What the label lists and what reports show
Methylphenidate side effects
Methylphenidate's FDA label: “The most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.” FAERS holds 73,102 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (3,318 reports).
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule II
Check it at the source: the methylphenidate FDA label on DailyMed (effective July 31, 2026, Lannett Company, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Methylphenidate HCl Extended-Release Capsules CD?Methylphenidate HCl Extended-Release Capsules CD may cause serious side effects, including: See “ What is the most important information I should know about Methylphenidate HCl Extended-Release Capsules CD? ” Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If your child develops priapism, get medical help right away. Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include: fingers or toes may feel numb, cool, painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. […]
Source: FDA drug label, Lannett Company, LLC, effective July 31, 2026 (SPL set e45c75dc-d381-475b-b649-a871c8a36e60), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc.
Table 1: Common Adverse Reactions Occurring in ≥ 2% of Pediatric Patients (6 to 17 years of age) with ADHD Taking Methylphenidate Hydrochloride Extended-Release and at a Rate Greater than Placebo (Study 2)
This table is printed in the methylphenidate hydrochloride label published by Actavis Pharma, Inc. of October 31, 2025; the label quoted above does not print one.
| System Organ Class Adverse Reaction | Methylphenidate Hydrochloride Extended-Release (n=183) | Placebo (n=47) |
|---|---|---|
| Headache | 10.9% | 8.5% |
| Insomnia | 9.8% | 2.1% |
| Dizziness | 2.2% | 2.1% |
| Abdominal pain upper | 8.2% | 0% |
| Nausea | 3.8% | 2.1% |
| Vomiting | 3.8% | 0% |
| Decreased Appetite | 4.9% | 0% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to Methylphenidate and Other Component of Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 )] Hypertensive Crisis when Used Concomitantly with MAOIs [see Contraindications (4) and Drug Interactions ( 7 )] 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 (≥ 5% and twice the rate of placebo) were anorexia and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. …
Source: FDA drug label, Lannett Company, LLC, effective July 31, 2026 (SPL set e45c75dc-d381-475b-b649-a871c8a36e60), via openFDA; the full label on DailyMed
What do FAERS reports show?
73,102 reports list methylphenidate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,733 are coded as a death and 12,315 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Methylphenidate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions