Aphonia 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 January 2004 to June 2026, FDA received 13,739 adverse event reports that record the MedDRA preferred term Aphonia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 831 reports in the 12 months to June 2026 and 854 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 703 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, 831 (0.1%) record this term. Reports for female patients were 69% 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 122 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 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 Aphonia name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	51
Actemra	Interleukin-6 receptor antagonist	71
Advair Diskus	Corticosteroid	123
Advair Diskus 100/50		242
Advair Hfa	Corticosteroid	183
Afinitor	Kinase inhibitor	49
Albuterol	beta2-Adrenergic agonist	26
Albuterol sulfate	beta2-Adrenergic agonist	85
Alemtuzumab	CD52-directed cytolytic antibody	32
Ambrisentan	Endothelin receptor antagonist	32
Amoxicillin	Penicillin-class antibacterial	35
Anoro Ellipta	Anticholinergic	28
Arikayce	Aminoglycoside antibacterial	502
Avastin	Vascular endothelial growth factor inhibitor	49
Avonex	Interferon beta	77
Benlysta	B lymphocyte stimulator-specific inhibitor	28
Bevacizumab	Vascular endothelial growth factor inhibitor	38
Botox	Acetylcholine release inhibitor	30
Breo Ellipta	Corticosteroid	155
Breztri	Corticosteroid	67
Budesonide	Corticosteroid	47
Cabometyx	Kinase inhibitor	105
Capecitabine	Nucleoside metabolic inhibitor	27
Celebrex	Nonsteroidal anti-inflammatory drug	26
Certolizumab pegol	Tumor necrosis factor blocker	33
Chantix	Partial cholinergic nicotinic agonist	37
Cimzia	Tumor necrosis factor blocker	25
Combivent		33
Cosentyx	Interleukin-17A antagonist	190
Crestor	HMG-CoA reductase inhibitor	52
Cymbalta		35
Dexamethasone	Corticosteroid	30
Diovan	Angiotensin 2 receptor blocker	31
Dulera	Corticosteroid	51
Dupixent	Interleukin-4 receptor alpha antagonist	314
Eliquis	Factor Xa inhibitor	30
Enbrel	Tumor necrosis factor blocker	434
Entresto	Angiotensin 2 receptor blocker	124
Fasenra	Interleukin-5 receptor alpha-directed cytolytic antibody	33
Flovent	Corticosteroid	75
Fluticasone	Corticosteroid	30
Fluticasone propionate and salmeterol	Corticosteroid	38
Forteo	Parathyroid hormone analog	113
Fruquintinib		26
Fulvestrant	Estrogen receptor antagonist	27
Gabapentin	Anti-epileptic agent	55
Gilenya	Sphingosine 1-phosphate receptor modulator	92
Glycopyrrolate	Anticholinergic	34
Humalog	Insulin analog	34
Human immunoglobulin g	Human immunoglobulin G	40
Humira		526
Ibrance	Kinase inhibitor	144
Imbruvica	Kinase inhibitor	43
Inflectra	Tumor necrosis factor blocker	88
Infliximab	Tumor necrosis factor blocker	67
Inlyta	Kinase inhibitor	184
Insulin glargine	Insulin analog	32
Jakafi	Janus kinase inhibitor	25
Kesimpta	CD20-directed cytolytic antibody	79
Keytruda	Programmed death Receptor-1 blocking antibody	38
Kisqali	Kinase inhibitor	67
Lamira Nebulizer System		164
Lenvima	Kinase inhibitor	61
Letairis	Endothelin receptor antagonist	26
Levofloxacin	Fluoroquinolone antibacterial	44
Lisinopril	Angiotensin converting enzyme inhibitor	26
Losartan	Angiotensin 2 receptor blocker	25
Lucentis	Vascular endothelial growth factor inhibitor	32
Lyrica		142
Mepolizumab	Interleukin-5 antagonist	74
Methotrexate	Folate analog metabolic inhibitor	126
Methotrexate sodium	Folate analog metabolic inhibitor	34
Mounjaro	GLP-1 receptor agonist	28
Nexium	Proton pump inhibitor	152
Nucala	Interleukin-5 antagonist	73
Ocrevus	CD20-directed cytolytic antibody	102
Ofev	Kinase inhibitor	55
Omalizumab	Anti-IgE	119
Omeprazole	Proton pump inhibitor	49
Opsumit	Endothelin receptor antagonist	59
Orencia	Selective T cell costimulation modulator	28
Otezla	Phosphodiesterase 4 inhibitor	35
Ozempic	GLP-1 receptor agonist	34
Paxlovid		67
Pegasys	Interferon alpha	27
Pomalyst	Thalidomide analog	40
Prednisone	Corticosteroid	171
Prolia	RANK ligand inhibitor	38
Pulmicort Turbuhaler		37
Ramipril	Angiotensin converting enzyme inhibitor	28
Remicade	Tumor necrosis factor blocker	53
Repatha	PCSK9 inhibitor	128
Revlimid	Thalidomide analog	216
Rinvoq	Janus kinase inhibitor	77
Rituxan	CD20-directed cytolytic antibody	28
Rituximab	CD20-directed cytolytic antibody	109
Sandostatin LAR Depot		52
Seretide		28
Seroquel	Atypical antipsychotic	40
Singulair	Leukotriene receptor antagonist	70
Skyrizi	Interleukin-23 antagonist	65
Soliris	Complement inhibitor	29
Spiriva Respimat	Anticholinergic	38
Stivarga	Kinase inhibitor	54
Symbicort	Corticosteroid	346
Tecfidera		72
Tiotropium bromide	Anticholinergic	308
Tobi	Aminoglycoside antibacterial	28
TOBI Podhaler	Aminoglycoside antibacterial	50
Tobramycin	Aminoglycoside antibacterial	35
Tramadol		33
Trelegy Ellipta	Anticholinergic	144
Trulicity	GLP-1 receptor agonist	26
Tudorza Pressair	Anticholinergic	25
Tysabri	Integrin receptor antagonist	140
Tyvaso	Prostacycline vasodilator	44
Tyvaso DPI	Prostacycline vasodilator	25
Vedolizumab	Integrin receptor antagonist	49
Ventolin Hfa	beta2-Adrenergic agonist	34
Xeljanz	Janus kinase inhibitor	255
Xolair	Anti-IgE	248
Xyrem	Central nervous system depressant	82

