Drug

Neratinib

73 flagged reaction(s) · 5,773 total co-reports · max PRR 60.0

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Breast Cancer Metastatic	70	60.0	61.9	signal
2	Metastases To Central Nervous System	43	30.8	31.4	signal
3	Ejection Fraction Decreased	49	28.9	29.5	signal
4	Appendicitis	23	22.7	22.9	signal
5	Diarrhoea	1,249	17.8	37.8	signal
6	Prescribed Underdose	38	17.4	17.7	signal
7	Mucosal Inflammation	40	14.0	14.3	signal
8	Hypokalaemia	68	13.6	13.9	signal
9	Blood Potassium Decreased	41	12.5	12.7	signal
10	Disease Progression	157	12.2	13.0	signal
11	Hypomagnesaemia	18	11.9	12.0	signal
12	Aphonia	18	11.8	11.9	signal
13	Constipation	277	11.7	13.2	signal
14	Metastases To Lung	14	11.1	11.2	signal
15	Lacrimation Increased	34	10.4	10.6	signal
16	Dehydration	147	10.1	10.7	signal
17	Decreased Appetite	253	10.0	11.1	signal
18	Palmar-plantar Erythrodysaesthesia Syndrome	24	9.4	9.5	signal
19	Hospice Care	10	9.3	9.3	signal
20	Colitis	38	9.2	9.4	signal
21	Dyspepsia	98	9.1	9.5	signal
22	Neuropathy Peripheral	94	9.1	9.4	signal
23	Underdose	70	8.8	9.0	signal
24	Metastases To Bone	15	8.4	8.4	signal
25	Rash Pruritic	49	8.3	8.5	signal
26	Stomatitis	54	8.1	8.3	signal
27	Brain Neoplasm	8	8.0	8.0	signal
28	Breast Pain	9	7.7	7.7	signal
29	Impaired Quality Of Life	11	7.0	7.0	signal
30	Product Prescribing Error	18	7.0	7.0	signal
31	Dementia	21	6.9	7.0	signal
32	Metastases To Liver	13	6.8	6.8	signal
33	Nausea	554	6.4	8.1	signal
34	Skin Fissures	13	6.3	6.3	signal
35	Vomiting	313	6.1	6.9	signal
36	Musculoskeletal Chest Pain	10	5.9	5.9	signal
37	Abdominal Distension	67	5.9	6.0	signal
38	Cholelithiasis	20	5.6	5.6	signal
39	Fatigue	473	5.6	6.8	signal
40	Malignant Neoplasm Progression	62	5.6	5.7	signal
41	Throat Irritation	27	5.5	5.6	signal
42	Therapy Partial Responder	9	5.5	5.5	signal
43	Hospitalisation	91	5.5	5.6	signal
44	Lethargy	34	5.4	5.5	signal
45	Panic Attack	21	5.3	5.3	signal
46	Rectal Haemorrhage	24	5.1	5.1	signal
47	Coagulopathy	9	5.0	5.0	signal
48	Diarrhoea Haemorrhagic	5	4.9	4.9	signal
49	Dysphonia	31	4.9	4.9	signal
50	Hyperglycaemia	19	4.8	4.8	signal
51	Pain Of Skin	14	4.7	4.8	signal
52	Pneumonitis	14	4.7	4.8	signal
53	Feeding Disorder	10	4.6	4.6	signal
54	Thrombocytopenia	54	4.4	4.5	signal
55	Peritonitis	10	4.4	4.4	signal
56	Neutropenia	65	4.4	4.5	signal
57	Flatulence	27	4.4	4.4	signal
58	Off Label Use	410	4.3	5.0	signal
59	Pancytopenia	26	4.3	4.3	signal
60	Thirst	8	4.1	4.1	signal
61	Adverse Drug Reaction	37	3.8	3.8	signal
62	Febrile Neutropenia	27	3.7	3.8	signal
63	Dry Skin	52	3.6	3.7	signal
64	Neoplasm Progression	13	3.4	3.4	signal
65	Eructation	7	3.4	3.4	signal
66	Product Dose Omission	24	3.3	3.3	signal
67	Hot Flush	27	3.3	3.3	signal
68	Haematotoxicity	3	3.0	3.0	no signal
69	Acne	21	2.5	2.5	signal
70	Drug Administration Error	8	2.3	2.4	signal
71	Drug Dose Omission	43	2.3	2.4	signal
72	Hair Texture Abnormal	3	2.0	2.0	no signal
73	Breast Cancer	17	1.7	1.7	no signal