MedDRA preferred term · a respiratory infection

Respiratory tract infection: adverse event reports recording this term

25,575 reports to FDA record it, 2004–2026; 0.1% 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.

25,575
reports recording the term: 0.1% of all reports; 1,846
reports, 12 months to June 2026: 1,978 in the 12 months before; 81.6%
marked serious by the reporter: 57.4% across all reports; 11.1%
record death among outcomes, as reported: 9.1% across all reports

"Respiratory tract infection" (in plain words, a respiratory infection) is a MedDRA preferred term recorded in 25,575 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,846 reports recorded it in the 12 months to June 2026, close to the 1,978 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, 81.6% are marked serious, 11.1% include death among the outcomes and 40.5% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Enbrel, Humira and Rituximab. 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
Enbrel	Tumor necrosis factor blocker	1,286	0.2%
Humira	—	1,236	0.2%
Rituximab	CD20-directed cytolytic antibody	1,234	0.8%
Prednisone	Corticosteroid	1,206	0.7%
Methotrexate	Folate analog metabolic inhibitor	800	0.4%
Dexamethasone	Corticosteroid	737	0.6%
Dupixent	Interleukin-4 receptor alpha antagonist	701	0.2%
Omalizumab	Anti-IgE	696	6.7%
Revlimid	Thalidomide analog	633	0.2%
Singulair	Leukotriene receptor antagonist	546	2.9%
Xolair	Anti-IgE	522	0.8%
Cosentyx	Interleukin-17A antagonist	513	0.3%
Advair Hfa	Corticosteroid	507	2.6%
Aspirin	Nonsteroidal anti-inflammatory drug	501	0.7%
Cyclophosphamide	Alkylating drug	499	0.4%
Human immunoglobulin g	Human immunoglobulin G	490	2.9%
Clonazepam	Benzodiazepine	454	1.2%
Ergocalciferol	Provitamin D2 compound	447	4.4%
Xeljanz	Janus kinase inhibitor	434	0.3%
Theophylline	Methylxanthine	382	9.4%
Risedronate sodium	Bisphosphonate	363	10.3%
Folate Sodium	—	360	40.6%
Mepolizumab	Interleukin-5 antagonist	347	2.1%
Beclomethasone	—	345	28.9%
Tramadol hydrochloride	Opioid agonist	341	1.2%

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 0.1% 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	4,247	0.5%	0.1%
Tumor necrosis factor blocker	2,797	0.3%	0.2%
CD20-directed cytolytic antibody	1,768	0.6%	0.3%
Anti-IgE	1,222	1.5%	0.8%
Thalidomide analog	1,204	0.2%	0.3%
Nonsteroidal anti-inflammatory drug	1,135	0.2%	0%
Fluoroquinolone antibacterial	1,036	1.2%	0.9%
Folate analog metabolic inhibitor	1,027	0.3%	0.1%
Kinase inhibitor	942	0.1%	0%
Leukotriene receptor antagonist	860	2.2%	2%

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%383

2 to 112.7%692

12 to 171.3%329

18 to 4411.7%2,982

45 to 6424.5%6,278

65 to 7415.3%3,921

75 and over10.5%2,675

Age not given32.5%8,315

Patient sex

Female58.1%14,867

Male31.4%8,026

Not given10.5%2,682

Grey bar: all 20,646,523 reports in the database. 46.4% of these reports give the United States as the country.

Questions about "Respiratory tract infection"

What does "Respiratory tract infection" mean in an adverse event report?

In plain language: a respiratory infection. 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 respiratory tract infection?

25,575 reports through June 2026 (0.1% of all reports), 1,846 of them in the latest 12 months.

Which drugs appear most often in these reports?

Enbrel (1,286), Humira (1,236), Rituximab (1,234), Prednisone (1,206) and Methotrexate (800). 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.