DOCOSANOL: 7,855 Adverse Event Reports & Safety Profile
Visibly Younger Skin in Weeks
Synevra Lift & Lock — Swiss peptide serum + nutrients. 60-day money-back guarantee.
Route: TOPICAL · Manufacturer: WALMART INC. (see also Equate) · FDA Application: 020941 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20010111 · Latest Report: 20250812
What Are the Most Common DOCOSANOL Side Effects?
All DOCOSANOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 2,679 | 34.1% | 0 | 0 |
| Condition aggravated | 1,523 | 19.4% | 0 | 3 |
| Oral herpes | 1,459 | 18.6% | 0 | 2 |
| Incorrect drug administration duration | 803 | 10.2% | 0 | 0 |
| Drug administration error | 721 | 9.2% | 0 | 0 |
| Incorrect product administration duration | 634 | 8.1% | 0 | 0 |
| Wrong technique in product usage process | 548 | 7.0% | 0 | 1 |
| Inappropriate schedule of drug administration | 489 | 6.2% | 0 | 0 |
| Inappropriate schedule of product administration | 391 | 5.0% | 0 | 0 |
| Product complaint | 374 | 4.8% | 0 | 0 |
| Lip swelling | 373 | 4.8% | 0 | 2 |
| Product quality issue | 321 | 4.1% | 0 | 0 |
| Application site pain | 256 | 3.3% | 0 | 0 |
| Product use in unapproved indication | 244 | 3.1% | 0 | 0 |
| Product use issue | 202 | 2.6% | 0 | 0 |
| Expired product administered | 175 | 2.2% | 0 | 0 |
| Hypersensitivity | 161 | 2.1% | 0 | 2 |
| Oral discomfort | 142 | 1.8% | 0 | 1 |
| Drug effective for unapproved indication | 123 | 1.6% | 0 | 0 |
| Rash | 106 | 1.4% | 0 | 17 |
Who Reports DOCOSANOL Side Effects? Age & Gender Data
Gender: 73.0% female, 27.0% male. Average age: 53.9 years. Most reports from: US. View detailed demographics →
Is DOCOSANOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 3 | 0 | 3 |
| 2006 | 1 | 0 | 0 |
| 2010 | 13 | 0 | 11 |
| 2011 | 13 | 0 | 7 |
| 2014 | 85 | 0 | 0 |
| 2015 | 186 | 0 | 0 |
| 2016 | 220 | 0 | 0 |
| 2017 | 212 | 0 | 1 |
| 2018 | 249 | 0 | 0 |
| 2019 | 232 | 0 | 0 |
| 2020 | 131 | 0 | 1 |
| 2021 | 74 | 0 | 0 |
| 2022 | 77 | 0 | 0 |
| 2023 | 97 | 0 | 0 |
| 2024 | 47 | 0 | 1 |
| 2025 | 25 | 0 | 0 |
What Is DOCOSANOL Used For?
| Indication | Reports |
|---|---|
| Oral herpes | 5,774 |
| Product used for unknown indication | 1,597 |
| Aphthous ulcer | 64 |
| Chapped lips | 46 |
| Herpes virus infection | 36 |
| Herpes zoster | 23 |
| Acne | 22 |
| Blister | 21 |
| Pain | 13 |
| Rash | 12 |
DOCOSANOL vs Alternatives: Which Is Safer?
Official FDA Label for DOCOSANOL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Directions: Wash hands before and after applying, adults and children12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor.
Dosage & Administration
Directions
- adults and children 12 years or over:
- wash hands before and after applying cream
- apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
- early treatment ensures the best results
- rub in gently but completely
- use 5 times a day until healed
- children under 12 years: ask a doctor Other information
- store at 20° to 25°C (68° to 77°F).
- do not freeze
Warnings
Warnings Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty breathing shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only Do not use if you are allergic to any ingredient in this product When using this product apply only to the affected areas do not use in or near the eyes avoid applying directly inside your mouth do not share this product with anyone. This may spread the infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions adults and children 12 years or over:
- wash hands before and after applying cream
- apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle)
- early treatment ensures the best results
- rub in gently but completely
- use 5 times a day until healed children under 12 years: ask a doctor
Active Ingredient
Active ingredients Docosanol 10%-------------Cold sore / fever blister treatment
Inactive Ingredients
Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate Questions or comments? call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)