Over-the-counter medication · Antihistamine (Nasal)
azelastine
Also sold as Astelin, Astepro. This medicine treats symptoms of seasonal allergies in adults and kids 5 years and older.
Data updated 2026-05-15
- 16,672
- FDA reportsModerately reported
- In shortage
- FDA status
What the data shows
azelastine (Astelin) is an over-the-counter Antihistamine (Nasal), reported at a middle-of-the-pack volume (16,672 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
azelastine (Astelin) is an over-the-counter Antihistamine (Nasal). This medicine treats symptoms of seasonal allergies in adults and kids 5 years and older.
Azelastine nasal spray is an antihistamine medicine. It helps relieve allergy and non-allergy nasal symptoms.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
azelastine is currently listed as to be discontinued by the FDA. Affected manufacturer: Mylan Pharmaceuticals Inc., a Viatris Company.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.26/unit
Generic Available
Yes (17 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats symptoms of seasonal allergies in adults and kids 5 years and older.
Common side effects
Bitter taste, Headache, Sleepiness
Key warnings
Azelastine nasal spray can cause sleepiness.
The sections below are summarized in plain English from azelastine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Azelastine is an antihistamine. It blocks histamine, a natural substance that your body makes during an allergic reaction. By blocking histamine, azelastine helps reduce allergy symptoms like sneezing, runny nose, and itchy eyes.
Side Effects (from patient reports)
Based on 16,672 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for azelastine, by number of reports
- Treatment Failure
Treatment Failure
1,876 reports
- Fatigue
Fatigue
1,144 reports
- Headache
Headache
883 reports
- Nausea
Nausea
879 reports
- Dyspnoea
Dyspnoea
836 reports
- Diarrhoea
Diarrhoea
766 reports
- Pain
Pain
755 reports
- Cough 719
Cough
719 reports
- Sinusitis 685
Sinusitis
685 reports
- Dizziness 615
Dizziness
615 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for azelastine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where azelastine sits
azelastine has more FDA adverse-event reports than 51% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is azelastine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 16,672 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
16,672
Reports Mentioning Death
522
3.1% of reports — not proof of cause
Hospitalization Reports
2,849
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | TREATMENT FAILURE | 1,876 |
| 3 | FATIGUE | 1,144 |
| 5 | HEADACHE | 883 |
| 6 | NAUSEA | 879 |
| 7 | DYSPNOEA | 836 |
| 8 | DIARRHOEA | 766 |
| 9 | PAIN | 755 |
| 10 | COUGH | 719 |
| 11 | SINUSITIS | 685 |
| 12 | DIZZINESS | 615 |
| 13 | ASTHMA | 544 |
| 15 | PNEUMONIA | 535 |
| 16 | ARTHRALGIA | 515 |
| 17 | COVID-19 | 506 |
| 18 | FALL | 488 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Azelastine nasal spray can cause sleepiness. Be careful driving or operating machinery until you know how this medicine affects you. Avoid drinking alcohol or taking other medicines that can cause sleepiness while using this spray.
Common Questions
How do I prime the spray?
Can I use this spray in my eyes?
Will this medicine make me sleepy?
Can I drink alcohol while using this spray?
How long does it take for this medicine to work?
Can I use this with other allergy medicines?
What should I do if I get a bitter taste in my mouth?
Can children use this medication?
Is there a generic version of this medicine?
What ingredients are in this medication?
What are the common side effects of azelastine?
What drug class is azelastine?
What pregnancy or breastfeeding source fields are listed for azelastine?
Has azelastine been recalled?
Is azelastine currently in shortage?
Active Recalls
Lack of Assurance of Sterility
Apotex Corp.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
Related Medications in Antihistamine (Nasal)
Other drugs grouped near azelastine - same-class peers and common alternatives.
budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
Compare with azelastine →
cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with azelastine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with azelastine →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with azelastine →
desloratadine
Clarinex
Desloratadine is an antihistamine medicine.
Compare with azelastine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for azelastine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,672.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 3.13%.
- netarsudil Δ 0.01 pts · 1,797 reports · Rho Kinase Inhibitor (Ophthalmic) 3.12%death share
- guanfacine Δ 0.04 pts · 7,386 reports · Central Alpha-2 Agonist 3.09%death share
- conjugated estrogens Δ 0.05 pts · 57,675 reports · Conjugated Estrogen 3.08%death share
- pegloticase Δ 0.06 pts · 3,350 reports · Recombinant Uricase 3.19%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for azelastine
The FDA label for azelastine (sold under brand names such as Astelin, Astepro) classifies it as an over-the-counter product in the Antihistamine (Nasal) class. This medicine treats symptoms of seasonal allergies in adults and kids 5 years and older. Official labeling lists 13 commonly reported side effects, including Bitter taste, Headache, Sleepiness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 16,672 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.26.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: November 6, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages