Is Breztri a Steroid? Ingredients and Side Effects

Breztri Aerosphere contains one steroid and two non-steroid medicines in a single inhaler. The steroid component is budesonide, an inhaled corticosteroid that reduces airway inflammation. The other two ingredients, glycopyrrolate and formoterol fumarate, are bronchodilators that work through entirely different mechanisms. So calling Breztri “a steroid” is technically incomplete: it is a triple-combination therapy prescribed for chronic obstructive pulmonary disease (COPD), and understanding which part is the steroid matters for making sense of both its benefits and its side effects.

What Is Inside Breztri

Breztri belongs to a drug class abbreviated ICS/LAMA/LABA, which stands for inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta-2 agonist. Each abbreviation corresponds to one of the three active ingredients, and each targets a different aspect of COPD.

Budesonide (ICS): This is the steroid. It works by dampening immune and inflammatory activity inside the airways, reducing the swelling and mucus production that make breathing difficult.¹ Budesonide is one of the most widely used inhaled corticosteroids worldwide and has been available in other formulations for decades.
Glycopyrrolate (LAMA): Not a steroid. Glycopyrrolate blocks a specific receptor on airway smooth muscle that, when activated by the nervous system, causes the airways to tighten. By blocking that receptor, it keeps the airways more relaxed and open.²
Formoterol fumarate (LABA): Also not a steroid. Formoterol relaxes airway smooth muscle through a different pathway. It begins working within about five minutes and keeps the airways open for around twelve hours per dose.³

In short, only one of the three ingredients is a steroid. The other two are bronchodilators that open the airways through complementary, non-hormonal routes. The combination exists because COPD involves both chronic inflammation and airway constriction, and treating only one of those problems often is not enough.

Why the Word “Steroid” Worries People

When many people hear “steroid,” they picture the anabolic steroids associated with bodybuilding, aggression, or sports scandals. Inhaled corticosteroids like budesonide are a completely different class of drug. They are synthetic versions of cortisol, a hormone your body makes naturally to regulate inflammation. They do not build muscle, do not raise testosterone, and do not carry the same risks as anabolic steroids. Some families have been known to confuse the two categories to the point of fearing, for example, that an inhaled steroid might cause a child to grow a beard.⁴ That will not happen. The doses in an inhaler are tiny compared to what the body produces on its own, and the drug is designed to act locally in the lungs rather than flooding the entire body.

This confusion, sometimes called “corticophobia,” can lead people to stop using their prescribed inhaler or to avoid filling it altogether. That fear is usually worse for them than the medicine itself. The real side effects of inhaled corticosteroids are worth understanding clearly, but they have nothing in common with the risks of anabolic steroids.

Side Effects From the Steroid Component

Budesonide’s side effects divide into two categories: local effects that happen where the drug lands, and systemic effects that happen when small amounts of the drug get absorbed into the bloodstream.

Local side effects are the most common. They include oral thrush (a yeast infection in the mouth), hoarseness or voice changes, and irritation of the throat lining.⁵ Oral thrush happens because the steroid suppresses the immune response in the mouth and throat, letting naturally occurring yeast overgrow. Hoarseness occurs when the drug deposits on the vocal cords. Both of these are manageable and, for most people, preventable with a simple habit: rinsing your mouth with water (and spitting it out) after each use. Research has found that while most patients know rinsing can reduce mouth and throat problems, very few realize it can also reduce the small amount of drug that gets swallowed and absorbed systemically.⁶

Systemic side effects are less common but more clinically significant when they occur. With long-term use at higher doses, inhaled corticosteroids can reduce bone mineral density, interfere with blood sugar regulation, and in some cases contribute to eye problems like cataracts or glaucoma.⁵ Studies comparing budesonide to other inhaled steroids have shown that both budesonide and fluticasone can dampen the body’s cortisol response at higher doses, though neither drug at the doses typically used in inhalers produced significant suppression of bone formation markers.⁷ In practical terms, the systemic effects are usually a concern only for people on higher doses over many months or years, not for someone using a standard maintenance dose.

Pneumonia Risk With Inhaled Corticosteroids in COPD

One risk that deserves its own mention is pneumonia. Unlike the local side effects, which are annoying but manageable, pneumonia is serious, and the link between inhaled corticosteroids and pneumonia in COPD patients is well established. A large observational study found that current use of inhaled corticosteroids was associated with a roughly 69% increase in the rate of serious pneumonia compared to non-use.⁸ Separate research confirmed that this risk increases with dose: low-dose users had about a 38% higher risk, medium-dose users about 69% higher, and high-dose users roughly two and a half times the risk of someone not using inhaled corticosteroids at all.⁹

This does not mean Breztri is too dangerous to use. It means the steroid component carries a specific, dose-related trade-off: it reduces inflammation and flare-ups, but it also suppresses some of the lung’s local immune defenses, making infections more likely. For many people with moderate-to-severe COPD, the benefit outweighs the risk. The pneumonia risk is one of the main reasons doctors do not prescribe inhaled corticosteroids to every COPD patient, though. If your COPD involves frequent flare-ups or has features that overlap with asthma, the steroid component becomes more clearly worth the trade-off. If your COPD is stable and you rarely have exacerbations, your doctor may prefer a dual bronchodilator (LAMA/LABA) without the steroid.

Side Effects From the Non-Steroid Components

Glycopyrrolate and formoterol have their own side-effect profiles, distinct from the steroid-related ones. Since glycopyrrolate blocks the same type of nerve receptor throughout the body (not just in the lungs), it can cause dry mouth, constipation, urinary retention, and occasionally blurred vision. These are classic anticholinergic effects. A study looking at glycopyrrolate use found that the most frequently noted problems included behavioral changes, constipation, excessive dryness of the mouth or secretions, and difficulty urinating.¹⁰ That study was conducted in a pediatric population using glycopyrrolate for a different purpose, so the doses and context differ from COPD treatment. But the side-effect profile of the drug itself is consistent: dry mouth and constipation are the ones most Breztri users will notice if they notice anything from this component.

Formoterol, as a beta-2 agonist, can cause tremor (usually a mild hand shake), headache, increased heart rate, and occasionally muscle cramps. These effects tend to be most noticeable when you first start the medication or if the dose is increased, and they generally settle down over time. Formoterol’s fast onset of action, working within about five minutes, sometimes gives people a brief feeling of jitteriness that passes quickly.¹¹

How Breztri Delivers Its Three Drugs at Once

Combining three drugs in a single inhaler is not just about convenience. The delivery system matters because the three ingredients are chemically different, and getting them to behave consistently inside a pressurized canister is an engineering problem. Breztri uses what its manufacturer calls co-suspension delivery technology. Drug crystals are combined with tiny porous phospholipid particles inside the canister. These particles hold the drug crystals in a stable, uniform suspension so that each puff delivers a consistent dose of all three medicines. Once the spray reaches your airways, the phospholipid particles dissolve and release the drugs where they need to act.¹²

This matters practically because some older inhalers require shaking before each use to redistribute the drug, and even then the first and last puffs from the canister may deliver uneven amounts. The Aerosphere design is meant to reduce that variability. Breztri is a metered-dose inhaler (MDI), which means it uses a propellant to deliver a measured spray. Some people find MDIs harder to coordinate than dry-powder inhalers, since you need to time your breath with the puff. Using a spacer (a tube that attaches to the inhaler) can help if coordination is an issue.

Drug Interactions to Watch For

The budesonide in Breztri is broken down by a liver enzyme called CYP3A4. Drugs that strongly inhibit that enzyme can cause budesonide to build up in the body, amplifying both its intended effects and its side effects. The antifungal ketoconazole is the classic example: taking it alongside budesonide can cause several-fold increases in the amount of budesonide circulating in your blood.¹³ Other strong CYP3A4 inhibitors include certain HIV medications (like ritonavir), the antibiotic clarithromycin, and some antifungals beyond ketoconazole. If you are prescribed any of these while using Breztri, your doctor may need to adjust the treatment plan.

