What the label lists and what reports show
Ipratropium side effects
Ipratropium's FDA label: “The most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis.” FAERS holds 35,481 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (6,050 reports).
- Generic listed
Check it at the source: the ipratropium FDA label on DailyMed (effective January 8, 2026, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported nasal adverse events were transient episodes of nasal dryness or epistaxis.
Table 1: % of Patients Reporting Events +
| Reaction | Incidence % | Discontinued % | Incidence % | Discontinued % |
|---|---|---|---|---|
| Headache | 9.8 | 0.6 | 9.2 | 0.0 |
| Upper respiratory tract infection | 9.8 | 1.4 | 7.2 | 1.4 |
| Epistaxis Epistaxis reported by 7.0% of ipratropium bromide patients and 2.3% of vehicle… | 9.0 | 0.3 | 4.6 | 0.3 |
| Nasal dryness | 5.1 | 0.0 | 0.9 | 0.3 |
| Nasal irritation Nasal irritation includes reports of nasal itching, nasal burning, nasal… | 2.0 | 0.0 | 1.7 | 0.6 |
| Other nasal symptoms Other nasal symptoms include reports of nasal congestion, increased… | 3.1 | 1.1 | 1.7 | 0.3 |
| Pharyngitis | 8.1 | 0.3 | 4.6 | 0.0 |
| Nausea | 2.2 | 0.3 | 0.9 | 0.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedAdverse reaction information on ipratropium bromide nasal solution, 0.03% in patients with perennial rhinitis was derived from four multicenter, vehicle-controlled clinical trials involving 703 patients (356 patients on ipratropium bromide and 347 patients on vehicle), and a one-year, open-label, follow-up trial. In three of the trials, patients received ipratropium bromide, 0.03% three times daily, for eight weeks. In the other trial, ipratropium bromide, 0.03% was given to patients two times daily for four weeks. Of the 285 patients who entered the open-label, follow-up trial, 232 were treated for 3 months, 200 for 6 months, and 159 up to one year. The majority (>86%) of patients treated for one year were maintained on 42 mcg per nostril, two or three times daily, of ipratropium bromide, 0.03%. Table 1 shows adverse events, and the frequency that these adverse events led to the discontinuation of treatment, reported for patients who received ipratropium bromide, 0.03% at the recommended dose of 42 mcg per nostril, or vehicle two or three times daily for four or eight weeks. Only adverse events reported with an incidence of at least 2.0% in the ipratropium bromide group and higher in the ipratropium bromide group than in the vehicle group are shown. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective January 8, 2026 (SPL set 13a45df5-a8e3-41d6-91f4-773255b5a04b), via openFDA; the full label on DailyMed
What do FAERS reports show?
35,481 reports list ipratropium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,693 are coded as a death and 15,676 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ipratropium: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions