Azelastine (nasal spray)
Pronunciation: pronunciation varies by local usage.
- Generic name
- azelastine hydrochloride
- Brand names
- ASTEPRO ALLERGY, ASTELIN, ASTEPRO
- Drug class
- Antihistamine
- Form
- Metered nasal spray
- Route
- Intranasal
- Legal status
- Over-the-counter (Astepro Allergy 0.15%) and prescription-only (Astelin 0.1%) nasal spray
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What azelastine hydrochloride is and how it works
Azelastine hydrochloride is a nasal-spray antihistamine that temporarily relieves symptoms of allergic rhinitis (hay fever) such as nasal congestion, runny nose, sneezing, and itchy nose. An OTC product (Astepro Allergy 0.15%) is approved for ages 6 and older; the prescription product Astelin (0.1%) is approved for seasonal allergic rhinitis (ages 5+) and for vasomotor rhinitis (ages 12+). (1) (2)
This page covers nasal-spray forms only; ophthalmic azelastine is a separate product not addressed here.
Mechanism of action: how azelastine hydrochloride works
Azelastine is an antihistamine. Not established from the sources reviewed: further mechanistic detail beyond this was not established in the sources reviewed for this page. (1) (2)
What azelastine hydrochloride is used for
Allergic rhinitis (hay fever) — OTC (Astepro Allergy)
For adults and children 6 years and older: temporarily relieves nasal congestion, runny nose, sneezing, and itchy nose caused by hay fever or other upper-respiratory allergies. Children 6–11 years require adult supervision. (1)
Seasonal allergic rhinitis — prescription (Astelin)
For patients 5 years and older: treatment of seasonal allergic rhinitis symptoms such as rhinorrhea, sneezing, and nasal itching. (2)
Vasomotor rhinitis — prescription (Astelin)
For patients 12 years and older: treatment of vasomotor rhinitis symptoms including rhinorrhea, nasal congestion, and postnasal drip. (2)
Before taking azelastine hydrochloride
Do not take / not appropriate for
- This product should not be used by anyone with a known allergy to azelastine hydrochloride or any ingredient in the product; discuss with a healthcare professional or pharmacist if you are uncertain about a prior reaction. (all products) (1) (2)
- The OTC product (Astepro Allergy) is not recommended for children under 6 years; the prescription product (Astelin) is approved for seasonal allergic rhinitis from 5 years and for vasomotor rhinitis from 12 years. (age-specific) (1) (2)
Tell your clinician about
- Any history of recent nasal ulcers, nasal surgery, or unhealed nasal injury (noted on the OTC product label).
- If you are pregnant or breastfeeding.
- All medications you are currently taking, especially alcohol, sedatives, tranquilizers, cimetidine (a stomach acid reducer), or other central nervous system depressants.
- If you develop severe or frequent nosebleeds.
How to take azelastine hydrochloride
- Azelastine nasal spray is for intranasal use only. Follow the specific product's instructions for use.
- Do not use more than the recommended number of sprays in 24 hours for your specific product and age group: see product-specific dosing below.
- If drowsiness occurs, avoid driving or operating machinery, and avoid alcoholic beverages and other CNS depressants.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3)
Missed dose
No specific missed-dose rule is stated in the product labels. If you miss a dose, refer to the product instructions or ask your pharmacist. Do not use extra sprays to catch up.
Overdose
If overdose is suspected, seek medical attention immediately or contact a Poison Control Center. (1) (2)
Side effects
The most commonly reported adverse reactions include bitter taste, headache, somnolence, nasal burning, and pharyngitis. Drowsiness may occur; avoid driving or operating machinery if affected.
Bitter taste
What to notice: A bitter or unpleasant taste in the mouth after spraying. Bending the head slightly downward during administration may help reduce the taste.
What to do: Usually harmless; if intolerable, discuss with a healthcare professional. Do not stop using the product without medical advice if prescribed. (1) (2)
Somnolence (drowsiness)
What to notice: Feeling unusually sleepy or fatigued.
What to do: Avoid driving, operating machinery, or drinking alcohol. If severe, contact a healthcare provider. (2)
Headache
What to notice: Mild to moderate headache.
What to do: If persistent or severe, consult a healthcare professional. (2)
Nasal discomfort or sneezing
What to notice: Temporary stinging, burning, itching, or sneezing immediately after spraying.
What to do: Usually short-lived; if persistent, discuss with a clinician. (1)
Nosebleeds (epistaxis)
What to notice: Frequent or prolonged nosebleeds.
What to do: If nosebleeds become severe or troublesome, seek medical evaluation, especially if you have a history of recent nasal ulcers, surgery, or injury. (1) (3)
Other possible side effects
What to notice: Dry mouth, fatigue, dizziness, nausea, weight increase, dysesthesia (unusual sensation), rhinitis, sinusitis, paroxysmal sneezing, and pharyngitis have been reported.
What to do: Discuss any bothersome or persistent symptoms with a healthcare provider. (3)
Severe drowsiness
What to notice: Excessive sleepiness that affects ability to drive, work, or perform daily tasks.
What to do: Consult a healthcare provider; do not drive or operate machinery. (1) (2)
Severe or frequent nosebleeds
What to notice: Severe or frequent nosebleeds.
