Panthenol side effects: what 290 FDA adverse event reports show

Panthenol · 22 reaction terms · 251 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

290 reports · 93% serious · 96 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1 step. Apply a small amount of the serum to the roots of the eyelashes and leave them to be absorbed. 2 step. Apply the serum evenly on the tips of the eyelashes and let it absorb.

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 20 strongest signals

Reporting / coding artifact 1No label text to screen 19

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. 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
Appendicitis	13	101.3 59.5–172.3ROR 106.0 · χ² 1,191 / p 3e-261	88.4 EB05 55.0 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.4	no trial data cached
Ventricular fibrillation	12	78.0 44.8–135.7ROR 81.3 · χ² 836 / p 4e-184	69.6 EB05 42.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 48.3	no trial data cached
Folliculitis	11	77.1 43.2–137.6ROR 80.1 · χ² 751 / p 1e-165	68.3 EB05 40.7 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 56.0	no trial data cached
Helicobacter infection	10	71.0 38.6–130.6ROR 73.5 · χ² 621 / p 2e-137	62.8 EB05 36.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.3	no trial data cached
Bursitis	11	66.0 36.9–117.8ROR 68.5 · χ² 640 / p 2e-141	59.5 EB05 35.4 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 48.0	no trial data cached
Pemphigus	11	64.0 35.9–114.3ROR 66.5 · χ² 621 / p 3e-137	57.9 EB05 34.5 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.7	no trial data cached
Hand deformity	11	60.8 34.1–108.6ROR 63.2 · χ² 589 / p 2e-130	55.3 EB05 32.9 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.9	no trial data cached
Joint range of motion decreased	11	59.5 33.3–106.3ROR 61.9 · χ² 576 / p 1e-127	54.2 EB05 32.3 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9	no trial data cached
Incorrect route of product administration	13	56.0 32.9–95.2ROR 58.6 · χ² 648 / p 3e-143	51.9 EB05 32.3 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 69.1	no trial data cached
Cardiogenic shock	11	55.8 31.2–99.6ROR 57.9 · χ² 538 / p 2e-119	51.1 EB05 30.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.4	no trial data cached
Synovitis	13	52.1 30.6–88.7ROR 54.5 · χ² 602 / p 4e-133	48.6 EB05 30.2 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Irritable bowel syndrome	15	50.8 31.0–83.2ROR 53.5 · χ² 683 / p 6e-151	47.9 EB05 30.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.9	no trial data cached
Obesity	11	49.9 27.9–89.1ROR 51.8 · χ² 479 / p 2e-106	46.1 EB05 27.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.8	no trial data cached
Fibromyalgia	16	47.7 29.6–76.8ROR 50.4 · χ² 685 / p 2e-151	45.2 EB05 29.5 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.7	no trial data cached
Pericarditis	10	43.4 23.6–79.8ROR 44.9 · χ² 373 / p 2e-83	40.3 EB05 23.4 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.0	no trial data cached
Ascites	17	41.8 26.4–66.3ROR 44.4 · χ² 637 / p 6e-141	40.1 EB05 26.5 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.2	no trial data cached
Wound	13	33.8 19.9–57.5ROR 35.4 · χ² 382 / p 2e-85	32.4 EB05 20.1 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0	no trial data cached
Glossodynia (burning tongue/mouth pain)	10	32.4 17.6–59.5ROR 33.5 · χ² 273 / p 1e-61	30.6 EB05 17.7 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.0	no trial data cached
Systemic lupus erythematosus	11	22.5 12.6–40.2ROR 23.3 · χ² 205 / p 8e-47	21.5 EB05 12.3 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3	no trial data cached
Psoriatic arthropathy	11	19.8 11.1–35.3ROR 20.5 · χ² 178 / p 6e-41	18.7 EB05 10.4 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.4	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
Ascites	17	41.8 26.4–66.3ROR 44.4 · χ² 637 / p 6e-141	40.1 EB05 26.5 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.2	no trial data cached
Fibromyalgia	16	47.7 29.6–76.8ROR 50.4 · χ² 685 / p 2e-151	45.2 EB05 29.5 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 38.7	no trial data cached
Irritable bowel syndrome	15	50.8 31.0–83.2ROR 53.5 · χ² 683 / p 6e-151	47.9 EB05 30.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.9	no trial data cached
Wound	13	33.8 19.9–57.5ROR 35.4 · χ² 382 / p 2e-85	32.4 EB05 20.1 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0	no trial data cached
Synovitis	13	52.1 30.6–88.7ROR 54.5 · χ² 602 / p 4e-133	48.6 EB05 30.2 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.7	no trial data cached
Incorrect route of product administration	13	56.0 32.9–95.2ROR 58.6 · χ² 648 / p 3e-143	51.9 EB05 32.3 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 69.1	no trial data cached
Appendicitis	13	101.3 59.5–172.3ROR 106.0 · χ² 1,191 / p 3e-261	88.4 EB05 55.0 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 63.4	no trial data cached
Ventricular fibrillation	12	78.0 44.8–135.7ROR 81.3 · χ² 836 / p 4e-184	69.6 EB05 42.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 48.3	no trial data cached
Psoriatic arthropathy	11	19.8 11.1–35.3ROR 20.5 · χ² 178 / p 6e-41	18.7 EB05 10.4 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.4	no trial data cached
Systemic lupus erythematosus	11	22.5 12.6–40.2ROR 23.3 · χ² 205 / p 8e-47	21.5 EB05 12.3 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3	no trial data cached
Obesity	11	49.9 27.9–89.1ROR 51.8 · χ² 479 / p 2e-106	46.1 EB05 27.5 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.8	no trial data cached
Cardiogenic shock	11	55.8 31.2–99.6ROR 57.9 · χ² 538 / p 2e-119	51.1 EB05 30.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.4	no trial data cached
Joint range of motion decreased	11	59.5 33.3–106.3ROR 61.9 · χ² 576 / p 1e-127	54.2 EB05 32.3 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9	no trial data cached
Hand deformity	11	60.8 34.1–108.6ROR 63.2 · χ² 589 / p 2e-130	55.3 EB05 32.9 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.9	no trial data cached
Pemphigus	11	64.0 35.9–114.3ROR 66.5 · χ² 621 / p 3e-137	57.9 EB05 34.5 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.7	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 Panthenol?

In FDA FAERS, the most frequently co-reported reaction terms for Panthenol are ascites, fibromyalgia, irritable bowel syndrome, wound, synovitis, appendicitis. 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 Panthenol have an FDA boxed warning?

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

Do FAERS signals prove that Panthenol 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 0520c228-88e8-0bd4-e063-6394a90af9df, effective 20230912; matched on openfda.generic_name.exact:"PANTHENOL")
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, 22 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.