Pharmacologic class (EPC) · 4 drug pages

Vasoconstrictor: adverse event reports filed with FDA

4,013 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,013
reports across the class: 0% of all reports; 385
reports, 12 months to June 2026: 605 in the 12 months before; 41.3%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Vasoconstrictor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,013 adverse event reports received by FDA, 0% of the database, from February 2004 to June 2026.

385 reports arrived in the 12 months to June 2026, down 36% from 605 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 41.3% of the class's reports are marked serious, 0.8% record death among the outcomes and 2.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug dependence (29.8%), drug ineffective (12.2%) and vision blurred (6.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
UpneeqOxymetazoline hydrochloride ophthalmic	brand	1,701	270	5.1%	Drug ineffective
Oxymetazoline hydrochloride	generic	1,017	14	30.9%	Drug ineffective
Afrin Original NasalOxymetazoline hydrochloride	brand	682	101	99.1%	Drug dependence
Afrin OriginalOxymetazoline hydrochloride	brand	613	0	94.8%	Drug dependence

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug dependencedependence on a medicine29.8%1,194
Drug ineffectivethe medicine did not work as expected12.2%490
Vision blurredblurred vision6.3%251
Eye irritationeye irritation5.4%215
Ocular hyperaemiaa red eye5.2%209
Off label useused for a purpose or in a way not on the label4.9%197
Headachehead pain4.8%191
Product use issuea problem in how the product was used3.7%150
Eye paineye pain3.5%142
Dry eyedry eye3.5%139
Mydriasis3%119
Dyspnoeashortness of breath2.5%100
Nasal discomfort2.2%89
Eye pruritus2.2%88
Incorrect product administration duration2.1%83
Lacrimation increasedwatery eyes2%81
Swelling of eyelid1.8%74
Rebound effect1.7%70
Nasal congestiona blocked nose1.7%68
Dizzinesslight-headedness or unsteadiness1.6%66
Drug effect decreasedthe medicine had less effect1.5%61
Epistaxisnosebleed1.5%61
Eye swellinga swollen eye1.5%61
Blood pressure increaseda raised blood pressure reading1.5%60
Anosmialoss of smell1.4%57

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.8%31

Life-threatening0.6%24

Hospitalisation (initial or prolonged)2.5%99

Disability1%41

Congenital anomaly0%2

Other serious38.6%1,549

Not serious58.7%2,356

Patient age

Under 20.2%10

2 to 110.3%11

12 to 170.6%26

18 to 4412%483

45 to 6415.6%626

65 to 7411%443

75 and over7.5%299

Age not given52.7%2,115

Who reported

Physician5.4%218

Pharmacist0.2%10

Other health professional5.8%232

Lawyer0.1%4

Consumer or non-health professional65.2%2,617

Not given23.2%932

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Vasoconstrictor reports

Which drugs are in the Vasoconstrictor class on this site?

Upneeq, Oxymetazoline hydrochloride, Afrin Original Nasal and Afrin Original. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,013 reports through June 2026, 385 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug dependence (29.8%), drug ineffective (12.2%), vision blurred (6.3%), eye irritation (5.4%) and ocular hyperaemia (5.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.