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INTUNIV

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Intuniv Adverse Events Reported to the FDA Over Time

How are Intuniv adverse event reports trending over time?

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

Most Common Intuniv Adverse Events Reported to the FDA

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

Syncope
104 (7.51%)
Somnolence
43 (3.1%)
Convulsion
42 (3.03%)
Dizziness
39 (2.82%)
Off Label Use
32 (2.31%)
Suicidal Ideation
29 (2.09%)
Hypotension
26 (1.88%)
Fatigue
25 (1.81%)
Loss Of Consciousness
24 (1.73%)
Headache
22 (1.59%)
Hallucination
18 (1.3%)
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Aggression
17 (1.23%)
Inappropriate Schedule Of Drug Admi...
17 (1.23%)
Bradycardia
16 (1.16%)
Blood Pressure Decreased
15 (1.08%)
Homicidal Ideation
15 (1.08%)
Lethargy
15 (1.08%)
Agitation
14 (1.01%)
Pallor
14 (1.01%)
Fall
13 (.94%)
Sinus Bradycardia
13 (.94%)
Heart Rate Decreased
12 (.87%)
Unresponsive To Stimuli
12 (.87%)
Abdominal Pain Upper
11 (.79%)
Anger
11 (.79%)
Blood Pressure Increased
11 (.79%)
Feeling Abnormal
11 (.79%)
Hypoaesthesia
11 (.79%)
Decreased Appetite
10 (.72%)
Depressed Mood
10 (.72%)
Head Injury
10 (.72%)
Sedation
10 (.72%)
Anxiety
9 (.65%)
Drug Interaction
9 (.65%)
Hallucination, Visual
9 (.65%)
Heart Rate Increased
9 (.65%)
Hypersomnia
9 (.65%)
Intentional Overdose
9 (.65%)
Irritability
9 (.65%)
Malaise
9 (.65%)
Pancreatitis
9 (.65%)
Vomiting
9 (.65%)
Adverse Event
8 (.58%)
Atrioventricular Block
8 (.58%)
Chest Pain
8 (.58%)
Condition Aggravated
8 (.58%)
Disturbance In Attention
8 (.58%)
Dyskinesia
8 (.58%)
Insomnia
8 (.58%)
Muscle Twitching
8 (.58%)
Physical Assault
8 (.58%)
Abnormal Behaviour
7 (.51%)
Affect Lability
7 (.51%)
Drug Effect Decreased
7 (.51%)
Incorrect Dose Administered
7 (.51%)
Depression
6 (.43%)
Dysarthria
6 (.43%)
Grand Mal Convulsion
6 (.43%)
Heart Rate Irregular
6 (.43%)
Muscle Spasms
6 (.43%)
Pyrexia
6 (.43%)
Tic
6 (.43%)
Accidental Overdose
5 (.36%)
Asthenia
5 (.36%)
Depressed Level Of Consciousness
5 (.36%)
Drug Ineffective
5 (.36%)
Emotional Disorder
5 (.36%)
Fear
5 (.36%)
Hallucination, Auditory
5 (.36%)
Lip Swelling
5 (.36%)
Negativism
5 (.36%)
Nightmare
5 (.36%)
Palpitations
5 (.36%)
Presyncope
5 (.36%)
Staring
5 (.36%)
Tremor
5 (.36%)
Abdominal Discomfort
4 (.29%)
Abdominal Pain
4 (.29%)
Accidental Exposure
4 (.29%)
Benign Intracranial Hypertension
4 (.29%)
Blood Pressure Diastolic Decreased
4 (.29%)
Body Temperature Increased
4 (.29%)
Cardiac Murmur
4 (.29%)
Concussion
4 (.29%)
Crying
4 (.29%)
Dehydration
4 (.29%)
Drug Effect Increased
4 (.29%)
Enuresis
4 (.29%)
Excessive Eye Blinking
4 (.29%)
Eye Pain
4 (.29%)
Feeling Cold
4 (.29%)
Gastrooesophageal Reflux Disease
4 (.29%)
Haemoptysis
4 (.29%)
Haemorrhage
4 (.29%)
Hyperhidrosis
4 (.29%)
Imprisonment
4 (.29%)
Impulsive Behaviour
4 (.29%)
Intentional Self-injury
4 (.29%)
Medication Error
4 (.29%)
Mood Swings
4 (.29%)
Oropharyngeal Pain
4 (.29%)

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

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

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

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

Attention Deficit/hyperactivity Dis...
258
Product Used For Unknown Indication
129
Drug Use For Unknown Indication
20
Oppositional Defiant Disorder
13
Impulsive Behaviour
8
Psychomotor Hyperactivity
4
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Affective Disorder
3
Tic
3
Tourettes Disorder
3
Aggression
3
Hypertension
2
Impulse-control Disorder
2
Bipolar Disorder
2
Autism Spectrum Disorder
2
Disturbance In Attention
2
Anxiety
1
Cerebral Palsy
1
Negativism
1
Abnormal Behaviour
1
Unevaluable Event
1
Aspergers Disorder
1
Mood Altered
1
Fatigue
1
Anger
1
Autism
1
Agitation
1
Personality Disorder
1
Depression
1

Drug Labels

LabelLabelerEffective
IntunivShire US Manufacturing Inc.20-FEB-13

Intuniv Case Reports

What Intuniv 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 Intuniv. 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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