Skip to Content
Vaccines aren’t just for kids. Is your teen protected?

Norfloxacin Pregnancy and Breastfeeding Warnings

Norfloxacin is also known as: Noroxin

Norfloxacin Pregnancy Warnings

Norfloxacin has been assigned to pregnancy category C by the FDA. High-dose animal studies have revealed evidence of embryolethality. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathies have been reported in immature animals giving rise to concern over effects on fetal bone formation. Because safer alternatives are generally available, some experts consider norfloxacin contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of norfloxacin during pregnancy when benefit outweighs risk.

Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including norfloxacin), congenital malformations were reported in 4.8%; however, this was not higher than the background rate. In the Michigan Medicaid study, major birth defects were reported in 5 of 139 exposed neonates. Berkovitch et al. reviewed 35 pregnancies in women who received norfloxacin or ciprofloxacin during the first trimester for the treatment of urinary tract infections. No malformations were reported among these infants. When compared to infants not exposed to quinolones, there was no difference in the acquisition of developmental milestones and no joint problems or walking delays.

See references

Norfloxacin Breastfeeding Warnings

It is not known whether norfloxacin is excreted into human milk. However, since other fluoroquinolone antibiotics are excreted into human milk, it is likely that norfloxacin is also. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Ramakrishnan K, Scheid DC "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician 71 (2005): 933-42
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  3. "Product Information. Noroxin (norfloxacin)." Merck & Co, Inc, West Point, PA.
  4. Berkovitch M, Pastuszak A, Gazarian M, Lewis M, Koren G "Safety of the new quinolones in pregnancy." Obstet Gynecol 84 (1994): 535-8

References for breastfeeding information

  1. "Product Information. Noroxin (norfloxacin)." Merck & Co, Inc, West Point, PA.
  2. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.