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- Clinician Information:
Tubersol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tubersol (tuberculin purified protein derivative) is indicated as an aid in the detection of infection with M. tuberculosis. It is a cell-free purified protein derived from Mycobacterium tuberculosis. This medication may be available in generic form. Uncommon side effects include ulceration of the skin at the test site. Rarely, an allergic reaction may occur.
The dose of Tubersol is 0.1 mL administered under the skin in what's called the Mantoux tuberculin test (also known as a PPD, purified protein derivative). A health care professional will monitor your reaction at 48 and 72 hours after the test is performed to determine the presence of a positive reaction to M. tuberculosis. Tubersol may interact with certain other live vaccines. Tell your doctor all medications you use. During pregnancy, Tubersol should be used only if prescribed. Consult your doctor before breast-feeding.
Our Tubersol (tuberculin purified protein) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tubersol FDA Prescribing Information: Side Effects
Very rare: Vesiculation, ulceration or necrosis may appear at the test site in highly sensitive persons. Cold packs or topical steroid preparations may be employed for symptomatic relief of the associated pain, pruritus and discomfort.
Strongly positive reactions may result in scarring at the test site.
Uncommon: Immediate erythematous or other reactions may occur at the injection site. The reason(s) for these occurences are presently unknown.
Rare: There have been rare systemic allergic reactions reported that were manifested by immediate skin rash or generalized rash within 24 hours. Two of the reported cases had concurrent symptoms of upper respiratory stridor. These reactions were treated with epinephrine and steroids and resolved. No cause and effect was able to be established with a specific component of skin test.27
Reporting of Adverse Events
Reporting by patients, parents or guardians of all adverse events occuring after a tuberculin skin test should be encouraged. Adverse events following the test should be reported by the health-care provider to the Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088.28
The health-care provider also may report these events to the Director of Medical Affairs, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370-0187 or call 1-800-822-2463.
Read the entire FDA prescribing information for Tubersol (Tuberculin Purified Protein) »
Additional Tubersol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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