theophylline – seizures and tachycardia; QT-prolonging agents – torsades de pointes. In diabetic patients on antidiabetics, fluoroquinolones cause both hypo- and hyperglycemia. Long flights and physical exertion during therapy raise the risk of Achilles tendon rupture and are discussed with the patient.

Common myths

Myth: "fluoroquinolone is a universal antibiotic, fits any infection". Fact: since 2018 and have restricted fluoroquinolone use because of severe irreversible adverse effects. They are not prescribed for simple UTI, sinusitis, or bronchitis when alternatives are available.

Myth: "tendinitis is a rare complication, nothing to watch for". Fact: tendinitis occurs in 0.1-0.4% of patients, up to 6% in the elderly on glucocorticoids. Tendon pain is an indication to stop immediately.

Myth: "can be combined with calcium and vitamins". Fact: co-administration with calcium, iron, magnesium, zinc, or antacids cuts norfloxacin bioavailability 2-3-fold. The interval is at least 2 hours.

Safety

Boxed warning

FDA boxed warning for the entire fluoroquinolone class: risk of tendinitis and tendon rupture, peripheral neuropathy and CNS effects, and myasthenia gravis exacerbation. The cumulative risk of these adverse effects outweighs benefit in sinusitis, bronchitis, and uncomplicated UTI when alternatives are available. Since 2018, FDA has restricted fluoroquinolone use in these indications.

Contraindications

Hypersensitivity to fluoroquinolones in history
Tendinitis or tendon rupture on fluoroquinolones in history
Age under 18 (cartilage and arthropathy risk)
Pregnancy and breastfeeding
QT prolongation, uncorrected hypokalemia/hypomagnesemia
History of aortic aneurysm or dissection
Connective tissue disorders (Marfan, Ehlers-Danlos syndromes)
Epilepsy or seizure history

Serious adverse effects

Achilles and rotator cuff tendon rupture, especially in the elderly and on systemic glucocorticoids
Peripheral neuropathy, often irreversible
Aortic aneurysm and dissection
Psychiatric disturbances: depression, psychosis, suicidal ideation
Hypoglycemia, hyperglycemia (especially in elderly on antidiabetic agents)
Severe ventricular arrhythmias including torsades de pointes
C. difficile-associated colitis

Common adverse effects

Nausea, diarrhea, abdominal discomfort
Headache, dizziness
Insomnia, increased anxiety
Rash, photosensitivity

Uncommon adverse effects

Tendinitis, especially of the Achilles tendon
QT interval prolongation on ECG
Crystalluria with inadequate urine output

PregnancyFDA C

FDA category C. Animal studies show cartilage damage in immature animals. Human data are limited and norfloxacin is generally avoided in pregnancy, with beta-lactams and fosfomycin preferred for UTI and erythromycin for enteric infections. The drug is used only for vital indications when no alternatives exist.

Breastfeeding

Norfloxacin passes into breast milk. Breastfeeding is interrupted during the course or an alternative compatible with lactation is selected.

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Frequently asked

What is Norfloxacin used for?

Norfloxacin is evaluated for the following indications with varying evidence strength: Spontaneous bacterial peritonitis prophylaxis (evidence tier B), Travelers' diarrhea (evidence tier C), Uncomplicated acute cystitis in outpatient non-pregnant women (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Norfloxacin?

Common side effects of Norfloxacin (≥ 1 in 100): Nausea, diarrhea, abdominal discomfort, Headache, dizziness, Insomnia, increased anxiety, Rash, photosensitivity. See the Safety section for uncommon and serious reactions.

Is Norfloxacin safe during pregnancy?

FDA category C. FDA category C. Animal studies show cartilage damage in immature animals. Human data are limited and norfloxacin is generally avoided in pregnancy, with beta-lactams and fosfomycin preferred for UTI and erythromycin for enteric infections. The drug is used only for vital indications when no alternatives exist.

Is Norfloxacin compatible with breastfeeding?

Norfloxacin passes into breast milk. Breastfeeding is interrupted during the course or an alternative compatible with lactation is selected.

Who should not take Norfloxacin?

Norfloxacin is contraindicated in: Hypersensitivity to fluoroquinolones in history; Tendinitis or tendon rupture on fluoroquinolones in history; Age under 18 (cartilage and arthropathy risk); Pregnancy and breastfeeding; QT prolongation, uncorrected hypokalemia/hypomagnesemia. Full list in the Safety section.

Does Norfloxacin carry an FDA boxed warning?

fluoroquinolone is a universal antibiotic, fits any infection

since 2018 FDA and EMA have restricted fluoroquinolone use because of severe irreversible adverse effects. They are not prescribed for simple UTI, sinusitis, or bronchitis when alternatives are available.

tendinitis is a rare complication, nothing to watch for

tendinitis occurs in 0.1-0.4% of patients, up to 6% in the elderly on glucocorticoids. Tendon pain is an indication to stop immediately.

can be combined with calcium and vitamins

co-administration with calcium, iron, magnesium, zinc, or antacids cuts norfloxacin bioavailability 2-3-fold. The interval is at least 2 hours.

Norfloxacin

Mechanism of action

Indications

Spontaneous bacterial peritonitis prophylaxis

Travelers' diarrhea

Marketing claims without evidence base

Uncomplicated acute cystitis in outpatient non-pregnant women