Pharmacologic class (EPC) · 2 drug pages

alpha-1 adrenergic agonist: adverse event reports filed with FDA

4,830 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.

4,830
reports across the class: 0% of all reports; 765
reports, 12 months to June 2026: 1,055 in the 12 months before; 94%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

alpha-1 adrenergic agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,830 adverse event reports received by FDA, 0% of the database, from February 2004 to June 2026.

765 reports arrived in the 12 months to June 2026, down 27% from 1,055 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 94% of the class's reports are marked serious, 38.2% record death among the outcomes and 54.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (28.1%), off label use (27%) and maternal exposure during pregnancy (23%). 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
Phenylephrine hydrochloride	generic	2,800	613	96.7%	Off label use
Phenylephrine	generic	2,030	152	90.3%	Drug ineffective

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 ineffectivethe medicine did not work as expected28.1%1,355
Off label useused for a purpose or in a way not on the label27%1,302
Maternal exposure during pregnancythe mother took the medicine during pregnancy23%1,110
Pemphigus20.1%970
Joint swellinga swollen joint19.6%946
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease18.8%910
Painpain, site not specified18.8%909
Infusion related reactiona reaction during or soon after an infusion18.4%891
Systemic lupus erythematosuslupus, an autoimmune disease18.4%891
Pericarditisinflammation of the sac around the heart18.2%880
Glossodynia18.2%879
Wound17.9%864
Synovitis17.7%854
Condition aggravatedthe condition being treated got worse17.5%844
Arthropathy17.2%832
Folliculitis17%821
Helicobacter infection17%821
Type 2 diabetes mellitustype 2 diabetes17%820
Rashskin rash16.8%811
Hepatic enzyme increasedraised liver enzymes16.7%805
Hand deformity16.6%800
Mobility decreasedreduced ability to move about16.6%800
Arthralgiajoint pain16.3%785
Hypoaesthesianumbness16.2%782
Swellingswelling16.1%776

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death38.2%1,847

Life-threatening42.6%2,056

Hospitalisation (initial or prolonged)54.6%2,638

Disability33.1%1,601

Congenital anomaly27.1%1,310

Other serious74.8%3,615

Not serious6%290

Patient age

Under 21.7%81

2 to 110.9%42

12 to 171.2%58

18 to 4438.1%1,842

45 to 6412.6%609

65 to 745.6%271

75 and over7.3%354

Age not given32.6%1,573

Who reported

Physician17.9%863

Pharmacist3.8%182

Other health professional70.7%3,414

Lawyer0.1%3

Consumer or non-health professional5.4%261

Not given2.2%107

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 alpha-1 adrenergic agonist reports

Which drugs are in the alpha-1 adrenergic agonist class on this site?

Phenylephrine hydrochloride and Phenylephrine. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,830 reports through June 2026, 765 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 ineffective (28.1%), off label use (27%), maternal exposure during pregnancy (23%), pemphigus (20.1%) and joint swelling (19.6%).

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.