Drug class · FAERS comparison
Kinase Inhibitor side effects compared: 32 drugs, 470,886 FDA adverse event reports
How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous.
Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Palbociclib (Ibrance) | 94,819 | 53% | 10,577 | – | White blood cell count decreased; Neutropenia; Neutrophil count decreased | Neoplasm progression; Metastases to bone |
| Ibrutinib (Imbruvica) | 80,310 | 78% | 13,715 | – | Onychoclasis; Cytopenia; Petechiae | Increased tendency to bruise; Aspergillus infection |
| Ruxolitinib (Jakafi, Jakafi Xr) | 71,064 | 49% | 9,813 | – | Graft versus host disease in gastrointestinal tract; Graft versus host disease in skin; Myeloproliferative neoplasm | Splenomegaly; Spleen disorder |
| Everolimus | 49,204 | 77% | 10,666 | – | Bk virus infection; Pancreatic neuroendocrine tumour; Insulinoma | Metastases to liver; Metastases to bone |
| Pazopanib | 26,904 | 67% | 6,943 | boxed | Tumour pain | Hair colour changes; Metastatic renal cell carcinoma |
| Sorafenib | 20,648 | 89% | 5,087 | – | Hepatic encephalopathy; Hepatic neoplasm malignant; Hyperkeratosis | Palmar-plantar erythrodysaesthesia syndrome; Metastases to lung |
| Axitinib (Inlyta) | 19,366 | 66% | 3,908 | – | Dysphonia; Stomatitis; Hypothyroidism | Neoplasm progression; Palmar-plantar erythrodysaesthesia syndrome |
| Everolimus | 16,669 | 89% | 2,572 | – | Bk virus infection; Pancreatic neuroendocrine tumour; Insulinoma | Polyomavirus-associated nephropathy; Polyomavirus viraemia |
| Crizotinib (Xalkori) | 12,638 | 73% | 3,792 | – | Metastases to central nervous system; Photopsia; Oesophagitis | Neoplasm progression; Lung neoplasm malignant |
| Acalabrutinib (Calquence) | 12,042 | 84% | 2,592 | – | Tumour lysis syndrome; Lymphocytosis; Chronic lymphocytic leukaemia recurrent | Lymphadenopathy; Splenomegaly |
| Vemurafenib (Zelboraf) | 11,948 | 75% | 2,073 | – | Photosensitivity reaction; Sunburn; Squamous cell carcinoma | Metastases to central nervous system; Mass |
| Gefitinib | 8,974 | 95% | 1,952 | – | Interstitial lung disease; Paronychia; Dermatitis acneiform | Metastases to central nervous system; Metastases to bone |
| Lorlatinib (Lorbrena) | 6,976 | 83% | 1,867 | – | Weight increased; Blood cholesterol increased; Oedema | Neoplasm progression; Hallucination |
| Tucatinib (Tukysa) | 6,932 | 65% | 708 | – | Diarrhoea; Dehydration; Neuropathy peripheral | Palmar-plantar erythrodysaesthesia syndrome; Metastases to central nervous system |
| Ripretinib (Qinlock) | 5,185 | 44% | 494 | – | Alopecia; Constipation; Muscle spasms | Extra dose administered; Neoplasm progression |
| Pazopanib | 4,418 | 97% | 929 | boxed | Alanine aminotransferase increased; Aspartate aminotransferase increased; Thyroid cancer | Metastases to lung; Neoplasm progression |
| Brigatinib (Alunbrig) | 3,628 | 89% | 786 | – | Metastases to central nervous system; Blood pressure increased; Pneumonitis | Lung neoplasm malignant; Neoplasm progression |
| Pacritinib (Vonjo) | 2,964 | 37% | 339 | – | Diarrhoea; Haemoglobin decreased; Splenomegaly | Fatigue; Peripheral swelling |
| Ceritinib (Zykadia) | 2,378 | 81% | 552 | – | Diarrhoea; Alanine aminotransferase increased; Aspartate aminotransferase increased | Metastases to central nervous system; Neoplasm progression |
| Rydapt | 1,943 | 73% | 465 | – | Pancytopenia; Febrile neutropenia; Platelet count decreased | Bone marrow failure; Lymphadenopathy |
| Vandetanib (Caprelsa) | 1,794 | 67% | 161 | boxed | Diarrhoea; Electrocardiogram qt prolonged; Acne | Stomatitis; Metastases to liver |
| Pralsetinib (Gavreto) | 1,788 | 62% | 252 | boxed | Blood pressure increased; White blood cell count decreased; Platelet count decreased | Myelosuppression |
