Ishancare Hemorrhoid Cream side effects: what 435 FDA adverse event reports show

Ishancare Hemorrhoid Cream · 12 reaction terms · 145 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

435 reports · 83% serious · 72 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Directions Adults apply to the affected area up to 2-3 times daily clean affected area with mild soap and warm water, or sitz bath in warm salt water, rinse thoroughly, and then gently dry (pat or blot with tissue or soft cloth before use)

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 11 strongest signals

Lab value / disease marker 1No label text to screen 10

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. 1 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	11	57.8 32.2–103.6ROR 59.3 · χ² 558 / p 1e-123	52.7 EB05 31.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.2	no trial data cached
Skin infection	12	51.9 29.7–90.7ROR 53.3 · χ² 549 / p 1e-121	48.1 EB05 29.3 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.4	no trial data cached
Schizophrenia	12	47.6 27.2–83.2ROR 48.9 · χ² 502 / p 2e-111	44.4 EB05 27.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.0	no trial data cached
Vitamin d deficiency	9	44.5 23.3–85.1ROR 45.5 · χ² 341 / p 2e-76	40.9 EB05 23.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.0	no trial data cached
Accident	10	40.5 22.0–74.8ROR 41.4 · χ² 347 / p 1e-77	37.8 EB05 21.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.3	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	10	32.0 17.3–59.0ROR 32.7 · χ² 270 / p 6e-61	30.2 EB05 17.4 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.1	no trial data cached
Blood bilirubin increased	16	28.5 17.6–46.1ROR 29.5 · χ² 398 / p 9e-89	27.6 EB05 18.0 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 22.6	no trial data cached
Cellulitis (skin infection)	29	27.7 19.5–39.4ROR 29.6 · χ² 722 / p 3e-159	27.3 EB05 19.9 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.8	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	8	17.3 8.7–34.4ROR 17.6 · χ² 107 / p 2e-25	15.2 EB05 6.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.0	no trial data cached
Dermatitis atopic	16	15.4 9.5–25.0ROR 16.0 · χ² 202 / p 3e-46	14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial data cached
Lung neoplasm malignant	9	10.5 5.5–20.1ROR 10.7 · χ² 68 / p 7e-17	8.2 EB05 4.2 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.3	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
Cellulitis (skin infection)	29	27.7 19.5–39.4ROR 29.6 · χ² 722 / p 3e-159	27.3 EB05 19.9 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.8	no trial data cached
Dermatitis atopic	16	15.4 9.5–25.0ROR 16.0 · χ² 202 / p 3e-46	14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial data cached
Blood bilirubin increased	16	28.5 17.6–46.1ROR 29.5 · χ² 398 / p 9e-89	27.6 EB05 18.0 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 22.6	no trial data cached
Schizophrenia	12	47.6 27.2–83.2ROR 48.9 · χ² 502 / p 2e-111	44.4 EB05 27.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.0	no trial data cached
Skin infection	12	51.9 29.7–90.7ROR 53.3 · χ² 549 / p 1e-121	48.1 EB05 29.3 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.4	no trial data cached
Iron deficiency anaemia	11	57.8 32.2–103.6ROR 59.3 · χ² 558 / p 1e-123	52.7 EB05 31.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 42.2	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	10	32.0 17.3–59.0ROR 32.7 · χ² 270 / p 6e-61	30.2 EB05 17.4 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.1	no trial data cached
Accident	10	40.5 22.0–74.8ROR 41.4 · χ² 347 / p 1e-77	37.8 EB05 21.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 33.3	no trial data cached
Lung neoplasm malignant	9	10.5 5.5–20.1ROR 10.7 · χ² 68 / p 7e-17	8.2 EB05 4.2 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.3	no trial data cached
Vitamin d deficiency	9	44.5 23.3–85.1ROR 45.5 · χ² 341 / p 2e-76	40.9 EB05 23.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.0	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	8	17.3 8.7–34.4ROR 17.6 · χ² 107 / p 2e-25	15.2 EB05 6.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.0	no trial data cached
Injection site induration	3	11.2 3.6–34.5ROR 11.2 · χ² 19 / p 8e-6	5.6 EB05 1.9 · IC025 +0.1	No label text to screen label has no adverse-reaction text	serious n=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 Ishancare Hemorrhoid Cream?

In FDA FAERS, the most frequently co-reported reaction terms for Ishancare Hemorrhoid Cream are cellulitis, dermatitis atopic, blood bilirubin increased, schizophrenia, skin infection, iron deficiency anaemia. 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 Ishancare Hemorrhoid Cream have an FDA boxed warning?

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

Do FAERS signals prove that Ishancare Hemorrhoid Cream 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 19fa2b13-1b23-a8b5-e063-6294a90ae5fd, effective 20260213; matched on openfda.generic_name.exact:"ISHANCARE HEMORRHOID CREAM")
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, 12 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.