OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Lumateperone

169 flagged reaction(s) · 10,480 total co-reports · max PRR 52.0
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 Mania 284 52.0 54.1 signal
2 Akathisia 177 38.9 39.8 signal
3 Sedation 274 31.4 32.6 signal
4 Tardive Dyskinesia 200 20.9 21.5 signal
5 Hallucination, Auditory 83 15.5 15.7 signal
6 Paranoia 73 12.5 12.6 signal
7 Brain Fog 60 12.2 12.3 signal
8 Schizophrenia 49 12.0 12.0 signal
9 Psychotic Disorder 115 11.6 11.7 signal
10 Hypersomnia 89 9.2 9.3 signal
11 Burning Sensation 216 9.1 9.4 signal
12 Neuroleptic Malignant Syndrome 36 9.0 9.0 signal
13 Euphoric Mood 29 8.3 8.4 signal
14 Restless Legs Syndrome 47 7.7 7.7 signal
15 Dyskinesia 103 7.5 7.6 signal
16 Orthostatic Hypotension 44 7.5 7.5 signal
17 Suicidal Ideation 224 7.2 7.4 signal
18 Restlessness 88 7.1 7.2 signal
19 Dystonia 46 7.0 7.0 signal
20 Delusion 36 6.9 6.9 signal
21 Extrapyramidal Disorder 57 6.7 6.8 signal
22 Dry Mouth 180 6.6 6.7 signal
23 Bipolar Disorder 23 6.2 6.2 signal
24 Somnolence 416 6.1 6.5 signal
25 Muscle Twitching 46 5.9 5.9 signal
26 Feeling Cold 55 5.8 5.9 signal
27 Sexual Dysfunction 22 5.6 5.6 signal
28 Unevaluable Event 135 5.3 5.4 signal
29 Irritability 107 5.3 5.3 signal
30 Middle Insomnia 33 5.3 5.3 signal
31 Dizziness Postural 17 5.2 5.3 signal
32 Anger 58 5.1 5.1 signal
33 Agitation 116 4.7 4.7 signal
34 Initial Insomnia 16 4.6 4.7 signal
35 Serotonin Syndrome 30 4.6 4.7 signal
36 Nightmare 54 4.6 4.6 signal
37 Feeling Hot 95 4.6 4.6 signal
38 Incontinence 16 4.5 4.5 signal
39 Dysarthria 56 4.4 4.4 signal
40 Migraine 140 4.4 4.4 signal
41 Thirst 26 4.3 4.3 signal
42 Skin Burning Sensation 103 4.3 4.3 signal
43 Dizziness 719 4.3 4.6 signal
44 Muscle Tightness 23 4.2 4.2 signal
45 Therapeutic Product Effect Decreased 62 4.1 4.2 signal
46 Apathy 20 4.1 4.1 signal
47 Crying 49 4.0 4.0 signal
48 Withdrawal Syndrome 54 3.8 3.8 signal
49 Hallucination 95 3.8 3.8 signal
50 Pharyngeal Swelling 12 3.7 3.7 signal
51 Tremor 207 3.7 3.8 signal
52 Hallucination, Visual 26 3.7 3.7 signal
53 Thinking Abnormal 23 3.6 3.6 signal
54 Coordination Abnormal 17 3.6 3.6 signal
55 Feeling Jittery 23 3.6 3.6 signal
56 Urinary Incontinence 35 3.5 3.5 signal
57 Feeling Abnormal 273 3.4 3.5 signal
58 Aggression 55 3.2 3.3 signal
59 Panic Attack 38 3.1 3.1 signal
60 Anxiety 282 2.9 3.0 signal
61 Disturbance In Attention 53 2.9 2.9 signal
62 Mood Swings 31 2.9 2.9 signal
63 Hypophagia 24 2.8 2.8 signal
64 Insomnia 252 2.8 2.9 signal
65 Poor Quality Sleep 20 2.8 2.8 signal
66 Affect Lability 9 2.8 2.8 signal
67 Body Temperature Increased 19 2.7 2.8 signal
68 Parkinsonism 9 2.7 2.7 signal
69 Drug Effect Less Than Expected 13 2.7 2.7 signal
70 Muscle Rigidity 11 2.7 2.7 signal
71 Movement Disorder 29 2.7 2.7 signal
72 Seizure 102 2.6 2.7 signal
73 Micturition Urgency 10 2.6 2.6 signal
74 Temperature Intolerance 9 2.6 2.6 signal
75 Peripheral Coldness 12 2.6 2.6 signal
76 Paraesthesia 137 2.6 2.6 signal
77 Disorientation 32 2.4 2.4 signal
78 Photophobia 15 2.4 2.4 signal
79 Salivary Hypersecretion 8 2.4 2.4 signal
80 Depression 182 2.4 2.4 signal
81 Head Discomfort 14 2.4 2.4 signal
82 Balance Disorder 68 2.3 2.3 signal
83 Mydriasis 10 2.3 2.3 signal
84 Psychomotor Hyperactivity 13 2.3 2.3 signal
85 Headache 488 2.3 2.4 signal
86 Abnormal Behaviour 30 2.2 2.2 signal
87 Therapeutic Product Effect Incomplete 53 2.2 2.2 signal
