OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Loratadine Pseudoephedrine Sulfate

232 flagged reaction(s) · 8,484 total co-reports · max PRR 24.0
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 Drug Effect Decreased 394 24.0 25.5 signal
2 Feeling Jittery 134 23.3 23.8 signal
3 Poor Quality Sleep 90 13.9 14.1 signal
4 Extra Dose Administered 105 8.7 8.8 signal
5 Therapeutic Response Unexpected 104 7.6 7.8 signal
6 Expired Product Administered 74 7.4 7.5 signal
7 Insomnia 592 7.3 8.0 signal
8 Psychomotor Hyperactivity 36 7.1 7.2 signal
9 Product Use Issue 377 6.7 7.0 signal
10 Dry Mouth 161 6.6 6.7 signal
11 Dry Throat 20 6.5 6.5 signal
12 Nervousness 101 6.4 6.4 signal
13 Thirst 32 5.9 6.0 signal
14 Incorrect Product Administration Duration 36 5.9 5.9 signal
15 Initial Insomnia 18 5.8 5.8 signal
16 Drug Effect Incomplete 64 5.7 5.8 signal
17 Dysuria 62 5.6 5.6 signal
18 Sneezing 33 4.9 4.9 signal
19 Palpitations 172 4.9 5.0 signal
20 Product Prescribing Issue 29 4.7 4.7 signal
21 Product Packaging Issue 13 4.6 4.6 signal
22 Seasonal Allergy 19 4.4 4.5 signal
23 Mitral Valve Incompetence 15 4.4 4.4 signal
24 Unevaluable Event 99 4.3 4.4 signal
25 Somnolence 248 4.1 4.2 signal
26 Middle Insomnia 21 3.7 3.7 signal
27 Heart Rate Increased 111 3.7 3.8 signal
28 Sinus Congestion 15 3.7 3.7 signal
29 Lacrimation Increased 33 3.6 3.7 signal
30 Rhinorrhoea 71 3.6 3.7 signal
31 Drug Effective For Unapproved Indication 32 3.6 3.6 signal
32 Cholecystitis 13 3.6 3.6 signal
33 Bursitis 13 3.6 3.6 signal
34 Euphoric Mood 11 3.5 3.5 signal
35 Drug Ineffective 1,348 3.4 4.0 signal
36 Head Discomfort 18 3.4 3.4 signal
37 Restlessness 37 3.3 3.3 signal
38 Gallbladder Disorder 18 3.3 3.3 signal
39 Intervertebral Disc Degeneration 9 3.2 3.2 signal
40 Laceration 9 3.1 3.1 signal
41 Incorrect Drug Administration Duration 26 3.0 3.0 signal
42 Sinus Disorder 18 3.0 3.0 signal
43 Pharyngeal Oedema 14 3.0 3.0 signal
44 Respiratory Tract Congestion 14 2.9 2.9 signal
45 Ear Discomfort 9 2.9 2.9 signal
46 Nasal Congestion 51 2.9 2.9 signal
47 Eye Pruritus 28 2.8 2.8 signal
48 Pharyngitis Streptococcal 9 2.7 2.7 signal
49 Accidental Overdose 30 2.7 2.7 signal
50 Drug Ineffective For Unapproved Indication 45 2.7 2.7 signal
51 Cyst 10 2.7 2.7 signal
52 Pharyngitis 10 2.7 2.7 signal
53 Irritable Bowel Syndrome 17 2.6 2.6 signal
54 Ovarian Cyst 8 2.6 2.6 signal
55 Micturition Urgency 9 2.6 2.6 signal
56 Tendonitis 12 2.5 2.6 signal
57 Feeling Abnormal 185 2.5 2.6 signal
58 Anorexia 10 2.5 2.5 signal
59 Pharmaceutical Product Complaint 20 2.5 2.5 signal
60 Anosmia 11 2.5 2.5 signal
61 Breast Pain 8 2.5 2.5 signal
62 Sinusitis 77 2.5 2.5 signal
63 Flank Pain 7 2.5 2.5 signal
64 Choking 14 2.4 2.4 signal
65 Upper Respiratory Tract Infection 33 2.4 2.4 signal
66 Carpal Tunnel Syndrome 10 2.4 2.4 signal
67 Thinking Abnormal 13 2.3 2.3 signal
68 Sluggishness 7 2.3 2.3 no signal
69 Injury 48 2.2 2.3 signal
70 Wrong Technique In Drug Usage Process 25 2.2 2.2 signal
71 Toothache 12 2.2 2.2 signal
72 Restless Legs Syndrome 12 2.2 2.2 signal
73 Retching 14 2.2 2.2 signal
74 Haematocrit Decreased 13 2.2 2.2 signal
75 Abnormal Dreams 18 2.1 2.1 signal
76 No Therapeutic Response 8 2.1 2.1 no signal
77 Blood Pressure Increased 99 2.1 2.2 signal
78 Cardiomegaly 8 2.1 2.1 no signal
