Rotator cuff syndrome 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 12,650 adverse event reports that record the MedDRA preferred term Rotator cuff syndrome. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 430 reports in the 12 months to June 2026 and 647 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.

Data version

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

Drugs in these reports

The table has the 113 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 Rotator cuff syndrome name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	57
Acetaminophen		42
Actemra	Interleukin-6 receptor antagonist	124
Actonel	Bisphosphonate	65
Alendronate sodium	Bisphosphonate	238
Ambrisentan	Endothelin receptor antagonist	27
Ampyra	Potassium channel blocker	59
Androgel		38
Arava	Antirheumatic agent	51
Aredia		85
Atorvastatin		26
Avelox		65
Avonex	Interferon beta	206
Baclofen	gamma-Aminobutyric acid-ergic agonist	68
Boniva		75
Byetta	GLP-1 receptor agonist	44
Celebrex	Nonsteroidal anti-inflammatory drug	105
Celecoxib	Nonsteroidal anti-inflammatory drug	34
Certolizumab pegol	Tumor necrosis factor blocker	32
Cimzia	Tumor necrosis factor blocker	31
Cipro	Corticosteroid	78
Ciprofloxacin	Fluoroquinolone antibacterial	229
Cosentyx	Interleukin-17A antagonist	136
Creon		28
Crestor	HMG-CoA reductase inhibitor	60
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	88
Diamicron		27
Digoxin	Cardiac glycoside	25
Dupixent	Interleukin-4 receptor alpha antagonist	120
Eliquis	Factor Xa inhibitor	41
Enbrel	Tumor necrosis factor blocker	684
Entresto	Angiotensin 2 receptor blocker	51
Erelzi		28
Etanercept	Tumor necrosis factor blocker	35
Forteo	Parathyroid hormone analog	145
Fosamax	Bisphosphonate	639
Fosamax Plus D		128
Gabapentin	Anti-epileptic agent	81
Gilenya	Sphingosine 1-phosphate receptor modulator	40
Gliclazide		28
Golimumab	Tumor necrosis factor blocker	34
Humalog	Insulin analog	82
Human immunoglobulin g	Human immunoglobulin G	52
Humira		2,275
Hydroxychloroquine	Antimalarial	38
Ibrance	Kinase inhibitor	36
Ibuprofen	Nonsteroidal anti-inflammatory drug	54
Imbruvica	Kinase inhibitor	61
Inflectra	Tumor necrosis factor blocker	44
Infliximab	Tumor necrosis factor blocker	34
Jakafi	Janus kinase inhibitor	30
Januvia	Dipeptidyl peptidase 4 inhibitor	62
Kevzara	Interleukin-6 receptor antagonist	25
Lantus Solostar	Insulin analog	26
Leflunomide	Antirheumatic agent	129
Leucovorin		31
Levaquin		1,074
Levofloxacin	Fluoroquinolone antibacterial	107
Lipitor	HMG-CoA reductase inhibitor	58
Lisinopril	Angiotensin converting enzyme inhibitor	31
Lyrica		152
Metformin	Biguanide	58
Methotrexate	Folate analog metabolic inhibitor	308
Methotrexate sodium	Folate analog metabolic inhibitor	93
Methylprednisolone	Corticosteroid	56
Micardis		48
Naproxen	Nonsteroidal anti-inflammatory drug	43
Neurontin		26
Nexium	Proton pump inhibitor	114
Ocrevus	CD20-directed cytolytic antibody	27
Opsumit	Endothelin receptor antagonist	27
Orencia	Selective T cell costimulation modulator	91
Otezla	Phosphodiesterase 4 inhibitor	43
OxyContin	Opioid agonist	41
Ozempic	GLP-1 receptor agonist	40
Pantoprazole	Proton pump inhibitor	31
Plaquenil	Antimalarial	26
Prednisolone	Corticosteroid	36
Prednisone	Corticosteroid	326
Prilosec	Proton pump inhibitor	32
Prolia	RANK ligand inhibitor	113
Propecia	5-alpha reductase inhibitor	28
Rebif	Interferon beta	71
Remicade	Tumor necrosis factor blocker	83
Repatha	PCSK9 inhibitor	53
Revlimid	Thalidomide analog	154
Rinvoq	Janus kinase inhibitor	297
Rituxan	CD20-directed cytolytic antibody	41
Rituximab	CD20-directed cytolytic antibody	123
Rosuvastatin	HMG-CoA reductase inhibitor	28
Rosuvastatin calcium	HMG-CoA reductase inhibitor	37
Sandostatin	Somatostatin analog	28
Seroquel	Atypical antipsychotic	44
Simponi	Tumor necrosis factor blocker	65
Skyrizi	Interleukin-23 antagonist	243
Steroids		33
Sulfasalazine	Aminosalicylate	83
Symbicort	Corticosteroid	31
Synthroid	l-Thyroxine	27
Tecfidera		61
Tiotropium bromide	Anticholinergic	44
Tramadol hydrochloride	Opioid agonist	28
Trulicity	GLP-1 receptor agonist	30
Tylenol	Expectorant	53
Tysabri	Integrin receptor antagonist	154
Vedolizumab	Integrin receptor antagonist	27
Vioxx		301
Xarelto	Factor Xa inhibitor	38
Xeljanz	Janus kinase inhibitor	216
Xolair	Anti-IgE	39
Xyrem	Central nervous system depressant	177
Xywav	Central nervous system depressant	30
Zometa		124

