Drug · FAERS side-effect profile with label screen

Beclomethasone Dipropionate Hfa side effects: what 13,313 FDA adverse event reports show

Beclomethasone Dipropionate Hfa · Qvar Redihaler · 126 reaction terms · 4,209 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording

Brand names

Qvar Redihaler

openFDA label

Who reports

13,313 reports · 96% serious · 1,146 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm. QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older.

FDA label, Indications and Usage

What it is

The active component of QVAR REDIHALER 40 mcg Inhalation Aerosol and QVAR REDIHALER 80 mcg Inhalation Aerosol is beclomethasone dipropionate, USP, a corticosteroid having the chemical name 9-chloro-11ß,17,21-trihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate.

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) 5Likely indication confounding 1Reporting / coding artifact 16Not in label — unassessed 12

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. 86 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
Device delivery system issue	192	55.6 48.4–63.7ROR 59.6 · χ² 10,169 / p <1e-300	54.9 EB05 48.7 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device malfunction	254	28.5 25.3–32.0ROR 31.2 · χ² 6,704 / p <1e-300	28.3 EB05 25.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product taste abnormal	50	28.0 21.3–36.9ROR 28.5 · χ² 1,271 / p 9e-279	27.7 EB05 21.8 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Impaired quality of life	47	24.6 18.5–32.7ROR 25.0 · χ² 1,038 / p 5e-228	24.3 EB05 19.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Asthma	339	22.8 20.6–25.2ROR 25.8 · χ² 7,051 / p <1e-300	22.7 EB05 20.7 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached
Device defective	43	20.0 14.9–26.9ROR 20.3 · χ² 756 / p 1e-166	19.8 EB05 15.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Candida infection (yeast infection)	43	19.4 14.4–26.1ROR 19.7 · χ² 731 / p 3e-161	19.2 EB05 14.8 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Incorrect dose administered by device	56	16.6 12.8–21.5ROR 16.9 · χ² 804 / p 4e-177	16.4 EB05 13.1 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Pharyngeal swelling	21	16.5 10.8–25.3ROR 16.6 · χ² 290 / p 2e-65	16.0 EB05 10.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Device issue	178	15.3 13.3–17.7ROR 16.3 · χ² 2,378 / p <1e-300	15.3 EB05 13.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product substitution issue	97	12.7 10.4–15.4ROR 13.1 · χ² 1,032 / p 8e-227	12.5 EB05 10.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Infusion site pain	21	12.4 8.1–18.9ROR 12.5 · χ² 208 / p 2e-47	11.6 EB05 7.5 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Throat irritation	69	11.6 9.2–14.7ROR 11.9 · χ² 658 / p 2e-145	11.4 EB05 9.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dry throat	15	11.1 6.7–18.4ROR 11.2 · χ² 128 / p 6e-30	9.8 EB05 5.8 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Inability to afford medication	13	9.9 5.8–17.1ROR 10.0 · χ² 96 / p 7e-23	8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product odour abnormal	13	9.4 5.5–16.2ROR 9.5 · χ² 89 / p 2e-21	7.8 EB05 4.6 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug prescribing error	24	9.3 6.2–13.8ROR 9.3 · χ² 169 / p 8e-39	8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Choking	23	8.9 5.9–13.4ROR 9.0 · χ² 153 / p 2e-35	8.0 EB05 5.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Wrong technique in device usage process	54	8.9 6.8–11.6ROR 9.0 · χ² 370 / p 1e-82	8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Seasonal allergy	16	8.5 5.2–13.9ROR 8.6 · χ² 99 / p 1e-23	7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Wheezing	67	8.5 6.7–10.8ROR 8.7 · χ² 437 / p 2e-97	8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Oral candidiasis (oral thrush)	14	8.1 4.8–13.6ROR 8.1 · χ² 80 / p 2e-19	6.7 EB05 4.1 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Product prescribing error	25	7.9 5.4–11.7ROR 8.0 · χ² 145 / p 1e-33	7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Expired product administered	33	7.5 5.3–10.5ROR 7.6 · χ² 179 / p 5e-41	6.9 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Dermatitis contact	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
