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RITALIN

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Ritalin Adverse Events Reported to the FDA Over Time

How are Ritalin adverse event reports trending over time?

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

Most Common Ritalin Adverse Events Reported to the FDA

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

Drug Ineffective
310 (1.63%)
Aggression
301 (1.58%)
Agitation
256 (1.34%)
Anxiety
247 (1.3%)
Headache
243 (1.28%)
Depression
233 (1.22%)
Abnormal Behaviour
199 (1.05%)
Insomnia
193 (1.01%)
Feeling Abnormal
174 (.91%)
Nausea
171 (.9%)
Dizziness
170 (.89%)
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Suicide Attempt
167 (.88%)
Fatigue
165 (.87%)
Suicidal Ideation
158 (.83%)
Somnolence
157 (.82%)
Tachycardia
154 (.81%)
Tremor
154 (.81%)
Decreased Appetite
151 (.79%)
Irritability
147 (.77%)
Overdose
146 (.77%)
Disturbance In Attention
145 (.76%)
Vomiting
140 (.74%)
Confusional State
131 (.69%)
Completed Suicide
129 (.68%)
Drug Interaction
128 (.67%)
Hypertension
128 (.67%)
Hyperhidrosis
127 (.67%)
Hallucination
122 (.64%)
Heart Rate Increased
118 (.62%)
Intentional Overdose
117 (.61%)
Weight Decreased
115 (.6%)
Drug Dependence
110 (.58%)
Convulsion
109 (.57%)
Depressed Mood
109 (.57%)
Malaise
105 (.55%)
Tic
104 (.55%)
Palpitations
102 (.54%)
Intentional Drug Misuse
101 (.53%)
Psychotic Disorder
101 (.53%)
Crying
100 (.53%)
Chest Pain
99 (.52%)
Loss Of Consciousness
96 (.5%)
Blood Pressure Increased
93 (.49%)
Restlessness
93 (.49%)
Dyspnoea
89 (.47%)
Pyrexia
84 (.44%)
Sleep Disorder
81 (.43%)
Hallucination, Auditory
80 (.42%)
Drug Abuse
79 (.41%)
Dyskinesia
78 (.41%)
Anorexia
76 (.4%)
Fall
76 (.4%)
Drug Exposure During Pregnancy
75 (.39%)
Anger
74 (.39%)
Cardiac Arrest
74 (.39%)
Delusion
74 (.39%)
Attention Deficit/hyperactivity Dis...
72 (.38%)
Drug Toxicity
71 (.37%)
Weight Increased
71 (.37%)
Death
69 (.36%)
Drug Effect Decreased
69 (.36%)
Psychomotor Hyperactivity
66 (.35%)
Blood Creatine Phosphokinase Increa...
65 (.34%)
Hallucination, Visual
65 (.34%)
Bipolar Disorder
62 (.33%)
Syncope
62 (.33%)
Drug Abuser
61 (.32%)
Condition Aggravated
59 (.31%)
Abdominal Pain
58 (.3%)
Memory Impairment
57 (.3%)
Speech Disorder
56 (.29%)
Apathy
54 (.28%)
Mental Disorder
54 (.28%)
Depressed Level Of Consciousness
53 (.28%)
Disorientation
52 (.27%)
Incorrect Dose Administered
52 (.27%)
Paranoia
52 (.27%)
Delirium
51 (.27%)
Mydriasis
51 (.27%)
Abdominal Pain Upper
50 (.26%)
Muscle Spasms
50 (.26%)
Respiratory Arrest
50 (.26%)
Asthenia
48 (.25%)
Dysarthria
47 (.25%)
Withdrawal Syndrome
47 (.25%)
Aspartate Aminotransferase Increase...
46 (.24%)
Drug Withdrawal Syndrome
46 (.24%)
Euphoric Mood
46 (.24%)
Pain
46 (.24%)
Product Substitution Issue
46 (.24%)
Dystonia
45 (.24%)
Vision Blurred
45 (.24%)
Peripheral Coldness
44 (.23%)
Alanine Aminotransferase Increased
43 (.23%)
Growth Retardation
43 (.23%)
Hypoaesthesia
43 (.23%)
Mood Swings
43 (.23%)
Pallor
42 (.22%)
Nervousness
41 (.22%)
Paraesthesia
41 (.22%)
Gait Disturbance
40 (.21%)

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This graph shows the top adverse events submitted to the FDA for Ritalin, 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 Ritalin 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 Ritalin

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

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This graph shows the top categories of adverse events submitted to the FDA for Ritalin, 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 Ritalin 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 Ritalin According to Those Reporting Adverse Events

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

Attention Deficit/hyperactivity Dis...
2363
Drug Use For Unknown Indication
263
Product Used For Unknown Indication
225
Depression
195
Fatigue
150
Narcolepsy
138
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Psychomotor Hyperactivity
133
Disturbance In Attention
88
Ill-defined Disorder
65
Somnolence
47
Sleep Apnoea Syndrome
27
Autism
25
Hypersomnia
18
Abnormal Behaviour
16
Oppositional Defiant Disorder
15
Suicide Attempt
14
Malaise
14
Major Depression
13
Anxiety
13
Bipolar Disorder
12
Apathy
11
Obsessive-compulsive Disorder
10
Asthenia
9
Depressed Mood
9
Aggression
9
Hyperkinesia
8
Pain
8
Depressed Level Of Consciousness
8
Energy Increased
8
Sleep Disorder
8
Affective Disorder
7
Dementia Alzheimers Type
7
Psychomotor Retardation
7
Drug Exposure During Pregnancy
7
Agitation
7
Cognitive Disorder
7
Poor Quality Sleep
6
Headache
6
Memory Impairment
6
Distractibility
6
Central Nervous System Stimulation
6
Aspergers Disorder
6
Autism Spectrum Disorder
6
Learning Disability
5
Intentional Overdose
5
Post-traumatic Stress Disorder
5
Tourettes Disorder
5
Drug Abuse
5
Completed Suicide
5
Postural Orthostatic Tachycardia Sy...
5
Intermittent Explosive Disorder
5

Drug Labels

LabelLabelerEffective
RitalinNovartis Pharmaceuticals Corporation12-DEC-10
Ritalin SrNovartis Pharmaceuticals Corporation12-DEC-10
Ritalin Physicians Total Care, Inc.20-JAN-12
RitalinlaNovartis Pharmaceuticals Corporation18-JUN-12

Ritalin Case Reports

What Ritalin 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 Ritalin. 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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