Prostatic disorder 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 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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 February 2004 to June 2026, FDA received 5,447 adverse event reports that record the MedDRA preferred term Prostatic disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 154 reports in the 12 months to June 2026 and 207 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 1,354 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, 154 (under 0.1%) record this term. Reports for female patients were 0.8% 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 134 drug pages with 5 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Drugs that the reports with the term Prostatic disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	13
Actemra	Interleukin-6 receptor antagonist	6
Amlodipine besylate	Dihydropyridine calcium channel blocker	5
Androgel		6
Apixaban	Factor Xa inhibitor	19
Aspirin	Nonsteroidal anti-inflammatory drug	15
Atenolol	beta-Adrenergic blocker	5
Avastin	Vascular endothelial growth factor inhibitor	6
Avodart		15
Avonex	Interferon beta	16
Ayvakit	Kinase inhibitor	5
Breo Ellipta	Corticosteroid	6
Cabometyx	Kinase inhibitor	9
Calquence	Kinase inhibitor	6
Camzyos		7
Carbidopa levodopa	Aromatic amino acid	7
Cardura	alpha-Adrenergic blocker	9
Carvedilol	alpha-Adrenergic blocker	7
Celebrex	Nonsteroidal anti-inflammatory drug	15
Certolizumab pegol	Tumor necrosis factor blocker	5
Chantix	Partial cholinergic nicotinic agonist	7
Cialis	Phosphodiesterase 5 inhibitor	18
Ciprofloxacin	Fluoroquinolone antibacterial	15
Cosentyx	Interleukin-17A antagonist	23
Crestor	HMG-CoA reductase inhibitor	8
Cymbalta		9
Dapagliflozin	Sodium-Glucose cotransporter 2 inhibitor	5
Daratumumab Hyaluronidase-Fihj		5
Desloratadine	Histamine-1 receptor antagonist	5
Dexamethasone	Corticosteroid	5
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		9
Diovan	Angiotensin 2 receptor blocker	16
Duodopa		9
Dupixent	Interleukin-4 receptor alpha antagonist	32
Eligard	Gonadotropin releasing hormone receptor agonist	16
Eliquis	Factor Xa inhibitor	116
Enbrel	Tumor necrosis factor blocker	77
Entresto	Angiotensin 2 receptor blocker	58
Exelon	Cholinesterase inhibitor	15
Exforge	Angiotensin 2 receptor blocker	6
Exforge HCT	Angiotensin 2 receptor blocker	7
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	12
Finasteride	5-alpha reductase inhibitor	22
Flomax		18
Fosamax	Bisphosphonate	8
Furosemide	Loop diuretic	5
Galvus Met		5
Genotropin		8
Glassia	Human alpha-1 proteinase inhibitor	5
Human immunoglobulin g	Human immunoglobulin G	7
Humira		170
Imbruvica	Kinase inhibitor	72
Incivek		5
Inflectra	Tumor necrosis factor blocker	18
Infliximab	Tumor necrosis factor blocker	12
Invokana	Sodium-Glucose cotransporter 2 inhibitor	6
Jakafi	Janus kinase inhibitor	28
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	6
Kayexalate		6
Lantus	Insulin analog	6
Leflunomide	Antirheumatic agent	9
Lenalidomide	Thalidomide analog	18
Lipitor	HMG-CoA reductase inhibitor	31
Lisinopril	Angiotensin converting enzyme inhibitor	12
Losartan	Angiotensin 2 receptor blocker	10
Lyrica		16
Mepolizumab	Interleukin-5 antagonist	11
Methotrexate	Folate analog metabolic inhibitor	18
Methotrexate sodium	Folate analog metabolic inhibitor	5
Metoprolol	beta-Adrenergic blocker	8
Minocycline	Tetracycline-class drug	6
Mycophenolate mofetil	Antimetabolite immunosuppressant	6
Nexium	Proton pump inhibitor	19
Niaspan		6
Nitrofurantoin	Nitrofuran antibacterial	6
Norethindrone	Progestin	23
Nuplazid	Atypical antipsychotic	12
Ocrevus	CD20-directed cytolytic antibody	10
Ofev	Kinase inhibitor	9
Omeprazole	Proton pump inhibitor	14
Orencia	Selective T cell costimulation modulator	10
Orgovyx	Gonadotropin releasing hormone receptor antagonist	9
Otezla	Phosphodiesterase 4 inhibitor	17
OxyContin	Opioid agonist	11
Paxlovid		6
Pegasys	Interferon alpha	11
Permixon		5
Plavix	P2Y12 platelet inhibitor	6
Pomalyst	Thalidomide analog	34
Ponatinib		5
Pradaxa	Direct thrombin inhibitor	8
Praluent	PCSK9 inhibitor	6
Prednisone	Corticosteroid	8
Propecia	5-alpha reductase inhibitor	33
Proscar	5-alpha reductase inhibitor	13
Ranitidine	Histamine-2 receptor antagonist	1,133
Ranitidine Hci		217
Ranitidine hydrochloride	Histamine-2 receptor antagonist	144
Remicade	Tumor necrosis factor blocker	27
Repatha	PCSK9 inhibitor	18
Revlimid	Thalidomide analog	156
Rinvoq	Janus kinase inhibitor	16
Rituxan	CD20-directed cytolytic antibody	11
Rituximab	CD20-directed cytolytic antibody	18
Sandostatin LAR Depot		13
Seroquel	Atypical antipsychotic	13
Skyrizi	Interleukin-23 antagonist	33
Spironolactone	Aldosterone antagonist	6
Sprycel	Kinase inhibitor	8
Stalevo		7
Strattera	Norepinephrine reuptake inhibitor	7
Sutent	Kinase inhibitor	6
Symbicort	Corticosteroid	28
Tamsulosin		22
Tamsulosin hydrochloride	alpha-Adrenergic blocker	14
Teduglutide	GLP-2 analog	5
Testosterone cypionate	Androgen	30
Tikosyn	Antiarrhythmic	6
Tiotropium bromide	Anticholinergic	35
Toviaz		5
Trelegy Ellipta	Anticholinergic	8
Tysabri	Integrin receptor antagonist	12
Vedolizumab	Integrin receptor antagonist	17
Venclexta	BCL-2 inhibitor	15
Viagra	Phosphodiesterase 5 inhibitor	98
Vioxx		65
Vyndamax		12
Xalatan	Prostaglandin analog	9
Xarelto	Factor Xa inhibitor	20
Xeljanz	Janus kinase inhibitor	24
Xolair	Anti-IgE	7
Xtandi	Androgen receptor inhibitor	6
Xyrem	Central nervous system depressant	22
Zantac		1,901

