Product leakage adverse event reports that record this term

Kind of term: MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From June 2014 to June 2026, FDA received 5,263 adverse event reports that record the MedDRA preferred term Product leakage. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 814 reports in the 12 months to June 2026 and 667 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 112 drug pages with 5 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Product leakage name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	28
Abilify Maintena		15
Absorica LD	Retinoid	9
Activase		6
Adalimumab	Tumor necrosis factor blocker	9
Adalimumab-aaty		9
Advil	Nonsteroidal anti-inflammatory drug	5
Albuterol	beta2-Adrenergic agonist	8
Albuterol sulfate	beta2-Adrenergic agonist	6
Aleve	Nonsteroidal anti-inflammatory drug	28
Arcalyst		5
Aristada	Atypical antipsychotic	31
Asmanex	Corticosteroid	26
Azelastine hydrochloride	Histamine-1 receptor antagonist	50
Bimekizumab		9
Bimzelx		71
Blincyto		13
Butrans	Partial opioid agonist	9
Bydureon		17
Bydureon Bcise		8
Carboplatin	Platinum-based drug	7
Certolizumab pegol	Tumor necrosis factor blocker	12
Cimzia	Tumor necrosis factor blocker	11
Clariscan	Gadolinium-based contrast agent	8
Clobetasol propionate	Corticosteroid	8
Cosentyx	Interleukin-17A antagonist	145
Cuvitru	Human immunoglobulin G	5
Cyclophosphamide	Alkylating drug	7
Device		10
Dianeal		5
Dianeal for Peritoneal Dialysis		6
Doxorubicin	Anthracycline topoisomerase inhibitor	6
Dupixent	Interleukin-4 receptor alpha antagonist	17
Eligard	Gonadotropin releasing hormone receptor agonist	326
Epinephrine Bitartrate Lidocaine Hydrochloride		26
Estradiol	Estrogen	13
Etoposide	Topoisomerase inhibitor	7
Evrysdi	Survival of motor neuron 2 splicing modifier	5
Extavia		12
Fentanyl	Opioid agonist	16
Fentanyl Transdermal System		19
Fiasp	Insulin analog	10
Firmagon		11
Gemcitabine	Nucleoside metabolic inhibitor	6
Genotropin		32
Guselkumab	Interleukin-23 antagonist	25
Hizentra	Human immunoglobulin G	35
Human immunoglobulin g	Human immunoglobulin G	34
Human Immunoglobulin G Hyaluronidase Recombinant Human		12
Humira		22
Ifosfamide	Alkylating drug	6
Ilumya	Interleukin-23 antagonist	7
Infliximab	Tumor necrosis factor blocker	13
Invega Sustenna	Atypical antipsychotic	56
Invega Trinza	Atypical antipsychotic	23
Ipratropium bromide	Anticholinergic	14
Kesimpta	CD20-directed cytolytic antibody	31
Lanreotide acetate	Somatostatin analog	7
Lantus	Insulin analog	6
Latanoprost	Prostaglandin analog	8
Levulan Kerastick		13
Lidocaine	Amide local anesthetic	8
Natpara		10
Novorapid		345
Omega-3-acid ethyl esters		11
Omnitrope	Recombinant human growth hormone	35
Onapgo	Dopaminergic agonist	7
Opsumit	Endothelin receptor antagonist	6
Orencia	Selective T cell costimulation modulator	93
Orenitram	Prostacycline vasodilator	6
Oxervate		5
Ozempic	GLP-1 receptor agonist	13
Pantoprazole	Proton pump inhibitor	9
Polatuzumab vedotin		7
Prednisolone	Corticosteroid	7
Prednisolone acetate	Corticosteroid	6
Pregnyl		7
Proctofoam Hc		43
Proventil		5
Radicava		10
Remicade	Tumor necrosis factor blocker	10
Remodulin	Prostacycline vasodilator	207
Risperdal Consta		44
Rituximab	CD20-directed cytolytic antibody	7
Rocklatan	Prostaglandin analog	7
Sandostatin LAR Depot		34
Simponi	Tumor necrosis factor blocker	89
Spravato		6
Stelara	Interleukin-12 antagonist	364
Sterile water		6
Tacrolimus	Calcineurin inhibitor immunosuppressant	14
Tadalafil	Phosphodiesterase 5 inhibitor	5
Teduglutide	GLP-2 analog	18
Testosterone	Androgen	12
Tezspire		19
Timolol maleate	beta-Adrenergic blocker	5
Tremfya	Interleukin-23 antagonist	848
Treprostinil	Prostacycline vasodilator	22
Tresiba	Insulin analog	12
Tyvaso	Prostacycline vasodilator	8
Vascepa		95
Vedolizumab	Integrin receptor antagonist	15
Vincristine		7
Vivitrol		26
Wegovy	GLP-1 receptor agonist	19
Winrevair		5
Xembify	Human immunoglobulin G	24
Xolair	Anti-IgE	16
Xolair PFS	Anti-IgE	5
Yuflyma		9
Zecuity		268
Zymfentra	Tumor necrosis factor blocker	5

