What the label lists and what reports show
Albuterol and ipratropium side effects
Albuterol and ipratropium's FDA label lists its adverse reactions in its own words. FAERS holds 4,316 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 (695 reports).
- Generic listed
Check it at the source: the albuterol and ipratropium FDA label on DailyMed (effective June 22, 2026, Cipla USA Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects with ipratropium bromide and albuterol sulfate inhalation solution?Ipratropium bromide and albuterol sulfate inhalation solution may cause the following serious side effects: Worsening of the narrowing in your airways (bronchospasm). This side effect can be life-threatening and has happened with both of the medicines that are in ipratropium bromide and albuterol sulfate inhalation solution. Stop ipratropium bromide and albuterol sulfate inhalation solution and call your doctor right away or get emergency help if your breathing problems get worse while or after using ipratropium bromide and albuterol sulfate inhalation solution. Serious and life-threatening allergic reactions. […]
Source: FDA drug label (Ipratropium Bromide and Albuterol Sulfate), Sun Pharmaceutical Industries, Inc., effective April 9, 2026 (SPL set 38f9a201-3954-4370-8e71-7ec2df88a1ff), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsAdverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial. ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE Summary of Heart Protection Study Results Body System COSTART Term Albuterol n (%) Ipratropium n (%) Ipratropium Bromide and Albuterol Sulfate Inhalation Solution n (%) NUMBER OF PATIENTS 761 754 765 N (%) Patients with AE 327 (43.0) 329 (43.6) 367 (48.0) BODY AS A WHOLE Pain 8 (1.1) 4 (0.5) 10 (1.3) Pain chest 11 (1.4) 14 (1.9) 20 (2.6) DIGESTIVE Diarrhea 5 (0.7) 9 (1.2) 14 (1.8) Dyspepsia 7 (0.9) 8 (1.1) 10 (1.3) Nausea 7 (0.9) 6 (0.8) 11 (1.4) MUSCULO-SKELETAL Cramps leg 8 (1.1) 6 (0.8) 11 (1.4) RESPIRATORY Bronchitis 11 (1.4) 13 (1.7) 13 (1.7) Lung Disease 36 (4.7) 34 (4.5) 49 (6.4) Pharyngitis 27 (3.5) …
Summary of Heart Protection Study Results
| Body System COSTART Term | Albuterol n (%) | Ipratropium n (%) | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution n (%) |
|---|---|---|---|
| NUMBER OF PATIENTS | 761 | 754 | 765 |
| N (%) Patients with AE | 327 (43.0) | 329 (43.6) | 367 (48.0) |
| Pain | 8 (1.1) | 4 (0.5) | 10 (1.3) |
| Pain chest | 11 (1.4) | 14 (1.9) | 20 (2.6) |
| Diarrhea | 5 (0.7) | 9 (1.2) | 14 (1.8) |
| Dyspepsia | 7 (0.9) | 8 (1.1) | 10 (1.3) |
| Nausea | 7 (0.9) | 6 (0.8) | 11 (1.4) |
| Cramps leg | 8 (1.1) | 6 (0.8) | 11 (1.4) |
| Bronchitis | 11 (1.4) | 13 (1.7) | 13 (1.7) |
| Lung Disease | 36 (4.7) | 34 (4.5) | 49 (6.4) |
| Pharyngitis | 27 (3.5) | 27 (3.6) | 34 (4.4) |
| Pneumonia | 7 (0.9) | 8 (1.1) | 10 (1.3) |
| Infection urinary tract | 3 (0.4) | 9 (1.2) | 12 (1.6) |
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.
Source: FDA drug label, Cipla USA Inc., effective June 22, 2026 (SPL set 3c64255e-074c-41f8-a344-3686a0685020), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,316 reports list albuterol and ipratropium among the medicines taken, each a report of something that happened, not proof the medicine caused it; 373 are coded as a death and 1,262 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, 6 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?
- Albuterol and 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