FDA-filed SPL labeling · retrieved through openFDA

Azelastine Nasal Spray

Azelastine nasal spray is an antihistamine used to relieve symptoms of seasonal allergic rhinitis (hay fever) and vasomotor rhinitis (non-allergic nasal irritation) in eligible adults and children.

Brand names Astepro Allergy Nasal SprayAstelin Nasal SprayAsteproAstepro AllergyChildren Astepro Allergy
Drug classes ⓘ Histamine H1 Receptor Antagonists
Rx/OTC Form 1 Route Nasal
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 25 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveDec 4, 2025
Clinical labels in scope ⓘ25
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1996
FDA-listed product records ⓘ61
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
⭐ Azelastine Nasal Spray at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Azelastine nasal spray is an effective antihistamine spray that relieves nasal allergy symptoms from seasonal allergic rhinitis and, in adults and teens, vasomotor rhinitis. The most important thing to know: it can make you drowsy, so skip alcohol and be cautious behind the wheel. A bitter taste is common but normal — tilting your head downward when spraying can help.
How we write & review this content — our editorial policy →

📖 Azelastine Nasal Spray: Patient Information Guide

A plain-language walkthrough of Azelastine Nasal Spray — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Azelastine nasal spray is approved to relieve nasal symptoms caused by two different types of rhinitis (nasal inflammation):

  • Seasonal allergic rhinitis (hay fever): approved for adults and children 5 years and older
  • Vasomotor rhinitis (non-allergic nasal irritation): approved for adults and adolescents 12 years and older
  • Children Astepro Allergy is specifically intended for pediatric patients — always follow the age-appropriate dosing on the label
  • Astepro Allergy is used in adults and adolescents per prescriber or label direction
⚙️How it works▾

Azelastine is an antihistamine that works by blocking H1 receptors — the docking sites that histamine (your body's allergy alarm chemical) uses to trigger symptoms like sneezing, itching, and a runny nose. By occupying those receptors, azelastine prevents histamine from causing its usual chain reaction. Its main breakdown product in the body, desmethylazelastine, also blocks H1 receptors, so the anti-allergy effect continues even as azelastine is processed.

💊How it's taken▾

Azelastine nasal spray is sprayed into each nostril — never swallowed or used in the eyes. It is used once or twice daily depending on age, condition, and the specific product. Before first use, prime the bottle by releasing 6 sprays until a fine mist appears; if the bottle hasn't been used for 3 or more days, re-prime with 2 sprays. Always follow your prescriber's instructions and the product label for the right number of sprays and schedule for your situation.

🤒Side effects — in detail▾

The most common side effects reported with azelastine nasal spray include:

  • Bitter taste (very common — tilting your head down while spraying can reduce this)
  • Drowsiness or sleepiness
  • Headache
  • Nasal burning or discomfort
  • Sneezing right after use
  • Dry mouth
  • Nausea
  • Dizziness
  • Nosebleeds (epistaxis)
  • Fatigue

In children 5–11, cold-like symptoms and cough were also reported more often than with placebo. Stop use and contact your doctor if you develop a skin rash, signs of an allergic reaction, or severe or frequent nosebleeds.

⚠️Warnings & precautions▾
  • Drowsiness: Azelastine can cause significant sleepiness. Avoid driving, operating machinery, or any task requiring full alertness until you know how it affects you.
  • Alcohol and sedatives: Combining azelastine with alcohol, sedatives, or tranquilizers worsens drowsiness and mental impairment — avoid this combination.
  • Do not spray in eyes or mouth: This product is for nasal use only.
  • Do not share your bottle: Sharing can spread germs.
  • Recent nasal surgery or injury: Ask your doctor before using if your nose hasn't healed from surgery, ulcers, or injury.
  • Allergic reaction: Stop using and seek medical attention if you develop a rash or other signs of an allergic reaction to the product.
  • Keep out of reach of children: Swallowing antihistamines can cause serious harm in young children.
🔀What it interacts with▾

A few important interactions to know about before using azelastine nasal spray:

  • Alcohol — increases drowsiness and impairs coordination; avoid while using this spray
  • Sedatives and tranquilizers — any medication that causes drowsiness (sleep aids, anti-anxiety drugs, certain pain medications) can make the sedation from azelastine significantly worse
  • Other CNS depressants — any drug that slows brain activity can compound azelastine's drowsiness effect
  • Cimetidine (a heartburn/ulcer medication) — when azelastine is taken orally, cimetidine raises azelastine blood levels considerably; discuss with your pharmacist if you take both

