Drug Safety Information for RITALIN (Methylphenidate hydrochloride)

Safety-related Labeling Changes for RITALIN (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for RITALIN-SR (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

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

Safety-related Labeling Changes for METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

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

Safety-related Labeling Changes for METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADHANSIA XR (METHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for RITALIN* (Methylphenidate hydrochloride)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with RITALIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective1661
2Headache*1017
3Nausea942
4Fatigue922
5Depression*892
6Anxiety*830
7Insomnia*772
8Aggression760
9Decreased appetite*713
10Vomiting669
11Abnormal behaviour654
12Dizziness624
13Suicidal ideation623
14Feeling abnormal581
15Disturbance in attention574
16Agitation563
17Somnolence*557
18Product quality issue552
19Product substitution issue550
20Weight decreased*544

* This side effect also appears in "Top 10 Side Effects of RITALIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking RITALIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Attention deficit/hyperactivity disorder*22680
2Product used for unknown indication8989
3Fatigue*1247
4Depression*1158
5Narcolepsy*1012
6Disturbance in attention887
7Psychomotor hyperactivity*722
8Somnolence*215
9Ill-defined disorder196
10Sleep apnoea syndrome149

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for RITALIN

Total Reports Filed with FDA: 78988


Number of FDA Adverse Event Reports by Patient Age for RITALIN

Total Reports Filed with FDA: 78988*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methylphenidate hydrochloride (Aptensio xr, Quillivant, Concerta, Methylphenidate hcl, Methylphenidate, Methylin, Ritalin la, Metadate cd, Quillivant xr, Ritalin, Metadate er, Methylin er, Ritalin-sr)

Charts are based on 78988 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and RITALIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.