Dexmethylphenidate: uses, dosing, side effects & brands
Dexmethylphenidate is a central nervous system stimulant sold in the U.S. under 2 brand and generic names, for attention deficit disorder with hyperactivity. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Central Nervous System Stimulant
- Treats (across its forms)
- Attention Deficit Disorder with Hyperactivity
- Available as
- Tablet · Capsule, extended release
- Sold as
- 2 products — Focalin and Focalin XR
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $46 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How Focalin is dosed
From the FDA label for Focalin (application NDA021278). Other dexmethylphenidate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer orally twice daily, 4 hours apart with or without food ( 2 ). • For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily) ( 2.2 ). • For patients currently taking methylphenidate: Initiate Focalin therapy with half (1/2) the current total daily dose of methylphenidate ( 2.2 ). • Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) ( 2.2 ). 2.1 Pretreatment Screening Prior to treating patients with Focalin, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Focalin [see Warnings and Precautions ( 5.10 )] . 2.2 Recommended Dosage Patients New to Methylphenidate The recommended starting dose of Focalin for pediatric patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg daily (2.5 mg twice daily) with or without food. Patients Currently on Methylphenidate The recommended starting dose of Focalin for pediatric patients currently using methylphenidate is half (1/2) the total daily dose of racemic methylphenidate. Titration Schedule The dose may be…
Everything below is the FDA label for Focalin (tablet). Dexmethylphenidate is also sold as capsule, extended release, and those are different medicines to take — follow the label for the one you were prescribed.
Focalin side effects
The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] • Known hypersensitivity to methylphenidate or other ingredients of Focalin [see Contraindications ( 4 )] • Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Priapism [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, Including Raynaud’s phenomenon [see Warnings and Precautions ( 5.6 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.7 )] • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10 )] The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia ( 6.1 ). To report SUSPECTED ADVERSE…
Who shouldn’t take Focalin
Hypersensitivity to methylphenidate or other components of Focalin. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )] . • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )] . • Known hypersensitivity to methylphenidate or other components of Focalin ( 4 ). • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).
Focalin drug interactions
Antihypertensive Drugs : Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions with Focalin Table 2 presents clinically important drug interactions with Focalin. Table 2: Clinically Important Drug Interactions with Focalin Monoamine Oxidase Inhibitors (MAOIs) Clinical impact Concomitant use of MAOIs and CNS stimulants, including Focalin, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )] . Intervention Concomitant use of Focalin with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Focalin may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] . Intervention Adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical impact Concomitant use of halogenated anesthetics and Focalin may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Monitor blood pressure and avoid use of Focalin in patients being treated with anesthetics on the day of surgery. 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). Intervention Monitor for signs of EPS.
Every dexmethylphenidate product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Tablet | Generic | $46 | View → | |
| 2 | 68/100 | Prescription | Capsule | Generic | $46 | View → |
What dexmethylphenidate pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| IX;683 | 10 mg | white, purple | capsule | — |
| IX;686 | 30 mg | white | capsule | — |
| IX;684 | 15 mg | pink, white | capsule | — |
| IX;682 | 5 mg | white, purple | capsule | — |
| IX;685 | 20 mg | white, pink | capsule | — |
| par;430 | 30 mg | white | capsule | — |
| par;428 | 15 mg | white | capsule | — |
| NP046;10 | 10 mg | blue | round | — |
| NP045;5 | 5 mg | yellow | round | — |
Combination products containing dexmethylphenidate
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Dexmethylphenidate recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Can you crush or split dexmethylphenidate?
At least one dexmethylphenidateproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each dexmethylphenidate label says about crushing, splitting and chewingHow long dexmethylphenidate keeps
No dexmethylphenidate label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does dexmethylphenidate expire? The in-use limits and storage rules from its labelsDexmethylphenidate and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for dexmethylphenidate: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of dexmethylphenidate during breastfeeding; however, the manufacturer estimates that a fully breastfed infant would receive a relative dose of 0.2 to 0.7% of the maternal weight-adjusted dose. Dexmethylphenidate is an isomer of methylphenidate. Methylphenidate levels in milk are low and not detectable in the serum of a few breastfed infants. If dexmethylphenidate is required by the mother, it is not a reason to discontinue breastfeeding. It is possible that large dosages of dexmethylphenidate might interfere with milk production, especially in women whose lactation is not well established.
National Institute of Child Health and Human Development, record revised August 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about dexmethylphenidate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 817 reports naming dexmethylphenidate, and the FDA flagged 30% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea59 reports
- headache56 reports
- disturbance in attention55 reports
- decreased appetite51 reports
- feeling abnormal51 reports
- dizziness48 reports
- anxiety46 reports
- fatigue46 reports
Read these as a signal, not a rate. A report does not mean dexmethylphenidate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is Focalin?
Focalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration.
What kind of drug is dexmethylphenidate?
The FDA classifies dexmethylphenidate as a central nervous system stimulant. CNS stimulants raise the levels of the brain's signaling chemicals dopamine and norepinephrine, either by releasing more of them or by blocking their reuptake. This heightened activity in attention and arousal circuits increases alertness, energy, and focus. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take dexmethylphenidate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run dexmethylphenidate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is dexmethylphenidate sold under?
We track 2 dexmethylphenidate-containing products in the U.S.: Focalin and Focalin XR. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does dexmethylphenidate come in?
Across the brands we track, dexmethylphenidate is currently marketed as tablet and capsule, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic dexmethylphenidate?
We do not currently list a generic-labelled dexmethylphenidate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has dexmethylphenidate been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions dexmethylphenidate. The most recent: Focalin XR (dexmethylphenidate HCl) 5 mg (Jun 1, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Dexmethylphenidate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/dexmethylphenidate
- MLA
- “Dexmethylphenidate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/dexmethylphenidate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for dexmethylphenidate on DailyMed (NIH) ↗ — including its boxed warning in full.