Pharmacologic class (EPC) · 100 drug pages

Kinase inhibitor: adverse event reports filed with FDA

849,161 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

849,161
reports across the class: 4.1% of all reports; 57,453
reports, 12 months to June 2026: 63,885 in the 12 months before; 70.8%
marked serious by the reporter: 57.4% across all reports; 100
drugs with a page: brand and generic names counted separately

Kinase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 100 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 849,161 adverse event reports received by FDA, 4.1% of the database, from January 2004 to June 2026.

57,453 reports arrived in the 12 months to June 2026, down 10% from 63,885 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.8% of the class's reports are marked serious, 19% record death among the outcomes and 26.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (11.5%), diarrhoea (10.5%) and fatigue (9.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
IbrancePalbociclib	brand	81,912	2,380	47.1%	Fatigue
ImbruvicaIbrutinib	brand	67,039	2,283	74.4%	Death
CabometyxCabozantinib	brand	41,818	4,904	40.4%	Diarrhoea
SutentSunitinib malate	brand	33,215	175	74.5%	Death
AfinitorEverolimus	brand	30,706	161	71.3%	Death
SprycelDasatinib	brand	27,255	557	49.7%	Fatigue
TasignaNilotinib	brand	24,911	328	70.9%	Death
KisqaliRibociclib	brand	24,603	3,413	79.2%	Nausea
OfevNintedanib	brand	23,907	2,434	66.9%	Diarrhoea
GleevecImatinib mesylate	brand	23,132	81	74.7%	Death
TagrissoOsimertinib	brand	23,085	1,410	92.3%	Death
LenvimaLenvatinib	brand	22,350	2,643	87.3%	Diarrhoea
VotrientPazopanib hydrochloride	brand	22,084	119	60.9%	Death
MekinistTrametinib	brand	17,070	916	64%	Death
InlytaAxitinib	brand	15,696	388	60.9%	Death
NexavarSorafenib	brand	15,449	67	87.5%	Diarrhoea
TafinlarDabrafenib	brand	15,285	703	66.8%	Pyrexia
VerzenioAbemaciclib	brand	14,225	2,610	35.1%	Diarrhoea
Imatinib	generic	13,822	1,030	87.1%	Drug ineffective
Everolimus	generic	13,640	1,188	89.5%	Malignant neoplasm progression
Erlotinib	generic	13,630	99	97.9%	Death
AyvakitAvapritinib	brand	11,435	2,277	28%	Fatigue
Ibrutinib	generic	10,657	605	97.1%	Atrial fibrillation
Palbociclib	generic	9,939	698	96.2%	Neutropenia
TykerbLapatinib	brand	9,860	23	53.5%	Diarrhoea
Sirolimus	generic	9,816	990	86.4%	Off label use
StivargaRegorafenib	brand	9,221	267	89.3%	Off label use
Lenvatinib	generic	8,833	1,146	92.8%	Diarrhoea
XalkoriCrizotinib	brand	8,335	129	64.2%	Death
Dasatinib	generic	8,194	751	91.6%	Pleural effusion
ZelborafVemurafenib	brand	7,791	97	65.5%	Rash
Osimertinib	generic	7,639	3,093	98.8%	Death
CalquenceAcalabrutinib	brand	7,565	639	77.2%	Death
BosulifBosutinib	brand	7,110	240	49.9%	Diarrhoea
AlecensaAlectinib hydrochloride	brand	7,095	481	54.3%	Death
IressaGefitinib	brand	6,466	77	94.1%	Malignant neoplasm progression
Ribociclib	generic	6,223	1,075	97.3%	Neutropenia
Trametinib	generic	6,043	337	96.8%	Pyrexia
Sorafenib	generic	5,594	137	95.2%	Diarrhoea
GilotrifAfatinib	brand	5,308	39	84.5%	Diarrhoea
Idelalisib	generic	5,152	27	98.9%	Disease progression
QinlockRipretinib	brand	5,104	1,059	42.4%	Fatigue
IclusigPonatinib hydrochloride	brand	5,072	198	85.9%	Death
Dabrafenib	generic	4,979	222	96.8%	Pyrexia
Abemaciclib	generic	4,935	1,165	97.6%	Diarrhoea
Sunitinib malate	generic	4,677	79	97%	Diarrhoea
Lapatinib	generic	4,544	57	97.7%	Diarrhoea
TukysaTucatinib	brand	4,482	494	50.8%	Diarrhoea
Pazopanib	generic	4,170	164	97.5%	Malignant neoplasm progression
Vemurafenib	generic	3,866	59	92.4%	Pyrexia
Acalabrutinib	generic	3,864	1,665	97.4%	Death
Crizotinib	generic	3,770	205	92%	Death
Nilotinib	generic	3,646	323	93.3%	Drug intolerance
Lorlatinib	generic	3,558	810	91%	Death
Imatinib mesylate	generic	3,482	234	83.5%	Death
BrukinsaZanubrutinib	brand	3,112	1,050	69.8%	Off label use
LorbrenaLorlatinib	brand	3,022	812	75.8%	Death
Nintedanib	generic	2,923	929	95.5%	Diarrhoea
VonjoPacritinib	brand	2,830	396	35.1%	Diarrhoea
Cabozantinib	generic	2,790	139	95.4%	Diarrhoea
Erlotinib hydrochloride	generic	2,691	24	99.3%	Death
Axitinib	generic	2,670	197	94.2%	Diarrhoea
CometriqCabozantinib	brand	2,578	42	37.5%	Off label use
Brigatinib	generic	2,201	189	94.4%	Death
Cobimetinib	generic	2,185	66	94.7%	Diarrhoea
Tucatinib	generic	2,125	143	95.4%	Diarrhoea
CotellicCobimetinib	brand	2,029	96	70.6%	Off label use
TabrectaCapmatinib	brand	1,918	70	53.8%	Death
Rydapt	generic	1,859	50	72.7%	Death
Gefitinib	generic	1,790	63	98.4%	Malignant neoplasm progression
ZykadiaCeritinib	brand	1,782	2	77.6%	Diarrhoea
LitfuloRitlecitinib	brand	1,710	568	18.1%	Drug ineffective
NerlynxNeratinib	brand	1,696	48	49.1%	Diarrhoea
Regorafenib	generic	1,677	78	96.7%	Palmar-plantar erythrodysaesthesia syndrome
ZydeligIdelalisib	brand	1,650	10	90.9%	Diarrhoea
FotivdaTivozanib	brand	1,468	136	33.6%	Fatigue
GavretoPralsetinib	brand	1,422	337	56.8%	Product prescribing issue
Bosutinib	generic	1,366	91	86.5%	Drug intolerance
AlunbrigBrigatinib	brand	1,281	96	81.6%	Non-small cell lung cancer
ZortressEverolimus	brand	1,269	3	58.2%	Death
CaprelsaVandetanib	brand	1,059	62	54.5%	Diarrhoea
RetevmoSelpercatinib	brand	943	162	70.2%	Death
KoselugoSelumetinib	brand	915	252	70.5%	Off label use
Afatinib	generic	872	97	98.2%	Diarrhoea
RhapsidoRemibrutinib	brand	848	848	17.8%	Petechiae
JoenjaLeniolisib	brand	818	347	17.8%	Infection
TuralioPexidartinib hydrochloride	brand	708	48	15.8%	Product dose omission issue
BalversaErdafitinib	brand	662	100	64.4%	Death
VitrakviLarotrectinib	brand	659	52	68.4%	Dizziness
Vandetanib	generic	655	10	85.2%	Diarrhoea
OjjaaraMomelotinib	brand	644	252	39%	Death
TepmetkoTepotinib hydrochloride	brand	634	160	72.2%	Death
Momelotinib	generic	625	336	94.7%	Thrombocytopenia
PemazyrePemigatinib	brand	603	98	69.5%	Off label use
Selumetinib	generic	578	196	95.7%	Blood creatine phosphokinase increased
Avapritinib	generic	543	148	42.2%	Off label use
Erdafitinib	generic	538	19	85.7%	Death
RomvimzaVimseltinib	brand	528	455	12.7%	Fatigue
Zanubrutinib	generic	523	153	95.4%	Disease progression
JaypircaPirtobrutinib	brand	503	272	56.1%	Death

