Methylphenidate side effects: what 28,775 FDA adverse event reports show

Methylphenidate · 1,132 reaction terms · 98,853 drug–reaction co-reports · data 2026-09-14

Drug class

Central Nervous System Stimulant

FDA label (Established Pharmacologic Class) · compare the class

Who reports

28,775 reports · 38% serious · 1,105 with death outcome · 45% 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 (related wording) 9Reporting / coding artifact 10Lab value / disease marker 1Not in label — unassessed 20

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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). 1,092 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Adhesive tape use	141	453.9 367.7–560.3ROR 456.1 · calibrated p 3e-13 ✓	268.3 EB05 233.2 · IC025 +6.9 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=45 · 87% consumer	not reported in cached trials
Intentional removal of drug delivery system by patient	14	205.1 113.3–371.4ROR 205.2 · calibrated p 6e-9 ✓	131.5 EB05 83.3 · IC025 +3.7 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	–	not reported in cached trials
Mycobacterial peritonitis	19	179.5 108.6–296.7ROR 179.6 · calibrated p 8e-9 ✓	125.9 EB05 85.2 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=19	not reported in cached trials
Disturbance in social behaviour	452	172.1 155.4–190.6ROR 174.9 · calibrated p 1e-9 ✓	138.2 EB05 127.9 · IC025 +6.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 85.1 (70.0–103.3)	Reporting / coding artifact	♀ 21% (drug 45%) · 89% consumer	not reported in cached trials
Respiratory tract malformation	24	164.1 105.3–255.6ROR 164.2 · calibrated p 1e-8 ✓	121.1 EB05 85.6 · IC025 +4.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 15.9 (9.5–26.5)	Not in label — unassessed	serious n=24 · 100% clinician	not reported in cached trials
Pulmonary malformation	57	139.7 105.2–185.4ROR 139.9 · calibrated p 2e-8 ✓	112.7 EB05 90.2 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 20.8 (14.6–29.6)	Not in label — unassessed	serious n=57 · ♀ 100% (drug 45%) · 91% clinician	not reported in cached trials
Product ineffective	83	99.3 79.0–124.9ROR 99.6 · calibrated p 2e-7 ✓	85.7 EB05 71.3 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 30.8 (22.3–42.5)	Reporting / coding artifact	100% consumer	not reported in cached trials
Mycobacterium fortuitum infection	22	98.1 62.8–153.1ROR 98.2 · calibrated p 5e-7 ✓	80.6 EB05 56.1 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=22 · ♀ 0% (drug 45%)	not reported in cached trials
Educational problem	182	88.6 76.0–103.3ROR 89.2 · calibrated p 3e-7 ✓	78.4 EB05 69.3 · IC025 +5.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 20.2 (16.6–24.6)	Not in label — unassessed	serious n=30 · 86% consumer	not reported in cached trials
Dermal absorption impaired	29	85.3 58.1–125.4ROR 85.4 · calibrated p 9e-7 ✓	72.8 EB05 53.2 · IC025 +4.4 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=9 · 79% consumer	not reported in cached trials
Application site oedema	31	77.5 53.5–112.3ROR 77.6 · calibrated p 2e-6 ✓	67.3 EB05 49.7 · IC025 +4.5 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	81% consumer	not reported in cached trials
Oppositional defiant disorder	31	61.3 42.5–88.5ROR 61.4 · calibrated p 7e-6 ✓	54.8 EB05 40.4 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.5 (7.5–17.6)	Not in label — unassessed	serious n=26 · ♀ 0% (drug 45%)	not reported in cached trials
Decreased eye contact	23	59.8 39.1–91.5ROR 59.9 · calibrated p 1e-5 ✓	53.0 EB05 37.2 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 12.5 (7.6–20.7)	Labeled (related wording) related wording	serious n=22 · ♀ 0% (drug 45%) · 100% clinician	not reported in cached trials
Lung cyst	29	58.0 39.7–84.6ROR 58.0 · calibrated p 1e-5 ✓	52.0 EB05 38.0 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.3 (10.8–27.8)	Not in label — unassessed	serious n=29 · ♀ 100% (drug 45%)	not reported in cached trials
Incorrect storage of drug	118	52.5 43.6–63.3ROR 52.8 · calibrated p 1e-5 ✓	48.7 EB05 41.7 · IC025 +5.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Reporting / coding artifact	80% consumer	not reported in cached trials
Application site erythema	1,699	50.2 47.9–52.7ROR 53.3 · calibrated p 9e-6 ✓	47.0 EB05 45.2 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 168.3 (147.4–192.2)	Labeled (related wording) related wording	serious n=86 · 85% consumer	not reported in cached trials
Application site bleeding	16	49.5 29.8–82.2ROR 49.5 · calibrated p 4e-5 ✓	44.1 EB05 28.8 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	–	not reported in cached trials
Drug administered at inappropriate site	680	49.4 45.8–53.4ROR 50.6 · calibrated p 1e-5 ✓	46.3 EB05 43.4 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 449.6 (323.1–625.8)	Not in label — unassessed	serious n=9 · 79% consumer	not reported in cached trials
Application site urticaria	140	48.0 40.4–56.9ROR 48.2 · calibrated p 2e-5 ✓	44.8 EB05 38.9 · IC025 +5.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	serious n=7 · 80% consumer	not reported in cached trials
High risk sexual behaviour	11	47.6 25.8–87.6ROR 47.6 · calibrated p 8e-5 ✓	41.7 EB05 24.8 · IC025 +2.9 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=11	not reported in cached trials
Drug administration error	1,901	47.4 45.3–49.5ROR 50.6 · calibrated p 1e-5 ✓	44.5 EB05 42.8 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 238.5 (205.9–276.2)	Reporting / coding artifact	serious PRR 1.1 · 90% consumer	not reported in cached trials
Change in sustained attention	18	47.0 29.2–75.7ROR 47.0 · calibrated p 5e-5 ✓	42.3 EB05 28.3 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	–	not reported in cached trials
Choreoathetosis	40	45.1 32.8–62.0ROR 45.1 · calibrated p 4e-5 ✓	41.7 EB05 31.9 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.4 (7.8–16.6)	Not in label — unassessed	serious n=40 · ♀ 0% (drug 45%) · 100% clinician	not reported in cached trials
Drug prescribing error	1,079	42.7 40.2–45.3ROR 44.3 · calibrated p 3e-5 ✓	40.3 EB05 38.3 · IC025 +5.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 145.9 (124.7–170.6)	Reporting / coding artifact	serious n=9 · 88% consumer	not reported in cached trials
Obsessive-compulsive symptom	20	41.9 26.7–65.7ROR 41.9 · calibrated p 9e-5 ✓	38.3 EB05 26.2 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=19	not reported in cached trials
Application site irritation	659	40.7 37.7–44.0ROR 41.6 · calibrated p 4e-5 ✓	38.5 EB05 36.1 · IC025 +5.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 114.3 (95.4–137.1)	Labeled (related wording) related wording	serious n=38 · 80% consumer	not reported in cached trials
Wrong technique in drug usage process	1,772	36.8 35.1–38.5ROR 39.1 · calibrated p 6e-5 ✓	35.0 EB05 33.7 · IC025 +5.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 154.3 (136.1–174.9)	Reporting / coding artifact	serious PRR 1.2 · 81% consumer	not reported in cached trials
Rapid eye movement sleep behaviour disorder	19	36.4 22.9–57.7ROR 36.4 · calibrated p 2e-4 ✓	33.6 EB05 22.7 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=19	not reported in cached trials
Application site erosion	60	35.5 27.4–45.9ROR 35.5 · calibrated p 1e-4 ✓	33.5 EB05 27.0 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	73% consumer	not reported in cached trials
Labelled drug-disease interaction medication error	27	34.9 23.7–51.3ROR 34.9 · calibrated p 2e-4 ✓	32.6 EB05 23.5 · IC025 +3.7 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	100% consumer	not reported in cached trials
Cataplexy	65	34.7 27.1–44.5ROR 34.8 · calibrated p 1e-4 ✓	32.9 EB05 26.7 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 4.4 (3.4–5.8)	Not in label — unassessed	serious n=59 · ♀ 70% (drug 45%)	not reported in cached trials
Exposure via direct contact	42	33.5 24.6–45.6ROR 33.5 · calibrated p 2e-4 ✓	31.6 EB05 24.4 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Reporting / coding artifact	serious n=21 · 83% consumer	not reported in cached trials
Precocious puberty	24	32.0 21.2–48.1ROR 32.0 · calibrated p 3e-4 ✓	30.0 EB05 21.2 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.3 (7.0–18.3)	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Incorrect drug administration duration	1,191	31.7 30.0–33.6ROR 33.0 · calibrated p 2e-4 ✓	30.4 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 306.7 (249.0–377.9)	Reporting / coding artifact	♀ 23% (drug 45%) · 90% consumer	not reported in cached trials
Lactation disorder	20	31.1 19.9–48.6ROR 31.1 · calibrated p 4e-4 ✓	29.1 EB05 19.9 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=19	not reported in cached trials
Lipoprotein (a) increased	12	30.7 17.2–54.6ROR 30.7 · calibrated p 6e-4 ✓	28.2 EB05 17.1 · IC025 +2.8 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Lab value / disease marker	serious n=12	not reported in cached trials
Defiant behaviour	12	29.9 16.8–53.3ROR 29.9 · calibrated p 7e-4 ✓	27.6 EB05 16.7 · IC025 +2.8 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	–	not reported in cached trials
Product quality issue	5,246	29.5 28.7–30.2ROR 35.8 · calibrated p 1e-4 ✓	28.3 EB05 27.7 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 85.1 (80.4–89.9)	Reporting / coding artifact	serious PRR 5.1 · 86% consumer	not reported in cached trials
No adverse event	6,897	29.4 28.8–30.1ROR 38.4 · calibrated p 7e-5 ✓	28.3 EB05 27.8 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 164.1 (153.9–175.0)	Reporting / coding artifact	serious PRR 19.2 · 90% consumer	not reported in cached trials
