Drug · FAERS side-effect profile with label screen

Dextroamphetamine combination (4 ingredients) side effects: what 41,214 FDA adverse event reports show

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate · Xelstrym · 1,189 reaction terms · 157,836 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

41,214 reports · 44% serious · 504 with death outcome · 71% 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 adverse reaction 1Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 28

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.
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). 1,149 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
Cataplexy	175	70.9 60.6–83.1ROR 71.2 · calibrated p 1e-6 ✓	61.9 EB05 54.5 · IC025 +5.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.3 (14.2–20.9)	Not in label — unassessed	serious n=133	no trial arm names this drug
Pre-existing condition improved	679	61.3 56.6–66.3ROR 62.3 · calibrated p 3e-6 ✓	54.6 EB05 51.3 · IC025 +5.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 28.0 (25.1–31.2)	Labeled (related wording) related wording	serious n=358	no trial arm names this drug
Product administration interrupted	647	46.8 43.2–50.7ROR 47.5 · calibrated p 2e-5 ✓	42.8 EB05 40.1 · IC025 +5.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 32.3 (28.7–36.3)	Reporting / coding artifact	serious n=597	no trial arm names this drug
Asthma exercise induced	25	39.4 26.2–59.1ROR 39.4 · calibrated p 1e-4 ✓	35.7 EB05 25.4 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=21	no trial arm names this drug
Periodic limb movement disorder	24	35.3 23.4–53.5ROR 35.4 · calibrated p 2e-4 ✓	32.3 EB05 22.9 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=20 · ♀ 100% (drug 71%)	no trial arm names this drug
Sleep-related eating disorder	61	35.3 27.2–45.7ROR 35.3 · calibrated p 1e-4 ✓	32.7 EB05 26.4 · IC025 +4.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.6 (12.6–24.4)	Not in label — unassessed	serious n=36	no trial arm names this drug
Sleep paralysis	94	34.8 28.3–42.9ROR 34.9 · calibrated p 1e-4 ✓	32.4 EB05 27.3 · IC025 +4.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 31.5 (23.2–42.8)	Not in label — unassessed	serious n=50	no trial arm names this drug
Manufacturing issue	28	33.3 22.7–48.8ROR 33.3 · calibrated p 2e-4 ✓	30.7 EB05 22.3 · IC025 +3.7 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=15 · 100% consumer	no trial arm names this drug
Narcolepsy	115	33.0 27.3–39.8ROR 33.0 · calibrated p 2e-4 ✓	30.8 EB05 26.4 · IC025 +4.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 16.6 (13.1–21.0)	Not in label — unassessed	serious n=103 · 76% consumer	no trial arm names this drug
Perinatal depression	25	30.2 20.1–45.2ROR 30.2 · calibrated p 4e-4 ✓	28.0 EB05 19.9 · IC025 +3.5 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=23 · ♀ 100% (drug 71%)	no trial arm names this drug
Parasomnia	37	28.3 20.3–39.4ROR 28.3 · calibrated p 5e-4 ✓	26.5 EB05 20.1 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 12.9 (8.7–19.3)	Not in label — unassessed	serious n=20	no trial arm names this drug
Abnormal sleep-related event	66	26.6 20.8–34.1ROR 26.6 · calibrated p 6e-4 ✓	25.2 EB05 20.5 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 23.4 (16.7–32.8)	Not in label — unassessed	serious n=35	no trial arm names this drug
Sleep attacks	23	25.9 17.0–39.3ROR 25.9 · calibrated p 9e-4 ✓	24.2 EB05 17.0 · IC025 +3.3 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	–	no trial arm names this drug
