Drug
Dexmethylphenidate 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 | Abnormal Behaviour | 168 | 21.1 | 21.9 | signal |
| 2 | Psychomotor Hyperactivity | 62 | 18.6 | 18.9 | signal |
| 3 | Disturbance In Attention | 158 | 14.6 | 15.1 | signal |
| 4 | Anger | 98 | 14.4 | 14.7 | signal |
| 5 | Aggression | 144 | 14.3 | 14.8 | signal |
| 6 | Paranoia | 47 | 13.6 | 13.7 | signal |
| 7 | Mood Swings | 66 | 10.3 | 10.5 | signal |
| 8 | Product Physical Issue | 40 | 10.0 | 10.1 | signal |
| 9 | Brain Injury | 20 | 9.9 | 10.0 | signal |
| 10 | Crying | 72 | 9.9 | 10.0 | signal |
| 11 | Irritability | 118 | 9.8 | 10.0 | signal |
| 12 | Emotional Disorder | 60 | 9.7 | 9.8 | signal |
| 13 | Product Substitution Issue | 108 | 9.4 | 9.6 | signal |
| 14 | Hypertensive Crisis | 20 | 8.9 | 9.0 | signal |
| 15 | Product Availability Issue | 39 | 8.7 | 8.8 | signal |
| 16 | Gynaecomastia | 53 | 8.5 | 8.5 | signal |
| 17 | Bipolar Disorder | 18 | 8.2 | 8.2 | signal |
| 18 | Mydriasis | 18 | 7.0 | 7.0 | signal |
| 19 | Initial Insomnia | 14 | 6.9 | 6.9 | signal |
| 20 | Pharyngitis Streptococcal | 14 | 6.5 | 6.5 | signal |
| 21 | Mood Altered | 35 | 6.4 | 6.5 | signal |
| 22 | Amenorrhoea | 21 | 6.3 | 6.3 | signal |
| 23 | Feeling Jittery | 24 | 6.3 | 6.3 | signal |
| 24 | Personality Change | 11 | 5.9 | 5.9 | signal |
| 25 | Muscle Twitching | 27 | 5.8 | 5.9 | signal |
| 26 | Drug Dispensing Error | 18 | 5.8 | 5.8 | signal |
| 27 | Suicidal Ideation | 105 | 5.7 | 5.8 | signal |
| 28 | Insurance Issue | 17 | 5.7 | 5.7 | signal |
| 29 | Drug Prescribing Error | 22 | 5.6 | 5.7 | signal |
| 30 | Drug Administered At Inappropriate Site | 12 | 5.6 | 5.6 | signal |
| 31 | Withdrawal Syndrome | 47 | 5.6 | 5.6 | signal |
| 32 | Hallucination, Auditory | 17 | 5.3 | 5.3 | signal |
| 33 | Wrong Technique In Drug Usage Process | 39 | 5.3 | 5.3 | signal |
| 34 | Affect Lability | 10 | 5.2 | 5.2 | signal |
| 35 | Psychotic Disorder | 30 | 5.1 | 5.1 | signal |
| 36 | Tardive Dyskinesia | 28 | 4.9 | 4.9 | signal |
| 37 | Treatment Failure | 79 | 4.8 | 4.9 | signal |
| 38 | Agitation | 69 | 4.7 | 4.7 | signal |
| 39 | Prescribed Overdose | 18 | 4.6 | 4.7 | signal |
| 40 | Depressed Mood | 48 | 4.5 | 4.6 | signal |
| 41 | Hypophagia | 23 | 4.5 | 4.5 | signal |
| 42 | Application Site Irritation | 11 | 4.4 | 4.4 | signal |
| 43 | Drug Effect Less Than Expected | 12 | 4.2 | 4.3 | signal |
| 44 | Retching | 18 | 4.2 | 4.2 | signal |
| 45 | Product Use Complaint | 13 | 4.2 | 4.2 | signal |
| 46 | Sleep Apnoea Syndrome | 16 | 4.2 | 4.2 | signal |
| 47 | Liver Injury | 20 | 4.1 | 4.1 | signal |
| 48 | Product Packaging Quantity Issue | 9 | 4.1 | 4.1 | signal |
| 49 | Coeliac Disease | 8 | 4.1 | 4.1 | signal |
| 50 | Fear | 22 | 4.0 | 4.1 | signal |
| 51 | Hallucination, Visual | 17 | 4.0 | 4.1 | signal |
