Drug · FAERS side-effect profile with label screen
Methylphenidate Hydrochloride side effects: what 58,431 FDA adverse event reports show
Drug class
Central Nervous System Stimulant
FDA label (Established Pharmacologic Class) · compare the class
Who reports
58,431 reports · 61% serious · 2,604 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Methylphenidate transdermal system is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Us e The use of methylphenidate transdermal system is not recommended in ped.
FDA label, Indications and Usage
What it is
Methylphenidate transdermal system is an adhesive-based matrix transdermal system containing methylphenidate that is applied to intact skin.
FDA label, Description section
Boxed warning
ABUSE, MISUSE, AND ADDICTION Methylphenidate transdermal system has a high potential for abuse and misuse, which can lead to the development of substance use disorder, including addiction. Misuse and abuse of CNS sti.
FDA label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled — boxed warning 1Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 4Not in label — unassessed 30
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,175 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Respiratory tract malformation | 37 | 140.9 96.2–206.3ROR 141.0 · calibrated p 2e-8 ✓ | 95.9 EB05 72.7 · IC025 +4.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 37.7 (22.6–63.0) | Not in label — unassessed | serious n=37 · ♀ 100% (drug 51%) · 100% clinician | not reported in cached trials |
| Pulmonary malformation | 67 | 82.9 63.5–108.2ROR 83.0 · calibrated p 7e-7 ✓ | 66.0 EB05 53.8 · IC025 +5.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 28.8 (20.2–40.9) | Not in label — unassessed | serious n=67 · ♀ 100% (drug 51%) · 100% clinician | not reported in cached trials |
| Oppositional defiant disorder | 55 | 56.8 42.7–75.6ROR 56.9 · calibrated p 9e-6 ✓ | 48.3 EB05 38.5 · IC025 +4.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 32.0 (21.4–47.9) | Not in label — unassessed | serious n=47 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Cataplexy | 177 | 50.3 43.0–58.8ROR 50.4 · calibrated p 1e-5 ✓ | 43.9 EB05 38.7 · IC025 +5.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.6 (14.5–21.3) | Not in label — unassessed | serious n=146 · ♀ 74% (drug 51%) | not reported in cached trials |
| Decreased eye contact | 35 | 46.4 32.6–66.1ROR 46.5 · calibrated p 4e-5 ✓ | 40.3 EB05 30.3 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 25.9 (16.1–41.7) | Labeled (related wording) related wording | serious n=34 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Choreoathetosis | 78 | 45.6 36.0–57.7ROR 45.7 · calibrated p 3e-5 ✓ | 40.1 EB05 33.2 · IC025 +4.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 39.8 (27.8–56.9) | Not in label — unassessed | serious n=78 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Educational problem | 187 | 44.6 38.3–51.9ROR 44.7 · calibrated p 3e-5 ✓ | 39.5 EB05 35.0 · IC025 +4.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 21.3 (17.5–25.9) | Not in label — unassessed | serious n=74 · ♀ 31% (drug 51%) | not reported in cached trials |
| Lung cyst | 41 | 41.4 29.9–57.2ROR 41.4 · calibrated p 6e-5 ✓ | 36.5 EB05 28.1 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 34.6 (21.5–55.6) | Not in label — unassessed | serious n=41 · ♀ 100% (drug 51%) · 100% clinician | not reported in cached trials |
| Trichotillomania | 57 | 38.0 28.9–50.0ROR 38.1 · calibrated p 9e-5 ✓ | 34.0 EB05 27.3 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 53.6 (33.7–85.3) | Not in label — unassessed | serious n=37 | not reported in cached trials |
| Product ineffective | 66 | 37.5 29.1–48.3ROR 37.5 · calibrated p 1e-4 ✓ | 33.6 EB05 27.4 · IC025 +4.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 19.5 (14.1–26.9) | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Precocious puberty | 52 | 35.6 26.8–47.4ROR 35.7 · calibrated p 1e-4 ✓ | 32.1 EB05 25.4 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 53.0 (32.7–86.0) | Not in label — unassessed | serious n=45 · 100% clinician | not reported in cached trials |
| Tic | 492 | 35.2 32.1–38.6ROR 35.5 · calibrated p 1e-4 ✓ | 32.0 EB05 29.7 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 39.6 (34.3–45.7) | Labeled — boxed warning exact term | serious n=295 · ♀ 21% (drug 51%) | not reported in cached trials |
