Levofloxacin side effects: what 59,938 FDA adverse event reports show

Levofloxacin · 1,245 reaction terms · 240,223 drug–reaction co-reports · data 2026-09-14

Drug class

Fluoroquinolone Antibacterial

FDA label (Established Pharmacologic Class)

Who reports

59,938 reports · 88% serious · 8,134 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Levofloxacin 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 .

FDA label, Indications and Usage

What it is

Levofloxacin tablets, USP are synthetic antibacterial agents for oral administration.

FDA label, Description section

Boxed warning

SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin,.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 3Reporting / coding artifact 2Lab value / disease marker 5Not in label — unassessed 28

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,205 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Congenital hiatus hernia	113	366.9 281.5–478.1ROR 367.6 · calibrated p 3e-12 ✓	172.9 EB05 147.8 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 0% (drug 51%)	no trial arm names this drug
Spirometry abnormal	262	283.5 240.8–333.8ROR 284.8 · calibrated p 2e-11 ✓	154.2 EB05 139.1 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious n=262 · ♀ 0% (drug 51%)	no trial arm names this drug
Pulmonary vasculitis	230	271.1 228.1–322.1ROR 272.1 · calibrated p 3e-11 ✓	150.2 EB05 134.6 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=230 · ♀ 0% (drug 51%)	no trial arm names this drug
Mite allergy	255	234.0 199.6–274.3ROR 235.0 · calibrated p 1e-10 ✓	138.3 EB05 124.6 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=254 · ♀ 0% (drug 51%)	no trial arm names this drug
Total lung capacity abnormal	139	201.8 163.7–248.8ROR 202.3 · calibrated p 5e-10 ✓	125.4 EB05 108.9 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=139 · ♀ 0% (drug 51%)	no trial arm names this drug
Mycotic allergy	256	153.0 132.0–177.2ROR 153.6 · calibrated p 4e-9 ✓	105.4 EB05 95.0 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=255 · ♀ 0% (drug 51%)	no trial arm names this drug
Dust allergy	260	129.3 112.1–149.1ROR 129.9 · calibrated p 2e-8 ✓	93.6 EB05 84.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=259 · ♀ 0% (drug 51%)	no trial arm names this drug
Capillaritis	63	107.3 80.9–142.4ROR 107.4 · calibrated p 1e-7 ✓	80.1 EB05 64.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=63 · ♀ 0% (drug 51%)	no trial arm names this drug
Sedation complication	468	80.5 72.8–89.0ROR 81.2 · calibrated p 6e-7 ✓	65.3 EB05 60.5 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=466 · ♀ 100% (drug 51%)	no trial arm names this drug
Conjunctivitis allergic	270	79.1 69.4–90.3ROR 79.5 · calibrated p 7e-7 ✓	64.3 EB05 58.1 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=270 · ♀ 0% (drug 51%)	no trial arm names this drug
Tendon discomfort	131	73.4 60.8–88.7ROR 73.6 · calibrated p 1e-6 ✓	60.2 EB05 52.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=120	no trial arm names this drug
Antineutrophil cytoplasmic antibody positive	116	66.2 54.3–80.7ROR 66.3 · calibrated p 3e-6 ✓	55.2 EB05 47.3 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=116 · ♀ 0% (drug 51%)	no trial arm names this drug
Neuritis	231	61.7 53.7–71.0ROR 62.0 · calibrated p 4e-6 ✓	52.3 EB05 46.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=230 · ♀ 0% (drug 51%)	no trial arm names this drug
Disseminated mucormycosis	57	60.2 45.4–79.7ROR 60.2 · calibrated p 6e-6 ✓	50.5 EB05 40.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=57 · 100% clinician	no trial arm names this drug
Tendon pain	1,070	57.5 53.9–61.3ROR 58.5 · calibrated p 5e-6 ✓	49.4 EB05 46.9 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious n=972	no trial arm names this drug
Dysbiosis	110	55.6 45.5–68.0ROR 55.7 · calibrated p 8e-6 ✓	47.6 EB05 40.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=110	no trial arm names this drug
Delusion of grandeur	61	55.1 42.1–72.2ROR 55.2 · calibrated p 1e-5 ✓	47.0 EB05 37.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=61 · ♀ 0% (drug 51%) · 100% clinician	no trial arm names this drug
Creatinine renal clearance decreased	463	45.3 41.2–49.9ROR 45.7 · calibrated p 2e-5 ✓	40.1 EB05 37.1 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=462 · ♀ 100% (drug 51%)	no trial arm names this drug
