Drug · FAERS side-effect profile with label screen
Aclidinium side effects: what 6,373 FDA adverse event reports show
Drug class
Anticholinergic
FDA label, Indications wording of the closest related product
Label matched
Aclidinium Bromide (Tudorza Pressair)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,373 reports · 56% serious · 288 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)
FDA label, Indications and Usage
What it is
TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only. Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors.
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) 1Likely indication confounding 2Reporting / coding artifact 9Lab value / disease marker 4Not in label — unassessed 24
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. 373 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 |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 451 | 138.6 126.5–151.8ROR 149.0 · χ² 58,971 / p <1e-300 | 132.2 EB05 122.3 · IC025 +6.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 142.5 | no trial data cached |
| Full blood count abnormal | 221 | 70.4 61.8–80.3ROR 72.9 · χ² 14,745 / p <1e-300 | 68.6 EB05 61.3 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious PRR 94.8 | no trial data cached |
| Device failure | 296 | 65.5 58.5–73.3ROR 68.6 · χ² 18,369 / p <1e-300 | 63.9 EB05 58.1 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 34.4 · 85% consumer | no trial data cached |
| Device malfunction | 1,282 | 64.0 60.9–67.2ROR 79.9 · χ² 78,143 / p <1e-300 | 62.7 EB05 59.9 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 97.4 · 88% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 784 | 50.2 47.0–53.7ROR 57.1 · χ² 37,292 / p <1e-300 | 49.4 EB05 46.6 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 47.2 | no trial data cached |
| Sputum discoloured | 140 | 49.5 41.9–58.3ROR 50.5 · χ² 6,502 / p <1e-300 | 48.4 EB05 42.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 66.1 · ♀ 87% (drug 64%) | no trial data cached |
| Body height decreased | 150 | 46.3 39.5–54.3ROR 47.4 · χ² 6,511 / p <1e-300 | 45.4 EB05 39.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=63 · 98% consumer | no trial data cached |
| Wheezing | 665 | 37.4 34.8–40.2ROR 41.6 · χ² 23,319 / p <1e-300 | 36.9 EB05 34.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.7 | no trial data cached |
| Emphysema | 109 | 35.8 29.7–43.2ROR 36.4 · χ² 3,615 / p <1e-300 | 35.2 EB05 30.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.4 | no trial data cached |
| Sleep disorder due to a general medical condition | 165 | 33.9 29.1–39.5ROR 34.8 · χ² 5,187 / p <1e-300 | 33.5 EB05 29.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 68.8 | no trial data cached |
| Hypercholesterolaemia | 96 | 33.3 27.3–40.7ROR 33.8 · χ² 2,950 / p <1e-300 | 32.8 EB05 27.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 36.3 · ♀ 18% (drug 64%) | no trial data cached |
| Blood iron decreased | 113 | 31.8 26.5–38.2ROR 32.4 · χ² 3,313 / p <1e-300 | 31.4 EB05 26.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 44.5 · ♀ 96% (drug 64%) | no trial data cached |
| Intentional product misuse | 741 | 28.3 26.4–30.3ROR 31.9 · χ² 19,403 / p <1e-300 | 28.1 EB05 26.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 91% consumer | no trial data cached |
| Schizophrenia | 96 | 26.2 21.4–31.9ROR 26.6 · χ² 2,282 / p <1e-300 | 25.9 EB05 21.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 100% (drug 64%) · 95% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 364 | 25.5 23.1–28.2ROR 27.0 · χ² 8,493 / p <1e-300 | 25.3 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 | no trial data cached |
| Joint injury | 158 | 24.5 21.0–28.6ROR 25.1 · χ² 3,513 / p <1e-300 | 24.2 EB05 21.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.2 | no trial data cached |
| Micturition urgency | 83 | 24.3 19.6–30.1ROR 24.6 · χ² 1,815 / p <1e-300 | 24.0 EB05 19.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 40.3 · ♀ 5% (drug 64%) | no trial data cached |
