What the label lists and what reports show
Lisdexamfetamine side effects
Lisdexamfetamine's FDA label: “Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability …” FAERS holds 34,602 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,150 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the lisdexamfetamine FDA label on DailyMed (effective April 30, 2026, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VYVANSE?VYVANSE may cause serious side effects, including: See " What is the most important information I should know about VYVANSE? " Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with VYVANSE. VYVANSE treatment may be stopped if your child is not growing or gaining weight as expected. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include: fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. […]
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective April 30, 2026 (SPL set 704e4378-ca83-445c-8b45-3cfa51c1ecad), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.
Table 4 Adverse Reactions Reported by 2% or More of Adult Patients with BED Taking VYVANSE and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in 12-Week Clinical Trials (Study 11 and 12)
| Reaction | VYVANSE (N=373) | Placebo (N=372) |
|---|---|---|
| Dry Mouth | 36% | 7% |
| Insomnia Includes all preferred terms containing the word "insomnia." | 20% | 8% |
| Decreased Appetite | 8% | 2% |
| Increased Heart Rate Includes the preferred terms "heart rate increased" and… | 7% | 1% |
| Feeling Jittery | 6% | 1% |
| Constipation | 6% | 1% |
| Anxiety | 5% | 1% |
| Diarrhea | 4% | 2% |
| Decreased Weight | 4% | 0% |
| Hyperhidrosis | 4% | 0% |
| Vomiting | 2% | 1% |
| Gastroenteritis | 2% | 1% |
| Paresthesia | 2% | 1% |
| Pruritus | 2% | 1% |
| Upper Abdominal Pain | 2% | 0% |
| Energy Increased | 2% | 0% |
| Urinary Tract Infection | 2% | 0% |
| Nightmare | 2% | 0% |
| Restlessness | 2% | 0% |
| Oropharyngeal Pain | 2% | 0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2 , 9.3) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. …
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective April 30, 2026 (SPL set 704e4378-ca83-445c-8b45-3cfa51c1ecad), via openFDA; the full label on DailyMed
What do FAERS reports show?
34,602 reports list lisdexamfetamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 470 are coded as a death and 4,332 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lisdexamfetamine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions