Pharmacologic class (EPC) · 3 drug pages

Non-Standardized chemical allergen: adverse event reports filed with FDA

15,731 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

15,731
reports across the class: 0.1% of all reports; 208
reports, 12 months to June 2026: 327 in the 12 months before; 7.3%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Non-Standardized chemical allergen is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 15,731 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

208 reports arrived in the 12 months to June 2026, down 36% from 327 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 7.3% of the class's reports are marked serious, 0.2% record death among the outcomes and 2.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (46.7%), oral herpes (15.1%) and condition aggravated (12%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
AbrevaDocosanol	brand	13,634	96	0.7%	Drug ineffective
Refresh OptiveCarboxymethylcellulose sodium, glycerin	brand	1,206	54	18.8%	Eye irritation
Glycerin	generic	891	58	93.2%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected46.7%7,353
Oral herpesa cold sore15.1%2,379
Condition aggravatedthe condition being treated got worse12%1,895
Drug administration errora mistake in giving the medicine11.3%1,773
Incorrect drug administration duration5.1%803
Herpes simplexa cold sore or genital herpes4.5%702
Incorrect product administration duration3.9%611
Macular degenerationa disease of the central retina3.7%586
Wrong technique in product usage processthe product was used in the wrong way3.5%549
Product quality issuea problem with the product itself3.4%537
Lip swellingswollen lips3.4%534
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.1%492
Application site pain2.8%439
Painpain, site not specified2.6%414
Inappropriate schedule of product administrationthe product was taken at the wrong times2.5%387
Off label useused for a purpose or in a way not on the label2.4%385
Product complaint2.3%366
Hypersensitivityan allergic-type reaction2%320
Eye irritationeye irritation2%312
Swelling facea swollen face1.8%285
Erythemaskin redness1.8%282
Constipationconstipation1.7%275
Product use in unapproved indicationused for a purpose not on the label1.7%267
Paraesthesia oral1.6%259
Therapeutic product effect incomplete1.6%256

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.2%30

Life-threatening0.6%91

Hospitalisation (initial or prolonged)2.9%457

Disability0.1%18

Congenital anomaly0.1%9

Other serious6.8%1,070

Not serious92.7%14,577

Patient age

Under 20.1%12

2 to 110.5%83

12 to 170.8%127

18 to 4421.4%3,367

45 to 6419.9%3,132

65 to 7410.5%1,644

75 and over7.9%1,241

Age not given38.9%6,125

Who reported

Physician1.2%192

Pharmacist0.1%20

Other health professional3.8%591

Lawyer0%1

Consumer or non-health professional94.7%14,902

Not given0.2%25

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Non-Standardized chemical allergen reports

Which drugs are in the Non-Standardized chemical allergen class on this site?

Abreva, Refresh Optive and Glycerin. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

15,731 reports through June 2026, 208 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (46.7%), oral herpes (15.1%), condition aggravated (12%), drug administration error (11.3%) and incorrect drug administration duration (5.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.