FDA-filed SPL labeling · retrieved through openFDA

Olodaterol Oral Inhalation

Olodaterol is a long-acting bronchodilator (airway-opener) used as a once-daily maintenance treatment for airflow obstruction in adults with chronic obstructive pulmonary disease (COPD).

Brand names Striverdi RespimatStriverdi
Drug classes Adrenergic Beta2-agonists
Rx Form 1 Route Respiratory (inhalation)
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 →

At a glance
Linked label effectiveJan 3, 2025
AvailabilityRx
Earliest approval/marketing year 2014
FDA-listed product records 6
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Olodaterol Oral Inhalation at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Striverdi Respimat is a once-daily maintenance inhaler that helps keep airways open in adults with COPD — it is not a rescue inhaler and must never be used for asthma. Always keep a short-acting rescue inhaler on hand for sudden symptoms. If your rescue inhaler is not working as well as it used to, contact your doctor promptly because your COPD may need reassessment.

📖 Olodaterol Oral Inhalation: Patient Information Guide

A plain-language walkthrough of Olodaterol 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

Olodaterol inhalation is used as a long-term maintenance bronchodilator for adults with COPD. Here is what it is approved for:

  • Striverdi Respimat is indicated for once-daily maintenance treatment of airflow obstruction in adults with COPD, including chronic bronchitis and/or emphysema
  • Striverdi Respimat is not for acute (sudden) COPD flare-ups — it will not work fast enough to help in an emergency
  • Striverdi Respimat is not approved for asthma — using it for asthma can be dangerous and is contraindicated
⚙️How it works

Olodaterol is a long-acting beta-2 adrenergic agonist (LABA). When inhaled, it travels into the lungs and binds to beta-2 receptors on the smooth muscle cells that surround the airways. This triggers a chain reaction inside the cells that raises levels of a signaling molecule called cAMP, which causes the airway muscles to relax. Relaxed muscles mean wider, more open airways — and easier breathing. Because it binds these receptors for a long time, a single daily dose provides around-the-clock airway support.

Olodaterol is highly selective for beta-2 receptors (the ones on airway muscle), but those receptors also exist in the heart and other tissues — which is why cardiovascular effects are possible, especially at higher-than-recommended doses.

💊How it's taken

Striverdi Respimat is inhaled through the mouth using the Respimat device. The standard dosing is two inhalations once daily, taken at the same time every day. There is no food restriction. Do not use more than two inhalations in any 24-hour period.

  • Prime the inhaler before first use and after long periods of non-use (over 3 or 21 days, depending on how long it has been idle)
  • Always have a short-acting rescue inhaler available — Striverdi Respimat does not work quickly enough for sudden symptoms
  • If you miss a dose, take it as soon as you remember — but never double up to make up for a missed dose; never exceed two inhalations in 24 hours
  • No dose adjustment is needed for older adults or those with mild-to-moderate liver or kidney impairment, but follow your prescriber's guidance
🤒Side effects — in detail

The most commonly reported side effects with Striverdi Respimat (occurring in at least 2% of patients in clinical trials) include:

  • Nasopharyngitis (cold-like symptoms — runny nose, sore throat)
  • Upper respiratory tract infection
  • Bronchitis
  • Urinary tract infection
  • Cough
  • Dizziness
  • Skin rash
  • Diarrhea
  • Back pain and joint pain (arthralgia)

Serious but less common reactions include COPD exacerbation, pneumonia, and atrial fibrillation (irregular heartbeat). Seek prompt medical attention if breathing suddenly worsens, you develop chest pain, notice an irregular heartbeat, or have signs of a severe allergic reaction such as facial swelling or throat tightening.

