What the label lists and what reports show
Beclomethasone side effects
Beclomethasone's FDA label: “Most common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.” FAERS holds 5,600 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (477 reports).
- Generic approved
Check it at the source: the beclomethasone FDA label on DailyMed (effective June 25, 2024, A-S Medication Solutions); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of QVAR REDIHALER?QVAR REDIHALER may cause serious side effects, including: fungal infections (thrush) in your mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat. Rinse your mouth with water without swallowing after using QVAR REDIHALER to help prevent an infection in your mouth or throat. worsening asthma or sudden asthma attacks. You should contact your healthcare provider right away if you do not get relief from your sudden asthma attacks, after using your rescue inhaler, during your treatment with QVAR REDIHALER. reduced adrenal function (adrenal insufficiency). Reduced adrenal function that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. […]
Source: FDA drug label, NDA207921 (Norton Waterford), as published by A-S Medication Solutions, effective June 25, 2024 (SPL set ccd3aaec-4892-40d0-ad60-3e570178fbe1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.
Table 2. Adverse Events With ≥ 2% Incidence and Greater than Placebo in QNASL Nasal…
This table is printed in the QNASL label published by Teva Respiratory, LLC of September 27, 2022; the label quoted above does not print one.
| Reaction | QNASL Nasal Aerosol 80 mcg (N=668) n (%) | Placebo (N=451) n (%) |
|---|---|---|
| Headache | 23 (3.4) | 15 (3.3) |
| Pyrexia | 19 (2.8) | 7 (1.6) |
| Upper respiratory tract infection | 17 (2.5) | 8 (1.8) |
| Nasopharyngitis | 15 (2.2) | 6 (1.3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Oropharyngeal candidiasis [see Warnings and Precautions ( 5.1 )] Immunosuppression and risk of infections [see Warnings and Precautions ( 5.4 )] Hypercorticism and adrenal suppression [see Warnings and Precautions ( 5.7 )] Reduction in bone mineral density [see Warnings and Precautions ( 5.9 )] Growth effects [see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.4 )] Glaucoma and cataracts [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence > 3% and > placebo) include oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience A total of 1858 subjects participated in the QVAR REDIHALER clinical development program. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, NDA207921 (Norton Waterford), as published by A-S Medication Solutions, effective June 25, 2024 (SPL set ccd3aaec-4892-40d0-ad60-3e570178fbe1), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,600 reports list beclomethasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 536 are coded as a death and 2,027 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Beclomethasone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions