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Adderall Adverse Events Reported to the FDA Over Time

How are Adderall adverse event reports trending over time?

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

Most Common Adderall Adverse Events Reported to the FDA

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

Age 1-9 Years

Aggression
43 (.34%)
Abnormal Behaviour
40 (.32%)
Insomnia
26 (.21%)
Convulsion
24 (.19%)
Headache
22 (.17%)
Irritability
21 (.17%)
Drug Ineffective
20 (.16%)
Decreased Appetite
17 (.13%)
Psychotic Disorder
17 (.13%)
Suicidal Ideation
16 (.13%)
Anorexia
15 (.12%)
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Heart Rate Increased
15 (.12%)
Product Substitution Issue
15 (.12%)
Crying
14 (.11%)
Weight Decreased
14 (.11%)
Anxiety
13 (.1%)
Agitation
12 (.09%)
Dyskinesia
12 (.09%)
Anger
11 (.09%)
Drug Effect Decreased
10 (.08%)
Feeling Abnormal
10 (.08%)
Grand Mal Convulsion
10 (.08%)
Medication Error
10 (.08%)
Attention Deficit/hyperactivity Dis...
9 (.07%)
Chest Pain
9 (.07%)
Hallucination
9 (.07%)
Overdose
9 (.07%)
Tachycardia
9 (.07%)
Tic
9 (.07%)
Abdominal Pain Upper
8 (.06%)
Condition Aggravated
8 (.06%)
Coordination Abnormal
8 (.06%)
Mood Altered
8 (.06%)
Suicide Attempt
8 (.06%)
Tremor
8 (.06%)
Homicidal Ideation
7 (.06%)
Mood Swings
7 (.06%)
Psychomotor Hyperactivity
7 (.06%)
Vomiting
7 (.06%)
Accidental Exposure
6 (.05%)
Affect Lability
6 (.05%)
Disturbance In Attention
6 (.05%)
Fatigue
6 (.05%)
Fear
6 (.05%)
Hallucination, Visual
6 (.05%)
Movement Disorder
6 (.05%)
Nausea
6 (.05%)
Respiratory Arrest
6 (.05%)
Somnolence
6 (.05%)
Ataxia
5 (.04%)
Diarrhoea
5 (.04%)
Dizziness
5 (.04%)
Dystonia
5 (.04%)
Electrocardiogram Abnormal
5 (.04%)
Gait Disturbance
5 (.04%)
Muscular Weakness
5 (.04%)
Paranoia
5 (.04%)
Rash
5 (.04%)
Screaming
5 (.04%)
Sleep Disorder
5 (.04%)
Abdominal Pain
4 (.03%)
Accidental Drug Intake By Child
4 (.03%)
Angina Pectoris
4 (.03%)
Cardiac Arrest
4 (.03%)
Congenital Tricuspid Valve Stenosis
4 (.03%)
Constipation
4 (.03%)
Delusion
4 (.03%)
Depression
4 (.03%)
Drug Withdrawal Syndrome
4 (.03%)
Dyspnoea
4 (.03%)
Growth Retardation
4 (.03%)
Hypoplastic Right Heart Syndrome
4 (.03%)
Pallor
4 (.03%)
Palpitations
4 (.03%)
Panic Attack
4 (.03%)
Skin Discolouration
4 (.03%)
Sneezing
4 (.03%)
Speech Disorder
4 (.03%)
Theft
4 (.03%)
Thrombocytopenia
4 (.03%)
Type 1 Diabetes Mellitus
4 (.03%)
Urinary Incontinence
4 (.03%)
Viral Infection
4 (.03%)
Withdrawal Syndrome
4 (.03%)
Affective Disorder
3 (.02%)
Blood Pressure Increased
3 (.02%)
Cardiac Disorder
3 (.02%)
Chorea
3 (.02%)
Confusional State
3 (.02%)
Contusion
3 (.02%)
Decreased Activity
3 (.02%)
Depressed Mood
3 (.02%)
Discomfort
3 (.02%)
Drooling
3 (.02%)
Drug Dose Omission
3 (.02%)
Drug Toxicity
3 (.02%)
Erythema
3 (.02%)
Hyperhidrosis
3 (.02%)
Impulsive Behaviour
3 (.02%)
Malignant Hypertension
3 (.02%)
Musculoskeletal Stiffness
3 (.02%)

