MedDRA preferred term

Respiration abnormal: adverse event reports recording this term

6,738 reports to FDA record it, 2004–2026; 0% 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.

6,738
reports recording the term: 0% of all reports; 513
reports, 12 months to June 2026: 495 in the 12 months before; 65.8%
marked serious by the reporter: 57.4% across all reports; 7.7%
record death among outcomes, as reported: 9.1% across all reports

"Respiration abnormal" is a MedDRA preferred term recorded in 6,738 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

513 reports recorded it in the 12 months to June 2026, close to the 495 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, 65.8% are marked serious, 7.7% include death among the outcomes and 38% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Dupixent, Orkambi and Tiotropium bromide. 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	471	0.1%
Orkambi	Cystic fibrosis transmembrane conductance regulator potentiator	188	2.3%
Tiotropium bromide	Anticholinergic	175	0.2%
Prednisone	Corticosteroid	145	0.1%
Tyvaso	Prostacycline vasodilator	145	0.5%
Opsumit	Endothelin receptor antagonist	140	0.3%
Ipratropium bromide	Anticholinergic	132	1.6%
Symbicort	Corticosteroid	132	0.3%
Orenitram	Prostacycline vasodilator	131	0.8%
Remodulin	Prostacycline vasodilator	131	0.3%
Ambrisentan	Endothelin receptor antagonist	129	0.2%
Revlimid	Thalidomide analog	125	0%
Nucala	Interleukin-5 antagonist	119	0.4%
Albuterol	beta2-Adrenergic agonist	107	0.6%
Singulair	Leukotriene receptor antagonist	103	0.5%
Albuterol sulfate	beta2-Adrenergic agonist	102	0.2%
Adcirca	Phosphodiesterase 5 inhibitor	98	0.8%
Mepolizumab	Interleukin-5 antagonist	98	0.6%
Humira	—	93	0%
Advair Hfa	Corticosteroid	81	0.4%
Alvesco	—	79	1.8%
Fluoxetine	Serotonin reuptake inhibitor	77	0.3%
Combivent	—	75	0.6%
Furosemide	Loop diuretic	74	0.2%
Entresto	Angiotensin 2 receptor blocker	73	0.1%

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% 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	877	0.1%	0%
Interleukin-4 receptor alpha antagonist	495	0.1%	0.2%
Anticholinergic	493	0.3%	0.1%
Prostacycline vasodilator	484	0.4%	0.4%
Endothelin receptor antagonist	341	0.2%	0.2%
beta2-Adrenergic agonist	226	0.2%	0.1%
Opioid agonist	221	0%	0%
Interleukin-5 antagonist	217	0.5%	0.4%
Phosphodiesterase 5 inhibitor	206	0.2%	0.1%
Leukotriene receptor antagonist	199	0.5%	0.5%

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 21.5%102

2 to 112.2%151

12 to 171.6%111

18 to 4412.9%872

45 to 6421.1%1,422

65 to 7412.2%823

75 and over11.8%792

Age not given36.6%2,465

Patient sex

Female56.8%3,828

Male34.8%2,347

Not given8.4%563

Grey bar: all 20,646,523 reports in the database. 68.4% of these reports give the United States as the country.

Questions about "Respiration abnormal"

What does "Respiration abnormal" mean in an adverse event report?

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 respiration abnormal?

6,738 reports through June 2026 (0% of all reports), 513 of them in the latest 12 months.

Which drugs appear most often in these reports?

Dupixent (471), Orkambi (188), Tiotropium bromide (175), Prednisone (145) and Tyvaso (145). 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.