Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Kinase inhibitor adverse event reports that FDA received for the drugs of this class

Kind of class
Pharmacologic class (FDA Established Pharmacologic Class)
Drug pages
100

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 . The data have the reports that FDA received through .

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 .

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 .

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

Kinase inhibitor is a pharmacologic class: an FDA Established Pharmacologic Class. The class has 100 drug pages on this site.

From January 2004 to June 2026, FDA received 849,161 adverse event reports that name a drug of the class. In these reports the drug is a suspect or interacting product. A report that names two drugs of the class counts one time for each.

FDA received 57,453 reports in the 12 months to June 2026 and 63,885 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 57,453 (4.3%) name a drug of the class. Reports for patients aged 18 to 44 were 5.7% of the reports that name a drug of the class and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

Pharmacologic class

The Established Pharmacologic Class (EPC) of FDA is the class on the label of a drug. The site puts a drug in the class that its reports have most often.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs of the class

The rows are in order of name. A brand name and its generic name are separate rows, because reporters name them separately.

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 .

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 . The site read the page on .

Drug pages of the class Kinase inhibitor, in order of name
DrugName typeReportsReports, 12 months to June 2026
AbemaciclibGeneric name4,9351,165
AcalabrutinibGeneric name3,8641,665
AfatinibGeneric name87297
AfinitorEverolimusBrand name30,706161
AlecensaAlectinib hydrochlorideBrand name7,095481
AlunbrigBrigatinibBrand name1,28196
AvapritinibGeneric name543148
AxitinibGeneric name2,670197
AyvakitAvapritinibBrand name11,4352,277
BalversaErdafitinibBrand name662100
BosulifBosutinibBrand name7,110240
BosutinibGeneric name1,36691
BrigatinibGeneric name2,201189
BrukinsaZanubrutinibBrand name3,1121,050
CabometyxCabozantinibBrand name41,8184,904
CabozantinibGeneric name2,790139
CalquenceAcalabrutinibBrand name7,565639
CaprelsaVandetanibBrand name1,05962
CobimetinibGeneric name2,18566
CometriqCabozantinibBrand name2,57842
CotellicCobimetinibBrand name2,02996
CrizotinibGeneric name3,770205
DabrafenibGeneric name4,979222
DasatinibGeneric name8,194751
ErdafitinibGeneric name53819
ErlotinibGeneric name13,63099
Erlotinib hydrochlorideGeneric name2,69124
EverolimusGeneric name13,6401,188
FotivdaTivozanibBrand name1,468136
GavretoPralsetinibBrand name1,422337
GefitinibGeneric name1,79063
GilotrifAfatinibBrand name5,30839
GleevecImatinib mesylateBrand name23,13281
IbrancePalbociclibBrand name81,9122,380
Ibrutinib (form s4)Generic name10,657605
IclusigPonatinib hydrochlorideBrand name5,072198
IdelalisibGeneric name5,15227
ImatinibGeneric name13,8221,030
Imatinib mesylateGeneric name3,482234
ImbruvicaIbrutinib (form s4)Brand name67,0392,283
InlytaAxitinibBrand name15,696388
IressaGefitinibBrand name6,46677
JaypircaPirtobrutinibBrand name503272
JoenjaLeniolisibBrand name818347
KisqaliRibociclibBrand name24,6033,413
KoselugoSelumetinibBrand name915252
LapatinibGeneric name4,54457
LenvatinibGeneric name8,8331,146
LenvimaLenvatinibBrand name22,3502,643
LitfuloRitlecitinibBrand name1,710568
LorbrenaLorlatinibBrand name3,022812
LorlatinibGeneric name3,558810
MekinistTrametinibBrand name17,070916
MomelotinibGeneric name625336
NerlynxNeratinibBrand name1,69648
NexavarSorafenibBrand name15,44967
NilotinibGeneric name3,646323
NintedanibGeneric name2,923929
OfevNintedanibBrand name23,9072,434
OjjaaraMomelotinibBrand name644252
OsimertinibGeneric name7,6393,093
PalbociclibGeneric name9,939698
PazopanibGeneric name4,170164
PemazyrePemigatinibBrand name60398
QinlockRipretinibBrand name5,1041,059
RegorafenibGeneric name1,67778
RetevmoSelpercatinibBrand name943162
RhapsidoRemibrutinibBrand name848848
RibociclibGeneric name6,2231,075
RomvimzaVimseltinibBrand name528455
RydaptGeneric name1,85950
SelumetinibGeneric name578196
SirolimusGeneric name9,816990
SorafenibGeneric name5,594137
SprycelDasatinibBrand name27,255557
StivargaRegorafenibBrand name9,221267
Sunitinib malateGeneric name4,67779
SutentSunitinib malateBrand name33,215175
TabrectaCapmatinibBrand name1,91870
TafinlarDabrafenibBrand name15,285703
TagrissoOsimertinibBrand name23,0851,410
TasignaNilotinibBrand name24,911328
TepmetkoTepotinib hydrochlorideBrand name634160
TrametinibGeneric name6,043337
TucatinibGeneric name2,125143
TukysaTucatinibBrand name4,482494
TuralioPexidartinib hydrochlorideBrand name70848
TykerbLapatinibBrand name9,86023
VandetanibGeneric name65510
VemurafenibGeneric name3,86659
VerzenioAbemaciclibBrand name14,2252,610
VitrakviLarotrectinibBrand name65952
VonjoPacritinibBrand name2,830396
VotrientPazopanib hydrochlorideBrand name22,084119
XalkoriCrizotinibBrand name8,335129
ZanubrutinibGeneric name523153
ZelborafVemurafenibBrand name7,79197
ZortressEverolimusBrand name1,2693
ZydeligIdelalisibBrand name1,65010
ZykadiaCeritinibBrand name1,7822

Reaction lookup

These are the reaction terms that the reports of the class record. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 5,001 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 848,217 of the 849,161 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

The table shows the first 50 of 5,001 terms.

