MedDRA preferred term

Product supply issue: adverse event reports recording this term

6,963 reports to FDA record it, 2012–2026; 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.

6,963
reports recording the term: 0% of all reports; 628
reports, 12 months to June 2026: 738 in the 12 months before; 55.5%
marked serious by the reporter: 57.4% across all reports; 3.1%
record death among outcomes, as reported: 9.1% across all reports

"Product supply issue" is a MedDRA preferred term recorded in 6,963 adverse event reports received by FDA, 0% of the database, from March 2012 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

628 reports recorded it in the 12 months to June 2026, down 15% from 738 in 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, 55.5% are marked serious, 3.1% include death among the outcomes and 20.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Cosentyx, Epidiolex and Otezla. 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
Cosentyx	Interleukin-17A antagonist	362	0.2%
Epidiolex	—	298	1.7%
Otezla	Phosphodiesterase 4 inhibitor	277	0.2%
Revlimid	Thalidomide analog	228	0.1%
Kesimpta	CD20-directed cytolytic antibody	159	0.5%
Lenalidomide	Thalidomide analog	131	0.2%
Kisqali	Kinase inhibitor	110	0.4%
Pomalyst	Thalidomide analog	108	0.1%
Trileptal	Anti-epileptic agent	106	1.4%
Tegretol	Mood stabilizer	96	0.6%
Haegarda	—	95	2%
Aimovig	—	91	0.2%
Eltrombopag olamine	Thrombopoietin receptor agonist	91	2.9%
Enbrel	Tumor necrosis factor blocker	90	0%
Hizentra	Human immunoglobulin G	88	0.4%
Xifaxan	Rifamycin antibacterial	81	0.6%
Repatha	PCSK9 inhibitor	73	0%
Xolair	Anti-IgE	72	0.1%
Tice Bcg	—	64	3.7%
Tacrolimus	Calcineurin inhibitor immunosuppressant	59	0.1%
Human immunoglobulin g	Human immunoglobulin G	58	0.3%
Opsumit	Endothelin receptor antagonist	53	0.1%
Gilenya	Sphingosine 1-phosphate receptor modulator	52	0.1%
Entresto	Angiotensin 2 receptor blocker	50	0%
Ilaris	—	50	0.5%

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
Thalidomide analog	469	0.1%	0.1%
Interleukin-17A antagonist	372	0.2%	0.1%
Kinase inhibitor	283	0%	0%
Phosphodiesterase 4 inhibitor	277	0.2%	0%
Tumor necrosis factor blocker	236	0%	0%
CD20-directed cytolytic antibody	196	0.1%	0%
Human immunoglobulin G	168	0.2%	0.1%
Thrombopoietin receptor agonist	136	0.4%	0%
Angiotensin 2 receptor blocker	125	0.1%	0%
Anti-epileptic agent	122	0%	0%

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 20.2%11

2 to 111.7%115

12 to 171.4%100

18 to 4413.7%953

45 to 6421.5%1,499

65 to 7411.2%779

75 and over8.5%590

Age not given41.9%2,916

Patient sex

Female53.9%3,753

Male33.6%2,337

Not given12.5%873

Grey bar: all 20,646,523 reports in the database. 66.2% of these reports give the United States as the country.

Questions about "Product supply issue"

What does "Product supply issue" 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 supply issue?

6,963 reports through June 2026 (0% of all reports), 628 of them in the latest 12 months.

Which drugs appear most often in these reports?

Cosentyx (362), Epidiolex (298), Otezla (277), Revlimid (228) and Kesimpta (159). 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.