MedDRA preferred term · the product was not available

Product availability issue: adverse event reports recording this term

22,123 reports to FDA record it, 2012–2026; 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.

22,123
reports recording the term: 0.1% of all reports; 2,390
reports, 12 months to June 2026: 3,306 in the 12 months before; 48%
marked serious by the reporter: 57.4% across all reports; 1.9%
record death among outcomes, as reported: 9.1% across all reports

"Product availability issue" (in plain words, the product was not available) is a MedDRA preferred term recorded in 22,123 adverse event reports received by FDA, 0.1% of the database, from March 2012 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,390 reports recorded it in the 12 months to June 2026, down 28% from 3,306 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, 48% are marked serious, 1.9% include death among the outcomes and 16.8% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Jakafi, Vyvanse and Cimzia. 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
Jakafi	Janus kinase inhibitor	1,911	3.5%
Vyvanse	Central nervous system stimulant	1,419	8.1%
Cimzia	Tumor necrosis factor blocker	982	1.1%
Bimzelx	—	716	4.2%
Vedolizumab	Integrin receptor antagonist	715	1.2%
Adderall	Central nervous system stimulant	576	5.7%
Lisdexamfetamine dimesylate	Central nervous system stimulant	476	11.1%
Certolizumab pegol	Tumor necrosis factor blocker	443	1.6%
Cosentyx	Interleukin-17A antagonist	394	0.3%
Opzelura	Janus kinase inhibitor	355	10.8%
Concerta	Central nervous system stimulant	315	2.9%
Entresto	Angiotensin 2 receptor blocker	278	0.3%
Lacosamide	—	268	1.8%
Brivaracetam	—	236	6%
Tice Bcg	—	235	13.7%
Omnitrope	Recombinant human growth hormone	217	1.9%
Enzalutamide	Androgen receptor inhibitor	209	1.9%
Tegretol	Mood stabilizer	201	1.2%
Idursulfase	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	194	8.9%
Gemtesa	beta3-Adrenergic agonist	163	2.8%
Mesalamine	Aminosalicylate	157	1.8%
Human immunoglobulin g	Human immunoglobulin G	155	0.9%
Teduglutide	GLP-2 analog	153	1.7%
Briviact	—	149	4.9%
Quviviq	Orexin receptor antagonist	146	6.3%

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
Central nervous system stimulant	3,093	2.8%	0.3%
Janus kinase inhibitor	2,337	0.7%	0%
Tumor necrosis factor blocker	1,764	0.2%	0%
Integrin receptor antagonist	747	0.3%	0.1%
Atypical antipsychotic	486	0.1%	0%
Angiotensin 2 receptor blocker	482	0.2%	0.1%
Corticosteroid	475	0.1%	0%
Kinase inhibitor	429	0.1%	0%
Interleukin-17A antagonist	416	0.2%	0.2%
Benzodiazepine	295	0.1%	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 20.1%32

2 to 112.2%477

12 to 171.4%305

18 to 4411.7%2,579

45 to 6413.7%3,021

65 to 746.7%1,492

75 and over5.4%1,193

Age not given58.9%13,024

Patient sex

Female46.5%10,282

Male28.7%6,341

Not given24.9%5,500

Grey bar: all 20,646,523 reports in the database. 71% of these reports give the United States as the country.

Questions about "Product availability issue"

What does "Product availability issue" mean in an adverse event report?

In plain language: the product was not available. 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 availability issue?

22,123 reports through June 2026 (0.1% of all reports), 2,390 of them in the latest 12 months.

Which drugs appear most often in these reports?

Jakafi (1,911), Vyvanse (1,419), Cimzia (982), Bimzelx (716) and Vedolizumab (715). 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.