FDA Warnings & Alerts
The Food and Drug Administration (FDA) describes a Boxed Warning (also known as a “black box warning”) as its strongest required safety warning, reserved for serious or potentially life-threatening risks. The FDA’s major Boxed Warnings and related labeling changes for fluoroquinolones apply to systemic formulations, including oral and injectable/IV products. FDA labeling for some fluoroquinolone eye and ear products acknowledges systemic absorption or includes warnings about systemic quinolone-type hypersensitivity reactions. However, these products do not carry the same Boxed Warnings required for oral and injectable/IV fluoroquinolones.
FDA warnings state that systemic fluoroquinolones are associated with disabling and potentially permanent serious side effects involving the tendons, muscles, joints, nerves, and central nervous system, which can occur together in the same patient. FDA warnings also include risks of peripheral neuropathy, mental health side effects, serious low blood sugar, tendon rupture, possible aortic aneurysm or dissection, and worsening of myasthenia gravis. The 2024 FDA-approved labeling for ciprofloxacin/Cipro lists acute myocardial ischemia, with or without myocardial infarction occurring as part of an allergic reaction, among adverse reactions reported during postmarketing use.
The FDA advises reserving systemic fluoroquinolones for patients with acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or uncomplicated urinary tract infections when no suitable alternative treatment options are available, because the risks generally outweigh the benefits for these patients.
🟦FDA Safety Announcement, December 20, 2018:
Fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.
🟦FDA Safety Announcement, July 10, 2018:
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes.
🟦FDA Drug Safety Communication, July 26, 2016:
FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects.
🟦FDA Drug Safety Communication, May 12, 2016:
FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.
🟦FDA Safety Announcement August 2013:
FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection. Peripheral neuropathy is a nerve
disorder occurring in the arms or legs. Symptoms include pain, burning, tingling, numbness, weakness,
or a change in sensation to light touch, pain or temperature, or the sense of body position. It can occur
at any time during treatment with fluoroquinolones and can last for months to years after the drug is
stopped or be permanent.
https://wayback.archive-it.org/7993/20170112031629/http:/www.fda.gov/Drugs/DrugSafety/ucm365050.htm
🟦FDA Boxed Warning (black box) added February 2011:
Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
🟦FDA Boxed Warning (black box) added in 2008:
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture; this risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Multiple FDA Warnings, Updates & Articles in English & Spanish:
https://www.fda.gov/search?s=+Fluoroquinolone&sort_bef_combine=rel_DESC
Fluoroquinolone Detailed Medication Guide & Label Changes
FDA ciprofloxacin/Cipro Label 2024
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019537s095%2C020780s050lbl.pdf
FDA ciprofloxacin/Cipro IV Label 2024
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019847Orig1s064correctedlbl.pdf
FDA levofloxacin/Levaquin (name brand discontinued) Label 2019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020634s069lbl.pdf#page=51
FDA moxifloxacin/Avelox (name brand discontinued) Label 2019
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021085s065,021277s061lbl.pdf#page=33
FDA Cipro Label: Postmarketing Adverse Event Reports (2024):
Per the FDA: The following adverse events have been reported from worldwide marketing experience with fluoroquinolones, including CIPRO.
Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug:
Acute generalized exanthematous pustulosis (AGEP), acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction, agitation, anosmia, candidiasis (oral, gastrointestinal, vaginal), cholesterol elevation (serum), confusion, delirium, exacerbation of myasthenia gravis, fixed eruption, hepatic failure (including fatal cases), hyperesthesia, hypertonia, hypesthesia, methemoglobinemia, myalgia, myasthenia, myoclonus, nystagmus, pancytopenia (life-threatening or fatal outcome), peripheral neuropathy, polyneuropathy, potassium elevation (serum), prothrombin time prolongation or decrease, pseudomembranous colitis, QT prolongation, serum sickness-like reaction, taste loss, tendinitis, tendon rupture, torsade de pointes, twitching, vasculitis, and ventricular arrhythmia.
See full document here - page 19-20 :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019537s095%2C020780s050lbl.pdf
Fluoroquinolone Associated Disability (FQAD)
In 2015, following patient testimony and a joint meeting of the FDA’s Antimicrobial Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, the FDA used the term “fluoroquinolone-associated disability,” or FQAD, to describe a specific group of reports involving persistent, disabling adverse effects following systemic fluoroquinolone use. FQAD is not currently established as a distinct diagnosis in ICD-10-CM. However, new ICD-10-CM codes identifying poisoning, adverse effects and underdosing of fluoroquinolone antibiotics became effective October 1, 2025.
View the FDA presentation: https://www.fda.gov/media/104060/download
Criteria Used in the FDA’s FQAD Case Review
Submit adverse reactions to the FDA
Patients and healthcare professionals are encouraged to report serious suspected adverse reactions to FDA MedWatch. These reports help the FDA identify and evaluate potential medication safety concerns. Include as much relevant information as possible, and submit significant new or updated medical information as a follow-up to the original report when appropriate. https://www.fda.gov/safety/report-problem-fda
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