Ipratropium side effects: what 35,447 FDA adverse event reports show
Drug class
Anticholinergic
Label matched
Ipratropium Bromide (Atrovent Hfa)
Who reports
35,447 reports · 76% serious · 4,692 with death outcome · 58% female
Used for
ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema ( 1 )
What it is
The active ingredient in ATROVENT HFA is ipratropium bromide (monohydrate). It is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo[3.2.1]octane, 3-(3-hydroxy-1-oxo-2-p.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,181 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Heart sounds | 71 | 1,654.1 1,048.7–2,609.0ROR 1,657.4 · calibrated p 3e-18 ✓ | 386.4 EB05 316.7 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=71 · ♀ 100% (drug 58%) | not reported in cached trials |
| Appendicolith | 273 | 1,558.9 1,242.0–1,956.5ROR 1,571.0 · calibrated p 3e-19 ✓ | 412.4 EB05 373.0 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=273 · ♀ 0% (drug 58%) · 96% clinician | not reported in cached trials |
| Antacid therapy | 82 | 1,290.8 875.7–1,902.7ROR 1,293.8 · calibrated p 2e-17 ✓ | 367.5 EB05 305.4 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=82 · ♀ 22% (drug 58%) · 100% clinician | not reported in cached trials |
| Fractional exhaled nitric oxide increased | 112 | 1,105.6 806.8–1,515.2ROR 1,109.1 · calibrated p 4e-17 ✓ | 358.7 EB05 306.3 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=112 · ♀ 0% (drug 58%) | not reported in cached trials |
| Sleep disorder therapy | 118 | 1,041.3 770.6–1,407.2ROR 1,044.8 · calibrated p 7e-17 ✓ | 352.7 EB05 302.5 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=118 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 168 | 959.3 750.2–1,226.6ROR 963.9 · calibrated p 1e-16 ✓ | 348.6 EB05 306.5 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=168 · ♀ 92% (drug 58%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 277 | 680.7 572.5–809.4ROR 686.1 · calibrated p 3e-15 ✓ | 307.7 EB05 278.5 · IC025 +7.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=277 | not reported in cached trials |
| Hyper ige syndrome | 53 | 514.5 355.6–744.3ROR 515.3 · calibrated p 2e-13 ✓ | 249.1 EB05 197.7 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=53 · ♀ 100% (drug 58%) | not reported in cached trials |
| Analgesic therapy | 132 | 449.6 358.3–564.1ROR 451.3 · calibrated p 3e-13 ✓ | 245.2 EB05 212.0 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=132 · ♀ 13% (drug 58%) · 100% clinician | not reported in cached trials |
| Drug therapy | 125 | 381.2 304.3–477.5ROR 382.5 · calibrated p 2e-12 ✓ | 222.9 EB05 192.0 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=125 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Bronchial neoplasm | 50 | 342.6 241.6–485.8ROR 343.1 · calibrated p 1e-11 ✓ | 199.7 EB05 157.4 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=50 · ♀ 100% (drug 58%) | not reported in cached trials |
| Anticoagulant therapy | 82 | 248.7 192.1–322.1ROR 249.3 · calibrated p 1e-10 ✓ | 167.8 EB05 139.5 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=82 · ♀ 22% (drug 58%) · 100% clinician | not reported in cached trials |
| Prolonged expiration | 74 | 230.5 176.1–301.6ROR 231.0 · calibrated p 2e-10 ✓ | 158.7 EB05 130.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 100% (drug 58%) | not reported in cached trials |
| Malignant melanoma stage 0 | 45 | 195.6 139.6–274.1ROR 195.8 · calibrated p 1e-9 ✓ | 138.2 EB05 107.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 46 | 154.9 111.9–214.3ROR 155.1 · calibrated p 8e-9 ✓ | 116.7 EB05 91.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 167 | 131.8 111.5–155.9ROR 132.4 · calibrated p 2e-8 ✓ | 106.4 EB05 93.5 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=167 | not reported in cached trials |
| Bronchial haemorrhage | 51 | 114.2 84.6–154.2ROR 114.4 · calibrated p 8e-8 ✓ | 92.5 EB05 73.1 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 · ♀ 100% (drug 58%) | not reported in cached trials |
| Respiratory gas exchange disorder | 60 | 114.2 86.6–150.6ROR 114.4 · calibrated p 7e-8 ✓ | 92.9 EB05 74.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=60 · ♀ 100% (drug 58%) | not reported in cached trials |
