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.
Data updated 2026-05-15
- 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.
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
- Nausea
Nausea
196 reports
- Anxiety
Anxiety
189 reports
- Headache
Headache
183 reports
- Fatigue
Fatigue
169 reports
- Abnormal Behaviour
Abnormal Behaviour
166 reports
- Feeling Abnormal
Feeling Abnormal
162 reports
- Disturbance In Attention
Disturbance In Attention
155 reports
- Decreased Appetite
Decreased Appetite
152 reports
- Aggression
Aggression
141 reports
- Insomnia
Insomnia
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) 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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for dexmethylphenidate?
Related Medications in CNS Stimulant
Other drugs grouped near dexmethylphenidate - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with dexmethylphenidate →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with dexmethylphenidate →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with dexmethylphenidate →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with dexmethylphenidate →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with dexmethylphenidate →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for dexmethylphenidate: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 4,083.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 0.88%.
- benzoyl peroxide Δ 0.11 pts · 6,624 reports · Antimicrobial (Topical) 0.77%death share
- minoxidil Δ 0.13 pts · 43,650 reports · Vasodilator 1.01%death share
- bempedoic acid Δ 0.14 pts · 2,157 reports · ACL Inhibitor 0.74%death share
- abaloparatide Δ 0.20 pts · 24,667 reports · PTHrP Analog 1.08%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: October 2, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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