| Asthma | 820 | 24.2 22.7–25.8ROR 27.7 · χ² 18,210 / p <1e-300 | 24.1 EB05 22.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Sinus disorder | 139 | 23.2 19.7–27.4ROR 23.7 · χ² 2,915 / p <1e-300 | 23.0 EB05 20.0 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 49.3 · ♀ 90% (drug 64%) | no trial data cached |
| Skin laceration | 73 | 22.4 17.8–28.1ROR 22.6 · χ² 1,461 / p <1e-300 | 22.1 EB05 18.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 33.4 · ♀ 94% (drug 64%) | no trial data cached |
| Loss of personal independence in daily activities | 304 | 21.2 19.0–23.6ROR 22.2 · χ² 5,795 / p <1e-300 | 21.0 EB05 19.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Dyspnoea exertional | 239 | 21.1 18.6–23.9ROR 21.9 · χ² 4,530 / p <1e-300 | 20.9 EB05 18.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.6 | no trial data cached |
| Product taste abnormal | 82 | 20.2 16.3–25.0ROR 20.4 · χ² 1,467 / p <1e-300 | 20.0 EB05 16.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=25 · 100% consumer | no trial data cached |
| Drug dose omission | 1,017 | 20.1 19.0–21.2ROR 23.7 · χ² 18,446 / p <1e-300 | 19.9 EB05 18.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 26.4 · 86% consumer | no trial data cached |
| Body temperature increased | 115 | 18.6 15.5–22.3ROR 18.9 · χ² 1,887 / p <1e-300 | 18.4 EB05 15.8 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 23.2 · ♀ 95% (drug 64%) | no trial data cached |
| Circumstance or information capable of leading to medication error | 186 | 18.3 15.9–21.1ROR 18.9 · χ² 3,019 / p <1e-300 | 18.2 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=60 · 86% consumer | no trial data cached |
| Device issue | 475 | 18.0 16.5–19.6ROR 19.4 · χ² 7,601 / p <1e-300 | 17.9 EB05 16.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 · 88% consumer | no trial data cached |
| Coronary artery disease | 157 | 17.0 14.6–19.9ROR 17.4 · χ² 2,341 / p <1e-300 | 16.9 EB05 14.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 43% (drug 64%) | no trial data cached |
| Lower respiratory tract infection | 232 | 16.9 14.9–19.2ROR 17.5 · χ² 3,450 / p <1e-300 | 16.8 EB05 15.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 | no trial data cached |
| Hypokinesia | 72 | 16.4 13.0–20.6ROR 16.6 · χ² 1,020 / p 4e-224 | 16.2 EB05 13.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · ♀ 92% (drug 64%) | no trial data cached |
| Therapeutic product effect incomplete | 340 | 15.9 14.3–17.6ROR 16.7 · χ² 4,723 / p <1e-300 | 15.8 EB05 14.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 30.8 | no trial data cached |
| Blood pressure systolic increased | 94 | 15.9 13.0–19.4ROR 16.1 · χ² 1,289 / p 2e-282 | 15.7 EB05 13.2 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 17.8 · ♀ 87% (drug 64%) | no trial data cached |
| Pulmonary mass | 71 | 15.8 12.5–19.9ROR 15.9 · χ² 964 / p 6e-212 | 15.6 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Sleep apnoea syndrome | 90 | 15.6 12.7–19.1ROR 15.8 · χ² 1,206 / p 1e-264 | 15.4 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 | no trial data cached |
| Hypoaesthesia oral | 70 | 15.4 12.2–19.4ROR 15.5 · χ² 922 / p 9e-203 | 15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 · ♀ 93% (drug 64%) | no trial data cached |
| Lung neoplasm malignant | 190 | 15.2 13.2–17.5ROR 15.6 · χ² 2,499 / p <1e-300 | 15.1 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 89% (drug 64%) | no trial data cached |
| Blood test abnormal | 63 | 14.8 11.6–19.0ROR 15.0 · χ² 795 / p 3e-175 | 14.6 EB05 11.8 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 23.4 · ♀ 98% (drug 64%) | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 358 | 14.8 13.3–16.3ROR 15.6 · χ² 4,572 / p <1e-300 | 14.7 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 | no trial data cached |
| Product quality issue | 592 | 14.5 13.4–15.7ROR 15.9 · χ² 7,448 / p <1e-300 | 14.4 EB05 13.5 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 · 83% consumer | no trial data cached |