Ehlers-danlos syndrome	22	25.3 16.5–38.9ROR 25.3 · calibrated p 0.001 ✓	23.7 EB05 16.5 · IC025 +3.3 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=18	no trial arm names this drug
Attention deficit hyperactivity disorder	189	24.2 –ROR 24.3 · –	–	Likely indication confounding term in indications	serious n=134 · 72% consumer	no trial arm names this drug
Postural orthostatic tachycardia syndrome	58	23.5 18.1–30.6ROR 23.5 · calibrated p 0.001 ✓	22.3 EB05 17.9 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 36.4 (24.3–54.6)	Not in label — unassessed	serious n=45	no trial arm names this drug
Somnambulism	288	23.2 20.6–26.1ROR 23.4 · calibrated p 1e-3 ✓	22.2 EB05 20.1 · IC025 +4.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 23.3 (19.8–27.3)	Not in label — unassessed	serious n=162	no trial arm names this drug
Enuresis	176	23.1 19.9–26.9ROR 23.2 · calibrated p 0.001 ✓	22.1 EB05 19.5 · IC025 +4.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 15.1 (12.5–18.2)	Not in label — unassessed	serious n=86	no trial arm names this drug
Obstructive sleep apnoea syndrome	60	22.8 17.6–29.5ROR 22.8 · calibrated p 0.001 ✓	21.7 EB05 17.5 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 22.9 (16.1–32.6)	Not in label — unassessed	serious n=55	no trial arm names this drug
Substance use	66	22.7 17.7–29.1ROR 22.7 · calibrated p 0.001 ✓	21.7 EB05 17.6 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.6 (12.8–24.1)	Reporting / coding artifact	serious n=38	no trial arm names this drug
Snoring	158	22.2 18.9–26.0ROR 22.3 · calibrated p 0.001 ✓	21.2 EB05 18.6 · IC025 +4.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 25.1 (20.1–31.3)	Not in label — unassessed	serious n=87	no trial arm names this drug
Attention deficit/hyperactivity disorder	126	20.3 17.0–24.3ROR 20.4 · calibrated p 0.002 ✓	19.5 EB05 16.8 · IC025 +3.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 9.0 (7.3–11.0)	Likely indication confounding term in indications	serious n=72 · 76% consumer	no trial arm names this drug
Amphetamines positive	28	19.5 13.4–28.4ROR 19.5 · calibrated p 0.003 ✓	18.5 EB05 13.4 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 40.3 (22.1–73.6)	Lab value / disease marker	–	no trial arm names this drug
Dissociation	278	19.4 17.2–21.9ROR 19.6 · calibrated p 0.002 ✓	18.7 EB05 16.9 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 40.5 (33.4–49.0)	Not in label — unassessed	serious n=245	no trial arm names this drug
Job dissatisfaction	23	18.7 12.3–28.3ROR 18.7 · calibrated p 0.004 ✓	17.7 EB05 12.2 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	–	no trial arm names this drug
Sleep apnoea syndrome	646	17.7 16.4–19.2ROR 18.0 · calibrated p 0.003 ✓	17.2 EB05 16.1 · IC025 +4.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 15.3 (13.9–16.9)	Not in label — unassessed	serious PRR 25.2	no trial arm names this drug
Inability to afford medication	308	16.4 14.7–18.4ROR 16.5 · calibrated p 0.005 ✓	15.9 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Central Nervous System Stimulants: PRR 58.0 (47.2–71.1)	Not in label — unassessed	serious n=47 · 74% consumer	no trial arm names this drug
Hangover	107	15.8 13.1–19.2ROR 15.9 · calibrated p 0.006 ✓	15.3 EB05 13.0 · IC025 +3.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 27.8 (21.1–36.7)	Not in label — unassessed	serious n=52	no trial arm names this drug
Product tampering	52	15.1 11.5–19.9ROR 15.2 · calibrated p 0.008 ✓	14.6 EB05 11.5 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 318.1 (115.0–879.3)	Reporting / coding artifact	serious n=28	no trial arm names this drug
