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CONCERTA

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Concerta Adverse Events Reported to the FDA Over Time

How are Concerta adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Concerta, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Concerta is flagged as the suspect drug causing the adverse event.

Most Common Concerta Adverse Events Reported to the FDA

What are the most common Concerta adverse events reported to the FDA?

Aggression
364 (1.68%)
Headache
317 (1.47%)
Suicidal Ideation
305 (1.41%)
Insomnia
287 (1.33%)
Drug Ineffective
263 (1.22%)
Decreased Appetite
257 (1.19%)
Suicide Attempt
252 (1.17%)
Agitation
247 (1.14%)
Depression
245 (1.13%)
Tachycardia
243 (1.12%)
Anxiety
239 (1.11%)
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Overdose
238 (1.1%)
Abnormal Behaviour
237 (1.1%)
Hallucination
209 (.97%)
Growth Retardation
207 (.96%)
Psychotic Disorder
197 (.91%)
Weight Decreased
197 (.91%)
Chest Pain
191 (.88%)
Tic
190 (.88%)
Nausea
185 (.86%)
Dizziness
176 (.81%)
Drug Interaction
176 (.81%)
Vomiting
174 (.8%)
Fatigue
170 (.79%)
Hypertension
168 (.78%)
Convulsion
154 (.71%)
Heart Rate Increased
150 (.69%)
Irritability
143 (.66%)
Completed Suicide
138 (.64%)
Tremor
133 (.62%)
Dyskinesia
132 (.61%)
Intentional Overdose
132 (.61%)
Palpitations
129 (.6%)
Restlessness
128 (.59%)
Feeling Abnormal
123 (.57%)
Hallucination, Visual
117 (.54%)
Dyspnoea
115 (.53%)
Abdominal Pain
114 (.53%)
Syncope
106 (.49%)
Psychomotor Hyperactivity
105 (.49%)
Blood Pressure Increased
96 (.44%)
Off Label Use
96 (.44%)
Dystonia
95 (.44%)
Disturbance In Attention
93 (.43%)
Somnolence
93 (.43%)
Loss Of Consciousness
92 (.43%)
Anorexia
89 (.41%)
Hallucination, Auditory
89 (.41%)
Confusional State
88 (.41%)
Pyrexia
88 (.41%)
Weight Increased
88 (.41%)
Drug Abuse
87 (.4%)
Paranoia
86 (.4%)
Abdominal Pain Upper
85 (.39%)
Arrhythmia
85 (.39%)
Asthenia
84 (.39%)
Cardiac Arrest
82 (.38%)
Crying
82 (.38%)
Incorrect Dose Administered
80 (.37%)
Depressed Mood
79 (.37%)
Malaise
79 (.37%)
Attention Deficit/hyperactivity Dis...
76 (.35%)
Hyperhidrosis
76 (.35%)
Delusion
75 (.35%)
Anger
72 (.33%)
Sleep Disorder
72 (.33%)
Intentional Drug Misuse
68 (.31%)
Electrocardiogram Qt Prolonged
67 (.31%)
Drug Dose Omission
66 (.31%)
Mydriasis
66 (.31%)
Drug Effect Decreased
65 (.3%)
Mania
64 (.3%)
Obsessive-compulsive Disorder
64 (.3%)
Vision Blurred
64 (.3%)
Epistaxis
63 (.29%)
Death
62 (.29%)
Haematuria
61 (.28%)
Drug Exposure During Pregnancy
58 (.27%)
Paraesthesia
56 (.26%)
Muscle Spasms
55 (.25%)
Rash
54 (.25%)
Depressed Level Of Consciousness
53 (.25%)
Multiple Drug Overdose Intentional
53 (.25%)
Blood Creatine Phosphokinase Increa...
52 (.24%)
Pain
52 (.24%)
Product Substitution Issue
51 (.24%)
Nervousness
50 (.23%)
Mood Swings
49 (.23%)
Speech Disorder
48 (.22%)
Withdrawal Syndrome
47 (.22%)
Apathy
46 (.21%)
Dysarthria
46 (.21%)
Hypoaesthesia
46 (.21%)
Social Avoidant Behaviour
45 (.21%)
Treatment Noncompliance
45 (.21%)
Respiratory Arrest
44 (.2%)
Condition Aggravated
43 (.2%)
Muscle Twitching
43 (.2%)
Bipolar Disorder
42 (.19%)
Hypotension
42 (.19%)
Medication Error
42 (.19%)

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This graph shows the top adverse events submitted to the FDA for Concerta, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Concerta is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Concerta

What are the most common Concerta adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Concerta, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Concerta is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Concerta According to Those Reporting Adverse Events

Why are people taking Concerta, according to those reporting adverse events to the FDA?

Attention Deficit/hyperactivity Dis...
3620
Drug Use For Unknown Indication
1056
Product Used For Unknown Indication
500
Ill-defined Disorder
109
Psychomotor Hyperactivity
87
Disturbance In Attention
70
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Depression
67
Narcolepsy
52
Fatigue
51
Abnormal Behaviour
27
Oppositional Defiant Disorder
26
Bipolar Disorder
22
Somnolence
20
Autism
20
Suicide Attempt
18
Drug Exposure During Pregnancy
17
Drug Abuse
13
Apathy
11
Hyperkinesia
10
Tourettes Disorder
10
Foetal Exposure During Pregnancy
9
Restlessness
9
Major Depression
9
Conduct Disorder
9
Aggression
9
Obsessive-compulsive Disorder
8
Anxiety
8
Learning Disability
7
Psychomotor Retardation
7
Aspergers Disorder
6
Affective Disorder
6
Mental Retardation
6
Autism Spectrum Disorder
6
Hypersomnia
6
Mental Disorder
6
Cognitive Disorder
6
Dementia Alzheimers Type
5
Accidental Exposure
5
Drug Abuser
5
Intentional Overdose
5
Impulsive Behaviour
5
Psychotic Disorder
4
Unevaluable Event
4
Overdose
4
Sleep Disorder
4
Post-traumatic Stress Disorder
4
Energy Increased
4
Sedation
3
Disturbance In Social Behaviour
3
Traumatic Brain Injury
3
Decreased Activity
3

Drug Labels

LabelLabelerEffective
ConcertaPhysicians Total Care, Inc.01-NOV-10
ConcertaJanssen Pharmaceuticals, Inc.01-NOV-12

Concerta Case Reports

What Concerta safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Concerta. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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