Drug
Guanfacine Hydrochloride
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 |