Drug · FAERS side-effect profile with label screen
Dextroamphetamine side effects: what 3,717 FDA adverse event reports show
Drug class
Central Nervous System Stimulant
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Xelstrym
openFDA label
Who reports
3,717 reports · 49% serious · 117 with death outcome · 66% 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 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 11Labeled (related wording) 4Likely indication confounding 3Reporting / coding artifact 10Not in label — unassessed 11
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 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. 250 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 |
|---|---|---|---|---|---|---|
| Application site irritation | 78 | 35.6 28.5–44.3ROR 36.3 · χ² 2,572 / p <1e-300 | 35.1 EB05 29.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Application site erythema | 117 | 25.2 21.1–30.1ROR 26.0 · χ² 2,685 / p <1e-300 | 25.0 EB05 21.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Application site pain | 91 | 23.4 19.1–28.7ROR 24.0 · χ² 1,924 / p <1e-300 | 23.2 EB05 19.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=2 | no trial data cached |
| Application site rash | 41 | 16.8 12.4–22.8ROR 17.0 · χ² 592 / p 4e-131 | 16.6 EB05 12.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Application site pruritus | 66 | 16.4 12.9–20.9ROR 16.7 · χ² 940 / p 8e-207 | 16.3 EB05 13.2 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=2 | no trial data cached |
| Sleep apnoea syndrome | 43 | 12.7 9.4–17.1ROR 12.8 · χ² 452 / p 2e-100 | 12.4 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Product administered at inappropriate site | 40 | 12.5 9.1–17.0ROR 12.6 · χ² 409 / p 3e-91 | 12.1 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | 70% consumer | no trial data cached |
| Initial insomnia | 21 | 11.6 7.6–17.8ROR 11.7 · χ² 193 / p 3e-44 | 10.8 EB05 7.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=9 · ♀ 45% (drug 66%) | no trial data cached |
| Brain fog | 30 | 11.6 8.1–16.6ROR 11.7 · χ² 280 / p 3e-63 | 11.0 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · 80% consumer | no trial data cached |
| Serotonin syndrome | 38 | 11.2 8.2–15.4ROR 11.3 · χ² 343 / p 6e-77 | 10.8 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.2 · ♀ 41% (drug 66%) · 95% clinician | no trial data cached |
| Impaired gastric emptying | 25 | 11.1 7.5–16.4ROR 11.1 · χ² 219 / p 8e-50 | 10.3 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · 71% consumer | no trial data cached |
| Posterior reversible encephalopathy syndrome | 16 | 9.5 5.8–15.5ROR 9.5 · χ² 113 / p 1e-26 | 8.2 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Affect lability | 16 | 9.3 5.7–15.2ROR 9.4 · χ² 111 / p 3e-26 | 8.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Product substitution issue | 92 | 9.0 7.4–11.1ROR 9.2 · χ² 650 / p 1e-143 | 8.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 74% consumer | no trial data cached |
| Mydriasis | 20 | 8.8 5.7–13.6ROR 8.9 · χ² 131 / p 1e-30 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 | no trial data cached |
| Product adhesion issue | 55 | 8.8 6.7–11.4ROR 8.9 · χ² 371 / p 7e-83 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | 78% consumer | no trial data cached |
| Poor quality sleep | 33 | 8.7 6.2–12.2ROR 8.8 · χ² 217 / p 2e-49 | 8.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 42% (drug 66%) | no trial data cached |
| Hunger | 20 | 8.4 5.4–13.0ROR 8.4 · χ² 123 / p 7e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Product availability issue | 33 | 8.3 5.9–11.7ROR 8.4 · χ² 205 / p 8e-47 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 79% consumer | no trial data cached |
| Vitamin d deficiency | 14 | 8.1 4.8–13.7ROR 8.1 · χ² 80 / p 2e-19 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.2 | no trial data cached |
| Coordination abnormal | 20 | 8.0 5.2–12.5ROR 8.1 · χ² 116 / p 2e-27 | 7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.7 · ♀ 20% (drug 66%) | no trial data cached |
| Sedation | 35 | 7.6 5.5–10.5ROR 7.6 · χ² 193 / p 3e-44 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Psychomotor hyperactivity | 21 | 7.1 4.6–10.9ROR 7.1 · χ² 104 / p 9e-25 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · ♀ 25% (drug 66%) | no trial data cached |
| Decreased activity | 13 | 6.9 4.0–11.8ROR 6.9 · χ² 59 / p 7e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.3 | no trial data cached |
| Restless legs syndrome | 22 | 6.8 4.5–10.4ROR 6.9 · χ² 104 / p 1e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Disturbance in attention | 65 | 6.8 5.3–8.6ROR 6.9 · χ² 315 / p 7e-71 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.3 · 71% consumer | no trial data cached |