⚠️Warnings & precautions
  • Asthma risk: Using olodaterol (a LABA) alone for asthma — without an inhaled corticosteroid — is associated with a significantly increased risk of asthma-related death and hospitalization. Striverdi Respimat must never be used for asthma.
  • Not a rescue inhaler: Do not use Striverdi Respimat for sudden breathing problems. Always use a short-acting inhaler for acute symptoms. If your rescue inhaler is less effective or you need it more often, contact your doctor right away.
  • Paradoxical bronchospasm: In rare cases, the inhaler can cause airways to tighten instead of relax immediately after use. Stop using Striverdi Respimat and get emergency help if this occurs.
  • Cardiovascular effects: Olodaterol can raise heart rate and blood pressure, cause heart rhythm changes, and should be used cautiously in patients with heart disease, arrhythmias, or high blood pressure.
  • Low potassium / high blood sugar: Beta-agonists can lower potassium levels and raise blood glucose — particularly relevant for patients with diabetes or severe COPD.
  • Excessive use is dangerous: Using more than the recommended dose, or combining with another long-acting beta-agonist, can cause serious cardiovascular harm and has been associated with fatal outcomes.
🔀What it interacts with

Olodaterol can interact with several types of medications, sometimes seriously. Tell your doctor and pharmacist about everything you take:

  • Beta-blockers (e.g., metoprolol, atenolol) — can block olodaterol's effect and may cause severe airway tightening in COPD patients; avoid unless medically necessary
  • Other adrenergic (stimulant) drugs — can amplify olodaterol's cardiovascular side effects
  • MAO inhibitors and tricyclic antidepressants — can strongly intensify heart-related effects; use with extreme caution
  • QT-prolonging drugs — combining these with olodaterol increases the risk of dangerous heart rhythm problems (ventricular arrhythmias)
  • Xanthines (e.g., theophylline), corticosteroids, and diuretics (water pills) — can worsen low potassium levels when taken alongside olodaterol
  • Non-potassium-sparing diuretics (loop or thiazide diuretics) — can worsen both potassium loss and abnormal ECG changes
  • Ketoconazole (a strong antifungal and CYP/P-gp inhibitor) — significantly increases olodaterol blood levels; inform your doctor if you use it

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
  • Asthma: Do not use Striverdi Respimat if you have asthma — it is contraindicated and can increase the risk of asthma-related death when used without an inhaled corticosteroid
  • Heart disease: Tell your doctor if you have coronary artery disease, irregular heartbeat (arrhythmia), a known prolonged QT interval, or high blood pressure
  • Seizure disorder or thyroid disease: Use with caution; olodaterol can worsen these conditions
  • Diabetes: Beta-agonists can raise blood glucose — closely monitor blood sugar, especially if diabetes is not well controlled
  • Pregnancy: No adequate human studies exist; during labor, use only if benefits clearly outweigh risks due to potential effects on uterine contractions
  • Breastfeeding: It is unknown whether olodaterol passes into human breast milk; discuss the risks and benefits with your doctor
  • Children: Not approved for pediatric use — safety and effectiveness have not been established
  • Severe liver impairment: No data are available; use with caution and close monitoring
  • Severe kidney impairment: Olodaterol levels are higher in this group; inform your doctor
  • Other long-acting bronchodilators: Do not combine with another LABA — the risk of cardiovascular harm increases significantly
🚑If you take too much

Taking too much olodaterol can cause excessive stimulation of the nervous system and heart, leading to symptoms such as fast or irregular heartbeat, chest pain (angina), high or low blood pressure, dizziness, tremor, insomnia, low potassium, high blood sugar, nausea, headache, muscle spasms, and anxiety. In severe cases, cardiac arrest and death have been associated with overdose of inhaled medicines like olodaterol.

If an overdose is suspected, stop using the inhaler immediately, seek emergency medical care, and expect cardiac monitoring. There is not enough evidence to know whether dialysis helps in an overdose situation.

📡Pharmacodynamics — effects in the body

Olodaterol works primarily on beta-2 receptors in the airway smooth muscle, causing relaxation and airway widening (bronchodilation). At recommended doses, it did not cause clinically meaningful changes in blood potassium levels compared to placebo. At doses higher than recommended, it can prolong the QT interval on an ECG (a measure of heart electrical activity) in a dose-dependent way, and it may raise heart rate or blood pressure in some people. Beta-2 receptors are also present in the heart, which means cardiovascular effects are possible even with a highly airway-selective medicine like olodaterol.

