Formoterol / Glycopyrrolate
Formoterol and glycopyrrolate is a combination inhaler used for the long-term maintenance treatment of COPD (chronic obstructive pulmonary disease).
🧬 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 →
📖 Formoterol / Glycopyrrolate: Patient Information Guide
A plain-language walkthrough of Formoterol / Glycopyrrolate — 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▾
Formoterol and glycopyrrolate is an inhaled combination medicine for adults with COPD. Here's what the supported product is approved for:
- Bevespi Aerosphere (inhaler): maintenance treatment of COPD (chronic obstructive pulmonary disease) — taken every day to keep airways open and reduce COPD symptoms over time
- Bevespi Aerosphere is not approved to relieve sudden breathing attacks (acute bronchospasm) — it won't work fast enough in an emergency
- Bevespi Aerosphere is not approved for asthma — using a LABA like formoterol without an inhaled corticosteroid in asthma carries serious risks
⚙️How it works▾
Bevespi Aerosphere works through two complementary mechanisms to open and relax the airways. Glycopyrrolate is an anticholinergic — it blocks muscarinic M3 receptors on the smooth muscle lining the airways, which stops the signals that would cause the airways to squeeze shut. Formoterol is a long-acting beta2-agonist (LABA) — it activates beta2 receptors on the same airway muscle cells, triggering a chain reaction that raises levels of a chemical called cyclic AMP, which causes the muscles to relax and the airways to open. Because these two ingredients work through different pathways, their combined effect is broader than either alone.
💊How it's taken▾
Bevespi Aerosphere is inhaled by mouth twice a day — once in the morning and once in the evening. Before your first use, the inhaler must be primed (releasing sprays into the air before you inhale). If you haven't used it for more than 7 days, re-prime it before your next dose.
- Do not take more than two inhalations twice a day
- Do not use it as a rescue inhaler — keep a separate short-acting inhaler for sudden symptoms
- Watch the dose counter on the inhaler and replace it when it reaches zero
🤒Side effects — in detail▾
The most common side effects reported with Bevespi Aerosphere include:
- Cough
- Urinary tract infection
- Headache
- Dry mouth
- Dizziness
- Muscle spasms
- Nausea
- Fatigue
- Rapid or irregular heartbeat (associated with formoterol)
- Tremor (associated with formoterol)
Stop using Bevespi Aerosphere and get help right away if you have sudden worsening of breathing right after using it, signs of a serious allergic reaction (swelling, hives, trouble breathing), eye pain or vision changes, or difficulty urinating — these are signs of potentially serious reactions that need prompt attention.
⚠️Warnings & precautions▾
- LABA and asthma risk: Formoterol, a LABA, must not be used in asthma without an inhaled corticosteroid — doing so increases the risk of serious asthma events and death. Bevespi Aerosphere is only approved for COPD.
- Not a rescue inhaler: Do not use Bevespi Aerosphere for sudden breathing attacks. Always have a short-acting rescue inhaler available.
- Paradoxical bronchospasm: In rare cases, the inhaler can cause the airways to suddenly tighten right after use. If this happens, stop using it and get help immediately.
- Heart effects: Formoterol can raise pulse rate and blood pressure. Use with extra caution if you have coronary artery disease, heart arrhythmias, or high blood pressure.
- Glaucoma: Glycopyrrolate can worsen narrow-angle glaucoma. Contact your doctor immediately if you develop eye pain, blurred vision, or see halos.
- Urinary retention: Glycopyrrolate can worsen urinary problems, especially in men with an enlarged prostate. Tell your doctor if you have trouble urinating.
- Do not exceed the recommended dose or combine with other LABA-containing medicines — overuse can cause serious, potentially fatal heart effects.