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 45 pharmacologic classes with 10 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 2 Oct 2026.

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 11 Mar 2026. The site read the page on 2 Oct 2026.

Pharmacologic classes of the drugs that the reports with the term Prostatic disorder name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	68
alpha-Adrenergic blocker	34
Androgen	33
Androgen receptor inhibitor	10
Angiotensin 2 receptor blocker	112
Angiotensin converting enzyme inhibitor	22
Anticholinergic	49
Atypical antipsychotic	31
BCL-2 inhibitor	15
beta-Adrenergic blocker	21
CD20-directed cytolytic antibody	39
Central nervous system depressant	24
Cholinesterase inhibitor	15
Corticosteroid	62
Endothelin receptor antagonist	10
Factor Xa inhibitor	159
Fluoroquinolone antibacterial	15
Folate analog metabolic inhibitor	23
Gonadotropin releasing hormone receptor agonist	20
Histamine-1 receptor antagonist	15
Histamine-2 receptor antagonist	1,277
HMG-CoA reductase inhibitor	42
Insulin analog	23
Integrin receptor antagonist	33
Interferon alpha	11
Interferon beta	18
Interleukin-17A antagonist	23
Interleukin-23 antagonist	33
Interleukin-4 receptor alpha antagonist	32
Interleukin-5 antagonist	13
Janus kinase inhibitor	68
Kinase inhibitor	125
Nonsteroidal anti-inflammatory drug	35
Opioid agonist	27
P2Y12 platelet inhibitor	16
PCSK9 inhibitor	24
Phosphodiesterase 4 inhibitor	19
Phosphodiesterase 5 inhibitor	116
Progestin	25
Proton pump inhibitor	50
Selective T cell costimulation modulator	23
Sodium-Glucose cotransporter 2 inhibitor	29
Thalidomide analog	208
Tumor necrosis factor blocker	142
Vascular endothelial growth factor inhibitor	12

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

Reports by month

Reports that record Prostatic disorder, by month, five years to June 2026

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 Prostatic disorder
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	8	0.1%
18 to 44	130	2.4%
45 to 64	1,005	18.5%
65 to 74	892	16.4%
75 and over	671	12.3%
Age not given	2,741	50.3%

Sex of the patient in the reports that record Prostatic disorder
Sex	Reports	Share
Female	45	0.8%
Male	4,432	81.4%
Unknown or not given	970	17.8%

Age and sex are as the report gives them. 75.8% 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

MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Prostatic disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/prostatic-disorder/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

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 Prostatic disorder 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 2 Oct 2026.

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 2 Oct 2026.

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 2 Oct 2026.

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