Reported Reactions

Adverse event reports that FDA received

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Night sweats adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
sweating at night

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 31,670 adverse event reports that record the MedDRA preferred term Night sweats. In plain words, the term means: sweating at night. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 2,071 reports in the 12 months to June 2026 and 2,474 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 354 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, 2,071 (0.2%) record this term. Reports for patients aged 18 to 44 were 22.5% of the reports that record this term and 12.3% 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

Sweating at night. 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 136 drug pages with 250 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 Night sweats name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen1,677
Acetaminophen and codeineOpioid agonist391
Acetaminophen Oxycodone Hydrochloride402
ActemraInterleukin-6 receptor antagonist2,034
AdalimumabTumor necrosis factor blocker1,293
Aimovig750
Alendronate sodiumBisphosphonate882
Alendronate Sodium Cholecalciferol333
Alendronic Acid981
ApremilastPhosphodiesterase 4 inhibitor503
AravaAntirheumatic agent1,566
Asacol351
Atomoxetine hydrochlorideNorepinephrine reuptake inhibitor297
AzathioprinePurine antimetabolite583
Berinert477
Botulinum toxin type aAcetylcholine release inhibitor465
ButransPartial opioid agonist397
Calcium294
Calcium Ascorbate368
Calcium carbonateBlood coagulation factor571
Calcium Glubionate548
CandesartanAngiotensin 2 receptor blocker706
CelebrexNonsteroidal anti-inflammatory drug720
CelecoxibNonsteroidal anti-inflammatory drug601
Certolizumab pegolTumor necrosis factor blocker584
CetirizineHistamine-1 receptor antagonist776
Cetirizine hydrochlorideHistamine-1 receptor antagonist1,017
Cetirizine hydrochloride, pseudoephedrine hydrochlorideHistamine-1 receptor antagonist751
Chloraprep610
Chlorhexidine858
Chlorhexidine gluconate687
Chlorhexidine Gluconate Isopropyl Alcohol271
Cholecalciferol814
CimziaTumor necrosis factor blocker1,903
CortisoneCorticosteroid471
Cortisone acetateCorticosteroid1,041
CosentyxInterleukin-17A antagonist1,745
Cymbalta393
DesoximetasoneCorticosteroid1,295
DiclofenacNonsteroidal anti-inflammatory drug968
Diclofenac diethylamine549
Diclofenac potassiumNonsteroidal anti-inflammatory drug911
Diclofenac sodiumNonsteroidal anti-inflammatory drug1,428
Dietary Supplement Herbals384
Domperidone maleate384
DoxycyclineTetracycline-class drug265
DupixentInterleukin-4 receptor alpha antagonist262
EligardGonadotropin releasing hormone receptor agonist279
EnbrelTumor necrosis factor blocker2,495
Erelzi1,387
ErgocalciferolProvitamin D2 compound654
EtanerceptTumor necrosis factor blocker259
Flumethasone Pivalate1,089
Folic acid1,378
FosamaxBisphosphonate1,318
GoldStandardized chemical allergen318
Gold Sodium Thiomalate633
GolimumabTumor necrosis factor blocker512
Humira2,477
HydrocortisoneCorticosteroid728
Hydrocortisone acetateCorticosteroid359
Hydrocortisone butyrateCorticosteroid264
HydroxychloroquineAntimalarial1,060
Hydroxychloroquine sulfateAntimalarial889
HyrimozTumor necrosis factor blocker357
IbranceKinase inhibitor332
IbuprofenNonsteroidal anti-inflammatory drug307
ImbruvicaKinase inhibitor293
InfliximabTumor necrosis factor blocker1,261
Isopropyl alcoholStandardized chemical allergen559
JakafiJanus kinase inhibitor609
KevzaraInterleukin-6 receptor antagonist630
LamictalAnti-epileptic agent473
LamotrigineAnti-epileptic agent251
LeflunomideAntirheumatic agent1,899
Lupron Depot474
Lyrica592
Magnesium280
Magnesium citrateCalculi dissolution agent253
Meglumine254
MethotrexateFolate analog metabolic inhibitor2,401
Methotrexate sodiumFolate analog metabolic inhibitor408
MethylprednisoloneCorticosteroid381
Methylprednisolone sodium succinateCorticosteroid486
MinocyclineTetracycline-class drug311
Minocycline hydrochlorideTetracycline-class drug273
MirenaProgestin252
Mycophenolate mofetilAntimetabolite immunosuppressant797
Myrbetriqbeta3-Adrenergic agonist528
NaproxenNonsteroidal anti-inflammatory drug782
Naproxen sodiumNonsteroidal anti-inflammatory drug1,018
NucalaInterleukin-5 antagonist691
OrenciaSelective T cell costimulation modulator2,057
OrgovyxGonadotropin releasing hormone receptor antagonist492
OtezlaPhosphodiesterase 4 inhibitor821
OxycodoneOpioid agonist1,377
Oxycodone hydrochlorideOpioid agonist686
Oxycodone Terephthalate1,219
PantoprazoleProton pump inhibitor494
Pantoprazole sodiumProton pump inhibitor429
Periogard1,023
Phenylephrine hydrochloridealpha-1 adrenergic agonist452
Phthalylsulfathiazole1,244
PlaquenilAntimalarial491
PrednisoloneCorticosteroid356
PrednisoneCorticosteroid1,979
Pregabalin382
Pseudoephedrine653
Pseudoephedrine hydrochloridealpha-Adrenergic agonist899
RamiprilAngiotensin converting enzyme inhibitor853
RanitidineHistamine-2 receptor antagonist312
Ranitidine hydrochlorideHistamine-2 receptor antagonist252
RemicadeTumor necrosis factor blocker1,204
RevlimidThalidomide analog685
RituxanCD20-directed cytolytic antibody255
RituximabCD20-directed cytolytic antibody1,979
SertralineSerotonin reuptake inhibitor275
SimponiTumor necrosis factor blocker1,849
Sirukumab299
StelaraInterleukin-12 antagonist1,123
Sulfamethoxazole569
Sulfamethoxazole and trimethoprimDihydrofolate reductase inhibitor antibacterial408
Sulfamethoxazole, trimethoprimDihydrofolate reductase inhibitor antibacterial510
SulfasalazineAminosalicylate1,473
Tecfidera350
TocilizumabInterleukin-6 receptor antagonist548
TofacitinibJanus kinase inhibitor459
Tofacitinib citrateJanus kinase inhibitor463
TopicortCorticosteroid267
Topiramate462
Tramadol hydrochlorideOpioid agonist702
Triamcinolone acetonideCorticosteroid595
UstekinumabInterleukin-12 antagonist309
Vitamin cVitamin C743
XeljanzJanus kinase inhibitor1,485
XyremCentral nervous system depressant381