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 45 pharmacologic classes with 50 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 Rotator cuff syndrome name, in order of name
Class	Reports with this term
Aminosalicylate	83
Angiotensin 2 receptor blocker	99
Angiotensin converting enzyme inhibitor	59
Anti-epileptic agent	83
Anti-IgE	60
Anticholinergic	51
Antimalarial	77
Antirheumatic agent	180
Atypical antipsychotic	53
beta-Adrenergic blocker	54
Biguanide	73
Bisphosphonate	968
CD20-directed cytolytic antibody	196
Central nervous system depressant	212
Corticosteroid	660
Dipeptidyl peptidase 4 inhibitor	66
Endothelin receptor antagonist	77
Expectorant	53
Factor Xa inhibitor	90
Fluoroquinolone antibacterial	357
Folate analog metabolic inhibitor	405
gamma-Aminobutyric acid-ergic agonist	70
GLP-1 receptor agonist	151
HMG-CoA reductase inhibitor	233
Human immunoglobulin G	62
Insulin analog	189
Integrin receptor antagonist	183
Interferon beta	281
Interleukin-17A antagonist	154
Interleukin-23 antagonist	243
Interleukin-4 receptor alpha antagonist	128
Interleukin-6 receptor antagonist	153
Janus kinase inhibitor	553
Kinase inhibitor	142
Nonsteroidal anti-inflammatory drug	317
Opioid agonist	257
Parathyroid hormone analog	150
PCSK9 inhibitor	63
Potassium channel blocker	68
Proton pump inhibitor	222
RANK ligand inhibitor	121
Selective T cell costimulation modulator	148
Serotonin and norepinephrine reuptake inhibitor	123
Thalidomide analog	186
Tumor necrosis factor blocker	1,064

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

Reports by month

Reports that record Rotator cuff syndrome, 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 Rotator cuff syndrome
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	1	under 0.1%
12 to 17	8	0.1%
18 to 44	553	4.4%
45 to 64	3,933	31.1%
65 to 74	1,896	15%
75 and over	851	6.7%
Age not given	5,406	42.7%

Sex of the patient in the reports that record Rotator cuff syndrome
Sex	Reports	Share
Female	7,981	63.1%
Male	4,145	32.8%
Unknown or not given	524	4.1%

Age and sex are as the report gives them. 81.8% 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. Rotator cuff syndrome: adverse event reports that record this term. https://reportedreactions.com/reaction/rotator-cuff-syndrome/ 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 Rotator cuff syndrome 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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