Drug side effects
levofloxacin Side Effects
The reactions most often reported to the FDA for levofloxacin (also sold as Levaquin), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 58,038
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2003 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of levofloxacin come from 58,038 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 58,038 reports to the FDA Adverse Event Reporting System (FAERS) for levofloxacin (Levaquin): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
58,038
Reports Mentioning Death
7,897
13.6% of reports — not proof the medicine caused the death
Hospitalizations
27,056
46.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 7,897 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,757 |
| PNEUMONIA | 720 |
| ACUTE KIDNEY INJURY | 508 |
| SEPSIS | 449 |
| RESPIRATORY FAILURE | 441 |
| PYREXIA | 422 |
| DIARRHOEA | 407 |
| DYSPNOEA | 405 |
| SEPTIC SHOCK | 403 |
| RENAL FAILURE | 386 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 365 |
| CONDITION AGGRAVATED | 357 |
| CHRONIC KIDNEY DISEASE | 334 |
| NAUSEA | 315 |
| THROMBOCYTOPENIA | 310 |
| FATIGUE | 301 |
| ANAEMIA | 297 |
| FEBRILE NEUTROPENIA | 289 |
Reactions in Hospitalization Reports
Top reactions in 27,056 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PNEUMONIA | 2,155 |
| PYREXIA | 1,851 |
| DYSPNOEA | 1,801 |
| NAUSEA | 1,394 |
| DIARRHOEA | 1,387 |
| ACUTE KIDNEY INJURY | 1,314 |
| FATIGUE | 1,199 |
| HYPOTENSION | 1,126 |
| PAIN | 1,123 |
| VOMITING | 1,121 |
| FEBRILE NEUTROPENIA | 1,054 |
| FALL | 1,045 |
| CONDITION AGGRAVATED | 995 |
| ANAEMIA | 972 |
| DRUG INTERACTION | 940 |
| ASTHENIA | 897 |
| CONSTIPATION | 880 |
| COUGH | 760 |
Nearby, Related Medications
What the FAERS Data Reveals About levofloxacin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 58,038 voluntary reports linked to levofloxacin and its brand equivalents (Levaquin), spanning 2003 through 2025. Of those, 7,897 (13.6%) listed death as an outcome and 27,056 (46.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 48% male; age distribution skews toward 45-64, with 13,983 reports in that bracket. The single most reported reaction is dyspnoea with 2,950 submissions, followed by pneumonia and nausea.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to levofloxacin's 58,038.
Read our methodology - how this data is sourced, computed, and verified.