MedDRA preferred term

Product preparation error: adverse event reports recording this term

20,438 reports to FDA record it, 2006–2026; 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.

20,438
reports recording the term: 0.1% of all reports; 1,789
reports, 12 months to June 2026: 2,159 in the 12 months before; 10.8%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

20,438 reports in FDA's adverse event database record the MedDRA term "Product preparation error": 0.1% of all reports received between August 2006 and June 2026. Coders pick the term that best matches the reporter's description.

1,789 reports recorded it in the 12 months to June 2026, down 17% from 2,159 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, 10.8% are marked serious, 0.6% include death among the outcomes and 3.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are BOTOX Cosmetic, Dupixent and Repatha. 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	3,250	8.4%
Dupixent	Interleukin-4 receptor alpha antagonist	2,951	0.6%
Repatha	PCSK9 inhibitor	2,831	1.8%
Suboxone	Opioid antagonist	771	3.7%
Dysport	Acetylcholine release inhibitor	749	11.4%
Tanzeum	—	691	8.2%
Albuterol sulfate	beta2-Adrenergic agonist	552	1.2%
Neulasta	Leukocyte growth factor	517	0.6%
Eligard	Gonadotropin releasing hormone receptor agonist	450	1%
Praluent	PCSK9 inhibitor	412	1.8%
Botox	Acetylcholine release inhibitor	389	1.3%
Xyrem	Central nervous system depressant	215	0.4%
Orencia	Selective T cell costimulation modulator	201	0.2%
Remicade	Tumor necrosis factor blocker	154	0.1%
Dupilumab	Interleukin-4 receptor alpha antagonist	133	1%
Vivitrol	—	131	0.5%
Sterile diluent	Insulin analog	122	3.8%
Device	—	121	2.4%
Blincyto	—	107	1.7%
Aimovig	—	102	0.2%
Enbrel	Tumor necrosis factor blocker	97	0%
Definity	Contrast agent for ultrasound imaging	94	1.7%
Kyprolis	Proteasome inhibitor	92	0.8%
Actemra	Interleukin-6 receptor antagonist	90	0.1%
Nulojix	Selective T cell costimulation blocker	85	4.6%

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
Acetylcholine release inhibitor	4,396	5%	0.7%
PCSK9 inhibitor	3,245	1.8%	1%
Interleukin-4 receptor alpha antagonist	3,084	0.6%	0.8%
Opioid antagonist	781	2.5%	0%
beta2-Adrenergic agonist	581	0.6%	0%
Leukocyte growth factor	541	0.5%	0.1%
Gonadotropin releasing hormone receptor agonist	452	0.7%	0%
Tumor necrosis factor blocker	334	0%	0%
Central nervous system depressant	235	0.3%	0.2%
Insulin analog	207	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 20.6%130

2 to 111.9%386

12 to 171.5%316

18 to 4412.6%2,579

45 to 6421.3%4,363

65 to 7410.5%2,136

75 and over7.1%1,450

Age not given44.4%9,078

Patient sex

Female50.2%10,251

Male27.9%5,698

Not given22%4,489

Grey bar: all 20,646,523 reports in the database. 94.4% of these reports give the United States as the country.

Questions about "Product preparation error"

What does "Product preparation error" 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 preparation error?

20,438 reports through June 2026 (0.1% of all reports), 1,789 of them in the latest 12 months.

Which drugs appear most often in these reports?

BOTOX Cosmetic (3,250), Dupixent (2,951), Repatha (2,831), Suboxone (771) and Dysport (749). 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.