RETINOL: 296 Adverse Event Reports & Safety Profile

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296

Total FAERS Reports

58 (19.6%)

Deaths Reported

198

Hospitalizations

296

As Primary/Secondary Suspect

Life-Threatening

Disabilities

HYDRASPHERE PLUS LLC

Manufacturer

Route: CUTANEOUS · Manufacturer: HYDRASPHERE PLUS LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 19961204 · Latest Report: 20250325

What Are the Most Common RETINOL Side Effects?

#1 Most Reported

Gastrooesophageal reflux disease

113 reports (38.2%)

#2 Most Reported

Somnolence

86 reports (29.1%)

#3 Most Reported

Pneumonia aspiration

85 reports (28.7%)

All RETINOL Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Gastrooesophageal reflux disease	113	38.2%	21	103
Somnolence	86	29.1%	1	83
Coma	85	28.7%	0	82
Pneumonia aspiration	85	28.7%	0	82
Off label use	82	27.7%	48	68
Drug ineffective	64	21.6%	45	51
Infusion related reaction	49	16.6%	43	48
Type 2 diabetes mellitus	49	16.6%	48	48
Confusional state	45	15.2%	38	44
Pain	44	14.9%	32	38
Swelling	44	14.9%	43	43
C-reactive protein increased	43	14.5%	43	43
Product use in unapproved indication	43	14.5%	37	39
Underdose	42	14.2%	15	41
Nausea	41	13.9%	32	40
Rash	41	13.9%	33	32
Dyspnoea	40	13.5%	35	36
Drug hypersensitivity	39	13.2%	35	36
Headache	38	12.8%	27	35
Pericarditis	37	12.5%	37	36

Who Reports RETINOL Side Effects? Age & Gender Data

Gender: 91.8% female, 8.2% male. Average age: 56.3 years. Most reports from: CA. View detailed demographics →

Is RETINOL Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2003	1	0	1
2013	2	0	1
2014	4	0	0
2015	5	4	4
2016	16	0	10
2017	7	0	0
2018	4	0	1
2019	10	0	3
2020	15	0	8
2021	5	0	1
2022	2	1	0
2023	2	0	0
2024	1	0	0
2025	2	0	0

View full timeline →

What Is RETINOL Used For?

Indication	Reports
Product used for unknown indication	171
Cystic fibrosis	10
Keratitis	10
Rheumatoid arthritis	8
Acne	6
Herpes ophthalmic	6
Punctate keratitis	6
Foetal exposure during pregnancy	5
Muscle building therapy	5

RETINOL vs Alternatives: Which Is Safer?

RETINOL vs REVATIO RETINOL vs REVEFENACIN RETINOL vs REVLIMID RETINOL vs REVOLADE RETINOL vs REVUMENIB RETINOL vs REYATAZ RETINOL vs REZAFUNGIN RETINOL vs RIBASPHERE RETINOL vs RIBAVIRIN RETINOL vs RIBOCICLIB

Official FDA Label for RETINOL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Directions for Use: Product Name: HYDRASPHERE+ Anti Wrinkle Correction & Prevention Directions for Use: Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Dosage & Administration

Directions for Use: Apply directly to deep facial lines and wrinkles in the targeted area. Avoid direct contact with the eye. In the event of excess product application, gently remove using a cotton swab.

Warnings

WARNINGS and PRECAUTIONS: Keep out of reach of children.For external use only.Avoid contact with eyes ormucous membranes.Perform a patch test before firstuse. lf irritation occurs,discontinue use.May increase sun sensitivityuse SPF.

Active Ingredient

active RETINOL

Inactive Ingredients

inactive Water Magnesium Aluminum Silicate Sodium Polystyrene Sulfonate Cucumber Fruit Extract Rhodiola Rosea Root Extract Xanthan Gum Caprylic/Capric Triglyceride Sodium Hyaluronate Avocado Oil Coffea Arabica Extract Tuber Magnatum Extract Saccharomyces Cerevisiae Extract Hesperidin Methyl Chalcone Sodium Silicate Hyaluronic Acid Dipeptide Diaminobutyroyl Benzylamide Diacetate Tremella Fuciformis Polysaccharide Xanthan Gum ACETYL HEXAPEPTIDE-8 Dimethylaminoethanol Tartrate Retinyl Palmitate Tocopheryl Acetate Dipeptide-2 Palmitoyl Tetrapeptide-7 Mica Titanium Dioxide