OTC Update: Asthma Medications

Drug Topics JournalDrug Topics February 2022
Volume 166
Issue 02

Patients seeking OTC remedies for asthma should be counseled on the risks associated with OTC asthma products.

When patients first experience asthma symptoms, their first instinct may be to try an over-the-counter (OTC) bronchodilator. That these remedies are sold OTC may lead patients to believe that there are no contraindications—but that’s far from the case.

Asthma is a chronic disease in which lung airways become inflamed and narrow, making it difficult for the patient to breathe. Asthma symptoms include shortness of breath, chest tightness or pain, wheezing, and coughing. While OTC products may temporarily alleviate some symptoms, the inflammation associated with repeated asthma attacks can permanently scar airways. Patients need to relieve symptoms, but they also need a way to prevent future attacks. For that reason, asthma is best treated under medical supervision, and getting a professional diagnosis is an important first step.

“There are other diseases with similar symptoms,” said Melanie Carver, chief mission officer, Asthma and Allergy Foundation of America (AAFA). “People with asthma strongly benefit from having an accurate diagnosis and a tailored treatment approach from an allergist, pulmonologist, or primary care provider. The National Institute of Health’s Guidelines for the Diagnosis and Management of Asthma1 recommend the use of control medicines to reduce airway swelling and inflammation and quick-relief medicines to open the airways. These asthma guidelines do not recommend the use of [OTC] products.”

Asthma medications relax the muscles around the airways while reducing swelling and mucus inside. Approved treatment regimens2 can include a combination of short- and long-term bronchodilators, as well as oral medications, to prevent and treat asthma symptoms. While some OTC products are promoted as useful for mild, intermittent asthma, that recommendation is not necessarily echoed by medical professionals.

“According to the national guidelines that were updated in December 2020, patients with very mild asthma would be on a short-acting bronchodilator,” said Rachel L. Miller MD, FAAAAI, system division chief, Division of Clinical Immunology, Icahn School of Medicine at Mount Sinai. “No [OTC] asthma medications are recommended for patients without evaluation by a physician.”

Two OTC products currently sold to treat asthma are Primatene Mist HFA, an inhaler containing epinephrine, and Asthmanefrin, a bronchodilator that contains racepinephrine. Primatene Mist HFA is the only nonprescription inhaler approved by the FDA,3 but that approval comes with certain conditions.

“The FDA recommends that [OTC] products for asthma…only be used by people with a prior diagnosis of mild intermittent asthma,” Carver explained, adding that regular use of these products may lead to medication overuse because underlying lung inflammation is not being treated. “The medication should not be used by patients who have heart disease, high blood pressure, diabetes, thyroid disease, seizures, benign prostatic hyperplasia, or glaucoma,” Carver added.

Primatene Mist HFA was removed from pharmacy shelves in 2011 because it used chlorofluorocarbons (CFCs), a propellant banned by the EPA. The inhaler returned to the market in 2019 after CFCs were replaced with hydrofluoroalkane (HFA). However, medical professionals and health organizations like the AAFA, the American Thoracic Society,4 and the American Association for Respiratory Care5 expressed concerns about the decision to return Primatene to the shelves, citing the potential for misuse and the lack of efficacy. Epinephrine can overstimulate the heart and studies have found it less effective than albuterol, found in prescription medications such as Ventolin HFA.

“These OTC products also have side effects to be aware of such as increased blood pressure or heart rate,” Carver said. “Patients should not stop or switch their prescribed asthma medicines to take [OTC] options instead. If someone is experiencing asthma symptoms 2 or more times per week, they need medical care to assess their asthma severity and control.”

Tommy Thompson, RPh, owner of Mechanicsville Drug Store in Mechanicsville, Virginia, believes OTC medications like Primatene have their place.

“They’re not widely used in my pharmacy because most of my customers have some kind of relationship with a physician,” Thompson said. “The albuterol inhalers are effective, and most people have insurance that covers them.”

Thompson notes that most patients who buy these OTC products have already seen a physician, but occasionally people will buy OTC medications because they are waiting to see their physician or cannot afford the visit. Keeping these medications behind the counter gives Thompson a chance to ask patients about their symptoms and discuss treatment options.

“If someone is taking it for the wrong reasons, we are going to suggest that it won’t help,” said Thompson. “That’s why we keep it behind the counter—not because it’s being abused a lot where we are, but more so that we can counsel patients about why they are using it.”

View the rest of our February 2022 issue here.


  1. 2020 focused updates to the asthma management guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. National Institutes of Health. December 2020. Accessed January 4, 2022. https://www.nhlbi.nih.gov/health-topics/all-publications-and-resources/2020-focused-updates-asthma-management-guidelines
  2. Understand your asthma medication. American Lung Association. Updated June 23, 2020. Accessed January 4, 2022. https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/living-with-asthma/managing-asthma/understand-your-medication
  3. FDA statement on approval of OTC Primatene Mist to treat mild asthma. News release. FDA. November 8, 2018. Accessed January 4, 2022. https://www.fda.gov/news-events/press-announcements/fda-statement-approval-otc-primatene-mist-treat-mild-asthma
  4. Sadreameli SC, Brigham EP, Patel A. The surprising reintroduction of Primatene Mist in the United States. Ann Am Thorac Soc. 2019;16(10):1234-1236. doi:10.1513/AnnalsATS.201902-164HP
  5. Willden H. FDA announces new OTC option, AARC raises concerns. American Association for Respiratory Care. November 9, 2018. Accessed January 4, 2022. https://www.aarc.org/fda-announces-new-otc-option-aarc-raises-concerns/
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