Reported Reactions

Adverse event reports that FDA received

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Peripheral coldness 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 . 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 13,545 adverse event reports that record the MedDRA preferred term Peripheral coldness. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 689 reports in the 12 months to June 2026 and 710 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 812 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, 689 (0.1%) record this term. Reports for female patients were 58.3% 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 145 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 .

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 Peripheral coldness name as a suspect product, in order of name
DrugClassReports with this term
Acetaminophen27
Aclasta29
ActemraInterleukin-6 receptor antagonist65
AfinitorKinase inhibitor45
Aimovig42
AlemtuzumabCD52-directed cytolytic antibody47
AllopurinolXanthine oxidase inhibitor25
AmbrisentanEndothelin receptor antagonist38
AmlodipineCalcium channel blocker148
AmpyraPotassium channel blocker77
Anticoagulant Sodium CitrateAnti-coagulant72
AripiprazoleAtypical antipsychotic27
AspirinNonsteroidal anti-inflammatory drug86
Atenololbeta-Adrenergic blocker109
Atorvastatin51
AubagioPyrimidine synthesis inhibitor59
AvastinVascular endothelial growth factor inhibitor34
AvonexInterferon beta135
AyvakitKinase inhibitor30
Baclofengamma-Aminobutyric acid-ergic agonist35
Bisoprololbeta-Adrenergic blocker79
Bisoprolol fumaratebeta-Adrenergic blocker33
ByettaGLP-1 receptor agonist69
CabometyxKinase inhibitor29
CapecitabineNucleoside metabolic inhibitor64
Carbidopa levodopaAromatic amino acid37
CarboplatinPlatinum-based drug48
Carvedilolalpha-Adrenergic blocker54
ChantixPartial cholinergic nicotinic agonist25
CiprofloxacinFluoroquinolone antibacterial117
ClopidogrelP2Y12 platelet inhibitor50
Coregalpha-Adrenergic blocker32
CosentyxInterleukin-17A antagonist57
Coumadin25
CrestorHMG-CoA reductase inhibitor48
CyclophosphamideAlkylating drug32
Cymbalta86
DexamethasoneCorticosteroid52
DiclofenacNonsteroidal anti-inflammatory drug30
Diclofenac sodiumNonsteroidal anti-inflammatory drug45
DigoxinCardiac glycoside35
DupixentInterleukin-4 receptor alpha antagonist101
EliquisFactor Xa inhibitor110
EnbrelTumor necrosis factor blocker231
EntrestoAngiotensin 2 receptor blocker138
EntyvioIntegrin receptor antagonist29
ErgocalciferolProvitamin D2 compound36
FirdapsePotassium channel blocker36
FluorouracilNucleoside metabolic inhibitor48
ForteoParathyroid hormone analog82
FurosemideLoop diuretic88
GabapentinAnti-epileptic agent54
GilenyaSphingosine 1-phosphate receptor modulator132
Hemangeolbeta-Adrenergic blocker178
HumalogInsulin analog36
Humira393
HydrocortisoneCorticosteroid35
IbranceKinase inhibitor57
IbuprofenNonsteroidal anti-inflammatory drug44
ImbruvicaKinase inhibitor53
IndapamideThiazide-like diuretic43
InflectraTumor necrosis factor blocker54
InfliximabTumor necrosis factor blocker51
IxazomibProteasome inhibitor26
JakafiJanus kinase inhibitor64
KesimptaCD20-directed cytolytic antibody65
LamictalAnti-epileptic agent29
LamotrigineAnti-epileptic agent33
LansoprazoleProton pump inhibitor26
LenalidomideThalidomide analog35
Levaquin44
LevofloxacinFluoroquinolone antibacterial75
Levothyroxine29
LipitorHMG-CoA reductase inhibitor53
LisinoprilAngiotensin converting enzyme inhibitor48
LorazepamBenzodiazepine56
LosartanAngiotensin 2 receptor blocker27
Lyrica271
MeloxicamNonsteroidal anti-inflammatory drug25
MetforminBiguanide56
MethotrexateFolate analog metabolic inhibitor136
MethylprednisoloneCorticosteroid30
Methylprednisolone sodium succinateCorticosteroid31
Metoprololbeta-Adrenergic blocker99
Metoprolol succinatebeta-Adrenergic blocker58
Metoprolol tartratebeta-Adrenergic blocker28
MetronidazoleNitroimidazole antimicrobial26
Mirtazapine42
MounjaroGLP-1 receptor agonist47
Neurontin48
OcrevusCD20-directed cytolytic antibody53
OmeprazoleProton pump inhibitor65
OpsumitEndothelin receptor antagonist37
OxaliplatinPlatinum-based drug73
OxyContinOpioid agonist30
OzempicGLP-1 receptor agonist34
PaclitaxelMicrotubule inhibitor37
PegasysInterferon alpha45
PlavixP2Y12 platelet inhibitor30
PomalystThalidomide analog43
PradaxaDirect thrombin inhibitor47
PrednisoneCorticosteroid62
Pregabalin28
ProliaRANK ligand inhibitor79
Propranololbeta-Adrenergic blocker83
Propranolol hydrochloridebeta-Adrenergic blocker36
RamiprilAngiotensin converting enzyme inhibitor125
RebifInterferon beta62
RemicadeTumor necrosis factor blocker94
RemodulinProstacycline vasodilator41
RepathaPCSK9 inhibitor58
RevlimidThalidomide analog276
RibavirinNucleoside analog antiviral34
RinvoqJanus kinase inhibitor36
RituxanCD20-directed cytolytic antibody31
RituximabCD20-directed cytolytic antibody77
SandostatinSomatostatin analog62
Sandostatin LAR Depot43
SimvastatinHMG-CoA reductase inhibitor93
SkyriziInterleukin-23 antagonist28
SpironolactoneAldosterone antagonist44
StratteraNorepinephrine reuptake inhibitor61
Synthroidl-Thyroxine60
Tecfidera93
TelmisartanAngiotensin 2 receptor blocker31
Toprol-Xl33
Tramadol31
TrulicityGLP-1 receptor agonist27
TylenolExpectorant34
TysabriIntegrin receptor antagonist196
UltravistRadiographic contrast agent33
UptraviProstacyclin receptor agonist31
ValsartanAngiotensin 2 receptor blocker37
VedolizumabIntegrin receptor antagonist47
VenlafaxineSerotonin and norepinephrine reuptake inhibitor36
Venlafaxine hydrochlorideSerotonin and norepinephrine reuptake inhibitor27
VyvanseCentral nervous system stimulant52
XareltoFactor Xa inhibitor46
XeljanzJanus kinase inhibitor127
XelodaNucleoside metabolic inhibitor34
XolairAnti-IgE40
XtandiAndrogen receptor inhibitor33
XyremCentral nervous system depressant110
ZejulaPoly(ADP-Ribose) polymerase inhibitor31
Zometa44

