Injection site extravasation 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 January 2004 to June 2026, FDA received 12,301 adverse event reports that record the MedDRA preferred term Injection site extravasation. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 186 reports in the 12 months to June 2026 and 239 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 1,332 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 186 (under 0.1%) record this term. Reports for female patients were 61.4% of the reports that record this term and 52.7% of all drug reports.

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 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 140 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 Injection site extravasation name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	12
Actemra	Interleukin-6 receptor antagonist	138
Activase		19
Aimovig		120
Ajovy		165
Alteplase		10
Amlodipine	Calcium channel blocker	24
Atenolol	beta-Adrenergic blocker	13
Avastin	Vascular endothelial growth factor inhibitor	20
Avonex	Interferon beta	111
Azithromycin	Macrolide antimicrobial	18
Benlysta	B lymphocyte stimulator-specific inhibitor	22
Boniva		120
Bydureon		1,469
Bydureon 2mg Suspension		18
Bydureon Bcise		1,285
Byetta	GLP-1 receptor agonist	458
Byetta Pen Disposable		12
Calcium chloride	Blood coagulation factor	14
Ceftazidime	Cephalosporin antibacterial	32
Celebrex	Nonsteroidal anti-inflammatory drug	17
CellCept	Antimetabolite immunosuppressant	15
Cimzia	Tumor necrosis factor blocker	19
Ciprofloxacin	Fluoroquinolone antibacterial	23
Copaxone		29
Cosentyx	Interleukin-17A antagonist	110
Crestor	HMG-CoA reductase inhibitor	30
Cuvitru	Human immunoglobulin G	16
Darzalex	CD38-directed cytolytic antibody	17
Definity	Contrast agent for ultrasound imaging	11
Domperidone		26
Dotarem	Gadolinium-based contrast agent	10
Dupilumab	Interleukin-4 receptor alpha antagonist	14
Dupixent	Interleukin-4 receptor alpha antagonist	157
Eligard	Gonadotropin releasing hormone receptor agonist	28
Eloxatin		13
Emgality		30
Enbrel	Tumor necrosis factor blocker	1,517
Entyvio	Integrin receptor antagonist	19
Erythromycin		14
Esomeprazole	Proton pump inhibitor	17
Extavia		11
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	28
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	27
Faslodex	Estrogen receptor antagonist	21
Ferinject		11
Forteo	Parathyroid hormone analog	94
Furosemide	Loop diuretic	29
Gazyva	CD20-directed cytolytic antibody	12
Genotropin		82
Glatiramer acetate injection		27
Glatopa		58
Herceptin	HER2/neu receptor antagonist	13
Hizentra	Human immunoglobulin G	90
Humalog	Insulin analog	29
Human immunoglobulin g	Human immunoglobulin G	16
Humatrope		13
Humira		1,687
Humira 40 Mg/0 8 Ml Pen		28
Hyqvia		19
Ilaris		21
Inflectra	Tumor necrosis factor blocker	17
Infliximab	Tumor necrosis factor blocker	25
Injectafer	Parenteral iron replacement	11
Invega Sustenna	Atypical antipsychotic	30
Kadcyla		30
Kesimpta	CD20-directed cytolytic antibody	62
Lantus	Insulin analog	28
Lantus Solostar	Insulin analog	72
Levemir	Insulin analog	11
Lexiscan(r) (regadenoson)		356
Lisinopril	Angiotensin converting enzyme inhibitor	87
Magnevist		24
Makena		59
Metformin hcl	Biguanide	16
Methotrexate	Folate analog metabolic inhibitor	57
Methotrexate sodium	Folate analog metabolic inhibitor	10
Methylprednisolone	Corticosteroid	11
Methylprednisolone sodium succinate	Corticosteroid	13
Metoprolol	beta-Adrenergic blocker	11
Metoprolol tartrate	beta-Adrenergic blocker	17
Mycophenolate mofetil	Antimetabolite immunosuppressant	37
Neulasta	Leukocyte growth factor	21
Nexium	Proton pump inhibitor	10
Norepinephrine	Catecholamine	14
Ocrevus	CD20-directed cytolytic antibody	19
Octreotide	Somatostatin analog	13
Ofirmev		10
Omeprazole	Proton pump inhibitor	25
Omnipaque	Radiographic contrast agent	39
Omnitrope	Recombinant human growth hormone	116
Optiray	Radiographic contrast agent	23
Orencia	Selective T cell costimulation modulator	51
Ozempic	GLP-1 receptor agonist	41
Pantoprazole	Proton pump inhibitor	17
Pegasys	Interferon alpha	26
Perindopril		26
Piperacillin and tazobactam	Penicillin-class antibacterial	13
Piperacillin sodium,tazobactam sodium		13
Plaquenil	Antimalarial	32
Praluent	PCSK9 inhibitor	104
Prednisone	Corticosteroid	85
Prolia	RANK ligand inhibitor	22
Rebif	Interferon beta	20
Remicade	Tumor necrosis factor blocker	98
Remodulin	Prostacycline vasodilator	44
Repatha	PCSK9 inhibitor	186
Ribavirin	Nucleoside analog antiviral	14
Risperdal Consta		14
Rituxan	CD20-directed cytolytic antibody	77
Rituximab	CD20-directed cytolytic antibody	137
Rosuvastatin	HMG-CoA reductase inhibitor	14
Rosuvastatin calcium	HMG-CoA reductase inhibitor	33
Sandostatin LAR Depot		11
Sodium chloride	Osmotic laxative	11
Soliris	Complement inhibitor	23
Solostar		25
Stelara	Interleukin-12 antagonist	12
Sublocade	Partial opioid agonist	141
Sumavel Dosepro		12
Tamoxifen		22
Taxol		22
Taxotere		37
Toujeo	Insulin analog	14
Trastuzumab	HER2/neu receptor antagonist	30
Tremfya	Interleukin-23 antagonist	13
Treprostinil	Prostacycline vasodilator	11
Tresiba	Insulin analog	18
Trulicity	GLP-1 receptor agonist	28
Vancomycin	Glycopeptide antibacterial	21
Vancomycin hydrochloride	Glycopeptide antibacterial	11
Vedolizumab	Integrin receptor antagonist	300
Veklury	SARS-CoV-2 nucleotide analog RNA polymerase inhibitor	15
Venofer (iron sucrose)	Parenteral iron replacement	12
Victoza	GLP-1 receptor agonist	31
Vinorelbine tartrate		24
Vivitrol		18
Wegovy	GLP-1 receptor agonist	299
Xeloda	Nucleoside metabolic inhibitor	26
Xolair	Anti-IgE	12

