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Drug

Guanfacine Hydrochloride

251 flagged reaction(s) · 7,818 total co-reports · max PRR 28.1
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 Sinus Bradycardia 58 28.1 28.4 signal
2 Aggression 221 20.6 21.6 signal
3 Psychomotor Hyperactivity 65 18.2 18.5 signal
4 Serotonin Syndrome 53 12.9 13.1 signal
5 Bradycardia 145 12.8 13.1 signal
6 Intentional Overdose 168 12.3 12.8 signal
7 Abnormal Behaviour 102 11.9 12.2 signal
8 Intentional Self-injury 51 11.8 11.9 signal
9 Dystonia 48 11.5 11.6 signal
10 Sedation 64 11.5 11.6 signal
11 Electrocardiogram Qt Prolonged 86 11.2 11.4 signal
12 Anger 80 11.0 11.2 signal
13 Agitation 150 9.5 9.8 signal
14 Neuroleptic Malignant Syndrome 24 9.4 9.5 signal
15 Irritability 114 8.8 9.0 signal
16 Orthostatic Hypotension 33 8.8 8.9 signal
17 Respiratory Depression 23 8.8 8.8 signal
18 Affect Lability 18 8.7 8.7 signal
19 Product Substitution Issue 104 8.4 8.6 signal
20 Mania 29 8.2 8.3 signal
21 Therapy Change 17 8.2 8.3 signal
22 Therapy Partial Responder 24 7.4 7.5 signal
23 Posterior Reversible Encephalopathy Syndrome 15 7.4 7.4 signal
24 Device Mechanical Issue 20 7.2 7.3 signal
25 Emotional Disorder 46 6.9 7.0 signal
26 Generalised Tonic-clonic Seizure 23 6.6 6.6 signal
27 Bipolar Disorder 15 6.4 6.4 signal
28 Increased Appetite 25 6.2 6.2 signal
29 Lethargy 75 6.1 6.2 signal
30 Hallucination, Auditory 20 5.9 5.9 signal
31 Mood Swings 40 5.9 5.9 signal
32 Toxicity To Various Agents 205 5.7 5.9 signal
33 Product Dispensing Error 26 5.6 5.6 signal
34 Rebound Effect 13 5.3 5.4 signal
35 Somnolence 225 5.2 5.4 signal
36 Suicide Attempt 68 5.2 5.3 signal
37 Salivary Hypersecretion 11 5.1 5.1 signal
38 Muscle Rigidity 13 5.1 5.1 signal
39 Initial Insomnia 11 5.0 5.0 signal
40 Presyncope 26 5.0 5.0 signal
41 Suicidal Ideation 98 5.0 5.1 signal
42 Restlessness 39 5.0 5.0 signal
43 Impaired Quality Of Life 15 4.9 4.9 signal
44 Dysarthria 38 4.7 4.7 signal
45 Coma 48 4.7 4.7 signal
46 Blindness Unilateral 14 4.6 4.6 signal
47 Depressed Level Of Consciousness 39 4.6 4.6 signal
48 Sinus Tachycardia 14 4.6 4.6 signal
49 Drug Interaction 155 4.6 4.7 signal
50 Drug Level Increased 16 4.5 4.5 signal
51 Intentional Dose Omission 26 4.4 4.5 signal
52 Treatment Failure 78 4.4 4.5 signal
53 Withdrawal Syndrome 40 4.4 4.4 signal
54 Mydriasis 12 4.4 4.4 signal
55 Disturbance In Attention 50 4.3 4.3 signal
56 Hypotension 185 4.3 4.5 signal
57 Inability To Afford Medication 9 4.3 4.3 signal
58 Product Physical Issue 18 4.2 4.2 signal
59 Brain Fog 13 4.2 4.2 signal
60 Status Epilepticus 10 4.1 4.1 signal
61 Akathisia 12 4.1 4.1 signal
62 Brain Oedema 11 4.1 4.1 signal
63 Paranoia 15 4.0 4.0 signal
64 Gynaecomastia 27 4.0 4.0 signal
