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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.

METHIONINE: 34 Adverse Event Reports & Safety Profile

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34
Total FAERS Reports
3 (8.8%)
Deaths Reported
15
Hospitalizations
34
As Primary/Secondary Suspect
Professional Complementary ...
Manufacturer

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

First Report: 19960110 · Latest Report: 20250621

What Are the Most Common METHIONINE Side Effects?

#1 Most Reported
Ureteric dilatation
9 reports (26.5%)
#2 Most Reported
Pyelocaliectasis
9 reports (26.5%)
#3 Most Reported
Foetal growth restriction
9 reports (26.5%)

All METHIONINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal growth restriction 9 26.5% 0 0
Pyelocaliectasis 9 26.5% 0 0
Ureteric dilatation 9 26.5% 0 0
Leukopenia 7 20.6% 0 0
Maternal exposure during pregnancy 7 20.6% 0 0
Respiratory distress 7 20.6% 0 0
Off label use 6 17.7% 0 3
Somnolence 5 14.7% 0 5

Who Reports METHIONINE Side Effects? Age & Gender Data

Gender: 51.4% female, 48.6% male. Average age: 52.0 years. Most reports from: FR. View detailed demographics →

Is METHIONINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 1 0 0
2016 1 1 0
2017 1 0 1
2018 2 0 2
2019 1 0 0
2022 13 0 4
2025 1 0 1

View full timeline →

What Is METHIONINE Used For?

IndicationReports
Product used for unknown indication 11
Alveolar proteinosis 10

Official FDA Label for METHIONINE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of minor joint pain or stiffness, shortness of breath, coughing, sneezing, runny nose, sadness, difficulty losing weight, or dry skin.*

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-Methionine 15X, 20X, 30X, 60X, 200X

Inactive Ingredients

INACTIVE INGREDIENTS 20% ethanol, purified water.