Drug
Gaunfacine
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 | 49 | 29.6 | 30.0 | signal |
| 2 | Aggression | 185 | 21.6 | 22.7 | signal |
| 3 | Psychomotor Hyperactivity | 61 | 21.4 | 21.7 | signal |
| 4 | Serotonin Syndrome | 52 | 15.9 | 16.1 | signal |
| 5 | Intentional Overdose | 148 | 13.6 | 14.1 | signal |
| 6 | Bradycardia | 121 | 13.3 | 13.7 | signal |
| 7 | Abnormal Behaviour | 88 | 12.9 | 13.2 | signal |
| 8 | Intentional Self-injury | 44 | 12.7 | 12.9 | signal |
| 9 | Dystonia | 41 | 12.3 | 12.4 | signal |
| 10 | Anger | 71 | 12.2 | 12.4 | signal |
| 11 | Sedation | 50 | 11.2 | 11.3 | signal |
| 12 | Neuroleptic Malignant Syndrome | 22 | 10.8 | 10.9 | signal |
| 13 | Electrocardiogram Qt Prolonged | 66 | 10.7 | 10.9 | signal |
| 14 | Respiratory Depression | 22 | 10.5 | 10.5 | signal |
| 15 | Affect Lability | 17 | 10.3 | 10.3 | signal |
| 16 | Product Substitution Issue | 99 | 10.0 | 10.3 | signal |
| 17 | Irritability | 98 | 9.5 | 9.7 | signal |
| 18 | Mania | 26 | 9.2 | 9.3 | signal |
| 19 | Agitation | 115 | 9.1 | 9.4 | signal |
| 20 | Device Mechanical Issue | 20 | 9.0 | 9.1 | signal |
| 21 | Therapy Change | 14 | 8.5 | 8.5 | signal |
| 22 | Orthostatic Hypotension | 25 | 8.4 | 8.4 | signal |
| 23 | Generalised Tonic-clonic Seizure | 20 | 7.1 | 7.2 | signal |
| 24 | Rebound Effect | 13 | 6.7 | 6.7 | signal |
| 25 | Hallucination, Auditory | 18 | 6.6 | 6.6 | signal |
| 26 | Emotional Disorder | 35 | 6.6 | 6.6 | signal |
| 27 | Toxicity To Various Agents | 179 | 6.2 | 6.5 | signal |
| 28 | Increased Appetite | 20 | 6.2 | 6.2 | signal |
| 29 | Posterior Reversible Encephalopathy Syndrome | 10 | 6.1 | 6.1 | signal |
| 30 | Mood Swings | 33 | 6.0 | 6.1 | signal |
| 31 | Lethargy | 59 | 6.0 | 6.1 | signal |
| 32 | Muscle Rigidity | 12 | 5.9 | 5.9 | signal |
| 33 | Salivary Hypersecretion | 10 | 5.8 | 5.8 | signal |
| 34 | Blindness Unilateral | 14 | 5.8 | 5.8 | signal |
| 35 | Sinus Tachycardia | 14 | 5.8 | 5.8 | signal |
| 36 | Impaired Quality Of Life | 14 | 5.7 | 5.7 | signal |
| 37 | Inability To Afford Medication | 9 | 5.3 | 5.3 | signal |
| 38 | Bipolar Disorder | 10 | 5.3 | 5.3 | signal |
| 39 | Drug Level Increased | 15 | 5.3 | 5.3 | signal |
| 40 | Product Physical Issue | 18 | 5.3 | 5.3 | signal |
| 41 | Coma | 43 | 5.3 | 5.3 | signal |
| 42 | Somnolence | 180 | 5.2 | 5.4 | signal |
| 43 | Treatment Failure | 73 | 5.2 | 5.3 | signal |
| 44 | Suicidal Ideation | 80 | 5.1 | 5.2 | signal |
| 45 | Suicide Attempt | 53 | 5.1 | 5.1 | signal |
| 46 | Mydriasis | 11 | 5.0 | 5.0 | signal |
| 47 | Dysarthria | 32 | 5.0 | 5.0 | signal |
| 48 | Gynaecomastia | 26 | 4.8 | 4.9 | signal |
| 49 | Akathisia | 11 | 4.7 | 4.7 | signal |
