Concertamethylphenidate
According to the FDA label: CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ].
23,806 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Concerta in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Drug Ineffective 2,654 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Headache 1,245 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,195 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 1,082 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,077 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Anxiety 1,068 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Insomnia 884 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Depression 808 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Suicidal Ideation 795 reports
Thoughts of suicide. This term records that such thoughts were reported, and its presence does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Decreased Appetite 730 reports
Disturbance in Attention 703 reports
Difficulty concentrating or staying focused.
Full definition in the glossary →Aggression 701 reports
A report of hostile or aggressive behavior. The term records what was reported and does not establish that a medication was the cause.
Full definition in the glossary →Somnolence 682 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Dizziness 678 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Vomiting 661 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 11,499 |
| Female | 9,165 |
| Unknown | 238 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 6,332 |
| 18-34 | 3,213 |
| 35-49 | 2,029 |
| 50-64 | 1,239 |
| 65-74 | 356 |
| 75+ | 124 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Concerta. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 10,750 |
| Non-Serious | 9,129 |
| Hospitalization | 4,854 |
| Death | 766 |
| Life-Threatening | 734 |
| Disability | 577 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Concerta. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 501 |
| 2005 | 510 |
| 2006 | 503 |
| 2007 | 555 |
| 2008 | 549 |
| 2009 | 620 |
| 2010 | 619 |
| 2011 | 561 |
| 2012 | 669 |
| 2013 | 626 |
| 2014 | 639 |
| 2015 | 2,083 |
| 2016 | 1,658 |
| 2017 | 1,486 |
| 2018 | 1,417 |
| 2019 | 1,422 |
| 2020 | 1,209 |
| 2021 | 1,069 |
| 2022 | 1,607 |
| 2023 | 1,969 |
| 2024 | 1,629 |
| 2025 | 1,542 |
| 2026 (partial) | 363 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Concerta
In FDA adverse event reports that mention Concerta, these medications appeared most often in the same report.
- Oxybate (1,525 reports)
- Ergocalciferol (1,067 reports)
- Aripiprazole (1,066 reports)
- Risperidone (1,033 reports)
- Atomoxetine (939 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026