All Ages and Genders

Drug Ineffective
309 (2.44%)
Product Substitution Issue
219 (1.73%)
Headache
206 (1.63%)
Insomnia
188 (1.49%)
Aggression
171 (1.35%)
Completed Suicide
169 (1.34%)
Overdose
162 (1.28%)
Anxiety
159 (1.26%)
Depression
148 (1.17%)
Fatigue
140 (1.11%)
Agitation
136 (1.08%)
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Abnormal Behaviour
129 (1.02%)
Suicidal Ideation
129 (1.02%)
Feeling Abnormal
128 (1.01%)
Nausea
121 (.96%)
Disturbance In Attention
106 (.84%)
Psychotic Disorder
106 (.84%)
Drug Effect Decreased
105 (.83%)
Heart Rate Increased
103 (.81%)
Irritability
102 (.81%)
Somnolence
96 (.76%)
Dizziness
94 (.74%)
Product Quality Issue
93 (.74%)
Convulsion
91 (.72%)
Palpitations
89 (.7%)
Drug Interaction
88 (.7%)
Death
83 (.66%)
Weight Decreased
83 (.66%)
Chest Pain
82 (.65%)
Drug Abuse
82 (.65%)
Tremor
80 (.63%)
Cardiac Arrest
79 (.62%)
Condition Aggravated
78 (.62%)
Dyspnoea
71 (.56%)
Blood Pressure Increased
68 (.54%)
Drug Toxicity
67 (.53%)
Loss Of Consciousness
67 (.53%)
Drug Abuser
66 (.52%)
Respiratory Arrest
65 (.51%)
Vomiting
65 (.51%)
Cardio-respiratory Arrest
63 (.5%)
Hyperhidrosis
63 (.5%)
Confusional State
62 (.49%)
Malaise
62 (.49%)
Anger
61 (.48%)
Hallucination
60 (.47%)
Decreased Appetite
59 (.47%)
Paranoia
58 (.46%)
Tachycardia
56 (.44%)
Suicide Attempt
55 (.43%)
Hypertension
54 (.43%)
Fall
52 (.41%)
Diarrhoea
51 (.4%)
Intentional Drug Misuse
51 (.4%)
Multiple Drug Overdose
51 (.4%)
Pyrexia
48 (.38%)
Attention Deficit/hyperactivity Dis...
47 (.37%)
Anorexia
45 (.36%)
Asthenia
45 (.36%)
Crying
43 (.34%)
Tic
43 (.34%)
Drug Withdrawal Syndrome
42 (.33%)
Dyskinesia
42 (.33%)
Weight Increased
42 (.33%)
Mania
41 (.32%)
Medication Error
41 (.32%)
Mood Swings
40 (.32%)
Pain
40 (.32%)
Delusion
39 (.31%)
Drug Dependence
39 (.31%)
Incorrect Dose Administered
39 (.31%)
Thinking Abnormal
39 (.31%)
Abdominal Pain Upper
38 (.3%)
Hypoaesthesia
38 (.3%)
Drug Screen Positive
37 (.29%)
Multiple Drug Overdose Intentional
36 (.28%)
Cardiomegaly
35 (.28%)
Myocardial Infarction
35 (.28%)
Drug Dispensing Error
34 (.27%)
Memory Impairment
34 (.27%)
Off Label Use
34 (.27%)
Therapeutic Response Unexpected Wit...
34 (.27%)
Poisoning
33 (.26%)
Restlessness
33 (.26%)
Grand Mal Convulsion
32 (.25%)
Blood Pressure Decreased
31 (.25%)
Drug Exposure During Pregnancy
31 (.25%)
Intentional Overdose
31 (.25%)
Rhabdomyolysis
31 (.25%)
Paraesthesia
30 (.24%)
Sudden Death
30 (.24%)
Vision Blurred
30 (.24%)
Chest Discomfort
29 (.23%)
Cough
29 (.23%)
Lethargy
29 (.23%)
Mood Altered
29 (.23%)
Rash
29 (.23%)
Amnesia
28 (.22%)
Syncope
28 (.22%)
Abdominal Pain
27 (.21%)
Dry Mouth
27 (.21%)

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

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

Age 1-9 Years

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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 Adderall, 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 Adderall 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 Adderall According to Those Reporting Adverse Events

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

Attention Deficit/hyperactivity Dis...
2128
Product Used For Unknown Indication
320
Drug Use For Unknown Indication
279
Fatigue
129
Depression
81
Narcolepsy
81
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Disturbance In Attention
48
Anxiety
32
Sleep Disorder
28
Bipolar Disorder
20
Drug Abuse
19
Chronic Fatigue Syndrome
19
Suicide Attempt
17
Psychomotor Hyperactivity
15
Asthenia
14
Ill-defined Disorder
12
Somnolence
12
Sleep Apnoea Syndrome
10
Memory Impairment
9
Hypersomnia
9
Multiple Sclerosis
9
Oppositional Defiant Disorder
8
Mental Disorder
8
Obsessive-compulsive Disorder
7
Hypertension
6
Head Injury
6
Energy Increased
6
Major Depression
6
Drug Abuser
6
Abnormal Behaviour
5
Autism
5
Prophylaxis
5
Post-traumatic Stress Disorder
5
Autism Spectrum Disorder
4
Completed Suicide
4
Drug Withdrawal Syndrome
4
Nervous System Disorder
4
Central Nervous System Stimulation
4
Intervertebral Disc Protrusion
3
Appetite Disorder
3
Thinking Abnormal
3
Withdrawal Syndrome
3
Back Pain
3
Fibromyalgia
3
Cerebral Palsy
3
Cataplexy
3
Aspergers Disorder
2
Weight Control
2
Sedation
2
Sluggishness
2
Distractibility
2

Child Safety Precautions


Drug Labels

LabelLabelerEffective
AdderallxrPhysicians Total Care, Inc.25-SEP-12
AdderallBryant Ranch Prepack23-OCT-12
AdderallBryant Ranch Prepack23-OCT-12
AdderallBarr Laboratories Inc.27-NOV-12
AdderallxrShire US Manufacturing Inc.11-JAN-13

Adderall Case Reports

What Adderall 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 Adderall. 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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