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 50 pharmacologic classes with 5 or more reports that record this term. The rows are in order of name.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Product leakage name, in order of name
Class	Reports with this term
Alkylating drug	13
Amide local anesthetic	8
Androgen	12
Anthracycline topoisomerase inhibitor	9
Anti-IgE	21
Anticholinergic	16
Atypical antipsychotic	118
Azole antifungal	6
beta-Adrenergic blocker	5
beta2-Adrenergic agonist	14
Calcineurin inhibitor immunosuppressant	16
Carbonic anhydrase inhibitor	8
CD20-directed cytolytic antibody	38
CD38-directed cytolytic antibody	6
Corticosteroid	66
Dopaminergic agonist	7
Endothelin receptor antagonist	6
Estrogen	16
General anesthetic	5
GLP-1 receptor agonist	40
GLP-2 analog	18
Gonadotropin releasing hormone receptor agonist	328
Histamine-1 receptor antagonist	52
Human immunoglobulin G	100
Insulin analog	36
Integrin receptor antagonist	15
Interleukin-12 antagonist	367
Interleukin-17A antagonist	147
Interleukin-23 antagonist	882
Interleukin-4 receptor alpha antagonist	17
Interleukin-5 receptor alpha-directed cytolytic antibody	6
Nonsteroidal anti-inflammatory drug	43
Nucleoside metabolic inhibitor	6
Opioid agonist	16
Osmotic laxative	8
Partial opioid agonist	9
Phosphodiesterase 5 inhibitor	7
Platinum-based drug	7
Programmed death Receptor-1 blocking antibody	9
Prostacycline vasodilator	246
Prostaglandin analog	20
Proton pump inhibitor	9
Recombinant human growth hormone	35
Retinoid	6
Selective T cell costimulation modulator	121
Serotonin-1b and Serotonin-1d receptor agonist	5
Somatostatin analog	7
Survival of motor neuron 2 splicing modifier	5
Topoisomerase inhibitor	7
Tumor necrosis factor blocker	150

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Product leakage, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Product leakage
Age	Reports	Share
Under 2	3	0.1%
2 to 11	74	1.4%
12 to 17	128	2.4%
18 to 44	908	17.3%
45 to 64	1,029	19.6%
65 to 74	371	7%
75 and over	247	4.7%
Age not given	2,503	47.6%

Sex of the patient in the reports that record Product leakage
Sex	Reports	Share
Female	2,742	52.1%
Male	1,475	28%
Unknown or not given	1,046	19.9%

Age and sex are as the report gives them. 82.2% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Product leakage: adverse event reports that record this term. https://reportedreactions.com/reaction/product-leakage/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Product leakage mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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