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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.

LYSINE: 78 Adverse Event Reports & Safety Profile

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78
Total FAERS Reports
23 (29.5%)
Deaths Reported
49
Hospitalizations
78
As Primary/Secondary Suspect
36
Life-Threatening
25
Disabilities
Professional Complementary ...
Manufacturer

Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available

First Report: 201103 · Latest Report: 20250704

What Are the Most Common LYSINE Side Effects?

#1 Most Reported
Peripheral venous disease
22 reports (28.2%)
#2 Most Reported
Infusion related reaction
22 reports (28.2%)
#3 Most Reported
Gastrooesophageal reflux disease
22 reports (28.2%)

All LYSINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Blepharospasm 22 28.2% 22 22
Condition aggravated 22 28.2% 10 22
Depression 22 28.2% 21 21
Diarrhoea 22 28.2% 18 20
Gastrooesophageal reflux disease 22 28.2% 22 22
Infusion related reaction 22 28.2% 22 22
Peripheral venous disease 22 28.2% 22 22
Arthralgia 21 26.9% 18 19
Dizziness 21 26.9% 18 19
Contraindicated product administered 20 25.6% 20 20
Dry mouth 20 25.6% 18 20
Folliculitis 20 25.6% 20 20
General physical health deterioration 20 25.6% 20 20
Headache 20 25.6% 17 18
Rash 20 25.6% 18 18
Taste disorder 20 25.6% 20 20
Weight increased 20 25.6% 18 19
Abdominal discomfort 19 24.4% 18 18
Decreased appetite 19 24.4% 18 19
Muscle spasms 19 24.4% 18 19

Who Reports LYSINE Side Effects? Age & Gender Data

Gender: 66.2% female, 33.8% male. Average age: 47.7 years. Most reports from: CA. View detailed demographics →

Is LYSINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 1
2014 2 0 0
2015 1 0 1
2016 3 0 2
2017 3 0 1
2018 3 0 2
2019 1 0 0
2020 2 0 0
2022 1 0 0
2025 1 0 0

View full timeline →

What Is LYSINE Used For?

IndicationReports
Product used for unknown indication 31
Overdose 11
Oral herpes 5

Official FDA Label for LYSINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of itchy, painful, red, or irritated skin, anxiousness, diarrhea, or indigestion.*

Dosage & Administration

DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS In case of overdose, get medical help or contact a poison control center right away. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Active Ingredient

ACTIVE INGREDIENTS L-Lysine 15X, 20X, 30X, 60X, 200X

Inactive Ingredients

INACTIVE INGREDIENTS 20% ethanol, purified water.