🔀What it interacts with▾
Several medicines and drug classes can interact with formoterol and glycopyrrolate:
- Other LABAs: Never use a second LABA alongside Bevespi Aerosphere — this increases the risk of overdose and serious cardiovascular effects
- Other anticholinergics: Combining with other anticholinergic medicines can intensify side effects like dry mouth, urinary retention, and worsening glaucoma
- Beta-blockers: Can block formoterol's airway-opening effect and may cause severe bronchospasm in COPD patients; only use if medically necessary
- MAO inhibitors and tricyclic antidepressants: Can greatly amplify formoterol's effects on the heart and blood pressure — use with extreme caution
- QTc-prolonging drugs: Medicines that affect heart rhythm may increase the risk of dangerous arrhythmias when combined with formoterol
- Non-potassium-sparing diuretics (loop or thiazide): Can worsen the potassium-lowering effect of formoterol, which may affect the heart
- Xanthine derivatives, steroids, or other diuretics: May add to the risk of low potassium (hypokalemia) when used with formoterol
- Other adrenergic medicines: May amplify formoterol's stimulant effects on the heart and blood vessels
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▾
- Allergy: Do not use if you are allergic to glycopyrrolate, formoterol fumarate, or any ingredient in Bevespi Aerosphere
- Asthma: Do not use Bevespi Aerosphere for asthma — using a LABA without an inhaled corticosteroid in asthma can be life-threatening
- Heart conditions: Tell your doctor if you have coronary artery disease, heart rhythm problems, or high blood pressure
- Eye problems: Tell your doctor if you have narrow-angle glaucoma
- Prostate or urinary problems: Tell your doctor if you have an enlarged prostate or difficulty urinating
- Seizure disorders or thyroid disease: Mention these to your doctor before starting
- Diabetes: Formoterol can raise blood sugar — monitor carefully and tell your doctor
- Severe kidney disease: Use only if the benefit clearly outweighs the risk; glycopyrrolate can build up in the body
- Liver disease: Formoterol is processed by the liver — liver problems may cause it to accumulate; monitor closely
- Pregnancy: No adequate human studies exist; discuss with your doctor before use, especially near delivery since beta-agonists may affect uterine contractions
- Breastfeeding: It is not known if these medicines pass into human breast milk; discuss with your doctor
- Children: Bevespi Aerosphere is not approved for pediatric use — safety and effectiveness in children have not been established
- Older adults: No dose adjustment is needed based on age alone, but older individuals may be more sensitive to the medicine
🚑If you take too much▾
Too much Bevespi Aerosphere can cause symptoms of both glycopyrrolate and formoterol overdose. Glycopyrrolate excess may cause nausea, vomiting, blurred vision, difficulty urinating, or increased eye pressure. Too much formoterol can cause a rapid or irregular heartbeat, chest pain, high or low blood pressure, tremor, headache, seizures, low potassium, high blood sugar, or — in severe cases — cardiac arrest. If you suspect an overdose, stop using the inhaler and seek medical care immediately; cardiac monitoring is recommended.
📡Pharmacodynamics — effects in the body▾
At standard doses, Bevespi Aerosphere causes only a small, clinically insignificant change in heart rhythm (QTc interval) and a modest, transient increase in heart rate — well below the threshold considered clinically concerning. Studies using 24-hour heart monitoring in people with COPD found no meaningful effects on cardiac rhythm at the recommended dose. Formoterol can also temporarily lower blood potassium levels and slightly raise blood sugar in some patients, though clinical trials of Bevespi Aerosphere did not show a significant treatment effect on either in people with COPD.
🔬Pharmacokinetics — how your body processes it▾
After inhalation of Bevespi Aerosphere, glycopyrrolate reaches peak blood levels within about 5 minutes, while formoterol peaks within 20 to 60 minutes. Both medicines reach steady levels in the body within 2 to 3 days of regular twice-daily use. Glycopyrrolate is mainly cleared through the kidneys (about 85% is found in urine), while formoterol is primarily broken down by the liver and excreted in urine and stool. Both have a terminal half-life (the time for the body to clear half the drug) of about 11.8 hours. People with severe kidney disease may have significantly higher glycopyrrolate exposure, and those with liver disease may have higher formoterol levels.