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 50 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 Aphonia name, in order of name
Class	Reports with this term
Acetylcholine release inhibitor	71
Aminoglycoside antibacterial	631
Angiotensin 2 receptor blocker	208
Angiotensin converting enzyme inhibitor	57
Anti-epileptic agent	85
Anti-IgE	370
Anticholinergic	625
Atypical antipsychotic	160
beta2-Adrenergic agonist	174
Calcineurin inhibitor immunosuppressant	53
CD20-directed cytolytic antibody	343
Central nervous system depressant	95
Corticosteroid	1,504
Endothelin receptor antagonist	127
Factor Xa inhibitor	54
Fluoroquinolone antibacterial	66
Folate analog metabolic inhibitor	160
GLP-1 receptor agonist	162
HER2/neu receptor antagonist	66
HMG-CoA reductase inhibitor	117
Human immunoglobulin G	65
Insulin analog	97
Integrin receptor antagonist	198
Interferon beta	89
Interleukin-17A antagonist	206
Interleukin-23 antagonist	67
Interleukin-4 receptor alpha antagonist	327
Interleukin-5 antagonist	147
Interleukin-6 receptor antagonist	86
Janus kinase inhibitor	360
Kinase inhibitor	1,000
Leukotriene receptor antagonist	94
Nonsteroidal anti-inflammatory drug	106
Opioid agonist	69
Parathyroid hormone analog	115
PCSK9 inhibitor	142
Platinum-based drug	52
Programmed death Receptor-1 blocking antibody	88
Prostacycline vasodilator	136
Proton pump inhibitor	295
Selective T cell costimulation modulator	79
Sphingosine 1-phosphate receptor modulator	100
Thalidomide analog	269
Tumor necrosis factor blocker	737
Vascular endothelial growth factor inhibitor	123

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

Reports by month

Reports that record Aphonia, 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 Aphonia
Age	Reports	Share
Under 2	4	under 0.1%
2 to 11	33	0.2%
12 to 17	45	0.3%
18 to 44	1,501	10.9%
45 to 64	3,409	24.8%
65 to 74	1,941	14.1%
75 and over	1,497	10.9%
Age not given	5,309	38.6%

Sex of the patient in the reports that record Aphonia
Sex	Reports	Share
Female	9,474	69%
Male	3,270	23.8%
Unknown or not given	995	7.2%

Age and sex are as the report gives them. 71.5% 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. Aphonia: adverse event reports that record this term. https://reportedreactions.com/reaction/aphonia/ 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 Aphonia 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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