Dextroamphetamine Sulfate side effects: what 4,056 FDA adverse event reports show
Drug class
Central Nervous System Stimulant
Brand names
Xelstrym
Who reports
4,056 reports · 52% serious · 100 with death outcome · 64% female
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.
What it is
XELSTRYM (dextroamphetamine) transdermal system, contains dextroamphetamine, a CNS stimulant. Dextroamphetamine is the dextro isomer of the compound d , l -amphetamine.
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.
Causality screen of the 40 strongest signals
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.
- 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. 228 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sleep apnoea syndrome | 94 | 25.5 20.9–31.2ROR 26.1 · χ² 2,183 / p <1e-300 | 25.3 EB05 21.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Product availability issue | 102 | 23.6 19.5–28.6ROR 24.2 · χ² 2,180 / p <1e-300 | 23.4 EB05 19.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 93% consumer | no trial data cached |
| Brain fog | 32 | 11.4 8.0–16.1ROR 11.4 · χ² 292 / p 1e-65 | 10.8 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 72% consumer | no trial data cached |
| Bipolar disorder | 24 | 11.4 7.6–16.9ROR 11.4 · χ² 216 / p 3e-49 | 10.6 EB05 7.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Disturbance in attention | 110 | 10.5 8.8–12.7ROR 10.8 · χ² 941 / p 8e-207 | 10.4 EB05 8.8 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.7 · 78% consumer | no trial data cached |
| Apathy | 26 | 9.3 6.3–13.6ROR 9.3 · χ² 183 / p 4e-42 | 8.4 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 43% (drug 64%) | no trial data cached |
| Intervertebral disc degeneration | 16 | 8.9 5.5–14.5ROR 8.9 · χ² 104 / p 8e-25 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Pharmaceutical product complaint | 44 | 8.7 6.4–11.6ROR 8.7 · χ² 290 / p 2e-65 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 44% (drug 64%) | no trial data cached |
| Therapeutic response unexpected | 74 | 8.5 6.8–10.7ROR 8.7 · χ² 483 / p 2e-107 | 8.2 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · 72% consumer | no trial data cached |
| Initial insomnia | 16 | 8.1 5.0–13.3ROR 8.2 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=5 | no trial data cached |
| Paranoia | 26 | 7.8 5.3–11.4ROR 7.8 · χ² 147 / p 5e-34 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Vitamin d deficiency | 14 | 7.4 4.4–12.5ROR 7.5 · χ² 72 / p 1e-17 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.8 | no trial data cached |
| Hypersomnia | 41 | 7.4 5.5–10.1ROR 7.5 · χ² 221 / p 3e-50 | 6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 74% consumer | no trial data cached |
| Hunger | 19 | 7.3 4.7–11.5ROR 7.3 · χ² 97 / p 3e-23 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Spinal operation | 17 | 7.3 4.5–11.7ROR 7.3 · χ² 86 / p 1e-20 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Psychotic disorder | 41 | 7.2 5.3–9.7ROR 7.2 · χ² 212 / p 2e-48 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · ♀ 35% (drug 64%) | no trial data cached |
| Product substitution issue | 74 | 6.7 5.3–8.3ROR 6.8 · χ² 351 / p 2e-78 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 · 91% consumer | no trial data cached |
| Euphoric mood | 13 | 6.5 3.8–11.2ROR 6.5 · χ² 55 / p 5e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Psychomotor hyperactivity | 21 | 6.5 4.3–10.0ROR 6.5 · χ² 93 / p 3e-22 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Serotonin syndrome | 24 | 6.5 4.4–9.7ROR 6.5 · χ² 106 / p 4e-25 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.7 | no trial data cached |
| Affect lability | 12 | 6.4 3.6–11.3ROR 6.4 · χ² 50 / p 9e-13 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Muscle twitching | 28 | 6.3 4.3–9.1ROR 6.3 · χ² 119 / p 6e-28 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Sexual dysfunction | 14 | 6.2 3.7–10.5ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Fibromyalgia | 29 | 6.2 4.3–8.9ROR 6.2 · χ² 121 / p 2e-28 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Panic attack | 43 | 6.1 4.5–8.2ROR 6.2 · χ² 178 / p 5e-41 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Surgery | 68 | 6.1 4.8–7.7ROR 6.2 · χ² 284 / p 6e-64 | 5.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.6 | no trial data cached |
| Poor quality sleep | 25 | 6.0 4.1–8.9ROR 6.1 · χ² 100 / p 7e-24 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Feeling jittery | 22 | 6.0 3.9–9.0ROR 6.0 · χ² 86 / p 9e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 | no trial data cached |
| Activities of daily living impaired | 23 | 5.9 3.9–8.9ROR 6.0 · χ² 89 / p 2e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Coeliac disease | 11 | 5.8 3.2–10.5ROR 5.8 · χ² 39 / p 2e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Sedation | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 109 / p 7e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Back injury | 12 | 5.7 3.3–10.1ROR 5.7 · χ² 42 / p 4e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Migraine | 105 | 5.7 4.7–6.9ROR 5.9 · χ² 406 / p 1e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Restless legs syndrome | 20 | 5.7 3.7–8.8ROR 5.7 · χ² 73 / p 8e-18 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Dental caries | 12 | 5.6 3.2–9.9ROR 5.6 · χ² 41 / p 7e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Obesity | 17 | 5.5 3.4–8.9ROR 5.5 · χ² 58 / p 1e-14 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Irritability | 64 | 5.5 4.3–7.0ROR 5.6 · χ² 232 / p 1e-52 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 71% consumer | no trial data cached |
| Seasonal allergy | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 51 / p 5e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Disability | 21 | 5.5 3.6–8.4ROR 5.5 · χ² 73 / p 7e-18 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Incontinence | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 658 | 2.6 2.4–2.8ROR 2.9 · χ² 680 / p 3e-150 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 71% consumer | no trial data cached |
| Anxiety | 263 | 4.8 4.2–5.4ROR 5.0 · χ² 790 / p 4e-174 | 4.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Depression | 229 | 5.2 4.6–5.9ROR 5.4 · χ² 777 / p 2e-171 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Feeling abnormal | 201 | 4.3 3.8–4.9ROR 4.5 · χ² 516 / p 2e-114 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 76% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 199 | 3.9 3.4–4.4ROR 4.0 · χ² 424 / p 2e-94 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 73% consumer | no trial data cached |
| Somnolence (drowsiness) | 194 | 5.0 4.4–5.7ROR 5.2 · χ² 621 / p 2e-137 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Product dose omission issue | 149 | 2.7 2.3–3.2ROR 2.8 · χ² 161 / p 4e-37 | 2.7 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 81% consumer | no trial data cached |
| Disturbance in attention | 110 | 10.5 8.8–12.7ROR 10.8 · χ² 941 / p 8e-207 | 10.4 EB05 8.8 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.7 · 78% consumer | no trial data cached |
| Weight increased (weight gain) | 105 | 2.4 2.0–2.9ROR 2.5 · χ² 89 / p 3e-21 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.7 | no trial data cached |
| Migraine | 105 | 5.7 4.7–6.9ROR 5.9 · χ² 406 / p 1e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Product availability issue | 102 | 23.6 19.5–28.6ROR 24.2 · χ² 2,180 / p <1e-300 | 23.4 EB05 19.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 93% consumer | no trial data cached |
| Sleep apnoea syndrome | 94 | 25.5 20.9–31.2ROR 26.1 · χ² 2,183 / p <1e-300 | 25.3 EB05 21.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Blood pressure increased | 86 | 2.9 2.4–3.6ROR 2.9 · χ² 106 / p 3e-25 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 2.9 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 81 | 4.6 3.7–5.7ROR 4.6 · χ² 223 / p 8e-51 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Drug hypersensitivity | 78 | 2.1 1.7–2.6ROR 2.1 · χ² 43 / p 3e-11 | 2.1 EB05 1.7 · IC025 +0.7 | Labeled (related wording) related wording | serious PRR 5.3 · ♀ 89% (drug 64%) | 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=94, PRR 25.5
- Brain fog — n=32, PRR 11.4
- Apathy — n=26, PRR 9.3
- Pharmaceutical product complaint — n=44, PRR 8.7
- Hypersomnia — n=41, PRR 7.4
- Fibromyalgia — n=29, PRR 6.2
- Panic attack — n=43, PRR 6.1
- Activities of daily living impaired — n=23, PRR 5.9
- Sedation — n=29, PRR 5.8
- Migraine — n=105, PRR 5.7
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 anxiety, depression, feeling abnormal, insomnia, somnolence, disturbance in attention. 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, 268 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.