OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Doxepn Hydrochloride

138 flagged reaction(s) · 3,840 total co-reports · max PRR 77.2
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 Ataxia 86 77.2 80.6 signal
2 Nocturia 83 73.3 76.4 signal
3 Micturition Urgency 77 72.6 75.5 signal
4 Muscle Spasticity 77 66.3 69.0 signal
5 Central Nervous System Lesion 78 60.2 62.6 signal
6 Respiratory Depression 43 37.4 38.2 signal
7 Erectile Dysfunction 81 33.5 34.9 signal
8 Movement Disorder 86 28.4 29.6 signal
9 Completed Suicide 189 23.9 26.3 signal
10 Dysarthria 83 23.5 24.5 signal
11 Pollakiuria 83 21.2 22.1 signal
12 Blood Test Abnormal 24 18.2 18.4 signal
13 Blood Count Abnormal 26 18.0 18.2 signal
14 Bradycardia 85 17.0 17.7 signal
15 Hyperlipidaemia 19 16.9 17.0 signal
16 Cardio-respiratory Arrest 54 13.6 14.0 signal
17 Intervertebral Disc Degeneration 11 12.6 12.6 signal
18 Multiple Sclerosis Relapse 80 12.3 12.8 signal
19 Psychotic Disorder 33 11.9 12.1 signal
20 Rotator Cuff Syndrome 14 11.5 11.6 signal
21 Depressed Level Of Consciousness 42 11.3 11.5 signal
22 Sleep Disorder Due To A General Medical Condition 17 11.2 11.3 signal
23 Respiratory Arrest 29 11.1 11.2 signal
24 Balance Disorder 86 10.6 11.0 signal
25 Iron Deficiency Anaemia 9 10.4 10.5 signal
26 Hypothyroidism 31 10.3 10.5 signal
27 Type 2 Diabetes Mellitus 31 9.8 9.9 signal
28 Toxicity To Various Agents 153 9.7 10.4 signal
29 Skin Haemorrhage 13 9.6 9.6 signal
30 Tenderness 9 9.2 9.2 signal
31 Aggression 42 8.9 9.1 signal
32 Impaired Quality Of Life 12 8.9 8.9 signal
33 Memory Impairment 111 8.6 9.0 signal
34 Irritable Bowel Syndrome 17 8.5 8.5 signal
35 Mania 13 8.4 8.5 signal
36 Myocardial Ischaemia 9 8.3 8.4 signal
37 Fibromyalgia 19 8.3 8.4 signal
38 Scratch 8 8.2 8.2 signal
39 Pulmonary Congestion 10 8.0 8.1 signal
40 Skin Laceration 8 7.9 7.9 signal
41 Osteopenia 11 7.7 7.7 signal
42 Chronic Obstructive Pulmonary Disease 37 7.5 7.7 signal
43 Bronchitis 52 7.4 7.6 signal
44 Obesity 11 7.3 7.4 signal
45 Sleep Apnoea Syndrome 13 7.2 7.3 signal
46 Hypoaesthesia 100 7.1 7.4 signal
47 Sinus Congestion 9 7.1 7.1 signal
48 Blood Pressure Systolic Increased 13 7.0 7.1 signal
49 Cyst 8 6.8 6.9 signal
50 Blood Cholesterol Increased 30 6.8 6.9 signal
51 Seasonal Allergy 9 6.8 6.8 signal
52 Hyperthyroidism 9 6.6 6.6 signal
53 Dermatitis Contact 7 6.5 6.6 signal
54 Ligament Sprain 6 6.5 6.5 signal
55 Body Temperature Decreased 6 6.4 6.4 signal
56 Therapy Partial Responder 9 6.3 6.4 signal
57 Insomnia 159 6.3 6.8 signal
58 Arthropathy 33 6.3 6.4 signal
59 Coronary Artery Disease 18 6.3 6.3 signal
60 Initial Insomnia 6 6.2 6.3 signal
61 Eye Discharge 6 6.2 6.3 signal
62 Mental Impairment 14 6.1 6.2 signal
63 Serotonin Syndrome 11 6.1 6.1 signal
64 Poisoning 7 5.9 5.9 signal
65 Laryngitis 6 5.9 5.9 signal