| 50 | Drug Interaction | 127 | 4.7 | 4.8 | signal |
| 51 | Status Epilepticus | 9 | 4.6 | 4.6 | signal |
| 52 | Hypotension | 158 | 4.6 | 4.8 | signal |
| 53 | Depressed Level Of Consciousness | 31 | 4.6 | 4.6 | signal |
| 54 | Completed Suicide | 64 | 4.4 | 4.5 | signal |
| 55 | Disturbance In Attention | 41 | 4.4 | 4.5 | signal |
| 56 | Withdrawal Syndrome | 32 | 4.4 | 4.4 | signal |
| 57 | Obesity | 12 | 4.4 | 4.4 | signal |
| 58 | Paranoia | 13 | 4.4 | 4.4 | signal |
| 59 | Presyncope | 18 | 4.3 | 4.4 | signal |
| 60 | Restlessness | 27 | 4.3 | 4.3 | signal |
| 61 | Mood Altered | 20 | 4.3 | 4.3 | signal |
| 62 | Therapy Partial Responder | 11 | 4.3 | 4.3 | signal |
| 63 | Parkinsonism | 7 | 4.2 | 4.2 | signal |
| 64 | Seizure | 79 | 4.0 | 4.1 | signal |
| 65 | Apathy | 10 | 4.0 | 4.0 | signal |
| 66 | Brain Fog | 10 | 4.0 | 4.0 | signal |
| 67 | Tachycardia | 60 | 3.9 | 4.0 | signal |
| 68 | Product Availability Issue | 15 | 3.9 | 3.9 | signal |
| 69 | Drug Ineffective For Unapproved Indication | 37 | 3.9 | 3.9 | signal |
| 70 | End Stage Renal Disease | 12 | 3.8 | 3.8 | signal |
| 71 | Thinking Abnormal | 12 | 3.7 | 3.7 | signal |
| 72 | Device Breakage | 25 | 3.7 | 3.7 | signal |
| 73 | Brain Oedema | 8 | 3.7 | 3.7 | signal |
| 74 | Impaired Gastric Emptying | 8 | 3.7 | 3.7 | signal |
| 75 | Dizziness Postural | 6 | 3.6 | 3.6 | signal |
| 76 | Intentional Dose Omission | 17 | 3.6 | 3.6 | signal |
| 77 | Blood Triglycerides Increased | 11 | 3.6 | 3.6 | signal |
| 78 | Prescribed Overdose | 12 | 3.6 | 3.6 | signal |
| 79 | Insurance Issue | 9 | 3.5 | 3.5 | signal |
| 80 | Product Taste Abnormal | 8 | 3.5 | 3.5 | signal |
| 81 | Hypersomnia | 17 | 3.5 | 3.5 | signal |
| 82 | Hypothermia | 6 | 3.4 | 3.5 | signal |
| 83 | Euphoric Mood | 6 | 3.4 | 3.4 | signal |
| 84 | Delusion | 9 | 3.4 | 3.4 | signal |
| 85 | Pulmonary Oedema | 26 | 3.4 | 3.4 | signal |
| 86 | Application Site Irritation | 7 | 3.3 | 3.3 | signal |
| 87 | Abnormal Weight Gain | 7 | 3.3 | 3.3 | signal |
| 88 | Gastroenteritis Viral | 10 | 3.2 | 3.2 | signal |
| 89 | Product Dispensing Error | 12 | 3.2 | 3.2 | signal |
| 90 | Crying | 20 | 3.2 | 3.2 | signal |
| 91 | Hallucination | 41 | 3.2 | 3.2 | signal |
| 92 | Dyskinesia | 22 | 3.2 | 3.2 | signal |
| 93 | Therapy Non-responder | 24 | 3.1 | 3.2 | signal |
| 94 | Product Adhesion Issue | 19 | 3.1 | 3.1 | signal |
| 95 | Encephalopathy | 13 | 3.1 | 3.1 | signal |
| 96 | Dermatitis Contact | 6 | 3.1 | 3.1 | signal |
| 97 | Hallucination, Visual | 11 | 3.1 | 3.1 | signal |
| 98 | Accidental Overdose | 19 | 3.0 | 3.0 | signal |
| 99 | Retching | 11 | 3.0 | 3.0 | signal |
| 100 | Product Use Complaint | 8 | 3.0 | 3.0 | signal |
| 101 | Sexual Dysfunction | 6 | 3.0 | 3.0 | signal |