65 Product Availability Issue 19 4.0 4.0 signal
66 Mood Altered 23 3.9 4.0 signal
67 Dizziness Postural 8 3.9 3.9 signal
68 Seizure 95 3.9 3.9 signal
69 Apathy 12 3.9 3.9 signal
70 Parkinsonism 8 3.8 3.8 signal
71 Completed Suicide 69 3.8 3.9 signal
72 Insurance Issue 12 3.8 3.8 signal
73 Dermatitis Contact 9 3.7 3.7 signal
74 Thirst 14 3.7 3.7 signal
75 Mental Disorder 34 3.6 3.7 signal
76 Euphoric Mood 8 3.6 3.6 signal
77 Encephalopathy 19 3.6 3.6 signal
78 Tachycardia 68 3.6 3.6 signal
79 Skin Haemorrhage 11 3.6 3.6 signal
80 Obesity 12 3.5 3.5 signal
81 Pharyngitis Streptococcal 8 3.4 3.5 signal
82 Hypersomnia 21 3.4 3.4 signal
83 Impaired Gastric Emptying 9 3.3 3.3 signal
84 Depressed Mood 37 3.3 3.3 signal
85 Eating Disorder 15 3.3 3.3 signal
86 Unresponsive To Stimuli 18 3.3 3.3 signal
87 Middle Insomnia 13 3.3 3.3 signal
88 Dyskinesia 28 3.2 3.2 signal
89 Cognitive Disorder 32 3.2 3.2 signal
90 Device Breakage 27 3.2 3.2 signal
91 Crying 25 3.2 3.2 signal
92 Accidental Overdose 25 3.2 3.2 signal
93 Drug Ineffective For Unapproved Indication 38 3.2 3.2 signal
94 Blood Triglycerides Increased 12 3.2 3.2 signal
95 Prescribed Overdose 13 3.1 3.1 signal
96 Ataxia 8 3.1 3.1 signal
97 Product Taste Abnormal 9 3.1 3.1 signal
98 Hallucination 50 3.1 3.1 signal
99 Gastroenteritis Viral 12 3.1 3.1 signal
100 Sleep Disorder 46 3.1 3.1 signal
101 End Stage Renal Disease 12 3.0 3.0 signal
102 Altered State Of Consciousness 14 3.0 3.0 signal
103 Product Use Complaint 10 3.0 3.0 signal
104 Insomnia 172 3.0 3.1 signal
105 Thinking Abnormal 12 3.0 3.0 signal
106 Ear Infection 17 3.0 3.0 signal
107 Drug Effect Less Than Expected 9 3.0 3.0 signal
108 Skin Fissures 12 3.0 3.0 signal
109 Dermatitis Atopic 31 2.9 2.9 signal
110 Device Leakage 26 2.9 2.9 signal
111 Mental Status Changes 17 2.9 2.9 signal
112 Poor Quality Sleep 13 2.8 2.8 signal
113 Pulmonary Oedema 27 2.8 2.8 signal
114 Sexual Dysfunction 7 2.8 2.8 signal
115 Anxiety 171 2.8 2.9 signal
116 Hypothermia 6 2.8 2.8 signal
117 Sluggishness 6 2.8 2.8 signal
118 Therapy Non-responder 26 2.7 2.7 signal
119 Blood Creatine Phosphokinase Increased 17 2.7 2.7 signal
120 Delusion 9 2.7 2.7 signal
121 Hallucination, Visual 12 2.7 2.7 signal
122 Product Quality Issue 77 2.7 2.7 signal
123 Treatment Noncompliance 31 2.7 2.7 signal
124 Application Site Erythema 15 2.7 2.7 signal
125 Wrong Technique In Drug Usage Process 21 2.7 2.7 signal
126 Incontinence 6 2.6 2.6 signal
127 Product Adhesion Issue 20 2.6 2.6 signal
128 Application Site Irritation 7 2.6 2.6 signal
129 Abnormal Weight Gain 7 2.6 2.6 signal
130 Cardiogenic Shock 8 2.6 2.6 signal
131 Sleep Disorder Due To A General Medical Condition 9 2.6 2.6 signal
132 Product Administration Error 11 2.6 2.6 signal
