FDA Warns That Abuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm (2021)

On March 25, 2021, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication warning that the abuse and misuse of propylhexedrine — a nasal decongestant sold over the counter (without a prescription) in an inhaler — “can lead to serious harm such as heart and mental health problems,” some of which “can lead to hospitalization, disability, or death.” The agency asked every manufacturer of these inhalers to consider design changes that support safe use. The condition the medicine is labeled for is described on the site’s Allergic Rhinitis (Hay Fever) page.

This page reports what the FDA’s own documents say: what the agency announced and asked for, what the medicine is and how it is labeled, the poison-center, adverse-event and literature data the FDA reviewed, the harms it describes, what the warning does not do, its status as of October 18, 2026, and how it fits other FDA actions on misused medicines. No brand or manufacturer is named here.

Table of Contents

  1. What the FDA Announced on March 25, 2021
  2. What the FDA Asked Manufacturers to Do
  3. What Propylhexedrine Is and How It Is Labeled
  4. What the FDA Found in Poison Control Center Data
  5. What the FDA Found in Its Own Reports and Emergency Department Data
  6. What the Published Medical Literature Showed
  7. The Harms the FDA Describes
  8. What the FDA Tells Consumers and Health Care Professionals
  9. What the Warning Does Not Do
  10. Dates and Legal Status as of October 18, 2026
  11. How It Fits Other FDA Actions on Misused Medicines
  12. Primary Documents
  13. Key Research Papers
  14. Connections
  15. Featured Videos

1. What the FDA Announced on March 25, 2021

The action took the form of an FDA Drug Safety Communication, dated March 25, 2021 — a public notice, written in question-and-answer form, in which the agency sets out a safety concern about a medicine, what it is doing about it and what it found. It was published on the FDA’s website, with a PDF copy, a Spanish version and a recorded Drug Safety Podcast. It was not a Federal Register document, so it carries no Federal Register citation and no public docket (the numbered public file where an agency collects comments on a proposal).

The communication’s headline reads: “FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm,” with the subtitle “This includes heart and mental health problems or death.” Its opening answer states that the complications “include fast or abnormal heart rhythm, high blood pressure, and paranoia,” and that “Reports of individuals abusing and misusing propylhexedrine have increased in recent years.”

In the same paragraph the FDA adds a sentence that frames the whole warning: “Propylhexedrine is safe and effective when used as directed.” The concern the agency describes is with use outside the directions on the label, not with the medicine used as labeled.

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2. What the FDA Asked Manufacturers to Do

Under the heading “What is FDA doing?” the agency wrote: “We are requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use.”

The FDA gave two examples of the kind of change it had in mind:

The request asks manufacturers to consider these changes; the communication does not state a deadline or require a particular design. The FDA closed the section with: “We continue to evaluate this safety issue and will determine if additional FDA actions are needed.”

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3. What Propylhexedrine Is and How It Is Labeled

The FDA describes propylhexedrine as “a nasal decongestant that is available OTC in an inhaler.” “OTC” means over the counter: it can be bought without a prescription. According to the communication, it “is used short term to temporarily relieve nasal congestion due to colds, hay fever, or other upper respiratory allergies,” and it “works by reducing swelling and inflammation of the mucous membrane lining of the nose.”

The communication restates the labeled directions:

The FDA lists the common side effects of the medicine when used as labeled as “temporary discomfort such as burning, stinging, sneezing, or increasing nasal discharge.” The communication also states that the medicine was, at the time, marketed under only one brand name (not named here).

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4. What the FDA Found in Poison Control Center Data

The FDA’s Data Summary explains that, “In response to increasing reports of abuse and misuse of propylhexedrine,” the agency reviewed calls to U.S. poison control centers, case reports submitted to the FDA and published in the medical literature, cases seen in U.S. emergency departments, and an observational study.

From the national poison-center database (the American Association of Poison Control Centers’ National Poison Data System), the FDA reported:

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5. What the FDA Found in Its Own Reports and Emergency Department Data

The FDA also reviewed two further sources: the FDA Adverse Event Reporting System (FAERS), the database that holds side-effect reports sent voluntarily to the agency, from January 1969 through January 31, 2020; and the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project (NEISS-CADES), which tracks emergency department visits, from January 1, 2016, through December 31, 2018.

The FDA adds: “There are likely additional cases that we have not identified.”

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6. What the Published Medical Literature Showed

The FDA reviewed “49 case reports and an observational study published in the medical literature,” and states that “These publications showed similar findings compared to the cases identified from poison control calls and emergency department visits and the cases reported to FDA.”

The communication lists its 25 references, several of which appear in the Key Research Papers section below.

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7. The Harms the FDA Describes

Across the data sources, the FDA lists the most commonly reported side effects of abuse and misuse as rapid heart rate, agitation, high blood pressure, chest pain, tremor, hallucinations, delusions, confusion, nausea and vomiting.

In its information for consumers, the FDA describes the serious heart and mental health problems as including “fast or abnormal heart rhythms, high blood pressure, heart attack, heart failure, agitation, delusions, paranoia, hallucinations, and death even after a few hours of abuse or misuse.” Related conditions are described on the site’s Arrhythmia, Hypertension, Heart Attack and Heart Failure pages.

In its information for health care professionals, the FDA lists the major problems that may have to be managed during intoxication: “severe agitation, tachycardia, hypertension, myocardial infarction, hyperthermia, stroke, bowel obstruction, pulmonary hypertension, and seizures.” It adds: “Long-term use can also lead to lung damage, arrhythmias, and cardiac damage.” The communication states that there is no specific reversal agent (no antidote) for acute propylhexedrine intoxication, so care is symptomatic and supportive.