| Selumetinib (Koselugo) | 1,518 | 81% | 99 | – | Acne; Dry skin; Retinal detachment | Neoplasm progression; Haematochezia |
| Erdafitinib (Balversa) | 1,215 | 74% | 342 | – | Stomatitis; Dry mouth; Dry eye | Taste disorder; Palmar-plantar erythrodysaesthesia syndrome |
| Remibrutinib (Rhapsido) | 967 | 19% | 0 | – | Petechiae; Contusion; Gingival bleeding | Angioedema |
| Larotrectinib (Vitrakvi) | 874 | 74% | 161 | – | Liver function test increased; Metastases to central nervous system | – |
| Pirtobrutinib (Jaypirca) | 822 | 70% | 209 | – | Pancytopenia | Lymphadenopathy; Cytokine release syndrome |
| Pemigatinib (Pemazyre) | 820 | 63% | 144 | – | Stomatitis; Dry eye; Palmar-plantar erythrodysaesthesia syndrome | Taste disorder |
| Lazertinib (Lazcluze) | 701 | 71% | 32 | – | Infusion related reaction; Skin disorder; Interstitial lung disease | – |
| Inavolisib (Itovebi) | 521 | 66% | 25 | – | Hyperglycaemia; Blood glucose increased; Stomatitis | – |
| Vimseltinib (Romvimza) | 493 | 14% | 1 | – | Lacrimation increased | Swelling face; Eye swelling |
| Rilzabrutinib (Wayrilz) | 363 | 19% | 3 | – | – | – |
Class-wide signals (flagged in at least 16 of 32 members)
No term is flagged in at least half the members.
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Egfr gene mutation | Gefitinib | 130 | 1,233.0 | Likely indication confounding |
| Malignant transformation | Gefitinib | 70 | 432.5 | Not in label — unassessed |
| Soft tissue sarcoma | Pazopanib | 109 | 354.8 | Likely indication confounding |
| Hepatocellular carcinoma | Sorafenib | 1,899 | 337.6 | Likely indication confounding |
| Hepatic neoplasm malignant | Sorafenib | 391 | 227.2 | Labeled (related wording) |
| Bronchiolitis obliterans syndrome | Ruxolitinib | 61 | 166.6 | Not in label — unassessed |
| Hyperglycaemia | Inavolisib | 133 | 146.2 | Labeled adverse reaction |
| Chronic graft versus host disease in lung | Ruxolitinib | 56 | 146.0 | Not in label — unassessed |
| Myelofibrosis | Ruxolitinib | 931 | 130.9 | Likely indication confounding |
| Primary myelofibrosis | Ruxolitinib | 92 | 120.5 | Likely indication confounding |
| Skin papilloma | Vemurafenib | 234 | 108.6 | Labeled adverse reaction |
| Micrographic skin surgery | Ibrutinib | 61 | 107.2 | Not in label — unassessed |
| Sunburn | Vemurafenib | 373 | 92.4 | Labeled adverse reaction |
| Metastatic malignant melanoma | Vemurafenib | 102 | 81.6 | Labeled (related wording) |
| Neuroendocrine tumour | Everolimus | 227 | 78.5 | Likely indication confounding |
| Angina bullosa haemorrhagica | Ibrutinib | 50 | 70.5 | Not in label — unassessed |
| Paronychia | Gefitinib | 126 | 70.1 | Labeled adverse reaction |
| Myeloproliferative neoplasm | Ruxolitinib | 112 | 60.7 | Labeled adverse reaction |
| Acute myeloid leukaemia recurrent | Sorafenib | 118 | 59.5 | Not in label — unassessed |
| Transfusion | Pacritinib | 84 | 57.0 | Labeled adverse reaction |
| Melanocytic naevus | Vemurafenib | 137 | 56.6 | Likely indication confounding |
| Polycythaemia vera | Ruxolitinib | 129 | 55.5 | Likely indication confounding |
| Graft versus host disease in liver | Ruxolitinib | 109 | 53.1 | Not in label — unassessed |
| Hepatic encephalopathy | Sorafenib | 454 | 51.9 | Labeled (related wording) |
| Squamous cell carcinoma | Vemurafenib | 239 | 45.6 | Labeled adverse reaction |
Common questions
Which kinase inhibitor has the most FDA adverse event reports?
Palbociclib has the most FAERS co-reports in this class (94,819), followed by Ibrutinib (80,310). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across kinase inhibitor drugs?
No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.