Eosinophilic granulomatosis with polyangiitis	200	38.4 33.2–44.4ROR 38.5 · calibrated p 7e-5 ✓	34.5 EB05 30.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=200 · ♀ 0% (drug 51%)	no trial arm names this drug
Multiple drug therapy	68	37.7 29.3–48.4ROR 37.7 · calibrated p 9e-5 ✓	33.8 EB05 27.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=68 · ♀ 100% (drug 51%)	no trial arm names this drug
Normochromic normocytic anaemia	291	37.5 33.2–42.3ROR 37.7 · calibrated p 8e-5 ✓	33.8 EB05 30.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=291 · ♀ 0% (drug 51%)	no trial arm names this drug
Tendon disorder	632	37.4 34.5–40.6ROR 37.8 · calibrated p 7e-5 ✓	33.8 EB05 31.7 · IC025 +4.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=586	no trial arm names this drug
Small fibre neuropathy	68	35.8 27.9–46.0ROR 35.9 · calibrated p 1e-4 ✓	32.3 EB05 26.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=67 · 100% consumer	no trial arm names this drug
Computerised tomogram thorax abnormal	62	34.1 26.3–44.2ROR 34.1 · calibrated p 2e-4 ✓	30.8 EB05 24.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=62 · ♀ 100% (drug 51%) · 100% clinician	no trial arm names this drug
Bloody discharge	100	33.2 27.1–40.8ROR 33.3 · calibrated p 2e-4 ✓	30.2 EB05 25.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=100 · ♀ 100% (drug 51%)	no trial arm names this drug
Creatinine renal clearance increased	65	33.0 25.6–42.6ROR 33.1 · calibrated p 2e-4 ✓	30.0 EB05 24.4 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=65 · ♀ 100% (drug 51%) · 100% clinician	no trial arm names this drug
Respiratory symptom	236	32.1 28.1–36.7ROR 32.2 · calibrated p 2e-4 ✓	29.4 EB05 26.4 · IC025 +4.6 3/3 methods agree	Labeled (related wording) related wording	serious n=235 · ♀ 0% (drug 51%)	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	89	31.5 25.3–39.1ROR 31.5 · calibrated p 2e-4 ✓	28.8 EB05 24.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=89	no trial arm names this drug
Rebound acid hypersecretion	244	30.2 26.5–34.4ROR 30.3 · calibrated p 3e-4 ✓	27.8 EB05 25.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=244 · 100% consumer	no trial arm names this drug
Vascular purpura	104	28.2 23.1–34.4ROR 28.3 · calibrated p 4e-4 ✓	26.0 EB05 22.1 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=104 · 100% clinician	no trial arm names this drug
Tendonitis	1,145	27.7 26.1–29.4ROR 28.3 · calibrated p 4e-4 ✓	25.7 EB05 24.5 · IC025 +4.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 19.8	no trial arm names this drug
Crystal nephropathy	43	27.6 20.2–37.7ROR 27.6 · calibrated p 5e-4 ✓	25.4 EB05 19.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=43 · ♀ 100% (drug 51%) · 100% clinician	no trial arm names this drug
Nephrogenic anaemia	341	27.5 24.6–30.7ROR 27.6 · calibrated p 4e-4 ✓	25.5 EB05 23.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=341	no trial arm names this drug
Sputum purulent	48	27.3 20.3–36.6ROR 27.3 · calibrated p 6e-4 ✓	25.1 EB05 19.7 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 0% (drug 51%)	no trial arm names this drug
Hypocoagulable state	68	26.0 20.3–33.3ROR 26.1 · calibrated p 7e-4 ✓	24.1 EB05 19.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=68	no trial arm names this drug
Collagen disorder	39	25.5 18.4–35.3ROR 25.5 · calibrated p 8e-4 ✓	23.5 EB05 18.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=38 · ♀ 100% (drug 51%) · 100% consumer	no trial arm names this drug
Hyperparathyroidism secondary	166	24.5 20.9–28.7ROR 24.6 · calibrated p 8e-4 ✓	22.9 EB05 20.1 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=166	no trial arm names this drug
Malignant melanoma in situ	82	24.3 19.4–30.4ROR 24.3 · calibrated p 9e-4 ✓	22.6 EB05 18.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=82 · ♀ 0% (drug 51%)	no trial arm names this drug
Contrast media allergy	113	23.5 19.4–28.4ROR 23.5 · calibrated p 0.001 ✓	22.0 EB05 18.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 100% (drug 51%)	no trial arm names this drug
International normalised ratio fluctuation	132	23.5 19.7–28.0ROR 23.5 · calibrated p 1e-3 ✓	22.0 EB05 19.0 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=132 · ♀ 100% (drug 51%)	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Tendon disorder	3,012	30.028.9–31.1	signal
Severe cutaneous reaction	1,525	7.36.9–7.7	signal
Neutropenia / agranulocytosis	3,028	4.34.2–4.5	signal
Kidney injury	4,825	3.73.6–3.8	signal
Interstitial lung disease	954	3.53.3–3.7	signal
Thrombocytopenia	2,087	3.33.2–3.5	signal
Arrhythmia / qt	1,573	2.92.7–3.0	signal
Liver injury	2,367	2.82.7–2.9	signal
Serious infection	5,901	2.72.6–2.8	signal
Anaemia	2,137	2.52.4–2.6	signal
Rhabdomyolysis / myopathy	544	2.42.2–2.6	signal
Hyponatraemia	540	2.42.2–2.6	signal
Opportunistic infection	882	2.32.1–2.4	signal
Anaphylaxis / angioedema	662	1.91.7–2.0	raised
Venous thromboembolism	1,141	1.81.7–2.0	raised
Hypoglycaemia	493	1.81.7–2.0	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Levofloxacin only as a background or rescue medication (NCT02800785, NCT03032510); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Off label use (used outside approved label)	3,287	1.3 1.3–1.4ROR 1.3 · calibrated p 0.538	1.3 EB05 1.3 · IC025 +0.3	Reporting / coding artifact	age-adj. PRR 1.3 · serious PRR 1.4	no trial arm names this drug
Drug ineffective (drug did not work)	3,087	0.8 0.8–0.8ROR 0.8 · calibrated p 0.189	0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 1.1 · serious PRR 1.4	no trial arm names this drug
Dyspnoea (shortness of breath)	3,047	1.9 1.8–2.0ROR 1.9 · calibrated p 0.909	1.9 EB05 1.8 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.6	no trial arm names this drug
Pneumonia (lung infection)	2,964	3.2 3.1–3.3ROR 3.3 · calibrated p 0.525	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 2.7 · serious PRR 2.1	no trial arm names this drug
Nausea	2,903	1.3 1.2–1.3ROR 1.3 · calibrated p 0.510	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.4	no trial arm names this drug
Pyrexia (fever)	2,800	2.8 2.7–2.9ROR 2.9 · calibrated p 0.648	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.6 · serious PRR 2.2	no trial arm names this drug
Fatigue (tiredness)	2,756	1.2 1.2–1.3ROR 1.3 · calibrated p 0.476	1.2 EB05 1.2 · IC025 +0.2	Labeled — boxed warning synonym match	age-adj. PRR 1.1 · serious PRR 1.3	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	2,631	6.1 5.9–6.4ROR 6.4 · calibrated p 0.128	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 3.7 · serious PRR 3.9	no trial arm names this drug
Diarrhoea (diarrhea)	2,553	1.4 1.3–1.4ROR 1.4 · calibrated p 0.580	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.3	no trial arm names this drug
Pain	2,469	1.4 1.4–1.5ROR 1.4 · calibrated p 0.590	1.4 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.3	no trial arm names this drug
Arthralgia (joint pain)	2,320	2.0 1.9–2.0ROR 2.0 · calibrated p 0.945	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 2.0	no trial arm names this drug
Chronic kidney disease	2,289	10.7 10.3–11.2ROR 11.1 · calibrated p 0.022 ✓	10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 9.0 · serious PRR 6.9	no trial arm names this drug
Pain in extremity	1,958	2.3 2.2–2.4ROR 2.4 · calibrated p 0.869	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.1 · serious PRR 2.3	no trial arm names this drug
Vomiting	1,945	1.5 1.4–1.5ROR 1.5 · calibrated p 0.621	1.5 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.3	no trial arm names this drug
Death	1,834	0.7 0.7–0.8ROR 0.7 · calibrated p 0.149	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction boxed warning mentions mortality	age-adj. PRR 0.7 · serious PRR 0.5	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Congenital hiatus hernia — n=113, PRR 366.9
Pulmonary vasculitis — n=230, PRR 271.1
Mite allergy — n=255, PRR 234.0
Total lung capacity abnormal — n=139, PRR 201.8
Mycotic allergy — n=256, PRR 153.0
Dust allergy — n=260, PRR 129.3
Capillaritis — n=63, PRR 107.3
Conjunctivitis allergic — n=270, PRR 79.1
Tendon discomfort — n=131, PRR 73.4
Neuritis — n=231, PRR 61.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Levofloxacin (fluoroquinolones) ↔ Aortic aneurysm / dissection.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Levofloxacin?

In FDA FAERS, the most frequently co-reported reaction terms for Levofloxacin are dyspnoea, pneumonia, nausea, pyrexia, fatigue, acute kidney injury. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Levofloxacin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including levofloxacin,.

Do FAERS signals prove that Levofloxacin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 05d179f5-b200-8597-e063-6394a90a10cc, effective 20250304; matched on openfda.generic_name.exact:"LEVOFLOXACIN")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,245 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query LEVOFLOXACIN, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.