Two medicines, side by side
Dexmethylphenidate vs amphetamine
Dexmethylphenidate and amphetamine are both labeled for ADHD. Drugs@FDA records approvals of dexmethylphenidate since 2001 and of amphetamine since 2016. Pharmacies paid $1.45 per dexmethylphenidate ER 10 mg capsule and $0.449 per amphetamine sulfate 10 mg tablet (NADAC, October 7, 2026). Amphetamine's other strengths are brand-only: $2.76 per mL (Dyanavel XR 2.5 mg/mL suspension).
Check it at the source: the dexmethylphenidate FDA label on DailyMed (effective May 30, 2024); the amphetamine FDA label on DailyMed (effective August 20, 2026).
Highlights of the dexmethylphenidate record
Dexmethylphenidate (Focalin) · label of May 30, 2024
ABUSE, MISUSE, AND ADDICTION Focalin has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin, can result in overdose and death [see Overdosage ( 10 )], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Focalin, assess each patient’s risk for abuse, misuse, and addiction.
Used for
From the label: indicationsFocalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )]. Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
On the market
- Earliest approval on file
- November 13, 2001
- Generic labelers
- 13 labelers
- Pharmacy cost
- $1.45 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Highlights of the amphetamine record
Amphetamine (Dyanavel) · label of August 20, 2026
WARNING: ABUSE, MISUSE, AND ADDICTION AMPHETAMINE SULFATE TABLET HAS A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION. MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING AMPHETAMINE SULFATE, CAN RESULT IN OVERDOSE AND DEATH (SEE OVERDOSAGE)], AND THIS RISK IS INCREASED WITH HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING OR INJECTION.
Used for
From the label: indicationsAmphetamine Sulfate Tablets USP are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. […]
On the market
- Earliest approval on file
- January 27, 2016
- Generic labelers
- 13 labelers
- Pharmacy cost
- $0.449 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Dexmethylphenidate label of May 30, 2024, Amphetamine label of August 20, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do dexmethylphenidate and amphetamine differ on the record?
Both are in FDA's class central nervous system stimulants.
Both labels carry a boxed warning; the records quote them.
Generics: dexmethylphenidate since 2007; amphetamine since 1976 (Drugs@FDA).
| Dexmethylphenidate | Amphetamine | |
|---|---|---|
| Labeled for | ADHD | ADHD |
| Pharmacologic class | Central Nervous System Stimulant | Central Nervous System Stimulant |
| How it works (label) | Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known. | n/a |
| Half-life (label) | The mean terminal elimination half-life of dexmethylphenidate was approximately 2.2 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | November 13, 2001 | January 27, 2016 |
| First generic approved | January 29, 2007 | February 26, 1976 |
| Generic labelers (NDC) | 13 labelers | 13 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $1.45 per capsule (Dexmethylphenidate ER 10 mg capsule) | $0.449 per tablet (Amphetamine sulfate 10 mg tablet) |
| 12-month price change | +4% | +14% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 4,207 | 8,452 |
| DEA schedule | CII | CII |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Amphetamine label, warningsIf concomitant use of Amphetamine Sulfate Tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Amphetamine Sulfate Tablets with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
Source: FDA drug labels via openFDA
What next?
- Alternatives to dexmethylphenidate
- every medicine labeled for the same conditions