What the label lists and what reports show
Dextroamphetamine side effects
Dextroamphetamine's FDA label lists its adverse reactions in its own words. FAERS holds 7,605 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 (591 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the dextroamphetamine FDA label on DailyMed (effective November 26, 2025, Azurity Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of Zenzedi?Zenzedi may cause serious side effects, including: See “What is the most important information I should know about Zenzedi?” Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Zenzedi. Your healthcare provider may stop your child’s Zenzedi treatment if they are not growing or gaining weight as expected. Seizures. Your healthcare provider may stop treatment with Adderall if you or your child have a seizure. 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, Azurity Pharmaceuticals, Inc., effective November 26, 2025 (SPL set d6394df5-f2c9-47eb-b57e-f3e9cfd94f84), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsCardiovascular Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette's syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic Urticaria Endocrine Impotence, changes in libido, frequent or prolonged erections. Musculoskeletal Rhabdomyolysis
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the XELSTRYM label published by Noven Therapeutics, LLC of December 23, 2025; the label quoted above does not print one.
| System Organ Class Preferred Term | XELSTRYM All Doses (n = 105) % | Placebo (n = 105) % |
|---|---|---|
| Decreased appetite | 12 | 2 |
| Headache | 6 | 4 |
| Insomnia | 8 | 6 |
| Affect lability | 3 | 0 |
| Tic | 2 | 0 |
| Vomiting | 4 | 0 |
| Abdominal pain | 4 | 2 |
| Nausea | 3 | 1 |
| Irritability | 2 | 1 |
| Blood pressure increased | 2 | 1 |
| Heart rate increased | 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.
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective November 26, 2025 (SPL set d6394df5-f2c9-47eb-b57e-f3e9cfd94f84), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,605 reports list dextroamphetamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 217 are coded as a death and 1,181 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 21 reactions below, 6 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?
- Dextroamphetamine: 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