Aclidinium Oral Inhalation
Aclidinium is a long-acting anticholinergic bronchodilator used as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Aclidinium Oral Inhalation: Patient Information Guide
A plain-language walkthrough of Aclidinium Oral Inhalation — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Aclidinium inhalation powder is approved for the ongoing daily management of COPD in adults.
- Tudorza Pressair (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of COPD — it helps keep the airways open day to day.
- Tudorza Pressair is not a rescue inhaler — it does not treat sudden COPD flares or acute bronchospasm (sudden airway tightening).
⚙️How it works▾
Aclidinium is a long-acting anticholinergic — it works by blocking M3 muscarinic receptors on the smooth muscle surrounding the airways. When those receptors are blocked, the airways relax and open up, making it easier to breathe. This effect is largely site-specific, meaning it acts mainly in the lungs with very little drug reaching the rest of the body.
💊How it's taken▾
Tudorza Pressair is inhaled through the mouth twice a day — once in the morning and once in the evening, spaced about 12 hours apart. It is used with its own specially designed inhaler device. There are no food restrictions with this medication.
- Use it at the same times each day to keep it working consistently.
- If you miss a dose, take it as soon as you remember — but if it is almost time for your next dose, skip the missed one and continue your regular schedule.
- Always follow your prescriber's instructions and the device guide included in the package.
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Headache
- Nasopharyngitis (runny or stuffy nose, sore throat)
- Cough
- Diarrhea
- Sinusitis (sinus infection or congestion)
- Nausea or vomiting
- Dry mouth (reported at low frequency)
More serious reactions — including sudden worsening of breathing, eye pain or vision changes, trouble urinating, fast heartbeat, or signs of a severe allergic reaction (throat swelling, hives, difficulty breathing) — require immediate medical attention. Stop using the inhaler and call your doctor or emergency services right away if any of these occur.
⚠️Warnings & precautions▾
- Not a rescue inhaler: Tudorza Pressair is for daily maintenance only. It will not work fast enough to treat a sudden breathing attack. Always have a separate fast-acting rescue inhaler available.
- Paradoxical bronchospasm: In rare cases, inhaling this medication can actually cause sudden airway tightening. If your breathing gets worse right after using it, stop immediately and seek medical help.
- Narrow-angle glaucoma: This medication can worsen this eye condition. Watch for eye pain, blurred vision, or seeing halos around lights, and contact your doctor immediately if these develop.
- Urinary problems: Aclidinium can make it harder to urinate, especially in men with prostate enlargement or bladder obstruction. Tell your doctor right away if you notice difficulty or pain with urination.
- Serious allergic reactions: Anaphylaxis (a life-threatening allergic reaction), throat swelling, hives, and rash have been reported. Stop use and get emergency help if these occur.
🔀What it interacts with▾
Aclidinium has a low potential for drug interactions through liver enzymes, but there is one key interaction to be aware of:
- Other anticholinergic medications: Using aclidinium alongside other anticholinergic drugs can add up their effects and increase the risk of side effects like dry mouth, blurred vision, constipation, and urinary retention. Avoid combining them.
- Common COPD medications (short-acting beta-agonists, methylxanthines, inhaled or oral steroids): These did not show increased adverse effects when used together with aclidinium in clinical studies.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use if you are severely allergic to milk proteins, aclidinium bromide, or any other ingredient in Tudorza Pressair.
- Tell your doctor if you have narrow-angle glaucoma — aclidinium can worsen it.
- Tell your doctor if you have prostate enlargement, urinary retention, or bladder-neck obstruction — aclidinium can make urination more difficult.
- If you are pregnant or planning to become pregnant, talk to your doctor — there are no adequate human studies on safety in pregnancy.
- If you are breastfeeding, discuss with your doctor — it is not known whether aclidinium passes into human breast milk.
- Tudorza Pressair has not been studied in children — COPD does not normally occur in children.
- Older adults (including those 70 and older) can use aclidinium without dose changes; no significant safety or effectiveness differences were found in this age group.
- People with kidney impairment do not need a dose adjustment.
- The effects of liver impairment have not been formally studied, but because aclidinium breaks down mainly through hydrolysis (not liver enzymes), it is not expected to cause significant problems in people with liver disease.
🚑If you take too much▾
No overdose cases were reported in clinical studies with Tudorza Pressair. In a study of healthy volunteers, a single inhaled dose far exceeding the usual amount did not cause significant systemic anticholinergic effects. If you think you or someone else has used too much, contact Poison Control or seek medical attention right away.
