Flunisolide side effects: what 1,488 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,488 reports · 71% serious · 100 with death outcome · 31% female
Used for
Flunisolide nasal solution is indicated for the treatment of the nasal symptoms of seasonal or perennial rhinitis. Flunisolide nasal solution should not be used in the presence of untreated localized infection involving nasal mucosa.
What it is
DESCRIPTION Flunisolide Nasal Solution USP, 0.025% is intended for administration as a spray to the nasal mucosa. Flunisolide, the active component of flunisolide nasal solution, is an anti-inflammatory steroid. Flunisolide is represented by the following structural formula: C 24 H 31 FO 6 Mol. Wt. 434.51
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
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.
- 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. 39 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Economic problem | 31 | 28.4 20.0–40.2ROR 29.0 · χ² 791 / p 2e-174 | 27.9 EB05 20.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 23.6 · ♀ 10% (drug 31%) | no trial data cached |
| Anorexia | 18 | 19.4 12.3–30.8ROR 19.7 · χ² 296 / p 1e-66 | 18.9 EB05 12.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Anhedonia | 31 | 16.5 11.7–23.4ROR 16.8 · χ² 436 / p 3e-97 | 16.2 EB05 11.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| End stage renal disease | 21 | 16.1 10.5–24.6ROR 16.3 · χ² 282 / p 1e-63 | 15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Osteopenia | 17 | 15.7 9.8–25.2ROR 15.9 · χ² 220 / p 5e-50 | 15.0 EB05 9.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | no trial data cached |
| Atelectasis | 10 | 14.5 7.8–27.0ROR 14.6 · χ² 113 / p 1e-26 | 12.8 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Impaired gastric emptying | 13 | 14.4 8.4–24.7ROR 14.5 · χ² 149 / p 2e-34 | 13.2 EB05 7.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Hyperlipidaemia | 12 | 14.1 8.0–24.8ROR 14.2 · χ² 133 / p 4e-31 | 12.7 EB05 6.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Chronic kidney disease | 70 | 12.9 10.2–16.2ROR 13.5 · χ² 757 / p 5e-167 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Sleep apnoea syndrome | 16 | 11.8 7.2–19.2ROR 11.9 · χ² 148 / p 3e-34 | 10.6 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| International normalised ratio increased | 24 | 11.8 7.9–17.5ROR 11.9 · χ² 226 / p 3e-51 | 11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 10.7 · ♀ 0% (drug 31%) · 91% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 14 | 11.7 6.9–19.7ROR 11.8 · χ² 126 / p 1e-29 | 10.3 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Acute myocardial infarction | 23 | 11.0 7.3–16.4ROR 11.1 · χ² 198 / p 2e-45 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 4% (drug 31%) | no trial data cached |
| Renal injury | 23 | 10.8 7.2–16.2ROR 11.0 · χ² 195 / p 1e-44 | 10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 9% (drug 31%) | no trial data cached |
| Drug toxicity | 10 | 10.2 5.5–18.9ROR 10.3 · χ² 74 / p 4e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Tubulointerstitial nephritis | 13 | 9.8 5.7–16.8ROR 9.9 · χ² 94 / p 2e-22 | 8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Blood sodium decreased | 12 | 9.0 5.1–15.8ROR 9.1 · χ² 78 / p 7e-19 | 7.3 EB05 4.2 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Mental status changes | 15 | 7.6 4.6–12.6ROR 7.7 · χ² 80 / p 2e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Throat irritation | 23 | 7.3 4.8–10.9ROR 7.4 · χ² 118 / p 9e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | no trial data cached |
| Renal failure acute | 22 | 7.2 4.8–10.9ROR 7.3 · χ² 112 / p 2e-26 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 9% (drug 31%) | no trial data cached |
| Chronic obstructive pulmonary disease | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 117 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Bone density decreased | 14 | 6.2 3.7–10.5ROR 6.3 · χ² 56 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Epistaxis (nosebleed) | 32 | 6.0 4.3–8.5ROR 6.1 · χ² 129 / p 3e-30 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Coronary artery disease | 13 | 6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Nightmare | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 8e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Emotional distress | 43 | 5.0 3.7–6.7ROR 5.1 · χ² 134 / p 3e-31 | 4.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 kidney disease | 70 | 12.9 10.2–16.2ROR 13.5 · χ² 757 / p 5e-167 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Emotional distress | 43 | 5.0 3.7–6.7ROR 5.1 · χ² 134 / p 3e-31 | 4.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Epistaxis (nosebleed) | 32 | 6.0 4.3–8.5ROR 6.1 · χ² 129 / p 3e-30 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Anhedonia | 31 | 16.5 11.7–23.4ROR 16.8 · χ² 436 / p 3e-97 | 16.2 EB05 11.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| Economic problem | 31 | 28.4 20.0–40.2ROR 29.0 · χ² 791 / p 2e-174 | 27.9 EB05 20.6 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 23.6 · ♀ 10% (drug 31%) | no trial data cached |
| Chronic obstructive pulmonary disease | 25 | 6.8 4.6–10.0ROR 6.9 · χ² 117 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| International normalised ratio increased | 24 | 11.8 7.9–17.5ROR 11.9 · χ² 226 / p 3e-51 | 11.0 EB05 7.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 10.7 · ♀ 0% (drug 31%) · 91% clinician | no trial data cached |
| Throat irritation | 23 | 7.3 4.8–10.9ROR 7.4 · χ² 118 / p 9e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | no trial data cached |
| Renal injury | 23 | 10.8 7.2–16.2ROR 11.0 · χ² 195 / p 1e-44 | 10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 9% (drug 31%) | no trial data cached |
| Acute myocardial infarction | 23 | 11.0 7.3–16.4ROR 11.1 · χ² 198 / p 2e-45 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 4% (drug 31%) | no trial data cached |
| Renal failure acute | 22 | 7.2 4.8–10.9ROR 7.3 · χ² 112 / p 2e-26 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 9% (drug 31%) | no trial data cached |
| End stage renal disease | 21 | 16.1 10.5–24.6ROR 16.3 · χ² 282 / p 1e-63 | 15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Anorexia | 18 | 19.4 12.3–30.8ROR 19.7 · χ² 296 / p 1e-66 | 18.9 EB05 12.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 | no trial data cached |
| Osteopenia | 17 | 15.7 9.8–25.2ROR 15.9 · χ² 220 / p 5e-50 | 15.0 EB05 9.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | no trial data cached |
| Sleep apnoea syndrome | 16 | 11.8 7.2–19.2ROR 11.9 · χ² 148 / p 3e-34 | 10.6 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | 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.
- Anhedonia — n=31, PRR 16.5
- End stage renal disease — n=21, PRR 16.1
- Chronic kidney disease — n=70, PRR 12.9
- Acute myocardial infarction — n=23, PRR 11.0
- Renal injury — n=23, PRR 10.8
- Renal failure acute — n=22, PRR 7.2
- Chronic obstructive pulmonary disease — n=25, PRR 6.8
- Emotional distress — n=43, PRR 5.0
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 Flunisolide?
In FDA FAERS, the most frequently co-reported reaction terms for Flunisolide are chronic kidney disease, emotional distress, epistaxis, anhedonia, chronic obstructive pulmonary disease, international normalised ratio increased. 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 Flunisolide have an FDA boxed warning?
No. The FDA label retrieved for Flunisolide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Flunisolide 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 f39cae46-c68f-47ef-82f3-4fd3dd46c74c, effective 20250430; matched on
openfda.generic_name.exact:"FLUNISOLIDE") - 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, 65 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.