Is azelastine over the counter?

In this article:

• Is azelastine over the counter?
• OTC Astepro vs. prescription azelastine
• What does azelastine treat?
• How to use azelastine
• Side effects
• Cost
• FAQs

In this article

• Is azelastine over the counter?
• OTC Astepro vs. prescription azelastine
• What does azelastine treat?
• How to use azelastine
• Side effects
• Cost
• FAQs

When it comes to most medications, it’s easy to tell and to remember whether you can buy them over the counter (OTC) or if they require a prescription. Ibuprofen? Definitely OTC. Antibiotics? Prescription all the way. But for some drugs, the line can get a little fuzzy. One of these is azelastine antihistamine nasal spray, which can refer to both an OTC brand-name product and a prescription-only generic.

So, what’s the difference? Keep reading to learn exactly what azelastine-based medications you can find on drugstore shelves and which ones require a prescription, plus how to determine the right treatment for your allergy symptoms.

Is azelastine over the counter?

Yes, you can get azelastine nasal spray over the counter, but it is sold under a different name. “The OTC version is called Astepro Allergy,” says Oluwatosin Ajao, MD, an internal medicine physician and founder of Hydration Bar MD. “It contains 0.15% azelastine.” In 2021, the U.S. Food and Drug Administration (FDA) approved  over-the-counter Astepro, making it the first nasal antihistamine available without a prescription. Astepro is approved for use in children and adults ages 6 and older. Next to Astepro Allergy on the shelf is Children’s Astepro Allergy, which is actually the exact same FDA-approved formulation as regular Astepro, just with different directions on how to use it (and a different label).

Now, the key distinction is that unlike many other OTC medications, you won’t find a generic version on the shelf next to Astepro. Generic azelastine is still only available with a prescription. Why? “[Prescription] azelastine exists in different formulations and strengths,” explains Sue Ojageer, Pharm.D., a pharmacist and founder of PharmaSue, a concierge health practice. “For example, azelastine 0.1% nasal spray has prescription products, and combination nasal sprays containing azelastine plus fluticasone may also be prescription products. Azelastine is also available in an ophthalmic formulation for the eyes.” Only the precise formulation used in Astepro Allergy has been approved by the FDA for sale over the counter.

What’s the difference between OTC Astepro and prescription azelastine?

On the inside? Very little. “The active ingredient and strength are the same in OTC Astepro Allergy and [one formulation of] prescription azelastine. Both contain azelastine 0.15%,” Dr. Ajao says. “The main differences are how authorities approve and label them, not how the medicine works.”

However, additional strengths and formulations of azelastine are prescription only, including 0.1% and all azelastine eye drops.

Ultimately though, the main difference is a regulatory issue. “The fact that a medication moves from prescription to OTC status does not mean the active ingredient suddenly became different,” Dr. Ojageer explains. “It means the FDA determined that the specific product can be used safely and effectively by consumers according to the OTC labeling without the supervision required for a prescription.”

What does azelastine treat?

“Azelastine is an antihistamine,” Dr. Ojageer says. It’s not a steroid, despite being shelved next to steroid nasal sprays like Flonase (fluticasone) and Nasonex (mometasone). Azelastine works by blocking the action of histamine, the substance that causes allergy symptoms, to quickly get rid of nasal congestion, runny nose, sneezing, and nasal itching. “One of the biggest benefits is that it starts working quickly, usually within about 15 minutes,” Dr. Ajao adds.

OTC Astepro Allergy is approved to treat allergy symptoms caused by allergic rhinitis, while some prescription azelastine sprays are approved to treat a runny or stuffy nose that is not caused by allergies (vasomotor rhinitis). Prescription azelastine eye drops treat allergic conjunctivitis, or itchy eyes caused by allergies.

How do you use azelastine nasal spray?

Children between 6 and 11 years old should use 1 spray of Astepro Allergy in each nostril every 12 hours and no more than 2 sprays per nostril every 24 hours. Adults and children older than 12 may use 2 sprays in each nostril once daily or 1 to 2 sprays in each nostril every 24 hours, not exceeding 4 sprays per nostril every 24 hours. If you are using prescription azelastine nasal spray, make sure to follow the specific instructions from your prescribing provider, as the formulation or strength may be different.

“Technique can make a big difference with nasal sprays,” Dr. Ojageer says. “First, blow your nose gently to clear the nasal passages. Keep your head tilted slightly downward rather than leaning it backward, insert the spray tip into the nostril and sniff gently while spraying.” Even though it may seem counterintuitive, Dr. Ojageer warns against tilting your head back immediately after using the spray. “[Keeping your head forward] can help prevent the medication from running down the throat and may reduce the bitter taste that some people experience with azelastine,” she explains.

It’s also important to prime the bottle, which just means that you’re getting it ready to spray when you put it in your nose. “Before you use it for the first time, spray it into the air four times until you see a fine mist. If you have not used it for three days or more, spray it into the air two times before using it again,” Dr. Ajao suggests. This way, you can be sure that you’re getting a full dose of the medication when you use it.

What are the side effects of azelastine?

Azelastine may cause side effects. While none are serious, you should call your healthcare provider if any of the following become severe or don’t go away:

• Bitter taste
• Nasal burning, pain, or nosebleeds
• Headache
• Sore throat
• Dry mouth
• Dizziness
• Nausea
• Tiredness

“Azelastine can cause drowsiness in some people, so patients should see how it affects them before driving or operating machinery,” Dr. Ojageer says. “Alcohol, sedatives, and tranquilizers may increase that drowsiness.” So, be careful with combining them.

If you develop a skin rash after using azelastine, seek emergency medical treatment, as this can be a sign of a serious allergic reaction.

How much does azelastine cost?

OTC Astepro Allergy typically retails for between $15 and $21, depending on where you buy it. Prescription generic azelastine retails higher, around $130 for a 30 ml bottle of 0.1% azelastine, but can be purchased for $9 with a SingleCare Prescription Discount Card. Just show the coupon to your pharmacist when you pick up the medication.

Frequently asked questions

Is generic azelastine available over the counter, or only the Astepro brand?

Only Astepro Allergy is available over the counter. Generic azelastine is available with a prescription.

Does insurance or a discount card cover azelastine nasal spray?

Insurance may cover prescription azelastine, but it varies based on your plan. You save on prescription azelastine by using a SingleCare coupon.

Can I take azelastine with other allergy medications like Flonase?

Yes, using azelastine and a different type of medication like Flonase can work better than one medication alone for moderate to severe allergies, Dr. Ajao says. In fact, azelastine and fluticasone are available combined into a single prescription nasal spray called Dymista.