Drug · FAERS side-effect profile with label screen

Calamine and Pramoxine side effects: what 439 FDA adverse event reports show

Calamine, Pramoxine Hcl · 19 reaction terms · 232 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Calamine (Calamine)

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

Who reports

439 reports · 77% serious · 47 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

dries the oozing and weeping of poison: ivy oak sumac

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 16 strongest signals

Lab value / disease marker 1No label text to screen 15

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. 3 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
Vaginal discharge	17	81.0 50.8–129.1ROR 84.2 · χ² 1,262 / p 9e-277	74.3 EB05 49.2 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=17	no trial data cached
Appendicitis	14	72.0 43.0–120.7ROR 74.4 · χ² 910 / p 3e-200	65.8 EB05 41.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.0	no trial data cached
Lacrimation increased	31	49.6 35.3–69.7ROR 53.3 · χ² 1,429 / p <1e-300	48.2 EB05 35.6 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 93.8 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Mucosal inflammation	22	40.4 26.8–60.6ROR 42.4 · χ² 806 / p 2e-177	39.1 EB05 27.2 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.3 · ♀ 100% (drug 60%) · 91% clinician	no trial data cached
Ejection fraction decreased	13	39.9 23.4–68.2ROR 41.1 · χ² 455 / p 3e-101	37.9 EB05 23.5 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 30.5	no trial data cached
Muscle twitching	19	39.3 25.3–61.0ROR 41.0 · χ² 671 / p 2e-148	37.9 EB05 25.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.6	no trial data cached
Neuralgia	18	35.5 22.6–55.8ROR 36.9 · χ² 569 / p 4e-126	34.3 EB05 22.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.6	no trial data cached
Dementia	14	24.0 14.3–40.2ROR 24.8 · χ² 287 / p 1e-64	23.3 EB05 14.6 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.0	no trial data cached
Dermatitis allergic	6	23.0 10.4–50.9ROR 23.3 · χ² 105 / p 5e-25	20.0 EB05 7.7 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.7	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	7	22.2 10.6–46.3ROR 22.5 · χ² 121 / p 2e-28	19.9 EB05 8.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.7	no trial data cached
Drug eruption	8	21.7 10.9–43.1ROR 22.1 · χ² 138 / p 4e-32	19.9 EB05 9.5 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.8	no trial data cached
Panic attack	15	19.6 11.9–32.3ROR 20.3 · χ² 247 / p 5e-56	19.0 EB05 11.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.0	no trial data cached
Depressed mood	21	19.1 12.6–28.9ROR 20.0 · χ² 342 / p 1e-76	18.7 EB05 12.7 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.0	no trial data cached
Sleep disorder due to a general medical condition	5	14.8 6.2–35.3ROR 14.9 · χ² 51 / p 4e-13	10.3 EB05 3.6 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	5	9.3 3.9–22.3ROR 9.4 · χ² 29 / p 3e-8	5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial data cached
Premature baby	5	7.9 3.3–18.9ROR 8.0 · χ² 24 / p 6e-7	5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.0	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
Lacrimation increased	31	49.6 35.3–69.7ROR 53.3 · χ² 1,429 / p <1e-300	48.2 EB05 35.6 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 93.8 · ♀ 100% (drug 60%) · 93% clinician	no trial data cached
Mucosal inflammation	22	40.4 26.8–60.6ROR 42.4 · χ² 806 / p 2e-177	39.1 EB05 27.2 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.3 · ♀ 100% (drug 60%) · 91% clinician	no trial data cached
Depressed mood	21	19.1 12.6–28.9ROR 20.0 · χ² 342 / p 1e-76	18.7 EB05 12.7 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.0	no trial data cached
Muscle twitching	19	39.3 25.3–61.0ROR 41.0 · χ² 671 / p 2e-148	37.9 EB05 25.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 43.6	no trial data cached
Neuralgia	18	35.5 22.6–55.8ROR 36.9 · χ² 569 / p 4e-126	34.3 EB05 22.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.6	no trial data cached
Vaginal discharge	17	81.0 50.8–129.1ROR 84.2 · χ² 1,262 / p 9e-277	74.3 EB05 49.2 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=17	no trial data cached
Panic attack	15	19.6 11.9–32.3ROR 20.3 · χ² 247 / p 5e-56	19.0 EB05 11.9 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.0	no trial data cached
Dementia	14	24.0 14.3–40.2ROR 24.8 · χ² 287 / p 1e-64	23.3 EB05 14.6 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.0	no trial data cached
Appendicitis	14	72.0 43.0–120.7ROR 74.4 · χ² 910 / p 3e-200	65.8 EB05 41.6 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 51.0	no trial data cached
Ejection fraction decreased	13	39.9 23.4–68.2ROR 41.1 · χ² 455 / p 3e-101	37.9 EB05 23.5 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 30.5	no trial data cached
Drug eruption	8	21.7 10.9–43.1ROR 22.1 · χ² 138 / p 4e-32	19.9 EB05 9.5 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.8	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	7	22.2 10.6–46.3ROR 22.5 · χ² 121 / p 2e-28	19.9 EB05 8.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.7	no trial data cached
Dermatitis allergic	6	23.0 10.4–50.9ROR 23.3 · χ² 105 / p 5e-25	20.0 EB05 7.7 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.7	no trial data cached
Premature baby	5	7.9 3.3–18.9ROR 8.0 · χ² 24 / p 6e-7	5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.0	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	5	9.3 3.9–22.3ROR 9.4 · χ² 29 / p 3e-8	5.9 EB05 2.6 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	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 Calamine and Pramoxine?

In FDA FAERS, the most frequently co-reported reaction terms for Calamine and Pramoxine are lacrimation increased, mucosal inflammation, depressed mood, muscle twitching, neuralgia, vaginal discharge. 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 Calamine and Pramoxine have an FDA boxed warning?

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

Do FAERS signals prove that Calamine and 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 90d9d908-57ea-4062-ade0-8a4888939c91, effective 20260129; matched on openfda.generic_name.exact:"CALAMINE")
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, 19 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.