OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Varenicline

183 flagged reaction(s) · 8,513 total co-reports · max PRR 118.6
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 Sneezing 740 118.6 135.0 signal
2 Abnormal Dreams 211 26.5 27.4 signal
3 Nightmare 213 21.4 22.1 signal
4 Throat Irritation 180 14.0 14.4 signal
5 Rhinorrhoea 232 12.5 13.0 signal
6 Eye Pain 184 11.6 11.9 signal
7 Hepatic Encephalopathy 29 10.8 10.8 signal
8 Ocular Discomfort 32 10.2 10.3 signal
9 Lacrimation Increased 88 10.2 10.4 signal
10 Eye Irritation 141 8.8 9.0 signal
11 Product Use Complaint 39 8.7 8.8 signal
12 Device Delivery System Issue 65 8.6 8.7 signal
13 Product Packaging Quantity Issue 27 8.6 8.6 signal
14 Suicidal Ideation 218 8.3 8.5 signal
15 Epistaxis 177 8.2 8.4 signal
16 Photophobia 41 7.6 7.7 signal
17 Eye Discharge 22 7.5 7.5 signal
18 Agitation 153 7.2 7.4 signal
19 Mood Swings 63 6.9 6.9 signal
20 Hepatic Cirrhosis 35 6.5 6.5 signal
21 Anger 57 5.8 5.9 signal
22 Ocular Hyperaemia 76 5.6 5.7 signal
23 Hepatotoxicity 36 5.6 5.7 signal
24 Product Administration Error 32 5.6 5.6 signal
25 Depression 361 5.5 5.8 signal
26 Dry Eye 71 5.1 5.1 signal
27 Irritability 86 5.0 5.0 signal
28 Paranoia 23 4.6 4.6 signal
29 Mood Altered 36 4.6 4.6 signal
30 Dry Throat 13 4.4 4.4 signal
31 Neuroleptic Malignant Syndrome 15 4.4 4.4 signal
32 Full Blood Count Abnormal 13 4.3 4.3 signal
33 Sedation 31 4.1 4.1 signal
34 Inappropriate Antidiuretic Hormone Secretion 12 4.1 4.1 signal
35 Ear Discomfort 12 4.1 4.1 signal
36 Eye Inflammation 11 4.0 4.0 signal
37 Eye Swelling 41 3.8 3.9 signal
38 Mania 18 3.8 3.8 signal
39 Drug-induced Liver Injury 33 3.7 3.7 signal
40 Sinus Disorder 21 3.7 3.7 signal
41 Sleep Disorder Due To A General Medical Condition 17 3.6 3.7 signal
42 Pharyngeal Swelling 10 3.6 3.6 signal
43 Aggression 52 3.6 3.6 signal
44 Pharyngeal Oedema 16 3.6 3.6 signal
45 Hallucination, Auditory 16 3.5 3.5 signal
46 Hypoaesthesia Oral 15 3.5 3.5 signal
47 Poor Quality Sleep 21 3.4 3.4 signal
48 Therapy Cessation 50 3.4 3.4 signal
49 Paraesthesia Oral 14 3.4 3.4 signal
50 Eye Pruritus 32 3.4 3.4 signal
51 Impaired Driving Ability 11 3.4 3.4 signal
52 Therapeutic Response Unexpected 43 3.3 3.3 signal
53 Device Use Issue 16 3.2 3.2 signal
54 Drug Effect Less Than Expected 13 3.2 3.2 signal
55 Inability To Afford Medication 9 3.2 3.2 signal
56 Oropharyngeal Pain 84 3.1 3.2 signal
57 Secretion Discharge 11 3.1 3.1 signal
58 Nasal Congestion 52 3.1 3.1 signal
59 Mental Status Changes 24 3.0 3.0 signal
60 Psychotic Disorder 25 2.9 2.9 signal
61 Vomiting 390 2.9 3.0 signal
62 Depressed Mood 43 2.8 2.8 signal
63 Sinus Congestion 11 2.8 2.8 signal
64 Thinking Abnormal 15 2.8 2.8 signal
65 Hallucination 58 2.7 2.7 signal
66 Therapy Interrupted 53 2.7 2.7 signal
67 Brain Fog 11 2.6 2.6 signal
68 Incorrect Dose Administered By Device 19 2.6 2.6 signal
69 Vision Blurred 101 2.6 2.6 signal
70 Nausea 582 2.6 2.7 signal
71 Insomnia 196 2.5 2.6 signal
72 Cough 204 2.5 2.6 signal
73 Aphonia 10 2.5 2.5 signal
74 Economic Problem 11 2.5 2.5 signal
75 Suicide Attempt 41 2.3 2.3 signal
76 Burning Sensation 47 2.3 2.3 signal
77 Treatment Noncompliance 36 2.3 2.3 signal
78 Retching 14 2.3 2.3 signal
79 Intentional Product Misuse 57 2.3 2.3 signal
80 Drug Interaction 103 2.3 2.3 signal
81 Increased Appetite 12 2.2 2.2 signal
82 Productive Cough 30 2.2 2.2 signal
83 Head Discomfort 11 2.2 2.2 signal
84 Eye Infection 7 2.2 2.2 no signal
85 Ear Pain 12 2.1 2.1 signal
86 Dermatitis Contact 7 2.1 2.1 no signal
87 Vitreous Floaters 6 2.1 2.1 no signal
88 Ligament Sprain 6 2.1 2.1 no signal
89 Device Failure 9 2.1 2.1 no signal
90 Throat Tightness 16 2.1 2.1 signal
91 Tooth Abscess 6 2.0 2.0 no signal
92 Euphoric Mood 6 2.0 2.0 no signal
93 Abnormal Behaviour 23 2.0 2.0 no signal
94 Anxiety 163 2.0 2.0 no signal
95 Withdrawal Syndrome 24 2.0 2.0 no signal
