Drug · FAERS side-effect profile with label screen

Dextroamphetamine side effects: what 863 FDA adverse event reports show

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate · Xelstrym · 22 reaction terms · 369 drug–reaction co-reports · data 2026-09-14

Drug class

Central Nervous System Stimulant

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Xelstrym

openFDA label

Who reports

863 reports · 21% serious · 5 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older . Limitations of Use The use of XELSTRYM is not recommended in pediatric patien.

FDA label, Indications and Usage

What it is

XELSTRYM (dextroamphetamine) transdermal system, contains dextroamphetamine, a CNS stimulant. Dextroamphetamine is the dextro isomer of the compound d , l -amphetamine.

FDA label, Description section

Boxed warning

ABUSE, MISUSE, AND ADDICTION XELSTRYM 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 XELST.

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 5Likely indication confounding 1Reporting / coding artifact 8Not in label — unassessed 4

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.
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. 4 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
Inability to afford medication	43	106.7 79.7–142.9ROR 112.3 · χ² 4,381 / p <1e-300	101.6 EB05 78.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=8 · 74% consumer	no trial data cached
Insurance issue	37	60.7 44.2–83.2ROR 63.3 · χ² 2,108 / p <1e-300	58.8 EB05 44.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 37.5 · 70% consumer	no trial data cached
Product availability issue	45	48.9 36.8–65.0ROR 51.5 · χ² 2,060 / p <1e-300	47.8 EB05 37.2 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5	no trial data cached
Product physical issue	19	23.2 14.9–36.2ROR 23.7 · χ² 381 / p 3e-85	22.7 EB05 15.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Therapeutic response shortened	21	16.0 10.5–24.5ROR 16.4 · χ² 282 / p 2e-63	15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5	no trial data cached
Disturbance in attention	31	13.9 9.9–19.7ROR 14.4 · χ² 360 / p 1e-80	13.6 EB05 9.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 7.5	no trial data cached
Drug effect less than expected	8	13.8 6.9–27.5ROR 13.9 · χ² 83 / p 5e-20	11.3 EB05 5.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Bipolar disorder	5	11.1 4.6–26.6ROR 11.2 · χ² 36 / p 8e-10	7.1 EB05 2.9 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.2	no trial data cached
Middle insomnia	8	10.5 5.2–20.8ROR 10.5 · χ² 59 / p 7e-15	7.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Feeling jittery	8	10.2 5.1–20.3ROR 10.3 · χ² 57 / p 2e-14	7.6 EB05 3.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Anger	13	9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21	7.7 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Irritability	21	8.5 5.6–12.9ROR 8.7 · χ² 131 / p 1e-30	7.5 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Therapeutic product effect decreased	15	8.2 5.0–13.6ROR 8.3 · χ² 88 / p 3e-21	6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Intentional dose omission	9	8.0 4.2–15.3ROR 8.1 · χ² 48 / p 2e-12	6.1 EB05 3.3 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 30.4	no trial data cached
Sedation	7	6.5 3.1–13.6ROR 6.6 · χ² 27 / p 8e-8	4.8 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.3	no trial data cached
No adverse event	45	6.2 4.6–8.2ROR 6.5 · χ² 191 / p 9e-44	5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Withdrawal syndrome	10	5.8 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Drug effect decreased	9	4.0 2.1–7.7ROR 4.0 · χ² 17 / p 1e-5	3.4 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 8.5	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
No adverse event	45	6.2 4.6–8.2ROR 6.5 · χ² 191 / p 9e-44	5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product availability issue	45	48.9 36.8–65.0ROR 51.5 · χ² 2,060 / p <1e-300	47.8 EB05 37.2 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5	no trial data cached
Inability to afford medication	43	106.7 79.7–142.9ROR 112.3 · χ² 4,381 / p <1e-300	101.6 EB05 78.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=8 · 74% consumer	no trial data cached
Insurance issue	37	60.7 44.2–83.2ROR 63.3 · χ² 2,108 / p <1e-300	58.8 EB05 44.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 37.5 · 70% consumer	no trial data cached
Disturbance in attention	31	13.9 9.9–19.7ROR 14.4 · χ² 360 / p 1e-80	13.6 EB05 9.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 7.5	no trial data cached
Irritability	21	8.5 5.6–12.9ROR 8.7 · χ² 131 / p 1e-30	7.5 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9	no trial data cached
Therapeutic response shortened	21	16.0 10.5–24.5ROR 16.4 · χ² 282 / p 2e-63	15.6 EB05 10.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.5	no trial data cached
Product physical issue	19	23.2 14.9–36.2ROR 23.7 · χ² 381 / p 3e-85	22.7 EB05 15.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Therapeutic product effect decreased	15	8.2 5.0–13.6ROR 8.3 · χ² 88 / p 3e-21	6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Anger	13	9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21	7.7 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Withdrawal syndrome	10	5.8 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Drug effect decreased	9	4.0 2.1–7.7ROR 4.0 · χ² 17 / p 1e-5	3.4 EB05 2.0 · IC025 +0.7	Reporting / coding artifact	serious PRR 8.5	no trial data cached
Intentional dose omission	9	8.0 4.2–15.3ROR 8.1 · χ² 48 / p 2e-12	6.1 EB05 3.3 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 30.4	no trial data cached
Feeling jittery	8	10.2 5.1–20.3ROR 10.3 · χ² 57 / p 2e-14	7.6 EB05 3.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=4	no trial data cached
Middle insomnia	8	10.5 5.2–20.8ROR 10.5 · χ² 59 / p 7e-15	7.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	–	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.

Inability to afford medication — n=43, PRR 106.7
Insurance issue — n=37, PRR 60.7

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 Dextroamphetamine?

In FDA FAERS, the most frequently co-reported reaction terms for Dextroamphetamine are inability to afford medication, insurance issue, disturbance in attention, irritability, anger, withdrawal syndrome. 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 Dextroamphetamine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION XELSTRYM 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 XELST.

Do FAERS signals prove that Dextroamphetamine 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 0862f02a-72a8-41cc-8845-57cf4974bb6f, effective 20251223; matched on openfda.generic_name.exact:"DEXTROAMPHETAMINE")
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, 22 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.