Lanoxindigoxin
According to the FDA label: LANOXIN is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in adults with chronic atrial fibrillation. ( 1.3 ) 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults.
70,803 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lanoxin in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Dyspnoea 6,110 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 4,781 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Dizziness 4,476 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Fatigue 4,200 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Atrial Fibrillation 3,995 reports
An irregular, often rapid heart rhythm.
Full definition in the glossary →Diarrhoea 3,778 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthenia 3,629 reports
Physical weakness or lack of strength.
Full definition in the glossary →Death 3,432 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Vomiting 3,377 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Hypotension 3,201 reports
Cardiac Failure Congestive 3,141 reports
A form of heart failure, often called congestive heart failure, where the heart cannot pump blood as well as it should, leading to fluid buildup.
Full definition in the glossary →Pain 3,002 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fall 2,931 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Drug Interaction 2,810 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Pneumonia 2,735 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 35,564 |
| Male | 31,198 |
| Unknown | 239 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 989 |
| 18-34 | 1,318 |
| 35-49 | 2,584 |
| 50-64 | 9,278 |
| 65-74 | 13,441 |
| 75+ | 23,454 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Lanoxin. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Hospitalization | 36,018 |
| Other Serious | 28,530 |
| Death | 13,738 |
| Non-Serious | 12,142 |
| Life-Threatening | 5,261 |
| Disability | 2,256 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Lanoxin. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 1999 | 3 |
| 2003 | 4 |
| 2004 | 2,671 |
| 2005 | 2,601 |
| 2006 | 2,529 |
| 2007 | 2,010 |
| 2008 | 4,392 |
| 2009 | 3,558 |
| 2010 | 3,378 |
| 2011 | 4,013 |
| 2012 | 3,944 |
| 2013 | 3,401 |
| 2014 | 4,322 |
| 2015 | 4,309 |
| 2016 | 4,282 |
| 2017 | 4,069 |
| 2018 | 3,908 |
| 2019 | 3,315 |
| 2020 | 2,990 |
| 2021 | 2,277 |
| 2022 | 1,862 |
| 2023 | 2,304 |
| 2024 | 2,177 |
| 2025 | 2,074 |
| 2026 (partial) | 410 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Lanoxin
In FDA adverse event reports that mention Lanoxin, these medications appeared most often in the same report.
- Furosemide (26,124 reports)
- Aspirin (11,845 reports)
- Warfarin (10,377 reports)
- Spironolactone (10,305 reports)
- Metoprolol (9,995 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026