MedDRA preferred term

Product complaint: adverse event reports recording this term

24,630 reports to FDA record it, 2009–2026; 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.

24,630
reports recording the term: 0.1% of all reports; 2,789
reports, 12 months to June 2026: 3,044 in the 12 months before; 13.8%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

"Product complaint" is a MedDRA preferred term recorded in 24,630 adverse event reports received by FDA, 0.1% of the database, from December 2009 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,789 reports recorded it in the 12 months to June 2026, close to the 3,044 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, 13.8% are marked serious, 0.6% include death among the outcomes and 4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Trelegy Ellipta, Breo Ellipta and Nucala. 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
Trelegy Ellipta	Anticholinergic	2,872	10.7%
Breo Ellipta	Corticosteroid	1,831	8.2%
Nucala	Interleukin-5 antagonist	1,573	5.1%
Albuterol sulfate	beta2-Adrenergic agonist	1,323	3%
Benlysta	B lymphocyte stimulator-specific inhibitor	1,316	5.1%
Anoro Ellipta	Anticholinergic	1,183	9.4%
Ventolin Hfa	beta2-Adrenergic agonist	1,010	4.5%
Advair Diskus	Corticosteroid	851	4.1%
Flovent	Corticosteroid	497	4.6%
Actemra	Interleukin-6 receptor antagonist	406	0.5%
Abreva	Non-Standardized chemical allergen	366	2.7%
Sumatriptan succinate	Serotonin-1b and Serotonin-1d receptor agonist	351	9.8%
Xolair	Anti-IgE	327	0.5%
Nicoderm Cq	Cholinergic nicotinic agonist	324	2.1%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	275	0.5%
Arnuity Ellipta	Corticosteroid	274	10.5%
Advair Hfa	Corticosteroid	267	1.4%
Incruse Ellipta	Anticholinergic	264	5.8%
Fluticasone Propionate Salmeterol Xinafoate	—	240	7.5%
Cabotegravir	—	221	2.8%
Flonase Sensimist Allergy Relief	—	212	10.5%
Voltaren Arthritis Pain	—	207	1.2%
Cabenuva	—	204	3.4%
Flonase Allergy Relief	—	204	6%
Alli	Intestinal lipase inhibitor	191	0.9%

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 0.1% 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
Anticholinergic	4,407	2.8%	0%
Corticosteroid	4,255	0.5%	0%
beta2-Adrenergic agonist	2,415	2.6%	0%
Interleukin-5 antagonist	1,683	3.6%	0.7%
B lymphocyte stimulator-specific inhibitor	1,341	4.4%	2.8%
Nonsteroidal anti-inflammatory drug	661	0.1%	0%
Cholinergic nicotinic agonist	653	1.2%	0.8%
Interleukin-6 receptor antagonist	461	0.3%	0.1%
Serotonin-1b and Serotonin-1d receptor agonist	459	1.6%	0%
Anti-IgE	385	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 20.1%29

2 to 110.8%204

12 to 170.6%156

18 to 446.8%1,676

45 to 6411.8%2,909

65 to 748.7%2,133

75 and over7.8%1,927

Age not given63.3%15,596

Patient sex

Female58.6%14,428

Male29.1%7,172

Not given12.3%3,030

Grey bar: all 20,646,523 reports in the database. 93.8% of these reports give the United States as the country.

Questions about "Product complaint"

What does "Product complaint" 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 product complaint?

24,630 reports through June 2026 (0.1% of all reports), 2,789 of them in the latest 12 months.

Which drugs appear most often in these reports?

Trelegy Ellipta (2,872), Breo Ellipta (1,831), Nucala (1,573), Albuterol sulfate (1,323) and Benlysta (1,316). 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.