Infusion site extravasation adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: infusion fluid leaked into surrounding tissue

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 November 2005 to June 2026, FDA received 6,137 adverse event reports that record the MedDRA preferred term Infusion site extravasation. In plain words, the term means: infusion fluid leaked into surrounding tissue. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 321 reports in the 12 months to June 2026 and 302 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.

Plain meaning

Infusion fluid leaked into surrounding tissue. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

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

Drugs in these reports

The table has the 102 drug pages with 10 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 Infusion site extravasation name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	13
Aclasta		18
Actemra	Interleukin-6 receptor antagonist	36
Activase		10
Acyclovir	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	39
Aldurazyme	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	18
Alemtuzumab	CD52-directed cytolytic antibody	48
Avelox		10
Bamlanivimab		45
Benlysta	B lymphocyte stimulator-specific inhibitor	13
Boniva		13
Carboplatin	Platinum-based drug	23
Cerezyme	Hydrolytic lysosomal glucocerebroside-specific enzyme	10
Ciprofloxacin	Fluoroquinolone antibacterial	10
Cleviprex	Dihydropyridine calcium channel blocker	10
Covid-19 Vaccine		11
Cuvitru	Human immunoglobulin G	72
Cyclophosphamide	Alkylating drug	18
Dalvance		15
Darzalex	CD38-directed cytolytic antibody	34
Definity	Contrast agent for ultrasound imaging	12
Docetaxel	Microtubule inhibitor	32
Doxorubicin	Anthracycline topoisomerase inhibitor	16
Elaprase	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	17
Enfortumab vedotin		39
Entyvio	Integrin receptor antagonist	71
Erbitux	Epidermal growth factor receptor antagonist	21
Etesevimab		14
Exondys 51	Antisense oligonucleotide	14
Fabrazyme	Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme	53
Fentanyl	Opioid agonist	12
Feraheme	Parenteral iron replacement	44
Ferinject		91
Ferric carboxymaltose	Parenteral iron replacement	11
Fluorouracil	Nucleoside metabolic inhibitor	18
Fosphenytoin sodium	Anti-epileptic agent	10
GAMMAGARD Liquid	Human immunoglobulin G	78
Gamunex C		10
Gamunex-C	Human immunoglobulin G	11
Glassia	Human alpha-1 proteinase inhibitor	16
Hizentra	Human immunoglobulin G	411
Human immunoglobulin g	Human immunoglobulin G	186
Human Immunoglobulin G Hyaluronidase Recombinant Human		56
Human Immunoglobulin Hyaluronidase		26
Human Normal Immunoglobulin Liquid		12
Hyqvia		118
Idursulfase	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	25
Inflectra	Tumor necrosis factor blocker	333
Infliximab	Tumor necrosis factor blocker	255
Infliximab Recombinant		14
Injectafer	Parenteral iron replacement	24
Iopamidol	Radiographic contrast agent	12
Ixifi		11
Kcentra		18
Keytruda	Programmed death Receptor-1 blocking antibody	34
Kyprolis	Proteasome inhibitor	47
Letairis	Endothelin receptor antagonist	10
Lexiscan(r) (regadenoson)		55
Libtayo		11
Lumizyme	Hydrolytic lysosomal glycogen-specific enzyme	13
Methotrexate	Folate analog metabolic inhibitor	17
Methylprednisolone sodium succinate	Corticosteroid	15
Nexviazyme	Hydrolytic lysosomal glycogen-specific enzyme	12
Ocrevus	CD20-directed cytolytic antibody	39
Omnipaque	Radiographic contrast agent	48
Onpattro	Small interfering RNA	45
Opdivo	Programmed death Receptor-1 blocking antibody	17
Orbactiv		14
Orencia	Selective T cell costimulation modulator	37
Oxaliplatin	Platinum-based drug	20
Paclitaxel	Microtubule inhibitor	11
Pembrolizumab	Programmed death Receptor-1 blocking antibody	11
Prednisone	Corticosteroid	22
Privigen	Human immunoglobulin G	56
Prolastin-C Liquid	Human alpha-1 proteinase inhibitor	21
Provenge		27
Reclast	Bisphosphonate	20
Remdesivir	SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	72
Remicade	Tumor necrosis factor blocker	252
Remodulin	Prostacycline vasodilator	250
Renflexis	Tumor necrosis factor blocker	14
Rituxan	CD20-directed cytolytic antibody	33
Rituximab	CD20-directed cytolytic antibody	60
Ruxience	CD20-directed cytolytic antibody	34
Simponi Aria	Tumor necrosis factor blocker	14
Skyrizi	Interleukin-23 antagonist	12
Sodium chloride	Osmotic laxative	12
Soliris	Complement inhibitor	61
Sotrovimab		30
Torisel		19
Treanda	Alkylating drug	50
Treprostinil	Prostacycline vasodilator	11
Truxima	CD20-directed cytolytic antibody	13
Tysabri	Integrin receptor antagonist	172
Vancomycin	Glycopeptide antibacterial	15
Vancomycin hydrochloride	Glycopeptide antibacterial	10
Vedolizumab	Integrin receptor antagonist	129
Veklury	SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	63
Venofer (iron sucrose)	Parenteral iron replacement	49
Vimizim	Hydrolytic lysosomal glycosaminoglycan-specific enzyme	31
Vyepti		42
Vyvgart	Neonatal Fc receptor blocker	11