133 Infusion Site Pain 7 2.6 2.6 signal
134 Weight Increased 122 2.6 2.6 signal
135 Psychotic Disorder 16 2.5 2.5 signal
136 Urinary Retention 18 2.5 2.5 signal
137 Diplopia 14 2.5 2.5 signal
138 Ventricular Fibrillation 6 2.5 2.5 signal
139 Drug Dose Omission By Device 41 2.5 2.5 signal
140 Blood Pressure Decreased 35 2.5 2.5 signal
141 Movement Disorder 17 2.5 2.5 signal
142 Hunger 7 2.4 2.4 signal
143 Nightmare 18 2.4 2.4 signal
144 Retching 11 2.4 2.4 signal
145 Drug Prescribing Error 10 2.4 2.4 signal
146 Overdose 111 2.4 2.4 signal
147 Urinary Incontinence 15 2.4 2.4 signal
148 Blood Lactate Dehydrogenase Increased 8 2.3 2.3 signal
149 Sensory Disturbance 8 2.3 2.3 signal
150 Therapeutic Product Effect Decreased 22 2.3 2.3 signal
151 Glomerular Filtration Rate Decreased 6 2.3 2.3 no signal
152 Mental Impairment 12 2.3 2.3 signal
153 Tardive Dyskinesia 14 2.3 2.3 signal
154 Drug Level Decreased 5 2.3 2.3 no signal
155 Paralysis 7 2.3 2.3 no signal
156 Application Site Pruritus 11 2.3 2.3 signal
157 Poor Venous Access 5 2.3 2.3 no signal
158 Hyperhidrosis 62 2.2 2.3 signal
159 Gastrointestinal Disorder 42 2.2 2.2 signal
160 Therapeutic Response Shortened 15 2.2 2.2 signal
161 Depression 105 2.1 2.2 signal
162 Obstructive Airways Disorder 5 2.1 2.1 no signal
163 Product Use Issue 83 2.1 2.1 signal
164 Fear 12 2.1 2.1 signal
165 Product Prescribing Issue 9 2.1 2.1 no signal
166 Drug Effect Decreased 24 2.0 2.1 signal
167 Lactic Acidosis 14 2.0 2.0 signal
168 Application Site Rash 6 2.0 2.0 no signal
169 Poisoning Deliberate 4 2.0 2.0 no signal
170 Product Dose Omission Issue 120 2.0 2.0 no signal
171 Feeling Jittery 8 2.0 2.0 no signal
172 Drug Ineffective 546 1.9 2.1 no signal
173 Therapy Cessation 21 1.9 1.9 no signal
174 Coeliac Disease 4 1.9 1.9 no signal
175 Pallor 11 1.9 1.9 no signal
176 Neurotoxicity 7 1.9 1.9 no signal
177 Extrapyramidal Disorder 10 1.9 1.9 no signal
178 Brain Injury 4 1.9 1.9 no signal
179 Illness 40 1.9 1.9 no signal
180 Device Adhesion Issue 6 1.8 1.8 no signal
181 Product Dose Omission 26 1.8 1.8 no signal
182 Scratch 4 1.8 1.8 no signal
183 Nervous System Disorder 12 1.8 1.8 no signal
184 Device Use Error 13 1.8 1.8 no signal
185 Hereditary Angioedema 4 1.8 1.8 no signal
186 Eczema 19 1.8 1.8 no signal
187 Product Dose Omission In Error 10 1.7 1.7 no signal
188 Device Issue 32 1.7 1.7 no signal
189 Product Packaging Quantity Issue 4 1.7 1.7 no signal
190 Hypertensive Crisis 4 1.7 1.7 no signal
191 Wrong Technique In Device Usage Process 16 1.6 1.6 no signal
192 Therapeutic Response Decreased 21 1.6 1.6 no signal
193 Anhedonia 9 1.6 1.6 no signal
194 Diabetic Ketoacidosis 8 1.6 1.6 no signal
195 Renal Injury 10 1.6 1.6 no signal
196 Spinal Operation 4 1.5 1.5 no signal
