FDA Adverse Events Reports (FAERS) Summary for CONCERTA

These tables and charts are based on 17,993 total reports for CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 16,802 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,191 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 1,191 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CONCERTA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with CONCERTA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	1782
2	HEADACHE	915
3	OFF LABEL USE	901
4	NAUSEA	801
5	ANXIETY	782
6	FATIGUE	761
7	INSOMNIA	676
8	DEPRESSION	655
9	SUICIDAL IDEATION	617
10	AGGRESSION	569
11	DECREASED APPETITE	534
12	DISTURBANCE IN ATTENTION	525
13	PRODUCT DOSE OMISSION ISSUE	513
14	DIZZINESS	503
15	VOMITING	501
16	FEELING ABNORMAL	488
17	WEIGHT DECREASED	480
18	PRODUCT SUBSTITUTION ISSUE	462
19	DROWSINESS	455
20	ABNORMAL BEHAVIOUR	435
21	WEIGHT INCREASED	427
22	PAIN	394
23	DRUG DOSE OMISSION	375
24	MALAISE	372
25	HOSPITALIZATION	358
26	CONDITION AGGRAVATED	353
27	IRRITABILITY	338
28	PRODUCT AVAILABILITY ISSUE	334
29	AGITATION	328
30	SUICIDE ATTEMPT	318
31	HIGH BLOOD PRESSURE	306
32	TREMOR	301
33	OVERDOSE	300
34	SHORTNESS OF BREATH	299
35	HEART RATE INCREASED	297
36	PALPITATIONS	283
37	FEVER	267
38	BLOOD PRESSURE INCREASED	266
39	RASH	264
40	RAPID HEART RATE (TACHYCARDIA)	263
41	ADVERSE EVENT	256
42	PRODUCT USE ISSUE	254
43	LACK OF STRENGTH AND ENERGY (ASTHENIA)	253
44	ABDOMINAL PAIN	251
45	HALLUCINATION	251
46	TIC	248
47	CHEST PAIN	247
48	ANGER	245
49	INCORRECT DOSE ADMINISTERED	245
50	DIARRHEA	240
51	INTENTIONAL OVERDOSE	240
52	ABDOMINAL PAIN UPPER	238
53	JOINT PAIN	233
54	ITCHING	218
55	PSYCHOTIC DISORDER	218
56	BREAST ENLARGEMENT MALE	214
57	TREATMENT NONCOMPLIANCE	213
58	DRUG INTERACTION	207
59	PSYCHOMOTOR HYPERACTIVITY	204
60	COMMON COLD	200
61	EXCESS SWEATING	199
62	PRODUCT USE IN UNAPPROVED INDICATION	196
63	MIGRAINE	195
64	COUGH	191
65	DRUG EFFECT DECREASED	190
66	MOOD SWINGS	190
67	CONFUSIONAL STATE	189
68	FALL	185
69	INTENTIONAL SELF-INJURY	185
70	TOXICITY TO VARIOUS AGENTS	185
71	DRUG ABUSE	183
72	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	182
73	PAIN IN EXTREMITY	181
74	GROWTH RETARDATION	179
75	PRODUCT QUALITY ISSUE	179
76	SLEEP DISORDER	176
77	LOSS OF CONSCIOUSNESS	175
78	CRYING	170
79	DYSKINESIA	169
80	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	169
81	VISION BLURRED	167
82	MEMORY IMPAIRMENT	166
83	EMOTIONAL DISORDER	165
84	DEPRESSED MOOD	163
85	INTENTIONAL PRODUCT USE ISSUE	161
86	RESTLESSNESS	155
87	BACK PAIN	152
88	NUMBNESS	151
89	DRUG DEPENDENCE	142
90	HYPERSENSITIVITY	142
91	FAINTING	142
92	COVID-19	141
93	MUSCLE SPASMS	139
94	PINS AND NEEDLES	136
95	CONVULSION	134
96	CONSTIPATION	132
97	WITHDRAWAL SYNDROME	132
98	STRESS	131
99	HIVES	129
100	ABDOMINAL DISCOMFORT	125

Latest Known Outcomes for Reactions Reported for CONCERTA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	8660
2	Patient recovered	2978
3	Patient has not recovered/symtoms have not resolved	2807
4	Patient is recovering/symptoms resolving	1149
5	Patient died	247
6	Patient has recovered but has consequent health issues	79

Search all MedWatch and FAERS by keyword:

CONCERTA Total Reports

Male	Female	Unknown	Total
9004	6986	2003	17,993

Top Countries Reporting

	Country	Number of Reports
1	United States	8699
2	Canada	1193
3	Japan	994
4	United Kingdom	367
5	Sweden	366
6	France	304
7	Netherlands	131
8	Germany	126
9	Spain	106
10	Switzerland	93

Outcomes for Reports

Serious: 11038
Not Serious: 6941
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

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

Top Companies Reporting

JOHNSON AND JOHNSON

Safety-Related FDA Updates

FDA Approval Date: 2000-12-08

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug:
Weight loss risk in children under age 6; not recommended for use in young children Safety-related Labeling Changes

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 the cases for CONCERTA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.