Generic name
Digoxin: adverse event reports filed with FDA
15,776 reports list it as a suspect or interacting product, 2004–2026. Class: Cardiac glycoside. Also reported as Digoxin Tab, Digoxin Tablets, Digoxin 125.
- 15,776
- reports as suspect product
- 0.1% of all reports · about 701 a year
- 416
- reports, 12 months to June 2026
- 559 in the 12 months before
- 95%
- marked serious by the reporter
- 94.4% across the class
- 26.8%
- record death among outcomes, as reported
- 4,224 reports · not verified by FDA
Between January 2004 and June 2026, 15,776 adverse event reports received by FDA list digoxin, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (46,878) are left out of every figure here.
In the 12 months to June 2026, 416 reports listed it, down 26% from 559 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 701 reports a year and 0.1% of the 20,646,523 reports in the database, and 92.4% of the reports for the cardiac glycoside class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are nausea (14.2%), dizziness (13.4%) and toxicity to various agents (13.3%). A report can list several reactions, so shares add to more than 100%; 2,329 different terms appear across these reports. Nausea is recorded in 14.2% of these reports, a larger share than in the median cardiac glycoside drug (10.5%).
95% of the reports are marked serious by the reporter (94.4% across the class); 26.8% record death among the outcomes and 55.6% record hospitalisation, as reported. 28.6% of the reports came from other health professionals, and the largest patient age group is 75 and over (32.7%). 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 Digoxin reports recording the termmedian drug in cardiac glycoside
- Nauseafeeling sick14.2%2,246
- Dizzinesslight-headedness or unsteadiness13.4%2,118
- Toxicity to various agentspoisoning or toxic effect of one or more substances13.3%2,095
- Dyspnoeashortness of breath11.6%1,825
- Bradycardiaslow heart rate11.3%1,785
- Vomitingbeing sick10.8%1,704
- Atrial fibrillationan irregular heart rhythm9.8%1,553
- Fatiguetiredness9.6%1,521
- Painpain, site not specified8.9%1,408
- Economic problema financial problem8.6%1,357
- Hypotensionlow blood pressure8.5%1,341
- Astheniaweakness or lack of energy8.2%1,286
- Drug interactionan interaction between medicines8.1%1,275
- Diarrhoealoose or frequent stools7.7%1,222
- Anxietyanxiety7.6%1,192
- Therapeutic agent toxicity6.7%1,050
- Malaisegeneral feeling of being unwell6.5%1,020
- Chest painchest pain6.4%1,009
- Palpitationsawareness of the heartbeat6.2%979
- Dehydrationdehydration6.2%976
- Cardiac failure congestivecongestive heart failure6%954
- Myocardial infarctionheart attack6%947
- Multiple injuries5.9%934
- Cardioactive drug level increased5.5%865
- Ventricular tachycardiaa fast rhythm from the lower heart chambers5.4%854
- Headachehead pain5.2%822
- Falla fall5%794
- Injurya physical injury5%794
- Renal failurekidney failure4.9%767
- Deaththe patient died; cause not stated by this term4.8%765
Top 30 of 2,329 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 2 drugs in the cardiac glycoside 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 17,077 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. 57% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Atrial fibrillation | 2,354 | 14.9% |
| Cardiac disorder | 715 | 4.5% |
| Cardiac failure congestive | 537 | 3.4% |
| Cardiac failure | 447 | 2.8% |
| Cerebrovascular accident prophylaxis | 398 | 2.5% |
| Arrhythmia | 383 | 2.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 15,776 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Digoxin reports |
|---|---|---|
| Furosemide | 3,177 | 20.1% |
| Aspirin | 1,926 | 12.2% |
| Spironolactone | 1,466 | 9.3% |
| Lasix | 1,294 | 8.2% |
| Bisoprolol | 1,145 | 7.3% |
| Omeprazole | 1,104 | 7% |
| Simvastatin | 1,052 | 6.7% |
| Lisinopril | 997 | 6.3% |
| Metoprolol | 944 | 6% |
| Potassium chloride | 926 | 5.9% |
Other products listed in reports where Digoxin is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Digoxin | Cardiac glycoside | All reports |
|---|---|---|---|
| Reports as suspect product | 15,776 | 17,077 | 20,646,523 |
| Share of that pool | — | 92.4% | 0.1% |
| Reports, latest 12 months | 416 | — | 1,332,454 |
| Marked serious | 95% | 94.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 268 | 257 | 91 |
| Hospitalisation recorded, per 1,000 reports | 556 | 557 | 213 |
| Consumer-filed share | 14% | 15.5% | 45.8% |
| Top term, share of reports | Nausea 14.2% | median 10.5% | 3.8% |
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 cardiac glycoside class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lanoxin | brand | 1,301 | 10 | 87.7% |
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 Digoxin reports
How many adverse event reports has FDA received for Digoxin?
15,776 reports list Digoxin as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 416 of them arrived in the latest 12 months. Another 46,878 list it only as a concomitant medication.
What reactions are recorded in Digoxin reports?
nausea (14.2%), dizziness (13.4%), toxicity to various agents (13.3%), dyspnoea (11.6%) and bradycardia (11.3%). 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 Digoxin was responsible.
How serious are the reports?
95% are marked serious by the reporter. Among the outcomes recorded, 26.8% of reports include death and 55.6% 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?
other health professional (28.6%), not given (25.1%) and physician (16.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Digoxin rising?
416 reports in the 12 months to June 2026, down 26% from 559 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 Digoxin 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 Digoxin?
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 Digoxin as a suspect or interacting product; reports listing it only as a concomitant medication (46,878) 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.