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What the label lists and what reports show

Tuberculin purified protein derivative side effects

Tuberculin purified protein derivative's FDA label lists its adverse reactions in its own words. FAERS holds 1,852 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is poor quality product administered (405 reports).

  • No generic listed

Check it at the source: the tuberculin purified protein derivative FDA label on DailyMed (effective May 1, 2026); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

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. …

Source: FDA drug label, Sanofi Vaccines US Inc., effective May 1, 2026 (SPL set a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,852 reports list tuberculin purified protein derivative among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 143 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Poor Quality Product Administered405
  • Product Storage Error322
  • Expired Product Administered (a use or a product term, not a reaction)137
  • Pruritus (named in the label)102
  • Erythema (named in the label)98
  • Wrong Product Administered98
  • Dyspnoea (named in the label)95
  • Injection Site Erythema (named in the label)91
  • Incorrect Route Of Product Administration86
  • Nausea71
  • Urticaria (named in the label)69
  • Rash (named in the label)65
  • Dizziness64
  • Hypersensitivity (named in the label)58
  • Injection Site Pruritus (named in the label)53
  • Injection Site Pain (named in the label)49
  • Headache47
  • Injection Site Reaction47
  • Pyrexia (named in the label)46
  • Injection Site Induration42
  • Pain42
  • Overdose (a use or a product term, not a reaction)37
  • Syncope (named in the label)37
  • Asthenia36
  • Pain In Extremity35

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tuberculin purified protein derivative: the full record
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Side effects hub
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