Injection site discolouration 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 February 2004 to June 2026, FDA received 12,220 adverse event reports that record the MedDRA preferred term Injection site discolouration. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 870 reports in the 12 months to June 2026 and 737 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 680 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, 870 (0.1%) record this term. Reports for female patients were 76.4% 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 128 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 discolouration name as a suspect product, in order of name
Drug	Class	Reports with this term
Actemra	Interleukin-6 receptor antagonist	37
Acthar	Adrenocorticotropic hormone	45
Aimovig		64
Ajovy		63
Alirocumab	PCSK9 inhibitor	12
Alirocumab Prefilled Pen		21
Ampyra	Potassium channel blocker	19
Asfotase alfa		13
Avonex	Interferon beta	120
Avonex Pen	Interferon beta	12
Benadryl	Histamine-1 receptor antagonist	12
Benlysta	B lymphocyte stimulator-specific inhibitor	18
BESREMi		11
Betaferon		55
Betaseron		91
Botox	Acetylcholine release inhibitor	23
BOTOX Cosmetic	Acetylcholine release inhibitor	37
Bydureon		191
Bydureon Bcise		145
Byetta	GLP-1 receptor agonist	56
Certolizumab pegol	Tumor necrosis factor blocker	244
Certolizumab Pegol Autoclicks		14
Certolizumab Pegol Ra		11
Cimzia	Tumor necrosis factor blocker	423
Copaxone		208
Corticotropin		256
Cosentyx	Interleukin-17A antagonist	109
Cyclosporine	Calcineurin inhibitor immunosuppressant	15
Depo-Provera	Progestin	19
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	15
Docetaxel Actavis		15
Dupilumab	Interleukin-4 receptor alpha antagonist	49
Dupixent	Interleukin-4 receptor alpha antagonist	882
Dysport	Acetylcholine release inhibitor	12
Eligard	Gonadotropin releasing hormone receptor agonist	13
Emgality		68
Enbrel	Tumor necrosis factor blocker	2,979
Enoxaparin sodium	Low molecular weight heparin	19
Enoxaparin Sodium - Winthrop		11
Epinephrine	Catecholamine	13
Epipen	Catecholamine	57
Epipen Jr	Catecholamine	10
Erelzi		10
Evenity		19
Extavia		84
Ferinject		13
Forteo	Parathyroid hormone analog	376
Genotropin		20
Glatiramer acetate		23
Glatiramer acetate injection		18
Glatopa		52
H P Acthar		21
Hizentra	Human immunoglobulin G	22
Humalog	Insulin analog	32
Humira		861
Humira 40 Mg/0 8 Ml Pen		52
Humira 40 Mg/0 8 Ml Pre-Filled Syringe		10
Humulin N	Insulin	11
Hydrochlorothiazide	Thiazide diuretic	17
Ibuprofen	Nonsteroidal anti-inflammatory drug	11
Injectafer	Parenteral iron replacement	23
Insulin glargine	Insulin analog	13
Kenalog		39
Kenalog-40	Corticosteroid	20
Kesimpta	CD20-directed cytolytic antibody	22
Kevzara	Interleukin-6 receptor antagonist	48
Kineret	Interleukin-1 receptor antagonist	72
Kybella		28
Kynamro		27
Lantus	Insulin analog	37
Lantus Solostar	Insulin analog	128
Leqvio		22
Levemir	Insulin analog	23
Lisinopril	Angiotensin converting enzyme inhibitor	15
Lovenox	Low molecular weight heparin	40
Makena		37
Methotrexate	Folate analog metabolic inhibitor	30
Methotrexate sodium	Folate analog metabolic inhibitor	13
Mounjaro	GLP-1 receptor agonist	102
Nemluvio		17
Nucala	Interleukin-5 antagonist	10
Ocrevus	CD20-directed cytolytic antibody	10
Omalizumab	Anti-IgE	14
Omnitrope	Recombinant human growth hormone	38
Orencia	Selective T cell costimulation modulator	37
Ozempic	GLP-1 receptor agonist	52
Palynziq		12
Pegasys	Interferon alpha	46
Pegintron		13
Plegridy	Interferon beta	72
Praluent	PCSK9 inhibitor	106
Pravastatin		12
Prednisone	Corticosteroid	25
Prolia	RANK ligand inhibitor	34
Qwo		39
Rebetol		13
Rebif	Interferon beta	253
Remodulin	Prostacycline vasodilator	45
Repatha	PCSK9 inhibitor	516
Repository corticotropin	Adrenocorticotropic hormone	28
Ribavirin	Nucleoside analog antiviral	31
Rituxan	CD20-directed cytolytic antibody	16
Rituximab	CD20-directed cytolytic antibody	10
Sandostatin LAR Depot		10
Saxenda	GLP-1 receptor agonist	10
Simponi	Tumor necrosis factor blocker	22
Skyrizi	Interleukin-23 antagonist	23
Solostar		67
Strensiq		250
Sublocade	Partial opioid agonist	27
Taltz	Interleukin-17A antagonist	57
Tanzeum		15
Telmisartan	Angiotensin 2 receptor blocker	12
Toujeo	Insulin analog	22
Tremfya	Interleukin-23 antagonist	13
Triamcinolone acetonide	Corticosteroid	26
Trulicity	GLP-1 receptor agonist	113
Tryngolza		16
Tubersol	Skin test antigen	10
Tymlos		105
Velcade	Proteasome inhibitor	34
Venofer (iron sucrose)	Parenteral iron replacement	10
Victoza	GLP-1 receptor agonist	36
Vivitrol		48
Wegovy	GLP-1 receptor agonist	17
Xiaflex		22
Xolair	Anti-IgE	33
Zepbound	GLP-1 receptor agonist	68

