Drug · FAERS side-effect profile with label screen
Ciclesonide side effects: what 13,540 FDA adverse event reports show
Drug class
Inhaled corticosteroid
FDA label, Indications wording
Brand names
Alvesco
openFDA label
Who reports
13,540 reports · 90% serious · 622 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age.
FDA label, Indications and Usage
What it is
The active component of ALVESCO 80 mcg, and ALVESCO 160 mcg is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna-1,4-diene-3,20-dione, 16,17-[[(R)-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α).
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 (related wording) 6Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 21
What the badges mean
- 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. 1,125 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 |
|---|---|---|---|---|---|---|
| Plethysmography | 25 | 38,178.8 5,173.4–281,751.2ROR 38,249.4 · χ² 35,254 / p <1e-300 | 689.0 EB05 490.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 66%) · 100% consumer | not reported in cached trials |
| Cftr gene mutation | 20 | 7,635.8 2,610.2–22,337.0ROR 7,647.0 · χ² 24,189 / p <1e-300 | 572.2 EB05 391.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Airway remodelling | 96 | 5,429.9 3,544.1–8,319.0ROR 5,468.6 · χ² 113,194 / p <1e-300 | 962.0 EB05 811.0 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=96 · ♀ 33% (drug 66%) | not reported in cached trials |
| Broncholithiasis | 22 | 3,733.0 1,719.2–8,105.8ROR 3,739.1 · χ² 22,759 / p <1e-300 | 556.5 EB05 387.4 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=22 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Inspiratory capacity abnormal | 18 | 2,748.9 1,269.1–5,953.9ROR 2,752.5 · χ² 16,690 / p <1e-300 | 479.4 EB05 320.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Total lung capacity increased | 168 | 2,515.3 1,967.9–3,215.1ROR 2,546.9 · χ² 158,564 / p <1e-300 | 857.2 EB05 753.8 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=168 · ♀ 96% (drug 66%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 300 | 2,140.9 1,797.9–2,549.2ROR 2,189.3 · χ² 266,266 / p <1e-300 | 843.5 EB05 766.4 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=300 | not reported in cached trials |
| Congenital hiatus hernia | 122 | 1,920.7 1,472.0–2,506.3ROR 1,938.2 · χ² 102,834 / p <1e-300 | 750.3 EB05 645.1 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 0% (drug 66%) | not reported in cached trials |
| Central nervous system mass | 51 | 1,899.6 1,259.7–2,864.6ROR 1,906.8 · χ² 42,287 / p <1e-300 | 641.8 EB05 507.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 0% (drug 66%) | not reported in cached trials |
| Spirometry abnormal | 317 | 1,840.7 1,564.5–2,165.7ROR 1,884.8 · χ² 263,475 / p <1e-300 | 794.8 EB05 724.1 · IC025 +8.3 3/3 methods agree | Lab value / disease marker | serious n=317 · ♀ 8% (drug 66%) | not reported in cached trials |
| Mite allergy | 307 | 1,451.5 1,242.7–1,695.4ROR 1,485.2 · χ² 227,413 / p <1e-300 | 711.4 EB05 647.1 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=307 · ♀ 5% (drug 66%) | not reported in cached trials |
| Hyper ige syndrome | 55 | 1,448.2 1,001.8–2,093.4ROR 1,454.1 · χ² 40,086 / p <1e-300 | 590.1 EB05 470.5 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=55 · ♀ 100% (drug 66%) | not reported in cached trials |
| Wall motion score index abnormal | 51 | 1,342.8 922.1–1,955.5ROR 1,347.9 · χ² 35,676 / p <1e-300 | 563.1 EB05 444.9 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 0% (drug 66%) | not reported in cached trials |
| Lung diffusion test abnormal | 43 | 1,287.6 858.4–1,931.3ROR 1,291.7 · χ² 29,298 / p <1e-300 | 532.5 EB05 411.8 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=43 · ♀ 100% (drug 66%) | not reported in cached trials |
| Muscle tension dysphonia | 30 | 954.5 605.0–1,505.7ROR 956.6 · χ² 17,002 / p <1e-300 | 427.1 EB05 313.6 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=30 | not reported in cached trials |
| Bronchial neoplasm | 50 | 898.3 633.7–1,273.4ROR 901.6 · χ² 27,655 / p <1e-300 | 464.8 EB05 366.4 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=50 · ♀ 100% (drug 66%) | not reported in cached trials |
| Mycotic allergy | 300 | 861.2 748.3–991.1ROR 880.7 · χ² 164,270 / p <1e-300 | 532.2 EB05 483.5 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=300 · ♀ 3% (drug 66%) | not reported in cached trials |
| Forced expiratory volume | 12 | 796.8 396.6–1,600.9ROR 797.5 · χ² 5,755 / p <1e-300 | 285.6 EB05 174.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Dust allergy | 316 | 758.8 663.7–867.4ROR 776.9 · χ² 159,263 / p <1e-300 | 492.1 EB05 448.2 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious n=316 · ♀ 4% (drug 66%) | not reported in cached trials |
