FDA Adverse Events Reports (FAERS) Summary for FOCALIN

These tables and charts are based on 3,703 total reports for FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 3,202 pharmaceutical company-submitted and non-U.S. FAERS reports and 501 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 501 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch FOCALIN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	600
2	ANXIETY	168
3	NAUSEA	157
4	ABNORMAL BEHAVIOUR	156
5	HEADACHE	154
6	OFF LABEL USE	145
7	FATIGUE	136
8	INSOMNIA	133
9	AGGRESSION	131
10	DEPRESSION	131
11	DECREASED APPETITE	129
12	FEELING ABNORMAL	128
13	DISTURBANCE IN ATTENTION	118
14	VOMITING	113
15	IRRITABILITY	106
16	WEIGHT INCREASED	101
17	DIZZINESS	96
18	DROWSINESS	93
19	MALAISE	92
20	PRODUCT QUALITY ISSUE	91
21	ANGER	88
22	WEIGHT DECREASED	86
23	PRODUCT SUBSTITUTION ISSUE	80
24	ABDOMINAL PAIN UPPER	78
25	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	78
26	SUICIDAL IDEATION	77
27	NO ADVERSE EVENT	70
28	PRODUCT DOSE OMISSION ISSUE	70
29	RASH	70
30	AGITATION	67
31	TREATMENT FAILURE	66
32	CRYING	63
33	PAIN	61
34	SHORTNESS OF BREATH	60
35	FEVER	60
36	PSYCHOMOTOR HYPERACTIVITY	59
37	TIC	58
38	DIARRHEA	57
39	HEART RATE INCREASED	55
40	TREMOR	55
41	EMOTIONAL DISORDER	54
42	HALLUCINATION	54
43	BREAST ENLARGEMENT MALE	53
44	CONDITION AGGRAVATED	52
45	CONVULSION	47
46	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	46
47	DEPRESSED MOOD	44
48	FALL	44
49	HYPERSENSITIVITY	44
50	HIGH BLOOD PRESSURE	44
51	COMMON COLD	43
52	ITCHING	43
53	JOINT PAIN	42
54	LACK OF STRENGTH AND ENERGY (ASTHENIA)	42
55	CHEST PAIN	42
56	COUGH	42
57	DRUG DOSE OMISSION	42
58	EXCESS SWEATING	42
59	PRODUCT USE IN UNAPPROVED INDICATION	42
60	EMOTIONAL DISTRESS	40
61	INCORRECT DOSE ADMINISTERED	40
62	PRODUCT USE ISSUE	39
63	SEIZURE	39
64	CONFUSIONAL STATE	38
65	MOOD SWINGS	38
66	PALPITATIONS	38
67	WRONG TECHNIQUE IN DRUG USAGE PROCESS	38
68	SKIN REDNESS	37
69	HIVES	37
70	DIFFICULTY SWALLOWING	35
71	INJECTION SITE PAIN	35
72	SINUSITIS	35
73	RAPID HEART RATE (TACHYCARDIA)	35
74	CONSTIPATION	34
75	PRODUCT AVAILABILITY ISSUE	34
76	DRUG EFFECT DECREASED	33
77	MIGRAINE	33
78	LETHARGY	32
79	BLOOD PRESSURE INCREASED	31
80	LOSS OF CONSCIOUSNESS	31
81	MOOD ALTERED	31
82	PNEUMONIA	31
83	DRUG DOSE OMISSION BY DEVICE	30
84	MEMORY IMPAIRMENT	30
85	NERVOUSNESS	30
86	ABDOMINAL PAIN	29
87	INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION	29
88	PSYCHOTIC DISORDER	29
89	DRY MOUTH	28
90	INFLUENZA	28
91	PRODUCT PHYSICAL ISSUE	28
92	SLEEP DISORDER	28
93	UNEVALUABLE EVENT	28
94	ABDOMINAL DISCOMFORT	27
95	BACK PAIN	27
96	ILLNESS	26
97	MUSCLE TWITCHING	26
98	TARDIVE DYSKINESIA	26
99	VISUAL IMPAIRMENT	26
100	WITHDRAWAL SYNDROME	26

Latest Known Outcomes for Reactions Reported for FOCALIN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1992
2	Patient recovered	506
3	Patient has not recovered/symtoms have not resolved	484
4	Patient is recovering/symptoms resolving	169
5	Patient died	15
6	Patient has recovered but has consequent health issues	3

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	22
2005	31
2006	81
2007	83
2008	81
2009	83
2010	82
2011	114
2012	128
2013	118
2014	146
2015	376
2016	378
2017	275
2018	190
2019	238
2020	244
2021	159
2022	166
2023	236
2024	197
2025	197
2026	78

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	559
11-20	637
21-30	149
31-40	106
41-50	109
51-60	92
61-70	51
71-80	16
81-90	2
91+	11

Based on 1732 reports that included a patient age.

FOCALIN Total Reports

Male	Female	Unknown	Total
1897	1319	487	3,703

Top Countries Reporting

	Country	Number of Reports
1	United States	2990
2	Switzerland	35
3	Israel	5
4	Austria	1
5	Canada	1
6	United Kingdom	1
7	Greece	1
8	Puerto Rico	1
9	U.S. Virgin Islands	1

Outcomes for Reports

Serious: 1437
Not Serious: 2264
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

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 2001-11-13

FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with FOCALIN? Rate FOCALIN 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

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for FOCALIN 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 July 30, 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.