What the label lists and what reports show
Ciclesonide side effects
Ciclesonide's FDA label: “Most common adverse reactions (≥ 3%) are headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity and back pain.” FAERS holds 13,541 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 (4,621 reports).
- No generic listed
Check it at the source: the ciclesonide FDA label on DailyMed (effective February 28, 2025, Covis Pharma US, Inc); 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 ALVESCO?ALVESCO may cause serious side effects, including: Thrush (Candida), a fungal infection of your nose, mouth, or throat. Tell your healthcare provider if you have discomfort or pain in your throat, have hoarseness in your voice or have any redness or white colored patches in your mouth or throat. Rinse your mouth after you use your ALVESCO. Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use ALVESCO. Symptoms of an infection may include: fever pain aches chills feeling tired nausea vomiting Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. […]
Source: FDA drug label, NDA021658 (Azurity), as published by Covis Pharma US, Inc, effective February 28, 2025 (SPL set 9f6112fb-78ef-43cf-8ae3-36370eb45468), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 3%) are headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity and back pain.
Table 1 Adverse Events from Controlled Clinical Trials 2 to 6 Weeks in Duration in Patients 12 Years of Age and Older with Seasonal or Perennial Allergic Rhinitis
This table is printed in the Omnaris label published by Covis Pharma US, Inc of November 8, 2022; the label quoted above does not print one.
| Adverse Event | OMNARIS Nasal Spray 200 mcg Once Daily (N = 546) % | Placebo (N = 544) % |
|---|---|---|
| Headache | 6.0 | 4.6 |
| Epistaxis | 4.9 | 2.9 |
| Nasopharyngitis | 3.7 | 3.3 |
| Ear Pain | 2.2 | 0.6 |
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 ( 5.3 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.6 )] Growth Effects [see Warnings and Precautions ( 5.7 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (≥ 3%) are headache, nasopharyngitis, sinusitis, pharyngolaryngeal pain, upper respiratory infection, arthralgia, nasal congestion, pain in extremity and back pain. ( 6 ) Other adverse reactions have been reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience The safety data described below for adult and pediatric patients 12 years of age and older reflect exposure to ALVESCO in doses ranging from 80 mcg to 640 mcg twice daily in five double-blind placebo-controlled clinical trials. Studies with once daily dosing are omitted from the safety database because the doses studied once daily are lower than the highest recommended twice daily doses. …
Source: FDA drug label, NDA021658 (Azurity), as published by Covis Pharma US, Inc, effective February 28, 2025 (SPL set 9f6112fb-78ef-43cf-8ae3-36370eb45468), via openFDA; the full label on DailyMed
What do FAERS reports show?
13,541 reports list ciclesonide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 622 are coded as a death and 6,094 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, 9 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?
- Ciclesonide: 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