methylphenidate
Brand names: Ritalin, Concerta
Methylphenidate extended-release capsules are a stimulant medicine. They are used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6 to 12.
Drug Shortage Alert
methylphenidate is currently listed as in shortage by the FDA. Affected manufacturer: Noven Pharmaceuticals, Inc.. Status: Available.
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$1.14/unit
Generic Price
$2.24/unit
Generic Available
Yes (42 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats Attention Deficit Hyperactivity Disorder (ADHD) in children.
Common side effects
Headache, Trouble sleeping (insomnia), Upper abdominal pain
Key warnings
This medicine has a high potential for abuse and dependence.
How It Works
Methylphenidate is a central nervous system (CNS) stimulant. It works by affecting chemicals in the brain that contribute to hyperactivity and impulsivity. The extended-release capsules release the medicine in two stages, providing both an immediate and a delayed effect.
How to Take It
Take this medicine once a day in the morning. You can swallow the capsule whole, or open it and sprinkle the contents on a spoonful of applesauce. Do not crush, chew, or divide the capsule or its contents. Take it exactly as your doctor tells you to.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. There is a pregnancy registry for women who take ADHD medicines during pregnancy.
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.
Storage
Store this medicine at room temperature, away from heat and moisture.
Side Effects (from patient reports)
Based on 30,029 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 27,931 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
27,931
Death-Related Reports
1,071
Hospitalization Reports
3,510
Top Indication
Attention Deficit/Hyperactivity Disorder
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NO ADVERSE EVENT | 6,875 |
| 2 | OFF LABEL USE | 5,881 |
| 3 | PRODUCT QUALITY ISSUE | 5,241 |
| 4 | DRUG INEFFECTIVE | 2,873 |
| 5 | DRUG ADMINISTRATION ERROR | 1,901 |
| 6 | WRONG TECHNIQUE IN DRUG USAGE PROCESS | 1,772 |
| 7 | APPLICATION SITE ERYTHEMA | 1,684 |
| 8 | DRUG DOSE OMISSION | 1,478 |
| 9 | INCORRECT DRUG ADMINISTRATION DURATION | 1,191 |
| 10 | WRONG TECHNIQUE IN PRODUCT USAGE PROCESS | 1,133 |
| 11 | DRUG PRESCRIBING ERROR | 1,079 |
| 12 | DISTURBANCE IN ATTENTION | 907 |
| 13 | PRODUCT ADHESION ISSUE | 867 |
| 14 | ANXIETY | 833 |
| 15 | FATIGUE | 823 |
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
This medicine has a high potential for abuse and dependence. Your doctor will assess your risk before prescribing it and monitor you during treatment. Misuse of this medicine may cause sudden death or serious heart problems.
Known Drug Interactions
Concomitant use of XADAGO with methylphenidate, amphetamine, and their derivatives is contraindicated [see Warnings and Precautions (5.1 , 5.2) ] .
Mechanism: These drugs both increase certain brain chemicals that can cause your blood pressure to rise to dangerous levels.
What to do: Avoid using these medications at the same time.
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.
Methylphenidate Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS). Monitor for symptoms of EPS with concomitant use of risperidone tablets and methylphenidate [see Adverse Reactions ( 6.2 )].
Mechanism: Combining these medicines can increase the chance of developing movement problems, especially if the dose of either drug is changed.
What to do: Watch for signs of muscle stiffness or shaking and let your doctor know if these symptoms occur.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride extended-release capsules may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] .
Mechanism: Methylphenidate can raise blood pressure, which makes drugs used to lower blood pressure work less effectively.
What to do: Your doctor may need to monitor your blood pressure and adjust your medication dosages.
Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride extended-release capsules may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] .
Mechanism: Methylphenidate can raise blood pressure, which makes drugs used to lower blood pressure work less effectively.
What to do: Your doctor may need to monitor your blood pressure and adjust your medication dosages.
Common Questions
Can I take this medicine with other medicines?
Can I stop taking this medicine suddenly?
Will this medicine affect my child's growth?
Can this medicine cause heart problems?
Can this medicine cause mental health problems?
What should I do if I have a prolonged erection?
Can this medicine affect blood flow to my fingers and toes?
Who should not take this medicine?
What are the signs of abuse and dependence?
How should I dispose of unused medicine?
What are the common side effects of methylphenidate?
Does methylphenidate interact with other medications?
What drug class is methylphenidate?
Is methylphenidate safe during pregnancy?
Has methylphenidate been recalled?
Is methylphenidate currently in shortage?
Active Recalls
Defective Delivery System: Out of specification for shear.
Noven Pharmaceuticals Inc
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Noven Pharmaceuticals Inc
Defective Delivery System: customer complaints exceeded respective action limits.
Noven Pharmaceuticals Inc
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
RISING PHARMACEUTICALS
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What the FDA Data Shows for methylphenidate
The FDA label for methylphenidate (sold under brand names such as Ritalin, Concerta) classifies it as a prescription-only medication in the CNS Stimulant class. This medicine treats Attention Deficit Hyperactivity Disorder (ADHD) in children. Official labeling lists 5 commonly reported side effects, including Headache, Trouble sleeping (insomnia), Upper abdominal pain.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 30,029 voluntary reports. The database also lists 11 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $2.24 versus $1.14 for the brand.
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 (currently 4 recall records on file), 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). Shortage status: FDA Drug Shortages Database.
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: December 31, 2019
Read our methodology — how this data is sourced, computed, and verified.
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