Drug · FAERS side-effect profile with label screen
Betamethasone Dipropionate side effects: what 6,455 FDA adverse event reports show
Drug class
Corticosteroid
FDA label, Indications wording
Who reports
6,455 reports · 66% serious · 512 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Betamethasone Dipropionate Cream USP (Augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone Dipropionat.
FDA label, Indications and Usage
What it is
Betamethasone Dipropionate Cream USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity.
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 2Labeled (related wording) 2Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 33
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.
- 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.
- 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.
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. 551 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 532 | 151.8 139.6–165.0ROR 165.3 · χ² 75,970 / p <1e-300 | 144.2 EB05 134.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 136.1 · ♀ 100% (drug 59%) | no trial data cached |
| Full blood count abnormal | 129 | 40.2 33.9–47.7ROR 41.0 · χ² 4,835 / p <1e-300 | 39.5 EB05 34.1 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 45.9 · ♀ 0% (drug 59%) | no trial data cached |
| Sleep disorder due to a general medical condition | 171 | 34.7 29.9–40.3ROR 35.6 · χ² 5,506 / p <1e-300 | 34.2 EB05 30.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 39.8 · ♀ 28% (drug 59%) | no trial data cached |
| Obstructive airways disorder | 116 | 34.1 28.4–40.9ROR 34.7 · χ² 3,656 / p <1e-300 | 33.6 EB05 28.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.5 · ♀ 0% (drug 59%) | no trial data cached |
| Arteriosclerosis | 94 | 32.7 26.7–40.0ROR 33.2 · χ² 2,829 / p <1e-300 | 32.2 EB05 27.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 29.1 · ♀ 8% (drug 59%) | no trial data cached |
| Incorrect route of product administration | 160 | 31.2 26.8–36.4ROR 32.0 · χ² 4,606 / p <1e-300 | 30.8 EB05 27.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 35.6 | no trial data cached |
| Vasculitis | 110 | 30.9 25.7–37.2ROR 31.4 · χ² 3,126 / p <1e-300 | 30.5 EB05 26.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 0% (drug 59%) | no trial data cached |
| Vaginal discharge | 81 | 26.4 21.2–32.8ROR 26.7 · χ² 1,938 / p <1e-300 | 26.0 EB05 21.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=81 · ♀ 100% (drug 59%) | no trial data cached |
| Drug eruption | 142 | 26.4 22.4–31.0ROR 26.9 · χ² 3,415 / p <1e-300 | 26.1 EB05 22.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.8 · ♀ 5% (drug 59%) · 97% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 99 | 24.9 20.5–30.3ROR 25.3 · χ² 2,230 / p <1e-300 | 24.6 EB05 20.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 29.5 · ♀ 95% (drug 59%) | no trial data cached |
| Paraesthesia oral | 107 | 24.3 20.2–29.4ROR 24.7 · χ² 2,356 / p <1e-300 | 24.1 EB05 20.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 37.6 · ♀ 100% (drug 59%) | no trial data cached |
| Appendicitis | 69 | 24.3 19.2–30.7ROR 24.5 · χ² 1,506 / p <1e-300 | 24.0 EB05 19.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 · ♀ 0% (drug 59%) · 96% clinician | no trial data cached |
| Pulmonary fibrosis | 134 | 22.9 19.4–27.1ROR 23.4 · χ² 2,770 / p <1e-300 | 22.7 EB05 19.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.0 · ♀ 12% (drug 59%) | no trial data cached |
| Nodule | 88 | 22.0 17.9–27.1ROR 22.3 · χ² 1,735 / p <1e-300 | 21.8 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.5 · ♀ 6% (drug 59%) | no trial data cached |
| Hypercholesterolaemia | 63 | 21.5 16.8–27.5ROR 21.7 · χ² 1,204 / p 3e-264 | 21.3 EB05 17.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · 94% clinician | no trial data cached |
