pharmacopeia

Docosanol

AntiviralsUS-FDASourced from openFDA
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Indications

Sourced from openFDA
  • Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itchingICD-10: B00.9

Dosage & administration

Sourced from openFDA

Directions adults and children 12 years or over: wash hands before and after applying cream apply to affected area on the 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

Warnings & precautions

Sourced from openFDA

Allergy Alert: This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only

Approval history

Sourced from openFDA
  • Jul 25, 2000NDANDA020941Haleon Us Holdings
  • Nov 19, 2018ANDAANDA208754P And L
  • May 3, 2022ANDAANDA215839Alembic
  • Oct 7, 2022ANDAANDA212385P And L Development
  • Oct 26, 2023ANDAANDA214454Sun Pharma Canada
  • Mar 1, 2024ANDAANDA217090Aurobindo Pharma Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
14,518 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective7,03248%
  2. 2Oral Herpes2,44917%
  3. 3Condition Aggravated1,95713%
  4. 4Drug Administration Error1,77912%
  5. 5Incorrect Drug Administration Duration8035.5%
  6. 6Herpes Simplex7064.9%
  7. 7Incorrect Product Administration Duration6374.4%
  8. 8Lip Swelling5563.8%
  9. 9Wrong Technique In Product Usage Process5513.8%
  10. 10Product Quality Issue5393.7%
  11. 11Inappropriate Schedule Of Drug Administration4933.4%
  12. 12Application Site Pain4453.1%
  13. 13Inappropriate Schedule Of Product Administration3992.7%
  14. 14Product Complaint3742.6%
  15. 15Hypersensitivity3182.2%

Clinical trials

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The 7 most recently updated of 7 ClinicalTrials.gov registrations naming Docosanol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Docosanol used for?
According to FDA labeling, Docosanol carries indications including: Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Docosanol?
Docosanol is classified as Antivirals.
What are the brand names for Docosanol?
Docosanol is marketed under brand names including Abreva.
Note. Data for docosanol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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