| Tympanosclerosis | 15 | 673.7 367.1–1,236.6ROR 674.5 · χ² 6,532 / p <1e-300 | 293.1 EB05 188.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Pulmonary vasculitis | 153 | 633.2 524.8–764.0ROR 640.4 · χ² 67,824 / p <1e-300 | 424.1 EB05 370.6 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=153 · ♀ 0% (drug 66%) | not reported in cached trials |
| Total lung capacity abnormal | 109 | 623.4 499.3–778.5ROR 628.5 · χ² 47,660 / p <1e-300 | 410.9 EB05 350.2 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=109 · ♀ 0% (drug 66%) | not reported in cached trials |
| Capillaritis | 63 | 476.3 359.1–631.7ROR 478.5 · χ² 22,416 / p <1e-300 | 327.2 EB05 264.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 0% (drug 66%) | not reported in cached trials |
| Atopy | 63 | 453.8 342.7–600.9ROR 455.9 · χ² 21,596 / p <1e-300 | 316.4 EB05 256.1 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 0% (drug 66%) | not reported in cached trials |
| Conjunctivitis allergic | 318 | 431.3 381.3–487.9ROR 441.6 · χ² 106,124 / p <1e-300 | 329.8 EB05 300.5 · IC025 +7.6 3/3 methods agree | Labeled (related wording) related wording | serious n=317 · ♀ 4% (drug 66%) | not reported in cached trials |
| Fev1/fvc ratio decreased | 26 | 426.9 276.5–659.3ROR 427.8 · χ² 8,305 / p <1e-300 | 268.1 EB05 192.3 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bronchial wall thickening | 151 | 408.1 341.3–488.0ROR 412.7 · χ² 48,075 / p <1e-300 | 309.6 EB05 270.3 · IC025 +7.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=151 | not reported in cached trials |
| Laryngeal dyskinesia | 23 | 394.7 249.6–624.0ROR 395.3 · χ² 6,867 / p <1e-300 | 249.0 EB05 174.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 66%) · 100% consumer | not reported in cached trials |
| Forced expiratory flow decreased | 19 | 376.8 228.1–622.4ROR 377.4 · χ² 5,415 / p <1e-300 | 232.1 EB05 157.0 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=19 | not reported in cached trials |
| Eosinophil count | 22 | 369.2 231.8–588.0ROR 369.8 · χ² 6,212 / p <1e-300 | 236.5 EB05 164.7 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · ♀ 0% (drug 66%) | not reported in cached trials |
| Eosinophilic pneumonia chronic | 55 | 347.1 259.1–464.9ROR 348.5 · χ² 15,184 / p <1e-300 | 257.7 EB05 205.4 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=55 | not reported in cached trials |
| Forced expiratory volume decreased | 496 | 328.8 298.8–361.7ROR 341.2 · χ² 133,113 / p <1e-300 | 267.9 EB05 248.7 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=494 | not reported in cached trials |
| Reversible airways obstruction | 88 | 320.0 254.4–402.4ROR 322.1 · χ² 22,872 / p <1e-300 | 250.3 EB05 209.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 94% (drug 66%) | not reported in cached trials |
| Rib deformity | 43 | 312.7 225.3–433.9ROR 313.7 · χ² 10,832 / p <1e-300 | 232.9 EB05 180.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 66%) | not reported in cached trials |
| Cryopyrin associated periodic syndrome | 32 | 305.4 209.0–446.3ROR 306.2 · χ² 7,840 / p <1e-300 | 221.2 EB05 164.0 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=32 · ♀ 100% (drug 66%) | not reported in cached trials |
| Obstructive airways disorder | 1,818 | 301.8 287.9–316.5ROR 348.5 · χ² 455,150 / p <1e-300 | 251.5 EB05 242.0 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 166.8 | not reported in cached trials |
| Eosinophilic bronchitis | 33 | 301.8 207.8–438.2ROR 302.5 · χ² 8,011 / p <1e-300 | 220.1 EB05 164.0 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=33 | not reported in cached trials |
| Bronchial haemorrhage | 51 | 299.6 222.0–404.2ROR 300.7 · χ² 12,439 / p <1e-300 | 229.1 EB05 181.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 · ♀ 100% (drug 66%) | not reported in cached trials |
| Eosinophil count abnormal | 114 | 279.9 229.4–341.5ROR 282.3 · χ² 26,539 / p <1e-300 | 227.7 EB05 194.7 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=114 | not reported in cached trials |
| Blood immunoglobulin e decreased | 23 | 268.1 172.2–417.5ROR 268.6 · χ² 4,982 / p <1e-300 | 192.0 EB05 134.8 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=23 · ♀ 100% (drug 66%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ciclesonide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00404547 — Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102) (N=1121, PHASE4; 8 AE terms posted; arms: Alvesco; Usual Asthma Care and Dosage)
