Serdexmethylphenidate and Dexmethylphenidate
Serdexmethylphenidate and dexmethylphenidate is a combination CNS stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Azstarys carries a serious FDA boxed warning about the risk of abuse, misuse, and addiction. Like all CNS stimulants, it has a high potential for misuse, which can lead to a substance use disorder — including addiction. Misusing it — especially by taking higher doses than prescribed, snorting, or injecting it — can result in overdose and death. Before starting Azstarys, your prescriber should discuss your personal risk. Throughout treatment, watch for signs of misuse such as taking more than prescribed, strong cravings, or using it in ways other than directed. Store it securely and dispose of unused medication properly.
📖 Serdexmethylphenidate and Dexmethylphenidate: Patient Information Guide
A plain-language walkthrough of Serdexmethylphenidate and Dexmethylphenidate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Serdexmethylphenidate and dexmethylphenidate is a CNS stimulant combination approved to treat the following condition:
- Azstarys (oral capsule) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older
- Azstarys is not recommended for children younger than 6 years of age due to higher drug exposure and greater risk of side effects such as weight loss in that age group
⚙️How it works▾
Serdexmethylphenidate is a prodrug — it is inactive on its own but gets converted into dexmethylphenidate, the active form, mainly in the lower gastrointestinal tract. Dexmethylphenidate is a CNS (central nervous system) stimulant that blocks the reuptake (reabsorption) of dopamine and norepinephrine into nerve cells, and also increases the release of these chemicals into the spaces between neurons. This raises the availability of these two brain chemicals, which is thought to improve focus, attention, and impulse control in people with ADHD — though the exact mechanism in ADHD is not fully understood.
💊How it's taken▾
Azstarys is taken by mouth once daily in the morning. It can be taken with or without food, though food may delay the time it takes to reach peak levels in the blood by a couple of hours. The capsule can be swallowed whole or opened and mixed into water or applesauce — but that mixture must be taken right away (within 10 minutes) and never saved.
- Take once every morning, with or without food
- Capsule contents can be sprinkled into water or applesauce if swallowing whole is difficult
- Do not switch to or from other methylphenidate products at the same milligram dose without your prescriber's guidance — Azstarys has a different drug profile
- If a dose is missed, follow your prescriber's instructions; do not double up
🤒Side effects — in detail▾
The most commonly reported side effects with methylphenidate-based medicines like Azstarys include:
- Decreased appetite and weight loss
- Trouble sleeping (insomnia)
- Nausea, vomiting, or stomach pain
- Upset stomach (dyspepsia)
- Increased heart rate (tachycardia) or blood pressure
- Irritability or emotional ups and downs
- Dizziness
- Anxiety
Seek medical help right away for serious reactions including chest pain, hallucinations, a painful erection that won't go away, signs of a severe allergic reaction (swelling, hives, breathing trouble), or any signs of overdose such as seizures or loss of consciousness.
⚠️Warnings & precautions▾
- Abuse, misuse, and addiction: Azstarys is a controlled stimulant with a high potential for misuse. Misusing it — especially by taking higher amounts, snorting, or injecting — can cause overdose and death. Store it securely and never share it.
- Heart risks: Stimulants can raise blood pressure and heart rate. Azstarys should be avoided in people with structural heart defects, cardiomyopathy, serious heart arrhythmias, or coronary artery disease. Sudden death has been reported in patients with serious heart conditions taking stimulants.
- Psychiatric effects: Can trigger or worsen psychosis, hallucinations, or mania — especially in people with a history of these conditions. Screen for bipolar disorder before starting.
- Growth suppression in children: Long-term use may slow expected height and weight gain in children. Regular monitoring is needed.
- Priapism: A prolonged, painful erection can occur (rarely) and requires immediate medical attention.
- Peripheral vasculopathy (Raynaud's phenomenon): Numbness, pain, or color changes in fingers or toes have been reported. Tell your doctor if you notice these.
- Eye pressure: Azstarys may raise intraocular pressure. Use with caution in patients with glaucoma or elevated eye pressure.
- Tics and Tourette's syndrome: May worsen motor or verbal tics. Screen patients for tics before starting treatment.
