OpenPV Signal Explorer
FAERS disproportionality dashboard
← All drugs
Drug

Nicotine Polacrilex Gum

115 flagged reaction(s) · 9,126 total co-reports · max PRR 168.9
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 Macular Degeneration 567 168.9 185.8 signal
2 Oral Discomfort 329 81.9 86.4 signal
3 Intentional Drug Misuse 333 53.9 56.9 signal
4 Paraesthesia Oral 165 39.3 40.3 signal
5 Vaginal Discharge 82 27.8 28.2 signal
6 Oral Candidiasis 84 22.0 22.3 signal
7 Drug Administration Error 199 21.8 22.4 signal
8 Expired Product Administered 209 21.4 22.1 signal
9 Incorrect Route Of Product Administration 94 19.0 19.3 signal
10 Dental Caries 58 17.8 18.0 signal
11 Throat Irritation 234 17.8 18.4 signal
12 Procedural Pain 125 15.3 15.6 signal
13 Product Taste Abnormal 49 12.4 12.4 signal
14 Drug Effect Less Than Expected 48 11.5 11.6 signal
15 Frequent Bowel Movements 87 11.0 11.1 signal
16 Dyspepsia 314 10.9 11.4 signal
17 Oral Pain 71 10.7 10.8 signal
18 Salivary Hypersecretion 30 10.2 10.2 signal
19 Therapeutic Product Effect Incomplete 175 8.4 8.6 signal
20 Glossodynia 52 7.9 7.9 signal
21 Retching 49 7.8 7.9 signal
22 Stomatitis 139 7.8 7.9 signal
23 Colitis 83 7.5 7.6 signal
24 Wrong Technique In Product Usage Process 419 7.0 7.5 signal
25 Rectal Haemorrhage 87 6.8 6.9 signal
26 Pharyngeal Oedema 31 6.7 6.8 signal
27 Infusion Related Reaction 125 6.4 6.5 signal
28 Colitis Ulcerative 84 6.4 6.5 signal
29 Pharyngeal Swelling 18 6.4 6.4 signal
30 Throat Tightness 50 6.3 6.3 signal
31 Tooth Fracture 20 6.1 6.2 signal
32 Incorrect Drug Administration Duration 49 5.8 5.9 signal
33 Toothache 31 5.8 5.8 signal
34 Haematochezia 85 5.2 5.3 signal
35 Incorrect Route Of Drug Administration 55 5.1 5.2 signal
36 Dysgeusia 107 4.8 4.9 signal
37 Flatulence 65 3.9 3.9 signal
38 Hypoaesthesia Oral 17 3.8 3.8 signal
39 Oropharyngeal Pain 104 3.8 3.8 signal
40 Dry Throat 11 3.7 3.7 signal
41 Drug Ineffective 1,401 3.6 4.4 signal
42 Abdominal Discomfort 168 3.4 3.5 signal
43 Mouth Ulceration 21 3.4 3.4 signal
44 Eructation 17 3.0 3.0 signal
45 Feeling Jittery 17 3.0 3.0 signal
46 Nausea 701 3.0 3.3 signal
47 Gingival Bleeding 12 3.0 3.0 signal
48 Euphoric Mood 9 3.0 3.0 signal
49 Pain In Jaw 24 2.9 2.9 signal
50 Product Use Complaint 13 2.8 2.8 signal
51 Product Quality Issue 109 2.7 2.8 signal
52 Therapeutic Product Effect Decreased 35 2.7 2.7 signal
53 Accidental Exposure To Product 75 2.5 2.6 signal
54 Tooth Disorder 16 2.4 2.4 signal
55 Swollen Tongue 22 2.4 2.4 signal
56 Lip Swelling 23 2.3 2.3 signal
57 Underdose 50 2.3 2.3 signal
58 Incorrect Dose Administered 150 2.3 2.3 signal
59 Malaise 288 2.2 2.3 signal
60 Skin Laceration 7 2.2 2.2 no signal
61 Nightmare 22 2.1 2.1 signal
62 Dry Mouth 49 2.0 2.1 signal
63 Product Physical Issue 12 2.0 2.0 signal
64 Blood Potassium Increased 9 1.9 1.9 no signal
65 Pruritus Generalised 12 1.8 1.9 no signal
66 Product Packaging Issue 5 1.8 1.8 no signal
67 Drug Withdrawal Syndrome Neonatal 8 1.8 1.8 no signal
68 Nervousness 28 1.8 1.8 no signal
69 Laceration 5 1.8 1.8 no signal
70 Autoimmune Disorder 5 1.8 1.8 no signal
71 Erythema 105 1.7 1.7 no signal
72 Therapeutic Response Unexpected 23 1.7 1.7 no signal
73 Abdominal Pain Upper 103 1.7 1.7 no signal
74 Palpitations 58 1.7 1.7 no signal
75 Heart Rate Increased 47 1.6 1.6 no signal
76 Burning Sensation 33 1.6 1.6 no signal
77 Blood Glucose Increased 88 1.6 1.6 no signal
78 Choking 9 1.6 1.6 no signal
79 Drug Ineffective For Unapproved Indication 25 1.5 1.5 no signal
80 Brain Neoplasm 4 1.5 1.5 no signal
81 Application Site Rash 6 1.5 1.5 no signal
82 Dependence 24 1.5 1.5 no signal
83 Aphonia 6 1.5 1.5 no signal
84 Tooth Extraction 5 1.4 1.4 no signal
85 Product Complaint 10 1.4 1.4 no signal
86 Abnormal Dreams 11 1.3 1.3 no signal
87 Ageusia 9 1.2 1.2 no signal
88 Tooth Loss 7 1.1 1.1 no signal
89 Withdrawal Syndrome 14 1.1 1.1 no signal
90 Overdose 71 1.1 1.1 no signal
91 Respiratory Depression 4 1.1 1.1 no signal
92 Lymphoma 5 1.1 1.1 no signal
93 Increased Appetite 6 1.1 1.1 no signal
94 Drug Effective For Unapproved Indication 9 1.0 1.0 no signal
95 Adverse Reaction 4 1.0 1.0 no signal
96 Irritability 18 1.0 1.0 no signal
97 Poor Quality Product Administered 3 1.0 1.0 no signal
98 Local Swelling 5 1.0 1.0 no signal
99 Breast Pain 3 1.0 1.0 no signal
100 Drug Effect Decreased 15 0.9 0.9 no signal
101 Suicidal Ideation 25 0.9 0.9 no signal
102 Application Site Pruritus 6 0.9 0.9 no signal
103 Bone Loss 4 0.9 0.9 no signal
104 Mania 4 0.8 0.8 no signal
105 Poisoning 3 0.8 0.8 no signal
106 Tuberculosis 3 0.8 0.8 no signal
107 Glycosylated Haemoglobin Increased 5 0.7 0.7 no signal
108 Device Failure 3 0.7 0.7 no signal
109 Inappropriate Schedule Of Drug Administration 14 0.7 0.7 no signal
110 Application Site Erythema 5 0.6 0.6 no signal
111 Application Site Pain 4 0.6 0.6 no signal
112 No Adverse Event 32 0.6 0.6 no signal
113 Drug Dependence 27 0.6 0.6 no signal
114 Product Adhesion Issue 5 0.5 0.5 no signal
115 Drug Withdrawal Syndrome 9 0.3 0.3 no signal