Poor sucking reflex	15	28.2 16.8–47.2ROR 28.2 · calibrated p 8e-4 ✓	26.3 EB05 16.9 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=15	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
No adverse event	6,897	29.4 28.8–30.1ROR 38.4 · calibrated p 7e-5 ✓	28.3 EB05 27.8 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 164.1 (153.9–175.0)	Reporting / coding artifact	serious PRR 19.2 · 90% consumer	not reported in cached trials
Off label use (used outside approved label)	5,947	5.0 4.9–5.1ROR 6.1 · calibrated p 0.146	5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 22.4 (21.7–23.1)	Reporting / coding artifact	serious PRR 1.8 · 84% consumer	not reported in cached trials
Product quality issue	5,246	29.5 28.7–30.2ROR 35.8 · calibrated p 1e-4 ✓	28.3 EB05 27.7 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 85.1 (80.4–89.9)	Reporting / coding artifact	serious PRR 5.1 · 86% consumer	not reported in cached trials
Drug ineffective (drug did not work)	2,926	1.6 1.6–1.7ROR 1.7 · calibrated p 0.763	1.6 EB05 1.6 · IC025 +0.6 vs other Central Nervous System Stimulants: PRR 5.2 (5.0–5.4)	Reporting / coding artifact	serious PRR 1.8 · 71% consumer	not reported in cached trials
Drug administration error	1,901	47.4 45.3–49.5ROR 50.6 · calibrated p 1e-5 ✓	44.5 EB05 42.8 · IC025 +5.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 238.5 (205.9–276.2)	Reporting / coding artifact	serious PRR 1.1 · 90% consumer	not reported in cached trials
Wrong technique in drug usage process	1,772	36.8 35.1–38.5ROR 39.1 · calibrated p 6e-5 ✓	35.0 EB05 33.7 · IC025 +5.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 154.3 (136.1–174.9)	Reporting / coding artifact	serious PRR 1.2 · 81% consumer	not reported in cached trials
Application site erythema	1,699	50.2 47.9–52.7ROR 53.3 · calibrated p 9e-6 ✓	47.0 EB05 45.2 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 168.3 (147.4–192.2)	Labeled (related wording) related wording	serious n=86 · 85% consumer	not reported in cached trials
Drug dose omission	1,478	6.5 6.2–6.8ROR 6.8 · calibrated p 0.109	6.4 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 28.9 (26.9–31.2)	Reporting / coding artifact	serious PRR 1.5 · 92% consumer	not reported in cached trials
Incorrect drug administration duration	1,191	31.7 30.0–33.6ROR 33.0 · calibrated p 2e-4 ✓	30.4 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 306.7 (249.0–377.9)	Reporting / coding artifact	♀ 23% (drug 45%) · 90% consumer	not reported in cached trials
Wrong technique in product usage process	1,156	4.2 4.0–4.4ROR 4.3 · calibrated p 0.323	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.4 (16.2–18.8)	Reporting / coding artifact	serious PRR 3.6 · 90% consumer	not reported in cached trials
Drug prescribing error	1,079	42.7 40.2–45.3ROR 44.3 · calibrated p 3e-5 ✓	40.3 EB05 38.3 · IC025 +5.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 145.9 (124.7–170.6)	Reporting / coding artifact	serious n=9 · 88% consumer	not reported in cached trials
Disturbance in attention	916	12.5 11.8–13.4ROR 12.9 · calibrated p 0.013 ✓	12.3 EB05 11.7 · IC025 +3.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 8.3 (7.7–8.9)	Labeled (related wording) related wording	serious PRR 4.5 · 88% consumer	not reported in cached trials
Product adhesion issue	896	18.9 17.7–20.1ROR 19.4 · calibrated p 0.002 ✓	18.4 EB05 17.4 · IC025 +4.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 83.0 (72.4–95.2)	Reporting / coding artifact	serious n=175 · 88% consumer	not reported in cached trials
Fatigue (tiredness)	861	0.8 0.8–0.9ROR 0.8 · calibrated p 0.185	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC vs other Central Nervous System Stimulants: PRR 2.4 (2.2–2.5)	Labeled adverse reaction exact term	serious PRR 1.3	not reported in cached trials
Anxiety	860	2.2 2.1–2.3ROR 2.2 · calibrated p 0.934	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 2.9 (2.7–3.2)	Not in label — unassessed	serious PRR 3.3	not reported in cached trials

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.

Adhesive tape use — n=141, PRR 453.9
Respiratory tract malformation — n=24, PRR 164.1
Pulmonary malformation — n=57, PRR 139.7
Mycobacterium fortuitum infection — n=22, PRR 98.1
Educational problem — n=182, PRR 88.6
Dermal absorption impaired — n=29, PRR 85.3
Oppositional defiant disorder — n=31, PRR 61.3
Lung cyst — n=29, PRR 58.0
Drug administered at inappropriate site — n=680, PRR 49.4
Choreoathetosis — n=40, PRR 45.1

✓ 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 application site erythema, disturbance in attention, fatigue, anxiety. 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, field patient.drug.openfda.generic_name.exact, 1,132 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.