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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for tiotropium?
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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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 30, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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