Azelastine (nasal)

FDA label, Apotex Corp., nasal, effective 2026-09-08. Full label on DailyMed

Patient handout

Looking up MedlinePlus…

From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

Important Administration Instructions Administer azelastine hydrochloride nasal spray by the intranasal route only. Priming Prime azelastine hydrochloride nasal spray before initial use by releasing 4 sprays or until a fine mist appears. When azelastine hydrochloride nasal spray has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears.

Avoid spraying azelastine hydrochloride nasal spray into the eyes.

Drug interactions

Check azelastine (nasal) against a medication list
Label text (2 paragraphs)

7 DRUG INTERACTIONS

7.1 Central Nervous System Depressants Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur [see Warnings and Precautions ( 5.1 )].

Contraindications

None. None ( 4 )

Safety data

Reported adverse events (FAERS)

Loading
Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for azelastine (nasal). Check the label's hepatic warnings.

Pregnancy and lactation

Breastfeeding (LactMed)

Small occasional doses of azelastine nasal spray would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use of the nasal spray may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Infant rejection of the breast might occur because of the bitter taste of the drug. The oral, nonsedating antihistamines are preferred alternatives. Because absorption from the eye is limited, azelastine would not be expected to cause any adverse effects in breastfed infants. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Alternatives LactMed suggests considering:
Source: LactMed: Azelastine (NICHD, public domain)Revised Jan 15, 2026

Supply and cost

Drug shortage status

Loading

Recalls (last 24 months)

Loading

Therapeutic equivalence (Orange Book)

Loading

Price ladder

Not the price at the counter
Loading

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

Loading

Recruiting clinical trials

Loading