Thyrotoxic crisis	32	14.8 10.4–21.0ROR 14.8 · calibrated p 0.009 ✓	14.1 EB05 10.2 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	serious n=32 · ♀ 0% (drug 71%) · 100% clinician	no trial arm names this drug
Terminal insomnia	48	14.4 10.8–19.2ROR 14.4 · calibrated p 0.009 ✓	13.9 EB05 10.8 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 15.7 (10.9–22.5)	Labeled adverse reaction exact term	100% consumer	no trial arm names this drug
Product availability issue	609	14.2 13.1–15.4ROR 14.4 · calibrated p 0.008 ✓	13.8 EB05 12.9 · IC025 +3.6 3/3 methods agree vs other Central Nervous System Stimulants: PRR 19.1 (17.2–21.2)	Reporting / coding artifact	serious PRR 5.7	no trial arm names this drug
Sudden onset of sleep	37	13.8 10.0–19.2ROR 13.9 · calibrated p 0.012 ✓	13.2 EB05 9.8 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Labeled (related wording) related wording	serious n=24	no trial arm names this drug
Sleep talking	44	13.4 9.9–18.1ROR 13.4 · calibrated p 0.013 ✓	12.8 EB05 9.8 · IC025 +3.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.4 (11.8–25.5)	Not in label — unassessed	serious n=15	no trial arm names this drug
Post-traumatic stress disorder	171	13.3 11.4–15.4ROR 13.3 · calibrated p 0.012 ✓	12.9 EB05 11.3 · IC025 +3.4 3/3 methods agree vs other Central Nervous System Stimulants: PRR 28.3 (22.7–35.2)	Not in label — unassessed	serious n=146	no trial arm names this drug
Therapeutic product effect variable	95	12.9 10.6–15.9ROR 13.0 · calibrated p 0.013 ✓	12.5 EB05 10.5 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 24.2 (18.2–32.1)	Reporting / coding artifact	serious n=22 · 80% consumer	no trial arm names this drug
Tachyphrenia	85	12.8 10.3–15.8ROR 12.8 · calibrated p 0.014 ✓	12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 24.5 (18.1–33.0)	Not in label — unassessed	serious n=41	no trial arm names this drug
Generalised anxiety disorder	36	12.8 9.2–17.8ROR 12.8 · calibrated p 0.016 ✓	12.1 EB05 8.9 · IC025 +2.9 3/3 methods agree vs other Central Nervous System Stimulants: PRR 27.5 (17.1–44.3)	Labeled (related wording) related wording	serious n=29	no trial arm names this drug
Feeling drunk	177	12.3 10.6–14.3ROR 12.4 · calibrated p 0.015 ✓	12.0 EB05 10.6 · IC025 +3.3 3/3 methods agree vs other Central Nervous System Stimulants: PRR 31.8 (25.5–39.8)	Not in label — unassessed	serious n=88	no trial arm names this drug
Binge eating	25	12.1 8.1–18.0ROR 12.1 · calibrated p 0.021 ✓	11.2 EB05 7.6 · IC025 +2.6 3/3 methods agree vs other Central Nervous System Stimulants: only this drug	Not in label — unassessed	–	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dextroamphetamine only as a background or rescue medication (NCT01436175, NCT01436149); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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)	4,743	1.8 1.8–1.9ROR 1.9 · calibrated p 0.912	1.8 EB05 1.8 · IC025 +0.8 vs other Central Nervous System Stimulants: PRR 9.7 (9.4–10.0)	Reporting / coding artifact	serious PRR 1.8 · 72% consumer	no trial arm names this drug
Fatigue (tiredness)	3,231	2.1 2.0–2.2ROR 2.2 · calibrated p 0.944	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 12.2 (11.7–12.7)	Labeled adverse reaction exact term	serious PRR 2.3 · 71% consumer	no trial arm names this drug
Nausea	2,922	1.9 1.8–2.0ROR 2.0 · calibrated p 0.918	1.9 EB05 1.8 · IC025 +0.9 vs other Central Nervous System Stimulants: PRR 12.8 (12.3–13.4)	Labeled adverse reaction exact term	serious PRR 2.2	no trial arm names this drug
Headache	2,674	2.2 2.1–2.3ROR 2.3 · calibrated p 0.923	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.4 (10.9–11.9)	Labeled adverse reaction exact term	serious PRR 2.6	no trial arm names this drug
