Needle issue adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: a problem with the needle

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 April 2009 to June 2026, FDA received 28,225 adverse event reports that record the MedDRA preferred term Needle issue. In plain words, the term means: a problem with the needle. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,959 reports in the 12 months to June 2026 and 3,224 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 256 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, 2,959 (0.2%) record this term. Reports for patients 75 and over were 5.6% of the reports that record this term and 9.5% 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.

Plain meaning

A problem with the needle. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 129 drug pages with 25 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 Needle issue name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	118
Abrilada		57
Actemra	Interleukin-6 receptor antagonist	314
Actemra ACTPen	Interleukin-6 receptor antagonist	28
Adalimumab	Tumor necrosis factor blocker	53
Adrenaclick		64
Afinitor	Kinase inhibitor	150
Aimovig		235
Ajovy		272
Amlodipine	Calcium channel blocker	63
Aranesp	Erythropoiesis-stimulating agent	50
Aristada	Atypical antipsychotic	636
Atenolol	beta-Adrenergic blocker	67
Atorvastatin		39
Atorvastatin calcium	HMG-CoA reductase inhibitor	27
Avonex	Interferon beta	170
Avonex Pen	Interferon beta	37
BESREMi		28
Bimzelx		80
Bisoprolol	beta-Adrenergic blocker	57
Bydureon		758
Bydureon Bcise		1,320
Byetta	GLP-1 receptor agonist	101
Certolizumab pegol	Tumor necrosis factor blocker	133
Cimzia	Tumor necrosis factor blocker	286
Codeine		42
Copaxone		111
Cosentyx	Interleukin-17A antagonist	1,098
Cuvitru	Human immunoglobulin G	35
Depo Provera		34
Depo-Provera	Progestin	173
Device		104
Dupilumab	Interleukin-4 receptor alpha antagonist	65
Dupixent	Interleukin-4 receptor alpha antagonist	709
Eligard	Gonadotropin releasing hormone receptor agonist	630
Enbrel	Tumor necrosis factor blocker	734
Enoxaparin		27
Enoxaparin sodium	Low molecular weight heparin	117
Enoxaparin Sodium - Winthrop		39
Epinephrine	Catecholamine	98
Epipen	Catecholamine	199
Epipen Jr	Catecholamine	60
Erelzi		31
Eylea	Vascular endothelial growth factor inhibitor	32
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	122
Folic acid		25
Forteo	Parathyroid hormone analog	31
Fragmin	Anti-coagulant	227
Furosemide	Loop diuretic	45
Ganirelix acetate	Gonadotropin releasing hormone receptor antagonist	77
Gattex	GLP-2 analog	28
Genotropin		626
Glatiramer acetate		30
Glatiramer acetate injection		25
Glatopa		69
Guselkumab	Interleukin-23 antagonist	294
Hizentra	Human immunoglobulin G	54
Human immunoglobulin g	Human immunoglobulin G	226
Human Immunoglobulin G Hyaluronidase Recombinant Human		62
Humira		1,144
Humira 40 Mg/0 8 Ml Pen		33
Hyrimoz	Tumor necrosis factor blocker	88
Ilaris		32
Iluvien	Corticosteroid	39
Indapamide	Thiazide-like diuretic	42
Invega Sustenna	Atypical antipsychotic	151
Invega Trinza	Atypical antipsychotic	69
Kesimpta	CD20-directed cytolytic antibody	233
Kevzara	Interleukin-6 receptor antagonist	26
Kineret	Interleukin-1 receptor antagonist	55
Lanreotide acetate	Somatostatin analog	45
Lantus	Insulin analog	50
Lantus Solostar	Insulin analog	141
Leflunomide	Antirheumatic agent	25
Lisinopril	Angiotensin converting enzyme inhibitor	35
Lorazepam	Benzodiazepine	41
Lovenox	Low molecular weight heparin	74
Medroxyprogesterone	Progestin	91
Medroxyprogesterone acetate	Progestin	54
Metformin	Biguanide	130
Metformin hydrochloride	Biguanide	37
Methotrexate	Folate analog metabolic inhibitor	100
Metoprolol	beta-Adrenergic blocker	60
Morphine	Opioid agonist	52
Morphine sulfate	Opioid agonist	51
Neulasta	Leukocyte growth factor	482
Neupogen	Leukocyte growth factor	41
Nexplanon	Progestin	167
Ngenla	Recombinant human growth hormone	34
Octreotide	Somatostatin analog	29
Octreotide acetate	Somatostatin analog	58
Omnitrope	Recombinant human growth hormone	329
Orencia	Selective T cell costimulation modulator	642
Ozempic	GLP-1 receptor agonist	127
Ozurdex	Corticosteroid	41
Pantoprazole	Proton pump inhibitor	38
Pegasys	Interferon alpha	56
Prednisone	Corticosteroid	31
Prolia	RANK ligand inhibitor	73
Propranolol hydrochloride	beta-Adrenergic blocker	27
Ramipril	Angiotensin converting enzyme inhibitor	102
Remodulin	Prostacycline vasodilator	67
Repatha	PCSK9 inhibitor	163
Risperdal Consta		374
Risperidone	Atypical antipsychotic	31
Rosuvastatin	HMG-CoA reductase inhibitor	35
Sandostatin	Somatostatin analog	764
Sandostatin LAR Depot		2,330
Semglee	Insulin analog	58
Simponi	Tumor necrosis factor blocker	1,137
Skyrizi	Interleukin-23 antagonist	79
Somatropin	Recombinant human growth hormone	61
Somavert		115
Stelara	Interleukin-12 antagonist	2,051
Sumatriptan	Serotonin-1b and Serotonin-1d receptor agonist	152
Taltz	Interleukin-17A antagonist	35
Teduglutide	GLP-2 analog	155
Teriparatide	Parathyroid hormone analog	31
Tezspire		49
Toujeo	Insulin analog	31
Tremfya	Interleukin-23 antagonist	2,007
Triptodur		195
Tymlos		227
Victoza	GLP-1 receptor agonist	37
Vivitrol		726
Wegovy	GLP-1 receptor agonist	67
Xolair	Anti-IgE	502
Xolair PFS	Anti-IgE	51
Yutiq	Corticosteroid	58

