Quick answers
- What is Tuberculin purified protein derivative used for?
- The FDA-approved label (Tubersol, Sanofi Vaccines US Inc., May 1, 2026) says: “TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Tuberculin purified protein derivative?
- The “Adverse Reactions” section of the FDA label (Tubersol, Sanofi Vaccines US Inc., May 1, 2026) begins: “Induration at the TUBERSOL injection site is the expected reaction for a positive skin test. (See Interpretation of the Test.) The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL. General disorders and administration site conditions Injection site pain, injection site pruritus and injection site discomfort.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Tuberculin purified protein derivative?
- The “Drug Interactions” section of the FDA label (Tubersol, Sanofi Vaccines US Inc., May 1, 2026) begins: “Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (7) Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tuberculin purified protein derivative have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tuberculin purified protein derivative?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tuberculin purified protein derivative been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tuberculin purified protein derivative?
- 2 companies list prescription products of Tuberculin purified protein derivative in the FDA NDC Directory, including A-S Medication Solutions and Sanofi Vaccines US Inc.
What Tuberculin purified protein derivative is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at …
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intradermal), Tubersol, Sanofi Vaccines US Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Tuberculin purified protein derivative side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Induration at the TUBERSOL injection site is the expected reaction for a positive skin test. (See Interpretation of the Test.) The information pertaining to adverse events has been compiled from historical clinical studies and post-marketing experience with TUBERSOL. General disorders and administration site conditions Injection site pain, injection site pruritus and injection site discomfort.
Read more of this section
Injection site erythema or injection site rash (without induration) occurring within 12 hours of testing. These reactions do not indicate TB infection. Injection site hemorrhage and injection site hematoma up to three days after the administration of the test. Injection site vesicles, injection site ulcer or injection site necrosis in highly sensitive persons. Injection site scar as a result of strongly positive reactions. Pyrexia Immune system disorders Hypersensitivity, including anaphylaxis/anaphylactic reactions, angioedema, urticaria Respiratory, thoracic, and mediastinal disorders Stridor, dyspnea Skin and subcutaneous tissue disorders Rash, generalized rash Nervous system disorders Presyncope, syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in transient loss of consciousness with injury Reporting of Adverse Events To report SUSPECTED ADVERSE REACTIONS, contact the Pharmacovigilance Department, Sanofi Vaccines US Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463 (1-800-VACCINE) or Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088 and www.fda.gov/medwatch.
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
Tuberculin purified protein derivative drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (7) Reactivity to TUBERSOL may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). If a parenteral live attenuated virus vaccine has been administered recently, tuberculin testing should be delayed for >1 month after vaccination.
Read more of this section
(7)(11) (See Interpretation of the Test.) When tuberculin screening is required at the same time as a measles-containing vaccine or other parenteral live attenuated virus vaccine, simultaneous administration of TUBERSOL and the vaccine at separate sites is the preferred option.
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
Tuberculin purified protein derivative dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Dosage Five (5) tuberculin units (TU) per test dose of 0.1 mL is the standard strength used for intradermal (Mantoux) testing. Method of Administration TUBERSOL is indicated for intradermal injection only. Do not inject intravenously, intramuscularly, or subcutaneously. If subcutaneous injection occurs, the test cannot be interpreted. Inspect for extraneous particulate matter and/or discoloration before use. If these conditions exist, do not administer the product.