88 Personality Change 7 2.2 2.2 no signal
89 Intentional Self-injury 15 2.2 2.2 signal
90 Mental Impairment 18 2.2 2.2 signal
91 Swollen Tongue 23 2.2 2.2 signal
92 Head Injury 23 2.2 2.2 signal
93 Aphasia 22 2.1 2.2 signal
94 Speech Disorder 38 2.1 2.2 signal
95 Vertigo 44 2.1 2.1 signal
96 Amenorrhoea 12 2.1 2.1 signal
97 Emotional Disorder 22 2.1 2.1 signal
98 Suicide Attempt 43 2.1 2.1 signal
99 Presyncope 17 2.1 2.1 signal
100 Pollakiuria 29 2.1 2.1 signal
101 Nausea 549 2.1 2.1 signal
102 Cognitive Disorder 32 2.0 2.0 signal
103 Musculoskeletal Stiffness 60 2.0 2.0 signal
104 Abnormal Dreams 19 2.0 2.0 signal
105 Night Sweats 22 2.0 2.0 signal
106 Sensory Disturbance 11 2.0 2.0 signal
107 Throat Tightness 18 2.0 2.0 no signal
108 Hot Flush 50 2.0 2.0 no signal
109 Urinary Retention 22 2.0 2.0 no signal
110 Therapeutic Response Shortened 21 2.0 2.0 no signal
111 Palpitations 77 1.9 2.0 no signal
112 Chills 76 1.9 1.9 no signal
113 Gait Inability 21 1.9 1.9 no signal
114 Vision Blurred 83 1.8 1.8 no signal
115 Drug Interaction 95 1.8 1.8 no signal
116 Motor Dysfunction 6 1.8 1.8 no signal
117 Fear 16 1.7 1.7 no signal
118 Inappropriate Antidiuretic Hormone Secretion 6 1.7 1.7 no signal
119 Mood Altered 16 1.7 1.7 no signal
120 Ear Discomfort 6 1.7 1.7 no signal
121 Gait Disturbance 111 1.7 1.7 no signal
122 Dysphagia 54 1.7 1.7 no signal
123 Hyperhidrosis 73 1.7 1.7 no signal
124 Blood Triglycerides Increased 10 1.7 1.7 no signal
125 Nasal Congestion 33 1.7 1.7 no signal
126 Memory Impairment 77 1.7 1.7 no signal
127 Syncope 56 1.7 1.7 no signal
128 Product Dose Omission Issue 157 1.6 1.6 no signal
129 Impaired Gastric Emptying 7 1.6 1.6 no signal
130 Lethargy 31 1.6 1.6 no signal
131 Diplopia 14 1.6 1.6 no signal
132 Hunger 7 1.5 1.5 no signal
133 Limb Discomfort 16 1.5 1.5 no signal
134 Dysstasia 15 1.5 1.5 no signal
135 Intentional Dose Omission 14 1.5 1.5 no signal
136 Therapeutic Response Unexpected 23 1.5 1.5 no signal
137 Body Temperature Decreased 5 1.5 1.5 no signal
138 Dry Throat 5 1.5 1.5 no signal
139 Weight Increased 109 1.4 1.5 no signal
140 Drug Ineffective For Unapproved Indication 27 1.4 1.4 no signal
141 Mental Disorder 21 1.4 1.4 no signal
142 Increased Appetite 9 1.4 1.4 no signal
143 Discomfort 29 1.4 1.4 no signal
144 Amnesia 30 1.4 1.4 no signal
145 Pain In Jaw 13 1.4 1.4 no signal
146 Depressed Mood 24 1.3 1.4 no signal
147 Impaired Driving Ability 5 1.3 1.3 no signal
148 Influenza Like Illness 35 1.3 1.3 no signal
149 Illness 42 1.2 1.2 no signal
150 Glycosylated Haemoglobin Increased 10 1.2 1.2 no signal
151 Hypothermia 4 1.2 1.2 no signal
152 Therapy Cessation 19 1.1 1.1 no signal
153 Libido Decreased 4 1.0 1.0 no signal
154 Exposure During Pregnancy 20 1.0 1.0 no signal
155 Erectile Dysfunction 8 0.9 0.9 no signal
156 Product Dose Omission In Error 8 0.9 0.9 no signal
157 Completed Suicide 25 0.9 0.9 no signal
158 Product Odour Abnormal 3 0.9 0.9 no signal
159 Blood Glucose Fluctuation 3 0.8 0.8 no signal
160 Product Availability Issue 6 0.8 0.8 no signal
161 Rebound Effect 3 0.8 0.8 no signal
162 Product Physical Issue 5 0.7 0.7 no signal
163 Dysmenorrhoea 3 0.7 0.7 no signal
164 Extra Dose Administered 8 0.6 0.6 no signal
165 Menstruation Irregular 5 0.6 0.6 no signal
166 Intentional Overdose 12 0.6 0.6 no signal
167 Skin Irritation 7 0.5 0.5 no signal
168 Dermatitis Atopic 6 0.4 0.4 no signal
169 Drug Withdrawal Syndrome 10 0.3 0.3 no signal