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Allergy to azelastine: Do not use if you've ever had an allergic reaction to this product or any of its ingredients
  • Recent nasal surgery, ulcers, or injury: Ask your doctor before use if your nose hasn't fully healed
  • Pregnancy: Limited human data are available; ask a health professional before using
  • Breastfeeding: It is unknown whether azelastine passes into breast milk; breastfed infants should be watched for signs of milk rejection due to the medication's bitter taste
  • Children under 5: Safety and effectiveness for seasonal allergic rhinitis have not been established in this age group
  • Children under 12: Safety and effectiveness for vasomotor rhinitis have not been established in this age group
  • Older adults: Use cautiously; start at the lower end of dosing, as older patients may be more sensitive due to changes in liver, kidney, or heart function
🚑If you take too much▾

There are no reported overdoses with azelastine nasal spray, and accidental overuse by adults is unlikely to cause serious problems beyond increased drowsiness. However, swallowing antihistamines can cause serious harm in young children, so always keep the bottle out of reach. If an overdose is suspected, contact a Poison Control Center or seek emergency medical care right away — there is no specific antidote.

📡Pharmacodynamics — effects in the body▾

In a clinical study of patients with allergic rhinitis, azelastine nasal spray used at the recommended dose did not meaningfully affect the heart's electrical rhythm (specifically, the QT interval — the time it takes the heart to reset between beats). This suggests the nasal spray form, used as directed, does not carry a clinically significant risk of heart rhythm disturbance.

🔬Pharmacokinetics — how your body processes it▾

After being sprayed into the nose, about 40% of azelastine is absorbed into the bloodstream, with peak blood levels reached within 2 to 3 hours. The body breaks it down mainly through the liver using enzymes called cytochrome P450, producing an active breakdown product (desmethylazelastine) that also fights allergy symptoms. Azelastine has an elimination half-life (the time it takes for blood levels to drop by half) of about 22 hours, and most of the drug leaves the body through the stool.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) . Protect from freezing.

📄 Written from Azelastine Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Azelastine Nasal Spray — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does azelastine nasal spray treat? ▾
It treats two types of nasal conditions. The first is seasonal allergic rhinitis — that's hay fever, where your nose runs, you sneeze, and you feel congested because of allergens like pollen. The second is vasomotor rhinitis, which is similar nasal irritation but not caused by allergies. The hay fever use is approved for adults and kids as young as 5; the vasomotor rhinitis use is for adults and teens 12 and up.
Will this spray make me sleepy? ▾
It can, yes — drowsiness is one of the more common side effects. This is especially important to know before you drive or operate any machinery. Alcohol, sedatives, and tranquilizers make the drowsiness significantly worse, so avoid those while you're using this spray. If you find the sleepiness is really bothersome, let your doctor know.
Why does it leave such a bitter taste in my mouth? ▾
That bitter taste is very common with azelastine — it's just how the medication tastes, and it's not a sign anything's wrong. A simple trick: tilt your head slightly downward while you spray. That helps the medication land in your nose rather than dripping back into your throat, which is what causes the taste.
How do I use the spray correctly — is there anything special I need to do? ▾
Before you use it for the very first time, you need to prime the bottle — just press the pump 6 times until you see a fine mist coming out. If you haven't used it in 3 or more days, give it 2 priming sprays before using it again. Spray only into your nose — never in your eyes or mouth. And don't share the bottle with anyone else, as that can spread germs.
Is it safe to use during pregnancy or while breastfeeding? ▾
There's limited data on humans, so the honest answer is we don't have a full picture. Animal studies at very high doses showed some concerns, but those doses were far above what you'd use in your nose. If you're pregnant or breastfeeding, talk to your doctor or pharmacist before using it. If you do use it while breastfeeding, watch your baby for any signs they're refusing to feed — the bitter taste can sometimes transfer.
When should I stop using it and call my doctor? ▾
Stop using it and contact your doctor if you develop a skin rash or any other signs of an allergic reaction to the spray itself, or if you're having severe or frequent nosebleeds. In a real emergency — like if a child swallows some of the bottle — call Poison Control right away. Swallowing antihistamines can be dangerous for young kids, so always keep this out of their reach.
Is Azelastine Nasal Spray available over the counter? ▾
Both — Azelastine Nasal Spray is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Azelastine Nasal Spray first available? ▾
Azelastine Nasal Spray has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Azelastine Nasal Spray? ▾
Azelastine Nasal Spray is supplied by 28 manufacturers listed in the FDA NDC Directory, including Bayer HealthCare LLC., A-S Medication Solutions, Apotex Corp..

