Injection site haematoma 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 July 2004 to June 2026, FDA received 14,464 adverse event reports that record the MedDRA preferred term Injection site haematoma. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 152 reports in the 12 months to June 2026 and 149 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 1,356 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, 152 (under 0.1%) record this term. Reports for female patients were 71.6% 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 145 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 Injection site haematoma name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	10
Actemra	Interleukin-6 receptor antagonist	9
Aimovig		5
Albuterol sulfate	beta2-Adrenergic agonist	7
Alirocumab Prefilled Pen		8
Amlodipine	Calcium channel blocker	6
Amlodipine besylate	Dihydropyridine calcium channel blocker	6
Anticoagulant Sodium Citrate	Anti-coagulant	242
Apidra	Insulin analog	10
Apixaban	Factor Xa inhibitor	11
Apomorphine hydrochloride	Dopaminergic agonist	5
Aranesp	Erythropoiesis-stimulating agent	6
Arixtra	Factor Xa inhibitor	66
Aspirin	Nonsteroidal anti-inflammatory drug	20
Avonex	Interferon beta	530
Avonex Pen	Interferon beta	9
Betaferon		31
Betaseron		136
Bevacizumab	Vascular endothelial growth factor inhibitor	10
Bisoprolol	beta-Adrenergic blocker	6
Boniva		6
Botox	Acetylcholine release inhibitor	5
BOTOX Cosmetic	Acetylcholine release inhibitor	72
Bydureon		28
Bydureon Bcise		24
Byetta	GLP-1 receptor agonist	151
Cabotegravir		13
Caverject	Prostaglandin analog	5
Cimzia	Tumor necrosis factor blocker	111
Clexane		14
Copaxone		135
Corticotropin		14
Cosentyx	Interleukin-17A antagonist	35
Coumadin		49
Diclofenac	Nonsteroidal anti-inflammatory drug	6
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	6
Diltiazem		7
Dupixent	Interleukin-4 receptor alpha antagonist	69
Egrifta		35
Eligard	Gonadotropin releasing hormone receptor agonist	45
Eliquis	Factor Xa inhibitor	18
Emgality		15
Enbrel	Tumor necrosis factor blocker	6,042
Enoxaparin		16
Enoxaparin sodium	Low molecular weight heparin	37
Epipen	Catecholamine	36
Epipen Jr	Catecholamine	14
Erelzi		8
Etanercept	Tumor necrosis factor blocker	8
Evista	Estrogen Agonist/Antagonist	5
Extavia		67
Faslodex	Estrogen receptor antagonist	12
Firazyr	Bradykinin B2 receptor antagonist	6
Forsteo		7
Forteo	Parathyroid hormone analog	567
Fragmin	Anti-coagulant	5
Furosemide	Loop diuretic	6
Genotropin		36
Glatopa		6
Glipizide	Sulfonylurea	5
Heparin		6
Heparin sodium	Anti-coagulant	6
Hizentra	Human immunoglobulin G	10
Humalog	Insulin analog	32
Humalog Mix 75/25		10
Humira		2,576
Humira 40 Mg/0 8 Ml Pen		6
Humulin N	Insulin	19
Humulin R	Insulin	5
Imitrex	Serotonin-1b and Serotonin-1d receptor agonist	19
Influenza virus vaccine		11
Insulin glargine	Insulin analog	12
Interferon beta-1a	Interferon beta	6
Interferon beta-1b		7
Invega Sustenna	Atypical antipsychotic	9
Kardegic		6
Kenalog		6
Kesimpta	CD20-directed cytolytic antibody	6
Kineret	Interleukin-1 receptor antagonist	18
Lantus	Insulin analog	102
Lantus Solostar	Insulin analog	7
Levemir	Insulin analog	72
Levetiracetam		5
Lonsurf	Nucleoside analog antiviral	8
Lovenox	Low molecular weight heparin	125
Lupron Depot		19
Lupron Depot-PED		6
Makena		5
Mepolizumab	Interleukin-5 antagonist	17
Methotrexate	Folate analog metabolic inhibitor	39
Metoject		5
Montelukast	Leukotriene receptor antagonist	8
Morphine sulfate	Opioid agonist	7
Mounjaro	GLP-1 receptor agonist	23
Neupogen	Leukocyte growth factor	13
Nicardipine	Dihydropyridine calcium channel blocker	5
Novolog	Insulin analog	28
Omalizumab	Anti-IgE	27
Omnitrope	Recombinant human growth hormone	6
Opticlick		8
Peg-Intron		8
Pegasys	Interferon alpha	22
Plavix	P2Y12 platelet inhibitor	15
Praluent	PCSK9 inhibitor	28
Prednisone	Corticosteroid	11
Pregabalin		5
Procrit	Erythropoiesis-stimulating agent	8
Prolia	RANK ligand inhibitor	8
Pulmicort Turbuhaler		8
Rebif	Interferon beta	508
Remodulin	Prostacycline vasodilator	6
Repatha	PCSK9 inhibitor	105
Revlimid	Thalidomide analog	5
Ribavirin	Nucleoside analog antiviral	20
Rilpivirine	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	10
Rituximab	CD20-directed cytolytic antibody	8
Sandostatin	Somatostatin analog	19
Sandostatin Lar		9
Sandostatin LAR Depot		35
Simponi	Tumor necrosis factor blocker	29
Skenan		6
Skyrizi	Interleukin-23 antagonist	6
Solostar		44
Sublocade	Partial opioid agonist	12
Symbicort	Corticosteroid	7
Symlin		11
Teriparatide	Parathyroid hormone analog	16
Theophylline	Methylxanthine	7
Tirofiban	Platelet aggregation inhibitor	6
Trulicity	GLP-1 receptor agonist	31
Tymlos		20
Tysabri	Integrin receptor antagonist	14
Valsartan	Angiotensin 2 receptor blocker	5
Vedolizumab	Integrin receptor antagonist	7
Velcade	Proteasome inhibitor	5
Victoza	GLP-1 receptor agonist	355
Victoza Solution for Injection 6 Mg/Ml		15
Victoza Solution for Injection 6mg/Ml		63
Vidaza	Nucleoside metabolic inhibitor	14
Vivitrol		83
Warfarin sodium	Vitamin K antagonist	12
Xiaflex		45
Xolair	Anti-IgE	22
Zepbound	GLP-1 receptor agonist	19
Zoladex	Gonadotropin releasing hormone receptor agonist	19

