Levofloxacin Side Effects and Safety: What the FDA Record Shows

Levofloxacin Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Levofloxacin: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Levofloxacin Is Prescribed For, and Where Levofloxacin Side Effects Come From

According to the FDA label, evofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1, 12.4). Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3) Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5) Chronic bacterial prostatitis (1.6) Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12) Acute Pyel […]

Two separate official sources describe levofloxacin side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Warnings and Precautions -psychiatric adverse reactions ( 5.4 ) 10/2018 Warnings and Precautions – hypoglycemic coma or death 10/2018 ( 5.13 ) Warnings and Precautions – Risk of Aortic Aneurysm and 12/2018 Dissection ( 5.9 ) A recent revision usually means new safety information was added.

The FDA Boxed Warning on Levofloxacin

A boxed warning is the most serious warning the FDA requires on a prescription label. It does not mean the medicine should not be used. It means there is a specific risk serious enough that the FDA requires it to appear at the very top of the prescribing information, so that prescribers weigh it deliberately for each patient.

Prescribers see this warning every time they consult the label. If it concerns you, it is a reasonable thing to raise at your next appointment and ask how it applies to your own situation.

Warnings Beyond the Common Levofloxacin Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Levofloxacin it covers: naphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose ( 4 , 5.7 ) Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses ( 5.6 ) Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported.

Discontinue immediately if signs and symptoms of hepatitis occur ( 5.8 ) Clostridium difficile -associated colitis: evaluate if diarrhea occurs ( 5.10 ) Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.

Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval ( 5.11 , 8.5 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine levofloxacin side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Levofloxacin Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Serious and Otherwise Important Adverse Reactions The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [ see Warnings and Precautions (5.1)] Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2)] Peripheral Neuropathy [see Warnings and Precautions (5.3)] Central Nervous System Effects [see Warnings and Precautions ( 5.4)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)] Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions ( 5.6)] Hypersensitivit […]

Trial data is the most reliable source for how common levofloxacin side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Levofloxacin Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Levofloxacin should not be used in certain situations: evofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions ( 5.3 )]. Known hypersensitivity to levofloxacin or other quinolones ( 4 , 5.7 )

Interactions with other medicines. nteracting Drug Interaction Multivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablets are taken within 2 hours of these products. (2.4, 7.1) Warfarin Effect may be enhanced. […]

Older adults. 8.5 Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. […]

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Levofloxacin Recall History

The FDA enforcement database records 11 recall entries involving Levofloxacin products (1 Class I, 6 Class II, 4 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.

The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.

If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.

Is Levofloxacin the Subject of Litigation?

As of the date on this page, we are not tracking consolidated federal litigation over Levofloxacin. Safety questions have been raised about this medicine, and questions being raised is not the same thing as a case being filed or proven.

We monitor federal court filings and FDA safety communications, and this page is updated when the record changes. Our active case pages list the drug and device litigation currently underway.

If You Are Worried About Levofloxacin Side Effects

Concern about levofloxacin side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its levofloxacin side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported levofloxacin side effects?

In FDA reports, the most frequently mentioned are dyspnoea, pneumonia, nausea. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Levofloxacin been recalled?

There are 11 recall records for Levofloxacin products, the most recent dated 2022-06-15. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.

Does Levofloxacin have a boxed warning?

Yes. The boxed warning is reproduced above. It is the most serious warning the FDA requires, and it exists so that prescribers weigh a specific risk for each patient rather than overlooking it.

Do the FDA report numbers tell me how common these levofloxacin side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check levofloxacin side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Levofloxacin and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Levofloxacin caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.