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 46 pharmacologic classes with 500 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 Night sweats name, in order of name
ClassReports with this term
Acetylcholine release inhibitor519
alpha-Adrenergic agonist899
Aminosalicylate1,771
Angiotensin 2 receptor blocker876
Angiotensin converting enzyme inhibitor1,098
Anti-epileptic agent844
Antimalarial2,444
Antimetabolite immunosuppressant857
Antirheumatic agent3,465
Atypical antipsychotic783
beta3-Adrenergic agonist568
Bisphosphonate2,371
Blood coagulation factor858
CD20-directed cytolytic antibody2,502
Central nervous system depressant553
Corticosteroid9,646
Dihydrofolate reductase inhibitor antibacterial992
Estrogen1,014
Fluoroquinolone antibacterial561
Folate analog metabolic inhibitor2,816
Gonadotropin releasing hormone receptor antagonist611
Histamine-1 receptor antagonist2,862
Histamine-2 receptor antagonist576
Integrin receptor antagonist519
Interleukin-12 antagonist1,432
Interleukin-17A antagonist2,004
Interleukin-5 antagonist722
Interleukin-6 receptor antagonist3,346
Janus kinase inhibitor3,257
Kinase inhibitor1,764
Nonsteroidal anti-inflammatory drug7,264
Norepinephrine reuptake inhibitor575
Opioid agonist4,344
Partial opioid agonist624
Phosphodiesterase 4 inhibitor1,324
Proton pump inhibitor1,322
Provitamin D2 compound677
Purine antimetabolite848
Selective T cell costimulation modulator2,273
Serotonin and norepinephrine reuptake inhibitor550
Serotonin reuptake inhibitor1,092
Standardized chemical allergen1,105
Tetracycline-class drug1,098
Thalidomide analog905
Tumor necrosis factor blocker11,862
Vitamin C909

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

Reports by month

Reports that record Night sweats, by month, five years to June 2026
025050020222023202420252026

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 Night sweats
AgeReportsShareShare as a bar
Under 2200.1%
2 to 111250.4%
12 to 171210.4%
18 to 447,13922.5%
45 to 647,40323.4%
65 to 743,42110.8%
75 and over2,1946.9%
Age not given11,24735.5%
Sex of the patient in the reports that record Night sweats
SexReportsShareShare as a bar
Female19,25260.8%
Male9,34329.5%
Unknown or not given3,0759.7%

Age and sex are as the report gives them. 64.9% of these reports give the United States as the country.

Terms near this one

Official pages

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Reported Reactions. Night sweats: adverse event reports that record this term. https://reportedreactions.com/reaction/night-sweats/ 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 Night sweats mean in an adverse event report?

In plain words: sweating at night. 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 .