Calcipotriene side effects: what 379 FDA adverse event reports show

Calcipotriene, Betamethasone Dipropionate · 20 reaction terms · 268 drug–reaction co-reports · data 2026-09-14

Drug class

Vitamin D Analog

FDA label (Established Pharmacologic Class) · compare the class

Who reports

379 reports · 72% serious · 12 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

FDA label, Indications and Usage

What it is

DESCRIPTION Calcipotriene Topical Solution, 0.005% (Scalp Solution) is a colorless topical solution containing 0.005% calcipotriene in a vehicle of isopropanol (51% v/v), propylene glycol, hydroxypropyl cellulose, sodium citrate, menthol and purified water.

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 14 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 10

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.

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. 6 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
Psoriasis	117	49.6 42.6–57.6ROR 71.2 · χ² 5,547 / p <1e-300	49.1 EB05 42.1 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 86.0	no trial data cached
Skin haemorrhage	12	46.0 26.4–80.4ROR 47.5 · χ² 485 / p 1e-107	43.1 EB05 26.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Skin infection	9	44.6 23.4–85.2ROR 45.7 · χ² 342 / p 1e-76	41.0 EB05 23.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Pharyngitis streptococcal	8	40.9 20.6–81.2ROR 41.8 · χ² 273 / p 1e-61	37.5 EB05 20.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Psoriatic arthropathy	28	38.5 27.0–55.1ROR 41.5 · χ² 988 / p 4e-217	37.6 EB05 27.3 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.8	no trial data cached
Squamous cell carcinoma	6	35.2 15.9–78.0ROR 35.8 · χ² 167 / p 2e-38	31.5 EB05 14.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.0	no trial data cached
Skin fissures	10	29.3 15.9–54.0ROR 30.1 · χ² 246 / p 1e-55	27.8 EB05 16.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Scratch	5	26.7 11.2–63.9ROR 27.1 · χ² 99 / p 1e-23	22.6 EB05 7.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Skin lesion	13	26.4 15.5–45.1ROR 27.3 · χ² 293 / p 5e-66	25.5 EB05 15.7 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.0	no trial data cached
Pain of skin	12	24.6 14.1–42.9ROR 25.4 · χ² 249 / p 2e-56	23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 68.9	no trial data cached
Secretion discharge	5	22.4 9.4–53.5ROR 22.7 · χ² 82 / p 7e-20	18.2 EB05 5.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 29.4	no trial data cached
Skin cancer	5	12.8 5.4–30.7ROR 13.0 · χ² 43 / p 2e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Drug effect incomplete	6	9.0 4.1–19.9ROR 9.1 · χ² 35 / p 2e-9	6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 18.9	no trial data cached
Injection site bruising	11	7.7 4.3–13.8ROR 7.9 · χ² 58 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	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
Psoriasis	117	49.6 42.6–57.6ROR 71.2 · χ² 5,547 / p <1e-300	49.1 EB05 42.1 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 86.0	no trial data cached
Psoriatic arthropathy	28	38.5 27.0–55.1ROR 41.5 · χ² 988 / p 4e-217	37.6 EB05 27.3 · IC025 +3.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.8	no trial data cached
Skin lesion	13	26.4 15.5–45.1ROR 27.3 · χ² 293 / p 5e-66	25.5 EB05 15.7 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.0	no trial data cached
Pain of skin	12	24.6 14.1–42.9ROR 25.4 · χ² 249 / p 2e-56	23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 68.9	no trial data cached
Skin haemorrhage	12	46.0 26.4–80.4ROR 47.5 · χ² 485 / p 1e-107	43.1 EB05 26.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Injection site bruising	11	7.7 4.3–13.8ROR 7.9 · χ² 58 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Skin fissures	10	29.3 15.9–54.0ROR 30.1 · χ² 246 / p 1e-55	27.8 EB05 16.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Skin infection	9	44.6 23.4–85.2ROR 45.7 · χ² 342 / p 1e-76	41.0 EB05 23.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 49.3	no trial data cached
Pharyngitis streptococcal	8	40.9 20.6–81.2ROR 41.8 · χ² 273 / p 1e-61	37.5 EB05 20.3 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Drug effect incomplete	6	9.0 4.1–19.9ROR 9.1 · χ² 35 / p 2e-9	6.1 EB05 2.8 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 18.9	no trial data cached
Squamous cell carcinoma	6	35.2 15.9–78.0ROR 35.8 · χ² 167 / p 2e-38	31.5 EB05 14.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.0	no trial data cached
Skin cancer	5	12.8 5.4–30.7ROR 13.0 · χ² 43 / p 2e-11	8.5 EB05 3.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Secretion discharge	5	22.4 9.4–53.5ROR 22.7 · χ² 82 / p 7e-20	18.2 EB05 5.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 29.4	no trial data cached
Scratch	5	26.7 11.2–63.9ROR 27.1 · χ² 99 / p 1e-23	22.6 EB05 7.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Pancreatic carcinoma	4	7.6 2.9–20.2ROR 7.7 · χ² 17 / p 2e-5	4.6 EB05 1.9 · IC025 +0.4	Not in label — unassessed	serious PRR 6.1	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 Calcipotriene?

In FDA FAERS, the most frequently co-reported reaction terms for Calcipotriene are psoriasis, psoriatic arthropathy, skin lesion, pain of skin, skin haemorrhage, injection site bruising. 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 Calcipotriene have an FDA boxed warning?

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

Do FAERS signals prove that Calcipotriene 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 21378c25-5622-8bf7-1a8c-b05940a846a0, effective 20221115; matched on openfda.generic_name.exact:"CALCIPOTRIENE")
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, 20 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.