Ventolin Hfa: adverse event reports filed with FDA

22,690

reports as suspect product

0.1% of all reports · about 1,028 a year

446

reports, 12 months to June 2026

462 in the 12 months before

20.2%

marked serious by the reporter

40.5% across the class

2.5%

record death among outcomes, as reported

575 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 Ventolin Hfa reports recording the termmedian drug in beta2-adrenergic agonist

1. Wrong technique in product usage processthe product was used in the wrong way28.2%6,405
2. Device use errora mistake in using the device20.7%4,695
3. Dyspnoeashortness of breath12.6%2,850
4. Wrong technique in device usage process11.5%2,603
5. Drug ineffectivethe medicine did not work as expected8.6%1,945
6. Product cleaning inadequate7.8%1,761
7. Product quality issuea problem with the product itself6.1%1,385
8. Asthmaasthma5.2%1,173
9. Drug dose omissiona dose was missed5%1,132
10. Product complaint4.5%1,010
11. Coughcough4.1%925
12. Underdoseless than the intended dose3.6%816
13. Malaisegeneral feeling of being unwell3.3%742
14. Expired product administeredthe product was used past its expiry date3.1%706
15. Product use issuea problem in how the product was used3.1%702
16. Pneumonialung infection2.8%632
17. Wheezingwheezing2.7%607
18. Product use in unapproved indicationused for a purpose not on the label2.7%602
19. Product dose omissiona dose was missed2.6%594
20. Product storage errorthe product was stored wrongly2.6%592
21. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease2.3%527
22. Product dose omission issuea dose was missed2.2%509
23. Overdosea dose above the recommended amount2%459
24. Medication errora mistake in prescribing, dispensing or taking a medicine1.9%428
25. Hospitalisationadmission to hospital1.7%393
26. Nasopharyngitisa cold1.6%367
27. Bronchitischest infection1.6%364
28. Off label useused for a purpose or in a way not on the label1.4%311
29. Deaththe patient died; cause not stated by this term1.3%290
30. Falla fall1.3%288

Top 30 of 1,042 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. 97.8% 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 22,690 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ventolin Hfa 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 Ventolin Hfa as a suspect or interacting product; reports listing it only as a concomitant medication (16,036) 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.