Cough	262	7.0 6.3–7.9ROR 7.7 · χ² 1,368 / p 1e-299	7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Dysphonia	50	6.4 4.9–8.5ROR 6.5 · χ² 224 / p 5e-51	6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dermatitis atopic	40	6.0 4.4–8.2ROR 6.1 · χ² 163 / p 2e-37	5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product prescribing issue	16	5.9 3.6–9.6ROR 5.9 · χ² 60 / p 4e-15	5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Respiratory tract infection	20	5.8 3.7–9.0ROR 5.8 · χ² 74 / p 3e-18	5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Product dose omission in error	20	5.6 3.6–8.7ROR 5.6 · χ² 71 / p 2e-17	5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Sleep disorder due to a general medical condition	12	5.6 3.2–9.8ROR 5.6 · χ² 41 / p 9e-11	4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Insurance issue	11	5.6 3.1–10.0ROR 5.6 · χ² 37 / p 7e-10	4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Illness	74	5.5 4.4–6.9ROR 5.7 · χ² 271 / p 3e-61	5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Middle insomnia	13	5.2 3.1–9.0ROR 5.3 · χ² 41 / p 9e-11	4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Oropharyngeal pain (sore throat)	63	5.1 4.0–6.5ROR 5.2 · χ² 205 / p 9e-47	4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Chest discomfort	69	5.1 4.0–6.4ROR 5.2 · χ² 223 / p 9e-51	4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Upper respiratory tract infection (cold/sinus infection)	31	5.0 3.6–7.2ROR 5.1 · χ² 97 / p 4e-23	4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Sinus disorder	12	4.5 2.6–8.0ROR 4.6 · χ² 30 / p 2e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Product physical issue	12	4.5 2.6–8.0ROR 4.5 · χ² 29 / p 3e-8	3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	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
Asthma	339	22.8 20.6–25.2ROR 25.8 · χ² 7,051 / p <1e-300	22.7 EB05 20.7 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached
Dyspnoea (shortness of breath)	318	4.2 3.8–4.7ROR 4.6 · χ² 800 / p 2e-176	4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Cough	262	7.0 6.3–7.9ROR 7.7 · χ² 1,368 / p 1e-299	7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Device malfunction	254	28.5 25.3–32.0ROR 31.2 · χ² 6,704 / p <1e-300	28.3 EB05 25.5 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device delivery system issue	192	55.6 48.4–63.7ROR 59.6 · χ² 10,169 / p <1e-300	54.9 EB05 48.7 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device issue	178	15.3 13.3–17.7ROR 16.3 · χ² 2,378 / p <1e-300	15.3 EB05 13.5 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product use in unapproved indication	122	3.8 3.2–4.5ROR 3.9 · χ² 246 / p 9e-56	3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in product usage process	111	4.1 3.4–5.0ROR 4.3 · χ² 262 / p 3e-59	4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product dose omission issue	106	2.8 2.3–3.4ROR 2.9 · χ² 122 / p 1e-28	2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product substitution issue	97	12.7 10.4–15.4ROR 13.1 · χ² 1,032 / p 8e-227	12.5 EB05 10.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Covid-19	96	4.1 3.3–5.0ROR 4.2 · χ² 221 / p 2e-50	4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Illness	74	5.5 4.4–6.9ROR 5.7 · χ² 271 / p 3e-61	5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Chest discomfort	69	5.1 4.0–6.4ROR 5.2 · χ² 223 / p 9e-51	4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Throat irritation	69	11.6 9.2–14.7ROR 11.9 · χ² 658 / p 2e-145	11.4 EB05 9.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Inappropriate schedule of product administration	67	2.8 2.2–3.6ROR 2.9 · χ² 79 / p 3e-19	2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	–	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.

Impaired quality of life — n=47, PRR 24.6
Pharyngeal swelling — n=21, PRR 16.5
Throat irritation — n=69, PRR 11.6
Choking — n=23, PRR 8.9
Dysphonia — n=50, PRR 6.4
Dermatitis atopic — n=40, PRR 6.0
Chest discomfort — n=69, PRR 5.1

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 Hfa?

In FDA FAERS, the most frequently co-reported reaction terms for Beclomethasone Dipropionate Hfa are asthma, dyspnoea, cough, covid-19, chest discomfort, throat irritation. 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 Hfa have an FDA boxed warning?

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

Do FAERS signals prove that Beclomethasone Dipropionate Hfa 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 2814cf81-392e-4dd4-9816-ae7e6e5ec84f, effective 20230920; matched on openfda.generic_name.exact:"BECLOMETHASONE DIPROPIONATE HFA")
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, 126 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.