🔀What it interacts with▾
Azstarys can interact with several medications in clinically important ways:
- MAOIs (e.g., phenelzine, selegiline): Combining with Azstarys — or using within 14 days of stopping an MAOI — can cause a life-threatening spike in blood pressure (hypertensive crisis). This combination is contraindicated.
- Blood pressure (antihypertensive) medications: Azstarys can blunt the effectiveness of these drugs; blood pressure should be monitored closely and medication adjusted if needed.
- Halogenated anesthetics: Used during surgery, these drugs can cause sudden dangerous rises in blood pressure and heart rate when combined with Azstarys — avoid Azstarys on surgery days.
- Risperidone: Combined use — especially with dose changes of either drug — may raise the risk of extrapyramidal symptoms (uncontrolled muscle movements or stiffness).
- Serotonergic drugs: Serotonin syndrome (dangerous excess of serotonin, causing agitation, high fever, rapid heart rate) has been reported when methylphenidate is combined with drugs that affect serotonin.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have any heart problems, structural heart defects, arrhythmia, coronary artery disease, or a family history of sudden cardiac death
- Tell your doctor if you or a family member has a history of tics or Tourette's syndrome
- Tell your doctor if you have a history of psychosis, bipolar disorder, depression, or other mental health conditions
- Tell your doctor if you have glaucoma or elevated eye pressure (intraocular pressure)
- Pregnancy: There are no definitive human studies on Azstarys in pregnancy; CNS stimulants may reduce blood flow to the placenta. Enroll in the National Pregnancy Registry for Psychostimulants (1-866-961-2388) if you become pregnant while taking this medication
- Breastfeeding: Methylphenidate passes into breast milk in small amounts; monitor your infant for agitation, poor appetite, or poor weight gain
- Children under 6: Azstarys is not recommended for this age group due to higher drug exposure and increased adverse effects
- Do not take Azstarys if you have a known allergy to serdexmethylphenidate, methylphenidate, or any ingredient in the capsule
- Do not take Azstarys if you are currently taking or have taken an MAOI within the past 14 days
🚑If you take too much▾
Taking too much Azstarys can cause serious or life-threatening effects, including a very fast or irregular heartbeat, dangerously high blood pressure, agitation, confusion, hallucinations, seizures, very high body temperature, and loss of consciousness. If you suspect an overdose, call the Poison Help line at 1-800-222-1222 or call 911 immediately. Dialysis is not helpful because of the way this medicine is distributed and broken down in the body.
📡Pharmacodynamics — effects in the body▾
Dexmethylphenidate — the active form of this medication — blocks the reuptake (reabsorption) of the brain chemicals dopamine and norepinephrine into nerve cells, and increases their release into the spaces between neurons. This raises levels of both chemicals in the brain. At very high concentrations (far above therapeutic levels), serdexmethylphenidate does not cause meaningful changes to the heart's electrical rhythm (QT interval), suggesting a low risk of that particular cardiac effect at prescribed doses.
🔬Pharmacokinetics — how your body processes it▾
After taking Azstarys by mouth, serdexmethylphenidate is converted to the active drug dexmethylphenidate mainly in the lower digestive tract. Under fasting conditions, blood levels of dexmethylphenidate peak in about 2 hours; food slows this to about 4–4.5 hours but does not meaningfully change the total amount absorbed. The active drug dexmethylphenidate has a half-life of roughly 11–12 hours in adults, meaning the body takes that long to clear half of it. Steady, consistent blood levels are generally reached after about three once-daily doses. The drug and its breakdown products are eliminated primarily through urine.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from moisture. Dispense in tight container (USP).
