Reported Reactions

Adverse event reports that FDA received

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Pain adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
pain, site not specified

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 . The data have the reports that FDA received through .

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 .

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 .

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 606,385 adverse event reports that record the MedDRA preferred term Pain. In plain words, the term means: pain, site not specified. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 27,198 reports in the 12 months to June 2026 and 29,225 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 14 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, 27,198 (2%) record this term. Reports for female patients were 63.5% 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.

Plain meaning

Pain, site not specified. 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 97 drug pages with 2,500 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 .

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 . The site read the page on .

Drugs that the reports with the term Pain name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen7,366
Acetaminophen Oxycodone Hydrochloride6,601
Acetaminophen Oxycodone Hydrochloride Oxycodone Terephthalate4,230
ActemraInterleukin-6 receptor antagonist17,565
AdalimumabTumor necrosis factor blocker4,826
Alendronate sodiumBisphosphonate4,960
Alendronic Acid2,521
AravaAntirheumatic agent11,235
Atripla4,301
AvonexInterferon beta4,810
ButransPartial opioid agonist6,244
CelebrexNonsteroidal anti-inflammatory drug4,536
Certolizumab pegolTumor necrosis factor blocker3,111
CetirizineHistamine-1 receptor antagonist3,024
Cetirizine hydrochlorideHistamine-1 receptor antagonist7,293
Cetirizine hydrochloride, pseudoephedrine hydrochlorideHistamine-1 receptor antagonist2,619
CimziaTumor necrosis factor blocker13,361
CiprofloxacinFluoroquinolone antibacterial2,502
Cortisone acetateCorticosteroid5,682
CosentyxInterleukin-17A antagonist15,355
Cymbalta3,200
DesoximetasoneCorticosteroid7,212
DiclofenacNonsteroidal anti-inflammatory drug4,677
Diclofenac sodiumNonsteroidal anti-inflammatory drug7,090
DilaudidOpioid agonist18,278
DupixentInterleukin-4 receptor alpha antagonist8,915
EnbrelTumor necrosis factor blocker40,164
Erelzi4,975
ErgocalciferolProvitamin D2 compound2,539
FentanylOpioid agonist4,287
Folic acid9,209
ForteoParathyroid hormone analog6,862
FosamaxBisphosphonate8,130
GabapentinAnti-epileptic agent3,731
GilenyaSphingosine 1-phosphate receptor modulator2,815
Humira43,976
Hydrocodone bitartrateOpioid agonist4,531
Hydrocodone bitartrate and acetaminophenOpioid agonist10,948
Hydromorphone2,618
HydroxychloroquineAntimalarial7,214
Hydroxychloroquine sulfateAntimalarial8,543
Hysingla EROpioid agonist3,604
IbranceKinase inhibitor3,053
InfliximabTumor necrosis factor blocker5,702
KesimptaCD20-directed cytolytic antibody3,478
KevzaraInterleukin-6 receptor antagonist5,280
LeflunomideAntirheumatic agent10,095
Lyrica16,253
MethadoneOpioid agonist2,539
MethotrexateFolate analog metabolic inhibitor21,109
Methotrexate sodiumFolate analog metabolic inhibitor4,402
MetoclopramideDopamine-2 receptor antagonist3,549
MirenaProgestin6,530
MorphineOpioid agonist2,518
Morphine sulfateOpioid agonist9,922
MS ContinOpioid agonist14,263
NaproxenNonsteroidal anti-inflammatory drug3,090
NexiumProton pump inhibitor3,182
Ocella2,600
OrenciaSelective T cell costimulation modulator19,378
OtezlaPhosphodiesterase 4 inhibitor5,538
OxycodoneOpioid agonist5,904
Oxycodone and acetaminophenOpioid agonist4,082
Oxycodone hydrochlorideOpioid agonist24,730
Oxycodone Terephthalate2,944
OxyContinOpioid agonist47,762
ParaGard T 380ACopper-containing intrauterine device5,752
PercocetOpioid agonist2,607
Phthalylsulfathiazole7,195
PlaquenilAntimalarial5,587
PrednisoneCorticosteroid15,011
ProliaRANK ligand inhibitor4,479
Pseudoephedrine hydrochloridealpha-Adrenergic agonist4,743
RemicadeTumor necrosis factor blocker13,561
RepathaPCSK9 inhibitor2,872
RevlimidThalidomide analog4,951
RinvoqJanus kinase inhibitor4,927
RituxanCD20-directed cytolytic antibody4,912
RituximabCD20-directed cytolytic antibody13,720
SimponiTumor necrosis factor blocker11,316
SkyriziInterleukin-23 antagonist3,123
StelaraInterleukin-12 antagonist4,657
SulfasalazineAminosalicylate11,640
Taxotere4,657
Tecfidera3,103
TocilizumabInterleukin-6 receptor antagonist4,159
Tramadol4,460
Trasylol2,844
TruvadaHuman immunodeficiency virus nucleoside analog reverse transcriptase inhibitor6,473
TysabriIntegrin receptor antagonist5,668
Vicodin3,198
VireadHepatitis B virus nucleoside analog reverse transcriptase inhibitor2,915
XeljanzJanus kinase inhibitor21,387
XolairAnti-IgE2,748
Yasmin8,528
Yaz9,412
Zantac3,373

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 36 pharmacologic classes with 5,000 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 .

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 . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Pain name, in order of name
ClassReports with this term
Aminosalicylate12,938
Angiotensin 2 receptor blocker6,983
Anti-epileptic agent7,467
Antimalarial21,494
Antirheumatic agent21,330
Atypical antipsychotic7,845
Benzodiazepine6,910
Bisphosphonate17,931
CD20-directed cytolytic antibody25,343
Copper-containing intrauterine device5,752
Corticosteroid53,147
Fluoroquinolone antibacterial6,135
Folate analog metabolic inhibitor26,066
Histamine-1 receptor antagonist16,739
HMG-CoA reductase inhibitor9,767
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor8,464
Integrin receptor antagonist8,424
Interferon beta7,381
Interleukin-12 antagonist5,857
Interleukin-17A antagonist16,752
Interleukin-4 receptor alpha antagonist9,325
Interleukin-6 receptor antagonist27,763
Janus kinase inhibitor31,495
Kinase inhibitor22,735
Nonsteroidal anti-inflammatory drug33,979
Opioid agonist168,212
Parathyroid hormone analog7,200
Partial opioid agonist8,407
Phosphodiesterase 4 inhibitor7,212
Progestin8,574
Proton pump inhibitor18,317
RANK ligand inhibitor5,235
Selective T cell costimulation modulator21,422
Serotonin reuptake inhibitor5,478
Thalidomide analog7,313
Tumor necrosis factor blocker99,784

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

Reports by month

Reports that record Pain, by month, five years to June 2026
025,00050,00020222023202420252026

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 Pain
AgeReportsShareShare as a bar
Under 26030.1%
2 to 113,0890.5%
12 to 174,6870.8%
18 to 4484,67314%
45 to 64142,68023.5%
65 to 7460,36610%
75 and over37,6116.2%
Age not given272,67645%
Sex of the patient in the reports that record Pain
SexReportsShareShare as a bar
Female385,04163.5%
Male174,88128.8%
Unknown or not given46,4637.7%

Age and sex are as the report gives them. 76.6% 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

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Reported Reactions. Pain: adverse event reports that record this term. https://reportedreactions.com/reaction/pain/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 Pain mean in an adverse event report?

In plain words: pain, site not specified. 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 .

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 .

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 .