Lisdexamfetamine Dimesylate side effects: what 32,770 FDA adverse event reports show

Lisdexamfetamine Dimesylate · 1,147 reaction terms · 121,022 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

32,770 reports · 41% serious · 305 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Lisdexamfetamine Dimesylate Capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older . Moderate to severe binge eating disorder (BED) in adults .

FDA label, Indications and Usage

What it is

Lisdexamfetamine dimesylate capsules, a CNS stimulant, are for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.

FDA label, Description section

Boxed warning

ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CN.

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 1Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 7Lab value / disease marker 2Not in label — unassessed 24

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.
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). 1,107 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
Rhesus incompatibility	68	807.9 564.2–1,156.8ROR 809.6 · calibrated p 2e-15 ✓	322.3 EB05 263.0 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=68	no trial arm names this drug
Amphetamines negative	28	705.3 411.3–1,209.3ROR 705.9 · calibrated p 8e-14 ✓	271.5 EB05 197.1 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Adulterated product	28	108.8 72.9–162.5ROR 108.9 · calibrated p 2e-7 ✓	87.6 EB05 63.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=27 · ♀ 85% (drug 60%)	no trial arm names this drug
Change in sustained attention	43	108.3 78.4–149.7ROR 108.4 · calibrated p 1e-7 ✓	89.0 EB05 68.8 · IC025 +5.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=18 · 74% consumer	no trial arm names this drug
Disseminated mycobacterium avium complex infection	26	89.0 59.0–134.1ROR 89.0 · calibrated p 8e-7 ✓	74.0 EB05 53.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 0% (drug 60%)	no trial arm names this drug
Steroid dependence	102	87.2 70.9–107.2ROR 87.4 · calibrated p 4e-7 ✓	75.6 EB05 64.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 0% (drug 60%) · 91% clinician	no trial arm names this drug
Catarrh	102	82.8 67.4–101.7ROR 83.0 · calibrated p 6e-7 ✓	72.3 EB05 61.3 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 0% (drug 60%) · 92% clinician	no trial arm names this drug
Negativism	86	81.3 65.0–101.8ROR 81.5 · calibrated p 7e-7 ✓	71.0 EB05 59.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=18 · ♀ 26% (drug 60%)	no trial arm names this drug
Dermatillomania	63	77.3 59.5–100.4ROR 77.5 · calibrated p 1e-6 ✓	67.6 EB05 54.7 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=31	no trial arm names this drug
Onychophagia	29	75.5 51.3–110.9ROR 75.5 · calibrated p 2e-6 ✓	64.7 EB05 47.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Inability to afford medication	1,012	73.3 68.8–78.2ROR 75.6 · calibrated p 9e-7 ✓	65.7 EB05 62.4 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=105 · 84% consumer	no trial arm names this drug
Jaw clicking	19	67.2 41.9–107.9ROR 67.3 · calibrated p 6e-6 ✓	57.5 EB05 38.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Amphetamines positive	66	61.0 47.4–78.6ROR 61.1 · calibrated p 5e-6 ✓	54.9 EB05 44.6 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=9	no trial arm names this drug
Conduct disorder	17	56.3 34.3–92.5ROR 56.4 · calibrated p 2e-5 ✓	49.1 EB05 32.5 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial arm names this drug
Trichotillomania	46	54.0 40.0–73.0ROR 54.1 · calibrated p 1e-5 ✓	48.9 EB05 38.2 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Premenstrual dysphoric disorder	15	51.1 30.2–86.4ROR 51.1 · calibrated p 4e-5 ✓	44.8 EB05 28.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Product availability issue	1,574	48.2 45.9–50.7ROR 50.6 · calibrated p 1e-5 ✓	44.8 EB05 43.0 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 18.6	no trial arm names this drug
Educational problem	112	45.7 37.7–55.3ROR 45.8 · calibrated p 3e-5 ✓	42.4 EB05 36.2 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 24% (drug 60%)	no trial arm names this drug
Binge eating	71	45.2 35.5–57.5ROR 45.3 · calibrated p 3e-5 ✓	41.8 EB05 34.3 · IC025 +4.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=36 · ♀ 83% (drug 60%)	no trial arm names this drug
Tic	360	45.1 40.5–50.1ROR 45.5 · calibrated p 3e-5 ✓	42.0 EB05 38.5 · IC025 +5.1 3/3 methods agree	Labeled — boxed warning exact term	serious n=106 · ♀ 25% (drug 60%)	no trial arm names this drug
Burns second degree	111	43.3 35.7–52.4ROR 43.4 · calibrated p 4e-5 ✓	40.3 EB05 34.4 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=110 · ♀ 0% (drug 60%)	no trial arm names this drug
Urine amphetamine positive	21	43.1 27.7–67.0ROR 43.1 · calibrated p 7e-5 ✓	39.1 EB05 27.0 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Drug effect variable	72	42.7 33.7–54.2ROR 42.8 · calibrated p 4e-5 ✓	39.7 EB05 32.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Drug effect increased	181	38.2 32.9–44.3ROR 38.4 · calibrated p 7e-5 ✓	35.9 EB05 31.7 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=25	no trial arm names this drug
Intentional self-injury	1,089	36.4 34.3–38.7ROR 37.6 · calibrated p 7e-5 ✓	34.5 EB05 32.8 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 49.3	no trial arm names this drug
Suspected product tampering	27	33.5 22.8–49.4ROR 33.6 · calibrated p 2e-4 ✓	31.3 EB05 22.6 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious n=10 · 100% consumer	no trial arm names this drug
Cryptosporidiosis infection	26	33.2 22.4–49.3ROR 33.2 · calibrated p 3e-4 ✓	31.0 EB05 22.2 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 0% (drug 60%)	no trial arm names this drug
