OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Doxylamine Succinate

236 flagged reaction(s) · 8,051 total co-reports · max PRR 12.5
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 Poisoning Deliberate 33 12.5 12.5 signal
2 Underdose 218 10.5 10.8 signal
3 Disease Recurrence 140 10.3 10.5 signal
4 Drug Effective For Unapproved Indication 80 9.6 9.7 signal
5 Incorrect Product Administration Duration 50 8.7 8.7 signal
6 Somnolence 492 8.6 9.3 signal
7 Sinus Tachycardia 34 8.4 8.5 signal
8 Poor Quality Sleep 49 8.0 8.1 signal
9 Therapeutic Product Effect Decreased 101 8.0 8.1 signal
10 Drug Effect Less Than Expected 32 8.0 8.0 signal
11 Mydriasis 29 7.9 8.0 signal
12 Maternal Exposure During Pregnancy 192 7.6 7.9 signal
13 Nightmare 73 7.4 7.4 signal
14 Restless Legs Syndrome 37 7.1 7.2 signal
15 Exposure During Pregnancy 111 6.3 6.4 signal
16 Poisoning 22 6.1 6.1 signal
17 Product Administration Error 34 6.0 6.0 signal
18 Abnormal Dreams 47 5.9 6.0 signal
19 Acute Hepatic Failure 22 5.7 5.7 signal
20 Intentional Overdose 98 5.4 5.5 signal
21 Toxicity To Various Agents 248 5.2 5.4 signal
22 Accidental Overdose 54 5.2 5.2 signal
23 Sluggishness 15 5.2 5.2 signal
24 Middle Insomnia 26 4.9 4.9 signal
25 Serotonin Syndrome 26 4.8 4.8 signal
26 Drug Toxicity 18 4.6 4.6 signal
27 Coma 59 4.3 4.4 signal
28 Hypersomnia 35 4.3 4.3 signal
29 End Stage Renal Disease 22 4.2 4.2 signal
30 Therapeutic Product Effect Incomplete 84 4.2 4.2 signal
31 Drug Abuse 95 4.0 4.0 signal
32 Muscle Spasticity 14 4.0 4.0 signal
33 Brain Fog 16 3.8 3.9 signal
34 Covid-19 192 3.8 3.9 signal
35 Generalised Tonic-clonic Seizure 17 3.6 3.6 signal
36 Premature Delivery 16 3.5 3.5 signal
37 Psychomotor Hyperactivity 16 3.4 3.4 signal
38 Suicide Attempt 58 3.3 3.4 signal
39 Sneezing 21 3.3 3.3 signal
40 Chronic Kidney Disease 71 3.2 3.3 signal
41 Aspiration 10 3.2 3.2 signal
42 Seasonal Allergy 13 3.2 3.2 signal
43 Rhabdomyolysis 38 3.2 3.2 signal
44 Insomnia 241 3.2 3.3 signal
45 Completed Suicide 76 3.2 3.2 signal
46 Expired Product Administered 29 3.1 3.1 signal
47 Nasopharyngitis 161 3.1 3.1 signal
48 Caesarean Section 10 3.0 3.0 signal
49 Arteriosclerosis 8 3.0 3.0 signal
50 Feeling Jittery 16 2.9 2.9 signal
51 Rhinorrhoea 53 2.9 2.9 signal
52 Drug Ineffective 1,080 2.9 3.3 signal
53 Feeling Abnormal 195 2.8 2.9 signal
54 Incorrect Dose Administered 177 2.8 2.8 signal
55 Initial Insomnia 8 2.7 2.8 signal
56 Intentional Product Misuse 66 2.7 2.7 signal
57 Cholecystitis 9 2.7 2.7 signal
58 Overdose 164 2.7 2.7 signal
59 Sinus Disorder 15 2.7 2.7 signal
60 Hallucination, Auditory 12 2.6 2.6 signal
61 Flank Pain 7 2.6 2.6 signal
62 Panic Attack 27 2.6 2.6 signal
63 Dysgeusia 55 2.6 2.6 signal
64 Nasal Congestion 43 2.6 2.6 signal
65 Akathisia 10 2.6 2.6 signal
66 Dizziness Postural 7 2.6 2.6 signal
67 Abortion Spontaneous 29 2.5 2.5 signal
68 Multiple Organ Dysfunction Syndrome 20 2.5 2.5 signal
69 Incorrect Route Of Product Administration 12 2.5 2.5 signal
70 Blood Urea Increased 12 2.5 2.5 signal
71 Impaired Gastric Emptying 9 2.5 2.5 signal
72 Extra Dose Administered 28 2.5 2.5 signal
73 Faeces Discoloured 15 2.4 2.4 signal
74 Accident 8 2.4 2.4 signal
75 Foetal Exposure During Pregnancy 54 2.3 2.3 signal
76 Drug Level Increased 11 2.3 2.3 signal
77 Premature Baby 20 2.3 2.3 signal
78 Schizophrenia 8 2.3 2.3 signal
79 Lactic Acidosis 21 2.3 2.3 signal
