Drug · FAERS side-effect profile with label screen
Calcipotriene and Betamethasone Dipropionate side effects: what 3,231 FDA adverse event reports show
Who reports
3,231 reports · 58% serious · 115 with death outcome · 56% 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 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 4Not in label — unassessed 31
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.
- 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. 132 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Psoriasis | 644 | 32.1 30.0–34.4ROR 39.8 · χ² 19,400 / p <1e-300 | 31.9 EB05 29.9 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.1 | no trial data cached |
| Psoriatic arthropathy | 118 | 19.1 16.0–22.8ROR 19.8 · χ² 2,002 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 20.7 | no trial data cached |
| Squamous cell carcinoma | 17 | 11.7 7.3–18.8ROR 11.8 · χ² 156 / p 4e-36 | 10.6 EB05 6.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Skin lesion | 42 | 10.0 7.4–13.5ROR 10.1 · χ² 332 / p 2e-74 | 9.5 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 | no trial data cached |
| Skin haemorrhage | 22 | 9.9 6.5–15.0ROR 10.0 · χ² 167 / p 2e-38 | 8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Skin infection | 17 | 9.9 6.2–15.9ROR 9.9 · χ² 127 / p 9e-30 | 8.7 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Pain of skin | 36 | 8.7 6.3–12.0ROR 8.7 · χ² 236 / p 1e-53 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 | no trial data cached |
| Cellulitis (skin infection) | 66 | 8.5 6.7–10.8ROR 8.7 · χ² 429 / p 1e-95 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Skin fissures | 24 | 8.3 5.5–12.3ROR 8.3 · χ² 146 / p 7e-34 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=14 · ♀ 83% (drug 56%) | no trial data cached |
| Pharyngitis streptococcal | 13 | 7.8 4.5–13.4ROR 7.8 · χ² 70 / p 3e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Folliculitis | 12 | 7.5 4.3–13.3ROR 7.6 · χ² 62 / p 2e-15 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Oral candidiasis (oral thrush) | 15 | 7.5 4.5–12.4ROR 7.5 · χ² 78 / p 5e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Dermatitis | 23 | 7.2 4.8–10.8ROR 7.3 · χ² 117 / p 2e-27 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 | no trial data cached |
| Basal cell carcinoma | 17 | 7.1 4.4–11.4ROR 7.1 · χ² 83 / p 5e-20 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Scratch | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 50 / p 9e-13 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Skin disorder | 33 | 6.4 4.6–9.0ROR 6.5 · χ² 146 / p 6e-34 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Malignant melanoma | 13 | 6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Skin exfoliation | 70 | 5.5 4.3–6.9ROR 5.6 · χ² 252 / p 5e-57 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Musculoskeletal chest pain | 13 | 5.4 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Product prescribing error | 18 | 4.9 3.1–7.8ROR 5.0 · χ² 53 / p 2e-13 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Neuralgia | 18 | 4.8 3.0–7.6ROR 4.8 · χ² 51 / p 5e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Synovitis | 13 | 4.7 2.7–8.0ROR 4.7 · χ² 34 / p 3e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Candida infection (yeast infection) | 12 | 4.7 2.7–8.2ROR 4.7 · χ² 31 / p 1e-8 | 4.0 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hepatocellular injury | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Localised infection | 17 | 4.6 2.8–7.3ROR 4.6 · χ² 44 / p 2e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hepatic steatosis | 13 | 4.5 2.6–7.8ROR 4.5 · χ² 32 / p 6e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 32 | 4.5 3.2–6.4ROR 4.5 · χ² 84 / p 3e-20 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Gastroenteritis | 10 | 4.5 2.4–8.3ROR 4.5 · χ² 23 / p 6e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Inflammation | 35 | 4.4 3.2–6.2ROR 4.5 · χ² 90 / p 2e-21 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Frequent