| Rib deformity | 41 | 112.6 80.6–157.3ROR 112.8 · calibrated p 1e-7 ✓ | 90.7 EB05 69.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 100% (drug 58%) | not reported in cached trials |
| Nasal turbinate hypertrophy | 57 | 105.7 79.7–140.2ROR 105.9 · calibrated p 1e-7 ✓ | 87.1 EB05 69.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 58%) | not reported in cached trials |
| Ventricular failure | 46 | 100.7 73.7–137.7ROR 100.9 · calibrated p 2e-7 ✓ | 83.1 EB05 64.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 100% (drug 58%) | not reported in cached trials |
| Bacteroides infection | 37 | 98.4 69.5–139.4ROR 98.5 · calibrated p 3e-7 ✓ | 80.9 EB05 61.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Reversible airways obstruction | 73 | 97.7 76.3–125.2ROR 97.9 · calibrated p 2e-7 ✓ | 82.1 EB05 67.5 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=73 | not reported in cached trials |
| Endometrial ablation | 50 | 97.1 72.0–130.9ROR 97.2 · calibrated p 3e-7 ✓ | 80.9 EB05 63.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 100% (drug 58%) | not reported in cached trials |
| Chronic obstructive airways disease exacerbated | 43 | 82.7 60.1–113.7ROR 82.8 · calibrated p 8e-7 ✓ | 70.3 EB05 54.4 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=42 · 100% clinician | not reported in cached trials |
| Obstructive airways disorder | 1,348 | 81.2 76.8–85.9ROR 84.4 · calibrated p 4e-7 ✓ | 71.3 EB05 68.2 · IC025 +6.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 55.8 | NCT00400153: 1/486 (0.2%) on Ipratropium (serious AE) |
| Total lung capacity decreased | 164 | 67.4 57.4–79.2ROR 67.7 · calibrated p 2e-6 ✓ | 60.1 EB05 52.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=161 | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 137 | 64.3 53.9–76.7ROR 64.5 · calibrated p 3e-6 ✓ | 57.6 EB05 49.9 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=136 · ♀ 29% (drug 58%) | not reported in cached trials |
| Breast conserving surgery | 47 | 59.8 44.3–80.7ROR 59.8 · calibrated p 7e-6 ✓ | 53.2 EB05 41.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 100% (drug 58%) | not reported in cached trials |
| Venous pressure jugular increased | 32 | 56.3 39.2–80.9ROR 56.4 · calibrated p 1e-5 ✓ | 50.0 EB05 37.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 100% (drug 58%) | not reported in cached trials |
| Status asthmaticus | 41 | 55.4 40.2–76.3ROR 55.5 · calibrated p 1e-5 ✓ | 49.6 EB05 38.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Hyperphosphataemia | 181 | 55.2 47.4–64.2ROR 55.4 · calibrated p 8e-6 ✓ | 50.2 EB05 44.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=181 · ♀ 16% (drug 58%) · 100% clinician | not reported in cached trials |
| Rhonchi | 117 | 54.5 45.1–65.8ROR 54.6 · calibrated p 9e-6 ✓ | 49.5 EB05 42.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=116 | not reported in cached trials |
| Eosinophil count abnormal | 62 | 53.6 41.3–69.5ROR 53.7 · calibrated p 1e-5 ✓ | 48.5 EB05 39.2 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=61 | not reported in cached trials |
| Lung hyperinflation | 69 | 51.3 40.1–65.6ROR 51.4 · calibrated p 2e-5 ✓ | 46.6 EB05 38.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=67 | not reported in cached trials |
| Infective exacerbation of chronic obstructive airways disease | 51 | 50.9 38.2–67.7ROR 50.9 · calibrated p 2e-5 ✓ | 46.1 EB05 36.4 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 · 100% clinician | NCT00400153: 1/486 (0.2%) on Ipratropium (serious AE) |
| Forced vital capacity decreased | 51 | 50.4 37.9–67.1ROR 50.5 · calibrated p 2e-5 ✓ | 45.8 EB05 36.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=50 | not reported in cached trials |
| Myoglobin blood increased | 118 | 49.2 40.8–59.4ROR 49.4 · calibrated p 2e-5 ✓ | 45.2 EB05 38.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=118 · ♀ 0% (drug 58%) | not reported in cached trials |
| Vital capacity decreased | 34 | 48.2 34.0–68.3ROR 48.2 · calibrated p 3e-5 ✓ | 43.6 EB05 32.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 58%) | not reported in cached trials |
| Restrictive pulmonary disease | 88 | 48.1 38.7–59.8ROR 48.2 · calibrated p 2e-5 ✓ | 44.1 EB05 36.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 58%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ipratropium as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT00400153 — Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) (N=1480, PHASE3; 49 AE terms posted; arms: COMBIVENT Respimat 20/100 mcg; COMBIVENT CFC-MDI 36/206 mcg; Ipratropium Respimat 20 mcg)
- NCT01524198 — The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room (N=945, PHASE2, PHASE3; 2 AE terms posted; arms: Normal Saline, Albuterol, Ipratropium Br; Budesonide, Albuterol, Ipratropium Bromi)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 6,051 | 6.4 6.2–6.5ROR 7.5 · calibrated p 0.081 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | NCT00400153: 2/491 (0.4%) on Ipratropium (serious AE) |
| Asthma | 4,040 | 22.1 21.4–22.7ROR 24.8 · calibrated p 7e-4 ✓ | 21.3 EB05 20.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.3 | not reported in cached trials |
| Pneumonia (lung infection) | 3,169 | 5.8 5.7–6.0ROR 6.3 · calibrated p 0.131 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | NCT00400153: 1/483 (0.2%) on Ipratropium (serious AE) |
| Cough | 3,049 | 6.5 6.3–6.7ROR 7.0 · calibrated p 0.098 | 6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,689 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.457 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Wheezing | 2,670 | 27.9 26.9–29.0ROR 30.1 · calibrated p 3e-4 ✓ | 26.7 EB05 25.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 | not reported in cached trials |
| Fatigue (tiredness) | 2,240 | 1.7 1.6–1.8ROR 1.8 · calibrated p 0.803 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Nausea | 1,998 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.660 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | not reported in cached trials |
| Chronic obstructive pulmonary disease | 1,854 | 21.8 20.8–22.8ROR 22.9 · calibrated p 0.001 ✓ | 21.0 EB05 20.2 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.8 | NCT00400153: 8/483 (1.7%) on Ipratropium (serious AE) |
| Off label use (used outside approved label) | 1,747 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.440 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,696 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.699 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Malaise (feeling unwell) | 1,696 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.879 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | not reported in cached trials |
| Vomiting | 1,683 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.960 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | not reported in cached trials |
| Headache | 1,627 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.683 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.8 | not reported in cached trials |
| Dizziness | 1,518 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.854 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
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.
- Heart sounds — n=71, PRR 1,654.1
- Appendicolith — n=273, PRR 1,558.9
- Fractional exhaled nitric oxide increased — n=112, PRR 1,105.6
- Total lung capacity increased — n=168, PRR 959.3
- Prolonged expiration — n=74, PRR 230.5
- Malignant melanoma stage 0 — n=45, PRR 195.6
- Congenital hiatus hernia — n=46, PRR 154.9
- Respiratory gas exchange disorder — n=60, PRR 114.2
- Rib deformity — n=41, PRR 112.6
- Nasal turbinate hypertrophy — n=57, PRR 105.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Ipratropium are dyspnoea, asthma, pneumonia, cough, wheezing, fatigue. 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 have an FDA boxed warning?
No. The FDA label retrieved for Ipratropium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ipratropium 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 170e98ef-5560-4068-be7d-e649068eb884, effective 20251105; matched on
openfda.generic_name.exact:"IPRATROPIUM BROMIDE") - 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, 1,221 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 - ClinicalTrials.gov API v2 (query
IPRATROPIUM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.