Reaction terms in the reports that name a kinase inhibitor drug, most reports first
Reaction term (MedDRA) and plain meaningReportsShare of the 849,161 reports
Deaththe patient died; cause not stated by this term97,71911.5%
Diarrhoealoose or frequent stools89,54910.5%
Fatiguetiredness78,8599.3%
Nauseafeeling sick61,1817.2%
Off label useused for a purpose or in a way not on the label41,1824.8%
Malignant neoplasm progression37,0654.4%
Decreased appetitereduced appetite35,7634.2%
Vomitingbeing sick35,1524.1%
Rashskin rash32,8473.9%
Astheniaweakness or lack of energy31,8773.8%
Pyrexiafever29,0813.4%
Dyspnoeashortness of breath29,0623.4%
Headachehead pain25,0833%
Disease progressionthe disease advanced24,7492.9%
Weight decreasedweight loss24,0612.8%
Malaisegeneral feeling of being unwell23,9592.8%
Drug ineffectivethe medicine did not work as expected23,4322.8%
Painpain, site not specified22,7352.7%
White blood cell count decreasedlow white cell count20,3462.4%
Constipation20,2122.4%
Neoplasm progression20,1452.4%
Hypertensionhigh blood pressure19,4722.3%
Arthralgiajoint pain19,3812.3%
Pneumonialung infection19,2422.3%
Dizzinesslight-headedness or unsteadiness18,5612.2%
Neutropenialow neutrophils, a type of white blood cell18,2402.1%
Cough17,5832.1%
Anaemialow red blood cells17,5382.1%
Stomatitissore mouth17,0462%
Alopeciahair loss16,6992%
Pain in extremitypain in an arm or leg16,2241.9%
Pruritusitching14,6751.7%
Pleural effusionfluid around the lung14,3011.7%
Abdominal painstomach or belly pain14,1191.7%
Platelet count decreasedlow platelet count14,0881.7%
Dehydration14,0001.6%
Blood pressure increaseda raised blood pressure reading13,8481.6%
Abdominal pain upperupper stomach pain13,3071.6%
Palmar-plantar erythrodysaesthesia syndrome12,4021.5%
Falla fall12,0741.4%
Back pain11,5131.4%
Thrombocytopenialow platelets11,4781.4%
Peripheral swellingswelling of the arms or legs11,1881.3%
Abdominal discomfortstomach discomfort10,7461.3%
Dry skin10,1611.2%
Haemoglobin decreasedlow haemoglobin9,6621.1%
Muscle spasmsmuscle cramps9,4541.1%
Myalgiamuscle pain9,3651.1%
Product dose omission issuea dose was missed9,3271.1%
Product use in unapproved indicationused for a purpose not on the label9,2111.1%

Download all 5,001 terms of the class (CSV)

The counts add to more than 849,161 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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 .

Reports by month

Reports that name a kinase inhibitor drug, by month, five years to June 2026
05,00010,00020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Outcomes, patients and reporters

Outcomes in the reports of the class Kinase inhibitor
OutcomeReportsShareShare as a bar
Death161,03619%
Life-threatening22,3432.6%
Hospitalization (initial or prolonged)224,10926.4%
Disability or Permanent Damage8,3541%
Congenital Anomaly/Birth Defect295under 0.1%
Other Serious (Important Medical Events)343,24840.4%
Not serious248,31629.2%

An outcome in a report is not proof that a drug was the cause. The reporter gives the outcome, and FDA does not verify it. A report can have more than one outcome. FDA says:

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 .

Age of the patient in the reports of the class Kinase inhibitor
AgeReportsShareShare as a bar
Under 21,0640.1%
2 to 115,0240.6%
12 to 174,8340.6%
18 to 4448,0785.7%
45 to 64193,08522.7%
65 to 74149,45517.6%
75 and over114,59313.5%
Age not given333,02839.2%
Type of reporter in the reports of the class Kinase inhibitor
ReporterReportsShareShare as a bar
Physician238,65828.1%
Pharmacist52,7526.2%
Other health professional170,96120.1%
Lawyer375under 0.1%
Consumer or non-health professional359,15142.3%
Not given27,2643.2%

Official pages

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

Cite this page

Reported Reactions. Kinase inhibitor: adverse event reports that FDA received. https://reportedreactions.com/class/kinase-inhibitor/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

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 class of a drug is the Established Pharmacologic Class that openFDA attaches to its reports most often. When the reports have none, it is the class in the NDC Directory. 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

Which drugs are in the Kinase inhibitor class on this site?

Abemaciclib, Acalabrutinib, Afatinib, Afinitor, Alecensa, Alunbrig and 94 more, in order of name. The class of a drug comes from the pharmacologic class (EPC) on its FDA label.

Can the table of drugs rank the drugs?

No. FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

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 .

Drugs also differ in the conditions that they treat and in their time on the market.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.