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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DIGITOXIN: 500 Adverse Event Reports & Safety Profile

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500
Total FAERS Reports
76 (15.2%)
Deaths Reported
332
Hospitalizations
500
As Primary/Secondary Suspect
60
Life-Threatening
8
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 084100 ·

First Report: 19950130 · Latest Report: 20250705

What Are the Most Common DIGITOXIN Side Effects?

#1 Most Reported
Bradycardia
154 reports (30.8%)
#2 Most Reported
Atrial fibrillation
125 reports (25.0%)
#3 Most Reported
Dizziness
86 reports (17.2%)

All DIGITOXIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Bradycardia 154 30.8% 14 126
Atrial fibrillation 125 25.0% 2 94
Dizziness 86 17.2% 1 81
Dyspnoea 70 14.0% 4 68
General physical health deterioration 52 10.4% 0 47
Oedema peripheral 50 10.0% 0 43
Stevens-johnson syndrome 43 8.6% 16 23
Syncope 43 8.6% 1 43
Insomnia 42 8.4% 0 22
Arrhythmia 40 8.0% 1 37
Overdose 40 8.0% 6 39
Hypertension 39 7.8% 2 37
Toxic epidermal necrolysis 38 7.6% 19 16
Acute kidney injury 37 7.4% 18 29
Blister 36 7.2% 14 19
Fall 36 7.2% 2 36
Myalgia 35 7.0% 0 35
C-reactive protein increased 34 6.8% 1 34
Haemoglobin decreased 34 6.8% 0 33
Incorrect dose administered 34 6.8% 0 34

Who Reports DIGITOXIN Side Effects? Age & Gender Data

Gender: 65.0% female, 35.0% male. Average age: 75.2 years. Most reports from: DE. View detailed demographics →

Is DIGITOXIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 9 0 5
2002 1 0 1
2003 8 0 8
2004 14 14 0
2005 10 1 10
2006 3 0 3
2008 4 0 4
2009 2 1 1
2010 1 0 1
2012 1 0 1
2013 23 0 23
2014 7 2 6
2015 15 4 8
2016 15 5 11
2017 20 5 15
2018 2 0 2
2019 23 3 23
2020 18 0 15
2021 2 0 2
2022 3 0 3
2025 1 0 0

View full timeline →

What Is DIGITOXIN Used For?

IndicationReports
Product used for unknown indication 309
Cardiac failure 46
Atrial fibrillation 32
Cardiac disorder 25
Coronary artery disease 9
Arrhythmia 5
Tachyarrhythmia 5

DIGITOXIN vs Alternatives: Which Is Safer?

DIGITOXIN vs DIGOXIN DIGITOXIN vs DIHYDRALAZINE DIGITOXIN vs DIHYDROCODEINE DIGITOXIN vs DIHYDROERGOTAMINE DIGITOXIN vs DILANTIN DIGITOXIN vs DILAUDID DIGITOXIN vs DILTIAZEM DIGITOXIN vs DIMENHYDRINATE DIGITOXIN vs DIMETHICONE DIGITOXIN vs DIMETHICONE\LOPERAMIDE

Official FDA Label for DIGITOXIN

Official prescribing information from the FDA-approved drug label.