Prescription medication · CNS Stimulant
dexmethylphenidate
Also sold as Focalin, Focalin XR. AZSTARYS is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older.
- 4,083
- FDA reportsLightly reported
- 2
- InteractionsFew interactions
- 92% less
- Generic vs brandHuge savings
- $4.90
- Brand price (NADAC)
What the data shows
dexmethylphenidate (Focalin) is a prescription CNS Stimulant, among the least-reported drugs the FDA tracks (4,083 FDA reports), whose generic costs a fraction of the brand (about 92% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
dexmethylphenidate (Focalin) is a prescription CNS Stimulant. AZSTARYS is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older.
AZSTARYS is a stimulant medicine used to treat ADHD. It can help increase attention and decrease impulsiveness and hyperactivity.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$4.90/unit
Generic Price
$0.38/unit
Generic Savings
92%
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
What it does
AZSTARYS is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older.
Common side effects
Decreased appetite, Trouble sleeping, Feeling sick to your stomach
Key warnings
AZSTARYS has a high risk for abuse and addiction.
The sections below are summarized in plain English from dexmethylphenidate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
AZSTARYS contains two ingredients that affect chemicals in the brain. These chemicals help improve focus and attention. One ingredient is released right away, and the other is released slowly over time.
How to Take It
Take AZSTARYS once a day in the morning. You can take it with or without food. You can swallow the capsule whole, or open it and sprinkle the contents on applesauce or in water. Eat the applesauce or drink the water right away; do not save it for later.
This is a plain-language summary of dexmethylphenidate's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if AZSTARYS will harm your unborn baby. There is a pregnancy registry to track outcomes in women who take ADHD medicines during pregnancy.
This is a plain-language summary of dexmethylphenidate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of dexmethylphenidate's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store AZSTARYS at room temperature, away from moisture.
Side Effects (from patient reports)
Based on 4,083 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for dexmethylphenidate, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
196 reports
- Feeling worried or nervous
Feeling worried or nervous
189 reports
- Pain in your head
Pain in your head
183 reports
- Feeling very tired
Feeling very tired
169 reports
- Acting in a strange way
Acting in a strange way
166 reports
- Feeling not like yourself
Feeling not like yourself
162 reports
- Trouble paying attention
Trouble paying attention
155 reports
- Not feeling hungry
Not feeling hungry
152 reports
- Acting in a violent or angry way
Acting in a violent or angry way
141 reports
- Trouble sleeping
Trouble sleeping
139 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for dexmethylphenidate each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where dexmethylphenidate sits
dexmethylphenidate has more FDA adverse-event reports than 23% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is dexmethylphenidate; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 4,083 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
4,083
Reports Mentioning Death
36
0.9% of reports — not proof of cause
Hospitalization Reports
384
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | NAUSEA | 196 |
| 3 | ANXIETY | 189 |
| 4 | HEADACHE | 183 |
| 5 | FATIGUE | 169 |
| 6 | ABNORMAL BEHAVIOUR | 166 |
| 7 | FEELING ABNORMAL | 162 |
| 8 | DISTURBANCE IN ATTENTION | 155 |
| 9 | DECREASED APPETITE | 152 |
| 11 | AGGRESSION | 141 |
| 12 | INSOMNIA | 139 |
| 13 | DEPRESSION | 135 |
| 14 | VOMITING | 134 |
| 15 | DIZZINESS | 125 |
| 16 | SOMNOLENCE | 115 |
| 17 | IRRITABILITY | 114 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
AZSTARYS has a high risk for abuse and addiction. Misusing it can lead to overdose and death. Your doctor will check your risk before and during treatment. Store it safely and don't give it to others.
Known Drug Interactions
Risperidone 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).
Mechanism: Using these medications together can increase the risk of movement problems, especially if you change the dose of either drug. This happens because the drugs can affect how your brain controls your muscles.
What to do: Your doctor should watch you closely for any signs of muscle stiffness or tremors if your dosage is adjusted.
Risperidone 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).
Mechanism: Taking these two drugs together can interfere with how your nerves control your muscles, especially when doses are changed. This can cause involuntary movements like shaking or muscle spasms.
What to do: Watch for any unusual body movements and let your healthcare provider know if you experience any new muscle stiffness.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take AZSTARYS if I have heart problems?
Will AZSTARYS affect my child's growth?
Can AZSTARYS cause mental health problems?
Can AZSTARYS cause tics?
Can I drive while taking AZSTARYS?
What should I do if I have side effects?
Can I stop taking AZSTARYS suddenly?
Does AZSTARYS interact with other medications?
How long does AZSTARYS take to work?
Is AZSTARYS a controlled substance?
What are the common side effects of dexmethylphenidate?
Does dexmethylphenidate interact with other medications?
What drug class is dexmethylphenidate?
Is there a generic version of dexmethylphenidate?
Is dexmethylphenidate safe during pregnancy?
Related Medications in CNS Stimulant
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alprazolam
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amitriptyline
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Medication Guides
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FDA requirements, cost savings, and when the difference matters
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Common Drug Interactions
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What the FDA Data Shows for dexmethylphenidate
The FDA label for dexmethylphenidate (sold under brand names such as Focalin, Focalin XR) classifies it as a prescription-only medication in the CNS Stimulant class. AZSTARYS is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. Official labeling lists 11 commonly reported side effects, including Decreased appetite, Trouble sleeping, Feeling sick to your stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,083 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.38 versus $4.90 for the brand - a 92% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 2, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages