Drug · FAERS side-effect profile with label screen
Natamycin side effects: what 398 FDA adverse event reports show
Drug class
Polyene Antimicrobial
FDA label (Established Pharmacologic Class)
Brand names
Natacyn
openFDA label
Who reports
398 reports · 75% serious · 88 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
NATACYN ® (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial .
FDA label, Indications and Usage
What it is
DESCRIPTION: NATACYN ® (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration.
FDA label, Description section
Boxed warning
None in the current 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 28 strongest signals
Reporting / coding artifact 3Lab value / disease marker 1No label text to screen 24
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicitis | 52 | 296.4 229.8–382.2ROR 340.8 · χ² 14,935 / p <1e-300 | 265.9 EB05 210.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 230.6 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Ventricular fibrillation | 51 | 242.3 187.4–313.4ROR 277.8 · χ² 11,968 / p <1e-300 | 221.3 EB05 174.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.4 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Cardiogenic shock | 48 | 177.8 136.3–231.9ROR 202.1 · χ² 8,241 / p <1e-300 | 165.6 EB05 129.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.6 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Bacterial infection | 41 | 116.6 87.2–155.8ROR 129.8 · χ² 4,576 / p <1e-300 | 110.4 EB05 84.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 103.6 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Incorrect route of product administration | 37 | 116.2 85.5–158.1ROR 128.1 · χ² 4,107 / p <1e-300 | 109.6 EB05 83.0 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 178.8 · ♀ 0% (drug 51%) · 97% clinician | no trial data cached |
| Neuralgia | 46 | 100.1 76.3–131.4ROR 113.1 · χ² 4,412 / p <1e-300 | 96.0 EB05 74.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.4 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Ascites | 52 | 93.3 72.4–120.2ROR 107.2 · χ² 4,654 / p <1e-300 | 90.1 EB05 71.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.9 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 48 | 90.8 69.6–118.4ROR 103.1 · χ² 4,171 / p <1e-300 | 87.6 EB05 68.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.8 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Hyperlipidaemia | 18 | 79.2 50.4–124.5ROR 82.9 · χ² 1,312 / p 1e-287 | 73.2 EB05 49.0 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.2 | no trial data cached |
| Ulcer | 21 | 69.5 45.8–105.5ROR 73.3 · χ² 1,350 / p 8e-296 | 65.5 EB05 45.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.6 · 90% clinician | no trial data cached |
| Blood test abnormal | 17 | 63.9 40.1–101.7ROR 66.7 · χ² 990 / p 2e-217 | 59.7 EB05 39.5 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 75.3 | no trial data cached |
| Ocular discomfort | 12 | 58.3 33.4–101.8ROR 60.1 · χ² 619 / p 6e-137 | 53.5 EB05 32.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| End stage renal disease | 20 | 57.3 37.3–87.8ROR 60.2 · χ² 1,050 / p 1e-230 | 54.4 EB05 37.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.1 · 90% clinician | no trial data cached |
| Gout | 19 | 55.8 36.0–86.5ROR 58.5 · χ² 968 / p 9e-213 | 52.9 EB05 35.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.0 | no trial data cached |
| Blood cholesterol increased | 43 | 48.6 36.7–64.5ROR 54.4 · χ² 1,961 / p <1e-300 | 47.6 EB05 36.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 56.8 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 48 | 45.0 34.5–58.7ROR 51.1 · χ² 2,026 / p <1e-300 | 44.3 EB05 34.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.6 · ♀ 2% (drug 51%) · 94% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 43 | 43.5 32.8–57.7ROR 48.6 · χ² 1,746 / p <1e-300 | 42.7 EB05 33.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.1 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Eye pain | 40 | 38.2 28.5–51.2ROR 42.3 · χ² 1,414 / p <1e-300 | 37.5 EB05 28.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · ♀ 71% (drug 51%) | no trial data cached |
| Stress | 47 | 34.4 26.3–45.1ROR 38.9 · χ² 1,497 / p <1e-300 | 34.0 EB05 26.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.1 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Dry mouth | 51 | 33.2 25.7–42.9ROR 37.9 · χ² 1,566 / p <1e-300 | 32.8 EB05 25.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.8 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Sleep disorder | 44 | 33.2 25.1–43.8ROR 37.1 · χ² 1,344 / p 2e-294 | 32.7 EB05 25.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.2 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Diabetes mellitus | 48 | 33.0 25.3–43.1ROR 37.4 · χ² 1,464 / p <1e-300 | 32.6 EB05 25.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.7 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Thrombosis | 47 | 30.7 23.5–40.2ROR 34.7 · χ² 1,326 / p 2e-290 | 30.4 EB05 23.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.6 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Intentional product misuse | 44 | 26.7 20.2–35.3ROR 29.9 · χ² 1,067 / p 3e-234 | 26.4 EB05 20.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 46.8 · ♀ 2% (drug 51%) · 95% clinician | no trial data cached |
