CONCERTA FDA MedWatch Direct Reports Summary

These tables and charts are created from 1,191 voluntary U.S. reports for CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS CONCERTA Report.

Top Adverse Effects Associated with CONCERTA (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	PRODUCT SUBSTITUTION ISSUE	399
2	DRUG INEFFECTIVE	356
3	DISTURBANCE IN ATTENTION	104
4	HEADACHE	102
5	ANXIETY	99
6	PRODUCT QUALITY ISSUE	81
7	TREATMENT FAILURE	73
8	IRRITABILITY	69
9	NAUSEA	59
10	DEPRESSION	51
11	DRUG EFFECT DECREASED	51
12	INSOMNIA	51
13	ANGER	48
14	ABNORMAL BEHAVIOUR	46
15	FATIGUE	44
16	DIZZINESS	41
17	MOOD SWINGS	41
18	AGGRESSION	39
19	CONDITION AGGRAVATED	39
20	EDUCATIONAL PROBLEM	39
21	FEELING ABNORMAL	39
22	PALPITATIONS	37
23	SUICIDAL IDEATION	35
24	DROWSINESS	30
25	DECREASED APPETITE	27

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CONCERTA Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
486	469	236	1,191

Medwatch Reporter Type	Count
Consumer	637
Physician	80
Pharmacist	31
Other Health Professional	101

Top Indications

Product used for unknown indication
Attention deficit hyperactivity disorder
Migraine
Substance use
Seizure

Type of Outcome Reported
Serious: 550
Not Serious: 641
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 1191
Concomitant Drugs: 529
Note: A single MedWatch report can list more than one drug. This summary includes CONCERTA identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug:
FDA Safety-related Labeling Changes

Weight loss risk in children under age 6; not recommended for use in young children

Have experience (good or bad) with CONCERTA? Rate CONCERTA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.