Albuterol sulfate: adverse event reports filed with FDA

44,777

reports as suspect product

0.2% of all reports · about 1,991 a year

4,209

reports, 12 months to June 2026

5,723 in the 12 months before

36.7%

marked serious by the reporter

40.5% across the class

3%

record death among outcomes, as reported

1,327 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Albuterol sulfate reports recording the termmedian drug in beta2-adrenergic agonist

1. Dyspnoeashortness of breath25.1%11,223
2. Wrong technique in product usage processthe product was used in the wrong way23.9%10,722
3. No adverse eventno adverse event was reported18.1%8,085
4. Device delivery system issuea problem with the delivery system17.5%7,853
5. Asthmaasthma17.5%7,840
6. Drug dose omission by device17.1%7,640
7. Wheezingwheezing11.8%5,274
8. Drug ineffectivethe medicine did not work as expected9.6%4,288
9. Coughcough9%4,038
10. Therapeutic product effect incomplete7.5%3,357
11. Loss of personal independence in daily activities6.9%3,076
12. Wrong technique in device usage process6.4%2,845
13. Sleep disorder due to a general medical condition5.3%2,381
14. Off label useused for a purpose or in a way not on the label4.8%2,168
15. Product dose omission issuea dose was missed4.7%2,106
16. Obstructive airways disorder4.2%1,880
17. Full blood count abnormal4.2%1,872
18. Device deposit issue4%1,809
19. Product storage errorthe product was stored wrongly4%1,801
20. Chest discomfortchest discomfort4%1,788
21. Pneumonialung infection4%1,775
22. Product use in unapproved indicationused for a purpose not on the label3.7%1,658
23. Productive cougha cough with phlegm3.6%1,614
24. Malaisegeneral feeling of being unwell3.1%1,404
25. Device malfunctionthe device did not work properly3%1,346
26. Product complaint3%1,323
27. Headachehead pain2.9%1,316
28. Product quality issuea problem with the product itself2.8%1,272
29. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease2.7%1,227
30. Hypertensionhigh blood pressure2.7%1,196

Top 30 of 2,286 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the beta2-adrenergic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 91,817 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 72% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 44,777 reports.

Drugs most often listed in the same reports

Other products listed in reports where Albuterol sulfate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the beta2-adrenergic agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Albuterol sulfate as a suspect or interacting product; reports listing it only as a concomitant medication (98,201) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.