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 54 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 Needle issue name, in order of name
Class	Reports with this term
Angiotensin 2 receptor blocker	54
Angiotensin converting enzyme inhibitor	139
Anti-coagulant	250
Anti-IgE	569
Antirheumatic agent	28
Atypical antipsychotic	928
Benzodiazepine	47
beta-Adrenergic blocker	245
Biguanide	174
Blood coagulation factor	27
Bradykinin B2 receptor antagonist	33
Calcium channel blocker	63
Catecholamine	357
CD20-directed cytolytic antibody	241
Corticosteroid	213
Erythropoiesis-stimulating agent	69
Folate analog metabolic inhibitor	136
GLP-1 receptor agonist	358
GLP-2 analog	183
Gonadotropin releasing hormone receptor agonist	664
Gonadotropin releasing hormone receptor antagonist	77
HMG-CoA reductase inhibitor	105
Human immunoglobulin G	337
Insulin analog	379
Interferon alpha	56
Interferon beta	223
Interleukin-1 receptor antagonist	55
Interleukin-12 antagonist	2,065
Interleukin-17A antagonist	1,133
Interleukin-23 antagonist	2,385
Interleukin-4 receptor alpha antagonist	774
Interleukin-5 receptor alpha-directed cytolytic antibody	136
Interleukin-6 receptor antagonist	370
Kinase inhibitor	185
Leukocyte growth factor	570
Loop diuretic	45
Low molecular weight heparin	191
Nucleoside metabolic inhibitor	35
Opioid agonist	109
Parathyroid hormone analog	62
PCSK9 inhibitor	181
Progestin	485
Prostacycline vasodilator	76
Proton pump inhibitor	69
RANK ligand inhibitor	87
Recombinant human growth hormone	431
Selective T cell costimulation modulator	760
Serotonin and norepinephrine reuptake inhibitor	43
Serotonin-1b and Serotonin-1d receptor agonist	178
Sodium-Glucose cotransporter 2 inhibitor	32
Somatostatin analog	911
Thiazide-like diuretic	42
Tumor necrosis factor blocker	2,468
Vascular endothelial growth factor inhibitor	42

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

Reports by month

Reports that record Needle issue, 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 Needle issue
Age	Reports	Share
Under 2	48	0.2%
2 to 11	720	2.6%
12 to 17	673	2.4%
18 to 44	3,795	13.4%
45 to 64	5,730	20.3%
65 to 74	2,864	10.1%
75 and over	1,585	5.6%
Age not given	12,810	45.4%

Sex of the patient in the reports that record Needle issue
Sex	Reports	Share
Female	13,948	49.4%
Male	8,715	30.9%
Unknown or not given	5,562	19.7%

Age and sex are as the report gives them. 77.5% 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.

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Reported Reactions. Needle issue: adverse event reports that record this term. https://reportedreactions.com/reaction/needle-issue/ 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 Needle issue mean in an adverse event report?

In plain words: a problem with the needle. 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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