📡Pharmacodynamics — effects in the body▾
In clinical studies, Tudorza Pressair did not significantly affect the heart's electrical activity (QT interval) or heart rhythm at the recommended dose or at higher doses, based on monitoring in both healthy volunteers and COPD patients. This suggests the medication's effects are largely confined to the airways rather than the heart and circulation.
🔬Pharmacokinetics — how your body processes it▾
After inhalation, aclidinium is absorbed quickly, with peak blood levels reached within about 10 minutes — but very little of the dose (about 6%) actually enters the bloodstream, because most of it acts directly in the lungs. The body breaks aclidinium down rapidly through a process called hydrolysis (chemical breakdown), turning it into inactive byproducts that leave the body mainly in the urine and, to a lesser extent, in feces. The effective half-life (how long it takes for half the drug to be cleared) is about 5 to 8 hours after inhalation, supporting twice-daily dosing.
📦How to store it▾
unit containing the drug-product formulation, and a mouthpiece covered by a green protective cap. Store TUDORZA PRESSAIR in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) . store the inhaler on a vibrating surface.
📄 Written from Aclidinium Oral Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Aclidinium Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tudorza Pressair supposed to do for my COPD? ▾
Can I use this if I'm having a sudden breathing attack? ▾
What side effects should I expect, and which ones mean I need to call my doctor? ▾
I take another inhaler for COPD. Is it safe to use both? ▾
I have prostate issues — is this inhaler safe for me? ▾
I'm pregnant — can I still use this inhaler? ▾
Is Aclidinium Oral Inhalation available over the counter? ▾
When was Aclidinium Oral Inhalation first available? ▾
Who makes Aclidinium Oral Inhalation? ▾
💬 Answers drafted from Aclidinium Oral Inhalation’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Aclidinium Oral Inhalation comes
Aclidinium Oral Inhalation is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Inhalation powder
How this form is used
- Tudorza Pressair is indicated for the maintenance treatment of COPD in adults
- Tudorza Pressair is not for use as a rescue treatment during acute COPD episodes
- Tudorza Pressair is inhaled through the mouth using the Pressair inhaler device twice daily — once in the morning and once in the evening, approximately 12 hours apart
- Tudorza Pressair is for oral inhalation only — do not swallow the powder
- Follow the step-by-step instructions provided with the Tudorza Pressair device to ensure a correct dose is delivered
- Do not use Tudorza Pressair with other anticholinergic inhalers at the same time
📊 Aclidinium Oral Inhalation across the U.S. market
How Aclidinium Oral Inhalation appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Aclidinium Oral Inhalation is used
A general measure of how commonly Aclidinium Oral Inhalation is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Aclidinium Oral Inhalation is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Aclidinium Oral Inhalation prescribed? Of the 1,597 medications we measure, Aclidinium Oral Inhalation ranks #1,184 by Medicaid prescriptions — more than 26% of them.
Utilization by Aclidinium Oral Inhalation product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
60 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1303102
30 ACTUAT aclidinium bromide 0.4 MG/ACTUAT Dry Powder Inhaler
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1607111
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Aclidinium Oral Inhalation, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 7 listed Aclidinium Oral Inhalation NDCs with Medicaid activity.
🔍 Compare Aclidinium Oral Inhalation products
A representative set of FDA-listed product records for Aclidinium Oral Inhalation — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhalation powder | ||||
| 400 mcg | Respiratory (inhalation) | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| 400 mcg | Respiratory (inhalation) | Circassia Pharmaceuticals Inc. | NDA | View NDC → |
| 400 mcg | Respiratory (inhalation) | Covis Pharma US, Inc | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Inke S.a. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Aclidinium Oral Inhalation NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Aclidinium Oral Inhalation — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Aclidinium Oral Inhalation in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Aclidinium Oral Inhalation went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1303098 1 dose form · 2 strengths
-
Dose form (SCDF) Dry Powder Inhaler RxCUI 1303101In current FDA listingsClinical drug / strength (SCD) 30 ACTUAT aclidinium bromide 0.4 MG/ACTUATRxCUI 160711160 ACTUAT aclidinium bromide 0.4 MG/ACTUATRxCUI 1303102
Look up RxCUI 1303098 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Aclidinium Oral Inhalation is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Aclidinium Oral Inhalation belongs to the Anticholinergic class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Covis Pharma US, Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.