Read more of this section
Use a separate syringe and needle for each injection. (12) The following procedure is recommended for performing the Mantoux test: The preferred site of the test is the volar aspect of the forearm. Avoid areas on the skin that are red or swollen. Avoid visible veins. Clean the skin site with a suitable germicide and allow the site to dry prior to injection of the antigen. Administer the test dose (0.1 mL) of TUBERSOL with a 1 mL syringe calibrated in tenths and fitted with a short, one-quarter to one-half inch, 26 or 27 gauge needle. Wipe the stopper of the vial with a suitable germicide and allow to dry before needle insertion. Then insert the needle gently through the stopper and draw 0.1 mL of TUBERSOL into the syringe. Avoid injection of excess air with removal of each dose so as not to over pressurize the vial and possibly cause seepage at the puncture site. Insert the point of the needle into the most superficial layers of the skin with the needle bevel pointing upward and administer the dose by slow intradermal injection. If the intradermal injection is performed properly, a definite pale bleb will rise at the needle point, about 10 mm (3 / 8 ") in diameter. This bleb will disperse within minutes. Do not dress the site. A drop of blood may appear at the administration site following injection. Blot the site lightly to remove the blood but avoid squeezing out the injected tuberculin test fluid. In the event of an improperly performed injection (i.e., no bleb formed), repeat the test immediately at another site, at least 2 inches from the first site and circle the second injection site as an indication that this is the site to be read. Inform the patient of the need to return for the reading of the test by a trained health professional. Self-reading may be inaccurate and is strongly discouraged. Interpretation of the Test The skin test should be read by a trained health professional 48 to 72 hours after administration of TUBERSOL. Skin test sensitivity is indicated by induration only; redness should not be measured. Measure the diameter of induration transversely to the long axis of the forearm and record the measurement in millimeters (including 0 mm). (7) The tip of a ballpoint pen, gently pushed at a 45° angle toward the site of injection, will stop at the edge of induration. Also record presence and size (if present) of necrosis and edema, although these are not used in the interpretation of the test. Positive Reactions Tuberculin reactivity may indicate latent infection, prior infection and/or disease with M. tuberculosis and does not necessarily indicate the presence of active tuberculous disease.
Table from the label
| Reaction ≥5 mm of Induration | Reaction ≥10 mm of Induration | Reaction ≥15 mm of Induration |
|---|---|---|
| HIV-positive persons Recent contacts of tuberculosis (TB) case patients Fibrotic changes on chest radiograph consistent with prior TB Patients with organ transplants and other immunosuppressed patients (receiving the equivalent of ≥15 mg/d of prednisone for 1 month or more)Risk of TB in patients treated with corticosteroids increases with higher dose and longer duration. | Recent immigrants (i.e., within the last 5 yrs) from high prevalence countries Injection drug users Residents or employeesFor persons who are otherwise at low risk and are tested at the start of employment, a reaction of ≥15 mm induration is considered positive. of the following high-risk congregate settings: prisons and jails, nursing homes and other long-term facilities for the elderly, hospitals and other healthcare facilities, residential facilities for patients with acquired immunodeficiency syndrome (AIDS) and homeless shelters Mycobacteriology laboratory personnel Persons with the following clinical conditions that place them at high risk: silicosis, diabetes mellitus, chronic renal failure, some hematologic disorders (e.g., leukemias and lymphomas), other specific malignancies (e.g., carcinoma of the head or neck and lung), weight loss of ≥10% of ideal body weight, gastrectomy and jejunoileal bypass Children younger than 4 yrs of age or infants, children, and adolescents exposed to adults at high-risk | Persons with no risk factors for TB |
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. This is part of the section. Read the full label on DailyMed →
Tuberculin purified protein derivative in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Animal reproduction studies have not been conducted with TUBERSOL. It is also not known whether TUBERSOL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TUBERSOL should be given to a pregnant woman only if clearly needed.
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
Tuberculin purified protein derivative and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether TUBERSOL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TUBERSOL is administered to a nursing woman.
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
When Tuberculin purified protein derivative should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Allergy to any component of TUBERSOL or an anaphylactic or other allergic reaction to a previous test of tuberculin PPD is a contraindication to the use of TUBERSOL.
Read more of this section
(See DESCRIPTION and HOW SUPPLIED.) TUBERSOL should not be administered to: Persons who have had a severe reaction (e.g., necrosis, blistering, anaphylactic shock, or ulcerations) to a previous TST, Persons with documented active tuberculosis or a clear history of treatment for TB infection or disease, (9) Persons with extensive burns or eczema.
— FDA label: Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intradermal |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Tubersol, Aplisol |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions3 products
- Sanofi Vaccines US Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0566-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21 — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 313532, 798408, 798415 |
|---|---|
| SPL set ID of the quoted label | a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd |
| FDA labels (SPL) | 4 |
| FDA applications | BLA103782, BLA103941 |
| Active ingredients (FDA) | TUBERCULIN PURIFIED PROTEIN DERIVATIVE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- A-S Medication SolutionsMaker or distributor
- Sanofi Vaccines US Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tubersol, Sanofi Vaccines US Inc., effective May 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →