What the label lists and what reports show
Albuterol side effects
Albuterol's FDA label lists its adverse reactions in its own words. FAERS holds 292,136 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 (42,443 reports).
- Generic listed
Check it at the source: the albuterol FDA label on DailyMed (effective April 30, 2026, Ritedose Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the side effects with albuterol inhalation solution?Albuterol inhalation solution may cause the following serious side effects: Worsening of the tightening and swelling of the muscles around your child’s airways (bronchospasm). This side effect can be life-threatening. Call your child’s doctor or get emergency help right away if your child’s breathing is not helped or gets worse during treatment with albuterol inhalation solution. Serious and life-threatening allergic reactions. Symptoms of a serious allergic reaction include: Hives, rash Swelling of your child’s face, eyelids, lips, tongue, or throat, and trouble swallowing Worsening of your child’s breathing problems such as wheezing, chest tightness or shortness of breath Shock (loss of blood pressure and consciousness). The most common side effects with albuterol inhalation solution include a fast or irregular heartbeat, chest pain, shakiness, or nervousness. […]
Source: FDA drug label (Albuterol Sulfate), Nephron Pharmaceuticals Corporation, effective April 6, 2026 (SPL set 285a656c-f77f-4e77-b0a8-a0e9c901803f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsClinical Trial Experience Adverse events reported in >1% of patients receiving Albuterol Inhalation Solution and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg Albuterol Inhalation Solution (N=115) 0.63 mg Albuterol Inhalation Solution (N=117) Placebo (N=117) Asthma Exacerbation 13 11.1 8.5 Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4 1.7 Gastroenteritis 0.9 3.4 0.9 Cold Symptoms 0 3.4 1.7 Flu Syndrome 2.6 2.6 1.7 Lymphadenopathy 2.6 0.9 1.7 Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7 0.9 Nausea 1.7 0.9 0.9 There was one case of ST segment depression in the 1.25 mg Albuterol …
Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group)
| Reaction | 1.25 mg Albuterol Inhalation Solution (N=115) | 0.63 mg Albuterol Inhalation Solution (N=117) | Placebo (N=117) |
|---|---|---|---|
| Asthma Exacerbation | 13 | 11.1 | 8.5 |
| Otitis Media | 4.3 | 0.9 | 0 |
| Allergic Reaction | 0.9 | 3.4 | 1.7 |
| Gastroenteritis | 0.9 | 3.4 | 0.9 |
| Cold Symptoms | 0 | 3.4 | 1.7 |
| Flu Syndrome | 2.6 | 2.6 | 1.7 |
| Lymphadenopathy | 2.6 | 0.9 | 1.7 |
| Skin/Appendage Infection | 1.7 | 0 | 0 |
| Urticaria | 1.7 | 0.9 | 0 |
| Migraine | 0.9 | 1.7 | 0 |
| Chest Pain | 0.9 | 1.7 | 0 |
| Bronchitis | 0.9 | 1.7 | 0.9 |
| Nausea | 1.7 | 0.9 | 0.9 |
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, Ritedose Pharmaceuticals, LLC, effective April 30, 2026 (SPL set d4c532be-1f41-60d3-e053-2995a90a98be), via openFDA; the full label on DailyMed
What do FAERS reports show?
292,136 reports list albuterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,583 are coded as a death and 84,002 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 18 reactions below, 2 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: 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