| Weight fluctuation | 12 | 6.5 3.7–11.4ROR 6.5 · χ² 50 / p 6e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Pharyngeal swelling | 11 | 6.5 3.6–11.7ROR 6.5 · χ² 46 / p 7e-12 | 5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Intentional self-injury | 23 | 6.4 4.3–9.7ROR 6.5 · χ² 100 / p 7e-24 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 · 100% clinician | no trial data cached |
| Seasonal allergy | 16 | 6.4 3.9–10.4ROR 6.4 · χ² 68 / p 1e-16 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Bipolar disorder | 12 | 6.2 3.5–10.9ROR 6.2 · χ² 47 / p 3e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 100 | 6.2 5.1–7.5ROR 6.3 · χ² 429 / p 2e-95 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Irritability | 65 | 6.1 4.8–7.8ROR 6.2 · χ² 272 / p 2e-61 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | no trial data cached |
| Intentional overdose | 68 | 6.0 4.8–7.6ROR 6.1 · χ² 280 / p 3e-63 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 43% (drug 66%) · 95% clinician | no trial data cached |
| Therapeutic response unexpected | 48 | 6.0 4.5–8.0ROR 6.1 · χ² 196 / p 7e-45 | 5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 79% consumer | no trial data cached |
| Surgery | 59 | 5.7 4.5–7.4ROR 5.8 · χ² 227 / p 1e-51 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 | no trial data cached |
| Mood altered | 27 | 5.6 3.9–8.2ROR 5.6 · χ² 98 / p 2e-23 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · ♀ 33% (drug 66%) | no trial data cached |
| Anger | 33 | 5.5 3.9–7.7ROR 5.5 · χ² 117 / p 2e-27 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Apathy | 14 | 5.4 3.2–9.2ROR 5.5 · χ² 46 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Intentional product use issue | 80 | 5.1 4.1–6.4ROR 5.2 · χ² 263 / p 2e-59 | 5.0 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | 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 |
|---|---|---|---|---|---|---|
| Anxiety | 229 | 4.5 4.0–5.1ROR 4.8 · χ² 635 / p 2e-140 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Depression | 203 | 5.0 4.4–5.7ROR 5.2 · χ² 655 / p 9e-145 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Insomnia (trouble sleeping) | 145 | 3.1 2.6–3.6ROR 3.2 · χ² 202 / p 3e-46 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Somnolence (drowsiness) | 140 | 3.9 3.3–4.6ROR 4.0 · χ² 306 / p 9e-69 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Feeling abnormal | 135 | 3.2 2.7–3.7ROR 3.2 · χ² 200 / p 9e-46 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Product dose omission issue | 128 | 2.5 2.1–3.0ROR 2.6 · χ² 119 / p 5e-28 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
| Application site erythema | 117 | 25.2 21.1–30.1ROR 26.0 · χ² 2,685 / p <1e-300 | 25.0 EB05 21.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 100 | 6.2 5.1–7.5ROR 6.3 · χ² 429 / p 2e-95 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Product substitution issue | 92 | 9.0 7.4–11.1ROR 9.2 · χ² 650 / p 1e-143 | 8.8 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · 74% consumer | no trial data cached |
| Application site pain | 91 | 23.4 19.1–28.7ROR 24.0 · χ² 1,924 / p <1e-300 | 23.2 EB05 19.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=2 | no trial data cached |
| Intentional product use issue | 80 | 5.1 4.1–6.4ROR 5.2 · χ² 263 / p 2e-59 | 5.0 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Application site irritation | 78 | 35.6 28.5–44.3ROR 36.3 · χ² 2,572 / p <1e-300 | 35.1 EB05 29.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Hyperhidrosis (excessive sweating) | 75 | 3.3 2.6–4.1ROR 3.3 · χ² 117 / p 1e-27 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Wrong technique in product usage process | 73 | 2.0 1.6–2.6ROR 2.1 · χ² 38 / p 4e-10 | 2.0 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 4.7 · 79% consumer | no trial data cached |
| Memory impairment | 69 | 2.8 2.2–3.6ROR 2.9 · χ² 80 / p 2e-19 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | 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.
- Sleep apnoea syndrome — n=43, PRR 12.7
- Brain fog — n=30, PRR 11.6
- Impaired gastric emptying — n=25, PRR 11.1
- Hunger — n=20, PRR 8.4
- Sedation — n=35, PRR 7.6
- Restless legs syndrome — n=22, PRR 6.8
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 anxiety, depression, insomnia, somnolence, feeling abnormal, application site erythema. 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, fieldpatient.drug.openfda.generic_name.exact, 290 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.