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8. What the FDA Tells Consumers and Health Care Professionals

The communication contains the FDA’s own guidance to two audiences. It is reported here as the agency’s statement.

To consumers, the FDA states that propylhexedrine is to be used only according to the directions on its Drug Facts label (the standard information panel on an over-the-counter medicine), and warns that using it “in ways other than by inhalation” can cause serious harm, including heart and mental health problems, some of which can lead to death. The FDA directs people to call 911 or poison control (1-800-222-1222) for anyone using propylhexedrine who has severe anxiety or agitation, confusion, hallucinations or paranoia; a rapid heartbeat or abnormal heart rhythm; or chest pain or tightness. Its consumer section also notes that inhalers are not to be shared, because use by more than one person “may spread infection,” and points people with questions to a pharmacist or health care professional.

To health care professionals, the FDA writes that “some individuals are abusing or misusing propylhexedrine, particularly using it by routes other than nasal inhalation,” which “can result in serious cardiac and psychiatric adverse events or death.” In a suspected overdose, the agency describes trying to determine whether a patient used propylhexedrine alone or with other substances, and it asks clinicians to counsel consumers not to exceed the labeled dose.

Both audiences are asked to report side effects to the FDA’s MedWatch program.

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9. What the Warning Does Not Do

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10. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: the warning stands as issued, and no later FDA action on propylhexedrine was found. A Federal Register check for documents mentioning propylhexedrine from January 1, 2021, through October 18, 2026, returned none, and the communication itself had not been updated with any follow-up action. Propylhexedrine remains an over-the-counter nasal decongestant. The communication does not report whether any manufacturer changed its inhaler design in response to the request.

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11. How It Fits Other FDA Actions on Misused Medicines

The propylhexedrine warning was one of several Drug Safety Communications the FDA issued in 2021. Others covered here include the boxed warnings on JAK inhibitors and the removal of the strongest statin warning against use in pregnancy; the same year the agency also acted on hand-sanitizer safety and on a nitrosamine impurity in varenicline.

Later FDA actions covered here deal with the misuse of other medicines and substances, by different tools:

Background on substance use, from a medical rather than regulatory angle, is on the site’s Addiction and Substance Use Disorders page, and stimulant harms from other products are covered under Stimulants in Weight-Loss and Energy Products.

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12. Primary Documents

  1. U.S. Food and Drug Administration. FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm: This includes heart and mental health problems or death. FDA Drug Safety Communication, March 25, 2021 (content current as of April 13, 2021). Not a Federal Register document; no docket — fda.gov Drug Safety Communication
  2. U.S. Food and Drug Administration. Drug Safety Communication, March 25, 2021 (PDF version, 93 KB) — fda.gov Drug Safety Communication PDF
  3. U.S. Food and Drug Administration. FDA Drug Safety Podcast: FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm (content current as of January 20, 2022) — fda.gov Drug Safety Podcast
  4. U.S. Food and Drug Administration. Spanish-language version of the Drug Safety Communication (La FDA advierte que el abuso y el uso indebido del descongestionante nasal propilhexedrina causan daños graves) — fda.gov Comunicado de seguridad
  5. U.S. Food and Drug Administration. Drug Safety Communications (index of all communications) — fda.gov Drug Safety Communications

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Key Research Papers

  1. Pakkir Maideen NM, Rashid SA (2026). Cardiovascular and Cerebrovascular Events Linked to Abuse and Misuse of Sympathomimetic Nasal Decongestants: A Narrative Review of Clinical Evidence. Cardiovascular & Hematological Agents in Medicinal Chemistry 24(1):33-44 — PubMed PMID: 41603177
  2. Horowitz KM, Cassidy E, Temple C (2024). Neurologic Deficits Following Oral Misuse of the Nasal Decongestant Propylhexedrine. Journal of Medical Toxicology 20(4):427-429 — PubMed PMID: 39103667
  3. Teja N, Dodge CP, Stanciu CN (2020). Abuse, Toxicology and the Resurgence of Propylhexedrine: A Case Report and Review of Literature. Cureus 12(10):e10868 — PubMed PMID: 33178521
  4. Fernandez Julia P, Francis EM (2012). Propylhexedrine: a vintage drug of abuse, rediscovered. Journal of Psychoactive Drugs 44(3):277-279 — PubMed PMID: 23061329
  5. Holler JM, Vorce SP, McDonough-Bender PC, Magluilo J Jr, Solomon CJ, Levine B (2011). A drug toxicity death involving propylhexedrine and mitragynine. Journal of Analytical Toxicology 35(1):54-59 — PubMed PMID: 21219704
  6. Smith DE, Wesson DR, Sees KL, Morgan JP (1988). An epidemiological and clinical analysis of propylhexedrine abuse in the United States. Journal of Psychoactive Drugs 20(4):441-442 — PubMed PMID: 2907528
  7. Croft CH, Firth BG, Hillis LD (1982). Propylhexedrine-induced left ventricular dysfunction. Annals of Internal Medicine 97(4):560-561 — PubMed PMID: 6127046

The first paper is a 2026 narrative review of heart and brain-circulation events reported with the abuse and misuse of stimulant-type nasal decongestants. The second and third are case reports published around and after the FDA warning; a 2019 conference poster with the same title as the third, by two of its authors, is in the FDA’s reference list. The last four — a review of the drug’s re-emergence, a toxicology death report, a 1980s U.S. analysis and an early report of heart-muscle dysfunction — are among the literature the FDA cites in its Data Summary.

PubMed Topic Searches

  1. PubMed: propylhexedrine
  2. PubMed: propylhexedrine toxicity
  3. PubMed: nasal decongestant misuse

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Connections

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