| Attention deficit/hyperactivity disorder | 278 | 33.0 29.2–37.3ROR 33.1 · calibrated p 2e-4 ✓ | 30.2 EB05 27.3 · IC025 +4.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 35.4 (29.5–42.6) | Likely indication confounding term in indications | serious n=203 | not reported in cached trials |
| Self-destructive behaviour | 61 | 31.5 24.3–40.9ROR 31.5 · calibrated p 3e-4 ✓ | 28.8 EB05 23.2 · IC025 +4.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 71.1 (43.3–116.7) | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Growth retardation | 232 | 30.2 26.4–34.5ROR 30.3 · calibrated p 3e-4 ✓ | 27.8 EB05 25.0 · IC025 +4.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 177.4 (122.6–256.6) | Not in label — unassessed | serious n=225 · ♀ 20% (drug 51%) | not reported in cached trials |
| Parasomnia | 51 | 27.9 21.0–37.1ROR 27.9 · calibrated p 5e-4 ✓ | 25.7 EB05 20.3 · IC025 +3.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 22.3 (15.3–32.6) | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Social anxiety disorder | 46 | 26.7 19.8–36.0ROR 26.7 · calibrated p 6e-4 ✓ | 24.6 EB05 19.2 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: only this drug | Not in label — unassessed | serious n=38 | not reported in cached trials |
| Pre-existing condition improved | 438 | 26.5 24.1–29.2ROR 26.7 · calibrated p 5e-4 ✓ | 24.7 EB05 22.8 · IC025 +4.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 12.8 (11.4–14.4) | Labeled (related wording) related wording | serious n=225 · ♀ 75% (drug 51%) | not reported in cached trials |
| Dermatillomania | 39 | 25.4 18.4–35.2ROR 25.5 · calibrated p 8e-4 ✓ | 23.5 EB05 18.0 · IC025 +3.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 39.8 (23.9–66.1) | Not in label — unassessed | ♀ 0% (drug 51%) | not reported in cached trials |
| Narcolepsy | 124 | 25.0 20.8–30.0ROR 25.0 · calibrated p 7e-4 ✓ | 23.3 EB05 20.1 · IC025 +4.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 18.8 (14.9–23.8) | Not in label — unassessed | serious n=111 · ♀ 73% (drug 51%) | not reported in cached trials |
| Sleep-related eating disorder | 59 | 23.8 18.3–31.0ROR 23.8 · calibrated p 0.001 ✓ | 22.2 EB05 17.8 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 16.6 (11.9–23.1) | Not in label — unassessed | serious n=33 | not reported in cached trials |
| Distractibility | 67 | 21.9 17.1–28.0ROR 21.9 · calibrated p 0.001 ✓ | 20.6 EB05 16.8 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 30.4 (21.2–43.4) | Not in label — unassessed | serious n=29 | not reported in cached trials |
| Hallucination, tactile | 38 | 21.7 15.6–30.1ROR 21.7 · calibrated p 0.002 ✓ | 20.3 EB05 15.4 · IC025 +3.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 58.1 (32.4–104.2) | Not in label — unassessed | serious n=35 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Oromandibular dystonia | 41 | 21.4 15.6–29.3ROR 21.4 · calibrated p 0.002 ✓ | 20.1 EB05 15.4 · IC025 +3.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 83.6 (43.9–159.0) | Not in label — unassessed | serious n=35 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Impulsive behaviour | 210 | 21.0 18.3–24.2ROR 21.1 · calibrated p 0.002 ✓ | 19.9 EB05 17.7 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 24.5 (20.2–29.6) | Not in label — unassessed | serious n=115 · ♀ 28% (drug 51%) | not reported in cached trials |
| Attention deficit hyperactivity disorder | 231 | 20.9 –ROR 21.0 · – | – | Likely indication confounding term in indications | serious n=166 | not reported in cached trials |
| Enuresis | 190 | 17.5 15.2–20.3ROR 17.6 · calibrated p 0.004 ✓ | 16.7 EB05 14.8 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.1 (14.2–20.6) | Not in label — unassessed | serious n=120 | not reported in cached trials |
| Coronary artery dissection | 39 | 17.2 12.5–23.7ROR 17.2 · calibrated p 0.005 ✓ | 16.2 EB05 12.3 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 18.7 (12.3–28.4) | Not in label — unassessed | serious n=39 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Disturbance in social behaviour | 105 | 16.5 13.6–20.0ROR 16.5 · calibrated p 0.005 ✓ | 15.7 EB05 13.3 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 5.4 (4.4–6.7) | Reporting / coding artifact | serious n=31 · ♀ 19% (drug 51%) · 82% consumer | not reported in cached trials |