🔬Pharmacokinetics — how your body processes it

After inhalation, olodaterol is absorbed mainly through the lungs, reaching peak blood levels within 10 to 20 minutes. About 30% of the inhaled dose enters the bloodstream; any swallowed portion contributes very little (less than 1% absorbed by the gut). With once-daily use, steady levels in the blood are reached after about 8 days. The drug is extensively distributed into body tissues and is broken down mainly in the liver, then cleared through both urine and feces. The effective working half-life at the recommended dose is approximately 7.5 hours, supporting once-daily dosing.

📦How to store it

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Avoid freezing.

📄 Written from Olodaterol 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 Olodaterol Oral Inhalation — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Striverdi Respimat used for, and will it help if I have a sudden attack?
Striverdi Respimat is a maintenance inhaler — meaning it works in the background every day to keep your airways more open if you have COPD. It is not a rescue inhaler and won't act fast enough to help during a sudden flare-up. Your doctor should also prescribe you a short-acting rescue inhaler (like albuterol) for those moments. Keep both on hand.
I have asthma too — can I use this inhaler for both my COPD and my asthma?
No, and this is really important — Striverdi Respimat is not approved for asthma, and using it alone for asthma can actually increase the risk of serious, life-threatening asthma events, including death. Make sure your doctor knows about your asthma so they can find a safe treatment plan for both conditions.
How do I use the inhaler correctly, and do I need to prime it?
Yes, you do need to prime it before the very first use. Insert the cartridge into the inhaler, then press the dose-release button until you see a mist, and repeat that three more times. Once primed, you take two inhalations once a day at the same time each day. If you haven't used it for more than 3 days, actuate it once before using. If it's been more than 21 days, re-prime it fully — mist until you see the cloud, then three more times. Your pharmacist can walk you through the steps if you're unsure.
What side effects should I watch for, and which ones mean I should call my doctor?
The most common side effects are things like a runny nose or sore throat, cough, diarrhea, back pain, dizziness, and skin rash — usually manageable and not dangerous. But call your doctor right away if you need your rescue inhaler more than usual (that can signal your COPD is getting worse), or if you notice a fast or irregular heartbeat, chest pain, or any signs of a severe allergic reaction like swelling of the face or throat. And if the inhaler ever seems to make your breathing worse right after you use it, stop immediately and get emergency help.
I take a blood pressure medication called a beta-blocker — is that a problem?
Yes, that's something your doctor needs to know about. Beta-blockers can actually block the effect of olodaterol and, in COPD patients, may cause severe airway tightening. That said, there are situations — like after a heart attack — where a beta-blocker may still be necessary. Your doctor will weigh the risks and may choose a more heart-selective type if needed. Don't stop or change either medication without talking to your doctor first.
I'm pregnant — is it safe to keep using this inhaler?
There are no good human studies yet to tell us for sure whether olodaterol is safe during pregnancy. Animal studies at very high doses did show some fetal effects. If you're pregnant or planning to become pregnant, talk with your doctor as soon as possible so they can help weigh the benefits of continuing the medication against any potential risks. During labor especially, the medicine may affect uterine contractions, so your care team will need to be aware you're using it.
Is Olodaterol Oral Inhalation available over the counter?
Olodaterol Oral Inhalation is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Olodaterol Oral Inhalation first available?
Olodaterol Oral Inhalation has been available in the United States since at least 2014, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Olodaterol Oral Inhalation?
Olodaterol Oral Inhalation is supplied by 4 manufacturers listed in the FDA NDC Directory, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim Pharma GmbH and Co. KG, Inke SA.

💬 Answers drafted from Olodaterol 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 Olodaterol Oral Inhalation comes

Olodaterol 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.

