Drug

Lemborexant

107 flagged reaction(s) · 2,311 total co-reports · max PRR 22.0

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	Altered State Of Consciousness	62	22.0	22.5	signal
2	Suicide Attempt	148	18.6	19.7	signal
3	Nightmare	77	17.0	17.4	signal
4	Pneumonia Aspiration	49	15.0	15.3	signal
5	Cytokine Release Syndrome	36	14.5	14.6	signal
6	Hepatic Function Abnormal	69	14.2	14.6	signal
7	Neuroleptic Malignant Syndrome	20	12.9	13.0	signal
8	Middle Insomnia	29	11.9	12.0	signal
9	Inappropriate Antidiuretic Hormone Secretion	15	11.3	11.3	signal
10	Suicidal Ideation	130	10.8	11.3	signal
11	Interstitial Lung Disease	65	10.3	10.5	signal
12	Parkinsonism	13	10.2	10.2	signal
13	Abnormal Dreams	37	10.2	10.3	signal
14	Drug Eruption	22	9.5	9.6	signal
15	Schizophrenia	15	9.4	9.5	signal
16	Delirium	41	9.1	9.2	signal
17	Hallucination, Auditory	18	8.6	8.7	signal
18	Cerebral Infarction	27	8.4	8.5	signal
19	Sedation	28	8.2	8.3	signal
20	Erythema Multiforme	10	8.2	8.2	signal
21	Intentional Overdose	61	7.3	7.5	signal
22	Therapy Non-responder	42	7.2	7.3	signal
23	Disseminated Intravascular Coagulation	13	7.0	7.1	signal
24	Pneumocystis Jirovecii Pneumonia	9	6.9	6.9	signal
25	Covid-19 Pneumonia	10	6.4	6.4	signal
26	Delusion	13	6.4	6.4	signal
27	Depressed Level Of Consciousness	33	6.4	6.5	signal
28	Adrenal Insufficiency	10	6.4	6.4	signal
29	Adverse Drug Reaction	72	6.2	6.3	signal
30	Initial Insomnia	8	6.0	6.0	signal
31	Sudden Death	8	5.7	5.7	signal
32	Poor Quality Sleep	16	5.7	5.7	signal
33	Mania	12	5.6	5.6	signal
34	Dizziness Postural	7	5.6	5.6	signal
35	Underdose	53	5.5	5.6	signal
36	Drug Level Increased	12	5.5	5.6	signal
37	Liver Disorder	32	5.5	5.6	signal
38	Prescribed Underdose	14	5.4	5.4	signal
39	Somnolence	140	5.3	5.6	signal
40	Paralysis	10	5.3	5.3	signal
41	Nocturia	8	5.0	5.1	signal
42	Restlessness	24	5.0	5.0	signal
43	Feeding Disorder	13	5.0	5.0	signal
44	Neutrophil Count Decreased	26	4.9	4.9	signal
45	Epilepsy	19	4.8	4.8	signal
46	Hallucination, Visual	13	4.7	4.8	signal
47	Drug-induced Liver Injury	19	4.7	4.7	signal
48	Shock	14	4.7	4.7	signal
49	Restless Legs Syndrome	11	4.6	4.6	signal
50	Urinary Retention	20	4.6	4.6	signal
51	Hypophagia	15	4.5	4.5	signal
52	Foot Fracture	11	4.4	4.4	signal
53	Renal Impairment	48	4.4	4.4	signal
54	Hallucination	43	4.4	4.4	signal
55	Ileus	7	4.3	4.4	signal
56	Cytomegalovirus Infection	9	4.1	4.1	signal
57	Colon Cancer	8	4.1	4.1	signal
58	Myocarditis	6	4.0	4.1	signal
59	Fracture	10	4.0	4.0	signal
60	Device Related Infection	8	4.0	4.0	signal
61	Akathisia	7	3.9	3.9	signal
62	Blood Creatine Phosphokinase Increased	15	3.9	3.9	signal
63	Lymphocyte Count Decreased	9	3.9	3.9	signal
64	Muscle Rigidity	6	3.8	3.8	signal
65	Mental Impairment	12	3.8	3.8	signal
66	Tooth Extraction	6	3.7	3.7	signal
67	Apathy	7	3.7	3.7	signal
68	Abnormal Behaviour	19	3.6	3.7	signal
69	Infusion Site Pain	6	3.6	3.6	signal
70	Head Discomfort	8	3.5	3.5	signal
71	Tooth Fracture	5	3.5	3.5	signal
72	Thirst	8	3.4	3.4	signal
73	Therapeutic Response Shortened	14	3.4	3.4	signal
74	Dyskinesia	17	3.2	3.2	signal
75	Therapy Change	4	3.2	3.2	no signal
76	Pulmonary Arterial Hypertension	6	3.1	3.2	signal
77	Respiratory Depression	5	3.1	3.1	signal
78	Febrile Neutropenia	27	3.1	3.1	signal
79	Intestinal Obstruction	15	3.1	3.1	signal
80	Salivary Hypersecretion	4	3.1	3.1	no signal
81	Hypothermia	4	3.0	3.0	no signal
82	Palmar-plantar Erythrodysaesthesia Syndrome	9	2.9	2.9	signal
83	Intentional Dose Omission	10	2.8	2.8	signal
84	Bipolar Disorder	4	2.8	2.8	no signal
85	Femur Fracture	11	2.7	2.7	signal
86	Metastases To Lung	4	2.6	2.6	no signal
87	Cytopenia	4	2.6	2.6	no signal
88	Anger	11	2.5	2.5	signal
89	Myelosuppression	11	2.5	2.5	signal
90	Dementia	9	2.5	2.5	signal
91	Affect Lability	3	2.4	2.4	no signal
92	Dystonia	6	2.4	2.4	no signal
93	Inappropriate Schedule Of Product Administration	53	2.3	2.3	signal
94	Diabetic Ketoacidosis	7	2.2	2.2	no signal
95	Completed Suicide	24	2.2	2.2	signal
96	Drug Resistance	7	2.1	2.1	no signal
97	Erectile Dysfunction	7	2.1	2.1	no signal
98	Fistula	3	2.0	2.0	no signal
99	Overdose	53	1.9	1.9	no signal
100	Amenorrhoea	4	1.8	1.8	no signal
101	Tardive Dyskinesia	6	1.6	1.6	no signal
102	Drug Withdrawal Syndrome Neonatal	3	1.5	1.5	no signal
103	Malignant Neoplasm Progression	20	1.5	1.5	no signal
104	Circumstance Or Information Capable Of Leading To Medication Error	6	1.4	1.4	no signal
105	Withdrawal Syndrome	7	1.3	1.3	no signal
106	Extrapyramidal Disorder	4	1.2	1.2	no signal
107	Intentional Self-injury	3	1.1	1.1	no signal