Drug · FAERS side-effect profile with label screen

Echinacea (Angustifolia) side effects: what 707 FDA adverse event reports show

Echinacea (Angustifolia), Tabebuia Impetiginosa, Hydrastis Canadensis, Glandula Suprarenalis Suis, Thymus (Suis), Thyroidinum (Suis), Arsenicum Album, Bryonia (Alba), Cocculus Indicus, Colchicum Autumnale, Ledum Palustre, Mercurius Cyanatus, Natrum Sulphuricum, Pulsatilla (Pratensis), Sepia, Silicea, Aflatoxin (B1) · 20 reaction terms · 689 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

closest label found was a multi-ingredient product (Echinacea (Angustifolia), Tabebuia Impetiginosa, Hydrastis Canadensis, Glandula Suprarenalis Suis, Thymus (Suis), Thyroi) and was not used

Who reports

707 reports · 97% serious · 212 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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 18 strongest signals

Lab value / disease marker 6No label text to screen 12

What the badges mean

Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 2 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
Acute myeloid leukaemia	61	116.6 91.7–148.3ROR 127.6 · χ² 6,856 / p <1e-300	112.2 EB05 90.5 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 69.3 · 90% clinician	no trial data cached
Febrile neutropenia	153	68.7 59.7–79.0ROR 87.4 · χ² 10,145 / p <1e-300	68.0 EB05 59.4 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 40.8 · 95% clinician	no trial data cached
Myelosuppression	65	56.8 45.0–71.6ROR 62.4 · χ² 3,505 / p <1e-300	55.8 EB05 45.3 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 33.7 · 94% clinician	no trial data cached
Hepatic function abnormal	68	54.5 43.5–68.3ROR 60.2 · χ² 3,518 / p <1e-300	53.6 EB05 43.8 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 34.3 · 100% clinician	no trial data cached
Neutrophil count decreased	45	33.0 24.9–43.8ROR 35.2 · χ² 1,365 / p 5e-299	32.5 EB05 25.3 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 22.7 · 96% clinician	no trial data cached
Bone marrow failure	21	30.5 20.0–46.4ROR 31.4 · χ² 569 / p 4e-126	29.7 EB05 20.5 · IC025 +3.4 3/3 methods agree	No label text to screen	serious PRR 18.1 · 100% clinician	no trial data cached
Cytopenia	11	27.3 15.2–49.1ROR 27.7 · χ² 253 / p 3e-57	26.1 EB05 15.4 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 16.7	no trial data cached
Platelet count decreased	91	25.4 20.9–30.7ROR 29.0 · χ² 2,114 / p <1e-300	25.2 EB05 21.2 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 18.4	no trial data cached
Blood lactate dehydrogenase increased	13	24.2 14.1–41.5ROR 24.6 · χ² 266 / p 4e-60	23.3 EB05 14.3 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	no trial data cached
Electrocardiogram qt prolonged	26	21.4 14.7–31.3ROR 22.2 · χ² 487 / p 3e-108	21.1 EB05 15.1 · IC025 +3.3 3/3 methods agree	No label text to screen	serious PRR 12.9 · 92% clinician	no trial data cached
Liver disorder	32	21.4 15.3–30.1ROR 22.4 · χ² 604 / p 1e-133	21.2 EB05 15.7 · IC025 +3.4 3/3 methods agree	No label text to screen	serious PRR 15.0 · 94% clinician	no trial data cached
Disseminated intravascular coagulation	10	21.0 11.4–38.9ROR 21.3 · χ² 171 / p 2e-39	19.8 EB05 10.7 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 12.5	no trial data cached
Bacteraemia	8	20.2 10.1–40.2ROR 20.4 · χ² 127 / p 8e-30	18.3 EB05 8.5 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 12.1	no trial data cached
Blood creatine phosphokinase increased	16	16.2 10.0–26.4ROR 16.6 · χ² 214 / p 1e-48	15.5 EB05 9.6 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.7	no trial data cached
Skin infection	6	16.0 7.2–35.4ROR 16.1 · χ² 70 / p 3e-17	12.4 EB05 4.7 · IC025 +1.5 3/3 methods agree	No label text to screen	serious PRR 13.1	no trial data cached
