Drug · FAERS side-effect profile with label screen
Beclomethasone Dipropionate side effects: what 5,600 FDA adverse event reports show
Drug class
Corticosteroid
FDA label, Indications wording
Who reports
5,600 reports · 96% serious · 536 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm.
FDA label, Indications and Usage
What it is
The active component of beclomethasone dipropionate HFA inhalation aerosol 40 mcg inhalation aerosol and beclomethasone dipropionate HFA inhalation aerosol 80 mcg inhalation aerosol is beclome.
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 6Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 27
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.
- 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. 527 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 |
|---|---|---|---|---|---|---|
| Personality change | 45 | 13.9 10.4–18.6ROR 14.0 · χ² 524 / p 3e-116 | 13.6 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · ♀ 79% (drug 56%) | no trial data cached |
| Pharyngeal swelling | 41 | 12.4 9.1–16.8ROR 12.4 · χ² 416 / p 1e-92 | 12.0 EB05 9.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Wheezing | 215 | 10.5 9.2–12.0ROR 10.8 · χ² 1,835 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · ♀ 83% (drug 56%) | no trial data cached |
| Mood altered | 96 | 10.2 8.4–12.4ROR 10.3 · χ² 785 / p 4e-173 | 10.0 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Oral candidiasis (oral thrush) | 45 | 10.0 7.5–13.4ROR 10.0 · χ² 354 / p 3e-79 | 9.5 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Nightmare | 113 | 9.4 7.8–11.3ROR 9.5 · χ² 836 / p 3e-184 | 9.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Asthma | 357 | 9.2 8.3–10.2ROR 9.6 · χ² 2,603 / p <1e-300 | 9.1 EB05 8.3 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.3 | no trial data cached |
| Sneezing | 67 | 8.6 6.8–11.0ROR 8.7 · χ² 444 / p 6e-99 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Respiratory tract infection | 76 | 8.4 6.7–10.6ROR 8.5 · χ² 490 / p 6e-109 | 8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · ♀ 89% (drug 56%) · 96% clinician | no trial data cached |
| Anger | 86 | 7.3 5.9–9.0ROR 7.4 · χ² 461 / p 1e-102 | 7.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Psychomotor hyperactivity | 40 | 6.9 5.1–9.4ROR 7.0 · χ² 196 / p 7e-45 | 6.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Circulatory collapse | 40 | 6.7 4.9–9.2ROR 6.8 · χ² 190 / p 2e-43 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hypercholesterolaemia | 22 | 6.6 4.4–10.1ROR 6.6 · χ² 99 / p 1e-23 | 5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 85% (drug 56%) | no trial data cached |
| Aggression | 113 | 6.5 5.4–7.8ROR 6.6 · χ² 520 / p 2e-115 | 6.3 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Gastrointestinal pain | 24 | 6.3 4.2–9.4ROR 6.3 · χ² 102 / p 3e-24 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Abnormal behaviour | 84 | 6.1 4.9–7.5ROR 6.1 · χ² 351 / p 1e-78 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Hiatus hernia | 27 | 6.0 4.1–8.7ROR 6.0 · χ² 107 / p 2e-25 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · ♀ 87% (drug 56%) | no trial data cached |
| Sinus bradycardia | 20 | 6.0 3.8–9.2ROR 6.0 · χ² 77 / p 7e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Brain fog | 30 | 5.9 4.1–8.5ROR 5.9 · χ² 118 / p 9e-28 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 78% (drug 56%) | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 32 | 5.9 4.1–8.3ROR 5.9 · χ² 124 / p 5e-29 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 35% (drug 56%) | no trial data cached |
| Lower respiratory tract infection | 91 | 5.8 4.7–7.1ROR 5.8 · χ² 356 / p 1e-79 | 5.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 · ♀ 34% (drug 56%) | no trial data cached |
| Full blood count abnormal | 21 | 5.7 3.7–8.8ROR 5.8 · χ² 77 / p 7e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Bronchospasm (airway tightening) | 28 | 5.6 3.9–8.2ROR 5.7 · χ² 102 / p 3e-24 | 5.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.9 | no trial data cached |
| Depressed mood | 102 | 5.6 4.6–6.8ROR 5.7 · χ² 380 / p 8e-85 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 52 | 5.6 4.2–7.3ROR 5.6 · χ² 189 / p 2e-43 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hyperlipidaemia | 23 | 5.5 3.7–8.3ROR 5.5 · χ² 81 / p 1e-19 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Obesity | 30 | 5.4 3.8–7.7ROR 5.4 · χ² 104 / p 1e-24 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Mouth ulceration | 39 | 5.3 3.9–7.3ROR 5.4 · χ² 133 / p 4e-31 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 77% (drug 56%) | no trial data cached |
