Drug · FAERS side-effect profile with label screen

Ipratropium Bromide and Albuterol Sulfate side effects: what 1,644 FDA adverse event reports show

Ipratropium Bromide And Albuterol Sulfate · 66 reaction terms · 927 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Ipratropium Bromide And Albuterol Sulfate (Ipratropium Bromide And Albuterol Sulfate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,644 reports · 49% serious · 162 with death outcome · 63% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ipratropium bromide and albuterol sulfate inhalation solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.

FDA label, Indications and Usage

What it is

DESCRIPTION The active components in ipratropium bromide and albuterol sulfate inhalation solution, USP are albuterol sulfate USP and ipratropium bromide USP. Albuterol sulfate, is a salt of r.

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 23 strongest signals

Labeled adverse reaction 3Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 13

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.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 43 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product taste abnormal	32	30.4 21.5–42.8ROR 31.0 · χ² 878 / p 2e-193	29.8 EB05 22.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=3 · 73% consumer	no trial data cached
Product packaging quantity issue	21	24.6 16.0–37.6ROR 24.9 · χ² 451 / p 3e-100	24.0 EB05 16.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	85% consumer	no trial data cached
Chronic obstructive pulmonary disease	69	16.9 13.4–21.3ROR 17.6 · χ² 1,016 / p 3e-223	16.8 EB05 13.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.0	no trial data cached
Oral discomfort	15	13.7 8.3–22.8ROR 13.9 · χ² 165 / p 5e-38	12.7 EB05 7.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Respiratory tract infection	22	10.8 7.1–16.4ROR 10.9 · χ² 186 / p 1e-42	9.9 EB05 6.6 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.1	no trial data cached
Productive cough (cough with phlegm)	39	10.5 7.7–14.3ROR 10.7 · χ² 326 / p 3e-73	10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Hypoxia (low oxygen)	28	10.2 7.0–14.7ROR 10.3 · χ² 223 / p 1e-50	9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Acute respiratory failure	15	10.0 6.0–16.5ROR 10.1 · χ² 112 / p 1e-26	8.6 EB05 5.2 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Dysgeusia (altered taste)	55	9.4 7.2–12.2ROR 9.7 · χ² 405 / p 2e-90	9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.8 · 81% consumer	no trial data cached
Expired product administered	22	8.5 5.6–12.8ROR 8.6 · χ² 137 / p 5e-32	7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=3 · 82% consumer	no trial data cached
Economic problem	10	8.3 4.5–15.3ROR 8.3 · χ² 57 / p 2e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.6	no trial data cached
Glaucoma	12	7.9 4.5–14.0ROR 8.0 · χ² 66 / p 2e-16	6.4 EB05 3.8 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.5	no trial data cached
Pulmonary hypertension	13	7.9 4.6–13.6ROR 8.0 · χ² 72 / p 1e-17	6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Oxygen saturation decreased	34	7.8 5.6–10.8ROR 7.9 · χ² 194 / p 2e-44	7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 8.3	no trial data cached
Dysphonia	33	7.2 5.1–10.1ROR 7.3 · χ² 170 / p 3e-39	6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 73% consumer	no trial data cached
Asthma	63	7.2 5.6–9.1ROR 7.4 · χ² 330 / p 6e-74	6.9 EB05 5.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Dyspnoea exertional	21	7.1 4.7–10.9ROR 7.2 · χ² 105 / p 7e-25	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 70% consumer	no trial data cached
Nervousness	27	6.6 4.5–9.5ROR 6.6 · χ² 122 / p 1e-28	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 85% consumer	no trial data cached
Wheezing	30	6.5 4.5–9.2ROR 6.6 · χ² 133 / p 4e-31	5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8	no trial data cached
Haemoptysis	14	6.4 3.8–10.8ROR 6.4 · χ² 58 / p 1e-14	5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Throat irritation	18	5.1 3.2–8.1ROR 5.2 · χ² 56 / p 4e-14	4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Product quality issue	47	4.4 3.4–5.9ROR 4.5 · χ² 123 / p 8e-29	4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 79% consumer	no trial data cached
Drug effect decreased	14	3.3 1.9–5.5ROR 3.3 · χ² 20 / p 4e-6	3.0 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 3.8	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
Chronic obstructive pulmonary disease	69	16.9 13.4–21.3ROR 17.6 · χ² 1,016 / p 3e-223	16.8 EB05 13.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.0	no trial data cached
Asthma	63	7.2 5.6–9.1ROR 7.4 · χ² 330 / p 6e-74	6.9 EB05 5.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Dysgeusia (altered taste)	55	9.4 7.2–12.2ROR 9.7 · χ² 405 / p 2e-90	9.0 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.8 · 81% consumer	no trial data cached
Product quality issue	47	4.4 3.4–5.9ROR 4.5 · χ² 123 / p 8e-29	4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 79% consumer	no trial data cached
Productive cough (cough with phlegm)	39	10.5 7.7–14.3ROR 10.7 · χ² 326 / p 3e-73	10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.7	no trial data cached
Oxygen saturation decreased	34	7.8 5.6–10.8ROR 7.9 · χ² 194 / p 2e-44	7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 8.3	no trial data cached
Dysphonia	33	7.2 5.1–10.1ROR 7.3 · χ² 170 / p 3e-39	6.6 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 73% consumer	no trial data cached
Product taste abnormal	32	30.4 21.5–42.8ROR 31.0 · χ² 878 / p 2e-193	29.8 EB05 22.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=3 · 73% consumer	no trial data cached
Wheezing	30	6.5 4.5–9.2ROR 6.6 · χ² 133 / p 4e-31	5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8	no trial data cached
Hypoxia (low oxygen)	28	10.2 7.0–14.7ROR 10.3 · χ² 223 / p 1e-50	9.5 EB05 6.6 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Nervousness	27	6.6 4.5–9.5ROR 6.6 · χ² 122 / p 1e-28	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.7 · 85% consumer	no trial data cached
Expired product administered	22	8.5 5.6–12.8ROR 8.6 · χ² 137 / p 5e-32	7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious n=3 · 82% consumer	no trial data cached
Respiratory tract infection	22	10.8 7.1–16.4ROR 10.9 · χ² 186 / p 1e-42	9.9 EB05 6.6 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.1	no trial data cached
Dyspnoea exertional	21	7.1 4.7–10.9ROR 7.2 · χ² 105 / p 7e-25	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 70% consumer	no trial data cached
Product packaging quantity issue	21	24.6 16.0–37.6ROR 24.9 · χ² 451 / p 3e-100	24.0 EB05 16.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	85% consumer	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.

Chronic obstructive pulmonary disease — n=69, PRR 16.9
Productive cough — n=39, PRR 10.5
Hypoxia — n=28, PRR 10.2
Dysgeusia — n=55, PRR 9.4
Dysphonia — n=33, PRR 7.2
Asthma — n=63, PRR 7.2
Dyspnoea exertional — n=21, PRR 7.1
Nervousness — n=27, PRR 6.6

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 chronic obstructive pulmonary disease, asthma, dysgeusia, productive cough, oxygen saturation decreased, dysphonia. 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 370516c4-718f-4a71-bdc8-8822060ccefe, effective 20231031; matched on openfda.generic_name.exact:"IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE")
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, field patient.drug.openfda.generic_name.exact, 66 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.