Drug · FAERS side-effect profile with label screen

Olopatadine and Mometasone Furoate side effects: what 1,987 FDA adverse event reports show

Olopatadine Hydrochloride And Mometasone Furoate · 37 reaction terms · 3,386 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Olopatadine (Olopatadine)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,987 reports · 13% serious · 12 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

FDA label, Indications and Usage

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 23 strongest signals

Reporting / coding artifact 18No label text to screen 5

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.
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. 14 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
Device delivery system issue	702	291.1 273.9–309.3ROR 449.3 · χ² 197,368 / p <1e-300	281.0 EB05 264.0 · IC025 +7.8 3/3 methods agree	Reporting / coding artifact	serious n=5 · 82% consumer	no trial data cached
Device occlusion	133	101.8 86.3–120.0ROR 109.0 · χ² 13,052 / p <1e-300	99.4 EB05 86.0 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 86% consumer	no trial data cached
Drug dose omission by device	519	71.9 66.8–77.5ROR 97.0 · χ² 36,105 / p <1e-300	71.2 EB05 66.2 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 89% consumer	no trial data cached
Device defective	63	41.2 32.3–52.6ROR 42.5 · χ² 2,423 / p <1e-300	40.6 EB05 32.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=2 · 84% consumer	no trial data cached
Wrong technique in device usage process	144	33.3 28.4–39.0ROR 35.8 · χ² 4,475 / p <1e-300	33.1 EB05 28.8 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=2 · 84% consumer	no trial data cached
Product use in unapproved indication	607	26.3 24.6–28.1ROR 37.4 · χ² 14,859 / p <1e-300	26.2 EB05 24.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5 · 82% consumer	no trial data cached
Product use issue	426	24.1 22.1–26.2ROR 30.4 · χ² 9,461 / p <1e-300	24.0 EB05 22.1 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Product odour abnormal	21	21.4 14.0–32.7ROR 21.6 · χ² 387 / p 2e-86	20.9 EB05 14.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Device failure	29	20.2 14.1–29.0ROR 20.5 · χ² 509 / p 5e-113	19.9 EB05 14.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	76% consumer	no trial data cached
Device issue	159	19.2 16.6–22.3ROR 20.8 · χ² 2,738 / p <1e-300	19.2 EB05 16.8 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 83% consumer	no trial data cached
Product prescribing issue	36	18.7 13.5–25.8ROR 19.0 · χ² 584 / p 2e-129	18.5 EB05 13.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug effective for unapproved indication	51	18.4 14.1–24.2ROR 18.9 · χ² 823 / p 2e-181	18.3 EB05 14.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · 90% consumer	no trial data cached
Epistaxis (nosebleed)	125	17.6 14.9–20.9ROR 18.7 · χ² 1,945 / p <1e-300	17.5 EB05 15.1 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.0	no trial data cached
Device mechanical issue	20	16.4 10.6–25.3ROR 16.5 · χ² 273 / p 1e-61	15.9 EB05 10.5 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	95% consumer	no trial data cached
Product taste abnormal	17	13.3 8.3–21.4ROR 13.4 · χ² 182 / p 1e-41	12.4 EB05 7.6 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Incorrect dose administered by device	31	12.9 9.1–18.3ROR 13.1 · χ² 328 / p 1e-73	12.4 EB05 8.9 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	77% consumer	no trial data cached
Product packaging quantity issue	10	9.7 5.2–17.9ROR 9.7 · χ² 69 / p 4e-17	7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug ineffective for unapproved indication	46	8.7 6.5–11.6ROR 8.9 · χ² 307 / p 6e-69	8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device breakage	23	6.2 4.1–9.3ROR 6.2 · χ² 95 / p 1e-22	5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	87% consumer	no trial data cached
Throat irritation	19	4.5 2.9–7.0ROR 4.5 · χ² 48 / p 2e-12	4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.1	no trial data cached
Nasal congestion (stuffy nose)	24	4.3 2.9–6.4ROR 4.4 · χ² 58 / p 1e-14	4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Device malfunction	22	3.5 2.3–5.2ROR 3.5 · χ² 36 / p 1e-9	3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	86% consumer	no trial data cached
Wrong technique in product usage process	62	3.2 2.5–4.1ROR 3.3 · χ² 94 / p 1e-22	3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 84% consumer	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
Device delivery system issue	702	291.1 273.9–309.3ROR 449.3 · χ² 197,368 / p <1e-300	281.0 EB05 264.0 · IC025 +7.8 3/3 methods agree	Reporting / coding artifact	serious n=5 · 82% consumer	no trial data cached
Product use in unapproved indication	607	26.3 24.6–28.1ROR 37.4 · χ² 14,859 / p <1e-300	26.2 EB05 24.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5 · 82% consumer	no trial data cached
Drug dose omission by device	519	71.9 66.8–77.5ROR 97.0 · χ² 36,105 / p <1e-300	71.2 EB05 66.2 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 89% consumer	no trial data cached
Product use issue	426	24.1 22.1–26.2ROR 30.4 · χ² 9,461 / p <1e-300	24.0 EB05 22.1 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2	no trial data cached
Device issue	159	19.2 16.6–22.3ROR 20.8 · χ² 2,738 / p <1e-300	19.2 EB05 16.8 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 83% consumer	no trial data cached
Wrong technique in device usage process	144	33.3 28.4–39.0ROR 35.8 · χ² 4,475 / p <1e-300	33.1 EB05 28.8 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=2 · 84% consumer	no trial data cached
Device occlusion	133	101.8 86.3–120.0ROR 109.0 · χ² 13,052 / p <1e-300	99.4 EB05 86.0 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	serious n=2 · 86% consumer	no trial data cached
Epistaxis (nosebleed)	125	17.6 14.9–20.9ROR 18.7 · χ² 1,945 / p <1e-300	17.5 EB05 15.1 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.0	no trial data cached
Device defective	63	41.2 32.3–52.6ROR 42.5 · χ² 2,423 / p <1e-300	40.6 EB05 32.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=2 · 84% consumer	no trial data cached
Wrong technique in product usage process	62	3.2 2.5–4.1ROR 3.3 · χ² 94 / p 1e-22	3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 1.4 · 84% consumer	no trial data cached
Drug effective for unapproved indication	51	18.4 14.1–24.2ROR 18.9 · χ² 823 / p 2e-181	18.3 EB05 14.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · 90% consumer	no trial data cached
Drug ineffective for unapproved indication	46	8.7 6.5–11.6ROR 8.9 · χ² 307 / p 6e-69	8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product prescribing issue	36	18.7 13.5–25.8ROR 19.0 · χ² 584 / p 2e-129	18.5 EB05 13.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect dose administered by device	31	12.9 9.1–18.3ROR 13.1 · χ² 328 / p 1e-73	12.4 EB05 8.9 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	77% consumer	no trial data cached
Device failure	29	20.2 14.1–29.0ROR 20.5 · χ² 509 / p 5e-113	19.9 EB05 14.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	76% consumer	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 Olopatadine and Mometasone Furoate?

In FDA FAERS, the most frequently co-reported reaction terms for Olopatadine and Mometasone Furoate are drug dose omission by device, epistaxis, drug effective for unapproved indication. 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 Olopatadine and Mometasone Furoate have an FDA boxed warning?

No. The FDA label retrieved for Olopatadine and Mometasone Furoate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Olopatadine and Mometasone Furoate 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 55142e80-c5db-46a5-85a5-e8a040bcc8cf, effective 20240325; matched on openfda.generic_name.exact:"OLOPATADINE")
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, 37 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.