📦How to store it▾
Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Keep out of reach of children. store near heat or open flame.
📄 Written from Formoterol / Glycopyrrolate’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 Formoterol / Glycopyrrolate — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Bevespi Aerosphere do, and will I feel it working right away? ▾
Can I use my Bevespi Aerosphere when I'm having a sudden breathing attack? ▾
I've heard LABAs can be dangerous in asthma. Should I be worried about taking this for my COPD? ▾
Are there any medicines I should avoid while taking Bevespi Aerosphere? ▾
What side effects are most likely, and when should I call my doctor? ▾
How do I know when my inhaler is running out, and is there anything special about setting it up? ▾
Is Formoterol / Glycopyrrolate available over the counter? ▾
When was Formoterol / Glycopyrrolate first available? ▾
Who makes Formoterol / Glycopyrrolate? ▾
💬 Answers drafted from Formoterol / Glycopyrrolate’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 Formoterol / Glycopyrrolate comes
Formoterol / Glycopyrrolate 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.
Inhaler
How this form is used
- Bevespi Aerosphere is used for the long-term maintenance treatment of COPD in adults
- Bevespi Aerosphere is not for relief of sudden breathing attacks (acute bronchospasm)
- Bevespi Aerosphere is not approved for the treatment of asthma
- Bevespi Aerosphere is inhaled by mouth twice daily — once in the morning and once in the evening
- Before first use, prime Bevespi Aerosphere by releasing 4 sprays into the air, shaking well before each spray; if not used for more than 7 days, re-prime with 2 sprays
- Bevespi Aerosphere has a dose counter that shows remaining inhalations — discard when the counter reaches zero
- Do not use Bevespi Aerosphere more than twice daily, and do not use it with another inhaler that contains a long-acting beta-agonist
📊 Formoterol / Glycopyrrolate across the U.S. market
How Formoterol / Glycopyrrolate 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Formoterol / Glycopyrrolate is used
A general measure of how commonly Formoterol / Glycopyrrolate 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 Formoterol / Glycopyrrolate 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 Formoterol / Glycopyrrolate prescribed? Of the 1,596 medications we measure, Formoterol / Glycopyrrolate ranks #873 by Medicaid prescriptions — more than 45% of them.
Utilization by Formoterol / Glycopyrrolate 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.
120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUAT Metered Dose Inhaler
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790639
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 Formoterol / Glycopyrrolate, 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 1 of 3 listed Formoterol / Glycopyrrolate NDCs with Medicaid activity.
🔍 Compare Formoterol / Glycopyrrolate products
A representative set of FDA-listed product records for Formoterol / Glycopyrrolate — 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 |
|---|---|---|---|---|
| 💊Inhaler | ||||
| GLYCOPYRROLATE 9 mcg/1; FORMOTEROL FUMARATE 4.8 mcg | Respiratory (inhalation) | AstraZeneca Pharmaceuticals LP | NDA | View NDC → |
| 4.8; 9 mcg/1; mcg | Respiratory (inhalation) | AstraZeneca Pharmaceuticals LP × 2 listings | NDA | View NDC → |
| GLYCOPYRROLATE 9 mcg/1; FORMOTEROL FUMARATE 4.8 mcg | — | Bespak HC Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Formoterol / Glycopyrrolate 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 Formoterol / Glycopyrrolate — 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 Formoterol / Glycopyrrolate 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 Formoterol / Glycopyrrolate 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 exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1790638 1 dose form · 1 strength
-
Dose form (SCDF) Metered Dose Inhaler RxCUI 1790637In current FDA listingsClinical drug / strength (SCD) 120 ACTUAT formoterol fumarate 0.0048 MG/ACTUAT / glycopyrrolate 0.009 MG/ACTUATRxCUI 1790639
Look up RxCUI 1790638 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 Formoterol / Glycopyrrolate 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
Formoterol / Glycopyrrolate 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.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. AstraZeneca Pharmaceuticals LP 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.