80 Dry Mouth 52 2.3 2.3 signal
81 Cardio-respiratory Arrest 27 2.2 2.3 signal
82 Electrocardiogram Qt Prolonged 23 2.2 2.2 signal
83 Paranoia 11 2.2 2.2 signal
84 Restlessness 23 2.2 2.2 signal
85 Head Discomfort 11 2.2 2.2 signal
86 Acute Kidney Injury 95 2.2 2.2 signal
87 Therapeutic Response Unexpected 28 2.2 2.2 signal
88 Anosmia 9 2.2 2.2 signal
89 Impaired Driving Ability 7 2.2 2.2 no signal
90 Dysmenorrhoea 8 2.1 2.1 no signal
91 Respiratory Arrest 17 2.1 2.1 signal
92 Sars-cov-2 Test Positive 8 2.1 2.1 no signal
93 Taste Disorder 12 2.1 2.1 signal
94 Blood Potassium Decreased 18 2.1 2.1 signal
95 Hunger 8 2.1 2.1 no signal
96 Dry Throat 6 2.1 2.1 no signal
97 Eye Discharge 6 2.1 2.1 no signal
98 Irritability 35 2.0 2.0 signal
99 Hallucination, Visual 12 2.0 2.0 signal
100 Respiratory Depression 7 2.0 2.0 no signal
101 Secretion Discharge 7 2.0 2.0 no signal
102 Dystonia 11 2.0 2.0 no signal
103 Incorrect Drug Administration Duration 16 2.0 2.0 no signal
104 Hallucination 42 2.0 2.0 no signal
105 Depressed Level Of Consciousness 22 2.0 2.0 no signal
106 Body Height Decreased 6 1.9 1.9 no signal
107 Body Temperature Increased 11 1.9 1.9 no signal
108 Tooth Infection 7 1.9 1.9 no signal
109 Oropharyngeal Pain 49 1.9 1.9 no signal
110 Rebound Effect 6 1.9 1.9 no signal
111 Hair Texture Abnormal 7 1.8 1.8 no signal
112 Sinus Congestion 7 1.8 1.8 no signal
113 Tachypnoea 7 1.8 1.8 no signal
114 Oral Herpes 10 1.8 1.8 no signal
115 Migraine 48 1.8 1.8 no signal
116 Lethargy 29 1.8 1.8 no signal
117 Disorientation 20 1.8 1.8 no signal
118 Renal Injury 15 1.8 1.8 no signal
119 Loss Of Consciousness 64 1.7 1.8 no signal
120 Sedation 13 1.7 1.7 no signal
121 Transaminases Increased 11 1.7 1.7 no signal
122 Chromaturia 11 1.7 1.7 no signal
123 Impaired Quality Of Life 7 1.7 1.7 no signal
124 Euphoric Mood 5 1.7 1.7 no signal
125 Libido Decreased 6 1.7 1.7 no signal
126 Influenza 54 1.7 1.7 no signal
127 Disturbance In Attention 26 1.7 1.7 no signal
128 Tubulointerstitial Nephritis 9 1.7 1.7 no signal
129 Hair Colour Changes 6 1.7 1.7 no signal
130 Agitation 35 1.7 1.7 no signal
131 Renal Pain 5 1.7 1.7 no signal
132 Eructation 9 1.7 1.7 no signal
133 Palpitations 55 1.6 1.7 no signal
134 Throat Irritation 21 1.6 1.6 no signal
135 Decreased Activity 5 1.6 1.6 no signal
136 Unresponsive To Stimuli 12 1.6 1.6 no signal
137 Hypoaesthesia Oral 7 1.6 1.6 no signal
138 Tremor 77 1.6 1.6 no signal
139 Gastrointestinal Pain 5 1.6 1.6 no signal
140 Tinnitus 21 1.6 1.6 no signal
141 Immune System Disorder 6 1.6 1.6 no signal
142 Mental Impairment 11 1.6 1.6 no signal
143 Dental Caries 5 1.6 1.6 no signal
144 Eye Haemorrhage 6 1.6 1.6 no signal
145 Product Taste Abnormal 6 1.6 1.6 no signal
146 Metabolic Acidosis 14 1.5 1.6 no signal
147 Anger 15 1.5 1.5 no signal
148 Ageusia 11 1.5 1.5 no signal
149 Nervousness 23 1.5 1.5 no signal
150 Sensory Disturbance 7 1.5 1.5 no signal
151 Aphonia 6 1.5 1.5 no signal
152 Personality Change 4 1.5 1.5 no signal
153 Madarosis 5 1.5 1.5 no signal
154 Abortion Induced 4 1.5 1.5 no signal
155 Emotional Disorder 13 1.5 1.5 no signal
156 Hyperhidrosis 54 1.5 1.5 no signal
157 Wrong Technique In Product Usage Process 84 1.5 1.5 no signal
158 Vitreous Floaters 4 1.4 1.4 no signal
159 Hepatic Cytolysis 5 1.4 1.4 no signal
160 Coeliac Disease 4 1.4 1.4 no signal
161 Drug Effect Decreased 22 1.4 1.4 no signal