Disturbance in social behaviour	116	32.9 27.3–39.6ROR 33.0 · calibrated p 2e-4 ✓	31.2 EB05 26.7 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=37 · ♀ 20% (drug 60%)	no trial arm names this drug
Insurance issue	722	32.6 30.3–35.1ROR 33.3 · calibrated p 1e-4 ✓	31.0 EB05 29.2 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 11.6 · 75% consumer	no trial arm names this drug
Impulsive behaviour	172	30.6 26.3–35.7ROR 30.8 · calibrated p 2e-4 ✓	29.2 EB05 25.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=75 · ♀ 33% (drug 60%)	no trial arm names this drug
Oppositional defiant disorder	18	30.1 18.8–48.4ROR 30.2 · calibrated p 5e-4 ✓	28.0 EB05 18.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Product tampering	78	29.0 23.1–36.4ROR 29.1 · calibrated p 4e-4 ✓	27.6 EB05 22.8 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious n=25	no trial arm names this drug
Compulsive hoarding	14	28.8 16.9–49.2ROR 28.8 · calibrated p 8e-4 ✓	26.7 EB05 16.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Penis injury	15	27.5 16.4–46.0ROR 27.5 · calibrated p 9e-4 ✓	25.6 EB05 16.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Social anxiety disorder	27	27.3 18.6–40.1ROR 27.3 · calibrated p 7e-4 ✓	25.8 EB05 18.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Attention deficit hyperactivity disorder	170	27.3 –ROR 27.4 · –	–	Likely indication confounding term in indications; also in warnings	serious n=145	no trial arm names this drug
Logorrhoea	141	26.6 22.4–31.4ROR 26.7 · calibrated p 5e-4 ✓	25.4 EB05 22.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=37 · ♀ 38% (drug 60%)	no trial arm names this drug
Hypermetabolism	21	26.6 17.2–41.1ROR 26.6 · calibrated p 9e-4 ✓	25.0 EB05 17.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial arm names this drug
Therapeutic product effect variable	151	26.3 22.3–30.9ROR 26.4 · calibrated p 6e-4 ✓	25.2 EB05 22.0 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=32 · 77% consumer	no trial arm names this drug
Theft	26	25.8 17.4–38.2ROR 25.8 · calibrated p 9e-4 ✓	24.4 EB05 17.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Lisdexamfetamine Dimesylate 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)	4,670	2.3 2.2–2.3ROR 2.5 · calibrated p 0.821	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4	no trial arm names this drug
Fatigue (tiredness)	2,044	1.7 1.6–1.8ROR 1.7 · calibrated p 0.787	1.7 EB05 1.6 · IC025 +0.7	Not in label — unassessed	serious PRR 2.4	no trial arm names this drug
Off label use (used outside approved label)	2,030	1.5 1.4–1.6ROR 1.5 · calibrated p 0.661	1.5 EB05 1.4 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.8	no trial arm names this drug
Anxiety	1,802	4.1 3.9–4.2ROR 4.2 · calibrated p 0.337	4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6	no trial arm names this drug
Headache	1,765	1.8 1.7–1.9ROR 1.8 · calibrated p 0.859	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 2.7	no trial arm names this drug
Product availability issue	1,574	48.2 45.9–50.7ROR 50.6 · calibrated p 1e-5 ✓	44.8 EB05 43.0 · IC025 +5.4 3/3 methods agree	Reporting / coding artifact	serious PRR 18.6	no trial arm names this drug
Nausea	1,555	1.3 1.2–1.3ROR 1.3 · calibrated p 0.490	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Insomnia (trouble sleeping)	1,488	3.6 3.4–3.8ROR 3.7 · calibrated p 0.438	3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9	no trial arm names this drug
Depression	1,376	3.9 3.7–4.1ROR 4.0 · calibrated p 0.379	3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	no trial arm names this drug
Feeling abnormal	1,357	3.6 3.4–3.8ROR 3.7 · calibrated p 0.431	3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.7	no trial arm names this drug
Product use issue	1,319	4.5 4.3–4.8ROR 4.7 · calibrated p 0.272	4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial arm names this drug
Disturbance in attention	1,256	15.2 14.4–16.0ROR 15.7 · calibrated p 0.006 ✓	14.8 EB05 14.2 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.8	no trial arm names this drug
No adverse event	1,200	4.3 4.1–4.6ROR 4.5 · calibrated p 0.300	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial arm names this drug
Product quality issue	1,191	5.7 5.4–6.0ROR 5.9 · calibrated p 0.159	5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8	no trial arm names this drug
Intentional overdose	1,137	11.6 10.9–12.3ROR 12.0 · calibrated p 0.017 ✓	11.4 EB05 10.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 16.4 · 92% clinician	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.

Rhesus incompatibility — n=68, PRR 807.9
Adulterated product — n=28, PRR 108.8
Disseminated mycobacterium avium complex infection — n=26, PRR 89.0
Steroid dependence — n=102, PRR 87.2
Catarrh — n=102, PRR 82.8
Negativism — n=86, PRR 81.3
Onychophagia — n=29, PRR 75.5
Inability to afford medication — n=1,012, PRR 73.3
Trichotillomania — n=46, PRR 54.0
Educational problem — n=112, PRR 45.7

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 Lisdexamfetamine Dimesylate?

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

Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CN.

Do FAERS signals prove that Lisdexamfetamine Dimesylate 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 18a97c88-0f72-4b02-be0d-4d093886cca5, effective 20260316; matched on openfda.generic_name.exact:"LISDEXAMFETAMINE DIMESYLATE")
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, 1,147 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 LISDEXAMFETAMINE DIMESYLATE, 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.