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 58 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 .

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 Peripheral coldness name, in order of name
ClassReports with this term
Aldosterone antagonist56
alpha-Adrenergic blocker109
Angiotensin 2 receptor blocker309
Angiotensin converting enzyme inhibitor189
Anti-coagulant90
Anti-epileptic agent155
Anti-IgE61
Atypical antipsychotic184
Benzodiazepine120
beta-Adrenergic blocker770
Biguanide99
Bisphosphonate85
Calcium channel blocker168
CD20-directed cytolytic antibody248
CD52-directed cytolytic antibody63
Central nervous system depressant139
Central nervous system stimulant137
Corticosteroid297
Endothelin receptor antagonist115
Factor Xa inhibitor185
Fluoroquinolone antibacterial198
Folate analog metabolic inhibitor154
GLP-1 receptor agonist220
HMG-CoA reductase inhibitor233
Insulin analog82
Integrin receptor antagonist272
Interferon beta202
Interleukin-17A antagonist57
Interleukin-4 receptor alpha antagonist101
Interleukin-6 receptor antagonist80
Janus kinase inhibitor229
Kinase inhibitor401
l-Thyroxine99
Loop diuretic113
Microtubule inhibitor54
Nonsteroidal anti-inflammatory drug278
Norepinephrine reuptake inhibitor64
Nucleoside metabolic inhibitor181
Opioid agonist186
P2Y12 platelet inhibitor118
Parathyroid hormone analog94
PCSK9 inhibitor69
Phosphodiesterase 5 inhibitor59
Platinum-based drug138
Poly(ADP-Ribose) polymerase inhibitor57
Potassium channel blocker113
Prostacycline vasodilator114
Proton pump inhibitor152
Pyrimidine synthesis inhibitor76
RANK ligand inhibitor79
Serotonin and norepinephrine reuptake inhibitor135
Serotonin reuptake inhibitor137
Sodium-Glucose cotransporter 2 inhibitor63
Somatostatin analog81
Sphingosine 1-phosphate receptor modulator146
Thalidomide analog358
Tumor necrosis factor blocker493
Vascular endothelial growth factor inhibitor50

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

Reports by month

Reports that record Peripheral coldness, by month, five years to June 2026
05010020222023202420252026

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 Peripheral coldness
AgeReportsShareShare as a bar
Under 21971.5%
2 to 112211.6%
12 to 172421.8%
18 to 442,05815.2%
45 to 643,34624.7%
65 to 741,86513.8%
75 and over1,3219.8%
Age not given4,29531.7%
Sex of the patient in the reports that record Peripheral coldness
SexReportsShareShare as a bar
Female7,90158.3%
Male4,67134.5%
Unknown or not given9737.2%

Age and sex are as the report gives them. 58.1% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Peripheral coldness: adverse event reports that record this term. https://reportedreactions.com/reaction/peripheral-coldness/ 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 Peripheral coldness 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 .

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 .