79 Mass 9 2.1 2.1 signal
80 Grand Mal Convulsion 6 2.1 2.1 no signal
81 Cholelithiasis 21 2.1 2.1 signal
82 Tooth Fracture 7 2.1 2.1 no signal
83 Sputum Discoloured 6 2.1 2.1 no signal
84 Sleep Disorder 44 2.1 2.1 signal
85 Therapeutic Response Shortened 20 2.1 2.1 signal
86 Sleep Apnoea Syndrome 12 2.1 2.1 signal
87 Circumstance Or Information Capable Of Leading To Medication Error 21 2.1 2.1 signal
88 Pollakiuria 26 2.1 2.1 signal
89 Inappropriate Schedule Of Drug Administration 45 2.1 2.1 signal
90 Rotator Cuff Syndrome 8 2.0 2.1 no signal
91 Inflammatory Bowel Disease 6 2.0 2.0 no signal
92 Bladder Disorder 6 2.0 2.0 no signal
93 Hypoaesthesia Oral 9 2.0 2.0 no signal
94 Coronary Artery Disease 18 1.9 2.0 no signal
95 Osteopenia 9 1.9 1.9 no signal
96 Temperature Intolerance 6 1.9 1.9 no signal
97 Eye Discharge 6 1.9 1.9 no signal
98 Product Use Complaint 9 1.9 1.9 no signal
99 Dizziness 285 1.9 1.9 no signal
100 Urinary Retention 19 1.9 1.9 no signal
101 Tinnitus 26 1.9 1.9 no signal
102 Angina Pectoris 16 1.8 1.8 no signal
103 Fear 15 1.8 1.8 no signal
104 Laryngitis 6 1.8 1.8 no signal
105 Deep Vein Thrombosis 36 1.8 1.8 no signal
106 Irritability 33 1.8 1.8 no signal
107 Activities Of Daily Living Impaired 11 1.8 1.8 no signal
108 Increased Tendency To Bruise 5 1.8 1.8 no signal
109 Lip Swelling 18 1.8 1.8 no signal
110 Tooth Disorder 12 1.8 1.8 no signal
111 Hyperhidrosis 69 1.8 1.8 no signal
112 Product Taste Abnormal 7 1.7 1.7 no signal
113 Agitation 38 1.7 1.7 no signal
114 Anxiety 147 1.7 1.7 no signal
115 Throat Irritation 23 1.7 1.7 no signal
116 Eye Swelling 19 1.7 1.7 no signal
117 Drug Prescribing Error 10 1.7 1.7 no signal
118 Peripheral Coldness 7 1.7 1.7 no signal
119 Blood Triglycerides Increased 9 1.7 1.7 no signal
120 Intervertebral Disc Protrusion 11 1.7 1.7 no signal
121 Panic Attack 18 1.6 1.6 no signal
122 Conjunctivitis 9 1.6 1.6 no signal
123 Bone Disorder 9 1.6 1.6 no signal
124 Emotional Disorder 15 1.6 1.6 no signal
125 Product Use In Unapproved Indication 118 1.6 1.6 no signal
126 Disturbance In Attention 26 1.6 1.6 no signal
127 Disorientation 19 1.6 1.6 no signal
128 Scar 8 1.5 1.5 no signal
129 Musculoskeletal Discomfort 8 1.5 1.5 no signal
130 Therapeutic Response Decreased 28 1.5 1.5 no signal
131 Swelling Face 30 1.5 1.5 no signal
132 Nightmare 16 1.5 1.5 no signal
133 Bipolar Disorder 5 1.5 1.5 no signal
134 Asthma 51 1.5 1.5 no signal
135 Localised Infection 11 1.5 1.5 no signal
136 Cold Sweat 8 1.5 1.5 no signal
137 Fibromyalgia 11 1.5 1.5 no signal
138 Eye Infection 5 1.5 1.5 no signal
139 Anger 15 1.5 1.5 no signal
140 Cholecystectomy 5 1.5 1.5 no signal
141 Muscle Twitching 10 1.4 1.4 no signal
142 Chest Discomfort 44 1.4 1.4 no signal
143 Aphonia 6 1.4 1.4 no signal
144 Sexual Dysfunction 5 1.4 1.4 no signal
145 Personality Change 4 1.4 1.4 no signal
146 Tremor 71 1.4 1.4 no signal
147 Abnormal Behaviour 17 1.4 1.4 no signal
148 Drug Effect Less Than Expected 6 1.4 1.4 no signal
149 Affect Lability 4 1.4 1.4 no signal
150 Oropharyngeal Pain 38 1.4 1.4 no signal
151 Coeliac Disease 4 1.3 1.3 no signal
152 Product Physical Issue 8 1.3 1.3 no signal
153 Rash Papular 9 1.3 1.3 no signal
154 Convulsion 23 1.3 1.3 no signal
155 Local Swelling 7 1.3 1.3 no signal
156 Feeling Hot 24 1.3 1.3 no signal
157 Dysgeusia 29 1.3 1.3 no signal