| Ventricular fibrillation | 64 | 18.8 14.7–24.0ROR 18.9 · χ² 1,053 / p 3e-231 | 18.6 EB05 15.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 · ♀ 0% (drug 59%) · 94% clinician | no trial data cached |
| Skin fissures | 100 | 17.3 14.2–21.0ROR 17.5 · χ² 1,511 / p <1e-300 | 17.1 EB05 14.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=61 | no trial data cached |
| Hyperlipidaemia | 58 | 15.8 12.2–20.4ROR 15.9 · χ² 785 / p 5e-173 | 15.6 EB05 12.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 11% (drug 59%) · 91% clinician | no trial data cached |
| Cardiogenic shock | 65 | 14.9 11.7–18.9ROR 15.0 · χ² 823 / p 3e-181 | 14.7 EB05 11.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 0% (drug 59%) · 94% clinician | no trial data cached |
| Therapeutic product effect incomplete | 320 | 14.8 13.3–16.4ROR 15.5 · χ² 4,085 / p <1e-300 | 14.7 EB05 13.4 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 21.8 | no trial data cached |
| Haemoptysis | 123 | 14.3 12.0–17.1ROR 14.6 · χ² 1,509 / p <1e-300 | 14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · ♀ 3% (drug 59%) | no trial data cached |
| Psoriatic arthropathy | 173 | 14.0 12.1–16.2ROR 14.4 · χ² 2,074 / p <1e-300 | 13.9 EB05 12.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 | no trial data cached |
| Frequent bowel movements | 115 | 13.9 11.6–16.7ROR 14.2 · χ² 1,364 / p 9e-299 | 13.8 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 96% (drug 59%) | no trial data cached |
| Folliculitis | 44 | 13.9 10.3–18.7ROR 14.0 · χ² 511 / p 2e-113 | 13.6 EB05 10.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.8 · ♀ 88% (drug 59%) | no trial data cached |
| Procedural pain | 115 | 13.6 11.3–16.3ROR 13.8 · χ² 1,321 / p 2e-289 | 13.4 EB05 11.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · ♀ 98% (drug 59%) | no trial data cached |
| Bacterial infection | 77 | 13.5 10.8–16.9ROR 13.7 · χ² 877 / p 5e-193 | 13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 15% (drug 59%) · 96% clinician | no trial data cached |
| Hypothyroidism | 127 | 13.0 10.9–15.4ROR 13.2 · χ² 1,391 / p <1e-300 | 12.9 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 17% (drug 59%) | no trial data cached |
| Hepatic function abnormal | 143 | 12.6 10.7–14.8ROR 12.8 · χ² 1,508 / p <1e-300 | 12.5 EB05 10.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · ♀ 9% (drug 59%) · 97% clinician | no trial data cached |
| Psoriasis | 498 | 12.4 11.4–13.5ROR 13.4 · χ² 5,226 / p <1e-300 | 12.3 EB05 11.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 | no trial data cached |
| Lung disorder | 182 | 12.1 10.5–14.0ROR 12.4 · χ² 1,841 / p <1e-300 | 12.0 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 25% (drug 59%) | no trial data cached |
| Ulcer | 59 | 12.1 9.4–15.6ROR 12.2 · χ² 586 / p 1e-129 | 11.8 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 22% (drug 59%) | no trial data cached |
| Aspiration | 39 | 11.7 8.6–16.0ROR 11.8 · χ² 371 / p 6e-83 | 11.3 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 11% (drug 59%) · 95% clinician | no trial data cached |
| Neuralgia | 84 | 11.3 9.1–14.0ROR 11.4 · χ² 775 / p 7e-171 | 11.1 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.8 · ♀ 14% (drug 59%) | no trial data cached |
| Candida infection (yeast infection) | 56 | 10.9 8.4–14.2ROR 11.0 · χ² 494 / p 9e-110 | 10.6 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 92% (drug 59%) | no trial data cached |
| End stage renal disease | 60 | 10.6 8.2–13.7ROR 10.7 · χ² 511 / p 2e-113 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 15% (drug 59%) · 92% clinician | no trial data cached |
| Gout | 57 | 10.3 8.0–13.4ROR 10.4 · χ² 470 / p 2e-104 | 10.0 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · ♀ 10% (drug 59%) | no trial data cached |
