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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.

HYALURONIC ACID: 630 Adverse Event Reports & Safety Profile

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630
Total FAERS Reports
13 (2.1%)
Deaths Reported
64
Hospitalizations
630
As Primary/Secondary Suspect
6
Life-Threatening
13
Disabilities
Shengnan (Guangzhou) Cosmet...
Manufacturer

Route: CUTANEOUS · Manufacturer: Shengnan (Guangzhou) Cosmetics Co., LTD · HUMAN OTC DRUG · FDA Label: Available

First Report: 20060714 · Latest Report: 20250723

What Are the Most Common HYALURONIC ACID Side Effects?

#1 Most Reported
Off label use
184 reports (29.2%)
#2 Most Reported
Drug ineffective
75 reports (11.9%)
#3 Most Reported
Swelling face
65 reports (10.3%)

All HYALURONIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 184 29.2% 0 11
Drug ineffective 75 11.9% 1 7
Swelling face 65 10.3% 0 11
Erythema 50 7.9% 0 4
Headache 46 7.3% 1 9
Pain 44 7.0% 0 5
Swelling 39 6.2% 0 2
Product preparation error 38 6.0% 0 1
Injection site pain 35 5.6% 0 3
Contusion 34 5.4% 0 2
Eyelid ptosis 30 4.8% 0 1
Injection site swelling 30 4.8% 0 3
Lip swelling 30 4.8% 0 3
Rash 27 4.3% 0 3
Vision blurred 27 4.3% 0 3
Dizziness 26 4.1% 1 10
Dyspnoea 26 4.1% 0 10
Hypoaesthesia 26 4.1% 0 4
Eye swelling 25 4.0% 0 3
Injection site mass 25 4.0% 0 1

Who Reports HYALURONIC ACID Side Effects? Age & Gender Data

Gender: 95.1% female, 4.9% male. Average age: 51.7 years. Most reports from: US. View detailed demographics →

Is HYALURONIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 0 0
2008 1 0 0
2010 1 0 0
2011 6 0 1
2012 2 0 0
2013 6 0 0
2014 38 0 3
2015 34 1 7
2016 34 1 3
2017 31 1 4
2018 52 0 2
2019 52 1 7
2020 24 0 1
2021 34 0 5
2022 38 4 4
2023 27 1 7
2024 10 0 0
2025 7 0 1

View full timeline →

What Is HYALURONIC ACID Used For?

IndicationReports
Product used for unknown indication 229
Skin wrinkling 162
Skin cosmetic procedure 93
Dermal filler injection 29
Lip cosmetic procedure 17
Osteoarthritis 6

HYALURONIC ACID vs Alternatives: Which Is Safer?

HYALURONIC ACID vs HYALURONIC ACID\LIDOCAINE HYALURONIC ACID vs HYALURONIDASE HYALURONIC ACID vs HYALURONIDASE-OCSQ\OCRELIZUMAB HYALURONIC ACID vs HYALURONIDASE \RITUXIMAB HYALURONIC ACID vs HYALURONIDASE-ZZXF\PERTUZUMAB\TRASTUZUMAB HYALURONIC ACID vs HYDRALAZINE HYALURONIC ACID vs HYDRALAZINE\ISOSORBIDE DINITRATE HYALURONIC ACID vs HYDROCHLOROTHIAZIDE HYALURONIC ACID vs HYDROCHLOROTHIAZIDE\IRBESARTAN HYALURONIC ACID vs HYDROCHLOROTHIAZIDE\LISINOPRIL

Official FDA Label for HYALURONIC ACID

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Take an appropriate amount of theproduct and gently dab it onto the forehead.cheeks, nose, and chin using your fingertips.Gently spread the moisturizer evenly overyour entire face with your fingertips

Dosage & Administration

It is generally used twice a day, in the morning and evening. Or use it whenever you need to clean your eyelids. - Wash your hands thoroughly before use. - Remove the pad after opening the packet. - Close your eyes and wipe the eyelids and the base of your eyelashes with cloth. - Once used, throw away cloth without fail.

Warnings

1. Consult a specialist if you have abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using this product. 2. Please refrain from using the wound area 3. Precautions for Storage and Handling A. Please keep it out of the reach of children. B. Please store it in a cool place. 4. Wash it immediately when it gets into your eyes.

Active Ingredient

MAGNESIUM CHLORIDE,SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL,HYALURONIC ACID,VITIS VINIFERA (GRAPE) SEED OIL,TOCOPHEROL,LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL

Inactive Ingredients

AQUA BUTYROSPERMUM PARKII (SHEA BUTTER) ALOE BARBADENSIS FLOWER EXTRACT SQUALANE COCOS NUCIFERA (COCONUT) OIL TREMELLA FUCIFORMIS POLYSACCHARIDE GLYCERIN ROSA MULTIFLORA FRUIT EXTRACT PANTHENOL SODIUM LACTATE BIOSACCHARIDE GUM-1 CHRYSANTHELLUM INDICUM EXTRACT PORTULACA OLERACEA EXTRACT HOUTTUYNIA CORDATA EXTRACT OPUNTIA TUNA FRUIT EXTRACT 1,2-HEXANEDIOL