MedDRA preferred term

Deafness unilateral: adverse event reports recording this term

5,426 reports to FDA record it, 2004–2026; 0% 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.

5,426
reports recording the term: 0% of all reports; 293
reports, 12 months to June 2026: 346 in the 12 months before; 94.7%
marked serious by the reporter: 57.4% across all reports; 1.5%
record death among outcomes, as reported: 9.1% across all reports

"Deafness unilateral" is a MedDRA preferred term recorded in 5,426 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

293 reports recorded it in the 12 months to June 2026, down 15% from 346 in 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, 94.7% are marked serious, 1.5% include death among the outcomes and 18.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Cialis and Tecfidera. 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	—	378	0.1%
Cialis	Phosphodiesterase 5 inhibitor	89	0.6%
Tecfidera	—	84	0.1%
Tysabri	Integrin receptor antagonist	80	0%
Enbrel	Tumor necrosis factor blocker	78	0%
Viagra	Phosphodiesterase 5 inhibitor	77	0.3%
Avonex	Interferon beta	72	0.1%
Skyrizi	Interleukin-23 antagonist	64	0.1%
Rinvoq	Janus kinase inhibitor	56	0.1%
Imbruvica	Kinase inhibitor	52	0.1%
Rituximab	CD20-directed cytolytic antibody	52	0%
Cosentyx	Interleukin-17A antagonist	50	0%
Revlimid	Thalidomide analog	45	0%
Prednisone	Corticosteroid	44	0%
Prolia	RANK ligand inhibitor	43	0%
Methotrexate	Folate analog metabolic inhibitor	42	0%
Lyrica	—	41	0%
Tepezza	—	41	0.8%
Actemra	Interleukin-6 receptor antagonist	34	0%
Gilenya	Sphingosine 1-phosphate receptor modulator	33	0%
Humalog	Insulin analog	33	0%
Rebif	Interferon beta	33	0.1%
Ciprofloxacin	Fluoroquinolone antibacterial	31	0.1%
Lipitor	HMG-CoA reductase inhibitor	29	0.1%
Ambrisentan	Endothelin receptor antagonist	28	0.1%

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% 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
Phosphodiesterase 5 inhibitor	223	0.2%	0.1%
Tumor necrosis factor blocker	163	0%	0%
Kinase inhibitor	123	0%	0%
Corticosteroid	115	0%	0%
Interferon beta	112	0.1%	0%
Integrin receptor antagonist	104	0%	0%
CD20-directed cytolytic antibody	96	0%	0%
Janus kinase inhibitor	91	0%	0%
Insulin analog	79	0%	0%
Nonsteroidal anti-inflammatory drug	75	0%	0%

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 20.4%22

2 to 110.7%36

12 to 171.1%60

18 to 4411.2%608

45 to 6426.6%1,441

65 to 7413.1%712

75 and over9.8%530

Age not given37.2%2,017

Patient sex

Female55.7%3,024

Male37.9%2,054

Not given6.4%348

Grey bar: all 20,646,523 reports in the database. 58.5% of these reports give the United States as the country.

Questions about "Deafness unilateral"

What does "Deafness unilateral" mean in an adverse event report?

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 deafness unilateral?

5,426 reports through June 2026 (0% of all reports), 293 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (378), Cialis (89), Tecfidera (84), Tysabri (80) and Enbrel (78). 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.