Drug · FAERS side-effect profile with label screen

Pramoxine Hydrocortisone side effects: what 786 FDA adverse event reports show

Pramoxine Hydrochloride Hydrocortisone Acetate · 24 reaction terms · 515 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Pramoxine Hydrochloride Hydrocortisone Acetate (Proctofoam Hc)

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

Who reports

786 reports · 39% serious · 33 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Proctofoam ® HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

FDA label, Indications and Usage

What it is

DESCRIPTION Proctofoam ® HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1.

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 20 strongest signals

Reporting / coding artifact 12No label text to screen 8

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
Device delivery system issue	70	71.6 57.3–89.6ROR 78.6 · χ² 4,799 / p <1e-300	70.1 EB05 57.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	86% consumer	no trial data cached
Iron deficiency anaemia	16	46.5 28.6–75.6ROR 47.5 · χ² 667 / p 2e-147	44.2 EB05 28.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.5	no trial data cached
Product packaging quantity issue	18	44.1 27.9–69.6ROR 45.1 · χ² 714 / p 1e-157	42.2 EB05 28.2 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Haemorrhoids	26	35.5 24.3–51.9ROR 36.7 · χ² 838 / p 1e-184	34.7 EB05 24.9 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.0 · ♀ 85% (drug 58%)	no trial data cached
Device leakage	50	31.5 24.1–41.3ROR 33.6 · χ² 1,450 / p <1e-300	31.2 EB05 24.6 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	84% consumer	no trial data cached
Product quality issue	109	21.6 18.1–25.7ROR 24.9 · χ² 2,132 / p <1e-300	21.5 EB05 18.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 85% consumer	no trial data cached
Emphysema	8	21.1 10.6–42.1ROR 21.3 · χ² 134 / p 3e-31	19.3 EB05 9.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 35.6	no trial data cached
Hiatus hernia	10	20.6 11.1–38.1ROR 20.8 · χ² 167 / p 2e-38	19.4 EB05 10.4 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.9	no trial data cached
Obstructive airways disorder	8	19.1 9.6–38.1ROR 19.3 · χ² 120 / p 3e-28	17.2 EB05 7.8 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.7	no trial data cached
Product packaging issue	6	17.3 7.8–38.3ROR 17.4 · χ² 76 / p 1e-18	13.9 EB05 5.1 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	9	14.8 7.8–28.4ROR 15.0 · χ² 103 / p 2e-24	12.8 EB05 6.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Application site pain	11	13.3 7.4–24.0ROR 13.5 · χ² 114 / p 8e-27	11.6 EB05 6.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Rectal haemorrhage	20	12.4 8.0–19.1ROR 12.7 · χ² 198 / p 2e-45	11.5 EB05 7.4 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.9	no trial data cached
Device difficult to use	30	12.1 8.5–17.2ROR 12.6 · χ² 296 / p 1e-66	11.6 EB05 8.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	90% consumer	no trial data cached
Device issue	34	10.4 7.5–14.4ROR 10.8 · χ² 281 / p 3e-63	9.8 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Product use complaint	6	10.3 4.7–22.9ROR 10.4 · χ² 42 / p 5e-11	7.1 EB05 3.1 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Colitis ulcerative	17	10.2 6.4–16.3ROR 10.4 · χ² 132 / p 8e-31	8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Incorrect dose administered by device	9	9.5 4.9–18.1ROR 9.6 · χ² 60 / p 5e-15	7.2 EB05 3.8 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in product usage process	35	4.6 3.3–6.4ROR 4.8 · χ² 97 / p 4e-23	4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	83% consumer	no trial data cached
Device malfunction	8	3.2 1.6–6.3ROR 3.2 · χ² 10 / p 8e-4	2.8 EB05 1.6 · IC025 +0.3	Reporting / coding artifact	–	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
Product quality issue	109	21.6 18.1–25.7ROR 24.9 · χ² 2,132 / p <1e-300	21.5 EB05 18.3 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9 · 85% consumer	no trial data cached
Device delivery system issue	70	71.6 57.3–89.6ROR 78.6 · χ² 4,799 / p <1e-300	70.1 EB05 57.4 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	86% consumer	no trial data cached
Device leakage	50	31.5 24.1–41.3ROR 33.6 · χ² 1,450 / p <1e-300	31.2 EB05 24.6 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	84% consumer	no trial data cached
Wrong technique in product usage process	35	4.6 3.3–6.4ROR 4.8 · χ² 97 / p 4e-23	4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	83% consumer	no trial data cached
Device issue	34	10.4 7.5–14.4ROR 10.8 · χ² 281 / p 3e-63	9.8 EB05 7.2 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	79% consumer	no trial data cached
Device difficult to use	30	12.1 8.5–17.2ROR 12.6 · χ² 296 / p 1e-66	11.6 EB05 8.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	90% consumer	no trial data cached
Haemorrhoids	26	35.5 24.3–51.9ROR 36.7 · χ² 838 / p 1e-184	34.7 EB05 24.9 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.0 · ♀ 85% (drug 58%)	no trial data cached
Rectal haemorrhage	20	12.4 8.0–19.1ROR 12.7 · χ² 198 / p 2e-45	11.5 EB05 7.4 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.9	no trial data cached
Product packaging quantity issue	18	44.1 27.9–69.6ROR 45.1 · χ² 714 / p 1e-157	42.2 EB05 28.2 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Colitis ulcerative	17	10.2 6.4–16.3ROR 10.4 · χ² 132 / p 8e-31	8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.4	no trial data cached
Iron deficiency anaemia	16	46.5 28.6–75.6ROR 47.5 · χ² 667 / p 2e-147	44.2 EB05 28.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 73.5	no trial data cached
Application site pain	11	13.3 7.4–24.0ROR 13.5 · χ² 114 / p 8e-27	11.6 EB05 6.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Hiatus hernia	10	20.6 11.1–38.1ROR 20.8 · χ² 167 / p 2e-38	19.4 EB05 10.4 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.9	no trial data cached
Incorrect dose administered by device	9	9.5 4.9–18.1ROR 9.6 · χ² 60 / p 5e-15	7.2 EB05 3.8 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device defective	9	14.8 7.8–28.4ROR 15.0 · χ² 103 / p 2e-24	12.8 EB05 6.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Hydrocortisone?

In FDA FAERS, the most frequently co-reported reaction terms for Pramoxine Hydrocortisone are haemorrhoids, rectal haemorrhage, colitis ulcerative, iron deficiency anaemia, application site pain, 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 Hydrocortisone have an FDA boxed warning?

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

Do FAERS signals prove that Pramoxine Hydrocortisone 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 3831e931-ec0a-11e3-ac10-0800200c9a66, effective 20250415; matched on openfda.generic_name.exact:"PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE")
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, 24 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.