Drug Safety Information for DIGOXIN (Digoxin)

FDA Safety-related Labeling Changes for LANOXIN (DIGOXIN) Rx Drug: Safety Information Link

Adverse Drug Reactions for DIGOXIN* (Digoxin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with DIGOXIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea3570
2Nausea3194
3Dizziness3070
4Atrial fibrillation2741
5Asthenia2661
6Toxicity to various agents2456
7Cardiac failure congestive2416
8Fatigue*2259
9Vomiting2154
10Pain2103
11Hypotension2102
12Fall1945
13Diarrhoea1929
14Death1872
15Renal failure1723
16Renal failure acute1634
17Bradycardia1603
18Pneumonia1565
19Oedema peripheral1550
20Drug interaction1517

* This side effect also appears in "Top 10 Side Effects of DIGOXIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking DIGOXIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication22307
2Atrial fibrillation*20237
3Cardiac disorder9591
4Cardiac failure congestive*8010
5Arrhythmia4187
6Heart rate irregular3947
7Cardiac failure2586
8Cardiomyopathy*989
9Heart rate increased950
10Hypertension895

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for DIGOXIN

Total Reports Filed with FDA: 243547


Number of FDA Adverse Event Reports by Patient Age for DIGOXIN

Total Reports Filed with FDA: 243547*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Digoxin (Dilanacin, Lanacordin, Digoxine nativelle, Digoxin pediatric, Lenoxin, Lanoxicaps, Lanoxin, Digitek, Lanoxin pediatric, Hemigoxine nativelle, Digox, Digoxin, Lanicor)

Charts are based on 243547 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and DIGOXIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.