UREA: 150 Adverse Event Reports & Safety Profile
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Route: TOPICAL · Manufacturer: Cintex Services, LLC · FDA Application: 012154 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 19980418 · Latest Report: 20241001
What Are the Most Common UREA Side Effects?
All UREA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 48 | 32.0% | 14 | 14 |
| Off label use | 42 | 28.0% | 15 | 14 |
| Condition aggravated | 20 | 13.3% | 14 | 13 |
| Product use in unapproved indication | 19 | 12.7% | 15 | 13 |
| Decreased appetite | 16 | 10.7% | 14 | 13 |
| Drug intolerance | 16 | 10.7% | 14 | 15 |
| Fatigue | 16 | 10.7% | 13 | 14 |
| Vomiting | 16 | 10.7% | 13 | 14 |
| Abdominal discomfort | 15 | 10.0% | 14 | 14 |
| Arthralgia | 15 | 10.0% | 14 | 13 |
| C-reactive protein increased | 15 | 10.0% | 14 | 14 |
| Hepatic enzyme increased | 15 | 10.0% | 13 | 13 |
| Swelling | 15 | 10.0% | 13 | 15 |
| Alopecia | 14 | 9.3% | 14 | 13 |
| Blood cholesterol increased | 14 | 9.3% | 14 | 13 |
| Dizziness | 14 | 9.3% | 13 | 13 |
| Drug ineffective for unapproved indication | 14 | 9.3% | 0 | 0 |
| Intentional product use issue | 14 | 9.3% | 14 | 13 |
| Dyspnoea | 13 | 8.7% | 3 | 10 |
| Febrile neutropenia | 13 | 8.7% | 0 | 2 |
Who Reports UREA Side Effects? Age & Gender Data
Gender: 49.3% female, 50.7% male. Average age: 63.7 years. Most reports from: US. View detailed demographics →
Is UREA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 1 | 0 |
| 2013 | 3 | 0 | 1 |
| 2014 | 6 | 0 | 6 |
| 2015 | 2 | 0 | 1 |
| 2016 | 5 | 0 | 0 |
| 2017 | 4 | 0 | 1 |
| 2018 | 3 | 0 | 2 |
| 2019 | 3 | 0 | 0 |
| 2020 | 6 | 1 | 5 |
| 2021 | 1 | 0 | 0 |
| 2022 | 3 | 1 | 1 |
| 2023 | 13 | 0 | 11 |
| 2024 | 2 | 0 | 0 |
What Is UREA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 45 |
| Palmar-plantar erythrodysaesthesia syndrome | 23 |
| Psoriasis | 15 |
| Dry skin | 7 |
UREA vs Alternatives: Which Is Safer?
Official FDA Label for UREA
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Uracin 20% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 200 mg of urea in a vehicle consisting of the following inactive ingredients : Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower)
Seed
Oil, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Xanthan Gum. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure
FDA Approved Uses (Indications)
INDICATIONS AND USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails. Soothes rough and dry skin.
Dosage & Administration
Dosage and Administration Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician. All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each person's professional opinion and knowledge, upon evaluation of the active ingredients, excipients, inactive ingredients and chemical information provided herein.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Known Adverse Reactions
Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
WARNINGS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, lips and mucous membranes.
General
This product is to be used as directed by a licensed healthcare practitioner and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a licensed healthcare practitioner. Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C . Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
Nursing
Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Precautions
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician. Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
Nursing
Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Active Ingredient
Active ingredients Clotrimazole----1%----Antifungal
Inactive Ingredients
Water Glycerin Petrolatum Propylene Glycol Polysorbate 60 Cyclopentasiloxane Lauric/Myristic/Palmitic/Stearic Glycerides Cetearyl Alcohol Fragrance Tocopherol Collagen Hyaluronic Acid Carbomer Citrus Reticulata (Tangerine)
Extract Rosa Rugosa Flower
Extract