Drug · FAERS side-effect profile with label screen

Serdexmethylphenidate side effects: what 723 FDA adverse event reports show

Serdexmethylphenidate And Dexmethylphenidate · 20 reaction terms · 319 drug–reaction co-reports · data 2026-09-14

Drug class

Central nervous system (cns) stimulant

FDA label, Indications wording of the closest related product

Label matched

Serdexmethylphenidate And Dexmethylphenidate (Azstarys)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

723 reports · 15% serious · 0 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they ha.

FDA label, Indications and Usage

What it is

AZSTARYS (serdexmethylphenidate and dexmethylphenidate) capsules contain dexmethylphenidate, a CNS stimulant, and serdexmethylphenidate, a prodrug of dexmethylphenidate. AZSTARYS capsules are .

FDA label, Description section

Boxed warning

ABUSE, MISUSE, AND ADDICTION AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTA.

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 18 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 8

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. 2 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
Therapeutic response shortened	61	55.7 43.8–70.8ROR 60.7 · χ² 3,221 / p <1e-300	54.7 EB05 44.1 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 31.6	no trial data cached
Initial insomnia	11	31.3 17.4–56.3ROR 31.8 · χ² 293 / p 5e-66	29.8 EB05 17.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Psychomotor hyperactivity	14	24.4 14.5–41.0ROR 24.8 · χ² 291 / p 2e-65	23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Emotional disorder	22	20.6 13.6–31.1ROR 21.2 · χ² 391 / p 3e-87	20.2 EB05 14.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.0	no trial data cached
Anger	22	18.8 12.5–28.4ROR 19.4 · χ² 353 / p 4e-79	18.4 EB05 12.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Irritability	38	18.3 13.4–25.0ROR 19.3 · χ² 606 / p 4e-134	18.1 EB05 13.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3	no trial data cached
Mania	9	15.9 8.3–30.4ROR 16.1 · χ² 111 / p 3e-26	14.0 EB05 6.6 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.1	no trial data cached
Disturbance in attention	28	15.0 10.4–21.6ROR 15.6 · χ² 353 / p 4e-79	14.7 EB05 10.4 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.1 · 83% consumer	no trial data cached
Affect lability	5	15.0 6.3–35.9ROR 15.1 · χ² 52 / p 3e-13	10.5 EB05 3.7 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Feeling jittery	9	13.7 7.1–26.2ROR 13.8 · χ² 93 / p 2e-22	11.5 EB05 5.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hallucination, visual	9	12.4 6.5–23.8ROR 12.6 · χ² 84 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.6	no trial data cached
Abnormal behaviour	17	12.4 7.7–19.8ROR 12.6 · χ² 167 / p 2e-38	11.3 EB05 7.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Product physical issue	8	11.6 5.8–23.2ROR 11.8 · χ² 68 / p 1e-16	9.0 EB05 4.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Aggression	20	11.6 7.5–17.8ROR 11.9 · χ² 183 / p 5e-42	10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Panic attack	14	11.1 6.6–18.7ROR 11.3 · χ² 119 / p 4e-28	9.7 EB05 5.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Hallucination, auditory	6	10.9 4.9–24.3ROR 11.0 · χ² 45 / p 1e-11	7.5 EB05 3.3 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.3	no trial data cached
Product availability issue	8	10.4 5.2–20.6ROR 10.5 · χ² 59 / p 1e-14	7.8 EB05 3.8 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Mood swings	10	9.1 4.9–16.8ROR 9.2 · χ² 64 / p 5e-16	7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Therapeutic response shortened	61	55.7 43.8–70.8ROR 60.7 · χ² 3,221 / p <1e-300	54.7 EB05 44.1 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 31.6	no trial data cached
Irritability	38	18.3 13.4–25.0ROR 19.3 · χ² 606 / p 4e-134	18.1 EB05 13.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3	no trial data cached
Disturbance in attention	28	15.0 10.4–21.6ROR 15.6 · χ² 353 / p 4e-79	14.7 EB05 10.4 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.1 · 83% consumer	no trial data cached
Anger	22	18.8 12.5–28.4ROR 19.4 · χ² 353 / p 4e-79	18.4 EB05 12.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.6	no trial data cached
Emotional disorder	22	20.6 13.6–31.1ROR 21.2 · χ² 391 / p 3e-87	20.2 EB05 14.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.0	no trial data cached
Aggression	20	11.6 7.5–17.8ROR 11.9 · χ² 183 / p 5e-42	10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Abnormal behaviour	17	12.4 7.7–19.8ROR 12.6 · χ² 167 / p 2e-38	11.3 EB05 7.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Panic attack	14	11.1 6.6–18.7ROR 11.3 · χ² 119 / p 4e-28	9.7 EB05 5.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Psychomotor hyperactivity	14	24.4 14.5–41.0ROR 24.8 · χ² 291 / p 2e-65	23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Initial insomnia	11	31.3 17.4–56.3ROR 31.8 · χ² 293 / p 5e-66	29.8 EB05 17.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mood swings	10	9.1 4.9–16.8ROR 9.2 · χ² 64 / p 5e-16	7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Hallucination, visual	9	12.4 6.5–23.8ROR 12.6 · χ² 84 / p 3e-20	10.1 EB05 4.9 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.6	no trial data cached
Feeling jittery	9	13.7 7.1–26.2ROR 13.8 · χ² 93 / p 2e-22	11.5 EB05 5.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mania	9	15.9 8.3–30.4ROR 16.1 · χ² 111 / p 3e-26	14.0 EB05 6.6 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.1	no trial data cached
Product availability issue	8	10.4 5.2–20.6ROR 10.5 · χ² 59 / p 1e-14	7.8 EB05 3.8 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	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.

Emotional disorder — n=22, PRR 20.6
Anger — n=22, PRR 18.8
Aggression — n=20, PRR 11.6

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 Serdexmethylphenidate?

In FDA FAERS, the most frequently co-reported reaction terms for Serdexmethylphenidate are irritability, disturbance in attention, anger, emotional disorder, aggression, abnormal behaviour. 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 Serdexmethylphenidate have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTA.

Do FAERS signals prove that Serdexmethylphenidate 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 00b5e716-5564-4bbd-acaf-df2bc45a5663, effective 20260511; matched on openfda.generic_name.exact:"SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE")
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, 20 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.