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 60 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 Injection site discolouration name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	81
Adrenocorticotropic hormone	73
Androgen	7
Angiotensin 2 receptor blocker	12
Angiotensin converting enzyme inhibitor	15
Anti-IgE	47
Aromatase inhibitor	5
Atypical antipsychotic	7
B lymphocyte stimulator-specific inhibitor	18
Biguanide	8
Calcineurin inhibitor immunosuppressant	15
Catecholamine	81
CD20-directed cytolytic antibody	60
Corticosteroid	90
Dopaminergic agonist	6
Estrogen Agonist/Antagonist	9
Folate analog metabolic inhibitor	48
GLP-1 receptor agonist	460
GLP-2 analog	9
Gonadotropin releasing hormone receptor agonist	17
HER2/neu receptor antagonist	11
Histamine-1 receptor antagonist	12
HMG-CoA reductase inhibitor	6
Human immunoglobulin G	26
Insulin	21
Insulin analog	287
Integrin receptor antagonist	9
Interferon alpha	46
Interferon beta	459
Interleukin-1 receptor antagonist	72
Interleukin-12 antagonist	9
Interleukin-13 antagonist	9
Interleukin-17A antagonist	166
Interleukin-23 antagonist	38
Interleukin-4 receptor alpha antagonist	931
Interleukin-5 antagonist	10
Interleukin-5 receptor alpha-directed cytolytic antibody	7
Interleukin-6 receptor antagonist	90
Janus kinase inhibitor	5
Leukocyte growth factor	5
Low molecular weight heparin	59
Microtubule inhibitor	5
Nonsteroidal anti-inflammatory drug	39
Nucleoside analog antiviral	31
Nucleoside metabolic inhibitor	5
P2Y12 platelet inhibitor	6
Parathyroid hormone analog	385
Parenteral iron replacement	44
Partial opioid agonist	27
PCSK9 inhibitor	634
Potassium channel blocker	19
Progestin	23
Prostacycline vasodilator	58
Proteasome inhibitor	34
RANK ligand inhibitor	34
Recombinant human growth hormone	43
Selective T cell costimulation modulator	37
Skin test antigen	10
Thiazide diuretic	17
Tumor necrosis factor blocker	3,680

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

Reports by month

Reports that record Injection site discolouration, 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 discolouration
Age	Reports	Share
Under 2	20	0.2%
2 to 11	163	1.3%
12 to 17	153	1.3%
18 to 44	2,201	18%
45 to 64	3,663	30%
65 to 74	1,364	11.2%
75 and over	805	6.6%
Age not given	3,851	31.5%

Sex of the patient in the reports that record Injection site discolouration
Sex	Reports	Share
Female	9,342	76.4%
Male	2,268	18.6%
Unknown or not given	610	5%

Age and sex are as the report gives them. 87.2% 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 discolouration: adverse event reports that record this term. https://reportedreactions.com/reaction/injection-site-discolouration/ 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 discolouration 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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