Inhaler

Inhaled
Brands Striverdi Respimat
How this form is used
What it may be used for
  • Striverdi Respimat is used for long-term, once-daily maintenance treatment of airflow obstruction in adults with COPD, including chronic bronchitis and/or emphysema
  • Striverdi Respimat is not for relief of sudden COPD symptoms and is not approved for asthma
Important instructions
  • Striverdi Respimat is taken as two inhalations once daily at the same time each day — never exceed two inhalations in 24 hours
  • Before first use, insert the Striverdi Respimat cartridge into the inhaler and prime it by actuating toward the ground until an aerosol cloud appears, then repeat three more times
  • If Striverdi Respimat has not been used for more than 3 days, actuate once before use; if not used for more than 21 days, prime again until an aerosol cloud is visible and repeat three more times
  • Striverdi Respimat is for oral inhalation only — follow the full instructions provided with the device and consult your prescriber or pharmacist if unsure
Available strengths 1 strength
3 FDA-listed product records

📊 Olodaterol Oral Inhalation across the U.S. market

How Olodaterol 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.

1
Dose forms
4
Manufacturers
1
Brand names
6
FDA-listed product records
2014
First marketed

Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Boehringer Ingelheim Pharmaceuticals, Inc.50%
Boehringer Ingelheim Pharma GmbH and Co. KG17%
Inke SA17%
Sicor de Mexico S.A. de C.V17%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Olodaterol Oral Inhalation is used

A general measure of how commonly Olodaterol 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 Olodaterol 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.

1,072
Medicaid prescriptions filled (Q1–Q4 2025)
$306,160 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Olodaterol Oral Inhalation prescribed? Of the 1,596 medications we measure, Olodaterol Oral Inhalation ranks #1,272 by Medicaid prescriptions — more than 20% of them.

Where Olodaterol Oral Inhalation ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Olodaterol 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 olodaterol 0.0025 MG/ACTUAT Inhalation Spray

1,072 Medicaid prescriptions (Q1–Q4 2025) 100% of Olodaterol Oral Inhalation prescriptions shown $306,160 gross reimbursement (before rebates) ≈ $286 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1546082

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 Olodaterol 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 1 of 1 listed Olodaterol Oral Inhalation NDCs with Medicaid activity.

🔍 Compare Olodaterol Oral Inhalation products

A representative set of FDA-listed product records for Olodaterol 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
💊Inhaler
2.5 mcg Respiratory (inhalation) Boehringer Ingelheim Pharmaceuticals, Inc. × 3 listings NDA View NDC →
💊Bulk drug substance
15 kg/15 kg Boehringer Ingelheim Pharma GmbH and Co. KG BULK INGREDIENT View NDC →
1 kg/kg Inke SA BULK INGREDIENT View NDC →
1 kg/kg Sicor de Mexico S.A. de C.V BULK INGREDIENT View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Olodaterol Oral Inhalation NDCs →

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.

Ingredient (IN) Olodaterol Oral Inhalation RxCUI 1546059 1 dose form · 1 strength

Look up RxCUI 1546059 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.

🏷️ Sold under these brand names

Striverdi Respimat Striverdi

🏭 Manufacturers & labelers

Boehringer Ingelheim Pharmaceuticals, Inc. 3 Boehringer Ingelheim Pharma GmbH and Co. KG 1 Inke SA 1 Sicor de Mexico S.A. de C.V 1

RxNorm drug class

Olodaterol Oral Inhalation belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-Agonists

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 3, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Olodaterol Oral Inhalation.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Olodaterol Oral Inhalation after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
6
Distinct labelers/manufacturers represented
4
Linked representative label
Boehringer Ingelheim Pharmaceuticals, Inc.
Linked label effective
Jan 3, 2025
Composite sections available
23
Linked SPL Set ID
5d9a5433-857e-44ea-b3d6-2a400ca0cef5
Linked SPL Document ID
376b43be-46b2-49d7-bc0f-a6408571efea
Open the linked representative label on DailyMed ↗

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. Boehringer Ingelheim Pharmaceuticals, 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.