Reported Reactions

Adverse event reports that FDA received

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Salivary hypersecretion 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 9,843 adverse event reports that record the MedDRA preferred term Salivary hypersecretion. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 564 reports in the 12 months to June 2026 and 569 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 923 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, 564 (under 0.1%) record this term. Reports for male patients were 44.5% of the reports that record this term and 34.6% 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 95 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 Salivary hypersecretion name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic280
Abilify Maintena25
Alcohol25
AmisulprideDopamine-2 receptor antagonist80
AmlodipineCalcium channel blocker40
AripiprazoleAtypical antipsychotic340
AspirinNonsteroidal anti-inflammatory drug30
Atorvastatin31
AyvakitKinase inhibitor30
BotoxAcetylcholine release inhibitor25
ByettaGLP-1 receptor agonist44
CarbamazepineMood stabilizer43
Carbidopa levodopaAromatic amino acid133
CarboplatinPlatinum-based drug36
ChantixPartial cholinergic nicotinic agonist42
ChlorpromazinePhenothiazine30
CitalopramSerotonin reuptake inhibitor41
ClobazamBenzodiazepine35
ClonazepamBenzodiazepine145
ClozapineAtypical antipsychotic1,102
ClozarilAtypical antipsychotic693
Commit61
Cymbalta40
DepakoteAnti-epileptic agent25
DiazepamBenzodiazepine202
Donepezil42
Duodopa83
DupixentInterleukin-4 receptor alpha antagonist48
EnbrelTumor necrosis factor blocker29
EscitalopramSerotonin reuptake inhibitor30
ExelonCholinesterase inhibitor38
FluorouracilNucleoside metabolic inhibitor31
FluoxetineSerotonin reuptake inhibitor74
Fluvoxamine25
GabapentinAnti-epileptic agent35
Haldol92
HaloperidolTypical antipsychotic218
Humira49
IbranceKinase inhibitor29
IngrezzaVesicular monoamine transporter 2 inhibitor131
InvegaAtypical antipsychotic43
Invega SustennaAtypical antipsychotic54
LamotrigineAnti-epileptic agent64
LansoprazoleProton pump inhibitor30
LatudaAtypical antipsychotic26
Leponex95
Levetiracetam27
Levothyroxine33
LithiumMood stabilizer87
Lithium carbonateMood stabilizer68
LorazepamBenzodiazepine166
Loxapine32
Lyrica43
MetforminBiguanide27
MethotrexateFolate analog metabolic inhibitor29
MetoclopramideDopamine-2 receptor antagonist25
Metoprololbeta-Adrenergic blocker29
Mirtazapine37
NexiumProton pump inhibitor40
NicoretteCholinergic nicotinic agonist41
Nicotine polacrilexCholinergic nicotinic agonist30
Nordazepam26
NuplazidAtypical antipsychotic83
OlanzapineAtypical antipsychotic461
OmeprazoleProton pump inhibitor51
OxaliplatinPlatinum-based drug34
PaliperidoneAtypical antipsychotic66
ParoxetineSerotonin reuptake inhibitor25
Paxlovid29
Pregabalin40
PropofolGeneral anesthetic26
QuetiapineAtypical antipsychotic218
Quetiapine fumarateAtypical antipsychotic69
RamiprilAngiotensin converting enzyme inhibitor56
RevlimidThalidomide analog42
RexultiAtypical antipsychotic30
RisperdalAtypical antipsychotic188
Risperdal Consta26
RisperidoneAtypical antipsychotic483
Rivotril44
SeroquelAtypical antipsychotic75
SertralineSerotonin reuptake inhibitor154
Tecfidera42
Topiramate26
Tramadol41
ValiumBenzodiazepine32
Valproate34
Valproate sodiumAnti-epileptic agent42
Valproic acidAnti-epileptic agent131
VenlafaxineSerotonin and norepinephrine reuptake inhibitor53
XanaxBenzodiazepine35
XtandiAndrogen receptor inhibitor35
XyremCentral nervous system depressant27
Zuclopenthixol43
ZyprexaAtypical antipsychotic82

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 51 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 .

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 Salivary hypersecretion name, in order of name
ClassReports with this term
Acetylcholine release inhibitor27
alpha-Adrenergic blocker34
Aminoglycoside antibacterial28
Androgen receptor inhibitor38
Angiotensin 2 receptor blocker54
Angiotensin converting enzyme inhibitor74
Anti-epileptic agent422
Anti-IgE30
Anticholinergic76
Aromatic amino acid204
Atypical antipsychotic4,406
Benzodiazepine698
beta-Adrenergic blocker81
Biguanide35
Calcium channel blocker40
CD20-directed cytolytic antibody30
Central nervous system depressant36
Central nervous system stimulant39
Cholinergic nicotinic agonist95
Cholinesterase inhibitor104
Corticosteroid79
Dopamine-2 receptor antagonist105
Endothelin receptor antagonist32
Factor Xa inhibitor34
Folate analog metabolic inhibitor31
gamma-Aminobutyric acid-ergic agonist36
General anesthetic41
GLP-1 receptor agonist128
Histamine-1 receptor antagonist48
HMG-CoA reductase inhibitor79
Interleukin-4 receptor alpha antagonist48
Kinase inhibitor200
Mood stabilizer218
Nonergot dopamine agonist30
Nonsteroidal anti-inflammatory drug83
Nucleoside metabolic inhibitor42
Opioid agonist44
Opioid antagonist28
Partial cholinergic nicotinic agonist45
Phenothiazine43
Platinum-based drug78
Poly(ADP-Ribose) polymerase inhibitor28
Prostacycline vasodilator37
Proton pump inhibitor166
Serotonin and norepinephrine reuptake inhibitor109
Serotonin reuptake inhibitor419
Thalidomide analog52
Tumor necrosis factor blocker50
Typical antipsychotic228
Vascular endothelial growth factor inhibitor35
Vesicular monoamine transporter 2 inhibitor145

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

Reports by month

Reports that record Salivary hypersecretion, 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 Salivary hypersecretion
AgeReportsShareShare as a bar
Under 21201.2%
2 to 113113.2%
12 to 172542.6%
18 to 442,15921.9%
45 to 642,20222.4%
65 to 741,05410.7%
75 and over8839%
Age not given2,86029.1%
Sex of the patient in the reports that record Salivary hypersecretion
SexReportsShareShare as a bar
Female4,60946.8%
Male4,38344.5%
Unknown or not given8518.6%

Age and sex are as the report gives them. 42.8% 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. Salivary hypersecretion: adverse event reports that record this term. https://reportedreactions.com/reaction/salivary-hypersecretion/ 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 Salivary hypersecretion 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 .