Brand name · Tuberculin purified protein derivative
Aplisol: adverse event reports filed with FDA
679 reports list it as a suspect or interacting product, 2004–2026. Class: Skin test antigen.
- 679
- reports as suspect product
- 0% of all reports · about 30 a year
- 13
- reports, 12 months to June 2026
- 6 in the 12 months before
- 16.9%
- marked serious by the reporter
- 25% across the class
- 0.1%
- record death among outcomes, as reported
- 1 reports · not verified by FDA
Between February 2004 and April 2026, 679 adverse event reports received by FDA list the brand name Aplisol (tuberculin purified protein derivative) as a suspect or interacting product. Reports that mention it only as a concomitant medication (55) are left out of every figure here.
In the 12 months to June 2026, 13 reports listed it, up 117% from 6 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 30 reports a year and 0% of the 20,646,523 reports in the database, and 28.9% of the reports for the skin test antigen class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are injection site erythema (20.2%), no adverse event (14.6%) and false positive tuberculosis test (14.4%). A report can list several reactions, so shares add to more than 100%; 102 different terms appear across these reports. Injection site erythema is recorded in 20.2% of these reports, a larger share than in the median skin test antigen drug (12.5%).
16.9% of the reports are marked serious by the reporter (25% across the class); 0.1% record death among the outcomes and 1.6% record hospitalisation, as reported. 40.8% of the reports came from consumers, and the largest patient age group is 18 to 44 (12.2%). 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 Aplisol reports recording the termmedian drug in skin test antigen
- Injection site erythemaredness where the injection was given20.2%137
- No adverse eventno adverse event was reported14.6%99
- False positive tuberculosis test14.4%98
- Tuberculin test false positive14%95
- Product quality issuea problem with the product itself13.7%93
- Injection site induration10.2%69
- Drug administration errora mistake in giving the medicine9.6%65
- Injection site pruritusitching where the injection was given8.7%59
- Incorrect route of drug administrationthe medicine was given by the wrong route7.7%52
- Incorrect dose administeredthe wrong dose was given7.4%50
- Injection site painpain where the injection was given5%34
- Injection site warmth4.4%30
- Wrong drug administeredthe wrong medicine was given4.4%30
- Injection site rash4.1%28
- Injection site swellingswelling where the injection was given4.1%28
- Hypersensitivityan allergic-type reaction3.4%23
- Erythemaskin redness3.2%22
- Pain in extremitypain in an arm or leg2.9%20
- Pruritusitching2.1%14
- Expired product administeredthe product was used past its expiry date1.6%11
- Injection site urticaria1.6%11
- Injection site vesicles1.5%10
- No adverse drug reaction1.5%10
- Blistera blister1.3%9
- Peripheral swellingswelling of the arms or legs1.3%9
- Suspected product quality issue1.3%9
- Nauseafeeling sick1.2%8
- Rash erythematousa red rash1.2%8
- Skin lesion1.2%8
Top 30 of 102 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 2 drugs in the skin test antigen 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 2,352 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. 97.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Tuberculin test | 492 | 72.5% |
| Mycobacterium tuberculosis complex test | 10 | 1.5% |
| Tuberculosis test | 4 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 679 reports.
In context
| Measure | Aplisol | Skin test antigen | All reports |
|---|---|---|---|
| Reports as suspect product | 679 | 2,352 | 20,646,523 |
| Share of that pool | — | 28.9% | 0% |
| Reports, latest 12 months | 13 | — | 1,332,454 |
| Marked serious | 16.9% | 25% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 1 | 2 | 91 |
| Hospitalisation recorded, per 1,000 reports | 16 | 42 | 213 |
| Consumer-filed share | 40.8% | 19.1% | 45.8% |
| Top term, share of reports | Injection site erythema 20.2% | median 12.5% | 0.6% |
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 skin test antigen class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Tubersol | brand | 1,673 | 73 | 28.3% |
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 Aplisol reports
How many adverse event reports has FDA received for Aplisol?
679 reports list Aplisol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 13 of them arrived in the latest 12 months. Another 55 list it only as a concomitant medication.
What reactions are recorded in Aplisol reports?
injection site erythema (20.2%), no adverse event (14.6%), false positive tuberculosis test (14.4%), tuberculin test false positive (14%) and product quality issue (13.7%). 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 Aplisol was responsible.
How serious are the reports?
16.9% are marked serious by the reporter. Among the outcomes recorded, 0.1% of reports include death and 1.6% 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?
consumer or non-health professional (40.8%), other health professional (30.8%) and pharmacist (19%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Aplisol rising?
13 reports in the 12 months to June 2026, up 117% from 6 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 Aplisol 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 Aplisol?
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 Aplisol as a suspect or interacting product; reports listing it only as a concomitant medication (55) 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.