Aclidinium: uses, dosing, side effects & brands
Aclidinium is an anticholinergic sold in the U.S. under one brand, for bronchial spasm and chronic obstructive pulmonary disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anticholinergic
- Treats
- Bronchial Spasm and Chronic Obstructive Pulmonary Disease
- Available as
- Powder, metered
- Sold as
- Tudorza Pressair
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How aclidinium is dosed
From the FDA label for Tudorza Pressair (application NDA202450). Other aclidinium products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily (morning and evening approximately 12 hours apart). For oral inhalation only • One inhalation of TUDORZA PRESSAIR 400 mcg twice daily. (2)
Aclidinium side effects
The 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. The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV 1 ) percent…
Who shouldn’t take aclidinium
The use of TUDORZA PRESSAIR is contraindicated in the following conditions: • Severe hypersensitivity to milk proteins [see Warnings and Precautions (5.5) ] • Hypersensitivity to aclidinium bromide or any of the excipients [see Warnings and Precautions (5.5) ] • Severe hypersensitivity to milk proteins. (4) • Hypersensitivity to any ingredient. (4)
Aclidinium drug interactions
In vitro studies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with TUDORZA PRESSAIR [see Clinical Pharmacology (12.3) ] . Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of TUDORZA PRESSAIR with other anticholinergic-containing drugs. ( 7.2 ) 7.1 Sympathomimetics, Methylxanthines, Steroids In clinical studies, concurrent administration of aclidinium bromide and other drugs commonly used in the treatment of COPD including sympathomimetics (short-acting beta 2 agonists), methylxanthines, and oral and inhaled steroids showed no increases in adverse drug reactions. 7.2 Anticholinergics There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of TUDORZA PRESSAIR with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.
Every aclidinium product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Tudorza Pressair.
Combination products containing aclidinium
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Aclidinium and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for aclidinium: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAlthough no published data exist on the use of aclidinium during breastfeeding, it produces low maternal serum levels because of rapid hydrolysis to inactive metabolites. The risk to the breastfed infant of maternal aclidinium inhalation is small. Breastfeeding can be continued during aclidinium therapy.
National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about aclidinium
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,445 reports naming aclidinium, and the FDA flagged 91% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea831 reports
- asthma713 reports
- wheezing617 reports
- obstructive airways disorder464 reports
- pneumonia464 reports
- chronic obstructive pulmonary disease449 reports
- cough440 reports
- bronchiectasis390 reports
Read these as a signal, not a rate. A report does not mean aclidinium caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is aclidinium?
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.
What kind of drug is aclidinium?
The FDA classifies aclidinium as an anticholinergic. Anticholinergic drugs block acetylcholine, the chemical messenger of the body's "rest and digest" nervous system, by occupying its muscarinic receptors. This eases muscle spasms, dries up secretions, relaxes the bladder and airways, and speeds the heart, depending on the tissue. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take aclidinium with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run aclidinium against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does aclidinium come in?
Across the brands we track, aclidinium is currently marketed as powder, metered, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic aclidinium?
We do not currently list a generic-labelled aclidinium product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Aclidinium: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/aclidinium
- MLA
- “Aclidinium: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/aclidinium.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for aclidinium on DailyMed (NIH) ↗.