| 102 | Urinary Retention | 17 | 3.0 | 3.0 | signal |
| 103 | Drug Dose Omission By Device | 39 | 3.0 | 3.0 | signal |
| 104 | Psychotic Disorder | 15 | 3.0 | 3.0 | signal |
| 105 | Product Administration Error | 10 | 2.9 | 2.9 | signal |
| 106 | Anxiety | 142 | 2.9 | 3.0 | signal |
| 107 | Device Leakage | 21 | 2.9 | 2.9 | signal |
| 108 | Glomerular Filtration Rate Decreased | 6 | 2.9 | 2.9 | signal |
| 109 | Sleep Disorder Due To A General Medical Condition | 8 | 2.9 | 2.9 | signal |
| 110 | Cognitive Disorder | 23 | 2.9 | 2.9 | signal |
| 111 | Sluggishness | 5 | 2.9 | 2.9 | signal |
| 112 | Cardiogenic Shock | 7 | 2.9 | 2.9 | signal |
| 113 | Initial Insomnia | 5 | 2.9 | 2.9 | signal |
| 114 | Nightmare | 17 | 2.9 | 2.9 | signal |
| 115 | Insomnia | 130 | 2.8 | 2.9 | signal |
| 116 | Paralysis | 7 | 2.8 | 2.8 | signal |
| 117 | Middle Insomnia | 9 | 2.8 | 2.8 | signal |
| 118 | Drug Prescribing Error | 9 | 2.7 | 2.7 | signal |
| 119 | Application Site Erythema | 12 | 2.7 | 2.7 | signal |
| 120 | Depressed Mood | 24 | 2.7 | 2.7 | signal |
| 121 | Mental Impairment | 11 | 2.6 | 2.6 | signal |
| 122 | Thirst | 8 | 2.6 | 2.6 | signal |
| 123 | Treatment Noncompliance | 24 | 2.6 | 2.6 | signal |
| 124 | Application Site Pruritus | 10 | 2.6 | 2.6 | signal |
| 125 | Product Quality Issue | 59 | 2.6 | 2.6 | signal |
| 126 | Lactic Acidosis | 14 | 2.5 | 2.5 | signal |
| 127 | Mental Disorder | 19 | 2.5 | 2.5 | signal |
| 128 | Sensory Disturbance | 7 | 2.5 | 2.5 | signal |
| 129 | Poisoning Deliberate | 4 | 2.5 | 2.5 | no signal |
| 130 | Drug Effect Less Than Expected | 6 | 2.5 | 2.5 | no signal |
| 131 | Feeling Jittery | 8 | 2.4 | 2.4 | signal |
| 132 | Altered State Of Consciousness | 9 | 2.4 | 2.4 | signal |
| 133 | Pallor | 11 | 2.3 | 2.4 | signal |
| 134 | Neurotoxicity | 7 | 2.3 | 2.4 | signal |
| 135 | Brain Injury | 4 | 2.3 | 2.3 | no signal |
| 136 | Product Dose Omission | 26 | 2.3 | 2.3 | signal |
| 137 | Therapy Cessation | 20 | 2.3 | 2.3 | signal |
| 138 | Poor Venous Access | 4 | 2.3 | 2.3 | no signal |
| 139 | Nervous System Disorder | 12 | 2.2 | 2.2 | signal |
| 140 | Overdose | 83 | 2.2 | 2.3 | signal |
| 141 | Device Use Error | 13 | 2.2 | 2.2 | signal |
| 142 | Hunger | 5 | 2.2 | 2.2 | no signal |
| 143 | Hypertensive Crisis | 4 | 2.1 | 2.1 | no signal |
| 144 | Wrong Technique In Drug Usage Process | 13 | 2.1 | 2.1 | signal |
| 145 | Product Prescribing Issue | 7 | 2.0 | 2.0 | no signal |
| 146 | Spinal Operation | 4 | 1.9 | 1.9 | no signal |
| 147 | Device Adhesion Issue | 5 | 1.9 | 1.9 | no signal |
| 148 | Blood Thyroid Stimulating Hormone Increased | 3 | 1.9 | 1.9 | no signal |
| 149 | Libido Decreased | 4 | 1.9 | 1.9 | no signal |
