Drug · FAERS side-effect profile with label screen

Beclomethasone Dipropionate, Formoterol and Glycopyrrolate side effects: what 13,313 FDA adverse event reports show

Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate · 56 reaction terms · 618 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording

Who reports

13,313 reports · 96% serious · 1,146 with death outcome · 61% 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 22 strongest signals

Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 17

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. 34 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
Hypomagnesaemia	20	18.2 11.8–28.2ROR 18.4 · χ² 309 / p 2e-69	17.8 EB05 11.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Chronic obstructive pulmonary disease	72	17.5 13.9–21.9ROR 18.2 · χ² 1,103 / p 5e-242	17.4 EB05 14.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bronchospasm (airway tightening)	16	14.1 8.7–23.0ROR 14.3 · χ² 182 / p 8e-42	13.2 EB05 8.0 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached
Tendonitis	16	13.0 8.0–21.2ROR 13.1 · χ² 165 / p 4e-38	12.0 EB05 7.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Brain fog	12	10.4 5.9–18.3ROR 10.5 · χ² 93 / p 3e-22	8.6 EB05 4.9 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Upper gastrointestinal haemorrhage	13	9.7 5.7–16.7ROR 9.8 · χ² 93 / p 2e-22	8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Epilepsy	20	8.3 5.4–12.8ROR 8.4 · χ² 121 / p 2e-28	7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyponatraemia (low sodium)	36	8.1 5.9–11.2ROR 8.3 · χ² 217 / p 2e-49	7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lip swelling	21	8.0 5.2–12.2ROR 8.1 · χ² 122 / p 1e-28	7.1 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug eruption	11	7.9 4.4–14.2ROR 7.9 · χ² 59 / p 6e-15	6.3 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
C-reactive protein increased	21	7.3 4.8–11.2ROR 7.4 · χ² 108 / p 1e-25	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Cholestasis (bile flow blockage)	11	7.3 4.0–13.1ROR 7.3 · χ² 53 / p 1e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Swollen tongue	18	7.3 4.6–11.5ROR 7.3 · χ² 91 / p 6e-22	6.3 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Melaena (black stool)	12	6.9 3.9–12.1ROR 6.9 · χ² 55 / p 8e-14	5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lower respiratory tract infection	24	6.7 4.5–10.0ROR 6.8 · χ² 111 / p 3e-26	6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Hallucination, visual	10	6.0 3.2–11.2ROR 6.1 · χ² 37 / p 6e-10	4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product availability issue	10	5.6 3.0–10.5ROR 5.7 · χ² 34 / p 3e-9	4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Throat tightness	12	5.6 3.2–9.9ROR 5.6 · χ² 41 / p 7e-11	4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Haematemesis (vomiting blood)	11	5.5 3.0–9.9ROR 5.5 · χ² 36 / p 1e-9	4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Angioedema (deep swelling of face/throat)	19	5.4 3.5–8.5ROR 5.5 · χ² 65 / p 5e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Anger	14	5.2 3.1–8.8ROR 5.2 · χ² 44 / p 2e-11	4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lactic acidosis	13	5.1 3.0–8.8ROR 5.2 · χ² 39 / p 2e-10	4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	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
Chronic obstructive pulmonary disease	72	17.5 13.9–21.9ROR 18.2 · χ² 1,103 / p 5e-242	17.4 EB05 14.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyponatraemia (low sodium)	36	8.1 5.9–11.2ROR 8.3 · χ² 217 / p 2e-49	7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lower respiratory tract infection	24	6.7 4.5–10.0ROR 6.8 · χ² 111 / p 3e-26	6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
C-reactive protein increased	21	7.3 4.8–11.2ROR 7.4 · χ² 108 / p 1e-25	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Lip swelling	21	8.0 5.2–12.2ROR 8.1 · χ² 122 / p 1e-28	7.1 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Epilepsy	20	8.3 5.4–12.8ROR 8.4 · χ² 121 / p 2e-28	7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hypomagnesaemia	20	18.2 11.8–28.2ROR 18.4 · χ² 309 / p 2e-69	17.8 EB05 11.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Angioedema (deep swelling of face/throat)	19	5.4 3.5–8.5ROR 5.5 · χ² 65 / p 5e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Swollen tongue	18	7.3 4.6–11.5ROR 7.3 · χ² 91 / p 6e-22	6.3 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Tendonitis	16	13.0 8.0–21.2ROR 13.1 · χ² 165 / p 4e-38	12.0 EB05 7.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bronchospasm (airway tightening)	16	14.1 8.7–23.0ROR 14.3 · χ² 182 / p 8e-42	13.2 EB05 8.0 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached
Anger	14	5.2 3.1–8.8ROR 5.2 · χ² 44 / p 2e-11	4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lactic acidosis	13	5.1 3.0–8.8ROR 5.2 · χ² 39 / p 2e-10	4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Upper gastrointestinal haemorrhage	13	9.7 5.7–16.7ROR 9.8 · χ² 93 / p 2e-22	8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Throat tightness	12	5.6 3.2–9.9ROR 5.6 · χ² 41 / p 7e-11	4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	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.

Hypomagnesaemia — n=20, PRR 18.2
Chronic obstructive pulmonary disease — n=72, PRR 17.5
Epilepsy — n=20, PRR 8.3
Hyponatraemia — n=36, PRR 8.1
Lip swelling — n=21, PRR 8.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.

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 chronic obstructive pulmonary disease, hyponatraemia, lower respiratory tract infection, c-reactive protein increased, lip swelling, epilepsy. 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, field patient.drug.openfda.generic_name.exact, 56 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.