What the label lists and what reports show
Amphetamine and dextroamphetamine side effects
Amphetamine and dextroamphetamine's FDA label lists its adverse reactions in its own words. FAERS holds 41,250 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 (3,231 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the amphetamine and dextroamphetamine FDA label on DailyMed (effective August 4, 2026, SUNRISE PHARMACEUTICAL, INC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsCardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders Vision blurred, mydriasis. 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, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. …
Table 2: Adverse Reactions Reported by 5% or More of Adolescents (13 to 17 Years Old) Weighing ≤75 kg/165 lbs Receiving ADDERALL XR with Higher Incidence than Placebo in a 287 Patient Clinical Forced Weekly-Dose…
This table is printed in the Adderall XR label published by Takeda Pharmaceuticals America, Inc. of April 30, 2026; the label quoted above does not print one.
| Preferred Term | ADDERALL XR (n=233) | Placebo (n=54) |
|---|---|---|
| Abdominal Pain (stomachache) | 11% | 2% |
| Loss of Appetite Dose-related adverse reactions. | 36% | 2% |
| Insomnia | 12% | 4% |
| Weight Loss | 9% | 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, SUNRISE PHARMACEUTICAL, INC., effective August 4, 2026 (SPL set ac102599-3a5b-4154-899e-6ff262be7ff7), via openFDA; the full label on DailyMed
What do FAERS reports show?
41,250 reports list amphetamine and dextroamphetamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 504 are coded as a death and 4,904 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, 5 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?
- Amphetamine and 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