Drug · FAERS side-effect profile with label screen

Dextroamphetamine Saccharate side effects: what 35,081 FDA adverse event reports show

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate · 1,175 reaction terms · 137,343 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

closest label found was a multi-ingredient product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate) and was not used

Who reports

35,081 reports · 46% serious · 461 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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

Reporting / coding artifact 2No label text to screen 38

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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). 1,135 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	162	76.4 64.9–89.9ROR 76.7 · calibrated p 9e-7 ✓	67.2 EB05 59.0 · IC025 +5.6 3/3 methods agree	No label text to screen	serious n=128	no trial arm names this drug
Pre-existing condition improved	645	68.0 62.7–73.7ROR 69.2 · calibrated p 2e-6 ✓	60.9 EB05 57.1 · IC025 +5.7 3/3 methods agree	No label text to screen	serious n=350	no trial arm names this drug
Product administration interrupted	639	54.3 50.1–58.8ROR 55.2 · calibrated p 7e-6 ✓	49.7 EB05 46.5 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious n=596	no trial arm names this drug
Asthma exercise induced	24	44.3 29.2–67.0ROR 44.3 · calibrated p 6e-5 ✓	40.0 EB05 28.3 · IC025 +3.8 3/3 methods agree	No label text to screen	serious n=20	no trial arm names this drug
Periodic limb movement disorder	24	41.5 27.5–62.8ROR 41.6 · calibrated p 8e-5 ✓	37.8 EB05 26.7 · IC025 +3.8 3/3 methods agree	No label text to screen	serious n=20 · ♀ 100% (drug 72%)	no trial arm names this drug
Sleep-related eating disorder	58	39.3 30.1–51.2ROR 39.3 · calibrated p 8e-5 ✓	36.5 EB05 29.3 · IC025 +4.4 3/3 methods agree	No label text to screen	serious n=35	no trial arm names this drug
Sleep paralysis	88	38.2 30.8–47.3ROR 38.3 · calibrated p 8e-5 ✓	35.6 EB05 29.8 · IC025 +4.6 3/3 methods agree	No label text to screen	serious n=47	no trial arm names this drug
Narcolepsy	107	35.9 29.5–43.6ROR 36.0 · calibrated p 1e-4 ✓	33.7 EB05 28.7 · IC025 +4.6 3/3 methods agree	No label text to screen	serious n=97 · 74% consumer	no trial arm names this drug
Perinatal depression	24	34.0 22.5–51.2ROR 34.0 · calibrated p 2e-4 ✓	31.4 EB05 22.2 · IC025 +3.6 3/3 methods agree	No label text to screen	serious n=22 · ♀ 100% (drug 72%)	no trial arm names this drug
Manufacturing issue	24	33.2 22.0–50.1ROR 33.3 · calibrated p 3e-4 ✓	30.8 EB05 21.8 · IC025 +3.6 3/3 methods agree	No label text to screen	100% consumer	no trial arm names this drug
Abnormal sleep-related event	63	29.8 23.1–38.3ROR 29.8 · calibrated p 3e-4 ✓	28.2 EB05 22.8 · IC025 +4.1 3/3 methods agree	No label text to screen	serious n=35	no trial arm names this drug
Parasomnia	33	29.5 20.8–41.8ROR 29.5 · calibrated p 4e-4 ✓	27.7 EB05 20.6 · IC025 +3.7 3/3 methods agree	No label text to screen	serious n=20	no trial arm names this drug
Sleep attacks	22	29.0 18.9–44.5ROR 29.0 · calibrated p 5e-4 ✓	27.1 EB05 18.9 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial arm names this drug
Postural orthostatic tachycardia syndrome	55	26.1 19.9–34.2ROR 26.2 · calibrated p 7e-4 ✓	24.9 EB05 19.8 · IC025 +3.9 3/3 methods agree	No label text to screen	serious n=45	no trial arm names this drug
Somnambulism	275	26.0 23.0–29.3ROR 26.2 · calibrated p 6e-4 ✓	24.9 EB05 22.5 · IC025 +4.4 3/3 methods agree	No label text to screen	serious n=155	no trial arm names this drug
Ehlers-danlos syndrome	19	25.5 16.1–40.4ROR 25.5 · calibrated p 0.001 ✓	24.0 EB05 16.2 · IC025 +3.2 3/3 methods agree	No label text to screen	serious n=16	no trial arm names this drug
