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Dextromethorphan Hydrobromide And Guaifenesin

106 flagged reaction(s) · 5,620 total co-reports · max PRR 39.7
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 334 39.7 42.5 signal
2 Mydriasis 50 16.8 17.0 signal
3 Euphoric Mood 34 14.2 14.3 signal
4 Overdose 431 8.6 9.3 signal
5 Psychomotor Hyperactivity 32 8.3 8.3 signal
6 Expired Product Administered 61 7.9 8.0 signal
7 Product Taste Abnormal 24 7.7 7.7 signal
8 Incorrect Drug Administration Duration 47 7.1 7.2 signal
9 Incorrect Product Administration Duration 30 6.4 6.4 signal
10 No Adverse Event 238 5.8 6.0 signal
11 Hallucination 97 5.6 5.7 signal
12 Product Complaint 32 5.5 5.5 signal
13 Hypoaesthesia Oral 16 4.6 4.6 signal
14 Drug Effective For Unapproved Indication 31 4.6 4.6 signal
15 Hallucination, Visual 22 4.5 4.5 signal
16 Feeling Jittery 20 4.5 4.5 signal
17 Drug Abuse 86 4.4 4.5 signal
18 Seasonal Allergy 14 4.3 4.3 signal
19 Drug Ineffective 1,260 4.1 5.2 signal
20 Inappropriate Schedule Of Drug Administration 66 3.9 4.0 signal
21 Disorientation 36 3.9 3.9 signal
22 Cough 250 3.8 4.0 signal
23 Dry Throat 9 3.8 3.8 signal
24 Retching 18 3.6 3.7 signal
25 Somnolence 169 3.6 3.7 signal
26 Dizziness 393 3.4 3.6 signal
27 Dysarthria 28 3.2 3.2 signal
28 Feeling Abnormal 174 3.1 3.2 signal
29 Productive Cough 34 3.1 3.1 signal
30 Product Use Complaint 11 3.1 3.1 signal
31 Chromaturia 16 3.0 3.1 signal
32 Abnormal Behaviour 28 3.0 3.0 signal
33 Nervousness 36 2.9 3.0 signal
34 Sputum Discoloured 6 2.7 2.7 signal
35 Respiratory Tract Congestion 10 2.7 2.7 signal
36 Intentional Overdose 40 2.7 2.7 signal
37 Insomnia 161 2.6 2.7 signal
38 Sinus Congestion 8 2.5 2.5 signal
39 Ataxia 7 2.5 2.5 signal
40 Delusion 9 2.5 2.5 signal
41 Paranoia 10 2.5 2.5 signal
42 Diarrhoea 358 2.4 2.5 signal
43 Paraesthesia Oral 8 2.4 2.4 signal
44 Faeces Discoloured 12 2.4 2.4 signal
45 Unresponsive To Stimuli 14 2.3 2.3 signal
46 Lip Swelling 18 2.3 2.3 signal
47 Inappropriate Schedule Of Product Administration 95 2.3 2.3 signal
48 Haemoptysis 15 2.3 2.3 signal
49 Photophobia 10 2.3 2.3 signal
50 Heart Rate Increased 53 2.3 2.3 signal
51 Contraindicated Product Administered 16 2.3 2.3 signal
52 Throat Tightness 14 2.2 2.2 signal
53 Choking 10 2.2 2.2 signal
54 Throat Irritation 23 2.2 2.2 signal
55 Cold Sweat 9 2.2 2.2 signal
56 Sinus Disorder 10 2.2 2.2 signal
57 Blood Pressure Increased 77 2.2 2.2 signal
58 Diplopia 13 2.2 2.2 signal
59 Gastroenteritis Viral 9 2.1 2.1 signal
60 Nocturia 6 2.1 2.1 no signal
61 Initial Insomnia 5 2.1 2.1 no signal
62 Eye Discharge 5 2.1 2.1 no signal
63 Anosmia 7 2.1 2.1 no signal
64 Brain Fog 7 2.1 2.1 no signal
65 Extra Dose Administered 19 2.0 2.1 signal
66 Restlessness 17 2.0 2.0 no signal
67 Laryngitis 5 2.0 2.0 no signal
68 Head Discomfort 8 2.0 2.0 no signal
69 Dysstasia 13 1.9 1.9 no signal
70 Increased Tendency To Bruise 4 1.9 1.9 no signal
71 Product Packaging Issue 4 1.9 1.9 no signal
72 Aphonia 6 1.9 1.9 no signal
73 Eye Disorder 14 1.8 1.8 no signal
74 Mania 7 1.8 1.8 no signal
75 Unevaluable Event 31 1.8 1.8 no signal
76 Pallor 11 1.7 1.7 no signal
77 Eye Swelling 14 1.6 1.6 no signal
78 Thinking Abnormal 7 1.6 1.6 no signal
79 Ocular Discomfort 4 1.6 1.6 no signal
80 Agitation 27 1.6 1.6 no signal
81 Bipolar Disorder 4 1.6 1.6 no signal
82 Impaired Driving Ability 4 1.5 1.5 no signal
83 Abnormal Dreams 9 1.4 1.4 no signal
84 Pharyngeal Oedema 5 1.4 1.4 no signal
85 Poisoning 4 1.4 1.4 no signal
86 Serotonin Syndrome 6 1.3 1.3 no signal
87 Dystonia 6 1.3 1.3 no signal
88 Anorexia 4 1.3 1.3 no signal
89 Coeliac Disease 3 1.3 1.3 no signal
90 Crying 11 1.3 1.3 no signal
91 Adverse Reaction 4 1.3 1.3 no signal
92 Convulsion 16 1.2 1.2 no signal
93 Circumstance Or Information Capable Of Leading To Medication Error 9 1.2 1.2 no signal
94 Underdose 19 1.1 1.1 no signal
95 Aggression 13 1.1 1.1 no signal
96 Gastric Disorder 9 1.1 1.1 no signal
97 Hallucination, Auditory 4 1.1 1.1 no signal
98 Blood Glucose Increased 42 1.0 1.0 no signal
99 Wrong Technique In Product Usage Process 44 0.9 0.9 no signal
100 Drug Effect Incomplete 6 0.7 0.7 no signal
101 Accidental Exposure To Product 14 0.6 0.6 no signal
102 Pharmaceutical Product Complaint 3 0.5 0.5 no signal
103 Tardive Dyskinesia 3 0.5 0.5 no signal
104 Device Use Error 3 0.4 0.4 no signal
105 Drug Dependence 9 0.2 0.2 no signal
106 Dependence 3 0.2 0.2 no signal