96 Dry Mouth 46 2.0 2.0 no signal
97 Dysgeusia 42 1.9 2.0 no signal
98 Ageusia 14 1.9 1.9 no signal
99 Device Defective 9 1.9 1.9 no signal
100 Impaired Quality Of Life 8 1.9 1.9 no signal
101 Toothache 10 1.9 1.9 no signal
102 Apathy 8 1.9 1.9 no signal
103 Flatulence 31 1.9 1.9 no signal
104 Intraocular Pressure Increased 7 1.9 1.9 no signal
105 Expired Product Administered 18 1.9 1.9 no signal
106 Poisoning Deliberate 5 1.9 1.9 no signal
107 Scab 6 1.8 1.8 no signal
108 Loss Of Personal Independence In Daily Activities 25 1.8 1.8 no signal
109 Therapeutic Product Effect Incomplete 37 1.8 1.8 no signal
110 Swelling Face 34 1.8 1.8 no signal
111 Tinnitus 24 1.8 1.8 no signal
112 Uveitis 7 1.8 1.8 no signal
113 Choking 10 1.8 1.8 no signal
114 Thirst 9 1.7 1.8 no signal
115 Accidental Exposure To Product 50 1.7 1.7 no signal
116 Device Difficult To Use 33 1.7 1.7 no signal
117 Palpitations 58 1.7 1.7 no signal
118 Panic Attack 18 1.7 1.7 no signal
119 Accidental Overdose 18 1.7 1.7 no signal
120 Poor Venous Access 5 1.7 1.7 no signal
121 Libido Decreased 6 1.7 1.7 no signal
122 Headache 303 1.7 1.7 no signal
123 Scratch 5 1.7 1.7 no signal
124 Anosmia 7 1.7 1.7 no signal
125 Wrong Technique In Product Usage Process 96 1.6 1.7 no signal
126 Renal Pain 5 1.6 1.6 no signal
127 Product Dose Omission Issue 134 1.6 1.6 no signal
128 Nodule 6 1.6 1.6 no signal
129 Eye Disorder 15 1.6 1.6 no signal
130 Gastrointestinal Pain 5 1.6 1.6 no signal
131 Delusion 7 1.6 1.6 no signal
132 Obstructive Airways Disorder 5 1.6 1.6 no signal
133 Product Taste Abnormal 6 1.5 1.5 no signal
134 Fear 12 1.5 1.5 no signal
135 Product Complaint 11 1.5 1.5 no signal
136 Illness 44 1.5 1.5 no signal
137 Angioedema 19 1.5 1.5 no signal
138 Dysphonia 25 1.5 1.5 no signal
139 Pain In Jaw 12 1.5 1.5 no signal
140 Swollen Tongue 13 1.4 1.4 no signal
141 Ill-defined Disorder 25 1.4 1.4 no signal
142 Dystonia 8 1.4 1.4 no signal
143 Intentional Self-injury 8 1.4 1.4 no signal
144 Wrong Technique In Device Usage Process 18 1.4 1.4 no signal
145 Mental Disorder 17 1.4 1.4 no signal
146 Anorexia 5 1.3 1.3 no signal
147 Anhedonia 10 1.3 1.3 no signal
148 Eye Haemorrhage 5 1.3 1.3 no signal
149 Feeling Jittery 7 1.3 1.3 no signal
150 Feeling Abnormal 88 1.3 1.3 no signal
151 Bipolar Disorder 4 1.3 1.3 no signal
152 Convulsion 21 1.3 1.3 no signal
153 Intentional Overdose 23 1.3 1.3 no signal
154 Psychomotor Hyperactivity 6 1.2 1.2 no signal
155 Circumstance Or Information Capable Of Leading To Medication Error 11 1.1 1.1 no signal
156 Blood Thyroid Stimulating Hormone Increased 3 1.1 1.1 no signal
157 Product Packaging Issue 3 1.1 1.1 no signal
158 Injection Site Discolouration 4 1.1 1.1 no signal
159 Emotional Disorder 10 1.1 1.1 no signal
160 Personality Change 3 1.1 1.1 no signal
161 Poisoning 4 1.1 1.1 no signal
162 Affect Lability 3 1.1 1.1 no signal
163 Product Substitution Issue 16 1.0 1.0 no signal
164 Product Dispensing Error 6 1.0 1.0 no signal
165 Product Administered At Inappropriate Site 5 1.0 1.0 no signal
166 Completed Suicide 22 0.9 0.9 no signal
167 Glycosylated Haemoglobin Increased 6 0.8 0.8 no signal
168 Product Quality Issue 32 0.8 0.8 no signal
169 Injection Site Irritation 3 0.8 0.8 no signal
170 Therapeutic Response Shortened 7 0.8 0.8 no signal
171 Drug Abuse 18 0.7 0.7 no signal
172 Device Use Error 7 0.7 0.7 no signal
173 Lung Neoplasm Malignant 8 0.7 0.7 no signal
174 Drug Withdrawal Syndrome 16 0.6 0.6 no signal
175 Injection Site Urticaria 4 0.6 0.6 no signal
176 Product Storage Error 13 0.5 0.5 no signal
177 Device Issue 13 0.5 0.5 no signal
178 Intentional Drug Misuse 3 0.5 0.5 no signal
179 Dermatitis Atopic 7 0.5 0.5 no signal
180 Exposure Via Skin Contact 3 0.5 0.5 no signal
181 Pharmaceutical Product Complaint 3 0.4 0.4 no signal
182 Device Breakage 4 0.4 0.4 no signal
183 Drug Dose Omission By Device 4 0.2 0.2 no signal