The glycopyrrolate component can interact with other anticholinergic drugs. If you are already taking medications with anticholinergic properties (some bladder medications, certain older antihistamines, some antidepressants), the combined effect can worsen dry mouth, constipation, or urinary problems. Formoterol can interact with beta-blockers, which work in the opposite direction by blocking beta receptors. Using a non-selective beta-blocker alongside formoterol can blunt the bronchodilator effect and potentially trigger airway tightening. If you need a beta-blocker for heart disease, a cardioselective one is usually safer.

Does Breztri Actually Help

The clinical evidence for Breztri comes primarily from two large trials known as KRONOS and ETHOS. When the full triple therapy was compared to dual-bronchodilator combinations (LAMA/LABA without the steroid), exacerbation rates dropped substantially. In patients whose COPD had features overlapping with asthma, the reduction in flare-ups was particularly striking, with an estimated rate ratio of about 0.28 compared to dual bronchodilator therapy alone, meaning roughly a 72% reduction.¹⁴

Perhaps more compelling is the mortality data. In the ETHOS trial, the higher-dose budesonide triple therapy (BGF 320) was linked to a 49% reduction in the risk of death from any cause compared to the dual bronchodilator arm, with a hazard ratio of 0.51.¹⁵ That is a large effect in a disease where treatments typically produce incremental rather than dramatic improvements. The comparison against the ICS/LABA arm (budesonide plus formoterol, without glycopyrrolate) showed a trend in the same direction but did not reach statistical significance, suggesting that the three-drug combination together is what produces the mortality benefit, not the steroid alone.¹⁵

Both approved triple therapies for COPD (Breztri and its competitor, Trelegy Ellipta) have shown mortality reductions compared to dual LAMA/LABA therapy, though no head-to-head trial has directly compared the two against each other for that outcome.¹⁶

Sticking With the Inhaler

An inhaler only works if you use it consistently, and adherence to COPD medications is notoriously poor. Breztri is taken twice daily, while Trelegy is taken once daily, and that dosing difference appears to have a real-world impact. Claims data from U.S. health plans showed that a significantly smaller proportion of Breztri users maintained adequate adherence at six months compared to Trelegy users: roughly 35% of Breztri patients met the threshold versus about 46% of Trelegy patients.¹⁷ The gap persisted at twelve months. Whether this translates to a meaningful difference in outcomes is harder to say, since a clinical trial controls for adherence while the real world does not. But if you have a history of forgetting doses, the dosing frequency is worth discussing with your doctor.

Breztri also requires the coordination of pressing the canister and breathing in simultaneously, which can be challenging for people with severe breathlessness or limited hand strength. Trelegy uses a dry-powder inhaler that is breath-activated, requiring less coordination. Neither device is perfect for everyone, and a bad match between a patient and an inhaler device can quietly undermine even the best medication.

When the Steroid Component Might Not Be Needed

Not every person with COPD needs the steroid portion of Breztri. Current treatment guidelines generally recommend starting with one or two bronchodilators and adding an inhaled corticosteroid only when the disease involves frequent exacerbations, elevated blood eosinophil counts (a marker suggesting an inflammatory component that responds to steroids), or overlapping features of asthma. For someone whose COPD is primarily driven by structural lung damage with few flare-ups, the steroid adds side-effect risk without enough benefit to justify it.

Stepping down from triple therapy to dual bronchodilator therapy is a conversation some patients can have with their physician once their disease has been stable for several months. Removing the steroid component requires careful monitoring, but evidence suggests that for the right patients, it can be done without a spike in exacerbations. The decision depends on why the steroid was added in the first place and what the patient’s eosinophil levels and flare-up history look like.

There is also a category of patients for whom the non-steroid components of Breztri need caution. Glycopyrrolate should be used carefully in people with narrow-angle glaucoma or severe urinary retention, since its anticholinergic effects can worsen both conditions. Formoterol, like all LABAs, carries a cardiovascular consideration: it can raise heart rate and, rarely, lower potassium levels, so people with unstable heart rhythms need monitoring. These are not reasons to avoid the medication outright, but they underscore that Breztri is not one-size-fits-all, and the non-steroid components have their own boundaries.