| Mucosal inflammation | 48 | 5.3 4.0–7.0ROR 5.3 · χ² 163 / p 1e-37 | 5.1 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Pulmonary congestion | 24 | 5.2 3.5–7.8ROR 5.2 · χ² 78 / p 6e-19 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Tendonitis | 28 | 5.2 3.6–7.5ROR 5.2 · χ² 90 / p 1e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Adrenal insufficiency | 21 | 5.1 3.3–7.8ROR 5.1 · χ² 64 / p 6e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Liver function test abnormal | 51 | 5.0 3.8–6.6ROR 5.0 · χ² 160 / p 5e-37 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Oedema | 94 | 5.0 4.1–6.1ROR 5.1 · χ² 297 / p 6e-67 | 4.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · ♀ 95% (drug 56%) · 91% clinician | no trial data cached |
| Poor quality sleep | 37 | 5.0 3.6–6.9ROR 5.0 · χ² 114 / p 7e-27 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Appendicitis | 16 | 5.0 3.0–8.1ROR 5.0 · χ² 47 / p 4e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Mood swings | 54 | 4.9 3.7–6.4ROR 4.9 · χ² 163 / p 2e-37 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Vaginal discharge | 17 | 4.9 3.0–7.8ROR 4.9 · χ² 49 / p 2e-12 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Paranoia | 29 | 4.8 3.4–6.9ROR 4.8 · χ² 84 / p 2e-20 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 36% (drug 56%) · 72% consumer | no trial data cached |
| Sleep apnoea syndrome | 32 | 4.8 3.4–6.8ROR 4.8 · χ² 93 / p 3e-22 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 544 | 2.8 2.6–3.0ROR 2.9 · χ² 630 / p 3e-139 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Asthma | 357 | 9.2 8.3–10.2ROR 9.6 · χ² 2,603 / p <1e-300 | 9.1 EB05 8.3 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.3 | no trial data cached |
| Headache | 352 | 1.6 1.5–1.8ROR 1.6 · χ² 85 / p 1e-20 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Vomiting | 340 | 2.1 1.9–2.3ROR 2.1 · χ² 196 / p 9e-45 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Malaise (feeling unwell) | 311 | 2.0 1.8–2.3ROR 2.1 · χ² 166 / p 2e-38 | 2.0 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Cough | 295 | 3.0 2.7–3.4ROR 3.1 · χ² 406 / p 2e-90 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · ♀ 78% (drug 56%) | no trial data cached |
| Pneumonia (lung infection) | 288 | 2.6 2.3–2.9ROR 2.6 · χ² 278 / p 1e-62 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.9 | no trial data cached |
| Dizziness | 246 | 1.4 1.3–1.6ROR 1.4 · χ² 31 / p 1e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.5 · ♀ 77% (drug 56%) | no trial data cached |
| Wheezing | 215 | 10.5 9.2–12.0ROR 10.8 · χ² 1,835 / p <1e-300 | 10.4 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · ♀ 83% (drug 56%) | no trial data cached |
| Pyrexia (fever) | 213 | 1.8 1.6–2.0ROR 1.8 · χ² 72 / p 1e-17 | 1.8 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Anxiety | 212 | 2.1 1.9–2.4ROR 2.2 · χ² 129 / p 3e-30 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Rash | 206 | 1.4 1.2–1.6ROR 1.4 · χ² 20 / p 3e-6 | 1.4 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Abdominal pain | 193 | 2.4 2.1–2.7ROR 2.4 · χ² 156 / p 4e-36 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Condition aggravated | 181 | 1.7 1.5–2.0ROR 1.7 · χ² 55 / p 5e-14 | 1.7 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Chest pain | 179 | 2.8 2.4–3.2ROR 2.8 · χ² 203 / p 2e-46 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | 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.
- Personality change — n=45, PRR 13.9
- Pharyngeal swelling — n=41, PRR 12.4
- Mood altered — n=96, PRR 10.2
- Nightmare — n=113, PRR 9.4
- Sneezing — n=67, PRR 8.6
- Anger — n=86, PRR 7.3
- Circulatory collapse — n=40, PRR 6.7
- Hypercholesterolaemia — n=22, PRR 6.6
- Gastrointestinal pain — n=24, PRR 6.3
- Abnormal behaviour — n=84, PRR 6.1
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 Beclomethasone Dipropionate?
In FDA FAERS, the most frequently co-reported reaction terms for Beclomethasone Dipropionate are dyspnoea, asthma, headache, vomiting, malaise, cough. 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 Beclomethasone Dipropionate have an FDA boxed warning?
No. The FDA label retrieved for Beclomethasone Dipropionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Beclomethasone 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 d853c96f-21a3-4def-931d-4d47d16acd62, effective 20200731; matched on
openfda.generic_name.exact:"BECLOMETHASONE 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, 567 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.