Generic name
Oxymetazoline hydrochloride: adverse event reports filed with FDA
1,017 reports list it as a suspect or interacting product, 2004–2026. Class: Vasoconstrictor. Also reported as Oxymetazoline Hydrochloride Spray.
- 1,017
- reports as suspect product
- 0% of all reports · about 45 a year
- 14
- reports, 12 months to June 2026
- 24 in the 12 months before
- 30.9%
- marked serious by the reporter
- 41.3% across the class
- 1.3%
- record death among outcomes, as reported
- 13 reports · not verified by FDA
1,017 adverse event reports received by FDA list oxymetazoline hydrochloride, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 1,802 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 14 reports listed it, down 42% from 24 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 45 reports a year and 0% of the 20,646,523 reports in the database, and 25.3% of the reports for the vasoconstrictor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (13.4%), drug dependence (9.4%) and nasal discomfort (7.4%). A report can list several reactions, so shares add to more than 100%; 246 different terms appear across these reports. Drug ineffective is recorded in 13.4% of these reports, a larger share than in the median vasoconstrictor drug (9.1%).
30.9% of the reports are marked serious by the reporter (41.3% across the class); 1.3% record death among the outcomes and 6.6% record hospitalisation, as reported. 83.4% of the reports came from consumers, and the largest patient age group is 18 to 44 (26.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Oxymetazoline hydrochloride reports recording the termmedian drug in vasoconstrictor
- Drug ineffectivethe medicine did not work as expected13.4%136
- Drug dependencedependence on a medicine9.4%96
- Nasal discomfort7.4%75
- Drug effect decreasedthe medicine had less effect6%61
- Anosmialoss of smell4.9%50
- Burning sensationa burning feeling4.3%44
- Epistaxisnosebleed3.8%39
- Headachehead pain3.8%39
- Ageusialoss of taste3.5%36
- Rhinorrhoeaa runny nose3.4%35
- Condition aggravatedthe condition being treated got worse3.1%32
- Nasal congestiona blocked nose3.1%32
- Feeling abnormalfeeling odd or not right2.8%28
- Dyspnoeashortness of breath2.7%27
- Rebound effect2.7%27
- Sneezing2.6%26
- Dependence2.5%25
- Off label useused for a purpose or in a way not on the label2.4%24
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2.3%23
- Product quality issuea problem with the product itself2.2%22
- Overdosea dose above the recommended amount1.9%19
- Dizzinesslight-headedness or unsteadiness1.7%17
- Insomniadifficulty sleeping1.7%17
- Painpain, site not specified1.6%16
- Wrong technique in drug usage processthe medicine was used in the wrong way1.6%16
- Blood pressure increaseda raised blood pressure reading1.5%15
- Oropharyngeal painsore throat1.4%14
- Product container issuea problem with the container1.4%14
Top 30 of 246 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the vasoconstrictor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,013 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 92.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Nasal congestion | 138 | 13.6% |
| Respiratory tract congestion | 55 | 5.4% |
| Nasopharyngitis | 45 | 4.4% |
| Hypersensitivity | 20 | 2% |
| Sinus disorder | 12 | 1.2% |
| Epistaxis | 8 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,017 reports.
In context
| Measure | Oxymetazoline hydrochloride | Vasoconstrictor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,017 | 4,013 | 20,646,523 |
| Share of that pool | — | 25.3% | 0% |
| Reports, latest 12 months | 14 | — | 1,332,454 |
| Marked serious | 30.9% | 41.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 13 | 8 | 91 |
| Hospitalisation recorded, per 1,000 reports | 66 | 25 | 213 |
| Consumer-filed share | 83.4% | 65.2% | 45.8% |
| Top term, share of reports | Drug ineffective 13.4% | median 9.1% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the vasoconstrictor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Upneeq | brand | 1,701 | 270 | 5.1% |
| Afrin Original Nasal | brand | 682 | 101 | 99.1% |
| Afrin Original | brand | 613 | 0 | 94.8% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Oxymetazoline hydrochloride reports
How many adverse event reports has FDA received for Oxymetazoline hydrochloride?
1,017 reports list Oxymetazoline hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 14 of them arrived in the latest 12 months. Another 1,802 list it only as a concomitant medication.
What reactions are recorded in Oxymetazoline hydrochloride reports?
drug ineffective (13.4%), drug dependence (9.4%), nasal discomfort (7.4%), drug effect decreased (6%) and anosmia (4.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Oxymetazoline hydrochloride was responsible.
How serious are the reports?
30.9% are marked serious by the reporter. Among the outcomes recorded, 1.3% of reports include death and 6.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (83.4%), not given (6%) and physician (5.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Oxymetazoline hydrochloride rising?
14 reports in the 12 months to June 2026, down 42% from 24 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Oxymetazoline hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Oxymetazoline hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Oxymetazoline hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,802) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.