Drug · FAERS side-effect profile with label screen
Ipratropium and Albuterol side effects: what 2,686 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Ipratropium Bromide And Albuterol (Combivent Respimat)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,686 reports · 55% serious · 211 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
COMBIVENT RESPIMAT is a combination of ipratropium bromide (an anticholinergic agent) and albuterol sulfate (a beta 2 -adrenergic agonist) indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.
FDA label, Indications and Usage
What it is
COMBIVENT RESPIMAT is a combination of ipratropium bromide (monohydrate) and albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 6Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 24
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 128 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seasonal allergy | 41 | 22.7 16.7–30.7ROR 23.0 · χ² 826 / p 7e-182 | 22.4 EB05 17.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · 78% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 101 | 15.1 12.5–18.3ROR 15.7 · χ² 1,317 / p 1e-288 | 15.0 EB05 12.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 15.0 | no trial data cached |
| Sputum discoloured | 14 | 11.5 6.8–19.5ROR 11.6 · χ² 124 / p 4e-29 | 10.1 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Wheezing | 84 | 11.1 9.0–13.7ROR 11.4 · χ² 760 / p 1e-167 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Infusion site pain | 18 | 11.0 6.9–17.4ROR 11.1 · χ² 153 / p 2e-35 | 9.9 EB05 6.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Pulmonary mass | 20 | 10.5 6.8–16.2ROR 10.6 · χ² 162 / p 2e-37 | 9.5 EB05 6.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Insurance issue | 19 | 10.0 6.4–15.6ROR 10.0 · χ² 144 / p 1e-33 | 8.9 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 21.6 | no trial data cached |
| Sinus congestion | 17 | 9.8 6.1–15.7ROR 9.8 · χ² 125 / p 2e-29 | 8.5 EB05 5.4 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Pharyngeal swelling | 12 | 9.8 5.6–17.2ROR 9.8 · χ² 86 / p 1e-20 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Secretion discharge | 15 | 9.5 5.7–15.7ROR 9.5 · χ² 105 / p 6e-25 | 8.1 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Emphysema | 12 | 9.2 5.3–16.2ROR 9.3 · χ² 80 / p 2e-19 | 7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Candida infection (yeast infection) | 19 | 8.9 5.7–13.9ROR 8.9 · χ² 125 / p 3e-29 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Dermatitis contact | 12 | 8.2 4.7–14.5ROR 8.3 · χ² 69 / p 5e-17 | 6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Asthma | 116 | 8.1 6.7–9.6ROR 8.4 · χ² 714 / p 2e-157 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Respiratory tract infection | 26 | 7.8 5.3–11.4ROR 7.9 · χ² 147 / p 3e-34 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | no trial data cached |
| Pulmonary congestion | 13 | 7.6 4.4–13.2ROR 7.7 · χ² 69 / p 6e-17 | 6.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Productive cough (cough with phlegm) | 45 | 7.4 5.5–9.9ROR 7.5 · χ² 243 / p 4e-55 | 7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Intentional product use issue | 83 | 7.4 5.9–9.1ROR 7.6 · χ² 451 / p 3e-100 | 7.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 88% consumer | no trial data cached |
| Respiratory tract congestion | 15 | 7.3 4.4–12.2ROR 7.4 · χ² 76 / p 1e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 | no trial data cached |
| Sleep apnoea syndrome | 18 | 7.3 4.6–11.6ROR 7.4 · χ² 92 / p 4e-22 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Acute respiratory failure | 18 | 7.3 4.6–11.6ROR 7.4 · χ² 92 / p 4e-22 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Covid-19 pneumonia | 11 | 7.2 4.0–13.0ROR 7.2 · χ² 53 / p 2e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Dyspnoea exertional | 34 | 7.1 5.1–9.9ROR 7.1 · χ² 171 / p 2e-39 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Product prescribing error | 20 | 6.6 4.3–10.2ROR 6.6 · χ² 89 / p 2e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.4 · 75% consumer | no trial data cached |
| Lung disorder | 41 | 6.5 4.8–8.8ROR 6.6 · χ² 186 / p 9e-43 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 80% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 434 | 6.0 5.5–6.5ROR 6.9 · χ² 1,842 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 75% consumer | no trial data cached |
