Drug · FAERS side-effect profile with label screen
Lisdexamfetamine side effects: what 6,681 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Lisdexamfetamine Dimesylate
openFDA label
Who reports
6,681 reports · 72% serious · 230 with death outcome · 62% 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, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.
FDA label, Description section
Boxed warning
ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate 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 stimulan.
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 7Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 9Not in label — unassessed 19
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. 260 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 |
|---|---|---|---|---|---|---|
| Intentional self-injury | 1,027 | 168.0 158.6–178.1ROR 198.3 · χ² 161,718 / p <1e-300 | 158.9 EB05 151.0 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious PRR 129.6 · 94% clinician | no trial data cached |
| Inability to afford medication | 387 | 128.3 116.3–141.7ROR 136.2 · χ² 46,846 / p <1e-300 | 122.5 EB05 112.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=59 · 87% consumer | no trial data cached |
| Product availability issue | 503 | 71.9 66.0–78.3ROR 77.6 · χ² 34,326 / p <1e-300 | 70.1 EB05 65.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 31.0 · 78% consumer | no trial data cached |
| Insurance issue | 259 | 55.6 49.3–62.7ROR 57.8 · χ² 13,589 / p <1e-300 | 54.4 EB05 49.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 77% consumer | no trial data cached |
| Intentional overdose | 1,081 | 54.0 51.1–57.1ROR 64.2 · χ² 55,402 / p <1e-300 | 53.1 EB05 50.5 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 44.4 · 96% clinician | no trial data cached |
| Product substitution issue | 437 | 24.0 21.9–26.2ROR 25.6 · χ² 9,543 / p <1e-300 | 23.8 EB05 21.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 83% consumer | no trial data cached |
| Impaired quality of life | 106 | 23.2 19.2–28.1ROR 23.6 · χ² 2,218 / p <1e-300 | 23.0 EB05 19.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 25.2 · ♀ 16% (drug 62%) | no trial data cached |
| Drug effect less than expected | 98 | 21.9 18.0–26.7ROR 22.2 · χ² 1,923 / p <1e-300 | 21.7 EB05 18.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=34 · 78% consumer | no trial data cached |
| Brain fog | 100 | 21.6 17.8–26.3ROR 21.9 · χ² 1,933 / p <1e-300 | 21.4 EB05 18.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · 80% consumer | no trial data cached |
| Product physical issue | 133 | 21.0 17.8–24.9ROR 21.4 · χ² 2,503 / p <1e-300 | 20.8 EB05 18.0 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=32 · 79% consumer | no trial data cached |
| Tubulointerstitial nephritis | 107 | 18.0 14.9–21.7ROR 18.3 · χ² 1,692 / p <1e-300 | 17.8 EB05 15.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · ♀ 9% (drug 62%) · 93% clinician | no trial data cached |
| Impaired work ability | 122 | 17.9 15.0–21.4ROR 18.2 · χ² 1,922 / p <1e-300 | 17.8 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · ♀ 14% (drug 62%) | no trial data cached |
| Serotonin syndrome | 90 | 14.8 12.0–18.2ROR 15.0 · χ² 1,140 / p 3e-250 | 14.7 EB05 12.3 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.0 | no trial data cached |
| Affect lability | 42 | 13.7 10.1–18.5ROR 13.7 · χ² 478 / p 3e-106 | 13.4 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.2 · ♀ 33% (drug 62%) | no trial data cached |
| Disturbance in attention | 230 | 13.4 11.8–15.2ROR 13.8 · χ² 2,616 / p <1e-300 | 13.3 EB05 11.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 78% consumer | no trial data cached |