| Drug screen negative | 77 | 16.2 12.9–20.4ROR 16.2 · calibrated p 0.006 ✓ | 15.4 EB05 12.7 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 69.8 (45.0–108.1) | Reporting / coding artifact | 71% consumer | not reported in cached trials |
| Product administration interrupted | 315 | 15.2 13.6–17.0ROR 15.3 · calibrated p 0.007 ✓ | 14.6 EB05 13.3 · IC025 +3.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 9.4 (8.2–10.7) | Reporting / coding artifact | serious n=281 · ♀ 72% (drug 51%) | not reported in cached trials |
| Sleep paralysis | 56 | 14.1 10.8–18.4ROR 14.1 · calibrated p 0.010 ✓ | 13.4 EB05 10.6 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 12.3 (9.0–17.0) | Not in label — unassessed | serious n=30 · ♀ 76% (drug 51%) | not reported in cached trials |
| Psychomotor hyperactivity | 626 | 13.9 12.8–15.0ROR 14.0 · calibrated p 0.009 ✓ | 13.4 EB05 12.5 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 19.9 (17.9–22.1) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.1 · ♀ 29% (drug 51%) | not reported in cached trials |
| Stereotypy | 35 | 13.8 9.8–19.3ROR 13.8 · calibrated p 0.012 ✓ | 13.0 EB05 9.5 · IC025 +2.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 57.1 (31.2–104.5) | Not in label — unassessed | serious n=29 · ♀ 0% (drug 51%) | not reported in cached trials |
| Hyperkinesia | 78 | 13.8 11.0–17.2ROR 13.8 · calibrated p 0.011 ✓ | 13.2 EB05 10.8 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 28.1 (20.3–38.8) | Not in label — unassessed | serious n=77 · ♀ 0% (drug 51%) · 100% clinician | not reported in cached trials |
| Logorrhoea | 131 | 13.7 11.5–16.3ROR 13.7 · calibrated p 0.011 ✓ | 13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 20.0 (15.9–25.2) | Not in label — unassessed | serious n=86 | not reported in cached trials |
| Abnormal sleep-related event | 48 | 13.3 10.0–17.8ROR 13.4 · calibrated p 0.013 ✓ | 12.6 EB05 9.8 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.5 (9.5–19.2) | Not in label — unassessed | serious n=26 | not reported in cached trials |
| Terminal insomnia | 62 | 13.2 10.2–16.9ROR 13.2 · calibrated p 0.013 ✓ | 12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 24.9 (17.5–35.4) | Not in label — unassessed | – | not reported in cached trials |
| Somnambulism | 222 | 12.4 10.8–14.1ROR 12.4 · calibrated p 0.015 ✓ | 11.9 EB05 10.7 · IC025 +3.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 14.7 (12.5–17.4) | Not in label — unassessed | serious n=145 · ♀ 76% (drug 51%) | not reported in cached trials |
| Antisocial behaviour | 33 | 12.0 8.5–17.0ROR 12.0 · calibrated p 0.020 ✓ | 11.2 EB05 8.1 · IC025 +2.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 100.9 (46.6–218.5) | Not in label — unassessed | serious n=25 · ♀ 0% (drug 51%) · 100% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Methylphenidate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT01552902 — Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (N=549, PHASE4; 12 AE terms posted; arms: Placebo; Lisdexamfetamine Dimesylate; Methylphenidate)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 6,203 | 1.7 1.6–1.7ROR 1.8 · calibrated p 0.806 | 1.7 EB05 1.6 · IC025 +0.7 vs other Central Nervous System Stimulants: PRR 14.4 (14.0–14.8) | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Fatigue (tiredness) | 3,183 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.633 | 1.5 EB05 1.4 · IC025 +0.5 vs other Central Nervous System Stimulants: PRR 11.9 (11.4–12.4) | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Headache | 2,967 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.786 | 1.7 EB05 1.6 · IC025 +0.7 vs other Central Nervous System Stimulants: PRR 13.3 (12.8–13.9) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT01552902: 35/219 (16.0%) on Methylphenidate; 9/110 (8.2%) control |
| Nausea | 2,963 | 1.3 1.3–1.4ROR 1.4 · calibrated p 0.546 | 1.3 EB05 1.3 · IC025 +0.4 vs other Central Nervous System Stimulants: PRR 13.1 (12.6–13.7) | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01552902: 11/219 (5.0%) on Methylphenidate; 3/110 (2.7%) control |