What to do: Seek medical evaluation promptly, especially if you have a history of recent nasal ulcers, surgery, or injury. (1)
Serious warnings
Known hypersensitivity (allergic reaction) to azelastine or a product ingredient — contact_clinician_promptly
Symptoms: Both the OTC and prescription labels state the product should not be used by anyone with a known allergic reaction to it or its ingredients.
Action: If you suspect an allergic reaction, seek medical attention promptly and let the clinician you see advise on whether to continue or stop azelastine. (1) (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Alcohol, sedatives, tranquilizers, and other CNS depressants | Increased or additive drowsiness and sedation. | Avoid alcohol while using azelastine. Discuss any sedating medications you take with your healthcare provider or pharmacist before combining them. (1) (2) |
| Cimetidine (a stomach acid reducer) | Cimetidine increased azelastine blood levels by approximately 65% in a study. | If you are taking cimetidine, inform your healthcare provider. (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Children and adolescents
The OTC product (Astepro Allergy) is not recommended for children under 6 years. The prescription product (Astelin) is approved for seasonal allergic rhinitis in children 5 years and older, and for vasomotor rhinitis in patients 12 years and older. (1) (2)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, consult a healthcare professional before use. Azelastine was previously classified as FDA Pregnancy Category C; use during pregnancy only if the potential benefit justifies the potential risk. It is unknown whether azelastine passes into breast milk. (1) (2)
Older adults
Discuss use with a healthcare provider.
Renal or hepatic impairment
No dose adjustment information is available for patients with kidney or liver problems. Use under medical supervision.
Monitoring
Before starting
- Verify the correct product and indication, and ensure no history of hypersensitivity to azelastine or excipients.
- Assess for recent nasal ulcers, nasal surgery, or unhealed nasal injury (an OTC-label caution); if present, consult a doctor before use.
- Review all concurrent medications, especially CNS depressants and cimetidine.
During treatment
- Monitor for signs of drowsiness; advise against driving or operating heavy machinery if affected.
- Watch for symptoms of an allergic reaction; seek medical attention promptly and let the clinician you see advise on whether to continue or stop azelastine.
- Evaluate for frequent or severe nosebleeds; if they develop, seek medical attention.
Storage
Store at room temperature between 20-25°C (68-77°F). Protect from freezing. Do not share the bottle with others, to avoid spreading infection.
Professional information
Clinician-facing context only. Use the current local label and guidelines for the specific azelastine product.
United States
Indication: Seasonal allergic rhinitis, vasomotor rhinitis
Dose summary: Use the appropriate product: OTC Astepro Allergy 0.15% for ages 6+ (adults 12+: 2 sprays per nostril once daily or 1-2 sprays per nostril twice daily; children 6-11: 1 spray per nostril twice daily). Prescription Astelin 0.1% for seasonal allergic rhinitis ages 5+ (5-11: 1 spray per nostril twice daily; 12+: 1-2 sprays per nostril twice daily) and vasomotor rhinitis ages 12+ (2 sprays per nostril twice daily).
Renal context: No renal adjustment information is available from the labels reviewed. (1) (2)
Hepatic guidance
No hepatic impairment dosing is available from the reviewed labels. Use local prescribing information and clinical judgement.
Overdose note
In case of overdose, contact a poison control center or seek emergency medical attention. (1) (2)
Frequently asked questions
Can I drink alcohol while using azelastine nasal spray?
It is not recommended. Alcohol can increase the drowsiness caused by azelastine. Avoid alcohol while using this medicine. (1) (2)
Does azelastine nasal spray cause drowsiness?
Yes, somnolence (drowsiness) is a known side effect. Avoid driving or operating machinery until you know how azelastine affects you. (2)
Can my child under 6 years use the OTC spray?
No, the OTC product is not recommended for children under 6 years. For children under 6, consult a healthcare provider for appropriate allergy treatment options. (1)
How can I minimize the bitter taste after using the spray?
Try tilting your head slightly downward while spraying to reduce the amount that reaches the back of your throat. Bitter taste is a common effect. (1)
Is the OTC product the same as the prescription product?
No, they differ in concentration and dosing. The OTC Astepro Allergy is 0.15% and has its own dosing schedule; prescription Astelin is 0.1% with different approved ages and indications. Always use the product as directed by the label or your prescriber. (1) (2)
What is the mechanism of action of azelastine hydrochloride?
Azelastine is an antihistamine. Not established from the sources reviewed: further mechanistic detail beyond this was not established in the sources reviewed for this page. (1) (2)
References
- ASTEPRO ALLERGY — azelastine HCl spray, metered (OTC, 0.15%)U.S. National Library of Medicine DailyMed · United States · accessed 2026-08-05 · source 1
- ASTELIN (azelastine hydrochloride) Nasal Spray (prescription, 0.1%)U.S. National Library of Medicine DailyMed · United States · accessed 2026-08-05 · source 2
- Azelastine (nasal spray) adverse effects — Medscape reference summaryMedscape · United States · accessed 2026-08-05 · source 3
Brand names by country
Single-ingredient azelastine hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Children Astepro Allergy205.5 ug · bayer healthcare llc.
- Astepro Allergy205.5 ug · bayer healthcare llc.