| Loss of personal independence in daily activities | 201 | 13.3 11.6–15.2ROR 13.7 · χ² 2,268 / p <1e-300 | 13.2 EB05 11.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 26% (drug 62%) | no trial data cached |
| Frequent bowel movements | 109 | 12.7 10.6–15.3ROR 12.9 · χ² 1,164 / p 2e-255 | 12.6 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · ♀ 4% (drug 62%) | no trial data cached |
| Irritability | 234 | 12.2 10.8–13.9ROR 12.6 · χ² 2,395 / p <1e-300 | 12.1 EB05 10.9 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.3 | no trial data cached |
| Apathy | 53 | 11.5 8.8–15.0ROR 11.5 · χ² 494 / p 8e-110 | 11.1 EB05 8.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 72% consumer | no trial data cached |
| Swollen tongue | 114 | 11.5 9.5–13.8ROR 11.6 · χ² 1,075 / p 4e-236 | 11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · ♀ 15% (drug 62%) | no trial data cached |
| Psychomotor hyperactivity | 60 | 11.3 8.8–14.6ROR 11.4 · χ² 552 / p 2e-122 | 11.0 EB05 8.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · ♀ 24% (drug 62%) | no trial data cached |
| Status epilepticus | 40 | 11.1 8.1–15.1ROR 11.2 · χ² 357 / p 7e-80 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Cardiogenic shock | 50 | 11.0 8.3–14.5ROR 11.1 · χ² 444 / p 8e-99 | 10.6 EB05 8.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.8 · 98% clinician | no trial data cached |
| Coordination abnormal | 45 | 10.1 7.5–13.5ROR 10.1 · χ² 357 / p 5e-80 | 9.6 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 · ♀ 10% (drug 62%) | no trial data cached |
| Bipolar disorder | 35 | 10.0 7.2–14.0ROR 10.1 · χ² 275 / p 4e-62 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 | no trial data cached |
| Poisoning deliberate | 29 | 9.8 6.8–14.1ROR 9.8 · χ² 220 / p 6e-50 | 9.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 93% (drug 62%) · 100% clinician | no trial data cached |
| Nightmare | 107 | 9.7 8.0–11.7ROR 9.8 · χ² 822 / p 5e-181 | 9.5 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 · ♀ 4% (drug 62%) | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 278 | 9.5 8.5–10.7ROR 9.9 · χ² 2,116 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Systemic lupus erythematosus | 102 | 9.1 7.5–11.0ROR 9.2 · χ² 722 / p 3e-159 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · ♀ 3% (drug 62%) · 91% clinician | no trial data cached |
| Accidental overdose | 105 | 9.0 7.5–10.9ROR 9.1 · χ² 740 / p 3e-163 | 8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 0% (drug 62%) · 90% clinician | no trial data cached |
| Euphoric mood | 29 | 8.8 6.1–12.7ROR 8.9 · χ² 193 / p 3e-44 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
| Mydriasis | 36 | 8.8 6.4–12.2ROR 8.9 · χ² 241 / p 1e-54 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 | no trial data cached |
| Depressed mood | 145 | 8.6 7.4–10.2ROR 8.8 · χ² 973 / p 7e-214 | 8.5 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Medication error | 148 | 8.4 7.1–9.8ROR 8.5 · χ² 953 / p 1e-209 | 8.2 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · ♀ 23% (drug 62%) | no trial data cached |
| Sexual dysfunction | 30 | 8.1 5.6–11.5ROR 8.1 · χ² 178 / p 6e-41 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 83% consumer | no trial data cached |
| Aggression | 126 | 7.9 6.6–9.4ROR 8.0 · χ² 751 / p 2e-165 | 7.7 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 · ♀ 30% (drug 62%) | no trial data cached |
| Tinnitus (ringing in the ears) | 114 | 7.8 6.5–9.3ROR 7.9 · χ² 666 / p 3e-147 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 12% (drug 62%) | no trial data cached |
| Product packaging quantity issue | 27 | 7.8 5.3–11.3ROR 7.8 · χ² 152 / p 3e-35 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=6 · 78% consumer | no trial data cached |
| Rectal haemorrhage | 105 | 7.6 6.3–9.2ROR 7.7 · χ² 599 / p 1e-132 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 0% (drug 62%) · 92% clinician | no trial data cached |