| 150 | Tardive Dyskinesia | 9 | 1.8 | 1.8 | no signal |
| 151 | Therapeutic Product Effect Decreased | 14 | 1.8 | 1.8 | no signal |
| 152 | Therapeutic Response Shortened | 10 | 1.8 | 1.8 | no signal |
| 153 | Drug Effect Decreased | 17 | 1.8 | 1.8 | no signal |
| 154 | Device Issue | 27 | 1.8 | 1.8 | no signal |
| 155 | Wrong Technique In Device Usage Process | 14 | 1.8 | 1.8 | no signal |
| 156 | Dermatitis Atopic | 15 | 1.7 | 1.8 | no signal |
| 157 | Incorrect Product Administration Duration | 6 | 1.7 | 1.7 | no signal |
| 158 | Application Site Rash | 4 | 1.7 | 1.7 | no signal |
| 159 | Hereditary Angioedema | 3 | 1.7 | 1.7 | no signal |
| 160 | Extrapyramidal Disorder | 7 | 1.6 | 1.6 | no signal |
| 161 | Incorrect Dose Administered By Device | 7 | 1.6 | 1.6 | no signal |
| 162 | Product Administered At Inappropriate Site | 5 | 1.6 | 1.6 | no signal |
| 163 | Product Packaging Quantity Issue | 3 | 1.6 | 1.6 | no signal |
| 164 | Device Delivery System Issue | 7 | 1.6 | 1.6 | no signal |
| 165 | Drug Withdrawal Syndrome Neonatal | 4 | 1.6 | 1.6 | no signal |
| 166 | Emotional Distress | 32 | 1.5 | 1.5 | no signal |
| 167 | No Adverse Event | 46 | 1.5 | 1.5 | no signal |
| 168 | Sickle Cell Anaemia With Crisis | 4 | 1.5 | 1.5 | no signal |
| 169 | Wrong Technique In Product Usage Process | 50 | 1.4 | 1.4 | no signal |
| 170 | Device Defective | 4 | 1.4 | 1.4 | no signal |
| 171 | Product Complaint | 6 | 1.4 | 1.4 | no signal |
| 172 | Application Site Pain | 5 | 1.3 | 1.3 | no signal |
| 173 | Pain Of Skin | 6 | 1.3 | 1.3 | no signal |
| 174 | Drug Effect Incomplete | 8 | 1.3 | 1.3 | no signal |
| 175 | Drug Effective For Unapproved Indication | 6 | 1.2 | 1.2 | no signal |
| 176 | Extra Dose Administered | 8 | 1.2 | 1.2 | no signal |
| 177 | Glycosylated Haemoglobin Increased | 5 | 1.2 | 1.2 | no signal |
| 178 | Drug Dispensing Error | 3 | 1.1 | 1.1 | no signal |
| 179 | Incorrect Drug Administration Duration | 5 | 1.0 | 1.0 | no signal |
| 180 | Drug Withdrawal Syndrome | 15 | 1.0 | 1.0 | no signal |
| 181 | Device Difficult To Use | 11 | 1.0 | 1.0 | no signal |
| 182 | Injection Site Reaction | 10 | 0.8 | 0.8 | no signal |
| 183 | Product Preparation Error | 3 | 0.8 | 0.8 | no signal |
| 184 | Accidental Exposure To Product | 14 | 0.8 | 0.8 | no signal |
| 185 | Needle Issue | 4 | 0.8 | 0.8 | no signal |
| 186 | Injection Site Mass | 5 | 0.8 | 0.8 | no signal |
| 187 | Exposure Via Skin Contact | 3 | 0.8 | 0.8 | no signal |
| 188 | Injection Site Urticaria | 3 | 0.7 | 0.7 | no signal |
| 189 | Device Malfunction | 8 | 0.7 | 0.7 | no signal |
| 190 | Injection Site Pruritus | 7 | 0.6 | 0.6 | no signal |
| 191 | Drug Dependence | 9 | 0.3 | 0.3 | no signal |