Abrevadocosanol
According to the FDA label: Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching
14,518 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Abreva in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 7,032 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Oral Herpes 2,449 reports
Condition Aggravated 1,957 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Drug Administration Error 1,779 reports
A report that a medication was given or taken incorrectly in some way. This is a usage category.
Full definition in the glossary →Incorrect Drug Administration Duration 803 reports
A report that a medication was taken for a longer or shorter time than directed. This is a usage category.
Full definition in the glossary →- Herpes Simplex 706 reports
- Incorrect Product Administration Duration 637 reports
- Lip Swelling 556 reports
Wrong Technique in Product Usage Process 551 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Product Quality Issue 539 reports
A report of a possible problem with the medication's quality, such as appearance, packaging, or condition. This is a quality-tracking category.
Full definition in the glossary →Inappropriate Schedule of Drug Administration 493 reports
A report that a medication was taken on the wrong schedule, such as too often or at the wrong time. This is a usage category, the same idea as inappropriate schedule of product administration.
Full definition in the glossary →Application Site Pain 445 reports
Pain at the spot where a medication was applied, such as under a patch.
Full definition in the glossary →Inappropriate Schedule of Product Administration 399 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →- Product Complaint 374 reports
Hypersensitivity 318 reports
An exaggerated reaction by the immune system, similar to an allergic reaction.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 9,129 |
| Male | 3,093 |
| Unknown | 18 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 202 |
| 18-34 | 1,947 |
| 35-49 | 2,088 |
| 50-64 | 2,386 |
| 65-74 | 1,312 |
| 75+ | 896 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Abreva. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 14,228 |
| Other Serious | 203 |
| Hospitalization | 132 |
| Death | 9 |
| Life-Threatening | 7 |
| Disability | 5 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Abreva. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 5 |
| 2005 | 1,157 |
| 2006 | 1,355 |
| 2007 | 1,648 |
| 2008 | 5 |
| 2009 | 14 |
| 2010 | 9 |
| 2011 | 17 |
| 2012 | 13 |
| 2013 | 2,116 |
| 2014 | 216 |
| 2015 | 1,337 |
| 2016 | 974 |
| 2017 | 1,006 |
| 2018 | 1,074 |
| 2019 | 855 |
| 2020 | 479 |
| 2021 | 453 |
| 2022 | 333 |
| 2023 | 852 |
| 2024 | 344 |
| 2025 | 219 |
| 2026 (partial) | 37 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026