Attention deficit hyperactivity disorder	170	25.5 –ROR 25.6 · –	–	No label text to screen	serious n=125 · 70% consumer	no trial arm names this drug
Obstructive sleep apnoea syndrome	56	24.9 19.1–32.6ROR 25.0 · calibrated p 8e-4 ✓	23.8 EB05 19.0 · IC025 +3.9 3/3 methods agree	No label text to screen	serious n=53	no trial arm names this drug
Enuresis	160	24.6 21.0–28.8ROR 24.7 · calibrated p 8e-4 ✓	23.6 EB05 20.7 · IC025 +4.2 3/3 methods agree	No label text to screen	serious n=82	no trial arm names this drug
Substance use	61	24.6 19.0–31.8ROR 24.6 · calibrated p 9e-4 ✓	23.5 EB05 18.9 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious n=35	no trial arm names this drug
Snoring	147	24.2 20.5–28.5ROR 24.3 · calibrated p 8e-4 ✓	23.2 EB05 20.2 · IC025 +4.2 3/3 methods agree	No label text to screen	serious n=85	no trial arm names this drug
Attention deficit/hyperactivity disorder	113	21.3 17.7–25.7ROR 21.4 · calibrated p 0.002 ✓	20.6 EB05 17.6 · IC025 +3.9 3/3 methods agree	No label text to screen	serious n=68 · 76% consumer	no trial arm names this drug
Dissociation	255	20.9 18.4–23.6ROR 21.0 · calibrated p 0.002 ✓	20.2 EB05 18.2 · IC025 +4.1 3/3 methods agree	No label text to screen	serious n=223 · 90% clinician	no trial arm names this drug
Sleep apnoea syndrome	629	20.3 18.7–21.9ROR 20.6 · calibrated p 0.002 ✓	19.6 EB05 18.4 · IC025 +4.1 3/3 methods agree	No label text to screen	serious PRR 27.2	no trial arm names this drug
Job dissatisfaction	19	18.0 11.4–28.4ROR 18.0 · calibrated p 0.005 ✓	17.0 EB05 11.2 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial arm names this drug
Hangover	102	17.7 14.5–21.6ROR 17.8 · calibrated p 0.004 ✓	17.2 EB05 14.5 · IC025 +3.7 3/3 methods agree	No label text to screen	serious n=52	no trial arm names this drug
Thyrotoxic crisis	32	17.4 12.2–24.7ROR 17.4 · calibrated p 0.005 ✓	16.7 EB05 12.2 · IC025 +3.2 3/3 methods agree	No label text to screen	serious n=32 · ♀ 0% (drug 72%) · 100% clinician	no trial arm names this drug
Sudden onset of sleep	36	15.8 11.4–22.0ROR 15.8 · calibrated p 0.007 ✓	15.2 EB05 11.3 · IC025 +3.1 3/3 methods agree	No label text to screen	serious n=24	no trial arm names this drug
Choroidal effusion	20	15.3 9.8–23.9ROR 15.3 · calibrated p 0.009 ✓	14.4 EB05 9.4 · IC025 +2.7 3/3 methods agree	No label text to screen	serious n=20 · 100% clinician	no trial arm names this drug
Terminal insomnia	41	14.4 10.6–19.7ROR 14.4 · calibrated p 0.010 ✓	13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree	No label text to screen	100% consumer	no trial arm names this drug
Generalised anxiety disorder	34	14.1 10.1–19.9ROR 14.2 · calibrated p 0.011 ✓	13.5 EB05 9.9 · IC025 +3.0 3/3 methods agree	No label text to screen	serious n=29	no trial arm names this drug
Post-traumatic stress disorder	155	14.1 12.0–16.5ROR 14.1 · calibrated p 0.009 ✓	13.7 EB05 12.0 · IC025 +3.5 3/3 methods agree	No label text to screen	serious n=133	no trial arm names this drug
Sleep talking	39	13.9 10.1–19.1ROR 13.9 · calibrated p 0.011 ✓	13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree	No label text to screen	serious n=14	no trial arm names this drug
Feeling drunk	164	13.4 11.5–15.6ROR 13.5 · calibrated p 0.011 ✓	13.1 EB05 11.5 · IC025 +3.4 3/3 methods agree	No label text to screen	serious n=85	no trial arm names this drug
Mast cell activation syndrome	29	13.4 9.2–19.3ROR 13.4 · calibrated p 0.014 ✓	12.6 EB05 8.9 · IC025 +2.8 3/3 methods agree	No label text to screen	serious n=27 · ♀ 100% (drug 72%) · 100% consumer	no trial arm names this drug
Moaning	23	12.5 8.3–18.9ROR 12.5 · calibrated p 0.019 ✓	11.6 EB05 7.7 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial arm names this drug
Tachyphrenia	68	11.9 9.4–15.2ROR 12.0 · calibrated p 0.019 ✓	11.5 EB05 9.3 · IC025 +3.0 3/3 methods agree	No label text to screen	serious n=35	no trial arm names this drug
