Pharmacologic class (EPC) · 7 drug pages

Catecholamine: adverse event reports filed with FDA

22,692 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.

22,692
reports across the class: 0.1% of all reports; 1,913
reports, 12 months to June 2026: 2,328 in the 12 months before; 75.4%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Catecholamine is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 22,692 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,913 reports arrived in the 12 months to June 2026, down 18% from 2,328 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 75.4% of the class's reports are marked serious, 16.9% record death among the outcomes and 38.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (27.5%), off label use (7%) and product quality issue (6.9%). 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
Epinephrine	generic	10,460	877	76%	Drug ineffective
Norepinephrine	generic	4,736	372	98%	Drug ineffective
EpipenEpinephrine	brand	3,696	201	50.1%	Device failure
Norepinephrine bitartrate	generic	1,545	361	92.4%	Drug ineffective
Dopamine	generic	947	71	95.9%	Drug ineffective
Epipen JrEpinephrine	brand	664	18	36.3%	Product quality issue
Auvi-q	generic	644	13	16.1%	Accidental exposure to product

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 expected27.5%6,249
Off label useused for a purpose or in a way not on the label7%1,587
Product quality issuea problem with the product itself6.9%1,576
Hypotensionlow blood pressure6.5%1,482
Device failurethe device failed5.8%1,310
Drug hypersensitivityan allergic-type reaction to a medicine5%1,135
Condition aggravatedthe condition being treated got worse4.9%1,112
Toxicity to various agentspoisoning or toxic effect of one or more substances4.1%938
Accidental exposure to product4%909
Cardiac arrestthe heart stopped3.7%842
Cardiogenic shockshock from the heart failing to pump3.7%840
Multiple organ dysfunction syndromeseveral organs failing3.2%730
Dyspnoeashortness of breath3.1%702
Liquid product physical issue2.7%607
Nauseafeeling sick2.6%591
Vomitingbeing sick2.6%588
Bradycardiaslow heart rate2.5%575
Acute kidney injurysudden loss of kidney function2.5%572
Overdosea dose above the recommended amount2.4%547
Tachycardiafast heart rate2.4%537
Product use in unapproved indicationused for a purpose not on the label2.4%536
Hypertensionhigh blood pressure2.2%504
Metabolic acidosistoo much acid in the body fluids2.1%486
Stress cardiomyopathy2.1%473
Ventricular fibrillationa chaotic rhythm from the lower heart chambers2%459

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death16.9%3,831

Life-threatening23.9%5,432

Hospitalisation (initial or prolonged)38.1%8,647

Disability2.8%631

Congenital anomaly1%229

Other serious46%10,446

Not serious24.6%5,573

Patient age

Under 22.2%492

2 to 114.7%1,071

12 to 173.9%894

18 to 4419.1%4,328

45 to 6419.3%4,378

65 to 749.4%2,127

75 and over7.9%1,799

Age not given33.5%7,603

Who reported

Physician22%4,994

Pharmacist8%1,821

Other health professional42%9,523

Lawyer0.1%26

Consumer or non-health professional25.3%5,741

Not given2.6%587

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 Catecholamine reports

Which drugs are in the Catecholamine class on this site?

Epinephrine, Norepinephrine, Epipen, Norepinephrine bitartrate, Dopamine and Epipen Jr and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

22,692 reports through June 2026, 1,913 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 (27.5%), off label use (7%), product quality issue (6.9%), hypotension (6.5%) and device failure (5.8%).

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.