Cupric Oxide side effects: what 438 FDA adverse event reports show

Cupric Oxide · Cuprum Oxydatum Nigrum · 13 reaction terms · 1,375 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Cuprum Oxydatum Nigrum

openFDA label

Who reports

438 reports · 95% serious · 4 with death outcome · 93% female

openFDA FAERS counts, all years, deduplication not applied

Used for

See symptoms on front panel. Relieves nervousness in children

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. 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
Macular degeneration	375	1,555.9 1,491.1–1,623.6ROR 10,811.6 · χ² 562,964 / p <1e-300	1,397.8 EB05 1,283.1 · IC025 +8.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 987.6	no trial data cached
Paraesthesia oral	112	376.0 320.2–441.5ROR 504.8 · χ² 41,215 / p <1e-300	350.7 EB05 299.5 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 404.8	no trial data cached
Vaginal discharge	62	297.3 235.9–374.7ROR 346.2 · χ² 17,910 / p <1e-300	270.8 EB05 218.8 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=62	no trial data cached
Oral candidiasis (oral thrush)	62	229.2 181.9–288.9ROR 266.9 · χ² 13,803 / p <1e-300	213.2 EB05 172.3 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 194.2	no trial data cached
Procedural pain	110	191.2 162.6–224.8ROR 254.9 · χ² 20,563 / p <1e-300	184.3 EB05 157.2 · IC025 +6.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 199.3	no trial data cached
Frequent bowel movements	66	117.7 94.2–147.1ROR 138.4 · χ² 7,513 / p <1e-300	113.6 EB05 92.4 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 110.1	no trial data cached
Infusion related reaction (reaction during infusion)	111	80.6 68.6–94.7ROR 107.6 · χ² 8,657 / p <1e-300	79.4 EB05 67.7 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 61.1	no trial data cached
Colitis	61	77.7 61.5–98.0ROR 90.1 · χ² 4,540 / p <1e-300	75.8 EB05 61.1 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 50.7	no trial data cached
Therapeutic product effect incomplete	113	76.6 65.4–89.8ROR 102.9 · χ² 8,373 / p <1e-300	75.6 EB05 64.6 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 87.5	no trial data cached
Rectal haemorrhage	65	72.3 57.7–90.5ROR 84.7 · χ² 4,501 / p <1e-300	70.7 EB05 57.4 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 47.0	no trial data cached
Colitis ulcerative	64	68.8 54.8–86.3ROR 80.4 · χ² 4,211 / p <1e-300	67.4 EB05 54.6 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 44.9	no trial data cached
Haematochezia (blood in stool)	63	54.8 43.6–68.9ROR 63.8 · χ² 3,278 / p <1e-300	53.9 EB05 43.6 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Dyspepsia (indigestion)	111	54.2 46.2–63.7ROR 72.3 · χ² 5,767 / p <1e-300	53.7 EB05 45.8 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 65.4	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
Macular degeneration	375	1,555.9 1,491.1–1,623.6ROR 10,811.6 · χ² 562,964 / p <1e-300	1,397.8 EB05 1,283.1 · IC025 +8.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 987.6	no trial data cached
Therapeutic product effect incomplete	113	76.6 65.4–89.8ROR 102.9 · χ² 8,373 / p <1e-300	75.6 EB05 64.6 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 87.5	no trial data cached
Paraesthesia oral	112	376.0 320.2–441.5ROR 504.8 · χ² 41,215 / p <1e-300	350.7 EB05 299.5 · IC025 +6.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 404.8	no trial data cached
Dyspepsia (indigestion)	111	54.2 46.2–63.7ROR 72.3 · χ² 5,767 / p <1e-300	53.7 EB05 45.8 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 65.4	no trial data cached
Infusion related reaction (reaction during infusion)	111	80.6 68.6–94.7ROR 107.6 · χ² 8,657 / p <1e-300	79.4 EB05 67.7 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 61.1	no trial data cached
Procedural pain	110	191.2 162.6–224.8ROR 254.9 · χ² 20,563 / p <1e-300	184.3 EB05 157.2 · IC025 +6.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 199.3	no trial data cached
Frequent bowel movements	66	117.7 94.2–147.1ROR 138.4 · χ² 7,513 / p <1e-300	113.6 EB05 92.4 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 110.1	no trial data cached
Rectal haemorrhage	65	72.3 57.7–90.5ROR 84.7 · χ² 4,501 / p <1e-300	70.7 EB05 57.4 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 47.0	no trial data cached
Colitis ulcerative	64	68.8 54.8–86.3ROR 80.4 · χ² 4,211 / p <1e-300	67.4 EB05 54.6 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 44.9	no trial data cached
Haematochezia (blood in stool)	63	54.8 43.6–68.9ROR 63.8 · χ² 3,278 / p <1e-300	53.9 EB05 43.6 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 36.6	no trial data cached
Oral candidiasis (oral thrush)	62	229.2 181.9–288.9ROR 266.9 · χ² 13,803 / p <1e-300	213.2 EB05 172.3 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 194.2	no trial data cached
Vaginal discharge	62	297.3 235.9–374.7ROR 346.2 · χ² 17,910 / p <1e-300	270.8 EB05 218.8 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=62	no trial data cached
Colitis	61	77.7 61.5–98.0ROR 90.1 · χ² 4,540 / p <1e-300	75.8 EB05 61.1 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 50.7	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 Cupric Oxide?

In FDA FAERS, the most frequently co-reported reaction terms for Cupric Oxide are macular degeneration, paraesthesia oral, dyspepsia, infusion related reaction, procedural pain, frequent bowel movements. 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 Cupric Oxide have an FDA boxed warning?

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

Do FAERS signals prove that Cupric Oxide 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 163cb0dd-0f63-4e32-e063-6394a90a4608, effective 20240416; matched on openfda.generic_name.exact:"CUPRIC OXIDE")
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, 13 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.