Drugs › Non-Standardized food allergenic extract
Generic name
Salicylic acid: adverse event reports filed with FDA
874 reports list it as a suspect or interacting product, 2004–2026. Class: Non-Standardized food allergenic extract.
- 874
- reports as suspect product
- 0% of all reports · about 39 a year
- 150
- reports, 12 months to June 2026
- 207 in the 12 months before
- 89.7%
- marked serious by the reporter
- 70.4% across the class
- 59.3%
- record death among outcomes, as reported
- 518 reports · not verified by FDA
874 adverse event reports received by FDA list salicylic acid, a generic name as a suspect or interacting product, from February 2004 to June 2026. A further 1,100 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 150 reports listed it, down 28% from 207 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 39 reports a year and 0% of the 20,646,523 reports in the database, and 37.5% of the reports for the non-Standardized food allergenic extract class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded type 2 diabetes mellitus (18.1%), urticaria (17.2%) and vomiting (17.2%). A report can list several reactions, so shares add to more than 100%; 380 different terms appear across these reports. Type 2 diabetes mellitus is recorded in 18.1% of these reports, with no counterpart in the median non-Standardized food allergenic extract drug (0%).
89.7% of the reports are marked serious by the reporter (70.4% across the class); 59.3% record death among the outcomes and 22.2% record hospitalisation, as reported. 59.8% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (22.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Salicylic acid reports recording the termmedian drug in non-standardized food allergenic extract
- Type 2 diabetes mellitustype 2 diabetes18.1%158
- Urticariahives17.2%150
- Vomitingbeing sick17.2%150
- Weight increasedweight gain17.2%150
- Hypertensionhigh blood pressure16.9%148
- Pruritusitching16.8%147
- Hypoaesthesianumbness16.4%143
- Irritable bowel syndrome16.1%141
- Joint stiffnessa stiff joint15.9%139
- Joint dislocationa dislocated joint15.7%137
- Wheezingwheezing15.7%137
- Joint range of motion decreasedreduced movement of a joint15.6%136
- Infusion related reactiona reaction during or soon after an infusion15.4%135
- Prescribed underdose15.1%132
- Hypersensitivityan allergic-type reaction15%131
- Osteoarthritis15%131
- Pneumonialung infection14.9%130
- Visual impairmentreduced vision14.9%130
- Infectionan infection, type not specified14.8%129
- Nasopharyngitisa cold14.8%129
- Wound infectionan infected wound14.6%128
- Pericarditisinflammation of the sac around the heart14.5%127
- Upper respiratory tract infectiona cold or similar infection14.5%127
- Weight decreasedweight loss14.3%125
- Wound14.2%124
- Mobility decreasedreduced ability to move about14.1%123
- Toxicity to various agentspoisoning or toxic effect of one or more substances14.1%123
- Condition aggravatedthe condition being treated got worse13.8%121
- Impaired healingslow healing13%114
- Hypercholesterolaemia12.9%113
Top 30 of 380 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 food allergenic extract 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 2,328 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 33.5% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Uveitis | 20 | 2.3% |
| Rheumatoid arthritis | 17 | 1.9% |
| Psoriasis | 15 | 1.7% |
| Skin papilloma | 14 | 1.6% |
| Suicide attempt | 14 | 1.6% |
| Premedication | 6 | 0.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 874 reports.
In context
| Measure | Salicylic acid | Non-Standardized food allergenic extract | All reports |
|---|---|---|---|
| Reports as suspect product | 874 | 2,328 | 20,646,523 |
| Share of that pool | — | 37.5% | 0% |
| Reports, latest 12 months | 150 | — | 1,332,454 |
| Marked serious | 89.7% | 70.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 593 | 263 | 91 |
| Hospitalisation recorded, per 1,000 reports | 222 | 249 | 213 |
| Consumer-filed share | 18.3% | 32.9% | 45.8% |
| Top term, share of reports | Type 2 diabetes mellitus 18.1% | median 0% | 0.2% |
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 food allergenic extract class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Zicam | brand | 844 | 6 | 36.3% |
| Radiation | brand | 610 | 0 | 90% |
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.
Questions about Salicylic acid reports
How many adverse event reports has FDA received for Salicylic acid?
874 reports list Salicylic acid as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 150 of them arrived in the latest 12 months. Another 1,100 list it only as a concomitant medication.
What reactions are recorded in Salicylic acid reports?
type 2 diabetes mellitus (18.1%), urticaria (17.2%), vomiting (17.2%), weight increased (17.2%) and hypertension (16.9%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Salicylic acid was responsible.
How serious are the reports?
89.7% are marked serious by the reporter. Among the outcomes recorded, 59.3% of reports include death and 22.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (59.8%), consumer or non-health professional (18.3%) and physician (15.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Salicylic acid rising?
150 reports in the 12 months to June 2026, down 28% from 207 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Salicylic acid was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Salicylic acid?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Salicylic acid as a suspect or interacting product; reports listing it only as a concomitant medication (1,100) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.