| 52 | Middle Insomnia | 15 | 4.0 | 4.0 | signal |
| 53 | Abnormal Weight Gain | 10 | 4.0 | 4.0 | signal |
| 54 | Eating Disorder | 17 | 4.0 | 4.0 | signal |
| 55 | Micturition Urgency | 9 | 4.0 | 4.0 | signal |
| 56 | Convulsion | 46 | 4.0 | 4.0 | signal |
| 57 | Product Quality Issue | 102 | 3.8 | 3.8 | signal |
| 58 | Obesity | 12 | 3.8 | 3.8 | signal |
| 59 | Grand Mal Convulsion | 7 | 3.7 | 3.7 | signal |
| 60 | Hallucination | 56 | 3.7 | 3.8 | signal |
| 61 | Supraventricular Tachycardia | 7 | 3.7 | 3.7 | signal |
| 62 | Mania | 12 | 3.6 | 3.6 | signal |
| 63 | Application Site Erythema | 19 | 3.6 | 3.6 | signal |
| 64 | Inability To Afford Medication | 7 | 3.5 | 3.6 | signal |
| 65 | Application Site Pruritus | 16 | 3.5 | 3.5 | signal |
| 66 | Thinking Abnormal | 13 | 3.5 | 3.5 | signal |
| 67 | Feeling Abnormal | 166 | 3.4 | 3.5 | signal |
| 68 | Drug Level Decreased | 7 | 3.4 | 3.4 | signal |
| 69 | Anxiety | 195 | 3.4 | 3.5 | signal |
| 70 | Decreased Appetite | 158 | 3.4 | 3.5 | signal |
| 71 | Restlessness | 25 | 3.4 | 3.4 | signal |
| 72 | Euphoric Mood | 7 | 3.4 | 3.4 | signal |
| 73 | Ear Infection | 18 | 3.4 | 3.4 | signal |
| 74 | Hunger | 9 | 3.3 | 3.3 | signal |
| 75 | Dystonia | 13 | 3.3 | 3.3 | signal |
| 76 | Gastroenteritis Viral | 12 | 3.3 | 3.3 | signal |
| 77 | Peripheral Coldness | 9 | 3.3 | 3.3 | signal |
| 78 | Sedation | 17 | 3.3 | 3.3 | signal |
| 79 | Lethargy | 37 | 3.2 | 3.2 | signal |
| 80 | Drug Effect Decreased | 35 | 3.2 | 3.2 | signal |
| 81 | Increased Appetite | 12 | 3.2 | 3.2 | signal |
| 82 | Cyanosis | 10 | 3.2 | 3.2 | signal |
| 83 | Cold Sweat | 11 | 3.1 | 3.1 | signal |
| 84 | Therapy Change | 6 | 3.1 | 3.1 | signal |
| 85 | Device Mechanical Issue | 8 | 3.1 | 3.1 | signal |
| 86 | Rebound Effect | 7 | 3.1 | 3.1 | signal |
| 87 | Brain Fog | 9 | 3.1 | 3.1 | signal |
| 88 | Depression | 138 | 3.0 | 3.1 | signal |
| 89 | Therapeutic Response Unexpected | 27 | 3.0 | 3.0 | signal |
| 90 | Therapeutic Response Shortened | 19 | 3.0 | 3.0 | signal |
| 91 | Intentional Self-injury | 12 | 3.0 | 3.0 | signal |
| 92 | Dyskinesia | 24 | 3.0 | 3.0 | signal |
| 93 | Nervousness | 31 | 2.9 | 3.0 | signal |
| 94 | Heart Rate Increased | 58 | 2.9 | 2.9 | signal |
| 95 | Intentional Dose Omission | 16 | 2.9 | 2.9 | signal |
| 96 | Somnolence | 116 | 2.9 | 2.9 | signal |
| 97 | Drug Ineffective | 757 | 2.9 | 3.3 | signal |
| 98 | Palpitations | 67 | 2.9 | 2.9 | signal |
| 99 | Thirst | 10 | 2.8 | 2.8 | signal |
| 100 | Medication Error | 31 | 2.8 | 2.8 | signal |
| 101 | Impaired Quality Of Life | 8 | 2.8 | 2.8 | signal |
| 102 | Skin Laceration | 6 | 2.8 | 2.8 | signal |
| 103 | Apathy | 8 | 2.7 | 2.7 | signal |
| 104 | Panic Attack | 20 | 2.7 | 2.7 | signal |
| 105 | Nightmare | 19 | 2.7 | 2.7 | signal |
