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Vyvanse Adverse Events Reported to the FDA Over Time

How are Vyvanse adverse event reports trending over time?

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

Most Common Vyvanse Adverse Events Reported to the FDA

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

Age >60

Drug Ineffective
6 (.05%)
Product Quality Issue
6 (.05%)
Disturbance In Attention
5 (.04%)
Drug Effect Decreased
5 (.04%)
Insomnia
5 (.04%)
Headache
4 (.03%)
Inappropriate Schedule Of Drug Admi...
4 (.03%)
Nausea
4 (.03%)
Tremor
4 (.03%)
Agitation
3 (.02%)
Bruxism
3 (.02%)
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Condition Aggravated
3 (.02%)
Drug Prescribing Error
3 (.02%)
Dry Mouth
3 (.02%)
Dyspnoea
3 (.02%)
Feeling Abnormal
3 (.02%)
Vomiting
3 (.02%)
Weight Decreased
3 (.02%)
Breast Cancer
2 (.02%)
Bronchitis
2 (.02%)
Chest Pain
2 (.02%)
Chills
2 (.02%)
Depression
2 (.02%)
Drug Effect Increased
2 (.02%)
Hypersensitivity
2 (.02%)
Malaise
2 (.02%)
Myocardial Infarction
2 (.02%)
Off Label Use
2 (.02%)
Overdose
2 (.02%)
Pain In Extremity
2 (.02%)
Palpitations
2 (.02%)
Pharyngeal Oedema
2 (.02%)
Pyrexia
2 (.02%)
Road Traffic Accident
2 (.02%)
Sluggishness
2 (.02%)
Swollen Tongue
2 (.02%)
Therapeutic Response Unexpected
2 (.02%)
Upper Limb Fracture
2 (.02%)
Yawning
2 (.02%)
Abdominal Pain Upper
1 (.01%)
Abnormal Dreams
1 (.01%)
Abnormal Loss Of Weight
1 (.01%)
Aggression
1 (.01%)
Amphetamines Positive
1 (.01%)
Anaemia
1 (.01%)
Anger
1 (.01%)
Anorexia
1 (.01%)
Arthralgia
1 (.01%)
Asthenia
1 (.01%)
Atrial Fibrillation
1 (.01%)
Bladder Distension
1 (.01%)
Blood Pressure Increased
1 (.01%)
Bradyphrenia
1 (.01%)
Cardiac Disorder
1 (.01%)
Cataract
1 (.01%)
Chest Discomfort
1 (.01%)
Chromaturia
1 (.01%)
Confusional State
1 (.01%)
Cough
1 (.01%)
Cyst
1 (.01%)
Decreased Activity
1 (.01%)
Dehydration
1 (.01%)
Dizziness
1 (.01%)
Drug Screen False Positive
1 (.01%)
Drug Screen Positive
1 (.01%)
Drug Withdrawal Syndrome
1 (.01%)
Dry Throat
1 (.01%)
Dysphonia
1 (.01%)
Facial Pain
1 (.01%)
Fatigue
1 (.01%)
Feeling Hot
1 (.01%)
Flat Affect
1 (.01%)
Heart Rate Increased
1 (.01%)
Heart Rate Irregular
1 (.01%)
Homicidal Ideation
1 (.01%)
Hostility
1 (.01%)
Hyperhidrosis
1 (.01%)
Hypertension
1 (.01%)
Hyperthyroidism
1 (.01%)
Hypoaesthesia
1 (.01%)
Impaired Gastric Emptying
1 (.01%)
Incontinence
1 (.01%)
Incorrect Dose Administered
1 (.01%)
Influenza
1 (.01%)
Initial Insomnia
1 (.01%)
Intentional Drug Misuse
1 (.01%)
Irritability
1 (.01%)
Joint Stiffness
1 (.01%)
Kidney Infection
1 (.01%)
Lethargy
1 (.01%)
Mental Impairment
1 (.01%)
Migraine
1 (.01%)
Muscle Fatigue
1 (.01%)
Muscle Tightness
1 (.01%)
Muscle Twitching
1 (.01%)
Musculoskeletal Discomfort
1 (.01%)
Musculoskeletal Pain
1 (.01%)
Nervousness
1 (.01%)
Oedema Peripheral
1 (.01%)
Pancreatitis Relapsing
1 (.01%)
Pollakiuria
1 (.01%)

