Are Primatene Mist And Generic Epinephrine Inhalers Safe?

Primatene Mist, as well as other generic epinephrine inhalers, that are powered by chlorofluorocarbons (CFCs) are no longer currently available for the treatment of asthma in the United States. Primatene Mist was approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

Many companies have switched propellants from CFCs to hydrofluoroalkane (HFA). HFA inhalers care used in the same manner as CFC inhalers. No over-the-counter epinephrine inhaler made without CFCs is currently available.

In 2014 an FDA advisory panel voted to not to recommend over the counter marketing for a Primatene Mist HFA inhaler. But after reformulating with HFA propellant and changing the inhaler device, Primatene Mist is once again available over the counter in 2019.

In 2009, federal laws mandated that inhaler propellants (the substance that causes the medicine from your inhaler to enter into your lungs when pressed) change from chlorofluorocarbons (CFCs) to hydroflouroalkane (HFA) in order to decrease ozone levels and protect the environment. This allowed pharmaceutical companies to start increasing costs, as the new propellants were considered a "new drug."

Primatene Mist and other generic epinephrine CFC inhalers were taken off the market in the United States, December 31, 2011.

Other OTC Meds Have Entered the Market

Asthmanefrin is not a CFC or HFA inhaler, but is a device that creates a fine mist that can be inhaled into the lung from a liquid. Single unit doses are placed into the well of the device and the mist is the created and breathe in. You continuously inhale until no more mist is created.

Like Primatene Mist, Asthmanefrin is indicated for the "temporary relief of bronchial asthma, including shortness of breath, tightness of chest and wheezing."

Is Primatene Mist Safe?

Many healthcare providers have concerns about whether it is safe to sell over-the-counter asthma medications. We do not currently sell over-the-counter medications for hypertension, heart disease or cholesterol problems -- so many ask, why for asthma? As a result, a number of researchers have studied whether or not this practice is safe.

In general, Primatene Mist appears safe if used appropriately. An article in Chest, the journal of the American College of Chest Physicians, concluded that "the occasional use of OTC epinephrine inhalers appears to be safe and effective when used according to labeled instruction by individuals with only mild, intermittent disease." However, the authors went on to point out that 20% of people using OTC epinephrine inhalers like Primatene Mist should not be using them, and should actually be on other asthma medication and under the care of a physician.

Additionally, use of drugs like Primatene Mist has been associated with decreased use of inhaled steroids and under-utilization of physician services.

Who Should Use Primatene Mist?

As a physician, I would recommend that anyone who feels they need to use Primatene Mist see a doctor, as asthma is a serious disease that can get worse quickly. I am concerned that patients with a serious problem will use this over-the-counter medication to avoid seeking medical care.

According to its packaging information, Primatene Mist can be used "for temporary relief of occasional symptoms of mild asthma," such as:

The packaging says to ask a doctor before use if you have:

  • ever been hospitalized for asthma
  • heart disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • seizures
  • narrow angle glaucoma

Primatene Mist Side Effects

Common side effects of Primatene Mist include:

  • Appetite changes
  • Dizziness
  • Headache
  • Hyperactivity
  • Nausea
  • Nervousness
  • Shakiness
  • Sinus pain
  • Sore throat
  • Tremor
  • Trouble sleeping
  • Vomiting

More Serious Side Effects of Primatene Mist

Some Primatene Mist side effects require you to see a healthcare provider immediately. These would include:

  • Allergic reactions, like rash, hives, difficulty breathing, and swelling of the mouth, face, lips, or tongue
  • Chest pain
  • Ear pain
  • Fast or irregular heartbeat
  • Hoarseness
  • Pounding in the chest
  • Red, swollen, blistered, or peeling skin
  • Severe headache or dizziness
  • Trouble breathing

Buying Primatene Mist & Other Asthma Medications Over the Internet

I am commonly asked by patients if it is safe to purchase OTC medications, like Primatene Mist, and prescription medications over the Internet. The short answer is that if you use a reputable company and follow a few steps, it is probably just as safe as your local pharmacy. Reputable companies:

  • Are located in the U.S. and licensed by the National Association of Boards of Pharmacy (NABP)
  • Have a licensed pharmacist available to you to address any concerns you have about your asthma medication, just as the pharmacy down the street would
  • Only fill prescriptions for appropriately licensed healthcare providers
  • Do not sell products not approved by the FDA
  • Participate in the Verified Internet Pharmacy Practice Sites (VIPPS) certification program
  • Protect your privacy and keep your personal information safe

Financial Help for Asthma Medications

There are a number of patient assistance programs that can help you obtain free or low-cost asthma medications. The programs are all very different and will have different rules and qualification standards.

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Article Sources

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  1. U.S. Food & Drug Administration. CDER conversation: safely using the newly available OTC asthma inhaler Primatene Mist. Updated November 9, 2018.

  2. OINDP news. FDA approves OTC Primatene Mist for mild asthma. Updated November 8, 2018.

  3. Velsor-friedrich B, Militello LK, Zinn KK, Dewolff DK. Switching from CFC to HFA inhalers: what NPs and their patients need to know. Am J Nurse Pract. 2009;13(10):45-50.

  4. Young S. No more Primatene Mist in the U.S. after this year. CNN. Updated September 22, 2011.

  5. University of Florida, College of Pharmacy. Over-the-counter medicine not the best option for asthma. Updated May 9, 2014.

  6. U.S. Food & Drug Administration. Center for Drug Evaluation and Research. Summary review for regulatory action. Updated November 7, 2018. 

  7. U.S. Food & Drug Administration. Primatene. Updated November 7, 2019.

  8. Drugs.com. Primatene mist. Updated July 18, 2019.

  9. U.S. Food & Drug Administration. Buying prescription medicine online: a consumer safety guide. Updated 2019.

Additional Reading

  • Armstrong Pharmaceuticals. 
  • Dickinson BD, Altman RD, Deitchman SD and Champion HC. Safety of Over-the-Counter Inhalers for Asthma. Chest 2000;118;522-526.
  • FDA. Accessed January 31, 2010. Epinephrine CFC Metered-dose Inhalers - Questions and Answers
  • Kuschner WG, Hankinson TC, Wong HC and Blanc PD. Nonprescription Bronchodilator Medication Use in Asthma. Chest 1997;112;987-993.