Ejection fraction decreased	7	13.3 6.4–27.9ROR 13.5 · χ² 68 / p 8e-17	10.3 EB05 4.4 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 8.7	no trial data cached
White blood cell count decreased	42	11.5 8.6–15.4ROR 12.1 · χ² 393 / p 7e-88	11.1 EB05 8.4 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 9.7	no trial data cached
Cytomegalovirus infection	6	10.7 4.8–23.7ROR 10.8 · χ² 44 / p 2e-11	7.3 EB05 3.2 · IC025 +1.2 3/3 methods agree	No label text to screen	serious PRR 6.4	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
Febrile neutropenia	153	68.7 59.7–79.0ROR 87.4 · χ² 10,145 / p <1e-300	68.0 EB05 59.4 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 40.8 · 95% clinician	no trial data cached
Platelet count decreased	91	25.4 20.9–30.7ROR 29.0 · χ² 2,114 / p <1e-300	25.2 EB05 21.2 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 18.4	no trial data cached
Hepatic function abnormal	68	54.5 43.5–68.3ROR 60.2 · χ² 3,518 / p <1e-300	53.6 EB05 43.8 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 34.3 · 100% clinician	no trial data cached
Myelosuppression	65	56.8 45.0–71.6ROR 62.4 · χ² 3,505 / p <1e-300	55.8 EB05 45.3 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 33.7 · 94% clinician	no trial data cached
Acute myeloid leukaemia	61	116.6 91.7–148.3ROR 127.6 · χ² 6,856 / p <1e-300	112.2 EB05 90.5 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 69.3 · 90% clinician	no trial data cached
Neutrophil count decreased	45	33.0 24.9–43.8ROR 35.2 · χ² 1,365 / p 5e-299	32.5 EB05 25.3 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 22.7 · 96% clinician	no trial data cached
White blood cell count decreased	42	11.5 8.6–15.4ROR 12.1 · χ² 393 / p 7e-88	11.1 EB05 8.4 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 9.7	no trial data cached
Liver disorder	32	21.4 15.3–30.1ROR 22.4 · χ² 604 / p 1e-133	21.2 EB05 15.7 · IC025 +3.4 3/3 methods agree	No label text to screen	serious PRR 15.0 · 94% clinician	no trial data cached
Electrocardiogram qt prolonged	26	21.4 14.7–31.3ROR 22.2 · χ² 487 / p 3e-108	21.1 EB05 15.1 · IC025 +3.3 3/3 methods agree	No label text to screen	serious PRR 12.9 · 92% clinician	no trial data cached
Bone marrow failure	21	30.5 20.0–46.4ROR 31.4 · χ² 569 / p 4e-126	29.7 EB05 20.5 · IC025 +3.4 3/3 methods agree	No label text to screen	serious PRR 18.1 · 100% clinician	no trial data cached
Blood creatine phosphokinase increased	16	16.2 10.0–26.4ROR 16.6 · χ² 214 / p 1e-48	15.5 EB05 9.6 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.7	no trial data cached
Blood lactate dehydrogenase increased	13	24.2 14.1–41.5ROR 24.6 · χ² 266 / p 4e-60	23.3 EB05 14.3 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 15.3	no trial data cached
Cytopenia	11	27.3 15.2–49.1ROR 27.7 · χ² 253 / p 3e-57	26.1 EB05 15.4 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 16.7	no trial data cached
Disseminated intravascular coagulation	10	21.0 11.4–38.9ROR 21.3 · χ² 171 / p 2e-39	19.8 EB05 10.7 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 12.5	no trial data cached
Bacteraemia	8	20.2 10.1–40.2ROR 20.4 · χ² 127 / p 8e-30	18.3 EB05 8.5 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 12.1	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 Echinacea (Angustifolia)?

In FDA FAERS, the most frequently co-reported reaction terms for Echinacea (Angustifolia) are febrile neutropenia, platelet count decreased, hepatic function abnormal, myelosuppression, acute myeloid leukaemia, neutrophil count decreased. 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 Echinacea (Angustifolia) have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Echinacea (Angustifolia) 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 20 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.