Hyperkeratosis 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 5,440 adverse event reports that record the MedDRA preferred term Hyperkeratosis. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 282 reports in the 12 months to June 2026 and 299 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 1,250 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, 282 (under 0.1%) record this term. Reports for patients aged 45 to 64 were 29.4% of the reports that record this term and 20% 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 119 drug pages with 10 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 Hyperkeratosis name as a suspect product, in order of name
Drug	Class	Reports with this term
Abatacept	Selective T cell costimulation modulator	28
Abilify	Atypical antipsychotic	10
Acetaminophen		14
Acitretin	Retinoid	13
Actemra	Interleukin-6 receptor antagonist	110
Adalimumab	Tumor necrosis factor blocker	16
Afinitor	Kinase inhibitor	10
Alendronate sodium	Bisphosphonate	36
Amlodipine	Calcium channel blocker	26
Amoxicillin	Penicillin-class antibacterial	13
Aredia		55
Atorvastatin		20
Avastin	Vascular endothelial growth factor inhibitor	11
Avodart		15
Avonex	Interferon beta	17
Azathioprine	Purine antimetabolite	11
Azithromycin	Macrolide antimicrobial	10
Betamethasone		10
Bevacizumab	Vascular endothelial growth factor inhibitor	13
Breo Ellipta	Corticosteroid	10
Brinsupri		25
Cabometyx	Kinase inhibitor	422
Candesartan cilexetil	Angiotensin 2 receptor blocker	11
Capecitabine	Nucleoside metabolic inhibitor	30
Celebrex	Nonsteroidal anti-inflammatory drug	12
Ciclosporin		14
Ciprofloxacin	Fluoroquinolone antibacterial	24
Clobetasol		14
Cobimetinib	Kinase inhibitor	11
Cometriq	Kinase inhibitor	27
Cosentyx	Interleukin-17A antagonist	93
Cyclophosphamide	Alkylating drug	17
Cyclosporine	Calcineurin inhibitor immunosuppressant	36
Cymbalta		25
Dabrafenib	Kinase inhibitor	33
Dexamethasone	Corticosteroid	28
Dupilumab	Interleukin-4 receptor alpha antagonist	20
Dupixent	Interleukin-4 receptor alpha antagonist	96
Enbrel	Tumor necrosis factor blocker	282
Estrace	Estrogen	19
Fluorouracil	Nucleoside metabolic inhibitor	11
Forteo	Parathyroid hormone analog	23
Fosamax	Bisphosphonate	111
Fosamax Plus D		19
Gilenya	Sphingosine 1-phosphate receptor modulator	19
Gleevec	Kinase inhibitor	11
Humalog	Insulin analog	30
Humira		398
Humulin N	Insulin	12
Hydrochlorothiazide	Thiazide diuretic	22
Hydrocortisone	Corticosteroid	15
Hydromorph Contin		14
Hydroxychloroquine	Antimalarial	29
Hydroxychloroquine sulfate	Antimalarial	16
Hyzaar	Thiazide diuretic	19
Ibuprofen	Nonsteroidal anti-inflammatory drug	10
Imbruvica	Kinase inhibitor	29
Infliximab	Tumor necrosis factor blocker	15
Inlyta	Kinase inhibitor	67
Insulin glargine	Insulin analog	13
Invokana	Sodium-Glucose cotransporter 2 inhibitor	12
Kardegic		14
Keytruda	Programmed death Receptor-1 blocking antibody	25
Lamictal	Anti-epileptic agent	10
Lantus	Insulin analog	10
Leflunomide	Antirheumatic agent	31
Lenalidomide	Thalidomide analog	14
Lenvatinib mesylate		10
Lenvima	Kinase inhibitor	50
Levofloxacin	Fluoroquinolone antibacterial	14
Lisinopril	Angiotensin converting enzyme inhibitor	13
Lyrica		23
Magnevist		23
Medroxyprogesterone acetate	Progestin	17
Mekinist	Kinase inhibitor	22
Metformin	Biguanide	14
Methotrexate	Folate analog metabolic inhibitor	130
Methotrexate sodium	Folate analog metabolic inhibitor	24
Mirtazapine		10
Mycophenolate mofetil	Antimetabolite immunosuppressant	40
Nexavar	Kinase inhibitor	229
Nivolumab	Programmed death Receptor-1 blocking antibody	28
Omniscan	Paramagnetic contrast agent	18
Opdivo	Programmed death Receptor-1 blocking antibody	56
Orencia	Selective T cell costimulation modulator	12
Paclitaxel	Microtubule inhibitor	16
Pembrolizumab	Programmed death Receptor-1 blocking antibody	10
Perindopril		10
Prednisolone	Corticosteroid	42
Prednisone	Corticosteroid	33
Prolia	RANK ligand inhibitor	16
Qinlock	Kinase inhibitor	145
Regranex		20
Remicade	Tumor necrosis factor blocker	62
Revlimid	Thalidomide analog	27
Rinvoq	Janus kinase inhibitor	22
Rituxan	CD20-directed cytolytic antibody	34
Rituximab	CD20-directed cytolytic antibody	85
Seroquel	Atypical antipsychotic	11
Simponi	Tumor necrosis factor blocker	11
Skyrizi	Interleukin-23 antagonist	47
Sorafenib	Kinase inhibitor	10
Stelara	Interleukin-12 antagonist	21
Stivarga	Kinase inhibitor	142
Sutent	Kinase inhibitor	230
Tacrolimus	Calcineurin inhibitor immunosuppressant	24
Tafinlar	Kinase inhibitor	47
Tasigna	Kinase inhibitor	11
Trametinib	Kinase inhibitor	14
Triamcinolone		14
Tysabri	Integrin receptor antagonist	22
Vemurafenib	Kinase inhibitor	76
Verapamil		10
Vioxx		16
Votrient	Kinase inhibitor	34
Xeljanz	Janus kinase inhibitor	43
Xeloda	Nucleoside metabolic inhibitor	13
Zelboraf	Kinase inhibitor	115
Zometa		80

