Pharmacologic class (EPC) · 2 drug pages

Cardiac glycoside: adverse event reports filed with FDA

17,077 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.

17,077
reports across the class: 0.1% of all reports; 426
reports, 12 months to June 2026: 574 in the 12 months before; 94.4%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Cardiac glycoside 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 17,077 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

426 reports arrived in the 12 months to June 2026, down 26% from 574 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 94.4% of the class's reports are marked serious, 25.7% record death among the outcomes and 55.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (13.7%), toxicity to various agents (13.3%) and dizziness (12.7%). 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
Digoxin	generic	15,776	416	95%	Nausea
LanoxinDigoxin	brand	1,301	10	87.7%	Bradycardia

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

Nauseafeeling sick13.7%2,334
Toxicity to various agentspoisoning or toxic effect of one or more substances13.3%2,278
Dizzinesslight-headedness or unsteadiness12.7%2,166
Bradycardiaslow heart rate11.9%2,035
Dyspnoeashortness of breath11.1%1,888
Vomitingbeing sick10.6%1,804
Atrial fibrillationan irregular heart rhythm9.7%1,660
Fatiguetiredness9.1%1,560
Drug interactionan interaction between medicines8.4%1,433
Astheniaweakness or lack of energy8.4%1,426
Painpain, site not specified8.3%1,414
Hypotensionlow blood pressure8.3%1,413
Economic problema financial problem7.9%1,357
Diarrhoealoose or frequent stools7.4%1,262
Anxietyanxiety7%1,197
Therapeutic agent toxicity6.6%1,119
Malaisegeneral feeling of being unwell6.2%1,062
Chest painchest pain6%1,028
Dehydrationdehydration5.9%1,003
Palpitationsawareness of the heartbeat5.8%984
Cardiac failure congestivecongestive heart failure5.7%972
Myocardial infarctionheart attack5.6%959
Cardioactive drug level increased5.6%951
Multiple injuries5.5%934
Ventricular tachycardiaa fast rhythm from the lower heart chambers5%861

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

Death25.7%4,397

Life-threatening10.5%1,800

Hospitalisation (initial or prolonged)55.7%9,514

Disability3.4%589

Congenital anomaly0.4%70

Other serious43%7,347

Not serious5.6%955

Patient age

Under 20.9%159

2 to 110.4%71

12 to 170.3%59

18 to 444.5%765

45 to 6413.7%2,337

65 to 7416.7%2,855

75 and over34%5,800

Age not given29.5%5,031

Who reported

Physician17.8%3,033

Pharmacist11.1%1,896

Other health professional28%4,778

Lawyer4%679

Consumer or non-health professional15.5%2,642

Not given23.7%4,049

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 Cardiac glycoside reports

Which drugs are in the Cardiac glycoside class on this site?

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

How many reports does the class have?

17,077 reports through June 2026, 426 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?

nausea (13.7%), toxicity to various agents (13.3%), dizziness (12.7%), bradycardia (11.9%) and dyspnoea (11.1%).

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.