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 48 pharmacologic classes with 10 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 Infusion site extravasation name, in order of name
Class	Reports with this term
Alkylating drug	92
Anthracycline topoisomerase inhibitor	23
Anti-epileptic agent	14
Antisense oligonucleotide	21
B lymphocyte stimulator-specific inhibitor	13
Bisphosphonate	23
Blood coagulation factor	10
CD20-directed cytolytic antibody	189
CD38-directed cytolytic antibody	37
CD52-directed cytolytic antibody	55
Complement inhibitor	66
Contrast agent for ultrasound imaging	12
Corticosteroid	62
Endothelin receptor antagonist	27
Epidermal growth factor receptor antagonist	25
Factor Xa inhibitor	15
Fluoroquinolone antibacterial	12
Folate analog metabolic inhibitor	19
General anesthetic	12
Glycopeptide antibacterial	25
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	41
Histamine-1 receptor antagonist	14
Human alpha-1 proteinase inhibitor	42
Human immunoglobulin G	816
Hydrolytic lysosomal glucocerebroside-specific enzyme	15
Hydrolytic lysosomal glycogen-specific enzyme	25
Hydrolytic lysosomal glycosaminoglycan-specific enzyme	95
Hydrolytic lysosomal neutral glycosphingolipid-specific enzyme	57
Integrin receptor antagonist	372
Interleukin-23 antagonist	14
Interleukin-6 receptor antagonist	36
Microtubule inhibitor	45
Neonatal Fc receptor blocker	11
Nucleoside metabolic inhibitor	36
Opioid agonist	19
Osmotic laxative	17
Parenteral iron replacement	138
Penicillin-class antibacterial	11
Platinum-based drug	48
Programmed death Receptor-1 blocking antibody	70
Prostacycline vasodilator	267
Proteasome inhibitor	51
Radiographic contrast agent	88
SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	135
Selective T cell costimulation modulator	50
Small interfering RNA	45
Tumor necrosis factor blocker	877
Vascular endothelial growth factor inhibitor	18

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

Reports by month

Reports that record Infusion site extravasation, 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 Infusion site extravasation
Age	Reports	Share
Under 2	85	1.4%
2 to 11	160	2.6%
12 to 17	102	1.7%
18 to 44	831	13.5%
45 to 64	1,085	17.7%
65 to 74	650	10.6%
75 and over	516	8.4%
Age not given	2,708	44.1%

Sex of the patient in the reports that record Infusion site extravasation
Sex	Reports	Share
Female	2,898	47.2%
Male	1,861	30.3%
Unknown or not given	1,378	22.5%

Age and sex are as the report gives them. 67.6% 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. Infusion site extravasation: adverse event reports that record this term. https://reportedreactions.com/reaction/infusion-site-extravasation/ 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 Infusion site extravasation mean in an adverse event report?

In plain words: infusion fluid leaked into surrounding tissue. 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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