| 106 | Drug Administration Error | 17 | 2.7 | 2.7 | signal |
| 107 | Insomnia | 143 | 2.7 | 2.7 | signal |
| 108 | Product Taste Abnormal | 7 | 2.6 | 2.6 | signal |
| 109 | Therapeutic Product Effect Decreased | 23 | 2.6 | 2.6 | signal |
| 110 | Device Breakage | 20 | 2.5 | 2.5 | signal |
| 111 | Illness | 51 | 2.5 | 2.5 | signal |
| 112 | Hyperhidrosis | 65 | 2.5 | 2.5 | signal |
| 113 | Neck Pain | 28 | 2.5 | 2.5 | signal |
| 114 | Incorrect Drug Administration Duration | 14 | 2.4 | 2.5 | signal |
| 115 | Unevaluable Event | 37 | 2.4 | 2.5 | signal |
| 116 | Poor Venous Access | 5 | 2.4 | 2.4 | no signal |
| 117 | Swelling Face | 31 | 2.4 | 2.4 | signal |
| 118 | Feeling Hot | 29 | 2.4 | 2.4 | signal |
| 119 | Serotonin Syndrome | 9 | 2.3 | 2.3 | signal |
| 120 | Mental Disorder | 20 | 2.3 | 2.3 | signal |
| 121 | Weight Increased | 102 | 2.3 | 2.3 | signal |
| 122 | Mental Impairment | 11 | 2.3 | 2.3 | signal |
| 123 | Akathisia | 6 | 2.2 | 2.2 | no signal |
| 124 | Adverse Drug Reaction | 39 | 2.2 | 2.2 | signal |
| 125 | Nerve Compression | 4 | 2.2 | 2.2 | no signal |
| 126 | Movement Disorder | 14 | 2.2 | 2.2 | signal |
| 127 | Sleep Disorder Due To A General Medical Condition | 7 | 2.2 | 2.2 | no signal |
| 128 | Wrong Technique In Product Usage Process | 87 | 2.1 | 2.2 | signal |
| 129 | Coordination Abnormal | 6 | 2.1 | 2.1 | no signal |
| 130 | Product Prescribing Error | 10 | 2.1 | 2.1 | signal |
| 131 | Muscle Rigidity | 5 | 2.1 | 2.1 | no signal |
| 132 | Autoimmune Disorder | 4 | 2.1 | 2.1 | no signal |
| 133 | Intentional Product Misuse | 36 | 2.1 | 2.1 | signal |
| 134 | Product Dispensing Error | 9 | 2.1 | 2.1 | no signal |
| 135 | Loss Of Consciousness | 53 | 2.1 | 2.1 | signal |
| 136 | No Therapeutic Response | 5 | 2.0 | 2.0 | no signal |
| 137 | Body Temperature Decreased | 4 | 2.0 | 2.0 | no signal |
| 138 | Migraine | 38 | 2.0 | 2.0 | no signal |
| 139 | Drug Dose Omission By Device | 30 | 2.0 | 2.0 | no signal |
| 140 | No Adverse Event | 69 | 1.9 | 2.0 | no signal |
| 141 | Delusion | 6 | 1.9 | 1.9 | no signal |
| 142 | Anorexia | 5 | 1.9 | 1.9 | no signal |
| 143 | Dysmenorrhoea | 5 | 1.9 | 1.9 | no signal |
| 144 | Product Dose Omission Issue | 101 | 1.8 | 1.8 | no signal |
| 145 | Emotional Distress | 43 | 1.8 | 1.8 | no signal |
| 146 | Cholecystectomy | 4 | 1.8 | 1.8 | no signal |
| 147 | Product Dose Omission | 23 | 1.7 | 1.7 | no signal |
| 148 | Sexual Dysfunction | 4 | 1.7 | 1.7 | no signal |
| 149 | Schizophrenia | 4 | 1.6 | 1.6 | no signal |
| 150 | Product Complaint | 8 | 1.6 | 1.6 | no signal |
| 151 | Suicide Attempt | 19 | 1.6 | 1.6 | no signal |
| 152 | Knee Operation | 3 | 1.5 | 1.5 | no signal |
| 153 | Product Dose Omission In Error | 8 | 1.5 | 1.5 | no signal |