- NCT00953147 — A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Pere (N=1110, PHASE3; 46 AE terms posted; arms: Ciclesonide HFA 80 Mcg Once Daily; Ciclesonide HFA 160 Mcg Once Daily; Placebo Once Daily)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 5,858 | 85.4 83.7–87.1ROR 149.7 · χ² 465,115 / p <1e-300 | 80.9 EB05 79.2 · IC025 +6.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 71.6 | NCT00404547: 1/741 (0.1%) on Ciclesonide (serious AE) |
| Dyspnoea (shortness of breath) | 4,621 | 12.7 12.5–13.1ROR 18.8 · χ² 50,985 / p <1e-300 | 12.7 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | not reported in cached trials |
| Wheezing | 3,710 | 103.6 100.7–106.6ROR 142.4 · χ² 354,022 / p <1e-300 | 97.1 EB05 94.5 · IC025 +6.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 84.7 | not reported in cached trials |
| Therapeutic product effect incomplete | 2,598 | 59.1 57.0–61.2ROR 72.8 · χ² 143,179 / p <1e-300 | 56.9 EB05 55.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 68.0 | not reported in cached trials |
| Cough | 2,578 | 14.4 13.9–14.9ROR 17.5 · χ² 32,246 / p <1e-300 | 14.3 EB05 13.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.7 | NCT00953147: 19/475 (4.0%) on Ciclesonide; 8/243 (3.3%) control |
| Obstructive airways disorder | 1,818 | 301.8 287.9–316.5ROR 348.5 · χ² 455,150 / p <1e-300 | 251.5 EB05 242.0 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious PRR 166.8 | not reported in cached trials |
| Loss of personal independence in daily activities | 1,783 | 60.3 57.7–63.0ROR 69.3 · χ² 100,219 / p <1e-300 | 58.0 EB05 55.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.6 | not reported in cached trials |
| Pneumonia (lung infection) | 1,772 | 8.5 8.2–8.9ROR 9.7 · χ² 11,891 / p <1e-300 | 8.5 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | NCT00953147: 1/298 (0.3%) on Ciclesonide (serious AE) |
| Drug ineffective (drug did not work) | 1,554 | 1.8 1.7–1.9ROR 1.9 · χ² 621 / p 2e-137 | 1.8 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.1 | not reported in cached trials |
| Productive cough (cough with phlegm) | 1,518 | 51.3 48.9–53.8ROR 57.6 · χ² 72,537 / p <1e-300 | 49.6 EB05 47.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 46.7 | not reported in cached trials |
| Sleep disorder due to a general medical condition | 1,486 | 156.8 149.0–164.9ROR 176.0 · χ² 208,627 / p <1e-300 | 142.0 EB05 136.1 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious PRR 179.2 | not reported in cached trials |
| Fatigue (tiredness) | 1,293 | 2.6 2.4–2.7ROR 2.7 · χ² 1,296 / p 5e-284 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | not reported in cached trials |
| Chest discomfort | 1,207 | 18.5 17.6–19.6ROR 20.3 · χ² 19,864 / p <1e-300 | 18.3 EB05 17.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.1 | not reported in cached trials |
| Malaise (feeling unwell) | 1,150 | 4.1 3.8–4.3ROR 4.3 · χ² 2,698 / p <1e-300 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | not reported in cached trials |
| Condition aggravated | 1,080 | 5.6 5.2–5.9ROR 5.9 · χ² 4,073 / p <1e-300 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | not reported in cached trials |
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.
- Plethysmography — n=25, PRR 38,178.8
- Cftr gene mutation — n=20, PRR 7,635.8
- Airway remodelling — n=96, PRR 5,429.9
- Total lung capacity increased — n=168, PRR 2,515.3
- Asthma-chronic obstructive pulmonary disease overlap syndrome — n=300, PRR 2,140.9
- Congenital hiatus hernia — n=122, PRR 1,920.7
- Central nervous system mass — n=51, PRR 1,899.6
- Mite allergy — n=307, PRR 1,451.5
- Mycotic allergy — n=300, PRR 861.2
- Dust allergy — n=316, PRR 758.8
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 Ciclesonide?
In FDA FAERS, the most frequently co-reported reaction terms for Ciclesonide are asthma, dyspnoea, wheezing, cough, obstructive airways disorder, loss of personal independence in daily activities. 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 Ciclesonide have an FDA boxed warning?
No. The FDA label retrieved for Ciclesonide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ciclesonide 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 9f6112fb-78ef-43cf-8ae3-36370eb45468, effective 20250228; matched on
openfda.generic_name.exact:"CICLESONIDE") - 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, 1,165 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 - ClinicalTrials.gov API v2 (query
CICLESONIDE, results-bearing studies sorted by enrollment)
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.