Dexmethylphenidate side effects: what 4,204 FDA adverse event reports show
Drug class
Central nervous system (cns) stimulant
Label matched
Dexmethylphenidate Hydrochloride (Dexmethylphenidate Hydrochloride)
Who reports
4,204 reports · 37% serious · 36 with death outcome · 42% female
Used for
Dexmethylphenidate hydrochloride extended-release is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) . Dexmethylphenidate hydrochloride extended-release is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
What it is
Dexmethylphenidate hydrochloride extended-release contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride.
Boxed warning
ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate hydrochloride extended-release has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 159 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Abnormal behaviour | 168 | 21.1 18.2–24.5ROR 21.9 · χ² 3,186 / p <1e-300 | 21.0 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 · ♀ 20% (drug 42%) | no trial data cached |
| Psychomotor hyperactivity | 62 | 18.6 14.5–23.8ROR 18.9 · χ² 1,012 / p 2e-222 | 18.4 EB05 14.9 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 · ♀ 12% (drug 42%) | no trial data cached |
| Disturbance in attention | 158 | 14.6 12.5–17.0ROR 15.1 · χ² 1,988 / p <1e-300 | 14.5 EB05 12.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Anger | 98 | 14.4 11.9–17.5ROR 14.7 · χ² 1,209 / p 3e-265 | 14.3 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · ♀ 22% (drug 42%) | no trial data cached |
| Aggression | 144 | 14.3 12.2–16.9ROR 14.8 · χ² 1,774 / p <1e-300 | 14.3 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Paranoia | 47 | 13.6 10.2–18.0ROR 13.7 · χ² 533 / p 3e-118 | 13.3 EB05 10.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · ♀ 63% (drug 42%) | no trial data cached |
| Mood swings | 66 | 10.3 8.1–13.1ROR 10.5 · χ² 547 / p 3e-121 | 10.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 | no trial data cached |
| Product physical issue | 40 | 10.0 7.4–13.6ROR 10.1 · χ² 316 / p 7e-71 | 9.5 EB05 7.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Brain injury | 20 | 9.9 6.4–15.4ROR 10.0 · χ² 152 / p 3e-35 | 8.9 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 100% (drug 42%) · 95% clinician | no trial data cached |
| Crying | 72 | 9.9 7.8–12.4ROR 10.0 · χ² 564 / p 6e-125 | 9.6 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Irritability | 118 | 9.8 8.2–11.7ROR 10.0 · χ² 922 / p 6e-203 | 9.6 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 | no trial data cached |
| Emotional disorder | 60 | 9.7 7.5–12.4ROR 9.8 · χ² 457 / p 1e-101 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 75% consumer | no trial data cached |
| Product substitution issue | 108 | 9.4 7.8–11.3ROR 9.6 · χ² 800 / p 3e-176 | 9.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Hypertensive crisis | 20 | 8.9 5.8–13.9ROR 9.0 · χ² 133 / p 4e-31 | 7.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.9 · ♀ 100% (drug 42%) · 95% clinician | no trial data cached |
| Product availability issue | 39 | 8.7 6.4–11.9ROR 8.8 · χ² 257 / p 3e-58 | 8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 79% consumer | no trial data cached |
| Gynaecomastia (male breast enlargement) | 53 | 8.5 6.5–11.0ROR 8.5 · χ² 341 / p 2e-76 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.7 · ♀ 0% (drug 42%) · 86% consumer | no trial data cached |
| Bipolar disorder | 18 | 8.2 5.2–13.0ROR 8.2 · χ² 107 / p 3e-25 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| Mydriasis | 18 | 7.0 4.4–11.1ROR 7.0 · χ² 87 / p 6e-21 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Initial insomnia | 14 | 6.9 4.1–11.6ROR 6.9 · χ² 64 / p 6e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Pharyngitis streptococcal | 14 | 6.5 3.8–10.9ROR 6.5 · χ² 59 / p 7e-15 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Mood altered | 35 | 6.4 4.6–8.9ROR 6.5 · χ² 155 / p 7e-36 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 77% consumer | no trial data cached |
| Amenorrhoea (missed periods) | 21 | 6.3 4.1–9.6ROR 6.3 · χ² 88 / p 3e-21 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · ♀ 100% (drug 42%) · 95% clinician | no trial data cached |
| Feeling jittery | 24 | 6.3 4.2–9.3ROR 6.3 · χ² 101 / p 4e-24 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 · ♀ 70% (drug 42%) | no trial data cached |
| Personality change | 11 | 5.9 3.3–10.6ROR 5.9 · χ² 40 / p 2e-10 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Muscle twitching | 27 | 5.8 4.0–8.5ROR 5.9 · χ² 103 / p 2e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · 73% consumer | no trial data cached |
| Drug dispensing error | 18 | 5.8 3.7–9.2ROR 5.8 · χ² 67 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 105 | 5.7 4.7–6.9ROR 5.8 · χ² 405 / p 2e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | no trial data cached |
