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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.

ASPARTAME: 91 Adverse Event Reports & Safety Profile

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91
Total FAERS Reports
0
Deaths Reported
3
Hospitalizations
91
As Primary/Secondary Suspect
2
Disabilities
Professional Complementary ...
Manufacturer

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

First Report: 2000 · Latest Report: 20250101

What Are the Most Common ASPARTAME Side Effects?

#1 Most Reported
Drug hypersensitivity
49 reports (53.8%)
#2 Most Reported
Migraine
9 reports (9.9%)
#3 Most Reported
Feeling abnormal
8 reports (8.8%)

All ASPARTAME Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 49 53.9% 0 0
Migraine 9 9.9% 0 1
Feeling abnormal 8 8.8% 0 0
Nausea 7 7.7% 0 1
Hypersensitivity 6 6.6% 0 0
Pruritus 6 6.6% 0 0
Amnesia 5 5.5% 0 1
Constipation 5 5.5% 0 0
Drug ineffective 5 5.5% 0 0
Headache 5 5.5% 0 0

Who Reports ASPARTAME Side Effects? Age & Gender Data

Gender: 81.0% female, 19.0% male. Average age: 57.5 years. Most reports from: US. View detailed demographics →

Is ASPARTAME Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2010 1 0 0
2012 1 0 0
2013 2 0 1
2014 2 0 0
2015 1 0 0
2016 4 0 0
2018 2 0 0
2019 1 0 0
2020 2 0 0
2021 2 0 1
2022 2 0 0
2024 2 0 0
2025 1 0 0

View full timeline →

What Is ASPARTAME Used For?

IndicationReports
Product used for unknown indication 34

Official FDA Label for ASPARTAME

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS For the temporary relief of occasional headache, bloating, nausea or vomiting, diarrhea, difficulty breathing, cough, runny nose, skin irritation, itchy eyes, or irritability due to sensitivity to or exposure to artificial sweeteners.*

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 Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.

Active Ingredient

ACTIVE INGREDIENTS Gelsemium sempervirens 3X Natrum carbonicum 3X Nux vomica 6X Chelidonium majus 10X Aspartame 12X Cyclamate 12X Cysteine 12X Sulphur 12X Thioacetamide 12X Thioglycolic acid 12X

Inactive Ingredients

INACTIVE INGREDIENTS 40% ethanol, purified water.