ERYTHROMYCIN ESTOLATE: 98 Adverse Event Reports & Safety Profile

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Total FAERS Reports

1 (1.0%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Approved Prior to Jan 1, 1982

FDA Approved

Discontinued

Status

Yes

Generic Available

FDA Application: 050010 ·

First Report: 20150101 · Latest Report: 20250322

What Are the Most Common ERYTHROMYCIN ESTOLATE Side Effects?

#1 Most Reported

Drug hypersensitivity

76 reports (77.6%)

#2 Most Reported

Infection

69 reports (70.4%)

#3 Most Reported

International normalised ratio fluctuation

68 reports (69.4%)

Side Effect	Reports	% of Total	Hosp.
Drug hypersensitivity	76	77.6%	33
Infection	69	70.4%	33
Drug intolerance	68	69.4%	33
International normalised ratio fluctuation	68	69.4%	33
Nausea	61	62.2%	33
Vomiting	61	62.2%	33
Bloody discharge	60	61.2%	32
Lyme disease	58	59.2%	33
Therapeutic product effect incomplete	58	59.2%	32
Fatigue	56	57.1%	33
Dizziness	36	36.7%	32
Hypoaesthesia	35	35.7%	32
Iron deficiency	35	35.7%	32
Malaise	35	35.7%	32
Pain in extremity	35	35.7%	31
Platelet count increased	35	35.7%	32
Staphylococcal infection	35	35.7%	32
Red blood cell sedimentation rate increased	33	33.7%	30
Secretion discharge	33	33.7%	30
Drug ineffective	30	30.6%	29

Gender: 90.5% female, 9.5% male. Average age: 58.4 years. Most reports from: CA. View detailed demographics →

Year	Reports	Hosp.
2015	4	3
2018	1	0
2019	1	0
2020	1	0
2024	1	0
2025	1	1

Indication	Reports
Product used for unknown indication	69
Carcinoid syndrome	6

Official prescribing information from the FDA-approved drug label.