CONCERTA: 166 Adverse Event Reports & Safety Profile
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166
Total FAERS Reports
3 (1.8%)
Deaths Reported
19
Hospitalizations
166
As Primary/Secondary Suspect
7
Life-Threatening
9
Disabilities
First Report: 200607 · Latest Report: 20140613
What Are the Most Common CONCERTA Side Effects?
#1 Most Reported
Product substitution issue
46 reports (27.7%)
#2 Most Reported
Drug ineffective
35 reports (21.1%)
#3 Most Reported
Anxiety
14 reports (8.4%)
All CONCERTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product substitution issue | 46 | 27.7% | 0 | 0 |
| Drug ineffective | 35 | 21.1% | 0 | 1 |
| Anxiety | 14 | 8.4% | 1 | 0 |
| Drug effect decreased | 10 | 6.0% | 0 | 0 |
| Off label use | 9 | 5.4% | 0 | 2 |
| Palpitations | 9 | 5.4% | 1 | 2 |
| Product quality issue | 9 | 5.4% | 0 | 0 |
| Disturbance in attention | 8 | 4.8% | 0 | 0 |
| Abnormal behaviour | 7 | 4.2% | 0 | 0 |
| Growth retardation | 7 | 4.2% | 0 | 0 |
| Suicide attempt | 7 | 4.2% | 0 | 2 |
| Depression | 6 | 3.6% | 0 | 1 |
| Mood swings | 6 | 3.6% | 0 | 0 |
| Somnolence | 6 | 3.6% | 0 | 0 |
| Weight increased | 6 | 3.6% | 0 | 0 |
| Aggression | 5 | 3.0% | 0 | 0 |
| Educational problem | 5 | 3.0% | 0 | 0 |
| Headache | 5 | 3.0% | 0 | 1 |
| Nausea | 5 | 3.0% | 0 | 2 |
| Suicidal ideation | 5 | 3.0% | 0 | 0 |
Who Reports CONCERTA Side Effects? Age & Gender Data
Average age: 20.5 years. Most reports from: US. View detailed demographics →
Is CONCERTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 3 | 0 | 0 |
| 2010 | 3 | 0 | 1 |
| 2011 | 4 | 0 | 1 |
| 2012 | 2 | 0 | 1 |
| 2013 | 35 | 1 | 8 |
| 2014 | 54 | 0 | 4 |
What Is CONCERTA Used For?
| Indication | Reports |
|---|---|
| Attention deficit/hyperactivity disorder | 107 |
| Product used for unknown indication | 36 |
| Disturbance in attention | 5 |
| Psychomotor hyperactivity | 5 |
CONCERTA vs Alternatives: Which Is Safer?
CONCERTA vs CONESTAT ALFA
CONCERTA vs COPANLISIB
CONCERTA vs COPAXONE
CONCERTA vs COPEGUS
CONCERTA vs COPPER
CONCERTA vs CORDARONE
CONCERTA vs CORICIDIN HBP COLD AND FLU
CONCERTA vs CORTICOSTEROID NOS
CONCERTA vs CORTICOTROPIN
CONCERTA vs CORTISONE
Official FDA Label for CONCERTA
Official prescribing information from the FDA-approved drug label.