Berdazimer side effects: what 71 FDA adverse event reports show

Berdazimer · Zelsuvmi · 5 reaction terms · 83 drug–reaction co-reports · data 2026-09-14

Drug class

Nitric oxide (no) releasing agent

FDA label, Indications wording

Brand names

Zelsuvmi

openFDA label

Who reports

71 reports · 0% serious · 0 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ( 1 )

FDA label, Indications and Usage

What it is

ZELSUVMI (berdazimer) topical gel, 10.3%, a nitric oxide releasing agent, contains the drug substance berdazimer sodium, a white to off white powder with the chemical name poly[{[3-(methylamin.

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 5 strongest signals

Labeled adverse reaction 4Labeled (related wording) 1

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.

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. 0 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
Application site pain	41	551.0 451.4–672.6ROR 1,302.6 · χ² 21,944 / p <1e-300	437.3 EB05 336.1 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site erythema	22	247.1 174.6–349.7ROR 357.6 · χ² 5,151 / p <1e-300	203.5 EB05 141.6 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site irritation	7	166.2 82.2–335.9ROR 184.3 · χ² 990 / p 1e-217	115.1 EB05 59.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site rash	6	128.5 59.7–276.3ROR 140.2 · χ² 637 / p 8e-141	92.0 EB05 45.3 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Application site pruritus	7	91.1 45.1–184.1ROR 101.0 · χ² 537 / p 4e-119	73.5 EB05 38.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	–	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
Application site pain	41	551.0 451.4–672.6ROR 1,302.6 · χ² 21,944 / p <1e-300	437.3 EB05 336.1 · IC025 +5.7 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site erythema	22	247.1 174.6–349.7ROR 357.6 · χ² 5,151 / p <1e-300	203.5 EB05 141.6 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site pruritus	7	91.1 45.1–184.1ROR 101.0 · χ² 537 / p 4e-119	73.5 EB05 38.2 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site irritation	7	166.2 82.2–335.9ROR 184.3 · χ² 990 / p 1e-217	115.1 EB05 59.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Application site rash	6	128.5 59.7–276.3ROR 140.2 · χ² 637 / p 8e-141	92.0 EB05 45.3 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	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 Berdazimer?

In FDA FAERS, the most frequently co-reported reaction terms for Berdazimer are application site pain, application site erythema, application site pruritus, application site irritation, application site rash. 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 Berdazimer have an FDA boxed warning?

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

Do FAERS signals prove that Berdazimer 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 76b17622-bdb9-41ea-b962-c2acc0df71f7, effective 20250708; matched on openfda.generic_name.exact:"BERDAZIMER")
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, 5 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.