OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Aripiprazole Lauroxil

139 flagged reaction(s) · 7,935 total co-reports · max PRR 105.4
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 Needle Issue 637 105.4 122.5 signal
2 Product Administered At Inappropriate Site 211 54.4 57.0 signal
3 Hallucination, Auditory 175 51.4 53.5 signal
4 Syringe Issue 166 44.2 45.9 signal
5 Schizophrenia 102 39.1 40.0 signal
6 Therapeutic Response Shortened 180 26.3 27.4 signal
7 Akathisia 73 24.9 25.3 signal
8 Paranoia 89 23.9 24.4 signal
9 Delusion 75 22.5 22.9 signal
10 Injection Site Induration 54 19.4 19.6 signal
11 Product Administration Error 83 19.3 19.7 signal
12 Psychotic Disorder 119 18.7 19.2 signal
13 Injection Site Mass 145 18.3 18.8 signal
14 Injection Site Discomfort 39 17.5 17.7 signal
15 Mania 57 16.1 16.3 signal
16 Drug Administered At Inappropriate Site 33 14.3 14.4 signal
17 Wrong Technique In Device Usage Process 131 13.3 13.7 signal
18 Restlessness 86 10.9 11.1 signal
19 Underdose 169 10.7 11.1 signal
20 Apathy 31 9.9 10.0 signal
21 Restless Legs Syndrome 33 8.4 8.5 signal
22 Euphoric Mood 18 8.1 8.1 signal
23 Bipolar Disorder 19 8.0 8.1 signal
24 Drug Administration Error 54 8.0 8.1 signal
25 Agitation 126 7.9 8.1 signal
26 Abnormal Behaviour 67 7.8 7.9 signal
27 Thinking Abnormal 29 7.2 7.2 signal
28 Increased Appetite 29 7.1 7.2 signal
29 Hallucination, Visual 32 7.1 7.1 signal
30 Aggression 74 6.8 6.9 signal
31 Treatment Noncompliance 78 6.7 6.7 signal
32 Injection Site Pain 434 6.6 7.2 signal
33 Anger 47 6.4 6.5 signal
34 Hallucination 102 6.3 6.4 signal
35 Incorrect Route Of Product Administration 22 6.1 6.1 signal
36 Off Label Use 1,124 6.0 7.6 signal
37 Injection Site Nodule 14 5.9 5.9 signal
38 Pregnancy 25 5.7 5.8 signal
39 Product Physical Issue 24 5.6 5.6 signal
40 Neuroleptic Malignant Syndrome 14 5.5 5.5 signal
41 Hypersomnia 33 5.3 5.4 signal
42 Sedation 30 5.3 5.4 signal
43 Emotional Disorder 35 5.2 5.3 signal
44 Decreased Activity 12 5.2 5.2 signal
45 Hunger 15 5.2 5.2 signal
46 Muscle Twitching 25 5.0 5.0 signal
47 Irritability 62 4.8 4.8 signal
48 Injection Site Warmth 21 4.7 4.7 signal
49 Weight Increased 215 4.5 4.6 signal
50 Hospitalisation 143 4.3 4.5 signal
51 Dyskinesia 38 4.3 4.4 signal
52 Cognitive Disorder 42 4.2 4.2 signal
53 Sluggishness 9 4.1 4.1 signal
54 Impaired Driving Ability 10 4.1 4.1 signal
55 Incontinence 9 3.9 3.9 signal
56 Incorrect Dose Administered 190 3.9 4.0 signal
57 Tardive Dyskinesia 24 3.9 3.9 signal
58 Product Dose Omission 53 3.7 3.7 signal
59 Thirst 14 3.6 3.6 signal
60 Mood Altered 21 3.6 3.6 signal
61 Sexual Dysfunction 9 3.6 3.6 signal
62 Personality Change 7 3.5 3.5 signal
63 Suicidal Ideation 67 3.4 3.4 signal
64 Psychomotor Hyperactivity 12 3.3 3.3 signal
65 Mental Impairment 17 3.2 3.3 signal
66 Injection Site Swelling 50 3.1 3.1 signal
67 Disturbance In Attention 35 3.0 3.0 signal
68 Mental Disorder 28 3.0 3.0 signal
69 Feeling Jittery 12 2.9 2.9 signal
70 Depressed Mood 33 2.9 2.9 signal
71 Muscle Tightness 10 2.9 2.9 signal
