Pulmicort Respules: adverse event reports filed with FDA

1,710

reports as suspect product

0% of all reports · about 76 a year

30

reports, 12 months to June 2026

37 in the 12 months before

40.1%

marked serious by the reporter

77.7% across the class

3%

record death among outcomes, as reported

51 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 Pulmicort Respules reports recording the termmedian drug in corticosteroid

1. Dyspnoeashortness of breath16.4%281
2. Off label useused for a purpose or in a way not on the label10.9%186
3. Asthmaasthma8.5%146
4. Coughcough7.4%126
5. Wheezingwheezing5.3%91
6. Drug ineffectivethe medicine did not work as expected5.2%89
7. Chest discomfortchest discomfort4.3%73
8. Drug dose omissiona dose was missed3.3%56
9. Medication errora mistake in prescribing, dispensing or taking a medicine3.2%55
10. Product use issuea problem in how the product was used3.2%54
11. Dysphoniaa hoarse voice3%51
12. Pneumonialung infection3%51
13. Tremorshaking2.9%49
14. Malaisegeneral feeling of being unwell2.8%48
15. Psychomotor hyperactivity2.8%48
16. Insomniadifficulty sleeping2.7%46
17. Intentional product misusedeliberate use not as intended2.7%46
18. Heart rate increaseda fast heart rate reading2.6%44
19. Palpitationsawareness of the heartbeat2.6%44
20. Dizzinesslight-headedness or unsteadiness2.3%39
21. Rashskin rash2%34
22. Weight decreasedweight loss1.9%33
23. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease1.8%31
24. Oxygen saturation decreased1.8%31
25. Rhinorrhoeaa runny nose1.8%31
26. Headachehead pain1.8%30
27. Vomitingbeing sick1.8%30
28. Nasopharyngitisa cold1.7%29
29. Intentional drug misuse1.6%28
30. Deaththe patient died; cause not stated by this term1.5%26

Top 30 of 305 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 74 drugs in the corticosteroid 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 808,789 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. 75.9% 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 1,710 reports.

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 corticosteroid 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 Pulmicort Respules as a suspect or interacting product; reports listing it only as a concomitant medication (182) 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.