| Colitis ulcerative | 107 | 7.5 6.2–9.1ROR 7.6 · χ² 599 / p 1e-132 | 7.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 0% (drug 62%) · 91% clinician | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,082 | 2.6 2.4–2.7ROR 2.9 · χ² 1,110 / p 1e-243 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Intentional overdose | 1,081 | 54.0 51.1–57.1ROR 64.2 · χ² 55,402 / p <1e-300 | 53.1 EB05 50.5 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 44.4 · 96% clinician | no trial data cached |
| Intentional self-injury | 1,027 | 168.0 158.6–178.1ROR 198.3 · χ² 161,718 / p <1e-300 | 158.9 EB05 151.0 · IC025 +7.1 3/3 methods agree | Reporting / coding artifact | serious PRR 129.6 · 94% clinician | no trial data cached |
| Product availability issue | 503 | 71.9 66.0–78.3ROR 77.6 · χ² 34,326 / p <1e-300 | 70.1 EB05 65.1 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 31.0 · 78% consumer | no trial data cached |
| Fatigue (tiredness) | 486 | 2.0 1.8–2.1ROR 2.0 · χ² 236 / p 1e-53 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Headache | 457 | 2.3 2.1–2.5ROR 2.4 · χ² 340 / p 4e-76 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Anxiety | 444 | 4.9 4.5–5.3ROR 5.2 · χ² 1,383 / p <1e-300 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Product substitution issue | 437 | 24.0 21.9–26.2ROR 25.6 · χ² 9,543 / p <1e-300 | 23.8 EB05 21.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 · 83% consumer | no trial data cached |
| Inability to afford medication | 387 | 128.3 116.3–141.7ROR 136.2 · χ² 46,846 / p <1e-300 | 122.5 EB05 112.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=59 · 87% consumer | no trial data cached |
| Depression | 345 | 4.7 4.3–5.2ROR 4.9 · χ² 1,022 / p 1e-224 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Condition aggravated | 316 | 3.3 2.9–3.7ROR 3.4 · χ² 505 / p 3e-112 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · ♀ 41% (drug 62%) | no trial data cached |
| Insomnia (trouble sleeping) | 291 | 3.4 3.1–3.8ROR 3.5 · χ² 502 / p 2e-111 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 278 | 9.5 8.5–10.7ROR 9.9 · χ² 2,116 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Somnolence (drowsiness) | 270 | 4.2 3.7–4.7ROR 4.3 · χ² 663 / p 1e-146 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · ♀ 39% (drug 62%) | no trial data cached |
| Insurance issue | 259 | 55.6 49.3–62.7ROR 57.8 · χ² 13,589 / p <1e-300 | 54.4 EB05 49.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 77% consumer | 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.
- Inability to afford medication — n=387, PRR 128.3
- Insurance issue — n=259, PRR 55.6
- Impaired quality of life — n=106, PRR 23.2
- Brain fog — n=100, PRR 21.6
- Tubulointerstitial nephritis — n=107, PRR 18.0
- Impaired work ability — n=122, PRR 17.9
- Loss of personal independence in daily activities — n=201, PRR 13.3
- Frequent bowel movements — n=109, PRR 12.7
- Apathy — n=53, PRR 11.5
- Swollen tongue — n=114, PRR 11.5
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?
In FDA FAERS, the most frequently co-reported reaction terms for Lisdexamfetamine are fatigue, headache, anxiety, inability to afford medication, depression, insomnia. 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 have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate 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 stimulan.
Do FAERS signals prove that Lisdexamfetamine 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 efbde0f6-b848-4664-b741-c6c630e66108, effective 20260522; matched on
openfda.generic_name.exact:"LISDEXAMFETAMINE") - 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, 300 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.