Pharmacologic class (EPC) · 2 drug pages

Skin test antigen: adverse event reports filed with FDA

2,352 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.

2,352
reports across the class: 0% of all reports; 86
reports, 12 months to June 2026: 105 in the 12 months before; 25%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Skin test antigen is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,352 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

86 reports arrived in the 12 months to June 2026, down 18% from 105 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 25% of the class's reports are marked serious, 0.2% record death among the outcomes and 4.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are poor quality product administered (17.2%), product storage error (13.8%) and injection site erythema (9.2%). 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
TubersolTuberculin purified protein derivative	brand	1,673	73	28.3%	Poor quality product administered
AplisolTuberculin purified protein derivative	brand	679	13	16.9%	Injection site erythema

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

Poor quality product administered17.2%405
Product storage errorthe product was stored wrongly13.8%325
Injection site erythemaredness where the injection was given9.2%217
Expired product administeredthe product was used past its expiry date6.3%147
No adverse eventno adverse event was reported4.5%107
Pruritusitching4.5%107
Erythemaskin redness4.5%105
Injection site induration4.4%103
False positive tuberculosis test4.3%101
Tuberculin test false positive4.3%100
Product quality issuea problem with the product itself4.2%99
Injection site pruritusitching where the injection was given4.2%98
Wrong product administered4%94
Dyspnoeashortness of breath3.7%87
Incorrect route of product administrationthe product was given by the wrong route3.5%82
Hypersensitivityan allergic-type reaction3.3%77
Incorrect dose administeredthe wrong dose was given3.2%76
Injection site painpain where the injection was given3.2%75
Incorrect route of drug administrationthe medicine was given by the wrong route3%71
Urticariahives2.9%69
Nauseafeeling sick2.9%68
Drug administration errora mistake in giving the medicine2.8%65
Rashskin rash2.6%60
Dizzinesslight-headedness or unsteadiness2.4%57
Injection site warmth2.3%53

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death0.2%4

Life-threatening1.4%33

Hospitalisation (initial or prolonged)4.2%99

Disability0.5%11

Congenital anomaly0%0

Other serious21.2%498

Not serious75%1,763

Patient age

Under 20.7%16

2 to 112.3%53

12 to 173.5%83

18 to 4431.3%737

45 to 6410%236

65 to 741.6%37

75 and over1.4%33

Age not given49.2%1,157

Who reported

Physician13.4%316

Pharmacist10.5%247

Other health professional53.1%1,248

Lawyer0.1%3

Consumer or non-health professional19.1%449

Not given3.8%89

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 Skin test antigen reports

Which drugs are in the Skin test antigen class on this site?

Tubersol and Aplisol. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,352 reports through June 2026, 86 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?

poor quality product administered (17.2%), product storage error (13.8%), injection site erythema (9.2%), expired product administered (6.3%) and no adverse event (4.5%).

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.