| Oral candidiasis (oral thrush) | 57 | 14.5 11.2–18.8ROR 14.6 · χ² 699 / p 3e-154 | 14.3 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | 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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 1,875 | 10.9 10.5–11.4ROR 15.1 · χ² 17,337 / p <1e-300 | 10.9 EB05 10.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Device malfunction | 1,282 | 64.0 60.9–67.2ROR 79.9 · χ² 78,143 / p <1e-300 | 62.7 EB05 59.9 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious PRR 97.4 · 88% consumer | no trial data cached |
| Drug dose omission | 1,017 | 20.1 19.0–21.2ROR 23.7 · χ² 18,446 / p <1e-300 | 19.9 EB05 18.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 26.4 · 86% consumer | no trial data cached |
| Asthma | 820 | 24.2 22.7–25.8ROR 27.7 · χ² 18,210 / p <1e-300 | 24.1 EB05 22.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Chronic obstructive pulmonary disease | 784 | 50.2 47.0–53.7ROR 57.1 · χ² 37,292 / p <1e-300 | 49.4 EB05 46.6 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 47.2 | no trial data cached |
| Intentional product misuse | 741 | 28.3 26.4–30.3ROR 31.9 · χ² 19,403 / p <1e-300 | 28.1 EB05 26.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 91% consumer | no trial data cached |
| Off label use (used outside approved label) | 720 | 2.7 2.5–2.9ROR 3.0 · χ² 822 / p 5e-181 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Pneumonia (lung infection) | 710 | 7.2 6.8–7.8ROR 8.0 · χ² 3,864 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Wheezing | 665 | 37.4 34.8–40.2ROR 41.6 · χ² 23,319 / p <1e-300 | 36.9 EB05 34.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 47.7 | no trial data cached |
| Cough | 657 | 7.7 7.2–8.3ROR 8.5 · χ² 3,894 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 | no trial data cached |
| Product quality issue | 592 | 14.5 13.4–15.7ROR 15.9 · χ² 7,448 / p <1e-300 | 14.4 EB05 13.5 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.9 · 83% consumer | no trial data cached |
| Device issue | 475 | 18.0 16.5–19.6ROR 19.4 · χ² 7,601 / p <1e-300 | 17.9 EB05 16.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 · 88% consumer | no trial data cached |
| Obstructive airways disorder | 451 | 138.6 126.5–151.8ROR 149.0 · χ² 58,971 / p <1e-300 | 132.2 EB05 122.3 · IC025 +6.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 142.5 | no trial data cached |
| Malaise (feeling unwell) | 391 | 2.9 2.7–3.2ROR 3.1 · χ² 505 / p 4e-112 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Productive cough (cough with phlegm) | 364 | 25.5 23.1–28.2ROR 27.0 · χ² 8,493 / p <1e-300 | 25.3 EB05 23.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.9 | 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.
- Sputum discoloured — n=140, PRR 49.5
- Body height decreased — n=150, PRR 46.3
- Wheezing — n=665, PRR 37.4
- Emphysema — n=109, PRR 35.8
- Sleep disorder due to a general medical condition — n=165, PRR 33.9
- Hypercholesterolaemia — n=96, PRR 33.3
- Schizophrenia — n=96, PRR 26.2
- Productive cough — n=364, PRR 25.5
- Joint injury — n=158, PRR 24.5
- Micturition urgency — n=83, PRR 24.3
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 Aclidinium?
In FDA FAERS, the most frequently co-reported reaction terms for Aclidinium are dyspnoea, asthma, chronic obstructive pulmonary disease, pneumonia, wheezing, cough. 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 Aclidinium have an FDA boxed warning?
No. The FDA label retrieved for Aclidinium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aclidinium 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 6f92cceb-a63f-4470-99b6-56179d98f10f, effective 20220801; matched on
openfda.generic_name.exact:"ACLIDINIUM BROMIDE") - 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, 413 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.