What the label lists and what reports show
Amphetamine side effects
Amphetamine's FDA label lists its adverse reactions in its own words. FAERS holds 8,452 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 toxicity to various agents (2,183 reports).
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the amphetamine FDA label on DailyMed (effective August 20, 2026, Aurolife Pharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of Amphetamine Sulfate Tablets?Amphetamine Sulfate Tablets may cause serious side effects, including: See "What is the most important information I should know about Amphetamine Sulfate Tablets?" · slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with Amphetamine Sulfate Tablets. Your healthcare provider may stop your child’s Amphetamine Sulfate Tablets treatment if they are not growing or gaining weight as expected. · Seizures, your healthcare provider may stop treatment with Amphetamine Sulfate Tablets if you or your child have a seizure. · Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). […]
Source: FDA drug label, Aurolife Pharma, LLC, effective August 20, 2026 (SPL set 20735c2e-6304-425f-a4e4-584f6f90d6a0), 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 when amphetamines are used for other than the anorectic effect. Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections. Musculoskeletal Rhabdomyolysis
Table 4: Adverse Reactions Reported by 5% or More of Adults Receiving MAS ER with Higher Incidence Than Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study Included doses up to 60 mg.
This table is printed in the Adzenys XR-ODT label published by Neos Therapeutics Brands, LLC of May 6, 2026; the label quoted above does not print one.
| Preferred Term | MAS ER (n=191) | Placebo (n=64) |
|---|---|---|
| Headache | 26% | 13% |
| Dry Mouth | 35% | 5% |
| Insomnia | 27% | 13% |
| Tachycardia | 6% | 3% |
| Weight Loss | 10% | 0% |
| Urinary Tract Infection | 5% | 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, Aurolife Pharma, LLC, effective August 20, 2026 (SPL set 20735c2e-6304-425f-a4e4-584f6f90d6a0), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,452 reports list amphetamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,903 are coded as a death and 1,842 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 17 reactions below, 4 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: 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