Prescription medication · Long-Acting Muscarinic Antagonist (LAMA)
tiotropium
Also sold as Spiriva. STIOLTO RESPIMAT is used to treat chronic obstructive pulmonary disease (COPD).
Data updated 2026-05-15
- 102,307
- FDA reports
- 3
- InteractionsFew interactions
- $12.14
- Generic price (NADAC)
What the data shows
tiotropium (Spiriva) is a prescription Long-Acting Muscarinic Antagonist (LAMA), with 102,307 FDA adverse-event reports on file, with 3 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
tiotropium (Spiriva) is a prescription Long-Acting Muscarinic Antagonist (LAMA). STIOLTO RESPIMAT is used to treat chronic obstructive pulmonary disease (COPD).
STIOLTO RESPIMAT is a medicine that combines two drugs to help people with COPD breathe easier. It is used daily to keep airways open.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$12.14/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
STIOLTO RESPIMAT is used to treat chronic obstructive pulmonary disease (COPD).
Common side effects
Common cold, Cough, Back pain
Key warnings
LABA medicines like the one in STIOLTO RESPIMAT can be dangerous for people with asthma if they don't also use an inhaled steroid medicine.
The sections below are summarized in plain English from tiotropium's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
This medicine contains two drugs that work in different ways. Tiotropium helps to relax the muscles around your airways, opening them up. Olodaterol also opens airways by relaxing airway muscles.
How to Take It
Use STIOLTO RESPIMAT exactly as your doctor tells you. Inhale two puffs from the inhaler once a day, at the same time each day. Do not use more than two puffs in 24 hours. Make sure to prime the inhaler before using it for the first time.
This is a plain-language summary of tiotropium's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if STIOLTO RESPIMAT will harm your unborn baby. Talk to your doctor about the risks and benefits of using this medicine during pregnancy.
This is a plain-language summary of tiotropium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of tiotropium's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store STIOLTO RESPIMAT at room temperature, away from freezing temperatures.
Side Effects (from patient reports)
Based on 102,307 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for tiotropium, by number of reports
- Using the medicine the wrong way
Using the medicine the wrong way
23,320 reports
- Difficulty breathing
Difficulty breathing
22,319 reports
- Asthma
Asthma
10,817 reports
- Cough 8,611
Cough
8,611 reports
- Pneumonia 8,380
Pneumonia
8,380 reports
- Wheezing 6,761
Wheezing
6,761 reports
- Chronic obstructive pulmonary disease 6,235
Chronic obstructive pulmonary disease
6,235 reports
- Problem with the medicine's quality 5,971
Problem with the medicine's quality
5,971 reports
- Tiredness 5,361
Tiredness
5,361 reports
- Feeling unwell 4,532
Feeling unwell
4,532 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Serious Warnings
LABA medicines like the one in STIOLTO RESPIMAT can be dangerous for people with asthma if they don't also use an inhaled steroid medicine. Do not use STIOLTO RESPIMAT to treat sudden COPD symptoms. Using too much STIOLTO RESPIMAT can cause serious heart problems and may be fatal. If you have a bad reaction, like swelling or trouble breathing, stop using STIOLTO RESPIMAT right away.
Known Drug Interactions
( 7.6 ) 7.1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of olodaterol, one component of STIOLTO RESPIMAT, may be potentiated [see Warnings and Precautions (5.3 , 5.6 , 5.10 , 5.11) ] . Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol [see Warnings and Precautions (5.11) ] . 7.5 Beta-Blockers Beta-adrenergic receptor antagonists (beta-blockers) and the olodaterol component of STIOLTO RESPIMAT may interfere with...
Mechanism: Using other similar drugs can make the heart and nerve effects of olodaterol much stronger.
What to do: Use these medicines with caution and watch for signs like a fast heartbeat or high blood pressure.
Avoid administration of STIOLTO RESPIMAT with other anticholinergic-containing drugs. ( 7.6 ) 7.1 Adrenergic Drugs If additional adrenergic drugs are to be administered by any route, they should be used with caution because the sympathetic effects of olodaterol, one component of STIOLTO RESPIMAT, may be potentiated [see Warnings and Precautions (5.3 , 5.6 , 5.10 , 5.11) ] . Although the clinical significance of these effects is not known, caution is advised in the co-administration of STIOLTO RESPIMAT with non-potassium sparing diuretics.
Mechanism: Both of these medicines contain the same type of drug, and taking them together can cause an overdose of those effects.
What to do: Do not use these two medications at the same time.
7.7 Inhibitors of Cytochrome P450 and P-gp Efflux Transporter In a drug interaction study using the strong dual CYP and P-gp inhibitor ketoconazole, a 1.7-fold increase of olodaterol maximum plasma concentrations and AUC was observed [see Pharmacokinetics (12.3) ] .
Mechanism: Ketoconazole blocks the enzymes and transporters that normally clear the medicine from your body. This causes the medication to stay in your blood longer and reach higher levels than usual.
What to do: Your healthcare provider should monitor you for increased side effects since the levels of the medication in your body may rise.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I use STIOLTO RESPIMAT for asthma?
How often should I use STIOLTO RESPIMAT?
What should I do if I have trouble breathing after using STIOLTO RESPIMAT?
Can I use STIOLTO RESPIMAT for sudden breathing problems?
Does food affect STIOLTO RESPIMAT?
How long after opening is the inhaler good for?
What do I do if I get STIOLTO RESPIMAT in my eyes?
Can I use other inhalers with STIOLTO RESPIMAT?
What should I tell my doctor before using STIOLTO RESPIMAT?
How many puffs are in each inhaler?
What are the common side effects of tiotropium?
Does tiotropium interact with other medications?
What drug class is tiotropium?
Is tiotropium safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for tiotropium
The FDA label for tiotropium (sold under brand names such as Spiriva) classifies it as a prescription-only medication in the Long-Acting Muscarinic Antagonist (LAMA) class. STIOLTO RESPIMAT is used to treat chronic obstructive pulmonary disease (COPD). Official labeling lists 3 commonly reported side effects, including Common cold, Cough, Back pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 102,307 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $12.14.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: June 30, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages