Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Sexual dysfunction adverse event reports that record this term

Kind of term
MedDRA preferred term
Plain meaning
a sexual problem

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 11,406 adverse event reports that record the MedDRA preferred term Sexual dysfunction. In plain words, the term means: a sexual problem. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 697 reports in the 12 months to June 2026 and 955 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 805 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, 697 (0.1%) record this term. Reports for male patients were 69.1% 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.

Plain meaning

A sexual problem. 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 120 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 Sexual dysfunction name as a suspect product, in order of name
DrugClassReports with this term
AbilifyAtypical antipsychotic643
Abilify Maintena322
Acetaminophen Oxycodone Hydrochloride53
AmisulprideDopamine-2 receptor antagonist29
AmpyraPotassium channel blocker31
Androgel25
AripiprazoleAtypical antipsychotic570
Asenapine maleateAtypical antipsychotic31
Atorvastatin28
AubagioPyrimidine synthesis inhibitor69
Avodart70
Brintellix41
BupropionAminoketone56
Bupropion hydrochlorideAminoketone101
ButransPartial opioid agonist28
CelexaSerotonin reuptake inhibitor31
ChantixPartial cholinergic nicotinic agonist26
Cipralex34
CiprofloxacinFluoroquinolone antibacterial34
CitalopramSerotonin reuptake inhibitor278
Citalopram hydrobromideSerotonin reuptake inhibitor49
ClonazepamBenzodiazepine47
ClozapineAtypical antipsychotic427
ClozarilAtypical antipsychotic109
CosentyxInterleukin-17A antagonist61
CrestorHMG-CoA reductase inhibitor34
Cymbalta261
Desvenlafaxine succinateSerotonin and norepinephrine reuptake inhibitor62
DilaudidOpioid agonist71
DuloxetineSerotonin and norepinephrine reuptake inhibitor54
Duloxetine hydrochlorideSerotonin and norepinephrine reuptake inhibitor34
EffexorSerotonin and norepinephrine reuptake inhibitor50
EnbrelTumor necrosis factor blocker33
EscitalopramSerotonin reuptake inhibitor295
Escitalopram oxalateSerotonin reuptake inhibitor46
Finasteride5-alpha reductase inhibitor983
Flomax37
FluoxetineSerotonin reuptake inhibitor169
Flupentixol271
Flupentixol Decanoate187
Flupentixol Dihydrochloride177
GabapentinAnti-epileptic agent74
GeodonAtypical antipsychotic27
GilenyaSphingosine 1-phosphate receptor modulator47
Haldol36
HaloperidolTypical antipsychotic55
Humira51
Hydrocodone bitartrate and acetaminophenOpioid agonist113
InvegaAtypical antipsychotic271
Invega SustennaAtypical antipsychotic169
LamictalAnti-epileptic agent53
LamotrigineAnti-epileptic agent30
LatudaAtypical antipsychotic449
Levetiracetam35
LexaproSerotonin reuptake inhibitor131
LipitorHMG-CoA reductase inhibitor25
LithiumMood stabilizer40
Lurasidone hydrochlorideAtypical antipsychotic139
Lyrica92
MethotrexateFolate analog metabolic inhibitor43
MinoxidilArteriolar vasodilator88
MirenaProgestin64
Mirtazapine113
Morphine sulfateOpioid agonist96
MS ContinOpioid agonist69
Neurontin28
OlanzapineAtypical antipsychotic501
OrgovyxGonadotropin releasing hormone receptor antagonist43
Oxycodone and acetaminophenOpioid agonist68
Oxycodone hydrochlorideOpioid agonist212
OxyContinOpioid agonist210
PaliperidoneAtypical antipsychotic326
Paliperidone palmitateAtypical antipsychotic204
ParaGard T 380ACopper-containing intrauterine device253
ParoxetineSerotonin reuptake inhibitor92
Paroxetine hydrochlorideSerotonin reuptake inhibitor65
PaxilSerotonin reuptake inhibitor293
PercocetOpioid agonist55
Pregabalin59
Propecia5-alpha reductase inhibitor1,718
Proscar5-alpha reductase inhibitor299
ProzacSerotonin reuptake inhibitor158
QuetiapineAtypical antipsychotic238
Quetiapine fumarateAtypical antipsychotic458
RevlimidThalidomide analog36
RexultiAtypical antipsychotic27
RisperdalAtypical antipsychotic291
Risperdal Consta195
RisperidoneAtypical antipsychotic573
RotigotineNonergot dopamine agonist28
SaphrisAtypical antipsychotic402
SeroquelAtypical antipsychotic119
SertralineSerotonin reuptake inhibitor455
Sertraline hydrochlorideSerotonin reuptake inhibitor66
SimvastatinHMG-CoA reductase inhibitor43
StratteraNorepinephrine reuptake inhibitor99
Tamsulosin31
Tramadol59
Trazodone30
Trintellix111
TysabriIntegrin receptor antagonist37
VenlafaxineSerotonin and norepinephrine reuptake inhibitor168
Venlafaxine hclSerotonin and norepinephrine reuptake inhibitor25
Venlafaxine hydrochlorideSerotonin and norepinephrine reuptake inhibitor94
ViagraPhosphodiesterase 5 inhibitor49
Vicodin28
Viibryd48
Vioxx45
Vivitrol32
Vortioxetine41
WellbutrinAminoketone45
Zeldox44
ZiprasidoneAtypical antipsychotic114
Ziprasidone hydrochlorideAtypical antipsychotic373
ZoloftSerotonin reuptake inhibitor203
Zuclopenthixol208
Zuclopenthixol Acetate281
Zuclopenthixol Decanoate254
Zuclopenthixol Hydrochloride118
ZyprexaAtypical antipsychotic579

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 38 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 Sexual dysfunction name, in order of name
ClassReports with this term
5-alpha reductase inhibitor3,007
alpha-Adrenergic blocker32
Aminoketone228
Angiotensin 2 receptor blocker36
Anti-epileptic agent183
Arteriolar vasodilator88
Atypical antipsychotic7,085
Benzodiazepine135
beta-Adrenergic blocker54
Central nervous system stimulant85
Copper-containing intrauterine device253
Dopamine-2 receptor antagonist34
Fluoroquinolone antibacterial60
Folate analog metabolic inhibitor46
Gonadotropin releasing hormone receptor antagonist45
HMG-CoA reductase inhibitor111
Integrin receptor antagonist37
Interferon beta28
Interleukin-17A antagonist61
Mood stabilizer58
Nonergot dopamine agonist32
Nonsteroidal anti-inflammatory drug41
Norepinephrine reuptake inhibitor112
Opioid agonist1,070
Opioid antagonist25
Partial cholinergic nicotinic agonist26
Partial opioid agonist42
Phosphodiesterase 5 inhibitor73
Potassium channel blocker33
Progestin79
Pyrimidine synthesis inhibitor73
Retinoid31
Serotonin and norepinephrine reuptake inhibitor512
Serotonin reuptake inhibitor2,377
Sphingosine 1-phosphate receptor modulator47
Thalidomide analog43
Tumor necrosis factor blocker35
Typical antipsychotic65

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

Reports by month

Reports that record Sexual dysfunction, by month, five years to June 2026
010020020222023202420252026

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 Sexual dysfunction
AgeReportsShareShare as a bar
Under 200%
2 to 11110.1%
12 to 17810.7%
18 to 443,69432.4%
45 to 641,75815.4%
65 to 743443%
75 and over1181%
Age not given5,40047.3%
Sex of the patient in the reports that record Sexual dysfunction
SexReportsShareShare as a bar
Female2,68723.6%
Male7,88269.1%
Unknown or not given8377.3%

Age and sex are as the report gives them. 63.2% 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. Sexual dysfunction: adverse event reports that record this term. https://reportedreactions.com/reaction/sexual-dysfunction/ 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 Sexual dysfunction mean in an adverse event report?

In plain words: a sexual problem. 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 .