What the label lists and what reports show
Levalbuterol side effects
Levalbuterol's FDA label: “Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness.” FAERS holds 6,865 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 (825 reports).
- Generic listed
Check it at the source: the levalbuterol FDA label on DailyMed (effective December 10, 2025, Ritedose Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Levalbuterol Inhalation Solution, USP?Levalbuterol Inhalation Solution, USP can cause serious side effects including: sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using Levalbuterol Inhalation Solution, USP. worsening asthma heart problems death. If you use too much Levalbuterol Inhalation Solution, USP you can have heart or lung problems that can lead to death. serious allergic reactions. Call your doctor and stop using Levalbuterol Inhalation Solution, USP right away if you have any symptoms of an allergic reaction such as: swelling of the face, throat or tongue hives rash breathing problems low potassium levels in your blood Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms. […]
Source: FDA drug label, Ritedose Pharmaceuticals, LLC, effective December 10, 2025 (SPL set d6998949-e1cb-4c86-a480-c0dfd9cb75b5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness.
Table 3: Most Frequently Reported Adverse Reactions (≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old)
| Body System Preferred Term | Placebo (n = 59) | Levalbuterol Inhalation Solution, USP 0.31 mg (n = 66) | Levalbuterol Inhalation Solution, USP 0.63 mg (n = 67) | Racemic albuterol 1.25 mg (n = 64) | Racemic albuterol 2.5 mg (n = 60) |
|---|---|---|---|---|---|
| Abdominal pain | 3.4 | 0 | 1.5 | 3.1 | 6.7 |
| Accidental injury | 3.4 | 6.1 | 4.5 | 3.1 | 5.0 |
| Asthenia | 0 | 3.0 | 3.0 | 1.6 | 1.7 |
| Fever | 5.1 | 9.1 | 3.0 | 1.6 | 6.7 |
| Headache | 8.5 | 7.6 | 11.9 | 9.4 | 3.3 |
| Pain | 3.4 | 3.0 | 1.5 | 4.7 | 6.7 |
| Viral infection | 5.1 | 7.6 | 9.0 | 4.7 | 8.3 |
| Diarrhea | 0 | 1.5 | 6.0 | 1.6 | 0 |
| Lymphadenopathy | 0 | 3.0 | 0 | 1.6 | 0 |
| Myalgia | 0 | 0 | 1.5 | 1.6 | 3.3 |
| Asthma | 5.1 | 9.1 | 9.0 | 6.3 | 10.0 |
| Pharyngitis | 6.8 | 3.0 | 10.4 | 0 | 6.7 |
| Rhinitis | 1.7 | 6.1 | 10.4 | 3.1 | 5.0 |
| Eczema | 0 | 0 | 0 | 0 | 3.3 |
| Rash | 0 | 0 | 7.5 | 1.6 | 0 |
| Urticaria | 0 | 0 | 3.0 | 0 | 0 |
| Otitis media | 1.7 | 0 | 0 | 0 | 3.3 |
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, continuedThe following serious adverse reactions are described below and elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] Cardiovascular effects [see Warnings and Precautions (5.4) ] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescents 12 Years of Age and Older Adverse reaction information concerning Levalbuterol Inhalation Solution, USP in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older. …
Source: FDA drug label, Ritedose Pharmaceuticals, LLC, effective December 10, 2025 (SPL set d6998949-e1cb-4c86-a480-c0dfd9cb75b5), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,865 reports list levalbuterol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 466 are coded as a death and 1,970 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 19 reactions below, 10 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?
- Levalbuterol: 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