MedDRA preferred term · passing urine more often

Pollakiuria: adverse event reports recording this term

40,947 reports to FDA record it, 2004–2026; 0.2% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

40,947
reports recording the term: 0.2% of all reports; 2,421
reports, 12 months to June 2026: 2,212 in the 12 months before; 50%
marked serious by the reporter: 57.4% across all reports; 2.1%
record death among outcomes, as reported: 9.1% across all reports

"Pollakiuria" (in plain words, passing urine more often) is a MedDRA preferred term recorded in 40,947 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,421 reports recorded it in the 12 months to June 2026, close to the 2,212 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 50% are marked serious, 2.1% include death among the outcomes and 19% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Jardiance and Entresto. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Humira	—	950	0.1%
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	878	2.5%
Entresto	Angiotensin 2 receptor blocker	817	0.8%
Myrbetriq	beta3-Adrenergic agonist	599	3.1%
Orgovyx	Gonadotropin releasing hormone receptor antagonist	591	2.6%
Enbrel	Tumor necrosis factor blocker	559	0.1%
Tolvaptan	Vasopressin V2 receptor antagonist	505	7.3%
Revlimid	Thalidomide analog	462	0.1%
Invokana	Sodium-Glucose cotransporter 2 inhibitor	452	2%
Xeljanz	Janus kinase inhibitor	427	0.3%
Forteo	Parathyroid hormone analog	420	0.4%
Prednisone	Corticosteroid	410	0.2%
Farxiga	Sodium-Glucose cotransporter 2 inhibitor	397	2.4%
Ampyra	Potassium channel blocker	374	0.7%
Tymlos	—	358	1.3%
Omeprazole	Proton pump inhibitor	352	0.6%
Tecfidera	—	349	0.3%
Xyrem	Central nervous system depressant	339	0.6%
Tysabri	Integrin receptor antagonist	336	0.2%
Gilenya	Sphingosine 1-phosphate receptor modulator	319	0.4%
Fosamax	Bisphosphonate	311	0.9%
Xtandi	Androgen receptor inhibitor	311	0.7%
Eligard	Gonadotropin releasing hormone receptor agonist	296	0.7%
Avonex	Interferon beta	294	0.3%
Prevacid	Proton pump inhibitor	294	0.7%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.2% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Proton pump inhibitor	2,132	0.4%	0.3%
Sodium-Glucose cotransporter 2 inhibitor	2,044	2%	1.5%
Angiotensin 2 receptor blocker	1,401	0.6%	0.4%
Kinase inhibitor	1,343	0.2%	0.1%
Atypical antipsychotic	1,222	0.2%	0.1%
Corticosteroid	1,168	0.1%	0%
Tumor necrosis factor blocker	1,062	0.1%	0.1%
beta3-Adrenergic agonist	851	3.1%	3.1%
GLP-1 receptor agonist	838	0.2%	0.2%
HMG-CoA reductase inhibitor	792	0.4%	0.3%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.1%28

2 to 110.7%292

12 to 170.6%228

18 to 4410.4%4,244

45 to 6421.7%8,899

65 to 7414.1%5,766

75 and over13.1%5,367

Age not given39.4%16,123

Patient sex

Female51.5%21,097

Male39.8%16,297

Not given8.7%3,553

Grey bar: all 20,646,523 reports in the database. 73.8% of these reports give the United States as the country.

Questions about "Pollakiuria"

What does "Pollakiuria" mean in an adverse event report?

In plain language: passing urine more often. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record pollakiuria?

40,947 reports through June 2026 (0.2% of all reports), 2,421 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (950), Jardiance (878), Entresto (817), Myrbetriq (599) and Orgovyx (591). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.