Ordered by report count for navigation only. 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."

Reports by month, five years

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

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Deaththe patient died; cause not stated by this term11.5%97,719
Diarrhoealoose or frequent stools10.5%89,549
Fatiguetiredness9.3%78,859
Nauseafeeling sick7.2%61,181
Off label useused for a purpose or in a way not on the label4.8%41,182
Malignant neoplasm progression4.4%37,065
Decreased appetitereduced appetite4.2%35,763
Vomitingbeing sick4.1%35,152
Rashskin rash3.9%32,847
Astheniaweakness or lack of energy3.8%31,877
Pyrexiafever3.4%29,081
Dyspnoeashortness of breath3.4%29,062
Headachehead pain3%25,083
Disease progressionthe disease advanced2.9%24,749
Weight decreasedweight loss2.8%24,061
Malaisegeneral feeling of being unwell2.8%23,959
Drug ineffectivethe medicine did not work as expected2.8%23,432
Painpain, site not specified2.7%22,735
White blood cell count decreasedlow white cell count2.4%20,346
Constipationconstipation2.4%20,212
Neoplasm progression2.4%20,145
Hypertensionhigh blood pressure2.3%19,472
Arthralgiajoint pain2.3%19,381
Pneumonialung infection2.3%19,242
Dizzinesslight-headedness or unsteadiness2.2%18,561

Solid bar: share of all class reports. Hollow bar: the median share across the 100 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death19%161,036

Life-threatening2.6%22,343

Hospitalisation (initial or prolonged)26.4%224,109

Disability1%8,354

Congenital anomaly0%295

Other serious40.4%343,248

Not serious29.2%248,316

Patient age

Under 20.1%1,064

2 to 110.6%5,024

12 to 170.6%4,834

18 to 445.7%48,078

45 to 6422.7%193,085

65 to 7417.6%149,455

75 and over13.5%114,593

Age not given39.2%333,028

Who reported

Physician28.1%238,658

Pharmacist6.2%52,752

Other health professional20.1%170,961

Lawyer0%375

Consumer or non-health professional42.3%359,151

Not given3.2%27,264

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Kinase inhibitor reports

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

Ibrance, Imbruvica, Cabometyx, Sutent, Afinitor and Sprycel and 94 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

849,161 reports through June 2026, 57,453 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

death (11.5%), diarrhoea (10.5%), fatigue (9.3%), nausea (7.2%) and off label use (4.8%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.