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lisdexamfetamine Side Effects

Also known as: Vyvanse

Analysis of 5,840 adverse event reports submitted to the FDA from 2007 to 2025.

Total Reports

5,840

Death-Related

208

3.6% of reports

Hospitalizations

1,746

29.9% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

INTENTIONAL OVERDOSE
1,068
INTENTIONAL SELF-INJURY
1,009
DRUG INEFFECTIVE
904
PRODUCT AVAILABILITY ISSUE
487
FATIGUE
402
HEADACHE
377
ANXIETY
357
INABILITY TO AFFORD MEDICATION
348
PRODUCT SUBSTITUTION ISSUE
344
OFF LABEL USE
318
DEPRESSION
303
CONDITION AGGRAVATED
268
INSOMNIA
248
PRODUCT USE ISSUE
244
INSURANCE ISSUE
230
SUICIDAL IDEATION
224
SOMNOLENCE
221
NAUSEA
217
FEELING ABNORMAL
216
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION
195

Who Reports Side Effects

Gender Distribution

Female 2,887 (61%)
Male 1,795 (38%)
Unknown 29

Age Distribution

0-17 1,250 (37%)
18-44 1,589 (47%)
45-64 505 (15%)
65-74 41 (1%)
75+ 3 (0%)

Reporting Trend by Year

2007 2025

Reactions in Death Reports

Top reactions reported in 208 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
COMPLETED SUICIDE 95
TOXICITY TO VARIOUS AGENTS 55
CARDIO-RESPIRATORY ARREST 38
DEATH 29
CARDIAC ARREST 23
RESPIRATORY ARREST 19
HYPOTENSION 13
COMA 12
SUSPECTED SUICIDE 12
DEPRESSED LEVEL OF CONSCIOUSNESS 10
METABOLIC ACIDOSIS 9
RESPIRATORY DEPRESSION 9
ANION GAP 7
CIRCULATORY COLLAPSE 6
SEIZURE 6
ADRENERGIC SYNDROME 5
HYPERTHERMIA 5
AGGRESSION 4
AGITATION 4
BLOOD CREATINE PHOSPHOKINASE INCREASED 4

Reactions in Hospitalization Reports

Top reactions in 1,746 reports where hospitalization was an outcome.

Reaction Reports
INTENTIONAL OVERDOSE 895
INTENTIONAL SELF-INJURY 830
DRUG INTERACTION 105
TOXICITY TO VARIOUS AGENTS 95
SUICIDE ATTEMPT 77
DRUG INEFFECTIVE 66
AGITATION 59
OVERDOSE 54
SEROTONIN SYNDROME 48
TACHYCARDIA 47
VOMITING 46
NAUSEA 45
OFF LABEL USE 45
HYPOTENSION 43
ANXIETY 42
CARDIOGENIC SHOCK 41
HEADACHE 41
HYPERHIDROSIS 39
SUICIDAL IDEATION 37
DEPRESSION 33

Nearby — Related Medications

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What the FAERS Data Reveals About lisdexamfetamine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 5,840 voluntary reports linked to lisdexamfetamine and its brand equivalents (Vyvanse), spanning 2007 through 2025. Of those, 208 (3.6%) listed death as an outcome and 1,746 (29.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 61% were female and 38% male; age distribution skews toward 18-44, with 1,589 reports in that bracket. The single most reported reaction is intentional overdose with 1,068 submissions, followed by intentional self-injury and drug ineffective.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.