Abreva: adverse event reports filed with FDA

13,634

reports as suspect product

0.1% of all reports · about 606 a year

96

reports, 12 months to June 2026

174 in the 12 months before

0.7%

marked serious by the reporter

7.3% across the class

0%

record death among outcomes, as reported

0 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Abreva reports recording the termmedian drug in non-standardized chemical allergen

1. Drug ineffectivethe medicine did not work as expected48.7%6,639
2. Oral herpesa cold sore17.4%2,379
3. Condition aggravatedthe condition being treated got worse13.9%1,892
4. Drug administration errora mistake in giving the medicine13%1,773
5. Incorrect drug administration duration5.9%803
6. Herpes simplexa cold sore or genital herpes5.1%702
7. Incorrect product administration duration4.5%611
8. Wrong technique in product usage processthe product was used in the wrong way3.9%536
9. Product quality issuea problem with the product itself3.9%535
10. Lip swellingswollen lips3.9%534
11. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.6%489
12. Application site pain3.2%437
13. Inappropriate schedule of product administrationthe product was taken at the wrong times2.8%387
14. Product complaint2.7%366
15. Hypersensitivityan allergic-type reaction2.2%301
16. Swelling facea swollen face2%277
17. Application site erythemaredness where the product was applied1.8%242
18. Application site irritation1.7%226
19. Product use in unapproved indicationused for a purpose not on the label1.5%208
20. Application site swelling1.5%204
21. Product use issuea problem in how the product was used1.3%183
22. Expired product administeredthe product was used past its expiry date1.2%169
23. Application site scab1.2%165
24. Intentional drug misuse1.1%151
25. Oral discomfort1.1%151
26. Lip pain1.1%144
27. Rashskin rash1%142
28. Cheilitis1%139
29. Lip dry0.9%122
30. Application site reactiona reaction where the product was applied0.9%120

Top 30 of 270 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the non-standardized chemical allergen class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 15,731 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 13,634 reports.

Drugs most often listed in the same reports

Other products listed in reports where Abreva is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the non-standardized chemical allergen class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Abreva as a suspect or interacting product; reports listing it only as a concomitant medication (283) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.