July 27, 2016
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Tubersol

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Tubersol




Tubersol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/15/2015

Tubersol (tuberculin purified protein derivative) is a cell-free purified protein derived from Mycobacterium tuberculosis indicated as an aid in the detection of infection with M. tuberculosis. Tubersol may be available in generic form. Uncommon side effects of Tubersol include redness or ulceration of the skin at the test site, skin rash, or itching. 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
(Adverse Reactions)

SIDE EFFECTS

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.

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, angiodema, 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 Pasteur 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.

Read the entire FDA prescribing information for Tubersol (Tuberculin Purified Protein)

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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