Gambling disorder	51	11.4 8.7–15.1ROR 11.4 · calibrated p 0.022 ✓	10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree	No label text to screen	serious n=36	no trial arm names this drug
Binge eating	20	11.3 7.3–17.6ROR 11.3 · calibrated p 0.027 ✓	10.2 EB05 6.6 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial arm names this drug
Abnormal uterine bleeding	46	11.2 8.4–15.0ROR 11.2 · calibrated p 0.024 ✓	10.7 EB05 8.2 · IC025 +2.8 3/3 methods agree	No label text to screen	serious n=34 · ♀ 100% (drug 72%)	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dextroamphetamine Saccharate only as a background or rescue medication (NCT03327402); 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)	3,331	1.5 1.5–1.6ROR 1.6 · calibrated p 0.685	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.7 · 73% consumer	no trial arm names this drug
Fatigue (tiredness)	2,835	2.2 2.1–2.3ROR 2.3 · calibrated p 0.908	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	No label text to screen	serious PRR 2.3 · 71% consumer	no trial arm names this drug
Nausea	2,627	2.0 1.9–2.1ROR 2.1 · calibrated p 0.983	2.0 EB05 1.9 · IC025 +0.9	No label text to screen	serious PRR 2.2	no trial arm names this drug
Headache	2,305	2.2 2.1–2.3ROR 2.3 · calibrated p 0.909	2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree	No label text to screen	serious PRR 2.6	no trial arm names this drug
Anxiety	2,179	4.6 4.4–4.8ROR 4.8 · calibrated p 0.254	4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 5.0	no trial arm names this drug
Depression	1,881	4.9 4.7–5.2ROR 5.2 · calibrated p 0.217	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	No label text to screen	serious PRR 5.8	no trial arm names this drug
Pain	1,645	1.6 1.5–1.7ROR 1.6 · calibrated p 0.724	1.6 EB05 1.5 · IC025 +0.6	No label text to screen	serious PRR 1.9	no trial arm names this drug
Feeling abnormal	1,643	4.1 3.9–4.3ROR 4.3 · calibrated p 0.334	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 5.2 · 72% consumer	no trial arm names this drug
Dizziness	1,592	1.9 1.8–2.0ROR 2.0 · calibrated p 0.920	1.9 EB05 1.8 · IC025 +0.9	No label text to screen	serious PRR 2.1 · 70% consumer	no trial arm names this drug
Somnolence (drowsiness)	1,460	4.4 4.1–4.6ROR 4.5 · calibrated p 0.295	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 4.1	no trial arm names this drug
Insomnia (trouble sleeping)	1,380	3.1 2.9–3.3ROR 3.2 · calibrated p 0.569	3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree	No label text to screen	serious PRR 3.5 · 73% consumer	no trial arm names this drug
Off label use (used outside approved label)	1,228	0.8 0.8–0.9ROR 0.8 · calibrated p 0.207	0.8 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.9	no trial arm names this drug
Vomiting	1,180	1.5 1.4–1.6ROR 1.5 · calibrated p 0.656	1.5 EB05 1.4 · IC025 +0.5	No label text to screen	serious PRR 1.5	no trial arm names this drug
Fall	1,093	2.0 1.9–2.1ROR 2.0 · calibrated p 0.943	2.0 EB05 1.9 · IC025 +0.9	No label text to screen	serious PRR 2.2	no trial arm names this drug
Condition aggravated	1,044	2.1 1.9–2.2ROR 2.1 · calibrated p 0.998	2.1 EB05 2.0 · IC025 +0.9	Reporting / coding artifact	serious PRR 2.3	no trial arm names this drug

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Amphetamine ↔ Drug Abuse.

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 Saccharate?

In FDA FAERS, the most frequently co-reported reaction terms for Dextroamphetamine Saccharate are fatigue, nausea, headache, anxiety, depression, pain. 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 Saccharate have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Dextroamphetamine Saccharate 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 1,175 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 SACCHARATE, 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.