Tuberculin Purified Protein

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.