| 154 | Therapy Cessation | 15 | 1.5 | 1.5 | no signal |
| 155 | Product Odour Abnormal | 3 | 1.4 | 1.4 | no signal |
| 156 | Syringe Issue | 5 | 1.4 | 1.4 | no signal |
| 157 | Product Adhesion Issue | 10 | 1.4 | 1.4 | no signal |
| 158 | Extrapyramidal Disorder | 7 | 1.4 | 1.4 | no signal |
| 159 | Eczema | 14 | 1.4 | 1.4 | no signal |
| 160 | Extra Dose Administered | 11 | 1.4 | 1.4 | no signal |
| 161 | Application Site Pain | 6 | 1.4 | 1.4 | no signal |
| 162 | Abnormal Dreams | 7 | 1.3 | 1.3 | no signal |
| 163 | Menorrhagia | 5 | 1.3 | 1.3 | no signal |
| 164 | Drug Dose Omission | 41 | 1.2 | 1.2 | no signal |
| 165 | Muscle Spasticity | 3 | 1.2 | 1.2 | no signal |
| 166 | Intentional Drug Misuse | 5 | 1.2 | 1.2 | no signal |
| 167 | Complication Associated With Device | 3 | 1.1 | 1.1 | no signal |
| 168 | Injection Site Urticaria | 5 | 1.0 | 1.0 | no signal |
| 169 | Dermatitis Atopic | 10 | 1.0 | 1.0 | no signal |
| 170 | Incorrect Route Of Drug Administration | 7 | 1.0 | 1.0 | no signal |
| 171 | Incorrect Dose Administered | 43 | 1.0 | 1.0 | no signal |
| 172 | Drug Effect Incomplete | 7 | 0.9 | 0.9 | no signal |
| 173 | Pharmaceutical Product Complaint | 5 | 0.9 | 0.9 | no signal |
| 174 | Device Leakage | 8 | 0.9 | 0.9 | no signal |
| 175 | Menstruation Irregular | 5 | 0.9 | 0.9 | no signal |
| 176 | Acne | 14 | 0.9 | 0.9 | no signal |
| 177 | Device Issue | 16 | 0.9 | 0.9 | no signal |
| 178 | Drug Withdrawal Syndrome | 16 | 0.9 | 0.9 | no signal |
| 179 | Inappropriate Schedule Of Drug Administration | 13 | 0.9 | 0.9 | no signal |
| 180 | Exposure Via Skin Contact | 4 | 0.9 | 0.9 | no signal |
| 181 | Complication Of Device Removal | 3 | 0.9 | 0.9 | no signal |
| 182 | Wrong Technique In Device Usage Process | 8 | 0.9 | 0.9 | no signal |
| 183 | Needle Issue | 5 | 0.9 | 0.9 | no signal |
| 184 | Product Administered At Inappropriate Site | 3 | 0.8 | 0.8 | no signal |
| 185 | Injection Site Bruising | 13 | 0.8 | 0.8 | no signal |
| 186 | Device Use Error | 5 | 0.7 | 0.7 | no signal |
| 187 | Product Preparation Error | 3 | 0.7 | 0.7 | no signal |
| 188 | Intentional Overdose | 9 | 0.7 | 0.7 | no signal |
| 189 | Skin Burning Sensation | 10 | 0.7 | 0.7 | no signal |
| 190 | Device Malfunction | 9 | 0.7 | 0.7 | no signal |
| 191 | Injection Site Haemorrhage | 10 | 0.6 | 0.6 | no signal |
| 192 | Abortion Spontaneous | 5 | 0.6 | 0.6 | no signal |
| 193 | Injection Site Pain | 37 | 0.6 | 0.6 | no signal |
| 194 | Accidental Exposure To Product | 12 | 0.6 | 0.6 | no signal |
| 195 | Multiple Sclerosis Relapse | 8 | 0.6 | 0.6 | no signal |
| 196 | Device Dislocation | 5 | 0.6 | 0.6 | no signal |
| 197 | Injection Site Mass | 4 | 0.5 | 0.5 | no signal |
| 198 | Drug Dependence | 15 | 0.5 | 0.5 | no signal |
| 199 | Device Expulsion | 3 | 0.2 | 0.2 | no signal |