Drug · FAERS side-effect profile with label screen
Azelastine side effects: what 6,493 FDA adverse event reports show
Drug class
H 1 -receptor antagonist
FDA label, Indications wording
Brand names
Azelastine Hydrochloride
openFDA label
Who reports
6,493 reports · 29% serious · 127 with death outcome · 70% 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 40 strongest signals
Labeled adverse reaction 9Labeled (related wording) 12Likely indication confounding 1Reporting / coding artifact 8Not in label — unassessed 10
What the badges mean
- 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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 396 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 781 | 30.9 29.0–33.1ROR 35.0 · χ² 22,468 / p <1e-300 | 30.6 EB05 28.9 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | 79% consumer | no trial data cached |
| Seasonal allergy | 121 | 27.8 23.3–33.2ROR 28.4 · χ² 3,080 / p <1e-300 | 27.5 EB05 23.6 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=80 · 82% consumer | no trial data cached |
| Infusion site pain | 94 | 23.9 19.5–29.2ROR 24.2 · χ² 2,024 / p <1e-300 | 23.6 EB05 19.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=65 · 78% consumer | no trial data cached |
| Insurance issue | 65 | 14.2 11.1–18.0ROR 14.3 · χ² 779 / p 1e-171 | 14.0 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 54.4 · 77% consumer | no trial data cached |
| Sinus disorder | 74 | 12.1 9.6–15.1ROR 12.2 · χ² 738 / p 1e-162 | 11.8 EB05 9.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.5 · 70% consumer | no trial data cached |
| Dermatitis contact | 40 | 11.4 8.4–15.5ROR 11.4 · χ² 367 / p 3e-82 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=31 · 85% consumer | no trial data cached |
| Product odour abnormal | 33 | 10.3 7.3–14.4ROR 10.3 · χ² 266 / p 4e-60 | 9.6 EB05 7.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 85% consumer | no trial data cached |
| Ear infection | 83 | 10.1 8.2–12.5ROR 10.2 · χ² 670 / p 4e-148 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 29.2 | no trial data cached |
| Product packaging quantity issue | 33 | 9.8 6.9–13.7ROR 9.8 · χ² 250 / p 1e-56 | 9.1 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | 91% consumer | no trial data cached |
| Sinusitis | 308 | 9.7 8.7–10.8ROR 10.1 · χ² 2,393 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.3 | no trial data cached |
| Sputum discoloured | 28 | 9.6 6.6–13.9ROR 9.6 · χ² 206 / p 6e-47 | 8.8 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 · ♀ 46% (drug 70%) | no trial data cached |
| Respiratory tract infection | 76 | 9.5 7.6–11.8ROR 9.6 · χ² 565 / p 3e-125 | 9.2 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.4 | no trial data cached |
| Device defective | 47 | 9.4 7.1–12.5ROR 9.4 · χ² 343 / p 8e-77 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 77% consumer | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 122 | 8.5 7.2–10.2ROR 8.7 · χ² 804 / p 4e-177 | 8.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.4 | no trial data cached |
| Pharyngitis streptococcal | 28 | 8.4 5.8–12.1ROR 8.4 · χ² 174 / p 6e-40 | 7.6 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Sneezing | 54 | 7.8 6.0–10.2ROR 7.9 · χ² 313 / p 3e-70 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · 76% consumer | no trial data cached |
| Respiratory tract congestion | 37 | 7.5 5.4–10.4ROR 7.5 · χ² 202 / p 4e-46 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 · 70% consumer | no trial data cached |
| Hiatus hernia | 30 | 7.5 5.2–10.7ROR 7.5 · χ² 161 / p 3e-37 | 6.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 33% (drug 70%) | no trial data cached |
| Product taste abnormal | 31 | 7.4 5.2–10.6ROR 7.5 · χ² 166 / p 3e-38 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=5 · 77% consumer | no trial data cached |
| Sinus congestion | 31 | 7.4 5.2–10.5ROR 7.4 · χ² 165 / p 5e-38 | 6.8 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Productive cough (cough with phlegm) | 104 | 7.1 5.9–8.6ROR 7.2 · χ² 538 / p 2e-119 | 6.9 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Product dose omission issue | 624 | 7.1 6.6–7.6ROR 7.7 · χ² 3,286 / p <1e-300 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 20.1 · 75% consumer | no trial data cached |
| Device breakage | 85 | 7.0 5.7–8.6ROR 7.1 · χ² 430 / p 1e-95 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 80% consumer | no trial data cached |
| Eye infection | 24 | 6.9 4.6–10.3ROR 6.9 · χ² 115 / p 4e-27 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=19 · 79% consumer | no trial data cached |
| No adverse event | 371 | 6.8 6.1–7.5ROR 7.1 · χ² 1,823 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 80% consumer | no trial data cached |
| Nasal congestion (stuffy nose) | 119 | 6.6 5.5–7.8ROR 6.7 · χ² 556 / p 4e-123 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Eye pain | 111 | 6.5 5.4–7.8ROR 6.6 · χ² 510 / p 3e-113 | 6.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 84% consumer | no trial data cached |
