MedDRA preferred term · a problem preparing the product

Product preparation issue: adverse event reports recording this term

5,752 reports to FDA record it, 2009–2026; 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.

5,752
reports recording the term: 0% of all reports; 1,036
reports, 12 months to June 2026: 601 in the 12 months before; 20.9%
marked serious by the reporter: 57.4% across all reports; 1.1%
record death among outcomes, as reported: 9.1% across all reports

"Product preparation issue" (in plain words, a problem preparing the product) is a MedDRA preferred term recorded in 5,752 adverse event reports received by FDA, 0% of the database, from September 2009 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

1,036 reports recorded it in the 12 months to June 2026, up 72% from 601 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, 20.9% are marked serious, 1.1% include death among the outcomes and 7.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are BOTOX Cosmetic, Dupixent and Xeomin. 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
BOTOX Cosmetic	Acetylcholine release inhibitor	599	1.5%
Dupixent	Interleukin-4 receptor alpha antagonist	326	0.1%
Xeomin	Acetylcholine release inhibitor	206	3.8%
Kcentra	—	181	35.6%
Diacomit	—	173	13.5%
Haegarda	—	149	3.1%
Genotropin	—	136	0.3%
Orencia	Selective T cell costimulation modulator	133	0.1%
Dysport	Acetylcholine release inhibitor	123	1.9%
Egrifta Sv	—	120	8.1%
Botox	Acetylcholine release inhibitor	104	0.4%
Remicade	Tumor necrosis factor blocker	95	0.1%
Berinert	—	80	1.7%
Beriplex P/N	—	63	11.1%
Sterile diluent	Insulin analog	62	1.9%
Eligard	Gonadotropin releasing hormone receptor agonist	59	0.1%
Nulojix	Selective T cell costimulation blocker	58	3.1%
Jeuveau	Acetylcholine release inhibitor	54	1.4%
Cefuroxime axetil	Cephalosporin antibacterial	50	2.4%
Yervoy	CTLA-4-directed blocking antibody	50	0.2%
Praluent	PCSK9 inhibitor	44	0.2%
Lumryz	Central nervous system depressant	43	1.2%
Humatrope	—	41	0.7%
Benlysta	B lymphocyte stimulator-specific inhibitor	40	0.2%
Noctiva	—	39	7.9%

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% 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
Acetylcholine release inhibitor	1,088	1.2%	1.5%
Interleukin-4 receptor alpha antagonist	331	0.1%	0.1%
Selective T cell costimulation modulator	133	0.1%	0.1%
Tumor necrosis factor blocker	132	0%	0%
Osmotic laxative	77	0.1%	0%
PCSK9 inhibitor	72	0%	0%
Insulin analog	66	0%	0%
Central nervous system depressant	65	0.1%	0.1%
Gonadotropin releasing hormone receptor agonist	62	0.1%	0%
Cephalosporin antibacterial	60	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 21.3%74

2 to 114%231

12 to 172.4%139

18 to 449.9%571

45 to 6410.6%607

65 to 746.2%354

75 and over5.3%303

Age not given60.4%3,473

Patient sex

Female36.6%2,103

Male20.6%1,183

Not given42.9%2,466

Grey bar: all 20,646,523 reports in the database. 83.4% of these reports give the United States as the country.

Questions about "Product preparation issue"

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

In plain language: a problem preparing the product. 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 preparation issue?

5,752 reports through June 2026 (0% of all reports), 1,036 of them in the latest 12 months.

Which drugs appear most often in these reports?

BOTOX Cosmetic (599), Dupixent (326), Xeomin (206), Kcentra (181) and Diacomit (173). 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.