Drug · FAERS side-effect profile with label screen

Pramoxine side effects: what 487 FDA adverse event reports show

Pramoxine Hydrochloride · 15 reaction terms · 217 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Pramoxine Hydrochloride (Terramed Just Think Comfort Gynocare Bv Guard Intimate Wash)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

487 reports · 72% serious · 50 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

For the temporary relief of: • Pain, itching, and burning associated with minor external vaginal irritation • Minor skin irritation and discomfort in the external genital area

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 1No label text to screen 12

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
Iron deficiency anaemia	19	89.4 57.5–139.0ROR 93.0 · χ² 1,571 / p <1e-300	82.1 EB05 55.6 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 74.9	no trial data cached
Emphysema	16	68.3 42.2–110.6ROR 70.6 · χ² 994 / p 2e-218	63.3 EB05 41.3 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 61.2	no trial data cached
Obstructive airways disorder	16	61.9 38.2–100.3ROR 64.0 · χ² 898 / p 1e-197	57.8 EB05 37.7 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.0	no trial data cached
Hiatus hernia	18	59.9 38.1–94.3ROR 62.2 · χ² 984 / p 2e-216	56.5 EB05 37.8 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 53.9	no trial data cached
Candida infection (yeast infection)	18	46.6 29.6–73.3ROR 48.3 · χ² 758 / p 4e-167	44.5 EB05 29.8 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 50.0	no trial data cached
Sleep apnoea syndrome	17	38.4 24.1–61.2ROR 39.7 · χ² 582 / p 7e-129	36.9 EB05 24.4 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.1	no trial data cached
Haemorrhoids	12	26.5 15.2–46.4ROR 27.2 · χ² 270 / p 7e-61	25.5 EB05 15.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Dyspnoea exertional	21	24.2 15.9–36.7ROR 25.2 · χ² 444 / p 8e-99	23.7 EB05 16.3 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.2 · ♀ 85% (drug 61%)	no trial data cached
Fungal infection	18	23.3 14.8–36.7ROR 24.2 · χ² 363 / p 3e-81	22.8 EB05 15.2 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.8	no trial data cached
Frequent bowel movements	11	17.6 9.8–31.7ROR 18.0 · χ² 157 / p 3e-36	16.5 EB05 8.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.6	no trial data cached
Eczema	18	15.4 9.8–24.3ROR 16.0 · χ² 229 / p 4e-52	14.8 EB05 9.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.9	no trial data cached
Disease recurrence	16	14.5 8.9–23.4ROR 14.9 · χ² 188 / p 5e-43	13.6 EB05 8.2 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 22.7	no trial data cached
Colitis ulcerative	10	9.7 5.2–17.9ROR 9.9 · χ² 69 / p 4e-17	7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.4	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
Dyspnoea exertional	21	24.2 15.9–36.7ROR 25.2 · χ² 444 / p 8e-99	23.7 EB05 16.3 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.2 · ♀ 85% (drug 61%)	no trial data cached
Iron deficiency anaemia	19	89.4 57.5–139.0ROR 93.0 · χ² 1,571 / p <1e-300	82.1 EB05 55.6 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 74.9	no trial data cached
Eczema	18	15.4 9.8–24.3ROR 16.0 · χ² 229 / p 4e-52	14.8 EB05 9.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.9	no trial data cached
Fungal infection	18	23.3 14.8–36.7ROR 24.2 · χ² 363 / p 3e-81	22.8 EB05 15.2 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.8	no trial data cached
Candida infection (yeast infection)	18	46.6 29.6–73.3ROR 48.3 · χ² 758 / p 4e-167	44.5 EB05 29.8 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 50.0	no trial data cached
Hiatus hernia	18	59.9 38.1–94.3ROR 62.2 · χ² 984 / p 2e-216	56.5 EB05 37.8 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 53.9	no trial data cached
Sleep apnoea syndrome	17	38.4 24.1–61.2ROR 39.7 · χ² 582 / p 7e-129	36.9 EB05 24.4 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.1	no trial data cached
Disease recurrence	16	14.5 8.9–23.4ROR 14.9 · χ² 188 / p 5e-43	13.6 EB05 8.2 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 22.7	no trial data cached
Obstructive airways disorder	16	61.9 38.2–100.3ROR 64.0 · χ² 898 / p 1e-197	57.8 EB05 37.7 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.0	no trial data cached
Emphysema	16	68.3 42.2–110.6ROR 70.6 · χ² 994 / p 2e-218	63.3 EB05 41.3 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 61.2	no trial data cached
Haemorrhoids	12	26.5 15.2–46.4ROR 27.2 · χ² 270 / p 7e-61	25.5 EB05 15.4 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.7	no trial data cached
Frequent bowel movements	11	17.6 9.8–31.7ROR 18.0 · χ² 157 / p 3e-36	16.5 EB05 8.9 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.6	no trial data cached
Colitis ulcerative	10	9.7 5.2–17.9ROR 9.9 · χ² 69 / p 4e-17	7.6 EB05 4.1 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.4	no trial data cached
Drug level decreased	4	16.9 6.4–44.8ROR 17.0 · χ² 45 / p 1e-11	11.0 EB05 3.3 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 16.5	no trial data cached
Application site erythema	3	4.9 1.6–15.2ROR 4.9 · χ² 6 / p 0.008	3.2 EB05 1.3 · IC025 -0.4 PRR-only: not supported by EBGM or IC	No label text to screen label has no adverse-reaction text	serious n=2	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 Pramoxine?

In FDA FAERS, the most frequently co-reported reaction terms for Pramoxine are dyspnoea exertional, iron deficiency anaemia, eczema, fungal infection, candida infection, hiatus hernia. 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 Pramoxine have an FDA boxed warning?

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

Do FAERS signals prove that Pramoxine 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 09964550-049c-4c3b-817d-37e660c2e45c, effective 20260608; matched on openfda.generic_name.exact:"PRAMOXINE HYDROCHLORIDE")
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, 15 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.