All Ages and Genders

Off Label Use
513 (4.19%)
Insomnia
368 (3%)
Drug Ineffective
306 (2.5%)
Aggression
230 (1.88%)
Decreased Appetite
209 (1.71%)
Drug Effect Decreased
202 (1.65%)
Headache
195 (1.59%)
Suicidal Ideation
189 (1.54%)
Irritability
166 (1.35%)
Disturbance In Attention
156 (1.27%)
Anxiety
154 (1.26%)
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Weight Decreased
150 (1.22%)
Nausea
149 (1.22%)
Tic
145 (1.18%)
Agitation
142 (1.16%)
Abnormal Behaviour
139 (1.13%)
Fatigue
133 (1.09%)
Overdose
133 (1.09%)
Anger
128 (1.04%)
Dizziness
128 (1.04%)
Feeling Abnormal
122 (1%)
Depression
121 (.99%)
Abdominal Pain Upper
114 (.93%)
Anorexia
111 (.91%)
Condition Aggravated
107 (.87%)
Vomiting
106 (.87%)
Crying
102 (.83%)
Chest Pain
99 (.81%)
Dyspnoea
95 (.78%)
Psychomotor Hyperactivity
94 (.77%)
Heart Rate Increased
89 (.73%)
Product Quality Issue
86 (.7%)
Somnolence
83 (.68%)
Hallucination
81 (.66%)
Logorrhoea
79 (.64%)
Depressed Mood
78 (.64%)
Tremor
78 (.64%)
Drug Effect Increased
75 (.61%)
Syncope
75 (.61%)
Impulsive Behaviour
74 (.6%)
Mood Altered
71 (.58%)
Convulsion
70 (.57%)
Inappropriate Schedule Of Drug Admi...
70 (.57%)
Palpitations
68 (.56%)
Dry Mouth
67 (.55%)
Paranoia
65 (.53%)
Vision Blurred
64 (.52%)
Blood Pressure Increased
63 (.51%)
Negativism
61 (.5%)
Affect Lability
58 (.47%)
Malaise
58 (.47%)
Nervousness
58 (.47%)
Tachycardia
58 (.47%)
Psychotic Disorder
54 (.44%)
Confusional State
53 (.43%)
Drug Prescribing Error
51 (.42%)
Dyskinesia
51 (.42%)
Rash
51 (.42%)
Mood Swings
49 (.4%)
Social Avoidant Behaviour
49 (.4%)
Loss Of Consciousness
48 (.39%)
Hyperhidrosis
47 (.38%)
Incorrect Dose Administered
47 (.38%)
Intentional Overdose
46 (.38%)
Asthenia
45 (.37%)
Diarrhoea
41 (.33%)
Mania
41 (.33%)
Abdominal Discomfort
40 (.33%)
Lethargy
40 (.33%)
Pruritus
40 (.33%)
Alopecia
39 (.32%)
Feeling Jittery
39 (.32%)
Intentional Drug Misuse
39 (.32%)
Wrong Technique In Drug Usage Proce...
39 (.32%)
Weight Increased
38 (.31%)
Drug Diversion
37 (.3%)
Therapeutic Response Unexpected
37 (.3%)
Bruxism
35 (.29%)
Hypoaesthesia
34 (.28%)
Flat Affect
33 (.27%)
Mydriasis
33 (.27%)
Pain
33 (.27%)
Pain In Extremity
33 (.27%)
Restlessness
33 (.27%)
Educational Problem
32 (.26%)
Suicide Attempt
32 (.26%)
Drug Interaction
31 (.25%)
Hallucination, Visual
31 (.25%)
Emotional Distress
30 (.24%)
Fall
30 (.24%)
Pyrexia
30 (.24%)
Muscle Twitching
29 (.24%)
Oedema Peripheral
29 (.24%)
Speech Disorder
29 (.24%)
Drug Abuse
27 (.22%)
Emotional Disorder
27 (.22%)
Hallucination, Auditory
27 (.22%)
Hypersensitivity
27 (.22%)
Initial Insomnia
27 (.22%)
Abdominal Pain
26 (.21%)
Fear
26 (.21%)

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

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

Age >60

Show More Show More

All Ages and Genders

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ExportShare/Embed Graph Export Export Data

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

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

Attention Deficit/hyperactivity Dis...
2545
Drug Use For Unknown Indication
193
Product Used For Unknown Indication
192
Disturbance In Attention
34
Depression
21
Oppositional Defiant Disorder
11
Show More Show More
Bipolar Disorder
10
Fatigue
8
Narcolepsy
8
Autism
8
Affective Disorder
6
Aspergers Disorder
6
Abnormal Behaviour
6
Obsessive-compulsive Disorder
5
Psychomotor Hyperactivity
5
Bipolar Ii Disorder
4
Asthenia
4
Binge Eating
4
Somnolence
3
Mood Swings
3
Accidental Drug Intake By Child
3
Memory Impairment
3
Impulsive Behaviour
3
Fibromyalgia
3
Anxiety
3
Weight Control
2
Impulse-control Disorder
2
Tourettes Disorder
2
Apathy
2
Systemic Lupus Erythematosus
2
Dyslexia
2
Hypersomnia
2
Hypothyroidism
2
Sleep Disorder
2
Brain Injury
2
Weight Loss Diet
2
Multiple Sclerosis
2
Impaired Work Ability
1
Accidental Exposure
1
Autism Spectrum Disorder
1
Dysgraphia
1
Nervous System Disorder
1
Chronic Fatigue Syndrome
1
Lung Disorder
1
Oculodentodigital Dysplasia
1
Investigation
1
Ill-defined Disorder
1
Cognitive Disorder
1
Amnesia
1
Syncope
1
Bipolar I Disorder
1

Drug Labels

LabelLabelerEffective
VyvansePhysicians Total Care, Inc.13-JAN-12
VyvanseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC04-JUN-12
VyvanseShire LLC29-NOV-12

Vyvanse Case Reports

What Vyvanse 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 Vyvanse. 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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