MedDRA preferred term · asthma

Asthma: adverse event reports recording this term

110,374 reports to FDA record it, 2004–2026; 0.5% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

110,374
reports recording the term: 0.5% of all reports; 9,638
reports, 12 months to June 2026: 10,592 in the 12 months before; 71%
marked serious by the reporter: 57.4% across all reports; 3.7%
record death among outcomes, as reported: 9.1% across all reports

110,374 reports in FDA's adverse event database record the MedDRA term "Asthma" (in plain words, asthma): 0.5% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

9,638 reports recorded it in the 12 months to June 2026, close to the 10,592 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 71% are marked serious, 3.7% include death among the outcomes and 36.2% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Dupixent, Prednisone and Symbicort. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Dupixent	Interleukin-4 receptor alpha antagonist	15,469	3.3%
Prednisone	Corticosteroid	10,518	5.7%
Symbicort	Corticosteroid	7,849	20.1%
Albuterol sulfate	beta2-Adrenergic agonist	7,840	17.5%
Xolair	Anti-IgE	7,561	11.6%
Tiotropium bromide	Anticholinergic	6,966	9.1%
Nucala	Interleukin-5 antagonist	6,331	20.7%
Singulair	Leukotriene receptor antagonist	6,176	32.6%
Mepolizumab	Interleukin-5 antagonist	5,657	35%
Advair Hfa	Corticosteroid	5,067	25.8%
Albuterol	beta2-Adrenergic agonist	4,779	26.8%
Omalizumab	Anti-IgE	4,187	40.1%
Humira	—	3,711	0.6%
Salbutamol	—	3,666	45.4%
Rituximab	CD20-directed cytolytic antibody	3,092	2%
Salbutamol sulfate	—	3,053	78.5%
Alvesco	—	3,051	69.6%
Enbrel	Tumor necrosis factor blocker	2,942	0.5%
Breo Ellipta	Corticosteroid	2,869	12.9%
Budesonide Formoterol Fumarate	—	2,782	71.4%
Budesonide	Corticosteroid	2,676	18.2%
Ipratropium bromide	Anticholinergic	2,594	31.2%
Methotrexate	Folate analog metabolic inhibitor	2,415	1.2%
Montelukast	Leukotriene receptor antagonist	2,362	18.4%
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	2,158	14.9%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.5% across the whole database. 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."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Corticosteroid	48,061	5.9%	5%
Interleukin-4 receptor alpha antagonist	15,938	3.4%	3.5%
beta2-Adrenergic agonist	15,110	16.5%	16.6%
Anticholinergic	13,165	8.2%	1.6%
Interleukin-5 antagonist	12,033	25.5%	20.7%
Anti-IgE	11,969	15%	11.6%
Nonsteroidal anti-inflammatory drug	11,892	2.2%	0.3%
Tumor necrosis factor blocker	11,395	1.1%	1.1%
Leukotriene receptor antagonist	10,589	27.5%	30.6%
Opioid agonist	7,435	0.8%	0.3%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.3%325

2 to 112.2%2,417

12 to 171.5%1,702

18 to 4413.8%15,279

45 to 6425.6%28,306

65 to 7411.9%13,115

75 and over6.3%6,963

Age not given38.3%42,267

Patient sex

Female64.5%71,145

Male25.7%28,354

Not given9.9%10,875

Grey bar: all 20,646,523 reports in the database. 55.8% of these reports give the United States as the country.

Questions about "Asthma"

What does "Asthma" mean in an adverse event report?

In plain language: asthma. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record asthma?

110,374 reports through June 2026 (0.5% of all reports), 9,638 of them in the latest 12 months.

Which drugs appear most often in these reports?

Dupixent (15,469), Prednisone (10,518), Symbicort (7,849), Albuterol sulfate (7,840) and Xolair (7,561). Drugs with many reports overall lead almost every term's list. 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."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

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. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.