August 23, 2016
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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.


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

Read the Tubersol (tuberculin purified protein) Side Effects Center for a complete guide to possible side effects


Reactivity to the test may be depressed or suppressed in persons who are receiving corticosteroids or immunosuppressive agents. (8)

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. (8) (12) (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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/5/2016

Side Effects

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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