OVINE DIGOXIN IMMUNE FAB: 175 Adverse Event Reports & Safety Profile

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175

Total FAERS Reports

62 (35.4%)

Deaths Reported

Hospitalizations

175

As Primary/Secondary Suspect

Life-Threatening

Disabilities

BTG International Inc.

Manufacturer

Drug Class: Cardiac Glycoside [EPC] · Manufacturer: BTG International Inc. ·

First Report: 20071120 · Latest Report: 20240624

What Are the Most Common OVINE DIGOXIN IMMUNE FAB Side Effects?

#1 Most Reported

Off label use

41 reports (23.4%)

#2 Most Reported

Drug ineffective

35 reports (20.0%)

#3 Most Reported

Bradycardia

29 reports (16.6%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	41	23.4%	16	6
Drug ineffective	35	20.0%	16	12
Bradycardia	29	16.6%	4	3
Bone density decreased	19	10.9%	0	0
Calcium deficiency	19	10.9%	0	0
Weight decreased	19	10.9%	0	0
Toxicity to various agents	18	10.3%	5	3
Death	14	8.0%	14	1
Drug effect incomplete	11	6.3%	1	1
Rebound effect	10	5.7%	1	0
Cardiac arrest	9	5.1%	7	0
Acute kidney injury	8	4.6%	3	1
Cardiac failure	8	4.6%	6	0
Renal failure	8	4.6%	0	1
Cardioactive drug level increased	7	4.0%	2	2
Hyperkalaemia	7	4.0%	2	1
Vomiting	7	4.0%	0	1
Ventricular fibrillation	6	3.4%	3	0
Completed suicide	5	2.9%	5	0
Drug ineffective for unapproved indication	5	2.9%	3	0

Gender: 61.3% female, 38.7% male. Average age: 53.3 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2007	1	1	1
2013	1	0	0
2014	4	0	2
2015	10	2	0
2016	4	0	0
2017	5	1	0
2018	2	1	2
2019	4	2	2
2020	1	0	0
2021	1	0	0
2023	3	1	2
2024	1	0	0

Indication	Reports
Toxicity to various agents	118
Product used for unknown indication	29

Official prescribing information from the FDA-approved drug label.