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 59 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 Hyperkeratosis name, in order of name
Class	Reports with this term
Alkylating drug	19
Angiotensin 2 receptor blocker	41
Angiotensin converting enzyme inhibitor	15
Anti-epileptic agent	18
Antimalarial	45
Antimetabolite immunosuppressant	53
Antirheumatic agent	36
Atypical antipsychotic	45
Azole antifungal	13
Benzodiazepine	14
beta-Adrenergic blocker	19
Biguanide	16
Bisphosphonate	164
Calcineurin inhibitor immunosuppressant	72
Calcium channel blocker	28
CD20-directed cytolytic antibody	130
Corticosteroid	150
Estrogen	21
Factor Xa inhibitor	20
Fluoroquinolone antibacterial	38
Folate analog metabolic inhibitor	154
GLP-1 receptor agonist	20
HMG-CoA reductase inhibitor	20
Insulin	19
Insulin analog	71
Integrin receptor antagonist	26
Interferon beta	26
Interleukin-12 antagonist	23
Interleukin-17A antagonist	107
Interleukin-23 antagonist	47
Interleukin-4 receptor alpha antagonist	116
Interleukin-6 receptor antagonist	116
Janus kinase inhibitor	81
Kinase inhibitor	1,825
Loop diuretic	12
Macrolide antimicrobial	10
Microtubule inhibitor	21
Mood stabilizer	13
Nonsteroidal anti-inflammatory drug	48
Nucleoside metabolic inhibitor	69
Opioid agonist	19
Paramagnetic contrast agent	26
Parathyroid hormone analog	23
PCSK9 inhibitor	11
Penicillin-class antibacterial	13
Phosphodiesterase 4 inhibitor	12
Progestin	17
Programmed death Receptor-1 blocking antibody	119
Proton pump inhibitor	35
Purine antimetabolite	13
RANK ligand inhibitor	20
Retinoid	18
Selective T cell costimulation modulator	40
Sodium-Glucose cotransporter 2 inhibitor	22
Sphingosine 1-phosphate receptor modulator	19
Thalidomide analog	45
Thiazide diuretic	43
Tumor necrosis factor blocker	421
Vascular endothelial growth factor inhibitor	28

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

Reports by month

Reports that record Hyperkeratosis, 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 Hyperkeratosis
Age	Reports	Share
Under 2	8	0.1%
2 to 11	31	0.6%
12 to 17	39	0.7%
18 to 44	357	6.6%
45 to 64	1,599	29.4%
65 to 74	967	17.8%
75 and over	599	11%
Age not given	1,840	33.8%

Sex of the patient in the reports that record Hyperkeratosis
Sex	Reports	Share
Female	2,836	52.1%
Male	2,296	42.2%
Unknown or not given	308	5.7%

Age and sex are as the report gives them. 62.2% 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. Hyperkeratosis: adverse event reports that record this term. https://reportedreactions.com/reaction/hyperkeratosis/ 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 Hyperkeratosis 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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