bowel movements | 18 | 4.3 2.7–6.9ROR 4.4 · χ² 43 / p 3e-11 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Nasal congestion (stuffy nose) | 39 | 4.3 3.2–5.9ROR 4.4 · χ² 97 / p 4e-23 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Arthritis | 52 | 4.3 3.3–5.6ROR 4.3 · χ² 128 / p 6e-30 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Productive cough (cough with phlegm) | 31 | 4.2 3.0–6.0ROR 4.3 · χ² 74 / p 4e-18 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Therapy non-responder | 28 | 4.1 2.8–5.9ROR 4.1 · χ² 62 / p 2e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Therapeutic product effect incomplete | 44 | 4.0 3.0–5.4ROR 4.1 · χ² 98 / p 2e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Lower respiratory tract infection | 28 | 4.0 2.8–5.8ROR 4.0 · χ² 60 / p 4e-15 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Hepatic cirrhosis | 11 | 3.8 2.1–6.9ROR 3.8 · χ² 20 / p 4e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Liver function test abnormal | 17 | 3.8 2.3–6.1ROR 3.8 · χ² 32 / p 8e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Diverticulitis | 16 | 3.8 2.3–6.1ROR 3.8 · χ² 30 / p 3e-8 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Sinusitis | 59 | 3.7 2.9–4.8ROR 3.8 · χ² 115 / p 3e-27 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | 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 |
|---|---|---|---|---|---|---|
| Psoriasis | 644 | 32.1 30.0–34.4ROR 39.8 · χ² 19,400 / p <1e-300 | 31.9 EB05 29.9 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 46.1 | no trial data cached |
| Pruritus (itching) | 177 | 3.0 2.6–3.5ROR 3.2 · χ² 244 / p 2e-55 | 3.0 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Psoriatic arthropathy | 118 | 19.1 16.0–22.8ROR 19.8 · χ² 2,002 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 20.7 | no trial data cached |
| Erythema (skin redness) | 106 | 3.4 2.8–4.0ROR 3.4 · χ² 174 / p 5e-40 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Nasopharyngitis (common cold) | 98 | 3.4 2.8–4.2ROR 3.5 · χ² 169 / p 7e-39 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Injection site pain (pain where injected) | 78 | 1.7 1.3–2.1ROR 1.7 · χ² 20 / p 3e-6 | 1.7 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.7 · 73% consumer | no trial data cached |
| Skin exfoliation | 70 | 5.5 4.3–6.9ROR 5.6 · χ² 252 / p 5e-57 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Inappropriate schedule of product administration | 67 | 2.5 1.9–3.1ROR 2.5 · χ² 57 / p 2e-14 | 2.4 EB05 2.0 · IC025 +0.9 | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Cellulitis (skin infection) | 66 | 8.5 6.7–10.8ROR 8.7 · χ² 429 / p 1e-95 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Sinusitis | 59 | 3.7 2.9–4.8ROR 3.8 · χ² 115 / p 3e-27 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Dry skin | 55 | 2.7 2.1–3.5ROR 2.7 · χ² 58 / p 1e-14 | 2.7 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Arthritis | 52 | 4.3 3.3–5.6ROR 4.3 · χ² 128 / p 6e-30 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Oropharyngeal pain (sore throat) | 51 | 3.6 2.7–4.7ROR 3.6 · χ² 92 / p 4e-22 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Joint swelling | 47 | 2.5 1.9–3.4ROR 2.6 · χ² 42 / p 4e-11 | 2.5 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Drug dose omission | 44 | 1.7 1.3–2.3ROR 1.7 · χ² 12 / p 2e-4 | 1.7 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Skin haemorrhage — n=22, PRR 9.9
- Pain of skin — n=36, PRR 8.7
- Cellulitis — n=66, PRR 8.5
- Skin fissures — n=24, PRR 8.3
- Dermatitis — n=23, PRR 7.2
- Skin exfoliation — n=70, PRR 5.5
- Upper respiratory tract infection — n=32, PRR 4.5
- Inflammation — n=35, PRR 4.4
- Nasal congestion — n=39, PRR 4.3
- Arthritis — n=52, PRR 4.3
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, pruritus, psoriatic arthropathy, erythema, nasopharyngitis, injection site pain. 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, fieldpatient.drug.openfda.generic_name.exact, 172 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.