162 Intentional Dose Omission 11 1.4 1.4 no signal
163 Vaginal Discharge 4 1.4 1.4 no signal
164 Unevaluable Event 30 1.4 1.4 no signal
165 Pregnancy 8 1.4 1.4 no signal
166 Economic Problem 6 1.4 1.4 no signal
167 Toothache 7 1.4 1.4 no signal
168 Product Odour Abnormal 4 1.3 1.4 no signal
169 Product Prescribing Error 9 1.3 1.3 no signal
170 Thinking Abnormal 7 1.3 1.3 no signal
171 Gingival Bleeding 5 1.3 1.3 no signal
172 Abnormal Behaviour 14 1.2 1.2 no signal
173 Dyskinesia 14 1.2 1.2 no signal
174 Mental Disorder 15 1.2 1.2 no signal
175 Blood Glucose Decreased 16 1.2 1.2 no signal
176 Pruritus Generalised 7 1.1 1.1 no signal
177 Hot Flush 24 1.1 1.1 no signal
178 Eye Inflammation 3 1.1 1.1 no signal
179 Glossodynia 7 1.1 1.1 no signal
180 Menorrhagia 6 1.1 1.1 no signal
181 Inappropriate Schedule Of Product Administration 53 1.1 1.1 no signal
182 Activities Of Daily Living Impaired 6 1.0 1.0 no signal
183 Malignant Melanoma 4 1.0 1.0 no signal
184 Product Dose Omission In Error 8 1.0 1.0 no signal
185 Intentional Self-injury 6 1.0 1.0 no signal
186 Mood Altered 8 1.0 1.0 no signal
187 Hereditary Angioedema 3 1.0 1.0 no signal
188 Withdrawal Syndrome 12 1.0 1.0 no signal
189 Blindness Unilateral 4 1.0 1.0 no signal
190 Intentional Drug Misuse 6 1.0 1.0 no signal
191 Vaginal Haemorrhage 12 1.0 1.0 no signal
192 Injection Site Nodule 3 1.0 1.0 no signal
193 Erectile Dysfunction 7 1.0 1.0 no signal
194 Drug Effect Incomplete 10 1.0 1.0 no signal
195 Injection Site Mass 10 1.0 1.0 no signal
196 Drug Withdrawal Syndrome Neonatal 4 0.9 0.9 no signal
197 Drug Dependence 43 0.9 0.9 no signal
198 Injection Site Rash 8 0.9 0.9 no signal
199 Drug Administration Error 8 0.9 0.9 no signal
200 Product Physical Issue 5 0.9 0.9 no signal
201 Mood Swings 8 0.9 0.9 no signal
202 Emotional Distress 30 0.9 0.9 no signal
203 Injection Site Warmth 5 0.9 0.9 no signal
204 Injection Site Discolouration 3 0.8 0.8 no signal
205 Tooth Loss 5 0.8 0.8 no signal
206 Abasia 6 0.8 0.8 no signal
207 Aggression 12 0.8 0.8 no signal
208 Injection Site Induration 3 0.8 0.8 no signal
209 Anorexia 3 0.8 0.8 no signal
210 Injection Site Bruising 17 0.8 0.8 no signal
211 No Adverse Event 38 0.8 0.7 no signal
212 Hepatocellular Injury 3 0.7 0.7 no signal
213 Product Substitution Issue 12 0.7 0.7 no signal
214 Multiple Sclerosis Relapse 14 0.7 0.7 no signal
215 Dependence 11 0.7 0.7 no signal
216 Drug Reaction With Eosinophilia And Systemic Symptoms 5 0.7 0.7 no signal
217 Therapeutic Response Shortened 6 0.7 0.7 no signal
218 Injection Site Pruritus 12 0.6 0.6 no signal
219 Accidental Exposure To Product 18 0.6 0.6 no signal
220 Amenorrhoea 3 0.6 0.6 no signal
221 Plasma Cell Myeloma 7 0.6 0.6 no signal
222 Drug Dose Omission 29 0.6 0.6 no signal
223 Injection Site Urticaria 4 0.6 0.6 no signal
224 Skin Burning Sensation 11 0.5 0.5 no signal
225 Menstruation Irregular 4 0.5 0.5 no signal
226 Drug Withdrawal Syndrome 13 0.5 0.5 no signal
227 Injection Site Erythema 15 0.4 0.4 no signal
228 Injection Site Swelling 9 0.4 0.4 no signal
229 Device Use Error 4 0.4 0.4 no signal
230 Device Issue 10 0.4 0.4 no signal
231 Application Site Erythema 3 0.4 0.4 no signal
232 Product Adhesion Issue 4 0.4 0.4 no signal
233 Gynaecomastia 3 0.3 0.3 no signal
234 Device Dislocation 4 0.3 0.3 no signal
235 Injection Site Haemorrhage 7 0.3 0.3 no signal
236 Drug Exposure During Pregnancy 3 0.3 0.3 no signal