📄 Written from Serdexmethylphenidate and Dexmethylphenidate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Serdexmethylphenidate and Dexmethylphenidate
92 supplements and herbal products have documented interactions with Serdexmethylphenidate and Dexmethylphenidate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 10
- Moderate · 68
- Minor · 14
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Serdexmethylphenidate and Dexmethylphenidate — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Azstarys and what does it treat? ▾
How should I take Azstarys — does it matter if I take it with food? ▾
What side effects should I expect, and when should I call my doctor? ▾
Is it safe to take Azstarys if I'm on other medications? ▾
I've heard stimulants can be addictive — how worried should I be? ▾
My child is taking Azstarys — are there any special things I should watch for? ▾
Is Serdexmethylphenidate and Dexmethylphenidate available over the counter? ▾
Is Serdexmethylphenidate and Dexmethylphenidate a controlled substance? ▾
When was Serdexmethylphenidate and Dexmethylphenidate first available? ▾
Who makes Serdexmethylphenidate and Dexmethylphenidate? ▾
💬 Answers drafted from Serdexmethylphenidate and Dexmethylphenidate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Serdexmethylphenidate and Dexmethylphenidate comes
Serdexmethylphenidate and Dexmethylphenidate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Azstarys is used to treat ADHD in patients 6 years of age and older
- Azstarys is not recommended for children younger than 6 years of age
- Azstarys capsules are taken by mouth once daily in the morning, with or without food
- Azstarys capsules may be swallowed whole, or opened and sprinkled into 50 mL of water or over 2 tablespoons of applesauce — consume the mixture immediately or within 10 minutes, and do not store it
- Azstarys should not be substituted for other methylphenidate products on a milligram-per-milligram basis because it has a different pharmacokinetic profile
- If switching from another methylphenidate product to Azstarys, discontinue the other medication first and follow the Azstarys titration schedule your prescriber provides
📊 Serdexmethylphenidate and Dexmethylphenidate across the U.S. market
How Serdexmethylphenidate and Dexmethylphenidate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Serdexmethylphenidate and Dexmethylphenidate is used
A general measure of how commonly Serdexmethylphenidate and Dexmethylphenidate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Serdexmethylphenidate and Dexmethylphenidate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Serdexmethylphenidate and Dexmethylphenidate prescribed? Of the 1,596 medications we measure, Serdexmethylphenidate and Dexmethylphenidate ranks #417 by Medicaid prescriptions — more than 74% of them.
Utilization by Serdexmethylphenidate and Dexmethylphenidate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MG Oral Capsule Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2562191
dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MG Oral Capsule
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2562194
dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MG Oral Capsule
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2562187
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Serdexmethylphenidate and Dexmethylphenidate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 3 listed Serdexmethylphenidate and Dexmethylphenidate NDCs with Medicaid activity.
🔍 Compare Serdexmethylphenidate and Dexmethylphenidate products
A representative set of FDA-listed product records for Serdexmethylphenidate and Dexmethylphenidate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| SERDEXMETHYLPHENIDATE CHLORIDE 26.1 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2 mg | Oral | Commave Sub, LLC | NDA | View NDC → |
| SERDEXMETHYLPHENIDATE CHLORIDE 39.2 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 7.8 mg | Oral | Commave Sub, LLC | NDA | View NDC → |
| SERDEXMETHYLPHENIDATE CHLORIDE 52.3 mg/1; DEXMETHYLPHENIDATE HYDROCHLORIDE 10.4 mg | Oral | Commave Sub, LLC | NDA | View NDC → |
| 5.2; 26.1 mg/1; mg | Oral | Corium, Inc | NDA | View NDC → |
| 7.8; 39.2 mg/1; mg | Oral | Corium, Inc | NDA | View NDC → |
| 10.4; 52.3 mg/1; mg | Oral | Corium, Inc | NDA | View NDC → |
| 5.2; 26.1 mg/1; mg | Oral | Corium, LLC. | NDA | View NDC → |
| 7.8; 39.2 mg/1; mg | Oral | Corium, LLC. | NDA | View NDC → |
| 10.4; 52.3 mg/1; mg | Oral | Corium, LLC. | NDA | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Serdexmethylphenidate and Dexmethylphenidate NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Serdexmethylphenidate and Dexmethylphenidate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Serdexmethylphenidate and Dexmethylphenidate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Serdexmethylphenidate and Dexmethylphenidate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 2562192 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 2562189In current FDA listingsClinical drug / strength (SCD) dexmethylphenidate 10.4 MG / serdexmethylphenidate 52.3 MGRxCUI 2562194dexmethylphenidate 5.2 MG / serdexmethylphenidate 26.1 MGRxCUI 2562187dexmethylphenidate 7.8 MG / serdexmethylphenidate 39.2 MGRxCUI 2562191
Look up RxCUI 2562192 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Serdexmethylphenidate and Dexmethylphenidate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Serdexmethylphenidate and Dexmethylphenidate belongs to the Centrally acting sympathomimetics class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Commave Sub, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.