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 41 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 Injection site haematoma name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	81
Anti-coagulant	253
Anti-IgE	49
Calcium channel blocker	10
Catecholamine	52
CD20-directed cytolytic antibody	16
Corticosteroid	31
Dihydropyridine calcium channel blocker	11
Erythropoiesis-stimulating agent	17
Estrogen receptor antagonist	12
Factor Xa inhibitor	95
Folate analog metabolic inhibitor	41
GLP-1 receptor agonist	583
Gonadotropin releasing hormone receptor agonist	67
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	10
Human immunoglobulin G	14
Insulin	28
Insulin analog	272
Integrin receptor antagonist	21
Interferon alpha	22
Interferon beta	1,057
Interleukin-1 receptor antagonist	18
Interleukin-17A antagonist	39
Interleukin-4 receptor alpha antagonist	71
Interleukin-5 antagonist	19
Leukocyte growth factor	15
Leukotriene receptor antagonist	12
Low molecular weight heparin	162
Nonsteroidal anti-inflammatory drug	36
Nucleoside analog antiviral	28
Nucleoside metabolic inhibitor	16
P2Y12 platelet inhibitor	17
Parathyroid hormone analog	583
Partial opioid agonist	12
PCSK9 inhibitor	135
Selective T cell costimulation modulator	14
Serotonin-1b and Serotonin-1d receptor agonist	26
Somatostatin analog	21
Tumor necrosis factor blocker	6,198
Vascular endothelial growth factor inhibitor	14
Vitamin K antagonist	15

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

Reports by month

Reports that record Injection site haematoma, 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 haematoma
Age	Reports	Share
Under 2	11	0.1%
2 to 11	92	0.6%
12 to 17	56	0.4%
18 to 44	1,872	12.9%
45 to 64	2,920	20.2%
65 to 74	879	6.1%
75 and over	463	3.2%
Age not given	8,171	56.5%

Sex of the patient in the reports that record Injection site haematoma
Sex	Reports	Share
Female	10,362	71.6%
Male	2,522	17.4%
Unknown or not given	1,580	10.9%

Age and sex are as the report gives them. 87.3% 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 haematoma: adverse event reports that record this term. https://reportedreactions.com/reaction/injection-site-haematoma/ 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 haematoma 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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