72 Parkinsonism 6 2.8 2.9 signal
73 Crying 22 2.8 2.8 signal
74 Extrapyramidal Disorder 15 2.8 2.8 signal
75 Tremor 99 2.8 2.8 signal
76 Coordination Abnormal 8 2.6 2.6 signal
77 Inappropriate Schedule Of Drug Administration 41 2.6 2.6 signal
78 Mood Swings 18 2.6 2.6 signal
79 Inappropriate Schedule Of Product Administration 95 2.5 2.5 signal
80 Anxiety 153 2.5 2.5 signal
81 Product Preparation Error 11 2.5 2.5 signal
82 Wrong Technique In Product Usage Process 105 2.4 2.4 signal
83 Affect Lability 5 2.4 2.4 no signal
84 Therapeutic Response Decreased 31 2.4 2.4 signal
85 Depression 116 2.3 2.4 signal
86 Injury Associated With Device 10 2.3 2.3 signal
87 Drug Effect Less Than Expected 7 2.3 2.3 no signal
88 Presyncope 12 2.3 2.3 signal
89 Intentional Self-injury 10 2.3 2.3 signal
90 Middle Insomnia 9 2.2 2.2 signal
91 Injection Site Haemorrhage 38 2.2 2.2 signal
92 Somnolence 95 2.2 2.2 signal
93 Musculoskeletal Discomfort 8 2.2 2.2 no signal
94 Dystonia 9 2.1 2.1 signal
95 Nervousness 24 2.1 2.1 signal
96 Injection Site Bruising 35 2.1 2.1 signal
97 Fear 12 2.0 2.1 signal
98 Panic Attack 16 2.0 2.0 signal
99 Feeling Abnormal 105 2.0 2.0 signal
100 Stress 31 2.0 2.0 no signal
101 Drug Level Decreased 4 1.8 1.8 no signal
102 Drug Dose Omission 65 1.8 1.8 no signal
103 Incorrect Route Of Drug Administration 14 1.8 1.8 no signal
104 Suicide Attempt 23 1.8 1.8 no signal
105 Intentional Dose Omission 10 1.7 1.7 no signal
106 Injection Site Reaction 25 1.7 1.7 no signal
107 Accidental Overdose 13 1.6 1.6 no signal
108 No Adverse Event 62 1.6 1.6 no signal
109 Erectile Dysfunction 9 1.6 1.6 no signal
110 Drug Abuse 29 1.6 1.6 no signal
111 Product Prescribing Error 8 1.6 1.6 no signal
112 Insurance Issue 5 1.6 1.6 no signal
113 Myoclonus 4 1.6 1.6 no signal
114 Muscle Rigidity 4 1.5 1.5 no signal
115 Therapeutic Response Unexpected 15 1.5 1.5 no signal
116 Expired Product Administered 11 1.5 1.5 no signal
117 Blood Glucose Abnormal 6 1.5 1.5 no signal
118 Product Packaging Issue 3 1.5 1.5 no signal
119 Poor Quality Product Administered 3 1.4 1.4 no signal
120 Drug Effect Decreased 16 1.4 1.4 no signal
121 Product Dispensing Error 6 1.3 1.3 no signal
122 Injection Site Erythema 32 1.2 1.2 no signal
123 Abnormal Dreams 7 1.2 1.2 no signal
124 Extra Dose Administered 10 1.2 1.2 no signal
125 Injection Site Discolouration 3 1.1 1.1 no signal
126 Injection Site Irritation 3 1.1 1.1 no signal
127 Drug Effect Incomplete 8 1.0 1.0 no signal
128 Injection Site Urticaria 5 1.0 1.0 no signal
129 Accidental Underdose 3 1.0 1.0 no signal
130 Incorrect Dose Administered By Device 5 0.9 0.9 no signal
131 Withdrawal Syndrome 8 0.9 0.9 no signal
132 Accidental Exposure To Product 17 0.8 0.8 no signal
133 Injection Site Rash 5 0.8 0.8 no signal
134 Abortion Spontaneous 6 0.7 0.7 no signal
135 Device Issue 13 0.7 0.7 no signal
136 Completed Suicide 10 0.5 0.5 no signal
137 Device Leakage 5 0.5 0.5 no signal
138 Product Storage Error 10 0.5 0.5 no signal
139 Device Breakage 3 0.4 0.4 no signal