Prescription medication · Fluoroquinolone Antibiotic
levofloxacin
Also sold as Levaquin. Levofloxacin treats infections like pneumonia, skin infections, prostate infections, and urinary tract infections.
Data updated 2026-05-15
- 58,038
- FDA reportsOften reported
- 8
- InteractionsFew interactions
- 4
- Recall records
What the data shows
levofloxacin (Levaquin) is a prescription Fluoroquinolone Antibiotic, more reported than most tracked drugs (58,038 FDA reports), with 8 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
levofloxacin (Levaquin) is a prescription Fluoroquinolone Antibiotic. Levofloxacin treats infections like pneumonia, skin infections, prostate infections, and urinary tract infections.
Levofloxacin is an antibiotic that fights bacteria in your body. It is used to treat different types of infections.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.42/unit
Generic Available
Yes (20 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Levofloxacin treats infections like pneumonia, skin infections, prostate infections, and urinary tract infections.
Common side effects
Nausea, Headache, Diarrhea
Key warnings
This drug has serious warnings.
The sections below are summarized in plain English from levofloxacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Levofloxacin belongs to a class of drugs called fluoroquinolones. It works by stopping bacteria from multiplying. This helps your body fight off the infection.
Side Effects (from patient reports)
Based on 58,038 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for levofloxacin, by number of reports
- Dyspnoea
Dyspnoea
2,950 reports
- Pneumonia
Pneumonia
2,863 reports
- Nausea
Nausea
2,790 reports
- Pyrexia
Pyrexia
2,723 reports
- Fatigue
Fatigue
2,659 reports
- Acute Kidney Injury
Acute Kidney Injury
2,594 reports
- Diarrhoea
Diarrhoea
2,463 reports
- Pain
Pain
2,424 reports
- Chronic Kidney Disease
Chronic Kidney Disease
2,286 reports
- Arthralgia
Arthralgia
2,220 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for levofloxacin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where levofloxacin sits
levofloxacin has more FDA adverse-event reports than 76% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is levofloxacin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 58,038 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
58,038
Reports Mentioning Death
7,897
13.6% of reports — not proof of cause
Hospitalization Reports
27,056
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | DYSPNOEA | 2,950 |
| 4 | PNEUMONIA | 2,863 |
| 5 | NAUSEA | 2,790 |
| 6 | PYREXIA | 2,723 |
| 7 | FATIGUE | 2,659 |
| 8 | ACUTE KIDNEY INJURY | 2,594 |
| 9 | DIARRHOEA | 2,463 |
| 10 | PAIN | 2,424 |
| 11 | CHRONIC KIDNEY DISEASE | 2,286 |
| 12 | ARTHRALGIA | 2,220 |
| 13 | PAIN IN EXTREMITY | 1,901 |
| 14 | VOMITING | 1,878 |
| 15 | RENAL FAILURE | 1,763 |
| 16 | DEATH | 1,761 |
| 17 | DRUG HYPERSENSITIVITY | 1,746 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This drug has serious warnings. Levofloxacin can cause tendon problems, nerve damage, and central nervous system effects. It can also make muscle weakness worse if you have myasthenia gravis. If you have any of these side effects, stop taking the medicine and call your doctor right away. Only use this medicine if you have no other treatment options for uncomplicated urinary tract infections, bronchitis, or sinusitis.
Known Drug Interactions
7.8 Probenecid and Cimetidine No significant effect of probenecid or cimetidine on the Cmax of levofloxacin was observed in a clinical study involving healthy volunteers. The AUC and t 1/2 of levofloxacin were higher while CL/F and CLR were lower during concomitant treatment of levofloxacin with probenecid or cimetidine compared to levofloxacin alone. However, these changes do not warrant dosage adjustment for levofloxacin when probenecid or cimetidine is co-administered.
Mechanism: Probenecid slows down the kidneys' ability to remove levofloxacin, which keeps the antibiotic in your system for a longer time.
7.8 Probenecid and Cimetidine No significant effect of probenecid or cimetidine on the Cmax of levofloxacin was observed in a clinical study involving healthy volunteers. The AUC and t 1/2 of levofloxacin were higher while CL/F and CLR were lower during concomitant treatment of levofloxacin with probenecid or cimetidine compared to levofloxacin alone. However, these changes do not warrant dosage adjustment for levofloxacin when probenecid or cimetidine is co-administered.
Mechanism: Cimetidine makes it harder for the kidneys to clear levofloxacin, causing the antibiotic to stay in the body slightly longer.
7.5 Theophylline No significant effect of levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population.
Mechanism: Levofloxacin can prevent your body from breaking down theophylline as quickly as usual. This can cause theophylline to build up to unsafe levels in your blood.
(2.4, 7.1) Warfarin Effect may be enhanced. 7.2 Warfarin No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed.
Mechanism: Levofloxacin can increase the blood-thinning effects of warfarin, which may increase the risk of bleeding.
7.6 Cyclosporine No significant effect of levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have been reported in the patient population when co-administered with some other fluoroquinolones. Levofloxacin C max and k e were slightly lower while T max and t1/2 were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication.
Mechanism: Levofloxacin may slightly change how your body processes cyclosporine, and similar drugs have been known to raise cyclosporine levels in the blood.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I avoid while taking levofloxacin?
Can levofloxacin cause tendon damage?
What should I do if I experience nerve pain or numbness?
Can levofloxacin affect my blood sugar?
Is levofloxacin safe for children?
Can levofloxacin make me sensitive to the sun?
What are the symptoms of Clostridium difficile-associated diarrhea?
Can I take levofloxacin if I am allergic to other antibiotics?
Does levofloxacin interact with warfarin?
What should I do if I have side effects from levofloxacin?
What are the common side effects of levofloxacin?
Does levofloxacin interact with other medications?
What drug class is levofloxacin?
What pregnancy or breastfeeding source fields are listed for levofloxacin?
Has levofloxacin been recalled?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
CGMP Deviations:
Akorn, Inc.
Related Medications in Fluoroquinolone Antibiotic
Other drugs grouped near levofloxacin - same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
Compare with levofloxacin →
amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
Compare with levofloxacin →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with levofloxacin →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with levofloxacin →
azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
Compare with levofloxacin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for levofloxacin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 58,038.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 13.61%.
- calcium carbonate Δ 0.07 pts · 64,404 reports · Calcium Supplement / Antacid 13.53%death share
- torsemide Δ 0.10 pts · 31,122 reports · Loop Diuretic 13.70%death share
- nicardipine Δ 0.10 pts · 4,175 reports · Calcium Channel Blocker 13.51%death share
- fluoxetine Δ 0.17 pts · 64,119 reports · Selective Serotonin Reuptake Inhibitor (SSRI) 13.78%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for levofloxacin
The FDA label for levofloxacin (sold under brand names such as Levaquin) classifies it as a prescription-only medication in the Fluoroquinolone Antibiotic class. Levofloxacin treats infections like pneumonia, skin infections, prostate infections, and urinary tract infections. Official labeling lists 6 commonly reported side effects, including Nausea, Headache, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 58,038 voluntary reports. The database also lists 8 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.42.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: March 4, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages