Pharmacologic class (EPC) · 3 drug pages

Non-Standardized food allergenic extract: adverse event reports filed with FDA

2,328 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.

2,328
reports across the class: 0% of all reports; 156
reports, 12 months to June 2026: 210 in the 12 months before; 70.4%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Non-Standardized food allergenic extract 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 2,328 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

156 reports arrived in the 12 months to June 2026, down 26% from 210 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.4% of the class's reports are marked serious, 26.3% record death among the outcomes and 24.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are anosmia (23.3%), ageusia (13.5%) and vomiting (9.8%). 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
Salicylic acid	generic	874	150	89.7%	Type 2 diabetes mellitus
ZicamZinc acetate anhydrous and zinc gluconate	brand	844	6	36.3%	Anosmia
RadiationCapsicum annuum, cetraria islandica, fucus vesiculosus, glandula suprarenalis suis, thyroidinum (suis), cadmium iodatum, hydrangea arborescens, phosphoricum acidum, phosphorus, pulsatilla (pratensis), strontium carbonicum, uranium nitricum, x-ray	brand	610	0	90%	Nausea

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

Anosmialoss of smell23.3%543
Ageusialoss of taste13.5%315
Vomitingbeing sick9.8%228
Nauseafeeling sick8.5%197
Pneumonialung infection6.9%160
Type 2 diabetes mellitustype 2 diabetes6.8%158
Pyrexiafever6.7%157
Weight increasedweight gain6.7%155
Dyspnoeashortness of breath6.5%152
Weight decreasedweight loss6.5%152
Urticariahives6.5%151
Hypertensionhigh blood pressure6.4%150
Hypoaesthesianumbness6.4%148
Pruritusitching6.4%148
Irritable bowel syndrome6.1%141
Joint stiffnessa stiff joint6%139
Infectionan infection, type not specified5.9%137
Joint dislocationa dislocated joint5.9%137
Painpain, site not specified5.9%137
Wheezingwheezing5.9%137
Joint range of motion decreasedreduced movement of a joint5.8%136
Infusion related reactiona reaction during or soon after an infusion5.8%135
Hypersensitivityan allergic-type reaction5.7%133
Prescribed underdose5.7%132
Visual impairmentreduced vision5.7%132

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

Death26.3%612

Life-threatening5.9%137

Hospitalisation (initial or prolonged)24.9%579

Disability9%209

Congenital anomaly1.9%45

Other serious43.7%1,017

Not serious29.6%689

Patient age

Under 20.2%5

2 to 110.9%21

12 to 171%24

18 to 4414.5%337

45 to 6422.8%531

65 to 746.2%145

75 and over4.8%112

Age not given49.5%1,153

Who reported

Physician16.4%382

Pharmacist1.8%43

Other health professional29.9%696

Lawyer0.5%11

Consumer or non-health professional32.9%767

Not given18.4%429

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 food allergenic extract reports

Which drugs are in the Non-Standardized food allergenic extract class on this site?

Salicylic acid, Zicam and Radiation. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,328 reports through June 2026, 156 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?

anosmia (23.3%), ageusia (13.5%), vomiting (9.8%), nausea (8.5%) and pneumonia (6.9%).

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.