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Guaifenesin And Dextromethorphan Hydrobromide

213 flagged reaction(s) · 12,817 total co-reports · max PRR 43.2
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 Accidental Overdose 543 43.2 46.5 signal
2 Incorrect Product Administration Duration 222 31.7 32.6 signal
3 Drug Effective For Unapproved Indication 182 17.9 18.4 signal
4 Incorrect Drug Administration Duration 155 15.6 16.0 signal
5 Expired Product Administered 170 14.7 15.1 signal
6 Product Use Complaint 65 12.1 12.2 signal
7 Euphoric Mood 40 11.2 11.2 signal
8 Feeling Jittery 43 6.5 6.5 signal
9 Retching 43 5.8 5.8 signal
10 Mydriasis 25 5.6 5.6 signal
11 Overdose 390 5.2 5.4 signal
12 Dizziness 864 5.0 5.5 signal
13 Respiratory Tract Congestion 27 4.9 4.9 signal
14 Dry Throat 17 4.8 4.8 signal
15 Choking 31 4.6 4.6 signal
16 Product Complaint 39 4.5 4.5 signal
17 Seasonal Allergy 22 4.5 4.5 signal
18 Hallucination 114 4.4 4.4 signal
19 Somnolence 300 4.3 4.4 signal
20 Product Use In Unapproved Indication 357 4.2 4.4 signal
21 Anosmia 21 4.1 4.2 signal
22 Disorientation 57 4.1 4.1 signal
23 Haemoptysis 40 4.1 4.1 signal
24 Ageusia 34 3.9 3.9 signal
25 Nervousness 69 3.8 3.8 signal
26 Secretion Discharge 15 3.5 3.5 signal
27 Feeling Abnormal 291 3.5 3.6 signal
28 Pulmonary Congestion 16 3.5 3.5 signal
29 Drug Ineffective For Unapproved Indication 67 3.4 3.5 signal
30 Hypoaesthesia Oral 18 3.4 3.4 signal
31 Disease Recurrence 57 3.4 3.4 signal
32 Brain Fog 17 3.3 3.3 signal
33 Presyncope 28 3.3 3.3 signal
34 Aphonia 16 3.3 3.3 signal
35 Psychomotor Hyperactivity 19 3.3 3.3 signal
36 Blood Pressure Increased 174 3.3 3.3 signal
37 Epistaxis 84 3.2 3.2 signal
38 Productive Cough 53 3.2 3.2 signal
39 Laryngitis 12 3.2 3.2 signal
40 Palpitations 127 3.1 3.1 signal
41 Head Discomfort 19 3.1 3.1 signal
42 Eye Discharge 11 3.1 3.1 signal
43 Cold Sweat 19 3.1 3.1 signal
44 Heart Rate Increased 103 3.0 3.0 signal
45 Insomnia 268 2.9 2.9 signal
46 Diarrhoea 641 2.9 3.0 signal
47 Throat Irritation 44 2.8 2.8 signal
48 Restlessness 36 2.8 2.8 signal
49 Initial Insomnia 10 2.8 2.8 signal
50 Faeces Discoloured 21 2.8 2.8 signal
51 Sinus Congestion 13 2.8 2.8 signal
52 Sinus Disorder 19 2.7 2.7 signal
53 Wrong Technique In Product Usage Process 193 2.7 2.8 signal
54 Inappropriate Schedule Of Product Administration 165 2.7 2.7 signal
55 Hallucination, Visual 19 2.6 2.6 signal
56 Emphysema 9 2.5 2.5 signal
57 Sleep Apnoea Syndrome 17 2.5 2.5 signal
58 Ear Discomfort 9 2.5 2.5 signal
59 Lip Swelling 29 2.5 2.5 signal
60 Infusion Site Pain 11 2.5 2.5 signal
61 Respiratory Tract Infection 22 2.4 2.4 signal
62 Sputum Discoloured 8 2.4 2.4 signal
63 Dry Mouth 68 2.4 2.4 signal
64 Paraesthesia Oral 12 2.4 2.4 signal
65 No Adverse Event 146 2.4 2.4 signal
66 Panic Attack 30 2.4 2.4 signal
67 Bronchitis 61 2.3 2.4 signal
68 Cough 229 2.3 2.4 signal
69 Poor Quality Sleep 17 2.3 2.3 signal
70 Abdominal Pain Upper 161 2.2 2.3 signal
71 Confusional State 124 2.2 2.2 signal