| Off label use (used outside approved label) | 2,893 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.438 | 1.2 EB05 1.2 · IC025 +0.2 vs other Central Nervous System Stimulants: PRR 7.4 (7.1–7.7) | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Anxiety | 2,814 | 3.5 3.4–3.7ROR 3.7 · calibrated p 0.446 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.2 (12.7–13.8) | Not in label — unassessed | serious PRR 3.4 | not reported in cached trials |
| Depression | 2,348 | 3.7 3.5–3.8ROR 3.8 · calibrated p 0.418 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.8 (13.2–14.5) | Labeled adverse reaction exact term | serious PRR 3.8 | not reported in cached trials |
| Insomnia (trouble sleeping) | 2,163 | 2.9 2.8–3.0ROR 3.0 · calibrated p 0.635 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.7 (13.0–14.4) | Labeled adverse reaction exact term | serious PRR 3.3 | NCT01552902: 17/219 (7.8%) on Methylphenidate; 3/110 (2.7%) control |
| Somnolence (drowsiness) | 1,900 | 3.4 3.2–3.5ROR 3.5 · calibrated p 0.493 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree vs other Central Nervous System Stimulants: PRR 15.5 (14.7–16.4) | Labeled adverse reaction exact term | serious PRR 3.4 | not reported in cached trials |
| Dizziness | 1,809 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.511 | 1.3 EB05 1.2 · IC025 +0.3 vs other Central Nervous System Stimulants: PRR 11.8 (11.1–12.4) | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01552902: 11/219 (5.0%) on Methylphenidate |
| Feeling abnormal | 1,778 | 2.6 2.5–2.8ROR 2.7 · calibrated p 0.734 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 14.3 (13.5–15.1) | Not in label — unassessed | serious PRR 2.8 | not reported in cached trials |
| Vomiting | 1,736 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.528 | 1.3 EB05 1.3 · IC025 +0.3 vs other Central Nervous System Stimulants: PRR 12.1 (11.4–12.8) | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Suicidal ideation (thoughts of suicide) | 1,703 | 6.7 6.4–7.0ROR 6.9 · calibrated p 0.103 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 24.5 (22.9–26.1) | Labeled (related wording) related wording | serious PRR 6.4 | NCT01552902: 1/218 (0.5%) on Methylphenidate (serious AE) |
| Decreased appetite (loss of appetite) | 1,675 | 2.6 2.5–2.7ROR 2.6 · calibrated p 0.759 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.5 (12.7–14.3) | Labeled adverse reaction exact term | serious PRR 2.3 | NCT01552902: 51/219 (23.3%) on Methylphenidate; 11/110 (10.0%) control |
| Weight decreased (weight loss) | 1,625 | 2.1 2.0–2.2ROR 2.1 · calibrated p 0.997 | 2.1 EB05 2.0 · IC025 +1.0 vs other Central Nervous System Stimulants: PRR 16.2 (15.2–17.2) | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01552902: 11/219 (5.0%) on Methylphenidate |
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.
- Respiratory tract malformation — n=37, PRR 140.9
- Pulmonary malformation — n=67, PRR 82.9
- Oppositional defiant disorder — n=55, PRR 56.8
- Cataplexy — n=177, PRR 50.3
- Choreoathetosis — n=78, PRR 45.6
- Educational problem — n=187, PRR 44.6
- Lung cyst — n=41, PRR 41.4
- Trichotillomania — n=57, PRR 38.0
- Precocious puberty — n=52, PRR 35.6
- Self-destructive behaviour — n=61, PRR 31.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methylphenidate ↔ Hallucination, visual.
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 Methylphenidate?
In FDA FAERS, the most frequently co-reported reaction terms for Methylphenidate are fatigue, headache, nausea, anxiety, depression, insomnia. 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 Methylphenidate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION Methylphenidate transdermal system has a high potential for abuse and misuse, which can lead to the development of substance use disorder, including addiction. Misuse and abuse of CNS sti.
Do FAERS signals prove that Methylphenidate 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 1643b6a5-80da-4d4f-8c5f-feb907875702, effective 20251007; matched on
openfda.generic_name.exact:"METHYLPHENIDATE") - 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, 1,215 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 - ClinicalTrials.gov API v2 (query
METHYLPHENIDATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.