What the label lists and what reports show
Aclidinium side effects
Aclidinium's FDA label: “Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.” FAERS holds 6,373 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 (1,875 reports).
- No generic listed
Check it at the source: the aclidinium FDA label on DailyMed (effective August 1, 2022, 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 TUDORZA PRESSAIR?TUDORZA PRESSAIR can cause serious side effects including: • sudden breathing problems immediately after use of TUDORZA PRESSAIR. If you have sudden breathing problems immediately after inhaling TUDORZA PRESSAIR, stop using TUDORZA PRESSAIR and call your doctor right away or go to the nearest hospital emergency room. • new or worsened increased pressure in your eyes (acute narrow-angle glaucoma). Acute narrow-angle glaucoma can lead to permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: • eye pain or discomfort • nausea or vomiting • seeing halos or bright colors around lights • blurred vision • red eyes Using only eyedrops that are used to treat glaucoma is not effective in treating acute narrow-angle glaucoma that can happen with TUDORZA PRESSAIR. […]
Source: FDA drug label, NDA202450 (Azurity), as published by Covis Pharma US, Inc, effective August 1, 2022 (SPL set 6f92cceb-a63f-4470-99b6-56179d98f10f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough.
Table 1: Adverse Reactions (% Patients) in Placebo-Controlled Clinical Trials
| Adverse Reactions Preferred Term | TUDORZA PRESSAIR (N=636) n (%) | Placebo (N=640) n (%) |
|---|---|---|
| Headache | 42 (6.6) | 32 (5.0) |
| Nasopharyngitis | 35 (5.5) | 25 (3.9) |
| Cough | 19 (3.0) | 14 (2.2) |
| Diarrhea | 17 (2.7) | 9 (1.4) |
| Sinusitis | 11 (1.7) | 5 (0.8) |
| Rhinitis | 10 (1.6) | 8 (1.2) |
| Toothache | 7 (1.1) | 5 (0.8) |
| Fall | 7 (1.1) | 3 (0.5) |
| Vomiting | 7 (1.1) | 3 (0.5) |
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 adverse reactions are described in greater detail in other sections: • Paradoxical bronchospasm [see Warnings and Precautions (5.2) ] • Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.3) ] • Worsening of urinary retention [see Warnings and Precautions (5.4) ] • Immediate hypersensitivity reactions [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough. (6.1) 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 Trials Experience 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. 3-Month and 6-Month Trials TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily. …
Source: FDA drug label, NDA202450 (Azurity), as published by Covis Pharma US, Inc, effective August 1, 2022 (SPL set 6f92cceb-a63f-4470-99b6-56179d98f10f), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,373 reports list aclidinium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 288 are coded as a death and 1,892 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 16 reactions below, 2 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?
- Aclidinium: 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