158 Pain In Jaw 11 1.3 1.3 no signal
159 Crying 14 1.3 1.3 no signal
160 Ankylosing Spondylitis 5 1.3 1.3 no signal
161 Transient Ischaemic Attack 13 1.3 1.3 no signal
162 Road Traffic Accident 16 1.3 1.3 no signal
163 Hereditary Angioedema 4 1.3 1.3 no signal
164 Adverse Reaction 5 1.2 1.2 no signal
165 Impaired Work Ability 8 1.2 1.2 no signal
166 Skin Cancer 8 1.2 1.2 no signal
167 Mood Altered 10 1.2 1.2 no signal
168 Pulmonary Thrombosis 4 1.2 1.2 no signal
169 Gingival Bleeding 5 1.2 1.2 no signal
170 Pruritus Generalised 8 1.2 1.2 no signal
171 Ageusia 9 1.2 1.2 no signal
172 Oral Discomfort 5 1.2 1.2 no signal
173 Aggression 18 1.2 1.2 no signal
174 Underdose 26 1.2 1.2 no signal
175 Drug Administration Error 11 1.2 1.2 no signal
176 Impaired Driving Ability 4 1.2 1.2 no signal
177 Skin Haemorrhage 5 1.1 1.1 no signal
178 Post Procedural Haemorrhage 4 1.1 1.1 no signal
179 Ocular Hyperaemia 16 1.1 1.1 no signal
180 Wrong Technique In Product Usage Process 66 1.1 1.1 no signal
181 Libido Decreased 4 1.1 1.1 no signal
182 Increased Appetite 6 1.1 1.1 no signal
183 Drug Exposure During Pregnancy 11 1.1 1.1 no signal
184 Suicidal Ideation 29 1.0 1.0 no signal
185 Eructation 6 1.0 1.0 no signal
186 Hallucination, Auditory 5 1.0 1.0 no signal
187 Hernia 6 1.0 1.0 no signal
188 Psychotic Disorder 9 1.0 1.0 no signal
189 Incorrect Dose Administered 68 1.0 1.0 no signal
190 Dermatitis Atopic 15 1.0 1.0 no signal
191 Vaginal Discharge 3 1.0 1.0 no signal
192 Hunger 4 1.0 1.0 no signal
193 Emotional Distress 36 1.0 1.0 no signal
194 Femur Fracture 9 1.0 1.0 no signal
195 Product Odour Abnormal 3 1.0 1.0 no signal
196 Gastric Disorder 10 0.9 0.9 no signal
197 Drug Administered At Inappropriate Site 3 0.9 0.9 no signal
198 Breast Cancer Metastatic 3 0.9 0.9 no signal
199 Eczema 14 0.9 0.9 no signal
200 Overdose 60 0.9 0.9 no signal
201 Eye Irritation 15 0.9 0.9 no signal
202 Drug Dispensing Error 4 0.9 0.9 no signal
203 Mood Swings 8 0.8 0.8 no signal
204 Pregnancy 5 0.8 0.8 no signal
205 Mania 4 0.8 0.8 no signal
206 Osteonecrosis Of Jaw 6 0.8 0.8 no signal
207 Intraocular Pressure Increased 3 0.8 0.8 no signal
208 Injection Site Induration 3 0.8 0.8 no signal
209 Metrorrhagia 4 0.8 0.8 no signal
210 Drug Withdrawal Syndrome 20 0.7 0.7 no signal
211 Colitis Ulcerative 10 0.7 0.7 no signal
212 Injection Site Erythema 27 0.7 0.7 no signal
213 Drug Toxicity 3 0.7 0.7 no signal
214 Injection Site Bruising 17 0.7 0.7 no signal
215 Injection Site Haematoma 3 0.7 0.7 no signal
216 Intentional Drug Misuse 4 0.6 0.6 no signal
217 Amenorrhoea 3 0.6 0.6 no signal
218 Product Quality Issue 24 0.6 0.6 no signal
219 Injection Site Swelling 13 0.6 0.6 no signal
220 Drug Dependence 27 0.5 0.5 no signal
221 Accidental Exposure To Product 16 0.5 0.5 no signal
222 Skin Irritation 7 0.5 0.5 no signal
223 Injection Site Haemorrhage 12 0.5 0.5 no signal
224 Menstruation Irregular 4 0.5 0.5 no signal
225 Injection Site Pruritus 10 0.5 0.5 no signal
226 Injection Site Pain 43 0.5 0.5 no signal
227 Application Site Pruritus 3 0.4 0.4 no signal
228 Device Breakage 5 0.4 0.4 no signal
229 Breast Cancer Female 3 0.4 0.4 no signal
230 Incorrect Route Of Drug Administration 4 0.4 0.4 no signal
231 Tardive Dyskinesia 3 0.3 0.3 no signal
232 Device Expulsion 3 0.2 0.2 no signal