Drug Safety Information for FOCALIN XR (Dexmethylphenidate hydrochloride)

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

Safety-related Labeling Changes for FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for AZSTARYS (DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for FOCALIN XR* (Dexmethylphenidate 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 FOCALIN XR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective92
2Product quality issue65
3Abnormal behaviour56
4Convulsion53
5Aggression52
6Depression*52
7Insomnia*51
8Headache*51
9Nausea45
10Vomiting41
11Wrong technique in drug usage process40
12Weight increased39
13Anxiety*39
14Fatigue*38
15Decreased appetite*37
16Feeling abnormal36
17Disturbance in attention35
18Suicidal ideation35
19Hallucination35
20Agitation35

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

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

Reason # of FDA Reports
1Attention deficit/hyperactivity disorder*1621
2Product used for unknown indication285
3Fatigue75
4Asperger's disorder42
5Asthenia19
6Disturbance in attention14
7Narcolepsy14
8Depression13
9Educational problem10
10Aggression10

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


Types of Adverse Events for FOCALIN XR

Total Reports Filed with FDA: 4124


Number of FDA Adverse Event Reports by Patient Age for FOCALIN XR

Total Reports Filed with FDA: 4124*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dexmethylphenidate hydrochloride (Focalinxr, Focalin xr, Focalin)

Charts are based on 4124 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 FOCALIN XR 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.