Brand name · Tuberculin purified protein derivative
Tubersol: adverse event reports filed with FDA
1,673 reports list it as a suspect or interacting product, 2004–2026. Class: Skin test antigen.
- 1,673
- reports as suspect product
- 0% of all reports · about 74 a year
- 73
- reports, 12 months to June 2026
- 99 in the 12 months before
- 28.3%
- marked serious by the reporter
- 25% across the class
- 0.2%
- record death among outcomes, as reported
- 3 reports · not verified by FDA
Between January 2004 and June 2026, 1,673 adverse event reports received by FDA list the brand name Tubersol (tuberculin purified protein derivative) as a suspect or interacting product. Reports that mention it only as a concomitant medication (108) are left out of every figure here.
In the 12 months to June 2026, 73 reports listed it, down 26% from 99 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 74 reports a year and 0% of the 20,646,523 reports in the database, and 71.1% 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 reactions recorded most often are poor quality product administered (24.2%), product storage error (19.2%) and expired product administered (8.1%). A report can list several reactions, so shares add to more than 100%; 208 different terms appear across these reports. Poor quality product administered is recorded in 24.2% of these reports, a larger share than in the median skin test antigen drug (12.1%).
28.3% of the reports are marked serious by the reporter (25% across the class); 0.2% record death among the outcomes and 5.3% record hospitalisation, as reported. 62.1% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (39.1%). 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 Tubersol reports recording the termmedian drug in skin test antigen
- Product storage errorthe product was stored wrongly19.2%321
- Expired product administeredthe product was used past its expiry date8.1%136
- Pruritusitching5.6%93
- Dyspnoeashortness of breath5%83
- Erythemaskin redness5%83
- Incorrect route of product administrationthe product was given by the wrong route4.8%81
- Injection site erythemaredness where the injection was given4.8%80
- Urticariahives4%67
- Nauseafeeling sick3.6%60
- Rashskin rash3.5%58
- Hypersensitivityan allergic-type reaction3.2%54
- Dizzinesslight-headedness or unsteadiness3.2%53
- Injection site painpain where the injection was given2.5%41
- Injection site pruritusitching where the injection was given2.3%39
- Headachehead pain2.2%36
- Injection site reactiona reaction where the injection was given2.2%36
- Overdosea dose above the recommended amount1.9%32
- Throat tightnessa tight throat1.9%32
- Pyrexiafever1.7%29
- Painpain, site not specified1.7%28
- Syncopefainting1.7%28
- Paraesthesiatingling or pins and needles1.6%27
- Chest discomfortchest discomfort1.6%26
- Incorrect dose administeredthe wrong dose was given1.6%26
- Fatiguetiredness1.5%25
- Hypoaesthesianumbness1.4%24
- Pain in extremitypain in an arm or leg1.4%24
Top 30 of 208 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. 89% 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 | 1,137 | 68% |
| Immunisation | 159 | 9.5% |
| Skin test | 61 | 3.6% |
| Mycobacterium tuberculosis complex test | 60 | 3.6% |
| Tuberculosis | 11 | 0.7% |
| Exposure to communicable disease | 2 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,673 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Tubersol reports |
|---|---|---|
| Influenza Vaccine | 13 | 0.8% |
| Influenza virus vaccine | 7 | 0.4% |
| Albuterol | 6 | 0.4% |
| Aspirin | 6 | 0.4% |
| Singulair | 6 | 0.4% |
| Zoloft | 6 | 0.4% |
| Zyrtec | 6 | 0.4% |
| Benadryl | 5 | 0.3% |
| Lantus | 5 | 0.3% |
| Norvasc | 5 | 0.3% |
Other products listed in reports where Tubersol is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Tubersol | Skin test antigen | All reports |
|---|---|---|---|
| Reports as suspect product | 1,673 | 2,352 | 20,646,523 |
| Share of that pool | — | 71.1% | 0% |
| Reports, latest 12 months | 73 | — | 1,332,454 |
| Marked serious | 28.3% | 25% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 2 | 2 | 91 |
| Hospitalisation recorded, per 1,000 reports | 53 | 42 | 213 |
| Consumer-filed share | 10.3% | 19.1% | 45.8% |
| Top term, share of reports | Poor quality product administered 24.2% | median 12.1% | 0% |
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 |
|---|---|---|---|---|
| Aplisol | brand | 679 | 13 | 16.9% |
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 Tubersol reports
How many adverse event reports has FDA received for Tubersol?
1,673 reports list Tubersol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 73 of them arrived in the latest 12 months. Another 108 list it only as a concomitant medication.
What reactions are recorded in Tubersol reports?
poor quality product administered (24.2%), product storage error (19.2%), expired product administered (8.1%), pruritus (5.6%) and wrong product administered (5.6%). 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 Tubersol was responsible.
How serious are the reports?
28.3% are marked serious by the reporter. Among the outcomes recorded, 0.2% of reports include death and 5.3% 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 (62.1%), physician (16.3%) and consumer or non-health professional (10.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Tubersol rising?
73 reports in the 12 months to June 2026, down 26% from 99 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 Tubersol 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 Tubersol?
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 Tubersol as a suspect or interacting product; reports listing it only as a concomitant medication (108) 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.