| Insurance issue | 17 | 5.7 3.6–9.2ROR 5.7 · χ² 61 / p 2e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Drug prescribing error | 22 | 5.6 3.7–8.5ROR 5.7 · χ² 79 / p 3e-19 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=2 · 86% consumer | no trial data cached |
| Drug administered at inappropriate site | 12 | 5.6 3.2–9.9ROR 5.6 · χ² 41 / p 8e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Withdrawal syndrome | 47 | 5.6 4.2–7.4ROR 5.6 · χ² 171 / p 2e-39 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 · ♀ 73% (drug 42%) | no trial data cached |
| Hallucination, auditory | 17 | 5.3 3.3–8.6ROR 5.3 · χ² 56 / p 5e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Wrong technique in drug usage process | 39 | 5.3 3.9–7.2ROR 5.3 · χ² 131 / p 1e-30 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 83% consumer | no trial data cached |
| Affect lability | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Psychotic disorder | 30 | 5.1 3.5–7.2ROR 5.1 · χ² 94 / p 2e-22 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 28 | 4.9 3.4–7.1ROR 4.9 · χ² 83 / p 4e-20 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Treatment failure | 79 | 4.8 3.9–6.0ROR 4.9 · χ² 235 / p 3e-53 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 0.5 · 95% consumer | no trial data cached |
| Agitation | 69 | 4.7 3.7–5.9ROR 4.7 · χ² 196 / p 8e-45 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 17% (drug 42%) | no trial data cached |
| Prescribed overdose | 18 | 4.6 2.9–7.4ROR 4.7 · χ² 48 / p 2e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Depressed mood | 48 | 4.5 3.4–6.0ROR 4.6 · χ² 130 / p 3e-30 | 4.4 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 757 | 2.9 2.7–3.1ROR 3.3 · χ² 979 / p 3e-215 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Anxiety | 195 | 3.4 3.0–3.9ROR 3.5 · χ² 334 / p 7e-75 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Abnormal behaviour | 168 | 21.1 18.2–24.5ROR 21.9 · χ² 3,186 / p <1e-300 | 21.0 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 · ♀ 20% (drug 42%) | no trial data cached |
| Feeling abnormal | 166 | 3.4 3.0–4.0ROR 3.5 · χ² 288 / p 6e-65 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Decreased appetite (loss of appetite) | 158 | 3.4 2.9–4.0ROR 3.5 · χ² 268 / p 1e-60 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Disturbance in attention | 158 | 14.6 12.5–17.0ROR 15.1 · χ² 1,988 / p <1e-300 | 14.5 EB05 12.7 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Aggression | 144 | 14.3 12.2–16.9ROR 14.8 · χ² 1,774 / p <1e-300 | 14.3 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Insomnia (trouble sleeping) | 143 | 2.7 2.3–3.1ROR 2.7 · χ² 150 / p 9e-35 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Depression | 138 | 3.0 2.6–3.5ROR 3.1 · χ² 185 / p 2e-42 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Irritability | 118 | 9.8 8.2–11.7ROR 10.0 · χ² 922 / p 6e-203 | 9.6 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.6 | no trial data cached |
| Somnolence (drowsiness) | 116 | 2.9 2.4–3.4ROR 2.9 · χ² 141 / p 6e-33 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Product substitution issue | 108 | 9.4 7.8–11.3ROR 9.6 · χ² 800 / p 3e-176 | 9.2 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 14.0 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 105 | 5.7 4.7–6.9ROR 5.8 · χ² 405 / p 2e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | no trial data cached |
| Weight increased (weight gain) | 102 | 2.3 1.9–2.8ROR 2.3 · χ² 73 / p 7e-18 | 2.3 EB05 1.9 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Product quality issue | 102 | 3.8 3.1–4.6ROR 3.8 · χ² 206 / p 4e-47 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 73% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Abnormal behaviour — n=168, PRR 21.1
- Anger — n=98, PRR 14.4
- Aggression — n=144, PRR 14.3
- Paranoia — n=47, PRR 13.6
- Brain injury — n=20, PRR 9.9
- Crying — n=72, PRR 9.9
- Emotional disorder — n=60, PRR 9.7
- Mood altered — n=35, PRR 6.4
- Amenorrhoea — n=21, PRR 6.3
- Tardive dyskinesia — n=28, PRR 4.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Dexmethylphenidate?
In FDA FAERS, the most frequently co-reported reaction terms for Dexmethylphenidate are anxiety, abnormal behaviour, feeling abnormal, decreased appetite, disturbance in attention, aggression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Dexmethylphenidate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION Dexmethylphenidate hydrochloride extended-release has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and.
Do FAERS signals prove that Dexmethylphenidate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 06bcef7a-b321-4dd8-9bf6-5d8f8940f04a, effective 20240808; matched on
openfda.generic_name.exact:"DEXMETHYLPHENIDATE HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 199 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.