Drug · FAERS side-effect profile with label screen

Tuberculin Purified Protein Derivative side effects: what 1,852 FDA adverse event reports show

Tuberculin Purified Protein Derivative · Tubersol · 39 reaction terms · 1,826 drug–reaction co-reports · data 2026-09-14

Drug class

Skin Test Antigen, Tuberculosis Skin Test

FDA label (Established Pharmacologic Class)

Brand names

Tubersol

openFDA label

Who reports

1,852 reports · 32% serious · 20 with death outcome · 74% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST).

FDA label, Indications and Usage

What it is

DESCRIPTION TUBERSOL ® Tuberculin Purified Protein Derivative (Mantoux) (PPD) (1) for intradermal tuberculin testing is prepared from a large Master Batch Connaught Tuberculin (CT68) (2) and i.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 31 strongest signals

Labeled adverse reaction 7Labeled (related wording) 11Reporting / coding artifact 5Not in label — unassessed 8

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 8 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Poor quality product administered	405	467.2 427.7–510.4ROR 597.7 · χ² 180,499 / p <1e-300	439.2 EB05 404.4 · IC025 +8.0 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 95% clinician	no trial data cached
Incorrect route of product administration	86	58.2 47.3–71.6ROR 61.0 · χ² 4,760 / p <1e-300	57.2 EB05 47.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Expired product administered	137	46.9 39.9–55.2ROR 50.6 · χ² 6,098 / p <1e-300	46.5 EB05 40.3 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	90% clinician	no trial data cached
Product storage error	322	42.3 38.3–46.7ROR 51.0 · χ² 12,944 / p <1e-300	42.0 EB05 38.3 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site induration	42	36.8 27.3–49.7ROR 37.6 · χ² 1,423 / p <1e-300	36.1 EB05 27.9 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=21	no trial data cached
Injection site warmth	26	14.3 9.8–21.0ROR 14.5 · χ² 309 / p 2e-69	13.9 EB05 9.6 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=22 · ♀ 96% (drug 74%) · 100% clinician	no trial data cached
Throat tightness	34	14.3 10.2–19.9ROR 14.5 · χ² 406 / p 1e-90	14.0 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 32.8 · 90% clinician	no trial data cached
Injection site discolouration	14	12.8 7.6–21.6ROR 12.9 · χ² 141 / p 1e-32	11.5 EB05 6.6 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=4	no trial data cached
Paraesthesia oral	15	11.8 7.1–19.6ROR 11.9 · χ² 138 / p 4e-32	10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.7	no trial data cached
Pharyngeal oedema	16	11.6 7.1–18.9ROR 11.7 · χ² 145 / p 1e-33	10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 27.8	no trial data cached
Injection site irritation	11	9.9 5.5–17.8ROR 9.9 · χ² 79 / p 3e-19	8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious n=8	no trial data cached
Pallor	23	9.6 6.4–14.3ROR 9.7 · χ² 168 / p 1e-38	8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 96% clinician	no trial data cached
Injection site pruritus	53	9.0 6.9–11.8ROR 9.3 · χ² 371 / p 6e-83	8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 69.8 · ♀ 96% (drug 74%)	no trial data cached
Presyncope (near-fainting)	19	8.9 5.7–13.9ROR 9.0 · χ² 125 / p 2e-29	7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3	no trial data cached
Injection site erythema (redness where injected)	91	8.4 6.8–10.2ROR 8.7 · χ² 585 / p 2e-129	8.1 EB05 6.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 60.2	no trial data cached
Injection site rash	22	8.2 5.4–12.4ROR 8.3 · χ² 132 / p 6e-31	7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=16	no trial data cached
Injection site reaction	47	7.8 5.9–10.3ROR 7.9 · χ² 271 / p 4e-61	7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 52.8 · 93% clinician	no trial data cached
Pruritus generalised	15	7.7 4.7–12.8ROR 7.8 · χ² 82 / p 9e-20	6.5 EB05 4.1 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5	no trial data cached
Incorrect route of drug administration	24	7.5 5.0–11.2ROR 7.6 · χ² 129 / p 4e-30	6.7 EB05 4.7 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 56.7 · 91% clinician	no trial data cached
Product administered at inappropriate site	12	7.5 4.3–13.2ROR 7.5 · χ² 61 / p 3e-15	6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Swollen tongue	19	6.9 4.4–10.8ROR 6.9 · χ² 90 / p 1e-21	6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Rash generalised	15	6.5 3.9–10.7ROR 6.5 · χ² 64 / p 6e-16	5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.0	no trial data cached
Injection site urticaria	13	6.1 3.5–10.4ROR 6.1 · χ² 50 / p 7e-13	5.1 EB05 3.2 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious n=6	no trial data cached