| Swelling | 47 | 26.5 20.3–34.7ROR 29.9 · χ² 1,134 / p 8e-249 | 26.3 EB05 20.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 44 | 24.3 18.4–32.1ROR 27.2 · χ² 963 / p 8e-212 | 24.1 EB05 18.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Ocular hyperaemia | 21 | 23.7 15.6–35.9ROR 25.0 · χ² 435 / p 7e-97 | 23.2 EB05 16.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 81% (drug 51%) · 76% consumer | no trial data cached |
| Eye irritation | 25 | 23.6 16.2–34.5ROR 25.2 · χ² 521 / p 1e-115 | 23.3 EB05 16.5 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Ascites | 52 | 93.3 72.4–120.2ROR 107.2 · χ² 4,654 / p <1e-300 | 90.1 EB05 71.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.9 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Appendicitis | 52 | 296.4 229.8–382.2ROR 340.8 · χ² 14,935 / p <1e-300 | 265.9 EB05 210.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 230.6 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Dry mouth | 51 | 33.2 25.7–42.9ROR 37.9 · χ² 1,566 / p <1e-300 | 32.8 EB05 25.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.8 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Ventricular fibrillation | 51 | 242.3 187.4–313.4ROR 277.8 · χ² 11,968 / p <1e-300 | 221.3 EB05 174.9 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 186.4 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Diabetes mellitus | 48 | 33.0 25.3–43.1ROR 37.4 · χ² 1,464 / p <1e-300 | 32.6 EB05 25.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.7 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 48 | 45.0 34.5–58.7ROR 51.1 · χ² 2,026 / p <1e-300 | 44.3 EB05 34.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.6 · ♀ 2% (drug 51%) · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 48 | 90.8 69.6–118.4ROR 103.1 · χ² 4,171 / p <1e-300 | 87.6 EB05 68.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.8 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Cardiogenic shock | 48 | 177.8 136.3–231.9ROR 202.1 · χ² 8,241 / p <1e-300 | 165.6 EB05 129.9 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.6 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Swelling | 47 | 26.5 20.3–34.7ROR 29.9 · χ² 1,134 / p 8e-249 | 26.3 EB05 20.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Thrombosis | 47 | 30.7 23.5–40.2ROR 34.7 · χ² 1,326 / p 2e-290 | 30.4 EB05 23.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.6 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Stress | 47 | 34.4 26.3–45.1ROR 38.9 · χ² 1,497 / p <1e-300 | 34.0 EB05 26.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.1 · ♀ 0% (drug 51%) · 94% clinician | no trial data cached |
| Neuralgia | 46 | 100.1 76.3–131.4ROR 113.1 · χ² 4,412 / p <1e-300 | 96.0 EB05 74.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.4 · ♀ 0% (drug 51%) · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 44 | 24.3 18.4–32.1ROR 27.2 · χ² 963 / p 8e-212 | 24.1 EB05 18.7 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.8 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
| Intentional product misuse | 44 | 26.7 20.2–35.3ROR 29.9 · χ² 1,067 / p 3e-234 | 26.4 EB05 20.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 46.8 · ♀ 2% (drug 51%) · 95% clinician | no trial data cached |
| Sleep disorder | 44 | 33.2 25.1–43.8ROR 37.1 · χ² 1,344 / p 2e-294 | 32.7 EB05 25.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.2 · ♀ 0% (drug 51%) · 95% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Natamycin?
In FDA FAERS, the most frequently co-reported reaction terms for Natamycin are ascites, appendicitis, dry mouth, ventricular fibrillation, diabetes mellitus, hyponatraemia. 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 Natamycin have an FDA boxed warning?
No. The FDA label retrieved for Natamycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Natamycin 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 2818fcb8-5bac-41fb-864e-3b598308a428, effective 20251105; matched on
openfda.generic_name.exact:"NATAMYCIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, fieldpatient.drug.openfda.generic_name.exact, 34 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
Page generated 2026-10-08. 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.