66 Tooth Fracture 6 5.8 5.8 signal
67 Hiatus Hernia 7 5.7 5.7 signal
68 Sputum Discoloured 5 5.6 5.6 signal
69 Scar 9 5.6 5.6 signal
70 Asthma 58 5.5 5.6 signal
71 Limb Injury 14 5.5 5.5 signal
72 Poor Quality Sleep 11 5.5 5.5 signal
73 Synovitis 9 5.3 5.3 signal
74 Bursitis 6 5.3 5.3 signal
75 Suicidal Ideation 45 5.2 5.3 signal
76 Anxiety 140 5.2 5.5 signal
77 Angina Pectoris 14 5.2 5.2 signal
78 Migraine 46 5.1 5.2 signal
79 Poor Venous Access 5 5.1 5.2 signal
80 Product Use In Unapproved Indication 118 5.1 5.4 signal
81 Cardiac Arrest 40 5.1 5.2 signal
82 Insurance Issue 7 5.0 5.0 signal
83 Infusion Site Pain 6 5.0 5.0 signal
84 Eczema 23 4.9 4.9 signal
85 Tinnitus 21 4.8 4.9 signal
86 Sinus Disorder 9 4.8 4.8 signal
87 Dental Caries 5 4.8 4.8 signal
88 Product Dose Omission In Error 12 4.7 4.8 signal
89 Coma 21 4.7 4.7 signal
90 Disturbance In Attention 23 4.5 4.6 signal
91 Haematoma 11 4.5 4.5 signal
92 Spinal Disorder 4 4.5 4.5 signal
93 Joint Stiffness 11 4.5 4.5 signal
94 Pharyngeal Swelling 4 4.4 4.4 signal
95 Urticaria 69 4.4 4.5 signal
96 Decreased Immune Responsiveness 4 4.3 4.4 signal
97 Cold Sweat 7 4.2 4.2 signal
98 Mental Disorder 17 4.1 4.2 signal
99 Lymphoma 6 4.1 4.1 signal
100 Dermatitis Atopic 19 4.0 4.1 signal
101 Immune System Disorder 5 4.0 4.0 signal
102 Middle Insomnia 7 4.0 4.0 signal
103 Sars-cov-2 Test Positive 5 4.0 4.0 signal
104 Back Disorder 6 3.9 3.9 signal
105 Femur Fracture 11 3.8 3.8 signal
106 Sedation 9 3.7 3.7 signal
107 Nervousness 18 3.6 3.7 signal
108 Macular Degeneration 4 3.6 3.6 signal
109 Eye Pruritus 11 3.5 3.6 signal
110 Libido Decreased 4 3.4 3.4 signal
111 Ocular Hyperaemia 15 3.4 3.4 signal
112 Personality Change 3 3.4 3.4 no signal
113 Leukaemia 3 3.4 3.4 no signal
114 Inappropriate Schedule Of Product Administration 56 3.4 3.4 signal
115 Laceration 3 3.3 3.3 no signal
116 Therapeutic Response Shortened 10 3.3 3.3 signal
117 Drug Abuse 26 3.3 3.3 signal
118 Complication Associated With Device 4 3.2 3.2 signal
119 Intentional Overdose 19 3.2 3.2 signal
120 Hunger 4 3.2 3.2 no signal
121 Pain Of Skin 8 3.1 3.2 signal
122 Intentional Drug Misuse 6 3.0 3.0 signal
123 Anosmia 4 2.9 2.9 no signal
124 Bipolar Disorder 3 2.9 2.9 no signal
125 Exposure Via Skin Contact 6 2.8 2.8 signal
126 Suicide Attempt 16 2.8 2.8 signal
127 Hallucination, Auditory 4 2.7 2.7 no signal
128 Product Preparation Error 5 2.6 2.6 no signal
129 Overdose 50 2.5 2.5 signal
130 Psoriasis 27 2.2 2.2 signal
131 Injection Site Pain 53 1.9 1.9 no signal
132 Skin Irritation 8 1.9 1.9 no signal
133 Multiple Sclerosis 7 1.5 1.5 no signal
134 Skin Burning Sensation 9 1.3 1.3 no signal
135 Drug Withdrawal Syndrome 10 1.2 1.2 no signal
136 Tardive Dyskinesia 3 1.1 1.1 no signal
137 Dependence 4 0.8 0.8 no signal
138 Drug Dependence 11 0.7 0.7 no signal