💬 Answers drafted from Azelastine Nasal Spray’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerAzelastine Nasal Spray vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Azelastine Nasal Spray NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Azelastine Nasal Spray comes

Azelastine Nasal Spray is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Nasal spray

In the nose
Brands Astepro Allergy Children Astepro Allergy
How this form is used
What it may be used for
  • Treats seasonal allergic rhinitis symptoms in adults and children 5 years and older
  • Treats vasomotor rhinitis symptoms in adults and adolescents 12 years and older
  • Children Astepro Allergy is intended for use in younger patients — follow age-specific dosing guidance
  • Astepro Allergy is used for eligible adults and adolescents per prescriber or label direction
Important instructions
  • For use in the nose only — do not spray in eyes or mouth
  • Prime the bottle with 6 sprays before first use, or with 2 sprays if unused for 3 or more days, until a fine mist appears
  • Tilt your head downward while spraying to help reduce the bitter taste
  • Do not share the bottle with anyone else to avoid spreading germs
Available strengths 5 strengths
137 mcg 137 mcg/0.137 mL 205.5 mcg 1 mg/mL 1.5 mg/mL
61 FDA-listed product records ⓘ

📊 Azelastine Nasal Spray across the U.S. market

How Azelastine Nasal Spray appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
28
Manufacturers
6
Brand names
61
FDA-listed product records ⓘ
1996
First marketed ⓘ
Bayer HealthCare LLC.10%
A-S Medication Solutions8%
Apotex Corp.8%
RPK Pharmaceuticals, Inc.7%
Aurobindo Pharma Limited7%
Bryant Ranch Prepack5%
Other makers56%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Azelastine Nasal Spray is used

A general measure of how commonly Azelastine Nasal Spray is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Azelastine Nasal Spray is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,133,133
Medicaid prescriptions filled (Q1–Q4 2025)
$19.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Azelastine Nasal Spray prescribed? Of the 1,596 medications we measure, Azelastine Nasal Spray ranks #154 by Medicaid prescriptions — more than 90% of them.

Where Azelastine Nasal Spray ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #154 of 1,596
#149 Ofloxacin 1,194,981 Rx #150 Nicotine Transdermal P... 1,178,062 Rx #151 Hydrochlorothiazide /... 1,175,772 Rx #152 Senna 1,155,349 Rx #153 Medroxyprogesterone 1,134,727 Rx #154 Azelastine Nasal Spray 1,133,133 Rx #155 Paroxetine 1,132,136 Rx #156 Promethazine 1,115,560 Rx #157 Norethindrone 1,115,474 Rx #158 Epinephrine 1,108,898 Rx #159 Clotrimazole 1,108,672 Rx

Utilization by Azelastine Nasal Spray product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

azelastine hydrochloride 0.137 MG/ACTUAT Metered Dose Nasal Spray

1,133,133 Medicaid prescriptions (Q1–Q4 2025) 100% of Azelastine Nasal Spray prescriptions shown $19.3M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 6 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1797867

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azelastine Nasal Spray, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 20 listed Azelastine Nasal Spray NDCs with Medicaid activity.

🔍 Compare Azelastine Nasal Spray products

A representative set of FDA-listed product records for Azelastine Nasal Spray — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 61 of 61 products — FDA National Drug Code Directory. See every product, package size and price: browse all 61 Azelastine Nasal Spray NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Azelastine Nasal Spray RxCUI 18603 2 dose forms · 3 strengths
  2. Dose form (SCDF) Ophthalmic Solution RxCUI 636216 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 0.5 MG/ML RxCUI 860805

Look up RxCUI 18603 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Astepro Allergy Nasal Spray Astelin Nasal Spray Astepro Astepro Allergy Children Astepro Allergy

🏭 Manufacturers & labelers

Bayer HealthCare LLC. 6 A-S Medication Solutions 5 Apotex Corp. 5 RPK Pharmaceuticals, Inc. 4 Aurobindo Pharma Limited 4 Bryant Ranch Prepack 3 Preferred Pharmaceuticals Inc. 3 Amneal Pharmaceuticals LLC 3 AvKARE 3 Aurohealth LLC 2 Ascend Laboratories, LLC 2 Cvs Pharmacy, Inc 2 NuCare Pharmaceuticals,Inc. 2 Allegiant Health 2 Proficient Rx LP 2 Zydus Pharmaceuticals USA Inc. 1 Zydus Lifesciences Limited 1 YYBA Corp 1 West-Ward Pharmaceuticals Corp. 1 Walgreens 1 Zydus Pharmaceuticals (USA) Inc. 1 Sun Pharmaceutical Industries, Inc. 1 Padagis Israel Pharmaceuticals Ltd 1 NorthStar Rx LLC 1

…and 4 more on the FDA NDC directory.

RxNorm drug class

Azelastine Nasal Spray belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Other antihistamines for systemic use, Other antiallergics
How it works Histamine H1 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 4, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Azelastine Nasal Spray.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Azelastine Nasal Spray after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
25
NDC products indexed
61
Distinct labelers/manufacturers represented
28
Linked representative label ⓘ
Bayer HealthCare LLC.
Linked label effective
Dec 4, 2025
Composite sections available
26
Linked SPL Set ID
e0640846-19a6-7f79-e053-2995a90a8176
Linked SPL Document ID
452641af-4731-7fc3-e063-6394a90abceb
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 25 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bayer HealthCare LLC. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.