Drug · FAERS side-effect profile with label screen

Azelastine and Fluticasone Propionate side effects: what 108 FDA adverse event reports show

Azelastine Hydrochloride, Fluticasone Propionate · 7 reaction terms · 62 drug–reaction co-reports · data 2026-09-14

Drug class

H 1 -receptor antagonist

FDA label, Indications wording of the closest related product

Label matched

Azelastine (Azelastine Hydrochloride)

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

Who reports

108 reports · 60% serious · 2 with death outcome · 65% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

FDA label, Indications and Usage

What it is

Azelastine HCl nasal spray, 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37.

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 6 strongest signals

Labeled (related wording) 1Not in label — unassessed 5

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1 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
Obstructive airways disorder	10	174.1 96.4–314.3ROR 191.7 · χ² 1,552 / p <1e-300	131.1 EB05 76.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 173.0	no trial data cached
Nodule	10	148.9 82.5–268.7ROR 163.9 · χ² 1,324 / p 3e-290	116.4 EB05 67.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 220.4	no trial data cached
Lymphopenia	10	138.1 76.5–249.3ROR 152.1 · χ² 1,227 / p 4e-269	109.7 EB05 63.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 142.6	no trial data cached
Infusion site pain	9	136.9 73.2–256.0ROR 149.3 · χ² 1,082 / p 1e-237	106.6 EB05 60.0 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Obesity	10	121.8 67.4–219.8ROR 134.1 · χ² 1,080 / p 4e-237	99.2 EB05 57.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 135.1	no trial data cached
Prostate cancer	10	23.9 13.2–43.2ROR 26.2 · χ² 198 / p 3e-45	22.7 EB05 12.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 22.9	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
Prostate cancer	10	23.9 13.2–43.2ROR 26.2 · χ² 198 / p 3e-45	22.7 EB05 12.7 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 22.9	no trial data cached
Obesity	10	121.8 67.4–219.8ROR 134.1 · χ² 1,080 / p 4e-237	99.2 EB05 57.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 135.1	no trial data cached
Lymphopenia	10	138.1 76.5–249.3ROR 152.1 · χ² 1,227 / p 4e-269	109.7 EB05 63.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 142.6	no trial data cached
Nodule	10	148.9 82.5–268.7ROR 163.9 · χ² 1,324 / p 3e-290	116.4 EB05 67.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 220.4	no trial data cached
Obstructive airways disorder	10	174.1 96.4–314.3ROR 191.7 · χ² 1,552 / p <1e-300	131.1 EB05 76.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 173.0	no trial data cached
Infusion site pain	9	136.9 73.2–256.0ROR 149.3 · χ² 1,082 / p 1e-237	106.6 EB05 60.0 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=5	no trial data cached
Device leakage	3	13.8 4.5–42.0ROR 14.1 · χ² 24 / p 5e-7	7.0 EB05 2.1 · IC025 +0.2 3/3 methods agree	Reporting / coding artifact	serious n=3	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 Azelastine and Fluticasone Propionate?

In FDA FAERS, the most frequently co-reported reaction terms for Azelastine and Fluticasone Propionate are prostate cancer, obesity, lymphopenia, nodule, obstructive airways disorder, infusion site pain. 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 Azelastine and Fluticasone Propionate have an FDA boxed warning?

No. The FDA label retrieved for Azelastine and Fluticasone Propionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Azelastine and Fluticasone Propionate 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 7902605c-944a-4d7e-a7d4-eb4a71bcacdb, effective 20181018; matched on openfda.generic_name.exact:"AZELASTINE")
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, 7 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.