72 Dysuria 28 2.2 2.2 signal
73 Drug Ineffective 989 2.2 2.3 signal
74 Burning Sensation 50 2.0 2.0 signal
75 Sinusitis 73 2.0 2.0 signal
76 Delusion 11 2.0 2.0 signal
77 Inappropriate Schedule Of Drug Administration 51 2.0 2.0 signal
78 Loss Of Consciousness 88 2.0 2.0 no signal
79 Pruritus Generalised 15 2.0 2.0 no signal
80 Scratch 7 1.9 1.9 no signal
81 Thirst 12 1.9 1.9 no signal
82 Feeling Hot 41 1.9 1.9 no signal
83 Abdominal Discomfort 111 1.9 1.9 no signal
84 Toothache 12 1.9 1.9 no signal
85 Drug Abuse 55 1.9 1.9 no signal
86 Illness 66 1.9 1.9 no signal
87 Iron Deficiency Anaemia 6 1.9 1.9 no signal
88 Nausea 515 1.9 1.9 no signal
89 Oropharyngeal Pain 60 1.9 1.9 no signal
90 Musculoskeletal Chest Pain 10 1.8 1.8 no signal
91 Wheezing 38 1.8 1.8 no signal
92 Pharyngeal Oedema 10 1.8 1.8 no signal
93 Blood Urine Present 12 1.8 1.8 no signal
94 Hyperhidrosis 81 1.8 1.8 no signal
95 Pharyngeal Swelling 6 1.8 1.8 no signal
96 Dizziness Postural 6 1.8 1.8 no signal
97 Micturition Urgency 7 1.8 1.8 no signal
98 Anxiety 176 1.8 1.8 no signal
99 Nasal Congestion 36 1.8 1.8 no signal
100 Dysstasia 18 1.8 1.8 no signal
101 Vomiting 288 1.8 1.8 no signal
102 Unevaluable Event 46 1.7 1.7 no signal
103 Rhinorrhoea 39 1.7 1.7 no signal
104 Chest Discomfort 61 1.7 1.7 no signal
105 Intentional Overdose 38 1.7 1.7 no signal
106 Tremor 98 1.7 1.7 no signal
107 Cholecystitis 7 1.7 1.7 no signal
108 Covid-19 103 1.7 1.7 no signal
109 Glossodynia 13 1.7 1.7 no signal
110 Therapeutic Product Effect Incomplete 41 1.7 1.7 no signal
111 Syncope 58 1.7 1.7 no signal
112 Paranoia 10 1.7 1.7 no signal
113 Swollen Tongue 18 1.6 1.7 no signal
114 Oral Discomfort 8 1.6 1.6 no signal
115 Lacrimation Increased 17 1.6 1.6 no signal
116 Ear Pain 11 1.6 1.6 no signal
117 Muscle Twitching 13 1.6 1.6 no signal
118 Vision Blurred 76 1.6 1.6 no signal
119 Eye Swelling 20 1.5 1.6 no signal
120 Lethargy 31 1.5 1.5 no signal
121 Chronic Obstructive Pulmonary Disease 28 1.5 1.5 no signal
122 Eye Infection 6 1.5 1.5 no signal
123 Speech Disorder 28 1.5 1.5 no signal
124 Dysphagia 50 1.5 1.5 no signal
125 Heart Rate Irregular 12 1.5 1.5 no signal
126 Adverse Reaction 7 1.5 1.5 no signal
127 Impaired Driving Ability 6 1.5 1.5 no signal
128 Throat Tightness 14 1.5 1.5 no signal
129 Ligament Sprain 5 1.5 1.5 no signal
130 Dyspnoea 286 1.4 1.5 no signal
131 Product Physical Issue 10 1.4 1.4 no signal
132 Salivary Hypersecretion 5 1.4 1.4 no signal
133 Muscle Tightness 8 1.4 1.4 no signal
134 Conjunctivitis 9 1.4 1.4 no signal
135 Oral Pain 11 1.4 1.4 no signal
136 Small Intestinal Obstruction 6 1.4 1.4 no signal
137 Balance Disorder 42 1.4 1.4 no signal
138 Poor Venous Access 5 1.4 1.4 no signal
139 Nasopharyngitis 89 1.4 1.4 no signal
140 Product Use Issue 90 1.4 1.4 no signal
141 Thinking Abnormal 9 1.4 1.4 no signal
142 Dysphonia 28 1.4 1.4 no signal
143 Eructation 9 1.4 1.4 no signal
144 Headache 293 1.3 1.4 no signal
145 Hernia 9 1.3 1.3 no signal
146 Feeling Cold 13 1.3 1.3 no signal
