Tobacco Leaf side effects: what 214 FDA adverse event reports show

Tobacco Leaf · A-30 · 17 reaction terms · 318 drug–reaction co-reports · data 2026-09-14

Drug class

Non-Standardized Plant Allergenic Extract

FDA label (Established Pharmacologic Class) · compare the class

Brand names

A-30

openFDA label

Who reports

214 reports · 98% serious · 22 with death outcome · 27% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Allergies.

FDA label, Indications and Usage

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 13 strongest signals

Reporting / coding artifact 2No label text to screen 11

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 4 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
Drug abuse	155	181.9 167.4–197.6ROR 657.1 · χ² 27,763 / p <1e-300	177.6 EB05 155.4 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious PRR 107.8 · 96% clinician	no trial data cached
Mydriasis	11	84.1 47.3–149.7ROR 88.7 · χ² 822 / p 4e-181	73.7 EB05 43.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.8	no trial data cached
Withdrawal syndrome	28	65.0 46.0–91.8ROR 74.7 · χ² 1,704 / p <1e-300	62.3 EB05 45.3 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 54.9 · 96% clinician	no trial data cached
Poisoning deliberate	5	52.7 22.1–125.3ROR 53.9 · χ² 204 / p 1e-46	44.0 EB05 19.9 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.8	no trial data cached
Orthostatic hypotension (dizziness on standing)	9	50.6 26.7–95.8ROR 52.7 · χ² 389 / p 6e-87	45.9 EB05 25.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Hepatic cytolysis	6	48.1 21.9–106.0ROR 49.5 · χ² 232 / p 1e-52	42.0 EB05 20.5 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.2	no trial data cached
Obstructive airways disorder	5	43.9 18.5–104.4ROR 44.9 · χ² 169 / p 6e-39	37.5 EB05 16.5 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.8	no trial data cached
Premature delivery	7	42.9 20.7–88.9ROR 44.3 · χ² 246 / p 9e-56	38.6 EB05 19.9 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.8	no trial data cached
Drug withdrawal syndrome neonatal	5	32.8 13.8–77.9ROR 33.5 · χ² 124 / p 4e-29	28.2 EB05 11.1 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.2	no trial data cached
Aggression	16	31.3 19.5–50.1ROR 33.7 · χ² 440 / p 6e-98	30.2 EB05 19.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9	no trial data cached
Drug dependence	39	23.5 17.7–31.2ROR 28.5 · χ² 824 / p 2e-181	23.3 EB05 17.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1 · 100% clinician	no trial data cached
Premature baby	7	22.7 11.0–47.1ROR 23.5 · χ² 125 / p 3e-29	20.5 EB05 9.1 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.5	no trial data cached
Drug withdrawal syndrome	10	11.0 6.0–20.2ROR 11.5 · χ² 82 / p 7e-20	8.9 EB05 4.7 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2	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
Drug abuse	155	181.9 167.4–197.6ROR 657.1 · χ² 27,763 / p <1e-300	177.6 EB05 155.4 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious PRR 107.8 · 96% clinician	no trial data cached
Drug dependence	39	23.5 17.7–31.2ROR 28.5 · χ² 824 / p 2e-181	23.3 EB05 17.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 14.1 · 100% clinician	no trial data cached
Withdrawal syndrome	28	65.0 46.0–91.8ROR 74.7 · χ² 1,704 / p <1e-300	62.3 EB05 45.3 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 54.9 · 96% clinician	no trial data cached
Aggression	16	31.3 19.5–50.1ROR 33.7 · χ² 440 / p 6e-98	30.2 EB05 19.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.9	no trial data cached
Mydriasis	11	84.1 47.3–149.7ROR 88.7 · χ² 822 / p 4e-181	73.7 EB05 43.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.8	no trial data cached
Drug withdrawal syndrome	10	11.0 6.0–20.2ROR 11.5 · χ² 82 / p 7e-20	8.9 EB05 4.7 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2	no trial data cached
Orthostatic hypotension (dizziness on standing)	9	50.6 26.7–95.8ROR 52.7 · χ² 389 / p 6e-87	45.9 EB05 25.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Premature baby	7	22.7 11.0–47.1ROR 23.5 · χ² 125 / p 3e-29	20.5 EB05 9.1 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.5	no trial data cached
Premature delivery	7	42.9 20.7–88.9ROR 44.3 · χ² 246 / p 9e-56	38.6 EB05 19.9 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.8	no trial data cached
Hepatic cytolysis	6	48.1 21.9–106.0ROR 49.5 · χ² 232 / p 1e-52	42.0 EB05 20.5 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.2	no trial data cached
Drug withdrawal syndrome neonatal	5	32.8 13.8–77.9ROR 33.5 · χ² 124 / p 4e-29	28.2 EB05 11.1 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.2	no trial data cached
Obstructive airways disorder	5	43.9 18.5–104.4ROR 44.9 · χ² 169 / p 6e-39	37.5 EB05 16.5 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.8	no trial data cached
Poisoning deliberate	5	52.7 22.1–125.3ROR 53.9 · χ² 204 / p 1e-46	44.0 EB05 19.9 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.8	no trial data cached
Poisoning	4	31.1 11.8–82.0ROR 31.6 · χ² 88 / p 3e-21	24.6 EB05 6.7 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.6	no trial data cached
Status epilepticus	4	34.6 13.1–91.5ROR 35.3 · χ² 99 / p 1e-23	27.8 EB05 8.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Tobacco Leaf?

In FDA FAERS, the most frequently co-reported reaction terms for Tobacco Leaf are withdrawal syndrome, aggression, mydriasis, drug withdrawal syndrome, orthostatic hypotension, premature baby. 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 Tobacco Leaf have an FDA boxed warning?

No. The FDA label retrieved for Tobacco Leaf has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Tobacco Leaf 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 62aab64a-7cb7-46c1-9886-ee0c7ffd0b13, effective 20250109; matched on openfda.generic_name.exact:"TOBACCO LEAF")
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, 17 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.