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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.

ALPHA.-LIPOIC ACID: 141 Adverse Event Reports & Safety Profile

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141
Total FAERS Reports
7 (5.0%)
Deaths Reported
34
Hospitalizations
141
As Primary/Secondary Suspect
7
Life-Threatening
8
Disabilities
Deseret Biologicals, Inc.
Manufacturer

Route: ORAL · Manufacturer: Deseret Biologicals, Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 200205 · Latest Report: 20250818

What Are the Most Common ALPHA.-LIPOIC ACID Side Effects?

#1 Most Reported
Drug ineffective
28 reports (19.9%)
#2 Most Reported
Dizziness
20 reports (14.2%)
#3 Most Reported
Fatigue
18 reports (12.8%)

All ALPHA.-LIPOIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 28 19.9% 2 4
Dizziness 20 14.2% 0 2
Fatigue 18 12.8% 0 0
Drug intolerance 16 11.4% 0 0
Headache 16 11.4% 0 1
Somnolence 16 11.4% 1 0
Nausea 15 10.6% 0 0
Anaemia 14 9.9% 0 0
Suicidal ideation 14 9.9% 0 1
Therapeutic product effect incomplete 14 9.9% 0 0
Cervicogenic headache 13 9.2% 0 0
Migraine without aura 13 9.2% 0 0
Off label use 13 9.2% 2 4
Pineal gland cyst 13 9.2% 0 0
Tension headache 13 9.2% 0 0
Drug hypersensitivity 11 7.8% 0 4
Rash 11 7.8% 0 1
Condition aggravated 9 6.4% 0 2
Pain 9 6.4% 0 1
Constipation 8 5.7% 3 3

Who Reports ALPHA.-LIPOIC ACID Side Effects? Age & Gender Data

Gender: 65.0% female, 35.0% male. Average age: 54.6 years. Most reports from: US. View detailed demographics →

Is ALPHA.-LIPOIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 5 0 0
2010 1 0 1
2011 3 0 0
2014 3 0 1
2015 3 0 3
2018 7 0 3
2019 6 0 2
2020 8 0 3
2021 3 0 1
2022 6 1 0
2024 1 0 0
2025 1 0 0

View full timeline →

What Is ALPHA.-LIPOIC ACID Used For?

IndicationReports
Product used for unknown indication 48
Burning mouth syndrome 9
Diabetic neuropathy 9
Neuropathy peripheral 8
Neuralgia 6
Supplementation therapy 6
Pain in extremity 5
Pleuritic pain 5
Seizure 5

ALPHA.-LIPOIC ACID vs Alternatives: Which Is Safer?

ALPHA.-LIPOIC ACID vs ALPHA.-TOCOPHEROL ALPHA.-LIPOIC ACID vs ALPHA.-TOCOPHEROL, D- ALPHA.-LIPOIC ACID vs ALPHA.-TOCOPHEROL, DL- ALPHA.-LIPOIC ACID vs ALPHA.1-PROTEINASE INHIBITOR HUMAN ALPHA.-LIPOIC ACID vs ALPRAZOLAM ALPHA.-LIPOIC ACID vs ALPROSTADIL ALPHA.-LIPOIC ACID vs ALTEPLASE ALPHA.-LIPOIC ACID vs ALTERNARIA ALTERNATA ALPHA.-LIPOIC ACID vs ALTHIAZIDE ALPHA.-LIPOIC ACID vs ALTHIAZIDE\SPIRONOLACTONE

Official FDA Label for ALPHA.-LIPOIC ACID

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

USES:

  • For the temporary relief of symptoms including:
  • bloating
  • stomach upset
  • gas
  • occasional diarrhea
  • occasional constipation
  • fatigue These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage & Administration

DIRECTIONS Take 15 minutes before meals Adults and children 12 years and older 20 drops in a little water 2 times per day Children between 12 years and 6 years of age. 10 drops in a little water 2 times per day Children under 6 years 5 drops in a glass of water 2 times per day

Warnings

WARNINGS Stop use and ask doctor if symptoms persist more than 5 days. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Contains ethyl alcohol 30%

Active Ingredient

ACTIVE INGREDIENTS/PURPOSE ACETYL-L-CARNITINE 3X IMPROVES MEMORY ADENOSINUM CYCLOPHOSPHORICUM 6X PROMOTES CELL METABOLISM A-LIPOICUM ACIDUM 3X ANTIOXIDANT ALPHA TOCOPHEROL 3X ANTIOXIDANT ASCORBIC ACID 3X ANTIOXIDANT CALCIUM CARBONATE 3X METABOLIC SUPPORT CITRICUM ACIDUM 3X ANTIOXIDANT COBALAMIN 3X ANTIOXIDANT COLCHICUM AUTUMNALE 6X 12X 30X ANTIOXIDANT CONIUM MACULATUM 6X 12X 30X ANTIOXIDANT CUPRUM SULPHURICUM 3X ANTIOXIDANT DNA 6X IMMUNE SUPPORT FERRUM FUMARICUM 3X ANTI-INFLAMMATORY FOLIC ACID 3X ANTIOXIDANT FUMARICUM ACIDUM 3X ANTI-INFLAMMATORY KALIUM ASPARTICUM 3X PROMOTES CELL METABOLISM MAGNESIA PHOSPHORICA 3X PROMOTES CELL METABOLISM MANGANESE GLUCONATE 3X PROMOTES CELL METABOLISM MANGANUM PHOSPHORICUM 6X ANTIOXIDANT METHYLGLYOXAL 10X ANTIOXIDANT NATRUM OXALACETICUM 3X PROMOTES CELL METABOLISM NATRUM PYRUVICUM 3X PROMOTES CELL METABOLISM NIACIN 3X ANTIOXIDANT PANTOTHENIC ACID 3X ANTIOXIDANT PHOSPHORUS 4X IMPROVES MEMORY PODOPHYLLUM PELTATUM 6X 12X 30X PAIN RELIEF PYRIDOXINUM HYDROCHLORICUM 6X ANTIOXIDANT RIBOFLAVINUM 6X ANTIOXIDANT RNA 6X IMMUNE SUPPORT SELENOMETHIONINE 3X ANTIOXIDANT SUCCINICUM ACIDUM 3X PROMOTE CELL METABOLISM SULPHUR 3X DETOXIFICATION THIAMINUM HYDROCHLORICUM 4X ANTIOXIDANT ZINCUM METALLICUM 3X IMMUNE SUPPORT

Inactive Ingredients

​Inactive ingredients Alcohol, Vegetable Glycerin, Purified Water