FDA Adverse Events Reports (FAERS) Summary for RITALIN LA

These tables and charts are based on 1,982 total reports for RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 1,917 pharmaceutical company-submitted and non-U.S. FAERS reports and 65 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 65 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch RITALIN LA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	240
2	HEADACHE	149
3	ANXIETY	121
4	DEPRESSION	115
5	DISTURBANCE IN ATTENTION	103
6	NAUSEA	103
7	FATIGUE	97
8	AGITATION	96
9	DROWSINESS	96
10	FEELING ABNORMAL	88
11	INSOMNIA	82
12	MALAISE	81
13	AGGRESSION	71
14	DECREASED APPETITE	68
15	ABNORMAL BEHAVIOUR	65
16	DIZZINESS	65
17	VOMITING	63
18	DRUG DEPENDENCE	61
19	WEIGHT DECREASED	57
20	IRRITABILITY	55
21	TREMOR	55
22	CONDITION AGGRAVATED	53
23	PAIN	52
24	FALL	48
25	SUICIDAL IDEATION	48
26	SHORTNESS OF BREATH	47
27	HIGH BLOOD PRESSURE	46
28	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	42
29	PSYCHOMOTOR HYPERACTIVITY	40
30	DEPRESSED MOOD	39
31	DEATH	38
32	NERVOUSNESS	38
33	WEIGHT INCREASED	38
34	DRUG INTOLERANCE	36
35	INTENTIONAL PRODUCT USE ISSUE	36
36	PRODUCT USE ISSUE	36
37	HEART RATE INCREASED	35
38	MEMORY IMPAIRMENT	35
39	SLEEP APNEA	35
40	RAPID HEART RATE (TACHYCARDIA)	35
41	EXCESS SWEATING	34
42	JOINT PAIN	33
43	DIARRHEA	33
44	SEIZURE	33
45	BLOOD PRESSURE INCREASED	32
46	PALPITATIONS	32
47	FEVER	32
48	ABDOMINAL PAIN UPPER	31
49	CRYING	31
50	INFLUENZA	31
51	LOSS OF CONSCIOUSNESS	30
52	COMMON COLD	30
53	SURGERY	30
54	ABDOMINAL PAIN	29
55	CONFUSIONAL STATE	29
56	FAINTING	29
57	LACK OF STRENGTH AND ENERGY (ASTHENIA)	28
58	HYPERSENSITIVITY	28
59	UNEVALUABLE EVENT	28
60	OFF LABEL USE	27
61	RESTLESSNESS	27
62	HALLUCINATION	26
63	MIGRAINE	26
64	STRESS	26
65	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	25
66	COUGH	25
67	PRODUCT DOSE OMISSION ISSUE	25
68	SLEEP DISORDER	25
69	DRUG EFFECT INCREASED	25
70	DRUG HYPERSENSITIVITY	24
71	PINS AND NEEDLES	22
72	AUTISM SPECTRUM DISORDER	21
73	CHEST PAIN	21
74	DRUG ABUSE	21
75	PRE-EXISTING CONDITION IMPROVED	21
76	PRODUCT USE IN UNAPPROVED INDICATION	21
77	CONSTIPATION	20
78	NUMBNESS	20
79	PRODUCT AVAILABILITY ISSUE	20
80	SUICIDE ATTEMPT	20
81	ABDOMINAL DISCOMFORT	19
82	ANGER	19
83	MUSCLE SPASMS	19
84	BIPOLAR DISORDER	18
85	DRY MOUTH	18
86	DIFFICULTY SWALLOWING	18
87	PSYCHOTIC DISORDER	18
88	SPEECH DISORDER	18
89	APATHY	17
90	ASTHMA	17
91	INCORRECT DOSE ADMINISTERED	17
92	PAIN IN EXTREMITY	17
93	URINARY TRACT INFECTION	17
94	WRONG TECHNIQUE IN DRUG USAGE PROCESS	17
95	BALANCE DISORDER	16
96	COGNITIVE DISORDER	16
97	GAIT DISTURBANCE	16
98	GASTROOESOPHAGEAL REFLUX DISEASE	16
99	PRODUCT ADMINISTRATION INTERRUPTED	16
100	ITCHING	16

Latest Known Outcomes for Reactions Reported for RITALIN LA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1127
2	Patient has not recovered/symtoms have not resolved	476
3	Patient recovered	396
4	Patient is recovering/symptoms resolving	216
5	Patient died	43
6	Patient has recovered but has consequent health issues	6

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	27
2005	31
2006	33
2007	25
2008	42
2009	49
2010	41
2011	68
2012	86
2013	160
2014	75
2015	228
2016	415
2017	67
2018	116
2019	103
2020	78
2021	44
2022	72
2023	79
2024	80
2025	43
2026	20

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	151
11-20	218
21-30	100
31-40	118
41-50	107
51-60	80
61-70	40
71-80	19
81-90	6
91+	3

Based on 842 reports that included a patient age.

RITALIN LA Total Reports

Male	Female	Unknown	Total
889	1008	85	1,982

Top Countries Reporting

	Country	Number of Reports
1	United States	993
2	Brazil	401
3	Germany	69
4	Mexico	48
5	Australia	28
6	Israel	18
7	Switzerland	15
8	South Africa	15
9	Sweden	10
10	Argentina	8

Outcomes for Reports

Serious: 1335
Not Serious: 646
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

Attention deficit hyperactivity disorder

Top Companies Reporting

SANDOZ

Safety-Related FDA Updates

FDA Approval Date: 2014-10-27

RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with RITALIN LA? Rate RITALIN LA 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 RITALIN LA 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.