Anxiety	2,507	4.5 4.3–4.7ROR 4.7 · calibrated p 0.267	4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.1 (10.6–11.6)	Labeled adverse reaction exact term	serious PRR 5.0	no trial arm names this drug
Depression	2,133	4.8 4.6–5.0ROR 5.0 · calibrated p 0.236	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree vs other Central Nervous System Stimulants: PRR 11.9 (11.4–12.6)	Labeled adverse reaction exact term	serious PRR 5.8	no trial arm names this drug
Feeling abnormal	2,015	4.3 4.1–4.5ROR 4.5 · calibrated p 0.303	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 17.6 (16.6–18.6)	Labeled (related wording) related wording	serious PRR 5.3 · 71% consumer	no trial arm names this drug
Pain	1,781	1.5 1.4–1.5ROR 1.5 · calibrated p 0.638	1.5 EB05 1.4 · IC025 +0.5 vs other Central Nervous System Stimulants: PRR 10.7 (10.2–11.3)	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Dizziness	1,761	1.8 1.7–1.9ROR 1.8 · calibrated p 0.852	1.8 EB05 1.7 · IC025 +0.8 vs other Central Nervous System Stimulants: PRR 11.3 (10.7–11.9)	Labeled adverse reaction exact term	serious PRR 2.1	no trial arm names this drug
Somnolence (drowsiness)	1,717	4.4 4.2–4.6ROR 4.5 · calibrated p 0.294	4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other Central Nervous System Stimulants: PRR 13.2 (12.5–14.0)	Labeled adverse reaction exact term	serious PRR 4.1	no trial arm names this drug
Insomnia (trouble sleeping)	1,626	3.1 3.0–3.3ROR 3.2 · calibrated p 0.565	3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree vs other Central Nervous System Stimulants: PRR 9.0 (8.6–9.6)	Labeled adverse reaction exact term	serious PRR 3.5 · 73% consumer	no trial arm names this drug
Off label use (used outside approved label)	1,492	0.9 0.8–0.9ROR 0.9 · calibrated p 0.224	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC vs other Central Nervous System Stimulants: PRR 3.3 (3.2–3.5)	Reporting / coding artifact	serious PRR 0.9	no trial arm names this drug
Vomiting	1,291	1.4 1.3–1.5ROR 1.4 · calibrated p 0.585	1.4 EB05 1.3 · IC025 +0.4 vs other Central Nervous System Stimulants: PRR 8.0 (7.5–8.5)	Labeled adverse reaction exact term	serious PRR 1.5	no trial arm names this drug
Malaise (feeling unwell)	1,183	1.4 1.3–1.4ROR 1.4 · calibrated p 0.562	1.4 EB05 1.3 · IC025 +0.4 vs other Central Nervous System Stimulants: PRR 9.1 (8.6–9.7)	Labeled adverse reaction exact term	serious PRR 1.4 · 75% consumer	no trial arm names this drug
Condition aggravated	1,166	2.0 1.9–2.1ROR 2.0 · calibrated p 0.941	2.0 EB05 1.9 · IC025 +0.9 vs other Central Nervous System Stimulants: PRR 7.2 (6.7–7.7)	Reporting / coding artifact	serious PRR 2.3	no trial arm names this drug

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.

Cataplexy — n=175, PRR 70.9
Asthma exercise induced — n=25, PRR 39.4
Periodic limb movement disorder — n=24, PRR 35.3
Sleep-related eating disorder — n=61, PRR 35.3
Sleep paralysis — n=94, PRR 34.8
Manufacturing issue — n=28, PRR 33.3
Narcolepsy — n=115, PRR 33.0
Perinatal depression — n=25, PRR 30.2
Parasomnia — n=37, PRR 28.3
Abnormal sleep-related event — n=66, PRR 26.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Gentamicin Sulfate ↔ Renal Failure.

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 fatigue, nausea, headache, anxiety, depression, feeling abnormal. 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, 1,189 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 DEXTROAMPHETAMINE, 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.