| End stage renal disease | 14 | 5.9 3.5–10.0ROR 5.9 · χ² 52 / p 2e-13 | 5.0 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Aphonia | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Ear infection | 19 | 5.6 3.6–8.7ROR 5.6 · χ² 67 / p 1e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.7 | no trial data cached |
| Carpal tunnel syndrome | 10 | 5.5 3.0–10.3ROR 5.6 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Bronchitis | 52 | 5.4 4.2–7.1ROR 5.5 · χ² 185 / p 2e-42 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Middle insomnia | 13 | 5.4 3.2–9.4ROR 5.5 · χ² 43 / p 3e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Sciatica | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Device defective | 11 | 5.3 2.9–9.5ROR 5.3 · χ² 34 / p 3e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Post procedural complication | 13 | 5.3 3.1–9.1ROR 5.3 · χ² 41 / p 9e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Joint injury | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Pneumothorax | 10 | 4.9 2.6–9.1ROR 4.9 · χ² 27 / p 8e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Pulmonary fibrosis | 12 | 4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Sinus disorder | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 31 / p 1e-8 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 | no trial data cached |
| Respiratory disorder | 18 | 4.7 2.9–7.4ROR 4.7 · χ² 48 / p 2e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 434 | 6.0 5.5–6.5ROR 6.9 · χ² 1,842 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 75% consumer | no trial data cached |
| Pneumonia (lung infection) | 192 | 4.6 4.0–5.3ROR 4.9 · χ² 550 / p 6e-122 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Cough | 159 | 4.4 3.8–5.1ROR 4.6 · χ² 424 / p 2e-94 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Asthma | 116 | 8.1 6.7–9.6ROR 8.4 · χ² 714 / p 2e-157 | 7.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Product dose omission issue | 104 | 2.8 2.4–3.4ROR 2.9 · χ² 124 / p 4e-29 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 · 76% consumer | no trial data cached |
| Chronic obstructive pulmonary disease | 101 | 15.1 12.5–18.3ROR 15.7 · χ² 1,317 / p 1e-288 | 15.0 EB05 12.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 15.0 | no trial data cached |
| Covid-19 | 84 | 3.7 3.0–4.6ROR 3.8 · χ² 164 / p 8e-38 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 70% consumer | no trial data cached |
| Wheezing | 84 | 11.1 9.0–13.7ROR 11.4 · χ² 760 / p 1e-167 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Intentional product use issue | 83 | 7.4 5.9–9.1ROR 7.6 · χ² 451 / p 3e-100 | 7.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 88% consumer | no trial data cached |
| Sinusitis | 61 | 4.6 3.6–5.9ROR 4.7 · χ² 170 / p 3e-39 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Product quality issue | 59 | 3.4 2.6–4.4ROR 3.5 · χ² 99 / p 2e-23 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 84% consumer | no trial data cached |
| Chest discomfort | 59 | 4.5 3.5–5.8ROR 4.6 · χ² 158 / p 1e-36 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Oropharyngeal pain (sore throat) | 52 | 4.4 3.3–5.7ROR 4.4 · χ² 132 / p 6e-31 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Bronchitis | 52 | 5.4 4.2–7.1ROR 5.5 · χ² 185 / p 2e-42 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Productive cough (cough with phlegm) | 45 | 7.4 5.5–9.9ROR 7.5 · χ² 243 / p 4e-55 | 7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Seasonal allergy — n=41, PRR 22.7
- Pulmonary mass — n=20, PRR 10.5
- Productive cough — n=45, PRR 7.4
- Dyspnoea exertional — n=34, PRR 7.1
- Lung disorder — n=41, PRR 6.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ipratropium and Albuterol?
In FDA FAERS, the most frequently co-reported reaction terms for Ipratropium and Albuterol are dyspnoea, pneumonia, cough, asthma, chronic obstructive pulmonary disease, covid-19. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ipratropium and Albuterol have an FDA boxed warning?
No. The FDA label retrieved for Ipratropium and Albuterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ipratropium and Albuterol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 9832312e-0310-4ab6-8501-afa976fc7eb2, effective 20251201; matched on
openfda.generic_name.exact:"IPRATROPIUM BROMIDE AND ALBUTEROL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 168 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.