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 40 pharmacologic classes with 25 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 Injection site extravasation name, in order of name
Class	Reports with this term
Angiotensin converting enzyme inhibitor	87
Antimalarial	35
Antimetabolite immunosuppressant	52
Atypical antipsychotic	46
beta-Adrenergic blocker	51
Biguanide	33
CD20-directed cytolytic antibody	309
Cephalosporin antibacterial	37
Corticosteroid	134
Fluoroquinolone antibacterial	25
Folate analog metabolic inhibitor	69
GLP-1 receptor agonist	876
Glycopeptide antibacterial	32
Gonadotropin releasing hormone receptor agonist	39
HER2/neu receptor antagonist	45
HMG-CoA reductase inhibitor	77
Human immunoglobulin G	129
Insulin analog	195
Integrin receptor antagonist	319
Interferon alpha	26
Interferon beta	136
Interleukin-17A antagonist	119
Interleukin-4 receptor alpha antagonist	171
Interleukin-5 receptor alpha-directed cytolytic antibody	27
Interleukin-6 receptor antagonist	146
Loop diuretic	37
Nucleoside metabolic inhibitor	36
Parathyroid hormone analog	96
Parenteral iron replacement	33
Partial opioid agonist	141
PCSK9 inhibitor	290
Prostacycline vasodilator	55
Proton pump inhibitor	90
Radiographic contrast agent	77
RANK ligand inhibitor	26
Recombinant human growth hormone	118
Selective T cell costimulation modulator	63
Sodium-Glucose cotransporter 2 inhibitor	28
Somatostatin analog	26
Tumor necrosis factor blocker	1,702

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

Reports by month

Reports that record Injection 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 Injection site extravasation
Age	Reports	Share
Under 2	35	0.3%
2 to 11	163	1.3%
12 to 17	162	1.3%
18 to 44	1,456	11.8%
45 to 64	3,055	24.8%
65 to 74	1,572	12.8%
75 and over	718	5.8%
Age not given	5,140	41.8%

Sex of the patient in the reports that record Injection site extravasation
Sex	Reports	Share
Female	7,547	61.4%
Male	3,741	30.4%
Unknown or not given	1,013	8.2%

Age and sex are as the report gives them. 88.2% 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. Injection site extravasation: adverse event reports that record this term. https://reportedreactions.com/reaction/injection-site-extravasation/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 29 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 Nov 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 Injection site extravasation 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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