147 Contraindicated Product Administered 14 1.3 1.3 no signal
148 Body Height Decreased 5 1.3 1.3 no signal
149 Vertigo 28 1.3 1.3 no signal
150 Pulmonary Thrombosis 5 1.3 1.3 no signal
151 Dental Caries 5 1.3 1.3 no signal
152 Product Taste Abnormal 6 1.3 1.3 no signal
153 Urticaria 74 1.3 1.3 no signal
154 Paraesthesia 70 1.3 1.3 no signal
155 Cholecystectomy 5 1.3 1.3 no signal
156 Hallucination, Auditory 7 1.3 1.3 no signal
157 Abasia 11 1.3 1.3 no signal
158 Wrong Technique In Drug Usage Process 16 1.2 1.2 no signal
159 Abnormal Dreams 12 1.2 1.2 no signal
160 Product Packaging Issue 4 1.2 1.2 no signal
161 Gastric Disorder 15 1.2 1.2 no signal
162 Diarrhoea Haemorrhagic 4 1.2 1.2 no signal
163 Spinal Pain 5 1.2 1.2 no signal
164 Drug Effect Less Than Expected 6 1.2 1.2 no signal
165 Disturbance In Attention 23 1.2 1.2 no signal
166 Hot Flush 32 1.2 1.2 no signal
167 Laceration 4 1.2 1.2 no signal
168 Dysgeusia 31 1.2 1.2 no signal
169 Pulmonary Arterial Hypertension 6 1.2 1.2 no signal
170 Hospice Care 4 1.2 1.2 no signal
171 Fear 11 1.2 1.2 no signal
172 Therapeutic Response Unexpected 18 1.1 1.1 no signal
173 Haematochezia 22 1.1 1.1 no signal
174 Full Blood Count Decreased 8 1.1 1.1 no signal
175 Poisoning 5 1.1 1.1 no signal
176 Sluggishness 4 1.1 1.1 no signal
177 Pain In Jaw 11 1.1 1.1 no signal
178 Intentional Drug Misuse 8 1.1 1.1 no signal
179 Flushing 38 1.1 1.1 no signal
180 Pharyngitis Streptococcal 4 1.1 1.1 no signal
181 Back Disorder 6 1.1 1.1 no signal
182 Serotonin Syndrome 7 1.0 1.0 no signal
183 Central Nervous System Lesion 5 1.0 1.0 no signal
184 Abnormal Behaviour 14 1.0 1.0 no signal
185 Dyskinesia 14 1.0 1.0 no signal
186 Eyelid Oedema 4 1.0 1.0 no signal
187 Spinal Operation 4 0.9 0.9 no signal
188 Surgery 19 0.9 0.9 no signal
189 Affect Lability 3 0.9 0.9 no signal
190 Metastases To Bone 5 0.9 0.9 no signal
191 Breast Cancer Metastatic 3 0.8 0.8 no signal
192 Product Packaging Quantity Issue 3 0.8 0.8 no signal
193 Device Failure 4 0.8 0.8 no signal
194 Convulsion 15 0.7 0.7 no signal
195 Palmar-plantar Erythrodysaesthesia Syndrome 6 0.7 0.7 no signal
196 Eye Irritation 14 0.7 0.7 no signal
197 Metastases To Central Nervous System 3 0.7 0.7 no signal
198 Blood Glucose Decreased 11 0.7 0.7 no signal
199 Complication Associated With Device 3 0.6 0.6 no signal
200 Prostatic Specific Antigen Increased 3 0.6 0.6 no signal
201 Product Quality Issue 26 0.6 0.6 no signal
202 Device Use Issue 3 0.5 0.5 no signal
203 Lung Neoplasm Malignant 7 0.5 0.5 no signal
204 Extra Dose Administered 6 0.4 0.4 no signal
205 Intentional Self-injury 3 0.4 0.4 no signal
206 Injection Site Mass 5 0.4 0.4 no signal
207 Incorrect Dose Administered By Device 3 0.3 0.3 no signal
208 Accidental Exposure To Product 11 0.3 0.3 no signal
209 Tardive Dyskinesia 3 0.3 0.3 no signal
210 Wrong Technique In Device Usage Process 4 0.3 0.2 no signal
211 Incorrect Route Of Drug Administration 3 0.2 0.2 no signal
212 Drug Dependence 11 0.2 0.2 no signal
213 Drug Dose Omission By Device 3 0.1 0.1 no signal