Prescription medicine
Dexmethylphenidate and serdexmethylphenidate Brand names: Azstarys
Dexmethylphenidate and serdexmethylphenidate (Azstarys) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $14.40 per Azstarys 26.1 mg-5.2 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the dexmethylphenidate and serdexmethylphenidate FDA label on DailyMed (effective May 11, 2026, Commave Sub, LLC); the NDA 212994 record on Drugs@FDA; every dexmethylphenidate and serdexmethylphenidate label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ABUSE, MISUSE, AND ADDICTION.
AZSTARYS 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 AZSTARYS, 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 AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 ) and Drug Abuse and Dependence ( 9.2 )]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. AZSTARYS 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 AZSTARYS, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. […]
Used for
From the label: indications and usageAZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
Forms and strengths
- 26.1 mg / 5.2 mg
- 39.2 mg / 7.8 mg
- 52.3 mg / 10.4 mg
Capsule.
On the market
- Earliest approval on file
- March 2, 2021 Azstarys, Commave Sub; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 9, 2037 Azstarys capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $14.40 per capsule Azstarys 26.1 mg-5.2 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 723 through July 30, 2026
What is dexmethylphenidate and serdexmethylphenidate used for?
From the label: indications and usageAZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. […]
Conditions named in the indications of dexmethylphenidate and serdexmethylphenidate's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Central Nervous System Stimulant.
Source: FDA drug label (AZSTARYS), Commave Sub, LLC, effective May 11, 2026 (SPL set 00b5e716-5564-4bbd-acaf-df2bc45a5663), via openFDA; the full label on DailyMed
What does the patient leaflet for dexmethylphenidate and serdexmethylphenidate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about AZSTARYS?AZSTARYS can cause serious side effects, including: Abuse misuse, and addiction. AZSTARYS has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of AZSTARYS, other methylphenidate containing medicines, and amphetamine containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of AZSTARYS or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with AZSTARYS and will monitor you or your child during treatment. AZSTARYS may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give AZSTARYS to anyone else. See “What is AZSTARYS?” for more information. Keep AZSTARYS in a safe place and properly dispose of any unused medicine. See “How should I store AZSTARYS?” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with AZSTARYS. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with AZSTARYS. Increased blood pressure and heart rate. […]
From the patient leaflet: How should I store AZSTARYS?Store AZSTARYS in a safe place and in a tightly closed container at room temperature between at room temperature between 68°F to 77°F (20°C to 25°C). Dispose of remaining, unused, or expired AZSTARYS by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or authorized collector is available, mix AZSTARYS with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away (discard) AZSTARYS in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep AZSTARYS and all medicines out of the reach of children.
Source: FDA drug label (AZSTARYS), Commave Sub, LLC, effective May 11, 2026 (SPL set 00b5e716-5564-4bbd-acaf-df2bc45a5663), via openFDA; the full label on DailyMed
Is there a generic for dexmethylphenidate and serdexmethylphenidate (Azstarys)?
No generic dexmethylphenidate and serdexmethylphenidate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Azstarys capsules: the compound patent runs to December 9, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dexmethylphenidate and serdexmethylphenidate (Azstarys)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $14.40 per Azstarys 26.1 mg-5.2 mg capsule, up 4% from $13.91 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Azstarys 26.1 mg-5.2 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Azstarys 26.1 mg-5.2 mg capsule | Brand | $14.40 per capsule | $432.03 | +4% |
| Azstarys 39.2 mg-7.8 mg capsule | Brand | $14.42 per capsule | $432.55 | +4% |
| Azstarys 52.3 mg-10.4 mg capsule | Brand | $14.41 per capsule | $432.38 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dexmethylphenidate and serdexmethylphenidate label say about other medicines?
The dexmethylphenidate and serdexmethylphenidate label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Methylphenidate | contraindications | CONTRAINDICATIONS AZSTARYS is contraindicated in patients: with known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of AZSTARYS. |
| Risperidone | drug interactions | Clinical Impact; Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). |
Check dexmethylphenidate and serdexmethylphenidate against other medicines
Source: FDA drug label (AZSTARYS), Commave Sub, LLC, effective May 11, 2026 (SPL set 00b5e716-5564-4bbd-acaf-df2bc45a5663), via openFDA; the full label on DailyMed
What do FAERS reports show for dexmethylphenidate and serdexmethylphenidate?
The FDA Adverse Event Reporting System holds 723 reports that list dexmethylphenidate and serdexmethylphenidate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 29 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dexmethylphenidate and serdexmethylphenidate?
9 other medicines are given the same way (oral) and in the same FDA class as dexmethylphenidate and serdexmethylphenidate or labeled mainly for the same use (ADHD), the same class first. ADHD lists all 12 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Methylphenidate | ADHD | 31 labelers | $0.158 per tablet 10 mg tablet | In shortage |
| Amphetamine and dextroamphetamine | ADHD | 25 labelers | $0.233 per tablet 10 mg tablet | In shortage |
| Lisdexamfetamine | ADHD | 19 labelers | $2.44 per capsule 20 mg capsule | In shortage |
| Amphetamine | ADHD | 13 labelers | $0.449 per tablet 10 mg tablet | No current entry |
| Dextroamphetamine | ADHD | 14 labelers | $0.373 per tablet 10 mg tablet | No current entry |
| Methamphetamine | ADHD | 3 labelers | $5.10 per tablet 5 mg tablet | No current entry |
| Atomoxetine | ADHD | 20 labelers | $0.442 per capsule 40 mg capsule | No current entry |
| Guanfacine | ADHD | 37 labelers | $0.147 per tablet 1 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as dexmethylphenidate and serdexmethylphenidate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dexmethylphenidate and serdexmethylphenidate
- 9 medicines for the same use
- Other stimulants
- the pharmacologic class, with prices and generics
- Dexmethylphenidate and serdexmethylphenidate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other