| Multiple organ dysfunction syndrome | 88 | 10.3 8.3–12.6ROR 10.4 · χ² 726 / p 4e-160 | 10.0 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 6% (drug 59%) · 95% clinician | no trial data cached |
| Hypoxia (low oxygen) | 110 | 10.2 8.5–12.3ROR 10.4 · χ² 904 / p 8e-199 | 10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · ♀ 13% (drug 59%) | no trial data cached |
| Dermatitis atopic | 154 | 10.0 8.6–11.7ROR 10.3 · χ² 1,243 / p 1e-272 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=39 | no trial data cached |
| Joint range of motion decreased | 40 | 9.7 7.1–13.3ROR 9.8 · χ² 304 / p 2e-68 | 9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 92% (drug 59%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,471 | 3.6 3.5–3.8ROR 4.4 · χ² 2,986 / p <1e-300 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Off label use (used outside approved label) | 649 | 2.4 2.3–2.6ROR 2.6 · χ² 567 / p 1e-125 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Macular degeneration | 532 | 151.8 139.6–165.0ROR 165.3 · χ² 75,970 / p <1e-300 | 144.2 EB05 134.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 136.1 · ♀ 100% (drug 59%) | no trial data cached |
| Nausea | 523 | 2.2 2.0–2.3ROR 2.3 · χ² 334 / p 6e-75 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Psoriasis | 498 | 12.4 11.4–13.5ROR 13.4 · χ² 5,226 / p <1e-300 | 12.3 EB05 11.5 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 | no trial data cached |
| Pain | 459 | 2.4 2.2–2.6ROR 2.5 · χ² 394 / p 7e-88 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Pruritus (itching) | 456 | 3.9 3.6–4.3ROR 4.1 · χ² 1,006 / p 4e-221 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Condition aggravated | 421 | 4.5 4.1–5.0ROR 4.8 · χ² 1,171 / p 8e-257 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Fatigue (tiredness) | 403 | 1.7 1.5–1.9ROR 1.7 · χ² 116 / p 3e-27 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Rash | 401 | 3.0 2.7–3.3ROR 3.1 · χ² 545 / p 7e-121 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Pain in extremity | 395 | 4.3 4.0–4.8ROR 4.6 · χ² 1,029 / p 5e-226 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 34% (drug 59%) | no trial data cached |
| Headache | 380 | 2.0 1.8–2.2ROR 2.0 · χ² 186 / p 1e-42 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Product use in unapproved indication | 349 | 4.6 4.2–5.1ROR 4.9 · χ² 1,005 / p 9e-221 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Diarrhoea (diarrhea) | 347 | 1.8 1.6–1.9ROR 1.8 · χ² 115 / p 4e-27 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 344 | 2.0 1.8–2.2ROR 2.0 · χ² 169 / p 6e-39 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | 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.
- Macular degeneration — n=532, PRR 151.8
- Sleep disorder due to a general medical condition — n=171, PRR 34.7
- Obstructive airways disorder — n=116, PRR 34.1
- Arteriosclerosis — n=94, PRR 32.7
- Vasculitis — n=110, PRR 30.9
- Vaginal discharge — n=81, PRR 26.4
- Oral candidiasis — n=99, PRR 24.9
- Paraesthesia oral — n=107, PRR 24.3
- Appendicitis — n=69, PRR 24.3
- Pulmonary fibrosis — n=134, PRR 22.9
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 Betamethasone Dipropionate?
In FDA FAERS, the most frequently co-reported reaction terms for Betamethasone Dipropionate are macular degeneration, nausea, psoriasis, pain, pruritus, fatigue. 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 Betamethasone Dipropionate have an FDA boxed warning?
No. The FDA label retrieved for Betamethasone Dipropionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Betamethasone Dipropionate 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 0481ac0d-9220-472b-b3f2-af6e0bb6962d, effective 20240820; matched on
openfda.generic_name.exact:"BETAMETHASONE DIPROPIONATE") - 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, 591 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.