Anaphylactic reaction (severe allergic reaction)	29	6.0 4.2–8.6ROR 6.1 · χ² 116 / p 3e-27	5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.7 · 100% clinician	no trial data cached
Erythema (skin redness)	98	5.4 4.5–6.6ROR 5.7 · χ² 351 / p 1e-78	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.1	no trial data cached
Rash papular	10	5.0 2.7–9.4ROR 5.1 · χ² 29 / p 5e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Urticaria (hives)	69	4.7 3.7–5.9ROR 4.8 · χ² 199 / p 2e-45	4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.5	no trial data cached
Throat irritation	17	4.3 2.7–6.9ROR 4.3 · χ² 40 / p 1e-10	3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.9	no trial data cached
Injection site swelling	27	4.0 2.8–5.9ROR 4.1 · χ² 59 / p 9e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 40.4 · 95% clinician	no trial data cached
Extra dose administered	11	3.1 1.7–5.6ROR 3.1 · χ² 14 / p 1e-4	2.8 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious n=1	no trial data cached
Convulsion (seizure)	15	2.9 1.8–4.8ROR 2.9 · χ² 17 / p 2e-5	2.7 EB05 1.8 · IC025 +0.6	Labeled (related wording) related wording	serious PRR 5.5	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Poor quality product administered	405	467.2 427.7–510.4ROR 597.7 · χ² 180,499 / p <1e-300	439.2 EB05 404.4 · IC025 +8.0 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 95% clinician	no trial data cached
Product storage error	322	42.3 38.3–46.7ROR 51.0 · χ² 12,944 / p <1e-300	42.0 EB05 38.3 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Expired product administered	137	46.9 39.9–55.2ROR 50.6 · χ² 6,098 / p <1e-300	46.5 EB05 40.3 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	90% clinician	no trial data cached
Erythema (skin redness)	98	5.4 4.5–6.6ROR 5.7 · χ² 351 / p 1e-78	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.1	no trial data cached
Injection site erythema (redness where injected)	91	8.4 6.8–10.2ROR 8.7 · χ² 585 / p 2e-129	8.1 EB05 6.8 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 60.2	no trial data cached
Incorrect route of product administration	86	58.2 47.3–71.6ROR 61.0 · χ² 4,760 / p <1e-300	57.2 EB05 47.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Urticaria (hives)	69	4.7 3.7–5.9ROR 4.8 · χ² 199 / p 2e-45	4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.5	no trial data cached
Injection site pruritus	53	9.0 6.9–11.8ROR 9.3 · χ² 371 / p 6e-83	8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 69.8 · ♀ 96% (drug 74%)	no trial data cached
Injection site pain (pain where injected)	49	1.8 1.4–2.4ROR 1.9 · χ² 18 / p 1e-5	1.8 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 13.1	no trial data cached
Injection site reaction	47	7.8 5.9–10.3ROR 7.9 · χ² 271 / p 4e-61	7.3 EB05 5.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 52.8 · 93% clinician	no trial data cached
Injection site induration	42	36.8 27.3–49.7ROR 37.6 · χ² 1,423 / p <1e-300	36.1 EB05 27.9 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=21	no trial data cached
Throat tightness	34	14.3 10.2–19.9ROR 14.5 · χ² 406 / p 1e-90	14.0 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 32.8 · 90% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	29	6.0 4.2–8.6ROR 6.1 · χ² 116 / p 3e-27	5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.7 · 100% clinician	no trial data cached
Injection site swelling	27	4.0 2.8–5.9ROR 4.1 · χ² 59 / p 9e-15	3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 40.4 · 95% clinician	no trial data cached
Injection site warmth	26	14.3 9.8–21.0ROR 14.5 · χ² 309 / p 2e-69	13.9 EB05 9.6 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious n=22 · ♀ 96% (drug 74%) · 100% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Throat tightness — n=34, PRR 14.3
Pallor — n=23, PRR 9.6

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Tuberculin Purified Protein Derivative?

In FDA FAERS, the most frequently co-reported reaction terms for Tuberculin Purified Protein Derivative are poor quality product administered, erythema, injection site erythema, urticaria, injection site pruritus, injection site pain. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Tuberculin Purified Protein Derivative have an FDA boxed warning?

No. The FDA label retrieved for Tuberculin Purified Protein Derivative has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tuberculin Purified Protein Derivative causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 261efc52-a105-4c2c-a8ce-9eee20b62efc, effective 20230615; matched on openfda.generic_name.exact:"TUBERCULIN PURIFIED PROTEIN DERIVATIVE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 39 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.