Methylphenidate

Common brands: Daytrana, Cotempla Xr-Odt, Methylphenidate Transdermal System, Xyrem, Vitamin D

Top reporter: Noven Therapeutics, Llc

Central Nervous System Stimulant [EPC]Benzodiazepine [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Atypical Antipsychotic [EPC]Corticosteroid [EPC]
28,288
Total Reports
7,667
Serious Reports
1,091
Death Reports
30
Reported Reactions
Death Report Ratio: Moderate (3.86%)

Patient Demographics

Male
12,137
Female
10,019

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Methylphenidate.

# Reaction Reports % of Total
1 NO ADVERSE EVENT 6,876
15.5%
2 OFF LABEL USE 5,900
13.3%
3 PRODUCT QUALITY ISSUE 5,243
11.8%
4 DRUG INEFFECTIVE 2,899
6.5%
5 DRUG ADMINISTRATION ERROR 1,901
4.3%
6 WRONG TECHNIQUE IN DRUG USAGE PROCESS 1,772
4.0%
7 APPLICATION SITE ERYTHEMA 1,684
3.8%
8 DRUG DOSE OMISSION 1,478
3.3%
9 INCORRECT DRUG ADMINISTRATION DURATION 1,191
2.7%
10 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 1,135
2.6%
11 DRUG PRESCRIBING ERROR 1,079
2.4%
12 DISTURBANCE IN ATTENTION 911
2.1%
13 PRODUCT ADHESION ISSUE 868
2.0%
14 ANXIETY 849
1.9%
15 FATIGUE 843
1.9%
16 HEADACHE 819
1.8%
17 APPLICATION SITE PRURITUS 811
1.8%
18 NAUSEA 800
1.8%
19 DECREASED APPETITE 796
1.8%
20 INSOMNIA 723
1.6%
21 DRUG ADMINISTERED AT INAPPROPRIATE SITE 680
1.5%
22 TOXICITY TO VARIOUS AGENTS 668
1.5%
23 APPLICATION SITE IRRITATION 652
1.5%
24 DEPRESSION 616
1.4%
25 AGGRESSION 586
1.3%
26 SOMNOLENCE 551
1.2%
27 CONDITION AGGRAVATED 534
1.2%
28 DIZZINESS 534
1.2%
29 PSYCHOMOTOR HYPERACTIVITY 524
1.2%
30 VOMITING 511
1.2%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.