197 Blood Thyroid Stimulating Hormone Increased 3 1.5 1.5 no signal
198 Flushing 33 1.5 1.5 no signal
199 Libido Decreased 4 1.5 1.5 no signal
200 Drug Dispensing Error 5 1.5 1.5 no signal
201 No Adverse Event 57 1.5 1.5 no signal
202 Personality Change 3 1.5 1.5 no signal
203 Grand Mal Convulsion 3 1.5 1.5 no signal
204 Poisoning 4 1.5 1.5 no signal
205 Incorrect Dose Administered By Device 8 1.5 1.5 no signal
206 Drug Resistance 8 1.5 1.5 no signal
207 Complication Associated With Device 4 1.4 1.4 no signal
208 Hospitalisation 46 1.4 1.4 no signal
209 Activities Of Daily Living Impaired 6 1.4 1.4 no signal
210 Incorrect Product Administration Duration 6 1.4 1.4 no signal
211 Wrong Technique In Product Usage Process 58 1.3 1.3 no signal
212 Drug Administered At Inappropriate Site 3 1.3 1.3 no signal
213 Incorrect Drug Administration Duration 8 1.3 1.3 no signal
214 Emotional Distress 34 1.3 1.3 no signal
215 Extra Dose Administered 11 1.3 1.3 no signal
216 Therapy Interrupted 19 1.3 1.3 no signal
217 Product Administered At Inappropriate Site 5 1.3 1.3 no signal
218 Application Site Pain 6 1.3 1.3 no signal
219 Device Delivery System Issue 7 1.2 1.2 no signal
220 Drug Withdrawal Syndrome Neonatal 4 1.2 1.2 no signal
221 Pain Of Skin 7 1.2 1.2 no signal
222 Sickle Cell Anaemia With Crisis 4 1.2 1.2 no signal
223 Device Defective 4 1.2 1.2 no signal
224 Product Complaint 6 1.1 1.1 no signal
225 Drug Effective For Unapproved Indication 7 1.1 1.1 no signal
226 Injection Site Induration 3 1.1 1.1 no signal
227 Incorrect Dose Administered 50 1.0 1.0 no signal
228 Drug Effect Incomplete 8 1.0 1.0 no signal
229 Injection Site Mass 8 1.0 1.0 no signal
230 Glycosylated Haemoglobin Increased 5 0.9 0.9 no signal
231 Injection Site Swelling 15 0.9 0.9 no signal
232 Inappropriate Schedule Of Drug Administration 14 0.9 0.9 no signal
233 Product Preparation Error 4 0.9 0.9 no signal
234 Drug Administration Error 6 0.9 0.9 no signal
235 Device Difficult To Use 12 0.8 0.8 no signal
236 Injection Site Pain 55 0.8 0.8 no signal
237 Amenorrhoea 3 0.8 0.8 no signal
238 Complication Of Device Removal 3 0.8 0.8 no signal
239 Injection Site Reaction 12 0.8 0.8 no signal
240 Needle Issue 5 0.8 0.8 no signal
241 Drug Withdrawal Syndrome 15 0.8 0.8 no signal
242 Injection Site Urticaria 4 0.8 0.8 no signal
243 Complication Of Device Insertion 3 0.8 0.8 no signal
244 Accidental Exposure To Product 16 0.7 0.7 no signal
245 Drug Dose Omission 25 0.7 0.7 no signal
246 Device Malfunction 10 0.7 0.7 no signal
247 Exposure Via Skin Contact 3 0.6 0.6 no signal
248 Injection Site Pruritus 7 0.5 0.5 no signal
249 Device Dislocation 4 0.4 0.4 no signal
250 Drug Dependence 11 0.3 0.3 no signal
251 Device Expulsion 3 0.2 0.2 no signal