| Asthma | 223 | 6.4 5.6–7.3ROR 6.6 · χ² 1,018 / p 1e-223 | 6.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Gastroenteritis viral | 36 | 6.4 4.6–8.9ROR 6.4 · χ² 159 / p 9e-37 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.2 · ♀ 91% (drug 70%) · 72% consumer | no trial data cached |
| Laryngitis | 21 | 6.2 4.1–9.6ROR 6.3 · χ² 87 / p 5e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=16 · 80% consumer | no trial data cached |
| Skin laceration | 20 | 6.0 3.9–9.3ROR 6.0 · χ² 78 / p 6e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 · 80% consumer | no trial data cached |
| Hereditary angioedema | 19 | 5.8 3.7–9.1ROR 5.9 · χ² 71 / p 2e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Sleep disorder due to a general medical condition | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 110 / p 5e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Aphonia | 25 | 5.8 3.9–8.6ROR 5.8 · χ² 94 / p 2e-22 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · ♀ 43% (drug 70%) | no trial data cached |
| Emphysema | 18 | 5.7 3.6–9.1ROR 5.7 · χ² 66 / p 3e-16 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Dizziness postural | 17 | 5.7 3.6–9.2ROR 5.7 · χ² 61 / p 2e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Throat irritation | 77 | 5.6 4.4–6.9ROR 5.6 · χ² 283 / p 7e-64 | 5.4 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 77% consumer | no trial data cached |
| Viral infection | 57 | 5.5 4.3–7.2ROR 5.6 · χ² 207 / p 3e-47 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 70% consumer | no trial data cached |
| Bronchitis | 127 | 5.5 4.6–6.5ROR 5.6 · χ² 465 / p 2e-103 | 5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 · 71% consumer | no trial data cached |
| Skin infection | 19 | 5.5 3.5–8.6ROR 5.5 · χ² 65 / p 3e-16 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.9 | 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 |
|---|---|---|---|---|---|---|
| Treatment failure | 781 | 30.9 29.0–33.1ROR 35.0 · χ² 22,468 / p <1e-300 | 30.6 EB05 28.9 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | 79% consumer | no trial data cached |
| Product dose omission issue | 624 | 7.1 6.6–7.6ROR 7.7 · χ² 3,286 / p <1e-300 | 7.0 EB05 6.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 20.1 · 75% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 594 | 1.5 1.3–1.6ROR 1.5 · χ² 89 / p 2e-21 | 1.5 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 0.9 · 80% consumer | no trial data cached |
| Fatigue (tiredness) | 463 | 1.9 1.8–2.1ROR 2.0 · χ² 211 / p 4e-48 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Headache | 411 | 2.1 1.9–2.3ROR 2.2 · χ² 248 / p 4e-56 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 4.5 · 71% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 400 | 2.3 2.1–2.5ROR 2.4 · χ² 294 / p 4e-66 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| No adverse event | 371 | 6.8 6.1–7.5ROR 7.1 · χ² 1,823 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 80% consumer | no trial data cached |
| Cough | 370 | 4.3 3.9–4.7ROR 4.5 · χ² 933 / p 4e-205 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Sinusitis | 308 | 9.7 8.7–10.8ROR 10.1 · χ² 2,393 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.3 | no trial data cached |
| Pain | 292 | 1.5 1.4–1.7ROR 1.6 · χ² 55 / p 8e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Dizziness | 269 | 1.7 1.5–2.0ROR 1.8 · χ² 86 / p 8e-21 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Covid-19 | 269 | 4.9 4.4–5.5ROR 5.1 · χ² 838 / p 2e-184 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Pneumonia (lung infection) | 236 | 2.4 2.1–2.7ROR 2.4 · χ² 185 / p 2e-42 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Asthma | 223 | 6.4 5.6–7.3ROR 6.6 · χ² 1,018 / p 1e-223 | 6.3 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Arthralgia (joint pain) | 217 | 1.7 1.5–1.9ROR 1.7 · χ² 61 / p 2e-15 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
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.
- Insurance issue — n=65, PRR 14.2
- Sputum discoloured — n=28, PRR 9.6
- Pharyngitis streptococcal — n=28, PRR 8.4
- Hiatus hernia — n=30, PRR 7.5
- Productive cough — n=104, PRR 7.1
- Sleep disorder due to a general medical condition — n=29, PRR 5.8
- Aphonia — n=25, PRR 5.8
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?
In FDA FAERS, the most frequently co-reported reaction terms for Azelastine are fatigue, headache, dyspnoea, cough, sinusitis, 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 have an FDA boxed warning?
No. The FDA label retrieved for Azelastine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Azelastine 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, fieldpatient.drug.openfda.generic_name.exact, 436 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.